Royale Home Health Care, Inc.

“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.”

“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.”

“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.”

“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.”

“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.”

“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.”

“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 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.”

“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.”

“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.”

“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.”