Affinity Home Care Agency, Inc.

“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 conduct a full-scale community-based exercise or a facility-based functional exercise every 2 years, resulting in the potential for an unprepared response in the event of an actual emergency. Findings include: The agency’s Emergency Preparedness (EP) binder was reviewed on 9/10/24. During review of the binder, it was noted the agency performed tabletop drills to test their EP plan in 2022, 2023, and 2024. The Director of Nursing (Staff A) was interviewed on 9/10/24 at 4:00 PM regarding a full-scale community-based exercise or a facility-based functional exercise within the last 2 years. Staff A reported all 3 drills were tabletop exercises as she was unable to find anyone to participate in a community-based exercise. Staff A was unable to provide evidence of a facility-based functional exercise or evidence of an actual emergency that required activation of the agency’s emergency plan to meet the requirements of this regulation. Staff A acknowledged the findings.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure accepted standards of practice for infection control were followed for 1 (P-8) of 4 patients with home visits, resulting in the potential for transmission of infectious and communicable diseases to all patients receiving services from this agency. Findings include: **Policy titled “Equipment Maintenance” (revised October 2017) stated, “The Agency will maintain equipment owned and/or used by Agency staff, in accordance with manufacturers’ written guidelines.” P-8: This 98-year-old patient was admitted to this agency on 8/21/24 with the diagnoses of a stable burst fracture of the thoracic spine at T11-12 following a kyphoplasty procedure (done to stabilize the fracture with cement), diverticulosis, and anemia. During a joint home visit with the physical therapist (Staff B) on 9/11/24 at 12:45 PM, Staff B was observed using a cloth gait belt around the patient’s trunk to assist in walking and balance. Upon completion of the visit, Staff B was observed using a “Super Sani-Cloth” wipe to disinfect the belt. According to the manufacturers’ guidelines located online, “Super Sani-Cloth wipes are designed to be compatible with non-invasive medical devices and non-porous surfaces.” Staff B was interviewed regarding the disinfection of the gait belt following the visit. Staff B stated she never thought about the material but agrees the gait belt is porous due to being made of cloth, therefore the Sani-Cloth would not be recommended for proper disinfection. She acknowledged the findings. Findings were again reviewed with and acknowledged by the Director of Nursing (Staff A) during an interview on 9/11/24 at 3:00 PM.”

“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 record review and interview, the agency failed inform the patient in advance of which disciplines that would furnish care in 2 (P-3, 6) of 10 records reviewed, resulting in the potential for patients not being able to fully participate and consent to their care. Findings include: P-3: The Start of Care (SOC) was dated 9/5/24. The Plan of Care (POC) identified diagnoses of Proximal A-fib, Chronic Obstructive Pulmonary Disease, and Congestive Heart Failure. During record review on 9/10/24, it was noted that the referral dated 9/3/24 documented, “Referral Comments: dc (discharge) for tomorrow. Need for rn (registered nurse), pt (physical therapy), hha (home health aide)...” The signed consent dated 9/5/24 documented, “Skilled Nursing: 1w6, Physical therapy: Eval and Treat, Home Health Aide: Blank.” There was no signed documentation that the patient declined HHA services. The agency failed to provide HHA services as referred. These findings were reviewed with and acknowledged by the Staff A (Director of Nursing) during an interview on 9/12/24 at 10:40 am. P-6: This 88-year-old patient was admitted to this agency on 8/12/24 with the diagnoses of hemiplegia following a cerebral infraction (stroke) affecting the left side and essential primary hypertension (high blood pressure). During record review on 9/11/24, it was noted the on the plan of care dated 8/12/24, that the patient was to receive services from skilled nursing, physical therapy, and occupational therapy. Upon further review of the record, it was noted the consent form signed by the patient only identified skilled nursing as a service to be provided to this patient. Findings were reviewed with and acknowledged by the Director of Nursing (Staff A) during an interview on 9/12/24 at 11:30 AM.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status at the time of admission for 2 (P-7, 9) of 10 records reviewed, resulting in incomplete clinical information to aide in determining the needs of the patients to assist in developing the plan of care. Findings include: **Policy titled “Initial Assessments/Comprehensive Assessments” (revised October 2017) stated, “8. The Initial Comprehensive Assessment also includes:….Relevant diagnoses and current health status....Psychosocial status, functional and cognitive status.” P-7: This 69-year-old patient was admitted to this agency on 8/13/24 with the diagnoses of a fracture of the 1st lumbar vertebra, dizziness and giddiness, and incontinence. During record review on 9/10/24, it was noted on the Outcome and Assessment Information Set (OASIS) for the resumption of care dated 8/20/24 under “Past Medical History” that the patient was diabetic following her hospital stay. Further down on the OASIS under the “Endocrine” section, “No” was marked after the question that stated, “Is patient diabetic?”. Additionally, an intervention was documented for “SN to instruct Patient/Caregiver on all aspects of diabetic management to include disease process, foot assessment, sign and symptoms of hypo/hyperglycemia, glucometer use and preparation and administration of diabetic medications ordered by physician.” [sic] It was later determined on the nursing note dated 8/27/24 that the patient would not be testing her blood sugar at this time would follow up with her primary care physician to monitor her blood sugar. It was also noted she would not be using diabetic medication at this time. This was also confirmed during an interview with the patient after a joint home visit on 9/11/24 at 11:30 AM. The information in the comprehensive assessment is conflicting and does not provide a clear picture of the patient’s current status regarding diabetes. P-9: This 55-year-old patient was admitted to this agency on 8/28/24 with the diagnosis of aftercare following a cervical spinal fusion. During record review on 9/10/24, it was noted the OASIS indicated the patient required “Substantial/maximal assistance” at the comprehensive assessment to walk 10 feet. It then indicated the patient needed “Partial/moderate assistance” (less than substantial/maximal assistance) to walk 50 feet with 2 turns and to walk 150 feet. Further down on the OASIS, it was noted the patient walked 50 feet with CGA (contact guard assist) – which is significantly less assistance than the above assessment of the patient’s mobility. The information is conflicting and does not provide a clear picture of the patient’s current status regarding mobility. Findings were reviewed with and acknowledged by the Director of Nursing (Staff A) during an interview on 9/12/24 at 11:30 AM.”

“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 comprehensive assessment accurately reflected medications the patient was currently taking in 1 (P-1) of 10 sample records reviewed resulting in the agency being unaware of medications taken by the patient and the potential for harmful medication effects. Findings include: P-1: The Start of Care (SOC) was dated 5/6/24. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Congestive Heart Failure, and Chronic Obstructive Pulmonary Disease. During record review on 9/9/24, it was noted that the “Additional Documents H (History) & P (Physical)” dated 5/3/24 noted, “Pharmacy: Order Summary: Humalog Injection Solution 100 unit/ml: inject as per sliding scale: if 0-200 no insulin; 201-250=4 units;251-300=6 units; 301-350=8 units; 351-400=10 units;401-450=12 units, subcutaneously before meals for DM (Diabetes Mellitus). Insulin Glargine Subcutaneous Solution Pen-injector 100 unit/ml: inject 70 unit subcutaneously in the morning for DM. Mounjaro Subcutaneous Solution Pen-injector 5mg/0.5ml: inject 5 mg subcutaneously one time a day every Sun (Sunday) for DM. The medication profile dated 5/6/24 states, “Humalog subcutaneous 100 unit/ml 1 ml 3xday, Insulin Glargine subcutaneous 100 unit/ml 1 ml 1xday.” The medication profile failed to contain a sliding scale for Humalog Injection Solution, documented 1ml 1xday of Insulin Glargine instead of 0.7ml and contained no documentation of Mounjaro 5mg weekly. The agency failed to have a complete and accurate medication profile. These findings were reviewed with and acknowledged by the Staff A (Director of Nursing) during an interview on 9/12/24 at 10:45 am.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was individualized to the patient’s identified needs for 3 (P-2, 5, 7) of 10 records reviewed resulting in an inaccurate plan of care and the potential for poor patient outcomes. Findings included: **Policy titled “Initial Assessments/Comprehensive Assessments” (revised October 2017) stated, “8. The Initial Comprehensive Assessment also includes: …. Drug allergies, sensitivities...” P-2: The Start of Care (SOC) was dated 4/20/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Abdominal Wound, and Falls. During record review on 9/9/24, it was noted that the POC dated 4/20/24 stated, “Allergies: NKA (No Known Allergies).” The “Additional Notes” document dated 4/17/24 stated, “Allergies: Peanuts [Peanut], Penicillin’s.” The agency failed to document and accurately assess the patient’s allergies. Additionally, on 4/20/24 the Skilled Nurse documented a weight of 240 lbs during the comprehensive assessment. During the entrance interview on 9/9/24 at 9:45 am with Staff A, it was stated “If the agency is treating for Congestive Heart Failure, then there will be reportable weight parameters to notify the physician.” The POC failed to contain reportable weight parameters. P-5: The Start of Care (SOC) was dated 9/6/24. The Plan of Care (POC) identified diagnoses of Interstitial Pulmonary Disease, Weakness and Hypertension. During record review on 9/11/24, it was noted that the POC dated 9/6/24 stated, “Allergies: Levaquin.” The “Additional Notes” document dated 9/4/24 stated, “Allergies: Amoxicillin, Levaquin.” The agency failed to document and accurately assess the patient’s allergies. These findings were reviewed with and acknowledged by the Staff A (Director of Nursing) during an interview on 9/12/24 at 10:30 am. **Policy titled “Initial Assessments/Comprehensive Assessments” (revised October 2017) stated, “8. The Initial Comprehensive Assessment also includes:….Any medical equipment.” P-7: This 69-year-old patient was admitted to this agency on 8/13/24 with the diagnoses of a fracture of the 1st lumbar vertebra, dizziness and giddiness, and incontinence. During record review on 9/10/24, it was noted the physical therapy evaluation dated 8/14/24 indicated the patient’s back brace was broken when the physical therapist tried to assist the patient in adjusting it. There was no mention of a brace on the comprehensive assessment under DME (durable medical equipment). It is unclear whether this patient is supposed to be wearing a back brace following her procedure. Findings were reviewed with and acknowledged by the Director of Nursing (Staff A) during an interview on 9/12/24 at 11:30 AM.”

“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 communication with physicians involved in the plan of care in 2 (P-2, 10) of 10 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: **Agency Policy: “Skilled Professional Services,” (Revised October 2017). The policy states, “Patients receiving skilled professional services will receive appropriate assessments, reassessments, care planning, established outcomes and care per physician orders. Procedure: 3. Skilled professionals must assume responsibility for, but not be restricted to the following: Providing services that are ordered by the physician as indicated in the plan of care…Communication with all physicians involved in the plan of care...” P-2: The Start of Care (SOC) was dated 4/20/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Abdominal Wound, and Falls. During record review on 9/9/24, it was noted that POC contained the following reportable pulse ranges: (>) 100 or less than ( These findings were reviewed with and acknowledged by the Staff A (Director of Nursing) during an interview on 9/12/24 at 10:30 am. P-10: This 80-year-old patient was admitted to this agency on 6/14/24 with the diagnosis of an abdominal aortic aneurysm. During record review on 9/9/24, it was noted the Outcome and Assessment Information Set (OASIS) indicated the patient had an unintentional weight loss of 30 pounds over the last 3 months. There was no documentation of communication with the physician to ensure the physician was aware of this unusual and potentially concerning situation. Upon further review of the record, it was noted the physical therapy evaluation dated 6/17/24 reported the patient stated, “I’m having trouble doing everything because of my chest and low back pain (PS (pain scale) 10/10). It radiates from my chest all the way to my whole back.” It also noted the patient reported the pain medication “barely helps.” There was no documentation this was communicated with the physician or any other provider to assist the patient in getting effective pain relief. Findings were reviewed with and acknowledged by the Director of Nursing (Staff A) during an interview on 9/12/24 at 11:30 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 services were provided as ordered per the plan of care in 5 (P-1, 3, 6, 7, 10) of 10 records reviewed and failed to accurately assess and reassess pain in 1 (P-1) of 10 records reviewed, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: **Agency Policy: “Pain Assessment and Reassessment,” (Revised October 2017). The policy states, “Appropriate Agency staff will assess and reassess patient’s pain. Procedure: 2. Each patient receiving therapy services (PT (Physical Therapy), OT (Occupational Therapy) and/or SLP (Speech Therapy) will have pain assessed and reassessed as appropriate and relevant to the care provided by the therapist… Each therapist will use the same established criteria for assessing and reassessing pain...” P-1: The Start of Care (SOC) was dated 5/6/24. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Congestive Heart Failure, and Chronic Obstructive Pulmonary Disease. During record review on 9/9/24, it was noted that the POC dated 5/6/24 ordered “Occupational Therapy (OT): Evaluate and Treat.” The OT evaluation dated 5/9/24 was late by 1 day from the Physical Therapy (PT) Comprehensive Assessment dated 5/6/24. During the entrance interview on 9/9/24 at 9:45 am, when questioned on the timeframe for additional services to evaluate the patient, Staff A stated, “Within 48 hours.” The agency failed to evaluate the patient within 48 hours. Additionally, on 5/15/24 the PT completed a visit from 12:00 pm to 12:45 pm and documented, “No Pain Reported at Visit.” The OT completed a visit 15 minutes after the PT on 5/15/24 from 1:00 pm to 1:45 pm and documented, “Subjective Evaluation and Observation: Patient sitting in recliner chair upon arrival. Patient agreeable to OT session. Declined ADL (Activities of Daily Living) transfers today stating pain in BLE’s (Bilateral Lower Extremities) from LB (Lower Body) exercises… Pain Assessment: Pre-Therapy Intensity: 8, Post-Therapy Intensity: 8. Location: Both feet.” The agency failed to accurately document the pain assessment and reassessment. P-3: The Start of Care (SOC) was dated 9/5/24. The Plan of Care (POC) identified diagnoses of Proximal A-fib, Chronic Obstructive Pulmonary Disease, and Congestive Heart Failure. During record review on 9/10/24, it was noted that the POC dated 9/5/24 ordered “Physical Therapy: Evaluate and Treat.” The PT evaluation dated 9/9/24 was late by 2 days from the Skilled Nursing Comprehensive Assessment dated 9/5/24. The agency failed to evaluate the patient within 48 hours. These findings were reviewed with and acknowledged by the Staff A (Director of Nursing) during an interview on 9/12/24 at 10:55 am. P-6: This 88-year-old patient was admitted to this agency on 8/12/24 with the diagnoses of hemiplegia following a cerebral infraction (stroke) affecting the left side and essential primary hypertension (high blood pressure). During record review on 9/11/24, it was noted the Outcome and Assessment Information Set (OASIS) indicated that a systolic (top number) blood pressure greater than 160 should be reported to the physician. Upon further review of the OASIS, it was noted the patient’s blood pressure was recorded at 184/80 and 162/60. It was documented later in the OASIS the patient was sent to the emergency room due to head pain, however, there was no documentation if this occurred or of any communication with the physician. Additionally, it was noted under interventions on the plan of care dated 8/12/24 for “SN (skilled nursing) to assess patient’s weight log every visit.” There was no documentation in follow-up nursing notes dated 8/19/24, 8/26/24, and 9/3/24 that a weight log was assessed. Upon further review of the record, it was noted the plan of care dated 8/12/24 identified that physical therapy and occupational therapy services were ordered. During the entrance interview on 9/10/24 at 10:00 AM, the Administrator (Staff A) was interviewed regarding the agency expectation for other skilled disciplines to complete their evaluations after being ordered. Staff A stated staff is supposed to complete their evaluations within 48 hours from the start of care or from when ordered (if ordered later in the episode of care). It they are unable to complete it within this timeframe, Staff A stated staff is supposed to contact her and there should be documentation regarding the reason for the delay in care. According to the record, the physical therapy evaluation was completed the next day (8/13/24), however, the occupational therapy was not completed until 8/16/24 – 4 days after the start of care. It was also noted that an order for speech therapy was written on 9/4/24. According to the record, the speech therapy evaluation was not completed until 9/9/24 – 5 days after being ordered. There was no documentation regarding the reason for the delay in care. P-7: This 69-year-old patient was admitted to this agency on 8/13/24 with the diagnoses of a fracture of the 1st lumbar vertebra, dizziness and giddiness, and incontinence. During record review on 9/10/24, it was noted resumption of care was completed on 8/20/24 following a hospital stay. Upon further review of the record, it was determined physical therapy did not return to re-evaluate the patient according to the new orders until 8/24/24 – 4 days after the resumption of care. There was no documentation regarding the reason for the delay in care. P-10: This 80-year-old patient was admitted to this agency on 6/14/24 with the diagnosis of an abdominal aortic aneurysm. During record review on 9/9/24, it was identified on the plan of care dated 6/14/24 that physical therapy, occupational therapy, and social work services were ordered to evaluate and treat. According to the record, the physical therapy evaluation was completed on 6/17/24 (3 days after the start of care), the occupational therapy evaluation was completed on 6/21/24 (1 week after the start of care), and the social work evaluation was completed on 7/5/24 (3 weeks after the start of care). There was documentation of a missed social work evaluation visit on 6/19/24, however, there was no additional documentation to explain the delay in care. Additionally, the occupational therapy evaluation dated 6/21/24 indicated occupational therapy services would be provided 1 time a week for 3 weeks. According to the record, there were no occupational therapy visits performed after the evaluation. There was no documentation to explain the reason for the missed visits. Findings were reviewed with and acknowledged by the Director of Nursing (Staff A) during an interview on 9/12/24 at 11:30 AM.”

“Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained all interventions, treatments, and services in 4 (P-6, 7, 9, 10) of 10 records reviewed, resulting in an incomplete and inaccurate medical record. Findings include: **Policy titled “Medical Record Content” (revised October 2017) stated, “Each medical record will contain the following:….Initial and ongoing education of patients/caregivers….actions/interventions/procedures.” P-6: This 88-year-old patient was admitted to this agency on 8/12/24 with the diagnoses of hemiplegia following a cerebral infraction (stroke) affecting the left side and essential primary hypertension (high blood pressure). During record review on 9/11/24, it was noted the physical therapy (PT) note dated 9/3/24 stated, “Patient has written HEP (home exercise program)….”. It was also noted on the occupational therapy (OT) note dated 9/9/24, that “Information provided regarding home exercise program, via handouts….” There were no attachments in the record to represent the PT or OT HEP provided to the patient. There was also no written evidence of what exercises were given to the patient to perform at home. This is an incomplete record of the patient’s treatment interventions. Additionally, it was noted on the Outcome and Assessment Information Set (OASIS) dated 8/12/24 that “SN (skilled nursing) sent to ED (emergency department) for eval due to recent CVA (stroke)/hx of SDH (history of subdural hematoma/blood clot in the brain)” in response to the patient’s sudden onset of head pain and raised blood pressure during the evaluation. There was no further documentation in the record regarding if the patient went to the ED or what the results of the visit were. The comprehensive assessment was also fully completed on that day, so did not indicate any interruption in care. P-7: This 69-year-old patient was admitted to this agency on 8/13/24 with the diagnoses of a fracture of the 1st lumbar vertebra, dizziness and giddiness, and incontinence. During record review on 9/10/24, it was noted the PT evaluation dated 8/14/24 stated “Therapist will be on vacation and pt chose to wait ‘til the therapist comes back and she will perform HEP instead.” There was further mention of an HEP on the PT notes dated 8/24/24, 8/27/24 and 9/5/24. It was also noted on the OT evaluation dated 8/14/24 that “HEP established UE strength fall prevention instruction.” [sic] There were no attachments in the record to represent the PT or OT HEP provided to the patient. There was also no written evidence of what exercises were given to the patient to perform at home. This is an incomplete record of the patient’s treatment interventions. P-9: This 55-year-old patient was admitted to this agency on 8/28/24 with the diagnosis of aftercare following a cervical spinal fusion. During record review on 9/11/24, it was noted the OT evaluation dated 6/21/24 stated “HEP established…..”. There was no attachment in the record to represent the OT HEP provided to the patient. There was also no written evidence of what exercises were given to the patient to perform at home. This is an incomplete record of the patient’s treatment interventions. P-10: This 80-year-old patient was admitted to this agency on 6/14/24 with the diagnosis of an abdominal aortic aneurysm. During record review on 9/9/24, it was noted the PT evaluation dated 6/17/24 stated, “She was able to return demonstration of HEP safely and effectively with min cuing needed to correct form.” It was also noted the OT evaluation dated 6/21/24 stated, “HEP established…”. There were no attachments in the record to represent the PT or OT HEP provided to the patient. There was also no written evidence of what exercises were given to the patient to perform at home. This is an incomplete record of the patient’s treatment interventions. The Director of Nursing (Staff A) was interviewed on 9/12/24 at 11:30 AM regarding home exercise programs in the record. Staff A stated she has a few staff who send an attachment to the office to get scanned and save to the record and some who type out which exercises are given in the note; however, she was unable to locate that information for the records above. Staff A acknowledged the findings.”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure a discharge summary was 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 within 5 days of the patient’s discharge in 3 (P-1, 2, 10) of 3 closed records reviewed, resulting in the potential for unmet care needs for all patients discharged from this agency. Findings include: P-1: The Start of Care (SOC) was dated 5/6/24. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Congestive Heart Failure, and Chronic Obstructive Pulmonary Disease. During record review on 9/9/24, it was noted that the Physical Therapist (PT) completed the discharge on 6/12/24. The discharge summary fax cover sheet was dated 6/20/24, 6 business days after the discharge. The agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient’s discharge. P-2: The Start of Care (SOC) was dated 4/20/24. The Plan of Care (POC) identified diagnoses of Congestive Heart Failure, Abdominal Wound, and Falls. During record review on 9/9/24, it was noted that the PT completed the discharge on 6/12/24. The discharge summary fax cover sheet was dated 6/20/24, 6 business days after the discharge. The agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient’s discharge. These findings were reviewed with and acknowledged by the Staff A (Director of Nursing) during an interview on 9/12/24 at 10:30 am. **Policy titled “Discharge Summary” (revised October 2017) stated, “A discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner or other health professional who will be responsible for providing care and services to the patient.” P-10: This 80-year-old patient was admitted to this agency on 6/14/24 with the diagnosis of an abdominal aortic aneurysm. During record review on 9/9/24, it was noted the patient was discharged from this agency on 7/12/24. Upon further review of the record, it was noted the discharge summary wasn’t faxed to the doctor until 7/30/24 according to the fax cover sheet. Findings were reviewed with and acknowledged by the Director of Nursing (Staff A) during an interview on 9/12/24 at 11:30 AM.”