Every finding on record at Madison Medical Center

The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 09/27/2021. One condition level deficiency was identified at: - 484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies.

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 review of the Madison Medical Center Emergency Operations Plan (EOP), observation, and interview, the home health agency (HHA) failed to establish an emergency preparedness program to meet the federal, state, and local emergency preparedness program requirements. The emergency preparedness program must include, but not limited to, the following elements: - The HHA must develop and maintain an emergency preparedness plan that must be reviewed and updated at least every two (2) years (E0004); - The HHA plan must include a documented, facility based and community based risk assessment, utilizing an all-hazards approach and include strategies for addressing emergency events identified by the risk assessment (E0006); - The plan must address patient population, including but not limited to, the type of services the HHA has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans (E0007); - The plan must include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain and integrated response during a disaster or emergency situation (E0009); - The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every two (2) years (E0013); the policies and procedures must address the following: - (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency; the HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact (E0021); - (5) The use of volunteers in emergency or other emergency staffing strategies, including the process and role for integrations of State and Federally designated health care professionals to address surge needs during an emergency (E0024); - 484.102 (c) Communication plan: The HHA must develop and maintain a emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated at least every two (2) years and must include the following (E0029): - (1) The names and contact information for staff, entities providing services under arrangement, patients' physicians, and volunteers (E0030); - (2) Contact information for Federal, State, tribal, regional or local emergency preparedness staff, and other sources of assistance (E0031); - (3) Primary and alternate means for communicating with the HHA's staff, Federal, State, tribal, regional, and local emergency management agencies (E0032); - (4) A method for sharing information and medical documentation for patients under the HHA's care, as necessary, with other health care providers to maintain the continuity of care (E0033); and - (5) A means of providing information about the general condition and location of patients under the facility's care permitted under 45 CFR164.510(b)(4), (E0033); - (6) A means of providing information about the HHA's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee (E0034); - 484.102(d) Training and Testing: The HHA 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 must be reviewed and updated at least every two (2) years (E0036); - (1) Training Program: The HHA 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 two (2) years; (iii) Maintain documentation of the training; (iv) Demonstrate staff knowledge of emergency procedures; and (v) If the emergency policies and procedures are significantly updated, the HHA must conduct training on the updated policies and procedures (E0037); - (2) Testing: The HHA must conduct exercises to test the emergency plan at least annually and 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 and annual individual, facility-based functional exercise every two (2) years; or (B) If the HHA experiences and actual 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 on-set of the emergency event; (ii) Conduct an additional exercise every two (2) years, opposite the year the full scale exercise 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 included 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 (E0039); - 484.102 (e) Integrated Healthcare Systems: If an HHA is part of a healthcare system consisting of multiple certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the HHA may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must do all of the following: - (1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program; - (2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered; - (3) Demonstrate that each separately certified facility is capable of actively using the unifies and integrated emergency preparedness program and is in compliance with the program; - (4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a) (2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include all of the following; (i) A documented community-based risk assessment, utilizing an all-hazards approach; (ii) A documented individual facility-base risk assessment for each separately certified facility within the health system, utilizing an all hazards approach; and - (5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively (E0042). The cumulative effect of this deficient practice has the potential to affect the quality of care and safety of all agency patients.

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 review of the Madison Medical Center Emergency Operations Plan (EOP), observation and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she did not know when the last community wide exercise was held; - He/she was in charge of the emergency preparedness plan; - The hospital has emergency preparedness coordinators, but they do not do anything; and - The hospital did a yearly whole house fire safety in-service on 04/28/2021. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; - The Hazard Vulnerability Analysis for the entire campus is updated yearly on the computer; - The HHA did not have its own emergency preparedness program, they are included in the hospital program; - A tabletop exercise was offered on 03/10/2020 but there were no HHA staff in attendance; - Attendance to the exercise was voluntary; - He/she had no attendance record to show proof of attendance for HHA staff and contract personnel; - The hospital was involved in pandemic planning for COVID-19 on 06/09/2020 and a state wide drill for communication in 2021 but he/she did not have an attendance record for the HHA; and - The hospital does conduct yearly whole house education. During an interview on 09/22/2021 at 12:15 PM and 2:45 PM, the administrator of home health stated that: - The home health agency (HHA) staff are not included in anything the hospital does; - The HHA does not have an Emergency Preparedness plan; - Emergency preparedness is provided by the hospital for all hospital and HHA staff but the HHA has not participated in a community-based or table top exercise; - He/she did go over COVID-19 information with staff; - HHA staff can hear over the loud speaker if there is a fire drill being performed in the hospital sometimes, but usually the agency staff do not even hear the announcement of the drill and are not involved in the drill; and - The HHA did not do fire drills; there are no fire alarm pulls in the agency, only a fire extinguisher was available. Observation on 09/22/2021 at 2:45 PM showed: - The hospital announced over the loud speaker that the hospital fire drill was completed while the surveyor was in the HHA; - The surveyor and the administrator did not hear the first announcement that a fire drill was called; and - The hospital did not call or notify the administrator of the fire drill.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on review of the Madison Medical Center Emergency Operations Plan (EOP), observation and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements that is based on and includes a documented facility-based and community-based risk assessment, utilizing an all hazards approach and includes strategies for addressing emergency events identified by the risk assessment. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she did not know when the last community wide exercise was held; - He/she was in charge of the emergency preparedness plan; - The hospital has emergency preparedness coordinators, but they do not do anything; and - The hospital did a yearly whole house fire safety in-service on 04/28/2021. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; - The Hazard Vulnerability Analysis for the entire campus is updated yearly on the computer; - The HHA did not have its own emergency preparedness program, they are included in the hospital program; - A tabletop exercise was offered on 03/10/2020 but there were no HHA staff in attendance; - Attendance to the exercise was voluntary; - He/she had no attendance record to show proof of attendance for HHA staff and contract personnel; - The hospital was involved in pandemic planning for COVID-19 on 06/09/2020 and a state wide drill for communication in 2021 but he/she did not have an attendance record for the HHA; and - The hospital does conduct yearly whole house education. During an interview on 09/22/2021 at 12:15 PM and 2:45 PM, the administrator of home health stated that: - The home health agency (HHA) staff are not included in anything the hospital does; - The HHA does not have an Emergency Preparedness plan; and - Emergency preparedness is provided by the hospital for all hospital and HHA staff but the HHA has not participated in a community-based or table top exercise.

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), §485.625(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 review of the Madison Medical Center Emergency Operations Plan (EOP), observation and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements that addressed the patient population including but not limited to the types of services the home health agency has the ability to provide in an emergency and continuity of operations, including delegations of authority and succession plans. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; - The hospital has emergency preparedness coordinators, but they do not do anything; and - The hospital did a yearly whole house fire safety in-service on 04/28/2021. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; - The Hazard Vulnerability Analysis for the entire campus is updated yearly on the computer; - The HHA did not have its own emergency preparedness program, they are included in the hospital program; - A tabletop exercise was offered on 03/10/2020 but there were no HHA staff in attendance; - Attendance to the exercise was voluntary; - He/she had no attendance record to show proof of attendance for HHA staff and contract personnel; - The hospital was involved in pandemic planning for COVID-19 on 06/09/2020 and a state wide drill for communication in 2021 but he/she did not have an attendance record for the HHA; and - The hospital does conduct yearly whole house education. During an interview on 09/22/2021 at 12:15 PM and 2:45 PM, the administrator of home health stated that: - The home health agency (HHA) staff are not included in anything the hospital does; - The HHA does not have an Emergency Preparedness plan; and - Emergency preparedness is provided by the hospital for all hospital and HHA staff but the HHA has not participated in a community-based or table top exercise.

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency. This STANDARD is not met as evidenced by: Based on review of the Madison Medical Center Emergency Operations Plan (EOP), observation and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements to include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials to maintain an integrated response during a disaster or emergency situation. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; - The hospital has emergency preparedness coordinators, but they do not do anything; and - The hospital did a yearly whole house fire safety in-service on 04/28/2021. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments;and - The Hazard Vulnerability Analysis for the entire campus is updated yearly on the computer; - The HHA did not have its own emergency preparedness program, they are included in the hospital program; During an interview on 09/22/2021 at 12:15 PM and 2:45 PM, the administrator of home health stated that: - The home health agency (HHA) staff are not included in anything the hospital does; - The HHA does not have an Emergency Preparedness plan; and - Emergency preparedness is provided by the hospital for all hospital and HHA staff but the HHA has not participated in a community-based or table top exercise.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on observation and interview, the agency failed to comply with all federal, state, and local emergency preparedness (EP) requirements when the agency failed to establish and maintain a program that developed and implemented emergency preparedness policies and procedures based on risk assessment and a communication plan. This deficient practice has the potential to affect the health, safety, and well-being of all patients and staff of the agency. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she did not know when the last community wide exercise was held; - He/she was in charge of the emergency preparedness plan; and - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; - The Hazard Vulnerability Analysis for the entire campus is updated yearly on the computer; - The HHA did not have its own emergency preparedness program, they are included in the hospital program; - Attendance to the exercise was voluntary; and - He/she had no attendance record to show proof of attendance for HHA staff and contract personnel. During an interview on 09/22/2021 at 12:15 PM and 2:45 PM, the administrator of home health stated that: - The home health agency (HHA) staff are not included in anything the hospital does; - The HHA does not have an Emergency Preparedness plan; and - Emergency preparedness is provided by the hospital for all hospital and HHA staff but the HHA has not participated in a community-based or table top exercise.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on review of the Madison Medical Center Emergency Operations Plan (EOP), observation and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements and must include procedures to include procedures to follow up with on duty staff and patients to determine services needed if there is an interruption of services. The cumulative effect of this deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; - The HHA did not have its own emergency preparedness program, they are included in the hospital program;

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on review of the Madison Medical Center Emergency Operations Plan (EOP), observation, and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements and includes the plan for use of volunteers in an emergency or other emergency staffing strategies including the process and role for integration of State and Federally designated health care professionals to address surge needs. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; and - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; and - The HHA did not have its own emergency preparedness program, they are included in the hospital program.

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), §485.625(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 observation and interview, the agency failed to comply with all federal, state, and local emergency preparedness requirement when the agency failed to develop, establish, and maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated every two years. This deficient practice has the potential to affect the health, safety, and well being of all patients and staff of the agency. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; and - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; - The Hazard Vulnerability Analysis for the entire campus is updated yearly on the computer; - The HHA did not have its own emergency preparedness program, they are included in the hospital program; - Attendance to the exercise was voluntary; and - He/she had no attendance record to show proof of attendance for HHA staff and contract personnel. During an interview on 09/22/2021 at 12:15 PM and 2:45 PM, the administrator of home health stated that: - The home health agency (HHA) staff are not included in anything the hospital does; - The HHA does not have an Emergency Preparedness plan; and - Emergency preparedness is provided by the hospital for all hospital and HHA staff but the HHA has not participated in a community-based or table top exercise.

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), §485.625(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 review of the Madison Medical Center Emergency Operations Plan (EOP), observation, and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements and must include the names and contact information for staff, entities providing services under arrangement, patients physicians, and volunteers. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; and - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; and - The HHA did not have its own emergency preparedness program, they are included in the hospital program.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(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: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on review of the Madison Medical Center Emergency Operations Plan (EOP), observation and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements and must include contact information for Federal, State, tribal, regional, or local emergency preparedness staff and other sources of assistance. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; and - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; and - The HHA did not have its own emergency preparedness program, they are included in the hospital program.

Primary/Alternate Means for Communication CFR(s): 484.102(c)(3) §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(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: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID's staff, Federal, State, tribal, regional, and local emergency management agencies. This STANDARD is not met as evidenced by: Based on review of the Madison Medical Center Emergency Operations Plan (EOP), observation and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements and must include primary and alternate means for communicating with the agency staff, Federal, State, tribal, regional and local emergency management agencies. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; and - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; and - The HHA did not have its own emergency preparedness program, they are included in the hospital program.

Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(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: (4) A method for sharing information and medical documentation for patients under the [facility's] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility's] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). This STANDARD is not met as evidenced by: Based on review of the Madison Medical Center Emergency Operations Plan (EOP), observation, and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements to include a method for sharing information and medical documentation for patients with other health care providers to maintain continuity of care; and a means of providing information about the general condition and location of patients. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; and - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; and - The HHA did not have its own emergency preparedness program, they are included in the hospital program.

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), §485.625(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 review of the Madison Medical Center Emergency Operations Plan (EOP), observation and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements and must include a means of providing information about the agency's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; and - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; and - The HHA did not have its own emergency preparedness program, they are included in the hospital program.

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 observation, and interview, the agency failed to develop an emergency preparedness training and testing program. This deficient practice has the potential to affect all patients and staff served by the agency. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she did not know when the last community wide exercise was held; - He/she was in charge of the emergency preparedness plan; - The hospital has emergency preparedness coordinators, but they do not do anything; and - The hospital did a yearly whole house fire safety in-service on 04/28/2021. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; - The HHA did not have its own emergency preparedness program, they are included in the hospital program; - A tabletop exercise was offered on 03/10/2020 but there were no HHA staff in attendance; - Attendance to the exercise was voluntary; - He/she had no attendance record to show proof of attendance for HHA staff and contract personnel; - The hospital was involved in pandemic planning for COVID-19 on 06/09/2020 and a state wide drill for communication in 2021 but he/she did not have an attendance record for the HHA or an after action report; and - The hospital does conduct yearly whole house education. During an interview on 09/22/2021 at 12:15 PM and 2:45 PM, the administrator of home health stated that: - The home health agency (HHA) staff are not included in anything the hospital does; - The HHA does not have an Emergency Preparedness plan; - Emergency preparedness is provided by the hospital for all hospital and HHA staff but the HHA has not participated in a community-based or table top exercise; - He/she did go over COVID-19 information with staff; - HHA staff can hear over the loud speaker if there is a fire drill being performed in the hospital sometimes, but usually the agency staff do not even hear the announcement of the drill and are not involved in the drill; and - The HHA did not do fire drills; there are no fire alarm pulls in the agency, only a fire extinguisher was available. Observation on 09/22/2021 at 2:45 PM showed: - The hospital announced over the loud speaker that the hospital fire drill was completed while the surveyor was in the HHA; - The surveyor and the administrator did not hear the first announcement that a fire drill was called; and - The hospital did not call or notify the administrator of the fire drill.

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 employee file review, and interview, the agency failed to ensure/document if staff were provided initial and annual Emergency Preparedness (EP) training, in four (Employee #1, #2, #3, and #4) of five employee files reviewed. This deficient practice has the potential to affect all patients and staff served by the agency. Findings included: Review of the undated (partial copy) Madison Medical Center Emergency Operations Plan showed: - All employees will know and be prepared to fulfill their duties and responsibilities as part of a team effort to provide the best possible emergency care in any situation. Each supervisor at each level of the organization will ensure employees are aware of their responsibilities. Review of the Madison Medical Center Critical Access Hospital Administrator/Director of Home Health job description dated 04/30/18 showed: - Maintains accurate patient and employee records to meet state regulations; and - Responsible for the planning and direction of the in-service education programs for staff. Employee #1 (E1); - Date of hire: 07/2001; - Position: Registered nurse; and - No evidence of E training on orientation or every two years. Employee #2 (E2): - Date of hire: 06/2005; - Position: Licensed practical nurse; and - No evidence of EP training on orientation or every two years. Employee #3 (E3): - Date of hire: 03/03/2009; - Position: Certified nurse assistant; and - No evidence of EP training on orientation or every two years. Employee #4 (E4): - Date of hire: 12/16/2002; - Position: Physical therapist, department head; and - No evidence of EP training on orientation or every two years. During an interview on 09/22/2021 at 12:15 PM, the administer stated that: - He/she did not keep personnel records in the home health agency (HHA) office; - All personnel records are kept in the main hospital and he/she did not have access to those records; - He/she did not do any EP training through the HHA; - He/she did not know if these staff had EP training upon hire or any other time; and - The PT department head and occupational therapist (OT) kept their files at home or at their business and he/she did not have access to those files.

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 review of the Madison Medical Center Emergency Operations Plan (EOP), observation, and interview, the agency failed to establish and maintain an emergency preparedness program that meets federal requirements and must conduct exercises to test the emergency plan at least annually and must participate in a full scale exercise that is community based or an individual facility based functional exercise every two years; conduct an additional exercise every two years, opposite the year of the full scale or functional exercise; and analyze the agency's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the emergency plan as needed. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; - The Hazard Vulnerability Analysis for the entire campus is updated yearly on the computer; - The HHA did not have its own emergency preparedness program, they are included in the hospital program; - A tabletop exercise was offered on 03/10/2020 but there were no HHA staff in attendance; - Attendance to the exercise was voluntary; - He/she had no attendance record to show proof of attendance for HHA staff and contract personnel; - The hospital was involved in pandemic planning for COVID-19 on 06/09/2020 and a state wide drill for communication in 2021 but he/she did not have an attendance record for the HHA; and - The hospital does conduct yearly whole house education. During an interview on 09/22/2021 at 12:15 PM and 2:45 PM, the administrator of home health stated that: - The home health agency (HHA) staff are not included in anything the hospital does; - The HHA does not have an Emergency Preparedness plan; - Emergency preparedness is provided by the hospital for all hospital and HHA staff but the HHA has not participated in a community-based or table top exercise; - He/she did go over COVID-19 information with staff; - HHA staff can hear over the loud speaker if there is a fire drill being performed in the hospital sometimes, but usually the agency staff do not even hear the announcement of the drill and are not involved in the drill; and - The HHA did not do fire drills; there are no fire alarm pulls in the agency, only a fire extinguisher was available. Observation on 09/22/2021 at 2:45 PM showed: - The hospital announced over the loud speaker that the hospital fire drill was completed while the surveyor was in the HHA; - The surveyor and the administrator did not hear the first announcement that a fire drill was called; and - The hospital did not call or notify the administrator of the fire drill.

Integrated EP Program CFR(s): 484.102(e) §416.54(e), §418.113(e), §441.184(e), §460.84(e), §482.15(f), §483.73(f), §483.475(e), §484.102(e), §485.68(e), §485.625(f), §485.727(e), §485.920(e), §486.360(f), §491.12(e), §494.62(e). (e) [or (f)]Integrated healthcare systems. If a [facility] is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the [facility] may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must- [do all of the following:] (1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program. (2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered. (3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance [with the program]. (4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following: (i) A documented community-based risk assessment, utilizing an all-hazards approach. (ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach. (5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan, and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively. This STANDARD is not met as evidenced by: Based on review of the Madison Medical Center Emergency Operations Plan (EOP), observation, and interview, the agency who presented on survey, an emergency preparedness program that was part of the hospital healthcare system, failed to assure this plan is an integrated emergency preparedness program as outlined in this regulation. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Observation on 09/21/2021 at 11:30 AM showed: - The hospital chief executive officer (CEO) provided the Madison Medical Center Emergency Preparedness Manual; and - The manual showed policies and procedures for the EP plan for the hospital but not for the home health agency. During an interview on 09/21/2021 at 11:30 AM, the CEO of the hospital stated that: - The hospital staff goes over the emergency plan when a person was hired; - If staff had any questions they were to call the outpatient coordinator/orientation nurse; - Emergency preparedness people talk with department heads only; staff are not included; - He/she was in charge of the emergency preparedness plan; and - The hospital has emergency preparedness coordinators, but they do not do anything. During an interview on 09/22/2021 at 11:00 AM, the CEO state that: - The hospital emergency preparedness plan includes all departments; and - The HHA did not have its own emergency preparedness program, they are included in the hospital program.

An extended survey for Medicare certification for Madison Medical Center Home Health Agency was completed on 09/28/2021. The agency had 20 current patients. One condition-level deficiency was identified at an immediate jeopardy (IJ) level as follows: - 484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care. An immediate jeopardy (IJ) level citation related to the likelihood of serious harm for one current patient (Patient #2) and potential for future harm to all other patients was identified during the survey. The findings were confirmed as immediate jeopardy by the Centers for Medicare and Medicaid Services (CMS) Regional Office (RO) on 09/23/2021. On 09/23/2021 at 11:35 AM, the administrator (also the director of home health and clinical manager) was informed verbally and in writing, via the IJ Template, of the findings identified at an immediate jeopardy level. A formal written removal plan was submitted by the agency prior to exit. The removal plan was reviewed by the state agency and CMS RO and it was determined, at the time of the survey exit on 09/28/2021, that a satisfactory removal plan had been initiated related to the immediate jeopardy findings. The condition level citation identified above remains cited. Four additional condition level deficiencies were identified during the survey: - 484.50 Condition of Participation: Patient Rights; - 484.65 Condition of Participation: Quality Assessment and Performance Improvement (QAPI); - 484.75 Condition of Participation: Skilled Professional Services; and - 484.105 Condition of Participation: Organization and Administration of Services. The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 09/28/2021 and a condition level deficiency was identified as follows: - 484.102 Condition of Participation: Emergency Preparedness. A COVID-19 Focused Infection Control survey was completed on 09/28/2021 as part of the Medicare certification survey and one condition level deficiency was identified as follows: - 484.70 Condition of Participation: Infection Prevention and Control. A home health agency that is found out of compliance with any Condition of Participation evaluated as part of a standard survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at 484.80(f)(3) - see Tag G788.

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 review of current patient rights information, clinical record review, observation, and interview, the agency failed to develop and provide the patient and/or representative with a written notice of patient rights that included all required information. The agency failed to provide in writing, in advance of furnishing care, the following information: - The home health agency (HHA) must provide the patient and the patient's legal representative (if any), the notice of patient rights during the initial evaluation visit, in advance of furnishing care to the patient (G410); - Written notice of patient's rights and responsibilities under this rule, and the agency transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities (G412); - The patient has the right to participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriated, with respect to: * The completion of all assessments; and * The care to be furnished, based on the comprehensive assessment (G434); - The patient has the right to be advised orally and in writing of; the extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other Federally funded or Federal aid program known to the HHA, and any changes in the financial information provided in accordance with paragraph (c)(7) of this section when they occur, the agency must advise the patient and representative of these changes as soon as possible, in advance of the next home health visit, the agency must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f) (G440); - The patient has the right to be advised of the state toll free home health telephone hotline, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs (G444); and - Be advised of the names, addresses, and telephone numbers of the federally-funded and state-funded entities that serve the area where the patient resides that include: the Quality Improvement Organization of Livanta LLC (446). The cumulative effect of these deficient practices resulted in the agency's inability to ensure that all patients and/or representatives were informed of their rights and responsibilities.

Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to update the written notice of patient rights to include that the agency must provide the patient/representative, the notice of rights during the initial evaluation visit, in advance of furnishing care to the patient. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The agency administrator provided an admission packet for review on 09/20/2021. The agency notice of patient rights and other information given to a patient during the initial visit contained written information that showed a verbal notice of these rights and responsibilities will be given by the second skilled professional visit and written notice of these rights will be given within 4 business days of the initial visit. The findings were reviewed with the administrator on 09/20/2021 at 4:50 PM. He/she thought the patient rights were current. No additional information was provided.

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to update the written notice of patient rights to include: - Rights and responsibilities that are understandable to persons who have limited English proficiency; and - Rights and responsibilities accessible to individuals with disabilities. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The agency administrator provided an admission packet for review on 09/20/2021. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities. The findings were reviewed with the administrator on 09/20/2021 at 4:50 PM. He/she thought the patient rights were current. No additional information was provided.

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 review of the agency's current patient rights information, and interview, the agency failed to update the written notice of patient rights to include the patient has the right to participate in, be informed about, and consent to or refuse care, in advance of and during treatment, where appropriate with respect to completion of all assessments and any changes in the care to be furnished. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The administrator provided an admission packet for review on 09/20/2021. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding the patient's right to participate in, be informed about, and consent to or refuse care, in advance of and during treatment with respect to completion of all assessments and any changes in care to be furnished. The findings were reviewed with the administrator on 09/20/2021 at 4:50 PM. He/she thought the patient rights were current. No additional information was provided.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information, and interview, the agency failed to update the written notice of patient rights to be advised, orally and writing, of financial liability changes as soon as possible, in advance of the next home health visit of charges for services that may not be covered by Medicare, Medicaid, or any other Federally-funded or Federal aid program known to the home health agency, and the charges the individual may have to pay before care is initiated.. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The administrator provided an admission packet for review on 09/20/2021. The agency notice of patient rights and other information given to a patient during the initial visit contained no written information regarding the patient's right to be advised, orally and writing, of financial liability changes as soon as possible, in advance of the next home health visit of charges for services that may not be covered by Medicare, Medicaid, or any other Federally-funded or Federal aid program known to the home health agency, and the charges the individual may have to pay before care is initiated. The findings were reviewed with the administrator on 09/20/2021 at 4:50 PM. He/she thought the patient rights were current. No additional information was provided.

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information, admission packet review, and interview, the agency failed to ensure staff provided the written notice of patient rights to include that the Missouri state toll free home health telephone hotline was available seven days a week. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities for all patients/representatives served by the agency. Findings included: The administrator provided an admission packet for review on 09/20/2021. The agency notice of patient rights and other information given to a patient during the initial visit failed to include the Missouri state toll free home health telephone hotline was available seven days a week. The findings were reviewed with the administrator on 09/20/2021 at 4:50 PM. He/she thought the patient rights were current. No additional information was provided.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on policy review, review of the agency's current patient rights information, and interview, the agency failed to update the written notice of patient rights to include that the patient and representative (if any) be advised of the name, addresses, and telephone number of the following Federally funded and state funded entities that serve the area where the patient resides to include the current Quality Improvement Organization. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: The administrator provided an admission packet for review on 09/20/2021. The agency notice of patient rights and other information given to a patient during the initial visit showed the Quality Improvement Organization was Primaris. The findings were reviewed with the administrator on 09/20/2021 at 4:50 PM. He/she was not aware the Quality Improvement Organization was Livanta LLC. No additional information was provided.

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 policy review, record review, home visit observation, and interviews, the agency failed to ensure the patient's medications were reconciled during the start of care comprehensive assessment and that the medication profile was updated with medication changes in, two (Records/Patients #2 and #3) of five full records reviewed. This deficient practice has the potential to adversely affect the accuracy and safety of medication administration for all the agency's patients. Findings included: Review of the agency's undated policy titled, "Drug Regimen Review," showed, in part, the following: - The comprehensive assessment must include a review of all medications the patient is currently using, including all prescribed and over-the-counter medications, in order to identify any potential adverse effects and drug reactions, including: * Ineffective drug therapy; * Significant side effects; * Duplicate drug therapy; * Noncompliance with drug therapy; - Medication list/profile will be up-dated with each visit and medication review and instructions are given until the patient comprehends all medications as listed above; and - The physician will be notified promptly regarding any medication discrepancies, side effects, problems or reactions. RECORD/PATIENT #2: Review of the current Medication Profile dated on 07/21/2021 showed: - Lorsartan potassium (used to treat high blood pressure) 25 mg (milligrams) oral tab 50 mg every day; and - Tylenol (used to treat minor aches and pains, and reduces fever) 325 mg oral tablet 1000 mg twice a day. During an observation and interview during the home visit on 09/21/21 at 1:09 PM, showed the following: - Physical therapist (PT) department head said they ask the patient each visit if there have been any changes to their medications and do not pull medication bottles each visit to reconcile the patient's medication; - PT department head did not look at the patient's medications and asked the patient if he/she had any recent changes in his/her medications and the patient said "no"; - The patient had a tube of diclofenac sodium topical gel (pain gel) 1% on his/her table by the couch; - The patient said he/she rubs the gel on his/her knees and shoulders when his/her pain is a 5/10 (zero representing no pain and 10 representing the worst pain) (The medication was not on the medication list); - The patient's prescription medication bottle showed Losartan 50 mg by mouth daily (the medication list showed 25 mg oral tablet 50 mg everyday); and - The over the counter Tylenol bottle showed 500 mg tablets (the medication list showed 325 mg oral tab 1000 mg twice a day); and - The patient said he/she does not take pain medication for pain, he/she just used the diclofenac sodium topical gel. During an interview on 09/22/2021 at 12:00 PM, the administrator said therapy reconciles the patient's medications. No additional information was provided. RECORD/PATIENT #3: Review of the plan of care dated 09/17/2021 through 11/15/2021 showed: - No documentation of Miralax (for constipation) 17 grams, bottle cap filled to line in cap, daily. Review of Madison Medical Center Home Health Medication List dated 09/17/2021 showed: - Staff failed to document Miralax on the medication sheet left in the patient's home. During a home visit on 09/21/2021 at 10:00 AM, the caregiver showed the surveyor the bottle of Miralax and stated that the patient took the Miralax a long time. During a home visit on 09/21/2021 at 10:00 AM, registered nurse (RN) C stated that he/she did not know the patient took Miralax daily.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on policy review, clinical record review, observation, and interview, the agency failed to: - Provide an individualized plan of care (POC) that included all the required components(G574); - Ensure drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner (G580); - Ensure the home health agency (HHA) staff promptly alerted the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggested outcomes are not being achieved and/or that the POC should be altered (G590); - Ensure staff updated/revised the plan of care (G592); - Ensure staff coordinate care delivery to meet the patient's needs. and involve the patient, representative (if and), and caregiver(s), as appropriate in the coordination of care activities (G608); - Ensure staff provided the patient and/or caregiver a copy of written instructions outlining the visit schedule, including frequency of visits by agency personnel (G614); - Ensure the patient/caregiver received written instructions regarding treatments/wound care (G618); and - Provide in writing the name and contact number of the clinical manager (G622). The cumulative effect of these deficient practices has the potential to affect the provision of safe care for all patients served by the agency.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on policy review, review of job description, clinical record review, observation, and interview, the agency failed to ensure that each patient's written individualized plan of care (POC) included all required elements in two (Record/Patient #1 and #2) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the "Madison Medical Center Policy" titled, "Change in Patient Condition," revised 01/22/2021 showed, in part, depending on the process the licensed nurse will begin the nursing process (assess/establish a nursing diagnosis/plan/implement/evaluate). The licensed nurse may advise the staff regarding observable data needed, suggest an immediate action, and/or recommend a plan of care. The agency did not provide a job description for the Occupational Therapist (OT). Review of the agency's undated Physical Therapist (PT) job description, showed in part the physical therapist collaborates with other personnel in developing and implementing a physical therapy care plan. RECORD/PATIENT #1: Review of the comprehensive start of care assessment, dated 08/20/2021, showed, in part: - Fall with fracture; - History of two or more falls within the last 12 months; - Patient has moderate pain with non-verbal grimacing, the patient rates pain 2/10 (zero representing no pain and 10 representing the worst pain); - Plan for fall risk: Clear pathways and leave light on at night; - Risk factors for hospital admission/emergency room is, increased pain and fall risk; and - Assessment findings problems/issues; pain, fall risk, and safety issues. Review of the patient's plan of care dated 08/20/2021 to 10/18/2021, showed, in part: - Diagnoses included, but not limited to: Alzheimer's disease, upper fracture of upper end of left humerus (arm bone between your shoulder and your elbow), and pain in the left arm; - Patient complains of left arm pain and verbalizes pain controlled at acceptable level by 10/17/2021; - History of falls; and - Teach home safety/falls prevention. The plan of care failed to include pain parameters, patient specific interventions for pain control and patient specific safety precautions to protect against injury. During an interview on 09/21/2021 at 9:04 AM OT E stated: - The patient had a fall and fractured wrist; - The patient has significant dementia; - The patient's right hand was swollen but the swelling has gone down (there was no information about the right hand swelling in the plan of care); - He/she does not address pain on the plan of care; - He/she uses a face scale to assess the patient's pain and will put the patient's pain in the plan of care goals if something is an issue; - He/she writes problems and goals on the plan of care and the COTA (certified occupational therapy assistant) figures out the interventions the patient needs to meet their goals and and the OT will provide the COTA some guidance. RECORD/PATIENT #2: Review of the comprehensive start of care assessment dated 05/27/2021 showed the following: - History of two or more falls, pain less than daily, and at risk for falls; - The patient reported the level of pain that was tolerable was 2/10; - The location of the pain was general and the worst his/her pain gets is 2/10; and - Assessment findings problems/issues were; pain, integumentary status, and fall risk and safety issues. Review of the POC dated 05/27/2021 to 07/26/2021, showed, in part: - The patient was admitted to home health services on 05/27/2021; - Diagnoses included: Urinary tract infection, altered mental status, other malaise (general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify), and unspecified abnormalities of gait and mobility; - Short-stay acute hospital with diagnosis of status/fall; - Fall precautions and patient/caregiver knowledgeable of physician notification as needed; - The plan of care failed to show patient specific safety precautions to protect against injury; - The patient complains of chronic aching pain most of the time and will verbalize pain controlled at acceptable level by 09/23/2021; and - Verbalizes pain controlled at acceptable level and patient/caregiver knowledgeable about when to notify physician. - The plan of care failed to include pain parameters, patient specific interventions for pain control, and patient specific safety precautions to protect against injury. During an interview on 09/21/2021 at 1:09 PM, PT department head stated pain and specific fall interventions were not addressed in the plan of care. During an interview on 09/22/2021 at 12:00 PM, the administrator stated the following: - Registered nurse (RN) C does the plan of care and the care plans are "pretty much canned"; - He/she does not follow therapy at all and does not check their plan of care; and - He/she reviews therapy's notes but does not compare them to the plan of care. During an interview on 09/23/2021 at 9:00 A.M., the administrator stated the following: - He/she completes the plans of care and sends to the physician for signature; and - He/she gives a copy of the POC to therapy.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on clinical record review, and interview, the agency failed to ensure staff obtained physician orders and obtained the physician signed plan of care (POC) for orders and treatments and verbal or telephone orders in a timely manner which affected two (Record/Patient #1 and #4) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: The agency did not have a policy that pertained to signing of physician's orders or signing of POCs in a timely fashion. RECORD/PATIENT #1: Review of the POC dated 05/27/2021 to 07/26/2021, showed, in part: - The patient was admitted to home health services on 05/27/2021; - Diagnoses included: Urinary tract infection, altered mental status, other malaise (general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify), and unspecified abnormalities of gait and mobility; and - Short-stay acute hospital with diagnosis of urinary tract infection, dehydration, status/fall, and mental status changes. During a home visit observation on 09/21/2021 at 9:50 AM with occupational therapist (OT) E showed the following: - The patient's left arm was swollen; - OT said the patient's left hand was "pretty swollen"; - OT wrapped the patient's left hand with Coban (compression bandage) to help with swelling; - OT said this is used the same as edema massage to push the edema up; and - The OT taught the patient how to massage the swelling in his/her fingers back toward the heart. There were no physician orders for edema massage and the use of Coban wrap. RECORD/PATIENT #4: Review of the POC dated 08/13/2021 through 10/11/2021 showed: - The clinical manager signed the POC on 08/13/2021; and - The POC was signed and dated by the physician on 09/03/2021, 21 days after the start of care for the patient. Review of a Physician Plan of Treatment Interim Change order dated 08/13/2021 showed: - Home health physical therapy for lower extremity range of motion/strengthening, balance activities, gait/transfer training and HEP (home exercise program) instruction; 1 x wk x 1 wk (one time per week for one week) and 2 x w for 30 days; - Signed by the doctor of physical therapy (DPT) on 08/13/2021; and - Signed by the patient's physician on 09/03/2021, 21 days after PT treatment began. Review of a Physician Plan of Treatment Interim Change order dated 09/09/2021 showed: - Home health PT for lower extremity range of strengthening, balance activities, gait/transfer training and HEP instruction; 2 x wk x 30 days; and - No signature of staff writing the order and no physician signature as of 09/23/2021. During an interview on 09/22/2021 at 12:15 PM, the administrator stated that: - Home health staff take orders and POCs over daily for physicians to sign; - The patient's physician said he/she would sign when he/she had time; and - Staff check frequently with the physician to see if the orders were signed.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on policy review, review of job description, record review, observation, and interview, the agency failed to promptly alert the physician to changes in the patient's condition that may suggest a need to alter the plan of care (POC) in two (Records/Patients #2 and #5) of five records reviewed. The home health agency failed to notify the physician when one patient (Record/Patient #2), had 8 falls with 4 of the falls resulting in injury and/or pain. The findings in Record #2 and the observations on the home visit resulted in an immediate jeopardy finding. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the "Madison Medical Center Policy" titled, "Change in Patient Condition," revised 01/22/021 showed, in part: - When a change of condition or change from baseline is observed and reported, the community licensed nurse is responsible to evaluate the resident's condition. Examples of a condition change are as follows, but not limited to: * Abnormal change in vital signs; * Skin breakdown, open areas, rashes, and indication of bleeding; * Nausea and vomiting (one episode would constitute a change); * Signs and symptoms of an acute infection; * Falls; * New or increasing pain; - Staff will notify the facility nurse of any change in condition either short term change of condition or significant change in condition; - The licensed nurse, will evaluate the change in condition. Depending upon the circumstances the licensed nurse will begin the nursing process (assess/establish a nursing diagnosis/plan/implement/evaluate); and - The licensed nurse may advise the staff regarding observable data needed, suggest an immediate action, and/or recommend a plan of care. Review of the agency's undated physical therapy (PT) job description showed: - Physical Therapist: Responsible to the administrator; - Responsible for overall direction, supervision, instruction, and evaluation of professional and supportive staff; - Duties to provide leadership and direction for the functioning of the service on behalf of the patients, staff, and health care facility; - Delegate duties to other staff, consistent with their education, experience, and ability; - Give direct patient care including evaluation and treatment planning, reporting, and interpreting the results of the same; and - Collaborate with other personnel in developing and implementing the physical therapy care plan. Review of the agency's undated physical therapy assistant (PTA) job description showed: - Responsible to administrator and chief physical therapist; - Works within the physical therapy service administered by a registered physical therapist, under the direct supervision of the registered physical therapist he/she is directly responsible to; - Duties and responsibilities, assist the registered physical therapist in carrying out procedures and programs; - Performs routine treatment procedures in accordance with the planned program; - Observes, records, and reports to his/her supervisor conditions, reactions and responses related to his assigned duties; - Reports any pertinent findings to the registered physical therapist; - Helps to maintain appropriate records; and - Communicates with patient's physicians as necessary regarding patient's progress, treatments, etc., in consultation with registered physical therapist. RECORD/PATIENT #2: Review of the start of care assessment dated 05/27/2021 showed history of two or more falls, pain less than daily, and at risk for falls. The patient reported the level of pain that was tolerable was 2/10 (zero representing no pain and 10 representing the worst pain). The location of the pain was general and the worst his/her pain gets is 2/10. Review of the POC dated 05/27/2021 through 07/25/2021, showed, in part: - The patient was admitted to home health services on 05/27/2021; - Diagnoses included: Urinary tract infection, altered mental status, other malaise (general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify), and unspecified abnormalities of gait and mobility; - Short-stay acute hospital with diagnosis of urinary tract infection, dehydration, status/fall, and mental status changes; - 485-15 (safety measures): Fall precautions and patient/caregiver knowledgeable of physician notification as needed; - 485-21 (orders for discipline and treatments): PT to evaluate and teach home safety/falls prevention; and - 485-22 (goals/rehabilitation potential/discharge plans): verbalizes pain controlled at acceptable level (there were no parameters) and patient/caregiver knowledgeable about when to notify physician. Review of the medical record showed physical therapy assistant (PTA) A documented the following: - On 06/04/21, the patient reported he/she fell in the living room this morning, he/she tripped over his/her shoes at the end of the couch. He/she was able to get him/herself up from the floor by getting onto his/her knees and using the four wheeled walker and recliner to help him/herself up. He/she rated his/her pain as a 3/10 (tolerable level was 2) and took ibuprofen earlier today after the fall. The patient complains of pain to his/her right lower thigh and upper shin. The PTA held right LAQ (Long Arc Quadriceps) (exercises) and marching due to pain and the patient's pain had increased to 4/10 with weight bearing. (The documentation failed to include notification to the physician); and -On 06/16/21, the patient reported this morning he/she slid off of recliner to the floor, he/she was unable to get up from the floor and required his/her family to assist him/her off of the floor. He/she rated his/her current pain in the knee as a 5/10 at this time. He/she did take Tylenol approximately 30 minutes before the PTA's arrival. He/she sees the doctor tomorrow for continued knee pain. (The documentation failed to include notification to the physician.) Review of the physical therapy recertification note dated 06/23/2021 completed by the Doctor of Physical Therapy (DPT) showed: - The patient's daughter states that on 06/21/2021, the patient was taken to the emergency room due to decreased mental status and weakness; - The patient was under observation for approximately 24 hours before returning home on 06/22/2021; - The patient reported pain in his/her right knee 2/10 and no recent falls; - He/she felt his/her overall mobility continues to be limited due to weakness, however, states he/she is improving; - The patient has been consistent and compliant with PT and continues to make slow but steady progress toward all rehab goals; - His/her overall level of function continues to be decreased and also presents with an increased risk for falls primarily due to weakness, decreased balance, and decreased endurance; - Patient demonstrates safety awareness; and - The physician signed the note. (The DPT failed to include documentation related to the falls and pain on 06/04/21 and 06/16/2021.) Review of the medical record showed PTA A documented the following: - On 07/07/21, the patient reported that on 07/06/2021 he/she fell out of his/her recliner while trying to reach for his/her walker, there were no bumps, bruises or lacerations and minimal pain. (The documentation failed to include notification to the physician); - On 07/12/21, the patient reported he/she fell in the bathroom on 07/11/2021 while flushing the toilet. The patient fell into the cabinets and slid down. A family member had to help him/her up from the floor after the incident. The patient performed 10 repetitions of majority of exercises and during SL (single leg) stance (test used to assess static postural and balance control) activities such as hip abduction and extension the patient only completed 5 repetitions (per PT flow sheet the patient usually completed 10 repetitions). There was a bruise to the back of the right upper arm. (The documentation failed to include notification to the physician); - On 07/14/2021, the patient reported he/she fell last night, 07/13/2021, the patient stood up and lost his/her balance. (The documentation failed to include notification to the physician); and -On 07/19/2021, the patient said he/she was sore today and had pain 3/10 particularly the right knee. The patient said he/she fell on 07/16/2021 while exiting the bathroom and he/she lost his/her balance in the "posterior (behind) direction". The patient had several falls within the last couple of weeks and remains at a high risk for falls at this time. (The documentation failed to include notification to the physician.) Review of the OASIS (Outcome and Assessment Information Set) Physical Therapy Recertification/Follow-Up Assessment completed by the DPT, dated 07/21/2021 showed the following: - Diagnoses included: Urinary tract infection, dehydration, mental status changes, weakness, gait (pattern of walking) debility (physical weakness), and PT; - Had several falls since last OASIS due to decreased balance and weakness, no major injuries; - At risk for falls; - Recertification note: The patient is currently being seen by PT secondary to urinary tract infection and dehydration resulting in weakness and debility; - The patient has no complaints of pain; - The patient reports no falls since last PT visit, however, over the last few weeks he/she had multiple falls; - He/she stated he/she loses his/her balance and the patient states that falls are typically from being dizzy when he/she gets up from a seated position or posteriorly and is unable to regain his/her balance; - He/she reports no serious injuries from his/her falls; - Patient continues to present with lower extremity weakness, decreased balance, decreased endurance and poor safety awareness all of which significantly limits patient ability to independently and safely perform functional activities within his/her home and places this patient at significant increased risk for falls; - The physician signed the recertification note; and - The DPT failed to document when the falls occurred, the bruise to the back of the right upper arm, and patient's pain levels. Review of the medical record showed PTA A documented the following: - On 07/26/2021, the patient stated he/she is not feeling well, he/she has been nauseated over the last couple of days and no complaints of pain. (The documentation failed to include notification to the physician); - On 08/11/2021, the patient was sitting on the floor upon the PTA's arrival. The patient was attempting to unlock the door and got his/her feet tangled up with the dog causing him/her to fall on the floor. The patient had a marble size knot on the back of his/her head where his/her head connected with the transition strip for the living room into the dining room area. The patient also reported that he/she hit his/her left posterior shoulder when he/she fell. PTA A assisted family members to get the patient up. The patient did not lose consciousness and able to answer questions appropriately. (The documentation failed to include notification to the physician); and - On 08/16/2021, the patient denies pain and the knot on the back of his/her head is starting to get smaller but is still there, he/she reported the day after the fall he/she had some shoulder soreness and utilized his/her topical pain reliever on his/her shoulder over the weekend. (The documentation failed to include notification to the physician.) Review of the physical therapy recertification note dated 08/19/2021 completed by the DPT showed: - The patient is doing fair and progressing well with participation in PT; - He/she continues to notice decreased activity tolerance and decreased balance; - Complains of moderate pain throughout both knees and reports no new falls since last PT visit; - Steady progress continues to be made toward all rehabilitation goals; - The patient continues to present with significant decline in his/her overall level of functioning and presents with an increased risks for falls; - The patient continues to present with a number of impairments including decreased strength, decreased balance, and poor safety awareness which will be addressed with home health PT; - The note failed to address the nausea and the fall with injury on 08/11/2021. The physician signed the recertification note. Review of the medical record showed PTA A documented the following: - On 08/24/2021, the patient does report moderate pain (not rated with pain scale) on occasion in his/her knees; - On 08/26/2021, the patient has moderate pain (not rated with pain scale) in bilateral knees; - On 08/30/2021, reports pain in the right knee and rates this pain as moderate (not rated with pain scale) discomfort at times; - On 09/01/2021, the patient woke up this morning with his/her left ear hurting on the inside. PTA A did encourage the patient to let his/her family member know about the earache and to follow up with the primary care physician if this persists. (The documentation failed to include notification to the physician); - On 09/13/2021, the patient fell on 09/10/2021 in his/her bathroom between the bed and chest of drawers, he/she reported bilateral shoulders, bilateral knees and left wrist area with 5/10 pain. No use of Tylenol or other as needed pain medications. (The documentation failed to include notification to the physician); and - On 09/15/2021, the patient continued to report soreness in his/her knees, shoulders, and wrist rating 5/10 pain from his/her previous fall (09/13/2021). (The documentation failed to include notification to the physician.) During a home visit observation, with the PT department head, on 09/21/21 at 1:10 PM, the following was observed: - The patient said he/she had a fall and sustained a rug burn (occurs when the skin rubs or slides against an abrasive surface like a rug or carpet); - The patient had a large 13 cm x 3 ½ cm rug burn on his/her left outer knee; - There was a Band-Aid covering a 3 cm x 3 ½ cm area of the rug burn; - The patient had a tube of diclofenac sodium topical gel(pain gel) 1% on his/her table by the couch; and - The patient said he/she rubs the gel on his/her knees and shoulders when his/her pain is a 5/10. During an interview during the home visit observation on 09/21/21 at 1:09 PM, the PT department head stated the following: - When a patient falls, an adverse event form is filled out and sent to the administrator and skilled nursing; - The patient had a rug burn from his/her last fall (there was no documentation in the medical record about the rug burn); and - The PTA should have notified the physician if it was a "significant injury". During an interview on 09/21/2021 at 2:16 PM, the administrator stated the following: - He/she was not notified of Patient #2's falls; - He/she had no adverse event reports on Patient #2 for June, July, August and September; - PT would notify the physician of the falls; and - The physician is not notified of a "mild like fall" with no injuries. During an interview on 09/22/2021 at 12:00 PM, the administrator stated the following: - Unless he/she is informed of issues with the patient he/she does not see the patient; - If the patient is falling three times a week he/she will ask PT what they are going to do about the falls; and - He/she does not want to call the physician about the falls because he/she was not there and would rather therapy call first. During an interview on 09/22/2021 at 12:30 PM, PT department head stated the following: - PTA A did not fill out an adverse reaction report or notify the physician of Patient #2's falls; - PTA A called him/her the day after the fall to notify of the patient's fall and rug burn; - He/she did not do anything about it and did not think it was a big deal and thought it was taken care of; - PTA A assesses the patient after the fall and reports to PT, nursing and the physician; and - If there was an injury they may not need nursing and PT could provide basic assessment, vital signs, and wound measurement. PT would establish wound care either by talking to the physician or nursing. During an interview on 09/22/2021 at 1:28 PM, registered nurse (RN) C stated the following: - Nursing does a case conference with therapy every two weeks and discusses all patients; - He/she was not notified of Patient #2's falls and normally falls are discussed; and - Nursing would call the physician to get orders for skilled nursing visits if there was an issue with blood sugars, falls, increased blood pressure, and etcetera. During an interview on 09/23/21 at 8:47 AM, the PT department head stated the following: - The patient's rug burn was from the fall in his/her bedroom; - PTA A reported the fall and the PT did not report the fall to the physician because it did not result in a "major" injury; and - PT department head did not notify the physician of the patient's fall and rug burn since the home visit with the surveyor on 09/21/2021. During telephone interview on 09/23/2021 at 9:24 AM, PTA A stated the following: - He/she did not notify the physician of the falls because there was not a "major" injury; - He/she believed the patient had a rug burn to his/her left knee after the fall on his/her visit, he/she reported the injury of the knee to the PT department head and PT B, they discussed what was done during treatment, and he/she provided education and could not complete the visit the day of the fall; - Regarding the patient's reported nausea on 07/26/2021, that was standard for the patient at times, unable to recall, but the nausea may have improved with the discontinuation of the medication that made the patient dizzy and the physician was not notified; - The patient's earache may have been from seasonal allergies and PT A spoke to the patient but not his/her supervisor or the patient's family; and - The PT or PTA is responsible to notify the physician if the patient has a change in condition. During an interview on 09/23/2021 at 9:58 AM, PT B said the following: - PTA A relayed all of the patients falls to him/her; - PTA A documents the falls in his/her notes; - The physician is notified if there is a "major" injury or reoccurring falls; and - If a fall happens once in a 30 day period due to getting feet tangled up you do not notify the physician such as the case with patient #2. RECORD/PATIENT #5: Review of the skilled nursing plan of care dated 08/24/2021 through 10/22/2021 showed: - Diagnoses included, but no limited to: Atherosclerotic heart disease (hardening of the arteries), vertigo (a feeling of dizziness that occurs without any accompanying movement), restless leg syndrome, and history of falls; - Plavix (prevents blood clots and stroke) 75 milligrams (mg) daily; - Requip (used to treat Parkinson's disease, neurological disease that cause tremors, and restless leg syndrome), 0.25 mg at bedtime; - Zanaflex (used to treat muscle spasms) 4 mg TID (three times daily); - Ativan (used to treat anxiety) 0.5 mg TID as needed for anxiety; - Antivert (used to treat vertigo) 25 mg ½ tablet BID (two times daily) as needed for dizziness; and - Nitrostat (used for angina/heart pain) 0.4 mg under the tongue (SL), one tablet every five (5) minutes x three doses as needed; - Patient homebound due to weakness/debility, gait debility, restless leg syndrome and history of falls; - Patient goals: Demonstrates ability to follow home exercise program by 10/22/2021; - Rehab potential: Fair; and - Skilled nurse to evaluate. Review of the Comprehensive Adult Nursing Assessment completed by registered nurse (RN) C dated 08/24/2021 at 9:00 AM showed: - Fall risk assessment: Yes, fall risk indicated - A fall risk score of five (5); - Functional limitations: hearing, endurance, ambulation, uses walker; - Fall risk plan: Ambulate with walker, clear pathways, and leave light on at night; - Psychotropic drug use: Yes - Indicated a risk for falls; and - Limitations: Recent fall. Review of the Start of Care Assessment Therapy completed by the PT department head dated 08/24/2021 showed: - Required use of a two handed device (walker) to walk alone on a level surface and/or requires human supervision or assistance to negotiate stairs/steps or uneven surfaces; - Combined balance and gait score 12 of 28; and - No explanation of what the score meant. Review of the Physical Therapy Home Health Evaluation dated 08/24/2021 completed by the PT department head showed: - Lived in an assisted living facility with spouse; - The patient complained of right knee pain and difficulty with getting up/down from recliner and bed; - Increased difficulty with all activities; - Wheeled walker for all ambulation; - Fall as recently as yesterday (08/23/2021) in his/her room, lost balance and fell to ground; - Presents with signs and symptoms consistent with weakness, debility, difficulty walking, and right knee pain; - Fair-good rehab potential; - Continue home health PT 1-2 x per week for 30 days for exercise, transfer training, gait/balance activities, moist heat, and TENS/IFC (electrical stimulation to painful areas for assist with pain relief); and - Signed by the physician on 08/27/2021. Review of a PT Home Health Note documented by PTA A dated 09/13/2021, no time documented, showed: - Pain in knees with pain greater in right knee; - Patient stated it made it very difficult to stand up and down and at times his/her knees felt like they were going to give away; - Patient did not mention any recent falls however when electrical stimulation treatment was applied to bilateral knee, a couple of small abrasions were noted on his/her knee; - His/her spouse reported the patient had a fall but was not sure of the date; - Spoke with the staff at the assisted living facility and they confirmed that on 09/10/2021 the patient fell in his/her room when coming out of the bathroom area; and - PTA A did not document he/she contacted the PT department head, the home health administrator (also the clinical manager), or the physician of the fall. During an interview on 09/22/2021 at 12:30 PM, the PT department head stated that: - He/she nor PTA A completed an incident form for an adverse event, fall, for the patient on 09/13/2021; - PTA A notified him/her of the fall and there were no issues related to the fall; - PTAs assess patients after falls occur, notifies the PT department head, and the PT department head notifies nursing and the physician; and - The home health administrator and physician were not notified.

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 policy review, job description, record review, and interview, the agency failed to ensure the plan of care was revised/updated to address patients' needs for two (Record/Patient #1 and #2) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the "Madison Medical Center Policy" titled, "Change in Patient Condition," revised 01/22/021 showed, in part: - When a change of condition or change from baseline is observed and reported, the community licensed nurse is responsible to evaluate the resident's condition. Examples of a condition change are as follows, but not limited to: * Abnormal change in vital signs; * Skin breakdown, open areas, rashes, and indication of bleeding; * Nausea and vomiting (one episode would constitute a change); * Signs and symptoms of an acute infection; * Falls; * New or increasing pain; - Staff will notify the facility nurse of any change in condition either short term change of condition or significant change in condition; - The licensed nurse, will evaluate the change in condition. Depending upon the circumstances the licensed nurse will begin the nursing process (assess/establish a nursing diagnosis/plan/implement/evaluate); and - The licensed nurse may advise the staff regarding observable data needed, suggest an immediate action, and/or recommend a plan of care. Review of the agency's undated physical therapy (PT) job description showed: - Physical therapist: Responsible to the administrator; - Responsible for overall direction, supervision, instruction, and evaluation of professional and supportive staff; - Duties to provide leadership and direction for the functioning of the service on behalf of the patients, staff, and health care facility; - Delegate duties to other staff, consistent with their education, experience, and ability; - Give direct patient care including evaluation and treatment planning, reporting, and interpreting the results of the same; and - Collaborate with other personnel in developing and implementing the physical therapy care plan. Review of the agency's undated physical therapy assistant (PTA) job description showed: - Responsible to administrator and chief physical therapist; - Works within the physical therapy service administered by a registered physical therapist, under the direct supervision of the registered physical therapist he/she is directly responsible to; - Duties and responsibilities: Assist the registered physical therapist in carrying out procedures and programs; - Performs routine treatment procedures in accordance with the planned program; - Observes, records, and reports to his/her supervisor conditions, reactions and responses related to his assigned duties; - Reports any pertinent findings to the registered physical therapist; - Helps to maintain appropriate records; and - Communicates with patient's physicians as necessary regarding patient's progress, treatments, etc., in consultation with registered physical therapist. RECORD/PATIENT #2 Review of the Plan of Care (POC) dated 05/27/2021 to 07/26/2021, showed, in part: - The patient was admitted to home health services on 05/27/2021; - Diagnoses included: Urinary tract infection, altered mental status, other malaise (general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify), and unspecified abnormalities of gait and mobility; - Short-stay acute hospital with diagnoses of urinary tract infection, dehydration, status/fall, and mental status changes; - Fall precautions and patient/caregiver knowledgeable of physician notification as needed (no patient specific safety precautions to protect against injury documented); - The patient complains of chronic aching pain most of the time and will verbalize pain controlled at acceptable level by 09/23/2021; and - Verbalizes pain controlled at acceptable level and patient/caregiver knowledgeable about when to notify physician (no parameters for pain and no patient specific interventions for pain control). Review of the medical record showed PTA A documented the following: - On 06/4/21, the patient reported he/she fell in the living room this morning, he/she tripped over his/her shoes at the end of the couch. He/she was able to get him/herself up from the floor by getting onto his/her knees and using the four wheeled walker and recliner to help him/herself up. He/she rated his/her pain as a 3/10 and took ibuprofen earlier today after the fall. The patient complains of pain to his/her right lower thigh and upper shin. The PTA held right LAQ (Long Arc Quadriceps) (exercises) and marching due to pain and the patient's pain had increased to 4/10 with weight bearing; -On 06/16/21, the patient reported this morning he/she slid off of recliner to the floor, he/she was unable to get up from the floor and required his/her family to assist him/her off of the floor. He/she rated his/her current pain in the knee as a 5/10 at this time. He/she did take Tylenol approximately 30 minutes before the PTA's arrival. He/she sees the doctor tomorrow for continued knee pain; and - The agency failed to update the plan of care to include the patient's pain and falls. Review of the physical therapy recertification note dated 06/23/2021 completed by the doctor of physical therapy (DPT) showed: - The patient reported pain in his/her right knee 2/10 and no recent falls; and - His/her overall level of function continues to be decreased and also presents with an increased risk for falls primarily due to weakness, decreased balance, and decreased endurance. The agency failed to update the plan to include the patient's pain and patient specific safety precautions to protect against injury Review of the medical record showed PTA A documented the following: - On 07/07/21, the patient reported that on 07/06/2021 he/she fell out of his/her recliner while trying to reach for his/her walker, there were no bumps, bruises or lacerations and minimal pain. He/she did need help getting up from the floor; - On 07/12/21, the patient reported he/she fell in the bathroom on 07/11/2021 while flushing the toilet. The patient fell into the cabinets and slid down. A family member had to help him/her up from the floor after the incident. There was a bruise to the back of the right upper arm; -On 07/14/2021, the patient reported he/she fell last night, 07/13/2021, the patient stood up and lost his/her balance. The patient believes that his/her feet may have gotten tangled up; -On 07/19/2021, the patient said he/she was sore today and had pain 3/10 particularly the right knee. The patient said he/she fell on 07/16/2021 while exiting the bathroom and he/she lost his/her balance in the "posterior direction" (backward direction)The . Family member did assist him/her up from the floor. The patient had several falls within the last couple of weeks and remains at a high risk for falls at this time; and - The agency failed to update the plan of care to address the patient falls and pain. Review of the OASIS (Outcome and Assessment Information Set) Physical Therapy Recertification/Follow-Up Assessment completed by the DPT, dated 07/21/2021 showed the following: - The patient had several falls since the last OASIS due to decreased balance and weakness, no major injuries; - At risk for falls; - The patient has no complaints of pain; - The patient reports no falls since last PT visit, however, over the last few weeks he/she had multiple falls; - He/she stated he/she loses his/her balance and the patient states that falls are typically from being dizzy when he/she gets up from a seated position or posteriorly and is unable to regain his/her balance; - He/she reports no serious injuries from his/her falls; - Patient continues to present with lower extremity weakness, decreased balance, decreased endurance and poor safety awareness all of which significantly limits patient ability to independently and safely perform functional activities within his/her home and places this patient at significant increased risk for falls; - The plan of care was not updated. Review of the POC dated 07/26/2021 to 09/23/2021, showed, in part: - The patient was admitted to home health services on 05/27/2021; - Short-stay acute hospital with diagnoses of urinary tract infection, dehydration, status/fall, and mental status changes; - Fall precautions and patient/caregiver knowledgeable of physician notification as needed (no patient specific safety precautions to protect against injury were documented); - The patient complains of chronic aching pain most of the time and will verbalize pain, controlled at acceptable level by 09/23/2021; and - Verbalizes pain controlled at acceptable level and patient/caregiver knowledgeable about when to notify physician (no parameters for pain and no patient specific interventions for pain control documented). (No changes from previous plan of care). Review of the medical record showed PTA A documented the following: - On 08/11/2021, the patient was sitting on the floor upon the PTA's arrival. The patient was attempting to unlock the door and got his/her feet tangled up with the dog causing him/her to fall on the floor. The patient had a marble size knot on the back of his/her head where his/her head connected with the transition strip for the living room into the dining room area. The patient also reported that he/she hit his/her left posterior shoulder when he/she fell. PTA A assisted family members to get the patient up; - On 08/16/2021, the patient denies pain and the knot on the back of his/her head is starting to get smaller but is still there, he/she reported the day after the fall he/she had some shoulder soreness and utilized his/her topical pain reliever on his/her shoulder over the weekend; - The plan of care failed to be updated to address the patient's fall with injury and pain. Review of the physical therapy recertification note dated 08/19/2021 completed by the DPT showed: - He/she continues to notice decreased activity tolerance and decreased balance; - Complains of moderate pain throughout both knees and reports no new falls since last PT visit; - The patient continues to present with significant decline in her overall level of functioning and presents with an increased risks for falls; - The patient continues to present with a number of impairments including decreased strength, decreased balance, and poor safety awareness which will be addressed with home health PT; and - The plan of care failed to be updated to include the patient's pain and patient specific safety precautions to protect against injury Review of the medical record showed PTA A documented the following: - On 08/24/2021, the patient does report moderate pain (not rated with pain scale) on occasion in his/her knees; - On 08/26/2021, the patient has moderate pain (not rated with pain scale) in bilateral knees; - On 08/30/2021, reports pain in the right knee and rates this pain as moderate (not rated with pain scale) discomfort at times; - On 09/13/2021, the patient fell on 09/10/2021 in his/her bathroom between the bed and chest of drawers, he/she reported bilateral shoulders, bilateral knees and left wrist area with 5/10 pain. No use of Tylenol or other as needed pain medication or treatment; - On 09/15/2021, the patient continued to report soreness in his/her knees, shoulders, and wrist rating 5/10 pain from his/her previous fall (09/13/2021); and - The plan of care failed to be updated to address the patient's fall and pain. During a home visit observation with PT department head on 09/21/21 at 1:10 PM, the following was observed: - The patient said he/she had a fall and sustained a rug burn (occurs when the skin rubs or slides against an abrasive surface like a rug or carpet); - The patient had a large 13 cm x 3 ½ cm rug burn on his/her left outer knee; - A Band-Aid covered a 3 cm x 3 ½ cm area of the rug burn; - The patient had a tube of diclofenac sodium topical gel (pain gel) 1% on his/her table by the couch; - The patient said he/she rubs the gel on his/her knees and shoulders when his/her pain is a 5/10; - The plan failed to be updated to include the pain, rug burn and the diclofenac sodium topical gel. During an interview on 09/21/2021 at 1:09 PM, PT department head stated pain, specific fall interventions and the rug burn was not addressed in the plan of care. During an interview on 09/22/2021 at 12:00 PM, the administrator stated the following: - Registered nurse (RN) C does the plan of care and the care plans are "pretty much canned"; - He/she does not follow therapy at all and does not check their plan of care; and - He/she reviews therapy's notes but does not compare them to the plan of care. RECORD/PATIENT #1: Review of the patient's plan of care dated 08/20/2021 to 10/18/2021, showed, in part: - Diagnoses included, but not limited to Alzheimer's disease, upper fracture of upper end of left humerus (arm bone between your shoulder and your elbow), and pain in the left arm; - Patient complains of left arm pain and verbalizes pain controlled at acceptable level by 10/17/2021 (no parameters for pain and no patient specific interventions for pain control documented); - History of falls; and - Teach home safety/falls prevention (no patient specific safety precautions to protect against injury documented). Review of the PTA note, dated 08/24/2021 showed the patient complains of 4/10 pain (zero representing no pain and 10 representing the worst pain) to the left upper extremity and the patient stated he/she usually took one pain pill at night. There was swelling through entire left upper extremity. The plan of care failed to be updated to include pain of the left extremity and swelling to the patient's left upper extremity. Review of the PTA note, dated 08/26/2021 showed edema massage was performed to patient's left hand down to the wrist and forearm. The patient did have pain when he/she did try to use the left arm for any type of activity and had no complaints of pain at rest. The plan of care failed to be updated to include pain of the left arm; swelling to the patient's left arm and edema massage to help with the swelling. Review of the occupational therapy (OT) daily note electronically dated 09/09/2021, showed the patient had slight pain with limited range of motion and unable to rate. The patient had edema in fingers, wrist, bicep/tricep (muscles of the arm) and left upper extremity. The plan of care failed to be updated to include pain and edema to the patient's left extremity. During a home visit observation on 09/21/2021 at 9:50 AM with occupational therapist (OT) E showed the following: - The patient's left arm was swollen; - OT E said the patient's left hand was "pretty swollen"; - OT E wrapped the patient's left hand with Coban (compression bandage) to help with swelling; - OT E said this is used the same as edema massage to push the edema up; - OT E taught the patient how to massage the swelling in his/her fingers back toward the heart; and - The care plan failed to include pain, edema massage, and they just started using Coban (there were no interim orders for edema massage or the use of Coban). During an interview on 09/22/2021 at 12:00 PM, the administrator stated that if the patient is having a problem, nursing types a generalized 485 (POC) for the physician to sign, which is mostly just wound care. He/she identifies if a patient is having pain and/or falls and therapy adds the interventions. During an interview on 09/23/2021 at 9:00 A.M., the administrator stated the following: - During the new certification period he/she completes the plans of care with updates (he/she does not do the recertification assessment if the patient is receiving therapy only and he/she still fills out the plan of care) and sends the POC to the physician for signature and sends a copy to PT; and - If therapy is the only skilled service, therapy sends their recertification assessment to the physician for signature with their plan of care which is an addition to his/her plan of care.

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 policy review, clinical record review and interview the agency failed to ensure coordination of care delivery to meet the patient's needs in one (Record/Patient #2) of five records reviewed. This deficient practice has the potential to affect the coordination of care and services for all patients on service with the agency. Findings included: Review of the agency's policy titled, "Scope of Service", revised 01/18/2021 showed physical therapy and occupational therapy will evaluate and treat patients with home exercise programs. Nursing staff (registered nurse and licensed practical nurse) will evaluate patients and coordinate care ordered by the physician. Review of the agency's policy titled, "Coordination of Patient Services," revised 01/22/2021 showed, in part: - Coordination of patient services will be managed through the care team process; - To decrease "span" of control and increase the coordination of patient care, care teams were designed to have one supervisor and 4-6 primary nurses and other staff including physical therapy (PT), home health aides (HHA), social worker (SW), speech therapy (ST), and occupational therapy (OT), not to exceed 15 staff members total; - This design facilitates discussion and coordination of patient care; - Each clinical supervisor is responsible for the coordination patient services; - The clinical supervisors are responsible to ensure this policy; - The objectives of the care teams are: * Improve the quality of patient care or maintain a high quality; * Improve and/or maintain communication among staff members; * Evaluate and update patient care on an ongoing basis; * Evaluate the patient's plan of care and update or revise this as necessary; - Report of patient problems will be discussed; and - All clinical staff are required to participate in care conferences with other disciplines involved in each individual case as often as necessary but at least once every month. Review of the job description titled, "Madison Medical Center, A Critical Access Hospital, Director of Home Health/Administrator', "changed" 04/30/2018 (Administrator was hand written on the job description), showed: - Definition and role: This position is responsible for the planning, coordinating, everyday activities, staffing, and delivery of quality home health care and services to the patients in the communities served; - Responsibilities and duties: * Ensures that the patients served receive the highest quality of care; * Monitors the changing needs of the patients and/or family; * Monitors the skills and services if contracted staff; * Supervises the implementation of the physician's plan of care; * Coordinates the total plan of care with the appropriate resources; * Maintains an open line of communication with all staff members; * Maintains accurate patient and employee records to meet state regulations; * Provides staff with current knowledge of clinical changes; * Oversees all daily functions of the home health department and ensures that every effort is made to meet all client's needs; and * Knowledge of Medicare and Medicaid regulations required. RECORD/PATIENT #2: Review of the start of care assessment dated 05/27/2021 showed history of two or more falls, pain less than daily, and at risk for falls. The patient reported the level of pain that was tolerable was 2/10 (zero representing no pain and 10 representing the worst pain). The location of the pain was general and the worst his/her pain gets is 2/10. Review of the POC dated 05/27/2021 through 07/25/2021, showed, in part: - The patient was admitted to home health services on 05/27/2021; - Diagnoses included: Urinary tract infection, altered mental status, other malaise (general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify), and unspecified abnormalities of gait and mobility; - Short-stay acute hospital with diagnosis of urinary tract infection, dehydration, status/fall, and mental status changes; - PT/OT to evaluate and treat with home exercise program; - 485-15 (safety measures): Fall precautions and patient/caregiver knowledgeable of physician notification as needed; - 485-21 (orders for discipline and treatments): PT to evaluate and teach home safety/falls prevention; and - 485-22 (goals/rehabilitation potential/discharge plans): Verbalizes pain controlled at acceptable level (there were no parameters documented) and patient/caregiver knowledgeable about when to notify physician. Review of the physical therapy assistant (PTA) A note dated 06/04/21 showed: - The patient's pain was 3/10 and took ibuprofen earlier today after the fall; - The patient complains of pain to his/her right lower thigh and upper shin; - The PTA held right LAQ (Long Arc Quadriceps) (exercises) and marching due to pain and the patient pain had increased to 4/10 with weight bearing; - No description of the pain; - No assessment for injury from the fall; and - The documentation failed to include coordination of care with the physical therapist, clinical manager and physician (the agency did not identify a case manager). Review of the PTA A note dated 06/16/21 showed: - The patient reported he/she slid off of recliner to the floor; - Current pain in the knee 5/10; - The patient took Tylenol approximately 30 minutes before the PTA's arrival; - He/she sees the doctor tomorrow for continued knee pain. The documentation failed to show PTA A notified the physical therapist, clinical manager or physician of the fall and pain, head to toe assessment for injury from the fall and follow up regarding the increase in the patient's pain; - No assessment for injury from the fall; - No description of the pain; - No follow up regarding the patient's pain; and - The documentation failed to include coordination with the physical therapist, clinical manager and physician. Review of the physical therapy recertification note dated 06/23/2021 completed by the doctor of physical therapy (DPT) showed: - The patient currently being seen by physical therapy secondary to weakness and debility; - The patient's daughter stated that on 06/21/2021, the patient was taken to the emergency room due to decreased mental status and weakness; - The patient reported pain in his/her right knee 2/10 and no recent falls; - Patient demonstrates safety awareness; - The patient is very pleased with the PTA care and the PTA has done a good job following the established plan of care (POC); - The problem list showed one fall since beginning episode of care and continue with same goal; - No documentation regarding the two falls since the start of care; - No documentation regarding the pain from the two falls; - No head to toe assessment for injuries from the falls; - No documentation the PTA's notes were reviewed; and - The documentation failed to include coordination of care with the clinical manager and physical therapy assistant. Review of the PTA A note dated 07/06/21 showed: - The patient reported that on 07/06/2021 he/she fell out of his/her recliner while trying to reach for his/her walker, there were no bumps, bruises or lacerations and minimal pain; and - The documentation failed to include coordination of care with the clinical manager, physical therapist and physician. Review of the PTA A note dated 07/12/21 showed: - The patient reported he/she fell in the bathroom on 07/11/2021 while flushing the toilet. The patient fell into the cabinets and slid down. The patient performed 10 repetitions of majority of exercises and during SL (single leg) stance (test used to assess static postural and balance control) activities such as hip abduction and extension the patient only completed 5 repetitions (per PT flow sheet the patient usually completed 10 repetitions); - There was a bruise to the back of the right upper arm; - The documentation failed to include coordination of care with the clinical manager, physical therapist and physician. Review of the PTA A note dated 07/14/21 showed: - The patient reported he/she fell last night, 07/13/2021, the patient stood up and lost his/her balance; - There was no head to toe assessment for injury from the fall; and - The documentation failed to include coordination with the physical therapist, clinical manager and physician. Review of the PTA A note dated 7/19/21 showed: - The patient said he/she was sore today and had pain 3/10 particularly the right knee; - The patient had a fall on 07/16/2021 while exiting the bathroom and he/she lost his/her balance in the "posterior direction" (backward); - The patient had several falls within the last couple of weeks and remains at a high risk for falls at this time; - There was not a head to toe assessment to show if there was injury from the fall; and - There was no coordination of care with the physical therapist, clinical manager or physician. Review of the OASIS (Outcome and Assessment Information Set) Physical Therapy Recertification/Follow-Up Assessment completed by the DPT, dated 07/21/2021 showed the following: - Had several falls since last OASIS due to decreased balance and weakness, no major injuries; - At risk for falls; - The patient has no complaints of pain (failed to include the pain from the falls); - No documentation related to integumentary status and cardiopulmonary assessment; - Recertification note: The patient is currently being seen by PT secondary to urinary tract infection and dehydration resulting in weakness and debility; - The patient reports no falls since last PT visit, however, over the last few weeks he/she had multiple falls; - He/she stated he/she loses his/her balance and the patient states that falls are typically from being dizzy when he/she gets up from a seated position or posteriorly(backward) and is unable to regain his/her balance (there was no assessment of orthostatic blood pressure (a drop in blood pressure when going from lying down or sitting to the standing position that can cause dizziness and falls); - He/she reports no serious injuries from his/her falls; - The patient is very pleased with the PTA care and the PTA has done a good job following the established plan of care (POC); - No documentation that the PTA's notes were reviewed; - The physician signed the recertification note; and - The documentation failed to include coordination of care with the clinical manager and physical therapy assistant. Review of the PTA A note dated 07/26/21 showed: - The patient stated he/she is not feeling well and has been nauseated over the last couple of days and no complaints of pain; - No further assessment of the patient or reasons for nausea; and - The documentation failed to include coordination of care with the physical therapist, clinical manager and physician. Review of the PTA A note dated 08/11/21 showed: - The patient was sitting on the floor upon the PTA's arrival; - The patient was attempting to unlock the door and got his/her feet tangled up with the dog causing him/her to fall on the floor; - The patient had a marble size knot on the back of his/her head. The patient also reported that he/she hit his/her left posterior (behind) shoulder when he/she fell; - The patient did not lose consciousness and was able to answer questions appropriately; - There was no head to toe assessment to show if any other injury resulted from fall; and - The documentation failed to include coordination of care with the physical therapist, clinical manager or that the physician was notified of the fall with injury. Review of the PTA A note dated 08/16/21 showed: - The patient denies pain and the knot on the back of his/her head is starting to get smaller but is still there; - The day after the fall the patient had some shoulder soreness and utilized his/her topical pain reliever on his/her shoulder over the weekend; - The documentation failed to include coordination of care with the physical therapist, clinical manager and physician. Review of the physical therapy recertification note dated 08/19/2021 completed by the DPT showed: - The patient is doing fair and progressing well with participation in PT; - He/she continues to notice decreased activity tolerance and decreased balance; - Complains of moderate pain throughout both knees and reports no new falls since last PT visit; - Steady progress continues to be made toward all rehabilitation goals; - The patient continues to present with significant decline in her overall level of functioning and presents with an increased risks for falls; - The patient continues to present with a number of impairments including decreased strength, decreased balance, and poor safety awareness which will be addressed with home health PT; - No documentation of the nausea on 07/26/2021; - No documentation or follow-up with the injury to the patient's head on 08/11/2021; - The patient is very pleased with the PTA care and the PTA has done a good job following the established plan of care (POC); - No documentation that the PTA's notes were reviewed; - The physician signed the recertification note signed 08/27/2021; and - The documentation failed to include coordination of care with the clinical manager and physical therapy assistant. Review of the medical record showed the PTA A documented the following: - On 08/24/2021, the patient does report moderate pain on occasion in his/her knees; - On 08/26/2021, the patient has moderate pain in bilateral knees; - On 08/30/2021, reports pain in the right knee and rates this pain as moderate; - There was no rating of the pain and further assessment on what caused the pain, what the patient was doing to relieve the pain, and if it was effective; - On 09/01/2021, the patient woke up this morning with his/her left ear hurting on the inside; - PTA A did encourage the patient to let his/her family member know about the earache and to follow up with the primary care physician if this persists; and - There was no coordination of care regarding the pain and earache with the physical therapist, clinical manager and physician. Review of the PTA A note dated 09/13/2021 showed: - The patient fell on 09/10/2021 in his/her bathroom between the bed and chest of drawers; - He/she reported bilateral shoulders, bilateral knees and left wrist area with 5/10 pain and no use of Tylenol or other as needed pain medications; - No head to toe assessment to show if there was injury from the fall; - No documentation to show what the patient did or used to relieve the pain if not using any pain medications; and - There was no documentation related to coordination of care with the physical therapist, clinical manager and physician. Review of the PTA A note dated 09/15/2021 showed: - The patient continued to report soreness in his/her knees, shoulders, and wrist rating 5/10 pain from his/her previous fall (09/13/2021); - There was no head to toe assessment to show if there was injury from the fall; - No follow up with what the patient was doing for pain and if it was effective; - No coordination of care with the physical therapist, clinical manager and physician. During a home visit observation with the PT department head on 09/21/21 at 1:10 PM, the following was observed: - The patient said he/she had a fall and sustained a rug burn (occurs when the skin rubs or slides against an abrasive surface like a rug or carpet); - The patient had a large 13 cm x 3 ½ cm rug burn on his/her left outer knee; - A Band-Aid covered a 3 cm x 3 ½ cm area of the rug burn; - The patient had a tube of diclofenac sodium (pain gel) topical gel 1% on his/her table by the couch (not on the medication list); - The PT department head did not remove the bandage to assess the skin; and - The patient said he/she rubs the gel on his/her knees and shoulders when his/her pain is 5/10. During an interview during the home visit observation on 09/21/21 at 1:09 PM, the PT department head stated the following: - When a patient falls, an adverse event form is filled out and sent to the administrator and skilled nursing if applicable; - Therapy coordinates care by phone with other disciplines but this is not documented; - The patient had a rug burn from his/her last fall (there was no documentation in the medical record about the rug burn); - The PTA should have notified the physician if it was a "significant injury". During an interview on 09/21/2021 at 2:16 PM, the administrator stated the following: - He/she was not notified of Patient #2's falls; - He/she had no adverse event reports on Patient #2 for June, July, August and September; - PT would notify the physician of the falls; and - The physician is not notified of a "mild like fall" with no injuries. During an interview on 09/22/2021 at 12:00 PM and , the administrator stated the following:: - Unless he/she is informed of issues with the patient he/she does not see the patient; - Registered nurse (RN) C reviews all of the problems and he/she addresses the POC, they do not follow therapy at all and do not check their POC; - The PT department head is responsible for PT patients and the administrator, is the clinical manager, director of nursing and does not have time to coordinate every patient's care; - If the patient is falling three times a week he/she will ask PT what they are going to do about the falls; - He/she does not want to call the physician about the falls because he/she was not there and would rather therapy call first; - He/she does not follow therapy at all and "why would he/she" unless there is a problem; and - Nurses meet weekly and therapy does not attend. During an interview on 09/22/2021 at 12:30 PM, PT department head stated the following: - PTA A did not fill out an adverse reaction report or notify the physician of Patient #2's falls; - PTA A called him/her the day after the fall to notify of the patient's fall and rug burn; - He/she did not do anything about it and did not think it was a big deal and thought it was taken care of; - PTA A assesses the patient after the fall and reports to PT, nursing and the physician; and - If there was an injury they may not need nursing and PT could provide basic assessment, vital signs, and wound measurement. PT would establish wound care either by talking to the physician or nursing. During an interview on 09/22/2021 at 1:28 PM, registered nurse (RN) C stated the following: - Nursing does a case conference with therapy every two weeks and discusses all patients; - He/she was not notified of Patient #2's falls and normally falls are discussed; and - Nursing would call the physician to get orders for skilled nursing visits if there was an issue with blood sugars, falls, increased blood pressure, and etcetera. During an interview on 09/23/21 at 8:47 AM, the PT department head stated the following: - The patient's rug burn was from the fall in his/her bedroom; - PTA A reported the fall to him/her and the PT did not report the fall to the physician because it did not result in a "major" injury; and - He/she did not notify the physician of the fall and abrasion after the home visit with the surveyor on 09/21/2021. During telephone interview on 09/23/2021 at 9:24 AM, PTA A stated the following: - If the patient has a fall he/she reports injury and assesses range of motion, weight bearing status, edema and skin color and this is just a "verbal note"; - When the supervisor goes in to see the patient they list the goals and this is documented on the flow sheet; - He/she did not notify the physician of the falls because there was not a "notable" injury; - He/she believed the patient had a rug burn to his/her left knee after the fall on his/her visit (there was no documentation), he/she reported the injury of the knee to the PT department head and PT B, they discussed what was done during treatment, and he/she provided education and could not complete the visit the day of the fall (this was not documented); and - The PT or PTA is responsible to notify the physician if the patient has a change in condition. During an interview on 09/23/2021 at 9:58 AM, PT B said the following: - PTA A relayed all of the patients falls to him/her; - PTA A documents the falls in his/her notes; - The physician is notified if there is a "major injury" (any injury that could potentially lead to death prolonged disability or permanently diminished quality of life) or reoccurring falls; and - If a fall happens once in a 30 day period due to getting feet tangled up you do not notify the physician such as the case with patient #2.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on policy review, review of the current patient rights information, home visit observation, and interview, the agency failed to ensure staff provided a written visit schedule to patients that included what discipline was visiting, when the discipline would visit, and the frequency of visits in three (Record/Patient #1, #2, and #3) of three home visits. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's undated policy titled "Madison Medical Center Home Health Agency" "Management of Patient Care" showed staff would place phone calls to patients/family members/caregivers for scheduling of visits. Review of the current Patient Bill of Rights and Responsibilities left in patient home admission packet showed: - The home health agency must advise the patient in advance of the disciplines that will furnish care and the frequency of visits proposed to be furnished. RECORD/PATIENT #1: Review of the admission packet during a home visit observation on 09/21/2021 at 9:50 AM showed: - The agency's patient rights information showed the agency must advise the patient in advance of the disciplines that will furnish care and the frequency of visits proposed to be furnished; and - A blank copy of the calendar to be used to record discipline visits for the patients. During an interview on 09/21/2021 at 10:30 AM, occupational therapy (OT) E said they don't leave a visit schedule in the patient's home. RECORD/PATIENT #2: Review of the admission packet during a home visit observation on 09/21/2021 at 1:10 PM showed: - The agency's patient rights information showed the agency must advise the patient in advance of the disciplines that will furnish care and the frequency of visits proposed to be furnished; and - A blank copy of the calendar to be used to record discipline visits for the patients. During an interview on 09/21/2021 at 1:09 PM, the physical therapy (PT) department head said they develop a schedule for the week and notify the patient and call before the visit is made. They do not leave a visit schedule or frequency of visits in the home. RECORD/PATIENT #3: Review of the admission packet during a home visit observation on 09/21/2021 at 10:00 AM showed: - The agency's patient rights information showed the agency must advise the patient in advance of the disciplines that will furnish care and the frequency of visits proposed to be furnished; and - A blank copy of the calendar to be used to record discipline visits for the patients. During an interview on 09/21/2021 at 10:00 AM, registered nurse (RN) C stated that: - He/she did not write down visits for patients; - He/she just told the patients when he/she would return. During an interview on 09/22/2021 at 12:15 PM, the administrator stated that: - He/she made sure nurses called patients to tell them they were making a visit; - He/she did not have anything to do with the scheduling of PT or OT visits; and - Nursing staff did not use calendars in homes for visits.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on home visit observation and interview, the agency failed to provide the patient/caregiver with a copy of written instructions of any treatments being administered by the agency in two (Record/Patients #2, and #3) of three home visits. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #2: During a home visit observation on 09/21/2021 at 1:10 PM with the physical therapist (PT), the surveyor observed the patient's home folder. The agency failed to provide written instructions of the specific home exercises or any other treatments administered by the agency. During an interview on 09/21/2021 at 1:09 PM, the PT department head said there was no printed educational material left in the patient's home. RECORD/PATIENT #3: During a home visit observation on 09/21/2021 at 10:00 AM with the registered nurse (RN), the surveyor observed the patient's home folder. The agency failed to provide written instructions of the specific home exercises or any other treatments administered by the agency. During an interview on 09/22/2021 at 12:15 PM, the above information was reviewed with the administrator and no additional information was provided.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on home visit observation and interview, the agency failed to ensure each patient received written information related to the name and contact information of the agency's clinical manager in the admission packet during the initial assessment in three (Record/Patient #1, #2, and #3) of three home visit observations. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the hospital organizational chart dated May, 2018 showed the administrator was also the clinical manager of the agency. During the entrance interview on 09/20/2021 at 2:20 PM, the administrator stated that the home health agency did not have a clinical manager, but he/she performed all the tasks of the clinical manager. He/she said the name of the administrator and phone number was in the home packets of information. RECORD/PATIENT #1: During a home visit observation on 09/21/2021 at 9:50 AM, the admission packet of information that should include the clinical manager's name and contact number, failed to include that information. RECORD/PATIENT #2: During a home visit observation on 09/21/2021 at 1:10 PM, the admission packet of information that should include the clinical manager's name and contact number, failed to include that information. RECORD/PATIENT #3: During a home visit observation on 09/21/2021 at 10:00 AM, the admission packet of information that should include the clinical manager's name and contact number, failed to include that information.

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 observation and interview, the agency failed to : - Ensure there was evidence that the agency is measuring, analyzing, and tracking quality indicators (G642); - Ensure the agency used data collected to monitor the effectiveness and safety of the services and quality of care and identifying opportunities for improvement (G644); - Ensure performance improvement activities focused on high risk, high volume, or problems-prone areas (G648); - Ensure that performance improvement projects are conducted and document which projects are undertaken, the reasons for the projects, and the measurable progress of the projects (G658); and - Ensure the governing body was responsible for ensuring an ongoing program for quality improvement and patient safety (G660). The cumulative effect of these deficient practices has the potential to affect the quality of care and safety of all agency patients.

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 agency documents and interview, the agency failed to provide evidence that the agency was measuring, analyzing, and tracking quality indicators. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of hospital board meeting minutes dated July, August, and September, 2021 showed no discussion of a QAPI (Quality Assessment and Performance Improvement) program for the home health agency. During an interview on 09/21/2021 at 11:00 AM, the administrator stated that: - The agency did not have a QAPI program, everything was done through the hospital; - The home health agency did not have a governing body other than through the hospital; and - The agency did not have any evidence that the agency was measuring, analyzing, and tracking quality indicators.

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 review of agency documents and interview, the agency failed to provide evidence that collection of quality data was on-going to: - Monitor the effectiveness and safety of the services and quality of care; and - Identify opportunities for improvement. This deficient practice has the potential to affect the quality of care and safety of all patients served by the agency. Findings included: Review of hospital board meeting minutes dated July, August, and September, 2021 showed no discussion of a QAPI (Quality Assessment and Improvement) program for the home health agency. During an interview on 09/21/2021 at 11:00 AM, the administrator stated that: - The agency did not have a QAPI program, everything is done through the hospital; - The home health agency did not have a governing body other than through the hospital; and - He/she did not have any evidence that the agency monitored the effectiveness and safety of the services and quality of care and identified opportunities for improvement.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on review of agency documents and interview, the agency failed to provide evidence of any performance improvement activities that were focused on high risk, high volume, or problem prone areas. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of hospital board meeting minutes dated July, August, and September, 2021 showed no discussion of a QAPI( Quality Assessment and Performance Improvement) program for the home health agency. During an interview on 09/21/2021 at 11:00 AM, the administrator stated that: - The agency did not have a QAPI program, everything was done through the hospital; - The home health agency did not have a governing body other than through the hospital; and - He/she did not have any evidence that the agency had any performance improvement activities that were focused on high risk, high volume, or problem prone areas.

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 review of agency documents and interview, the agency's Quality Assessment and Performance Improvement (QAPI) activities failed to show the agency conducted at least one performance improvement project to reflect the scope, complexity, and past performance of the agency's services/operations with measurable progress achieved. This deficient practice has the potential to affect the quality of care and safety of all patients served by the agency. Findings included: Review of hospital board meeting minutes dated July, August, and September, 2021 showed no discussion of a QAPI (Quality Assessment and Performance Improvement) program for the home health agency. During an interview on 09/21/2021 at 11:00 AM, the administrator stated that: - The agency did not have a QAPI program, everything was done through the hospital. - The home health agency did not have a governing body other than through the hospital; and - He/she did not have any evidence that the agency conducted at least one performance improvement project to reflect the scope, complexity, and past performance of the agency's services/operation with measurable progress achieved.

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 review of agency documents and interview, the agency failed to provide evidence that the governing body was responsible for ensuring the agency had an ongoing program for quality improvement and patient safety. This deficient practice has the potential to affect the quality of care and safety of all patients served by the agency. Findings included: Review of hospital board meeting minutes dated July, August, and September, 2021 showed no discussion of a QAPI (Quality Assessment and Performance Improvement) program for the home health agency. During an interview on 09/21/2021 at 11:00 AM, the administrator stated that: - The agency did not have a QAPI program, everything was done through the hospital. - The home health agency did not have a governing body other than through the hospital; and - The agency did not have any evidence that the agency conducted at least one performance improvement project to show that the governing body was responsible for ensuring the agency had an ongoing program for quality improvement and patient safety.

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 review of agency documentation, employee file review, policy review, Centers for Medicare and Medicaid (CMS) COVID-19 guidance, home visit observation, and interview, the agency failed to maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. The agency failed to: - Maintain accepted standards of practice to prevent the transmission of infections and communicable diseases (G682); - Maintain a coordinated agency-wide program for surveillance, identification, prevention, control, and investigation of communicable diseases that is an integral part of the agency Quality Assessment and Performance Improvement program (QAPI) (G684); and - Provide infection control education to staff (G686). The cumulative effect of these systemic practices resulted in the agency's inability to ensure prevention, detection, or investigation of infections that could affect all patients served by the agency.

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: Based on policy review, home visit observation, and interviews, the agency failed to follow accepted standards of practice to prevent the transmission of infections and communicable diseases in three (Record/Patient #1, #2, and #3) of three home visit observations; failed to post signage on the entrance door related to COVID-19 recommendations, failed to check surveyors temperatures and ask COVID-19 questions upon entrance to the agency, and failed to continue to monitor patients for signs and symptoms of COVID-19 by checking temperatures and asking COVID-19 related questions prior to home visits. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: Review of the agency's policy titled "Madison Medical Center" "Infection Control Policy Book: Handwashing" last reviewed March, 2018, showed: - Purpose: To ensure that handwashing is conducted appropriately; - Policy: Handwashing is the single most important procedure to reduce the risks of transmitting microorganisms from one person to another or from one site to another; - Personnel should always decontaminate their hands before having direct contact with patients, after situations during which unanticipated microbial contamination of hands might have occurred especially those involving contact with mucous membranes, blood or body fluids, secretions, or excretions, if moving from a contaminated body site to clean body site during patient care, after touching inanimate sources that might have been contaminated with virulent or epidemiological important organisms, and after removing gloves; - Wearing gloves does not replace the need for handwashing because gloves may have a small unapparent defect, may be torn during use, and hands can become contaminated during removal of the gloves; - Hands are to be washed with hospital approved soap; and - Hospital approved waterless sanitizer may be used in place of washing hands with soap and water as long as hands are not visibly soiled. Review of the Madison County Health Officer Order No. 2020-01, 2019 Novel Coronavirus (COVID-19) Order and Issuance of Rules and Regulations, Emergency Health Order showed: - The overall intent of the order is meant to prevent the spread of the COVID-19 disease and reduce the number of people infected with the virus. RECORD/PATIENT #1: During the home visit observation on 09/21/2021 at 9:50 AM, occupational therapist (OT) E failed to follow acceptable standards of practice for handwashing when he/she did not wash or sanitize his/her hands throughout the entire home visit. He/she did not wash or sanitize his/her hands before having direct contact with the patient. He/she did not wash or sanitize his/her hands before/after removing and replacing items in his/her supply bag. He/she did not wash his/her hands (which was holding trash) before leaving the patient's home, walking through the assisted living facility and placing the trash in his/her car. During an interview on 09/21/2021 at 10:30 AM, OT E stated he/she washed his/her hands at the office before he/she left for the home visit, he/she did drive, touch his/her steering wheel and should have washed his/her hands when he/she went to the assisted living center to visit the patient. He/she could have placed the trash in the trash bag he/she used for a barrier to place supply bag on prior to leaving the patient's home and carrying it through the assisted living facility and placing it in his/her car. RECORD/PATIENT #2: During the home visit observation on 09/21/2021 at 1:09 PM, physical therapy (PT) department head failed to follow acceptable standards of practice for bag technique when he/she laid his/her bag on the patient's dining room chair without a barrier. He/she removed his/her stethoscope, blood pressure cuff, thermometer and pulse oximeter on the patient's dining room table which was covered with a table cloth. The PT department head failed to sanitize the table cloth before laying down equipment and placing equipment back in his/her bag. During an interview on 09/23/2021 at 9:00 AM, the administrator stated he/she expected staff to wash their hands prior to providing patient care and when going from dirty to clean. He/she expected staff to place their supplies and bag on a barrier. RECORD/PATIENT #3: During the home visit observation on 09/21/2021 at 10:00 AM, registered nurse (RN) C failed to follow acceptable standards of practice for handwashing when he/she did the following: - Assisted the patient to lie down to check the coccyx/buttock area for a reddened area; - Use hand sanitizer and applied gloves; - Pulled down the patient's pants and underwear; - Pulled back both buttocks to fully assess the reddened area and touched the area with his/her gloved fingers; - Stood up and asked the caregiver to get the Calmoseptine ointment (a moisture barrier that helps to prevent irritation and redness), placed his/her left hand on his/her hip (scrubs that he/she wore), touched the Calmoseptine tube, and applied Calmoseptine to the reddened area; - Then he/she removed his/her gloves and used hand sanitizer. During an interview on 09/21/2021 at 10:00 AM, RN C stated that: - He/she did change his/her gloves and used hand sanitizer after application of the Calmoseptine and agreed he/she did not change gloves or sanitize hands after touching the residents buttocks and before touching the tube of Calmoseptine, or that he/she touched his/her scrubs prior to application of the ointment.

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 review of agency documentation, policy review, review of Centers for Medicare and Medicaid Services (CMS) COVID-19 guidance, and interview, the agency failed to maintain a coordinated agency-wide program for surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the Quality Assessment and Performance Improvement (QAPI) program. This deficient practice has the potential to affect the health and safety of all the agency's patients. Findings included: Review of the "Madison Medical Center's" policy titled "Infectious Disease Policy" revised 03/05/2021 showed: - The home health agency (HHA) must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases; - The QAPI program will be adjusted to include a method of identifying infectious and communicable disease problems and a plan for the appropriate actions that are expected to result in improvement and disease prevention; and - In-service with staff will be provided to ensure each employee is aware of the updated QAPI program to provide documented evidence of a coordinated agency-wide program for surveillance, identification, prevention, control and/or investigation of infectious and communicable diseases. Review of CMS Quality, Safety and Oversight (QSO) Memo, QSO-21-08-NLTC (Non long term care) dated December 30, 2020 showed in part: - Facilities should have: * screening process to assess for signs/symptoms consistent with COVID-19 and for exposure to others with COVID-19; * screening questions with an assessment of illness, self-monitored pre-arrival temperature checks with reported absence of fever and symptoms, and facility- monitored temperature checks upon arrival and; * signage posted at facility entrances with visitation restrictions and screening procedures. Review of the "Operating a Critical Access Hospital", Process Improvement/Quality Improvement, Indicator Threshold Log Sheet for year of October, 2020 through September, 2021 showed: - Infection control per month beginning April, 2018; - 0% infections. Review of the "Hospital" QI Quarterly Summary for July, 2021 through September, 2021 showed: - Home health indicators unsolved: Infection control- Maintain a program for the surveillance, identification, prevention, control, and investigate infectious and communicable diseases. Observation showed on 09/20/2021 at 1:45 PM and on 09/21/2021 at 8:30 AM, the surveyors entered the agency and no signage was visible on the entry door related to COVID-19, masking, social distancing, hand hygiene, or other information. The staff did not ask COVID-19 related questions of the surveyors and did not take the surveyor's temperatures upon entry. During an interview on 09/21/2021 at 8:40 AM, the administrator stated that: - Upon entry to the agency, all staff needed to take their temperature and answer questions related to COVID-19; - He/she did not have signage on the door related to COVID-19; - No staff took the temperature of the surveyors upon entry but the surveyors could check their own temperatures when they enter and record on the sheet staff recorded information related to COVID-19; - Nurses do not ask questions about COVID-19 when they admit new patients; - They always ask if the patient has been out of the country; - No other documentation related to COVID-19 signs and symptoms is recorded in the admission assessment; - Nursing staff do not usually see patients more than one time, and that is for admission; - If nursing sees the patient again, they do not ask COVID-19 questions; and - There was no documentation from physical or occupational therapy as to questions related to COVID-19 in their visit notes. During an interview on 09/22/2021 at 8:40 AM, administrator stated that: - The agency did not have a QAPI program, everything goes through the hospital Quality Improvement (QI) program; - All information was discussed with the hospital governing board; - He/she reported discipline visits, number of in-home service visits, and beginning census report to the hospital governing board; - The administrator asked the surveyor how he/she could do QAPI when he/she was not responsible for patients; - He/she stated there were no infections from October, 2020 through September, 2021; and - Hospital QI meetings are held every four months.

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 employee file review and interview, the agency failed to maintain a coordinated agency-wide infection control program that included infection control education for a contracted staff which affected one (Employee #4) of five employee files reviewed. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: EMPLOYEE (E4): Review of E4's employee file showed: - Contracted employee; - Position: Physical therapist; - Date of hire: 12/16/2002; - No documentation found for yearly infection control training. During an interview on 09/22/2021 at 12:15 PM, the above information was reviewed with the administrator and no additional information was provided.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on policy review, job descriptions, organizational charts, clinical record review, home visit observation, and interview, the agency failed to meet the requirements for this condition of participation when the agency failed to: - Assume responsibility for ongoing interdisciplinary assessment of a patient (G706); - Provide services that were ordered by the physician in the plan of care (G710); and - Failed to ensure all staff, including contracted staff, received home health sponsored in-service training (G722).

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on policy review, job description, organizational chart review, clinical record review, and home visit observation, the agency failed to complete an ongoing interdisciplinary assessment of the patient in one (Record/Patient #2) of five records. This deficient practice has the potential to affect the interdisciplinary assessment of all patients served by the agency. Findings included: Review of the agency's policy titled, "Coordination of Patient Services," revised 01/22/2021 showed, in part: - Coordination of patient services will be managed through the care team process; - To decrease "span" of control and increase the coordination of patient care, care teams were designed to have one supervisor and 4-6 primary nurses and other staff including physical therapy (PT), home health aides (HHA), social worker (SW), speech therapy (ST), and occupational therapy (OT), not to exceed 15 staff members total; - This design facilitates discussion and coordination of patient care; - Each clinical supervisor is responsible for the coordination patient services; - The clinical supervisors are responsible to ensure this policy; - The objectives of the care teams are: * Improve the quality of patient care or maintain a high quality; * Improve and/or maintain communication among staff members; * Evaluate and update patient care on an ongoing basis; * Evaluate the patient's plan of care and update or revise this as necessary; - Report of patient problems will be discussed; and - All clinical staff are required to participate in care conferences with other disciplines involved in each individual case as often as necessary but at least once every month. Review of the job description titled "Madison Medical Center, A Critical Access Hospital, Director of Home Health/Administrator, "changed" 04/30/2018 (Administrator was hand written on the job description), showed: - Definition and role: This position is responsible for the planning, coordinating, everyday activities, staffing, and delivery of quality home health care and services to the patients in the communities served; - Responsibilities and duties: * Ensures that the patients served receive the highest quality of care; * Monitors the changing needs of the patients and/or family; * Monitors the skills and services of contracted staff; * Supervises the implementation of the physician's plan of care; * Coordinates the total plan of care with the appropriate resources; * Maintains an open line of communication with all staff members; * Maintains accurate patient and employee records to meet state regulations; * Provides staff with current knowledge of clinical changes; * Oversees all daily functions of the home health department and ensures that every effort is made to meet all client's needs; and * Knowledge of Medicare and Medicaid regulations required. Review of the hospital organizational chart dated May, 2018 showed: - Administrator of home health/Director of home health; Clinical manager with the name of the current agency administrator. Review of the agency's undated physical therapy (PT) job description showed: - Physical Therapist: Responsible to the administrator; - Responsible for overall direction, supervision, instruction, and evaluation of professional and supportive staff; - Duties to provide leadership and direction for the functioning of the service on behalf of the patients, staff, and health care facility; - Delegate duties to other staff, consistent with their education, experience, and ability; - Give direct patient care including evaluation and treatment planning, reporting, and interpreting the results of the same; and - Collaborate with other personnel in developing and implementing physical therapy care plan. Review of the agency's undated physical therapy assistant (PTA) job description showed: - Responsible to administrator and chief physical therapist; - Works within the physical therapy service administered by a registered Physical Therapist, under the direct and supervision of the registered physical therapist he/she is directly responsible to; - Duties and responsibilities, assist the registered physical therapist in carrying out procedures and programs; - Performs routine treatment procedures in accordance with the planned program; - Observes, records, and reports to his/her supervisor conditions, reactions and responses related to his assigned duties; - Reports any pertinent findings to the registered Physical Therapist; - Helps to maintain appropriate records; and - Communicate with patient's physicians as necessary regarding patient's progress, treatments, etc., in consultation with registered Physical Therapist. RECORD/PATIENT #2: Review of the start of care assessment dated 05/27/2021 showed history of two or more falls, pain less than daily, and at risk for falls. The patient reported the level of pain that was tolerable was 2/10 (zero representing no pain and 10 representing the worst pain). The location of the pain was general and the worst his/her pain gets is 2/10. Review of the POC dated 05/27/2021 through 07/25/2021, showed, in part: - The patient was admitted to home health services on 05/27/2021; - Diagnoses included: Urinary tract infection, altered mental status, other malaise (general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify), and unspecified abnormalities of gait and mobility; - Short-stay acute hospital with diagnosis of urinary tract infection, dehydration, status/fall, and mental status changes; - PT/OT to evaluate and treat with home exercise program; - 485-15 (safety measures): Fall precautions and patient/caregiver knowledgeable of physician notification as needed; - 485-21 (orders for discipline and treatments): PT to evaluate and teach home safety/falls prevention; and - 485-22 (goals/rehabilitation potential/discharge plans): verbalizes pain controlled at acceptable level (there were no parameters) and patient/caregiver knowledgeable about when to notify physician. Review of the medical record showed the physical therapy assistant (PTA) A documented the following: - On 6/4/21: The patient reported he/she fell in the living room this morning. He/she rated his/her pain as a 3/10 and took ibuprofen earlier today after the fall. The patient complains of pain to his/her right lower thigh and upper shin. The PTA held right LAQ (Long Arc Quadriceps) (exercises) and marching due to pain and the patient pain had increased to 4/10 with weight bearing. The documentation failed to show the PTA A notified the physical therapist, clinical manager or physician of the fall and pain, did a head to toe assessment for injury from the fall or followed up regarding the increase in the patient's pain with weight bearing; and -On 6/16/21: The patient reported this morning he/she slid off of recliner to the floor. His/her current pain in the knee as a 5/10. He/she did take Tylenol approximately 30 minutes before the PTA's arrival. He/she sees the doctor tomorrow for continued knee pain. The documentation failed to show the PTA A notified the physical therapist, clinical manager or physician of the fall and pain, did a head to toe assessment for injury from the fall or followed up regarding the increase in the patient's pain Review of the physical therapy recertification note dated 06/23/2021 completed by the Doctor of Physical Therapy (DPT) showed: - The patient's daughter states that on 06/21/2021, the patient was taken to the emergency room due to decreased mental status and weakness; - The patient was under observation for approximately 24 hours before returning home on 06/22/2021; - The patient reported pain in his/her right knee 2/10 and no recent falls; - He/she felt his/her overall mobility continues to be limited due to weakness, however, states he/she is improving; - The patient has been consistent and compliant with PT and continues to make slow but steady progress toward all rehab goals; - His/her overall level of function continues to be decreased and also presents with an increased risk for falls primarily due to weakness, decreased balance, and decreased endurance; - Patient demonstrates safety awareness; and - The problem list showed history of recent falls and current status was the patient has been compliant with using four wheeled walker for in-home mobility. One fall since beginning episode of care and continue with same goal. The documentation failed to show the DPT addressed the falls and pain from 06/04/2021 and 06/16/2021. There was no evidence of communication with the PTA regarding the patient's health status and any revisions needed in the plan of care. Review of the medical record showed the PTA A documented the following: - On 07/07/21: The patient reported that on 07/06/2021 he/she fell out of his/her recliner while trying to reach for his/her walker, there were no bumps, bruises or lacerations and minimal pain. The documentation failed to show the physical therapist, clinical manager or physician was notified of the fall; - On 7/12/21: The patient reported he/she fell in the bathroom on 07/11/2021 while flushing the toilet. The patient fell into the cabinets and slid down. The patient performed 10 repetitions of majority of exercises and during SL (single leg) stance (test used to assess static postural and balance control) activities such as hip abduction and extension the patient only completed 5 repetitions (per PT flow sheet the patient usually completed 10 repetitions). There was a bruise to the back of the right upper arm. The documentation failed to show the physical therapist, clinical manager or physician was notified of the fall, the patient not able to do all repetitions of hip abduction and extension exercises and the bruise to the right upper arm; -On 07/14/2021: The patient reported he/she fell last night (07/13/2021), the patient stood up and lost his/her balance. The documentation failed to show the physical therapist, clinical manager or physician was notified of the fall; and -On 7/19/2021: The patient said he/she was sore today and had pain 3/10 particularly the right knee. The patient said he/she fell on 07/16/2021 while exiting the bathroom and he/she lost his/her balance in the "posterior direction". The patient had several falls within the last couple of weeks and remains at a high risk for falls at this time. The documentation failed to show the physical therapist, clinical manager or physician was notified of the fall and pain. There was no head to toe assessment and no further assessment of the pain. Review of the OASIS (Outcome and Assessment Information Set) Physical Therapy Recertification/Follow-Up Assessment completed by the DPT, dated 07/21/2021 showed the following: - Had several falls since last OASIS due to decreased balance and weakness, no major injuries; - At risk for falls; - Recertification note: The patient is currently being seen by PT secondary to urinary tract infection and dehydration resulting in weakness and debility; - The patient has no complaints of pain; - The patient reports no falls since last PT visit, however, over the last few weeks he/she had multiple falls; - He/she stated he/she loses his/her balance and the patient states that falls are typically from being dizzy when he/she gets up from a seated position or posteriorly and is unable to regain his/her balance; - He/she reports no serious injuries from his/her falls; and - Patient continues to present with lower extremity weakness, decreased balance, decreased endurance and poor safety awareness all of which significantly limits patient ability to independently and safely perform functional activities within his/her home and places this patient at significant increased risk for falls; and - The physician signed the recertification note. The documentation failed to show the reason the falls happened and attempt to determine a root cause, the bruise to the back of the right upper arm, and pain. There was no interventions in place for pain and dizziness. The plans of care continued to show history of falls and to continue with same goals. There was no communication with the PTA regarding the patient's health status and any revisions needed in the plan of care. Review of the medical record showed the PTA A documented the following: - On 07/26/2021: The patient stated he/she is not feeling well, he/she has been nauseated over the last couple of days and no complaints of pain. The documentation failed to show further assessment of the patient or reasons for nausea and notification of the physical therapist, clinical manager and physician; - On 08/11/2021: The patient was sitting on the floor upon the PTA's arrival. The patient was attempting to unlock the door and got his/her feet tangled up with the dog causing him/her to fall on the floor. The patient had a marble size knot on the back of his/her head. The patient also reported that he/she hit his/her left posterior shoulder when he/she fell. The patient did not lose conscious and able to answer questions appropriately. The documentation failed to show the physical therapist, clinical manager or physician was notified of the fall with injury; and - On 08/16/2021: The patient denies pain and the knot on the back of his/her head is starting to get smaller but is still there, he/she reported the day after the fall he/she had some shoulder soreness and utilized his/her topical pain reliever on his/her shoulder over the weekend. The documentation failed to show the physical therapist, clinical manager or physician was notified of the fall with injury and the use of topical pain reliever. Review of the physical therapy recertification note dated 08/19/2021 completed by the DPT showed: - The patient is doing fair and progressing well with participation in PT; - He/she continues to notice decreased activity tolerance and decreased balance; - Complains of moderate pain throughout both knees and reports no new falls since last PT visit; - Steady progress continues to be made toward all rehabilitation goals; - The patient continues to present with significant decline in her overall level of functioning and presents with an increased risks for falls; - The patient continues to present with a number of impairments including decreased strength, decreased balance, and poor safety awareness which will be addressed with home health PT; - The documentation failed to address the nausea on 07/26/2021 and the fall with injury on 08/11/2021. There was no head to toe assessment documented and no documentation of the knot on the back of the patient's head. There was no communication with the PTA regarding the patient's health status and any revisions needed in the plan of care. Review of the medical record showed the PTA A documented the following: - On 08/24/2021: The patient does report moderate pain (not rated with pain scale) on occasion in his/her knees (there was no further assessment on what caused the pain and what was the patient doing to relieve the pain and was it effective); - On 08/26/2021: The patient has moderate pain (not rated with pain scale) in bilateral knees (there was no further assessment on what caused the pain and what was the patient doing to relieve the pain and was it effective); - On 08/30/2021: Reports pain in the right knee and rates this pain as moderate (not rated with pain scale) discomfort at times (there was no further assessment on what caused the pain and what was the patient doing to relieve the pain and was it effective); - On 09/01/2021: The patient woke up this morning with his/her left ear hurting on the inside. PTA A did encourage the patient to let his/her family member know about the earache and to follow up with the primary care physician if this persists. There was no documentation the physical therapist, clinical manager or physician was notified of the earache; - On 09/13/2021: The patient fell on 09/10/2021 in his/her bathroom between the bed and chest of drawers, he/she reported bilateral shoulders, bilateral knees and left wrist area with 5/10 pain. No use of Tylenol or other as needed pain medications. The documentation failed to include head to toe assessment, and what was used to relieve the pain if not using any pain medications and there was no documentation the physical therapist, clinical manager or physician was notified of the fall and pain; and - On 09/15/2021: The patient continued to report soreness in his/her knees, shoulders, and wrist rating 5/10 pain from his/her previous fall (09/13/2021). The documentation failed to include what was the patient using for pain and was it effective, there was no head to toe assessment to assess if any injury and the physical therapist, clinical manager or physician was not notified. During a home visit observation with PT department head on 09/21/21 at 1:10 PM, the following was observed: - The patient said he/she had a fall and sustained a rug burn (occurs when the skin rubs or slides against an abrasive surface like a rug or carpet); - The patient had a large 13 cm x 3 ½ cm rug burn on his/her left outer knee; - There was a Band-Aid covering a 3 cm x 3 ½ cm area of the rug burn; - The patient had a tube of diclofenac sodium topical gel 1% on her table by the couch (not on the medication list); - The PT department head did not remove the bandage to assess the skin; and - The patient said he/she rubs the gel on his/her knees and shoulders when his/her pain is a 5/10. During interview while on the home visit observation on 09/21/2021 at 1:10 PM, the PT department head stated the following: - When a patient falls, an adverse event form is filled out and sent to the administrator and skilled nursing if applicable; - Therapy coordinates care by phone with other disciplines but this is not documented; - The patient had a rug burn from his/her last fall (there was no documentation in the medical record about the rug burn); and - The PTA should have notified the physician if it was a "significant injury". During an interview on 09/21/2021 at 2:16 PM, the administrator stated the following: - He/she was not notified of Patient #2's falls; - He/she had no adverse event reports on Patient #2 for June, July, August and September; - PT would notify the physician of the falls; and - The physician is not notified of a "mild like fall" with no injuries. During an interview on 09/22/2021 at 12:00 PM, the administrator stated the following: - Unless he/she is informed of issues with the patient he/she does not see the patient; - Registered nurse (RN) C reviews all of the problems and he/she addresses the plan of care (POC), they do not follow therapy at all and do not check their POC; - The PT department head is responsible for PT patients and he/she is the administrator, clinical manager, director of nursing and does not have time; - If the patient is falling three times a week he/she will ask PT what they are going to do about the falls; - He/she does not want to call the physician about the falls because he/she was not there and would rather therapy call first; - He/she does not follow therapy at all and "why would he/she" unless there is a problem; and - Nurses meet weekly and therapy does not attend. During an interview on 09/22/2021 at 12:30 PM, PT department head stated the following: - PTA A did not fill out an adverse reaction report or notify the physician of Patient #2's falls; - PTA A called him/her the day after the fall to notify of the patient's fall and rug burn; - He/she did not do anything about it and did not think it was a big deal and thought it was taken care of; - PTA A assesses the patient after the fall and reports to PT, nursing and the physician; and - If there was an injury they may not need nursing and PT could provide basic assessment, vital signs, and wound measurement. PT would establish wound care either by talking to the physician or nursing. During an interview on 09/22/2021 at 1:28 PM, registered nurse (RN) C stated the following: - Nursing does a case conference with therapy every two weeks and discusses all patients; - He/she was not notified of Patient #2's falls and normally falls are discussed; and - Nursing would call the physician to get orders for skilled nursing visits if there was an issue with blood sugars, falls, increased blood pressure, and etcetera. During an interview on 09/23/2021 at 8:47 AM, the PT department head stated the following: - The patient's rug burn was from the fall in his/her bedroom; - PTA A reported the fall and the PT did not report the fall to the physician because it did not result in a "major" injury; and - He/she did not notify the physician of the fall and abrasion after the home visit with the surveyor on 09/21/2021. During telephone interview on 09/23/2021 at 9:24 AM, PTA A stated the following: - If the patient has a fall he/she reports injury and assesses range of motion, weight bearing status, edema and skin color and this is just a "verbal notes"; - When the supervisor goes in to see the patient they list the goals and this is documented on the flow sheet; - He/she did not notify the physician of the falls because there was not a "notable" injury; - He/she believed the patient had a rug burn to his/her left knee, the patient said he/she was at home "scooting around on the floor" and the rug burn appeared the day after the fall. On his/her next visit (after the fall), he/she reported the injury of the knee to the PT department head and PT B, they discussed what was done during treatment, and he/she provided education and could not complete the visit because the patient complained of the fall (this was not documented); and - The PT or PTA is responsible to notify the physician if the patient has a change in condition. During an interview on 09/23/2021 at 9:58 AM, PT B said the following: - PTA A relayed all of the patients falls to him/her; - PTA A documents the falls in his/her notes; - The physician is notified if there is a "major" injury or reoccurring falls; and - If a fall happens once in a 30 day period due to getting feet tangled up you do not notify the physician such as the case with patient #2.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on policy review, clinical record review and interview, the agency failed to provide skilled nursing services as ordered by the physician on the plan of care (POC) in one (Record/Patient #1) of five full records reviewed. This deficient practice has the potential to affect the quality of nursing care to all patients served by the agency. Findings included: Review of the agency's policy titled, "Scope of Service", revised 01/18/2021 showed physical therapy and occupational therapy will evaluate and treat patients with home exercise programs. Nursing staff (registered nurse and licensed practical nurse) will evaluate patients and coordinate care ordered by the physician. RECORD/PATIENT #1: Review of the POC, dated 05/27/2021 to 07/25/2021, showed physical therapy (PT) and occupational therapy (OT) to evaluate and treat with home exercise program. Review of the POC, dated 07/26/2021 to 09/23/2021, showed PT and OT to evaluate and treat with home exercise program. Review of the clinical record showed no OT evaluation or the reason the OT visit was not done from 05/27/2021 to 09/23/2021. During an interview on 09/21/2021 at 10:30 AM, occupational therapist (OT) E said he/she did not recall a referral on Patient #1. There were a few times his/her fax machine was not working so he/she may not have received the referral. He/she is the only occupational therapist to do evaluations. During an interview on 09/22/2021 at 12:00 PM, the administrator said he/she received the referrals. He/she called the therapy department for who the referrals were for and faxed the referral. He/she notified them when the insurance was approved and had nothing more to do with the referrals. No further information provided.

Participate in HHA-sponsored in-service CFR(s): 484.75(b)(9) Participation in HHA-sponsored in-service training. This ELEMENT is not met as evidenced by: Based on employee file review and interview, the agency failed to ensure staff were provided with agency in-service training in one (Employee #4) of five employee files reviewed. This deficient practice has the potential to affect all agency staff. EMPLOYEE #4 (E4): Review of E4's employee file showed: - Contracted staff; - Hire date: 12/16/2002; - No documentation of any agency in-service training. During an interview on 09/22/2021 at 12:15 PM, the above information was reviewed with the administrator and no additional information was provided.

Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This ELEMENT is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with seven Conditions of Participation: Patient rights; Care Planning, Coordination of Services and Quality of Care; Quality Assessment and Performance; Organization and Administration of Services; Emergency Preparedness; Infection Control; and Skilled Professional Services, the agency may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. The restriction ends 09/28/2023.

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 job description review, observation, interview, and current survey findings, the agency failed to organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care when the agency failed to show adequate governing body, administrative, and clinical manager oversight to patients resulting in seven Conditions of Participation citations. The following standard level deficiencies were cited under 485.105 Condition of Participation: Organization and Administrative Services: - Clinical manager: One or more qualified individuals must provide oversight of all patient care services and personnel (G958); and must include: - Making patient and personnel assignments (G960); - Coordinating patient care (G962); and - Must have a written agreement with another agency, with an organization, or individual when that entity or individual furnishes services under arrangements for agency patients. Must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked, or; (iv) Been debarred from participating in any government program (G978); and - All home health services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice: No documentation of Criminal Background Checks, Family Care Safety Results (FCSR), and Employee Disqualification List (EDL) checks for staff (G984). The cumulative effect of these systemic practices resulted in the agency's inability to ensure the patient's care needs would be met.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on current survey findings with seven condition level deficiencies, job description for administrator/director of home health, organizational chart review, policy review, and interview, the agency failed to ensure that the clinical manager/administrator/director of home health has effectively provided oversight of all patient care services and personnel. This deficient practice has the potential to affect all patients served by the agency. Findings included: The agency did not have a job description for clinical manager. Review of the job description titled "Madison Medical Center, A Critical Access Hospital, Director of Home Health/Administrator, "changed" 04/30/2018 (Administrator was hand written on the job description), showed: - Definition and role: This position is responsible for the planning, coordinating, everyday activities, staffing, and delivery of quality home health care and services to the patients in the communities served; - Responsibilities and duties: * Ensures that the patients served receive the highest quality of care; * Monitors the changing needs of the patients and/or family; * Monitors the skills and services of contracted staff; * Supervises the implementation of the physician's plan of care; * Coordinates the total plan of care with the appropriate resources; * Maintains an open line of communication with all staff members; * Maintains accurate patient and employee records to meet state regulations; * Provides staff with current knowledge of clinical changes; * Oversees all daily functions of the home health department and ensures that every effort is made to meet all client's needs; and * Knowledge of Medicare and Medicaid regulations required. Review of the hospital organizational chart dated May, 2018 showed: - Administrator of home health/Director of home health; Clinical manager with the name of the current agency administrator. Review of the agency's policy titled "Madison Medical Center Home Health Agency Coordination of Patient Services" revised 01/20/2021 showed: - Coordination of patient services will be managed through the care team process; - Objectives of the care team are: * Improve the quality of patient care or maintain a high quality; * Improve and/or maintain communication among staff members; * Evaluate and update the patient care on an ongoing basis; * Evaluate the patient's plan of care and update or revise as necessary; and * Coordinate care with other involved organizations or individuals. Current findings showed the administrator/director of home health/clinical manager failed to: - Coordinate care of patients through a managed care team process; - Assure a complete and accurate plan of care; - Assure the physician was notified of falls and injuries of patients; - Assure physical therapy staff assessed falls and injuries and updated plans of care with changes of condition of the patient and any new orders received; - Assure communication between nursing staff and contracted physical therapy (PT) and contracted occupational therapy (OT) staff related to patient condition; - Assure the scheduling of contracted staff to make home visits and complete assessments and care of patients; and - Assure physical therapy and occupational therapy contract service agreements met and stated the qualifications specified by Federal regulations. During an interview on 09/22/2021 at 12:15 PM, the administrator/director of home health/clinical manager stated that: - He/she provided oversight of day to day activities of the agency; - He/she provided scheduling for nursing staff, made sure calls were made to the patients to know when a nurse would make a home visit, scheduled lab work if any, and sent out supplies for patients; - Assures that physicians sign orders even though the physicians sign the orders when they "get time;" - PT and OT do their own scheduling to see patients and he/she did not know what they were doing for patients unless she read their plans of care or visit notes; - He/she did not know when they were going to make visits because PT and OT did not leave a schedule for him/her; - There were times when PT wanted to see the patient before the skilled nursing admission assessment was performed; - PT calls the agency frequently but patient care is not discussed, only calls to make sure nursing is not in the patient's home; - Care is not coordinated with PT or OT unless it pertains to a dressing change; - Continual assessment is not done unless he/she is informed of issues because he/she does not see patients except to introduce him/herself; - If there is a problem, he/she would rather PT inform him/her and then PT to notify the physician for change of condition or orders; - He/she only made sure patients seen by nursing staff are continually assessed; - Why would he/she follow unless there is a problem with PT or OT? - He/she or nursing staff update plans of care for nursing only; he/she does not follow PT or OT at all; - He/she did not have time to monitor all patients, not enough hours in the day; - He/she did not keep personnel records of staff or contracted staff in the agency office; - Human resources at the hospital kept those records and he/she did not have access to them; - Hospital administration provided and kept PT and OT service agreements, he/she did not have access to those agreements; - He/she did not provide emergency preparedness training for staff, the hospital provided that training.

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on administrator job description, organizational chart review, policy review, and interview, the agency failed to ensure the administrator (who was the clinical manager) made patient and personnel assignments. This deficient practice has the potential to affect all patients and staff served by the agency. Findings included: The agency did not have a job description for clinical manager. Review of the "Madison Center, A Critical Access Hospital" "Administrator/Director of Home Health Job Description", "changed" 04/30/2018 (Administrator was hand written on the job description), showed: - Definition and role: This position is responsible for the planning, coordinating, everyday activities, staffing, and delivery of quality home health care and services to the patients in the communities served; - Responsibilities and duties: * Ensures that the patients served receive the highest quality of care; * Monitors the changing needs of the patients and/or family; * Monitors the skills and services if contracted staff; * Supervises the implementation of the physician's plan of care; * Coordinates the total plan of care with the appropriate resources; * Maintains an open line of communication with all staff members; * Maintains accurate patient and employee records to meet state regulations; * Provides staff with current knowledge of clinical changes; * Oversees all daily functions of the home health department and ensures that every effort is made to meet all client's needs; and * Knowledge of Medicare and Medicaid regulations required. Review of the hospital organizational chart dated May, 2018 showed: - Administrator of home health/Director of Home Health and Clinical Manager with the name of the current agency administrator. An interview with agency administrator on 09/20/2021 at 2:20 PM showed: - The current administrator said the agency did not have a clinical manager; and - He/she performed all the tasks of the clinical manager. Review of the agency's policy titled "Madison Medical Center Home Health Agency Coordination of Patient Services" revised 01/20/2021 showed: - Coordination of patient services will be managed through the care team process; - Objectives of the care team are: * Improve the quality of patient care or maintain a high quality; * Improve and/or maintain communication among staff members; * Evaluate and update the patient care on an ongoing basis; * Evaluate the patient's plan of care and update or revise as necessary; and * Coordinated care with other involved organizations or individuals. During an interview on 09/22/2021 at 12:00 PM the administrator stated that: - He/she is the administrator, case manager, director of nursing and takes care of Medicare patients in home; - "They might as well let him/her go" because he/she cannot do all that is required per the regulations of clinical manager (making patient and personnel assignments, coordinating patient care, assuring patient needs are continually assessed and assuring development, implementation and updates of the individual plan of care); and - He/she just does nursing and not PT; - PT calls and tells him/her what he/she is going to do and the administrator has no say over PT; - The PT department head is responsible for physical therapy and OT E is responsible for occupational therapy. These are contracted services; - There was no one who was overall responsible for the coordination of care, they are only responsible for their departments; - The physical therapy department head called him/her "a 100 times a day" to make sure the nurse is not in the patient's home; - He/she did not discuss with PT, OT, or ST the care of the patients; and - PT would see patients before nursing opens or performs the admission for patients.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on current survey findings with seven condition level deficiencies, and interview, it cannot be assured that the administrator (clinical manager and director of nursing) has effectively assumed responsibility for the overall supervision and direction of skilled professional services and actively participates in all activities relevant to the professional services furnished, including coordination of patient care. Findings include: Review of the agency's policy titled, "Coordination of Patient Services," revised 01/22/2021 showed, in part: - Coordination of patient services will be managed through the care team process; - To decrease "span" of control and increase the coordination of patient care, care teams were designed to have one supervisor and 4-6 primary nurses and other staff including physical therapy (PT), home health aides (HHA), social worker (SW), speech therapy (ST), and occupational therapy (OT), not to exceed 15 staff members total; - This design facilitates discussion and coordination of patient care; - Each clinical supervisor is responsible for the coordination of patient services; - Visit schedules will be planned by the clinical staff weekly and at care team meeting and will be reviewed by the clinical supervisor on a daily basis to ensure quality and continuity of care; - The clinical supervisors are responsible to ensure this policy; - The objectives of the care teams are: * Improve the quality of patient care or maintain a high quality; * Improve and/or maintain communication among staff members; * Evaluate and update patient care on an ongoing basis; * Evaluate the patient's plan of care and update or revise this as necessary; - Each team member will come to care team with care team report completed; - Report of patient problems will be discussed; - These objectives will be measured by review of daywork, open chart audits and summarized monthly and on a quarterly basis through the use of statistical data; and - All clinical staff are required to participate in care conferences with other disciplines involved in each individual case as often as necessary but at least once every month. Based on current survey findings, the clinical manager (director of home health and administrator) failed to: - Assure complete and accurate medication review completed by the registered nurse; - Assure a complete and accurate plan of care; and - Assure physical therapy services were provided in a manner to assure that the needs of the patients were adequately assessed/documented and in accordance with applicable nursing standards, and coordination of patient needs and changes in condition occurred. During an interview on 09/22/2021 at 12:00 PM the administrator stated that: - He/she is the administrator, case manager, director of nursing and takes care of Medicare patients in home; - "They might as well let him/her go" because he/she cannot do all that is required per the regulations of clinical manager (making patient and personnel assignments, coordinating patient care, assuring patient needs are continually assessed and assuring development, implementation and updates of the individual plan of care: and - He/she just does nursing and not PT; - PT calls and tells him/her what he/she is going to do and the administrator has no say over PT; - The PT department head is responsible for physical therapy and OT E is responsible for occupational therapy. These are contracted services; and - There was no one who was overall responsible for the coordination of care, they are only responsible for their departments.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on review of contract agreements and interviews, the agency failed to ensure contract agreements between the home health agency and the agencies contracted for services, contain all the information required by this regulation. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the Physical Therapy Services Agreement for the licensed physical therapist dated 01/09/2007 did not include information to show the individual providing services may not have been denied Medicare or Medicaid enrollment, been excluded or terminated from and Federal health care program or Medicaid, had its Medicare billing privileges revoked or been debarred from participating in any government program. Review of the Occupational Therapy Services Agreement for the licensed occupational therapist dated 10/01/2020 did not include information to show the individual providing services may not have been denied Medicare or Medicaid enrollment, been excluded or terminated from and Federal health care program or Medicaid, had its Medicare billing privileges revoked or been debarred from participating in any government program. Review of the Speech Therapy Services Agreement for the licensed physical therapist dated 01/17/1994 did not include information to show the individual providing services may not have been denied Medicare or Medicaid enrollment, been excluded or terminated from and Federal health care program or Medicaid, had its Medicare billing privileges revoked or been debarred from participating in any government program. During an interview on 09/22/2021 at 12:15 PM, the administrator/director of home health/clinical manager stated that: - Hospital administration provided and kept PT, OT, and ST Service Agreements; he/she did not have access to those agreements.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on state law, the agency policy, employee file review, and interview, the agency failed to ensure all staff had the Employee Disqualification List (EDL) checked prior to hire for four (Employee #1, #2, #3, and #4) of five employee files reviewed, failed to ensure the Criminal Disclosure Statement was obtained prior to hire for four (Employee #1, #2, #3, and #4) of five employee files reviewed, and failed to ensure all staff had the Family Care Safety Registry (FCSR) checked prior to date of first patient contact, in five (Employee #1, #2, #3, #4, and #5) of five employee files reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of Section 192.2490.12 RSMo: "No person, corporation, organization, or association who received the employee disqualification list under subdivisions (1) and (7) of subsection 11 of this section shall knowingly employ any person who is on the employee disqualification list." Review of Section 192.2495.5 RSMo: An applicant for a position to have a contract with patients or residents of a provider shall: - (1) Sign a consent form as required by Section 43.540 so the provider may request a criminal records review; - (2) Disclose the applicant's criminal history. For the purposes of the subdivision "criminal history" includes any conviction or a plea of guilty to a misdemeanor or felony charge and shall include any suspended imposition of sentence, any execution of sentence or any period of probation or parole; - (3) Disclose if the applicant is listed on the employee disqualification list as provided in section 192.2490; and - (4) Disclose if the applicant is listed on any of the background checks in the family care safety registry established under section 210.903. A provider not otherwise prohibited from employing an individual listed on such background checks may deny employment to an individual listed on any of the background checks in such registry. Review of Section 192.2495.6, RSMo: "A provider is guilty of a Class A misdemeanor if the provider knowingly hires or retains person to have contact with patients or residents and the person has been found guilty in this state or any other states or has been found guilty of a crime, which if committed in Missouri would be a Class A or B felony violation of Chapter 565, 566, or 569, or any violation of Subsection 4 of section 198.070 or section 568.020." Review of the agency's policy titled Madison Medical Center, A Critical Access Hospital, Stockhoff Memorial Nursing Home/Home Health Agency Employee Disqualification List Check Procedure revised 06/11/2018 showed: - If the applicant is not registered with the Family Care Safety Registry that provides EDL status, a separate check of the EDL list must be performed prior to the date of hire; - Enter the social security number (SSN) of the applicant; - If the applicant is not on the EDL list, it will display "SSN not found on the EDL" as the message, and a confirmation number will be given. Print this page and include in the applicant's file; - If the SSN is found on the EDL, verify that the SSN was entered correctly. If so, the applicant may not be employed at the Madison Medical Center due to state regulation. Review of the agency's policy titled "Madison Medical Center, A Critical Access Hospital, Stockhoff Memorial Nursing Home/Home Health Agency, Family Care Safety Registry Check Policy and Procedure" reviewed 06/11/2018 showed: - According to MO Revised Statutes Chapter 660, Department of Social Services, Section 660.317, Hiring Restrictions, all providers are responsible for requesting FCSR criminal background screenings on all prospective employees; - For home health employees: If the applicant is not on the EDL, their criminal background check does not reveal a disqualifying class A or B felony, and their employment application does not indicate a criminal offense that would prohibit employment, the applicant may be hired pending the outcome of the FCSR screening. EMPLOYEE #1 (E1): Review of the E1's personnel file showed: - Registered nurse (RN): - Date of hire: July, 2001; - Date of first patient contact: None documented; - Failed to show a Criminal Disclosure Statement prior to hire; - Failed to show EDL results prior to hire; and - Failed to show FCSR results prior to patient contact. EMPLOYEE #2 (E2): Review of the E2's personnel file showed: - Licensed practical nurse (LPN); - Date of hire: June, 2005; - Date of first patient contact: None documented; - Failed to show a Criminal Disclosure Statement prior to hire; - Failed to show EDL results prior to hire; and - Failed to show FCSR results prior to patient contact. EMPLOYEE #3 (E3): Review of the E3's personnel file showed: - Certified Nurse Assistant (CNA); - Date of hire: 03/03/2009; - Date of first patient contact: None documented; - Failed to show a Criminal Disclosure Statement prior to hire; - Failed to show EDL results prior to hire; and - Failed to show FCSR results prior to patient contact. EMPLOYEE #4 (E4): Review of the E4's personnel file showed: - Physical therapist (PT); - Date of hire: 12/16/2002; - Date of first patient contact: 12/16/2002; - Criminal disclosure statement: 04/17/2007, five (5) years after hire date; - EDL results: 04/10/2007, five (5) years after hire date; - FCSR results: 08/16/2004, two (2) years after hire date/ patient contact. EMPLOYEE #5 (E5): Review of the E5's personnel file showed: - Certified occupational therapy assistant (COTA): - Date of hire: 12/23/2016: - Date of first patient contact: 10/06/2017; - Criminal disclosure statement: 12/28/2016, five (5) days after hire; - EDL results: 01/04/2017; one (1) year after hire date; - Failed to show FCSR results prior to hire. During an interview on 09/22/2021, the administrator stated that: - He/she did not keep personnel records in the home health agency office; - Employee personnel files were kept in the hospital human resources office and he/she was not allowed to access them; - The occupational therapist (OT) was contracted, owned the OT company, and kept all of the his/her and the COTA's personnel information at his/her place of business; - The PT was contracted and owned the PT company, and kept all of his/her and PT assistants personnel information at his/her place of business; and - The OT said the COTA did not start seeing home health patient's until 10/26/2017.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on agency policy, record review, review of Condition of Participation Interpretive Guidelines, and interview, the agency failed to ensure the medication list was sent with the transfer summary within five business days of a planned transfer to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge in one (Record/Patient #6) of two discharge records reviewed. This deficient practice has the potential to affect all discharged or transferred patients served by the agency. Findings included: Review of the agency's policy titled, "Discharge/Transfer," showed in part, the discharge summary shall be sent to the primary care physician or other health care professional responsible for providing care and services to the patient after discharge from the home health agency within 5 business days of the patient's discharge. Review of 484.110(a)(6)(i)-(iii) Interpretive Guidelines showed in part: Discharge/transfer summaries typically contain the following items: - Medications the patient is on at the time of discharge RECORD/PATIENT #6: Review of the clinical record showed physical therapy discharged the patient on 07/08/2021; the physical therapy discharge note failed to include a list of the patient's current medications. During an interview with the administrator/director of nursing on 09/22/2021 at 12:00 PM, stated the discharge summary did not include a medication list.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on policy review, record review and interview, the agency failed to ensure all documented entries included appropriate authentication that included, the time the plans of care were completed, the plan of care signed by the nurse, plans of care dated by the physician, and time the visits were completed in, but not limited to, two (Record/Patient #1 and #2) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled "Clinical Record Policy", dated 1/20/2021 showed clinical notes are made on each patient each visit and are signed and dated with the time in/out by the staff person making the visit. RECORD/PATIENT #1: Review of all clinical records showed all plans of care (485's) failed to include a signature of the registered nurses who completed the plans of care. Review of the patient's clinical visit notes showed the doctor of physical therapy (DPT), the physical therapist (PT) department head, and physical therapy assistant (PTA) A, failed to include the time the visits were completed. RECORD/PATIENT #2: The plan of care dated 05/27/2021 to 07/25/2021 showed the nurse failed to sign his/her name. The plan of care dated 07/26/2021 to 09/23/2021 showed the physician failed to provide a date he/she signed the plan of care. Review of the patient's clinical visit notes showed the DPT, the PT department head, and PTA A, failed to include the time the visits were completed. During an interview on 09/22/2021 at 12:00 PM, the administrator said therapy records the date of the visit on the visit note and someone types up the note. Physical therapy was usually behind two to three weeks getting their notes to sign. They put the date of the visit but don't date and time when they get the visit note back. This could be two to three weeks. He/she expected all notes to be dated and timed and dated and timed when the note is signed.