Capitol Care Inc.

“Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This Condition is not met as evidenced by: Based on review of clinical records, the agency’s policy, and interview with agency staff, the agency’s clinical staff failed to electronically report all OASIS [(Outcome & Assessment Information Set) data collected for five (5) of five (5) beneficiaries receiving skilled nursing services, (Patients # 14, 15, 16, 17, and 18). This is a repeated finding from the previous Federal Home Health Agency Recertification Survey that was conducted in conjunction with a Federal Complaint Investigation Survey 08/02/2021 through 08/06/2021. Findings included... The State Agency conducted an unannounced Federal Home Health Agency Recertification Survey, in conjunction with a Complaint Investigation Survey from 04/23/2024 to 05/08/2024. On 04/23/2024 at approximately 10:30 AM, the surveyor requested for the Agency’s OASIS (Outcome & Assessment Information Set) Validation Reports transmitted to CMS [Centers for Medicare and Medicaid Services] System. On 04/23/2024 at approximately 10:15 AM, the surveyor conducted a face-to-face interview with Employees #2, Registered Nurse who is the agency’s Clinical Manager, and #4, the agency’s Director of Operations, regarding failure to provide the OASIS Validation Reports as proof of successful transmission as requested. In response to the surveyor’s query, and after identifying the individual patients on the agency’s active census who were provided skilled services for wound care, Employee #4 reported that after some review, they determined that 15 of the agency’s patients received skilled services for various types of wound care provided by other agencies, or Wound Care Centers, but as of the time of the interview the agency had not collected OASIS data or transmitted any OASIS assessments. Following further clinical record review, the agency provided Comprehensive assessments with OASIS elements for Patients # 14, 15, 16, 17, and 18 and confirmed that these were never transmitted to CMS. The agency staff reported that they experienced multiple challenges with their electronic medical records system. Employees # 2 and 4 acknowledged and confirmed the findings on 04/25/2024 at approximately 11:30 AM.”

“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 interviews with agency staff, review of clinical records and the agency’s policies , the Home Health Agency failed to ensure that Registered Nurses document complete comprehensive assessment consistent with the patient’s immediate needs, within five (5) calendar days after the start of care(G520); failed to document complete comprehensive assessment that reflects the patient’s health, psychosocial, functional, cognition (G528); and failed review of all medications the patient was using 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 (G536). The cumulative effect of these systemic practices resulted in the Home Health Agency’s failure to comply with conditions of participation for Comprehensive Assessment of Patients.”

“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 interviews with agency staff and caregiver, review of clinical records and the agency’s policy, the Home Health Agency failed to ensure that each individualized plan of care included all required elements (G574); failed to include all physician orders in the Plan of Care (576); and failed to coordinate care delivery to meet the patient’s needs (G608). The cumulative effect of these systemic practices resulted in the Home Health Agency’s failure to comply with conditions of participation for Care planning, coordination of services, and quality of care.”

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on review of clinical records, interview with the agency’s staff, and patients, the Home Health Agency failed to provide skilled professional services directly or under arrangement for ten (10) of 10 patients received wound care, Patients #1, 2, 3, 4, 7, 8, 9, 10, 11, and 12). Findings included... A review of the Home Health Agency’s policy titled “Skilled Professional Services” showed the Home Health Agency will provide the skilled professional services of skilled nursing, physical therapy, occupational therapy, speech-language pathology, and medical social work services. a. On 04/23/2024 at approximately 10:30 AM, the surveyor conducted a face-to-face interview with Employee #2 who is the agency’s Clinical Manager regarding Patient #1’s recent hospitalization. Employee #2 denied being aware of Patient #1’s hospitalization prior to receiving a telephone call from a case manager at a local hospital. The case manager informed her of Patient #1’s inpatient overnight admission, including how he was found in his home by a friend, and brought to the hospital. The Clinical Manager stated that she was very surprised, because the agency has a system whereby one of the agency’s staff comes in to work early in the morning, works through CRISP [Chesapeake Regional Informational System for our Patients] to identify any of the agency’s beneficiaries or patients who may have been admitted to an area hospital overnight. She explained that CRISP, is a Health Information Exchange that allows sharing of health information among doctors’ offices, hospitals, labs, radiology centers, and other healthcare organizations. Additionally, CRISP allows providers and organizations to view patients’ medical history and facilitate coordination of patients’ care. Employee #2, stated that immediately following the phone call with the case manager, she called the Aide who was the assigned to work with Patient #1 and explained that she learned that the Aide was not on assignment at the patient’s home. The surveyor conducted a review of Patient #1’s clinical record on 04/24/2024 at approximately 11:20 AM that showed Employee #16, RN (Registered Nurse) prepared a ‘Comprehensive Adult Assessment’ dated 06/17/2019 for the Start of Care. The assessment showed Patient #1 was hospitalized from 11/17/2018 through 12/15/2018 for Spinal Surgery. The assessment showed that Patient #1 lived alone in an apartment and needed help with all activities due to right side weakness. At the time, the patient complained of Left Knee and Back Pain and used a wheelchair. In addition, the assessment reflected the patient stated that he sustained a Gunshot wound in 1993 and the bullet stayed in his back. Further the patient stated that he underwent surgery in 11/17/2018 and was unable to stand on his own since then, resulting in him becoming wheelchair bound. Additional review of Patient #1’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 06/17/2019, and a current annual Recertification Period for non-skilled services from 06/01/2023 through 05/31/2024. Plan of Care item # 13, titled Diagnosis (es) included Stiff Man Syndrome; Unspecified Disease of Spinal Cord; Hypertension, Chronic Pain, Symptoms involving Musculoskeletal, Wheelchair Dependence; and Bipolar Disorder, and Post traumatic Stress Disorder. The Plan of Care did not include all known diagnoses to include the history of Gunshot Wound to the Back, Pressure Ulcer and Spinal Surgery the patient underwent in 11/17/2018. Plan of Care item # 17, titled Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration showed the physician orders directed the Registered Nurse to conduct one (1) monthly and “ ...PRN [as needed]...” for 12 months to perform system assessments including vital signs, all body systems, the patient and caregiver knowledge of disease processes and associated care and treatment, and medication regimen. Physician orders on the Plan of Care directed the Personal Care Aide to visit eight (8) hours per day, seven (7) days weekly for 12 months to assist the patient with Activities of Daily Living and Instrumental Activities of Daily Living including personal hygiene tasks. Further review of the clinical record including the Plan of Care did not include i. a diagnosis of wound ii. physician’s orders for wound care iii. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #2 received skilled services provided by the agency staff. The surveyor conducted a face-to-face interview with Employees #2, a Registered Nurse who is the agency’s Clinical Manager and #4, the agency’s Director of Operations. They both acknowledged and confirmed the findings on 05/06/2024 at approximately 1:20 PM. b. The surveyor conducted a home visit with Patient#2 on 04/26/2024, at approximately 10:40 AM, in the presence of Employees #21 Personal Care Aide, and #3, a Registered Nurse, the agency’s Clinical Manager. During the home visit, the surveyor observed Patient#2’s Right Wrist with a healed linear, surgical scar on the top of two (2) bumps. In response to the surveyor’s question regarding her current state of health, Patient #2 stated that she underwent more than one surgical procedure for Hemodialysis access to her Right Wrist. She added that she used to have a central line inserted in her right chest for dialysis while the doctors waited for the surgical wound of the new to her Right Wrist to heal. Patient #2 granted permission upon the surveyor’s request to inspect her chest. The surveyor observed a small scar to the patient’s right chest and the absence of any intravenous device. During the Home Visit, Patient #2 denied having any other wounds for which she was receiving care. The surveyor conducted a review of Patient #2’s clinical record on 04/26/2024 at approximately 3:20 PM that showed a Plan of Care with a Start of Care date of 12/20/2022, and Recertification Period for non-skilled services from 10/01/2023 to 09/30/2024. The patient’s diagnoses on the Plan of Care included End Stage Renal Disease, Altered Mental Status, Diastolic (Congestive) Heart Failure, and Stage 1-4 Hypertensive Chronic Kidney Disease. Additional review of the Plan of Care showed an entry “…[Patient #2’s name] has a wound on her rt [Right] Leg and wound care is done by [name an outside wound clinic]…”. The Plan of Care showed Patient #2 had a Right Subclavian Permacath in place. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. a diagnosis of wound ii. physician’s orders for wound care iii. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #2 received skilled services provided by the agency staff. c. The surveyor conducted a home visit with Patient#3 on 04/26/2024, at approximately 2:10 PM, in the presence of Employee #3, a Registered Nurse, the agency’s Clinical Manager. During the home visit, the surveyor observed Patient#3 with tubular bandage to both lower extremities that covered from the knees to the ankles. In response to the surveyor’s question regarding her current state of health, Patient #3 stated that she was feeling relatively well and added that she previously received wound care at an outside clinic for a wound on her Left lower leg towards the ankle. She further stated that the wound healed in December 2023. The surveyor conducted a review of Patient #3’s clinical record on 04/26/2024 at approximately 4:00 PM that showed a Plan of Care with a Start of Care date of 03/15/2023, and Recertification Period for non-skilled services from 03/01/204 to 02/28/2025. The patient’s diagnoses on the Plan of Care included Chronic Kidney Disease, Hypertension, Chronic Pain Syndrome, and Morbid Obesity. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. a diagnosis of wound ii. physician’s orders for wound care iii. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #2 received skilled services provided by the agency staff. d. The surveyor conducted a home visit with Patient#4 on 04/30/2024, at approximately 9:50 AM, in the presence of Employees #17, Personal Care Aide, and #3, a Registered Nurse, the agency’s Clinical Manager. During the home visit, the surveyor observed Patient#4 with continuous rolled bandage wound dressing to both lower extremities that covered from the below the knees to just above the ankles. In response to the surveyor’s question regarding her current state of health, Patient #4 stated that she was getting ready to attend a doctor’s appointment and was about to do her wound dressing change before going out. She stated that she usually does the wound dressing changes herself and goes out to an outside clinic for wound care to both lower legs once or twice a week, or more frequently if she was having trouble. The surveyor observed Employee #2, Registered Nurse, assist Patient #4 during dressing change to her Right Leg Wound while getting dressed to attend an appointment. The patient’s diagnoses on the Plan of Care included Hypertension, Constipation, Pain, Chronic Embolism and Thrombosis of deep vein of Lower Extremities. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. a diagnosis of wound ii. physician’s orders for wound care iii. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #4 received skilled services provided by the agency staff. The surveyor conducted a face-to-face interview with Employee #2 on 05/06/2024, at approximately 12:20 PM who acknowledged and confirmed the findings. e. The surveyor conducted a review of Patient #7’s clinical record on 05/07/2024 at approximately 10:50 AM that showed Employee # 21 Prepared a General Assessment –PCA (Non-OASIS) (Outcome & Assessment Information Set) dated 09/28/2023. The diagnoses on the Non-OASIS (Outcome & Assessment Information Set) Assessment included Paraplegia, Neuromuscular Dysfunction of Bladder, and Sacral Pressure Ulcer. Additional review of the clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 02/01/2022, and a Recertification Period for non-skilled services from 08/07/2023 to 06/05/2023. The diagnoses on the current Plan of Care included Paraplegia, Neuromuscular Dysfunction of Bladder, and Sacral Pressure Ulcer. In addition, the Plan of Care directed Sacral Ulcer is being done daily by the patient’s mother. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. a diagnosis of wound ii. physician’s orders for wound care iii. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #4 received skilled services provided by the agency staff. f. The surveyor conducted a review of Patient #8’s clinical record on 05/07/2024 at approximately 10:20 AM that showed Employee # 21 Prepared a General Assessment –for ROC [Resumption of Care] (Non-OASIS (Outcome & Assessment Information Set)) dated 04/08/2024. The diagnoses on the Non-OASIS Assessment included Chronic Obstructive Pulmonary Disease with Acute Exacerbation, Acute Respiratory Distress, Type 2 Diabetes Mellitus, Hypertension, and Morbid Obesity. Additional review of the clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 05/12/2020, and a current annual Recertification Period for non-skilled services from 04/01/2024 to 03/31/2025. The diagnoses on the current Plan of Care included Chronic Obstructive Pulmonary Disease with Acute Exacerbation, Acute Respiratory Distress, Type 2 Diabetes Mellitus, Hypertension, and Morbid Obesity. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #8 received skilled services provided by the agency staff. g. The surveyor conducted a review of Patient #9’s clinical record on 04/29/2024 at approximately 9:50 AM that showed Employee # 21 prepared a ‘General Assessment–PCA SOC for the Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 03/06/2023. The diagnoses on the Non-OASIS Assessment included Seizures Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Additional review of the clinical record showed a General Assessment –PCA (Non-OASIS (Outcome & Assessment Information Set)) dated 03/06/2023. The diagnoses on the Non-OASIS Assessment included Seizures Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Patient #9’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 03/06/2023, and a Recertification Period for non-skilled services from 03/06/2023 to 01/31/2024. The diagnoses on the current Plan of Care included Seizures, Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Review of the Plan of care showed the following entry “[Patient #9’s name] has a sacral wond [wound] and 18 Fr. Foley Catheter. Wound care and Foley catheter change is done by [another named Home Health Agency] Further review of the clinical record including the Plan of Care did not include i. physician’s orders for wound care; and ii. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #9 received skilled services provided by the agency staff. h. The surveyor conducted a review of Patient #10’s clinical record on 05/08/2024 at approximately 9:20 AM that showed Employee # 21 Prepared a ‘General Assessment –PCA SOC for the Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 05/18/2023. The diagnoses on the Non-OASIS Assessment included Acquired Absence of Left Leg Below the Knee, Heart Failure, Moderate Persistent Asthma with Acute Exacerbation, Osteoarthritis of Right Hand, Type 2 Diabetes Mellitus, and Hypertension. Review of the assessment item titled ‘Integumentary’ showed “Skin: Dry, Warm”. In the section of the assessment titled Integumentary Status Locator, the nurse documented “…Chronic Ulcer of Right Heel: Wound Care is done by [Name of another Home Health Agency] …” Review of the Plan of care showed the following entry “[Patient #10’s name] has a sacral wond [wound] and 18 Fr. Foley Catheter. Wound care and Foley catheter change is done by [another named Home Health Agency]. Further review of the clinical record including the Plan of Care did not include i. physician’s orders for wound care; and ii. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #10 received skilled services provided by the agency staff. i. The surveyor conducted a review of Patient #11’s clinical record on 05/07/2024 at approximately 10:30 AM that showed Employee # 21 prepared a ‘General Assessment –PCA SOC Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 12/15/2022. The diagnoses on the Non-OASIS Assessment included Chronic Obstructive Pulmonary Disease, Lymphedema, Cellulitis of Right Lower Limb, Open Wound of Lower Leg (Unspecified), and Hypertension. Review of the assessment showed the following incomplete items: Assessment item titled ‘Integumentary’ showed “Skin: Dry, Warm”. In the section of the assessment titled ‘Integumentary Status Locator’, the nurse documented “…Stasis Ulcer on the right lower leg; wound care is done two times per week by [Name of outside wound clinic] …” Further review of the clinical record including the Plan of Care did not include i. physician’s orders for wound care; and ii. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #11 received skilled services provided by the agency staff. j. The surveyor conducted a review of Patient #12’s clinical record on 04/24/2024 at approximately 10:25 AM that showed Employee # 22 Prepared a ‘General Assessment –Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 04/05/2023. The diagnoses on the Non-OASIS Assessment included Encounter for Attention to Colostomy, Paraplegia, Neuromuscular Dysfunction of Bladder, Hypertension. In the section of the assessment titled ‘Narrative’, the nurse documented “…Patient has pressure Ulcers on his Sacrum and Right Foot. The patient is currently using Medihoney dressing. The area is cleansed with Wound Cleanser, pat dry, apply Medihoney and cover with Bordered gauze daily. Dressing change is done by his mother. RN [Registered Nurse] was not able to see the Pressure Ulcer and the wound because dressings were already done and covered...” Additional review of the clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 04/05/2023, and a Recertification Period for non-skilled services from 02/01/2024 to 12/31/2024. The diagnoses on the current Plan of Care included Encounter for Attention to Colostomy, Paraplegia, Neuromuscular Dysfunction of Bladder, Hypertension, Stage 3 Pressure of Sacral Region, and Stage 3 Pressure Ulcer of Left Hip. Further review of the clinical record including the Plan of Care did not include i. physician’s orders for wound care; and ii. physician’s orders for skilled services The clinical record lacked documented evidence that Patient #12 received skilled services provided by the agency staff. Employee#2 acknowledged and confirmed the aforementioned findings during the clinical record review on 05/07/2024, at approximately 12:00 PM.”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This Standard is not met as evidenced by: Based on interviews with agency staff, review of clinical records, supporting documentation review, the Home Health Agency’s Quality Assessment Performance Improvement (QAPI) program failed to analyze and audit high-risk and high-volume quality data, including OASIS (Outcome & Assessment Information Set)). Findings included... A review of the Home Health Agency’s policy titled “Skilled Professional Services” showed all skilled professionals who provide services to patients directly, or under arrangement, will participate in the Home Health Agency’s Quality Assessment Performance Improvement (QAPI) program. The surveyor conducted a review of the Home Health Agency’s clinical records for sampled patients from 04/23/2024 through 05/08/2024. Review of the clinical records in the sample identified patients with wounds at various time points. Additional review showed the agency did not collect and transmit OASIS data for patients identified with wounds, requiring wound care and did not include measures derived from the OASIS in the design of its QAPI program. On 05/08/2024 at approximately 12:10 PM, during review of the agency’s Quality assessment and performance improvement (QAPI) program, the surveyor conducted a face-to-face interview with Employees #2 who is the agency’s Clinical Manager, and #4, Director of Operations. A review of the agency’s program activities failed to identify and focus on the following high risk, high volume, and potentially problem-prone areas: i. Provision of skilled professional services; ii. Completion of accurate comprehensive assessments in a timely manner; iii. Medication reviews; iv. Contents of the Plan of Care; v. Coordination of care delivery; vi. Registered Nurses written patient care instructions for home health aides; and vii. Documentation of wounds. Additionally, the agency did not monitor and record the effectiveness, safety of services, quality of care; and did not identify opportunities for improvement. Both Employees #2 and #4, acknowledged and confirmed the findings on 05/08/2024 at approximately 2:10 PM.”

“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 review of clinical records and interview with agency staff, the Registered Nurse failed to review and revise the written patient care instructions for home health aides according to the changes in the patient’s care needs for one (1) patient, (Patient #1). Findings include... A review of the Home Health Agency’s undated policy titled “Plan of Care and Verbal Orders” shows that the patient care plan will also include the Home Health Aide assignment such as the type of service and/or procedure to be provided. The surveyor conducted a review of Patient #1’s clinical record on 04/24/2024 at approximately 11:20 AM that showed Employee # 16, RN (Registered Nurse) prepared a ‘Comprehensive Adult Assessment’ dated 06/17/2019 for the Start of Care. The assessment showed Patient #1 was recently hospitalized from 11/17/2018 through 12/15/2018 for Spinal Surgery. The assessment showed that Patient #1 lived alone in an apartment and needed help with all activities due to Right side weakness. At the time, the patient complained of Left Knee and Back Pain and used a wheelchair. In addition, the assessment reflected the patient stated that he sustained a Gunshot Wound in 1993 and the bullet stayed in his back. Further the patient stated that he underwent surgery in 11/17/2018 and was unable to stand on his own since then, resulting in him becoming wheelchair bound. Additional review of Patient #1’s clinical record showed a Plan of Care for non-skilled services with a Start of Care date of 10/01/2020, and a Recertification Period from 06/01/2022 through 05/31/2023. The clinical record also included a current Plan of Care for non-skilled services with a with a Start of Care date of 04/01/2023 and a current recertification period from 06/01/2023 through 05/31/2024. The patient’s diagnoses on the Plan of Care included Stiff Man Syndrome; Unspecified Disease of Spinal Cord; hypertension, Chronic Pain, Wheelchair Dependence; and Bipolar Disorder. Further review of the clinical record showed a Registered Nurse prepared a ‘Home Health Aide Care Plan’ dated 04/09/2023 with printed patient care instructions that directed in print, “Review and/ or revise at least every 60 days…” Review of the ‘Home Health Aide Care Plan’ showed Patient #1lived alone, was bed bound, non-weight bearing and was alert and oriented. A review of the ‘Home Health Aide Care Plan’ showed continuous vertical lines drawn through the assigned tasks that were identified for the Aide to perform on every visit in addition to separate check marks placed in the box corresponding with “Assist with Elimination”, and “Medication Reminder”. The clinical record lacked documented evidence that the Home Health Aide Care Plan was reviewed and revised according to the changes in the patient’s changing care needs. The surveyor conducted a face-to-face interview with Employees #2, the agency’s Clinical Manager and #4, the Director of Operations. They both acknowledged and confirmed the findings on 04/29/2024 at approximately 2:00 PM.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on review of clinical records, the agency’s policy, and interview with agency staff and caregiver, the Home Health Agency failed to document a complete comprehensive assessment consistent with the patient’s immediate needs, within five (5) calendar days for one (1) of five (5) clinical records, (Patient #1). Findings included... A review of the Home Health Agency’s policy titled “Completion of the Comprehensive Assessment” showed that each comprehensive assessment must be completed in its entirety. The surveyor conducted a review of Patient #1’s clinical record on 04/24/2024 at approximately 11:20 AM that showed Employee #16, RN (Registered Nurse) prepared a ‘Comprehensive Adult Assessment’ dated 06/17/2019 for the Start of Care. The assessment showed Patient #1 was hospitalized from 11/17/2018 through 12/15/2018 for Spinal Surgery. The assessment showed that Patient #1 lived alone in an apartment and needed help with all activities due to right side weakness. At the time, the patient complained of Left Knee and Back Pain and used a wheelchair. In addition, the assessment reflected the patient stated that he sustained a Gunshot wound in 1993 and the bullet stayed in his back. Further the patient stated that he underwent surgery in 11/17/2018 and was unable to stand on his own since then, resulting in him becoming wheelchair bound. A review of the assessment form titled ‘General Assessment-“Resertification” [Recertification](Non-OASIS) dated 04/09/2023 showed the following incomplete and/or inaccurate information: i. Assessment item titled ‘Significant Past Health History’ showed a blank space; ii. Assessment item titled ‘Past Surgical History’ showed a blank space; iii. Assessment item titled ‘Patient Diagnosis’ listed Stiff-man Syndrome, Disease of the Spinal Cord, Hypertension, and Bipolar Disorder; iv. Assessment item titled ‘Surgical Diagnosis’ showed a blank space, and did not include the patient’s history of “Spinal Surgery; v. Assessment item titled ‘Patient/Family Knowledge’ and ‘coping level regarding Present Diagnosis’ showed a blank space; vi. Assessment item titled ‘Changes made to Advance Directives since previous assessment’ showed a blank space; vii. Assessment item titled ‘Patient/Caregiver Concerns/Fears Regarding Present Diagnosis’ showed a blank space; viii. Assessment item titled ‘Patient History and Diagnosis Notes’ showed a blank space; ix. Assessment item titled ‘Cultural Religious Factors’ showed a blank space; x. Assessment item titled ‘Living Arrangements Notes’ showed a blank space; xi. Assessment item titled ‘Patient History’ showed a blank space; xii. Assessment item titled ‘Supportive Assistance (Names of Organizations/Others Providing Assistance)’ showed a blank space; xiii. Assessment item titled ‘Homebound Reason’ showed “Need Assistance for all activities, residual weakness, unable to safely leave home unassisted, Requires use of special transportation”; xiv. Assessment item titled ‘Supportive Assistance Notes’ showed a blank space; xv. Assessment item titled ‘Sensory Status Notes’ showed a blank space; xvi. Assessment item titled ‘Urinary Status’ showed the patient reported clear, yellow, incontinence and denies any signs and symptoms of urinary tract infection; xvii. Assessment item titled ‘Psychological Status’ shows the nurse documented Caregiver: Coping…Adequate Sleep/Rest, Hrs [hours]/ Night: 4 -6 hours. The assessment did not reflect the relationship or identification of the caregiver was, xix. Assessment item titled ‘Musculoskeletal’ did not reflect how the patient was affected by the listed diagnosis of ‘Stiff-man Syndrome’ and how this limited regular activities of daily living; xx. Assessment item titled ‘ADL (Activities of Daily Living)/ IADLs (Instrumental activities of daily living)’ showed “Up as tolerated, wheelchair”, and did not reflect that the patient needs assistance to get out of bed and assistance to transfer to the chair, and the extent the patient needs assistance. xxi. Assessment item titled ‘Functional Limitations’ showed the note entry “Endurance, Ambulation, Other”; and xxii. Assessment item titled ‘Nutrition’ showed a Nutritional Score of 5 , and indicated Patient #1’s meals are prepared by the Personal Care Aide. Employees # 2 and 4 acknowledged and confirmed the findings on 04/25/2024 at approximately 11:30 AM. Cross Referenced from Tags G0528 and G0536.”

“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 review of clinical records, the agency’s policy, and interview with the agency’s staff and caregiver, the Home Health Agency failed to document complete comprehensive assessment that reflects the patient’s health, psychosocial, functional, cognition for one (1) of five (5) clinical records, for patients receiving non-skilled services, (Patient #1). Findings included... A review of the Home Health Agency’s un-numbered and undated policy titled “Completion of the Comprehensive Assessment”, showed that the comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum the patient’s strengths, goals, and care preferences, including information that may be used to demonstrate the patient’s progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the Agency. The surveyor conducted a review of Patient #1’s clinical record on 04/24/2024 at approximately 11:20 AM that showed Employee #16, RN (Registered Nurse) prepared a ‘Comprehensive Adult Assessment’ dated 06/17/2019 for the Start of Care. The assessment showed Patient #1 was hospitalized from 11/17/2018 through 12/15/2018 for Spinal Surgery. The assessment showed that Patient #1 lived alone in an apartment and needed help with all activities due to right side weakness. At the time, the patient complained of Left Knee and Back Pain and used a wheelchair. In addition, the assessment reflected the patient stated that he sustained a Gunshot wound in 1993 and the bullet stayed in his back. Further the patient stated that he underwent surgery in 11/17/2018 and was unable to stand on his own since then, resulting in him becoming wheelchair bound. Review of assessment form titled ‘General Assessment-“Resertification” [Recertification](Non-OASIS) dated 04/09/2023 showed the following incomplete and/or inaccurate information: i. Assessment item titled ‘Significant Past Health History’ showed a blank space; ii. Assessment item titled ‘Past Surgical History’ showed a blank space; iii. Assessment item titled ‘Patient Diagnosis’ listed Stiff-man Syndrome, Disease of the Spinal Cord, Hypertension, and Bipolar Disorder and did not include all of the patient’s diagnoses; iv. Assessment item titled ‘Surgical Diagnosis’ showed a blank space, and did not include the patient’s history of “Spinal Surgery; v. Assessment item titled ‘Patient/Family Knowledge’ and ‘coping level regarding Present Diagnosis’ showed a blank space; vi. Assessment item titled ‘Patient/Caregiver Concerns/Fears Regarding Present Diagnosis’ showed a blank space; vii. Assessment item titled ‘Patient History and Diagnosis Notes’ showed a blank space; viii. Assessment item titled ‘Patient History’ showed a blank space; ix. ‘Homebound Reason’ showed “Need Assistance for all activities, residual weakness, unable to safely leave home unassisted, Requires use of special transportation”; The assessment did not demonstrate how the patient’s inability to do for himself could potentially put him at risk; x. Assessment item titled ‘Sensory Status Notes’ showed a blank space xi. Assessment item titled ‘Psychological Status’ shows the nurse documented Caregiver: Coping…Adequate Sleep/Rest, Hrs [hours]/ Night: 4 -6 hours. The assessment did not reflect the relationship or identification of the caregiver was xii. Assessment item titled ‘Musculoskeletal’ did not reflect how the patient was affected by the listed diagnosis of ‘Stiff-man Syndrome’ and how this limited regular activities of daily living; xiii. Assessment item titled ‘ADL (Activities of Daily Living)/ IADLs (Instrumental activities of daily living)’ showed “Up as tolerated, wheelchair”, and did not reflect that the patient needs assistance to get out of bed and assistance to transfer to the chair, and the extent the patient needs assistance; and xiv. Assessment item titled ‘Functional Limitations’ showed the note entry “Endurance, Ambulation, Other”. The assessment did not provide a complete picture of the patient’s status to assist the agency in developing an effective Plan of Care. Additionally, the assessment did not demonstrate Patient #1’s psychosocial status and his functional capacity within the community, or his ability to participate in his own activities of daily living. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. Cross Referenced from Tags G0520, and G0536.”

“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 interview with agency staff and caregiver, review of clinical records and the agency’s policy, the Home Health Agency failed to review of all medications the patient was using 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 for three (3) of three (3) clinical records for patients receiving non-skilled services, (Patients #9, 10, and 12). Findings included... A review of the Home Health Agency’s undated policy titled “Start of Care OASIS (Outcome & Assessment Information Set) Documentation” showed that medications will be reviewed by the admitting discipline for potential adverse effects, drug reactions, duplicate drug therapy, and noncompliance with drug therapy. . aThe surveyor conducted a review of Patient #9’s clinical record on 04/29/2024 at approximately 9:50 AM that showed Employee # 21 Prepared a ‘General Assessment –PCA [Personal Care Aid] SOC for the Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 03/06/2023. The diagnoses on the Non-OASIS Assessment included Seizures Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Additional review of the clinical record showed a General Assessment –PCA (Non-OASIS (Outcome & Assessment Information Set)) dated 03/06/2023. The diagnoses on the Non-OASIS Assessment included Seizures Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). The Non-OASIS Assessment showed a listing of Patient #9’s medications that included i. Xarelto 20 milligrams, one (1) tablet by mouth daily; and ii. Ammonium Lactate Topical Cream 12% for Topical application daily. Review of the clinical record including the Plan of Care did not include indications or diagnosis associated with the prescribed medication, Xarelto, and indications or diagnosis associated with the application of Ammonium Lactate Topical Cream including specific affected area for the application. Further, Patient #9’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 03/06/2023, and a Recertification Period for non-skilled services from 03/06/2023 to 01/31/2024. The diagnoses on the current Plan of Care included Seizures, Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Plan of Care item # 16, titled ‘Medications’ included Tramadol 50 milligrams, 2 Tablets by mouth every 12 hours for pain, with a Start Date of 03/06/2023. The Plan of Care did not include a complete order to include the duration or Stop Date for the controlled substance, Tramadol. The medication lists on the comprehensive assessment was inconsistent with the Plan of Care. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. b. Patient #9’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 03/06/2023, and a Recertification Period for non-skilled services from 03/06/2023 to 01/31/2024. The diagnoses on the current Plan of Care included Seizures, Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Plan of Care item # 16, titled ‘Medications’ included Tramadol 50 milligrams, 2 Tablets by mouth every 12 hours for pain, with a Start Date of 03/06/2023. The Plan of Care did not include a complete order to include the duration or Stop Date for the controlled substance, Tramadol. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. c. The surveyor conducted a review of Patient #10’s clinical record on 05/08/2024 at approximately 9:20 AM that showed Employee # 21 Prepared a ‘General Assessment –PCA [Personal Care Aide] SOC for the Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 05/18/2023. The diagnoses on the Non-OASIS Assessment included Acquired Absence of Left Leg Below the Knee, Heart Failure, Moderate Persistent Asthma with Acute Exacerbation, Osteoarthritis of Right Hand, Type 2 Diabetes Mellitus, and Hypertension. The Non-OASIS Assessment for the Start of Care showed a listing of Patient #10’s medications that included i. Clopidogrel 75 milligrams, one (1) tablet by mouth daily; ii. Duloxetine DR [Delayed Release] 30 milligrams, 2 capsules by mouth daily; and iii. Levocetirizine 5 milligrams, one (1) tablet by mouth at bedtime. Review of the clinical record including the Plan of Care did not include indications or diagnosis associated with the prescribed medications, Clopidogrel, Duloxetine DR, and Levocetirizine. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/08/2024, at approximately 12:00 PM. c. The surveyor conducted a review of Patient #12’s clinical record on 04/24/2024 at approximately 10:25 AM that showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 04/05/2023, and a Recertification Period for non-skilled services from 02/01/2024 to 12/31/2024. The diagnoses on the current Plan of Care included Encounter for Attention to Colostomy, Paraplegia, Neuromuscular Dysfunction of Bladder, Hypertension, Stage 3 Pressure of Sacral Region, and Stage 3 Pressure Ulcer of Left Hip. Plan of Care item # 16, titled ‘Medications’ included i. Senna Plus Oral Tablet (Sennosides-Docusate Sodium 8.6- 50 milligrams, 2 Tablets by mouth, 2 times a day with a Start Date of 04/05/2023; ii. Oxycodone HCL [Hydrochloride], 5 milligrams, 1 Tablet by mouth, every 6 hours as needed for pain, with a Start Date of 04/05/2023. The Plan of Care did not include a complete order to include the duration or Stop Date for the controlled substance, Oxycodone HCL. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. Cross Referenced from Tags G0520 and G0528.”

“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 review of clinical records, the agency’s policy, and interview with agency staff and patient’s caregiver, the agency’s staff failed to ensure that the patient’s Plan of Care was individualized and included all required elements, for one (1) of five (5) clinical records for patients receiving skilled services, (Patients #1 and 12). This is a repeated finding from the previous Federal Home Health Agency Recertification Survey that was conducted in conjunction with a Federal Complaint Investigation Survey 08/02/2021 through 08/06/2021. Findings included... https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/r23pim.pdf cms.gov Completion of Form CMS-485 A review of the Provider Manual: Appendix 5, Reporting and Assessment Forms/ Home Health Certification and Plan of Care Instructions titled ‘Completion of Form CMS--485’, Home Health Certification and Plan of Care directs for completion of item on the Plan of care, “Orders for Discipline and Treatments...The physician must specify the frequency and expected duration of the visits for each discipline...PRN [as needed] visits may be ordered on a plan of care only where they are qualified in a manner that is specific to the patient’s potential needs. Both the nature of the services and the number of PRN visits to be permitted for each type of service must be specified. Open-ended, unqualified PRN visits do not constitute physician orders since their nature nor their frequency is specified...” A review of the Home Health Agency’s undated policy titled “Plan of Care and Verbal Orders” showed that the plan of care shall include but not be limited to pertinent diagnoses, specific disciplines, frequency and duration of services, functional limitations, and safety precautions. a. The surveyor conducted a review of Patient #1’s clinical record on 04/24/2024 at approximately 11:20 AM that showed Employee # 16, RN (Registered Nurse) prepared a ‘Comprehensive Adult Assessment’ dated 06/17/2019 for the Start of Care. The assessment showed Patient #1 was recently hospitalized from 11/17/2018 through 12/15/2018 for Spinal Surgery. The assessment showed that Patient #1 lived alone in an apartment and needed help with all activities due to Right side weakness. At the time of the initial assessment, the patient complained of Left Knee and Back Pain and used a wheelchair. In addition, the assessment reflected the patient stated that he sustained a Gunshot Wound in 1993 and the bullet stayed in his back. Further the patient stated that he underwent surgery in 11/17/2018 and was unable to stand on his own since then, resulting in him becoming wheelchair bound. Additional review of Patient #1’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 06/17/2019, and a current annual Recertification Period for non-skilled services from 06/01/2023 through 05/31/2024. Plan of Care item # 13, titled Diagnosis (es) included Stiff Man Syndrome; Unspecified Disease of Spinal Cord; hypertension, Chronic Pain, Symptoms involving Musculoskeletal, Wheelchair Dependence; and Bipolar Disorder, and Post traumatic Stress Disorder. i. The Plan of Care did not include all known diagnoses to include the history of Gunshot Wound to the Back, Pressure Ulcer and Spinal Surgery the patient underwent in 11/17/2018. Plan of Care item # 17, titled Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration showed the physician orders directed the Registered Nurse to conduct one (1) monthly and “ ...PRN [as needed]...” for 12 months to perform system assessments including vital signs, all body systems, the patient and caregiver knowledge of disease processes and associated care and treatment, and medication regimen. ii. The physician’s orders on the Plan of Care for “...PRN visits [as needed] ...” were not qualified in a manner specific to the patient’s potential needs. The nature of the services to be permitted, “as needed” was not specified. Physician orders on the Plan of Care directed the Personal Care Aide to visit eight (8) hours per day, seven (7) days weekly for 12 months to assist the patient with Activities of Daily Living and Instrumental Activities of Daily Living including personal hygiene tasks. Plan of Care item titled ‘Teaching’ showed Patient #1’s diagnoses included CVA (Cerebrovascular Accident) or Stroke, and Kidney Failure. iii. The aforementioned Plan of Care item designated for diagnoses did not include CVA and Kidney Failure. The surveyor conducted a face-to-face interview with Employees #2, a Registered Nurse who is the agency’s Clinical Manager and #4, the agency’s Director of Operations. They both acknowledged and confirmed the findings following the review of the Plan of Care on 05/06/2024 at approximately 1:20 PM. b. The surveyor conducted a review of Patient #12’s clinical record on 04/24/2024 at approximately 10:25 AM that showed the following Patient #12’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 04/05/2023, and a Recertification Period for non-skilled services from 02/01/2024 to 12/31/2024. i. Plan of Care item # 13, titled Diagnosis (es) included Encounter for Attention to Colostomy, Paraplegia, Neuromuscular Dysfunction of Bladder, Hypertension, Stage 3 Pressure of Sacral Region, and Stage 3 Pressure Ulcer of Left Hip. ii. Plan of Care item # 16, titled ‘Medications’ included Senna Plus Oral Tablet (Sennosides-Docusate Sodium 8.6- 50 milligrams, 2 Tablets by mouth, 2 times a day with a Start Date of 04/05/2023; iii. Oxycodone HCL [Hydrochloride], 5 milligrams, 1 Tablet by mouth, every 6 hours as needed for pain, with a Start Date of 04/05/2023. iv. The Plan of Care did not include a complete order to include the duration or Stop Date for the controlled substance, Oxycodone HCL. v. Plan of Care item # 17, titled Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” vi. The physician’s orders on the Plan of Care for “...PRN visits [as needed] ...” were not qualified in a manner specific to the patient’s potential needs. The nature of the services to be permitted, “as needed” was not specified. vii. In addition, the physician orders on the Plan of Care directed the Registered Nurse to perform patient system assessments including neurological status, gastrointestinal, genitourinary, peripheral circulation, hydration and nutrition status, and vital signs. viii. Physician orders on the Plan of Care directed the Personal Care Aide to visit 13 hours, seven (7) days a week for 10 months to assist the patient with Activities of Daily Living and Instrumental Activities of Daily Living including bathing, grooming other personal hygiene tasks. ix. The Plan of Care did not include physician’s order for wound care to include Medihoney, and reflected “…Wound Care is cleaned and monitored by [Name of another Home Health Agency] …” x. Plan of Care item # 21, titled ‘DME [Durable Medical Equipment] and Supplies’ did not include urine drainage bags xi. Plan of Care item # 26, titled ‘Hospitalization’ showed Emergency Room Level of Risk as “High”, but did not include signs and symptoms that characterize Patient #12’s risk for hospitalization. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. Cross Referenced from Tags G0576 and G608.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on clinical record review, policy review, and staff interviews, the Home Health Agency staff failed to ensure that all patient care orders, including verbal orders, were recorded in the Plan of Care for one (1) of five (5) active clinical records (Patient # 12). Findings included... The Home Health Agency’s undated policy titled, “Plan of Care”, showed the Plan of Care will include all verbal orders. a. The surveyor conducted a review of Patient #12’s clinical record on 04/24/2024 at approximately 10:25 AM that showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 04/05/2023, and a Recertification Period for non-skilled services from 02/01/2024 to 12/31/2024. Patient #12’s diagnoses on the current Plan of Care included Encounter for Attention to Colostomy, Paraplegia, Neuromuscular Dysfunction of Bladder, Hypertension, Stage 3 Pressure of Sacral Region, and Stage 3 Pressure Ulcer of Left Hip. Further review of the clinical record showed a ‘Physician Order’ form for order change dated 01/09/2024. Review of the Physician’s Order form showed “Senna Pod 1 tablet PO [by mouth] daily. i. The order was incomplete and did not include an indication or diagnosis associated with the prescribed medication; and ii. The Plan of Care was not revised to include the order change. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. Cross Referenced from Tags G0574 and G0608.”

“Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient’s needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This Element is not met as evidenced by: Based on review of clinical records, the agency’s policy, and interview with the agency’s staff and caregiver, the Home Health Agency failed to coordinate care delivery to meet the patient’s needs for nine (9) of 9 patients who received wound care provided by outside entities, Patients #1, 2, 3, 4, 7, 9,10, 11, and 12). Findings included... A review of the Home Health Agency’s policy titled “Skilled Professional Services” showed that all skilled professionals who provide services to patients directly, or under arrangement, will participate in the coordination of the care/services being delivered to those patients and will assume responsibility for but not be limited to ongoing interdisciplinary assessment of the patient and preparing clinical notes. a.On 04/23/2024 at approximately 10:30 AM, the surveyor conducted a face-to-face interview with Employee #2 who is the agency’s Clinical Manager regarding Patient #1’s recent hospitalization. Employee #2 denied being aware of Patient #1’s hospitalization prior to receiving a telephone call from a case manager at a local hospital. The case manager informed her of Patient #1’s inpatient overnight admission, including how he was found in his home by a friend, and brought to the hospital. The Clinical Manager stated that she was very surprised, because the agency has a system whereby one of the agency’s staff comes in to work early in the morning, works through CRISP [Chesapeake Regional Informational System for our Patients] to identify any of the agency’s beneficiaries or patients who may have been admitted to an area hospital overnight. She explained that CRISP, is a Health Information Exchange that allows sharing of health information among doctors’ offices, hospitals, labs, radiology centers, and other healthcare organizations. Additionally, CRISP allows providers and organizations to view patients’ medical history and facilitate coordination of patients’ care. Employee #2, stated that immediately following the phone call with the case manager, she called the Aide who was the assigned to work with Patient #1 and explained that she learned that the Aide was not on assignment at the patient’s home. The surveyor conducted a review of Patient #1’s clinical record on 04/24/2024 at approximately 11:20 AM that showed Employee #16, RN (Registered Nurse) prepared a ‘Comprehensive Adult Assessment’ dated 06/17/2019 for the Start of Care. The assessment showed Patient #1 was hospitalized from 11/17/2018 through 12/15/2018 for Spinal Surgery. The assessment showed that Patient #1 lived alone in an apartment and needed help with all activities due to right side weakness. At the time, the patient complained of Left Knee and Back Pain and used a wheelchair. In addition, the assessment reflected the patient stated that he sustained a Gunshot wound in 1993 and the bullet stayed in his back. Further the patient stated that he underwent surgery in 11/17/2018 and was unable to stand on his own since then, resulting in him becoming wheelchair bound. Additional review of Patient #1’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 06/17/2019, and a current annual Recertification Period for non-skilled services from 06/01/2023 through 05/31/2024. Plan of Care item # 13, titled Diagnosis (es) included Stiff Man Syndrome; Unspecified Disease of Spinal Cord; Hypertension, Chronic Pain, Symptoms involving Musculoskeletal, Wheelchair Dependence; and Bipolar Disorder, and Post traumatic Stress Disorder. The Plan of Care did not include all known diagnoses to include the history of Gunshot Wound to the Back, Pressure Ulcer and Spinal Surgery the patient underwent in 11/17/2018. Plan of Care item # 17, titled Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration showed the physician orders directed the Registered Nurse to conduct one (1) monthly and “ ...PRN [as needed]...” for 12 months to perform system assessments including vital signs, all body systems, the patient and caregiver knowledge of disease processes and associated care and treatment, and medication regimen. The physician’s orders on the Plan of Care for “...PRN visits [as needed] ...” were not qualified in a manner specific to the patient’s potential needs. The nature of the services to be permitted, “as needed” was not specified. Physician orders on the Plan of Care directed the Personal Care Aide to visit eight (8) hours per day, seven (7) days weekly for 12 months to assist the patient with Activities of Daily Living and Instrumental Activities of Daily Living including personal hygiene tasks. Further review of the clinical record including the Registered Nurse’s assessments, visit notes, Aides time sheets, and communication notes lacked documented evidence of consistent ongoing communication between the patient, the patient’s physician, registered nurses, Aide providing care in the home, and the entity that provided wound care services. The surveyor conducted a face-to-face interview with Employees #2, a Registered Nurse who is the agency’s Clinical Manager and #4, the agency’s Director of Operations. They both acknowledged and confirmed the findings on 05/06/2024 at approximately 1:20 PM. b. The surveyor conducted a home visit with Patient#2 on 04/26/2024, at approximately 10:40 AM, in the presence of Employees #21 Personal Care Aide, and #3, a Registered Nurse, the agency’s Clinical Manager. During the home visit, the surveyor observed Patient#2’s Right Wrist with a healed linear, surgical scar on the top of two (2) bumps. In response to the surveyor’s question regarding her current state of health, Patient #2 stated that she underwent more than one surgical procedure for Hemodialysis access to her Right Wrist. She added that she used to have a central line inserted in her right chest for dialysis while the doctors waited for the surgical wound of the new to her Right Wrist to heal. Patient #2 granted permission upon the surveyor’s request to inspect her chest. The surveyor observed a small scar to the patient’s right chest and the absence of any intravenous device. During the Home Visit, Patient #2 denied having any other wounds for which she was receiving care. The surveyor conducted a review of Patient #2’s clinical record on 04/26/2024 at approximately 3:20 PM that showed a Plan of Care with a Start of Care date of 12/20/2022, and Recertification Period for non-skilled services from 10/01/2023 to 09/30/2024. The patient’s diagnoses on the Plan of Care included End Stage Renal Disease, Altered Mental Status, Diastolic (Congestive) Heart Failure, and Stage 1-4 Hypertensive Chronic Kidney Disease. Additional review of the Plan of Care showed an entry “…[Patient #2’s name] has a wound on her rt [Right] Leg and wound care is done by [name an outside wound clinic]…”. The Plan of Care showed Patient #2 had a Right Subclavian Permacath in place. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Registered Nurse’s assessments, visit notes, Aides time sheets, and communication notes lacked documented evidence of consistent ongoing communication between the patient, the patient’s physician, registered nurses, Aide providing care in the home, and the patient’s mother providing wound care services. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. c. The surveyor conducted a home visit with Patient#3 on 04/26/2024, at approximately 2:10 PM, in the presence of Employee #3, a Registered Nurse, the agency’s Clinical Manager. During the home visit, the surveyor observed Patient#3 with tubular bandage to both lower extremities that covered from the knees to the ankles. In response to the surveyor’s question regarding her current state of health, Patient #3 stated that she was feeling relatively well and added that she previously received wound care at an outside clinic for a wound on her Left lower leg towards the ankle. She further stated that the wound healed in December 2023. The surveyor conducted a review of Patient #3’s clinical record on 04/26/2024 at approximately 4:00 PM that showed a Plan of Care with a Start of Care date of 03/15/2023, and Recertification Period for non-skilled services from 03/01/204 to 02/28/2025. The patient’s diagnoses on the Plan of Care included Chronic Kidney Disease, Hypertension, Chronic Pain Syndrome, and Morbid Obesity. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Registered Nurse’s assessments, visit notes, Aides time sheets, and communication notes lacked documented evidence of consistent ongoing communication between the patient, the patient’s physician, registered nurses, Aide providing care in the home, and the patient’s mother providing wound care services. The surveyor conducted a face-to-face interview with Employee #2, following the home visit on 04/26/2024, at approximately 12:20 PM who acknowledged and confirmed the findings. d.The surveyor conducted a home visit with Patient#4 on 04/30/2024, at approximately 9:50 AM, in the presence of Employees #17, Personal Care Aide, and #3, a Registered Nurse, the agency’s Clinical Manager. During the home visit, the surveyor observed Patient#4 with continuous rolled bandage wound dressing to both lower extremities that covered from the below the knees to just above the ankles. In response to the surveyor’s question regarding her current state of health, Patient #4 stated that she was getting ready to attend a doctor’s appointment and was about to do her wound dressing change before going out. She stated that she usually does the wound dressing changes herself and goes out to an outside clinic for wound care to both lower legs once or twice a week, or more frequently if she was having trouble. The surveyor observed Employee #2, Registered Nurse, assist Patient #4 during dressing change to her Right Leg Wound while getting dressed to attend an appointment. The patient’s diagnoses on the Plan of Care included Hypertension, Constipation, Pain, Chronic Embolism and Thrombosis of deep vein of Lower Extremities. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Registered Nurse’s assessments, visit notes, Aides time sheets, and communication notes lacked documented evidence of consistent ongoing communication between the patient who performed her own wound care, her physician, the registered nurses, and the Aide providing care in the home. The surveyor conducted a face-to-face interview with Employee #2 on 05/06/2024, at approximately 12:20 PM who acknowledged and confirmed the findings. e .The surveyor conducted a review of Patient #7’s clinical record on 05/07/2024 at approximately 10:50 AM that showed Employee # 21 Prepared a General Assessment –PCA (Non-OASIS) (Outcome & Assessment Information Set) dated 09/28/2023. The diagnoses on the Non-OASIS (Outcome & Assessment Information Set) Assessment included Paraplegia, Neuromuscular Dysfunction of Bladder, and Sacral Pressure Ulcer. Additional review of the clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 02/01/2022, and a Recertification Period for non-skilled services from 08/07/2023 to 06/05/2023. The diagnoses on the current Plan of Care included Paraplegia, Neuromuscular Dysfunction of Bladder, and Sacral Pressure Ulcer. In addition, the Plan of Care directed Sacral Ulcer is being done daily by the patient’s mother. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Registered Nurse’s assessments, visit notes, Aides time sheets, and communication notes lacked documented evidence of consistent ongoing communication between the patient, the patient’s physician, registered nurses, Aide providing care in the home, and the patient’s mother providing wound care services. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. f. The surveyor conducted a review of Patient #9’s clinical record on 04/29/2024 at approximately 9:50 AM that showed Employee # 21 prepared a ‘General Assessment–PCA SOC for the Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 03/06/2023. The diagnoses on the Non-OASIS Assessment included Seizures Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Additional review of the clinical record showed a General Assessment –PCA (Non-OASIS (Outcome & Assessment Information Set)) dated 03/06/2023. The diagnoses on the Non-OASIS Assessment included Seizures Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Patient #9’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 03/06/2023, and a Recertification Period for non-skilled services from 03/06/2023 to 01/31/2024. The diagnoses on the current Plan of Care included Seizures, Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Review of the Plan of care showed the following entry “[Patient #9’s name] has a sacral wond [wound] and 18 Fr. Foley Catheter. Wound care and Foley catheter change is done by [another named Home Health Agency] Further review of the clinical record including the Registered Nurse’s assessments, visit notes, Aides time sheets, and communication notes lacked documented evidence of consistent ongoing communication between the patient, the patient’s physician, registered nurses, Aide providing care in the home, and the entity providing wound care services. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. g. The surveyor conducted a review of Patient #10’s clinical record on 05/08/2024 at approximately 9:20 AM that showed Employee # 21 Prepared a ‘General Assessment –PCA SOC for the Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 05/18/2023. The diagnoses on the Non-OASIS Assessment included Acquired Absence of Left Leg Below the Knee, Heart Failure, Moderate Persistent Asthma with Acute Exacerbation, Osteoarthritis of Right Hand, Type 2 Diabetes Mellitus, and Hypertension. Review of the Assessment item titled ‘Integumentary’ showed “Skin: Dry, Warm”. In the section of the assessment titled Integumentary Status Locator, the nurse documented “…Chronic Ulcer of Right Heel: Wound Care is done by [Name of another Home Health Agency] …” Review of the Plan of care showed the following entry “[Patient #10’s name] has a sacral wond [wound] and 18 Fr. Foley Catheter. Wound care and Foley catheter change is done by [another named Home Health Agency]. Further review of the clinical record including the Registered Nurse’s assessments, visit notes, Aides time sheets, and communication notes lacked documented evidence of consistent ongoing communication between the patient, the patient’s physician, registered nurses, Aide providing care in the home, and the entity providing wound care services. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. h. The surveyor conducted a review of Patient #11’s clinical record on 05/07/2024 at approximately 10:30 AM that showed Employee # 21 prepared a ‘General Assessment –PCA SOC Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 12/15/2022. The diagnoses on the Non-OASIS Assessment included Chronic Obstructive Pulmonary Disease, Lymphedema, Cellulitis of Right Lower Limb, Open Wound of Lower Leg (Unspecified), and Hypertension. Review of the assessment showed item titled ‘Integumentary’ showed “Skin: Dry, Warm”. In the section of the assessment titled ‘Integumentary Status Locator’, the nurse documented “…Stasis Ulcer on the right lower leg; wound care is done two times per week by [Name of outside wound clinic] …” Further review of the clinical record including the Registered Nurse’s assessments, visit notes, Aides time sheets, and communication notes lacked documented evidence of consistent ongoing communication between the patient, the patient’s physician, registered nurses, Aide providing care in the home, and the entity providing wound care services. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. i.The surveyor conducted a review of Patient #12’s clinical record on 04/24/2024 at approximately 10:25 AM that showed Employee # 22 Prepared a ‘General Assessment –Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 04/05/2023. The diagnoses on the Non-OASIS Assessment included Encounter for Attention to Colostomy, Paraplegia, Neuromuscular Dysfunction of Bladder, Hypertension. In the section of the assessment titled ‘Narrative’, the nurse documented “…Patient has pressure Ulcers on his Sacrum and Right Foot. The patient is currently using Medihoney dressing. The area is cleansed with Wound Cleanser, pat dry, apply Medihoney and cover with Bordered gauze daily. Dressing change is done by his mother. RN [Registered Nurse] was not able to see the Pressure Ulcer and the wound because dressings were already done and covered...” Additional review of the clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 04/05/2023, and a Recertification Period for non-skilled services from 02/01/2024 to 12/31/2024. The diagnoses on the current Plan of Care included Encounter for Attention to Colostomy, Paraplegia, Neuromuscular Dysfunction of Bladder, Hypertension, Stage 3 Pressure of Sacral Region, and Stage 3 Pressure Ulcer of Left Hip. Further review of the clinical record including the Registered Nurse’s assessments, visit notes, Aides time sheets, and communication notes lacked documented evidence of consistent ongoing communication between the patient, the patient’s physician, registered nurses, Aide providing care in the home, and the patient’s mother providing wound care services. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM. Cross Referenced from Tags G0574 and G0576.”

“Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient’s condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA’s policies and procedures. This Element is not met as evidenced by: Based on review of clinical records, the agency’s policy, and interview with the agency’s staff and caregiver, the Personal Care Aide failed to report changes in the patient’s condition to a Registered Nurse and complete appropriate records timely, in accordance with the agency’s policy for one (1) of one clinical record, (Patient #1). Findings included... A review of the Home Health Agency’s un-numbered and undated policy, titled “Occurrence Reports” showed that all agency employees should complete an occurrence report in the event an unusual occurrence takes place. The policy showed that all employee and client related unusual occurrences, accidents and injuries will be documented on an approved incident/occurrence report form. An incident includes but is not limited to endangerment of staff or client and appearance of bruises, broken skin, or wounds. Additionally, the policy showed that all Personal Care Aides must report to the clients assigned Nurse immediately there is a change noticed in condition including and not limited to falls, skin tears, new or reopened pressure ulcers, changes in vitals, noncompliance and so on. The surveyor conducted a review of Patient #1’s clinical record on 04/24/2024 at approximately 11:20 AM that showed Employee # 16, RN (Registered Nurse) prepared a ‘Comprehensive Adult Assessment’ dated 06/17/2019 for the Start of Care. The assessment showed Patient #1 was recently hospitalized from 11/17/2018 through 12/15/2018 for Spinal Surgery. The assessment showed that Patient #1 lived alone in an apartment and needed help with all activities due to Right side weakness. At the time, the patient complained of Left Knee and Back Pain and used a wheelchair. In addition, the assessment reflected the patient stated that he sustained a Gunshot Wound in 1993 and the bullet stayed in his back. Further the patient stated that he underwent surgery in 11/17/2018 and was unable to stand on his own since then, resulting in him becoming wheelchair bound. Additional review of Patient #1’s clinical record showed a Plan of Care for non-skilled services with a Start of Care date of 10/01/2020, and a Recertification Period from 06/01/2022 through 05/31/2023. The clinical record also included a current Plan of Care for non-skilled services with a with a Start of Care date of 04/01/2023 and a current recertification period from 06/01/2023 through 05/31/2024. The patient’s diagnoses on the Plan of Care included Stiff Man Syndrome; Unspecified Disease of Spinal Cord; hypertension, Chronic Pain, Wheelchair Dependence; and Bipolar Disorder. Further review of the clinical record showed a Registered Nurse prepared a ‘Home Health Aide Care Plan’ dated 04/09/2023 with printed patient care instructions that directed in print, “Review and/ or revise at least every 60 days…” Review of the ‘Home Health Aide Care Plan’ showed Patient #1lived alone, was bed bound, non-weight bearing and was alert and oriented. A review of ‘Home Health/Personal Care Aide Weekly Log [Aides Time Sheets]’ for the time frame from 01/29/2024 through 03/31/2024, showed that the weekday assigned Aide, Employee #19, consistently documented time on duty as 1:00 PM to 9:00 PM; Monday through Friday. In addition, the ‘Time Sheets’ showed the Aide entered various blocks of time allotted for performing each task on each day worked. Further, Employee #19 placed a check mark corresponding with the various options provided on the form that directs “State Client’s Daily Condition (Check What Applies)”. The check marks identified “Happy” and Appetite “Fair” Additional review of ‘Home Health/Personal Care Aide Weekly Log [Aides Time Sheets]’ for the time frame from 01/29/2024 through 03/31/2024, showed that the weekend assigned Aide, Employee #20, documented time on duty as 7:00 AM to 3:00 PM; on weekends; Saturdays and Sundays. In addition, the ‘Time Sheets’ showed the Aide entered various blocks of time allotted for performing each task. Further, Employee #20 placed a check mark corresponding with the various options provided on the form that directs “State Client’s Daily Condition (Check What Applies)”. The check marks identified “Happy”, “Active”, “Took Meds [Medications]”, and Appetite “Fair”. The ‘Home Health/Personal Care Aide Weekly Log [Aides Time Sheets]’ also reflected Employee #20 placed a note Entry In the section of the sheet titled ‘Notes’ under the following dates: On 02/04/24, “He has a wound developing at the buttock”. On 02/25/24, “[Patient #1’s name] has a wound at the buttocks”; and On 03/10/24“[Patient #1’s name] wound is disturbing…” The clinical record did not reflect any other entries regarding Patient #1’s skin alteration by the Aide, Employee #20, or Employee #19. The surveyor conducted a face-to-face interview with Employee #2 regarding the delay in the Registered Nurses visit to assess the patient in addition to assessing the wound status, Employee #2 stated that although Employee #20 wrote on the Time Sheet, the sheet was not turned into the office for payment until after three (3) weeks later. Employee #2 added that all Aides have received training when onboarding and in-services regarding their responsibilities to report patients’ condition to a Registered Nurse, completing appropriate records to include an occurrence report timely, and by calling the office in addition to communicating by documenting on the time sheets. The surveyor conducted a face-to-face interview on 04/24/2024 with Employees #2, the agency’s Clinical Manager and #4, the Director of Operations. They both acknowledged and confirmed the findings on 04/24/2024 at approximately 2:00 PM.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on review of clinical records, policy review, and interview with agency staff, the Registered Nurse failed to provide services in accordance with current clinical practice guidelines and accepted professional standards of practice for 11 of 11 patients with wounds, Patients #1, 2, 3, 4, 7, 8, 9, 10, 11, 12, and 13). Findings included… a. On 04/23/2024 at approximately 10:30 AM, the surveyor conducted a face-to-face interview with Employee #2 who is the agency’s Clinical Manager regarding Patient #1’s recent hospitalization. Employee #2 denied being aware of Patient #1’s hospitalization prior to receiving a telephone call from a case manager at a local hospital. The case manager informed her of Patient #1’s inpatient overnight admission, including how he was found in his home by a friend, and brought to the hospital. The Clinical Manager stated that she was very surprised, because the agency has a system whereby one of the agency’s staff comes in to work early in the morning, works through CRISP [Chesapeake Regional Informational System for our Patients] to identify any of the agency’s beneficiaries or patients who may have been admitted to an area hospital overnight. She explained that CRISP, is a Health Information Exchange that allows sharing of health information among doctors’ offices, hospitals, labs, radiology centers, and other healthcare organizations. Additionally, CRISP allows providers and organizations to view patients’ medical history and facilitate coordination of patients’ care. Employee #2, stated that immediately following the phone call with the case manager, she called the Aide who was the assigned to work with Patient #1 and explained that she learned that the Aide was not on assignment at the patient’s home. The surveyor conducted a review of Patient #1’s clinical record on 04/24/2024 at approximately 11:20 AM that showed Employee # 16, RN (Registered Nurse) prepared a ‘Comprehensive Adult Assessment’ dated 06/17/2019 for the Start of Care. The assessment showed Patient #1 was recently hospitalized from 11/17/2018 through 12/15/2018 for Spinal Surgery. The assessment showed that Patient #1 lived alone in an apartment and needed help with all activities due to Right side weakness. At the time, the patient complained of Left Knee and Back Pain and used a wheelchair. In addition, the assessment reflected the patient stated that he sustained a Gunshot Wound in 1993 and the bullet stayed in his back. Further the patient stated that he underwent surgery in 11/17/2018 and was unable to stand on his own since then, resulting in him becoming wheelchair bound. A review of the clinical record including nursing notes showed Employee # 14, RN (Registered Nurse) prepared a ‘Progress Summary’ dated 10/03/2023 and wrote “…Client’s wound is completely Healed…” On 02/20/2024, Employee # 14 documented a ‘Communication Note’ that showed “…Client is non compliant with medications , non compliant with scheduled appointments…He did not go to his scheduled appointments on 01/05/2024 at 5:20pm, and on 2/5/2024 at 5pm for wound care and many other appointments scheduled in the past to see his PCP [Primary Care] for wellness checkup and medication management even after being informed by RN and pca’s being made aware of all scheduled appointments…RN called PCP’s office to rescheduled another appointment on 02/23/2024 at 11am with [Doctor’s name] at [Name of PCP Provider] on [PCP’s office address] for medications and wound care as the client’s wound is gradually progressing . Client and pca were informed of the upcoming appointment and its importance…” The clinical record showed Employee # 14, RN visited on 03/07/2024 and prepared a ‘Progress Summary’ dated 10/03/2023 and wrote a ‘Skilled Nursing Visit Assessment’ note “…Client has a wound to right lower sacrum. Wound is not healing, PCP is made aware of client’s wound and client reports that his nephew stops by 2-3 times a week to assist with wound care. Client continues to refuse morning services per RN’s recommendations. Review of the clinical record showed the patient’s long-standing relationship for wound treatment with a local hospital’s wound clinic for a sacral pressure injury that heals and reopens frequently. He was seen in the clinic on 02/23/2024 for evaluation of a wound. On this visit the patient received a new referral to be evaluated for the reopening of a stage 2 sacral wound. Additional review of Patient #1’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 06/17/2019, and a current annual Recertification Period for non-skilled services from 06/01/2023 through 05/31/2024. The patient’s diagnoses on the Plan of Care included Stiff Man Syndrome; Unspecified Disease of Spinal Cord; Hypertension, Chronic Pain, Wheelchair Dependence; and Bipolar Disorder. Further review of the clinical record showed Patient #1 lived alone, was bed bound, non-weight bearing and was alert and oriented. b. The surveyor conducted a home visit with Patient#2 on 04/26/2024, at approximately 10:40 AM, in the presence of Employees #21 Personal Care Aide, and #3, a Registered Nurse, the agency’s Clinical Manager. During the home visit, the surveyor observed Patient#2’s Right Wrist with a healed linear, surgical scar on the top of two (2) bumps. In response to the surveyor’s question regarding her current state of health, Patient #2 stated that she underwent more than one surgical procedure for Hemodialysis access to her Right Wrist. She added that she used to have a central line inserted in her right chest for dialysis while the doctors waited for the surgical wound of the new to her Right Wrist to heal. Patient #2 granted permission upon the surveyor’s request to inspect her chest. The surveyor observed a small scar to the patient’s right chest and the absence of any intravenous device. During the Home Visit, Patient #2 denied having any other wounds for which she was receiving care. The surveyor conducted a review of Patient #2’s clinical record on 04/26/2024 at approximately 3:20 PM that showed a Plan of Care with a Start of Care date of 12/20/2022, and Recertification Period for non-skilled services from 10/01/2023 to 09/30/2024. The patient’s diagnoses on the Plan of Care included End Stage Renal Disease, Altered Mental Status, Diastolic (Congestive) Heart Failure, and Stage 1-4 Hypertensive Chronic Kidney Disease. Additional review of the Plan of Care showed an entry “…[Patient #2’s name] has a wound on her rt [Right] Leg and wound care is done by [name an outside wound clinic]…”. The Plan of Care showed Patient #2 had a Right Subclavian Permacath in place. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. a diagnosis of wound; ii. physician’s orders for wound care; and iii. physician’s orders for skilled services. c. The surveyor conducted a home visit with Patient#3 on 04/26/2024, at approximately 2:10 PM, in the presence of Employee #3, a Registered Nurse, the agency’s Clinical Manager. During the home visit, the surveyor observed Patient#3 with tubular bandage to both lower extremities that covered from the knees to the ankles. In response to the surveyor’s question regarding her current state of health, Patient #3 stated that she was feeling relatively well and added that she previously received wound care at an outside clinic for a wound on her Left lower leg towards the ankle. She further stated that the wound healed in December 2023. The surveyor conducted a review of Patient #3’s clinical record on 04/26/2024 at approximately 4:00 PM that showed a Plan of Care with a Start of Care date of 03/15/2023, and Recertification Period for non-skilled services from 03/01/204 to 02/28/2025. The patient’s diagnoses on the Plan of Care included Chronic Kidney Disease, Hypertension, Chronic Pain Syndrome, and Morbid Obesity. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. a diagnosis of wound; ii. physician’s orders for wound care; and iii. physician’s orders for skilled services. d. The surveyor conducted a home visit with Patient#4 on 04/30/2024, at approximately 9:50 AM, in the presence of Employees #17, Personal Care Aide, and #3, a Registered Nurse, the agency’s Clinical Manager. During the home visit, the surveyor observed Patient#4 with continuous rolled bandage wound dressing to both lower extremities that covered from the below the knees to just above the ankles. In response to the surveyor’s question regarding her current state of health, Patient #4 stated that she was getting ready to attend a doctor’s appointment and was about to do her wound dressing change before going out. She stated that she usually does the wound dressing changes herself and goes out to an outside clinic for wound care to both lower legs once or twice a week, or more frequently if she was having trouble. The surveyor observed Employee #2, Registered Nurse, assist Patient #4 during dressing change to her Right Leg Wound while getting dressed to attend an appointment. The patient’s diagnoses on the Plan of Care included Hypertension, Constipation, Pain, Chronic Embolism and Thrombosis of deep vein of Lower Extremities. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. a diagnosis of wound; ii. physician’s orders for wound care; and iii. physician’s orders for skilled services. e. The surveyor conducted a review of Patient #7’s clinical record on 05/07/2024 at approximately 10:50 AM that showed Employee # 21 Prepared a General Assessment –PCA (Non-OASIS) (Outcome & Assessment Information Set) dated 09/28/2023. The diagnoses on the Non-OASIS (Outcome & Assessment Information Set) Assessment included Paraplegia, Neuromuscular Dysfunction of Bladder, and Sacral Pressure Ulcer. Additional review of the clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 02/01/2022, and a Recertification Period for non-skilled services from 08/07/2023 to 06/05/2023. The diagnoses on the current Plan of Care included Paraplegia, Neuromuscular Dysfunction of Bladder, and Sacral Pressure Ulcer. In addition, the Plan of Care directed Sacral Ulcer is being done daily by the patient’s mother. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. a diagnosis of wound; ii. physician’s orders for wound care; and iii. physician’s orders for skilled services. f. The surveyor conducted a review of Patient #8’s clinical record on 05/07/2024 at approximately 10:20 AM that showed Employee # 21 Prepared a General Assessment –for ROC [Resumption of Care] (Non-OASIS (Outcome & Assessment Information Set)) dated 04/08/2024. The diagnoses on the Non-OASIS Assessment included Chronic Obstructive Pulmonary Disease with Acute Exacerbation, Acute Respiratory Distress, Type 2 Diabetes Mellitus, Hypertension, and Morbid Obesity. Additional review of the clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 05/12/2020, and a current annual Recertification Period for non-skilled services from 04/01/2024 to 03/31/2025. The diagnoses on the current Plan of Care included Chronic Obstructive Pulmonary Disease with Acute Exacerbation, Acute Respiratory Distress, Type 2 Diabetes Mellitus, Hypertension, and Morbid Obesity. Plan of Care item # 17, titled ‘Skilled Nursing Service(s) ordered (Specify amount/frequency/ duration’ showed the physician orders directed the Registered Nurse to conduct one (1) monthly for 10 months, and “ ...PRN [as needed]...” Further review of the clinical record including the Plan of Care did not include i. physician’s orders for skilled services. g. The surveyor conducted a review of Patient #9’s clinical record on 04/29/2024 at approximately 9:50 AM that showed Employee # 21 prepared a ‘General Assessment–PCA SOC for the Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 03/06/2023. The diagnoses on the Non-OASIS Assessment included Seizures Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Additional review of the clinical record showed a General Assessment –PCA (Non-OASIS (Outcome & Assessment Information Set)) dated 03/06/2023. The diagnoses on the Non-OASIS Assessment included Seizures Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Patient #9’s clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 03/06/2023, and a Recertification Period for non-skilled services from 03/06/2023 to 01/31/2024. The diagnoses on the current Plan of Care included Seizures, Diabetes Mellitus, Hypertension, Sacral Pressure Ulcer (Unspecified Stage). Review of the Plan of care showed the following entry “…[Patient #9’s name] has a sacral wond [wound] and 18 Fr. Foley Catheter. Wound care and Foley catheter change is done by [another named Home Health Agency] Further review of the clinical record including the Plan of Care did not include i. physician’s orders for wound care; and ii. physician’s orders for skilled services. h. The surveyor conducted a review of Patient #10’s clinical record on 05/08/2024 at approximately 9:20 AM that showed Employee # 21 Prepared a ‘General Assessment –PCA SOC for the Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 05/18/2023. The diagnoses on the Non-OASIS Assessment included Acquired Absence of Left Leg Below the Knee, Heart Failure, Moderate Persistent Asthma with Acute Exacerbation, Osteoarthritis of Right Hand, Type 2 Diabetes Mellitus, and Hypertension. Review of the assessment item titled ‘Integumentary’ showed “Skin: Dry, Warm”. In the section of the assessment titled Integumentary Status Locator, the nurse documented “…Chronic Ulcer of Right Heel: Wound Care is done by [Name of another Home Health Agency] …” Review of the Plan of care showed the following entry “[Patient #10’s name] has a sacral wond [wound] and 18 Fr. Foley Catheter. Wound care and Foley catheter change is done by [another named Home Health Agency]. Further review of the clinical record including the Plan of Care did not include i. physician’s orders for wound care; and ii. physician’s orders for skilled services. I. The surveyor conducted a review of Patient #11’s clinical record on 05/07/2024 at approximately 10:30 AM that showed Employee # 21 prepared a ‘General Assessment –PCA SOC Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 12/15/2022. The diagnoses on the Non-OASIS Assessment included Chronic Obstructive Pulmonary Disease, Lymphedema, Cellulitis of Right Lower Limb, Open Wound of Lower Leg (Unspecified), and Hypertension. Review of the assessment showed the following incomplete items: Assessment item titled ‘Integumentary’ showed “Skin: Dry, Warm”. In the section of the assessment titled ‘Integumentary Status Locator’, the nurse documented “…Stasis Ulcer on the right lower leg; wound care is done two times per week by [Name of outside wound clinic] …” Further review of the clinical record including the Plan of Care did not include i. physician’s orders for wound care; and ii. physician’s orders for skilled services. j. The surveyor conducted a review of Patient #12’s clinical record on 04/24/2024 at approximately 10:25 AM that showed Employee # 22 Prepared a ‘General Assessment –Start of Care (Non-OASIS (Outcome & Assessment Information Set))’ dated 04/05/2023. The diagnoses on the Non-OASIS Assessment included Encounter for Attention to Colostomy, Paraplegia, Neuromuscular Dysfunction of Bladder, Hypertension. In the section of the assessment titled ‘Narrative’, the nurse documented “…Patient has pressure Ulcers on his Sacrum and Right Foot. The patient is currently using Medihoney dressing. The area is cleansed with Wound Cleanser, pat dry, apply Medihoney and cover with Bordered gauze daily. Dressing change is done by his mother. RN [Registered Nurse] was not able to see the Pressure Ulcer and the wound because dressings were already done and covered...” Additional review of the clinical record showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 04/05/2023, and a Recertification Period for non-skilled services from 02/01/2024 to 12/31/2024. The diagnoses on the current Plan of Care included Encounter for Attention to Colostomy, Paraplegia, Neuromuscular Dysfunction of Bladder, Hypertension, Stage 3 Pressure of Sacral Region, and Stage 3 Pressure Ulcer of Left Hip. Further review of the clinical record including the Plan of Care did not include i. physician’s orders for wound care; and ii. physician’s orders for skilled services. j. The surveyor conducted a review of Patient #13’s clinical record on 04/24/2024 at approximately 10:25 AM that showed Employee # 21, RN, prepared a ‘General Assessment –Personal Care Aide Start of Care (Non-OASIS(Outcome & Assessment Information Set))’ assessment dated 06/26/2023. The diagnoses on the Non-OASIS Assessment included Morbid Obesity, Acquired Absence of Left Foot, Gout, Hypertension and Diabetes Mellitus. Additional review of the clinical record showed an annual ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 06/26/2023, and an Initial Certification Period for non-skilled services from 06/26/2023 to 05/31/2024. The diagnoses on the assessment included Morbid Obesity, Acquired Absence of Left Foot, Gout, Hypertension and Diabetes Mellitus. Review of the Non-OASIS (Outcome & Assessment Information Set) assessment showed the following incomplete, and/ or conflicting items: Assessment item titled ‘Integumentary’ showed “Skin: Dry, Warm, Wounds”. i. The aforementioned listed diagnoses did not include the presence of “Wounds”, the number of wounds. In the section of the assessment titled ‘Integumentary Status Locator’, the nurse documented “6R” which indicated the location of the wound, according to the anatomic diagram on the assessment form, corresponded with an unspecified toe on the patient’s Left Foot. ii. The assessment reflected conflicting findings as the aforementioned diagnoses included “Acquired Absence of Left Foot”. Assessment item titled ‘Functional Limitations’ included “Amputation…” Further review of the same assessment showed the Nurse documented the following note entry “[Patient’s Name] Right amputated Toe is treated and managed at [Name of outside wound clinic], once weekly…” iii. In the section of the assessment titled ‘Narrative’, the nurse repeated the documentation of the Right amputated toe wound and added “…Both feet in boots…” and did not document findings of a foot examination of Patient #13 who is an Insulin dependent diabetic. The clinical records lacked documented evidence that the Registered Nurse i. obtained physician’s orders for wound care; ii. performed a skin assessment, wound assessment(s), and documented wound characteristics or descriptors including the anatomic location (s), the type of wound, the type and degree of tissue damage, descriptors to include the wound bed, wound size or measurements, wound edges and periwound skin, the absence or presence of drainage, absence or presence odor, absence or presence of signs and symptoms of infection, pain, and staging as appropriate. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM.”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on interviews with agency staff, review of clinical records and the agency’s policy, the agency’s clinician failed to document complete discharge summaries in two (2) of (2) closed clinical records for patients discharged from the agency, (Patients # 5 and 6). This is a repeated finding from the previous Federal Home Health Agency Recertification Survey that was conducted in conjunction with a Federal Complaint Investigation Survey 08/02/2021 through 08/06/2021. Findings included... A review of the Home Health Agency’s un-numbered and undated policy, titled “Clinical Record Contents and Maintenance” shows that a Discharge summary (to be sent to the physician upon request) will contain the client’s status on admission and discharge and the services provided, date of discharge, extent to which goals were achieved and plan for follow-up and or referral to community resources. a. The surveyor conducted a review of Patient #5’s clinical record on 05/07/2024 at approximately 11:40 AM that showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 06/28/2023, and an Initial Certification Period for non-skilled services from 04/07/2023 to 06/05/2018. The diagnoses on the Plan of Care included Unsteadiness on Feet, Diabetes Mellitus with Arthropathy, Dorsalgia, and Major Depressive Disorder. Additional review of the Plan of Care showed physician orders directed nursing services monthly and as needed for 12 months. Further review of the clinical record showed Patient #5 received Skilled Nursing services. The ‘Discharge Summary’ report that covered the service period from 06/28/2023 through 04/15/2024 did not include: i. the reason for admission to Home Health; ii. The patient’s condition at discharge, and iii. patient and family post discharge instructions. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 11:50 AM. b. The surveyor conducted a review of Patient #6’s clinical record on 05/07/2024 at approximately 10:50 AM that showed a ‘Plan of Care for Medicaid Personal Care Aide (PCA), Home Health Aide and/or Skilled Nursing Services’ form with a Start of Care date of 02/01/2022, and a Recertification Period for non-skilled services from 08/07/2023 to 06/05/2023. The diagnoses on the current Plan of Care included Low Back Pain, Osteoarthritis of the Knee, Type 2 Diabetes Mellitus, Stage 3 Chronic Kidney Disease, and Tinea Unguim. Additional review of the Plan of Care showed physician orders directed nursing services monthly and as needed for 12 months. Further review of the clinical record showed Patient #1 received nursing services. The ‘Discharge Summary’ report that covered the service period from 02/01/2022 through 01/17/2024 did not include: i. the reason for admission to Home Health; ii. The patient’s condition at discharge, and iii. patient and family post discharge instructions. Employee#2 acknowledged and confirmed the findings during the clinical record review on 05/07/2024, at approximately 12:00 PM.”