Every finding on record at Neocare Health Systems, Inc

On 2/14/24 through 2/15/24, and continued 2/20/24 through 2/21/24, an Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. During the survey, Neocare Home Care was found to be not in compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness. The following condition level deficiency was identified: 42 CFR 484.102 Emergency Preparedness

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 their 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 at least every 2 years (See E0037); and failed to ensure exercises to test the emergency preparedness plan were conducted annually (See E0039). These deficient practices have the potential to negatively affect the health and safety of the agency's 2 current patients. 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.

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 their emergency preparedness plan was reviewed and updated at least every 2 years, resulting in the potential to negatively affect the health and safety of the agency's patients in the event of an emergency. Findings include: The agency's Emergency Preparedness (EP) documentation was reviewed on 2/21/24. During review of the binder, it was noted the agency had EP policies and procedures, however there was no evidence of the EP policies and procedures being reviewed since 9/1/21 upon purchase of the agency. The agency also failed to develop an EP plan that was based on both agency-based 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. These included a document titled "Organizational Chart for Disaster Response Team" with names of employees who no longer work for the agency; a document that identified the Incident Command Center as the previous agency location in another city; and a list of local and state contact numbers to be used for collaboration in the event of an emergency that were based off the previous agency location. During an interview on 2/21/24 at 12:50 PM, the Director of Nursing (Staff B), the Alternate Clinical Manager (Staff C), and Alternate Administrator (Staff D) were queried regarding the most recent update to the agency's EP Plan. Staff B was able to provide evidence of review on 9/1/21 upon purchase of the agency, however, was unable to provide evidence of anything done since then. Staff D admitted the agency hasn't done anything with the EP Plan since the agency moved to its new location in September 2022, therefore the information in the binder is inaccurate. Staff B, Staff C, and Staff D acknowledged the findings following the interview on 2/21/24 at 12:50 PM.

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 2/21/24. Upon review of the binder, it was noted there was no indication of when the policies and procedures had last been reviewed and updated. The Director of Nursing (Staff B) was asked to provide evidence of the policies and procedures being reviewed during an interview on 2/21/24 at 11:00 AM. Staff B initially reported "it should be in there", however was unable to locate it. Staff B reported it may be on the computer, but again, was unable to provide evidence of this. Upon further interview of Staff B, the Alternate Clinical Manager (Staff C), and the Alternate Administrator (Staff D) on 2/21/24 at 12:50 PM, Staff B was able to locate a signed document stating the policies and procedures for EP were reviewed on 9/1/21 upon purchase of the agency. Staff D admitted that there hasn't been a review of the EP policies and procedures since that time. The findings were acknowledged by Staff B, Staff C, and Staff D during the interview on 2/21/24 at 12:50 PM.

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 agency's 2 current patients in the event of an agency-based emergency or community disaster. Findings include: On 2/21/24, the agency’s Emergency Preparedness (EP) plan for communication was reviewed. The communication plan contained: 1. A list of physicians with addresses and phone numbers which was dated as follows: “Effective Date: 02/13/2018”. 2. A “Staff Phone Tree” (undated) with names and contact numbers for 13 employees, 12 of which were no longer listed on the current employees list received by the agency on 2/14/24 during entrance. Of note, the current employee list received by the agency on 2/14/24 contained 13 names and 12 of those names including, the Administrator (Staff A), the Director of Nursing (Staff B), the Clinical Manager (Staff C), and the Alternate Administrator (Staff D), were not found on the “Staff Phone Tree” in the Emergency Preparedness binder. 3. Emergency Organization Contacts list with no date for when last reviewed or updated by the agency. 4. Organizational Chart for Disaster Response Team (undated) with names of employees who no longer work for the agency but were named in the following positions of the Disaster Response Team: Incident Commander; Public Information; Safety & Security; Liaison Officer; Operations; Planning; and Finance. No other information was provided regarding the agency EP communication plan. These findings were reviewed and acknowledged on 2/21/24 during interview at 12:50 p.m. with Staff B; Staff C; and Staff D.

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 ensure all staff received emergency preparedness training at least every 2 years resulting in the potential to negatively affect the health and safety of the agency's 2 current patients. Findings include: On 2/20/24, the agency’s employee Emergency Preparedness (EP) training documentation was reviewed. The agency provided a list of 13 current employees. During review, no documentation was found for employee EP training after initial hire training. On 2/21/24 at 1:00 p.m., the Alternate Clinical Manager (Staff C) and the Alternate Administrator (Staff D) were queried regarding EP training for all staff. Staff D stated that they (the agency) had not been providing ongoing 2-year training in EP for their current employees.

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 emergency. Findings include: The agency's Emergency Preparedness documentation was reviewed on 2/21/24. Upon review of the binder, it was noted the agency had an exercise labeled "Emergency Response Planning Winter Storm 2022". This appeared to be a tabletop exercise that was performed in 2022, however there was no exact date of when it occurred, and no signatures or names of which staff were involved in the exercise. It only stated that it was approved by the Alternate Clinical Manager (Staff C). Another exercise was labeled "Tabletop Exercise Inclement Weather (Tornado/rain/other)". This exercise was signed and dated by Staff C on 8/1/23, however there were no signatures or names of which staff were involved in the exercise. A third exercise was located in the binder that was labeled "Windchill Advisory EP List". "December 2020" was written at the top of the first page. This exercise consisted of 15 pages of various patient names and phone numbers with no indication of what activity took place, who was involved, or what the results were. The Alternate Administrator (Staff D) was interviewed on 2/21/24 at 11:00 AM regarding the testing exercises and whether there was record of a full-scale community-based exercise that occurred in the last 2 years as required by the regulation. Staff D reported they "tried to" work with local departments to set something up but were unable to. Staff D was unable to provide any communication as evidence of their attempts to set something up. Staff D then stated the wind chill exercise was their full-scale exercise as it was an actual emergency that occurred last winter (agencies are allowed to use actual emergencies in place of full-scale exercise if one occurs). Staff D was asked to show documentation of what steps were taken during the emergency, what staff were involved, and the review of the exercise after the emergency. Staff D was unable to provide any further documentation. The Director of Nursing (Staff B), the Alternate Clinical Manager (Staff C), and Staff D all acknowledged the findings during an interview on 2/21/24 at 12:50 PM.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 2/14/24 through 2/15/24, and continued on 2/20/24 through 2/21/24 at: Neocare Home Care 1000 John R Rd. Suite 211 Troy, MI 48008 The agency had no additional branch locations. At the time of the survey, the agency had a patient census of 2. Clinical records reviewed included 2 active records with home visits and 5 discharge records for a total of 7 records. The following Condition level deficiencies were identified at: 42 CFR §484.102: Emergency Preparedness 42 CFR§484.110 Clinical Records As a result of the Condition level noncompliance, the agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure home health aide services were provided as outlined in the plan of care in 1 (P-1) of 7 sampled records reviewed potentially resulting in unmet patient care needs. Findings include: Agency policy titled “Home Health Aide Assignment C-660 (undated), was reviewed on 2/21/23. On page 98, it stated, “3. Any change in the assignment must be approved by the RN or Therapist supervising the home health aide under physicians orders… 4. Every attempt shall be made to assign the home health aide at the time that is convenient for the client/caregiver.” P-1: This 89-year-old patient was admitted to the agency on 4/5/23 with diagnoses which included Chronic Obstructive Pulmonary Disease (progressive lung disease); high blood pressure; and type 2 Diabetes. The medical record was reviewed on 2/15/24. The plan of care (POC) dated 4/5/23 included orders for home health aide services once per week for 6 weeks beginning 4/9/23. It was noted during review that the home health aide did not provide service to the patient for the first 2 weeks in which services were ordered (weeks beginning 4/9/23 and 4/16/23). There were “Missed Visit” forms filled out for 4/12/23 and 4/19/23 by the home health aide which documented the reason for the missed visit as “Family- Caregiver Able to Assist Patient”. There were no other home health aide visits scheduled during those 2 weeks of service. There was no documentation that home health aide services as ordered in the POC needed to be adjusted or changed. There was no documentation that the home health aide attempted to reschedule either visit. There was no documentation that the registered nurse or therapist was notified of the change in frequency per agency policy. These findings were reviewed and acknowledged on 2/21/24 during interview at 2:05 p.m. with the Director of Nursing (Staff B); the Alternate Clinical Manager (Staff C); and the Alternate Administrator (Staff D).

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initial assessment was performed within 48 hours of referral in 3 (P-3, 4, and 7) of 7 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: P-7: This 94-year-old patient was admitted to home care on 10/25/23 with diagnoses of congestive heart failure, pulmonary embolism, and atrial fibrillation. During record review on 2/15/24, it was noted that the physician order for home care was fax dated as 10/20/23. The start of care assessment was conducted 5 days after the date of the referral. There was no evidence that the physician had been notified for the reason for the delay. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m. P-3: This 96-year-old patient was admitted to the agency on 6/20/23 with diagnoses which included Chronic Obstructive Pulmonary Disease (progressive lung disease); Spondylosis (wear and tear over time affecting spine); and heart failure. The medical record was reviewed on 2/20/24. During review, it was noted the physician referral for home care was dated 6/16/23. The initial assessment was completed on 6/20/23 (4 days after the referral). There was no documentation which indicated the physician, patient, or caregiver requested a delay in the start of care. This finding was reviewed and acknowledged on 2/21/24 during interview at 2:05 p.m. with the Director of Nursing (Staff B); the Alternate Clinical Manager (Staff C); and the Alternate Administrator (Staff D). **Policy titled "Client Admission Process C-140" stated on page 36, "The initial assessment will be completed within 48 hours of referral or within 48 hours of the client's return home, or on the physician ordered start of care date." P-4: This 99-year-old patient was admitted to the agency on 1/23/24 with the diagnoses of bilateral shoulder pain, difficulty walking and generalized weakness. During record review on 2/15/24, it was determined the referral for home care was written by the physician on 1/17/24 and the initial assessment was performed 1/23/24 during the start of care - 6 days after the date on the referral. There was no documentation regarding the reason for the delay in care. The Director of Nursing (Staff B) and the Alternate Clinical Manager (Staff C) were interviewed on 2/21/24 at 3:00 PM regarding documentation to explain the reason for the delay. Staff C was unable to provide documentation to explain why care was delayed. Staff C reported there should have been documentation of this as well as an updated order from the physician. Staff B, Staff C and the Alternate Administrator (Staff D) acknowledged the findings during the interview on 2/21/24 at 3:00 PM.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was performed within 5 days of the start of care in 4 (P-2, 3, 4, 6) of 7 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: P-6: This 64-year-old patient was admitted to home care on 1/23/24 with diagnoses of stroke with hemiplegia (muscle weakness or partial paralysis on one side of the body), hypertension, aphasia (loss of ability to understand or express speech), and type 2 diabetes. During record review on 2/14/24, it was noted that the plan of care ordered skilled nursing, physical therapy, and medical social work. Skilled nursing conducted the start of care assessment on 1/23/24 and physical therapy evaluated the patient on 1/27/24. The medical social work evaluation was conducted on 2/20/24, 29 days after the start of care. There was no evidence that the physician had been notified of the reason for the delay for social work. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m. P-2: This 63-year-old patient was admitted to the agency on 3/20/23 with diagnoses which included critical illness myopathy (disease affecting muscles of limbs and breathing); Emphysema (disease of the lungs); and pressure wounds to right and left buttocks. The medical record was reviewed on 2/20/24. During review of the plan of care (POC) dated 3/20/23, it was noted that physical therapy (PT) services were ordered to evaluate and treat. The PT evaluation did not occur until 3/27/23 (7 days after ordered in the POC). There was no documentation found in the medical record which indicated an alternate plan had been requested by the patient or caregiver. P-3: This 96-year-old patient was admitted to the agency on 6/20/23 with diagnoses which included Chronic Obstructive Pulmonary Disease (progressive lung disease); Spondylosis (wear and tear over time affecting spine); and heart failure. The medical record was reviewed on 2/20/24. During review, it was noted the physician referral for home care dated 6/16/23 included orders for PT. It was also noted that the POC dated 6/20/23 included orders for PT to evaluate and treat. The PT evaluation did not occur until 7/5/23 (15 days after start of care and 19 days after referral to the agency). There was no documentation found in the medical record which indicated an alternate plan had been requested by the patient or caregiver. These findings were reviewed and acknowledged on 2/21/24 during interview at 2:05 p.m. with the Director of Nursing (Staff B); the Alternate Clinical Manager (Staff C); and the Alternate Administrator (Staff D). **Policy titled "Client Admission Process C-140" stated on page 37, "Upon acceptance and admission of a client, the admitting Registered Nurse or Therapist will assign the individual to the appropriately skilled professional. All efforts will be made to provide continuity and limit the number of individuals providing care. Services will be initiated within 24 hours after the assessment, unless documentation supports alternate plan based on client needs and wishes and caregiver availability." P-4: This 99-year-old patient was admitted to the agency on 1/23/24 with the diagnoses of bilateral shoulder pain, difficulty walking, and generalized weakness. The referral dated 1/17/24 ordered services from skilled nursing and physical therapy. During record review on 2/15/24, it was determined the start of care was dated 1/23/24 and the physical therapy evaluation was scheduled for 1/27/24. The physical therapy evaluation was completely blank, so it was not clear if it had been completed yet. Upon further record review on 2/20/24, it was noted the physical therapy evaluation was partially completed and dated 2/2/24. During a home visit with the physical therapist (Staff E) on 2/20/24 at 1:00 PM, Staff E was queried regarding when he had done his evaluation with P-4. Staff E reported that he was supposed to do it on 1/27/24 but was unable to do it until 2/2/24 - 10 days after the start of care. Findings were reviewed with and acknowledged by the Director of Nursing (Staff B), the Alternate Clinical Manager (Staff C) and Alternate Administrator (Staff D) during an interview on 2/21/24 at 3:00 PM.

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 the comprehensive assessment included an accurate review of all medications in 1 of 7 (P-7) records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this agency. Findings include: P-7: This 94-year-old patient was admitted to home care on 10/25/23 with diagnoses of congestive heart failure, pulmonary embolism, and atrial fibrillation. During record review on 2/15/24, it was noted that the initial RN assessment stated (under M2001 Drug Regimen Review) that “yes – issues found during review” and that the physician was contacted (M2003 Medication Follow-up). There was no indication of what issues were found and no evidence the physician was notified or if any orders were received. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the transfer summary included medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences in 2 (P-1, and 7) of 7 records reviewed, resulting in the potential for an unsafe and ineffective transition of care for these patients. Findings include: P-1: This 89-year-old patient was admitted to the agency on 4/5/23 with diagnoses which included Chronic Obstructive Pulmonary Disease (progressive lung disease); high blood pressure; and type 2 Diabetes. The medical record was reviewed on 2/15/24. It was noted the patient was transferred to the hospital on 4/25/23. The registered nurse (RN) signed a transfer summary on 4/25/23 which failed to include any of the following information: Transfer Facility Information; Summary of Care Provided by the HHA (Home Health Agency); Medicare Review; Significant Health History; Transfer Orders and Instructions; Description of Services Provided and Ongoing Needs that Cannot be Met; and a Narrative. There was no evidence that the receiving facility or health care practitioner received a transfer summary which included pertinent information to ensure the safe and effective transition of care after transfer. The agency resumed care for P-1 on 4/29/23 and included RN; Physical Therapy (PT); Occupational Therapy (OT) and home health aide services. RN and PT discharged the patient in the week beginning 5/14/23. OT signed a transfer summary on 5/24/23 and indicated the patient was admitted to the hospital. OT failed to include the following information on the transfer summary: Transfer Facility Information; Summary of Care Provided by the HHA; Medicare Review; Significant Health History; Transfer Orders and Instructions; Description of Services Provided and Ongoing Needs that Cannot be Met; and a Narrative. There was no evidence that the receiving facility or health care practitioner received a transfer summary which included pertinent information to ensure the safe and effective transition of care after transfer. This finding was reviewed and acknowledged on 2/21/24 during interview at 2:05 p.m. with the Director of Nursing (Staff B); the Alternate Clinical Manager (Staff C); and the Alternate Administrator (Staff D). P-7: This 94-year-old patient was admitted to home care on 10/25/23 with diagnoses of congestive heart failure, pulmonary embolism, and atrial fibrillation. During record review on 2/15/24, it was noted that the patient was admitted to the hospital on 11/15/23 for hematuria (blood in the urine) after kidney stent removal and was discharged home on 11/20/23. The transfer summary, dated 11/15/23, failed to include transfer facility information, summary of care provided by the home health agency (HHA), significant health history, and description of services provided and ongoing needs that cannot be met. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m.

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: **Policy titled "Plan of Care C-480" stated, "...If fewer visits are provided than ordered, the physician is notified, and either a telephone order for missed visits is obtained or documentation of physician's notification is incorporated into the clinical record." P-4: This 99-year-old patient was admitted to the agency on 1/23/24 with the diagnoses of bilateral shoulder pain, difficulty walking, and generalized weakness. During record review on 2/20/24, it was noted the physical therapy plan of care dated 2/2/24 indicated physical therapy services would be provided 1 time a week for 1 week and 2 times a week for 5 weeks starting 2/2/24. Due to records being left incomplete, the physical therapist (Staff E) was interviewed regarding what dates he saw P-4 during a home visit on 2/20/24 at 1:00 PM. Staff E reported he evaluated the patient on 2/2/24 and made 2 visits the following week (the week of 2/4/24), however these have not been documented yet. Staff E stated he was unable to see the patient the week of 2/11/24 due to the patient's caregiver being ill. Staff E was asked if there was any documentation in the record to show evidence of this or to show the doctor had been contacted per the policy above. Staff E acknowledged there was no documentation in the record and the doctor had not been informed of the change in frequency. P-5: This 90-year-old patient was admitted to home care on 3/27/23 with the diagnoses of seizures, polyneuropathy (a disorder that affects nerves), and difficulty with gait (walking) and mobility. During record review on 2/20/24, it was noted the plan of care (dated 3/27/23) indicated home health aide services were to be provided 1 time a week for 6 weeks. Upon further review of the record, it was noted the home health aide attempted a visit on 3/31/23, however the record stated this was a missed visit stating, "Caregiver refused home health services at this time." There were no future visits made with this patient. There was also no documentation to show a change in the plan of care had been reported to the physician. The Director of Nursing (Staff B) was interviewed on 2/21/24 at 3:00 PM regarding her expectations for missed visits resulting in a change of frequency. Staff B reported the doctor is to be contacted and that it should be documented in the records. The Alternate Clinical Manager (Staff C) confirmed there was no documentation of the physician being contacted regarding the changes in the plans of care for P-4 or P-5. Staff B, Staff C, and the Alternate Administrator (Staff D) acknowledged the findings during this interview.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included individualized, patient-specific, measurable outcomes and goals in 7 (P-1, 2, 3, 4, 5, 6 and 7) of 7 sampled records reviewed potentially resulting in insufficient information to adequately assess patient progress. Findings include: P-6: This 64-year-old patient was admitted to home care on 1/23/24 with diagnoses of stroke with hemiplegia (muscle weakness or partial paralysis on one side of the body), hypertension, aphasia (loss of ability to understand or express speech), and type 2 diabetes. During record review on 2/14/24, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. The plan of care contained the following goals, “Patient/Caregiver will demonstrate compliance with prescribed treatment regimen regarding HTN including adherence to cardiac regimen/programs,” and “patient's activity level will improve due to effective pain control.” There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. P-7: This 94-year-old patient was admitted to home care on 10/25/23 with diagnoses of congestive heart failure (CHF), pulmonary embolism, and atrial fibrillation. During record review on 2/15/24, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. The plan of care contained the following goals, “patient/Caregiver will demonstrate compliance with prescribed treatment regimen regarding CHF including adherence to cardiac regimen/program,” and “patient's activity level will improve due to effective pain control.” There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. These findings were reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m. P-1: This 89-year-old patient was admitted to the agency on 4/5/23 with diagnoses which included Chronic Obstructive Pulmonary Disease (progressive lung disease); high blood pressure; and type 2 Diabetes. The medical record was reviewed on 2/15/24. During review of the plan of care (POC) dated 4/5/23, the following examples of skilled nursing (SN) goals were noted: Patient/Caregiver will verbalize and demonstrate safe management of oxygen by (left blank); Patient/Caregiver demonstrate ability to effectively manage medication regimen; Patient’s activity level will improve due to effective pain control; and, Patient will maintain blood sugar within normal range by end of episode as evidenced by reading within therapeutic range. It was unclear how these goals were specific to this patient and how they would be measured in terms that would enable nursing staff to accurately perform an objective evaluation of the patient's progress toward the goals. P-2: This 63-year-old patient was admitted to the agency on 3/20/23 with diagnoses which included critical illness myopathy (disease affecting muscles of limbs and breathing); Emphysema (disease of the lungs); and pressure wounds to right and left buttocks. The medical record was reviewed on 2/20/24. During review of the POC dated 3/20/23, the following examples of SN goals were noted: Patient/Caregiver demonstrate ability to effectively manage medication regimen; Patient will receive safe and effective personal care during this episode of care; and, Patient/Caregiver will demonstrate understanding of individual emergency preparedness plan by/within time-period. It was unclear how these goals were specific to this patient and how they would be measured in terms that would enable nursing staff to accurately perform an objective evaluation of the patient's progress toward the goals. P-3: This 96-year-old patient was admitted to the agency on 6/20/23 with diagnoses which included Chronic Obstructive Pulmonary Disease (progressive lung disease); Spondylosis (wear and tear over time affecting spine); and heart failure. The medical record was reviewed on 2/20/24. During review of the POC dated 6/20/23, the following examples of SN goals were noted: Patient will demonstrate improvement from current functional level to prior functional level of independence before hospitalization, as evidenced by safe use of energy conservation techniques and adherence to cardiac regimen to increase functional activity; Patient will demonstrate return to stable respiratory status regarding COPD and verbalize improvement to symptoms with improved pulse oxygenation; and, Patient/Caregiver will demonstrate compliance with prescribed treatment regimen regarding CHF/HTN including adherence to cardiac regimen/program. It was unclear how these goals were specific to this patient and how they would be measured in terms that would enable nursing staff to accurately perform an objective evaluation of the patient's progress toward the goals. These findings were reviewed and acknowledged on 2/21/24 during interview at 2:05 p.m. with the Director of Nursing (Staff B); the Alternate Clinical Manager (Staff C); and the Alternate Administrator (Staff D). P-4: This 99-year-old patient was admitted to this agency on 1/23/24 with the diagnoses of bilateral shoulder pain and generalized weakness. During record review on 2/15/24, the following nursing goals were noted on the plan of care dated 1/23/24: "Patient will demonstrate return to stable cardiovascular status regarding BP/edema and verbalize improvement to symptoms and diet compliance." "Patient's activity level will improve due to effective pain control." "Patient will receive safe and effective personal care during this episode of care." "Patient will demonstrate improvement from current functional level to prior functional level of independence before hospitalization, as evidenced by adherence to prescribed regimen to increase functional activity." "Patient/Caregiver demonstrate ability to effectively manage medication regimen." These goals are not patient specific and do not include measurable information to effectively monitor the patient's progress. P-5: This 90-year-old patient was admitted to home care on 3/27/23 with the diagnoses of seizures, polyneuropathy (a disorder that affects nerves), and difficulty with gait (walking) and mobility. During record review on 2/20/24, the following nursing goals were noted on the plan of care dated 3/27/23: "Patient's activity level will improve due to effective pain control." "Patient/Caregiver demonstrate ability to effectively manage medication regimen." These goals are not patient specific and do not include measurable information to effectively monitor the patient's progress. Findings were reviewed with an acknowledged by the Director of Nursing (Staff B), the Alternate Clinical Manager (Staff C), and the Alternate Administrator (Staff D) during an interview on 2/21/24 at 3:00 PM.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was promptly notified of elevated pain levels outside of the reportable parameters in 1 (P-3) of 7 sample records reviewed resulting in the potential for untreated health concerns and unmet patient needs. Findings include: P-3: This 96-year-old patient was admitted to the agency on 6/20/23 with diagnoses which included Chronic Obstructive Pulmonary Disease (progressive lung disease); Spondylosis (wear and tear over time affecting spine); and heart failure. The medical record was reviewed on 2/20/24. The plan of care dated 6/20/23 included an order to report a pain level of greater than 6 to the physician. During review of the registered nurse (RN) visit note dated 6/27/23, the RN documented the patients current level of pain during the visit was a 7 out of 10 (where 0 is no pain and 10 is the worst pain) and included a description of “very intense”. There was no documentation that the physician was notified of the elevated pain level per ordered parameters during the visit. On the RN visit note dated 7/3/23, the RN documented the patients current level of pain during the visit was 8/10 and included a description that the patient was in “constant pain”. There was no documentation that the RN notified the physician of the elevated level of pain per ordered parameters during the visit. These findings were reviewed and acknowledged on 2/21/24 during interview at 2:05 p.m. with the Director of Nursing (Staff B); the Alternate Clinical Manager (Staff C); and the Alternate Administrator (Staff D).

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to implement, evaluate, and maintain an agency-wide, data driven Quality Assessment and Performance Improvement program annually. Resulting in no documented evidence of the agency's efforts to monitor agency processes and improve patient outcomes for the 32 patients admitted to the agency in the past 12 months. Findings include: On 2/21/24, the agency provided for review, a binder titled QAPI (Quality Assessment and Performance Improvement). The binder contained QAPI minutes dated 10/20/21, a QAPI report dated 12/31/2022, and QAPI meeting minutes with no date. During an interview on 2/21/24 at 12:10 p.m., the alternate administrator (Staff-D) stated a QAPI meeting was held in November 2023 and acknowledged the document failed to include the date. The agency selected two improvement projects, “to improve medication self-management by patients” and “improvement in star rating.” There was no evidence of procedures for measurement and analysis, or indication of frequency to evaluate and determine measurable improvement. The agency failed to follow its own policy titled, Quality Assurance/Improvement, B-260 (no date) which states, “Neocare Home Care shall maintain a planned systematic organization-wide approach to designing, measuring, assessing, and improving its performance.” This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 12:10 p.m.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to document the reasons for conducting performance improvement projects undertaken and the measurable progress achieved on these projects, resulting in the potential for poor quality outcomes for the 32 patients admitted to the agency in the past 12 months. Findings include: On 2/21/24, the agency provided for review, a binder titled QAPI (Quality Assessment and Performance Improvement). The binder contained QAPI minutes dated 10/20/21, a QAPI report dated 12/31/2022, and QAPI meeting minutes with no date. During an interview on 2/21/24 at 12:10 p.m., the alternate administrator (Staff-D) stated a QAPI meeting was held in November 2023 and acknowledged the document failed to include the date. The agency selected two improvement projects, “to improve medication self-management by patients” and “improvement in star rating.” There was no documented evidence for the reasons for selecting these initiatives and the measurable progress toward achieving the goals. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 12:10 p.m.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the governing body failed to ensure the agency maintained an agency-wide, data driven Quality Assessment and Performance Improvement program annually, resulting in the lack of oversight by the governing body to ensure patient safety and quality of care improvements for the 32 patients admitted to the agency in the past 12 months. Findings include: On 2/21/24, the agency provided for review, a binder titled QAPI (Quality Assessment and Performance Improvement), and a binder titled Governing Body. There was no documented evidence the governing body had responsibility or oversight of the agency’s QAPI program. The governing body minutes dated 2/2/23 and 8/11/23, failed to include a review of QAPI data, initiatives, or progress toward achieving goals. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 12:10 p.m.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals performed assessments of the patient's health status in 2 of 7 (P- 6, 7) records reviewed, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes. Findings include: P-6: This 64-year-old patient was admitted to home care on 1/23/24 with diagnoses of stroke with hemiplegia (muscle weakness or partial paralysis on one side of the body), hypertension, aphasia (loss of ability to understand or express speech), and type 2 diabetes. During record review on 2/14/24, it was noted that the physical therapy evaluation, completed on 1/27/24, failed to include a pain profile. The functional assessment comment states “pains on lower back area, bilateral knees, especially on the right, and right upper extremity; affecting proper bed mobility, transfers, and ambulation with proper gait pattern and safety.” This initial assessment failed to include a pain rating (scale of 0-10) to establish baseline for ongoing monitoring of pain, description of pain, nonverbal pain cues, pain relief measures, or current pain management effectiveness. P-7: This 94-year-old patient was admitted to home care on 10/25/23 with diagnoses of congestive heart failure (CHF), pulmonary embolism, and atrial fibrillation. During record review on 2/15/24, it was noted that the patient’s weight was documented on admission and on the resumption of care on 11/21/23. The other four nursing visits (11/1/23, 11/8/23, 11/29/23, and 12/5/23) documented by the nurse, failed to include a weight or ongoing monitoring or assessment with a primary diagnosis of CHF. These findings were reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided by skilled professionals as ordered by the physician or allowed practitioner as indicated in the plan of care in 2 (P-4, and 6) of 7 records reviewed, resulting in the potential for unmet care needs. Findings include: P-6: This 64-year-old patient was admitted to home care on 1/23/24 with diagnoses of stroke with hemiplegia (muscle weakness or partial paralysis on one side of the body), hypertension, aphasia (loss of ability to understand or express speech), and type 2 diabetes. During record review on 2/14/24, it was noted that the plan of care ordered skilled professionals to notify the physician for a pain level greater than 6 (on a scale of 0-10). On 1/31/24, the physical therapist documented a pain level of “7” before therapy and “6” after therapy. There was no evidence the physician was notified. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m. P-4: This 99-year-old patient was admitted to this agency on 1/23/24 with the diagnoses of bilateral shoulder pain, difficulty walking, and generalized weakness. During record review on 2/20/24, it was noted the physical therapy plan of care dated 2/2/24 indicated physical therapy services would be provided 1 time a week for 1 week and 2 times for 5 weeks starting 2/2/24. Upon further review of the record, it was noted that several of the physical therapy treatment visit notes were left incomplete. As a result, it was difficult to assess whether the patient had been receiving care as ordered. During a home visit on 2/20/24 at 1300, the physical therapist (Staff E) was queried regarding which days he saw the patient. Staff E reported he did his evaluation on 2/2/24 and saw the patient 2 times the week of 2/4/24 and 0 times the week of 2/11/24. Staff E reported he was unable to see the patient the week of 2/11/24 due to the patient's caregiver being ill. There was no documentation regarding missed visits or attempts to rescheduled visits during that week. There was no documentation of communication with the physician regarding missed visits or the change in frequency for this plan of are. The physical therapist failed to ensure visits were provided at the frequency ordered by the physician. Findings were reviewed with and acknowledged by the Director of Nursing (Staff B), the Alternate Clinical Administrator (Staff C), and the Alternate Administrator (Staff D) during an interview on 2/21/24 at 3:00 PM.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled nursing communicated with the physician to obtain orders for 1 of 7 (P-7) records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-7: This 94-year-old patient was admitted to home care on 10/25/23 with diagnoses of congestive heart failure, pulmonary embolism, and atrial fibrillation. During record review on 2/15/24, it was noted that the patient was admitted to the hospital on 11/15/23 for hematuria (blood in the urine) after kidney stent removal and was discharged home on 11/20/23. A stage 2 pressure ulcer on the coccyx, with an onset date of 11/16/23, was documented on the resumption of care assessment, dated 11/21/23. There was no evidence of wound care orders. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained completed assessments and visit notes for 2 (P- 4, and 6) of 7 records reviewed, resulting in a lack of information for the physician and all agency staff caring for these patients (See G1012); failed to ensure the clinical record contained goals for care in the patient’s plans of care for 2 (P-1, and 2) of 7 sample records reviewed resulting in difficulty determining the patient's progress toward achievement of goals (See G1016); failed to ensure contact information for the patient was updated and accurate in 1 (P-4) of 2 records reviewed with home visits, resulting in the potential for unmet care needs during an emergency (See 1018); and failed to ensure a completed transfer summary was sent within 2 business days of becoming aware of an unplanned transfer in 3 (P-1, 5, and 7) of 7 records reviewed, resulting in the potential for unmet care needs (See G1022). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR 484.110 Clinical Records.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained completed assessments and visit notes for 2 (P- 4, and 6) of 7 records reviewed, resulting in a lack of information for the physician and all agency staff caring for these patients. Findings include: P-6: This 64-year-old patient was admitted to home care on 1/23/24 with diagnoses of stroke with hemiplegia (muscle weakness or partial paralysis on one side of the body), hypertension, aphasia (loss of ability to understand or express speech), and type 2 diabetes. The plan of care indicates skilled nursing to visit once per week for five weeks, physical therapy once week one then twice a week for five weeks and once a week for one week, and medical social work to evaluate. During record review on 2/14/24, it was noted that the initial physical therapy initial evaluation dated 1/27/24, and physical therapy visits notes dated 1/31/24, 2/2/24, and 2/7/24 were blank of all information. Additionally, the skilled nursing visit dated 2/6/24 was also blank of all information. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m. **Policy titled "Therapy Services C-240" stated, "Documentation should be completed within 24 hours of visit." P-4: This 99-year-old patient was admitted to this agency on 1/23/24 with the diagnoses of bilateral shoulder pain, difficulty walking, and generalized weakness. During record review on 2/15/24, it was noted the physical therapy evaluation (scheduled for 1/27/24) and follow-up visits scheduled for 1/31/24, 2/2/24, 2/7/24, 2/9/24 were completely blank. During an interview with the physical therapist (Staff E) on 2/20/24 at 1:30 PM, he stated he did not evaluate the patient until 2/2/24, but he had been there 2 times the following week and zero times the week of 2/11/24 due to the patient's daughter being ill. Staff E was asked how a missed visit is to be documented in the record. Staff E reported there is a missed visit note that should be completed for all missed visits. Staff E was also asked when he is expected to have his documentation completed after a visit. Staff E stated he thinks it is 24 hours, but he would "be honest" and admitted it is usually a few days. Upon further review of the record on 2/20/24 after the interview with Staff E, it was noted the notes for the visits that were missed on 2/14/24 and 2/16/24 were completely blank. It was also noted the physical therapy evaluation was now partially completed at this time. As a result, it was determined there was no documentation for 4 missed visits (1/27/24, 1/31/24, 2/14/24 and 2/16/24) and the visit notes for the evaluation (2/2/24) and 2 follow-up visits (2/7/24 and 2/9/24) were incomplete. The Director of Nursing (Staff B) was queried regarding her expectation for documentation to complete during the entrance interview on 2/14/24 at 1020. Staff B reported documentation was due "within the week". Staff B and the Alternate Clinical Manager (Staff C) were asked again regarding their expectations for documentation to be completed during an interview on 2/21/24 at 12:50 PM. Staff B and Staff C reported "7 to 10" days. Staff B and Staff C were instructed to refer to their policy regarding physical therapy services (see above). Findings were reviewed with and acknowledged by the Staff B, the Alternate Clinical Manager (Staff C), and the Alternate Administrator (Staff D) during an interview on 2/21/24 at 3:00 PM.

Goals in the patient's plans of care CFR(s): 484.110(a)(3) Goals in the patient's plans of care and the patient's progress toward achieving them; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained goals for care in the patient’s plans of care for 2 (P-1, and 2) of 7 sample records reviewed resulting in difficulty determining the patient's progress toward achievement of goals. Findings include: P-1: This 89-year-old patient was admitted to the agency on 4/5/23 with diagnoses which included Chronic Obstructive Pulmonary Disease (progressive lung disease); high blood pressure; and type 2 Diabetes. The clinical record was reviewed on 2/15/24. During review, it was noted that Occupational Therapy (OT) was ordered 2 times weekly for 4 weeks on 4/29/23. OT completed a plan of care (POC) and full evaluation on 5/8/23. In the "Goals" section of the POC, the OT failed to include any goals and the following sentence was the only documentation found in that section: “There is no data for this section”. There were no OT goals of care to measure patient progress in the clinical record. P-2: This 63-year-old patient was admitted to the agency on 3/20/23 with diagnoses which included critical illness myopathy (disease affecting muscles of limbs and breathing); Emphysema (disease of the lungs); and pressure wounds to right and left buttocks. The clinical record was reviewed on 2/20/24. During review, it was noted that the POC dated 3/20/23 included orders for Physical Therapy (PT) to evaluate and treat. PT completed a POC with full evaluation on 3/27/23. In the “Goals” section of the POC, there were no goals of care listed and only the following sentence was noted: “Patient’s personal healthcare goal(s): Prior to his recent admission, patient was safely able to perform bed mobility, functional transfers and ambulate with supervision-mod.indep.” [sic]. There were no PT goals of care to measure patient progress in the clinical record. These findings were reviewed and acknowledged on 2/21/24 during interview at 2:05 p.m. with the Director of Nursing (Staff B); the Alternate Clinical Manager (Staff C); and the Alternate Administrator (Staff D).

Contact information for the patient CFR(s): 484.110(a)(4) Contact information for the patient, the patient's representative (if any), and the patient's primary caregiver(s); This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure contact information for the patient was updated and accurate in 1 (P-4) of 2 records reviewed with home visits, resulting in the potential for unmet care needs during an emergency. Findings include: **Policy titles "Client Admission Process C-140" stated on page 37, "10. The admission professional will: A. Verify all the information on the Intake Form with the client/caregiver." P-4: This 99-year-old patient was admitted to the agency on 1/23/24 with the diagnoses of bilateral shoulder pain, difficulty walking, and generalized weakness. Upon selection of this patient for a home visit with physical therapy, the patient's plan of care was requested to review the most current information, including the patient's address. The information was verified with the Director of Nursing (Staff B) prior to the home visit scheduled on 2/20/24 at 1300. Upon arrival to the address provided on the plan of care on 2/20/24 at 12:55 PM, it appeared the house was abandoned. The physical therapist (Staff E) was contacted, and it was determined the patient lives with her daughter about 1 mile away. Upon arrival to the patient's daughter's home, the daughter was asked if the patient had moved in with her recently. The patient's daughter stated, "Oh no, she's been here at least a year." Upon return to the agency on 2/20/24 at 2:15, Staff B and the Alternate Administrator (Staff D) were queried regarding the wrong information in the record. Staff D reported he thought it had been a recent change, and that was why the information was incorrect. Staff A and Staff B were informed the patient has lived with her daughter for over a year. Staff D looked further into the situation and reported it appeared the address on the referral from the doctor had been correct, however the information had not been updated in their medical record system and apologized for the inconvenience. Findings were again reviewed with and acknowledged by Staff B, Staff D and the Alternate Clinical Manager (Staff C) during an interview on 2/21/24 at 12:50 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 completed transfer summary was sent within 2 business days of becoming aware of an unplanned transfer in 3 (P-1, 5, and 7) of 7 records reviewed, resulting in the potential for unmet care needs. Findings include: P-7: This 94-year-old patient was admitted to home care on 10/25/23 with diagnoses of congestive heart failure, pulmonary embolism, and atrial fibrillation. During record review on 2/15/24, it was noted that the patient was admitted to the hospital on 11/15/23 for hematuria (blood in the urine) after kidney stent removal and was discharged home on 11/20/23. There was no documented evidence that a detailed transfer summary report was sent to the receiving agency within 2 business days of becoming aware of transfer. This finding was reviewed and acknowledged by the Director of Nursing (Staff B), alternate clinical manager (Staff C), and alternate administrator (Staff D) during an interview on 2/21/24 at 3:05 p.m. P-1: This 89-year-old patient was admitted to the agency on 4/5/23 with diagnoses which included Chronic Obstructive Pulmonary Disease (progressive lung disease); high blood pressure; and type 2 Diabetes. The medical record was reviewed on 2/15/24. During review, it was noted the patient was sent to the hospital on 5/24/23 and the Occupational Therapist signed the Transfer/Discharge form on 5/24/23. There was no documentation in the medical record indicating that a transfer had been sent to the receiving health care facility, or the health care professional who would be responsible for the patient’s care after transfer. The Director of Nursing supplied a spreadsheet with dates of transfer/discharge summaries which were sent to physicians and facilities. P-1 was on the list with a note that stated “Transfer-DC” but did not include a date indicating that a transfer summary had been sent. No other evidence of a transfer summary being sent to either a physician or receiving facility was provided. These findings were reviewed and acknowledged on 2/21/24 during interview at 2:05 p.m. with the Director of Nursing (Staff B); the Alternate Clinical Manager (Staff C); and the Alternate Administrator (Staff D). P-5: This 90-year-old patient was admitted to the agency on 3/27/23 with the diagnoses of seizures, polyneuropathy (a disorder affecting nerves), and difficulty with gait (walking) and mobility. During record review on 2/15/24, it was noted a transfer summary was completed on 5/2/23 due to the patient being admitted to the hospital after a fall. The Director of Nursing (Staff B) was interviewed on 2/21/24 at 2:45 regarding how the agency tracks if/when the transfer summary was sent to the new provider. Staff B reported it is entered on a spreadsheet when it was sent. When asked to see the spreadsheet with the information for P-5, it was noted it stated "Transfer-DC" instead of a date. Staff B stated she wasn't sure why there wasn't a date in that column and was unable to provide evidence the transfer summary was sent. Findings were again and reviewed with Staff B, the Alternate Clinical Manager (Staff C), and the Alternate Administrator (Staff D) during an interview on 2/21/24 at 3:00 PM.

On 2/23/21 through 2/26/21, a recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs at Neocare Home Care. This was a standard survey. The requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness were not reviewed.

The Michigan Department of Licensing and Regulatory Affairs conducted a Medicare authorized Recertification survey along with a focused infection control survey on 2/23/21 through 2/26/21, at: Neocare Home Care 28316 Franklin Southfield, MI 48034 Clinical records reviewed for this survey: 3 records with home visits and 4 records without home visits for a total of 7 records reviewed. The agency has no branch sites. At the conclusion of the survey, the agency was found to not be in compliance at the standard level for the conditions of participation for Home Health Agency at: 42 CFR Part §484.00

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on observation, 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, measurable data to use as a baseline for future assessments, and history of events leading to current home care needs for 3 of 7 sampled records reviewed (MR#s 1, 2, 3), resulting in incomplete clinical information to aid in determining the current and future care needs of the patient. Findings included: MR#1: The Start of Care (SOC) was dated 2/3/21. The Plan of Care (POC) for the certification period of 2/3/21 to 4/3/21 identified diagnoses of Congestive Heart Failure (CHF), Coronary Artery Disease (CAD); Hypertension (HTN), Diabetes Type 2 (DM2), and atrial fibrillation (A-fib). This patient was receiving Skilled Nursing (SN), Home Health aide (HHa), and Physical Therapy (PT) services. Upon review of the record under the category of "Diagnoses and Symptom Control" there was a list of diagnoses, however, there was no information regarding the current and past disease processes that included dates of onset, current status of the diseases, exacerbations or current treatments/conditions and history of events leading to current home care needs that warranted admission to the agency. MR#2: The Start of Care (SOC) was dated 1/19/2021. The Plan of Care (POC) for the certification period of 1/19 to 3/19/21 identified diagnoses of Diabetes Type 2 (DM2), Osteoarthritis, Chronic Obstructive Pulmonary Disease (COPD), Hypertension (HTN). This patient was receiving Skilled Nursing and Physical Therapy Services. Upon review of the record under the category of "Diagnoses and Symptom Control" there was a list of diagnoses, however, there was no information regarding the current and past disease processes that included dates of onset, current status of the diseases, exacerbations or current treatments/conditions and history of events leading to current home care needs that warranted admission to the agency. MR#3: The Start of Care (SOC) was dated 5/19/2020. The Plan of Care (POC) for the certification period of 5/19 to 6/30/20 identified diagnoses of cystitis, osteoarthritis, Crohns Disease, Coronary Artery Disease (CAD), and Hypertension (HTN). This patient was receiving Skilled Nursing (SN) services. Upon review of the record under the category of "Diagnoses and Symptom Control" there was a list of diagnoses, however, there was no information regarding the current and past disease processes that included dates of onset, current status of the diseases, exacerbations or current treatments/conditions and history of events leading to current home care needs that warranted admission to the agency. These findings were reviewed and acknowledged by Administrator (Adm#1) and DON#1 (director of nursing) during an interview on 2/26/21 at 12:00 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 the physician was notified of potential drug interactions for 2 of 7 (MR# 4, 6) records reviewed, resulting in the potential for harmful medication effects for these patients. Findings include: MR#4: This patient was admitted to the agency on 2/3/21 with diagnoses of type 2 diabetes mellitus, osteoarthritis, and kidney disease with dialysis. On 2/25/21 during clinical record review, there was no documentation of a medication review. The 2/3/21 comprehensive assessment completed by the nurse indicates for (M2001) drug regimen review that clinically significant medication issues were found during the review of the patient's medications. Utilizing the agency's own electronic medical record system on 2/26/21, a medication interaction check indicates there are 3 major interactions and 16 moderate interactions to the patient's current medications. There was no documentation to indicate that these findings were reported to the physician. The nurse failed to document the physician was notified of the medication interactions. The findings were reviewed with and acknowledged by Adm#1 (administrator) and DCS#1 (director of clinical services) during an interview on 2/26/21 at 1100 hours. MR#7: This patient was admitted to the agency on 2/6/21 with diagnoses of sciatica, heart failure, and depression. On 2/25/21 during clinical record review, there was no documentation of a medication review. The 2/6/21 comprehensive assessment completed by the physical therapist indicates for (M2001) drug regimen review that clinically significant medication issues were found during the review of the patient's medications. Utilizing the agency's own electronic medical record system on 2/26/21, a medication interaction check indicates there are 15 moderate interactions to the patient's current medications. There was no documentation to indicate that these findings were reported to the physician. The therapist failed to document the physician was notified of the medication interactions. The findings were reviewed with and acknowledged by Adm#1 (administrator) and DCS#1 (director of clinical services) during an interview on 2/26/21 at 1100 hours.

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 include all necessary treatments in the plan of care for 2 of 7 records reviewed (MR# 2, 4, 7), and failed to include objectively measureable goals to determined progress towards goals (MR#s 1, 2, and 3), resulting in the potential for patient decline and poor patient outcomes. Findings include: **Agency policy "Development of the Plan of Care" (dated 2021) stated, "A care plan...based upon the plan of treatment and an assessment of the patient's needs, resources, family and environment..." MR#4: This patient was admitted to the agency on 2/3/21 with diagnoses of type 2 diabetes mellitus, osteoarthritis, and kidney disease with dialysis. The plan of care dated 2/3/21 ordered to notify physician if out of range: blood sugar, fasting greater than (>) 180 Less than () 200, less than () Less than () 250, less than (<)." The plan of care failed to define the fasting blood sugar results for the greater than value; and failed to define the random blood sugar results for the less than value. Also, the POC failed to specify the frequency the patient/caregiver was to complete glucose monitoring on a daily basis. MR#3: The Start of Care (SOC) was dated 5/19/2020. The Plan of Care (POC) for the certification period of 5/19 to 6/30/20 identified diagnoses of cystitis, osteoarthritis, Crohns Disease, Coronary Artery Disease (CAD), and Hypertension (HTN). Upon review of the POC it was noted the goals on the POC were not objectively measurable as required to determine the patient's progress towards goals. Examples include: "Patient activity will improve due to effective pain control; Patient/Caregiver demonstrate effective management of medication regimen; Patient/Caregiver will demonstrate measures to prevent skin breakdown." These findings were reviewed and acknowledged by Administrator (Adm#1) and DON#1 (director of nursing) during an interview on 2/26/21 at 12:00 p.m.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to ensure the registered nurse performed assessments and re-assessments using objective measurements to determine if the patient's health status was improving or worsening during the course of care in 1 of 7 records reviewed in which nursing services were provided out of a total sample of 7 records reviewed (MR# 1), which resulted in the potential for unidentified patient needs. Findings included: MR#1: The Start of Care (SOC) was dated 2/3/21. The Plan of Care (POC) for the certification period of 2/3/21 to 4/3/21 identified a primary diagnosis of Congestive Heart Failure (CHF), and secondary diagnoses of Coronary Artery Disease (CAD); Hypertension (HTN), Diabetes Type 2 (DM2), and atrial fibrillation (A-fib). The patient was receiving Skilled Nursing (SN), Home Health aide (HHa) and Physical Therapy (PT) services. Upon review of the SOC, it was noted the SN documented a weight of 229 pounds. However, the SN failed to obtain weights for this patient with a primary diagnosis Congestive Heart Failure on any of the following 4 SN visits dated between 2/10/21 and 2/25/21 to determine if the patient was gaining weight as a result of possible water retention that potentially could result in a deterioration of the patient's health status. Additionally, the SN was using subjective measurements of 1+, 2+, 3+ rather than objective measurements such as the use of a tape measure to determine if the patient's lower extremity edema was improving or becoming worse. These findings were reviewed and acknowledged by Administrator (Adm#1) and DON#1 (director of nursing) during an interview on 2/26/21 at 12:00 p.m.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on Observation, record review, and interview, it was noted the physical therapist failed to provide the patient a written copy of the PT prescribed exercise program for the patient to use on days physical therapy was not providing services in the home for 1 of 6 records in which PT services were provided, resulting in the potential for decline in the patient's condition. Findings included: MR#1: The Start of Care (SOC) was dated 2/3/21. The Plan of Care (POC) for the certification period of 2/3/21 to 4/3/21 identified diagnoses of Congestive Heart Failure (CHF), Coronary Artery Disease (CAD); Hypertension (HTN), Diabetes Type 2 (DM2), and atrial fibrillation (A-fib). This patient was receiving Skilled Nursing (SN), Home Health aide (HHa), and Physical Therapy (PT) services. During a survey home visit on 2/24/21 with the physical therapist, it was observed the PT placing the written copy of the prescribed exercises for this patient to be used on a daily basis to improve the patient's strength and mobility. The patient stated, "that will be helpful." The PT failed to provide a copy of the home exercise program for the first 3 weeks of care potentially resulting in a delay in this patient gaining the strength and mobility needed as a result of the patient's health condition. These findings were reviewed and acknowledged by Administrator (Adm#1) and DON#1 (director of nursing) during an interview on 2/26/21 at 12:00 p.m.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse included safety measures in the patient care instructions for the home health aide in 1 of 2 (MR# 5) records reviewed in which the patient received home health aide services, resulting in the potential for the provision of unsafe care for this patient. Findings include: **Agency policy "Home Health Aide: Assignment" (reviewed 2020) stated, "The need for home health aide services is determined during the assessment by the nurse or therapist...To provide direction and supervision of care provided by the Home Health Aide..." MR#5: This patient was admitted to the agency on 2/3/20 with diagnoses of bilateral knee osteoarthritis, difficulty walking, and type 2 diabetic mellitus. The 2/3/20 plan of care ordered the aide to provide one time each week for 4 weeks. The plan of care specified the following safety precautions: diabetic: do not cut nails, DME and electrical safety, fall precautions, emergency/disaster plan development, neutropenic precautions, safety in ADL's, slow position changes, support during transfer and ambulation, and use of assistive devices. The aide care plan developed by the physical therapist on 2/3/20 failed to contain diabetic precautions for the aide to be aware of while providing care to the patient. The findings were reviewed and acknowledged by Adm#1 (administrator) and DCS#1 (director of nursing) during an interview on 2/26/21 at 1100 hours.

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient record included all required documents that were completed in a timely manner in 1 of 3 discharged records (MR#2) resulting in the patient not having a complete medical record to use as a resource for future health needs. Findings included: MR#2: The Start of Care (SOC) was dated 1/19/2021. The Plan of Care (POC) for the certification period of 1/19 to 3/19/21 identified diagnoses of Diabetes Type 2 (DM2), Osteoarthritis, Chronic Obstructive Pulmonary Disease (COPD), and Hypertension (HTN). The patient was receiving skilled nursing (SN) and physical therapy (PT) services. The skilled nurse completed a discharge summary on 2/23/21, and the DC Auto-generated form was dated 2/24/21. However, there was no discharge summary found in the record for PT. There was a discharge OASIS (outcome and assessment information set) dated 2/18/21 completed by the physical therapist. However, the DC OASIS was blank except for the following areas that were completed: Patient's date of birth, MRN# (chart identifier), pre-dated visit date of 2/18/21, and the discipline (PT) completing the form. Thus, the PT failed to submit a discharge summary or a completed DC OASIS. These findings were reviewed and acknowledged by the Administrator (Adm#1) and DON#1 (director of nursing) during an interview on 2/26/21 at 12:00 p.m.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a discharge summary was sent to the physician within 5 business days of the patient's discharge for 1 of 2 (MR# 5) records reviewed in which the patient was discharged from the agency, resulting in the physician not having knowledge of the patient's health status at the time of discharge which has the potential to negatively affect the patients discharged from the agency in the past twelve months. Findings include: MR#5: This patient was admitted to the agency on 2/3/20 with diagnoses of bilateral knee osteoarthritis, difficulty walking, and type 2 diabetic mellitus. The 2/3/20 plan of care specified physical therapy and home health aide services. The patient was discharged from services on 3/18/20 with a discharge OASIS (outcome and assessment information set) completed by the physical therapist. During record review on 2/25/21 there was no evidence a discharge summary was sent to the physician within 5 business days of the patient's discharge. The above findings were reviewed and acknowledged by Adm#1 (administrator) during an interview on 2/26/21 at 1100 hours. MR#2: The Start of Care (SOC) was dated 1/19/2021. The Plan of Care (POC) for the certification period of 1/19 to 3/19/21 identified diagnoses of Diabetes Type 2 (DM2), Osteoarthritis, Chronic Obstructive Pulmonary Disease (COPD), Hypertension (HTN). The patient was receiving skilled nursing (SN) and physical therapy (PT) services. The SN had completed a discharge summary dated 2/24/21 after visiting the patient on 2/23/21. However, there was no evidence the SN discharge summary had been sent to the physician within the required 5 business days of the patient's discharge. In addition, this patient was receiving physical therapy services. A discharge OASIS (outcome and assessment information set) was found in the patient's record and was dated 2/18/21. The form was to be completed by the physical therapist. However, the DC OASIS was blank except for the following areas: Patient's date of birth, MRN# (chart identifier), visit date of 2/18/21, and the discipline (PT) completing the form. There was no further information regarding the disposition of physical therapy services for this patient, no summary of care, and no evidence that the physical therapist had completed a discharge summary to be sent to the physician upon discharge of the patient from services. MR#3: The Start of Care (SOC) was dated 5/19/2020. The Plan of Care (POC) for the certification period of 5/19 to 6/30/20 identified diagnoses of cystitis, osteoarthritis, Crohns Disease, Coronary Artery Disease (CAD), and Hypertension (HTN). This patient was receiving skilled nursing (SN) services. The patient was discharged from services on 6/30/20 with a discharge OASIS (outcome and assessment information set) completed by the skilled nurse and signed by the SN on 7/8/20. During record review on 2/26/21 there was no evidence a discharge summary was sent to the physician within 5 business days of the patient's discharge. The above findings were reviewed and acknowledged by the Administrator (admin#1) during an interview on 2/26/21 at 12:00 p.m.