Every finding on record at Mareli Home Care, LLC

The following Condition level citation was identified at an Emergency Preparedness Survey along with a Covid-19 Focused Infection Control Survey, conducted by the Michigan Department of Licensing and Regulatory Affairs on 9/29/21 through 10/1/21 at: Mareli Home Care (Axis Home Care)15565 Northland Dr., Suite 208Southfield, MI 48075At the time of the survey, Michigan Home Health Services, was found to be non-compliant with the requirements for the Conditions of Participation at: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, §485.625, §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 develop an emergency preparedness plan that must be reviewed, updated, and included guidance for the Covid-19 pandemic, resulting in lack of direction for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all directly employed staff, regularly utilized contracted staff and all 12 patients actively serviced by this Agency in the event of a facility emergency or disaster (E0004); failed to ensure an emergency plan existed that was based on a documented facility and community-based risk assessment from an all-hazards approach, including strategies for the Covid-19 global pandemic, resulting in the potential for lack of preparedness and poor patient and staff outcomes, in the event of an actual emergency (E0006); Based on record review and interview, the Agency failed to develop and maintain a communication plan for emergency preparedness that included strategies for the global Covid-19 pandemic, resulting in the inability to communicate with staff and officials in the event of an actual disaster, and the potential for uncoordinated care for all 12 patients currently serviced by this Agency in the event of a facility emergency or disaster (E0029); failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patient's physicians, and volunteers, as appropriate, which had the potential to negatively affect the health and safety of the 12 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency (E0030); failed to provide initial training in emergency preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, and failed to maintain documentation of trainings, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services (E0037); and, failed to provide documentation for the required community/facility based full-scale exercises and failed to provide documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff being ill-prepared in the event of an actual emergency. This deficient practice could negatively affect all 12 patients currently serviced by this Agency (E0039). The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, 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), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop an emergency preparedness plan that must be reviewed, updated, and included guidance for the Covid-19 pandemic, resulting in lack of direction for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all directly employed staff, regularly utilized contracted staff and all 12 patients actively serviced by this Agency in the event of a facility emergency or disaster. Findings include: On 9/29/21 at 2:38 p.m., the agency's Emergency Preparedness documentation was reviewed. During the review, it was noted that the plan was undated. It was further noted that the agency's plan had not been updated to include strategies to address the Covid-19 global pandemic. There was no documented evidence that showed the agency had developed an Emergency Preparedness plan that had been reviewed/updated in accordance with the requirements of this section. These findings were reviewed with and confirmed by the Clinical Manager (CM #1) during a telephone interview on 9/30/21 at 4:39 p.m.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure an emergency plan existed that was based on a documented facility and community-based risk assessment from an all-hazards approach, including strategies for the Covid-19 global pandemic, resulting in the potential for lack of preparedness and poor patient and staff outcomes, in the event of an actual emergency. Findings include: On 9/29/21 at 2:38 p.m., the agency's Emergency Preparedness documents were reviewed. The Risk Assessment document was not dated. It was further noted that the document failed to include the Covid-19 global pandemic. Additionally, the agency's Emergency Preparedness Plan failed to include strategies to address Covid-19. These findings were reviewed with and confirmed by the Clinical Manager during an interview on 9/30/21 at 4:39 p.m.

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), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop and maintain a communication plan for emergency preparedness that included strategies for the global Covid-19 pandemic, resulting in the inability to communicate with staff and officials in the event of an actual disaster, and the potential for uncoordinated care for all 12 patients currently serviced by this Agency in the event of a facility emergency or disaster. Findings include: On 9/29/21 at 2:38 p.m., the agency's Emergency Preparedness documentation was reviewed. Upon review, there was no communication plan that provided direction as to how Agency personnel was to communicate with staff, Federal, State, and local emergency officials during a crisis. These findings were reviewed with and acknowledged by the Clinical Manager (CM #1) during a telephone interview n 9/30/21 at 4:39 p.m.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patient's physicians, and volunteers, as appropriate, which had the potential to negatively affect the health and safety of the 12 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency. Findings include: During a review of the agency's emergency preparedness documents on 9/29/21 at 2:38 p.m., it was noted that there was no contact information for all current staff, patient's physicians, or volunteers as appropriate. These findings were reviewed with and acknowledged by Clinical Manager (CM #1) during an interview on 9/30/21 at 4:39 p.m.

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), §485.625(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, "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, it was determined the Agency failed to provide evidence of initial training in emergency preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, and failed to maintain documentation of training's, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 9/29/21 at 2:38 p.m., The Agency's Emergency Preparedness documentation was reviewed. There was no documented evidence that The Agency failed to provide initial and ongoing training in emergency preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, and failed to maintain documentation of trainings. These findings were reviewed with and acknowledged by the Clinical Manager (CM #1) during a telephone interview on 9/30/21 at 4:39 p.m.

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), §485.625(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, 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 provide documentation for the required community/facility based full-scale exercises and failed to provide documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff being ill-prepared in the event of an actual emergency. This deficient practice could negatively affect all 12 patients currently serviced by this Agency. Findings include: During a review of the agency's Emergency Preparedness documents on 9/29/21 at 2:38 p.m., it was noted that there was no documented evidence that all agency staff participated in training or exercises to test the agencies emergency plan. A document titled "Emergency Operation Plan 2019" documented, "EOP Tabletop Exercise - Tornado/Severe Storm/Winds." There was no date in which this exercise occurred. Further, there was no mention of which if any staff were involved in the tabletop discussion, as no participants were listed and there was no associated sign in sheet. There was no documentation of an actual event that would qualify as a test of the emergency plan. These findings were reviewed with the Clinical Manager (CM #1) during a telephone interview on 9/30/21 at 4:39 p.m.

The following Condition and standard level deficiencies were identified at a Medicare authorized recertificaiton survey concurrent with a Covid-19 Focused Infection Control Survey, conducted by the Michigan Department of Licensing and Regulatory Affairs on 9/29/21 through 10/1/21 at: Mareli Home Care (Axis Home Health)15565 Northland Dr., Suite 208Southfield, MI 48075This agency had no additional branch locations. Records reviewed: 2 records with home visits, 5 records without home visit, for a total of 7 records reviewed. The required 3 home visits could not be conducted due to patient refusal. At the time of the survey, Michigan Home Health Services, was found to be non-compliant with the requirements for the Conditions of Participation a 42 CFR §484.65 Quality Assessment Performance Improvement. 42 CFR §484.75 Skilled Professional Services. 42 CFR §484.102, Emergency Preparedness. 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(f)(3).

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to include contact information for the Home Health Agency's Administrator in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed concerns for all patients serviced by this agency. Findings include: On 9/29/21 at 11:55 a.m. during a review of the Agency's Admission packet, it was noted that packet included a consent form, admission agreement, Beneficiary notice, and patient rights and responsibilities forms. Upon review, it was noted that there was no contact information for the Agency's Administrator (Adm #1). These findings were reviewed with and confirmed by Adm #1 and the Clinical Manager (CM #1) during an interview on 10/1/21 at 2:43 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, it was determined the registered nurse failed to review the patients medications and complete a drug regime review in 1 of 1 records in which the patient was admitted by a Physical Therapist out of a total sample of 7 records reviewed (MR #4), resulting in the potential for adverse medication reactions. Findings include: MR #4: The plan of care dated 1/29/21 stated the patient was admitted for physical therapy and home health aide services with the diagnosis of Polyosteoarthritis (Arthritis in multiple joints). The plan of care also specified the patient was taking 12 medications daily. The "Medication Profile" dated 1/29/21, which included documentation of the required drug regime review, was signed by a Physical Therapist. There was no evidence in the medical record that a registered nurse performed a review of the patient's medications. During an interview on 10/1/21 at 2:30 PM the Clinical Manager stated, "I did not review the medications for that patient and I am the one who is responsible for that."

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, it was determined the Agency failed to ensure the plan of care included all treatments, services, reportable parameters and measurable goals in order to meet the needs of the patient for 6 (MR's #2, 3, 4, 5, 6, and 7) records, from a total of 7 sampled records reviewed, resulting in the potential for unmet patient care needs. findings include: MR #2: The patient's start of care (SOC) was 9/11/21 with diagnoses that included right hip replacement, diabetes mellitus and hypertension. During the record review on 9/30/21 at 1:30 p.m., it was noted that the Initial Comprehensive Assessment dated 9/11/21, completed by the Registered nurse indicated the patient was admitted with a pain level of 5/10 and a blood glucose level of 146. The plan of care (POC) had set parameters to report to the Physician blood glucose levels greater and 400 and to report pain if greater than 9. These parameters were not specific to the needs of the patient. The referral for home care dated 9/1/21, documented, "Patient has hip and back pain. He is s/p (status post) right hip replacement, DM (diabetes mellitus) type 2", however, the POC listed the patient's chief diagnosis as hypertension. Further review revealed that all listed diagnoses on the POC had a start date of 9/11/21. The above findings and discrepancies were reviewed with and acknowledged by the Clinical Manager (CM #1) during an interview on 9/30/21 at 4:39 p.m. who reported, "They (staff) should put the actual diagnosis that the patient is being treated for. CM #1 offered no response in regard to the set reportable parameters. MR #3: The patient's SOC was 9/8/21 with diagnoses that included congestive heart failure, edema, diabetes mellitus and hypertension. The Initial Comprehensive Assessment dated 9/8/21 completed by the Registered Nurse documented a baseline pain level of 3/10 and a blood glucose level of 94. During the record review on 9/30/21 at 2:40 p.m., it was noted that the POC was not individualized according to the patient's needs. The plan of care (POC) had set parameters to report to the Physician blood glucose levels greater and 400 and to report pain if greater than 9. These parameters were not specific to the needs of the patient. The Initial Assessment documented, "Admitted with lower extremity edema." There were no interventions to monitor the patient's edema and weight in light of the diagnosis of congestive heart failure, and no reportable parameters in which to notify the Physician. Additionally, there were no goals related to any of the above diagnoses. These findings were reviewed with and acknowledged by CM #1 during an interview on 9/30/21 at 4:39 p.m. No response was offered. MR #4: The plan of care, dated 1/29/21, stated the patient's primary diagnosis was polyosteoarthritis (multiple areas of arthritis) and the secondary diagnoses included chronic pain, heart failure, hypertension and diabetes. The start of care comprehensive assessment, dated 1/29/21, stated the patient's baseline pain level was 7 on a scale of 0-10 (0= no pain, 10= worst pain), the blood pressure was 150/80 and the blood sugar was left blank. The plan of care includes reportable blood pressure parameters of systolic greater than 160 mmHg (millimeters of mercury) or less than 90 mmHg, diastolic greater than 90 mmHg or less than 50 mmHg and pain level greater than 9, which are used for all patient's regardless of baseline levels. There were no reportable blood sugar parameters on the plan of care. There was no evidence the plan of care included patient specific reportable parameters. The diagnosis list on the plan of care contained 6 diagnoses that all had the same exacerbation date of 1/29/21, the start of care date. MR #5: The plan of care, dated 8/5/21, stated the patient's primary diagnosis was diabetes and other pertinent diagnoses included osteoarthritis of the knees and low back pain. The start of care comprehensive assessment, dated 8/5/21, stated the patient's baseline blood sugar was 159, and the patient's pain level was five on a scale of 0-10 (0= no pain, 10= worst pain). The plan of care includes reportable blood sugar parameters of greater than 400, which is used for all patient's regardless of baseline level. There were no reportable pain parameters on the plan of care. There was no evidence the plan of care included patient specific reportable parameters. The diagnosis list on the plan of care contained 7 diagnoses that all had the same exacerbation date of 8/5/21, the start of care date. Additionally, the plan of care included goals such as: "Pt will demonstrate increased endurance by... Start Effective Date: 08/05/2021."; "Urinary elimination will be WNL (within normal limits) for Pt (patient) by:... Start Effective Date: 08/05/2021."; and "Pt/Pcg (patient/patient caregiver) will demonstrate use of assistive device(s) by:... Start Effective Date: 08/05/2021." The plan of care failed to include patient/caregiver specific measurable goals. MR #6: The plan of care, dated 9/3/21, stated the patient's primary diagnosis was Systemic Lupus Erythematosus, and the other pertinent diagnoses included hypertension, spondylosis in the lumbar region of the spine, and chronic obstructive pulmonary disease (difficulty breathing). The start of care comprehensive assessment, dated 9/3/21, stated the patient's baseline blood sugar was 159, and the patient's pain level was five on a scale of 0-10. The plan of care includes reportable blood sugar parameters of greater than 400, which is used for all patient's regardless of baseline level. There were no reportable pain parameters on the plan of care. There was no evidence the plan of care included patient specific reportable parameters. The diagnosis list on the plan of care contained 4 diagnoses that all had the same exacerbation date of 9/3/21, the start of care date. Additionally, the plan of care included goals such as: "Pt will demonstrate increased endurance by... Start Effective Date: 09/03/2021."; "Urinary elimination will be WNL (within normal limits) for Pt (patient) by:... Start Effective Date: 09/03/2021."; and "Pt/Pcg (patient/patient caregiver) will demonstrate use of assistive device(s) by:... Start Effective Date: 09/03/2021." The plan of care failed to include patient/caregiver specific measurable goals. MR #7: The plan of care, dated 8/2521, stated the patient's primary diagnosis was hypertension and the other pertinent diagnoses included carpal tunnel syndrome and polyosteoarthritis. The start of care comprehensive assessment, dated 8/25/21, stated the patient's blood pressure was 136/80 and the patient's pain level was 2 on a scale of 0-10. The plan of care includes reportable blood pressure parameters of systolic greater than 160 mmHg or less than 90 mmHg, diastolic greater than 90 mmHg or less than 50 mmHg and pain greater than 9, which is used for all patient's regardless of baseline level. There was no evidence the plan of care included patient specific reportable parameters. Additionally, the plan of care included goals such as: "Pt will demonstrate increased endurance by... Achieve By Date: 09/24/2021."; "Pt/Pcg will state understanding of measures to manage disease and identify S/S (signs and symptoms) to report by....Achieve By Date: 09/24/2021."; and "patient blood pressure will be in normal limits by:... Achieve By Date: 09/03/2021." The plan of care failed to include patient/caregiver specific measurable goals.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to have a Quality Assurance Performance Improvement program that measured, tracked and analyzed quality indicator data for the purpose of showing improvement in health outcomes, patient safety and quality of care (See G642); failed to collect and use quality indicator data to monitor the effectiveness and safety of services, and identify opportunities for improvement (See G644); failed to have an ongoing Quality Assessment Performance Improvement program that was based on high risk, high volume and problem prone areas (See G 648); failed to have an ongoing Quality Assessment Performance Improvement program that considered incidence, prevalence and severity of problems identified (See G 650); failed to have a Quality Assessment Performance Improvement program that would ensure an immediate correction of any identified problem that would directly or potentially threaten the health or safety of patients (See G 652); failed to document any actions taken to improve performance and measurement and tracking of quality indicator data to ensure improvements are sustained (See G 656); and failed to selected and the measurable progress achieved, as part of their QAPI program (See G 658). Findings include: The effects of these systemic failures had the potential to affect all 50 patients admitted in the past 12 months, resulting in the potential for poor patient outcomes and patient injury.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to have a Quality Assurance Performance Improvement program that measured, tracked and analyzed quality indicator data for the purpose of showing improvement in health outcomes, patient safety and quality of care that had the potential to affect all 50 patients served in the past 12 months, resulting in the potential for ongoing negative patient outcomes or patient injury. Findings include: On 9/30/21 at 10:45 AM this surveyor asked the Administrator for the agency's "Quality Assessment and Performance Improvement" (QAPI) documentation to be provided by the end of business that day. On 9/30/21 at 1:15 PM this surveyor asked the Administrator about the status of the QAPI documentation and the Administrator stated, "I don't know what that is, I don't know what you mean by QAPI." The QAPI requirements were explained to the Administrator who then stated, "I will call... (Clinical Manager)." On 9/30/21 at 4:10 PM the Administrator was again asked to provide QAPI documents and the Administrator stated, "The Consultant we used to have is putting it together and will bring it here." The Administrator was reminded that the documentation was to be provided by 5:00 PM. The Administrator then called the "Consultant" to request QAPI documents and the Consultant was heard to say, "I don't have much, but I will send you what I have." On 9/30/21 at 4:18 PM the Administrator provided a blank "Incident Report" and a generic QAPI template. When asked if this was all the agency had for QAPI documents the Administrator stated, "Yes, that is all we have." During a telephone interview on 10/1/21 at 1:00 PM CM-1 was asked if there was any other documentation for QAPI. CM-1 replied, I may have one incident report at home. I have reviewed some charts but I don't know if I have any documentation of the reviews. There is no documentation of my review. We have made a lot of changes and improvements, but we don't have any documentation of the improvements." There was no evidence of an ongoing QAPI program that included quality indicator data collection, tracking or analysis. There was no QAPI documentation to demonstrate the agency is making improvements in health outcomes, patient safety or quality of care.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the agency failed to collect and use quality indicator data to monitor the effectiveness and safety of services, and identify opportunities for improvement which affected all 50 patients admitted for services in the past 12 months, resulting in the potential for poor patient outcomes or patient injury. Findings include: On 9/30/21 at 10:45 AM this surveyor requested the agency's Quality Assessment Performance Improvement (QAPI) documentation. At 4:18 PM the Administrator provided a blank copy of an "Incident Report" form and a generic QAPI template. The Administrator was asked if that was all the QAPI documentation the agency had and the Administrator stated, "Yes." There was no documentation showing the agency was collecting and using quality indicator data to monitor the effectiveness and safety of care provided and to identify opportunities for improvement.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to have an ongoing Quality Assessment Performance Improvement program that was based on high risk, high volume and problem prone areas which had the potential to affect all 50 patients admitted in the past 12 months, resulting in the potential for poor patient outcomes and patient injury. Findings include: During the 9-30-21 review of the Quality Assessment Performance Improvement (QAPI), it was noted that there was no active QAPI program. The Administrator provided a blank "Incident Report" form and a generic QAPI template. There was no data collection or improvement activities documented to show that the agency had developed a QAPI program that was based on high risk, high volume and problem prone areas.

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to have an ongoing Quality Assessment Performance Improvement program that considered incidence, prevalence and severity of problems identified, which had the potential to affect all 50 patients admitted for services in the past 12 months, resulting in poor patient outcomes and patient injury. During the 9-30-21 review of the Quality Assessment Performance Improvement (QAPI), it was noted that there was no active QAPI program. The Administrator provided a blank "Incident Report" form and a generic QAPI template. There was no data collection or improvement activities documented to show that the agency had developed a QAPI program that considered incidence, prevalence and severity of problems identified.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to have a Quality Assessment Performance Improvement program that would ensure an immediate correction of any identified problem that would directly or potentially threaten the health or safety of patients, which had the potential to affect all 50 patients admitted for services in the past 12 months, resulting in the potential for poor patient outcomes or patient injury. During the 9-30-21 review of the Quality Assessment Performance Improvement (QAPI), it was noted that there was no active QAPI program. The Administrator provided a blank "Incident Report" form and a generic QAPI template. There was no data collection or improvement activities documented to show that the agency act immediately to correct any identified problem that would directly or potentially threaten the health and safety of patients.

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to document any actions taken to improve performance, measurement and tracking of quality indicator data to ensure improvements are sustained which had the potential to affect all 50 patients admitted in the past 12 months, resulting in the potential for poor patient outcomes or patient injury. Findings include: During the 9-30-21 review of the Quality Assessment Performance Improvement (QAPI) documents provided by the Administrator, it was noted that there was no documentation of any performance improvement actions taken or any data collected to determine if any improvement was obtained and sustained. During an interview on 10-1-21 CM-1 stated "We don't document actions taken to improve care. We're always doing things to improve how we are doing but we don't document what actions we put in place. We don't have any data documented."

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to have any performance improvement projects documented, with the reason the project was selected and the measurable progress achieved, as part of their QAPI program which had the potential to negatively affect all 50 patients admitted in the past 12 months, resulting in the potential for poor patient outcomes and patient injury. Findings include: During the 9-30-21 review of the Quality Assessment Performance Improvement (QAPI) documents provided, it was noted that the documents included only a blank "Incident Report" form and a generic QAPI program temp[late. There was no evidence of any data collection or performance improvement projects selected. During an interview on 10-1-21 at 1:00 PM CM-1 stated, "We haven't documented any performance improvement projects."

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on observation, interview and record review, it was determined that the Physical Therapist failed to utilize professional standards during ambulation for 1 (MR #2) of 1 patient observed during a Therapy home visit, resulting in the potential for fall with injury (G704); failed to ensure the Physical Therapist performed reassessments of a patient's oxygen level for 1 (MR #2) of 1 patient observed during a therapy home visit; and failed to ensure the Registered Nurse performed re-assessments of the patient's edema in 1 (MR #3) of 1 record of a patient with a diagnosis of Congestive Heart Failure, from a total of 7 sampled records reviewed, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes (G706); failed to ensure Occupational Therapy services were provided for 1 (MR #3) of 1 patient in which Occupational Therapy services were ordered, resulting in the potential for physical decline, and unmet care needs (G710). 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 §484.75 Skilled Professional Services.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on observation, interview and record review, it was determined that the Physical Therapist failed to utilize professional standards during ambulation for 1 (MR #2) of 1 patient observed during a Therapy home visit, resulting in the potential for fall with injury. Findings include: MR #2: The patient's start of care (SOC) was 9/11/21 with diagnoses that included right hip replacement, hypertension and COPD (chronic obstructive pulmonary disease). The clinical record review was conducted on 9/30 /21 at 1:30 p.m. The referral for home care dated 9/1/21 ordered Skilled Nursing and Physical therapy services to be provided. The Initial Comprehensive Assessment identified the patient as at risk for falls and indicated the patient ambulated with use of a walker and a cane. On 9/30/21 at 10:15 a.m., during a scheduled home visit, the Physical Therapist (PT #1) instructed the patient on therapy exercises and ambulation. PT #1 instructed the patient to ambulate the hallway of his apartment. PT #1 instructed the patient to stand by utilizing his nearby walker. PT #1 then grabbed the back of the patient's shirt and pants for support during ambulation. PT #1 failed to apply a gait belt prior to instructing the patient to walk in order to prevent falls. ( A gait belt is a device that helps to prevent falls while walking or moving from a bed to a chair or from sitting to standing). Upon completion of the visit, PT #1 was queried as to why he failed to utilize a gait belt in order to prevent the patient from falling during ambulation yet offered no response. These findings were reviewed with the Clinical Manager (CM #1) during an interview 0n 9/30/21 at 3:05 p.m. who reported, “They (Therapist) have to make sure they use the gait belt when ambulating a patient especially when they’ve been identified as being a falls risk.”

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 observation, interview and record review, it was determined that the agency failed to ensure the Physical Therapist performed reassessments of a patient's oxygen level for 1 (MR #2) of 1 patient observed during a therapy home visit; and failed to ensure the Registered Nurse performed re-assessments of the patient's edema in 1 (MR #3) of 1 record of a patient with a diagnosis of Congestive Heart Failure, from a total of 7 sampled records reviewed, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes. Findings included: MR #2: The patient's start of care (SOC) was 9/11/21 with diagnoses that included right hip replacement, hypertension and COPD (chronic obstructive pulmonary disease). The clinical recordre view was conducted on 9/30 /21 at 1:30 p.m. The referral for home care dated 9/1/21 documented that the patient underwent a right hip replacement. During hospitalization, the patient experienced shortness of breath and was "diagnosed as having CHF (congestive heart failure) exacerbation." The plan of care (POC) stated, "Patient complains of shortness of breath when walking more than 20 feet, uses oxygen at night, diminished breath sounds..., wheezing to bilateral lower lobes..., Noted patient fatigues easily." On 9/30/21 at 10:15 a.m., a home visit with the Physical Therapist (PT #1) was conducted. During the visit, PT #1 had the patient perform lower extremity exercises which included simulated biking and leg exercises and squats. The patient was observed with heavy breathing. PT #1 did not assess the patient’s oxygen level. PT #1 proceeded to have patient perform upper extremity exercises and stated, “these are more taxing because they work your upper extremities and affect your heart." PT #1 still did not check the patient’s oxygen level. At 11:07 a.m., PT #1 told patient, “We are now going to walk in the hall.” The patient interjected and stated, “Can you check my oxygen level? Can you leave the pulse oximeter on my finger so I can tell if my oxygen level goes down? I can tell when it gets hard to breath.” PT #1 then placed the unit on the patient’s finger and noted that the patient’s oxygen level had decreased from 97% to 93%. (Normal levels 95 - 100). The patient stated that it was hard to breath but that he was okay to continue. PT #1 continued with the course of treatment. The patient's oxygen level had decreased to 92% upon completion of the exercises with expressed fatigue and shortness of breath. PT #1 failed to assess the patient’s oxygen levels during physical exercises in light of the patient demonstrating heavy breathing and shortness of breath. After the visit, PT #1 was queried about not assessing the patient's oxygen level during the therapy session and reported, "I should have checked it." On 9/30/21 at 3:05 p.m., during a telephone interview, the Clinical Manager (CM #1) stated, “I would instruct them (Therapists) that they should take pulse ox (oxygen) in between exercises, especially if they notice the patient is breathing hard or short of breath.” MR #3: The patient's start of care (SOC) was 9/8/21 with diagnoses that included congestive heart failure, edema, diabetes mellitus and hypertension. The clinical record review was conducted on 9/30/21 at 2:40 p.m. The referral for home care dated 9/7/21 documented, "Symptoms that demonstrate need for home care: Abnormal/fluctuating VS (vital signs), lab values, weights, edema." The Initial Comprehensive Assessment dated 9/8/21 documented, "Admitted with lower extremity edema." There was no baseline assessment of edema recorded in the comprehensive assessment. During a review of the skilled nursing visit notes dated 9/8/21, 9/14/21, 9/21/21 and 9/28/21 it was noted that the nurse failed to assess the patient's edema. These findings were reviewed with and acknowledged by the clinical Manager (CM #1) during a telephone interview on 9/30/21 at 4:39 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, it was determined that the Agency failed to ensure Occupational Therapy services were provided for 1 (MR #3) of 1 patient in which Occupational Therapy services were ordered, resulting in the potential for physical decline, and unmet care needs. Findings include: MR #3: The patient's start of care (SOC) was 9/8/21 with diagnoses that included congestive heart failure, edema, diabetes and hypertension. During the clinical record review on 9/30/21 at 2:40 p.m., it was noted that the referral for home care dated 9/7/21, ordered Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. During the review, it was documented that the patient refused PT services, however, there was no documented evidence that the patient refused OT services. At the conclusion of the survey, OT services still had not been provided. These findings were reviewed with and confirmed by the clinical Manager (CM #1) during an interview on 9/30/21 at 4:39 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 that a discharge summary was completed, detailed the course of care and the status at the time of discharge for 2 (MR #1 and #4) of 2 patients who were discharged from the agency, resulting in lack of the clear clinical picture needed by the Physician in order to determine any continuing needs and the potential for unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 6/9/21 with diagnoses that included diabetes mellitus, falls and pain right knee. During the record review on 9/29/21 at 12:50 p.m., it was noted that the plan of care (POC) ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The patient was discharged from PT on 7/7/21 and discharged from SN on 8/5/21. There was no documented evidence that the PT discharge summary was sent to the Physician within 5 days of discharge. Additionally, there was no summary of care provided by SN, and no documented evidence that the Physician was made aware of the patient's discharge or that a SN discharge summary had been sent to the Physician within 5 days of discharge. These findings were reviewed with and acknowledged by the Clinical Manager (CM #1) during an interview on 9/30/21 at 4:39 p.m. MR #4: The plan of care dated 1-29-21 stated the patient was admitted for Physical therapy and home health aide services with diagnoses that included Polyosteoarthritis, chronic pain, heart failure, muscle weakness, hypertension and diabetes. The Physical Therapist documented a "Physical Therapy Discharge Summary" form dated 3-26-21. The Physical Therapist documented on the discharge summary that the patient's goals were "partially met.", however, there was no documentation of the specific goals that were met and those that were not met or the reason the goals could not be fully met. The summary did not include a summary of the home health aide services that were also provided to this patient. There was no evidence a copy of the discharge summary was sent to the physician. "

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation and interview, the Agency failed to ensure that patient records were safeguarded against loss, theft or misuse resulting in the potential for theft and unauthorized use of protected health information for all current and past patients serviced by this agency. findings include: On 9/29/21 at 9:50 a.m., upon arrival to agency and during an initial tour with the Intake Coordinator, it was noted that active patient records were stored on an open shelf with visible patient names. A box of files were observed on the floor and additional boxes of files dated 2016 were observed in the main reception area on top of cabinets. On 9/29/21 at 12:07 p.m., during an interview, the Administrator (Adm #1) was queried about persons with access to the agency suite and reported, "A company comes in to clean our office. They are supposed to come in and clean daily." The Agency failed to ensure patient records were safeguarded against unauthorized use. These findings were further reviewed with the Clinical Manager (CM #1) during a telephone interview on 9/29/21 at 2:43 p.m.