Purple Heart Home Health Care

“Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: Based on record review and interview, the agency failed to include delegations of authority and succession plans in the event of an emergency/disaster (See E0007); failed to incorporate an individual Emergency Preparedness Plan into the Comprehensive Patient Assessment as required (See E0017); failed to incorporate the use of volunteers or other staffing strategies to address surge needs during an emergency (See E0024); failed to develop and maintain an Emergency Preparedness communication plan that complies with Federal, State, and local laws (See E0029); failed to provide an alternate means of communicating with its staff, Federal, State, and local emergency management authorities (See E0032); failed to provide initial training in emergency preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, and failed to maintain documentation of training’s (See E0037); and failed to provide documentation for the required annual tabletop and community based full-scale exercises, nor any documentation of an actual event that would qualify as a test of the emergency plan (See E0039). 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 § 484.102: Emergency preparedness.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included interventions, safety precautions, and patient specific measurable goals (G574); failed to ensure that all services were provided only as ordered by the Physician (G580); failed to ensure Physician’s orders were signed, authenticated and dated by the Physician (G584); failed to ensure the Physician was promptly notified of major drug interactions and patient changes in condition (G590); and, failed to ensure patient needs were coordinated between Skilled Nursing and Physical Therapy services (608). 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 § 484.60: Care Planning, Coordination, Quality of Care.”

“EP Program Patient Population CFR(s): 484.102(a)(3) §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This Standard is not met as evidenced by: Based on record review and interview, the agency failed to include delegations of authority and succession plans in the event of an emergency, resulting in the potential to hinder the agency’s ability to provide continued patient care to all 8 patients currently receiving services. Findings include: On 6/13/2025, review of agency’s Emergency Preparedness plan revealed no evidence that provided delegations of authority and succession plans during an emergency. The agency’s communication plan had names of agency staff members but lacked any detail concerning who was responsible for what assigned task to facilitate an organized emergency response to meet the needs of its patients. The Administrator (Adm #1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 10:52 AM. The agency failed to incorporate delegations of authority among key personnel to ensure patient care would be continued.”

“HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA’s patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to incorporate an individual Emergency Preparedness Plan into the Comprehensive Patient Assessment for 2 (P-5, P-7) of 7 records reviewed for Emergency Preparedness, from a total sample of 7 records reviewed, resulting in the potential for negative patient outcomes in the event of an actual emergency for the agency’s current 8 patients. Findings include: Patient (P-7): This patient’s start of care was 6/26/24 with diagnoses that included Diabetes Mellitus with Left Heel Foot Ulcer. During the clinical record review on 6/11/25 at 2:10 p.m., it was noted that the Initial Comprehensive Assessment documented that the patient was chair bound, required assistance to ambulate, had an unsteady gait and morbid obesity. Additionally, the patient required wound care and Insulin. The “Patient Individualized Emergency Plan” dated 6/26/24 failed to include the aforementioned limitations or identified risks that would aide personnel in assisting the patient in the event of an emergency. The Administrator, Alternate Administrator and Intake Coordinator reviewed and acknowledged these findings during an interview on 6/12/25 at 2:55 p.m. Patient #5 (P-5)’s start of care date was on 1/6/2025 with diagnoses which included hypertensive chronic kidney disease, diabetes type-2, COPD (chronic obstructive pulmonary disease), and smoking while on supplemental oxygen. During record review on 6/12/25, it was revealed the “Patient Individualized Emergency Plan” (PIEP) failed to have any listed emergency contact numbers of family/friends and that P-1 lives alone. In addition, the initial comprehensive assessment documented P-1 had significant clinical needs such as being on supplemental oxygen while being an active smoker and requiring TPN (total parenteral nutrition or tube feeding) for intake needs. The PIEP also failed to include an update concerning a hospitalization on 3/26/25, where P-1’s cholecystectomy tube (drainage tube from gallbladder) was accidentally pulled out. P-1 is noted to be “confused and forgetful at times.” Further, The PIEP has three assigned priority levels: Level 1-needing attention within 24 hours, Level 2-within 24-48 hours, and Level 3-within 48-72 hours. The PIEP inappropriately classified P-1 as the lowest priority despite the above findings. The Administrator (Adm #1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 10:50 AM.”

“Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.542(b)(6), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop an Emergency Preparedness Plan that included policy and procedure concerning the use of volunteers, as appropriate, and/or other emergency staffing strategies to address surge staffing needs experienced during an emergency, resulting in the potential for the interruption in needed care and services for staff and all 8 patients currently serviced by this agency. Findings include: On 6/13/2025, review of the agency’s Emergency Preparedness (EP) policy and procedure binder revealed no specific language that included a process for the integration or use of volunteers, as appropriate, or other staffing strategies with local, regional, State, and Federal officials to address surge needs in the event of a large-scale emergency. The Administrator (Adm #1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 10:47 AM.”

“Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an Emergency Preparedness communication plan that integrated specific roles, tasks and responsibilities of its staff in the event of an actual emergency, resulting in the agency’s inability to ensure the coordination of patient care during an emergency/disaster and the potential to negatively affect the health and safety of all 59 patients who have received services within the past 3 years. Findings include: On 6/12/25, review of the agency’s Emergency Preparedness (EP) documentation for the last 3 years concerning its Communication Plan (CP) found no evidence of staff specific roles regarding how patient needs would be effectively communicated in the event of an actual emergency. Further review of the EP’s policy and procedure manual lacked any process/procedures of how staff members would communicate and coordinate the support of patient care needs within the agency and other healthcare providers during an emergency/disaster. The Administrator (Adm #1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 10:49 AM.”

“Primary/Alternate Means for Communication CFR(s): 484.102(c)(3) §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(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: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to provide an alternate means of communicating with its staff, Federal, State, and local emergency management agencies in the event of an actual emergency/disaster, resulting in the potential to negatively affect the safety and well-being of all 8 patients currently receiving services during an actual emergency. Findings include: On 6/12/25, review of the agency’s Emergency Preparedness (EP) plan found no evidence that an alternate means of communication was tested or utilized to ensure its effectiveness. Additional review of the EP binder found that the Agency’s Administrator (Adm #1) had checked a box noting the Agency had an alternate means of communication in the event of an emergency, but when the Administrator was asked to show what was used, Adm-1 was unable to show any evidence this was true. The Administrator (Adm #1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 10:54 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 provide initial training in its Emergency Preparedness (EP) policies and procedures for 3 of 3 contracted employees, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 6/13/25 at 9:15 AM, review of the agency’s personnel files revealed that 3 of 3 contracted staff who provide clinical services for the agency, failed to provide evidence that initial EP training was instructed as required. The Administrator (Adm #1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 10:57 AM. Adm #3 later confirmed the contracted staffing agency did not have records indicating the 3 contracted staff utilized by the home care agency had any initial EP training on 6/13/25 at 11:48 AM.”

“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 provide documentation for the required community/facility based full-scale exercises and tabletop exercises, and failed to provide documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff being unprepared in the event of an actual emergency. This deficient practice could negatively affect all 8 patients currently being serviced by this agency. Findings include: On 2/28/23 at 2:10 PM., review of the agency’s Emergency Preparedness binder found no evidence the Agency had conducted the required full-scale community-based exercise every two years as required. The agency’s Administrator (Adm #1) documented 2 actual events (3-7 inches of snow on 2/14/25 and severe weather on 8/28/24) that had no evidence of any staff participation. In addition, documentation of details concerning the actual drill itself by any staff member was not evidenced. The Administrator (Adm #1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 10:55 AM. The agency failed to provide sufficient evidence of compliance for both the agency and community-based testing exercises once every two years.”

“Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to utilize collected data concerning known patient infections to identify potential causative factors, track and trend data collected, and establish a corrective plan which would be monitored for its effectiveness as part of the agency’s Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for unrecognized and untreated infections among staff and all 8 patients currently being serviced. Findings include: On 6/13/25, the agency’s infection control program was reviewed, which noted collected data of known patient infections experienced during admission(s). However, follow-up documentation regarding the tracking/trending of infection control data was not found. The Administrator (Adm#1) and Alternate Administrator (Adm #3) were interviewed on 6/13/25 to ascertain the extent of collected infection control data that would be utilized to generate identified trends so resultant actions could be implemented for improvement in areas focusing on infection control. Adm#1 and Adm #3 were unable to provide documentation that suggested the Agency had effectively used any of the collected data as required. The Administrator (Adm#1) and Alternate Administrator (Adm #3) reviewed and acknowledged the above findings during an interview on 6/13/25 at 10:30 AM.”

“Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This Standard is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure Skilled Nursing (SN) had performed all clinical assessments appropriately in 1 (P-4) of 3 observed home visits, resulting in incomplete clinical information to aid in determining the clinical needs of this patient and the potential for a poor outcome. Findings include: Patient #4 (P-4)’s start of care date was on 5/26/25, with diagnoses that included hemiplegia with associated left sided weakness, hypertension, and chronic obstructive pulmonary disease (COPD). On 6/11/25 at 1:30 PM, a joint survey home visit with the Skilled Nursing (SN) was conducted. During the visit, SN was observed checking P-4 for bilateral lower leg edema (swelling). SN performed her edema check for only 1 second. After the assessment was complete, SN was asked to check for pitting edema (type of edema that leaves an indentation in the skin for a short period). SN was confused by the question and admittedly did not know how to appropriately check for pitting edema. SN was then asked to use her finger to press into the skin and hold for at least 5 to 10 seconds and release. SN proceeded to do so and found there was an indentation lasting 13 seconds or a grade of 2+ (moderate level). After the visit, additional record review found 2 of 2 home visits (initial comprehensive assessment on 5/26/25 and a routine home visit on 6/2/25) had charted non-pitting edema. This is clinically significant as pitting edema represents fluid overload and responds often to diuretics where non-pitting is likely caused by lymphatic system issues and often requires more specialized care. Record review found no evidence that the physician was made aware of the above findings. The Administrator (Adm#1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 11:06 AM.”

“Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide’s performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the individuals who furnished Home Health Aide services on its behalf, met the competency evaluation requirements of this section by ensuring the subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section were evaluated by a Registered Nurse who observed the Aide’s performance of the required tasks with a patient/pseudo-patient in 1 (HHa #1) of 1 Home Health Aide personnel record reviewed, resulting in the potential for the provision of substandard care and unmet care needs Findings include: On 6/12/25 at 3:25 p.m., a review of the Home Health Aide (HHa #1) personnel file revealed the following: HHa #1: Date of hire was 2/4/19. “The Initial Competency Checklist” dated 2/4/19 revealed topics such as “Temp, Pulse, Respiratory, Blood Pressure: reading & recording, sponge, tub, shower bath, oral hygiene, toileting & elimination, fluid intake, ambulation, range of motion, positioning...” There was no clear indication if any of the above tasks were directly observed on an actual or pseudo-patient as per this requirement. Additionally, the requirements for bathing include sponge bath, bathing, tub and the provision of a shower. The section titled, “Observed in home with patient:” was left blank. There was no documented evidence that the Registered Nurse observed HHa #1 perform all the required tasks. The Alternate Administrator reviewed and confirmed the above findings during an interview on 6/13/25 at 12:35 p.m. and confirmed”

“Basis and Scope CFR(s): §484.80(h)(1)(iv) A registered nurse or other appropriate skilled professional must make an annual on-site visit to the location where a patient is receiving care in order to observe and assess each aide while he or she is performing care. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the skilled discipline made an annual onsite observation visit at a patient’s residence to observe the care being provided, by 1 (HHa #1) of 1 Home Health Aide employed by this agency, who’s file reviewed, resulting in the potential for the provision of substandard care and unmet care needs. Findings include: On 6/12/25 at 3:25 p.m., a review of the Home Health Aide (HHa #1) personnel file revealed the following: HHa #1: Date of Hire was 2/4/19. There was no documented evidence in HHa #1’s personnel file that the skilled discipline made an annual onsite visit at a patient’s place of residence to assess and ensure the adequate provision of care. The Alternate Administrator reviewed and acknowledged the above findings at the time of the review and reported, “It (evaluation) wasn’t done with a patient or in a patient’s home.””

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure that 1 (P-4) of 3 home visit records reviewed out of a total of 7 records reviewed, were provided advance notice of which disciplines would furnish care and the visit frequency expected from each discipline, resulting in a lack of inclusion in planning, lack of informed consent, the potential for missed visits and unmet care needs. Findings include: Patient #4 (P-4)’s start of care date was on 5/26/25, with diagnoses that included hemiplegia with associated left sided weakness, hypertension, and chronic obstructive pulmonary disease (COPD). On 6/11/25 at 1:30 PM, a joint survey home visit with the Skilled Nursing (SN) was conducted. During the visit, the patient’s admission packet was reviewed and the “Admission Consent” was observed being blank concerning all potential disciplines and for any of the intended home visit frequencies. The Administrator (Adm#1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 10:59 AM.”

“Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to provide skilled services as ordered on the Plan of Care (POC) for 1 (P-4) of 7 total sample records reviewed, resulting in the potential for poor patient outcomes. Findings include: Patient #4 (P-4)’s start of care was on 5/26/25, with diagnoses that included hemiplegia with associated left sided weakness, hypertension, and chronic obstructive pulmonary disease (COPD). The POC effective 5/26/25, ordered skilled nursing (SN) services once weekly times 5 weeks. On 6/12/25, record review noted the following documentation on P-4’s POC: “MD has verbal order to draw blood culture, complete metabolic panel and lytes (electrolyte levels) next week.” The next SN visit occurred on 6/2/25 which documented the following: “Writer (Clinical Manager/CM #1) unable to obtain bottles for blood cultures... Patient’s lower legs are warm to touch. Slight redness noted to left leg.” The Administrator (Adm#1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 11:03 AM. Both were queried why CM #1 was not prepared to complete the physician’s order when she knew of the order the week before on P-4’s POC? Both had no answer as to why the order was not completed. No subsequent or follow-up SN visits had been performed by the time of exit on 6/13/25 at 2:05 PM to determine if P-4’s left leg continued to exhibit signs and symptoms of infection.”

“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 conduct the initial assessment visit within 48 hours of the referral date or within 48 hours of the patient’s return home from an inpatient hospitalization in 1 (P-1) of 7 records reviewed. Findings included: A review of the agency’s policy states, “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.” Patient #1’s (P-1) Start of Care (SOC) was dated 2/26/25. The Plan of Care (POC) identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Hypertensive Heart Disease with Heart Failure (HF), Diastolic Congestive Heart Failure (CHF), Low Back Pain, Hyperlipidemia, Morbid Obesity, Obstructive Sleep Apnea, and Dependance on supplemental oxygen. The patient was receiving Skilled Nursing (SN) and Physical Therapy (PT) services. Upon review of the record, it was noted the patient had been discharged from a hospitalization on 2/22/25. However, the Start of Care Assessment was dated 2/26/25, 4 days after the patients release from the hospital. There was no physician order found in the record that indicated the Physician had ordered a delayed Start of Care Assessment. These findings were reviewed and acknowledged by the Administrator (ADM#1) and Alternate Administrator (ADM#3) during an interview on 6/12/25 at 3:30 p.m.”

“Patient’s needs CFR(s): 484.55(c)(4) The patient’s medical, nursing, rehabilitative, social, and discharge planning needs; This Element is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure the patient’s Activity of Daily Living needs were adequately met in the patient’s home for 2 (P-6, P-7) of 2 patients assessed as needing assistance with grooming, from a total of 7 sampled records reviewed, resulting in the potential for poor hygiene, psychological decline, low self-esteem and unmet care needs. Findings include: Patient #6 (P-6)’s start of care (SOC) was 5/16/25 with diagnoses that included Metabolic Encephalopathy and Essential Hypertension. The Plan of Care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT) and Speech Therapy (ST) services to be provided. During the clinical record review on 6/11/25 at 12:35 p.m., it was noted that section M1800 (grooming) of the Initial Comprehensive Assessment dated 5/16/25 documented someone must assist with grooming, dressing, unable to participate effectively in bathing and is bathed totally by another person, someone must assist with toileting. The section titled “Care Management” documented, non-agency caregivers need training/supportive services to provide assistance.” The PT Initial Evaluation dated 5/16/25 documented, Need assist with adl’s [sic] (activities of daily living), Limited CG (caregiver) support. Upon further review, there was no documented evidence that a home health aide was either offered or provided to assist with the patient’s activities of daily living needs. The Administrator (Adm #1), Alternate Administrator (Adm #3) and Intake Coordinator (IC #1) reviewed and acknowledged the above findings during an interview on 6/12/25 at 2:30 p.m. P-7’s SOC was 6/26/24 with diagnoses that included Diabetes Mellitus with Foot Ulcer. The POC ordered SN and PT services to be provided. During the record review on 6/11/25 at 2:10 p.m., it was noted that the referral for home care dated 6/21/24 documented “Reason for home care: Difficulty ambulation and morbid obesity, chair bound, unsteady gait, required assistance to ambulate.” The section of the Initial Comprehensive Assessment dated 6/26/24 titled, “Patient Living Situation” failed to document an available, willing caregiver to assist with ADL’s. Section M1800 revealed someone must assist with grooming, dressing upper and lower body, must be reminded, assisted or supervised when toileting, requires assistance with toileting hygiene. Section M2102 documented, “Non-agency caregivers need training/supportive services to provide assistance.” Upon further review, there was no documented evidence that a home health aide was either offered or provided to assist with the patient’s activities of daily living needs. Adm #1, Adm #3 and IC #1 reviewed and acknowledged the above findings during an interview on 6/12/25 at 2:30 p.m.”

“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 interventions, safety precautions, and patient specific measurable goals in 5 (P-1, P-2, P-3, P-4, and P-7,) of 7 records reviewed, resulting in the inability to determine the patient’s progress towards goal and the potential for poor patient outcomes. Findings include: Patient #4 (P-4)’s start of care date was on 5/26/25, with diagnoses that included hemiplegia with associated left sided weakness, hypertension, and chronic obstructive pulmonary disease (COPD). On 6/11/25, review of the Plan of Care (POC) noted 18 of 18 listed skilled nursing goals were not written in measurable terms to track and trend P-4’s clinical progress made or lack of. Examples include: Patient/Caregiver will demonstrate competence with self-management of COPD as evidenced by adherence to medication regimen, ability to identify s/s (signs and symptoms) necessitating contact with medical professionals, diet regimen guidelines, activity compliance and symptom management by 06/14/2025; Patient/Caregiver will be able to verbalize signs and symptoms of cardiac complications, when to call physician, nurse or 911 by 06/07/2025; Patient/Caregiver will demonstrate understanding of individual emergency preparedness plan by 06/07/2025. In addition, review of the physician face to face assessment notes on 4/24/25 revealed P-4 was to be on aspiration (swallowing) precautions and DVT (deep vein thrombosis/blood clot) precautions resultant from a stroke causing hemiplegia (condition caused by brain damage that leads to paralysis on one side of the body). The safety precautions listed in the POC failed to acknowledge and include both precautions noted above. The Administrator (Adm#1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 11:10 AM. Patient #7 (P-7)’s start of care was 6/26/24 with diagnoses that included Diabetes Mellitus with Left Heel Foot Ulcer. The Plan of Care (POC) ordered Skilled Nursing (SN) services to perform wound care and Diabetic management. During the record review on 6/11/25 at 2:10 p.m., it was noted that the POC failed to include the frequency in which blood sugars were to be checked and how often wound care was to be performed. The Administrator, Alternate Administrator and Intake coordinator reviewed and acknowledged the above findings during an interview on 6/12/25 at 2:55 p.m. Patient #3 (P-3) was admitted to this home care agency on 6/4/25 with the diagnoses of a urinary tract infection, low back pain, and hypertension (high blood pressure). During record review on 6/11/25, the following skilled nursing goals were listed on the plan of care: “Patient/Caregiver demonstrate ability to effectively manage medication regimen by 7/12/2025.” [sic] “Patient will demonstrate compliance with medication regimen as evidenced by correct administration, reporting side effects or adverse reactions by 7/12/2025.” [sic] These goals lack measurable, quantifiable data to assess progress towards meeting them. Findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 6/13/25 at 12:52 PM. Patient #1 ‘s (P-1) Start of Care (SOC) was dated 2/26/25. The Plan of Care (POC) identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Hypertensive Heart Disease with Heart Failure (HF), Diastolic Congestive Heart Failure (CHF), Low Back Pain, Hyperlipidemia, Morbid Obesity, Obstructive Sleep Apnea, and Dependance on supplemental oxygen. The patient was receiving Skilled Nursing (SN) and Physical Therapy (PT) services. Upon review of the record, it was noted the goals on the Plan of Care were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples included: “The patient’s Bilateral Lower Extremity will get stronger and no reported fall for the whole certification period; The patient’s pain will be well managed; The patient/caregiver will know when to call 911 in case of emergency and to keep up with the different doctor’s appointments; Patient will remain free of infection during this episode of care; Patient and caregiver will be able to identify fall risk factors by 3/15/25; Patient/Caregiver will demonstrate understanding of individual emergency preparedness by 3/8/25.” These goals are not objectively measurable to determine the patient’s progress towards obtaining the goals. In addition, the agency failed to include an order in Plan of Care to weigh the patient daily to determine if the status of the patient’s Congestive Heart Failure was improving or worsening. In addition, there were no orders for the skilled nurse to measure the patient’s lower extremity edema at each visit to determine if the patient’s Congestive Heart Failure was improving or worsening. Patient #2’s (P-2) Start of Care was dated 5/28/25. The Plan of Care for the certification period 5/28/25 to 7/26/25 identified diagnoses of Hypertensive Heart Disease with Heart Failure, Severe protein malnutrition, Coronary Artery Disease (CAD), Peripheral Vascular Disease (PVD), Chronic Obstructive Pulmonary Disease (COPD), Muscle Weakness, Long Term use of oral hypoglycemic drugs, and history of falling. The patient was receiving Skilled Nursing (SN) services 1 time a week for 6 weeks; and Physical Therapy (PT) services for evaluation and treatment. Upon review of the patient’s Plan of Care, it was noted the goals were not objectively measurable to determine the patient’s progress towards obtaining the goals. Examples included: Nursing Goals: “Patient will attain optimal effectiveness of pain management regimen by 7/5/25; Patient will demonstrate compliance with daily weight monitoring; Physical Therapy evaluation will be performed and a plan of care to increase functional independence will be established and countersigned by physician. These goals are not patient specific or individualized to the patient’s needs, nor are they objectively measurable to determine the patient’s progress towards obtaining the goals. These findings were reviewed and acknowledged by the Administrator (ADM#1) and Alternate Administrator (ADM#3) during an interview on 6/12/25 at 3:30 p.m.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure that all services were provided only as ordered by the Physician for 1 (P-6) of 2 patients who resumed services under the agency’s care after an inpatient stay, from a total of 7 sampled records reviewed, resulting in the rendering of unauthorized care and services and the potential for unmet patient care needs. findings include: Patient #6 (P-6)’s start of care was 5/16/25 with diagnoses that included Metabolic Encephalopathy and Essential Hypertension. The Plan of Care ordered Skilled Nursing, Physical Therapy and Speech Therapy services to be provided. During the clinical record review on 6/11/25 at 12:35 p.m., it was noted that the patient was transferred to an inpatient facility on 5/30/25 due to altered mental status. The patient resumed services under the agency’s care on 6/5/25. Upon further review of the clinical record, there was no Physician’s order to resume services. The agency failed to ensure that all services were provided only as directed by the Physician. The Administrator, Alternate Administrator and Intake Coordinator reviewed and confirmed these findings during an interview on 6/12/25 at 2:30 p.m.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure Physician’s orders were signed, authenticated and dated by the Physician for 1 (P-7) of 1 patient ordered to receive wound care, from a total of 7 sampled records reviewed, resulting in the provision of unauthorized services and the potential for the rendering of unsafe care and services to all 6 patients currently serviced by this agency. Findings include: Patient #7 (P-7)’s start of care was 6/26/24 with diagnoses that included Diabetes Mellitus with foot ulcer. The Plan of Care ordered Skilled Nursing, Physical Therapy and Occupational Therapy services to be provided. During the clinical record review on 6/1/25 at 2:10 p.m., it was noted that the patient was discharged from the agency on 7/25/24. A verbal Physician’s order dated 6/26/24 ordered, “Santyl (medication used to remove dead tissue) 250 UNIT/GM (gram) External Ointment. Apply to affected area every wound care Topical (TOP).” [sic] An additional verbal Physician’s order dated 7/9/24 read, “Discontinue Santyl cream, New wound care: CLEANSED WITH WOUND WASH, APPLIED SANTYL OINTMENT, COVERED WITH 4X4 GAUZE AND ABDOMINAL GAUZE AND WRAPPED WITH KERLIX. New med; Robitussin 12 hour Cough 30 MG/5ML Oral Suspension Extended Release every 4 hours By mouth.” [sic] Both of the above orders had been electronically signed by the Nurse, however, the Physician’s signature was dated 8/13/24, after the patient was discharged from the agency’s services. The agency failed to ensure all verbal orders were signed and dated by the Physician who authorized care. The Administrator, Alternate Administrator and Intake Coordinator reviewed and confirmed these findings during an interview on 6/12/25 at 2:55 p.m.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure its skilled disciplines promptly notified the Physician of major drug interactions for 1 (P-6) of 1 patient and failed to promptly notify the Physician of a change in condition for 1 (P-7) of 1 patient who experience worsening of wound status, from a total of 7 sampled records reviewed, resulting in the potential for harmful medication effects, worsening of wound status, delayed healing and unmet care needs. Findings include: Patient #6 (P-6)’s start of care (SOC) was 5/16/25 with diagnoses that included Metabolic Encephalopathy and Essential Hypertension. The Plan of Care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT) and Speech Therapy (ST) services to be provided. During the clinical record review on 6/11/25 at 12:35 p.m., section M2001 of the Initial Comprehensive Assessment documented, “Yes-Issues found during review.” The agency’s drug interaction report identified major drug to drug interactions. There was no documented evidence that the Physician had been promptly notified of the untoward findings. During the review, a SN visit note dated 5/26/25 documented “Pt (patient) has irregular heartbeat.” The section of the Comprehensive Assessment titled “Cardiac Status” was void of any indication of an irregular heartbeat at the time of admission. Upon further review, there was no documented evidence that the SN promptly notified the Physician of the patient’s change in condition. The Administrator (Adm #1), Alternate Administrator (Adm #3) and Intake Coordinator (IC #1) reviewed and acknowledged the above findings during an interview on 6/12/25 at 2:30 p.m. P-7’s SOC was 6/26/24 with a diagnosis of Diabetes Mellitus with Foot Ulcer Left Heel. The POC ordered SN to provide wound care. During the clinical record review on 6/11/25 at 2:10 p.m., the following was noted: On 6/26/24, at the SOC, the Initial Comprehensive Assessment documented - 5.5 cm (centimeters) L (length) by 5 cm W (width), no odor, moderate serous (clear thin watery) drainage. A SN visit note dated 7/2/24 documented 5.5 cm L x 5 cm W, pail serous drainage, moderate drainage, no odor. A SN visit note dated 7/9/24 documented 5 cm L x 6.5 W (increase in size), area calloused and wound area is pinkish, heavy drainage, foul odor, purulent (thick yellowish or greenish fluid that can indicate an infection) drainage. A SN visit note dated 7/11/24 documented 5 cm L x 6.5 cm W, heavy drainage, foul odor, surrounding tissue calloused, purulent drainage. There was no documented evidence that the SN promptly notified the Physician of the patient’s declining wound status. Adm #1, Adm #3 and IC #1 reviewed and confirmed the above findings during an interview on 6/12/25 at 2:55 p.m.”

“Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient’s needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This Element is not met as evidenced by: Based on record review and interview, the agency failed to coordinate patient needs between Skilled Nursing (SN) and Physical Therapy (PT) in 1 (P-5) of 7 total sampled records reviewed, resulting in the potential for unrecognized safety concerns and poor clinical outcomes. Findings include: Patient #5 (P-5)’s start of care date was on 1/6/25, with diagnoses which included hypertensive chronic kidney disease, diabetes type-2, chronic obstructive pulmonary disease (COPD), and smoking while on supplemental oxygen. During record review on 6/12/25, SN documentation from the initial comprehensive assessment on 1/6/25 documented the following: “Patient (P-5) easily gets tired and fatigue and uses oxygen 2 to 3 LPNC (liters per nasal cannula) as needed. Instructed not to smoke when the patient is using oxygen.” P-5 was transferred to the hospital on 1/20/25 “due to shortness of breath (SOB).” On 2/6/25, P-5 had a SN resumption of care (ROC) visit which documented, “Dyspnea (difficulty in breathing)” and used oxygen at 2 liters/minute intermittently. P-5 “refused “No Smoking” sign outside the door and gets SOB with moderate exertion (for example, while dressing, using commode of bedpan...” Further review of the PT’s ROC evaluation dated 2/7/25, left the area under “Care Coordination” blank concerning the physician and SN. PT documented that “Patient is weak, poor muscle strength, poor balance, unsteady gait, patient needs assist for transfer skills.” The evaluation by PT failed to acknowledge the recent hospitalization due to breathing difficulties; failed to acknowledge P-5 needed oxygen at times when performing gait training; failed to assess any aspect of the respiratory system when working with the patient; and failed obtain blood oxygen saturation to determine if the patient was safe to perform therapy. No evidence was found in the medical record indicating an attempt to coordinate care between PT and SN services to ensure the needs of P-5 were being met. The Administrator (Adm#1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 11:13 AM.”

“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 skilled nursing provided care and services as ordered by the Physician for 2 (P-4, P-7) patients who required blood draws and wound care management, from a total of 7 sampled records reviewed, resulting in the potential for unidentified clinical needs, worsening of the patient’s wound, delayed healing and development of infection. Findings include: Patient #4 (P-4)’s start of care date was on 5/26/25, with diagnoses that included hemiplegia with associated left sided weakness, hypertension, and chronic obstructive pulmonary disease (COPD). The Plan of care (POC) ordered SN services once weekly times 5 weeks. On 6/12/25, review of the POC effective 5/26/25, noted the following documentation: “MD has verbal order to draw blood culture, complete metabolic panel and lytes (electrolyte levels) next week.” The next SN visit occurred on 6/2/25, which documented the following: “Writer (Clinical Manager/CM #1) unable to obtain bottles for blood cultures... Patient’s lower legs are warm to touch. Slight redness noted to left leg.” The Administrator (Adm#1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/13/25 at 11:03 AM. Both were queried why CM #1 was not prepared to complete the physician’s order when she knew of the order the week before? Both had no answer as to why the order was not completed. No subsequent or follow-up SN visits had been performed by the time of exit on 6/13/25 at 2:05 PM to fulfill the order and determine if P-4’s left leg continued to exhibit signs and symptoms of infection. The agency failed to ensure its policy was adhered to as referenced below. On 6/13/25, review of the agency’s policy titled, “Physician/NPP Orders and Verbal Orders” (implemented 2024) on pg. 68 stated, “The Agency staff only as ordered by the physician administers drugs and treatments.” Patient #7 (P-7)’s SOC was 6/26/24 with a diagnosis of Diabetes Mellitus with Foot Ulcer Left Heel. The Plan of Care ordered SN to provide wound care. During the clinical record review on 6/11/25 at 2:10 p.m., the following was noted: A verbal Physician’s order dated 6/26/24 ordered, “Santyl (topical medication used to remove dead tissue) 250 UNIT/GM External Ointment. Apply to affected area every wound care Topical (TOP).” [sic] A verbal Physician’s order dated 7/9/24 read, “Discontinue Santyl cream, New wound care: CLEANSED WITH WOUND WASH, APPLIED SANTYL OINTMENT, COVERED WITH 4X4 GAUZE AND ABDOMINAL GAUZE AND WRAPPED WITH KERLIX.” [sic] A SN visit note dated 7/11/24 documented 5 cm L x 6.5 cm W, heavy drainage, foul odor, surrounding tissue calloused, purulent drainage. There was no evidence that Santyl was applied to the patient’s wound as ordered. A SN visit note dated 7/18/24 documented 5 cm L x 4 cm serous drainage, moderate drainage, pungent odor, surrounding tissue redness. There was no evidence that Santyl was applied to the patient’s wound as ordered. The Administrator, Alternate Administrator and Intake Coordinator reviewed and acknowledged the above findings during an interview on 6/12/25 at 2:55 p.m.”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge summary was sent to the physician in 1 of 2 discharged records reviewed (P-1, P-2); and failed to send the transfer summary to the physician within 48 hours in 1 (P-5) of 1 record reviewed with a transfer out of a total sample of 7 records reviewed, resulting in the physician not having a clear picture of the patient’s status at the time of discharge, and the physician/receiving facility not having knowledge of the patient’s health status at the time of transfer. Findings include: Patient #6 (P-6): This patient’s start of care (SOC) was 5/16/25 with diagnoses that included Metabolic Encephalopathy. The Plan of Care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT) and Speech Therapy (ST) services to be provided. During the record review on 6/11/25 at 12:35 p.m., it was noted that the patient was transferred to an inpatient facility on 5/30/25 due to altered mental status. There was no documented evidence that a completed Transfer Summary was sent to the receiving facility. Further, there was no documented evidence that the Physician had been notified of the patient’s transfer to an inpatient facility. The Administrator (Adm #1), Alternate Administrator (Adm #3) and Intake Coordinator (IC #1) reviewed and acknowledged the above findings during an interview on 6/12/25 at 2:30 p.m. P-7: This patient’s SOC was 6/21/24 with diagnoses that included Diabetes Mellitus with Foot Ulcer Left Heel. The POC ordered SN and PT services to be provided. During the clinical record review on 6/11/25 at 2:10 p.m., it was noted that the patient was discharged from the agency on 7/25/24. The SN Discharge Summary dated 7/25/24 was void of a summary which detailed the course of care provided with responses and the overall status of the patient at the time of discharge. There was no indication of which, if any goals were met versus not met. Adm #1, Adm #3 and IC #1 reviewed and acknowledged the above findings during an interview on 6/12/25 at 2:55 p.m. Patient #5 (P-5)’s start of care date was on 1/6/2025, with diagnoses which included hypertensive chronic kidney disease, diabetes type-2, chronic obstructive pulmonary disease (COPD), and smoking while on supplemental oxygen. During record review on 6/12/25, it was noted that P-5 was transferred to the hospital on 1/20/25 due to shortness in breath and again on 6/6/25 for reasons unknown. Additional record review found no evidence that either hospital transfer was sent within 48 hours as required. Further, the 6/6/25 transfer was blank in the following areas: “Functional Abilities and Goals; Medications; Emergent Care (history); Summary (where and when the transfer summary was sent); Care Coordination; and Transfer Narrative (description of what caused the transfer).” The Administrator (Adm#1) and Alternate Administrator (Adm #3) reviewed and acknowledged the findings above during an interview on 6/12/25 at 10:15 AM. Patient #1’s (P-1) Start of Care (SOC) was dated 2/26/25. The Plan of Care (POC) for the certification period 2/26/25 to 4/2/25 identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Hypertensive Heart Disease with Heart Failure (HF), Diastolic Congestive Heart Failure (CHF), Low Back Pain, Hyperlipidemia, Morbid Obesity, Obstructive Sleep Apnea, and Dependance on supplemental oxygen. The patient was receiving Skilled Nursing (SN) and Physical Therapy (PT) services. Skilled Nursing services were discharged on 4/1/25 in stable condition while Physical Therapy continued providing services. However, there was no documented evidence that the nursing discharge summary had been sent to the physician. Patient #2’s (P-2) Start of Care was dated 5/28/25. The Plan of Care for the certification period 5/28/25 to 7/26/25 identified diagnoses of Hypertensive Heart Disease with Heart Failure, Severe protein malnutrition, Coronary Artery Disease (CAD), Peripheral Vascular Disease (PVD), Chronic Obstructive Pulmonary Disease (COPD), Muscle Weakness, Long Term use of oral hypoglycemic drugs, and history of falling. The patient was receiving Skilled Nursing (SN) services 1 times a week for 6 weeks; and Physical Therapy (PT) services for evaluation and treatment. Skilled Nursing services were discharged on 5/1/25 with patient in stable condition and all goals met. The Skilled nurse documented the “physician was notified of the discharge summary”, however there was no documented proof that the nursing discharge summary had been sent to the physician. PT services continued to provide services. These findings were reviewed and acknowledged by the Administrator (ADM#1) and Alternate Administrator (ADM#3) during an interview on 6/12/25 at 3:30 p.m.”