Balajie Home Health Care, Inc.

“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 develop emergency preparedness policies and procedures (see E0013); failed to ensure individual emergency plans were completed as part of the comprehensive patient assessment (see E0017); failed to ensure the communication plan included a method for sharing information and medical documentation (see E0033); and failed to develop and maintain an emergency preparedness training program (see E0037). Findings include:”

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to ensure a plan of care was developed by the skilled professionals in 1 (P-12) of 13 records reviewed (See G0708); failed to ensure that services ordered by the physician as indicated in the plan of care were provided for 2 (P-11 and P-12) of 13 records reviewed (See G0710); failed to ensure the clinical record was complete and included accurate physical therapy notes for 3 (P-4, P-6, P-13) of 13 records reviewed (See G0716); failed to ensure skilled professionals communicated assessment findings to the physician for 5 (P-6, P-8, P-9, P-10, and P-12) of 13 records reviewed (See G0718); failed to ensure the Licensed Practical Nurse was supervised by the Registered Nurse according to agency policy in 1 (P-12) of 12 records reviewed (G0726). The cumulative effect of these systemic problems resulted in the agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.75 Skilled Professional Services.”

“Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This Condition is not met as evidenced by: Based on record review and interview, the agency failed to provide documentation that an agency home health aide (HA-1) successfully completed a training and competency evaluation program (See G0754); failed to provide documentation of classroom and supervised practical training for an agency home health aide (HA-1) which totaled 75 hours (See G0760); failed to demonstrate the home health aide received 16 hours of classroom training preceding a minimum of 16 hours supervised practical training as part of a total 75 hours (See G0762); failed to provide evidence for a home health aide competency evaluation program resulting in a lack of documented training for an agency home health aide (See G0764); failed to ensure the Skilled Nurse prepared clear written patient care instructions for the Home Health Aide (See G0798); failed to ensure the home health aide provided services which were included in the plan of care (See G0800); failed to ensure the home health aide reported changes in the patient’s condition to a registered nurse (See G0804); and failed to ensure the registered nurse completed an on-site supervisory visit to the patient’s home at least every 14 days to supervise home health aide services (See G0808). Findings include: The cumulative effect of these systemic problems resulted in the agency’s inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR §484.80 Home Health Aide Services.”

“Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility 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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop written emergency preparedness policies and procedures that were based on an emergency preparedness plan, risk assessment, and communication plan, resulting in the agency’s inability to implement appropriate emergency actions. This deficient practice has the potential to negatively affect the health and safety of all patients served by this agency. Findings include: On 2/28/25, the Emergency Preparedness (EP) Plan, located within the agency’s policy and procedure binder, was reviewed. During the review, it was noted that there was no documented evidence of emergency preparedness policies and procedures that were based on an emergency preparedness plan, risk assessment, and communication plan. This finding was reviewed and acknowledged by the Administrator (Adm-1) during an interview on 2/28/25 at 10:00 a.m.”

“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 observation, record review, and interview, the agency failed to ensure individual emergency plans were completed as part of the comprehensive patient assessment in 3 (P-5, P-9, and P-10) of 13 records reviewed, resulting in the potential to negatively affect the health and safety of these patients. Findings include: Agency policy titled “Emergency Care”, Policy #: C-540 was reviewed on 2/28/25. On page 1., it stated “1. Agency will, with input from patient/family/caregiver, develop an emergency care procedure plan… 2… The RN/Therapist shall complete the Emergency Plan and leave a copy in the patient’s home.” P-9: This 70-year-old was admitted to the agency on 4/12/24 with diagnoses including lacerations to right upper back, right shoulder and right elbow. The medical record was reviewed on 2/28/25. During review, it was noted that no individualized emergency plan documentation could be found in the electronic medical record or the paper bound portion of the medical record. It is unclear if the individualized emergency plan was developed with the patient and a copy left in the home per agency policy. During interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1), this finding was reviewed. Adm-1 was unable to locate the emergency plan documentation for this patient and acknowledged the finding. P-10: This 73-year-old was admitted to the agency on 10/15/24 with diagnoses including type 2 Diabetes; heart failure; and below the knee amputation of the left leg. The medical record was reviewed on 2/27/25. During review, it was noted that only page 1 of a 2-page individualized emergency plan for this patient could be found in the medical record. During review with Adm-1 on 2/28/25 at 1:45 p.m., query was made to what information was missing by not having page 2 of the emergency plan in the medical record. Adm-1 provided a blank copy of the plan as found in the admission packet, and the missing information was noted as, the type of assistance that was needed during an emergency; medical equipment needs; Diabetes medication needs and how it would be administered; and other pertinent information. Adm-1 was queried to where page 2 may be located for this patient. Adm-1 was unable to locate page 2 of the emergency plan for this patient and acknowledged the finding. P-5: This 91-year-old patient was admitted to home care on 2/4/25 with diagnoses of femur fracture, Parkinson’s disease, and history of falling. During the home visit observation with the occupational therapist on 2/25/25, it was noted that the “Patient evacuation planning and individualized emergency plan,” located in the patient handbook was blank. This finding was reviewed and acknowledged by the Administrator (Adm-1) during an interview on 2/28/25 at 10:25 a.m. Adm-1 stated the registered nurse is aware and will complete during the next home visit.”

“Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(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: (4) A method for sharing information and medical documentation for patients under the [facility’s] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility’s] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI’s care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the communication plan included a method for sharing information and medical documentation for patients under the agency’s care, resulting in the agency’s inability to implement appropriate emergency actions. This deficient practice has the potential to negatively affect the health and safety of all patients served by this agency. Findings include: On 2/28/25, the Emergency Preparedness Plan, located within the agency’s policy and procedure binder, was reviewed. During the review, it was noted that the communication plan failed to include a current list of the agency’s patients and the patient priority code for emergency triage. This finding was reviewed and acknowledged by the Administrator (Adm-1) during an interview on 2/28/25 at 10:00 a.m.”

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(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 develop and maintain an emergency preparedness training program, resulting in the potential to negatively affect the health and safety of all patients served by this agency. Findings include: On 2/28/25, the Emergency Preparedness Plan, located within the agency’s policy and procedure binder, was reviewed. During an interview on 2/28/25 at 2:15 p.m., the administrator (Adm-1) and nurse consultant (RN-1) were queried regarding emergency preparedness initial and ongoing training. Adm-1 stated the agency has not provided initial training and the ongoing training as it relates to the completion of the patient evacuation planning and individualized emergency plan form, completed on admission.”

“Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to send necessary medical information pertaining to the patient’s current course of illness and treatments and treatment preferences to the receiving facility upon transfer to ensure the safe and effective transition of care in 1 (P-3) of 1 record reviewed in which the patient was transferred to the hospital. Findings included: P-3: The Start of Care was dated 10/29/2024. The Plan of Care for the certification period 12/28/2024 to 2/25/2025 identified diagnoses of Paroxysmal Atrial Fibrillation, Congestive Heart Failure, Pressure Ulcers of right and left buttocks-both stage 1, Erythema Intertrego, weakness Mixed Hyperlipidemia, Scoliosis, Malaise/Debility, Mixed Hyperlipidemia, Constipation, HX of TIA (Transient Ischemic Attack), Cerebral Infarction without deficits, Nicotine Dependence, Long-term use of anticoagulants, and Long term use of Aspirin. The patient was transferred to the hospital on 2/18/2025, for a foot infection, however there was no documented information regarding the patient’s condition at transfer. This area of the Transfer summary was blank. There was no information regarding the patient’s mental status, functional ability, pertinent labs, advance directives, family contact information. The agency failed to send necessary medical information pertaining to the patient’s current medical condition and information pertaining to the patient’s current illness to the medical facility upon transfer of care. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 2:30 p.m.”

“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 the plan of care included interventions with objectively measurable goals specific to the individualized needs of the patient in 13 (P-1, P-2, P-3, P-4, P-5, P-6, P-7, P-8, P-9, P-10, P-11, P-12, and P-13) of 13 records reviewed, resulting in the potential for poor patient outcomes and unmet care needs for these patients. Findings included: P-5: This 91-year-old patient was admitted to home care on 2/4/25 with diagnoses of femur fracture, Parkinson’s disease, and history of falling. During record review on 2/26/25, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. For example, one goal stated patient/caregiver will verbalize measures to manage neurological condition. Another goal for the occupational therapist stated increased knowledge of work simplification and energy conservation. There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. P-6: This 64-year-old patient was admitted to home care on 11/6/24 with diagnoses of left heel pressure ulcer, type 2 diabetes, and peripheral vascular disease. During record review on 2/26/25, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. For example, one goal stated patient/caregiver will verbalize/demonstrate symptoms to report, prevention of infection, and nutrition and hydration to promote healing. Another goal stated dyspnea will decrease. There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. P-7: This 73-year-old patient was admitted to home care on 12/22/24 with diagnoses of lung cancer, syncope, and diabetes mellitus. During record review on 2/26/25, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. For example, one goal stated dyspnea will decrease. Another goal stated free of respiratory infection. There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. P-8: This 83-year-old patient was admitted to home care on 1/2/25 with diagnoses of non-ST elevation myocardial infarction and essential hypertension. During record review on 2/26/25, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. For example, one goal stated patient will demonstrate energy conservation techniques. Another goal stated patient will demonstrate increased endurance. There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. P-13: This 77-year-old patient was admitted to home care on 1/3/25 with diagnoses of shingles, hypertension, and diabetes. During record review on 2/27/25, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. For example, one goal stated patient/caregiver will verbalize understanding and demonstrate safe effective wound care: supply management, dressing change, disposal of soiled dressings, monitoring for infection, and signs/symptoms to report. Another goal stated patient/caregiver will verbalize/demonstrate symptoms to report, prevention of infection, and nutrition and hydration to promote healing. There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m. P-9: This 70-year-old was admitted to the agency on 4/12/24 with diagnoses including laceration to the right upper back, shoulder and elbow; type 2 Diabetes; and atrial fibrillation (a heart arrythmia). The medical record was reviewed on 2/28/25. During review of the plan of care (POC) dated 4/12/24, the following examples of skilled nursing (SN) goals were noted: Patient/patient caregiver will verbalize measure to manage neurological condition by 5/18/24; Dyspnea (shortness of breath) will decrease by 5/18/24; Increased activity tolerance by 5/18/24. It was unclear how these goals were individualized for this patient and how the goals would be objectively measured by the SN to determine patient progress. P-10: This 73-year-old was admitted to the agency on 10/15/24 with diagnoses including type 2 Diabetes; heart failure; and amputation of the left leg below the knee. The medical record was reviewed on 2/27/25. During review of the POC dated 12/14/24, it was noted that the patient would be receiving skilled services from SN, Physical Therapy (PT), and Occupational Therapy (OT). The following examples of goals for care were noted on the POC: Increased activity tolerance by 2/11/25; Patient/patient caregiver will verbalize & demonstrate understanding of diabetic self-care needs by 2/11/25; and Bowel status will be within normal limits for the patient by 2/11/25. It was unclear how these goals were individualized for this patient and how the goals would be objectively measured by skilled clinicians to determine patient progress. P-11: This 80-year-old was admitted to the agency on 12/20/24 with diagnoses including stage 4 pressure ulcer to sacral region; type 2 Diabetes; and chronic kidney disease. The medical record was reviewed on 2/27/25. During review of the POC dated 2/17/25, it was noted that the patient would be receiving skilled services from SN, PT, and OT. The following examples of goals for care were noted on the POC: Patient will demonstrate increased endurance by 4/18/25; Urinary elimination will be within normal limits for patient by 4/18/25; and Clear lung sounds achieved by 4/18/25. It was unclear how these goals were individualized for this patient and how the goals would be objectively measured by skilled clinicians to determine patient progress. P-12: This 64-year-old was admitted to the agency on 12/16/24 with diagnoses including type 2 Diabetes; non-pressure ulcer of left foot; and end stage kidney disease. The medical record was reviewed on 2/28/25. During review of the POC dated 12/18/24, the following examples of SN goals were noted: Elimination status will be within normal limits for patient by 2/13/25; Patient/patient caregiver will demonstrate proper body mechanics by 2/13/25; and Patient/patient caregiver will demonstrate correct use of glucometer by 2/13/25. It was unclear how these goals were individualized for this patient and how the goals would be objectively measured by the SN to determine patient progress. These findings were reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1). P-1: The Start of Care was dated 2/18/24. The Plan of Care for the certification period 12/18/24 to 2/15/24 identified diagnoses of Metabolic encephalopathy, Alcohol abuse, Hypertension, Anemia, Acute Kidney Failure, Protein Calorie Malnutrition, weakness and malaise. Upon review of the Plan of Care it was noted the goals were not objectively measurable to determine the patient’s progress towards achieving the goals. Examples included: “Patient/Caregiver will verbalize measure to manage neurological condition by Achieve Date: 2/1/2025 {sic}; Clear lung sounds by Achieve Date 2/1/2025 {sic}; “Increased activity tolerance by 2/1/2025.” These goals are not objectively measurable to determine the patient’s progress towards achieving the goals. P-2: The Start of Care was dated 11/13/2024. The Plan of Care identified diagnoses of 11/13/2024 to 1/11/2025 identified diagnoses of Diabetes type 2, Chronic Kidney Disease, Atrial Fibrillation, Sequelae of Cerebral Infarction, Muscle Weakness, Anemia, and Hyperlipidemia. Upon review of the record, it was noted that the goals on the Plan of Care were not objectively measurable to determine the patient’s progress towards achieving the goals. Examples included: “Pt/Pcg will demonstrate deep breathing/coughing exercises by Achieve Date 1/4/25”, Pt will demonstrate energy conservation techniques by Achieve Buy Date 1/4/25”, “Pt/caregiver will verbalize measure to manage neurological condition by Achieve by Date: 1/4/2025...Start effective date 11/13/2024” {sic}. These goals are not objectively measurable to determine the patient’s progress towards achieving the goals. P-3: The Start of Care was dated 10/29/2024. The Plan of Care for the certification period 12/28/2024 to 2/25/2025 identified diagnoses of Paroxysmal Atrial Fibrillation, Congestive Heart Failure, Pressure Ulcers of right and left buttocks-both stage 1, Erythema Intertrego, weakness Mixed Hyperlipidemia, Scoliosis, Malaise/Debility, Mixed Hyperlipidemia, Constipation, HX of TIA (Transient Ischemic Attack), Cerebral Infarction without deficits, Nicotine Dependence, Long-term use of anticoagulants, Long term use of Aspirin. The patient was receiving Skilled Nursing 1xweekx6, PT services for Evaluation and Treatment. 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 achieving the goals. Examples included: “Dyspnea will decrease by 2/9/2025, Patient will demonstrate energy conservation techniques by 2/8/2025; Bowel will be WNL (within normal limits) for patient by 2/8/2025, Patient will verbalize understanding and demonstrate safe effective wound care. These goals are not objectively measurable to determine the patient’s progress towards achieving the goals. P-4: The Start of Care was dated 2/15/2024. The Plan of care for the certification period 2/15/2024 to 4/14/2024 identified diagnoses of Aftercare of following surgery, Absence of cervix and uterus, weakness, anemia, coronary angiopathy implant and graft, Long-term use of antibiotics, and Long-term use of opiates. The patient was receiving PT services. Upon review of the record, it was noted the goals on the Plan of Care were not objectively measurable. Findings included: “Patient/Caregiver will verbalize/demonstrate understanding of symptom management resource utilization and medication management to reduce unplanned hospital or emergency department visits by 4 weeks, achieve by 3/9/24; Patient will meet max rehab potential by 4 weeks; Return to optimal and functionality by 4 weeks. These goals are not objectively measurable to determine the patient’s progress towards achieving the goals. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 2:30 p.m.”

“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 and interview, the agency failed to ensure the home health aide followed accepted standards of practice to prevent the transmission of infectious diseases in 1 (P-10) of 1 sample records reviewed in which home observation with a home health aide was conducted potentially resulting in the transfer of infectious agents from dirty to clean areas for this patient. Findings include: P-10: This 73-year-old was admitted to the agency on 10/15/24 with diagnoses including type 2 Diabetes; heart failure; and amputation of the left leg below the knee. On 2/27/25, a joint home visit was conducted with the home health aide (HA-1), at 11:30 a.m. to observe care being provided and infection control procedures. Upon getting P-10 to sit on a shower chair and preparing the water temperature for a shower, HA-1 was observed applying soap to a clean washcloth and washing P-10 in the following order with the washcloth: back and then right lower leg (including a large, scabbed area on leg), right toes and right foot. HA-1 then handed the same washcloth to P-10 to wash his face, arms, chest, and buttocks. The washcloth was only changed after P-10 washed his buttocks prior to peri-area. After the shower, HA-1 was queried to why the leg and foot were washed with the same washcloth prior to cleaner areas (such as the face). HA-1 responded that she washes the parts the patient cannot reach first and then has the patient to do the rest. Once arriving back at the agency at 1:15 p.m., the Administrator (Adm-1) was queried to policy expectations for home health aides providing shower regarding clean to dirty areas being washed. Adm-1 stated that there was not a policy describing the order of washing but that during Aide training, they discuss how to properly bath (or assist with bathing) and acknowledged that it was not the agency expectation that feet would be washed before the face without first changing the washcloth.”

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the Skilled Nurse prepared clear written patient care instructions for the Home Health Aide regarding client needs in 2 (P-6, P-10) of 5 sample records reviewed which included Home Health Aide services, resulting in a lack of guidance for the services to be provided and the potential for unsafe care. Findings include: P-6: This 64-year-old patient was admitted to home care on 11/6/24 with diagnoses of left heel pressure ulcer, type 2 diabetes, and peripheral vascular disease. During record review on 2/26/25, it was noted that the patient has a history of urinary retention and has an indwelling catheter. The home health aide care plan failed to include the presence of the urinary catheter or catheter care. This finding was reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on Record Review and interview, the agency failed to ensure that a physician authenticated the order for Home Care Services in 1 of 13 records (P-2) reviewed, resulting in services being provided without authentication of physician orders. Findings included: P-2: The Start of Care was dated 11/13/2024. The Plan of Care for the certification period 11/13/24 to 1/11/24 identified diagnoses of Diabetes type 2 (DM2), Chronic Kidney Disease, Kidney Stones, Atrial Fibrillation, Muscle Weakness, and anemia. The patient was receiving Skilled Nurse Services 1xweekx8weeks; Physical Therapy Services for Evaluation; and Home Health Aide Services 1xweekx8weeks. Upon review of the record, it was noted the Plan of Care for the certification period 11/13/24 to 1/11/24 was signed and authenticated on 2/18/2025, 3 months and 5 days after the Start of Care, resulting in Home Health Services being provided without certification of a physician. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 2:30 p.m.”

“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 ensure patients received all services as outlined in the plan of care for 4 (P-5, P-6, P-7, P-13) of 13 records reviewed, resulting in the potential for unmet care needs. Findings include: P-5: This 91-year-old patient was admitted to home care on 2/4/25 with diagnoses of femur fracture, Parkinson’s disease, and history of falling. During record review on 2/26/25, it was noted that the plan of care ordered skilled nursing, physical therapy, occupational therapy, and home health aide (HHA) services once per week for 9 weeks. On 2/10/25, seven days after the start of care, the HHA made the initial visit. There was no evidence of further HHA visits. The medical record failed to include missed visit notes or communication between the HHA and the registered nurse noting the reason that frequency of visits was not met. P-6: This 64-year-old patient was admitted to home care on 11/6/24 with diagnoses of left heel pressure ulcer, type 2 diabetes, and peripheral vascular disease. During record review on 2/26/25, it was noted that the plan of care ordered physical therapy, home health aide, and skilled nursing twice per week for 8 weeks. The nurse made one of the ordered twice weekly visits during week 1, week 2, week 4, and week 5. The medical record failed to include missed visit notes or notification to the physician for these missed visits. P-7: This 73-year-old patient was admitted to home care on 12/22/24 with diagnoses of lung cancer, syncope, and diabetes mellitus. During record review on 2/26/25, it was noted that the plan of care ordered skilled nursing once a week for 9 weeks and physical therapy once a week for 1 week, twice a week for 6 weeks, then once a week for 2 weeks. The record contained a skilled nursing missed visit on 2/18/25. There was no evidence a second attempt was made for that week (2/16/25 – 2/22/25) and the note indicated the physician was not notified. In addition, physical therapy evaluated the patient on 12/27/24. The next physical therapy visit occurred on 1/23/25 with missed visit notes recorded on 12/31/24, 1/2/25, 1/7/25, 1/10/25, and 1/17/25. The physician was not notified for the first three missed visits. P-13: This 77-year-old patient was admitted to home care on 1/3/25 with diagnoses of shingles, hypertension, and diabetes. The patient was admitted to the hospital on 1/7/25 and was discharged 1/10/25. Home care resumed on 1/24/25. During record review on 2/27/25, it was noted that the plan of care ordered physical therapy once for one week, then twice weekly for 4 weeks. PT evaluated the patient on 1/29/25 and the record indicated one visit during week 2. The medical record failed to include missed visit notes or notification to the physician for the missed visit. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was completed in a timely manner per agency policy in 1 (P-10) of 13 sample records reviewed potentially resulting in unidentified needs of the patient and poor patient outcomes. Findings include: Agency policy titled “Patient Comprehensive Assessment”, Policy #: C-150, was reviewed on 2/28/25. On page 2., it stated “6. When the RN is the Case Manager, the RN must make the first visit within 48 hours of referral unless otherwise specified by the physician or per family request... 9. Any other discipline noted on the referral form or called onto the case by the Case Manager must make their visit within five (5) days of receiving the referral.” P-10: This 73-year-old was admitted to the agency on 10/15/24 with diagnoses including type 2 Diabetes; heart failure; and below the knee amputation of the left leg. The medical record was reviewed on 2/27/25. During review of the physician referral for home care sent to the agency on 10/13/24, it was noted that Skilled Nursing (SN), Physical Therapy (PT), and Occupational Therapy (OT) services were ordered. The start of care (SOC) visit was completed on 10/15/24 by the SN. The plan of care was developed (dated 10/15/24) and included orders for PT and OT services 1-2 times weekly for 3 weeks. PT did not complete an initial comprehensive evaluation until 10/21/24 (8 days after referral order). OT did not complete an initial comprehensive evaluation until 10/22/24 (9 days after referral order). PT and OT services (both) did not notify the physician of the delay in evaluation until the day of evaluation (after the fact) and made the comment on the plan of care update that the patient requested the delay. There was no evidence in the medical record that an attempt was made to provide PT or OT services within the 5-day time frame for the comprehensive assessment per agency policy or that the patient requested a delay prior to the evaluation date. These findings were reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1).”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient’s clinical record documented all medications for 1 (P-13) of 13 records reviewed, and failed to ensure the comprehensive assessment included a review of all medications to determine any potential adverse effects for 2 (P-9 and P-13) of 13 records reviewed, resulting in the potential for unrecognized medication side effects and drug interactions that could affect all patients serviced by the agency. Findings include: P-13: This 77-year-old patient was admitted to home care on 1/3/25 with diagnoses of shingles, hypertension, and diabetes. The patient was admitted to the hospital on 1/7/25 and was discharged 1/10/25. Home care resumed on 1/24/25. During a home visit observation on 2/27/25 with the registered nurse (RN), the RN was observed filling the patient’s medication container for the week. The plan of care indicated the patient was taking Acyclovir 800mg 1 tablet twice per day, while the RN stated the medication bottle from the hospital indicated the patient was taking 5 tablets per day. In addition, the plan of care failed to include the following medications: Aspirin 81mg, Centrum Silver multi vitamin, Vitamin D3, and Metoprolol 50mg. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m. P-9: This 70-year-old was admitted to the agency on 4/12/24 with diagnoses including laceration to the right upper back, shoulder and elbow; type 2 Diabetes; and atrial fibrillation (a heart arrythmia). The medical record was reviewed on 2/28/25. During review of the Medication Profile in the medical record, it was noted that there was a section titled “Drug Regime Review” which included questions with answer bubbles “Y” (for yes), or “N” (for no) for the clinician to mark to describe what findings were noted during the drug review. The review dated 4/12/24 was completed by a registered nurse (RN). The RN marked the bubble “N” for whether there was significant drug interactions found and “N” for if there were any duplicate drug therapies found. The review also included a list of interaction information retrieved by the agency’s electronic medical record system and described a “Duplicate Therapy” with 4 of the patients listed medications and a “Major” drug interaction between 2 of the patients listed medications. It was unclear if the major drug interaction or the medications with duplicate therapy were identified and evaluated by the RN during the comprehensive assessment. This finding was reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1).”

“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 Plan of Care failed to include information related to advanced directives in 1 of 13 records reviewed (P-1). Findings included: P-1: The Start of Care was dated 2/18/24. The Plan of Care for the certification period 12/18/24 to 2/15/24 identified diagnoses of Metabolic encephalopathy, Alcohol abuse, Hypertension, Anemia, Acute Kidney Failure, Protein Calorie Malnutrition, weakness and malaise. Upon review of the Continuing Plan of Care it was noted that the Continuing Plan of Care failed to include information regarding the Patient’s Code Status. There was no documentation in the area of the Plan of Care that addressed Code Status as “DNR” (Do not resuscitate)” or “Full Code”. That area on the Plan of Care was left blank with no further information documented regarding the patient’s preference or plans for their preferences for code status. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 2:30 p.m.”

“Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a plan of care was developed by the skilled professionals in 1 (P-12) of 13 sample records reviewed resulting in the lack of guidelines to care provided and lack of system to ensure physician orders are followed each visit. Findings include: P-12: This 64-year-old was admitted to the agency on 12/16/24 with diagnoses including type 2 Diabetes; non-pressure ulcer of left foot; and end stage kidney disease. The medical record was reviewed on 2/28/25. During review, it was noted that the original certification period for home health services was 12/16/25- 2/13/25. The registered nurse (RN) completed a recertification on 2/12/25. The Physical Therapist (PT) completed a re-evaluation on 2/12/25. There was a PT care plan opened on 2/12/25 by the PT but it was not signed by the clinician, had no date of onset or start date entered, and did not contain any orders for other services (nursing). There was no individualized Plan of Care developed for the certification period beginning on 2/14/25 at the time of this record review (14 days). This finding was reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1).”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure that services ordered by the physician as indicated in the plan of care were provided for 2 (P-11 and P-12) of 13 sample records reviewed potentially resulting in unmanaged health concerns and poor outcomes. Findings include: P-11: This 80-year-old was admitted to the agency on 12/20/24 with diagnoses including stage 4 pressure ulcer to sacral region; type 2 Diabetes; and chronic kidney disease. The medical record was reviewed on 2/27/25. During review of the plan of care (POC) dated 2/17/25, “Integumentary Interventions” listed for the skilled nurse (SN) regarding the stage 4 sacral wound care was to “Assess/Perform/Instruct” the patient/patient caregiver 3 times weekly (Monday, Wednesday, and Friday) and as needed beginning 12/20/24. The SN frequency was only noted to be 2 times weekly between the dates of 12/23/24 and 1/22/25 (5 weeks) with days of nursing visits varying in consistency between Mondays, Wednesdays, or Fridays of each week. It was unclear how the SN could perform the above intervention 3 times per week when the nursing visit frequency was only 2 times per week. P-12: This 64-year-old was admitted to the agency on 12/16/24 with diagnoses including type 2 Diabetes; non-pressure ulcer of left foot; and end stage kidney disease. The medical record was reviewed on 2/28/25. Findings include: During review of the POC dated 12/16/24, it was noted that Physical Therapy (PT) services were ordered to evaluate and treat. The PT evaluated the patient on 12/20/24 and established a physician ordered frequency of 1 time for 1 week ( week of 12/20/24), 2 times for 4 weeks, and then 1 time for 4 weeks. The following visit frequency was noted: On the first full week of scheduled services (12/23/24- 12/28/24), PT made no visits. There were 2 documented “Missed Visit” notes entered (one on 12/23/24 and one on 12/26/24) both indicated the patient was not answering the phone and the physician was notified. It was noted that the nurse did make visits to this patient on both of those days (12/23/24 and 12/26/24). On the second full week of scheduled services (12/29/24- 1/4/25), PT made no visits. There was one “Missed Visit” note entered on 12/30/24 which indicated that the patient did not answer the phone (the nurse did visit the patient on that day). There were no additional visits made by PT for the week and no missed visit notes entered indicating physician awareness of the missed frequency for that week. On the third full week of scheduled services (1/5/25- 1/11/25), PT made no visits and there were no notes entered for this patient by PT. There were no notes indicating the physician was made aware of the missed frequency for that week. There were no notes entered indicating the patient refused PT services. There were no notes indicating the agency was aware that this patient had only received 1 PT visit (initial evaluation) in 3 weeks of being on service. On the fourth full week of scheduled services (1/12/25- 1/18/25), PT completed a re-evaluation including a frequency of 2 times per week for 4 weeks to start on 1/13/25. PT made 2 visits in that week (meeting frequency). On the fifth week (1/19/25- 1/25/25), PT made no visits to this patient and entered 2 “Missed Visit” notes (one on 1/22/25 and one on 1/24/25) which both documented that the patient refused with no reason provided. PT did not notify the physician of the missed frequency for the week. PT made 7 out of 17 visits as ordered during the period reviewed (12/16/24- 12/13/25). During review of the POC dated 12/16/24, the following was also ordered: “SN Endocrine Interventions” which included “Assess/Perform/Instruct” on blood glucose testing, recording, and compliance every visit. The period reviewed was between 12/16/24 and 2/13/25. During that period, the SN made 15 revisits. There were no blood sugar results entered on any nursing notes for this patient whose primary diagnosis was type 2 Diabetes. The agency failed to ensure services were provided as ordered. These findings were reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1).”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was complete and included accurate physical therapy notes for 3 (P-4, P-6, P-13) of 13 records reviewed, resulting in the potential for the lack of continuity of care. Findings include: P-6: This 64-year-old patient was admitted to home care on 11/6/24 with diagnoses of left heel pressure ulcer, type 2 diabetes, and peripheral vascular disease. During record review on 2/26/25, it was noted that the plan of care ordered physical therapy twice a week for 4 weeks, then once a week for 4 weeks. The plan of care also ordered skilled professionals to notify physician if pain rating is greater than 5 on a 0-10 scale. Physical therapy evaluated the patient on 11/11/24. Physical therapy visit notes on 12/6/24 and 12/9/24 failed to include a pain assessment. P-13: This 77-year-old patient was admitted to home care on 1/3/25 with diagnoses of shingles, hypertension, and diabetes. During record review on 2/27/25, it was noted that the plan of care ordered physical therapy once for week one, then twice weekly for four weeks. The plan of care also ordered skilled professionals to notify physician if pain rating is greater than 8 on a 0-10 scale. Physical therapy evaluated the patient on 1/29/24. The physical therapy assistant notes from 2/8/25, 2/13/25, 2/15/25, 2/18/25, and 2/21/25 failed to include a pain assessment. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m. P-4: This patient was admitted to the agency on 2/15/2024 with diagnosis of Encounter for aftercare following surgical removal of the patient’s cervix and uterus. Secondary diagnoses included Acquired Absence of both cervix and uterus, Weakness, Anemia, Presence of Coronary Angioplasty Implant and Graft, Long-Term use of opiate analgesic, and Long-Term use of antibiotics. Upon review of the record, it was noted that there were many documentation errors, and many areas with no documentation. Examples included: The area under Primary Caregiver, the PT documented “patient does not have a Primary Caregiver”; Under Patient Representative, the PT documented, “Patient has not selected a Representative”, yet the patient’s Representative Name and Phone number were documented on the form, however there was no further information about the representative including address, relationship, role or contact information. Under the category of Integumentary, the PT did not document location, type, status such as color of the skin, measurements, or description of the surgical wound such as drainage type including odor, color or amount. There was no documentation regarding the wound care status or Wound Care that was provided by the Physical Therapist. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 2:30 p.m.”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals communicated assessment findings to the physician for 5 (P-6, P-8, P-9, P-10, and P-12) of 13 records reviewed, resulting in the potential for poor patient outcomes. Findings include: P-6: This 64-year-old patient was admitted to home care on 11/6/24 with diagnoses of left heel pressure ulcer, type 2 diabetes, and peripheral vascular disease. During record review on 2/26/25, it was noted that the plan of care ordered physical therapy twice a week for 4 weeks, then once a week for 4 weeks. The plan of care also ordered skilled professionals to notify physician if pain rating is greater than 5 on a 0-10 scale. During the initial physical therapy evaluation on 11/11/24, the patient rated their pain as a “7” on a 0-10 scale. Physical therapy notes from 11/15/24, 11/18/24, 11/20/24, and 11/25/24 indicated the patient’s pain level as a 6. There was no evidence the physician was notified. P-8: This 83-year-old patient was admitted to home care on 1/2/25 with diagnoses of non-ST elevation myocardial infarction and essential hypertension. During record review on 2/26/25, it was noted that the plan of care ordered physical therapy once week one, then twice a week for 7 weeks. The plan of care also ordered skilled professionals to notify physician if pain rating is greater than 5 on a 0-10 scale. During the initial physical therapy evaluation on 1/9/25, the patient rated their pain as a “7” on a 0-10 scale. The physical therapy assistant documented a pain level of 7 on 1/16/25. There was no evidence the physician was notified. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m. P-9: This 70-year-old was admitted to the agency on 4/12/24 with diagnoses including laceration to the right upper back, shoulder, and elbow; type 2 Diabetes; and atrial fibrillation (a heart arrythmia). The medical record was reviewed on 2/28/25. During review of the plan of care (POC) dated 4/12/24, it was noted that vital sign parameters were provided, and physician notification was ordered when the patient’s pain rating was greater than 5 on a scale of 0-10 (0 is no pain, 10 is the worst pain). On the Physical Therapy Revisit Note dated 4/18/24, the patient pain rating was 7/10 and no care coordination with the physician was documented. On the Physical Therapy Revisit Note dated 4/21/24, the patient pain rating was 6/10 and no care coordination with the physician was documented. The physical therapist (PT) did not notify the physician of the pain which fell outside of the reportable parameter. P-10: This 73-year-old was admitted to the agency on 10/15/24 with diagnoses including type 2 Diabetes; heart failure; and amputation of the left leg below the knee. The medical record was reviewed on 2/27/25. During review of the POC dated 12/14/24, it was noted that vital sign parameters were provided, and physician notification was ordered when the patient’s pain rating was greater than 5 on a scale of 0-10. On the Nurse Revisit Note dated 12/31/24, the patient pain rating was 6/10. There was no documented coordination of care with the physician regarding the finding. P-12: This 64-year-old was admitted to the agency on 12/16/24 with diagnoses including type 2 Diabetes; non-pressure ulcer of left foot; and end stage kidney disease. The medical record was reviewed on 2/28/25. During review of the POC dated 12/16/24, it was noted that vital sign parameters were provided, and physician notification was ordered if the patients systolic blood pressure (SBP) was greater than 160 and if the diastolic blood pressure (DBP) was less than 60. During review of the Nurse Revisit Notes, the following were noted: On 12/23/24, the DBP was recorded as 52 and was not rechecked or reported to the physician. On 1/27/25, the SBP was recorded as 164 and not rechecked. Additionally, the following was written by the nurse in a narrative: “Pt instructed to see physician immediately due to picking at wound may be due to anxiety. Pt has hypertension. Pt states she has not taken bp meds in 2 days due to vomiting” [sic]. None of these findings were reported to the physician and were left to the patient to report. On 1/31/25, the SBP/DBP was recorded as 80/50 and not rechecked or reported to the physician. These findings were reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1).”

“Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Licensed Practical Nurse was supervised by the Registered Nurse according to agency policy in 1 (P-12) of 12 sample records reviewed for which skilled nursing services were included, resulting in a lack of monitoring performance and provision of service from the Licensed Practical Nurse and potentially resulting in poor patient outcomes. Findings include: Agency policy titled “Licensed Practical Nurse Supervision”, Policy #: C-310, was reviewed on 2/28/25. On page 1., it stated “Policy… 2. The Registered Nurse will perform supervisory visits every 30 days (monthly)…” P-12: This 64-year-old was admitted to the agency on 12/16/24 with diagnoses including type 2 Diabetes; non-pressure ulcer of left foot; and end stage kidney disease. The medical record was reviewed on 2/28/25. The certification period reviewed was 12/16/24- 2/13/25. The Registered Nurse (RN) completed the start of care visit on 12/16/24 and included nursing frequency to be 2 times per week. The Licensed Practical Nurse (LPN) made 14 visits between 12/20/24- 2/13/25 (55 days). There were no LPN supervisory visits made by the RN during the period reviewed. This finding was reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1).”

“A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to provide documentation that an agency home health aide (HA-1) successfully completed a training and competency evaluation program resulting in the potential for substandard home health aide services being provided. Findings include: On 2/27/25, agency home health aide competency evaluations were reviewed. During review, it was noted that one of the agency home health aides (HA-1) did not have evidence of completion of a training and competency evaluation program in the personnel file. On 2/27/25 at 3:15 p.m., the agency Administrator (Adm-1) was queried regarding whether HA-1 had completed a competency evaluation program either provided by this agency, or another entity. Adm-1 stated that prior to hire, HA-1 had no prior experience as a home health aide and acknowledged that HA-1 had not brought evidence of completing a training and competency evaluation program from another entity upon hire. Adm-1 stated that HA-1 was trained by an agency registered nurse upon hire but was unable to provide documentation of the training and competency evaluation program completed by HA-1 and acknowledged the finding.”

“Classroom and supervised practical training CFR(s): 484.80(b)(1) Home health aide training must include classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. Classroom and supervised practical training must total at least 75 hours. This Element is not met as evidenced by: Based on record review and interview, the agency failed to provide documentation of classroom and supervised practical training for an agency home health aide (HA-1) which totaled 75 hours. Findings include: On 2/27/25 during interview at 3:15 p.m., request was made to the Administrator (Adm-1) to provide the content and duration of classroom and supervised practicum for a home health aide (HA-1) which totaled 75 hours. Adm-1 provided a binder which contained annual agency in-service education in which HA-1 attended in 2022, and a Skills Competency Assessment Checklist dated 2/1/22. After review, it was determined the in-services, and the Skills Competency Assessment Checklist did not provide evidence of 75 hours of classroom and supervised practical training for HA-1. On the Skills Competency Assessment Checklist, the registered nurse (RN) providing the assessment signed the bottom of the assessment and included a statement that HA-1 “completed over 75 hours of training with direct observation from this RN”. It was noted that the agency hire date for HA-1 was 1/25/22 and the Skills Competency Assessment Checklist was completed on 2/1/22 (7 days after the hire date). This finding was reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1).”

“Minimum hours of training CFR(s): 484.80(b)(2) A minimum of 16 hours of classroom training must precede a minimum of l6 hours of supervised practical training as part of the 75 hours. This Element is not met as evidenced by: Based on record review and interview, the agency failed to demonstrate the home health aide received 16 hours of classroom training preceding a minimum of 16 hours supervised practical training as part of a total 75 hours. Findings include: On 2/27/25 during interview at 3:15 p.m., request was made for the agency Administrator (Adm-1) to provide evidence of 16 hours of home health aide classroom training preceding 16 hours of supervised practicum training, and evidence for the remainder of 75 hours home health aide training for the agency home health aide (HA-1). Adm-1 was not able to provide any evidence of the training as described above and acknowledged this finding.”

“HH aide training program topics CFR(s): 484.80(b)(3) A home health aide training program must address each of the following subject areas: (i) Communication skills, including the ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff. (ii) Observation, reporting, and documentation of patient status and the care or service furnished. (iii) Reading and recording temperature, pulse, and respiration. (iv) Basic infection prevention and control procedures. (v) Basic elements of body functioning and changes in body function that must be reported to an aide’s supervisor. (vi) Maintenance of a clean, safe, and healthy environment. (vii) Recognizing emergencies and the knowledge of instituting emergency procedures and their application. (viii) The physical, emotional, and developmental needs of and ways to work with the populations served by the HHA, including the need for respect for the patient, his or her privacy, and his or her property. (ix) Appropriate and safe techniques in performing personal hygiene and grooming tasks that include -- (A) Bed bath; (B) Sponge, tub, and shower bath; (C) Hair shampooing in sink, tub, and bed; (D) Nail and skin care; (E) Oral hygiene; (F) Toileting and elimination; (x) Safe transfer techniques and ambulation; (xi) Normal range of motion and positioning; (xii) Adequate nutrition and fluid intake; (xiii) Recognizing and reporting changes in skin condition; and (xiv) Any other task that the HHA may choose to have an aide perform as permitted under state law. (xv) The HHA is responsible for training home health aides, as needed, for skills not covered in the basic checklist, as described in paragraph (b)(3)(ix) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to provide evidence for a home health aide competency evaluation program resulting in a lack of documented training for an agency home health aide (HA-1). Findings include: On 2/27/25, the agency Administrator (Adm-1) provided personnel files for agency home health aides. One aide (HA-1) did not have evidence of completion of a competency evaluation program in the personnel file. During interview on 2/27/25 at 3:15 p.m., Adm-1 was only able to provide a Skills Competency Assessment Checklist dated 2/1/22 as evidence of initial home health aide training for HA-1. The document was reviewed to determine content and duration of home health aide training and supervised practical training. During review, the following information was noted: The checklist contained 39 skills which were being assessed. Each of the 39 skills had boxes next to them for identifying a method of validation; the date the skill was performed, and a box for the registered nurse (RN) completing the assessment to initial. The “Method of Validation” for each skill had an identifier key noted as: Verbal review, identified by a “V”; Demonstration, identified by a “D”; In-service, identified by an “I”; and Protocol/verbal review, identified by a “P”. The checklist form included an (*) next to skills which needed to be performed on an actual patient (such as hair care/shampoo, feeding clients, and transfer techniques) while the RN observed. The Skills Competency Assessment Checklist was completed on 2/1/22, (7 calendar days after HA-1’s hire date). It was unclear what method the RN used to validate HA-1’s skills because a method of validation was marked in 2 different columns (“Method of Validation” and in “Initials) for all 39 skills. For example, for the skill of “Positioning”, the column titled “Method of Validation” was marked with a “V” indicating the skill was verbalized. In contrast, the column titled “Initials” next to the same skill included the validators initials and a “D” indicating that the skill was demonstrated. The methods entered in both of those columns did not match for 20 out of 39 skills. None of the 39 skills validated included a validation method of in-service training “I”, or protocol/verbal review “P”. There was no evidence of the content or duration of training for any of the 39 skills. During interview with the Administrator (Adm-1) on 2/27/25 at 3:15 p.m., Adm-1 stated that it is assumed the handwritten “D” and “V” in the “Method of Validation” column was written by HA-1. Adm-1 stated it is assumed the nurse separately identified the method of her validation after her initials in the “Initials” column. Adm-1 could not give a reason why the method marked in the “Method of Validation” column and the method identified next to the initials of validating nurse were different and could not confirm which method of validation was correct. Adm-1 acknowledged the content and duration of training was not provided on this document.”

“Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This Element is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the home health aide provided services which were included in the plan of care for 1 (P-10) of 1 sample records reviewed in which a joint home visit was conducted with a home health aide. This practice has the potential to result in patient harm. Findings include: P-10: This 73-year-old was admitted to the agency on 10/15/24 with diagnoses including type 2 Diabetes; heart failure; and amputation of the left leg below the knee. On 2/27/25, a joint home visit was conducted with the home health aide (HA-1), at 11:30 a.m. to observe care being provided. During the visit, HA-1 was observed assisting the patient in moving from a recliner chair to a wheelchair with use of a sliding board. HA-1 also assisted the patient in moving from the wheelchair to a shower chair using the sliding board. During review of the Home Health Aide Care Plan (HHACP) developed 2/11/25, it was noted the patient was to be assisted in activity with a wheelchair and walker every visit. There was no sliding board noted on the HHACP. The walker in the home was not used in the transferring of the patient during the observation. This finding was reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1).”

“Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient’s condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA’s policies and procedures. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide reported changes in the patient’s condition to a registered nurse in 2 (P-6 and P-10) of 5 records reviewed with home health aide services, resulting in the potential for physical decline and unmet care needs for these patients. Findings include: P-13: This 77-year-old patient was admitted to home care on 1/3/25 with diagnoses of shingles, hypertension, and diabetes. During record review on 2/27/25, it was noted that the plan of care ordered home health aide (HHA) once a week for five weeks. The HHA care plan indicated the HHA provide a shower every visit. The HHA revisit notes from 1/30/25, 2/3/25, and 2/10/25 indicate the patient refused to shower with no evidence the HHA notified or coordinated with the registered nurse. This finding was reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m. P-10: This 73-year-old was admitted to the agency on 10/15/24 with diagnoses including type 2 Diabetes; heart failure; and amputation of the left leg below the knee. The medical record was reviewed on 2/27/25. During review of the Plan of Care (POC) with certification period of 12/14/24- 2/11/25, it was noted that Home Health Aide services were ordered beginning 12/15/25 at a frequency of 1 time per week for 7 weeks. There was no Aide visit documented in week 1 (12/15/24- 12/21/24). There was no Aide visit documented in week 3 (12/29/24- 1/4/25). There was no Aide visit documented in week 5 (1/12/25- 1/18/25). There were no missed visits documented for the Aide. There were no notes that the patient refused Aide services in the weeks missing visits. There were no physician orders changing frequency of the Aide. There was no evidence the Aide reported the need to change frequency to the nurse. This finding was reviewed and acknowledged during interview on 2/28/25 at 1:45 p.m. with the Agency Administrator (Adm-1) and Nurse Consultant (RN-1).”

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse completed an on-site supervisory visit to the patient’s home at least every 14 days to supervise the services that were provided by the home health aide for 1 (P-6) of 5 records reviewed in which aide services were provided, resulting in lack of oversight of aide care and services for this patient. Findings include: *Policy –C-340: Home Health Aide Supervision (issued 9/2010). The RN/Therapist will perform and document supervisory visits every 14 days. P-6: This 64-year-old patient was admitted to home care on 11/6/24 with diagnoses of left heel pressure ulcer, type 2 diabetes, and peripheral vascular disease. During record review on 2/26/25, it was noted that the plan of care order home health aide (HHA) services once a week for eight weeks. The HHA provided care for six weeks. There was no evidence a supervisory HHA visit was completed by the registered nurse. The agency failed to follow their policy. This finding was reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient’s clinical record contained all clinical notes for 1 (P-13) of 13 records reviewed resulting in the potential for missed or unmet patient needs. Findings include: *Policy- C-580: Clinical Documentation (Revised 2/2025). The clinical note will be written the day of care provided to the patient. All notes will be completed and turned into the office at the end of the work week. P-13: This 77-year-old patient was admitted to home care on 1/3/25 with diagnoses of shingles, hypertension, and diabetes. The patient was admitted to the hospital on 1/7/25 and was discharged 1/10/25. During record review on 2/27/25, it was noted that the plan of care ordered skilled nursing once weekly for six weeks. Skilled nursing conducted a resumption of care assessment on 1/24/25, noting the delay was due to late notification of discharge from the hospital. It was noted that the registered nurse failed to document clinical notes on 2/1/25, 2/7/25, 2/14/25, and 2/20/25. In addition, the plan of care ordered home health aide (HHA) once weekly for five weeks. The HHA started care on 1/30/25. It was noted that the HHA failed to document clinical notes on 2/17/25 and 2/24/25. These findings were reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m.”

“Contact information for the patient CFR(s): 484.110(a)(4) Contact information for the patient, the patient’s representative (if any), and the patient’s primary caregiver(s); This Element is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the clinical record contained accurate patient contact information for 1 (P-13) of 13 records reviewed, resulting in the potential to negatively affect the health and safety for this patient. Findings include: P-13: This 77-year-old patient was admitted to home care on 1/3/25 with diagnoses of shingles, hypertension, and diabetes. The agency provided a copy of the plan of care for a home visit observation on 2/27/25 with the registered nurse (RN-3). The address listed on the plan of care was incorrect, listing the address from a different apartment complex building and an incorrect apartment number. This finding was reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m.”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a detailed discharge summary was sent to the physician within 5 business days of discharge for 1 (P-6) of 4 discharge records reviewed, resulting in a lack of information to ensure continuity of care. Findings include: P-6: This 64-year-old patient was admitted to home care on 11/6/24 with diagnoses of left heel pressure ulcer, type 2 diabetes, and peripheral vascular disease. During record review on 2/26/25, it was noted the patient was sent to the emergency room on 12/16/24, was admitted, and did not resume services with the agency. There was no evidence that a detailed discharge summary report was sent to the physician within 5 days of the patient’s discharge. This finding was reviewed and acknowledged by the administrator (Adm-1) and nurse consultant (RN-1) during an interview on 2/28/25 at 10:25 a.m.”