Every finding on record at Royale Home Health Care, Inc

The Michigan Department of Licensing and Regulatory Affairs performed an Emergency Preparedness survey from 5/27/25 through 5/30/25 at Royale Home Health Care, Inc. During the survey, Royale Home Health Care, Inc was found to be out of compliance with the requirements for participation in Medicare at 42 CFR 484.102 - Emergency Preparedness.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Emergency Preparedness (EP) communication plan included updated, complete, and accurate information to contact staff, resulting in the potential to affect the safety of all 13 patients receiving services from this agency in the event of an emergency. Findings include: During review of the agency’s Emergency Preparedness (EP) plan on 5/28/25 at 11:30 AM, the agency’s consultant (Con-1) was asked to provide the agency’s EP communication plan for contacting staff during an emergency. Con-1 provided a document titled “EMERGENCY PREPAREDNESS ROYALE HOME HEALTH CARE Emergency Preparedness Plan Telephone Tree" for review. This document indicated the Administrator (Adm-1) was responsible for contacting all field staff in the event of an emergency, however, there were no names or contact information listed on the phone tree or located in the EP binder. Con-1 stated this was the only communication plan documentation the agency had during an interview on 5/28/25 at 11:35 AM. A review agency policy titled “Continuity of Operations Plan (COOP) Emergency Procedure” (not dated) indicated to “Follow the emergency communication tree, if unable to reach employee on list, then proceed to next person on list.” [sic] Adm-1 and Con-1 reviewed and acknowledged the findings during an interview on 5/30/25 at 11:30 AM.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure Emergency Preparedness (EP) training was provided to staff every 2 years per regulation and annually per agency policy for 16 of 16 current staff members, resulting in the potential for an unprepared staff response in the event of an actual emergency. Findings include: A review of agency policy titled “Emergency Preparedness Policy” (not dated) revealed, “11. All employees, including contractors, are oriented about their responsibilities in the organization’s Emergency Preparedness and Response Plan, on hire, and the plan is reviewed, at least annually, with an emergency drill performed.” [sic] During review of the agency’s Emergency Preparedness (EP) binder on 5/28/25 at 11:56 AM, it was noted there was no documentation regarding on-going EP training for staff. During an interview with the office manager (OM-1) on 5/29/25 at 12:00 PM, OM-1 stated the agency does not have record of on-going EP training for staff. The Administrator (Adm-1) and consultant (Con-1) also reviewed and acknowledged the findings during an interview on 5/30/25 at 12:44 PM.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to include agency relevant scenarios to test the agency's emergency plan, failed to analyze the facility's response, and failed to maintain documentation for 5 of 5 Emergency Preparedness (EP) testing drills for 2 of 2 years, resulting in the potential for less than optimal outcomes for all patients in the event of an emergency. Findings include: The agency’s Emergency Preparedness (EP) information was reviewed on 5/28/25 through 5/30/25. During review of the EP testing exercises, the following was noted: A table top drill (dated 5/18/22) was performed regarding a fire at the “hospital next door.” When asked about where the hospital was located, the Administrator (Adm-1) stated, "It is across town." The drill included evacuation of hospital patients; however, it did not include information regarding how specific staff participated or what happened to the agency’s patients during the emergency. Additionally, the documentation included 18 after drill discussion questions, however, there were no responses documented in response to these questions.A mock disaster drill (dated 5/9/23) only included a sign in sheet with 3 employees listed. There was no other documentation of regarding what occurred during this drill.A table top drill (dated 5/11/23) was performed regarding a flood in the area. The details of the drill included how the agency helped “ER services”, however, it did not include information regarding how specific staff participated or what happened to the agency’s patients during the emergency. Additionally, the documentation included 23 after drill discussion questions, however, there were no responses documented in response to these questions.A table top drill (dated 1/10/24) was performed regarding the coronavirus pandemic. There was no documentation regarding what took place during this drill. Additionally, the documentation included 33 after drill discussion questions, however, there were no responses documented in response to these questions. A mock disaster drill (dated 6/7/24) was performed regarding 2 tornados in the area. The documentation included information regarding what occurred during the drill, however, there was no documentation regarding how agency staff specifically participated or what happened to the agency’s patients during the emergency. The documentation included a list of “Observations/evaluation,” however, none of the information was specific to agency policy or procedure on how to respond in the event of a tornado. A review of the agency policy titled “Training & Testing” (not dated) indicated, “1. After the event, the agency management will meet to discuss the effectiveness of the plan as well as what changes may be required for improved disaster/emergency preparedness in the future." Adm-1 and the consultant (Con-1) were interviewed on 5/30/25 at 11:24 AM regarding the contents of the EP testing drills. Adm-1 and Con-1 were asked to provide evidence of how the drills tested the agency's emergency policies and procedures for each emergency. Adm-1 and Con-1 were unable to provide evidence of how the testing drills related to agency specific policy and procedure. Con-1 also stated she did not understand that EP drills should test their own agency specific EP plan. Additionally, Adm-1 and Con-1 were asked to provide evidence of an analysis of the agency’s performance following the drills. Con-1 pointed out the questions listed as noted in the documentation above and reported they “talk about it”, however, she admitted it was never documented. Adm-1 and Con-1 acknowledged the findings at the time of interview.

An unannounced Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 5/27/25 to 5/30/25 at: Royale Home Health Care, Inc 20600 Eureka Rd, Suite 705A Taylor, MI 48180 The agency does not operate any additional branches. Records Reviewed: 3 active records with home visits, 2 active records without home visits, and 2 discharge records for a total of 7 records. At the conclusion of the survey, the agency was found to be out of compliance with conditions of participation for home health agencies at 42 CFR Part 484.

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: Based on record review and interview, the agency failed to ensure the initial assessment to determine immediate care needs for the patient was conducted within 48 hours of the referral in 4 (P-1, P-2, P-3, P-7) of 7 records reviewed resulting in the potential for unmet care needs and poor patient outcomes (See G0514); failed to ensure the comprehensive assessment accurately reflected the patient’s current health status at the time of admission for 2 (P-1 and P-2) of 7 records reviewed resulting in incomplete clinical information to aide in determining the needs of the patient and to assist in developing the plan of care (See G0528); failed to follow agency policy regarding reconciliation, management of high risk drugs, and faxing the physician in 4 (P-2, P-4, P-5, P-6) of 7 records reviewed; and failed to verify patient medications upon admission in 2 (P-2 and P-6) of 7 records reviewed, resulting in the potential for harmful medication interactions and poor patient outcomes (See G0536). Findings include: The cumulative effects of this systemic problem resulted in the Home Health Agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.55 Comprehensive Assessment of Patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initial assessment to determine immediate care needs for the patient was conducted within 48 hours of the referral in 4 (P-1, P-2, P-3, P-7) of 7 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: Patient #3 (P-3): This 81-year-old was admitted to this agency on 9/17/23 with diagnoses including arthritis affecting multiple joints and high blood pressure. The medical record was reviewed on 5/30/25. During review it was noted that the physician referral was dated 9/7/23. The initial visit was not completed until 9/17/23 (10 days later). There was no information in the medical record which gave a reason for the delay in the start of care. Patient #7 (P-7): This 68-year-old was admitted to this agency on 4/8/25 with diagnoses including high blood pressure and low back pain. The medical record was reviewed on 5/28/25. During review it was noted that the physician face-to-face form which included home health care referral information was signed on 3/31/25. The initial visit was not completed until 4/8/25 (8 days later). There was no information in the medical record which gave a reason for the delay in the start of care. The Administrator (ADM-1) and Consultant (Con-1) reviewed the findings during an interview on 5/30/25 at 12:00 p.m. Con-1 was questioned to whether the face-to-face document was used as the referral and Con-1 stated yes. ADM-1 stated that sometimes the patient wants a later start of care date. When questioned if any details for the late start were entered into the chart, ADM-1 stated that clinicians may not remember to add it in the medical record. Patient #1 (P-1): This 95-year-old patient was admitted to this home care agency on 10/29/24 with the diagnoses of type II diabetes mellitus and cervicalgia (neck pain). During record review on 5/28/25, it was determined the referral to start home care services was dated 10/14/24. Upon further review of the record, it was noted the initial assessment did not occur until 10/29/24 – 15 days after the referral was written. There was no documentation regarding the reason for the late start. Patient #2 (P-2): This 82-year-old patient was admitted to this home care agency on 5/22/25 with the diagnoses of osteoarthritis of the knee, lumbar (low back) disc degeneration, and type II diabetes. During record review on 5/29/25, it was determined the referral to start home care was dated 5/14/25. Upon further review of the record, it was noted the initial assessment did not occur until 5/22/25 – 8 days after the referral was writing. There was no documentation regarding the reason for the late start date. A review of the agency policy titled “Subject Admission Policy” (not dated) indicated, “A home visit is made by the RN or PT within 24-28 hours of the referral or according to physician orders and patient/family wishes.” The Administrator (Adm-1) and Consultant (Con-1) reviewed and acknowledged the findings during an interview on 5/30/25 at 12:44 PM.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (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 health status at the time of admission for 2 (P-1, P-2) of 7 records reviewed, resulting in incomplete clinical information to aide in determining the needs of the patient and to assist in developing the plan of care. Findings include: Patient #1 (P-1): This 95-year-old patient was admitted to this home care agency on 10/29/24 with the diagnoses of type II diabetes mellitus and cervicalgia (neck pain). During record review on 5/28/25, it was determined the Outcome Assessment and Information Set (OASIS) noted “No – No issues found during review” under "Drug Regimen Review." Upon review of the “Patient Medication Record” filled out by the registered nurse (Con-1), it was noted Con-1 listed 3 medications with discrepancies or duplications to be reported to the physician. Patient #2 (P-2): This 82-year-old patient was admitted to this home care agency on 5/22/25 with the diagnoses of osteoarthritis of the knee, lumbar (low back) disc degeneration, and type II diabetes. During record review on 5/29/25, it was determined the OASIS noted “No – No issues found during review” under "Drug Regimen Review." Upon review of the “Patient Medication Record” filled out by Con-1, it was noted Con-1 listed 8 medications with discrepancies or duplications to be reported to the physician. A review of agency policy titled “Subject: Comprehensive Client Assessment” (not dated) indicated, “2. The Comprehensive Assessment will include a review of all medications the client is using. This assessment will identify potential adverse effects and drug reactions, including ineffective therapy, significant side effects, significant drug interactions, duplicate drug therapy and non-compliance with therapy.” During an interview on 5/30/25 at 12:44 PM, the Administrator (Adm-1) and Con-1 were asked about the conflicting information in the records. Con-1 stated the agency always sends the doctor the report with interactions to review, however, acknowledged the information in the OASIS/comprehensive assessment is conflicting and does not show a clear picture of the patient’s status. Adm-1 and Con-1 acknowledged the findings on 5/30/25 at 12:55 PM.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to follow agency policy regarding reconciliation and management of high risk drugs in 4 (P-2, P-4, P-5, P-6) of 7 records reviewed; and failed to verify patient medications upon admission in 2 (P-2 and P-6) of 7 records reviewed, resulting in the potential for harmful medication interactions and poor patient outcomes. Findings include: Patient #6 (P-6): This 73-year-old was admitted to this agency on 5/22/25 with diagnoses including type 2 diabetes, heart failure, and arthritis affecting the left knee. On 5/28/25 at 1:45 p.m., a joint home visit was conducted with the Registered Nurse (RN). During the visit, the admission packet which had been given to P-6 by the agency RN at the start of care visit (5/22/25) was provided for surveyor review. It was noted that the packet contained a handwritten list of P-6’s medications which had been completed by the agency RN at the start of care and kept in the packet for patient/caregiver reference. On 5/29/25, the medical record was reviewed and included a comparison between the handwritten medication list prepared by the RN and left in P-6’s home, and the agency medication profile in P-6’s medical record. During comparison, the following medication discrepancies were noted: 1. Levothyroxine (thyroid hormone replacement): · The list in the patients home stated the dose was 137 micrograms (mcg) taken once daily. · The agency medication profile stated the dose was 137 mcg taken every 12 hours (twice daily). 2. Procardia Extended Release (also known as Nifedipine- used for treating high blood pressure and chest pain): · The list in the patients home stated the dose was 60 milligrams (mg) taken once daily. · The agency medication profile stated the dose was 90 mg taken once daily 3. Atrovent Inhaler (increases airflow in the lungs): · The list in the patients home stated the dose was 17 mcg, 4 times 2 puffs as needed (no additional frequency such as “daily”, was given). · The agency medication profile stated the dose was 17 mcg, 2 puffs daily as needed. These medication discrepancies were reviewed with the agency Administrator (ADM-1) and the agency Consultant (Con-1) during interview on 5/30/25 at 12:00 p.m. Con-1 (the assigned clinical manager for P-6) was asked which of these medication lists were correct (home list or agency profile). Con-1 was not able to give a determination for which list was correct, and no further explanation was given for the medication discrepancies identified during the surveyor review. Both ADM-1 and Con-1 acknowledged the finding. A review of the agency policy: "Medication Profile & Reconciliation" (Undated). The policy states, "Medication Reconciliation: 1. The agency will fax a current medication list to the referring physician and any other physician’s patient makes agency aware of on admission, recertification (as necessary-only if new or changed added), resumption of care (if new or changed), and at discharge. 2. The person faxing will either initial and date at bottom of page or attach fax copies to medication list/profile each time they fax.” Patient #4’s (P-4) Start of Care (SOC) was dated 4/5/25. The Plan of Care (POC) identified diagnoses of Acute Bronchitis, Spinal Stenosis, Hypertension and Congestive Heart Failure. During record review on 5/28/25, it was noted that the Medication Profile was competed and signed on 4/7/25 by the Consultant/RN (Con-1). The Medication Profile stated, “Physician notified of severe medication interactions? Yes. Please explain: Faxed MD 4/7/25 all RX interactions, High risk RX, duplicate RX: Metoprolol, Losartan & Amlodipine.” The Electronic Medical Record (EMR) had no evidence that a medication profile was faxed to the physician. Patient #5’s (P-5) Start of Care (SOC) was dated 5/21/25. The Plan of Care (POC) identified diagnoses of Pneumonia and Chronic Obstructive Pulmonary Disease. During record review on 5/29/25, it was noted that the Medication Profile was completed and signed on 5/2/25 by Con-1. The Medication Profile stated, “Physician notified of severe medication interactions? Yes. Please explain: Faxed MD 5/22/25 all RX interactions, High risk RX, duplicate RX: Trelegy, Ellipta & Albuterol.” The EMR had no evidence that a medication profile was faxed to the physician. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/30/25 at 1:10 pm. Patient #2 (P-2): This 82-year-old patient was admitted to this home health agency on 5/22/25 with the diagnoses of osteoarthritis of the knee, lumbar (low back) disc degeneration, and type II diabetes. During record review on 5/29/25, it was noted on the medication list the patient was taking “Novalin N” (a type of insulin). A review of agency policy titled “High Risk/High Alert Medications/Safety Measures” (not dated) revealed, “5. The field staff will ensure the following protocols are followed for any patient on ORAL HYPOGLYCEMICS & INSULIN:… c. All patients that are diabetic will require blood glucose monitoring using their own machines and if they do not have a machine the agency will get physician order for a blood glucose monitoring machine and have arrangements made to have delivered. d. The field staff will teach on insulin/oral hypoglycemic agent/s: patient has someone double check insulin syringe for correct dosage and insulin, patient/caregiver does site rotation, patient caregiver understand hypo/hyperglycemia and what to do for each, teach regarding side effects and purpose, reporting, tracking and performing blood glucose monitoring on a regular basis and/or physician orders, check sliding scale for accuracy and changes every visit and verify with staff, take medications daily as ordered (dose and route), do not skip doses, report any missed medications or signs and symptoms of hypo/hyperglycemia to physician immediately, when to hold medications if blood sugar too low (parameters on OASIS or per physician) or what to do if taken too much insulin or if blood sugar too high, patients take medications in a well-lighted environment, verify labels are correct, and what to do if took wrong dose of medication…. f. The field staff will document teaching and materials given and patient response to oral hypoglycemic agents and insulin. g. Have patient or caregiver do return demonstration of insulin or setting the pen and document in field staff notes. h. To have the different types of insulin segregated and labeled in legible print in the refrigerator. i. If sliding scale ordered by physician, MUST be written out on the medication profile…” Upon further review of the record, it was noted there was no documentation the steps above occurred. The Administrator (Adm-1) and consultant (Con-1) reviewed and acknowledged these findings during an interview on 5/30/25 at 12:44 PM. Additionally, during a joint home visit with the physical therapist (Adm-1) on 5/29/25 at 11:00 AM, the surveyor reviewed the medication list with P-2 and her daughter, who was present during the visit. Upon reading “Lisinopril” (a medication used to treat high blood pressure), P-2 stated, “I never took that.” P-2 explained the doctor recommended it “a long time ago,” but she did not want to take it due to some of the negative side effects. Following the visit on 5/29/25 at 11:45 AM, Adm-1 was interviewed regarding why Lisinopril was on P-2’s medication list. Adm-1 stated all medications the doctor has ever ordered sometimes come over on the referral, however, Adm-1 was unable to explain why he did not reconcile this at the start of care on 5/22/25. Adm-1 acknowledged the findings at the time of interview.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure missed visits altering the plan of care frequency were rescheduled and communicated with the doctor per agency policy in 2 (P-1 and P-3) of 7 records reviewed, resulting in the potential for unmet patient care needs and poor patient outcomes. Findings include: The agency’s policy titled “Subject: Hand off Communication/Missed Visit/Hold(s)” (undated) was provided for surveyor review on 5/30/25. On page 2., it stated “6… when the clinician cannot make the visit according to the frequency on the established plan of care-the discipline has to document another date to ‘make-up’ the visit within the Medicare week” [sic]. Patient #3 (P-3): This 81-year-old was admitted to this agency on 9/17/23 with diagnoses including arthritis affecting multiple joints and high blood pressure. The medical record was reviewed on 5/30/25. The initial physical therapy (PT) evaluation was completed on 9/22/25 and a PT re-evaluation with updates for PT frequency on the plan of care (POC) was completed on 10/16/25. The updated POC included physician orders for a PT frequency of 2 times per week for 1 week (week beginning 10/15/25), and then 1 time a week for 3 weeks (weeks beginning 10/22/25, 10/29/25, and 11/5/25), for a total of 5 visits in 4 weeks. During review of the PT visit schedule, it was noted that the PT missed one of the two visits ordered during the week beginning 10/15/25 and missed every ordered weekly visit for the next 3 weeks (weeks beginning 10/22/25, 10/29/25, and 11/5/25). PT missed 4 visits out of 5 total ordered visits, and the patient did not receive any PT care for 3 full weeks while on service with the agency. There was no documentation indicating that the PT attempted to reschedule or “make up” any of the 4 missed visits and no anticipated “make-up” date was included in missed visit documentation. The PT completed a “Missed Visit” form for each missed visit and documented that the physician was notified via “Fax” however there was no indication that the physician was aware that each of these missed visits equaled 3 full weeks with no PT care. The Administrator (ADM-1) and Consultant (Con-1) reviewed and acknowledged the above finding during an interview on 5/30/25 at 12:00 p.m. P-1: This 95-year-old patient was admitted to this home care agency on 10/29/24 with the diagnoses of type II diabetes mellitus and cervicalgia (neck pain). During record review on 5/28/25, it was a noted a missed physical therapy visit was documented on 11/14/24 due to, “PATIENT NOT FEELING GOOD TO DO EXERCISES” [sic] and that the doctor was notified by phone. It was also noted a missed physical therapy visit was documented on 11/19/24 due to, “No Answer to Phone Call” and that the doctor was notified by fax. A review of the agency policy titled “Subject: Hand off Communication/Missed Visit/Hold(s)” (not dated) revealed, “7. The clinician who missed the visit must complete the “missed visit” form: patient name, MR#, date of scheduled visit, reason why the visit did not happen, if the visit was rescheduled within the same Medicare week and if it was not, then document why it was not.” During an interview with the Administrator (Adm-1) on 5/30/25 at 12:44 pm, Adm-1 was asked for documentation regarding whether these visits were rescheduled within the same Medicare week or the reason it was not per agency policy above. Adm-1 stated there was no additional documentation regarding the missed visits besides what was in the missed visit notes. Adm-1 acknowledged the findings at time of interview.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the goals on the Plans of Care were objectively measurable to determine the patient's progress towards obtaining the goals in 2 (P-4, P-5) of 7 records reviewed resulting in the inability to determine the patient's progress towards obtaining the goals. Findings included: A review of the agency policy: "Royale Plan of Care Requirements" (Undated). The policy states, "Statement of Standard: The patient’s care/service plan addresses needs identified in the assessment process. Each patient must receive the home health services that are written in an individualized plan of care. The plan is developed, and evaluated, in partnership with the patient, representative (if any), and caregiver(s) and identifies patient-specific measurable outcomes and goals.” Patient #4’s (P-4) Start of Care (SOC) was dated 4/5/25. The Plan of Care (POC) identified diagnoses of Acute Bronchitis, Spinal Stenosis, Hypertension and Congestive Heart Failure. During record review on 5/28/25, it was noted that the goals on the POC were not measurable, for example the Skilled Nursing goals stated, "Patient will verbalize understanding of proper use of pain medication by 4/18/2025." Additionally, another goal stated, “The patient/caregiver will verbalize understanding of symptoms of cardiac complications and when to call 911 by 4/8/2025.” There was no evidence of how these goals could be quantitatively measured. Patient #5’s (P-5) SOC was dated 5/21/25. The POC identified diagnoses of Pneumonia and Chronic Obstructive Pulmonary Disease. During record review on 5/29/25, it was noted that the goals on the POC were not measurable, for example the Skilled Nursing goals stated, "Patient will verbalize understanding of proper use of pain medication by 5/31/2025." Additionally, another goal stated, “The patient will be free from injury during the certification period.” There was no evidence of how these goals could be quantitatively measured. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/30/25 at 1:15 pm.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to promptly notify the Physician concerning a vital sign outside of the specified reportable parameters for 1 (P-4) of 7 records reviewed, resulting in a potential poor clinical outcome. Findings include: A review of the agency policy: "Royale Plan of Care Requirements" (Undated). The policy states, "Steps to be taken, in developing the Care Plan include: 10. Include, on the plan of care, the physician or allowed practitioner’s parameters for vital signs, and fasting blood sugar.” Patient #4’s (P-4) Start of Care (SOC) was dated 4/5/25. The Plan of Care (POC) identified diagnoses of Acute Bronchitis, Spinal Stenosis, Hypertension and Congestive Heart Failure. During record review on 5/28/25, it was noted that the POC stated, “…to report to physician if…pain level greater than 7/10…” The Physical Therapist (PT) completed a visit on 4/10/25 and documented, “Pain Assessment: Primary Site: Pre-Therapy Intensity: 8. Post-Therapy Intensity: 8.” The was no documented evidence of the PT reporting the elevated pain level. The PT failed to notify the physician as per policy. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/30/25 at 1:20 pm.

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 ensure the patient and caregiver were provided with the name of the correct clinical manager, resulting in all 13 of the agency’s active patient’s being uninformed of who to contact with any concerns. Findings include: During the entrance interview with the Administrator (Adm-1) on 5/27/25 at 11:30 AM, Adm-1 indicated he was the Clinical Manager for the agency. Upon review of the agency’s admission packet on 5/28/25 at 10:45 AM, it was noted the name of the Clinical Manager was listed as the agency’s consultant (Con-1) instead of Adm-1. Adm-1 was asked why the information in the packet was incorrect during an interview on 5/30/25 at 1:00 PM. Adm-1 stated Con-1 moved to Florida in January 2025 and the admission packets were already printed. Con-1 was present during the interview and told Adm-1 she told him to use a sticker to correct the information for current and upcoming patients, however, Adm-1 stated he forgot. Adm-1 and Con-1 acknowledged the findings during the interview.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure personnel followed accepted Infection Control standards of practice during the provision of care and services for 2 (P-4 and P-6) of 3 joint patient home visit observations resulting in the potential for the transmission and development of infection. Findings include: The agency policy titled “Personal Protective Equipment” (undated), was provided for surveyor review on 5/30/25. On page 2., it stated “5. Never wash or decontaminate disposable gloves for reuse.” Patient #6 (P-6): This 73-year-old was admitted to this agency on 5/22/25 with diagnoses including type 2 diabetes, heart failure, and arthritis affecting the left knee. On 5/28/25 at 1:45 p.m., a joint home visit was conducted with the Registered Nurse (who is also the agency Consultant, Con-1). During the visit, it was noted that Con-1 brought a bag containing patient care supplies into the home for the visit. After washing her hands, Con-1 was observed putting on a new pair of disposable gloves to begin the visit. Con-1 performed multiple tasks during the visit such as removing items from the bag containing patient care supplies (stethoscope, thermometer, etc.); obtaining P-6’s blood pressure; checking P-6’s feet for swelling and pulses; checking P-6’s blood sugar; etc. Con-1 did not change the original pair of disposable gloves after any of the tasks completed and was observed applying hand sanitizer to the disposable gloves 6 times between tasks throughout the visit. During an interview with the Administrator (ADM-1) and Con-1 on 5/30/25 at 12:00 p.m., Con-1 was asked what standard of practice or agency policy determined how the disposable gloves could be decontaminated and reused. Con-1 stated that she knows there is not an accepted standard of practice or agency policy for decontaminating disposable gloves for reuse. Con-1 explained that she has a skin condition on her hands and is unable to wash her hands or use hand sanitizer properly due to this condition. ADM-1 and Con-1 both acknowledged that using hand sanitizer on disposable gloves is not an accepted standard of practice for preventing the transmission of disease. A review of the agency policy: "Hand Hygiene and Compliance Program" (Revised October 2017). The policy states, "Procedure: A. Indications for hand washing and asepsis: …Before applying sterile or non-sterile gloves and after removal of gloves…” Patient #4’s (P-4) Start of Care (SOC) was dated 4/5/25. The Plan of Care (POC) identified diagnoses of Acute Bronchitis, Spinal Stenosis, Hypertension and Congestive Heart Failure. During the observation home visit on 5/29/25 at 1:15 pm the Physical Therapist (ADM-1) was observed donning and wearing the same gloves throughout treatment that included: machine massage to bilateral knees, removing and placing a lap blanket on the patient, handling Biofreeze bottle and applying gel. After ADM-1 completed treatments, he removed the soiled gloves then did not sanitize hands. ADM-1 failed to follow agency policy. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/30/25 at 1:35 pm.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure their skilled professionals provided the services that were ordered by the physician as indicated in the plan of care in 2 (P-3 and P-6) of 7 records reviewed potentially resulting in unmet patient needs and a poor patient outcome. Findings include: Patient #3 (P-3): This 81-year-old was admitted to this agency on 9/17/23 with diagnoses including arthritis affecting multiple joints and high blood pressure. The medical record was reviewed on 5/30/25. During review it was noted that a physician order for Medical Social Work (MSW) to evaluate P-3 was signed on 11/7/23. The MSW completed an evaluation visit on 11/14/23 and updated the plan of care (POC) physician orders to include an MSW frequency of 2 visits a month for 1 month. There were no other visits made by the MSW after the initial evaluation. The MSW failed to follow the physician ordered frequency of services according to the POC. Patient #6 (P-6): This 73-year-old was admitted to this agency on 5/22/25 with diagnoses including type 2 diabetes, heart failure, and arthritis affecting the left knee. The POC dated 5/22/25 was provided for surveyor review on 5/28/25 and included physician orders for the nurse to assess the patient’s weight log every visit. On 5/28/25 at 1:45 p.m., a joint home visit was conducted with the Registered Nurse (who is also the agency Consultant, Con-1). During the visit, Con-1 did not ask P-6 or P-6’s family member (caregiver) about P-6’s weight or weight log. After Con-1 completed the visit, an interview was conducted at 2:30 p.m. with P-6’s caregiver. P-6’s caregiver was asked what the home health staff had taught her regarding weighing or logging weights for P-6. P-6’s caregiver stated that there was a scale to weigh P-6 in the home however no one discussed how often to weigh P-6 or told her that a log should be kept. The Administrator (ADM-1) and Con-1 reviewed and acknowledged the above findings during an interview on 5/30/25 at 12:00 p.m. with no additional explanation to add.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure their skilled professionals provided the patient's caregiver with education needed to properly evaluate the patient's blood sugars in 1 (P-6) of 7 records reviewed resulting in unmet needs of the caregiver and potentially resulting in poor patient outcomes. Findings include: Patient #6 (P-6): This 73-year-old was admitted to this agency on 5/22/25 with diagnoses including type 2 diabetes, heart failure, and arthritis affecting the left knee. On 5/28/25 at 1:45 p.m., a joint home visit was conducted with the Registered Nurse (who is also the agency Consultant, Con-1). During the visit, Con-1 was observed while checking P-6’s blood sugar with P-6’s home equipment (lancet, glucometer, and glucometer strips). It was noted through conversation between Con-1, P-6, and P-6’s family member (caregiver) that P-6 was not able to perform a check of his own blood sugar, but instead, the caregiver in the home would need to perform this function for P-6. It was also noted that during the procedure of checking P-6’s blood sugar, Con-1 completed the steps of the testing without providing education to P-6’s caregiver. After the procedure, Con-1 told P-6’s caregiver that she should check P-6’s blood sugar once per day and record the values so that everyone can keep an eye on the results. After Con-1 completed the visit, an interview was conducted at 2:30 p.m. with P-6’s caregiver. P-6’s caregiver was asked if she knew how to use the equipment in the home to check P-6’s blood sugar. P-6’s caregiver stated that she did not really know how, feared needles, and doubted that she could perform the blood sugar testing. The medical record was reviewed on 5/29/25. During the review, it was noted that the registered nurse who completed the comprehensive assessment failed to document whether P-6's caregiver was able to use the home equipment for checking the patient’s blood sugar. It was unclear from the medical record if the caregiver was ever educated on how to properly perform a task that she was asked to do. This finding was reviewed with the Administrator (ADM-1) and Con-1 during an interview on 5/30/25 at 12:00 p.m. Con-1 stated that she (Con-1) did not realize that P-6’s caregiver did not know how to use the equipment for checking P-6’s blood sugar. Con-1 also stated that she (Con-1) called the physician to request for an automatic blood sugar reading device so that P-6 would not have to get poked daily. During the interview, both ADM-1 and Con-1 acknowledged that education regarding use of the home equipment for checking P-6's blood sugar was not properly provided to the caregiver.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the administrator failed to be responsible for all day-to-day operations by not keeping an accurate record of his employee roster, resulting in the potential for unqualified or untrained personal to be working for this agency (see G948); failed to ensure a qualified, pre-designated person was identified and approved by the governing body as the alternate administrator to be responsible in fulfilling the roll of the administrator in his absence, resulting in the potential for lack of direction and oversight for the agency (see G954); failed to ensure the Clinical Manager coordinated services for 1 (P-4) of 7 records reviewed, resulting in services not being provided to this patient (see G962); failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the potential for all services to be provided by contracted staff (see G982). Findings include: The cumulative effects of this systemic problem resulted in the Home Health Agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.105 - Organization and administration of services.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to be responsible for all day-to-day operations by not keeping an accurate record of his employee roster showing 7 (Con-1, RPT-1, RN-3, HHA-1, PTA-1, OM-1, and AA-1) of the agency's 16 employees were not listed on the initial staff list provided, resulting in the potential for unqualified personal to be working for this agency. Findings include: Following the entrance interview on 5/27/25 at 11:30 AM, the Administrator (Adm-1) was sent an e-mail with a list of documentation required for the survey, including, “Current list of all direct and contracted employees including job title and hire date.” On 5/28/25 at 1:17 PM, the staff list had not been provided for review, so a second request was made to the office manager (OM-1). OM-1 provided 2 handwritten lists of employees. One was labeled “Direct Employees”, and the other was labeled “Direct Staffing Company.” Upon review of the staff lists provided, it was noted several employees, including the consultant (Con-1) and administrative assistant (AA-1), were missing from the lists. Con-1 and AA-1 had been present and assisting with the survey. Adm-1 provided 2 more lists titled “W2 Employees” and “1099 Employees” for review on 5/30/25 at 10:54 AM. Upon review of the 2nd lists provided, it was determined the name of the alternate administrator who is currently ill (RN-1) and the registered nurse (RN-3) who may be taking the position were missing from the list. The social worker (MSW-1) was also now listed as a W-2 employee; however, it was confirmed he was a contract employee upon interview with Adm-1 on 5/30/25 at 11:00 AM. A third set of lists were provided for review on 5/30/25 at 11:10 AM. Upon review of the lists, again titled “W2 Employees” and “1099 Employees”, it was noted RN-1 and RN-3 were still missing and the home health aide (HHA-1) was removed from the list. During an interview with Con-1 at that time, Con-1 stated HHA-1 had not worked “for a long time.” However, record reviews confirmed HHA-1 had at least worked in November of 2024. When asked for the personnel file for RN-1, Adm-1 stated he did not have one as she “never started” as the alternate administrator, even though she signed a paper accepting the role; therefore, she should be taken off the list. Adm-1 was unsure why RN-3 was still left off the list. Adm-1 presented a “final” typed list on 5/30/25 at 11:30 AM that included both W-2 and contract employees. HHA-1 was still missing from this list and had to be handwritten on the bottom. Upon comparison of the list first staff list provided with the "final" copy, it was determined Con-1, registered physical therapist (RPT-1), RN-3, HHA-1, physical therapy assistant (PTA-1), OM-1, and AA-1 were left off the original staff list. A review of agency policy titled “Disaster/Crisis Procedure” (not dated) stated, “3. The Administrator is responsible for the following:…g. Maintaining a list of all active employees and their home phone numbers.” During an interview with Adm-1 on 5/30/25 at 12:44 PM, Adm-1 was asked how he could be responsible for day-to-day operations of the agency if he didn’t know who worked for him. Adm-1 stated he agreed he should know who his employees are and acknowledged the findings at the time of interview.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a qualified, pre-designated person was identified and approved by the governing body as the alternate administrator to be responsible in fulfilling the roll of the administrator in his absence in 5 of 5 months since the previous alternate administrator left in January 2025, resulting in the potential for lack of direction and oversight for the agency. Findings include: During the entrance interview with the Administrator (Adm-1) on 5/27/25 at 11:30 AM, Adm-1 was asked for the name of the alternate administrator. Adm-1 stated the person who was in this position was very sick and may not be returning to work. Adm-1 stated he was looking for a new person to fill this role. The agency’s consultant (Con-1) was on the phone during the entrance interview and stated she was in the role until she moved to Florida in January 2025. Upon review of documentation provided by Con-1 on 5/28/25 at 12:22 PM, it was determined an alternate administrator was appointed on 1/2/25, however, there was not a typed/legible name next to the signature of the person who accepted the role. During an interview with Con-1 on 5/29/25 at 1:00 PM, Con-1 stated the person who signed the form was a registered nurse (RN-1), who was a friend of hers. Con-1 was asked how long RN-1 was able to work prior to her getting sick and having to stop. Con-1 stated RN-1 worked for the agency until late March 2025. Con-1 was unsure if RN-1 would be able to return to work due to her health. On 5/30/25 at 10:54 AM, Adm-1 was asked for the personnel file for RN-1. Adm-1 stated he did not have one as she “never started.” Con-1 confirmed RN-1 never had training and did not officially start work despite what she said during the interview the day before. Therefore, it was determined the agency has not had an appointed alternate administrator since January 2025 when Con-1 moved to Florida. Adm-1 and Con-1 acknowledged the findings on 5/30/25 at 11:00 AM.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the Clinical Manager coordinated services for 1 (P-4) of 7 records reviewed, resulting in services not being provided to this patient. Findings include: A review of the agency policy: "Case Management/Coordination of Care" (Undated). The policy states, "Policy: 2. All home care staff furnishing services will maintain liaison from admission to discharge to ensure that the patient receives care necessary for meeting specific outcomes. 3. The communication between the disciplines, physicians, other health care professionals, ancillary staff or any other person shall be documented in the patient medical record, dated and signed according to agency clinical record entry policy.” A review of the agency policy: "Hand Off Communication/Missed Visit/hold(s)" (Undated). The policy states, "Special Instructions: 6. A missed visit is: when a patient refuses a visit for whatever the reason may be or when the clinician cannot make the visit according to the frequency on the established plan of care-the discipline has to document another date to “make-up” the visit within the Medicare week. 7. The clinician who missed the visit must complete the “missed visit” form: patient name, MR#, date of scheduled visit, reason why the visit did not happen, if the visit was rescheduled within the same Medicare week and if it was not, then document why it was not. The physician must be notified (either fax or phone)-this is on the form along with the date physician was notified. The clinician must sign first initial, last name, credential and date.” Patient #4’s (P-4) Start of Care (SOC) was dated 4/5/25. The Plan of Care (POC) identified diagnoses of Acute Bronchitis, Spinal Stenosis, Hypertension and Congestive Heart Failure. During record review on 5/28/25, it was noted that the POC ordered Physical Therapy (PT) at a frequency of 2w4 (Two times a week for 4 weeks), 1w4. This surveyor completed an in-home observation visit on 5/29/25 with the Administrator (ADM-1) /PT/Clinical Manager. During the visit, P-4 stated, “Where were you on Tuesday (5/27/25)?” ADM-1 replied, “I was with the surveyors.” Additionally, the Electronic Medical Record (EMR) contained no evidence that a “missed visit” form was completed or that the physician was notified. ADM-1 failed to follow policy, communicate and coordinate services to meet the patient's needs. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/30/25 at 1:10 pm.

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on record review and interview, the administrator failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the potential for all services to be provided by contracted staff. Findings include: During the entrance conference on 5/27/25, Administrator (ADM-1) was asked what services were currently provided by the agency. The response was, "We offer Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW) and Home Health aide (HHa) services." When asked what service was provided directly by the agency, ADM-1 stated, "SN." The contracts were reviewed on 5/27/25 at 11:30 am and it was noted that a contract stated, “Home Care: Service… RN (Registered Nurse).” The agency failed to ensure that at least one qualifying service was provided directly by agency employees. The ADM-1 reviewed and acknowledged the findings listed about in an interview on 5/28/25 at 12:30 pm.

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 record review and interview, the agency failed to ensure the clinical record contained details of all interventions and treatments in 1 (P-1) of 7 records reviewed, resulting in an inaccurate and incomplete medical record. Findings include: Patient #1 (P-1): This 95-year-old patient was admitted to this home care agency on 10/29/24 with the diagnoses of type II diabetes mellitus and cervicalgia (neck pain). During record review on 5/28/25, it was noted the physical therapy notes dated 11/7/24 and 11/12/24 listed several generic exercises under “Training Exercises,” however, there was no documentation regarding what specific exercises were performed to know what treatment was performed that day. Additionally, the physical therapy notes dated 11/7/24 and 11/12/24 also stated, “Demonstrated And instructed home exercise program 2 times a day.” [sic] There was no documentation to indicate what exercises were given to the patient to perform at home. The Administrator (Adm-1) and consultant (Con-1) acknowledged the findings during an interview on 5/30/25 at 12:48 PM.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a discharge summary was completed, provided the patient's current health status at the time of discharge, and progress toward goals in 1 (P-4) of 2 closed records; the agency failed to ensure the discharge summary was sent to the physician in 1 (P-1) of 2 closed records, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: A review of the agency policy: "Discharge Policy & Summary" (Undated). The policy states, "Procedure: 3. The discharge summary shall include, but not limited to: Admission and discharge dates. Services provided. Diagnosis. Status upon admission. Status at time of discharge. Reason for discharge. Transfer information, if applicable. Unmet needs, referrals made. Instructions provided for family. Current medication list/profile/interactions, if applicable. If goals were met and if not met, reasons why. Initial problem/s. Action taken. Patient response to treatment.” Patient #4’s (P-4) Start of Care (SOC) was dated 4/5/25. The Plan of Care (POC) identified diagnoses of Acute Bronchitis, Spinal Stenosis, Hypertension and Congestive Heart Failure. During record review on 5/28/25, it was noted that the Skilled Nursing (SN) discharge dated 4/18/25 stated, "Care Summary: (Care Given, Progress, Regress Including Therapies): Skilled SN assessment, observation, evaluation every visits. Medications reviewed and reconciled with patient/cg (caregiver). Patient was instructed regarding Bronchitis management, infection control, Heart Failure management, importance of daily weights, Spinal stenosis management, safety measures, medications and diet. Patient verbalized understanding.” [SIC] The discharge summary failed to follow policy and detail the course of care provided, responses to treatment, any potential continuing needs, and failed to document the patient's health status at the time of discharge. The Administrator (ADM-1) reviewed and acknowledged the findings listed about in an interview on 5/30/25 at 1:10 pm. Patient #1 (P-1): This 95-year-old patient was admitted to this home care agency on 10/29/24 with the diagnoses of type II diabetes mellitus and cervicalgia (neck pain). During record review on 5/28/25, it was noted the patient was discharged from the agency on 12/17/25 and a discharge summary was completed. Upon further review of the record, it was determined there was no evidence the discharge summary was sent to the physician. The Administrator (Adm-1) and consultant (Con-1) reviewed and acknowledged the findings during an interview on 5/30/25 at 12:53 PM.

A recertification survey for Emergency Preparedness was conducted by the Michigan Department of Licensing and Regulatory Affairs, Bureau of Community and Health Systems on 6/21/22 through 6/23/22 at: Royale Home Health Care 20600 EUREKA RD, SUITE 705A TAYLOR, MI 48180 At the survey's conclusion, the agency was found to be in substantial compliance with the requirements for participation in Medicare/Medicaid at 42 CFR §484.102, Emergency Preparedness.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 6/21/22 through 6/23/22 at: Royale Home Health Care 20600 EUREKA RD, SUITE 705A TAYLOR, MI 48180 The services the agency provides are: Skilled Nursing, Physical Therapy, Occupational Therapy, Speech Therapy, Medical Social Work, and Home Health Aide. At the time of the survey, the agency did not operate any branch offices. COVID-19 vaccinations were reviewed during this survey. For this survey, 2 active records without home visits; 2 active records with home visits; 1 active record with an attempted home visit which was declined by the patient upon surveyor arrival; and 2 discharge records were reviewed for a total of 7 records reviewed. The following Condition level deficiencies were identified at: 42 CFR § 484.55 Comprehensive Assessment of Patients 42 CFR § 484.65 Quality Assessment/Performance Improvement 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).

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: Based on record review and interview, the agency failed to ensure the registered nurse conducted the initial assessment visit within 48 hours of referral, to determine the immediate care needs of the patient, including homebound status for 2 of 7 (MR#s 1 and 3) records reviewed (Refer to G-514); failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs in 2 of 7 (MR#s 1 and 2) records reviewed (refer to G-526); failed to ensure the physician was informed of the results of the medication review for any potential adverse effects such as: side effects, drug interactions, and duplicate drug therapy for 2 of 7 (MR#s 3 and 4) records reviewed (refer to G-536). The cumulative effect of these systemic problems resulted in the Home Health Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR 484.55 Comprehensive Assessment of Patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse conducted the initial assessment visit within 48 hours of referral, to determine the immediate care needs of the patient, including homebound status for 2 of 7 (MR#s 1 and 3) records reviewed in which Skilled Nursing services were ordered, resulting in a delay in needed care and services which has the potential to negatively affect the health and well-being of these patients. Findings include: MR#3: During record review on 6/21/22, it was noted that the referral for home care services was fax stamped on 2/28/22 at 11:34 a.m. The start of care comprehensive assessment visit was conducted by CM-B (clinical manager, registered nurse) on 3/5/22, which is 5 days after the agency received the referral for home care services. There was no documentation to indicate the patient/caregiver had delayed the initial assessment and no documentation that the physician had been informed of the 5-day delay in determining the immediate care and support needs of the patient. The agency failed to follow its own policy titled, Referral/Intake (not dated) which states, the case manager is notified by office staff of referral. They have 48 hours to open and must notify office after 48th hour of why they could not, document reasons why and notify physician-turn in for chart. The findings were reviewed with and acknowledged by the administrator (Admin-A) and the clinical manager (CM-B) during an interview on 6/23/22 at 2:00 p.m. **Agency Policy: "Referral/Intake," no date. The policy states, "The case manager is notified by office staff of referral. They have 48 hours to open and must notify office after 48th hour of why they could not, document reasons why, and notify physician-turn in for chart. If the agency staff is unable to see patient in 24-48 hours or the contracted agency staff unable to either, then the physician and patient is notified prior to the end of the 48th hour so patient may be transferred if patient desires to appropriate agency for services." MR#1: The Start of Care (SOC) was dated 3/9/2022/ The Plan of Care for the certification period 3/9/2022 to 5/7/2022 identified diagnoses of polyneuritis, congestive heart failure (CHF), and Diabetes type 2 (DM2). The patient was receiving Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), and Home Health aide (HHa) services. Upon review of of the record on 6/21/22, it was noted the Start of Care Comprehensive Assessment visit was conducted by the Registered Nurse (Staff C) on 3/9/2022. A Physician Order, dated 3/4/2022 included orders for "Home Health Care with PT, OT, RN, and aide Services with Royal Home Healthcare." The order document had a FAX stamp dated 3/4/22 at 4:26 p.m. The Start of Care Comprehensive Assessment visit occurred 5 days after the agency had received the referral for home care services. There were no further physician orders to delay the Start of Care, nor was there any documentation of a patient/caregiver request to delay the Start of Care. In addition, there was no documentation that the physician had been notified of the delay in care. The agency failed to perform the Start of Care Assessment within 48 hours of receiving the home care services order as required by agency policy. The agency failed to follow its own policy titled, Referral/Intake (not dated) which states, the case manager is notified by office staff of referral. They have 48 hours to open and must notify office after 48th hour of why they could not, document reasons why and notify physician-turn in for chart. The findings were reviewed with and acknowledged by the administrator (Admin-A) and the clinical manager (CM-B) during an interview on 6/23/22 at 3:00 p.m.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review, and interview, the Agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs in 2 of 7 records reviewed (MR#s 1 and 2) resulting in incomplete clinical information to aide in determining the needs of the patient. Findings included: Agency Policy: Comprehensive Client Assessment, no date. The policy states, "the purpose: to collect data about the client's health history, physical, functional, and psychological, demographics and history." MR #1: The patient was admitted to the agency on 3/9/2022. The Plan of Care identified diagnoses of Chronic Inflammatory Demyelinating Polyneuritis, Congestive Heart Failure (CHF), Hypertensive Heart Disease with Heart Failure (HF), Diabetes Type 2 (DM2), and Subluxation of left ankle joint. Upon review of the Start of Care Comprehensive Assessment under the category of "Past Medical History," the registered nurse (Staff-C) used check marks to indicate the patient had a history of CHF, Depression, anxiety, DM2, Thyroid problems, Chronic Obstructive Pulmonary Disease (COPD), Urinary Incontinence, COVID, Pneumonia, Fall with Ankle Subluxation and Repair, Obesity, and past surgical history of Appendectomy, Left Ankle Surgery, and Guillen Barre Disease. In addition, the registered nurse documented under the category of "(1021): Primary Diagnosis and (M1023) Other Diagnoses," 11 diagnoses, all with the same date of onset of 3/9/2022." Under the Category of "(M1028: Active Diagnoses-Comorbidities and Co-existing Conditions)", the Skilled Nurse documented, "Diabetes Mellitus." In conclusion, there was no documentation of the patient's past medical history that included the unique dates of onset, exacerbations, treatments, and outcomes and how the listed diagnoses had contributed to the current health of the patient or the need for the current home health care admission. MR#2: The SOC was dated 5/11/2022. The Plan of Care for the certification period 5/11/2022 to 7/9/2022 identified diagnoses of "Multiple Sclerosis, Bilateral osteoarthritis of hip, right and left shoulder, intervertebral disc degeneration of lumbar region, and spondylosis, hypertension (HTN), and bed confinement status. Upon review of the Start of Care Comprehensive Assessment, under the category of "Past Medical History, the registered nurse (Staff-M) used check marks to indicate the patient had a history of Hypertension, Constipation, Fecal Incontinence, Multiple Sclerosis, Urinary Incontinence, and Vision Problems. There was no documented indication of which of these diseases were current or in the past. In addition, under the category of "(1021): Primary Diagnosis and (M1023) Other Diagnoses" there were 8 diagnoses identified, all with the same date of onset of 5/11/2022." There was no documentation of the patient's past medical history that included the unique dates of onset, exacerbations, treatments, and outcomes and how they contributed to the current health of the patient or the need for the current home health care admission.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was informed of the results of the medication review for any potential adverse effects such as: side effects, drug interactions, and duplicate drug therapy for 2 of 7 (MR#s 3 and 4) records reviewed, resulting in the potential for harmful medication effects for these patients. Findings include: MR#3: This 72-year-old patient was admitted to home care on 3/5/22 with primary diagnoses of hypertensive chronic kidney disease, repeated falls, and dementia. During record review on 6/21/22, it was noted that the clinical manager (CM-B) documented on the patient medication record that the patient was on duplicate drug therapy (Fluoxetine and Seroquel). There was no documented evidence that the physician was informed of the duplicate drug therapy. MR#4: This 80-year-old patient was admitted to home care on 5/12/22 with primary diagnoses of diabetes and lower back disc degeneration. During record review on 6/22/22, it was noted that CM-B documented on the patient medication record that the patient was on duplicate drug therapy (Lotrel and Lisinopril). There was no documented evidence that the physician was informed of the duplicate drug therapy. The findings were reviewed with the administrator (Admin-A) and CM-B during an interview on 6/23/22 at 2:00 p.m. CM-B explained that a medication interaction report is generated thru Drugs.com, the results are faxed to the doctor, and a copy of the report is kept in the patient's chart. CM-B acknowledged that there were not copies of the reports in the patient's charts. There was no evidence the physicians were informed of the results of the medication reviews.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included measurable outcomes and goals for skilled nursing for 4 of 7 (MR#s 1, 2, 3, 4) records reviewed, resulting in the potential for poor patient outcomes due to a lack of quantifiable measures to determine patient progress towards goals. Findings include: MR#3: This 72-year-old patient was admitted to home care on 3/5/22 with primary diagnoses of hypertensive chronic kidney disease, repeated falls, and dementia. The 3/5/22 plan of care (POC) ordered weekly nursing visits for this patient. During record review on 6/21/22, it was noted that the POC included the following skilled nursing goals and outcomes: the Patient/Caregiver will be independent with medication management; able to verbalize an understanding of the indications for each medication; and be able to identify the correct dose, route, and frequency of each medication. The goals were not stated in measurable terms that would enable nursing staff to accurately perform an objective evaluation of the patient's progress toward her goals. MR#4: This 80-year-old patient was admitted to home care on 5/12/22 with primary diagnoses of diabetes, lower back disc degeneration, and Alzheimer's disease. The 5/12/22 POC ordered weekly nursing visits for this patient. During record review on 6/22/22, it was noted that the POC included the following skilled nursing goals and outcomes: patient will verbalize understanding of proper use of pain medication; verbalize an understanding of factors that contribute to shortness of breath; and verbalize an understanding of energy conserving measures. The goals were not stated in measurable terms that would enable nursing staff to accurately perform an objective evaluation of the patient's progress toward her goals. The findings were reviewed with and acknowledged by the administrator (Admin-A) and the clinical manager (CM-B) during an interview on 6/23/22 at 2:00 p.m. MR#1: The Start of Care (SOC) was dated 3/9/2022. The Plan of Care for the certification period 3/9/2022 to 5/7/2022 identified diagnoses of polyneuritis, congestive heart failure (CHF), and Diabetes type 2 (DM2), The patient was receiving skilled nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), and Home Health aide (HHa) services. Upon review of the Plan of Care, it was noted the goals were not objectively measurable to determine the patient's progress towards goals. Examples include: "The Patient/Caregiver will verbalize an understanding of skin conditions that must be reported to the Skilled Nurse or physician immediately." "Rehab potential: Fair to achieve stated goals with skilled intervention and patient's compliance with the plan of care." MR#2: The Start of Care was dated 5/11/2022. The Plan of Care for the certification period of 5/11/22 to 7/9/2022 identified diagnoses of Multiple Sclerosis, bilateral primary osteoarthritis of hip, right shoulder, left shoulder, hypertension, and bed confinement status. Upon review of the Plan of Care, it was noted the goals were not objectively measurable to determine the patient's progress towards goals. Examples include: "The patient/caregiver will verbalize understanding of individualized emergency plan by 5/11/22; The patient/caregiver will verbalize understanding of medication regimen, dose, route, frequency, indications, and side effects by 5/11/2022." These goals are not objectively measurable to determine the patient's progress towards goals.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide services as ordered in the Plan of Care in 1 of 7 records reviewed (MR#1), resulting in the potential decline of the patient's health status. Findings included: MR#1: MR#1: The Start of Care (SOC) was dated 3/9/2022/ The Plan of Care for the certification period 3/9/2022 to 5/7/2022 identified diagnoses of polyneuritis, congestive heart failure (CHF), and Diabetes type 2 (DM2). Upon review of the record it was noted that the skilled nurse failed to provide assessments as ordered in the Plan of Care. Findings included: The Plan of Care, dated 3/9/2022 included orders to report to the physician measurements outside the following parameters: "edema of the lower extremities greater than 3+; weight gain 2-4 pounds in 24 to 72 hours, or 5-6 pounds in 5-7 days." Upon review of the skilled nurse visit notes dated 3/9/22, 3/16/22, and 3/25/22, it was noted, the registered nurse (staff-C) failed to measure and document the patient's weights and lower extremity edema. The skilled nurse failed to provide services as ordered in the Plan of Care.

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 record review and interview the agency failed to develop a Quality Assessment Performance Improvement (QAPI) program to optimize patient outcomes. These practices could affect all of the agency's patients. The cumulative effect of these systemic problems resulted in the agency's inability to improve patient care, health outcomes, patient safety, and the agency's overall care performance resulting in the agency not providing quality health care. Findings included: The agency failed to develop a Quality Assessment Performance Improvement (QAPI) program to optimize patient outcomes (G-642); failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program to ensure the effectiveness and safety of services, quality of care, and to identify opportunities for improvement. (G-644); failed to initiate any performance improvement activities within their QAPI program that focused on high risk, high volume, or problem prone areas, resulting in the potential for agency issues with negative consequences for high risk, high volume, or problem prone areas that could affect all patient served by the agency (G-648); failed to initiate any performance improvement activities within their Quality Assessment Performance improvement Program (QAPI), that addressed incidence, prevalence, and severity of problems identified amongst the agency's own patient population as areas of focus to improve patient care, resulting in the potential for rendering substandard care and unmet care needs (G-650); failed to track adverse patient events, analyze their causes, and implement preventive actions (G-654); failed to document the agency's Performance Improvement Program for 2022 (G-658); and failed to ensure a Performance Improvement Program for quality improvement and patient safety is defined, implemented, maintained, addresses priorities for improved quality of care, patient safety, and that all improvement actions are evaluated for effectiveness (G660). The cumulative effect of these systemic problems results in poor patient outcomes.

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 reviewed and Interview, the Agency failed to develop a Quality Assessment Performance Improvement (QAPI) Program to optimize the agency's patient outcomes. This practice could affect all of the agency's patients admitted during 2021/2022. Findings included: Upon review of the agency's QAPI Program on 6/23/2022 it was discovered that the agency failed to initiate a QAPI program based on monitoring adverse or negative patient outcomes or processes the agency wishes to measure for improvements. A review of the QAPI program did include national indices, however there was no evidence that any data was used based on the agency's own patient population and record keeping to determine the need for a coordinated agency-wide program for the surveillance investigation, identification, and prevention of future negative outcomes. These findings were reviewed and acknowledged by the Clinical Manager (CM-B) on 6/23/2022 at 3:00 p.m.

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 and record review, the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program to ensure the effectiveness and safety of services, quality of care, and to identify opportunities for improvement. Findings included: During a review of the Agency QAPI Program on 6/23/2022, it was noted that the program included a large amount of statistics from National Home Care Venues, however there was no evidence the agency had developed a QAPI program that included methods to collect and monitor it's own patient data to ensure the safety of patients and the quality of care. There was also no indication that the Governing Body had approved the manner, frequency, and detail of patient data collection as a measurement to identify improvement in patient care. These findings were reviewed and acknowledged by the Clinical Manager (CM#1) on 6/23/22 at 3:00 p.m.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to initiate any performance improvement activities within their QAPI program that focused on high risk, high volume, or problem prone areas, resulting in the potential for agency issues with negative consequences for high risk, high volume, or problem prone areas that could affect all patient served by the agency. Findings included: During a review of the Agencies QAPI program, it was noted that there was no data collected specific to the agency's patient population. The large notebook that was provided for review did have data from multiple home care data sources, but no data was noted that was specific to the agency. During an interview with the Clinical Manager (CM#1) on 6/23/22 at 3:00 p.m., CM#2 stated, "the national data is collected as a baseline for which to compare our own patient population's data, but I am the acting Clinical Manager for many Home Care Agencies, and I will admit, I am behind on collecting patient QAPI data for this agency."

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on document review and interview, the Agency failed to initiate any performance improvement activities within their Quality Assessment Performance improvement Program (QAPI), that addressed incidence, prevalence, and severity of problems identified amongst the agency's own patient population as areas of focus to improve patient care, resulting in the potential for rendering substandard care and unmet care needs. Findings included: During a review of the agency's QAPI Program. it was noted the agency collected national data of Home Health Services. Due to the agency not collecting data for the Agency's own patients, and not having an active QAPI program initiated for the year 2022, the agency was unable to consider, incidence, prevalence, and severity of problems within their own agency to consider the severity of problems identified within the agency. These findings were reviewed and acknowledged during an interview with the Clinical Manager (CM-B) on 6/23/22 at 3:00 p.m.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on document review, and interview, the agency failed to track adverse patient events, analyze their causes, and implement preventive actions. Findings include: During an interview with the Clinical Manager (CM-B) on 6/23/22 at 3:00 p.m., the clinical manager was asked if the agency had tracked the agency's adverse patient events, and investigated the causes in order to implement preventive actions. The response was, "I can get that information from national reports, but I am behind on collecting QAPI data for our patients, and thus have no current agency data on our patients adverse events or the causes and solutions." These findings were acknowledged by the Clinical Manager (CM-B) on 6/23/2022 at 3:00 p.m.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to initiate any performance improvement projects for 2020 that were based on QAPI program activities, data collected, and emphasizes identified needs for agency and patient improvements resulting in no programs to improve the home health services provided by the agency. Findings included. During a review of the Agency's Quality Assessment and Performance Improvement program documents on 6/23/2022, it was noted there was no documentation of the agency's Performance Improvement Program for 2022. Findings included: During an interview on 6/23/2022 at 3:00 p.m., the Clinical Manager (CM-B) was asked to provide and discuss the agency's Performance Improvement Program for 2022. CM-B stated, "I'll be honest, we do not have a Performance Improvement Program for this year, I just have not had the time to implement one because I work for several Home Health Care agencies. Next year I plan to monitor and improve our patient satisfaction surveys." The agency failed to initiate a performance improvement program for 2022, resulting in a lack of needed improvements for this agency.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on document review and interview, the Governing Body failed to ensure a Performance Improvement Program for quality improvement and patient safety is defined, implemented, maintained, addresses priorities for improved quality of care, patient safety, and that all improvement actions are evaluated for effectiveness. Findings include: During an interview with the Clinical Manager (CM-B) on 6/23/2022 at 3:00 p.m., CM-B was asked what Quality Assessment and Performance Improvement project was approved and implemented by the agency for the year 2022. The response was, "I have been so busy this year we did not get approval by the Governing Board for a QAPI program this year. I work for several Home Care Agencies, and just have not had the time to initiate a program. We have been monitoring and tracking any COVID-19 infections reported by patient's and staff, but this was not formally approved by the Governing Body as a QAPI project." The agency failed to approve, implement, monitor, tract, maintain a QAPI program that addresses the agency priorities for improved care and patient safety and are evaluated for success.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure to document and track the COVID-19 vaccination completion, exemption, or temporary delay status for 1 of 14 (Staff-D) staff that provide patient care, treatment, or other services for the agency. This has the potential to negatively affect the health and well-being of the agency's 9 current patients. Findings include: On 6/22/22, the clinical manager (CM-B) provided a list of names of agency employees and identified which staff were vaccinated as of June 22, 2022. The list contained the names of 14 field staff and 2 office staff. A review of personnel files on 6/22/22, indicates that one contracted registered nurse (Staff-D) failed to have documentation of vaccination completion, exemption (medical or religious), or temporary delay status. During an interview on 6/22/22 at 12:45 p.m., CM-B explained that she was unaware that Staff-D has a religious exemption, and that documentation of the approved exemption was not available. This indicates a compliance rate of 93% for field staff. The finding was reviewed with and acknowledged by CM-B at the time of discovery.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the medical social worker performed an assessment of the patient's health status and needs in 1 of 2 (MR# 3) records reviewed with social work services, resulting in the potential for unidentified health concerns, delay in care needs, and poor patient outcomes. Findings include: MR#3: This 72-year-old patient was admitted to home care on 3/5/22 with primary diagnoses of hypertensive chronic kidney disease, repeated falls, and dementia. The 3/5/22 plan of care (POC) ordered skilled nursing, home health aide, physical therapy, occupational therapy, and social work services for this patient. The POC ordered the medical social worker (MSW) to evaluate and treat this patient. During record review on 6/21/22, it was noted that the MSW conducted an evaluation of this patient on 3/22/22, which is 17 days after MSW services were ordered. There was no documentation to indicate the patient had declined or delayed this service. The MSW failed to provide a timely interdisciplinary assessment of the patient's health status and care needs. The finding was reviewed with and acknowledged by the administrator (Admin-A) and the clinical manager (CM-B) during an interview on 6/23/22 at 2:00 p.m. CM-B stated the MSW assessment should have been conducted within 5 days of the physician order.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that the skilled nurse followed the visit frequency ordered by the physician as indicated in the patient plan of care in 1 (MR# 5) of 7 sample records reviewed resulting in potential for physical decline and unmet patient care needs. Findings include: MR# 5: This 61-year-old patient was admitted to the Agency on 6/10/22 with diagnoses of Type 2 diabetes (disease that develops when blood sugar is regularly too high); Osteoarthritis of both knees and right shoulder (protective cartilage of the joint is wearing down); and high blood pressure. During record review on 6/22/22, it was noted that the plan of care (POC) indicated the skilled nurse (SN) would have a visit frequency of one time a week for 3 weeks. The clinical record indicated that 6/15/22 was the target date for the second visit by an SN but the visit had not yet been started and no other visits were completed for that week (second week of care). There were no documented physician orders, or other communication that the SN visit frequency was changed, and no SN missed visit note had been completed for the second week of care. During interview on 6/23/22 at 2:25 p.m. with Administrator (Admin-A) and Clinical Manager (CM-B), it was acknowledged that the physician ordered frequency for SN was not followed and no visit occurred in week 2 of care for this patient.

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure 2 of 3 (Staff-J and Staff-K) home health aides were qualified to provide services, resulting in the potential provision of substandard care for the agency's 58 patients who may received aide services in the past 12 months. Findings include: During review of the home health aide personnel files on 6/22/22, the following was noted: Staff-J: Date of hire unknown, documents were not dated. The personnel file contained a certificate from the Foundation for Hospice and Homecare dated 4/13/93. The certificate indicates that Staff-J had successfully met the basic standards of training. There was no documentation to indicate the agency had ensured Staff-J had also completed a competency evaluation. Staff-K: Date of hire 3/1/22. The personnel file contained a certificate for the nurse aide registry utilized by the State of Michigan. The certificate expired on 4/30/22. The agency failed to ensure Staff-K was qualified to provide home health aide services. The findings were reviewed with and acknowledged by the administrator (Admin-A) and the clinical manager (CM-B) during an interview on 6/23/22 at 2:00 p.m.

Services under arrangement CFR(s): 484.105(e)(1) The HHA must ensure that all services furnished under arrangement provided by other entities or individuals meet the requirements of this part and the requirements of section 1861(w) of the Act (42 U.S.C. 1395x (w)). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure 1 of 1 contract (Contractor# 1) met the requirements of section 1861(w) of the Act (42 U.S.C. 1395x(w)), resulting in the potential to adversely affect the finances of all patients that received contracted services. Findings include: Contractor#1: On 6/22/22, the contract with Contractor#1 dated September 2020 to provide physical therapy and "other services" was reviewed. During review of the contract it was noted that the contract failed to include the regulatory language of section 1861(w) of the Act (42 U.S.C 1395x(w)), which states, "...receipt of payment by the...home health agency...with respect to services for which an individual is entitled to have payment made under this title, discharges the liability of such individual or any other person to pay for the services." The regulatory language ensures that both the contract agency and the home health agency would not simultaneously charge patients for covered services and items.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure to have a written agreement with 3 of 4 (Staff-D, Staff-E, and Staff-G) independent contractors furnishing services under arrangement to agency patients, resulting in a lack of overall responsibility by the agency for the services provided under arrangement. Findings include: During record review on 6/22/22, it was noted that 3 individuals were independent contractors providing services at the agency without agreements or contracts to ensure the agency retained overall responsibility for the services provided by these individual contractors. The following individuals are 1099 workers (independent contractors or self-employed) providing services at the agency: Staff-D provides registered nurse services and was hired on 4/10/22. Staff-E provides occupational therapy services and was hired on 10/26/21. Staff-G provides medical social worker services and was hired on 10/23/21. The findings were reviewed with the administrator (Admin-A) and the clinical manager (CM-B) during an interview on 6/23/22 at 2:00 p.m. Admin-A confirmed the 3 independent contractors did not have written agreements for review.

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 that the clinical record contained the individualized patient plan of care and the physical therapy evaluation in a timely manner in 1 (MR# 5) of 7 sample records reviewed resulting in the potential for unmet patient-specific care needs and education. MR# 5: This 61-year-old patient was admitted to the Agency on 6/10/22 with diagnoses of Type 2 diabetes (disease that develops when blood sugar is regularly too high); Osteoarthritis of both knees and right shoulder (protective cartilage of the joint is wearing down); and high blood pressure. During record review on Tuesday 6/21/22 at 3:30 p.m. (11 days after the start of care), it was noted that the clinical record did not contain the individualized patient specific plan of care (POC). The record also indicated that the physical therapy (PT) evaluation was “not started” but the target date for the visit was 6/14/22. On 6/22/22 at 10:30 a.m., this record reviewed continued, and it was noted that the POC had been entered and “sent to physician”, and the PT evaluation with visit date 6/14/22 had been completed and added to the clinical record. Agency policy: “Timely Submission of Patient Documentation” was reviewed on 6/22/22 and it states that all documentation including: physician orders, evaluations, plan of care, visit notes, etc, must be turned every Monday by 5PM and if Monday is a holiday, then Tuesday by 12 noon. Both the individualized POC and the PT evaluation were entered into the patient's clinical record later than the acceptable time frame indicated in the Agency policy. On 6/23/22 at 2:25 p.m. these findings were reviewed with and acknowledged by Admin-A (Administrator) and (Clinical Manager) CM-B.

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 insure a detailed transfer summary was sent to the receiving health care facility within 2 business of becoming aware of the transfer for 1 of 1 (MR# 3) records reviewed with transfers to other health care facilities, resulting in a lack of information to ensure continuity of care for this patient. Findings include: MR#3: This 72-year-old patient was admitted to home care on 3/5/22 with primary diagnoses of hypertensive chronic kidney disease, repeated falls, and dementia. During record review on 6/21/22, it was noted that the physical therapist (Admin-A) documented a transfer summary for this patient on 4/22/22. The summary notes that the patient had a fall on 4/21/22, was admitted to the hospital, and the hospital discharge planner was notified that the patient was receiving home health agency services. There was no evidence that a transfer summary had been sent to the receiving hospital within 2 business days of becoming aware of the transfer. The findings were reviewed with and confirmed by Admin-A and the clinical manager (CM-B) during an interview on 6/23/22 at 2:00 p.m. CM-B reviewed the medical record and could provide no evidence that the transfer summary had been sent to the receiving hospital.

Occupational Therapist CFR(s): 484.115(f) Standard: Occupational therapist. A person who- (1)(i) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the state in which practicing, unless licensure does not apply; (ii) Graduated after successful completion of an occupational therapist education program accredited by the Accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA), or successor organizations of ACOTE; and (iii) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). (2) On or before December 31, 2009- (i) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the state in which practicing; or (ii) When licensure or other regulation does not apply- (A) Graduated after successful completion of an occupational therapist education program accredited by the accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA) or successor organizations of ACOTE; and (B) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc., (NBCOT). (3) On or before January 1, 2008- (i) Graduated after successful completion of an occupational therapy program accredited jointly by the Committee on Allied Health Education and Accreditation of the American Medical Association and the American Occupational Therapy Association; or (ii) Is eligible for the National Registration Examination of the American Occupational Therapy Association or the National Board for Certification in Occupational Therapy. (4) On or before December 31, 1977- (i) Had 2 years of appropriate experience as an occupational therapist; and (ii) Had achieved a satisfactory grade on an occupational therapist proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. (5) If educated outside the United States, must meet both of the following: (i) Graduated after successful completion of an occupational therapist education program accredited as substantially equivalent to occupational therapist entry level education in the United States by one of the following: (A) The Accreditation Council for Occupational Therapy Education (ACOTE). (B) Successor organizations of ACOTE. (C) The World Federation of Occupational Therapists. (D) A credentialing body approved by the American Occupational Therapy Association. (E) Successfully completed the entry level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). (ii) On or before December 31, 2009, is licensed or otherwise regulated, if applicable, as an occupational therapist by the state in which practicing. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure 1 of 2 (Staff-F) contracted occupational therapists were licensed to provide therapy services, resulting in the potential for substandard care for the agency's 58 patients who may received occupational therapy services in the past 12 months. Findings include: During review of personnel files on 6/22/22, it was noted that the occupational therapist license for Staff-F had expired on 5/31/22. The findings were reviewed with and acknowledged by the administrator (Admin-A) and the clinical manager (CM-B) during an interview on 6/23/22 at 2:00 p.m.