Medlife Homecare Inc.

“Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: Based on record review and interview, the Agency failed develop and maintain a comprehensive emergency preparedness (EP) program that must be reviewed and updated at least every 2 years (E-0004); failed to ensure the development of an EP plan utilizing an all-hazards approach with a documented facility-based and community-based risk assessments (E-0006); failed to ensure the EP policies and procedures are established, reviewed, and updated at least every 2 years (E-0013); failed to develop policy and procedures that included the staffing strategies to address surge needs during an emergency (E-0024); failed to develop and maintain an EP communication plan (E-0029); failed to develop and maintain an EP communication plan that included contact information for staff, entities providing services under arrangement, patients’ physicians, and other facilities, as appropriate (E-0030); failed to develop and maintain an EP training and testing program that is based on an established agency EP plan, policies and procedures, and communication plan (E-0036); failed to provide initial and ongoing training in EP policies and procedures to all new and existing staff, including contract employees as appropriate, and failed to maintain documentation of training (E-0037); failed to develop an EP plan that can be tested at least annually by means of a community/facility-based full-scale exercise and an additional exercise every 2 years (E-0039). The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff are not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.”

“Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to establish a Quality Assurance and Performance Improvement (QAPI) program (G642); failed to utilize quality indicator data and failed to have details of data collection approved by the governing body (G644); failed to have performance improvement activities (G646); failed to have performance improvement projects (G658); and failed to ensure the governing body assumed overall responsibility and oversight of the QAPI program (G660). Findings include:”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to establish a governing body to assume full legal authority and responsibility for the agency’s overall management (G942); failed to ensure the administrator was appointed by the governing body (G946); failed to ensure the administrator was responsible for day-to-day operations (G948); failed to ensure a qualified pre-designated person was authorized in writing when the administrator is not available (G954); failed to ensure a written contract was established with/for individuals who would be granted clinical privileges and provide home health services under arrangement to the agency’s patients (G978); and failed to ensure that at least one qualifying service was provided directly by agency employees (G982). Findings include:”

“Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop a comprehensive emergency preparedness (EP) plan that had been reviewed and updated at least every 2 years, resulting in lack of direction for agency personnel in the event of an actual emergency or disaster. The Administrator (Staff-A) was requested to provide the agency’s EP plan on 5/5/26 at 11:58 PM and submitted a binder titled, “Emergency Preparedness Contact”, which was reviewed on 5/5/26 at 12:49 PM. During the review, it was noted the binder was void of an EP plan that was established and maintained by the agency. This is evidenced by a document, titled, “Emergency Preparedness Plan: Civil/Weather Disaster Code” (not dated), that provided the definitions of priority codes assigned to patients to identify those needing immediate attention during an emergency. This did not provide documentation of a comprehensive emergency preparedness program. During the interview with Staff-A on 5/5/26 at 1:18 PM, the findings were reviewed and acknowledged. Staff-A was asked to verify the findings that an EP plan had not been developed by the agency. Staff-A explained that the documents provided in the binder, “Emergency Preparedness Contact”, are from the previous owner and the document, titled “Emergency Preparedness Plan: Civil/Weather Disaster Code” is what is provided to the patients in the admission packet. Staff-A further explained that the documents have not been reviewed or updated by the agency since taking ownership in 2024, expressing “I can do that though.””

“Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure an emergency preparedness (EP) plan was developed based on a facility and community-based risk assessment, utilizing an all-hazards approach, resulting in the inability to identify, develop, and prioritize an emergency response based on the hazards most likely to occur in the local area and based on the needs of the patient population the agency serves. During the review of the binder titled, “Emergency Preparedness Contact” on 5/5/26 at 12:49 PM, it was noted to be void of a documented EP plan and facility and community-based risks assessments. On 5/5/26 at 1:18 PM the Administrator (Staff-A) confirmed during an interview that the agency did not develop or establish an EP plan or conduct a facility or community-based risk assessment. Based on these findings the agency did not provide evidence of an EP plan that was developed based on an all-hazards approach that had been reviewed and updated every 2 years. Staff-A reviewed and acknowledged the findings during an interview on 5/7/26 at 10:00 AM.”

“Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop and implement an emergency preparedness (EP) policy and procedure that aligned with an established EP and communication plans that utilized an all-hazards approach, resulting in the inability to review and update policies at least every 2 years. During the review on 5/5/26 at 1:00 PM, of the agency’s policies and procedures binder titled, “Administrative Policy and Procedure Manual” revealed a front-page policy review document titled, “Policy and Procedure Approval by the Board of Directors” that listed policy approval dates and signatures. The last policy approval was noted to be on 1/4/23. Further review noted the binder included a policy titled, “Emergency/Disaster Plan”, (no date). On 5/5/26 at 1:18 PM, the Administrator (Staff-A) confirmed during an interview that the agency did not develop or establish an EP plan. Based on this interview finding, the agency could not provide evidence of an EP policy and procedure that aligned with an established agency EP plan. Staff-A reviewed and acknowledged the findings during an interview on 5/7/26 at 10:00 AM. During the interview Staff-A explained that all policies and procedures in the binder, “Administrative Policy and Procedure Manual”, are from the previous owner and have been read through but not implemented or revised by the agency in the last 2 years.”

“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 record review and interview, the agency failed to develop an emergency preparedness (EP) policy and procedure that included the staffing strategies to address surge needs during an emergency, resulting in the potential for an overburdened healthcare system due to non-essential healthcare visits in the event of an emergency. During the record review on 5/5/26 at 12:49 PM of the binder titled, “Emergency Preparedness Contact”, it noted to be void of an EP plan. On 5/5/26 at 1:18 PM the Administrator (Staff-A) confirmed during an interview that the agency did not develop or establish an EP plan. Further interviewing of Staff-A on 5/7/26 at 10:00 AM revealed that all policies and procedures in the binder, “Administrative Policy and Procedure Manual”, are from the previous owner and have been read through but not implemented or revised by the agency in the last 2 years. Based on these findings, the agency could not provide evidence of an agency prepared EP policy that included staffing strategies to address surge needs in the event of an emergency. Staff-A reviewed and acknowledged the findings during the interview on 5/7/26 at 10:00 AM.”

“Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness (EP) communication plan, resulting in the inability to provide coordinated communication of patient care within the agency, across healthcare providers, and state and local emergency management officials during an emergency or disaster. During the record review on 5/5/26 at 12:49 PM of the agency’s emergency preparedness documents it noted to be void of an emergency preparedness (EP) plan that included a communication plan with an alternative communication plan if services are interrupted. No evidence was provided that included the means in which the agency will coordinate / communicate care with patients, staff, healthcare providers and emergency response officials during an emergency. On 5/5/26 at 1:18 PM the Administrator (Staff-A) confirmed during an interview that the agency did not develop or establish an EP program that included a communication plan. Staff-A reviewed and acknowledged the findings during the interview on 5/7/26 at 10:00 AM.”

“Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness (EP) communication plan that included contact information, resulting in the potential for the lack of effective communication and care coordination in the event of an emergency or disaster. The record review on 5/5/26 of the binder, titled, “Emergency Preparedness Contact” noted a document titled, “Emergency Communication System: Emergency Preparedness Plan Telephone Tree” that listed an administrator and clinical manager of which was not the agency’s administrator and clinical manager. The Administrator (Staff-A) reviewed findings during an interview on 5/5/26 at 1:18 PM and was queried if the emergency communication telephone tree was developed by the agency. Staff-A responded, “That is from the other owner, it has to be updated.” During the interview Staff-A confirmed the agency does not have a communication plan that included the name and contact information for staff, contracted staff, patient physicians, and emergency response agencies. Staff-A reviewed and acknowledged the findings during an interview on 5/7/26 at 10:00 AM.”

“EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness (EP) training and testing program that is based on agency established policies and procedures and an EP plan that had been reviewed and updated at least every 2 years. During the review of the EP documents provided on 5/5/26 at 12:49 PM, it noted the agency did not have evidence of EP plan. On 5/5/26 at 1:18 PM the Administrator (Staff-A) confirmed during an interview that the agency did not develop or establish an EP plan. Based on these findings, the agency did not have an EP testing and training program based on an agency established EP policy and procedure and an agency established EP plan that had been reviewed and updated at least every 2 years. Staff-A reviewed and acknowledged the findings during the interview on 5/7/26 at 10:00 AM.”

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “Organizations” under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF’s emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to provide initial and ongoing training in emergency preparedness policies and procedures to all new and existing staff, including contract employees as appropriate, and failed to maintain documentation of training. During the review of the EP documents provided on 5/5/26 at 12:49 PM, it noted the agency did not have evidence of EP plan. On 5/5/26 at 1:18 PM the Administrator (Staff-A) confirmed during an interview that the agency did not develop or establish an EP plan that included a testing and training program. On 5/6/26 at 10:58 AM the binder titled, “HHA-In-Service” was reviewed and noted an in-service for “Emergency/Disaster Plan”. The binder was void of who attended the in-service. This in-service is confusing considering the agency does not have an EP program to serve as the foundation of the education requirements needed to train all staff. Staff-A reviewed and acknowledged the findings during the interview an 5/7/26 at 10:00 AM. Further explaining, “I put all those in-services in the binder and read them.””

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop an emergency preparedness (EP) plan that can be tested annually and fulfill the required community/facility-based full-scale exercise at least every 2 years and an additional exercise every 2 years, opposite the year of the full-scale exercise, as per this requirement. During the review of the EP documents on 5/5/26 at 12:49 PM, it noted the agency did not have evidence of EP plan. On 5/5/26 at 1:18 PM the Administrator (Staff-A) confirmed this finding during an interview. Based on these findings, the agency did not have an established EP plan that could be tested as per this requirement. Staff-A reviewed and acknowledged the findings during the interview on 5/7/26 at 10:00 AM.”

“Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to establish a Quality Assurance and Performance Improvement (QAPI) program since August 2024, resulting in the potential for a lack of quality improvement for the agency. Findings include: On 5/6/26 at 11:50 AM, the administrator (Staff-A) was asked to provide the agency’s Quality Assessment and Performance Improvement (QAPI) program for review. When asked, Staff-A responded, “What is that?” Staff-A then asked if it was in the policy and procedure binder that belonged to the previous owner. Upon review of the information in the binder on 5/6/26 at 11:30 AM (prior to this interview), it was determined the binder included policies for the QAPI program, however, there was no information about an update or review of the program since Staff-A purchased the agency in 2024. When asked for a description of the agency’s QAPI program or for any QAPI data collected since he purchased the agency in 2024, Staff-A asked, “What am I supposed to have?” Staff-A was unable to provide evidence of an established QAPI program. A review of agency policy titled “Quality Assurance Performance Improvement (QAPI) Program” (not dated) revealed an objective of the QAPI program was to evaluate, “…at least annually the scope, organization and effectiveness of the QAPI program ensuring that actions taken are in pursuit of the objectives of this program and within the mission and goals of the Agency. This evaluation is submitted to the Board of Directors for review.” Staff-A acknowledged the findings at the time of interview.”

“Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA’s governing body. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to utilize quality indicator data and failed to have details of data collection approved by the governing body since August 2024, resulting in the potential for a lack of quality improvement for the agency. Findings include: On 5/6/26 at 11:50 AM, the administrator (Staff-A) was asked to provide the agency’s Quality Assurance and Performance Improvement (QAPI) program for review. Upon determining that there had not been any updates to the QAPI program since the agency was purchased in 2024, Staff-A was asked to confirm that there had not been any data collection regarding quality since that time. Staff-A confirmed this to be true and acknowledged the findings at the time of interview.”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to have performance improvement activities since August 2024, resulting in the potential for a lack of quality improvement for the agency. Findings include: On 5/6/26 at 11:50 AM, the administrator (Staff-A) was asked to provide the agency’s Quality Assessment and Performance Improvement (QAPI) program for review. Upon determining that there had not been any updates to the QAPI program since the agency was purchased in 2024, the Staff-A was asked to confirm the agency did not have any current performance improvement activities regarding quality. Staff-A stated, “What am I supposed to have?” Staff-A was unable to provide evidence of performance improvement activities and acknowledged the findings at the time of interview.”

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to have performance improvement projects since August 2024, resulting in the potential for a lack of quality improvement for the agency. Findings include: On 5/6/26 at 11:50 AM, the administrator (Staff-A) was asked to provide the agency’s Quality Assessment and Performance Improvement (QAPI) program for review. Upon determining that there had not been any updates to the QAPI program since the agency was purchased in 2024, Staff-A was asked to confirm agency did not have any current performance improvement projects. Staff-A was unable to provide evidence of performance improvement projects and acknowledged the findings at the time of interview.”

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the governing body assumed overall responsibility and oversight of the Quality Assurance and Performance Improvement (QAPI) program since August 2024, resulting in the potential for a lack of quality improvement for the agency. Findings include: During an interview on 5/5/26 at 12:20 PM, the administrator (Staff-A) confirmed the agency had not had an active governing body since he purchased the agency in August 2024. As a result, there was no governing body responsibility or oversight of the Quality Assurance and Performance Improvement (QAPI) program. Staff-A reviewed and acknowledged the findings during an interview on 5/7/26 at 11:10 AM.”

“Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop an effective coordinated agency-wide program for the surveillance, identification, prevention, coordination, and investigation of infectious and communicable diseases that is an integral part of the agency’s quality assessment and performance program. The Administrator (Staff-A) was requested to provide quality assessment and infection control documents on 5/6/26 at 11:50 AM, of which were not provided by the end of the day 5/6/26. During the interview with Staff-A on 5/7/26 at 10:00 AM, it was asked if the agency’s infection control program as it is described in the policy “Infection Control Program” (no date), could be explained. Staff-A responded, “No”. Further explaining that all the policies and procedures are from the previous owner and have been read through but not implemented or revised by the agency in the last 2 years. Based on these findings, the agency did not provide evidence of the development of an agency-wide program for the surveillance, identification, prevention, coordination, and investigation of infectious and communicable diseases. Staff-A reviewed and acknowledged findings during the interview 5/7/26 at 10:00 AM.”

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to provide evidence that infection control (IC) education was provided to all agency staff and failed to develop an IC program that included the IC education requirements for staff, patients and caregivers. On 5/5/26 at 11:58 AM, the Administrator (Staff-A) was requested to provide evidence of staff trainings and provided a binder titled, “HHA-In-Service”. On 5/6/26 at 10:58 AM the binder was reviewed. It noted in-services for infection control topics such as, “Infectious disease” and “Infection Control, Standard and Universal Precautions”. The binder was void of who attended the in-services. Staff-A was requested to provide the quality assessment and infection control documents on 5/6/26 at 11:50 AM, of which were not provided by the end of the day 5/6/26. During the interview with Staff-A on 5/7/26 at 10:00 AM, it was noted that the agency does not have a developed IC program. The agency failed to provide evidence of an IC program that included the IC education required for staff, patients and caregivers. Staff-A reviewed and acknowledged findings during the interview 5/7/26 at 10:00 AM.”

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to establish a governing body to assume full legal authority and responsibility for the agency’s overall management since August 2024, resulting in the potential for a lack of oversight for the agency. Findings include: On 5/5/26 at 12:20 PM, the administrator (Staff-A) was asked for the agency’s governing body meeting minutes for review. Upon request, Staff-A asked, “What is that?” Staff-A then asked if the minutes were in the policy and procedure binder that was previously provided for review. Staff-A was told that upon prior review of the policy and procedure binder on 5/5/26 at 12:00 PM, it was determined the binder contained some policies and appointment information for the previous administrator; however, there were no governing body meeting minutes or any updated information. Staff-A confirmed there had not been any governing body activity since he purchased the agency in August 2024 and stated, “I think we need to create that.” A review of agency policy titled “Committees & Responsibilities” (not dated) revealed, “The Board of Directors of this Agency shall manage the business of the Agency, according to written bylaws of the Agency’s operating agreement, which will be reviewed annually….Minutes of the meeting will be distributed to members and presented for review and signature at the next meeting.” [sic] Staff-A acknowledged the findings at the time of interview.”

“Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient’s home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the potential for interruption in continuity of care, missed visits and unmet patient care needs. Findings include: On 5/5/26 at 10:11 a.m., during the Entrance Conference, the Administrator (Staff-A) was queried as to what services were currently provided by the agency and reported, “We provide Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Speech Therapy (ST), Home Health Aide (HHa) and Registered Dietician (RD) services, as needed.” When asked if they utilized contract personnel, Staff-A said “Yes.” When asked which services were provided by the contract agency, Staff-A stated, “We contract PT, MSW, SN, PT, OT, RD, and ST. We don’t currently have a HHa.” When asked to clarify which service was directly provided by the Agency, Staff-A responded, “Skilled Nursing.” On 5/6/26 at 12:58 p.m., during a review of the agency’s (2) contracts, the following was noted: Contract #1 listed RN, HHa, PT and OT services. Contract #2 listed RN, PT, OT, ST services. There were no provisions made for MSW or RD services. The agency failed to ensure that at least one qualifying service was provided directly by agency employees. The Administrator (Staff-A) reviewed and acknowledged the above findings during an interview on 5/7/26 at 10:38 a.m.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure clinical record entries were properly authenticated for 1 (P-2) of 2 patients reviewed, resulting in an incomplete medical record. Findings include: Patient #2 (P-2): During record review on 5/6/26, it was noted 23 physical therapy notes between 11/11/25 and 2/10/26 (date of discharge) were left unsigned by the physical therapist. During an interview with the administrator (Staff-A) on 5/7/26 at 11:10 AM, Staff-A was asked why the notes were not signed by the physical therapist. Staff-A stated he was still doing quality assurance for billing for this patient; however, Staff-A agreed the notes should have been signed and completed by then (86 days after the date of discharge). Staff-A acknowledged the findings at the time of interview. A review of agency policy titled “Clinical Record Contents and Maintenance” (not dated) revealed, “The entry should include the time/date of when the actual event occurred, and be signed by the individual making the entry, along with the individual’s title.” The policy also stated, “Clinical notes should be written the day of service delivery, signed, and incorporated into the record at least weekly.” Lastly, the policy stated, “The patient’s medical record will be completely discharged within 15 days of the Agency last signed orders.””

“Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This Standard is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure 2 (P-1 and P-2) of 2 patients’ information was properly stored and safeguarded, resulting in the potential for unauthorized use of patient information. Findings included: During an interview with the administrator (Staff-A) on 5/7/26 at 11:10 AM, Staff-A was asked to locate a signed consent form, a signed plan of care, and a copy of the home emergency preparedness plan for Patient #2 (P-2). Staff-A was unable to locate the documents in the electronic medical record system or in the files on his computer, however, he stated he would contact the clinical manager to see if she had them after doing a quality assurance review. Staff-A later presented copies of the requested documents and stated he “took pictures” of them and found them on his personal phone. The agency failed to safely store patient clinical records to prevent unauthorized use of patient information. Staff-A reviewed and acknowledged the findings during an interview on 5/7/26 at 12:30 PM after producing the requested documents. Patient #1 (P-1)’s start of care was 12/4/25 with diagnoses that included Polyosteoarthritis. The Plan of Care ordered Physical Therapy (PT) services to be provided. An interview was conducted with the Administrator (Staff-A) on 5/7/26 at 10:28 a.m. During the interview, Staff-A was asked to provide evidence to support that documents (signed Plan of Care, Consent Form, Emergency Preparedness (EP) Assessment, Notice of Non-Coverage...) had been completed for P-1, to which Staff-A responded, “I have them. They’re in my cell phone.” Staff-A showed this writer his cell phone to reveal P-1’s Consent Form for treatment/home care and EP Assessment. Staff-A requested a moment to search for P-1’s signed Plan of Care, which was found in a folder on Staff-A’s personal computer. Staff-A was unable to locate P-1’s Notice of Non-Coverage at the time of this interview. Staff-A later produced P-1’s Notice of Non-Coverage form which he (Staff-A) stated was found in a random folder. The agency failed to ensure patient documents were stored in a manner to prevent unauthorized use of patient information. Staff-A reviewed and acknowledged the above findings at the time of discovery during the above interviews.”

“Administrator CFR(s): 484.115(a) Standard: Administrator, home health agency. (1) For individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure its Administrator was experienced and qualified to perform the day-to-day leadership functions required to oversee agency operations, resulting in lack of sufficient administrative oversight and the potential for the rendering of substandard care and unmet patient care needs. Findings include: On 5/5/26 at 1:13 p.m., during an interview, the Administrator on record (Staff-A) was queried about his qualifications and the process he undertook to become the agency’s Administrator to which he responded, “I’ve never been an administrator before. I’ve been a Physical Therapist (PT) since 2010. A friend told my wife and I about someone who was willing to sell their business (Home Health Agency). I spoke with my wife about it and that’s how we got into this one. We later realized there were so many rules and regulations that we didn’t understand, so we had one consultant to help us with the transfer. My wife owns a staffing company, so I work for her as a contracted staff member. That’s how I make my bread and butter.” The agency failed to employ a qualified Administrator to conduct the day-to-day operations and oversight over all patient care. During a subsequent interview on 5/7/26 at 10:38 a.m., Staff-A reiterated that neither he (Staff-A) nor his wife (Staff-C) had any prior leadership experience regarding health care management, as per this requirement. Staff-A confirmed the above findings during the interview on 5/5/26 at 1:13 p.m., and again on 5/7/26 at 10:38 a.m.”

“HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator’s name, business address, and business phone number in order to receive complaints. This Element is not met as evidenced by: Based on record review and interview, the agency failed to include complete contact information for the agency’s Administrator in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed patient concerns and complaints. Findings include: On 5/5/26 at 11:55 a.m., the agency’s admission packet was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and patient rights and responsibilities forms and Emergency Preparedness documents. During the review, it was noted that there was no contact information for the agency’s Administrator. The current Administrator (Staff-A) reviewed and acknowledged these findings during an interview on 5/7/26 at 10:38 a.m.”

“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 on record review and interview, the agency failed to ensure an initial assessment was performed within 48 hours of referral for 1 (P-2) of 2 patients reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: Patient #2 (P-2): During record review on 5/6/26, it was noted the initial referral for home care was dated 10/10/25. Upon further review of the record, it was determined the start of care date was 10/17/25 – 1 week after home care was initially ordered. A review of agency policy titled “Comprehensive Assessment and OASIS Collection Start of Care” (not dated) revealed, “The initial comprehensive assessment including OASIS data items or Start of Care (SOC) should be initiated within 48 hours of the referral or on the physician-ordered date, or within 48 hours of hospital discharge.” During an interview on 5/7/26 at 11:10 AM, the administrator (Staff-A) was asked about the reason for the delay in care. Staff-A stated it was due to patient request because of a family emergency; however, Staff-A was unable to provide documentation about this or of communication with the physician regarding the delayed start. Staff-A acknowledged the findings at the time of interview.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s health status at the time of admission for 2 (P-1 and P-2) of 2 patients reviewed, resulting in incomplete clinical information and a poor outcome towards determining the needs of these patients and for measuring the patient’s progress toward goals/outcomes. Findings include: Patient #1 (P-1)’s start of care was 12/4/25 with a diagnosis of Polyosteoarthritis. The plan of care ordered Physical Therapy (PT) services to be provided. During the clinical record review on 5/5/26 at 3:00 p.m., it was noted that section M1021 and M1023 of the Initial Comprehensive Assessment, dated 12/4/25, completed by the PT, listed all the patient’s diagnoses as having an exacerbation/onset date of 12/4/25 (same day of admission to this agency). There was no history or status of the listed diagnoses. The Comprehensive Assessment did not paint a clear clinical picture of the status and health care needs of the patient at the time of admission. The Administrator (Staff-A) reviewed and acknowledged the above findings during an interview on 5/7/26 at 10:38 a.m. Patient #2 (P-2): During record review on 5/6/26, it was noted the comprehensive assessment dated 12/16/25 listed 14 diagnoses with an onset date of 12/16/25 – the same day as the start of care. Additionally, four of the diagnoses were listed as “long term” issues, however, they still had the same date of onset listed. As a result, the comprehensive assessment failed to include the history or current status for each listed diagnosis. The comprehensive assessment failed to show a clear picture of the patient’s current status and health care needs at time of admission. The administrator (Staff-A) reviewed and acknowledged the findings during an interview on 5/7/26 at 11:10 AM.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Plan of Care included all the required elements to ensure the needs of 1 (P-1) of 1 patient were met, resulting in the potential for care and services not being provided according to the patient’s identified needs. Findings include: Patient #1 (P-1)’s start of care was 12/4/25 with a diagnosis of Polyosteoarthritis. The Plan of Care (POC) ordered Physical Therapy (PT) services to be provided. During the clinical record review on 5/5/26 at 3:00 p.m., it was noted that the Initial Comprehensive Assessment listed diagnoses of Polyosteoarthritis, Diabetes Mellitus, Hypercholesterolemia and history of falling. Upon further review, it was noted that the POC was void of any of the aforementioned diagnoses that would govern the course of care provided. Additionally, there was no interventions or associated measurable goals that would address the missing diagnoses. The POC failed to address the identified needs of the patient. The Administrator (Staff-A) reviewed and acknowledged the above findings during an interview on 5/7/26 at 10:22 a.m.”

“Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This Element is not met as evidenced by: Based on record review and interview, the agency failed to include contact information for the Home Health agency’s Clinical Manager in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed patient care concerns. Findings include: On 5/5/26 at 11:55 a.m., the agency’s admission packet was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and patient rights and responsibilities forms and Emergency Preparedness documents. During the review, it was noted that there was no contact information for the agency’s Clinical Manager. The Administrator (Staff-A) reviewed and acknowledged these findings during an interview on 5/7/26 at 10:38 a.m.”

“Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) Standard: Administrator. The administrator must: (i) Be appointed by and report to the governing body; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the administrator was appointed by the governing body, resulting in the potential for a lack of oversight for the agency. Findings include. During the entrance conference on 5/5/26 at 10:11 AM, the administrator (Staff-A) identified himself as the administrator of the agency. Following an interview with Staff-A on 5/5/26 at 12:20 PM, it was determined the agency has not had an active governing body since Staff-A purchased the agency in 2024; therefore, there is no evidence Staff-A was appointed to the position as required by the regulation and by agency policy. A review of agency policy titled “Committees & Responsibilities” (not dated) revealed, “The Board of Directors shall: Appoint a qualified Administrator.” Staff-A reviewed and acknowledged the finding during an interview on 5/7/26 at 11:10 AM.”

“Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the administrator was responsible for day-to-day operations since August 2024, resulting in the potential for a lack of oversight of the agency and the potential for poor patient outcomes. Findings include: During extended survey tasks from 5/5/26 through 5/7/26, it was noted the administrator (Staff-A) lacked knowledge of agency programs and operations since he purchased the agency in August of 2024. During the entrance conference on 5/5/26 at 10:11 AM, Staff-A was asked for the name of the alternate administrator. Staff-A stated the agency did not have one. When questioned again during an interview on 5/7/26 at 11:10 AM, Staff-A stated he did not know an alternate administrator was required. During an interview on 5/5/26 at 12:20 PM, Staff-A was asked about the agency’s governing body. Staff-A responded, “What is that?” and “I think we need to create that.” Staff-A then referred to a policy and procedure manual from the previous administrator and stated it might be in there. Staff-A was asked if he had any governing body meetings since he purchased the agency. Staff-A stated he had not and admitted he had no knowledge of what was required. When questioned further about the agency policy and procedure manual, Staff-A admitted he had not reviewed or updated it since he purchased the agency in August 2024. The last known date of policy and procedure review was 1/4/23 – before Staff-A became the administrator. During an interview on 5/5/26 at 1:18 PM, Staff-A was asked about the agency’s Emergency Preparedness (EP) plan. Staff-A confirmed he had not established an EP plan since he purchased the agency in August 2024. During an interview on 5/6/26 at 11:50 AM, Staff-A was asked about the agency’s Quality Assurance and Performance Improvement (QAPI) program. Staff-A responded, “What is that?” and “What am I supposed to have?” Staff-A again referred to the outdated policy and procedure manual but admitted he had no knowledge of what was required. Staff-A confirmed he had not performed any QAPI activities since he purchased the agency in August 2024. A review of agency policy titled “Administrator” (not dated), revealed the administrator, “Serves as a liaison among the governing body, the QAPI committee, and the professional and business staff. Responsible for overall operation of all programs.” [sic] Staff-A failed to demonstrate responsibility for all day-to-day operations of the agency and confirmed he has not updated program information since he purchased the agency in August 2024. Staff-A reviewed and acknowledged the findings during an interview on 5/7/26 at 11:10 AM.”

“Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a qualified pre-designated person was authorized, in writing, when the administrator is not available since 2024, resulting in the potential for a lack of oversight for the agency. Findings include: During the entrance conference on 5/5/26 at 10:11 AM, the administrator (Staff-A) was asked for the name of the alternate administrator. Staff-A stated the agency did not have an alternate administrator. A review of agency policy titled “Committees & Responsibilities” (not dated) revealed, “The Board of Directors shall: Appoint a person qualified to act in the absence of the Administrator.” Staff-A reviewed and acknowledged the findings during an interview on 5/7/26 at 11:10 AM.”

“Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA’s patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure a written contract was established with/for individuals who would be granted clinical privileges and provide home health services under arrangement to the agency’s patients, resulting in lack of administrative responsibility, patient safety and oversight and the potential for poor patient outcomes. Findings include: On 5/5/26 at 10:11 a.m., during the Entrance Conference, the Administrator (Staff-A) was queried as to what services were currently provided by the agency and responded, “Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Speech Therapy (ST), Home Health Aide (HHa) and Registered Dietician (RD) services, as needed.” When asked if the agency utilized contract personnel, Staff-A said “Yes.” When asked which services were provided by the contract agency, Staff-A stated, “We contract PT, MSW, SN, PT, OT, RD, and ST. We don’t currently have a HHa.” When asked to clarify which service was directly provided by the Agency, Staff-A responded, “Skilled Nursing.” On 5/6/26 at 12:58 p.m., during a review of the agency’s (2) contracts, it was noted that there were no established contracts made for the provision of MSW or RD services. The agency failed to establish a written contract for those individuals who would provide services under contractual agreement. Staff-A reviewed and acknowledged the above findings during an interview on 5/7/26 at 10:38 a.m. and again during the exit conference.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the medical records were complete and contained all assessments, plans of care, and visit notes for 2 (P-1 and P-2) of 2 patients reviewed, resulting in lack of the ability to establish and maintain continuity of care and unmet patient care needs. Findings include: Patient #2 (P-2): During record review on 5/6/26, it was noted the record was missing the consent form, signed plan of care, and a copy of the patient’s individualized emergency plan. During an interview with the administrator (Staff-A) on 5/7/26 at 11:10 AM, Staff-A was asked where to find those documents in the record. Staff-A was initially unable to locate the documents; however, he later produced copies from pictures on his phone on 5/7/26 at 12:10 PM. When asked why these documents had not been incorporated into the clinical record 86 days after the patient was discharged from the agency, Staff-A was unable to provide an explanation. A review of agency policy titled “Clinical Record Contents and Maintenance” (not dated) revealed, “The patient’s medical record will be completely discharged within 15 days of the Agency last signed orders.” Staff-A acknowledged the findings on 5/7/26 at 12:15 PM. Patient #1 (P-1)’s start of care was 12/4/25 with a diagnosis of Polyosteoarthritis. The Plan of Care ordered Physical Therapy (PT) services to be provided. The patient (P-1) was discharged from the agency’s services on 1/30/26. During the clinical record review on 5/5/26 at 3:00 p.m., it was noted that there was no evidence of a completed, signed Plan of Care, Consent for home care, Emergency Preparedness Assessment or Notice of Non-Coverage found in P-1’s Electronic Medical Record (EMR). On 5/7/26 at 10:22 a.m., an interview was conducted with the Administrator (Staff-A). During the interview, Staff-A was questioned regarding the aforementioned documents that were not included in P-1’s medical record and stated that the documents were in his personal cell phone and also on his personal computer. The agency failed to ensure P-1’s clinical record was complete. The Administrator (Staff-A) reviewed and acknowledged the above findings during the interview on 5/7/26 at 10:22 a.m.”

“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 record review and interview, the agency failed to ensure a completed discharge summary was forwarded to the Physician within 5 days of the date of discharge for 2 (P-1, P-2) of 2 patients discharged from the agency’s services, resulting in the potential for unidentified continuing health needs and lack of continuity of care. Findings include: Patient #2 (P-2): During record review on 5/6/26, it was noted a discharge note was started on 2/10/26. Upon further review of the record, it was determined the discharge note was not signed by the physical therapist, therefore it was not completed. As a result, there is no evidence that a discharge summary was sent to the physician within 5 days of discharge. A review of agency policy titled “Discharge planning, discharge summary and discharge OASIS” (not dated) revealed, “All discharge summaries shall be sent to the patient’s physician within 5 days of the patient’s discharge from services.” The administrator (Staff-A) reviewed and acknowledged the findings during an interview on 5/7/26 at 11:10 AM. Patient #1 (P-1)’s start of care was 12/4/25 with a diagnosis of Polyosteoarthritis. The Plan of Care ordered Physical Therapy (PT) services to be provided. During the clinical record review on 5/5/26 at 3:00 p.m., it was noted that the PT discharged P-1 from the agency’s services on 1/30/26. Upon further review, there was no documented evidence that the Discharge Summary was forwarded to the Physician within 5 days of the date of discharge from this agency. The Administrator (Staff-A) reviewed and acknowledged the above findings during an interview on 5/7/26 at 10:22 a.m.”