Every finding on record at Reflex 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 4/6/21 through 4/9/21 at: Reflex Home Care 7071 Orchard Lake Rd., Suite 110 West Bloomfield, MI 48322 At the time of the survey, Reflex Home Care, 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 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] 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: *[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: This condition of Participation has NOT been met. Based on record review and interview, the Agency failed to develop an emergency preparedness plan that must be reviewed and updated at least every 2 years, 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 11 directly employed staff, 35 regularly utilized contracted staff and all 39 patients actively serviced by this Agency in the event of a facility emergency or disaster (E0004); failed to include in its emergency plan, the procedures needed to follow-up with staff and patients to determine services that are needed in the event services are interrupted due to an emergency, and to inform state and local authorities of any on-duty staff or patients that the Agency is unable to contact, resulting in the potential for interruption in needed care and services (E0021); failed to develop an Emergency Preparedness policy/Plan, that included the use of volunteers, as appropriate, and/or other emergency staffing strategies to address surge needs during the COVID-19 crisis, resulting in the potential for the interruption in needed care and services for staff and all 39 patients currently serviced by this agency (E0024); 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 39 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency (E0030); failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency's emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster. This deficient practice could affect all 39 patients currently serviced by this Agency (E0036); failed to ensure all contracted staff received initial and annual training in the Agency's emergency preparedness program, including training on the Covid-19 pandemic, resulting in staff being ill-prepared in the event of an actual disaster or emergency. This deficient practice has the potential to negatively affect the 11 direct hire staff, 35 contracted staff employed by this agency, and all 39 patients currently serviced by this Agency (E0037); and failed to provide documentation for the required community 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 unprepared in the event of an actual emergency. This deficient practice could negatively affect all 39 patients actively 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) 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 and updated at least every 2 years, 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 all11 directly employed staff, 35 regularly utilized contracted staff and all 39 patients actively serviced by this Agency in the event of a facility emergency or disaster. Findings include: On 4/8/21 at 2:15 p.m., the agency's Emergency Preparedness documentation was reviewed. During the review, it was noted that the agency had no completed plan accessible and available for review. 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 Administrator during the time of discovery.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years.] At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to include in its emergency plan, the procedures needed to follow-up with staff and patients to determine services that are needed in the event services are interrupted due to an emergency, and to inform state and local authorities of any on-duty staff or patients that the Agency is unable to contact, resulting in the potential for interruption in needed care and services. Findings included: During a review of the agency's Emergency Preparedness documents on 4/8/21 at 2:15 p.m., it was noted that the documents failed to include language or procedures that clearly outlined what surrounding facilities the Agency would transfer arrangements and responsibilities to, to ensure the continuity of patient care, no contact numbers, timelines or indicated conditions that would warrant patients to be transferred, and failed to include procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. These findings were reviewed with the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/8/21 at 3:45 p.m.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years (annually for LTC).] At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop an Emergency Preparedness policy/Plan, that included the use of volunteers, as appropriate, and/or other emergency staffing strategies to address surge needs during the COVID-19 crisis, resulting in the potential for the interruption in needed care and services for staff and all 39 patients currently serviced by this agency. Findings included: A review the agency's Emergency Preparedness Plan was conducted on 4/8/21 at 2:15 p.m. During the review, it was noted that there was no specific language that included a process for the integration or use of volunteers, as appropriate, or other staffing strategies with local, regional, State, and Federal officials to address surge needs during an emergency and the COVID-19 crisis. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/8/21 at 3:45 p.m.

Names and Contact Information CFR(s): 484.102(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).] 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 39 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 4/8/21 and 4/9/21, 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 confirmed by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/9/21 at 10:30 a.m. During the interview, both Adm #1 and CM #1 reported that staff's phone numbers were located in their personal cell phones and saved in the computer. Adm #1 and CM #1 further acknowledged that staff's phone numbers would be inaccessible in the event of an emergency. When queried about Patient's, Physicians or volunteer contact information, Adm #1 and CM #1 were unable to provide this information.

EP Training and Testing CFR(s): 484.102(d) *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency's emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster. This deficient practice could affect all 39 patients currently serviced by this Agency. Findings include: During review of the agency's Emergency Preparedness documents and policies on 4/8/21, it was noted that the Agency did not have a formal Emergency Preparedness Plan, with all the required elements, in place and readily accessible. Further, there was no documented evidence that the Agency had developed a training and testing program for staff that was based on the agency's emergency plan. The above findings were reviewed with and confirmed by the Clinical Manager (CM #1) during an interview on 4/8/21 at 3:45 p.m. who reported, "I know we have a lot of stuff to do. We've been working on it."

EP Training Program CFR(s): 484.102(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 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 contracted staff received initial and annual training in the Agency's emergency preparedness program, including training on the Covid-19 pandemic, resulting in staff being ill-prepared in the event of an actual disaster or emergency. This deficient practice has the potential to negatively affect the 11 direct hire staff, 35 contracted staff employed by this agency, and all 39 patients currently serviced by this Agency. Findings include: On 4/8/21 at 2:15 p.m., the agency's Emergency Preparedness documentation was requested and reviewed. A request was made to review the staff's initial training in emergency preparedness that included the topic of Covid-19, as well as follow up training (every 2 years). With the Clinical Manager (CM #1) present, it was acknowledged that none of the agency's 35 regularly staffed contracted employees had received initial or ongoing training in Emergency Preparedness. Further, none of the contracted staff had received training in Covid-19. These findings were reviewed with and acknowledged by CM #1 at the time of discovery. CM #1 then stated, "We don't provide Emergency Preparedness training to any of our contracted staff. They get their training from the contract agency." When asked if the contracted entity trained the contract employees on Reflex Home Care's emergency protocol, CM #1 offered no response.

EP Testing Requirements CFR(s): 484.102(d)(2) *[For RNCHI at §403.748, ASCs at §416.54, HHAs at §484.102, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHC at §485.920, RHC/FQHC at §491.12, 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 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 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. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to provide documentation for the required community 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 unprepared in the event of an actual emergency. This deficient practice could negatively affect all 39 patients actively serviced by this Agency. Findings include: During review of the agency's Emergency/Disaster Preparedness documents on 4/8/21 at 2:15 p.m., it was noted that there was no evidence the agency had conducted a community based full-scale exercise. Further, there was no documentation of an actual event that would qualify as an emergency, as per this requirement. On 4/8/21 at 3:45 p.m., during an interview, the above findings were reviewed with the Administrator (Adm #1) and the Clinical Manager (CM #1). During the interview, CM #1 reported, "We had some drills." CM #1 then produced documents that appeared to be answer sheets. The documents were untitled. It could not be determined what topic was taught. CM #1 then stated, "I wrote what it was about on the back of a sheet of paper." On the back side of a sheet of paper were three notations, "Tornado, ??." There was no documented evidence that the agency conducted the required community based drill or experienced any event that would satisfy this regulatory requirement.

The following standard and condition level deficiencies were identified during an authorized Medicare recertification survey concurrent with a Focused Infection Control Covid-19 survey conducted on 4/6/2021 through 4/9/2021 by the Michigan Department of Licensing and Regulatory Affairs at: Reflex Home Care 7071 Orchard Lake Rd, Suite 110 West Bloomfield, MI 48322 At the time of the survey, the agency did not operate any branch locations. The services the agency provides are: Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Home Health Aide (HHa) and Speech Therapy (ST). Clinical records reviewed for this survey included: 3 records with home visits and 4 records without home visits, for a total of 7 records reviewed. Condition level deficiencies were identified at: 42 CFR §484.55 Comprehensive Assessment of Patients 42 CFR §484.60 Care Planning, Coordination, Quality of Care 42 CFR §484.65 Quality Assessment/Performance Improvement 42 CFR §484.110 Clinical Records 42 CFR §484.80 Home Health Aide 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 ensure patients were informed of the Administrator's name and business contact information, resulting in the potential for patient complaints or concerns to go unaddressed which could affect the quality of care for the agency's 39 current patients. Findings include: The agency provides their patients with a folder that contains many papers and forms including a consent for care, COVID-19 information, patient privacy rights, emergency plan, and a medication profile. On 4/6/21, the contents of the agency's admission folder were reviewed. There was no documentation of the administrator's name and contact information to enable patients to express their concerns or complaints. The finding was reviewed with and acknowledged by the Administrator during an interview on 4/8/21 at 9:20 am.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the patient received proper written notice (Notice of Medicare Provider Non-Coverage) in advance of the agency terminating on-going care for 2 (MR# 3, and 5) of 2 discharged records, resulting in the patient being denied the right to appeal the decision to end Medicare covered services. Findings include: MR #5: The patient's start of care was 1/25/21 with diagnoses that included Diabetes Mellitus, Hypertension, spondylosis, and blindness right eye. The record review conducted on 4/8/21 revealed the following: The plan of care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), and Home Health Aide (HHa) services to be provided. The patient discharged from the agency's services on 3/24/21. There was no documented evidence that the patient was provided the "Notice of Medicare Provider Non-Coverage" prior to being discharged from the agency. The Agency failed to ensure the patient received proper written Notice of Medicare Provider Non-Coverage in advance of the agency terminating on-going care. These findings were reviewed with and acknowledged by the Administrator (Adm #) and Clinical Manager (CM #1) during the exit interview on 4/9/21. MR#3: The Start of Care (SOC) was dated 1/25/21. The Plan of Care (POC) identified diagnoses of Low Back Surgery, Chronic Kidney Disease, and Diabetes Type 2. During record review on 4/8/21, it was noted the "Notice of Medicare Non-Coverage" was signed on 1/25/21, the date of the SOC. The form was also blank under the section "The effective Date Coverage of Your Current Home Health Care Services Will End." There was no documentation to indicate the patient was informed within 2 days of discharge. The CM#1 was questioned on 4/9/21 at 11:45 am and confirmed the findings stating, "The staff should not be completing that at the start of care. That should be done near the discharge date of the patient, but at least 2 days in advance of the discharge."

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: This Condition of Participation has NOT been met. Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status and the events that let to the need for home care for 7 (MR# 1, 2, 3, 4, 5, 6, 7) of 7 records reviewed, resulting in incomplete clinical information to aide in determining the needs of the patients and for measuring the patient's progress toward goals/outcomes (G528); and failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required and failed to ensure the physician was notified of major and potential drug interactions in 4 of 7 sampled records reviewed (MR's #1, 4, 6 and 7), resulting in the potential for harmful medication effects for all patients serviced by this Agency (G536). The cumulative effect of these systemic problems could potentially have a negative effect on the agency's ability to provide quality care as a Condition of Participation, in the area of: Comprehensive Assessment of Patients 42 CFR §484.55.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status and the events that led to the need for home care for 7 (MR# 1, 2, 3, 4, 5, 6, 7) of 7 records reviewed, resulting in incomplete clinical information to aide in determining the needs of the patients and for measuring the patient's progress toward goals/outcomes. Findings include: Policy: "Initial Assessments/Comprehensive Assessments", 1/2020 stated, "The assessment will reflect the patient's current health status and include information to demonstrate the patient's progress toward achievement of desired outcomes..., The comprehensive assessment will identify the patient's need for home care..." MR #5: The patient's start of care (SOC) was 1/25/21 with diagnoses that included diabetes mellitus, hypertension, spondylosis, and blindness right eye. The clinical record review was conducted on 4/8/21. The Initial Comprehensive Assessment dated 1/25/21 completed by the Registered Nurse (RN) revealed the following: Section 1021 "Primary Diagnosis" listed a primary diagnosis of spondylosis, lumbosacral region. Section 1023 "Other diagnoses" listed diabetes, hypertension, blindness, foot drop, and COPD (chronic obstructive pulmonary disease). All the listed diagnoses had no dates of onset or exacerbation (O/E). There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. Further, there was no documentation of the events that led to the need for home care. MR #6: The patient's SOC was 3/10/21 with diagnoses that included Osteoarthritis and COPD. The clinical record review was conducted on 4/8/21 at 9:27 a.m. The Initial Comprehensive Assessment dated 3/10/21 completed by the RN revealed the following: Section 1021, Primary diagnosis, listed a primary diagnosis of generalized osteoarthritis. Section 1023 listed diagnoses of bipolar disorder, muscle weakness, COPD, and hypertension. All the listed diagnoses had no dates of O/E. There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. Further, there was no documentation of the events that led to the need for home care. MR #7: The patient's SOC was 4/2/21 with diagnoses that included COPD and hypertension. During the clinical record review on 4/7/21 at 2:59 p.m., the following was noted: The Initial Comprehensive Assessment dated 4/2/21 completed by the RN revealed the following: Section 1021 Primary diagnosis listed a primary diagnosis of COPD. Section 1023 listed other diagnoses of hypertension, tremor, anemia, spinal stenosis, and nicotine dependence. All the listed diagnoses had no dates of O/E. There was no history of the status of the above diagnoses or diseases including treatments for past medical history problems and outcomes from the treatments. Further, there was no documentation of the events that led to the need for home care. On 4/7/21 at 11:30 a.m., during a home visit with the Licensed Practical Nurse (LPN #1), it was noted that the patient had wound dressings to his bilateral forearms and present with a raised blackened area on his tongue. The patient's wife reported that the patient came from the hospital with wounds to his arms as he pulled intravenous (IV) access from his arms and scratched his arms, creating the wounds. LPN #1 reported, "I first saw the patient on 4/6/21. He (patient) had dressing on his arms. I removed them and applied a new dressing. I also noticed the black areas on his tongue." The initial comprehensive assessment, completed by the RN failed to address the patient's skin condition or the condition of his oral cavity. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/8/21 at 12:23 p.m. MR#1: The Start of Care (SOC) was dated 3/10/21. The Plan of Care (POC) identified diagnoses of Diabetic Foot Ulcer, Diabetes Type 2, and Chronic Obstructive Pulmonary Disease (COPD). During record review on 4/6/21, it was noted that the SOC comprehensive assessment dated 3/10/21, documented under "Primary Diagnosis and Other Diagnoses", all 9 diagnoses were blank under onset/exacerbation and date of the onset/exacerbation. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#2: The Start of Care (SOC) was dated 3/1/21. The Plan of Care (POC) identified diagnoses of Bilateral Knee Osteoarthritis, Hypertension, and Diabetes Type 2. During record review on 4/7/21, it was noted that the SOC comprehensive assessment dated 3/1/21, documented under "Primary Diagnosis and Other Diagnoses", all 9 diagnoses were blank under onset/exacerbation and date of the onset/exacerbation. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#3: The Start of Care (SOC) was dated 1/25/21. The Plan of Care (POC) identified diagnoses of Low Back Surgery, Chronic Kidney Disease, and Diabetes Type 2. During record review on 4/8/21, it was noted that the SOC comprehensive assessment dated 1/25/21, documented under "Primary Diagnosis and Other Diagnoses", all 10 diagnoses were blank under onset/exacerbation and date of the onset/exacerbation. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#4: The Start of Care (SOC) was dated 2/18/21. The Plan of Care (POC) identified diagnoses of Cerebral Infarction and Diabetes Type 2. During record review on 4/8/21, it was noted that the SOC comprehensive assessment dated 2/18/21, documented under "Primary Diagnosis and Other Diagnoses", all 9 diagnoses were blank under onset/exacerbation and date of the onset/exacerbation. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. The CM#1 was questioned on 4/9/21 at 11:35 am and confirmed the findings stating, "The comprehensive assessment was not completed accurately."

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 Agency (HHA) failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required and failed to ensure the physician was notified of potential drug interactions in 4 of 7 sampled records reviewed (MR's #1, 4, 6 and 7), resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: **Agency policy: III.17, Medication Profile (Revised March 2018) stated, "The comprehensive assessment (OASIS) performed at the time of admission includes a review of all medications that 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, duplicative drug therapy and noncompliance with drug therapy." MR#1: The Start of Care (SOC) was dated 3/10/21. The Plan of Care (POC) identified diagnoses of Diabetic Foot Ulcer, Diabetes Type 2, and Chronic Obstructive Pulmonary Disease (COPD). During record review on 4/6/21, the POC contained a Skilled Nursing (SN) order "SN to perform wound care to left foot. Cleanse wound with normal saline, apply Santyl, apply 4x4, cover and secure with kerlix using aseptic technique every visit." The Medication profile did not list Santyl as one of the patients 13 medications. The agency failed to have a complete medication profile. MR#4: The Start of Care (SOC) was dated 2/18/21. The Plan of Care (POC) identified diagnoses of Cerebral Infarction and Diabetes Type 2. During record review on 4/8/21, it was noted that the "Drug-Drug Interaction" report was completed and filed into the patient's paper chart on 4/8/21, 49 days after the SOC. The report noted one major Drug-Drug interaction between Lisinopril and Losartan. Additionally, during the entrance interview on 4/6/21 at 10:45 am, CM#1 stated, "All major medication interactions are faxed or emailed to the primary physician and a database is kept of date of type of notification sent. The agency failed to provide the database listing how and if the physician was made aware of the major medication interaction. The CM#1 was questioned on 4/9/21 at 11:45 am and confirmed the findings stating, "Santyl should be listed on the medication profile. The database needs to list and detail that the physician is made aware of major medication interactions." MR #6: The patient's start of care (SOC) was 3/10/21 with diagnoses that included osteoarthritis and COPD (chronic obstructive pulmonary disease), Bipolar disorder and hypertension. The plan of care (POC) was reviewed in part, on 4/7/21 at 10:00 a.m., during a scheduled home visit with the Physical Therapist (PT #1). During the review, it was noted that the patient had 5 prescribed medications listed on the plan of care which included: Lisinopril (for blood pressure), Tylenol (pain and fever), Albuterol (breathing treatment), Multivitamin (supplement) and Omeprazole (for acid reflux). During the visit, the patient reported that her Norco (narcotic pain reliever) had been changed to a lower strength. There was no Norco listed on the patient's plan of care. The patient was then queried as to what medications she was currently taking and replied, "Let's see, I'm taking Coreg for my blood pressure, I take Claritin-D for my allergies, Norco, Vitamin-D, Topamax (migraines and seizures), Symbicort for my breathing, and I take medications for my Bipolar." A request was made to see the patient's medications, however, she stated, "I'd have to go get them later because my knee is really sore right now." None of the patient's reported medications were listed on the patient's plan of care." On 4/8/21 at 9:27 a.m., during a review of the clinical record, the Medication Profile revealed section M2001 of the Initial Comprehensive Assessment/Oasis dated 3/10/21 indicated "No issues found during review." It was further noted that the POC did not include any of the medications the patient reported to be taking. The agency failed to ensure a comprehensive drug review was conducted that include a review of all the patient's medications. The 5 medications listed on the patient's POC in addition to the 7 medications, as reported by the patient, were entered into "Drugs.com" (online drug interaction checker) and revealed: 2 major drug to drug interactions, 1 major drug to food interaction and 2 duplicate drugs. These findings were reviewed with and acknowledged by the Clinical Manager (CM #1) during an interview on 4/8/21 at 12:40 p.m. MR #7: The patient's SOC was 4/2/21 with diagnoses that included COPD and hypertension, spinal stenosis, and anemia. On 4/7/21 at 11:30 a.m., during a joint home visit with the Licensed Practical Nurse (LPN #1), the patient's admission packet was reviewed. The medications listed on the patient's hospital discharge "After Visit Summary", dated 4/1/21, was compared to the 17 medications listed on the plan of care (POC) during the home visit and revealed the presence of 13 additional drugs that had not been added onto the POC. Additionally the Medication profile in the patient's home only documented 9 medications. The 13 additional medications listed in the hospital discharge note were identified as: Protonix (heartburn, difficulty swallowing), Miralax (laxative), Catapres (high blood pressure), folic acid (vitamin), Ketotifen (eye drops for allergies), Loteprednol (eye drops used for infection and swelling), Tylenol (fever and pain), Meclizine (nausea, vomiting, dizziness), Meloxicam (arthritis pain and swelling), Methazolamide (increased pressure in the eye), Mirtazapine (antidepressant), Vitamin D, Tobramycin (eye infections). There was no documented evidence that any of the above listed medications had been discontinued. On 4/7/21 at 2:59 p.m., during the clinical record review, the following was noted: The patient was admitted to the hospital on 3/24/21 and discharged on 4/1/21 to the agency's services. The same After Visit Note was observed in the patient's clinical record and listed a combined total of 30 medications. The "Medication Profile" in the patient's electronic medical record listed the same 17 medications as identified on the POC. A "Drug-Drug Interactions" report dated 4/7/21 documented 2 major drug to drug interactions and 20 moderate drug to drug interactions. The agency failed to include the patient's 13 additional prescribed medications in the review. Additionally, the agency failed to notify the physician of any untoward interactions by midnight of the next day (4/3/21) as per Oasis/Comprehensive Assessment guidelines. These findings were reviewed with and confirmed by the Clinical Manager (CM #1) during an interview on 4/8/21 at 12:23 p.m.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to provide care and services in accordance with the plan of care in 5 (MR's # 2, 3, 4, 5 and 7) of 6 records reviewed for provision of services, from a total of 7 records reviewed, resulting in the potential for decline in physical functioning and unmet care needs (G572); failed to ensure the plan of care was individualized to the patient's identified needs for 2 of 7 records reviewed (MR#'s 1 and 3), resulting in an inaccurate plan of care and the potential for poor patient outcomes (G574); failed to ensure that all drugs, care, and services were provided only in accordance with Physician's orders for 1 (MR #6) of 3 records in which a home visit was conducted, from a total of 7 records reviewed, resulting in the potential for the provision of unsafe, unauthorized care and unmet care needs (G580); failed to ensure the Physician was promptly notified of elevated blood pressure readings, and elevated pain levels outside of the reportable parameters, for 1 (MR #6) of 3 patients observed during a Physical Therapy home visit, resulting in the potential for unidentified, untreated health concerns and unmet care needs (G590); and failed to inform their patients of the contact information of the clinical manager's name, address and business telephone number and the purpose for contact to discuss services (G622). The cumulative effect of these systemic problems resulted in the home health agency's Immediate Jeopardy and inability to ensure the provision of quality health care for the condition of participation of 42 CFR 484.60: Care Planning, Coordination of Services, and Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to provide care and services in accordance with the plan of care in 5 (MR's # 2, 3, 4, 5 and 7) of 6 records reviewed for provision of services, from a total of 7 records reviewed, resulting in the potential for decline in physical functioning and unmet care needs. Findings include: Policy: "Plan of Care - CMS #485 and Physician Orders" 3/2019 stated, "Each patient must receive the home health services that are written in an individualized plan of care..., If a physician refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician is consulted to approve additions or modifications to the original plan." MR #5: The patient's start of care (SOC) was 1/25/21 with diagnoses that included diabetes mellitus, hypertension, spondylosis and blindness right eye. The plan of care (POC) ordered Skilled Nursing (SN) 2w1, 1w3; Physical Therapy (PT) 1w1, 2w6; Occupational Therapy (OT) 1w1, 2w6; and Home Health Aide (HHa) services to be provided at a frequency of 2w6. During the clinical record review on 4/8/21 it was noted that HHa services were not initiated until 2/11/21 which was 17 days after the SOC date. There was no documented rationale for the delay in services. It was also noted that the HHa missed visits on 2/11/21, 2/23/21 and 2/25/21. There was no documented rationale for the missed visits, nor were there any documented attempts made to honor the ordered visit frequency. Further review revealed that PT had missed visits on 2/18/21, 2/23/21 and 3/2/21. There was no documented rationale for the missed visits, no documentation of patient refusal of services and no documented attempts made to honor the ordered visit frequency. The Agency failed to provide care and services in accordance with the plan of care. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/8/21 at 11:57 a.m. MR #7: The patient's SOC was 4/2/211 with diagnoses that included COPD (chronic obstructive pulmonary disease), and hypertension. The POC ordered SN to "perform medication review each skilled nursing visit and reconcile medications as indicated." On 4/7/21 at 11:30 a.m., during a scheduled SN home visit with the Licensed Practical Nurse (LPN #1), LPN conducted an assessment of the patient and provided teaching on nutrition. LPN #1 failed to review the patient's medications and reconcile them as indicated in the POC. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/8/21 at 11:57 a.m. MR#2: The Start of Care (SOC) was dated 3/1/21. The Plan of Care (POC) identified diagnoses of Bilateral Knee Osteoarthritis, Hypertension, and Diabetes Type 2. The Registered Nurse (RN) completed a discipline discharge summary on 3/24/21. On 4/7/21, a joint surveyor/clinician home visit was completed, 14 days after the discharge was completed. A screenshot of the patient's orders was taken on 4/7/21 at 1:35 pm and did not contain an order for the RN to complete the 4/7/21 visit. It was noted on 4/8/21 that an order was backdated to 3/24/21 that stated, "Extend nursing visits" and dated 4/7/21. During record review on 4/7/21, it was noted that Occupational Therapy (OT) evaluated the patient on 3/4/21, 3 days after the SOC. Additionally, it was noted that Physical Therapy (PT) evaluated the patient on 3/8/21, 7 days after the SOC. There was no documentation of the patient requesting a delay in services. During the entrance interview on 4/6/21 at 10:50 am, CM#1 stated, "All additional therapy's complete their evaluations within 48 hours." The agency failed to complete the additional evaluations within 48 hours. MR#3: The Start of Care (SOC) was dated 1/25/21. The Plan of Care (POC) identified diagnoses of Low Back Surgery, Chronic Kidney Disease, and Diabetes Type 2. During record review on 4/8/21, it was noted that PT evaluated the patient on 2/13/21, 15 days after the SOC. There was no documentation of the patient requesting a delay in services. Additionally, on 2/9/21, 2/11/21, 2/16/21, and 2/18/21 the Certified Occupational Therapy Assistant (COTA) documented "Missed Visit." Furthermore, the RN documented a "Missed Visit" on 2/24/21. The agency failed to evaluate the patient within 48 hours and failed to attempt to reschedule the missed visits to meet the ordered POC. MR#4: The Start of Care (SOC) was dated 2/18/21. The Plan of Care (POC) identified diagnoses of Cerebral Infarction and Diabetes Type 2. During record review on 4/8/21, it was noted the Licensed Practical Nurse (LPN) documented "Missed Visit" on 2/23/21 and 2/25/21. Additionally, PT documented "Missed Visit" on 3/8/21 and 3/10/21. Furthermore, the RN documented "Missed Visit" on 3/10/21. The agency failed to attempt to reschedule the missed visits to meet the ordered POC. The CM#1 was questioned on 4/9/21 at 11:50 am and confirmed the findings stating, "The nurse should not have completed the visit without an order. The therapies should have evaluated the patient within 48 hours. The staff should be attempting to reschedule the missed visits to meet the ordered frequencies."

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 was individualized to the patient's identified needs for 2 of 7 records reviewed (MR#'s 1 and 3), resulting in an inaccurate plan of care and the potential for poor patient outcomes. Findings included: **Agency Policy: "Plan of Care- CMS #485 and Physician Orders," (Revised March 2019). The policy states, "4. The individualized plan of care must include the following: Safety measures to protect against injury." MR#1: The Start of Care (SOC) was dated 3/10/21. The Plan of Care (POC) identified diagnoses of Diabetic Foot Ulcer, Diabetes Type 2, and Chronic Obstructive Pulmonary Disease (COPD). The POC dated 3/10/21 stated, "Allergies: NKA (no known allergies)." The referral dated 3/5/21 documented the following allergies: Morphine, iodinated contrast media, and shellfish containing products. The agency failed to document and accurately assess the patient's allergies. MR#3: The Start of Care (SOC) was dated 1/25/21. The Plan of Care (POC) identified diagnoses of Low Back Surgery, Chronic Kidney Disease, and Diabetes Type 2. The POC dated 1/25/21 stated, "Allergies: NKA (no known allergies)." The referral dated 1/25/21 documented the following allergies: Benadryl (Anaphylaxis), Trulicity (Respiratory Difficulties), Allopurinol (Hives), Augmentin (N/V), Colchicine (Diarrhea), Flu Vaccine (Vomiting and diarrhea). The agency failed to document and accurately assess the patient's allergies. The CM#1 was questioned on 4/9/21 at 11:35 am and confirmed the findings stating, "It is expected that the patient's allergies are documented on the plan of care."

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure that all drugs, care, and services were provided only in accordance with Physician's orders for 1 (MR #6) of 3 records in which a home visit was conducted, from a total of 7 records reviewed, resulting in the potential for the provision of unsafe, unauthorized care and unmet care needs. Findings include: Policy: "Physician Orders - Verbal Orders", 3/2018 stated, "Drugs and treatments are administered by the Agency staff only as ordered by the physician..., Orders are obtained prior to the provision of any care, including changes in the plan of care." MR #6: The patient's start of care was 3/10/21 with diagnoses that included Osteoarthritis and COPD (chronic obstructive pulmonary disease). During the clinical record review conducted on 4/8/21 at 9:27 a.m., it was noted that the plan of care POC ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The PT evaluation dated 3/14/21 documented, "biofreeze [sic] (Brand name pain relieving gel) STM (Soft Tissue Mobilization ) for LB (Lower back), LE's (Lower Extremities) x 10 mins." On 4/7/21 at 10:00 a.m., during a schedule home visit with PT #1, it was observed that PT #1 retrieved an unidentified tube of medication from his work back. PT #1 rubbed the cream on the patient's lower back and left knee and then returned the medication to his work bag. PT #1 was asked if the cream used was Biofreeze gel, as approved by the Physician, and replied, "No. This is different and doesn't contain Menthol." When requested to see the tube of medication, PT #1 was hesitant and stated, "You can just look at her medication profile." PT #1 was then informed that the writer was referencing the actual tube of medication used on the patient." PT #1 then retrieved the tube of medication from his bag to be reviewed. Upon review, the tube of medication was named, "equate (brand name) Arthricream Rub, Compare to Aspercream (brand name) . Active ingredient Trolamine Salicylate (Aspirin)10%." This medication was significantly different from the prescribed Biofreeze (Brand Name menthol based medicated topical ointment) . PT #1 was unable to justify the use of the non-prescribed medication. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/8/21 at 12:40 p.m.

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 observation, interview, and record review, it was determined that the agency failed to ensure the Physician was promptly notified of elevated blood pressure readings, and elevated pain levels outside of the reportable parameters, for 1 (MR #6) of 3 patients observed during a Physical Therapy home visit, resulting in the potential for unidentified, untreated health concerns and unmet care needs. Findings include: Policy: "Plan of Care - CMS #485 and Physician Orders" 3/2019 stated, "In the event of a change in patient condition or needs that suggest outcomes are not being achieved and/or the patient's plan of care should be altered, the Agency will notify both the responsible physician and the physician(s) associated with the relevant aspect of care." MR #6: The patient's start of care (SOC) was 3/10/21 with diagnoses that included osteoarthritis and COPD (chronic obstructive pulmonary disease). The plan of care (POC) ordered Skilled Nursing (SN) for SOC only, and Physical Therapy (PT) services to be provided at a frequency of 1w1, 2w5, 1w1. The POC ordered PT to "Notify Physician of vital sign parameters out of range: Pain level greater than 8; Systolic BP greater than 160, less than 0; Diastolic BP greater than 90, less than 60." On 4/7/21 at 10:00 a.m., during a scheduled home visit with the Physical Therapist (PT #1), the following was observed: PT #1 assessed the patient's blood pressure, prior to providing care, which reflected a reading of 155/89 and a reported pain level of 9/10 throbbing pain left knee. PT #1 then proceeded with the provision of PT exercises. At 10:24 a.m. PT checked the patient's BP which revealed a reading of 162/91 left arm (above reportable parameters). At 10:30 a.m., the patient's BP was 153/92 (diastolic reading outside/above reportable parameters). Upon completion of exercising, the patient reported a pain level of 10/10 to left knee (outside/above the reportable parameters. On 4/9/21 at 9:49 a.m., a PT visit note dated 4/7/21 was reviewed. There was no documented evidence that the Physician had been notified of the patient's elevated BP readings and elevated pain levels. Additionally, there was no documentation in the communication notes that indicated the Physician had been promptly notified of the patient's elevated blood pressures and elevated pain levels outside of the reportable parameters as ordered in the POC. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) on 4/9/21 at 12:00 p.m. No response was offered.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to include contact information for the Home Health Agency's Clinical Manager in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed patient concerns. Findings include: On 4/7/21 at 11:45 a.m., during a scheduled home visit, the Agency's Admission packet was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and patient rights and responsibilities forms and Emergency Preparedness documents. Upon review, it was noted that there was no contact information for the Agency's Clinical Manager. These findings were reviewed with and confirmed by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/9/21 at 12:30 p.m.

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 policy review and interview, it was determined the home health agency failed to develop a Quality Assessment and Performance Improvement (QAPI) policy and program, (refer to G-642); the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, (refer to G-644); failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program that focused on high risk, high volume or problem prone areas, (refer to G-648); and the agency failed to document the quality improvement projects for 2018, 2019 and 2020 and document the reasons for conducting these projects and the measurable progress achieved each year (Refer to G-0658); and failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section (refer to G-660). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care for all the patients the Home Health Agency serves for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).

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, it was determined the agency failed to develop, implement, and maintain a quality assessment and performance improvement program which had the potential to negatively affect all 109 patients that were admitted during the past 12 months, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: The CM#1 was questioned on 4/8/21 at 9:45 am and confirmed the findings stating, "I do not have anything for QAPI."

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 interview, the agency failed to monitor data for the Quality Performance Improvement (QAPI) program, to ensure the effectiveness and safety of services and quality of care to the patients and to identify opportunities for improvement, and there was no documented evidence the governing body approved the QAPI frequency and data collection process. Findings included: The CM#1 was questioned on 4/8/21 at 9:45 am and confirmed the findings stating, "I do not have anything for QAPI."

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 interview, it was determined the Home Health Agency (HHA) failed to develop a QAPI (Quality Assessment Performance Improvement) program that focused on high risk, high volume or problem-prone areas of the agency, to monitor the agency's improvement in these areas resulting in the agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: The CM#1 was questioned on 4/8/21 at 9:45 am and confirmed the findings stating, "I do not have anything for QAPI."

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 interview, it was determined the Agency failed to develop a Quality Assessment Performance Improvement program that documented the quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2017, 2018 and 2019 calendar years, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: The CM#1 was questioned on 4/8/21 at 9:45 am and confirmed the findings stating, "I do not have anything for QAPI."

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 interview, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all 39 patients currently receiving services and all 109 patients admitted over the past year. Findings include: The CM#1 was questioned on 4/8/21 at 9:45 am and confirmed the findings stating, "I do not have anything for QAPI."

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview, the agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control of infectious and communicable diseases including Covid-19, and failed to develop a method of screening all field staff employed by this agency, and those granted clinical privileges, resulting in the potential development and spread of the Covid-19 infection between staff and the agency's 39 current patients. Findings include: On 4/8/21 at 2:20 p.m., the Administrator (Adm #1), Assistant Administrator (Adm #2) and the Office Manager (OM #1) were queried about the process for the screening of field staff prior to the provision of care. OM #1 stated that field staff screen themselves. When asked if there was documented evidence of staff screening themselves, OM #1 responded, "No." Adm #1 then inquired, "Should we be doing that? (referencing maintaining documentation)." There was no protocol in place for screening of field staff prior to the provision of care and services. The Clinical Manager (CM #1) then stated, "The field staff have their own thermometers." CM #1 was again asked if there was documented evidence of staff self screening and responded, "No." Adm #1 acknowledged there was no screening process in place for office or field staff at the time of discovery.

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, the agency failed to adequately assess and monitor the needs of 1 (MR #6) of 1 patient observed during a Physical Therapy home visit, from a total sample of 7 sampled records reviewed, resulting in the potential for poor patient outcomes and unmet care needs. Findings include: Policy: "Skilled Professional Services", 3/2018 stated, "Patients receiving skilled professional services will receive appropriate assessments, reassessments, care planning, established outcomes and care..." MR #6: The patient's start of care (SOC) was 3/10/21 with diagnoses that included osteoarthritis and COPD (chronic obstructive pulmonary disease). The plan of care (POC) ordered Skilled Nursing (SN) for SOC only, and Physical Therapy (PT) services to be provided at a frequency of 1w1, 2w5, 1w1. The POC ordered PT to "Notify Physician of vital sign parameters out of range: Pain level greater than 8; Systolic BP greater than 160, less than 0; Diastolic BP greater than 90, less than 60." On 4/7/21 at 10:00 a.m., during a scheduled home visit with the Physical Therapist (PT #1), the following was observed: PT #1 assessed the patient's blood pressure, prior to providing care, which reflected a reading of 155/89 and a reported pain level of 9/10 throbbing pain left knee. PT #1 then proceeded with the provision of PT exercises, focusing on the patient's lower extremities and ambulation. At 10:24 a.m. PT checked the patient's BP which revealed a reading of 162/91 left arm (above/outside the reportable parameters). At 10:30 a.m., the patient's BP was 153/92 (diastolic reading outside/above reportable parameters). During the visit, the patient was observed grimacing due to reported pain to her left knee and lower back. PT # then stated, "I'm not going to continue on with the remaining exercises because they (exercises) work portions of the upper body and they will cause your (patient) blood pressure to go up even higher." PT #1 was then observed retrieving a rope/pulley type piece of equipment with handles on it from his work bag. PT #1 then instructed the patient to grab the handles and begin pulling. The patient performed this exercise repeatedly. The patient was then instructed to stand and perform in excess of 15 squats, and back exercises which required the patient to stand and lean back as far as she could to stretch the lower back. Upon completion of the visit, the patient reported a pain level of 10/10. Upon exiting the patient's home, PT #1 was queried about his decision to continue with therapy exercises after noting that the patient's blood pressure was elevated and reported, "Well, I know it was elevated, but to me, I didn't think it was that high." PT #1 was then queried about the patient's reports of elevated pain at 9/10 before therapy and 10/10 after therapy, yet offered no response. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) on 4/9/21 at 12:00 p.m. No response was offered.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: This Condition of Participation has NOT been met. Based on record review and interview, the Agency failed to ensure the individuals who furnished Home Health Aide services on its behalf met the competency evaluation requirements of this section by ensuring the required skills were evaluated by a Registered Nurse, who observed the Aide's performance of the required tasks with a patient for 2 (HHa #2 and HHa #3) of 3 Home Health Aide files reviewed, resulting in the potential for the provision of substandard care and unmet care needs (G768); failed to ensure that 2 (HHa #1 and HHa #2) of 3 Home Health Aide files reviewed, received the required 12 hours of annual in-service training, resulting in the potential for the rendering of substandard care and unmet care needs (G774); failed to maintain documentation of the required 12 hours of annual Home Health Aide in-services for 2 (HHa's #1 and 2) of 3 Home Health aide files reviewed, resulting in lack of evidence of ongoing education and training and the potential for the provision of unsafe care for all patients receiving Home Health Aide services (G778); failed to ensure Skilled Nursing prepared clear written patient care instructions for the home health aide regarding client needs, and safety precautions prior to providing care in 2 of 3 records (MR# 2) in which Home Health Aide services were ordered, resulting in the potential to negatively affect all the patients with home health aide services from this agency (G798); failed to supervise the home health aides' services no less frequently than every 14 days for 2 of 3 records reviewed (MR 2 and 3) with home health aide services, for a potential of unmet and unsafe patient care (G808); and failed to ensure the skilled discipline made an annual onsite observation visit at the patient's residence to observe the care being provided, for 2 (HHa #1 and HHa #2) of 3 Home Health Aide files reviewed, resulting in the potential for the provision of substandard care and unmet care needs (G812). 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 §484.80 Home Health Aide Services.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the individuals who furnished Home Health Aide services on its behalf met the competency evaluation requirements of this section by ensuring the required skills were evaluated by a Registered Nurse, who observed the Aide's performance of the required tasks with a patient for 2 (HHa #2 and HHa #3) of 3 Home Health Aide files reviewed, resulting in the potential for the provision of substandard care and unmet care needs. Findings include: Policy: "Home Health Aide Services and Training Program", 1/2020 stated, "An individual may furnish home health services on behalf of the Agency only after that individual has successfully completed a competency evaluation program..., The Agency must maintain documentation that demonstrates the requirements of this standard has been met." On 4/9/21 at 10:30 a.m., a review of the Home Health Aide (HHa) personnel files revealed the following: HHa #2: Date of Hire (DOH) was 5/6/19. There was no competency evaluation on file available for review that provided evidence that HHa #2 was evaluated in areas that addressed all the required subject areas of 484.80(b)(3)(ix), specifically, bed bath, sponge, tub, and shower bath; Hair shampooing in sink, tub and bed; Nail and skin care; Oral hygiene; Toileting and elimination; (b)(3)(x) Safe transfer techniques and ambulation; and (b)(3)(xi) Normal range of motion and positioning, prior to the provision of care, as per this requirement. HHa #3: DOH was 12/2020. There was no competency evaluation in HHa #2's personnel available for review. These findings were reviewed with the Clinical Manager (CM #1) during an interview on 4/9/2021 at 10:45 a.m. who reported, "The contract agency does their (Home Health Aides) competencies. I'll have to call them (contract agency) and have them (files) sent over. There was no documented evidence that a competency evaluation had been conducted by a Registered Nurse Prior to the provision of care.

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure that 2 (HHa #1 and HHa #2) of 3 Home Health Aide files reviewed, received the required 12 hours of annual in-service training, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: Agency Policy: "Home Health Aide Services and Training Program" 1/2020 stated, "A home health aide must receive at least 12 hours of in-service training during each 12-month period." On 4/9/21, a review of the Agency's Home Health Aide (HHa) personnel files revealed the following: HHa #1: Date of Hire (DOH) was 11/6/17. Upon review, it was noted that HHa #1 had no documented in-service hours for the 2019/2020 calendar year. HHa #2: Date of Hire (DOH) was 5/6/19. Upon review, it was noted that HHa #2 had no documented in-service hours for the 2019/2020 calendar year. There was no documented evidence that the Home Health Aides received the required 12-hours of annual in-service as per this requirement. These findings were reviewed with the (Clinical Manager (CM #1) during an interview on 4/9/21 at 10:50 a.m. who reported, "The contract agency would have their in-service records. I can have them sent over if you need to see them."

Documentation of inservice training CFR(s): 484.80(d)(2) The HHA must maintain documentation that demonstrates the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to maintain documentation of the required 12 hours of annual Home Health Aide in-services for 2 (HHa's #1 and 2) of 3 Home Health aide files reviewed, resulting in lack of evidence of ongoing education and training and the potential for the provision of unsafe care for all patients receiving Home Health Aide services. Findings include: Policy: "Home Health Aide Services and Training Program" 1/2020 stated, "The Agency must maintain documentation that demonstrates the requirements of this standard have been met." On 4/9/21 at 10:30 a.m., a review of the Home Health Aide's (HHa) personnel files for the 2019/2020 calendar year revealed the following: HHa #1: Date of Hire was 11/16/17. There were no documented in-services available for review for the 2019/2020 calendar year. HHa #2: Date of Hire was 5/16/19. There were no documented in-services available for review for the 2019/2020 calendar year. These findings were reviewed with and confirmed by the Clinical Manager (CM #1) during an interview on 4/9/21 at 10:50 a.m., who reported, "Their (HHa) contract agency keeps their records."

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, it was determined the Agency failed to ensure Skilled Nursing prepared clear written patient care instructions for the home health aide regarding client needs, and safety precautions prior to providing care in 2 of 3 records (MR# 2) in which Home Health Aide services were ordered, resulting in the potential to negatively affect all the patients with home health aide services from this agency. Findings include: MR#2: The Start of Care (SOC) was dated 3/1/21. The Plan of Care (POC) identified diagnoses of Bilateral Knee Osteoarthritis, Hypertension, and Diabetes Type 2. The POC ordered Home Health Aide (HHa) services at a frequency of 2w5 (two times a week for 5 week) with the following safety precautions: DME and Electrical Safety, Elevate Head of Bed, Emergency/Disaster Plan Development, Fall Precautions, Keep Pathways Clear, Safety in ADLs, Proper Handling of Biohazard Waste, Sharps Safety, Side Rails Up, Slow Position Changes, Standard Precautions/Infection Control, Support During Transfer and Ambulation, Use of Assistive Devices, Diabetic: Do Not Cut Nails, Bleeding Precautions. During record review on 4/7/21, the "Aide Care Plan" dated 3/1/21 completed by the RN failed to have the following safety precautions documented: DME and electrical safety, elevate head of bed, proper handling of biohazard waste, side rails up, standard precautions/infections control, support during transfer and ambulation, diabetic: do not cut nails, bleeding precautions. The POC contained the Nutritional Requirements: Low Fat, Sodium Restriction, Heart Healthy, Low Cholesterol, Calorie ADA Diet (1800), and No Concentrated Sweets. The Aide Care Plan failed to include the nutritional requirements: Low Fat, Low cholesterol, 1800 ADA diet, and No concentrated sweets. Additionally, the written Aide Care Plan in the paper chart dated 3/1/21 documented vital sign parameters to monitor every visit. The Aide Care Plan within the Electronical Medical Record was marked "N/A" under "Vital Sign Ranges." The HHA care plan failed to include all the necessary safety measure and precautions to alert the aide of the patient's health concerns and to monitor vital signs. MR#3: The Start of Care (SOC) was dated 1/25/21. The Plan of Care (POC) identified diagnoses of Low Back Surgery, Chronic Kidney Disease, and Diabetes Type 2. The POC ordered HHa services at a frequency of 2w6 with the following safety precautions: Keep Pathways Clear, Fall Precautions, Emergency/Disaster Plan Development, Proper Positioning During Meals, Safety in ADLs, Slow Position Changes, Standard Precautions/Infection Control, Use of Assistive Devices, Bleeding Precautions, Diabetic: Do Not Cut Nails, Sharps Safety, Support During Transfer and Ambulation, Prone to Skin Breakdown Precaution. During record review on 4/8/21, the "Aide Care Plan" dated 1/25/21 completed by the RN failed to have the following safety precautions documented: Fall precautions, Emergency/Disaster plan development, Bleeding precautions, Diabetic: Do not cut nails, Sharp's safety, prone to skin breakdown precaution. The POC contained the Nutritional Requirements: Heart Healthy, Calorie ADA Diet (1800 Cal ADA.). The Aide Care Plan was blank under the nutritional requirements. The HHA care plan failed to include all the necessary safety measure and precautions to alert the aide of the patient's health concerns. The CM#1 was questioned on 4/9/21 at 11:35 am and confirmed the findings stating, "The home health aide care plan safety precautions and diet should match the plan of care. The electronic home health aide care plan should match the written care plan."

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the registered nurse failed to supervise the home health aides' services no less frequently than every 14 days for 2 of 3 records reviewed (MR 2 and 3) with home health aide services, for a potential of unmet and unsafe patient care. Findings include: MR#2: The Start of Care (SOC) was dated 3/1/21. The Plan of Care (POC) identified diagnoses of Bilateral Knee Osteoarthritis, Hypertension, and Diabetes Type 2. During record review on 4/7/21, it was noted that the Home Health Aide (HHa) completed 10 visits on 3/4/21, 3/6/21, 3/11/21, 3/13/21, 3/15/21, 3/20/21, 3/22/21, 3/26/21, 3/29/21, and 3/31/21. There was no documented evidence the RN completed a supervisory visit from 3/4/21 to 3/31/21, no less frequently than every 14 days, to supervise the home health aide services. MR#3: The Start of Care (SOC) was dated 1/25/21. The Plan of Care (POC) identified diagnoses of Low Back Surgery, Chronic Kidney Disease, and Diabetes Type 2. During record review on 4/8/21, it was noted that the HHa completed 12 visits on 1/28/21, 1/30/21, 2/1/21, 2/5/21, 2/8/21, 2/12/21, 2/15/21, 2/20/21, 2/22/21, 2/25/21, 3/1/21, and 3/4/21. There was no documented evidence the RN completed a supervisory visit from 1/28/21 to 3/4/21, no less frequently than every 14 days, to supervise the home health aide services. The CM#1 was questioned on 4/9/21 at 11:35 am and confirmed the findings stating, "I do not see documentation of the aide supervision notes."

Direct observation every 12 months CFR(s): 484.80(h)(1)(iii) A registered nurse or other appropriate skilled professional must make an annual on-site visit to the location where a patient is receiving care in order to observe and assess each aide while he or she is performing care. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the skilled discipline made an annual onsite observation visit at the patient's residence to observe the care being provided, for 2 (HHa #1 and HHa #2) of 3 Home Health Aide files reviewed, resulting in the potential for the provision of substandard care and unmet care needs. Findings include: Policy: "Home Health Aide services and Training Program", 1/2020 stated, "The Agency will complete a performance review of each home health aide no less frequently than every 12 months. documentation is maintained to demonstrate that the competency evaluation, inservice and performance review requirements are met." On 4/9/21 at 10:30 a.m., a review of the Home Health Aide (HHa) personnel files revealed the following: HHa #1: Date of Hire was 11/16/17. There was no documented evidence in HHa #1's personnel file that the skilled discipline made an annual onsite visit at the patient's place of residency to ensure adequate provision of care. HHa #2: Date of Hire was 5/16/19. There was no documented evidence in HHa #1's personnel file that the skilled discipline made an annual onsite visit at the patient's place of residency to ensure adequate provision of care. These findings were reviewed with and confirmed by the Clinical Manager (CM #1) during an interview on 4/9/21 at 10:50 a.m.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Administrator was appointed by and reported to the Governing Body, resulting in no definitive lines of authority and the lack of oversight of patient care and operations of the agency, affecting all 109 patients admitted to the agency within the past 12 months, resulting in the potential for poor patient outcomes. Findings include: On 4/8/21 at 10:45 am, the Administrator was asked to provide the Governing Board meeting minutes that reflected the administrator's appointment. "I do not have that documented. We had a governing board meeting on 2/24/21, but we did not update the appointment of the administrator."

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Clinical Manager coordinated patient care in 1 (MR#4) of 1 record in which the Licensed Practical Nurse completed visits after the Registered Nurse completed a discipline discharge, resulting in the potential for the provision of care inconsistent with the plan of care and unmet care needs. Findings include: *Agency Policy: "Coordination of Patient Care", (revised March 2019) stated, "The Director of Clinical Services provides oversight of all patient care services. Oversight includes: Coordinating patient care." MR#4: The Start of Care (SOC) was dated 2/18/21. The Plan of Care (POC) identified diagnoses of Cerebral Infarction and Diabetes Type 2. During recorder review on 4/8/21, it was noted the Registered Nurse (RN) completed a discipline discharge on 3/10/21. On 3/13/21, the Licensed Practical Nurse completed an unscheduled visit. The agency failed to provide oversight and coordinate patient visits accordingly. The CM#1 was questioned on 4/9/21 at 11:35 am and confirmed the findings stating, "I do not know why the LPN made a visit after the RN discharged the patient from nursing services."

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 document review and interview, the agency failed to ensure the clinical record was complete and included all clinical notes and complete medical record for 2 records (MR# 1 and 2) from a total of 7 sampled records (G1012); the Physical Therapist failed to accurately document the patient's responses, (specifically elevated pain levels and blood pressure readings), before and after therapy services were rendered, for 1 (MR #6) of 1 patient observed during a therapy home visit, from a total of 7 sampled records reviewed, resulting in and inaccurate clinical record and the potential for unidentified, unaddressed health concerns and unmet care needs (G1014); and failed to ensure a discharge summary was complete, provided the patient's current health status at the time of discharge, progress toward goals, and forwarded to the physician within 5 days of discharge in 2 (MR# 3 and 5), of 2 closed records, from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs (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 was complete and included clinical notes for 2 (MR#'s 2, 9) of 7 records reviewed, resulting in the physician not having a clear and concise clinical picture of the patient's health status and progression towards goals, and incomplete clinical record and the potential for unmet care needs. Findings include: **Agency Policy: Timely Submission of Patient Documentation (Revised October 2017) states, "Itineraries, with all visit reports attached, must be submitted the next scheduled workday, not exceeding three (3) business days. All patient visit reports from contract personnel must be submitted within three (3) business days from the date of the visit, e.g., PT, SLP, etc." **Agency Policy: Medical Record Content (Revised March 2018) states, "The Agency will initiate and maintain an individual and accurate medical record for each patient receiving care in compliance with all federal/state laws and regulations." MR#1: The Start of Care (SOC) was dated 3/10/21. The Plan of Care (POC) identified diagnoses of Diabetic Foot Ulcer, Diabetes Type 2, and Chronic Obstructive Pulmonary Disease (COPD). During record review on 4/6/21, it was noted that the Electronic Medical Record (EMR) had incomplete Physical Therapy (PT) and Licensed Practical Nurse (LPN) visit notes. PT notes on 3/23/21, 3/25/21, 3/30/21 and 4/1/21 were all blank. Additionally, the LPN notes on 3/17/21, 3/19/21, 3/22/21, 3/24/21, 3/26/21, 3/29/21, 3/31/21 and 4/1/21 were blank. On 4/7/21 at 9:30, CM#1 stated, "All the PT and LPN notes are completed and in the EMR." The agency failed to submit the visit reports within 3 days. MR#2: The Start of Care (SOC) was dated 3/1/21. The Plan of Care (POC) identified diagnoses of Bilateral Knee Osteoarthritis, Hypertension, and Diabetes Type 2. During record review on 4/7/21, it was noted RN#1 completed a "Discharge Summary" on 3/24/21. On 4/8/21, one day after a joint surveyor/clinician home visit was completed with RN#1, the EMR did not contain the "Discharge Summary" that was completed on 3/24/21. The agency failed to keep an accurate EMR reflecting the patients documented visits and notes. The CM#1 was questioned on 4/9/21 at 11:50 am and confirmed the findings stating, "There is a delay in getting our visit notes put in, we need to work on that. I do not know why that Discharge Summary was deleted from the EMR."

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined that the Physical Therapist failed to accurately document the patient's responses, (specifically elevated pain levels and blood pressure readings), before and after therapy services were rendered, for 1 (MR #6) of 1 patient observed during a therapy home visit, from a total of 7 sampled records reviewed, resulting in and inaccurate clinical record and the potential for unidentified, unaddressed health concerns and unmet care needs. Findings include: MR #6: The patient's start of care (SOC) was 3/10/21 with diagnoses that included osteoarthritis and COPD (chronic obstructive pulmonary disease). The plan of care (POC) ordered Skilled Nursing (SN) for SOC only, and Physical Therapy (PT) services to be provided at a frequency of 1w1, 2w5, 1w1. The POC ordered PT to "Notify Physician of vital sign parameters out of range: Pain level greater than 8; Systolic BP greater than 160, less than 0; Diastolic BP greater than 90, less than 60." On 4/7/21 at 10:00 a.m., during a scheduled home visit with the Physical Therapist (PT #1), the following was observed: PT #1 assessed the patient's blood pressure, prior to providing care, which reflected a reading of 155/89 and a reported pain level of 9/10 throbbing pain left knee. PT #1 then proceeded with the provision of PT exercises. At 10:24 a.m. PT checked the patient's BP which revealed a reading of 162/91 left arm (above/outside the reportable parameters). At 10:30 a.m., the patient's BP was 153/92 (diastolic reading outside/above the reportable parameters). Upon completion of the PT visit, the patient informed PT #1 that she had a pain level of 10/10 to left knee (outside/above the reportable parameters). During the visit, the patient verbalized that she had been in an automobile accident that resulted in injuries to her back and left knee (torn meniscus). "I injured everything on my body." On 4/9/21 at 9:49 a.m., a PT visit note dated 4/7/21 was reviewed. The clinical record was noted to be inaccurate. PT #1 documented that the patient's blood pressure as 149/79. PT #1 further documented the patient's "Pain level prior to therapy" as being at a level of 7/10 and "Pain level after therapy" at a level of 4/10. These levels were inaccurately documented by PT #1. Additionally, PT #1 documented in the 4/7/21 visit note, "Post therapy feels good..., grades pain at 5/10." During the visit, PT #1 was observed to use a non-prescribed aspirin based arthritic cream on the patient's lower back and left knee. The visit note, authored by PT #1 documented, "biofreeze (prescribed medicated cream) for b/l (bilateral) knees, LB (lower back) x 10 mins [sic]. It was determined that PT #1 documented false information in the patient's clinical record that inaccurately reflected the patient status before and after the provided PT services. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) on 4/9/21 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 complete, provided the patient's current health status at the time of discharge, progress toward goals, and forwarded to the physician within 5 days of discharge in 2 (MR# 3 and 5), of 2 closed records, from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: Policy: "Discharge Summary" 3/2018 stated, "The Discharge Summary will include, but is not limited to discharge date, reason for discharge, laboratory data, patient's discharge condition, types of services provided and frequency of services, patient's outcomes in meeting goals in the plan of care patient/family post-discharge instructions, medications at time of discharge..., A Discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner..." MR #5: The patient's start of care (SOC) was 1/25/21 with diagnoses that included spondylosis, diabetes mellitus and blindness right eye. The plan of care (POC) ordered Skilled Nursing, Physical Therapy and Home Health Aide services to be provided. The POC ordered SN to "assess osteoarthritis, diabetes, hypertension, monitor other co-morbidities, manage and mitigate pain, asses integumentary status..." The SN Discharge Summary dated 2/17/21 provided no summary of care rendered during the period of care, responses to treatment, or the health status of the patient at the time of discharge. The summary documented, "Vital signs stable, positive feedback from SN instruction..., Patient Condition and Outcomes: improved..., if any problems arise, contact primary physician immediately." There was no indication of what the patient's blood sugar or pain level was at the time of discharge. Further There was no indication of which goals were met, or that the Discharge Summary had been forwarded to the Physician within 5 days of discharge. These findings were reviewed with the Clinical Manager (CM #1) during an interview on 4/8/21 at 11:57 a.m., who acknowledged the findings and reported, "I can see that the section on services provided is incomplete because it doesn't include Home Health Services. It (SN discharge Summary) says nothing." MR#3: The Start of Care (SOC) was dated 1/25/21. The Plan of Care (POC) identified diagnoses of Low Back Surgery, Chronic Kidney Disease, and Diabetes Type 2. The Physical Therapist (PT) completed a discharge OASIS (outcome and assessment information set) on 3/25/21. During record review on 4/8/21, it was noted that there was no documented evidence a discharge summary was sent to the physician within 5 business days of the patient's discharge. The CM#1 was questioned on 4/9/21 at 11:30 am and confirmed the findings stating, "Yes, the discharge summary was not sent to the physician within 5 business days."