Every finding on record at Mils Home Health Care Agency

A survey for compliance with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 8/11/25-8/14/25 during a recertification survey. The facility was not in compliance with the Appendix Z Emergency Preparedness Requirements.

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 interview and document review the agency failed to maintain a comprehensive emergency preparedness program (EPP) which included all the required elements including both a facility based and community-based assessment. This had the potential to affect the 60 patients receiving services from the agency. Findings include: Upon review of the agency’s emergency preparedness plan, it was identified the agency’s last agency Hazard Vulnerability Assessment (HVA) was completed on 3/17/25. This assessment identified the following threats which included severe weather (tornado, blizzard, flooding and extreme cold); fire and smoke hazards; extended power outages; pandemic of infectious disease outbreak; civil unrest or violence; and hazardous materiel management. This assessment lacked rating of the probability, level of vulnerability/degree of disruption, and level of preparedness with numerical rating to determine the highest potential for impact. A second policy was provided, titled Emergency Preparedness Plan, undated, identified the following threats which included severe weather (tornado, blizzard, and extreme cold), fire, and infectious disease outbreaks were identified with scores of seven and were noted to have high preparedness levels. The assessment went on to identify staff shortage with a score of six, rated as high preparedness level, and transportation disruption was scored at seven, but as medium preparedness level. The HVA identified flooding with a score of four and was rated at medium preparedness level. A previous assessment, completed 9/19/17, identified the above listed hazards, however, also included the following potential hazards: mass casualty event; terrorist attacks; workplace violence; bridge collapse; electrical failure; communications failure; information system failure; water failure; transportation interruption; environmental/altered air quality pollution; and animal attack. Additional items included, however, had decreased potential, included earthquake, hurricane and volcano. Although the assessment contained an area to rate the probability, level of vulnerability/degree of disruption, and level of preparedness with numerical rating to determine the highest potential for impact the assessment did rate the overall potential for impact. The highest areas of potential impact (scored as eight) were identified as transportation interruption. The areas rated as the next highest potential (scored as seven) included ice/snow, tornado, communications failure, and information failure system. Although the EPP vulnerability assessment lacked inclusion of concerns for transportation interruption, communications failure, and information system failure, the plan lacked any indication that this was no longer a concern. The areas of concern identified with the current HVA were those scored at a level seven and included weather, extended power outages, pandemic and infectious disease outbreak, civil unrest or violence, and hazardous materiel release. On 8/14/25 at 9:00 a.m. an interview was held with the Interim Administrator/registered nurse (RN)-B regarding the review and revision of the HVA. RN-B stated some of the potential hazards were removed due to likelihood (hurricane, earthquake and volcano), however, stated she was unsure how a Hazard Vulnerability Assessment was completed or that it was to include both facility and community-based assessments, including all geographic areas served. An agency policy, titled Emergency Preparedness Plan, reviewed and signed 3/17/25, identified the Interim Administrator was to complete and review the HVA. The plan identified the HVA was completed to identify the emergencies most like to occur in the service area (specifically identified city of agency location).

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 interview and document review the agency failed to develop a comprehensive emergency preparedness program (EPP) which included all areas identified within the Hazard Vulnerability Assessment (HVA). This had the potential to affect the 60 patients receiving services from the agency. Findings include: The agency’s most recent agency Hazard Vulnerability Assessment (HVA) was completed on 3/17/25. This identified threats of severe weather (tornado, blizzard, flooding and extreme cold); fire and smoke hazards; extended power outages; pandemic of infectious disease outbreak; civil unrest or violence; and hazardous materiel management. A second policy was provided, titled Emergency Preparedness Plan, undated, identified severe weather (tornado, blizzard, and extreme cold), fire, and infectious disease outbreaks, staff shortage, and transportation disruption. A HVA, completed 9/19/17, included the above concerns, as well as the potential hazards of mass casualty event; terrorist attacks; workplace violence; bridge collapse; electrical failure; communications failure; information system failure; water failure; environmental/altered air quality pollution; and animal attack. Additional areas with decreased potential or occurrence included earthquake, hurricane and volcano. The current HVA lacked inclusion of concern for the above listed discrepancies and lacked indication these areas were no longer a potential threat. A review of the EPP lacked plans for flooding, fire and smoke hazards, extended power outages, civil unrest or violence, staff shortages, hazardous and materiel management, transportation disruption and flooding. On 8/14/25 at 9:00 a.m. an interview was held with the Interim Administrator/registered nurse (RN)-B regarding the review of the HVA and current EPP. RN-B stated some of the potential hazards were removed due to likelihood (hurricane, earthquake and volcano), however, stated she was unaware of the use of the HVA in development of the EPP. Interim administrator stated she was unaware the EPP was to include strategies for addressing emergency events identified by the risk assessment. An agency policy, titled Emergency Preparedness Plan, reviewed and signed 3/17/25, identified the Interim Administrator was to complete and review the HVA. Under the Emergency Response Plan, the policy identified the Emergency Response Plan was to be tailored to identified hazards. The policy identified the plan was to include procedures for staff notification and recall, client notification and continuity of care, evacuation routes and shelter in place, and coordination with local emergency services. The policy did not direct agency to include strategies for addressing emergency events identified by the risk assessment.

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 interview and document review the agency failed to develop a comprehensive emergency preparedness program (EPP) which addressed the patient population, including persons at risk, with identified needs for required services. Additionally, the EP plan failed to identify the services the agency was able to provide in the event of an emergency. This had the potential to affect the 60 patients receiving services from the agency, as well as other potential patients they may serve in an emergent event. Findings include: A review was completed of the facility Admission Packet. Within the packet, it was noted there was a document which was titled Emergency and Contingency Plan. This document was to be completed upon admission, and with any change in condition. The information collected on the document included patient name, date of birth, phone number, address, primary physician, clinic, allergies, and reactions. In addition to the demographic information, there is also areas to identify Advance Directives (desire for resuscitation if one’s heart stops or they stop breathing), emergency contacts, and evacuation plan in the event of emergency. This was for individual data entry, however, did not represent a facility assessment of the population it served with information regarding “at-risk populations” which was defined as individuals who may need additional response assistance including those who had disabilities, lived in institutionalized settings, were from diverse cultures and racial and ethnic backgrounds, had limited English proficiency or were non-English speaking, lacked transportation, had chronic medical disorders, or had pharmacological dependency. An agency policy, titled Emergency Preparedness Plan, undated, identified under the Continuity of Operations Plan (COOP) the areas which were considered essential services for the agency and clients, however, lacked indication as to what services the agency could provide in the event of an emergency response. On 8/14/25 at 9:00 a.m. an interview was held with the Interim Administrator/registered nurse (RN)-B regarding the current EPP and status of the Facility Assessment or similar document which would identify the patient population served, potential at-risk client, and identified needs. RN-B stated she was unaware of the need for a Facility Assessment, and one was not available for review.

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 interview and document review the agency failed to demonstrate they had developed and implemented a process for collaboration with members of emergency management and preparedness at the local, regional, state, and federal level to continue ongoing development and implementation of emergency preparedness within the agency and for the patients served. This had the potential to affect all 60 patients served by the agency, as well as agency staff. Findings include: A review was completed of the facility Emergency Preparedness Plan, signed on 3/17/25. This document outlined within the portion labeled Action Checklist, the agency would maintain updated contact lists for emergency services (police, fire, and EMS (Emergency Medical Services), local hospitals and clinics, and county public health. Although this was identified as an action item, the plan lacked further information as to collaboration, identified resources, and additional contact information. A second Emergency Preparedness Plan, created 3/18/24, included a Business Emergency Plan. Within this document, the Emergency Contact Information directed staff to dial 9-1-1 in emergency. The document also provided the phone number for the police department in the city which the agency was located. The document lacked contact information for other geographic areas throughout the cities served by this agency. Although the document referenced Non-Emergency Police and Fire, it lacked contact information or phone numbers. The document lacked reference or contact information for local public health, local emergency management, other health care providers, local or regional health care coalition, or other information for collaboration for planning and response in the event of an emergency. An agency policy, titled Emergency Management Plan, agency review date 11/1/24, identified preparation activities would be taken to build capacity and identify resources that may be used in emergency response, however, lacked indication as to how they would do so. The procedure also indicated in the event of a community wide emergency with implementation of a community command staff structure an agency representative would report to the command site for assignment. Although this indicated participation in a collaborative nature, there were no supporting documents as to who these contacts were. On 8/14/25 at 9:00 a.m., an interview was held with the Interim Administrator/registered nurse (RN)-B stated she had awareness of home care provider support groups, however, had not participated in them at the agency level. RN-B verified there were no additional documents or information regarding planning with other collaborative partners, at the local, state, or regional levels. Additionally, RN-B stated they have not been in contact with the local/regional health care coalitions, or participated in any meetings, planning, or drills.

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 interview and document review the facility failed to utilize the Hazard Vulnerability Assessment to develop policies for the identified areas of threat and concerns in the agency plan for emergency preparedness. This had the potential to impact the 60 patients served by the agency, as well as the staff members of the agency. Findings include: Upon review of the agency’s emergency preparedness plan, it was identified the agency’s last agency Hazard Vulnerability Assessment (HVA) was completed on 3/17/25. This assessment identified the following threats which included severe weather (tornado, blizzard, flooding and extreme cold); fire and smoke hazards; extended power outages; pandemic of infectious disease outbreak; civil unrest or violence; and hazardous materiel management. This assessment lacked rating of the probability, level of vulnerability/degree of disruption, and level of preparedness with numerical rating to determine the highest potential for impact. A second policy was provided, titled Emergency Preparedness Plan, undated, identified the following threats which included severe weather (tornado, blizzard, and extreme cold), fire, and infectious disease outbreaks were identified with scores of seven and were noted to have high preparedness levels. The assessment went on to identify staff shortage with a score of six, rated as high preparedness level, and transportation disruption was scored at seven, but as medium preparedness level. The HVA identified flooding with a score of four and was rated at medium preparedness level. Upon review of the facilities policies as outlined under both the Emergency Preparedness Plan, undated and the Emergency Management Plan, agency review date of 1/1/24, policies were identified for the following: communication, tornado, extreme cold, fire, infectious diseases, and cyber security. The Emergency Preparedness lacked policies for the following areas identified within the facility HVA including smoke hazards, extended power outages, civil unrest and violence, and hazardous materiel management. The plan also lacked policies lacked policy and procedures for staff shortages, transportation disruption and flooding. On 8/14/25 at 9:00 a.m., an interview was held with the Interim Administrator/registered nurse (RN)-B regarding the review and revision of the HVA and the comparison of identified threats and concerns and identified policies. RN-B stated she was aware some of the policies were lacking. RN-B stated she was unaware a policy/procedure was indicated for all areas of threats and concerns identified within the HVA. An agency policy, titled Risk Assessment and Emergency Preparedness Policy, dated 10/7/24, indicated the agency would maintain a written Emergency Preparedness Plan which outlined specific procedures for natural disasters, infrastructure failures, care-related emergencies and other identified risks.

Homebound HHA/Hospice Inform EP Officials CFR(s): 484.102(b)(2) §418.113(b)(2), §460.84(b)(4), §484.102(b)(2) [(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. At a minimum, the policies and procedures must address the following:] *[For homebound Hospice at §418.113(b)(2), PACE at §460.84(b)(4), and HHAs at §484.102(b)(2):] The procedures to inform State and local emergency preparedness officials about [homebound Hospice, PACE or HHA] patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. This STANDARD is not met as evidenced by: Based on interview and document review the agency failed to develop policies to inform and collaborate with local and state emergency preparedness officials of need for potential evacuation of patients with medical, physical, and mental health concerns in the event of an emergency evacuation. This had the potential to to affect all 60 patients served by the agency. Findings include: A review was completed of the facility Emergency Preparedness Plan, signed on 3/17/25. This document outlined within the portion labeled Action Checklist, the agency would maintain updated contact lists for emergency services (police, fire, and EMS (Emergency Medical Services), local hospitals and clinics, and county public health. This plan lacked further information including identified agencies and contact information in the event of an emergency. A second Emergency Preparedness Plan, created 3/18/24, identified the Emergency Contact Information directed staff to dial 9-1-1 in emergency. The document provided the phone number for the police department in the city which the agency was physically located, however, lacked contact information for other geographic areas throughout the cities served by the agency. Both documents lacked information regarding the development of a policy or procedure as for notification of local and state health officials in the event of the emergency evacuation of clients. An agency policy, titled Emergency Management Plan, agency review date of 11/1/24, identified preparation activities would be taken to build capacity and identify resources that may be used in emergency response, however, lacked indication as to how they would do so On 8/14/25 at 9:00 a.m., an interview was held with the Interim Administrator/registered nurse (RN)-B stated she was unaware of the need for this policy and procedure within the emergency preparedness plan.

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 observation and document review, the facility failed to identify the agency use of volunteers in the event of an emergency. This had the potential to affect all 60 patients served by the agency. A review was completed of the facility Emergency Preparedness Plan, signed on 3/17/25. Upon review of this document, it was noted there was no reference as to how the facility would, or would not, implement the use of volunteers in the event of an emergency. A second Emergency Preparedness Plan, created 3/18/24, was reviewed and also lacked indication of volunteer use in the event of emergency. An agency policy, titled Emergency Management Plan, agency review date of 11/1/24, lacked the identification if volunteer services would, or would not be used in the event of an emergency. On 8/14/25 at 9:00 a.m., an interview was held with the Interim Administrator/registered nurse (RN)-B stated she was unaware of the need for this policy, procedure, or statement to be within the emergency preparedness plan.

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 interview and document review, the agency failed to develop a training and testing program based on the identified threats to the agency as identified in Hazard Vulnerability Assessment. This had the potential to affect all 60 patients served by the agency. Findings include: The agency’s most recent agency Hazard Vulnerability Assessment (HVA) was completed on 3/17/25. This identified threats of severe weather (tornado, blizzard, flooding and extreme cold); fire and smoke hazards; extended power outages; pandemic of infectious disease outbreak; civil unrest or violence; and hazardous materiel management. A second policy was provided, titled Emergency Preparedness Plan (EPP), undated, identified severe weather (tornado, blizzard, and extreme cold), fire, and infectious disease outbreaks, staff shortage, and transportation disruption. Upon review of the EPP, it was noted although the above listed threats were identified within the agency HVA, there was no training plans outlined as to how the agency would educate staff and patients as to the policies and procedures in place. Additionally, there was no outline as to how this education would be provided (for example educational offering (workshop), tabletop exercise (a review with walking through information) or full-scale exercise (a simulation where the actual tasks were performed). The facility plan, Emergency Management Plan, agency review date of 11/1/24, identified staff would perform mitigation activities to lessen the severity and impact of potential emergency. The policy indicated that this would be achieved with staff orientation and ongoing training. On 8/14/25 at 9:00 a.m., an interview was held with the Interim Administrator/registered nurse (RN)-B regarding the review of the HVA, identified concerns and the plans for training and education. RN-B stated the agency had completed severe weather drills, however, there was no training plan developed for upcoming drills/exercise/workshops based on the needs identified with the HVA.

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 interview and review of documents, the agency failed to meet the required testing for agencies in completing/participating in a full-scale community or facility exercise, or real time response, in conjunction with a second full-scale response, mock disaster drill or tabletop exercise. Findings include: The agency’s last agency Hazard Vulnerability Assessment (HVA) was completed on 3/17/25. This assessment identified the following threats which included severe weather (tornado, blizzard, flooding and extreme cold); fire and smoke hazards; extended power outages; pandemic of infectious disease outbreak; civil unrest or violence; and hazardous materiel management. A second policy was provided, titled Emergency Preparedness Plan, undated, identified the following threats which included severe weather (tornado, blizzard, and extreme cold), fire, and infectious disease outbreaks. The assessment went on to identify staff shortage, transportation disruption and flooding. The areas of concern identified with the current HVAs with the highest threat included weather, extended power outages, pandemic and infectious disease outbreak, civil unrest or violence, and hazardous materiel release. Upon review of documentation provided for exercises, a Severe Weather Drill Evaluation was provided for the dates of 5/1/24, 1/21/25, 6/19/25. The evaluation identified the time to complete the drills was documented as two minutes on 5/1/24, four minutes on 1/21/25, and three minutes on 6/19/25. The documentation lacked indication these "drills" were led by a facilitator, included group discussion, and included a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. Although the drills included recommendations/improvements, the documentation lacked a plan for improvement, or any follow through with changes to the policies. On 8/14/25 at 9:00 a.m., an interview was held with the Interim Administrator/registered nurse (RN)-B who stated the agency had not participated in any community wide exercises with other collaborative partners, nor had they completed any exercises/drills regarding any other topics of emergencies as identified by the HVA. An agency policy, titled Emergency Mangement Plan, reviewed and signed 11/1/24, identified the plan was to be tested and evaluated annually, either in response to an actual emergency or in a planned drill. The drill was to focus on the agency's ability to continue to serve clients in the event of an emergency.

On 8/11/25 through 8/14/25, a recertification survey was conducted. This resulted in a partial extended survey at MILS Home Health Care Agency. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. Unduplicated census previous 12 months: 3 Total home visits conducted: 3 List Parent Location visited: 2520 Broadway St NE, Suite 205, Minneapolis, MN 55413 List Hours of Operation: 9:00 a.m.- 4:00 p.m. List total number of records reviewed: 7

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on documentation and interview, the facility failed to report all Outcome and Assessment Information Sets (OASIS) data collected in accordance with federal regulations. Total number of records submitted beyond the 87 days was 130, which equaled 100% of the submissions submitted. Findings include: On the HHA Error Summary by Agency report period of 1/1/2024 - 12/31/2024, the agency had an error code of -3330: record submitted late. The description included the submission was more than 30 days after completion on the new record. The total number of records submitted beyond the 30 days within that period of time was 87 out of 87 submissions, which equaled 100% of the submissions submitted. A subsequent report was run from 1/1/2025 - 8/4/2025. The total number of records submitted beyond the 30 days within that period of time was 80 out of 80 submissions, which equaled 100% of the submissions submitted. During an interview on 8/12/25 at 3:45 a.m., interim administrator/registered nurse (RN)-B and director of nursing (DON) confirmed they had regular issues with their current OASIS software vendor with submitted assessment batches reports coming back with errors. RN-B and the DON stated there was a period of time from January through March when they had not been able to submit the OASIS assessments at all due to the platform being down with their vendor. RN-B and DON stated they had followed up with their current OASIS assessment vendor to resolve the issue at the time of the error reports being received. RN-B stated the vendor informed them they were no longer able to accommodate their needs, and would not be implementing system improvements to meet their requests. The DON stated they have been unable to enter new admissions with their current vendor since 6/1/25. The DON stated these admissions were being entered as readmissions, as they had been patients before. RN-B stated they were in the process of transferring to a new vendor and were hopeful this would be a better system for them to use. Both RN-B and the DON stated they had not reached out for any support regarding their OASIS submissions. RN-B stated they did not have a separate agency policy for OASIS completion and submission but followed the manual for OASIS from CMS (Centers for Medicare and Medicaid).

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and document review, the agency failed to complete a comprehensive medication review during a home visit to ensure medication profiles were accurate for 3 of 3 patients (P1, P2, and P3) observed during home visits. Findings include: P1 P1's plan of care (POC) for certification dates 8/9/25 to 10/7/25, indicated P1’s diagnoses included chronic obstructive pulmonary disease (a lung condition causing damage to the lungs which affects the ability to breathe), asthma (a disease which causes airways to become inflamed and narrow, causing difficulty with breathing), and chronic pain. P1’s POC ordered weekly skilled nursing visits to assist with medication management, med set up and general assessment of patient. On 8/12/25 at 11:30 a.m., during a home visit, director of nursing (DON) was observed during home visit to complete medication set up. Upon arrival P1's home, P1 was assessed for general well-being. DON obtained vital signs (temperature, pulse respirations, and blood pressure) including lung sounds and checking of oxygen saturation levels. DON then proceeded with medication set up. DON reported P1 had an additional two weeks set up in reserve and verified they were in place for future use. DON was observed as she set up medication for the following week as outlined on the medication profile, printed 8/12/25, and compared the profile to the labels on the medication bottles. DON stated there had been a new order received from the provider for B12-cyanocobalamin 1000 mcg (micrograms- a unit of measurement) daily. P1 stated they had not yet picked up the medication from the pharmacy. DON alerted P1 she would set up when available. DON identified P1 was independent with administration of the following medications: Albuterol Sulfate inhaler (an inhaler to be taken as needed for increased shortness of breath or difficulty), Breztri inhaler (an inhaler to be used as a rescue intervention to aide breathing), Estradiol tablets (a hormone replacement), and Narcan (an opioid antagonist-used if change in level of consciousness is noted related to opioid use). Upon comparison of the medication profile/485/and current medications reviewed, it was noted that there was greater than 10 boxes of Ipratropium Bromide/Albuterol Sulfate 0.5 mg/3 mg present in the dining room, as well as an additional supply in the bedroom. This medication was not identified either in POC or medication profile. DON stated she was unaware why this was not listed on either the 485 or medication profile as P1 had used this medication independently for a period of time. At the end of the home visit by the DON, surveyor reviewed self-administered medications with P1. P1 stated they have had no supply of Breztri for an unknown period of time, however, had used the Albuterol Inhaler. Additionally, P1 stated they had not used the Triamcinolone cream for quite some time and no longer had a supply. P1 also stated they did not have a supply of Estradiol as well. P1 stated they did use the Ipratropium Bromide/Albuterol Sulfate 0.5 mg/3 mg twice a day, however, went on to state sometimes the nebulized solution was used only weekly. DON stated she was unaware P1 no longer used Breztri or the Triamcinolone. DON she was unaware why the Ipratropium Bromide/Albuterol Sulfate 0.5 mg/3 mg was no longer listed on the 485. DON stated P1 was independent with managing Estradiol, including refills. On 8/12/25 at 12:30 p.m., DON stated medications were to be reviewed with each visit, especially with medication set up, due to potential for changes. DON stated the medication profile was reviewed and printed for patients prior to patient visit for medication set up. DON stated when there were discrepancies in use, new medications present, or medications no longer being used, the provider was to be contacted to clarify what orders were to be in place. P2 P2's POC with certification dates 7/5/25 to 9/2/25 indicated P2’s diagnoses included essential hypertension (high blood pressure), type two diabetes (adult-onset disease that impacts how your body manages the blood glucose as fuel). P2’s POC ordered weekly skilled nursing visits to assist with medication management, medication set up, blood sugar monitoring and general assessment of patient. On 8/12/25 at 1:00 p.m., registered nurse (RN)-B was observed as they completed skilled nurse visit with P2. DON was also present at visit as previously had followed P2. RN-B initiated visit by completing an assessment, which included vital signs being obtained, blood sugar checked, and lung sounds assessed. Once assessment was completed, RN-B proceeded to complete medication set up. P2 had an electronic medication planner, with a medication set up for three different times of day. P2 had medication sets which had been previously set up for future use. RN-B proceeded with medication set up, using P2’s medication profile, printed 8/11/25, to verify against the medication label. RN-B proceeded with application of a Clonidine patch at 0.3 mg patch. P2’s POC and medication profile indicated P2 should have receive a Clonidine patch 0.2 mg applied. The medication label indicated this was dispensed on 7/17/25. When the discrepancy was brought to the attention of RN-B, RN-B stated this would need to be clarified with the provider. RN-B did not seek immediate follow through with provider and left the Clonidine 0.3 mg patch in place. Once RN-B’s visit was completed, reviewed with RN-B that P2 had three inhalers sitting on the second shelf of the bedside stand. The following inhalers were noted: Advair Diskus (trade brand), no label present. Expiration date of 2019. 58 doses remain. P2 stated he used this “every now and then”. Fluticasone Propionate and Salmeterol 250 mcg/50 mg (generic for Advair Diskus). Expired 11/26. 58 doses remained. P2 stated he used this “every now and then”. Albuterol Sulfate 90 mcg. Dispensed 8/2/25. 200 doses remain. P2’s POC and medication profile identified P2 had an order for Breo Ellipta which contains fluticasone furoate and vilanterol. There was not a Breo Ellipta inhaler present. Upon review of inhaled medications, P2’s caregiver entered and stated the Albuterol Sulfate was dispensed 8/2/25 when they were last at the doctor. RN-B disposed of the outdated Advair Diskus. RN-B stated she would pursue clarification for the orders for Clonidine and inhalers. RN-B stated medication reconciliation should have been done with each visit, including medications used as needed. On 8/12/25 at 1:30 p.m., following the visit, DON affirmed medication reconciliation was to be done with each visit to assure the proper medications were set up and administered as ordered by the provider. P3 P3's plan of care (POC) with certification dates 7/10/25 to 9/7/25, indicated P3’s diagnoses included anxiety disorder, dysthymic disorder (a mild, but long-lasting case of depression), and attention and concentration deficit. P3’s POC ordered every other week skilled nursing visits to assist with medication management, med set up, monitoring of medication compliance, assess anxiety and overall mood state. On 8/12/25 at 2:00 p.m., during a home visit, DON, was observed during home visit with medication set up. DON proceeded with an assessment, including vital signs and lung sounds. Following this assessment, DON proceeded to complete medication set up for P3, using the medication profile printed 8/11/25 to compare to the medication labels. P3 has an electronic medication planner and had back up supplies for two weeks. Once medications were set up, after DON had completed the components of her visit, a review was completed with P3 regarding the remainder of the medications which were not set up for her, as well as reviewing the medications P3 had on the bookshelf. P3 stated she had no supply of Mupirocin present and has not used for some time, unable to recall last date used. P3 stated she has not used the Polyethylene Glycol (used for constipation and bowel regularity), although when asked did experience occasional constipation. P3 stated she did use the Melatonin 3 mg, but only took one tablet, and not two tablets as ordered. In addition to the medication listed on the medication profile and the POC, P3 was also noted to have a supply of Multivitamin Gummies which were outdated, which P3 stated she hadn’t used recently. P3 did have a bottle of One A Day Women’s 50+ multivitamin which she stated she used daily. P3 also had two unopened bottles, 24 count, of Tylenol Extra Strength 500 mg gelatin capsules, one of the bottles had expired 6/25. The other remained current for use. P3 stated she used them for back pain as needed. P3 stated there were no other medications currently used. Following visit, DON stated all medications used by P3 should have been outlined on the POC and medication profile. DON stated review of medications was important to assess usage pattern, understanding prescribed use of medications, and to assure there were no contraindications or interactions. Agency policy, Medication Management revised 1/10/25, instructed nurses to use a current medication profile or POC to set up medications. The policy also identified medications were to be reviewed at each visit to determine if there are new or changed medications. The policy further directs staff if medications are not taken as ordered, or not refilled, this was to be documented and reported to the patient’s provider. The policy further states the provider was to be contacted if there were unclear medication orders.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, interview, and document review, the agency failed to assure all medications currently used by patient on the home health plan of care (POC)/485 for 3 of 3 patients (P1, P2, and P3) observed during home visits. Finding include: Patient one (P1) P1's plan of care (POC) with certification dates 8/9/25 to 10/7/25 indicated P1’s diagnoses included chronic obstructive pulmonary disease (a lung condition causing damage to the lungs which affects the ability to breathe), asthma (a disease which causes airways to become inflamed and narrow, causing difficulty with breathing), and chronic pain. P1’s POC ordered weekly skilled nursing visits to assist with medication management, med set up and general assessment of patient. On 8/12/25, at 11:30 a.m. during a home visit, registered nurse (RN)-A, director of nursing (DON) was observed during home visit with medication set up. A brief physical assessment was completed, as well as interaction with P1 to determine overall and general well-being. RN-A proceeded with med set up for P1. Upon verified completion of services by RN-A, a review was completed with the medication profile and POC/485 for current medications ordered. Although not listed on the POC/485 and medication profile, it was noted that there was greater than 10 boxes of Ipratropium Bromide/Albuterol Sulfate 0.5 mg/3 mg present in the dining room, with an additional supply in the bedroom. RN-A stated she was unaware why this was not listed on either the 485 or medication profile as P1 had used this medication independently for a period of time. P1 stated they did use the Ipratropium Bromide/Albuterol Sulfate 0.5 mg/3 mg twice a day, however, went on to state sometimes the nebulized solution was used only weekly. On 8/12/25, at 12:30 p.m., RN-A/DON stated medications used by P1 was to be listed on both the POC/485 and current medication profile to accurately reflect what the provider had currently ordered. RN-A/DON stated the provider was to be contacted to clarify what orders were to be in place. Patient two (P2) P2's POC with certification dates 7/5/25 to 9/2/25 indicated P1’s diagnoses included essential hypertension (high blood pressure), type two diabetes (adult-onset disease that impacts how your body manages the blood glucose as fuel). P2’s POC ordered weekly skilled nursing visits to assist with medication management, med set up, blood sugar monitoring and general assessment of patient. On 8/12/25, at 1:00 p.m. RN-B was observed as they completed skilled nurse visit, which included physical assessment, and med set up for P2. RN-A also was present at visit as previously had followed P2. During medication set up P2 was assisted to remove previously placed Clonidine patch which was replaced with a new Clonidine patch 0.3 mg. P2’s POC/485 identified P2 was to receive Clonidine patch 0.2 mg weekly, not 0.3 mg which was applied. Once verified RN-B’s visit was completed, a review was completed to verify current medications present matched the orders on the POC/485 and medication profile. RN-B verified P2 was to have received Clonidine 0.2 mg per P2’s POC/485 and stated she would have to follow up with provider regarding dosage. The POC/485 and medication profile also identified P2 had an order for Breo Ellipta which contained fluticasone furoate and vilanterol. There was not a Breo Ellipta inhaler present. P2 had a supply of Advair Diskus (trade brand), no label present, with an expiration date of 2019, which had 58 doses remaining. P2 also had an inhaler of Propionate and Salmeterol 250 mcg/50 mg (generic for Advair Diskus), with an expiration date of 11/26, which had 58 doses remaining. P2 stated he used these inhalers “every now and then”. RN-B stated the medication profile and POC/485 was to correspond with what was used by P2, and would pursue clarification of orders. On 8/12/25, at 1:30 p.m., following the visit, DON affirmed medication reconciliation was to be done with each visit to assure the proper medications were given as ordered by the provider. Patient three (P3) P3's plan of care (POC) with certification dates 7/10/25 to 9/7/25 indicated P3’s diagnoses included anxiety disorder, dysthymic disorder (a mild, but long-lasting case of depression), and attention and concentration deficit. P3’s POC identified orders for skilled nurse visits every other to assist with medication management, med set up, monitoring of medication compliance, assess anxiety and overall mood state. On 8/12/25, at 2:00 p.m. during a home visit, RN-A, was observed as she completed an assessment of P3, followed by medication set up. After visit was verified as complete, a review was made by surveyor as to current medications used. P3 stated she no longer used Mupirocin. P3 stated she used Melatonin 3 mg at bedtime, not 6 mg as reflected on the POC/485. P3 stated she routinely used One A Day Women’s 50+ multivitamin daily, as well as Tylenol Extra Strength 500 mg gelatin capsules for back pain as needed. The use of these medication was not reflected on the POC/485. Following visit, RN-A/DON stated all medications used by P3 should be outlined on the POC/485 and medication profile. DON stated it was important to have all medications listed on the POC/485 to assure there were no contraindications or interactions with medications ordered. Agency policy, Medication Management revised 1/10/25, identified Agency nurses will set up medications for clients as ordered by the physician. The Registered Nurse (RN) or therapist was to complete a medication profile for each client at the time of admission and the profile was to be reviewed and updated as needed to reflect current medications the client is taking. The policy identified that this was completed to prevent medication errors or adverse effects related to clients taking medications that are not ordered or approved by the current physician.

A survey for compliance with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 4/24/23-4/26/23 during a recertification survey. The facility was not in compliance with the Appendix Z Emergency Preparedness Requirements.

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 interview and document review the agency failed to maintain a comprehensive emergency preparedness program (EPP). The agency failed to ensure their agency risk assessment was reviewed and updated at least every two years. This had the potential to affect all 68 patients receiving services from the agency, as well as all staff who worked for the agency. Upon review of the agency’s emergency preparedness plan, it was identified the agency’s last agency risk assessment was dated 9/19/17. The emergency preparedness plan lacked evidence of review within the past two years. On 4/25/23, at 1:35 p.m. the Administrator confirmed the agency risk assessment was not completed after 9/19/17. The Administrator indicated she did not realize it needed to be completed at least every two years. An agency policy titled Emergency Management Plan dated 3/15/20 failed to identify who was responsible for completing and reviewing the agency risk assessment as well as the frequency it needed to be done.

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 interview and document review the agency failed to maintain a comprehensive emergency preparedness program (EPP). The agency failed to ensure their contact list for Federal, State, local and tribal contacts was reviewed and updated at least every two years. This had the potential to affect all 68 patients receiving services from the agency, as well as all staff who worked for the agency. Contact information include department name, address and phone numbers for Federal, State, local and tribal emergency contacts was noted on the contact list, but the list was not updated after 2017. On 4/25/23, at 1:35 p.m. the Administrator confirmed the contact list was not reviewed and updated after 2017. The Administrator indicated she did not realize it needed to be reviewed and updated at least every two years. An agency policy titled Emergency Management Plan dated 3/15/20 failed to identify who was responsible for completing and reviewing contact list as well as the frequency it needed to be done.

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 interview and document review the agency failed to maintain a ensure their emergency preparedness program (EPP) include community-based testing at least every two years. This had the potential to affect all 68 patients receiving services from the agency, as well as all staff who worked for the agency. Review of the agencies annual testing and drills for the period of 2019-2023 included fire drills and basic office safety in the event of an emergency. The testing log failed to include community-based testing at least every two years. On 4/25/23, at 1:35 p.m. the Administrator confirmed annual testing focused on office staff and how to ensure their safety. The Administrator was not aware of the need to complete community-based testing. An agency policy titled Emergency Management Plan dated 3/15/20 indicated the plan will be tested and evaluated annually and will focus on the agency’s ability to continue to serve clients in the event of an emergency. The plan failed to indicate how the testing would be completed and the frequency of community-based testing.

On 4/24/23-4/26/23 a recertification survey was conducted. This resulted in a partial extended survey at MILS Home Health Care Agency. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. Unduplicated census previous 12 months: 8 Total home visits conducted: 3 List Parent Location visited: 2520 Broadway St NE, Suite 205, Minneapolis, MN 55413 List Hours of Operation: 9:00 a.m.- 4:00 p.m. List total number of records reviewed: 7 In addition to the recertification, the following complaints were reviewed. As a result: No deficiencies were issued for complaints: H8003013C (Intake ID 21348) H80031535C (Intake ID 71645)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and document review, the agency failed to complete a comprehensive medication review during a home visit to ensure medication profiles were accurate for 1 of 3 patients (P4) observed during home visits. P4's plan of care (POC) with certification dates 3/1/23- 4/29/23 indicated P4’s diagnoses included hypertension and depression. P4’s POC ordered monthly skilled nursing visits to assist with medication management included medication set up. Medications ordered on P4’s POC included Atorvastatin 80mg, one tab by mouth each day at bedtime. P4’s medication profile printed 4/24/23, noted medications included atorvastatin 80mg one tab by mouth each day at bedtime. Agency document, Skilled Care Note for [P4] dated 3/28/23, signed by licensed practical nurse (LPN)-A noted medications were set up for 30 days. Medication list included atorvastatin 80mg one tab by mouth each day at bedtime. On 4/25/23, at 10:45 a.m. during a home visit, registered nurse (RN)-A compared P4’s medications bottles to P4’s medication profile, printed 4/24/23. RN-A noted the label on the medication bottle for atorvastatin indicated the dose inside the bottle was 20mg, RN-A then noted the order on the medication profile for the atorvastatin was for 80mg. RN-A stated she would set up the medication planner according to the instructions on the prescription label. RN-A set up four weeks of medication, placing one tab of atorvastatin 20mg in each bedtime space of the planner and confirmed she was finished with medication set up. RN-A compared the medication bottle label to the medication profile after she was asked about the order for the change in dose. RN-A corrected the set up dose to 80mg after receiving clarification from the RN for P4’s primary provider. RN-A reviewed the previously set up medication planner. RN-A indicated the planner was set up 3/28/23 by LPN-A. RN-A noted atorvastatin in the previous planner was set up for 20mg each bedtime. RN-A confirmed the medication was not set up according to current orders and was a medication error. On 4/26/23, at 9:40 a.m. the director of nursing (DON) verified the medication error. DON expected the visit nurse printed an updated medication profile before going to each visit for medication set up. The visit nurse was expected to set up medications according to the medication profile and contact either the provider or the provider’s nurse if clarification of medication is needed. Agency policy, Medication Management revised 1/4/23, instructed nurses to use a current medication profile or POC to set up medications. Medications are reviewed at each visit to determine if there are new or changed medications.