Every finding on record at Affinity Home Care Agency, Inc

An unannounced standard Emergency Preparedness survey was conducted on 9/9/24 through 9/12/24 by the Michigan Department of Licensing and Regulatory Affairs. At the conclusion of the survey, Affinity Home Care Agency was found to be not in compliance with the requirements for participation in Medicare at 42 CFR 484.102 – Emergency Preparedness.

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.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 9/9/24 through 9/12/24 at: Affinity Home Care Agency, Inc 2655 E Oakley Park Rd., Ste 106 Commerce Township, MI 48390 This agency has no branches. Clinical records reviewed for this survey included 4 records with home visits, 3 active records without home visits, and 3 discharged records. At the conclusion of the survey the agency was found to be out of compliance for the conditions of participation for home health agencies at: 42 CFR Part 484.

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.

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.

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.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure there was a physician order for aide services for 1 of 4 (MR#4) records reviewed with aide services, resulting in no physician order for services to be provided to this one patient. Findings include: MR#4: This 76-year-old patient was admitted to home care on 1/25/22 with diagnoses of heart failure and coronary artery disease. The 1/25/22 plan of care ordered weekly skilled nursing, physical therapy, and occupational therapy services. the aide care plan developed by the registered nurse instructed the aide to provide one visit each week for two weeks. During record review on 2/1/22, it was noted that there was no physician order to provide aide services. The findings were reviewed with the director of nursing (CM-B) during an interview on 2/2/22 at 11:00 a.m. CM-B reviewed the medical record and confirmed there was no physician order for aide services.

An Emergency Preparedness Survey was conducted by the Michigan Department of Licensing and Regulatory Affairs (MDLARA) on September 14, 2021 through September 17, 2021 at: Affinity Home Care Agency2569 Union Lake Rd.Commerce Twp., MI 48382At the conclusion of the survey, Affinity Home Health Agency was determined to be in compliance with the Conditions of Participation at 42 CFR §484.102: Emergency Preparedness. At the conclusion of this survey, the Agency was determined to be non-compliant, at a standard level, with the Conditions of Participation at sub part 42 CFR Home Health Agencies. The following Conditions were Identified: 42 CFR §484.55 Comprehensive Assessment of Patients.42 CFR §484.60 Care Planning, Coordination, Quality of Care. As a result of the Condition level noncompliance, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

This Agency was determined to be in Immediate Jeopardy which was identified on 9/17/21 at 1:43 p.m. A plan to remove the Immediacy was submitted and accepted. The Immediate Jeopardy was removed on 9/17/21 at 4:35 p.m. The Condition and Standard level deficiencies were identified at a Medicare authorized recertification survey conducted by the Michigan Department of Licensing and Regulatory Affairs on 9/14/21 through 9/17/21 at: Affinity Home Care2569 Union Lake Rd.Commerce Twp., MI 48382This Agency had no additional branch locations Records: 4 with home visits; 6 without home visits, for a total of 10 records reviewed. At the conclusion of this survey, the Agency was determined to be non-compliant, at a standard level, with the Conditions of Participation at sub part 42 CFR Home Health Agencies. The following Conditions were Identified: 42 CFR §484.55 Comprehensive Assessment of Patients.42 CFR §484.60 Care Planning, Coordination, Quality of Care. As a result of the Condition level noncompliance, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

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 to inform the patient in advance of the disciplines that will furnish care in 1 record reviewed (MR# 9) from a total sample of 10 records reviewed, resulting in the patient not having knowledge of the plan for treatment and potential unmet care needs. Findings include: MR#9: The Start of Care (SOC) was dated 9/10/21. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack (TIA), Hypertension and Anxiety. During record review on 9/16/21, it was noted that the referral dated 9/8/21 documented, "Pt (patient) is discharging today. Will send HHC order soon. PT (Physical Therapy), OT (Occupational Therapy), Aide, Nurse, and Social Worker (MSW)." The Comprehensive Assessment completed on 9/10/21 documented, "Orders for Discipline and Treatments. SN (Skilled Nurse): 1w3 (1 time a week for 3 weeks), 1 prn. PT: Eval/treat. OT: Eval/treat. HHA (Home Health Aide): 2w2. MSW: n/a.” The agency failed to provide MSW services as referred. The Clinical Manager (CM#1) was questioned on 9/17/21 at 10:30 am and confirmed the findings stating, "A social worker should have evaluated the patient. I will follow-up with the patient."

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on interview and record review, the Agency failed to ensure the Initial Comprehensive Assessment was complete and accurately reflected the patient's health status at the time of admission for 6 (MR #'s 5, 6, 7, 8, 9 and 10) records, from a total of 10 sampled records reviewed and; failed to assess baseline blood glucose/sugar levels and incorporate all prescribed medications as part of the assessment for 1 (MR #5) of 1 patient newly diagnosis of Diabetes Mellitus and a recent history of a critically elevated blood glucose level (1,026 mg/dl). This resulted in Immediate Jeopardy (IJ) to the health and safety of MR #5 as a result of failure to provide initial assessment of his Endocrine status, medication management and ongoing monitoring. This deficient practice placed MR #5 at risk of serious injury, serious harm, and/or death (G528); failed to ensure the patient's Activities of Daily Living needs were adequately met in the patient's home in 1 (MR #3) of 5 records in which the patient required assistance with self-care, resulting in the potential for psychological decline, poor hygiene, caregiver burden and unmet care needs (G534); failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review, and failed to ensure the Physician was notified of potential drug interactions in 10 (MR#'s 1, 2, 3, 4, 5, 6, 7, 8, 9 and10) of 10 sampled records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency (G536). The Immediate Jeopardy (IJ) began on 8/2/21 The IJ was identified on 9/17/21 The Administrator (Adm #1) and Clinical Manager (CM #1) were notified of the IJ in person and by email on 9/17/21 at 1:43 p.m. A Plan to remove the immediacy was requested. The Immediacy/IJ was removed on 9/17/21 at 4:35 p.m. based on an acceptable plan of removal which was approved by the State Agency. Although the IJ was removed on 9/17/21, 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 §484.55 Comprehensive Assessment of Patients.

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 interview and record review, the Agency failed to ensure the Initial Comprehensive Assessment was complete and accurately reflected the patient's health status at the time of admission for 6 (MR #'s 5, 6, 7, 8, 9 and 10) records, from a total of 10 sampled records reviewed and; failed to assess baseline blood glucose/sugar levels and incorporate all prescribed medications as part of the assessment for 1 (MR #5) of 1 patient newly diagnosis of Diabetes Mellitus and a recent history of a critically elevated blood glucose level (1,026 mg/dl). This resulted in Immediate Jeopardy (IJ) to the health and safety of MR #5 as a result of failure to provide initial assessment of his Endocrine status, medication management and ongoing monitoring. This deficient practice placed MR #5 at risk of serious injury, serious harm, and/or death. Findings Include: Policy: "Initial Assessments/Comprehensive Assessments" 9.6.2-3 Revised 10/17 stated, "Each patient admitted will receive a comprehensive assessment. The assessment will reflect the patient's current health status..., Each patient's comprehensive assessment includes a review of all medications the patient is currently taking..., The Initial Comprehensive Assessment also includes: relevant diagnoses and current health status, relevant medical history, physical assessment/review of systems and pertinent physical findings." MR#6: The Start of Care (SOC) was dated 4/20/21. The Plan of Care (POC) identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Weakness and Falls. During record review on 9/14/21, it was noted that the SOC comprehensive assessment dated 4/20/21, documented under "Primary Diagnosis and Other Diagnoses", all 6 diagnoses had the same date of exacerbation documented, 4/19/21. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#7: The Start of Care (SOC) was dated 8/16/21. The Plan of Care (POC) identified diagnoses of Stage 4 Right Heal Ulcer and Stage 4 Coccyx Ulcer. During record review on 9/15/21, it was noted that the SOC comprehensive assessment dated 8/16/21, documented under "Primary Diagnosis and Other Diagnoses", all 13 diagnoses had the same date of exacerbation documented, 8/5/21. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#8: The Start of Care (SOC) was dated 8/30/21. The Plan of Care (POC) identified diagnoses of Stage 2 Pressure Ulcer Buttock, Diabetes Type 2 and Congestive Heart Failure (CHF). During record review on 9/16/21, it was noted that the SOC comprehensive assessment dated 8/30/21, documented under "Primary Diagnosis and Other Diagnoses", all 10 diagnoses had the same date of exacerbation documented, 8/27/21. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#9: The Start of Care (SOC) was dated 9/10/21. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack (TIA), Hypertension and Anxiety. During record review on 9/16/21, it was noted that the SOC comprehensive assessment dated 9/10/21, documented under "Primary Diagnosis and Other Diagnoses", all 7 diagnoses had the same date of exacerbation documented, 9/7/21. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#10: The Start of Care (SOC) was dated 8/23/21. The Plan of Care (POC) identified diagnoses of Seizure, Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD). During record review on 9/15/21, it was noted that the SOC comprehensive assessment dated 8/23/21, documented under "Primary Diagnosis and Other Diagnoses", all 9 diagnoses had the same date of exacerbation documented, 8/17/21. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. The Clinical Manager (CM#1) was questioned on 9/17/21 at 10:25 am and confirmed the findings." MR #5: The patient's Start of Care (SOC) was 8/2/21 with diagnoses that included Malignant Neoplasm right scalp and neck, Hypertension, Heart disease and Falls. The Plan of Care (POC) ordered Skilled Nursing (SN) services to be provided at a frequency of 2x/wk. x 3 wks. for wound care. On 9/16/21 at 12:26 p.m., during the clinical record review, it was noted that the patient was admitted to the Agency from a Hospital inpatient setting. The Hospital "Discharge Summary" dated 7/29/21, revealed that the patient was admitted to the hospital, via the Emergency Room, on 7/23/21 for a Malignant mass to his right scalp and neck and was discharged on 7/28/21. During the hospital stay, the patient was diagnosed with "Hyperosmolar nonketotic hyperglycemia (a dangerous condition resulting from very high blood glucose levels) and on 7/23/21 upon arrival to the hospital, was noted to have a blood glucose level of 1,026 mg/dl (Normal blood sugar level 70-130 mg/dl (milligrams per deciliter) per WebMD (online Physician's). The hospital records reflected that the patient was treated with a continuous intravenous Insulin (used to treat elevated blood glucose) infusion in order to manage his blood glucose levels. The Discharge Summary documented, "Patient was diagnosed with uncontrolled insulin-dependent diabetes in which patient will need to be on Lantus (Insulin used to treat elevated blood glucose/sugar levels) at bedtime along with Novolog (Insulin) prior to meals. It is determined he will need 18 units at bedtime and 5 units prior to meals." Review of the Initial Comprehensive Assessment dated 8/2/21, completed by the Registered Nurse (RN #1) revealed the following: Under the section titled "Past Medical History" the area that referenced Diabetes was left blank. Section M1021/M1023 "Primary/Other Diagnoses" had the same dates of onset/exacerbation of 7/23/21 for all listed diagnoses. Amongst the list of diagnoses, Diabetes was not listed. Section M1028 "Active Diagnoses - Check all that apply" listed Peripheral vascular disease and Diabetes Mellitus as options. RN #1 checked the box that stated, "None of the above." The section titled "Blood sugar/blood sugar checked by" was left blank. RN #1 failed to assess the patient's baseline blood sugar upon admission to the Agency. RN #1 documented, "Pt (patient) had elevated blood sugar in ER (Emergency Room) >1000..." The sections that addressed Interventions and Goals for the Diabetic patient were left blank. RN #1 further documented, "Medication review..." A review of the "Patient Medication Record (List of medications)." However, RN #1 failed to include the patient's prescribed Insulins as part of the Initial Comprehensive Assessment. RN #1 failed to ensure the Comprehensive Assessment was complete, included a baseline blood glucose reading, painted a clear clinical picture of the patient's health status and needs at the time of admission and included all prescribed medications as part of the Initial Assessment. On 9/16/21 at 1:00 p.m., the Administrator (Adm #1), who is also a licensed Physician, and the Clinical Manager were made aware of the above identified concerns. Adm #1 was queried as to his knowledge of the effects of an elevated blood sugar reading greater than 1000 and replied, "You know what could happen. A coma, cardiac arrest, they could die. It's serious." Adm #1 then stated, "Why wouldn't she (RN #1) just check it (Blood sugar). She's a good nurse. Once she saw the blood sugar was 1,026 in the hospital, why didn't she just check it in the home?" On 9/16/21 at 3:00 p.m., an interview was conducted with the Clinical Manager (CM #1). When queried about the above concerns. When asked of her expectations regarding assessing the baseline blood sugar of a patient with a recent critically high blood sugar level, CM #1 reported, "RN #1 did not obtain a baseline blood sugar. I would've contacted the Physician to get approval to check the patient's blood sugar." When queried about the inclusion of medications as part of the Comprehensive Assessment, CM #1 reported, "There's no way to weigh things if all the medications are not included. I'm looking at the order. They (Insulin) weren't added." On 9/16/21 at 3:34 p.m., a telephone interview was conducted with the Registered Nurse (RN #1) who stated, "I didn't feel it was necessary to take a baseline blood sugar because I feel his levels were elevated due to his infection, and plus he didn't have a glucometer in the home. My focus was on the mass on his neck. He didn't even have any insulin in the home and I asked his wife and she said he wasn't on insulin" RN #1 went on to acknowledge, "I didn't add any of the medications (Insulin) to his medication profile because it wasn't right there in front of me. What? Am I just supposed to write all the medications from his hospital orders?" During the telephone interview, CM #1 interjected to speak with RN #1 over the speakerphone. CM #1 began to explain to RN #1 that the TOC (Transition of Care) orders from the hospital ordered the patient to be on long term insulins and that the patient had a diagnosis of Diabetes Mellitus. RN #1 failed to incorporate the Hospital Discharge orders, including prescribed insulins, into the Initial Comprehensive Assessment. Further review of the clinical record revealed that no blood glucose monitoring had been conducted this specified course of care. It was further noted that the patient was transferred to the hospital on 8/13/21 with what was reported to be due to "uncontrolled pain." Review of the hospital paperwork revealed that the patient reported to the Emergency room on 8/13/21 with dizziness, confusion, and the urge to urinate in the parking lot. It was also noted that the patient had a blood sugar level of 410 mg/dl. (Normal 70- 130 mg/dl). Upon resumption of Care (ROC) on 8/18/21, it was noted that the patient's prescribed Insulins still had not been incorporated into the ROC Comprehensive Assessment or in the Plan of Care. The Agency failed to ensure the Comprehensive Assessments accurately reflected the patient's health status at the time of admission/readmission.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined the Agency failed to ensure the patient's Activities of Daily Living needs were adequately met in the patient's home in 1 (MR# 3) of 5 records in which the patient required assistance with self-care, resulting in the potential for psychological decline, poor hygiene, caregiver burden, and unmet care needs. Findings include: MR #3: The patient's SOC was 9/7/21 with diagnoses that included Cancer of the Central Nervous system, Pressure sore left heel, Diabetes Mellitus, generalized weakness and need for assistance with personal care. During the record review on 9/15/21 at 1:05 p.m., it was noted that Sections M1800 through M1860 of the Initial Comprehensive Assessment, completed by the Registered Nurse, documented, "Grooming: Patient depends entirely upon someone else for grooming needs, depends entirely upon another person to dress upper/lower body, is bathed totally by another person, is totally dependent in toileting..." On 9/15/21, a scheduled home visit was conducted with the Physical Therapist (PT #1). During the visit, the patient's wife voiced concerns about not having enough help with grooming for the patient. The patient's wife stated, "The Aide (HHa #1) that came out was wonderful. We really liked her. I inquired as to whether the staff providing services had been vaccinated and during a visit, HHa #1 informed me that she wasn't vaccinated and didn't believe in it. I voiced my concerns to the agency and I was told that they would get me another Home Health Aide. They haven't sent anyone out yet. I've been trying to do it (provide grooming for her spouse) myself but now I'm beginning to have lower back pain. I just can't do it. When the Occupational Therapist (OT) came out, she, said I may need to have Physical Therapy for my back." When asked if OT provided any assistance with bathing/grooming, the patient's wife stated, "No. I mean I know they (OT) can do it, but it's not something I just told her to do." During further review of the record, it was noted that the patient was to receive Home Health Aide services at a frequency of 2x/wk. x 2 wks. The patient had only received one Home Health Aide visit by the end of the survey. No additional grooming services had been provided. These findings were reviewed with and confirmed by the Clinical manager (CM #1) during an interview on 9/16/21 at 4:06 p.m.

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, it was determined the agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review, failed to ensure the Physician was notified of potential drug interactions as appropriate in 10 (MR's # 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10) of 10 sampled records reviewed, resulting in the potential for harmful medication effects for all patients currently serviced by this Agency. Findings include: MR #1: The patient's start of care (SOC) was 10/24/20 with diagnoses that included Wedge compression fracture, Heart failure, Falls and Hypertension. On 9/14/21 at 12:35 p.m., during a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 10/24/20, completed by the Registered Nurse (RN), indicated "Yes - Issues found during review." There was no documented evidence of what issues had been identified or that the Physician had been notified of those issues. . These findings were reviewed with and acknowledged by the clinical manager (CM #1) during an interview on 9/16/21 at 3:15 p.m. MR #2: The patient's SOC was 8/31/21 with diagnoses that included Obstruction of Bile Duct and Falls. On 9/15/21 at 9:35 a.m., during a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 8/31/21, completed by the RN indicated "Yes - Issues found during review." The "Patient Medication Record" dated 8/31/21 documented, "Interaction report faxed to physician; No interactions..." There was no documentation of what issues had been identified or what information had been faxed to the Physician. There was no documented evidence that a drug review had actually been conducted. These findings were reviewed with and confirmed by CM #1 during an interview on 9/16/21 at 4:00 p.m. MR #3: The patient's SOC was 9/15/21 with diagnoses that included Cancer of Central Nervous System, DM, and Dysphagia (difficulty swallowing). On 9/15/21 at 1:05 p.m., during a review of the clinical record, it was noted that section M2001 of the Initial Comprehensive Assessment/Oasis dated 9/15/21, completed by the RN indicated "Yes - issues found during review." There was no documented evidence of what issues had been identified or that the Physician had been notified of the findings as appropriate. These findings were reviewed with and acknowledged by CM #1 during an interview on 9/16/21 at 4:06 p.m. MR #4: The patient's SOC was 2/12/21 with diagnoses that included Heart Failure, Hypertension and Atrial fibrillation. On 9/15/21 during a review of the clinical record, it was noted that section M2001 of the Initial Comprehensive Assessment/Oasis dated 2/12/21 completed by the RN, indicated "Yes - issues found during review." There was no documented evidence of what issues had been identified or that the Physician had been notified of the findings as appropriate. The patient's 7 prescribed medications were entered in "Drugs.com" (online drug interaction checker) and revealed 1 Major drug to drug interaction, 3 moderate drug to drug interactions, 2 moderate drug to food interactions and 5 duplicate drug therapies. These findings were reviewed with and acknowledged by Adm #1 during an interview on 9/16/21 at 4:30 p.m. MR #5: The patient's SOC was 7/31/21 with diagnoses that included Malignant Melanoma of scalp and neck and Diabetes Mellitus. On 9/16/21 at 12:26 p.m., during the clinical record review, it was noted that section M2001 of the Initial Comprehensive Assessment dated 7/31/21 completed by the RN (RN #1), documented, "Yes-Issues found during the review." There was no documented evidence of what issues had been identified or that the Physician had been notified. Additional review revealed that the patient was transferred to an inpatient facility on 8/13/21 and resumed agency services on 8/18/21. Section M2001 of the Resumption of Care Assessment documented, "Yes - Issues found during review." Again, there was no documentation of what issues had been identified or that the Physician had been made aware of the findings. There was no documented evidence that a drug review had actually been conducted at the SOC or at the Resumption of Care (ROC) as per this requirement. These findings were reviewed with and confirmed by Adm #1 during an interview on 9/17/21 at 9:00 a.m. MR#6: The Start of Care (SOC) was dated 4/20/21. The Plan of Care (POC) identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Weakness and Falls. During record review on 9/14/21, it was noted that the Skilled Nurse (SN) documented on 5/6/21, “Pt (patient) is new to O2 (oxygen) but is not wearing all the time. O2 was 87% when first check by SN then O2 was put on and DB (deep breathing) exercises done and O2 went up to 95%.” (sic) Oxygen was not added to the patient’s medication profile. The agency failed to update the patients Medication Profile to reflect the current medication changes. Additionally, section M2001 of the "Comprehensive Assessment" dated 4/20/21 and completed by the registered nurse (RN), documented, "Yes - Issues found during review." The medication profile dated 4/20/21 stated, “Physician contacted regarding medication discrepancies: Yes. Please explain: 485 med sheet sent.” There was no documentation of what issues had been identified or what information had been faxed to the Physician. Furthermore, there was no documented evidence that a drug review was completed. MR#7: The Start of Care (SOC) was dated 8/16/21. The Plan of Care (POC) identified diagnoses of Stage 4 Right Heal Ulcer and Stage 4 Coccyx Ulcer. During record review on 9/14/21, section M2001 of the "Comprehensive Assessment" dated 8/16/21 and completed by the RN, documented, "Yes - Issues found during review." The medication profile dated 8/16/21 stated, “Physician contacted regarding medication discrepancies: Yes. Please explain: 485 med sheet sent.” There was no documentation of what issues had been identified or what information had been faxed to the Physician. Furthermore, there was no documented evidence that a drug review was completed. MR#8: The Start of Care (SOC) was dated 8/30/21. The Plan of Care (POC) identified diagnoses of Stage 2 Pressure Ulcer Buttock, Diabetes Type 2 and Congestive Heart Failure (CHF). During record review on 9/16/21, section M2001 of the "Comprehensive Assessment" dated 8/30/21 and completed by the RN, documented, "Yes - Issues found during review." The medication profile dated 8/30/21 stated, “Physician contacted regarding medication discrepancies: Yes. Please explain: 485 med sheet sent.” There was no documentation of what issues had been identified or what information had been faxed to the Physician. Furthermore, there was no documented evidence that a drug review was completed. MR#9: The Start of Care (SOC) was dated 9/10/21. The Plan of Care (POC) identified diagnoses of Transient Ischemic Attack (TIA), Hypertension and Anxiety. During record review on 9/16/21, section M2001 of the "Comprehensive Assessment" dated 9/10/21 and completed by the RN, documented, "Yes - Issues found during review." The medication profile dated 9/10/21 stated, “Physician contacted regarding medication discrepancies: Yes. Please explain: 485 med sheet sent.” There was no documentation of what issues had been identified or what information had been faxed to the Physician. Furthermore, there was no documented evidence that a drug review was completed. MR#10: The Start of Care (SOC) was dated 8/23/21. The Plan of Care (POC) identified diagnoses of Seizure, Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD). During record review on 9/15/21, section M2001 of the "Comprehensive Assessment" dated 8/23/21 and completed by the RN, documented, "Yes - Issues found during review." The medication profile dated 8/23/21 stated, “Physician contacted regarding medication discrepancies: Yes. Please explain: 485 med sheet sent.” There was no documentation of what issues had been identified or what information had been faxed to the Physician. Furthermore, there was no documented evidence that a drug review was completed. The Clinical Manager (CM#1) was questioned on 9/17/21 at 10:35 am and confirmed the findings.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on interview and record review, the Agency failed to ensure the Plan of Care included all appropriate interventions, reportable parameters, prescribed medications and measurable goals for 9 (MR #'s 5, 1, 2, 3, 6, 7, 8, 9 and 10) of 10 sampled records reviewed, resulting in patient's not receiving care and services specific to their individual needs, physiological decline and worsening of existing health conditions. (G574). 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 §484.60 Care Planning, Coordination, Quality of Care.

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 interview and record review, the Agency failed to ensure the Plan of Care included all appropriate interventions, reportable parameters, prescribed medications and measurable goals to meet the needs of the patients, for 9 (MR #'s 5, 1, 2, 3, 6, 7, 8, 9 and 10) of 10 sampled records reviewed, resulting in patient's not receiving care and services specific to their individual needs and the potential physiological decline and for poor patient outcomes. Findings include: Policy: "Plan of Care" 9.10.2 Revised 10/17 stated, "The individualized plan of care must include all pertinent diagnoses, types of services, supplies and equipment required, all medications and treatments, Patient and caregiver education, Patient-specific interventions and education, measurable outcomes and goals identified by the Agency and the patient. All patient care orders, including verbal orders, must be recorded in the plan of care." MR#6: The Start of Care (SOC) was dated 4/20/21. The Plan of Care (POC) identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Weakness and Falls. During record review on 9/14/21, it was noted that the goals on the POC were not measurable, for example the Skilled Nursing (SN) stated, "The patient will have no hospitalizations during the certification period. Patient will verbalize understanding of proper use of pain medication by 4/20/21. Patient skin integrity will remain intact during this episode." There was no evidence of how these goals could be quantitatively measured. Additionally, the POC contained the reportable vital sign parameters “FBS (fasting blood sugar): >150 / 150 / 150 / The Clinical Manager (CM#1) was questioned on 9/17/21 at 10:50 am and confirmed the findings. MR #5: The patient's Start of Care (SOC) was 8/2/21 with diagnoses that included Malignant Neoplasm of scalp and neck, Hypertension, Anxiety and Falls. The POC ordered Skilled Nursing (SN) services to provide wound care at a frequency of 2x/wk. x 3 wks. During the clinical record review on 9/16/21 at 12:26 p.m., it was noted that the patient was admitted to the Agency from the hospital. The patient's hospital discharge paperwork, dated 7/29/21, diagnosed the patient with Cancer of skin and Diabetes Mellitus. The "Discharge Instructions" ordered "Insulin (used to regulate elevated blood glucose levels) Lispro, rapid-acting 5 Units TIDAC (three time a day before meals) and Insulin gLARGine, LONG-acting 18 Units QHS (every night at bedtime)." The POC was void of the patient's diagnosis of Diabetes Mellitus and failed to include the patient's Insulins as prescribed. Additionally, there were no interventions to monitor or manage the patient's Diabetes with reportable parameters in which to notify the physician and no teaching or individualized goals related to the diagnosis of Diabetes Mellitus. These findings were reviewed with and confirmed by the Clinical Manager (CM #1) during an interview on 9/16/21 at 2:00 p.m. who reported, "Nope. [sic] Insulin is not listed. I don't see any listed and it should be listed. She (Registered Nurse/RN #1) missed it completely." MR #1: The patient's SOC was 10/24/20 with diagnoses that included 5th Vertebrae Wedge compression fracture, Congestive heart failure, Hypertension and Falls. The Plan of Care (POC) order Skilled Nursing (SN), Home Health Aide (HHa), Physical therapy (PT) and Occupational Therapy (OT) services to be provided. During a review of the POC on 9/14/21 at 12:35 p.m., it was noted that there were no interventions, reportable parameters or goals related to the diagnosis of Heart Failure. Additionally, the POC was vague and stated, "Skilled observation/Evaluation/Assessment of disease process..." The POC was not specific to the individual needs of the patient. These findings were reviewed with and confirmed by CM #1 during an interview on 9/16/21 at 3:15 p.m. MR #2: The patient's SOC was 8/31/21 with diagnoses that included Obstruction of bile duct, Hypertension and Falls. During review of the clinical record on 9/15/21 at 9:35 a.m., it was noted that the POC was vague in nature and stated, "Skilled Observation/Evaluation/Assessment of disease process and/or progression..." Additionally, the POC was void of any interventions to monitor pain, reportable pain parameters or pain goals. These findings were reviewed with and acknowledged by CM #1 during an interview on 9/15/21 at 9:35 a.m. MR #3: The patient's SOC was 9/7/21 with diagnoses that included Cancer of Central Nervous System, Pressure sore left heel, Diabetes Mellitus and Dysphagia (difficulty swallowing). During a review of the clinical record on 9/15/21 at 1:05 p.m., it was noted that there was no frequency in which to perform wound care noted on the POC. Additionally, there were no goals related to wound healing. These findings were reviewed with and acknowledged by CM #1 during an interview on 9/16/21 at 4:06 p.m.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to ensure the Registered Nurse performed re-assessments of the patient's health status and needs in 1 (MR #5) of 1 record of a patient with a new diagnosis of Diabetes Mellitus, from a total of 10 sampled records reviewed, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes. Findings included: MR #5: The patient's Start of Care (SOC) was 8/2/21 with diagnoses that included Malignant Melanoma of scalp and neck, Hypertension and Anxiety disorder. Hospital Discharge paperwork dated 7/29/21 revealed the patient was also diagnosed with Uncontrolled Diabetes Mellitus and prescribed insulin to be taken daily and at bedtime. The patient's Hospital labs revealed that the patient had an elevated blood glucose level of 1026 mg/dl. (Normal levels 70-120). The plan of care (POC) ordered Skilled Nursing (SN) 2x/wk. x 3 wk. for "Evaluation, Assessment of disease process and/or progression..., Instruct medications and medication regime..., Assessment of patient with wound dressing..., Instruct patient on nonpharmacologic pain relief, Assess skin for breakdown every visit..." During a review of the clinical record on 9/16/21 at 12:26 p.m., it was noted that the Registered Nurse (RN #1) failed to assess the patient's blood sugar upon admission. It was further noted that RN #1 saw the patient on 8/4/21, 8/10/21 and 8/12/21, and transferred the patient to an inpatient facility on 8/13/21. There were no documented blood glucose readings during the patient's course of stay from 8/2/21 to 8/13/21. RN #1 failed to assess the patient's blood glucose levels. These findings were reviewed with and confirmed by the Clinical Manager (CM #1) during an interview on 9/16/21.

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 record review and interview, it was determined the Agency failed to ensure Skilled Nursing prepared clear written patient care instructions for the Home Health Aides regarding client needs, and safety precautions, prior to the provision of care in 3 (MR#'s 1, 2 and 3) of 5 records in which Home Health Aide services were ordered, from a total of 10 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs. Findings include: Policy: "Home Health Aide Services and Training Program" 4.12.3 Revised 10/17 stated, "Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions..." MR #1: The patient's start of care (SOC) was 10/24/20 with diagnoses that included Wedge Compression Fracture, Heart Failure, Hypertension and Falls. During the record review on 9/14/21 at 12:35 p.m., it was noted that the 485/plan of care (POC) indicated the following: "Slow position change, Support during transfer and ambulation, Anticoagulant (bleeding) precautions and Fall precautions." The "Aide Care Plan" dated 10/24/20 failed to include any of the above-mentioned safety precautions. These findings were reviewed with and acknowledged by the Clinical Manager (CM #1) during an interview on 9/16/21 at 3:15 p.m. MR #2: The patient's SOC was 8/31/21 with diagnoses that included Obstruction of Bile duct, Hypertension and Falls. During the record review on 9/15/21 at 9:35 a.m., it was noted that the POC indicated the following: "Safety Measures: Support during transfer and ambulation, Fall Precautions." The Aide Care Plan failed to include any of the above-mentioned safety precautions. These findings were reviewed with and acknowledged by the CM #1 during an interview on 9/16/21 at 4:00 p.m. MR #3: The patient's SOC was 9/7/21 with diagnoses that included Cancer of Central Nervous System, Diabetes Mellitus, Pressure Sore left heel, and Dysphagia (difficulty swallowing). During the record review on 9/15/21 at 1:05 p.m., it was noted that the POC indicated the following: "Safety Measures: Slow Position Change, Anticoagulant (bleeding) precautions, Proper position during meals and float heels at all times." These findings were reviewed with and acknowledged by CM #1 during an interview on 9/16/21 at 4:06 p.m. The Registered Nurse failed to ensure the Aide Care Plan included all necessary safety precautions to ensure the adequate and safe provision of care.

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 clinical notes were accurate for 1 of 10 (MR# 8) records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: MR#8: The Start of Care (SOC) was dated 8/30/21. The Plan of Care (POC) identified diagnoses of Stage 2 Pressure Ulcer Buttock, Diabetes Type 2 and Congestive Heart Failure (CHF). During record review on 9/16/21, it was noted the Skilled Nurse (SN) failed to document the patient’s weight on 9/2/21, 9/7/21, and 9/10/21. 3 of the 4 SN visits completed failed to document weights for this CHF patient every visit. The Clinical Manager (CM#1) was questioned on 9/17/21 at 10:40 am and confirmed the findings stating, "All CHF patients are expected to have their weight recorded at each visit."

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the transfer/discharge summaries were complete, provided the patient's current health status at the time of transfer/discharge, progress toward goals, and forwarded to the receiving facility and the Physician within the required time, in 4 (MR#s 1, 5, 6, 7), of 4 records in which the patient was transferred to an inpatient facility, or discharged from the agency's services, from a total of 10 records reviewed, resulting in the potential for unidentified continuing health care concerns, lack of continuity of care, and unmet care needs. Findings include: Policy: "Discharge Summary" 9.31.1, Revised 10/17 stated, "A Discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner..." Policy: "Transfer/Referral Criteria" 9.29.1, Revised 10/17 stated, "A written Transfer Summary concerning the Agency's involvement with the patient, e.g., summary of care/services provided, patient's current physical and psychosocial status, instructions/referrals, current reconciled medication list will be provided within two business days of planned transfer or within two days of becoming aware of transfer..." MR#6: The Start of Care (SOC) was dated 4/20/21. The Plan of Care (POC) identified diagnoses of Chronic Obstructive Pulmonary Disease (COPD), Weakness and Falls. The Occupational Therapist (OT) completed a discharge OASIS (outcome and assessment information set) on 5/19/21. The agency faxed the discharge summary on 5/27/21, 6 business days after the patient’s discharge. The agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. Additionally, the Skilled Nursing (SN) discharge dated 5/13/21, stated, "Care Summary (care given, progress, regress including therapies): SN instructed pt (patient) on POC/SOC, home care regulations, ER and disaster plans, fall prevention, infectious control in home, covid s/s, O2 use and precautions, bowel regime, constipation relieving measures, medication use and side effects, pain control methods, skin care, rib care, and when and why to contact physician. PT (Physical Therapy), OT (Occupational Therapy)- eval/treat, HHA (Home Health Aide) to help with ADL'S (Activities of Daily Living)." (sic) The discharge summary failed to detail the course of care provided, responses to treatment, any potential continuing needs, and failed to document the patient's health status at the time of discharge in measurable terms. MR#7: The Start of Care (SOC) was dated 8/16/21. The Plan of Care (POC) identified diagnoses of Stage 4 Right Heal Ulcer and Stage 4 Coccyx Ulcer. The SN completed a Transfer OASIS (outcome and assessment information set) on 8/25/21. The agency faxed the Transfer Summary on 9/2/21. The agency failed to verify that the transfer summary was sent to the physician within 2 business days of the patient's transfer. MR#10: The Start of Care (SOC) was dated 8/23/21. The Plan of Care (POC) identified diagnoses of Seizure, Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD). The Physical Therapy (PT) discharge dated 9/8/21, stated, "Care Summary (care given, progress, regress including therapies): Patient received their ex (exercise), gait training, transfer training, HEP (home exercise program) and balance and coordination exercises." (sic) The discharge summary failed to detail the course of care provided, responses to treatment, any potential continuing needs, and failed to document the patient's health status at the time of discharge in measurable terms. The Clinical Manager (CM#1) was questioned on 9/17/21 at 10:20 am and confirmed the findings stating, "The discharge summary is incomplete and lacks detail. The summaries were not sent on time." MR #5: The patient's Start of Care (SOC) was 8/2/21 with diagnoses that included Malignant Melanoma of scalp and neck, Diabetes Mellitus, Heart disease and Hypertension. During the record review on 9/16/21 at 12:26 p.m., it was noted that the Plan of Care (POC) ordered Skilled Nursing (SN) at a frequency of 2x/wk. x 3 wks. to provide wound care and pain management. Hospital Discharge paperwork dated 7/29/21 prescribed Insulin for the new diagnosis of Diabetes Mellitus and ordered SN to provide management, oversight, and diabetic teaching. Further review revealed the patient was transferred to the Hospital on 8/13/21 and presented with dizziness and confusion. The Agency documented the reason for transfer as "Uncontrolled pain." A document titled "Transfer Summary" was noted to be a Fax cover sheet. There was no Transfer Summary available for review. The cover sheet further documented the date of the patient's transfer (8/13/21) and the date the Cover sheet was sent, which was 8/19/21. A Transfer Oasis Assessment Form had been completed by the Agency yet contained no details of the patient's course of care, current health status at the time of transfer, medications, and detailed reason for transfer to an inpatient facility. On 9/16/21 at 3:50 p.m., during an interview, the Clinical Manager (CM #1) was queried about the required Transfer Summary and reported, "We just send the Oasis (Transfer Oasis) as the summary." The agency failed to ensure a transfer summary was sent to the receiving facility with 2 days of becoming aware of the patient's transfer.