Total Homecare Solutions, Inc.

“Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan was reviewed and updated at least every 2 years (see E0004); failed to ensure emergency preparedness policies and procedures based on the emergency plan, risk assessment and communication plan were implemented, reviewed, and updated every 2 years (see E0013); failed to maintain an emergency preparedness communication plan that was updated at least every 2 years (see E0029); failed to ensure all staff received emergency preparedness training initially and at least every 2 years (see E0037); and failed to ensure exercises to test the emergency preparedness plan were conducted annually (see E0039), resulting in the potential to negatively affect the health and safety of all patient’s receiving services from this agency. Findings include: The cumulative effect of these systemic problems results in the agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.102, Emergency Preparedness.”

“Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This Condition is not met as evidenced by: Based on document review and interview, it was determined the home health agency failed to develop a Quality Assessment and Performance Improvement (QAPI) policy and program, (See G 642); the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, (See G 644); failed to document the quality improvement projects for 2020 and 2021 to date, and document the reasons for conducting these projects and the measurable progress achieved each year (See G 658); and failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section (See G 660). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure the provision of quality health care for all the patients the Home Health Agency has served for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).”

“Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This Condition is not met as evidenced by: Based on record review and interview, the Agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the Agency’s Quality Assessment Performance Improvement program (See G 684); and failed to provide infection control education to staff (See G 686). The cumulative effects of these systemic problems resulted in the agency’s inability to ensure the provision of safe health care for the condition of participation of 42 CFR§484.70 Infection Prevention and Control.”

“Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Emergency Preparedness plan was reviewed and updated at least every 2 years, resulting in the potential to negatively impact all patients receiving services from this agency in the event of an emergency. Finding include: The agency’s Emergency Preparedness (EP) documentation was reviewed on 4/16/24. Upon review of the binder, it was noted the agency failed to develop an EP plan that was based on both agency and community-based risk assessments. The Hazard Vulnerability Assessment (HVA) was located in the binder; however, it was not dated so there was no indication as to when the form had been completed. It was also noted the binder contained several documents with outdated/incorrect information or left blank. These included a policy titled “3.A Disaster Management Team” that listed a person who is no longer an employee as responsible for all duties related to plan activation; a list of local health department emergency preparedness coordinators that was last printed in 2017; and a policy titled “3.C Communication” with contact information for the Incident Command Center and alterative site and contact information for the Administrator and Incident Commander left blank. During an interview on 4/16/24 at 10:20 AM, the Alternate Administrator (Staff A) was asked when the EP plan was last reviewed and updated. Staff A was able to provide a Governing Board meeting agenda from 10/12/23 that stated, “Initial review of PP manual, EEP and patient records is completed.” However, due to the outdated/incorrect information located in the binder, it is evident the EP has not been effectively reviewed and updated for the agency’s current information. Staff A acknowledged the findings at the time of interview.”

“Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure emergency preparedness policies and procedures based on the emergency plan, risk assessment and communication plan were implemented, reviewed, and updated every 2 years, resulting in the potential for poor patient outcomes during the event of an emergency. Findings include: The agency’s emergency preparedness (EP) documentation was reviewed on 4/16/24. During review of the agency’s EP plan, it was determined the information was outdated/incorrect - including an undated Hazard Vulnerability Assessment, outdated Incident Commander information, and contact information for the Administrator and Incident Commander left blank. It was also noted a section titled “Section V” and “Strategies for Addressing Identified Possible Emergency Events” contained generic policies on how to handle emergency situations (including fire, weather, and bomb threats) instead of agency-specific and community-based procedures. As a result, it was determined the agency’s policies and procedures could not be accurately reviewed and up to date based on the information above. The Alternate Administrator (Staff A) acknowledged the findings during an interview on 4/16/24 at 10:20 AM.”

“Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to maintain an Emergency Preparedness communication plan that was updated at least every 2 years, resulting in the inability to coordinate patient care for the patients served by this agency in the event of an emergency. Findings include: On 4/16/24, the agency’s Emergency Preparedness (EP) plan for communication was reviewed. The communication plan included: 1) A list of local health department EP coordinators that was last printed in 2017 2) A policy titled “3.C Communication” with contact information for the Incident Command Center, alternate site, and contact information for the Administrator and Incident Commander left blank. 3) Policy “3.C Communication” also stated, “Total Homecare Solutions maintains an updated contact list of all staff, which is supplied to all supervisory personnel and staff. The contact list of all staff is posted on the Agency’s EMR system and/or distributed via e-mail.” It was noted there was not a contact list for staff included in the binder. During an interview on 4/16/24 at 10:20 AM, the Alternate Administrator (Staff A) was queried regarding the information located in the Communication Plan. Staff A acknowledged the list for EP coordinators was outdated and that the information regarding the Command Center, alternate site, Administrator and Incident Commander should have been filled out to reflect the current information. When asked to provide a contact list/phone tree for current staff to use in the event of an emergency, Staff A reported “everyone has everyone’s phone numbers.” Staff A was queried on how staff would know who was responsible for calling who in the event of an emergency. Staff A was unable to provide information on what procedures staff would follow regarding communication. Staff A acknowledged the findings at the time of interview.”

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “Organizations” under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF’s emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to provide initial training in emergency preparedness to 2 (Staff C, D) of 3 personnel files reviewed of clinical staff, resulting in the potential for unprepared responses to emergencies and an interruption in the provision of needed patient care services. Findings include: **Policy X.23 titled “Emergency/Disaster Plan” (not dated) stated “All employees shall be oriented to the plan and their responsibilities in carrying out the plan, upon hire.” Personnel files were reviewed on 4/16/24. During review, it was noted there was an orientation check list in the file for the Director of Nursing (Staff B) with a check mark next to Emergency Preparedness (EP). Upon further review of personnel files, it was noted there was not an orientation checklist present in the files for the physical therapists (Staff C, D). The Alternate Administrator (Staff A) was queried on 4/16/24 at 10:20 AM regarding initial EP training for Staff C and Staff D. Staff A reported Staff C and Staff D were contracted staff so do not have the orientation form like Staff B who was a direct hire. Staff A was asked how Staff C and Staff D would know how to respond in the event of an emergency. Staff A stated everything is “talked about” upon hire and the contracted staff were free to ask questions. Staff A was unable to provide evidence the contracted staff were provided with initial EP training. Staff A acknowledged the findings at the time of interview.”

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure exercises to test the emergency preparedness plan were conducted annually according to the regulation, resulting in the potential for poor patient outcomes in the event of an actual emergency. Findings include: The agency’s Emergency Preparedness (EP) documentation was reviewed on 4/16/24. Upon review of the binder, it was noted there was no documentation of training drills performed by the agency. The Alternate Administrator (Staff A) was queried regarding staff testing and drills during an interview on 4/16/24 at 10:20 AM. Staff A stated a fire drill was “talked about” during a meeting sometime after the agency was purchased on 10/11/23, however, he was unable to provide any evidence of this occurring, who was involved, or how it went. There was no record of any EP drills being performed. Staff A acknowledged the findings at the time of interview.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included patient-specific measurable outcomes and goals based on the comprehensive assessment and current patient needs in 5 (P-1, 2, 3, 4, 5) of 7 records reviewed; and failed to adhere to stated goals for discharge in the Plan of Care (POC) before discharging the patient in 1 (P-6) of 5 records with therapy only cases, out of a total sample of 7 records reviewed, resulting in the inability to determine the patient’s progress towards achieving goals and the potential for poor patient outcomes. Findings include: ***Agency Policy III.6: Physician’s Plan of Treatment/Change Orders, no date. The Policy States, “At the time of certification and recertification, a written summary shall include: “The patient’s progress toward measurable goals and outcomes identified by the Agency in the Plan of Care.” P-3: The Start of Care was dated 1/4/2024. The Plan of Care for the certification period 1/4/2024 to 3/3/2024 identified a primary diagnosis of Malignant neoplasm of the right breast, muscle spasms, pain of the right and left shoulder, and low back pain related to age-related osteoporosis. The patient was receiving Physical Therapy (PT) services. Upon review of the Plan of Care, it was noted the goals were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples include: “Increase safety to prevent fall {sic}; Decrease muscle spasm in cervical region; Teach safe and effective use of AD {sic} (undefined abbreviation); Improve fall safety, improve medication safety {sic}. These goals are not objectively measurable to determine the patient’s progress towards goals. P-4: The Start of Care was dated 12/17/2022. The Plan of Care for the certification period 12/17/2022 through 2/14/2023 identified diagnoses of Primary osteoarthritis, bilateral osteoarthritis, difficulty walking, and Chronic Obstructive Pulmonary Disease (COPD). The patient was receiving Physical Therapy (PT) services. Upon review of the Plan of Care, it was noted the goals were not objectively measurable to determine the patient’s progress towards obtaining the goal. Examples included: “Patient/Caregiver reports patient’s pain within comfort level by 1/21/2023; Patient/Caregiver demonstrates ability to follow home exercise program by 12/21/2022; Patient/Caregiver assumes responsibility for personal care needs by 12/31/2022. These goals are not objectively measurable to determine the patient’s progress towards achieving the goals. P-5: The Start of Care was dated 12/12/2022. The Plan of Care for the certification period 12/12/2022 to 2/9/2022 identified diagnoses of Lumbago with sciatica right side, Difficulty in walking, muscle weakness, Diabetes type 2; and hypertension. Upon review of the Plan of Care, it was noted the goals were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples included: “Patient/Caregiver reports patient’s pain within comfort level by 1/18/23; Patient/Caregiver demonstrates ability to follow home exercise program by 12/28/2022.” These goals are not objectively measurable to determine the patient’s progress towards obtaining the goal. These findings were reviewed and acknowledged by the Director of Nursing at 1:00 p.m. on 4/16/2024. P-6: The patient’s start of care (SOC) was 2/24/2024 with diagnoses that included low back pain, bilateral knee pain, and osteoarthritis. During the record review on 4/15/24, it was noted P-6’s POC by Physical Therapy (PT) documented a discharge ambulation goal of 60 feet times two (rest break in between) to help alleviate home bound status. The POC episode period was standard, 2/24/24 through 4/23/24 and ordered PT visits 1W1 (one visit weekly for one week), 3W1, and 2W1. On 4/15/24, record review noted the following PT visits with accompanying documented ambulation. 2/24/24: 4 feet x 2. 2/26/24: 6 feet x 2. 2/28/24: 15 feet x 2. 3/2/24: 15 feet x 2. 3/4/24: 30 feet x 2. 3/6/24: 35 feet x 2 with discharge from the Agency. The discharge summary on 3/6/24 by PT documented “Goals Met”. However, the goal was not met (60 feet x 2 vs. 35 feet x 2). The Agency’s Administrator (Staff A) and Director of Nursing (Staff B) were queried why the patient was prematurely discharged when P-6 was making good progress in the 11 days since being admitted. No explanation was given, and no reason was found in the medical record. A phone interview was attempted on 4/15/24 at 8:56 AM. P-6 stated she didn’t want to talk about it and hung up. Both Staff A and B noted they would investigate why P-6 was discharged so early without goals being met when the clinical record indicated significant progress was being made. The Agency failed to ensure PT adhered to the POC and acted in the patient’s best interest in achieving an optimal outcome in the allowed timeframe. P-1: This 89-year-old patient was admitted to this agency on 2/28/24 with the diagnoses of hypertension (high blood pressure), repeated falls, and dizziness. During record review on 4/11/24, it was noted the nursing goals on the plan of care dated 2/28/24 were not measurable or patient specific. The nursing goals were listed as follows: -patient will have no hospitalization -patient will be free of fall and injury -patient will be able to recall diversions for pain relief -patient will become knowledgeable on HTN (high blood pressure) and management of care -patient will be free of falls -patient will be free of drug interaction with knowledge on medication, action, side effects These goals do not include information that is specific to the patient, nor measurable parameters to assist in evaluating the patient’s progress/non-progress towards achieving the goals. P-2: This 75-year-old patient was admitted to this agency on 2/28/24 with the diagnoses of hypertension, chronic obstructive pulmonary disease, type II diabetes, and polyosteoarthritis (arthritis in multiple joints). During record review on 4/15/24, it was noted the nursing goals on the plan of care dated 2/28/24 were not measurable or patient specific. The nursing goals were listed as follows: -patient will be free of falls with tolerable pain level -patient will be taught on HTN and management of care. Patient HTN will remain under control during this episode of care -patient will become knowledgeable of DM II (diabetes) and management of care -patient will be free of medication reactions These goals do not include information that is specific to the patient, nor measurable parameters to assist in evaluating the patient’s progress/non-progress towards achieving the goals. The findings were reviewed with and acknowledged by the Alternate Administrator (Staff A) during an interview on 4/15/24 at 12:30 PM.”

“Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This Standard is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to develop, implement, and maintain a quality assessment and performance improvement program which had the potential to negatively affect all 8 patients that were admitted during the past 12 months, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: The Agency’s Quality Assessment and Performance Improvement (QAPI) documentation was reviewed on 4/16/24. There was no documentation to support the Agency’s performance improvement activities regarding their efforts to systematically collect data, monitor, analyze and improve patient outcomes. The QAPI binder contained one document (dated 1/8/2024) titled, “4th Quarter 2023 QAPI Data Analysis Report/Meeting” for the last 3 years. The lone document failed to produce any data which could be utilized to track and trend any quality improvement measures. In addition, the Agency failed to authenticate the lone QAPI document with any names or signatures. The above findings were reviewed and acknowledged by the Agency’s Alternate Administrator (Staff A) during an interview on 4/16/24 at 10:35 AM. The Agency failed to adhere to its policy referenced below. Agency Policy: “Quality Assurance Performance Improvement (QAPI) Program” VI.1 (undated) stated, “To maintain and improve the highest quality patient care and to reduce or eliminate risks and hazards within the patient’s environment by: Administering and coordinating the Agency’s QAPI program which is designed to ensure all QAPI activities are implemented... tracking identified problems to ensure improvement or resolution... documenting the findings, conclusions, recommendations, actions taken, and results of actions taken using a defined statistical process.””

“Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA’s governing body. This Standard is not met as evidenced by: Based on document review and interview, it was determined the Agency failed to collect and use data to monitor the effectiveness, safety of services and quality of care and identify opportunities for improvement by the Quality Assessment and Performance Improvement (QAPI) program, which had the potential to negatively affect all 8 patients serviced by the Agency during the past 12 months, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: During an interview on 4/16/2024 at 9:20 AM., a request was submitted to review the QAPI documents for the last 3 years concerning the evaluation of relevant program data. The Alternate Administrator (Staff A) was unable to produce any program data which could be measured for quality improvement in any areas going back to 2020. The Agency failed to adhere to its policy referenced below. Agency Policy: “Quality Assurance Performance Improvement (QAPI) Program” VI.1 (undated) stated, “To maintain and improve the highest quality patient care and to reduce or eliminate risks and hazards within the patient’s environment by: Administering and coordinating the Agency’s QAPI program which is designed to ensure all QAPI activities are implemented... tracking identified problems to ensure improvement or resolution... documenting the findings, conclusions, recommendations, actions taken, and results of actions taken using a defined statistical process.””

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to develop a Quality Assessment Performance Improvement (QAPI) program that documented any performance improvement projects, the reasons for conducting these projects along with measurable tracking and trending measures to ascertain progress achieved during the last three years, resulting in the Agency’s inability to improve in patient care, health outcomes, patient safety, and overall quality of care for all 8 patients that received services with the past 12 months. Findings include: During an interview on 4/16/24 at 10:30 AM., the Alternate Administrator (Staff A) was queried about documentation of the Agency’s QAPI Program and Performance Improvement Projects (PIP’s), reasons for conducting the projects along with measurable progress achieved. Staff A was unable to provide documentation of any PIP’s during the last 3 years. The Agency failed to follow its policy referenced below. Agency Policy: “Quality Assurance Performance Improvement (QAPI) Program” VI.1 (undated) stated, “The Agency will identify important processes and functions that affect health care outcomes, efficient use of Agency resources and customer perception of care. The focus will be on high-risk, high volume and/or problem-prone activities, choosing at least one process to be analyzed per year.””

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on record review and interview, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all 8 patients admitted in the last year. Findings include: During an interview on 4/16/24 at 10:45 AM., a request was made to review the Agency’s QAPI report and Governing Body meeting minutes for the last 3 years. Upon receipt and review of the agency’s QAPI data, there was no data made available for review that determined or affirmed the Governing Body’s oversight of the QAPI program since 2020. These findings were reviewed with and acknowledged by the Alternate Administrator (Staff A). The Agency failed to adhere to its policy referenced below. Agency Policy: “QAPI Monitoring and Responsibility” VI.2 (undated) stated, “ Responsibility for the QAPI program ultimately rests with the Board of Directors. Administrative responsibility for the QAPI program is delegated to the Administrator who may delegate certain activities.””

“Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the agency’s Quality Assessment Performance Improvement program, resulting in the potential spread of infections between patient care staff and the Agency’s 8 patients admitted in the past year. Findings include: On 4/16/24, the Agency’s Quality Assessment Performance Improvement (QAPI) documentation was reviewed, which consisted of one document titled, “QAPI Data Analysis Report/Meeting”. The document was dated 1/8/2024, had no names or signatures for authentication, had no infection control projects noted for the surveillance, and identification to track and trend for pre-established approved goals by the Agency’s Governing Board concerning infection control. It was noted the document listed no infections for the 2 admissions in the last year. No other quantitative measures regarding infection control were evidenced within the last 3 years under the Agency’s QAPI umbrella. The above findings were reviewed and acknowledged by the Agency’s alternate administrator (Staff A) during an interview on 4/16/24 at 10:47 AM. Staff A stated, “We will work on this immediately.””

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to provide infection control education to staff, resulting in the potential for transmission of communicable disease to all patients served by this agency. Findings include: The personnel files for the Director of Nursing (Staff B) and 2 contract Physical Therapists (Staff C and Staff D) were reviewed on 4/16/24. During review, it was noted there was no evidence of staff training on infection control upon hire. The Alternate Administrator (Staff A) was queried during an interview on 4/16/24 at 12:00 PM regarding staff education on infection control. Staff A provided a checklist for orientation for Staff A (a direct hire); however, this list did not include infection control. When asked whether contracted staff received education on infection control upon hire, Staff A stated the contract staff have been clinicians for a “long time” and should “already know it” or they would be trained by their contract company. Staff A was unable to provide evidence the contract companies provided infection control education. Staff A also stated infection control is “talked about” and information is provided when staff is hired. He stated the staff are told they can ask questions at any time. Staff A was unable to provide evidence this occurring at hire. Staff A acknowledged the findings at the time of interview.”

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based upon record review and interview, it was determined that the agency’s Governing Body (GB) consisted of one individual rather than “designated persons”, which had the potential to affect all 8 patients served by this Agency in the past 12 months, resulting in the potential for provision of substandard or unsafe care. Findings include: On 4/16/24, review of the Agency’s lone “Governing Board Meeting” during the last 3 years (10/12/23), it was noted the GB was represented by one individual, the owner of the Agency and acting Administrator. During an interview with the Alternate Administrator (Staff A) on 4/16/24 at 0915 AM., Staff A was queried if there were any other members on the Governing Body other than the owner. Staff A replied, “He is the only one on the Governing Board.” The Agency failed to establish a Governing Body that is composed of more than one individual as required.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the Agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient’s current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs in 1 of 7 records reviewed (MR# 3) resulting in incomplete clinical information to aide in determining the needs of the patient. Findings included: P-3: The Start of Care was dated 1/4/2024. The Plan of Care for the certification period 1/4/2024 to 3/3/2024 identified a primary diagnosis of Malignant neoplasm of the right breast, muscle spasms, pain of the right and left shoulder, and low back pain related to age-related osteoporosis. The patient was receiving Physical Therapy (PT) services. Upon review of the record, it was noted the patient was also diagnosed with Diabetes type II requiring monitoring of daily blood sugar levels and daily administration of insulin of 15 units. Upon review of the Comprehensive Assessment, it was noted the Physical Therapist documented under “Section N-Medications: N)415J1 Hypoglycemics (including insulin Is Taking?)”, the response was “No [Skip to N0415Z1]”. The Physical Therapist failed to document the patient was currently taking insulin, a hypoglycemic medication. In Addition, further review of the Comprehensive Assessment dated1/4/2024, it was noted the Physical Therapist only documented 4 of the 18 questions under “D0150: Patient Mood Interview”. The Physical Therapist marked “Skip Answer” to questions D0150B1 through D0150A2. The Physical Therapist failed to do a complete review of “D0150: Patient Mood Interview”, resulting in incomplete information regarding the patient’s social and psychological needs. These findings were reviewed and acknowledged by the Clinical Manager on 4/16/2023 at 1:00 p.m.”

“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 record review and interview, the Agency failed to ensure a physician’s response was documented when medication reconciliations identified safety concerns regarding drug interactions or duplications in 3 (P-1, P-2, P-6) of 7 records reviewed out of a total sample of 7 records, resulting in the continuance of potentially unsafe medication interactions that could adversely affect all 8 current patients serviced within the past 12 months. Findings include: P-6: The patient’s start of care (SOC) was 2/24/2024 with diagnoses that included low back pain, bilateral knee pain, and osteoarthritis. During the record review on 4/15/24, it was noted the Agency’s drug review was performed also on 2/24/2024, which revealed a major drug interaction (highest level) in the patient’s medication profile. However, additional review found no evidence in the medical record that noted the physician’s response if it was safe to continue with the current medication regimen or adjustments were needed. The Director of Nursing (Staff B) was interviewed on 4/16/24 at 9:55 AM., whether documentation was warranted if the patient’s medication regimen was safe to continue (or not) when major drug interaction(s) were discovered during review. Staff B acknowledged documentation was needed for clarification purposes to address any safety concerns identified. The Agency failed to ensure a documented physician’s response was noted when a safety concern was identified while performing P-6’s medication reconciliation review. **Policy III.17 titled “Medication Management” (not dated) stated, “The medications will be reviewed for potential adverse effects, drug reactions, ineffective drug therapy, significant drug interactions, duplicate drug therapy, and for patient non-compliance with drug therapy. The admitting clinician or the nurse reviewing the profile will contact the patient’s physician immediately if there are any questions or concerns regarding the medications a patient is taking. Clarification orders will be obtained if needed.” P-1: This 89-year-old patient was admitted to this agency on 2/28/24 with the diagnoses of hypertension (high blood pressure), repeated falls, and dizziness. During record review on 4/11/24, it was noted the OASIS (Outcome and Assessment Information Set) dated 2/28/24 asked under the “Drug Regimen Review” (page 35), “Did a complete drug regimen review identify potential clinically significant medication issues?”. This was marked “Yes – Issues found during review”. The next section titled “Medication Follow-up” asked, “Did the agency contact a physician (or physician-designee) by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potentially significant medical issues?”. This was marked as “Yes”. It was noted on page 36 of the OASIS that duplicate drug therapy was identified. P-2: This 75-year-old patient was admitted to this agency on 2/28/24 with the diagnoses of hypertension, chronic obstructive pulmonary disease (COPD), type II diabetes, and polyosteoarthritis (arthritis in multiple joints). During record review on 4/15/24, it was noted the OASIS dated 2/28/24 asked under the “Drug Regimen Review” (page 35), “Did a complete drug regimen review identify potential clinically significant medication issues?”. This was marked “Yes – Issues found during review”. The next section titled “Medication Follow-up” asked “Did the agency contact a physician (or physician-designee) by midnight of the next calendar day and complete prescribed/recommended actions in response to the identified potentially significant medical issues?”. This was marked as “Yes”. It was noted on page 36 of the OASIS that duplicate drug therapy and moderate drug interactions were identified. The Alternate Administrator (Staff A) was interviewed on 4/15/24 at 12:30 PM regarding the physician’s response to the notification. Staff A stated the doctor will “let them know” if there are any changes needed, however, he was unable to provide evidence of communication with the physician regarding the duplicate drug therapy or other interactions. Staff A acknowledged the findings.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Plan of Care (POC) covered all pertinent interventions with reportable parameters, and patient safety precautions for 7 (P-1, 2, 3, 4, 5, 6, 7) of 7 records reviewed, from a total sample of 7 records reviewed, resulting in the potential for unidentified, abnormal results not being reported to the physician and poor patient outcomes. Findings include: P-6: The patient’s start of care (SOC) was 2/24/2024 with diagnoses that included low back pain, bilateral knee pain, and osteoarthritis. During the record review on 4/15/24, it was noted the Plan of Care (POC) failed to have safety parameters to notify the physician in the event the patient’s conditioned deteriorated concerning blood pressure, temperature, pulse, respirations, and pain level. The findings above were reviewed and acknowledged by the Director of Nursing (Staff B) during an interview on 4/16/24 at 9:52 AM. Staff B noted the POC’s need safety parameters regarding the above to guide clinicians when to notify the physician. P-7: The patient’s SOC was 10/20/2022 with diagnoses that included lumbago with sciatica (nerve pain), and diabetes-type 2. During the record review on 4/15/24, it was noted the POC failed to have safety parameters concerning blood sugar readings, blood pressure, temperature, pulse, respirations, and pain level. In addition, P-7 was taking aspirin and Plavix, both known to be blood thinners. However, no bleeding precautions were evidenced in the patient’s POC. The findings above were reviewed and acknowledged by the Director of Nursing (Staff B) during an interview on 4/16/24 at 9:58 AM. Staff A also acknowledged the POC’s above failed to include all the required elements to meet the individualized needs of the patient and failed to adhere to its policy referenced below. Agency Policy: “Professional/Ancillary Care Plans” III.7 (undated) stated, “The care plan shall be based on a systematic process of assessment, problem and needs identification... Each plan will include: ...Safety measures...” P-3: The Start of Care was dated 1/4/2024. The Plan of Care for the certification period 1/4/2024 to 3/3/2024 identified a primary diagnosis of Malignant neoplasm of the right breast, muscle spasms, pain of the right and left shoulder, and low back pain related to age-related osteoporosis. The patient was receiving Physical Therapy (PT) services. Upon review of the record, it was noted the Plan of Care failed to include reportable parameters to report to the physician for increased pain for this patient with pain in right and left shoulders, low back, and the age-related osteoporosis. P-4: The Start of Care was dated 12/17/2022. The Plan of Care for the certification period 12/17/2022 to 2/14/2023 identified diagnoses of Osteoarthritis, difficulty walking, and Chronic Obstructive Pulmonary Disease. Upon review of the Plan of Care it was noted the agency failed to include reportable parameters in which to notify the physician regarding Blood Pressures, respirations, pulse, oxygen levels, and pain. P-5: The Start of Care was dated 12/12/2022. The Plan of Care for the certification period 12/12/2022 to 2/9/2022 identified diagnoses of Lumbago with sciatica right side, Difficulty in walking, muscle weakness, Diabetes type 2; and hypertension. Upon review of the plan of care there were no orders for reportable parameters to contact the physician to address pain for the patient’s diagnoses of Lumbago and Sciatica. These findings were reviewed and acknowledged by the Clinical Manager on 4/16/2024 at 1:00 p.m. P-1: This 89-year-old patient was admitted to this agency on 2/28/24 with the diagnoses of hypertension (high blood pressure), repeated falls, and dizziness. During record review on 4/11/24, it was noted the plan of care dated 2/28/24 failed to include reportable parameters to report to the physician for blood pressure. P-2: This 75-year-old patient was admitted to this agency on 2/28/24 with the diagnoses of hypertension, chronic obstructive pulmonary disease (COPD), type II diabetes, and polyosteoarthritis (arthritis in multiple joints). During record review on 4/15/24, it was noted the plan of care dated 2/28/24 failed to include reportable parameters to report to the physician for blood pressure, pulse oximetry (measures blood oxygen saturation, often affected in patients with COPD), or blood sugar. During an interview on 4/16/24 at 10:00 AM, the Director of Nursing (Staff B) was asked to locate reportable parameters on the plans of care. Staff B acknowledge there were no reportable parameters located on the plans of care. Findings were again reviewed with the Alternate Administrator (Staff A) during the exit interview on 4/16/24 at 12:30 PM.”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on record review and interview, the Agency failed to ensure a discharge summary was forwarded to the physician within 5 days of discharge in 5 (P-3, P-4, P-5, P-6, P-7) of 5 closed records reviewed, out of a total sample of 7 records reviewed. This deficient practice results in the physician/receiving facility not having knowledge of the patient’s health status at the time of discharge and the potential for unidentified continuing health care concerns and unmet care needs. Findings include: P-3: The Start of Care was dated 1/4/2024. The Plan of Care for the certification period 1/4/2024 to 3/3/2024 identified a primary diagnosis of Malignant neoplasm of the right breast, muscle spasms, pain of the right and left shoulder, and low back pain related to age-related osteoporosis. The patient was receiving Physical Therapy (PT) services. The patient was discharged from Home Care services on 2/12/2024 with a documented reason for discharge was “No Further Home Health Care is needed.” The Physical Therapist documented “the office scheduler was notified, the physician was notified, and an instruction sheet was left with the client”, however there was no documentation found in the record that indicated the discharge summary had been sent to the physician. P-4: The Start of Care was dated 12/17/2022. The Plan of Care for the certification period 12/17/2022 through 2/14/2023 identified diagnoses of Primary osteoarthritis, bilateral osteoarthritis, difficulty walking, and Chronic Obstructive Pulmonary Disease (COPD). The patient was receiving Physical Therapy (PT) services. The patient was discharged from the agency’s Home Care Services on 1/24/2023 with a documented reason for discharge was “No Further Home Health Care is needed.” The Physical Therapist documented “the office scheduler was notified, order and summary completed, the physician was notified.” however there was no documentation found in the record that indicated the discharge summary had been sent to the physician. P-5: The Start of Care was dated 12/12/2022. The Plan of Care for the certification period 12/12/2022 to 2/9/2022 identified diagnoses of Lumbago with sciatica right side, Difficulty in walking, muscle weakness, Diabetes type 2; and hypertension. The patient was receiving physical therapy services. The patient was discharged from the agency’s Home Care Services on 1/18/2023 with a documented reason of “No further Home Health Care needed”. The Physical Therapist documented “the office scheduler was notified, order and summary completed, the physician was notified.” however there was no documentation found in the record that indicated the discharge summary had been sent to the physician. These findings were reviewed and confirmed by the Clinical Manager on April 16th, 2024 at 1:00 p.m. P-6: The patient’s start of care (SOC) was 2/24/2024 with diagnoses that included low back pain, bilateral knee pain, and osteoarthritis. During the record review on 4/15/24, it was noted the patient was discharged on 3/6/2024 with “Care Completed”. Further review of the record found no evidence that a discharge summary was sent to the physician for review of the treatments and interventions furnished throughout the episode. PT (therapy only case) documented, “Notified Physician and Agency of PT d/c.” On 4/16/24 at 0915 AM., the Administrator (Staff A) was queried if a discharge summary was sent to the physician and when it was sent. Staff A was unable to produce evidence that a discharge summary was sent by the time of survey exit on 4/16/24 at 2 PM. P-7: The patient’s SOC was 10/20/2022, with diagnoses that included lumbago with sciatica (nerve pain), and diabetes-type 2. During the record review on 4/15/24, it was noted the patient was discharged on 3/6/2024 with “Care Completed”. Further review of the record found no evidence that a discharge summary was sent to the physician for review of the treatments and interventions furnished throughout the episode. PT (therapy only case) documented, “Notified Physician and Agency of PT d/c.” On 4/16/24 at 0920 AM., Staff A was queried if a discharge summary was sent to the physician and when. Staff A was unable to produce evidence that a discharge summary was sent by the time of survey exit on 4/16/24 at 2 PM. Staff A noted the Agency would create and then use a time stamp of when the discharge summary was sent to the physician for review. The Agency failed to adhere to its policy referenced below. Agency Policy: “Discharge Planning, Discharge Summary and Discharge OASIS” III.11 (undated) stated, “The professional staff is responsible for providing a written summary report for each patient. The case manager will prepare a written discharge summary, which will include the entire period of care. All discharge summaries shall be sent to the patient’s physician within 5 days of the patient’s discharge from services.” P-6: The patient’s start of care (SOC) was 2/24/2024 with diagnoses that included low back pain, bilateral knee pain, and osteoarthritis. During the record review on 4/15/24, it was noted the patient was discharged on 3/6/2024 with “Care Completed”. Further review of the record found no evidence that a discharge summary was sent to the physician for review of the treatments and interventions furnished throughout the episode. PT (therapy only case) documented, “Notified Physician and Agency of PT d/c.” On 4/16/24 at 0915 AM., the Administrator (Staff A) was queried if a discharge summary was sent to the physician and when it was sent. Staff A was unable to produce evidence that a discharge summary was sent by the time of survey exit on 4/16/24 at 2 PM. P-7: The patient’s SOC was 10/20/2022, with diagnoses that included lumbago with sciatica (nerve pain), and diabetes-type 2. During the record review on 4/15/24, it was noted the patient was discharged on 3/6/2024 with “Care Completed”. Further review of the record found no evidence that a discharge summary was sent to the physician for review of the treatments and interventions furnished throughout the episode. PT (therapy only case) documented, “Notified Physician and Agency of PT d/c.” On 4/16/24 at 0920 AM., Staff A was queried if a discharge summary was sent to the physician and when. Staff A was unable to produce evidence that a discharge summary was sent by the time of survey exit on 4/16/24 at 2 PM. Staff A noted the Agency would create and then use a time stamp of when the discharge summary was sent to the physician for review. The Agency failed to adhere to its policy referenced below. Agency Policy: “Discharge Planning, Discharge Summary and Discharge OASIS” III.11 (undated) stated, “The professional staff is responsible for providing a written summary report for each patient. The case manager will prepare a written discharge summary, which will include the entire period of care. All discharge summaries shall be sent to the patient’s physician within 5 days of the patient’s discharge from services.” P-3: The Start of Care was dated 1/4/2024. The Plan of Care for the certification period 1/4/2024 to 3/3/2024 identified a primary diagnosis of Malignant neoplasm of the right breast, muscle spasms, pain of the right and left shoulder, and low back pain related to age-related osteoporosis. The patient was receiving Physical Therapy (PT) services. The patient was discharged from Home Care services on 2/12/2024 with a documented reason for discharge was “No Further Home Health Care is needed.” The Physical Therapist documented “the office scheduler was notified, the physician was notified, and an instruction sheet was left with the client”, however there was no documentation found in the record that indicated the discharge summary had been sent to the physician. P-4: The Start of Care was dated 12/17/2022. The Plan of Care for the certification period 12/17/2022 through 2/14/2023 identified diagnoses of Primary osteoarthritis, bilateral osteoarthritis, difficulty walking, and Chronic Obstructive Pulmonary Disease (COPD). The patient was receiving Physical Therapy (PT) services. The patient was discharged from the agency’s Home Care Services on 1/24/2023 with a documented reason for discharge was “No Further Home Health Care is needed.” The Physical Therapist documented “the office scheduler was notified, order and summary completed, the physician was notified.” however there was no documentation found in the record that indicated the discharge summary had been sent to the physician. P-5: The Start of Care was dated 12/12/2022. The Plan of Care for the certification period 12/12/2022 to 2/9/2022 identified diagnoses of Lumbago with sciatica right side, Difficulty in walking, muscle weakness, Diabetes type 2; and hypertension. The patient was receiving physical therapy services. The patient was discharged from the agency’s Home Care Services on 1/18/2023 with a documented reason of “No further Home Health Care needed”. The Physical Therapist documented “the office scheduler was notified, order and summary completed, the physician was notified.” however there was no documentation found in the record that indicated the discharge summary had been sent to the physician. These findings were reviewed and confirmed by the Clinical Manager on April 16th, 2024 at 1:00 p.m.”