Every finding on record at Shiloh Homecare Corporation

Based on the findings of an onsite unannounced home health agency Medicare recertification survey-initiated January 8, 2024, through January 11, 2024, and completed off-site January 26, 2024, Comforcare Home Care, was found not to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness. As a result of the survey, one (1) condition level deficiency was cited at: 484.12 Establishment of the Emergency Program (EP) and nine (9) standard level deficiencies were cited. No immediate jeopardy situation was identified.

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on review of Agency documentation and interview with agency Administrator the agency failed to develop, in writing, an emergency preparedness program based on an all-hazards approach individualized to their specific provider type as required. Cross Reference: 484.102(a)-Develop EP plan, review and update annually--Tag 0004--the agency failed to ensure that the emergency preparedness plan was updated with change of director of nursing for one (1) of one (1) plan reviewed. EP #1. 484.102(a)(1)-(2)—plans based on all hazards risk assessment—tag 0006--the agency failed to ensure the emergency plan was specific for the current location and based on an all hazards risk assessment for one (1) of one (1) plan reviewed. EP #1. 484.102(a)(3)—EP program patient population—tag 0007--the agency failed to ensure the emergency plan was specific for the current location and addressed patient/client population for one (1) of one (1) plan reviewed. EP #1. 484.102(a)(4)—local, state and tribal collaboration process—tag 0009--the agency failed to ensure the emergency plan was specific for the current location and establishment of a relationship with a communitywide emergency management program for one (1) of one (1) plan reviewed. EP #1. 484.102(b)—Development of Ep policies and procedures-tag 0013- Based on review of emergency plan and interview with agency Administrator the agency failed to ensure the emergency plan was specific for the current location for one (1) of one (1) plan reviewed. EP #1. 484.102(b)(1)—Hha comprehensive assessment in disaster—tag 0017--the agency failed to ensure the emergency plan was specific for the current location for one (1) of one (1) plan reviewed. EP #1. 484.102(b)(2)—Homebound Hha/hospice inform EP officials—tag 0019-- the agency failed to ensure the emergency plan was specific for the current location and notification of emergency management officials was completed for one (1) of one (1) plan reviewed. EP #1. 484.102(b)(3)—Hha-procedures for follow up staff/pts—tag 0021--the agency failed to ensure the emergency plan was specific for the current location and development of a follow-up procedure for on-duty staff to determine need for services and informing state and/or local officials of any on-duty staff or patients that they are unable to contact for one (1) of one (1) plan reviewed. EP #1. 484.102(b)(4)—policies/procedures for medical documentation—tag 0023--the agency failed to ensure the emergency plan was specific for the current location and development of a procedure for a system of medical documentation that preserves …protects confidentiality…and secures and maintains the availability of records for one (1) of one (1) plan reviewed. EP #1. 484.102(b)(5)—policies/procedures for—volunteers and staffing—tag 0024--the agency failed to ensure the emergency plan was specific for the current location and development of a procedure for use of volunteers in an emergency or other emergency staffing strategies for one (1) of one (1) plan reviewed. EP #1. 484.102(c)- development of communication plan—tag 0029--the agency failed to ensure the emergency plan was specific for the current location and establishment of an emergency communication plan pertaining to coordination of patient care with state and local public health departments or of a relationship with a communitywide emergency management program for one (1) of one (1) plan reviewed. EP #1. 484.102© (1)—names and contact information ---tag 0030--the agency failed to ensure the emergency plan was specific for the current location and the agency failed to ensure that the emergency preparedness plan was updated with change of director of nursing for one (1) of one (1) plan reviewed. EP #1. 484.102©(2)—Emergency officials contact information –tag 0031--the agency failed to ensure the emergency plan was specific for the current location and a communication plan was established with state and local emergency management officials was completed for one (1) of one (1) plan reviewed. EP #1 484.102©(3)—Primary/alternate means for communication—tag 0032-- the agency failed to ensure the emergency plan was specific for the current location and development of a communication plan to identify primary and alternates means for communicating with staff and emergency management agencies for one (1) of one (1) plan reviewed. EP #1. 484.102©(4)-(5)—methods for sharing information—tag 0033--the agency failed to ensure the emergency plan was specific for the current location and development of a method for sharing information and medical documentation for patients with other health providers to maintain continuity of care for one (1) of one (1) plan reviewed. EP #1. 484.102© (6)—information on occupancy/needs—tag 0034-- the agency failed to ensure the emergency plan was specific for the current location and development of a means for providing information about the agency’s ability to provide assistance, to the authority having jurisdiction, the incident command center, during an emergency for one (1) of one (1) plan reviewed. EP #1. 484.102(d)—EP training and testing—tag 0036--the agency failed to ensure the emergency plan was specific for the current location and development of emergency preparedness training and testing program for one (1) of one (1) plan reviewed. EP #1. 484.102(d)(1)—EP training program—tag 0037--the agency failed to ensure the emergency plan was specific for the current location and documentation of all emergency training and demonstration of staffs’ knowledge of emergency procedures for one (1) of one (1) plan reviewed. EP #1. 484.102(d)(2)—EP testing requirements—tag 0039--the agency failed to ensure the emergency plan was specific for the current location and documentation of the agency conducting exercises to test the emergency plan on an annual basis for one (1) of one (1) plan reviewed. EP #1. Findings include:

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on review of emergency plan and interview with agency Administrator the agency failed to ensure the establishment of an emergency plan based on an all-hazards risk assessment for one (1) of one (1) plan reviewed. EP #1. Review of Comforcare Home Care Emergency Management plan policy on 1/26/24 at 10:10 AM revealed: Policy: “the agency will have an identified Emergency Management Plan in place to ensure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupt agency services. The agency conducts an annual risk assessment to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services." Review of the agency's emergency preparedness plan on January 10, 2024 at 2:30 PM revealed: 1. Emergency preparedness plan did not contain an emergency preparedness plan based on an all-hazards risk assessment. Emergency preparedness plan did not contain employee or client lists, no alternate work site for agency and no documentation of emergency drills performed. 2. Interview with Agency Administrator on January 10, 2024 at 2:00 PM revealed: “I’m not going to sugar coat it, we have our emergency preparedness policy but not much else. “ An interview with the Agency Administrator on January 10, 2024 at 2:30 PM confirmed the above findings

EP Program Patient Population CFR(s): 484.102(a)(3) §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: ["Persons at risk" does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This STANDARD is not met as evidenced by: Based on review of emergency plan and interview with agency Administrator the agency failed to establish an emergency plan based on the agency patient population for one (1) of one (1) plan reviewed. EP #1. Review of Comforcare Home Care Emergency Management plan policy on 1/26/24 at 10:10 AM revealed: Policy: “the agency will have an identified Emergency Management Plan in place to ensure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupt agency services. The agency conducts an annual risk assessment to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services. Purpose: “To establish guidelines for client care during periods of emergency or disaster. " Review of the agency's emergency preparedness plan on January 10, 2024 at 2:30 PM revealed: 1. Emergency preparedness plan did not contain an emergency preparedness plan based on an all-hazards risk assessment. Emergency preparedness plan did not contain employee or client lists, no alternate work site for agency and no documentation of emergency drills performed. 2. Interview with Agency Administrator on January 10, 2024 at 2:00 PM revealed: “I’m not going to sugar coat it, we have our emergency preparedness policy but not much else. “ An interview with the Agency Administrator on January 10, 2024 at 2:30 PM confirmed the above findings.

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), §485.542(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 emergency plan and interview with agency Administrator the agency failed to establish a relationship with a communitywide emergency management program for one (1) of one (1) plan reviewed. EP #1. Review of Comforcare Home Care Emergency Management plan policy on 1/26/24 at 10:10 AM revealed: Policy: “the agency will have an identified Emergency Management Plan in place to ensure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupt agency services. The agency conducts an annual risk assessment to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services. Purpose: “To establish guidelines for client care during periods of emergency or disaster. To provide direction and instruction for staff to follow in the event of a life threatening or potentially life-threatening situation that disrupts delivery of home care services.” “To establish a structure that identifies the agency’s relationship to a communitywide emergency management program.” Review of the agency's emergency preparedness plan on January 10, 2024 at 2:30 PM revealed: 1. Emergency preparedness plan did not contain an emergency preparedness plan based on an all-hazards risk assessment. Emergency preparedness plan did not contain employee or client lists, no alternate work site for agency and no documentation of emergency drills performed. 2. Interview with Agency Administrator on January 10, 2024 at 2:00 PM revealed: “I’m not going to sugar coat it, we have our emergency preparedness policy but not much else. “ An interview with the Agency Administrator on January 10, 2024 at 2:30 PM confirmed the above findings.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on review of emergency plan and interview with agency Administrator the agency failed to develop policies and procedures for an agency-wide emergency preparedness program for one (1) of one (1) plan reviewed. EP #1. Review of Comforcare Home Care Emergency Management plan policy on 1/26/24 at 10:10 AM revealed: Policy: “the agency will have an identified Emergency Management Plan in place to ensure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupt agency services. The agency conducts an annual risk assessment to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services. Purpose: “To establish guidelines for client care during periods of emergency or disaster. To provide direction and instruction for staff to follow in the event of a life threatening or potentially life-threatening situation that disrupts delivery of home care services.”; Procedure: 2. Reviews will be held at least annually; 3. A listing of all staff members and telephone numbers will be included in the plan. 13. “In the event of damage to the office, the Administrator will make arrangements for an alternate location to conduct business activities. 17. “All administrative emergency or disaster activities will be documented…” Review of the agency's emergency preparedness plan on January 10, 2024 at 2:30 PM revealed: 1. Emergency preparedness plan did not contain an emergency preparedness plan based on an all-hazards risk assessment. Emergency preparedness plan did not contain employee or client lists, no alternate work site for agency and no documentation of emergency drills performed. 2. Interview with Agency Administrator on January 10, 2024 at 2:00 PM revealed: “I’m not going to sugar coat it, we have our emergency preparedness policy but not much else. “ An interview with the Agency Administrator on January 10, 2024 at 2:30 PM confirmed the above findings.

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 emergency plan and interview with agency Administrator the agency failed to ensure a follow-up procedure for on-duty staff to determine a need for services and informing state and/or local officials of any on-duty staff or patients that they are unable to contact for one (1) of one (1) plan reviewed. EP #1. Review of Comforcare Home Care Emergency Management plan policy on 1/26/24 at 10:10 AM revealed: Policy: “the agency will have an identified Emergency Management Plan in place to ensure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupt agency services. The agency conducts an annual risk assessment to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services. Purpose: “To establish guidelines for client care during periods of emergency or disaster. To provide direction and instruction for staff to follow in the event of a life threatening or potentially life-threatening situation that disrupts delivery of home care services.”; Procedure: 2. Reviews will be held at least annually; 3. A listing of all staff members and telephone numbers will be included in the plan. 7. “Clients dependent on medical equipment that is necessary for maintaining life support should have battery pack backup available. Local authorities should be notified of these client’s high risk status at the time of admission.” 9. “In the event of a weather emergency or lack of public transportation, every effort will be made by the agency to provide vehicles or transportation of employees to client homes. Local police, highway patrol, and sheriff’s offices will be notified of clients with specific and imminent needs requiring services from agency staff.” 13. “In the event of damage to the office, the Administrator will make arrangements for an alternate location to conduct business activities. 17. “All administrative emergency or disaster activities will be documented…” Review of the agency's emergency preparedness plan on January 10, 2024 at 2:30 PM revealed: 1. Emergency preparedness plan did not contain an emergency preparedness plan based on an all-hazards risk assessment. Emergency preparedness plan did not contain employee or client lists, no alternate work site for agency and no documentation of emergency drills performed. 2. Interview with Agency Administrator on January 10, 2024 at 2:00 PM revealed: “I’m not going to sugar coat it, we have our emergency preparedness policy but not much else. “ An interview with the Agency Administrator on January 10, 2024 at 2:30 PM confirmed the above findings.

Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(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:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This STANDARD is not met as evidenced by: Based on review of emergency plan and interview with agency Administrator the agency failed to development a procedure for a system of medical documentation that preserves …protects confidentiality…and secures and maintains the availability of records for one (1) of one (1) plan reviewed. EP #1. Review of Comforcare Home Care Emergency Management plan policy on 1/26/24 at 10:10 AM revealed: Policy: “the agency will have an identified Emergency Management Plan in place to ensure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupt agency services. The agency conducts an annual risk assessment to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services. Purpose: “To establish guidelines for client care during periods of emergency or disaster. To provide direction and instruction for staff to follow in the event of a life threatening or potentially life-threatening situation that disrupts delivery of home care services.” “To establish a structure that identifies the agency’s relationship to a communitywide emergency management program.”; Procedure: 2. Reviews will be held at least annually; 3. A listing of all staff members and telephone numbers will be included in the plan. 13. “In the event of damage to the office, the Administrator will make arrangements for an alternate location to conduct business activities. A defined plan will be established will be established to allow for safe, confidential transfer of client records and personnel files.” Review of the agency's emergency preparedness plan on January 10, 2024 at 2:30 PM revealed: 1. Emergency preparedness plan did not contain an emergency preparedness plan based on an all-hazards risk assessment. Emergency preparedness plan did not contain employee or client lists, no alternate work site for agency and no documentation of emergency drills performed. No documentation of a system to maintain a medical record documentation system. 2. Interview with Agency Administrator on January 10, 2024 at 2:00 PM revealed: “I’m not going to sugar coat it, we have our emergency preparedness policy but not much else. “ An interview with the Agency Administrator on January 10, 2024 at 2:30 PM confirmed the above findings.

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), §485.542(b)(6), §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 emergency plan and interview with agency Administrator the agency failed develop a procedure for use of volunteers in an emergency or other emergency staffing strategy for one (1) of one (1) plan reviewed. EP #1. Review of Comforcare Home Care Emergency Management plan policy on 1/26/24 at 10:10 AM revealed: Policy: “the agency will have an identified Emergency Management Plan in place to ensure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupt agency services. The agency conducts an annual risk assessment to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services. Purpose: “To establish guidelines for client care during periods of emergency or disaster. To provide direction and instruction for staff to follow in the event of a life threatening or potentially life-threatening situation that disrupts delivery of home care services.”; Procedure: 2. Reviews will be held at least annually; 3. A listing of all staff members and telephone numbers will be included in the plan. 13. “In the event of damage to the office, the Administrator will make arrangements for an alternate location to conduct business activities. 17. “All administrative emergency or disaster activities will be documented…” Review of the agency's emergency preparedness plan on January 10, 2024 at 2:30 PM revealed: 1. Emergency preparedness plan did not contain an emergency preparedness plan based on an all-hazards risk assessment. Emergency preparedness plan did not contain employee or client lists, no alternate work site for agency and no documentation of emergency drills performed. 2. Interview with Agency Administrator on January 10, 2024 at 2:00 PM revealed: “I’m not going to sugar coat it, we have our emergency preparedness policy but not much else. “ An interview with the Agency Administrator on January 10, 2024 at 2:30 PM confirmed the above findings.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on review of emergency plan and interview with agency Administrator the agency failed to develop an emergency preparedness training and testing program for one (1) of one (1) plan reviewed. EP #1. Review of Comforcare Home Care Emergency Management plan policy on 1/26/24 at 10:10 AM revealed: Policy: “the agency will have an identified Emergency Management Plan in place to ensure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupt agency services. The agency conducts an annual risk assessment to identify potential emergencies and the direct and indirect effects these emergencies may have on agency operations and the demand for services. Purpose: “To establish guidelines for client care during periods of emergency or disaster. To provide direction and instruction for staff to follow in the event of a life threatening or potentially life-threatening situation that disrupts delivery of home care services.”; Procedure: 2. Reviews will be held at least annually; 3. A listing of all staff members and telephone numbers will be included in the plan. 13. “In the event of damage to the office, the Administrator will make arrangements for an alternate location to conduct business activities. 17. “All administrative emergency or disaster activities will be documented…” Review of the agency's emergency preparedness plan on January 10, 2024 at 2:30 PM revealed: 1. Emergency preparedness plan did not contain an emergency preparedness plan based on an all-hazards risk assessment. Emergency preparedness plan did not contain employee or client lists, no alternate work site for agency and no documentation of emergency drills performed. 2. Interview with Agency Administrator on January 10, 2024 at 2:00 PM revealed: “I’m not going to sugar coat it, we have our emergency preparedness policy but not much else. “ An interview with the Agency Administrator on January 10, 2024 at 2:30 PM confirmed the above findings.

Based on the findings of an onsite unannounced home health agency Medicare recertification and state re-licensure survey-initiated January 8, 2024, through January 11, 2024, and completed off-site January 26, 2024, Comforcare Home Care, was found not to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies. As a result of the survey, four (4) condition level deficiencies were cited at: 484.58 Discharge Planning, 484.65 Quality Assessment and Performance Improvement, 484.105 Organization and Administration of Services and 484.110 Clinical Records along with fifteen (15) standard level deficiencies. No immediate jeopardy situation was identified.

Treatment or care CFR(s): 484.50(e)(1)(i)(A) (i)(A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; and This ELEMENT is not met as evidenced by: Based on review of medical records (MR), policies/procedures and interview with the Agency Administrator and director of nursing, the agency failed to ensure medical records contained adequate and complete documentation. The agency failed to ensure that treatment or care was furnished appropriately for three (3) of six (6) records reviewed. ( MR #1-3); the agency failed to ensure that discharge summaries and/or transfer summaries were maintained in the medical record for one (1) of six (6) records reviewed. (MR # 6) Findings include: Review of Comforcare Home Care client record content policy on 1/26/24 at 10:35 AM revealed: Policy: “A client record will be maintained for every client…in accordance with state law and agency policy.” Purpose: “To maintain an accurate record of the services provided by the agency for each client.” Procedure: 3. The client record shall contain appropriate identifying information, including, but not limited to: plan of care, physician orders, visit schedule/frequency, transfer and discharge summaries.” Review of Comforcare Home Care Plan of care policy on 1/26/24 at 7:53 AM revealed: Policy: “Private duty nursing/skilled nursing services are furnished under the supervision and direction of the client’s physician; the plan will be consistently reviewed to ensure client needs are met, and will be updated as necessary, but at least every sixty (60) days.”; Purpose: “To provide guidelines for agency staff to develop a plan of care individualized to meet specific identified needs; to assure that the plan meets state/federal guidelines, and all applicable laws and regulations.” Procedure: “1. An individualized plan of care signed by a physician shall be required for each client….; 4. The plan of care is developed within five (5) working days or as required by agency/state guidelines. The written plan of care must be signed by the physician within thirty (30) days and returned to the agency.” Review of Comforcare Home Care Missed Visits policy on 1/26/24 at 8:14 AM revealed: Policy: “Missed visits that result in services provided not matching the ordered frequency of care within one agency defined standard work week will be communicated to the Manager of care services and the client’s physician…; all missed visits will be documented in the client record. The agency will have a system in place to respond to any anticipated or unanticipated missed shifts.”; Purpose: “To ensure that missed visits are documented and to monitor the effect of missed visits on client care.”; Definition: “A missed visit occurs when agency staff are unable to meet the frequency of care that is outline on the plan of care within the agency defined standard work week.” Procedure: “1. Direct care staff will notify the agency immediately upon knowing that they will not be able to provide a planned visit.; 4. All missed visits will be documented in the client record. Documentation will include: a. date and time of missed visit; e. physician notification of the missed visit, if missed visit results in non-adherence to a physician ordered frequency for care.” Review of Comforcare Home Care client discharge process policy on 1/26/24 at 9:43 AM revealed: Policy: “Discharge planning is initiated for every client at the time of the client’s admission for home care.” Purpose: “To ensure continuity of care, treatment and services when needed. To assure collaboration with the physician, client and/or representative, family and other disciplines in planning for discharge…; to record a discharge summary of care received by the client from start of care through discharge; to document client status at the time of discharge, unmet needs, and referrals initiated.; to document instructions given to the client/family regarding medications, treatment, and necessary follow-up.”; Procedure: 6. “The manager of care services/designee shall review the client record to assure accuracy and completion. A discharge plan shall be developed that is documented…; 8. “Upon discharge to self-care, the client will receive verbal/written information regarding…any procedures/treatments to be performed, and follow-up visits for physician care; 9. “To avoid charges of abandonment at the time of discharge agency documentation will include the following: a. evidence that the decision was not made unilaterally…”; 10. “A discharge summary will be completed on all client discharges…” Review of medical records (MR) conducted 1/8/24 from 10:30 AM-1:45 PM and 1/10/24 from 10:15 AM-11:45 AM revealed: Medical record (MR) # 1: Start of care (SOC): 7/20/21; certification period: 11/14/23-1/12/24; Skilled Nurse (SN) frequency ordered fifty-two and a half (52.5) hours per week usually seven (7)- ten (10) hours a day for nine (9) weeks. Missed visits for 11/23/23, 11/30/23. 12/1/23 and 12/25/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 2: SOC: 10/20/16; certification period: 12/11/23-2/8/24; SN frequency ordered forty-eight (48) hours per week for nine (9) weeks. Missed visits for 12/12/23, 12/15/23, 12/19/23, 12/22/23, 12/25/23 and 12/31/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 3: SOC: 9/2/21; certification period per approval from service coordinator: 11/10/23-1/11/24; no plan of care on chart for 11/10/23-1/11/24; last certification period plan of care for 9/26/23-11/24/23 noted on chart but no physician signature as of 1/8/24. (one hundred and seven (107) days. Missed visits for 11/28/23, 12/5/23, 12/12/23, 12/19/23, 12/26/23, 12/27/23,12/30/23, and 1/2/24 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 6; SOC: 2/24/20; Discharged: 7/31/23; admitting diagnosis: DiGeorge’s syndrome, appendico-vesicostomy status, idiopathic scoliosis, unspecified algoneurodystrophy (a complex regional pain syndrome- a form of chronic pain that usually affects an arm or a leg); no documentation of discharge orders, discharge summary sent to physician or discharge instructions given to client’s family. An interview conducted with the Agency Administrator and director of nursing on January 11, 2024 at approximately 3:30 PM revealed: “the client was discharged from the agency due to moving out of the state around the end of July.” An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings. A telephone interview conducted with the agency director of nursing on January 16, 2024 at 2:00 PM revealed: “We looked through MR # 6 chart both the paper chart and the electronic chart and can’t find any documentation about the discharge.” A telephone interview conducted with agency administrator on January 26, 2024 at approximately 1:50 PM reconfirmed the above findings.

Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This CONDITION is not met as evidenced by: Based on review of policy/procedures, medical records (MR) and interview with the staff (EMP), the agency failed to ensure that discharge planning was completed and documented in the medical record for one (1) of six (6) records reviewed. (MR # 6); the agency failed to ensure that discharge summaries and/or transfer summaries were created and maintained in the medical record for one (1) of six (6) records reviewed. (MR # 6) Findings: Cross Reference: 484.58 (a)Discharge Planning Tag 0562-- the agency failed to ensure that discharge planning was completed and documented in the medical record for one (1) of six (6) records reviewed 484.58 (b) (1) Discharge or transfer summary content-- the agency failed to ensure that discharge summaries and/or transfer summaries were created and maintained in the medical record for one (1) of six (6) records reviewed. (MR # 6)

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on review of policy/procedures, medical records (MR) and interview with the staff (EMP), the agency failed to ensure that discharge planning was completed and documented in the medical record for one (1) of six (6) records reviewed. (MR # 6) Findings include: Review of Comforcare Home Care client discharge process policy on 1/26/24 at 9:43 AM revealed: Policy: “Discharge planning is initiated for every client at the time of the client’s admission for home care.” Purpose: “To ensure continuity of care, treatment and services when needed. To assure collaboration with the physician, client and/or representative, family and other disciplines in planning for discharge…; to record a discharge summary of care received by the client from start of care through discharge; to document client status at the time of discharge, unmet needs, and referrals initiated.; to document instructions given to the client/family regarding medications, treatment, and necessary follow-up.”; Procedure: 6. “The manager of care services/designee shall review the client record to assure accuracy and completion. A discharge plan shall be developed that is documented…; 8. “Upon discharge to self-care, the client will receive verbal/written information regarding…any procedures/treatments to be performed, and follow-up visits for physician care; 9. “To avoid charges of abandonment at the time of discharge agency documentation will include the following: a. evidence that the decision was not made unilaterally…”; 10. “A discharge summary will be completed on all client discharges…” Review of Comforcare Home Care client record content policy on 1/26/24 at 10:35 AM revealed: Policy: “A client record will be maintained for every client…in accordance with state law and agency policy.” Purpose: “To maintain an accurate record of the services provided by the agency for each client.” Procedure: 3. The client record shall contain appropriate identifying information, including, but not limited to: plan of care, physician orders, visit schedule/frequency, transfer and discharge summaries.” MR # 6; SOC: 2/24/20; Discharged: 7/31/23; admitting diagnosis: DiGeorge’s syndrome, appendico-vesicostomy status, idiopathic scoliosis, unspecified algoneurodystrophy (a complex regional pain syndrome- a form of chronic pain that usually affects an arm or a leg); no documentation of discharge orders, discharge summary sent to physician or discharge instructions given to client’s family. An interview conducted with the Agency Administrator and director of nursing on January 11, 2024 at approximately 3:30 PM revealed: “the client was discharged from the agency due to moving out of the state around the end of July.” An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings. A telephone interview conducted with the agency director of nursing on January 16, 2024 at 2:00 PM revealed: “We looked through MR # 6 chart both the paper chart and the electronic chart and can’t find any documentation about the discharge.” A telephone interview conducted with agency administrator on January 26, 2024 at approximately 1:50 PM reconfirmed the above findings.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on review of policy/procedures, medical records (MR) and interview with the staff (EMP), the agency failed to ensure that discharge summaries and/or transfer summaries were created and maintained in the medical record for one (1) of six (6) records reviewed. (MR # 6) Findings include: Review of Comforcare Home Care client discharge process policy on 1/26/24 at 9:43 AM revealed: Policy: “Discharge planning is initiated for every client at the time of the client’s admission for home care.” Purpose: “To ensure continuity of care, treatment and services when needed. To assure collaboration with the physician, client and/or representative, family and other disciplines in planning for discharge…; to record a discharge summary of care received by the client from start of care through discharge; to document client status at the time of discharge, unmet needs, and referrals initiated.; to document instructions given to the client/family regarding medications, treatment, and necessary follow-up.”; Procedure: 6. “The manager of care services/designee shall review the client record to assure accuracy and completion. A discharge plan shall be developed that is documented…; 8. “Upon discharge to self-care, the client will receive verbal/written information regarding…any procedures/treatments to be performed, and follow-up visits for physician care; 9. “To avoid charges of abandonment at the time of discharge agency documentation will include the following: a. evidence that the decision was not made unilaterally…”; 10. “A discharge summary will be completed on all client discharges…” Review of Comforcare Home Care client record content policy on 1/26/24 at 10:35 AM revealed: Policy: “A client record will be maintained for every client…in accordance with state law and agency policy.” Purpose: “To maintain an accurate record of the services provided by the agency for each client.” Procedure: 3. The client record shall contain appropriate identifying information, including, but not limited to: plan of care, physician orders, visit schedule/frequency, transfer and discharge summaries.” MR # 6; SOC: 2/24/20; Discharged: 7/31/23; admitting diagnosis: DiGeorge’s syndrome, appendico-vesicostomy status, idiopathic scoliosis, unspecified algoneurodystrophy (a complex regional pain syndrome- a form of chronic pain that usually affects an arm or a leg); no documentation of discharge orders, discharge summary sent to physician or discharge instructions given to client’s family. An interview conducted with the Agency Administrator and director of nursing on January 11, 2024 at approximately 3:30 PM revealed: “the client was discharged from the agency due to moving out of the state around the end of July.” An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings. A telephone interview conducted with the agency director of nursing on January 16, 2024 at 2:00 PM revealed: “We looked through MR # 6 chart both the paper chart and the electronic chart and can’t find any documentation about the discharge.” A telephone interview conducted with agency administrator on January 26, 2024 at approximately 1:50 PM reconfirmed the above findings.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on review of medical records (MR), policies/procedures and interview with the Agency Administrator and director of nursing, the agency failed to ensure clients had a current plan of care in the medical record for one (1) of six (6) records reviewed. (MR # 3) Findings Include: Review of Comforcare Home Care Plan of care policy on 1/26/24 at 7:53 AM revealed: Policy: “Private duty nursing/skilled nursing services are furnished under the supervision and direction of the client’s physician; the plan will be consistently reviewed to ensure client needs are met, and will be updated as necessary, but at least every sixty (60) days.”; Purpose: “To provide guidelines for agency staff to develop a plan of care individualized to meet specific identified needs; to assure that the plan meets state/federal guidelines, and all applicable laws and regulations.” Procedure: “1. An individualized plan of care signed by a physician shall be required for each client….; 4. The plan of care is developed within five (5) working days or as required by agency/state guidelines. The written plan of care must be signed by the physician within thirty (30) days and returned to the agency.” Review of medical records (MR) conducted 1/8/24 from 10:30 AM-1:45 PM and 1/10/24 from 10:15 AM-11:45 AM revealed: MR # 3: SOC: 9/2/21; certification period per approval from service coordinator: 11/10/23-1/11/24; no plan of care on chart for 11/10/23-1/11/24; last certification period plan of care for 9/26/23-11/24/23 noted on chart but no physician signature as of 1/8/24. (one hundred and seven (107) days) An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of medical records (MR), policies/procedures and interview with the Agency Administrator and director of nursing, the agency failed to ensure compliance with the physician's orders for one (1) of one (1) medical record review. (MR # 3) Findings Include: Review of Comforcare Home Care Plan of care policy on 1/26/24 at 7:53 AM revealed: Policy: “Private duty nursing/skilled nursing services are furnished under the supervision and direction of the client’s physician; the plan will be consistently reviewed to ensure client needs are met, and will be updated as necessary, but at least every sixty (60) days.”; Purpose: “To provide guidelines for agency staff to develop a plan of care individualized to meet specific identified needs; to assure that the plan meets state/federal guidelines, and all applicable laws and regulations.” Procedure: “1. An individualized plan of care signed by a physician shall be required for each client….; 4. The plan of care is developed within five (5) working days or as required by agency/state guidelines. The written plan of care must be signed by the physician within thirty (30) days and returned to the agency.” Review of medical records (MR) conducted 1/8/24 from 10:30 AM-1:45 PM and 1/10/24 from 10:15 AM-11:45 AM revealed: MR # 3: SOC: 9/2/21; certification period per approval from service coordinator: 11/10/23-1/11/24; no plan of care on chart for 11/10/23-1/11/24; last certification period plan of care for 9/26/23-11/24/23 noted on chart but no physician signature as of 1/8/24. (one hundred and seven (107) days) An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings.

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and the patient's 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). This ELEMENT is not met as evidenced by: Based on review of medical records (MR), policies/procedures and interview with the Agency Administrator and director of nursing, the agency failed to ensure discharge plans were communicated with the client/family and client’s physician in one (1) of six (6) medical records reviewed. (MR # 6) Findings include: Review of Comforcare Home Care client discharge process policy on 1/26/24 at 9:43 AM revealed: Policy: “Discharge planning is initiated for every client at the time of the client’s admission for home care.” Purpose: “To ensure continuity of care, treatment and services when needed. To assure collaboration with the physician, client and/or representative, family and other disciplines in planning for discharge…; to record a discharge summary of care received by the client from start of care through discharge; to document client status at the time of discharge, unmet needs, and referrals initiated.; to document instructions given to the client/family regarding medications, treatment, and necessary follow-up.”; Procedure: 6. “The manager of care services/designee shall review the client record to assure accuracy and completion. A discharge plan shall be developed that is documented…; 8. “Upon discharge to self-care, the client will receive verbal/written information regarding…any procedures/treatments to be performed, and follow-up visits for physician care; 9. “To avoid charges of abandonment at the time of discharge agency documentation will include the following: a. evidence that the decision was not made unilaterally…”; 10. “A discharge summary will be completed on all client discharges…” Review of medical records (MR) conducted 1/8/24 from 10:30 AM-1:45 PM and 1/10/24 from 10:15 AM-11:45 AM revealed: MR # 6; SOC: 2/24/20; Discharged: 7/31/23; admitting diagnosis: DiGeorge’s syndrome, appendico-vesicostomy status, idiopathic scoliosis, unspecified algoneurodystrophy (a complex regional pain syndrome- a form of chronic pain that usually affects an arm or a leg); no documentation of discharge orders, discharge summary sent to physician or discharge instructions given to client’s family. An interview conducted with the Agency Administrator and director of nursing on January 11, 2024 at approximately 3:30 PM revealed: “the client was discharged from the agency due to moving out of the state around the end of July.” An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings. A telephone interview conducted with the agency director of nursing on January 16, 2024 at 2:00 PM revealed: “We looked through MR # 6 chart both the paper chart and the electronic chart and can’t find any documentation about the discharge.” A telephone interview conducted with agency administrator on January 26, 2024 at approximately 1:50 PM reconfirmed the above findings.

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 review of policy/procedure and Quality Assurance Performance Improvement (QAPI) binder, the agency failed to maintain an effective, ongoing data driven QAPI program for one (1) of one (1) program review. (Program # 1); the agency failed to maintain effective, ongoing performance improvement activities for their QAPI program for one (1) of one (1) program review. (Program # 1) Findings: Cross Reference: 484.65(b)(1),(2),(3) Program Data-Tag 0644-- the agency failed to maintain an effective, ongoing data driven QAPI program for one (1) of one (1) program review. (Program # 1) 484.65 (c) Program Activities---Tag 0646-- the agency failed to maintain effective, ongoing performance improvement activities for their QAPI program for one (1) of one (1) program review. (Program # 1)

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 policy/procedure and Quality Assurance Performance Improvement (QAPI) binder, the agency failed to maintain an effective, ongoing data driven QAPI program for one (1) of one (1) program review. (Program # 1) Findings include: Review of Comforcare Home Care Quality Assurance and Performance Improvement (QAPI) policy on 1/26/24 at 9:56 AM revealed: Policy: “the agency will develop, implement, evaluate, and maintain an effective, ongoing agencywide data-driven QAPI program. The agency will maintain documentary evidence of its QAPI program…”; Purpose: “To monitor the effectiveness and safety of services and the quality of care. Scope of Program: 5. The frequency and detail of data collection must be approved by the Governing Body.”; Program Methodology: 1. “Each quarter, the agency will review data from the following areas at a minimum: a. client record reviews; b. personnel file compliance; 2. “At least ten (10) client charts and ten (10) personnel files will be chosen at random for review each quarter. If the agency has less than ten (10) of either of those, a hundred percent (100%) review of the available charts or files will be completed. At least one (1) discharged client chart will be reviewed each quarter….” Performance improvement projects: 1.” The agency must have documented performance improvement projects each quarter.; 2. “The Governing Body is responsible for ensuring the following: a. An ongoing program for quality improvement and client safety is defined, implemented, and maintained…”; 3. “The administrator or their designee is responsible for coordinating Performance improvement (PI) activities.” Review of agency’s QAPI program on 1/10/24 between 2:00-3:00 PM revealed: Quality Assurance Performance Improvement calendar revealed: Quarter # 1 is from January to March; Quarter # 2 is from April to June; Quarter # 3 is from July to September and Quarter # 4 is from September to December with medical record and personnel file audits due on the following dates: Quarter #4 audits due January 15th; Quarter # 1 audits due April 15th, Quarter # 2 audits due July 15th and Quarter # 3 audits due October 15th. QAPI meetings are to be held on the following dates for each year: January 31st, April 30th, July 31st, and October 31st. No medical records or employee file audits completed since 7/2023 then 2/1/23 and 11/9/22. The last recorded meeting minutes were dated 10/28/22 and there was no current performance improvement action plan noted. An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on review of policy/procedure and Quality Assurance Performance Improvement (QAPI) binder, the agency failed to maintain effective, ongoing performance improvement activities for their QAPI program for one (1) of one (1) program review. (Program # 1) Findings include: Review of Comforcare Home Care Quality Assurance and Performance Improvement (QAPI) policy on 1/26/24 at 9:56 AM revealed: Policy: “the agency will develop, implement, evaluate, and maintain an effective, ongoing agencywide data-driven QAPI program. The agency will maintain documentary evidence of its QAPI program…”; Purpose: “To monitor the effectiveness and safety of services and the quality of care. Scope of Program: 5. The frequency and detail of data collection must be approved by the Governing Body.”; Program Methodology: 1. “Each quarter, the agency will review data from the following areas at a minimum: a. client record reviews; b. personnel file compliance; 2. “At least ten (10) client charts and ten (10) personnel files will be chosen at random for review each quarter. If the agency has less than ten (10) of either of those, a hundred percent (100%) review of the available charts or files will be completed. At least one (1) discharged client chart will be reviewed each quarter….” Performance improvement projects: 1.” The agency must have documented performance improvement projects each quarter.; 2. “The Governing Body is responsible for ensuring the following: a. An ongoing program for quality improvement and client safety is defined, implemented, and maintained…”; 3. “The administrator or their designee is responsible for coordinating Performance improvement (PI) activities.” Review of agency’s QAPI program on 1/10/24 between 2:00-3:00 PM revealed: Quality Assurance Performance Improvement calendar revealed: Quarter # 1 is from January to March; Quarter # 2 is from April to June; Quarter # 3 is from July to September and Quarter # 4 is from September to December with medical record and personnel file audits due on the following dates: Quarter #4 audits due January 15th; Quarter # 1 audits due April 15th, Quarter # 2 audits due July 15th and Quarter # 3 audits due October 15th. QAPI meetings are to be held on the following dates for each year: January 31st, April 30th, July 31st, and October 31st. No medical records or employee file audits completed since 7/2023 then 2/1/23 and 11/9/22. The last recorded meeting minutes were dated 10/28/22 and there was no current performance improvement action plan noted. An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings.

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 reviews of job descriptions, personnel files (PF) and interview with the agency administrator and director of nursing, the agency failed to ensure staff were screened for and were free from active mycobacterium tuberculosis (TB) prior to assignment with clients in four (4) of ten (10) files reviewed. (PFs #2, # 5, # 8 and # 9); the agency failed to ensure staff were screened for active mycobacterium tuberculosis (TB) and TB education on annual basis in ten (10) of ten (10) files reviewed. (PFs #1-PF #10) Findings include: The CDC guidelines state that all Health Care Workers (HCW) should receive baseline tuberculosis screening upon hire, using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. After baseline testing for infection with tuberculosis, HCWs should receive TB screen annually. HCWs with a baseline positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease. CDC Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, 2005. Morbidity and Mortality World Report 2005;(RR-17) http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf. Review of personnel files (PF) conducted on 1/8/24 from 2:30 PM-4:30 PM revealed the following: PF 1, Date of hire (DOH): 9/26/17; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2020, 2021, 2022, and 2023. PF 2, Date of hire (DOH): 7/6/23; had no documentation of tuberculosis testing upon hire; had no documentation of TB education for year 2023. PF 3, Date of hire (DOH): 12/1/22; had no documentation of tuberculosis screening for year 2023 and no annual TB education for year 2022 and 2023. PF 4, Date of hire (DOH): 10/6/16; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2021, 2022 and 2023. PF 5, Date of hire (DOH): 9/20/23; had no documentation of two-step tuberculosis testing upon hire. File contained a one-step test dated 9/20/23; had no documentation of TB education for year 2023. PF 6, Date of hire (DOH): 3/14/23; had no documentation of TB education for year 2023. PF 7, Date of hire (DOH): 10/24/23; had no documentation of TB education for year 2023. PF 8, Date of hire (DOH): 11/16/23; had no documentation of tuberculosis testing upon hire; had no documentation of TB education for year 2023. PF 9, Date of hire (DOH): 12/19/23; had no documentation of two-step tuberculosis testing upon hire. File contained a one-step test dated 12/19/23; had no documentation of TB education for year 2023. PF 10, Date of hire (DOH): 8/15/19; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2021, 2022, and 2023. An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on reviews of Personnel files (PFs), and an interview with the agency administrator and director of nursing, the agency failed to ensure completed documentation demonstrating each staff had satisfactorily completed an initial competency exam for six (6) of ten (10) files reviewed. (PFs #1, # 3, # 4, # 7, # 8, and # 9); the agency failed to ensure staff competency evaluations were completed on an annual basis for two (2) out of ten (10) personnel files reviewed. (PF # 3 and # 4) Findings: Review of personnel files (PF) conducted on 1/8/24 from 2:30 PM-4:30 PM revealed the following: PF # 1, Date of hire (DOH): 9/26/17; contained an incomplete written competency test for home health aide dated 9/18/17. There was no grade. PF # 3, DOH: 12/1/22; contained an incomplete written competency test for home health aide dated 11/30/22. There was no grade; did not contain documentation of an annual evaluation in 2023. PF # 4, DOH: 10/6/16; contained an incomplete written competency test for home health aide dated 10/5/16. There was no grade; did not contain documentation of an annual evaluation in year 2022 and 2023. PF # 7, DOH: 10/24/23, contained an incomplete written competency test for home health aide dated 10/23/23. There was no grade. PF # 8, DOH: 11/16/23, contained an incomplete written competency test for home health aide dated 11/15/23. There was no grade. PF # 9, DOH:12/19/23, contained an incomplete written competency test for home health aide. There was no grade or date of when the test was taken. An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings.

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 review of policies /procedures, job descriptions, personnel files (PF), medical records (MR), and an interview with the Agency Administrator, it was determined that the agency failed to ensure organization, management, and administration of its resources to attain and maintain the highest practicable functional capacity including providing optimal care to achieve the goals and outcomes identified in the patients' plans of care. Findings: Cross Reference: 484.105(a) Governing Body: Tag 0942- the governing body failed to ensure the overall operation of the agency to ensure the agency provided services in a compliant manner through appropriate plans of care and adherence to written policies and procedures. 484.105(b)(1) Administrator must: Tag 0944- the Agency administrator failed to ensure the agency adhered to written policies and procedures, was compliant in adhering to all federal, state, and local regulations and provided services in a compliant manner through appropriate plans of care and that staff were complaint in training and health screenings. The agency failed to ensure that treatment or care was furnished appropriately. 484.105(c) Clinical Manager: Tag 0958- the agency failed to ensure the Manager of Care Services fulfilled all job responsibilities for ensuring accurate and complete documentation, care was provided in a compliant manner through appropriate plans of care and staff was competent in their skills for one (1) of one (1) file reviewed. (PF #1) The cumulative effect of these systemic problems resulted in the Home Health Agency's inability to organize, manage and administer its resources to attain and maintain the highest practicable functional capacity and provide optimal care.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on review of policies/procedures, job descriptions, personnel files, medical records, and an interview with the Agency administrator, it was determined that the governing body failed to ensure the overall operation of the agency to ensure the agency provided services in a compliant manner through appropriate plans of care and adherence to written policies and procedures. Findings include: Review of Comforcare Home Care Governing body policy on 1/26/24 at 3:55 PM revealed: Policy: “The Governing Body shall assume full legal authority and responsibility for the overall management and operation of the agency.”; Purpose: “To provide direction and supervision of the agency’s operation and services; to ensure clients are provided with appropriate, quality services.”; 4. Provide direction and leadership and be directly involved in the agency’s QAPI program.” Review of medical records (MR) conducted 1/8/24 from 10:30 AM-1:45 PM and 1/10/24 from 10:15 AM-11:45 AM revealed: Medical record (MR) # 1: Start of care (SOC): 7/20/21; certification period: 11/14/23-1/12/24; Skilled Nurse (SN) frequency ordered fifty-two and a half (52.5) hours per week usually seven (7)- ten (10) hours a day for nine (9) weeks. Missed visits for 11/23/23, 11/30/23. 12/1/23 and 12/25/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 2: SOC: 10/20/16; certification period: 12/11/23-2/8/24; SN frequency ordered forty-eight (48) hours per week for nine (9) weeks. Missed visits for 12/12/23, 12/15/23, 12/19/23, 12/22/23, 12/25/23 and 12/31/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 3: SOC: 9/2/21; certification period per approval from service coordinator: 11/10/23-1/11/24; no plan of care on chart for 11/10/23-1/11/24; last certification period plan of care for 9/26/23-11/24/23 noted on chart but no physician signature as of 1/8/24. (one hundred and seven (107) days.; SN frequency ordered thirty-two (32)-eighty (80) hours per week for nine (9) weeks and/or forty-eight (48)-fifty-six (56) hours per week of home health aide if skilled nurse unavailable. Missed visits for 11/28/23, 12/5/23, 12/12/23, 12/19/23, 12/26/23, 12/27/23,12/30/23, and 1/2/24 with no documentation of missed visits or notification to physician or service coordinator of missed visits. Client cancelled visits on 1/3/24, 1/6/24 and 1/8/24-1/11/24. Interview with Agency administrator on 1/23/24 at 1:00 PM revealed: “He left the agency on his own accord on January 7th.” MR # 6; SOC: 2/24/20; Discharged: 7/31/23; admitting diagnosis: DiGeorge’s syndrome, appendico-vesicostomy status, idiopathic scoliosis, unspecified algoneurodystrophy (a complex regional pain syndrome- a form of chronic pain that usually affects an arm or a leg); no documentation of discharge orders, discharge summary sent to physician or discharge instructions given to client’s family. The CDC guidelines state that all Health Care Workers (HCW) should receive baseline tuberculosis screening upon hire, using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. After baseline testing for infection with tuberculosis, HCWs should receive TB screen annually. HCWs with a baseline positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease. CDC Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, 2005. Morbidity and Mortality World Report 2005;(RR-17) http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf. Review of personnel files (PF) conducted on 1/8/24 from 2:30 PM-4:30 PM revealed the following: PF 1, Date of hire (DOH): 9/26/17; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2020, 2021, 2022, and 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 9/18/17. There was no grade. PF 2, Date of hire (DOH): 7/6/23; had no documentation of tuberculosis testing upon hire. PF 3, Date of hire (DOH): 12/1/22; had no documentation of tuberculosis screening for year 2023 and no annual TB education for year 2022 and 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 11/30/22. There was no grade; did not contain documentation of an annual evaluation in 2023. PF 4, Date of hire (DOH): 10/6/16; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2021, 2022 and 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 10/5/16. There was no grade; did not contain documentation of an annual evaluation in year 2022 and 2023. PF 5, Date of hire (DOH): 9/20/23; had no documentation of two-step tuberculosis testing upon hire. File contained a one-step test dated 9/20/23; had no documentation of TB education for year 2023. PF 6, Date of hire (DOH): 3/14/23; had no documentation of TB education for year 2023. PF 7, Date of hire (DOH): 10/24/23; had no documentation of TB education for year 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 10/23/23. There was no grade. PF 8, Date of hire (DOH): 11/16/23; had no documentation of tuberculosis testing upon hire; had no documentation of TB education for year 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 11/15/23. There was no grade. PF 9, Date of hire (DOH): 12/19/23; had no documentation of two-step tuberculosis testing upon hire. File contained a one-step test dated 12/19/23; had no documentation of TB education for year 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated. There was no grade or date of when the test was taken. PF 10, Date of hire (DOH): 8/15/19; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2021, 2022, and 2023. An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings.

Administrator must: CFR(s): 484.105(b)(1) Standard: Administrator. The administrator must: This STANDARD is not met as evidenced by: Based on review of policies/procedures, job descriptions, personnel files, medical records, and an interview with the Agency administrator, the Agency administrator failed to ensure the agency adhered to written policies and procedures, was compliant in adhering to all federal, state, and local regulations and provided services in a compliant manner through appropriate plans of care and that staff were complaint in training and health screenings. The agency failed to ensure that treatment or care was furnished appropriately. Findings include: Review of Comforcare Home Care administrator job description on 1/26/24 at 3:40 PM revealed: Position summary: “Plans, develops, and directs the programs, services, activities, and employees of the agency.” “Reports to the Governing body”; Qualifications: “knowledge of the regulatory requirements at the state, federal, and local level.” Essential functions: “is responsible for all day-to-day operations of the agency; ensures that the agency employs qualified personnel…”; “assures compliance with federal/state regulations governing home care services”; “oversees or designates the oversight of the agency’s Quality Assurance Performance Improvement (QAPI) program.”; “participates in hiring, orientation, and development of management staff; developmenting of systems that support…. Recruitment, hiring and the ongoing professional development of agency staff.” Review of medical records (MR) conducted 1/8/24 from 10:30 AM-1:45 PM and 1/10/24 from 10:15 AM-11:45 AM revealed: Medical record (MR) # 1: Start of care (SOC): 7/20/21; certification period: 11/14/23-1/12/24; Skilled Nurse (SN) frequency ordered fifty-two and a half (52.5) hours per week usually seven (7)- ten (10) hours a day for nine (9) weeks. Missed visits for 11/23/23, 11/30/23. 12/1/23 and 12/25/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 2: SOC: 10/20/16; certification period: 12/11/23-2/8/24; SN frequency ordered forty-eight (48) hours per week for nine (9) weeks. Missed visits for 12/12/23, 12/15/23, 12/19/23, 12/22/23, 12/25/23 and 12/31/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 3: SOC: 9/2/21; certification period per approval from service coordinator: 11/10/23-1/11/24; no plan of care on chart for 11/10/23-1/11/24; last certification period plan of care for 9/26/23-11/24/23 noted on chart but no physician signature as of 1/8/24. (one hundred and seven (107) days.; SN frequency ordered thirty-two (32)-eighty (80) hours per week for nine (9) weeks and/or forty-eight (48)-fifty-six (56) hours per week of home health aide if skilled nurse unavailable. Missed visits for 11/28/23, 12/5/23, 12/12/23, 12/19/23, 12/26/23, 12/27/23,12/30/23, and 1/2/24 with no documentation of missed visits or notification to physician or service coordinator of missed visits. Client cancelled visits on 1/3/24, 1/6/24 and 1/8/24-1/11/24. Interview with Agency administrator on 1/23/24 at 1:00 PM revealed: “He left the agency on his own accord on January 7th.” MR # 6; SOC: 2/24/20; Discharged: 7/31/23; admitting diagnosis: DiGeorge’s syndrome, appendico-vesicostomy status, idiopathic scoliosis, unspecified algoneurodystrophy (a complex regional pain syndrome- a form of chronic pain that usually affects an arm or a leg); no documentation of discharge orders, discharge summary sent to physician or discharge instructions given to client’s family. The CDC guidelines state that all Health Care Workers (HCW) should receive baseline tuberculosis screening upon hire, using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. After baseline testing for infection with tuberculosis, HCWs should receive TB screen annually. HCWs with a baseline positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease. CDC Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, 2005. Morbidity and Mortality World Report 2005;(RR-17) http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf. Review of personnel files (PF) conducted on 1/8/24 from 2:30 PM-4:30 PM revealed the following: PF 1, Date of hire (DOH): 9/26/17; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2020, 2021, 2022, and 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 9/18/17. There was no grade. PF 2, Date of hire (DOH): 7/6/23; had no documentation of tuberculosis testing upon hire. PF 3, Date of hire (DOH): 12/1/22; had no documentation of tuberculosis screening for year 2023 and no annual TB education for year 2022 and 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 11/30/22. There was no grade; did not contain documentation of an annual evaluation in 2023. PF 4, Date of hire (DOH): 10/6/16; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2021, 2022 and 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 10/5/16. There was no grade; did not contain documentation of an annual evaluation in year 2022 and 2023. PF 5, Date of hire (DOH): 9/20/23; had no documentation of two-step tuberculosis testing upon hire. File contained a one-step test dated 9/20/23; had no documentation of TB education for year 2023. PF 6, Date of hire (DOH): 3/14/23; had no documentation of TB education for year 2023. PF 7, Date of hire (DOH): 10/24/23; had no documentation of TB education for year 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 10/23/23. There was no grade. PF 8, Date of hire (DOH): 11/16/23; had no documentation of tuberculosis testing upon hire; had no documentation of TB education for year 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 11/15/23. There was no grade. PF 9, Date of hire (DOH): 12/19/23; had no documentation of two-step tuberculosis testing upon hire. File contained a one-step test dated 12/19/23; had no documentation of TB education for year 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated. There was no grade or date of when the test was taken. PF 10, Date of hire (DOH): 8/15/19; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2021, 2022, and 2023. An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings.

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 reviews of job descriptions, medical records (MR), personnel files (PF) and interview with the agency administrator, the agency failed to ensure the Manager of Care Services fulfilled all job responsibilities for ensuring accurate and complete documentation, care was provided in a compliant manner through appropriate plans of care and staff was competent in their skills for one (1) of one (1) files reviewed. (PF #1) Findings include: Review of Comforcare Home Care Manager of Care services job description on 1/26/24 at 4:05 PM revealed: Position summary: “responsible for the direction of all home care services. Manages, supervises, coordinates, and develops client care teams to ensure quality care delivery….”; “Reports to administrator; Qualifications: “knowledge of home care federal and state regulations.”; Essential functions: “1. Plan, directs, coordinates, and monitors the delivery of all direct and indirect services to agency care clients ensuring safe, effective, and appropriate home care services. 11. Assures client records are maintained in compliance with state and federal laws…16. “Oversees/conducts timely performance evaluations in accordance with agency policy. 20. Ensures accuracy, completeness, and timeliness of documentation in accordance with agency policies and procedures, regulatory requirements, and industry standards. Review of Comforcare Home Care Licensed Practical Nurse (LPN) job description on 1/26/24 at 7:41 AM revealed: Position summary: “performs skilled nursing functions in accordance with the federal, state, and local laws and within the guidelines of his/her professional organization and agency; the LPN delivers care to clients as delegated by the Registered Nurse (RN); reports to manager of care services; essential functions/areas of accountability: Provides professional nursing care….and under the direction of a Registered Nurse; provides skilled nursing visits for clients as directed by the clinical supervisor. Follows the plan of care established by the Registered Nurse.” Review of Comforcare Home Care Home Health Aide (HHA) job description on 1/26/24 at 7:49 AM revealed: Position summary: “Provides personal care services under the direction of the Registered Nurse…”; reports to Manager of care services.” Review of Comforcare Home Care Plan of care policy on 1/26/24 at 7:53 AM revealed: Policy: “Private duty nursing/skilled nursing services are furnished under the supervision and direction of the client’s physician; the plan will be consistently reviewed to ensure client needs are met, and will be updated as necessary, but at least every sixty (60) days.”; Purpose: “To provide guidelines for agency staff to develop a plan of care individualized to meet specific identified needs; to assure that the plan meets state/federal guidelines, and all applicable laws and regulations.” Procedure: “1. An individualized plan of care signed by a physician shall be required for each client….; 4. The plan of care is developed within five (5) working days or as required by agency/state guidelines. The written plan of care must be signed by the physician within thirty (30) days and returned to the agency.” Review of Comforcare Home Care Missed Visits policy on 1/26/24 at 8:14 AM revealed: Policy: “Missed visits that result in services provided not matching the ordered frequency of care within one agency defined standard work week will be communicated to the Manager of care services and the client’s physician…; all missed visits will be documented in the client record. The agency will have a system in place to respond to any anticipated or unanticipated missed shifts.”; Purpose: “To ensure that missed visits are documented and to monitor the effect of missed visits on client care.”; Definition: “A missed visit occurs when agency staff are unable to meet the frequency of care that is outline on the plan of care within the agency defined standard work week.” Procedure: “1. Direct care staff will notify the agency immediately upon knowing that they will not be able to provide a planned visit.; 4. All missed visits will be documented in the client record. Documentation will include: a. date and time of missed visit; e. physician notification of the missed visit, if missed visit results in non-adherence to a physician ordered frequency for care.” Review of Comforcare Home Care client discharge process policy on 1/26/24 at 9:43 AM revealed: Policy: “Discharge planning is initiated for every client at the time of the client’s admission for home care.” Purpose: “To ensure continuity of care, treatment and services when needed. To assure collaboration with the physician, client and/or representative, family and other disciplines in planning for discharge…; to record a discharge summary of care received by the client from start of care through discharge; to document client status at the time of discharge, unmet needs, and referrals initiated.; to document instructions given to the client/family regarding medications, treatment, and necessary follow-up.”; Procedure: 6. “The manager of care services/designee shall review the client record to assure accuracy and completion. A discharge plan shall be developed that is documented…; 8. “Upon discharge to self-care, the client will receive verbal/written information regarding…any procedures/treatments to be performed, and follow-up visits for physician care; 9. “To avoid charges of abandonment at the time of discharge agency documentation will include the following: a. evidence that the decision was not made unilaterally…”; 10. “A discharge summary will be completed on all client discharges…” Review of medical records (MR) conducted 1/8/24 from 10:30 AM-1:45 PM and 1/10/24 from 10:15 AM-11:45 AM revealed: Medical record (MR) # 1: Start of care (SOC): 7/20/21; certification period: 11/14/23-1/12/24; Skilled Nurse (SN) frequency ordered fifty-two and a half (52.5) hours per week usually seven (7)- ten (10) hours a day for nine (9) weeks. Missed visits for 11/23/23, 11/30/23. 12/1/23 and 12/25/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 2: SOC: 10/20/16; certification period: 12/11/23-2/8/24; SN frequency ordered forty-eight (48) hours per week for nine (9) weeks. Missed visits for 12/12/23, 12/15/23, 12/19/23, 12/22/23, 12/25/23 and 12/31/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 3: SOC: 9/2/21; certification period per approval from service coordinator: 11/10/23-1/11/24; no plan of care on chart for 11/10/23-1/11/24; last certification period plan of care for 9/26/23-11/24/23 noted on chart but no physician signature as of 1/8/24. (one hundred and seven (107) days.; SN frequency ordered thirty-two (32)-eighty (80) hours per week for nine (9) weeks and/or forty-eight (48)-fifty-six (56) hours per week of home health aide if skilled nurse unavailable. Missed visits for 11/28/23, 12/5/23, 12/12/23, 12/19/23, 12/26/23, 12/27/23,12/30/23, and 1/2/24 with no documentation of missed visits or notification to physician or service coordinator of missed visits. Client cancelled visits on 1/3/24, 1/6/24 and 1/8/24-1/11/24. Interview with Agency administrator on 1/23/24 at 1:00 PM revealed: “He left the agency on his own accord on January 7th.” MR # 6; SOC: 2/24/20; Discharged: 7/31/23; admitting diagnosis: DiGeorge’s syndrome, appendico-vesicostomy status, idiopathic scoliosis, unspecified algoneurodystrophy (a complex regional pain syndrome- a form of chronic pain that usually affects an arm or a leg); no documentation of discharge orders, discharge summary sent to physician or discharge instructions given to client’s family. The CDC guidelines state that all Health Care Workers (HCW) should receive baseline tuberculosis screening upon hire, using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. After baseline testing for infection with tuberculosis, HCWs should receive TB screen annually. HCWs with a baseline positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease. CDC Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, 2005. Morbidity and Mortality World Report 2005;(RR-17) http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf. Review of personnel files (PF) conducted on 1/8/24 from 2:30 PM-4:30 PM revealed the following: PF 1, Date of hire (DOH): 9/26/17; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2020, 2021, 2022, and 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 9/18/17. There was no grade. PF 2, Date of hire (DOH): 7/6/23; had no documentation of tuberculosis testing upon hire. PF 3, Date of hire (DOH): 12/1/22; had no documentation of tuberculosis screening for year 2023 and no annual TB education for year 2022 and 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 11/30/22. There was no grade; did not contain documentation of an annual evaluation in 2023. PF 4, Date of hire (DOH): 10/6/16; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2021, 2022 and 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 10/5/16. There was no grade; did not contain documentation of an annual evaluation in year 2022 and 2023. PF 5, Date of hire (DOH): 9/20/23; had no documentation of two-step tuberculosis testing upon hire. File contained a one-step test dated 9/20/23; had no documentation of TB education for year 2023. PF 6, Date of hire (DOH): 3/14/23; had no documentation of TB education for year 2023. PF 7, Date of hire (DOH): 10/24/23; had no documentation of TB education for year 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 10/23/23. There was no grade. PF 8, Date of hire (DOH): 11/16/23; had no documentation of tuberculosis testing upon hire; had no documentation of TB education for year 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated 11/15/23. There was no grade. PF 9, Date of hire (DOH): 12/19/23; had no documentation of two-step tuberculosis testing upon hire. File contained a one-step test dated 12/19/23; had no documentation of TB education for year 2023; contained an incomplete written competency test for home health aide containing all sixteen (16) areas required dated. There was no grade or date of when the test was taken. PF 10, Date of hire (DOH): 8/15/19; had no documentation of tuberculosis screening for year 2022 and 2023 and no annual TB education for year 2021, 2022, and 2023. An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on review of policies /procedures, job descriptions, personnel files (PF), medical records (MR), and an interview with the Agency Administrator, it was determined that the agency failed to ensure medical records that are accurate, complete, and adherent to current clinical record documentation standards of practice. Findings: Cross Reference: 484.110(a) Content of clinical record: Tag 1010- the agency failed to ensure medical records contained adequate and complete documentation. The agency failed to ensure that treatment or care was furnished appropriately for three (3) of six (6) records reviewed. MR #1-3); the agency failed to ensure that discharge summaries and/or transfer summaries were maintained in the medical record for one (1) of six (6) records reviewed. (MR # 6). 484.110(a)(6)(i-iii) Discharge and transfer summaries: Tag 1022- the agency failed to ensure that discharge summaries and/or transfer summaries were created and maintained in the medical record for one (1) of six (6) records reviewed. (MR # 6)

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on review of medical records (MR), policies/procedures and interview with the Agency Administrator and director of nursing, the agency failed to ensure medical records contained adequate and complete documentation. The agency failed to ensure that treatment or care was furnished appropriately for three (3) of six (6) records reviewed. MR #1-3); the agency failed to ensure that discharge summaries and/or transfer summaries were maintained in the medical record for one (1) of six (6) records reviewed. (MR # 6). Findings include: Review of Comforcare Home Care client record content policy on 1/26/24 at 10:35 AM revealed: Policy: “A client record will be maintained for every client…in accordance with state law and agency policy.” Purpose: “To maintain an accurate record of the services provided by the agency for each client.” Procedure: 3. The client record shall contain appropriate identifying information, including, but not limited to: plan of care, physician orders, visit schedule/frequency, transfer and discharge summaries.” Review of medical records (MR) conducted 1/8/24 from 10:30 AM-1:45 PM and 1/10/24 from 10:15 AM-11:45 AM revealed: Medical record (MR) # 1: Start of care (SOC): 7/20/21; certification period: 11/14/23-1/12/24; Skilled Nurse (SN) frequency ordered fifty-two and a half (52.5) hours per week usually seven (7)- ten (10) hours a day for nine (9) weeks. Missed visits for 11/23/23, 11/30/23. 12/1/23 and 12/25/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 2: SOC: 10/20/16; certification period: 12/11/23-2/8/24; SN frequency ordered forty-eight (48) hours per week for nine (9) weeks. Missed visits for 12/12/23, 12/15/23, 12/19/23, 12/22/23, 12/25/23 and 12/31/23 with no documentation of missed visits or notification to physician or service coordinator of missed visits. MR # 3: SOC: 9/2/21; certification period per approval from service coordinator: 11/10/23-1/11/24; no plan of care on chart for 11/10/23-1/11/24; last certification period plan of care for 9/26/23-11/24/23 noted on chart but no physician signature as of 1/8/24. (one hundred and seven (107) days.; SN frequency ordered thirty-two (32)-eighty (80) hours per week for nine (9) weeks and/or forty-eight (48)-fifty-six (56) hours per week of home health aide if skilled nurse unavailable. Missed visits for 11/28/23, 12/5/23, 12/12/23, 12/19/23, 12/26/23, 12/27/23,12/30/23, and 1/2/24 with no documentation of missed visits or notification to physician or service coordinator of missed visits. Client cancelled visits on 1/3/24, 1/6/24 and 1/8/24-1/11/24. Interview with Agency administrator on 1/23/24 at 1:00 PM revealed: “He left the agency on his own accord on January 7th.” MR # 6; SOC: 2/24/20; Discharged: 7/31/23; admitting diagnosis: DiGeorge’s syndrome, appendico-vesicostomy status, idiopathic scoliosis, unspecified algoneurodystrophy (a complex regional pain syndrome- a form of chronic pain that usually affects an arm or a leg); no documentation of discharge orders, discharge summary sent to physician or discharge instructions given to client’s family. An interview conducted with the Agency Administrator and director of nursing on January 11, 2024 at approximately 3:30 PM revealed: “the client was discharged from the agency due to moving out of the state around the end of July.” An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings. A telephone interview conducted with the agency director of nursing on January 16, 2024 at 2:00 PM revealed: “We looked through MR # 6 chart both the paper chart and the electronic chart and can’t find any documentation about the discharge.” A telephone interview conducted with agency administrator on January 26, 2024 at approximately 1:50 PM reconfirmed the above findings.

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 review of policy/procedures, medical records (MR) and interview with the staff (EMP), the agency failed to ensure that discharge summaries and/or transfer summaries were created and maintained in the medical record for one (1) of six (6) records reviewed. (MR # 6) Findings include: Review of Comforcare Home Care client discharge process policy on 1/26/24 at 9:43 AM revealed: Policy: “Discharge planning is initiated for every client at the time of the client’s admission for home care.” Purpose: “To ensure continuity of care, treatment and services when needed. To assure collaboration with the physician, client and/or representative, family and other disciplines in planning for discharge…; to record a discharge summary of care received by the client from start of care through discharge; to document client status at the time of discharge, unmet needs, and referrals initiated.; to document instructions given to the client/family regarding medications, treatment, and necessary follow-up.”; Procedure: 6. “The manager of care services/designee shall review the client record to assure accuracy and completion. A discharge plan shall be developed that is documented…; 8. “Upon discharge to self-care, the client will receive verbal/written information regarding…any procedures/treatments to be performed, and follow-up visits for physician care; 9. “To avoid charges of abandonment at the time of discharge agency documentation will include the following: a. evidence that the decision was not made unilaterally…”; 10. “A discharge summary will be completed on all client discharges…” Review of Comforcare Home Care client record content policy on 1/26/24 at 10:35 AM revealed: Policy: “A client record will be maintained for every client…in accordance with state law and agency policy.” Purpose: “To maintain an accurate record of the services provided by the agency for each client.” Procedure: 3. The client record shall contain appropriate identifying information, including, but not limited to: plan of care, physician orders, visit schedule/frequency, transfer and discharge summaries.” MR # 6; SOC: 2/24/20; Discharged: 7/31/23; admitting diagnosis: DiGeorge’s syndrome, appendico-vesicostomy status, idiopathic scoliosis, unspecified algoneurodystrophy (a complex regional pain syndrome- a form of chronic pain that usually affects an arm or a leg); no documentation of discharge orders, discharge summary sent to physician or discharge instructions given to client’s family. An interview conducted with the Agency Administrator and director of nursing on January 11, 2024 at approximately 3:30 PM revealed: “the client was discharged from the agency due to moving out of the state around the end of July.” An interview with the agency administrator and director of nursing conducted on January 11, 2024, at approximately 3:40 PM confirmed the above findings. A telephone interview conducted with the agency director of nursing on January 16, 2024 at 2:00 PM revealed: “We looked through MR # 6 chart both the paper chart and the electronic chart and can’t find any documentation about the discharge.” A telephone interview conducted with agency administrator on January 26, 2024 at approximately 1:50 PM reconfirmed the above findings.

Based on the findings of an offsite complaint investigation survey completed September 8, 2022, Comforcare Home Care was found not to be in compliance with the requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of medical records (MR) and interview with Agency Administrator the agency failed to ensure skilled nursing visits were completed as ordered by the physician for one (1) of three (3) records reviewed. MR #1.; failed to obtain the physicians countersignature in a timely manner for one (1) of three (3) records reviewed. MR #1. Review of medical records completed September 8, 2022 at approximately 4:00PM and 5:00PM revealed: MR#3, start of care: 9/29/2021; certfication period: 6/30/22-8/28/2022; Primary Diagnosis: Sleep Apnea; Physician Orders: "SN at 32-80 hours per week for LPN and 48-56 per week for HHA x9 weeks". During the 9 week certification period, for dates reviewed, the LPN provided the following hours of skilled services: week 1: 96.5 hours week 2: 86.25 hours week 3: 80.25 hours week 4: 72.25 hours week 5: 81.25 hours week 6: 69 hours week 7: 96.5 hours week 8: 32 hours There was no documentation of notification made to the physician when the hours deviated from the orders. The plan of treatment was countersigned by the physician on:8/1/22 Thirty- one (31) days after the beginning of the certification period. Interview with Agency Administrator via telephone on 8/28/2022 at approximately 11:00AM confirmed the above findings.

Based on the findings of an onsite complaint investigation survey conducted on 4/6/2022, ComforCare Home Care, was found to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

Based on the findings of an onsite complaint investigation survey conducted on 4/6/2022, ComforCare Home Care, was found to be not in compliance with the requirements of 42 CFR, Part 484, Subparts B & C, Conditions of Participation: Home Health Agencies.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based upon review of agency policy, medical records (MR), and interview with owner (EMP # 1) and clinical director (EMP # 2) agency failed to have initial assessment conducted within forty-eight (48) hours {or two (2) days} of date of referral for two (2) of three (3) MR reviewed. (MR # 1; MR # 3). Findings included: Request for policy on 4/6/2022 at approximately 12:30 PM regarding start of care visit and timelines was not produced. Review of MR on 4/6/2022 between approximately 1:30 PM-3:00 PM revealed: MR # 1, Start of Care (SOC) 10/4/2021; a seven (7) year old male with diagnoses of autistic disorder {developmental disorder that impairs the ability to communicate and interact}; gastrostomy tube {feeding tube in stomach}; bronchopulmonary dysplasia {chronic lung disorder found in premature infants}. Referral made by AmeriHealth Insurance on 9/27/2021 and services started on 10/4/2021 or seven (7) days after referral was generated. MR # 3, SOC 10/4/2021; a twenty-four (24) year old female with diagnoses of other specified chromosomal disorder; cerebral palsy {congenital disorder of movement, muscle tone, or posture}; developmental disorder. Referral made by doctor’s office dated 9/27/2021 and services started on 10/4/2021 or seven (7) days after referral was generated. Interview with EMP # 1 and EMP # 2 on 4/6/2022 at approximately 3:00 PM confirmed above findings.

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 employee files, documentation and interview with administrator the agency failed to implement, and maintain policies and procedures of an infection control program which has a its goal the prevention and control of infections and communicable diseases. Findings include: Cross reference G 0687-agency failed to show employee staff were 100 % vaccinated for one hundred and twenty-five (125) employees providing care to home care patients. ( emp. # 66-125). G 684 - agency failed to show evidence agency has a plan or process for vaccine mandate for one hundred and twenty-one (121) employees. (# 1-121). Interview with agency administrator complete 4/6/22 at 3:30PM confirmed the above findings.

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 upon review of agency policy, COVID 19 Vaccination reports, and interview with owner (EMP # 1) and clinical director (EMP # 2), agency failed to show evidence agency has a plan or process for vaccine mandate for one hundred and twenty-one (121) employees. (# 1-121). Findings included: Review of agency policy on 4/6/2022 between approximately 12:30 PM-2:00 PM Policy # “ E101” titled “ Infection Control and Safety, COVID-19” stated “ (1.) The agency will monitor the Department of Health, the Centers for Disease Control (CDC), and local and county authorities’ websites for updates and procedures. The Agency’s response and plans may adjust according to the recommendations from these organizations.” Review of COVID tracking reports on 4/6/2022 at approximately 10:00 AM-12:00 PM revealed: Agency unable to produce plan for vaccinating all eligible staff, did not have a process or plan for providing exemptions and accommodations for those who are exempt. In addition, agency failed to develop a process for implementing additional precautions for any staff who are not vaccinated. Out of one hundred and twenty-five (125) employees sixty-five (65) employees had documentation of receiving the vaccine. These vaccinations were all completed during 2021. None documented as received in 2022. Sixty (60) staff or forty-eight (48) percent had no documentation of vaccination or exception request. Interview with EMP # 1 and EMP # 2 on 4/6/2022 at approximately 3:00 PM confirmed above findings.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based upon review of agency tracking forms agency failed to show employee staff were 100 % vaccinated for one hundred and twenty-five (125) employees providing care to home care patients. ( emp. # 66-125). Findings included: Review of COVID tracking reports on 4/6/2022 at approximately 10:00 AM-12:00 PM revealed: Agency unable to produce plan for vaccinating all eligible staff, did not have a process or plan for providing exemptions and accommodations for those who are exempt. In addition, agency failed to develop a process for implementing additional precautions for any staff who are not vaccinated. Out of one hundred and twenty-five (125) employees sixty-five (65) employees had documentation of receiving the vaccine. These vaccinations were all completed during 2021. None documented as received in 2022. Sixty (60) staff or forty-eight (48) percent had no documentation of vaccination or exception request. Interview with EMP # 1 and EMP # 2 on 4/6/2022 at approximately 3:00 PM confirmed above findings.

Home health aide qualifications CFR(s): 484.80(a) Standard: Home health aide qualifications. This STANDARD is not met as evidenced by: Based upon job description, personnel files (PF), and interview with owner (EMP # 1) and clinical director (EMP # 2), agency failed to show evidence employee signed job description for aide for one (1) of five (5) files reviewed. ( PF # 3). Findings included: Review of job description on 4/6/2022 at approximately 9:30 AM-12:00 PM titled (Policy # B335) " Job Desc: Home Health Aide (HHA)" stated " provides personal care services under the direction of the Registered Nurse. The Home Health Aide is assigned to specific clients by the Registered Nurse and performs services for clients as necessary to maintain their personal comfort." Review of PF on 4/6/2022 between approximately 9:30 AM-12:00 PM revealed: PF # 3, Date of Hire (DOH) 7/17/2020; agency unable to produce signed job description for this employee. Interview with EMP # 1 and EMP # 2 on 4/6/2022 at approximately 3:00 PM confirmed above findings.

Based on the findings of an unannounced onsite home health agency Medicare initial certification survey conducted December 29-30,2020 & January 5-7, 2021, Comforcare Home Care, was found to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

Based on the findings of an unannounced onsite home health agency Medicare initial certification survey conducted December 29-30, 2020 & January 5-7, 2021, Comforcare Home Care, was found to be not in compliance with the requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician- ordered start of care date. This ELEMENT is not met as evidenced by: Based upon review of agency policy, medical records (MR), and interview with clinical director (EMP #1), agency failed to complete the initial assessment within 48 hours of referral for five (5) of ten (10) files reviewed. ( MR # 2, 4-7). Findings included: Review of agency policy on 1/7/2021 between approximately 3:00 PM-3:30 PM titled " Admission Process " stated " (1.) Private Duty Nursing: The initial assessment will be completed within 48 hours of referral...." Review of MR on 1/5/2021 between approximately 9:00AM-12:00 PM & 1/6/2021 between approximately 9:00 AM-12:00 PM & 12:30 PM-2:00 PM revealed: MR # 2, Start of Care (SOC) 5/7/2020; referral date 4/28/2020 and initial assessment visit documented nine (9) days later on 5/7/2020. MR # 4, SOC 5/6/2020; referral date 4/28/2020 and initial assessment visit documented eight (8) days later on 5/6/2020. MR # 5, SOC 9/15/2020; referral date 8/26/2020 and initial assessment visit documented twenty (20) days later on 9/15/2020. MR # 6, SOC 2/24/2020; referral date 2/14/2020 and initial assessment visit documented ten (10) days later on 2/24/2020. MR # 7, SOC 10/16/2020; referral date 10/1/2020 and initial assessment visit documented fifteen (15) days later on 10/16/2020. Interview with EMP # 1 on 1/7/2021 between approximately 3:00 PM-4:00 PM confirmed above findings.

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 may choose to include. This ELEMENT is not met as evidenced by: Based upon review of agency policy, medical records (MR), and interview with clinical director (EMP #1), agency failed to include all required elements in the Plan of Care for eight (8) of eight (8) files reviewed. ( MR # 1-8). Findings included: Review of agency policy on 1/7/2021 between approximately 3:00 PM-3:30 PM titled " Plan of Care " stated " (2) The plan of care (485) shall be completed in full to include: (a) all pertinent diagnoses, principle and secondary, including date of onset. (c) type, frequency, and duration of all visits/services (d) specific procedures and modalities for therapy services (g) prognosis (h) rehabilitation potential (i) functional limitations and precautions (k) specific dietary or nutritional requirements or restriction (m) medical supplies and equipment required (n) any safety measures...(r) discharge plans. (4) orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency, and duration." Review of MR on 1/5/2021 between approximately 9:00AM-12:00 PM & 1/6/2021 between approximately 9:00 AM-12:00 PM & 12:30 PM-2:00 PM revealed: MR # 1, Start of Care (SOC) 10/10/2016; Physician orders: 11/29/2020-1/28/2021. Diagnoses: " Ischemic stroke { blood clot that blocks or plugs a blood vessel in the brain. This keeps blood from flowing to the brain. Within minutes, brain cells begin to die}, pulmonary embolism {blockage in one of the pulmonary arteries in your lungs}, COPD { Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lungs, Type 2 Diabetes {chronic condition that affects the way your body metabolizes sugar (glucose) - an important source of fuel for your body}" Skilled nursing orders: "52.5 hours/week. Usually 10 hours a day: 5 am til 3:30 PM 5 days a week. .. Take vital signs daily and PRN. Monitor blood glucose with fingerstick daily three times daily and PRN." Areas missing on the plan of care include: no duration for nursing frequency, no specific parameter to contact with blood sugar results, no specifics for vital signs including pulse ox. No rehabilitation potential or discharge plan documented. MR # 2, SOC 5/7/2020; Physician orders: 11/29/2020-1/28/2021. Diagnoses: " Gastrostomy tube { feeding tube into abdomen}, tracheostomy { surgically created hole (stoma) in your windpipe (trachea) that provides an alternative airway for breathing}, Parkinson's disease {progressive nervous system disorder that affects movement }, foley catheter { thin, flexible catheter used especially to drain urine from the bladder}, ventilator {appliance for artificial breathing}" Skilled nursing orders: " Client is 24/7 care. Two agencies working together to provide care to client. { Agency } provides care during dayshift and evening shift... Take vital signs q shift including blood pressure.... trach size not listed." Areas missing on the plan of care include: no duration for nursing frequency, no type of ventilator or settings listed, no specifics for vital signs, No rehabilitation potential documented. MR # 3, SOC 5/20/2019; Physician orders: 11/16/2020-1/15/2021. Diagnoses: " other specified intracranial injury without loss of consciousness, TBI { traumatic brain injury { disruption in the normal function of the brain}, nerve pain, seizure disorder, mood disorder." Skilled nursing orders: " 64 hours per week. Usual hours are 7:30 a-5:30 p. Thursdays also 5:30 p-11:00 p, and then on weekend per month from Friday at 5:30 p till Sunday at 5:00pm.... Nurse will obtain full set of vital signs every shift....." Areas missing on the plan of care include: no duration for nursing frequency, no specifics for vital signs No seizure precautions. No rehabilitation potential documented. MR # 4, SOC 5/6/2020; Physician orders: 11/2/2020-1/1/2021. Diagnoses: " quadriplegia [affected by or relating to paralysis of all four limbs]; neurogenic bladder {nerves that carry messages back-and-forth between the bladder and the spinal cord and brain don't work the way they should}, morbid obesity {Weight that is higher than what is considered as a healthy weight for a given height}, hypotension {low blood pressure}" Skilled nursing orders: " PDN ( private duty nursing) on Monday, Wednesday, Friday 7a to 100a ( 9 hours per week). Then HHA (aide) on Tuesday, Thursday, Saturday and Sunday 7a-9:30 a (10 hours per week). ...vitals every shift....foley cath care and changes every 2 weeks and as directed.... Areas missing on the plan of care include: no duration for nursing frequency, no specifics for vital signs. No specific HHA orders specified. No foley size listed. No rehabilitation potential documented. MR # 5, SOC 9/15/2020; Physician orders: 9/15/2020-11/14/2020. Diagnoses: "Cerebral Palsy{ group of disorders that affect a person's ability to move and maintain balance and posture. CP is the most common motor disability in childhood}, G-tube {feeding tube inserted through the wall of the abdomen directly into the stomach}, seizures {burst of uncontrolled electrical activity between brain cells (also called neurons or nerve cells) that causes temporary abnormalities in muscle tone or movements (stiffness, twitching or limpness), behaviors, sensations or states of awareness}, scoliosis {condition involving an abnormal sideways curvature of the spine}, asthma { a respiratory condition marked by spasms in the bronchi of the lungs, causing difficulty in breathing}". " Authorized for 3 days per week of 12 hour shifts ...father will call ..wants vital signs reported.. oxygen PRN as needed... only on oxygen if needed for low POX.{pulse ox- reads oxygen leven in blood} .. G-tube feeding.. at 80 cc per hour with 70 cc of water flush per hour......." Areas missing on the plan of care include: no specific order for skilled nursing, no duration for nursing frequency, no specifics for vital signs including pulse ox. No total amount of feeding to be given. No MIC button site care documented. No seizure precautions. No DME {durable medical equipment} and supplies listed. No rehabilitation potential documented. MR # 6, SOC 2/24/2020; Physician orders: 10/24/2020-12/23/2020. Diagnoses: "DiGeorge's Syndrome { immunodeficiency}, Appendicostomy {Malone procedure (MACE), is a surgery that makes a pathway from the belly button into the colon. Enema fluid will go through this pathway. With the Malone procedure, the enema can be given at the beginning of the colon (appendix), instead of being flushed up through the rectum}, scoliosis of lumbar spine {abnormal lateral curvature of the spine} AMPS disease{ Amplified musculoskeletal pain syndrome is a condition in which a person has pain that is more intense (amplified) than " normal " pain}, congenital anomaly of aortic arch {diverse subgroups of malformations that may be clinically silent or may present with severe respiratory or esophageal symptoms}, outlet dysfunction constipation {functional constipation}." " Authorized for 9 hours a day, 5 days a week total 45 hrs/week." Catheter is placed into appendicostomy and the balloon is inflated. The catheter must be taped down to the abdomen.... Areas missing on the plan of care include: no specific order for skilled nursing, no duration for nursing frequency, no rehabilitation potential documented. MR # 7, SOC 10/16/2020; Physician orders: 12/16/2020-2/15/2021. "Diagnoses: ALS { Amyotrophic lateral sclerosis is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control}, tracheostomy { breathing tube into the trachea}, gastric bypass {creating a small pouch from the stomach and connecting the newly created pouch directly to the small intestine}, jejunostomy tube{ tube placed through the skin of the abdomen into the midsection of the small intestine }, suprapubic catheter { (tube) drains urine from your bladder}, ventilator dependant { a device for introducing fresh air and when dependent, unable to be removed from device to breath on own}, colostomy { An opening into the colon from the outside of the body which provides a new path for waste material to leave the body after part of the colon has been removed}." Authorized for 73 hours per week. 2P-6a Monday through Friday and 6p-6a on Sundays...oxygen PRN { as needed} Ventilator dependent- uses the brand VOCSN machine which has the following built into it- ventilator, oxygen concentrator, cough assist, suctioning, and nebulizer. Areas missing on the plan of care include: date of birth, no specific order for skilled nursing, no duration for nursing frequency, no ventilator settings listed. no rehabilitation potential documented. no limits listed for oxygen. MR # 8, SOC 12/11/2020; physician orders: 12/11/2020-2/10/2021. "Diagnoses: unspecified open wound, left ankle, initial encounter. Wound debridement L ankle" Skilled Nursing Orders " Skilled nursing visit three times per week to change wound vac dressing. Take vitals shifts with each visit. Wound vac to run continuously around the clock". Areas missing on the plan of care include: date of birth, no duration for nursing frequency, no rate for vac and no color of dressing foam to use, no rehabilitation potential documented. . Interview with EMP # 1 on 1/7/2021 between approximately 3:00 PM-4:00 PM confirmed above findings.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician. This ELEMENT is not met as evidenced by: Based upon review of agency job description, medical records (MR), and interview with clinical director (EMP #1), staff failed to follow plan of care as ordered for five (5) of (8) files reviewed. ( MR # 1-5). Findings included: Review of agency job description on 1/7/2021 between approximately 3:00 PM-3:30 PM titled " Licensed Practical Nurse (LPN)/ Licensed Vocational Nurse (LVN) " stated " Essential Functions/areas of accoutability (1.a.) .. Follows the Plan of Cre established by the Registered Nurse." Review of MR on 1/5/2021 between approximately 9:00AM-12:00 PM & 1/6/2021 between approximately 9:00 AM-12:00 PM & 12:30 PM-2:00 PM revealed: MR # 1, Start of Care (SOC) 10/10/2016; Physician orders: 11/29/2020-1/28/2021. Diagnoses: " Ischemic stroke { blood clot that blocks or plugs a blood vessel in the brain. This keeps blood from flowing to the brain. Within minutes, brain cells begin to die}, pulmonary embolism {blockage in one of the pulmonary arteries in your lungs}, COPD { Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lungs, Type 2 Diabetes {chronic condition that affects the way your body metabolizes sugar (glucose) - an important source of fuel for your body}" Skilled nursing orders: "52.5 hours/week. Usually 10 hours a day: 5 am til 3:30 PM 5 days a week. .. Take vital signs daily and PRN (as needed). Monitor blood glucose with fingerstick daily three times daily and PRN." Nursing visit reviewed; 12/2/2020- under comments: " 02 sats { oxygen saturated blood} monitored throughout shift. 94% at 1 PM" Plan of care did not include order for pulse ox { tool used to measure oxygen in blood} or parameters to contact physician. Nurse provided care without orders. MR # 2, SOC 5/7/2020; Physician orders: 11/29/2020-1/28/2021. Diagnoses: " Gastrostomy tube { feeding tube into abdomen}, tracheostomy { surgically created hole (stoma) in your windpipe (trachea) that provides an alternative airway for breathing}, Parkinson's disease {progressive nervous system disorder that affects movement }, foley catheter { thin, flexible catheter used especially to drain urine from the bladder}, ventilator {appliance for artificial breathing}" Skilled nursing orders: " Client is 24/7 care. Two agencies working together to provide care to client. { Agency } provides care during dayshift and evening shift... Take vital signs q { every} shift including blood pressure.... trach size not listed. Medications: trach care Q shift with soap and water" Nursing visit notes reviewed: 12/9/2020 " trach stoma care- normal saline, 1/2 hydrogen peroxide. Nurse provided care without orders. MR # 3, SOC 5/20/2019; Physician orders: 11/16/2020-1/15/2021. Diagnoses: " other specified intracranial injury without loss of consciousness, TBI { traumatic brain injury { disruption in the normal function of the brain}, nerve pain, seizure disorder, mood disorder." Skilled nursing orders: " 64 hours per week. Usual hours are 7:30 a-5:30 p. Thursdays also 5:30 p-11:00 p, and then on weekend per month from Friday at 5:30 p till Sunday at 5:00pm.... Nurse will obtain full set of vital signs every shift....Doubled Tubigrips to BLE-{ double layering of support wrap}for edema, on in the morning, remove at HS (bedtime)." Nursing visit notes reviewed: 11/18/2020- " POX 95 % on room air.... No documentation double Tubigrips were applied. Nurse provided care {pulse oxygen} not ordered and failed to provide care per physician orders {tubigrips}. 12/10/2020- No documentation Tubigrips were applied as ordered. 12/11/2020- No documentation Tubigrips were applied as ordered. MR # 4, SOC 5/6/2020; Physician orders: 11/2/2020-1/1/2021. Diagnoses: " quadriplegia [affected by or relating to paralysis of all four limbs]; neurogenic bladder {nerves that carry messages back-and-forth between the bladder and the spinal cord and brain don't work the way they should}, morbid obesity {Weight that is higher than what is considered as a healthy weight for a given height}, hypotension {low blood pressure}" Skilled nursing orders: " PDN { private duty nursing} on Monday, Wednesday, Friday 7a to 100a ( 9 hours per week). Then HHA on Tuesday, Thursday, Saturday and Sunday 7a-9:30 a (10 hours per week). ...vitals every shift....foley cath care and changes every 2 weeks and as directed.... Nursing visit notes reviewed: 11/4/2020- " pulse ox documented 91-95 %. " Nurse provided care without orders. MR # 5, SOC 9/15/2020; Physician orders: 9/15/2020-11/14/2020. Diagnoses: "Cerebral Palsy{ group of disorders that affect a person's ability to move and maintain balance and posture. CP is the most common motor disability in childhood}, G-tube {feeding tube inserted through the wall of the abdomen directly into the stomach}, seizures {burst of uncontrolled electrical activity between brain cells (also called neurons or nerve cells) that causes temporary abnormalities in muscle tone or movements (stiffness, twitching or limpness), behaviors, sensations or states of awareness}, scoliosis {condition involving an abnormal sideways curvature of the spine}, asthma { a respiratory condition marked by spasms in the bronchi of the lungs, causing difficulty in breathing}". " Authorized for 3 days per week of 12 hour shifts ...father will call ..wants vital signs reported.. oxygen PRN as needed... only on oxygen if needed for low POX.{ pulse oxygenation- measuring level of oxygen in blood} .. G-tube feeding.. at 80 cc per hour with 70 cc of water flush per hour......." Nursing visits: 9/23/2020- " pulse ox was 88 % at that time. Pulse ox once up became 92 % after PRN Robafen and pulmivest respiratory treatment....client monitored for seiures, had 1 seizure today lasting 10 seconds with legs outreaches and fixed gaze/stare." Nurse provided care without orders. 10/23/2020- " pulse ox 98 %. Nurse provided care without orders. MR # 5, SOC 2/24/2020; Physician orders: 10/24/2020-12/23/2020. Diagnoses: " DiGeorge's Syndrome { chromosomal disorder caused when a small part of chromosome 22 is missing. This deletion results in poor development of several body systems}, appendicostomy { surgery that makes a pathway from the belly button into the colon. Enema fluid will go through this pathway. With the Malone procedure, the enema can be given at the beginning of the colon (appendix), instead of being flushed up through the rectum), scoliosis of lumbar spine { curvature of spine}, AMPS disease { pain that seems to be more intense (amplified) than " normal " pain }, outlet dysfunction constipation" " No orders present for speech therapy services" No speech therapy visits documented. Nursing visits: 11/11/2020- additional notes: " patient had speech therapy today at 1500 {3:00 PM}. Under section for neugological: " Speech therapy every Wednesday weekly at 1500." 12/3/2020- additional notes: " Speech therapy every Wednesday weekly at 1500." Interview with EMP # 1 on 1/7/2021 between approximately 3:00 PM-4:00 PM confirmed above findings.

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians issuing orders for the HHA plan of care, and the patient's 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). This ELEMENT is not met as evidenced by: Based upon review of agency policy, medical records (MR), and interview with clinical director (EMP #1), agency failed to show evidence physician was informed of discharge for two (2) of two (2) discharge records reviewed. ( MR # 9-10). Findings included: Review of agency policy on 1/6/2021 between approximately 3:00 PM-3:30 PM titled " Discharge Summary " stated " A discharge summary will be completed for clients discharged from the agency.... (1.) A copy will be sent to the physician ..." Review of MR on 1/5/2021 between approximately 9:00AM-12:00 PM & 1/6/2021 between approximately 9:00 AM-12:00 PM & 12:30 PM-2:00 PM revealed: MR # 9, Start of Care (SOC) 7/23/2016; Physician orders: 8/20/2020-10/19/2020; Diagnoses: Multiple Sclerosis (MS) { a chronic, typically progressive disease involving damage to the sheaths of nerve cells in the brain and spinal cord, whose symptoms may include numbness, impairment of speech and of muscular coordination, blurred vision, and severe fatigue}. Patient expired in hospital. No evidence physician was notified of patient death. Summary completed 10/21/2020. MR # 10, SOC 7/22/2016; Physician orders: 3/19/2020-5/18/2020; Diagnoses: Lumbar Spina Bifida {birth defect that occurs when the spine and spinal cord don't form properly}. Patient last skilled visit on 3/8/2020. No evidence physician was notified of patient discharge. Summary completed 1/4/2021. Interview with EMP # 1 on 1/6/2021 between approximately 2:00 PM-3:00 PM confirmed above findings.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based upon review of agency policy, medical records (MR), and interview with clinical director (EMP #1), agency failed to timely supervise the Licensed Practical Nurses (LPN) for six (6) of ten (10) files reviewed. ( MR # 1-3, 5-7). Findings included: Review of agency policy on 1/7/2021 between approximately 3:00 PM-3:30 PM titled " LPN/LVN Supervision " stated " Supervision of a licensed practical or vocational nurse by a registered nurse {RN} shall occur ... at least every 30 days....." Review of MR on 1/5/2021 between approximately 9:00AM-12:00 PM & 1/6/2021 between approximately 9:00 AM-12:00 PM & 12:30 PM-2:00 PM revealed: MR # 1, Start of Care (SOC) 10/10/2016; RN supervisory visit of an LPN documented as occurring on 8/26/2020, 10/26/2020, & 12/30/2020. Each visit exceeded thirty (30) days. MR # 2, SOC 5/7/2020; RN supervisory visit of an LPN documented as occurring on 10/27/2020 & 12/12/2020. Visit exceeded thirty (30) days. MR # 3, SOC 5/20/2019; RN supervisory visit of an LPN documented as occurring on 10/27/2020 & 12/17/2020. Visit exceeded thirty (30) days. MR # 5, SOC 9/15/2020; RN supervisory visit of an LPN documented as occurring on 9/15/2020 & 11/3/2020. Visit exceeded thirty (30) days. MR # 6, SOC 2/24/2020; RN supervisory visit of an LPN documented as occurring on 10/19/2020 & 12/22/2020. Visit exceeded thirty (30) days. MR # 7, SOC 10/16/2020; RN supervisory visit of an LPN documented as occurring on 11/3/2020 & 12/16/2020. Visit exceeded thirty (30) days. Interview with EMP # 1 on 1/7/2021 between approximately 3:00 PM-4:00 PM confirmed above findings.