Every finding on record at American Advantage Home Care, Inc

The following standard level deficiency was identified during a Medicare authorized complaint (102467) investigation, conducted by the Michigan Department of Licensing and Regulatory Affairs on 6/3/24 at: American Advantage Home Care 2040 Monroe, Ste. 208 Dearborn, MI 48124 This agency had no additional locations. Records reviewed: 2 discharge records and 1 active record, for a total of 3 records reviewed. At the conclusion of the investigation, this agency was determined to be not in compliance with federal certification requirements.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure patient care was coordinated to receive Skilled Nursing and Physical Therapy services for 3 (P-1, P-2, P-3) of 3 patients who required the ordered services, from a total of 3 sampled records reviewed, resulting in patients not receiving care based on their individualized plan of care and the potential for physiological decline and unmet care needs. Findings include: P-2: The Start of Care (SOC) was dated 3/13/23. The Plan of Care (POC) identified diagnoses of Urinary Tract Infection, Chronic Kidney Disease and Hypertension. During record review on 6/3/24, it was noted that the RN (Registered Nurse) completed a recertification on 7/6/23 and 9/7/23 with visit frequencies of 1w8 (One visit a week for eight weeks) for both certification periods. The RN had missed visits without documentation on 8/17/23, 8/24/23, 9/21/23, 10/12/23 and 10/19/23. The RN did document a missed visit on 10/26/23 with the reason being “Patient refused visit.” Additionally, the RN completed an OASIS Non-Visit DC on 11/3/23 which is not reviewable. The agency failed to provide oversight and coordinate patient visits accordingly. P-3: The Start of Care (SOC) was dated 7/3/23. The Plan of Care (POC) identified diagnoses of Diabetes Type 2, Unsteadiness on Feet and Hypertension. During record review on 6/3/24, it was noted that the POT (Physical Therapist) completed a comprehensive assessment on 7/3/23 with visit frequencies of 2w2, 1w3. An order was written on 8/24/23 stating, “Order to continue with Physical Therapy int recertification period (No frequency was documented).” The PT completed a recertification on 8/29/23 with frequencies of 1w6. The RN completed an evaluation on 7/19/23 with a frequency of 2m2. The RN had missed visits without documentation on 8/3/23, 8/8/23 and 8/22/23 (RN DC). Additionally, the PT documented missed visits on 7/28/23 due to “Patient refused visit due to not feeling well”, 9/8/23 due to “I received a call from patient’s sone requesting to reschedule PT appointment today due to patient is not feeling well” and 9/22/23 due to “I received a call from patient’s son requesting to reschedule patient PT appointment for next week due to not feeling well.” The agency failed to provide oversight and coordinate patient visits accordingly. P-1: The patient's start of care (SOC) was 9/13/24 with diagnoses that included Heart Failure and Atrial Fibrillation. The Plan of Care (POC) ordered Skilled Nursing (SN) 1w7, and Physical Therapy (PT) 1w6 services to be provided. On 6/3/24 at 3:08 p.m., during the clinical record review, the following was noted: there were only 3 visits in total, made to the patient's home. The SN saw the patient on 9/13/23 for the SOC visit. There was a SN missed visit (MV) on 9/21/23, 10/18/23 and 10/25/23. There was no MV note documenting the rationale for the missed SN visits. Further, PT saw the patient on 9/25/23 for the initial evaluation. There was a PT MV on 10/9/23, 10/16/23 and 10/23/23. There was no documented rationale for the MV on 10/9/23 or 10/23/23. The patient was subsequently discharged from the agency's services on 10/25/23. Additionally, the SN and PT discharge summary and discharge oasis had not been completed at the time of this review. There was no documented evidence to support the agency's coordination of care to ensure the patient received the proper care and ordered services. These findings were reviewed with and acknowledged by the Administrator/Owner who responded, "The missed visits either slipped through QA or the staff forgot to submit the note. I'll have to check the queue." After searching through the electronic medical record system, the Administrator acknowledged that there were no additional documents available for review. The Administrator further reported, "Essentially, if it's not documented, it's not done.

A Medicare authorized Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 7/25/23 through 7/28/23 at: American Advantage Home Care 2080 Monroe St., Suite 208 Dearborn, MI 48124 This Agency had no additional locations. Records reviewed: 1 record with home visit, 3 discharged records, 6 records without home visits for a total of 10 records reviewed. The required 4 home visits could not be met due to staff scheduling and patient refusal. At the conclusion of the survey, it was determined this agency was in compliance with the Conditions of Participation at sub part 42 CFR 484.102 Emergency Preparedness.

The following Condition and Standard level deficiencies were identified during a Medicare authorized recertification survey conducted by the Michigan Department of Licensing and Regulatory Affairs on 7/25/23 through 7/28/23 at: American Advantage Home Care 2080 Monroe St., Suite 208 Dearborn, MI 48 This Agency had no additional locations. Records reviewed: 1 record with home visit, 3 discharged records, 6 records without home visits for a total of 10 records reviewed. The required 4 home visits could not be met due to staff scheduling and patient refusal. The following Condition level deficiencies were identified: 42 CFR §484.55 Comprehensive Assessment of Patients. 42 CFR §484.60 Care Planning, Coordination, Quality of Care. 42 CFR §484.75 Skilled Professional Services. 42 CFR §484.80 Home Health Aide Services. 42 CFR §484.65 Quality Assessment/Performance Improvement. 42 CFR §484.70 Infection Control. At the conclusion of the survey, it was determined that this agency was out of compliance with the Conditions of Participation at sub part 42 CFR §484 Home Health Agencies. As a result of the Condition level noncompliance, the agency is prohibited for 2 years from offering a home health aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.36 (a)(2)(i).

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the patient received proper written Notice of Medicare Provider Non-Coverage in advance of the Agency terminating on-going care for 2 (P's #1, 2) of 3 discharged records, resulting in the patient being denied the right to appeal the decision to end Medicare covered services. Findings include: Policy: Financial responsibility and Medicare written notices, 1-003.1 4/2020 stated, "Medicare patients must be provided with timely, accurate, and comprehensible written notices in any case where a reduction or termination of services it to occur, or where services are to be denied before being initiated." P-1: The patient's start of care was 11/1/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure. During the record review on 7/26/23 at 10:15 a.m., it was noted that the patient was discharged from the agency's services on 12/8/22. The "Notice of Medicare Non-Coverage" had not been completed at the time of this review. These findings were reviewed with and acknowledged by the Administrator and Assistant Administrator during an interview on 7/26/23 at12:58 p.m. P-2: The patient's start of care was 7/26/22 with diagnoses that included Cancer of the Brain. During the record review on 7/26/23 at 11:25 a.m., it was noted that the patient was discharged from the agency's services on 9/9/22. The "Notice of Medicare Non-Coverage" was incomplete at the time of this review. These findings were reviewed with and acknowledged by the Administrator and Assistant Administrator during an interview on 7/26/23 at1:29 p.m.

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 record review and interview, the Agency failed to ensure the Registered Nurse completed the Initial Comprehensive Assessment within 48 hours of the date of referral, and failed to ensure the Nurse completed the initial assessment when both Nursing and Therapy services were ordered, for 6 (P's #2, 4, 6, 8, 9, 10) records, from a total of 10 sampled records reviewed, resulting in delay in needed care and services and the potential for decline in health status and unmet care needs (G514); failed to ensure the patient's Activity of Daily Living needs, Occupational Therapy needs, and medical needs were adequately met in the patient's home for 4 (P's #1, 2, 3, 6) patients who required the services, from a total of 10 sampled records reviewed, resulting in the potential for poor hygiene, physiological decline, and unmet care needs (G534); failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to provide documented evidence of the drug regime review: failed to ensure the Registered Nurse provided oversight of the review process, and failed to ensure the physician was notified of potential drug interactions in 7 (1, 2, 3, 4, 5, 6, 8) of 10 sampled records reviewed, resulting in the potential for harmful medication effects for all 93 patients currently serviced by this Agency (G536). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.55 Comprehensive Assessment of Patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Registered Nurse completed the Initial Comprehensive Assessment within 48 hours of the date of referral, and failed to ensure the Nurse completed the initial assessment when both Nursing and Therapy services were ordered, for 6 (P's #2, 4, 6, 8, 9, 10) records, from a total of 10 sampled records reviewed, resulting in delay in needed care and services and the potential for decline in health status and unmet care needs. Findings include: Policy: Initial and Comprehensive Assessment 2-007, 4/2020.1 stated, "The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient's return home, on the start of care date ordered by the physician, or at the patient/family request with the approval of the physician." P-2: The patient's start of care (SOC) was 7/26/22 with a diagnosis of Brain Cancer. During the record review on 7/26/23 at 11:25 a.m., it was noted that the referral for home care ordered Occupational Therapy (OT), Physical Therapy (PT), Skilled Nursing (SN) and Home Health Aide (HHa) services to be provided and was dated 7/18/22. This was 8 days after the date of the referral. There was no documented rationale as to why services were delayed. These findings were reviewed with and acknowledged by the Assistant Administrator (Adm #2) during an interview on 7/26/23 at 1:29 p.m. P-4: The patient's SOC was 7/3/23 with diagnoses that included Diabetes Mellitus and Unsteady gait. During the record review on 7/26/23 at 3:10 p.m., it was noted that the referral for home care ordered PT services to be provided and was dated 6/29/23. This was 4 days after the date of the referral. There was no documented rationale as to why services were delayed. These findings were reviewed with and acknowledged by the Assistant Administrator (Adm #2) during an interview on 7/26/23 at 4:00 p.m. P-6: The patient's SOC was 6/12/23 with diagnoses that included Acute Kidney Failure and Diabetes Mellitus. During the record review on 7/27/23 at 4:30 p.m., it was noted that the referral for home care ordered PT, OT, SN and HHa services and was dated 5/19/23. This was 24 days after the date of the referral. A communication note documented that PT contacted the patient on 6/9/23 (21 days after the date of the referral) to initiate care, however, the patient then requested a start of care date 6/12/23. There was no documented evidence that PT attempted to contact the patient prior to 6/9/23 in order to initiate services. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Adm #2 during an interview on 7/28/23 at 11:35 a.m. P-8: The patient's SOC was 6/24/23 with diagnoses that included Spinal Stenosis and Diabetes Mellitus. during the record review on7/28/23, it was noted that the referral for home care ordered PT services to be provided and was dated 6/19/23. PT initiated the SOC 5 days after the date of the referral. There was no documented rationale as to why services were delayed. These findings were reviewed with and acknowledged by the Adm #1 and Adm #2 during an interview on 7/28/23 at 11:40 a.m. P-9: The patient's SOC was 6/1/23 with diagnoses that included Lactic Acidosis and Aspiration Pneumonia. During the record review on 7/28/23, it was noted that the referral for home care ordered SN and PT services to be provided and was dated 5/22/23. The SN initiated services on 6/1/23, which was 10 days after the date of the referral. There was no documented rationale as to why services were delayed. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 7/28/23. P-10: The patient was referred to this Agency on 7/20/22 with a diagnosis of Hypertensive Chronic Kidney Disease. The services ordered were OT, PT, SN and HHa. The referral indicated the Agency was willing to accept the patient. At the time of this clinical record review on 7/28/23 at 12:15 p.m., the Initial Comprehensive Assessment had not been initiated by the SN. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 7/28/23 at 12:30 p.m.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure the patient's Activity of Daily Living needs, Occupational Therapy needs, and medical needs were adequately met in the patient's home for 4 (P's #1, 2, 3, 6) patients who required the services, from a total of 10 sampled records reviewed, resulting in the potential for poor hygiene, physiological decline, and unmet care needs. Findings include: P-1: The patient's start of care (SOC) was 11/1/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure. During the record review on 7/26/23 at 10:15 a.m., it was noted that the referral for home care dated 11/1/22 ordered Skilled Nursing (refused), Physical Therapy (PT), Occupational Therapy (OT) and Home Health Aide services to be provided. At the time of this review, no HHa services had been provided as ordered. Additionally, OT began services the 3rd week of care. There was no documented evidence that the patient declined services. The Agency failed to ensure the patient's needs were met. These findings were reviewed with the Administrator (Adm #1) and the Assistant Administrator (Adm #2) during an interview on 7/26/23 at 12:58 p.m. P-2: The patient's SOC was 7/26/22 with a diagnosis of Brain Cancer. During the record review on 7/26/23 at 11:25 a.m., it was noted that the referral for home care ordered OT, PT, SN and HHa services to be provided. Further review revealed the HHa did not begin services until August 9, 2022 (this was 2 weeks after the SOC). Additionally, OT did not begin services until August 16, 2022 (this was 3 weeks after the SOC). There was no documented rationale as to why services were not provided in the patient's home in a timely manner. The Agency failed to ensure the patient's needs were adequately met in the patient's home. These findings were reviewed with the Assistant Administrator (Adm #2) during an interview on 7/26/23 at 1:29 p.m. P-3: The patient's SOC was 7/15/23 with a diagnosis of Osteoarthritis left knee and history of bilateral knee replacements. During the record review, it was noted that the referral for home care ordered PT services to be provided. On 7/27/23 at 10:30 a.m., a scheduled home visit was conducted with the Physical Therapist (PT #1). The patient was observed to have a very unsteady gait and required the use of assistive devices such as, a walker and a cane. During the visit, the patient's admission packet was reviewed and revealed that the patient declined Aide services and Occupational Therapy services. When queried, the patient's wife stated, "We didn't decline. We were never offered. No one gave us an explanation of what OT does and how my husband could benefit from the service." PT #1 interjected and said to the patient's wife, "No. I didn't add PT because the referral just called for PT." PT #1 then retrieved a Home Exercise Plan that covered OT exercises and gave it to the patient's wife. PT #1 then began to have the patient perform arm exercises which resulted in the patient's complaints of pain to his right shoulder. The patient then stated, "It's hard for me to move my right arm and my hands. My shoulder hurts now." PT #1 then told the patient's wife, "I can have OT ordered so they can do an evaluation." The patient's wife responded, "We'd appreciate that." Upon further review of the clinical record, it was noted that section M1800 of the comprehensive assessment documented that someone must help the patient with toileting, dressing. The home health aide section documented that the patient/caregiver refused services. There was no assessment of the patient's upper body in order to determine his individualized needs. These findings were reviewed with and acknowledged by Adm #2 during an interview on 7/27/23. P-6: The patient's SOC was 6/12/23 with a diagnosis of Acute Kidney Failure and Diabetes Mellitus. During the record review on 7/27/23 at 4:30 p.m., it was noted that the referral for home care ordered Aide services to be provided. At the time of this review, no Home Health Aide services had been provided. Additionally, the record revealed this patient "takes insulin and oral blood sugar medications..., Does not have a glucometer." Upon review, there was no indication that skilled nursing services were offered to aid in monitoring the patient's blood sugars and medication management. It was further noted that during the entrance conference on 7/25/23, Adm #1 reported that if a patient did not have a glucometer, the agency would notify the physician and assist the patient with acquiring one. There was no documented evidence that the agency assisted the patient in the managing her Diabetes. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 7/28/23 at 11:35 a.m.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to provide documented evidence of the drug regime review: failed to ensure the Registered Nurse provided oversight of the review process, and failed to ensure the physician was notified of potential drug interactions in 7 (1, 2, 3, 4, 5, 6, 8) of 10 sampled records reviewed, resulting in the potential for harmful medication effects for all 93 patients currently serviced by this Agency. Findings include: A policy was requested regarding the drug review process, however, was not provided during the survey. P-1: The patient's start of care (SOC) was 11/1/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure. Section M2001 of the Initial Comprehensive Assessment documented, was completed by the Physical Therapist (PT) and documented "No issues found during review." However, the agency's drug interaction report documented, "Moderate Interactions." During the record review on 7/26/23 at 10:15 a.m., there was no documented evidence that the Registered Nurse (RN) conducted the drug review as per this requirement. The agency failed to ensure the comprehensive assessment included an accurate review of the patient's medications conducted by an RN. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Assistant Administrator (Adm #2) during an interview on 7/26/23 at 12:58 p.m. P-2: The patient's SOC was 7/26/22 with a diagnosis of Brain Cancer. Section M2001 of the Comprehensive assessment, completed by the Skilled Nurse (SN) documented, "No issues found during review." There was no drug interaction report available for review. The patient's Medication Profile listed 2 medications. The patient's History and Physical report dated 7/5/22 revealed the presence of 6 additional medications that had not been included on the patient's medication profile or in the drug review process. During the record review on 7/26/23 at 11:25 a.m., it was noted that the agency failed to ensure the comprehensive assessment included a thorough review of all the patient's medications in order to ascertain any untoward findings. These findings were reviewed with and confirmed by Adm #2 during an interview on 7/26/23 at 1:29 p.m. P-3: The patient's SOC was 7/15/23 with a diagnosis of Osteoarthritis and history of bilateral knee replacements. During the record review on 7/26/23 at 2:30 p.m., it was noted that section M2001 of the Initial Comprehensive Assessment, completed by the PT documented, "No issues found during review." The agency's drug interaction report, conducted at the time of the survey, identified Moderate drug to drug interactions. Additionally, there was no documented evidence that the RN provided oversight of the drug review process, as per this requirement. These findings were reviewed with and acknowledged by Adm #2 during an interview on 7/26/23. P-4: The patient's SOC was 7/3/23 with diagnoses that included Diabetes Mellitus and Unsteady Gait. During the record review on 7/26/23 at 3:10 p.m., it was noted that section M2001 of the Initial Comprehensive Assessment, completed by the PT documented "No issues found during review." The agency's drug interaction report, conducted at the time of the survey, documented Moderate drug to drug interactions. Additionally, the patient's History and Physical dated 6/29/23 listed 10 prescribed medications. PT only listed 9 medications on the medication profile which differed from the medications listed in the H&P. The agency failed to ensure the comprehensive assessment included an accurate review of the patient's medications by a Registered Nurse. These findings were reviewed with and acknowledged by Adm #2 during an interview on 7/26/23. P-5: The patient's SOC was 7/12/23 with a diagnosis of Knee Replacement. During the record review on 7/26/23 at 3:45 p.m., it was noted that section M2001 of the comprehensive assessment, completed by the PT, documented, "No issues found during the review." The agency's drug interaction report, conducted at the time of the survey, revealed moderate drug to drug interactions. The agency failed to ensure the comprehensive assessment included an accurate review of the patient's medications, by a Registered Nurse. These findings were reviewed with and acknowledged by Adm #2 during an interview on 7/27/23 at 5:18 p.m. P-6: The patient's SOC was 6/12/23 with diagnoses of Acute Kidney Failure and Diabetes Mellitus. During the record review on 7/27/23 at 4:30 p.m., it was noted that the referral for home care ordered Skilled Nursing (SN) and PT services to be provided. The initial comprehensive assessment, however, was completed by the PT. Section M2001 documented, "No issues found during review." The agency's drug interaction report, conducted at the time of the survey, identified moderate drug to drug interactions. There was no documented evidence that an accurate, comprehensive drug review had been conducted by the RN as per this requirement. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 7/28/23 at 11:35 a.m. P-8: The patient's SOC was 6/24/23 with diagnoses that included Spinal Stenosis and Diabetes Mellitus. During the record review on 7/28/23, it was noted that section M2001 of the initial comprehensive assessment, was completed by the PT and documented, "No issues found during review." The agency's drug interaction report, generated at the time of the survey documented, "No interactions found." It was further noted that PT listed 6 medications on the patient's medication profile, however, the physician's referral listed a total of 21 prescribed medications. There was no documented evidence that an accurate drug review was conducted by the SN that included all the patient's prescribed medications as per this requirement. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 7/28/23. Adm #1 reported, "I realize we have a lot of problems." The agency failed to ensure the Initial comprehensive assessment included a thorough review of all the patient's medications that was conducted by a Registered Nurse.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care covered all pertinent interventions with reportable parameters, safety precautions and objectively measurable goals specific to the needs of the patient and failed to ensure all prescribed medications had been included in the plan of care, for 5 (P's #1, 2, 4, 6, 8) records, from a total of 10 sampled records reviewed, resulting in patients not receiving care specific to their individual needs, the potential for decline in overall health and poor patient outcomes (G574); and, failed to include contact information for the Home Health Agency's Clinical Manager in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed patient concerns. (G622). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.60 Care Planning, Coordination, Quality of Care.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care covered all pertinent interventions with reportable parameters, safety precautions and objectively measurable goals specific to the needs of the patient and failed to ensure all prescribed medications had been included in the plan of care, for 5 (P's #1, 2, 4, 6, 8) records, from a total of 10 sampled records reviewed, resulting in patients not receiving care specific to their individual needs, the potential for decline in overall health and poor patient outcomes. Findings include: P-1: The patient's start of care (SOC) was 11/1/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Chronic Kidney Disease and Hypertension. During the record review on 7/26/23 at 10:15 a.m., it was noted that the plan of care (POC) was void of interventions, reportable parameters and associated goals that addressed the above diagnoses. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Assistant Administrator (Adm #2) during an interview on 7/26/23 at 12:58 p.m. P-2: The patient's SOC was 7/26/22 with a diagnosis of Brain Cancer. The referral for home care ordered Skilled Nursing (SN), Occupational Therapy (OT), Physical Therapy (PT) and Home Health Aide (HHa) services to be provided. The POC ordered Medical Social Work (MSW). During the record review on 7/26/23 at 11:25 a.m., it was noted that the POC was void of any mention of the HHa. The goals were not measurable and did not indicate a date in which the identified goals would be met. Additionally, upon review, the patient's History and Physical dated 7/5/22, listed 7 prescribed medications, however, the POC only made mention of 2 medications. The agency failed to ensure the POC included all required interventions, reportable parameters, associated goals and medications. These findings were reviewed with and acknowledged by Adm #2 during an interview on 7/26/23 at 1:29 p.m. P-4: The patient's SOC was 7/3/23 with diagnoses that included Diabetes Mellitus and Unsteady Gait. During the record review on 7/26/23 at 3:10 p.m., the patient's History and Physical dated 6/28/23 revealed the patient had allergies to Sulfa (anti-bacterial agents that causes the patient to experience diarrhea), and Glipizide (helps to lower blood sugar, and causes the patient to experience diarrhea and anaphylaxis (a severe whole-body allergic reaction, swelling of the mouth, breathing and swallowing difficulties). The section of the POC titled "Allergies" documented "NKA (No Known Allergies) to food, drugs, latex or environment. The agency failed to ensure the POC included all the patient's allergies in order to guide the provision of care and ensure the patient's safety. These findings were reviewed with and acknowledged by Adm #2 during an interview on 7/26/23. P-6: The patient's SOC was 6/12/23 with diagnoses that included Acute Kidney Failure and Diabetes Mellitus. During the record review on 7/27/3 at 4:30 p.m., it was noted that the POC was incomplete and had blank spaces throughout, such as, "Nurse to report to MD if Blood Sugar>___or__ or <__", however, Nursing was not added to this case. The agency failed to accurately reflect the needs of the patient with applicable interventions, reportable parameters with associated goals and accurate medications. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 7/28/23.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to include contact information for the Home Health Agency's Clinical Manager in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed patient concerns. Findings include: On 7/25/23 at 2:30 p.m., the Agency's Admission packet was requested and reviewed. The packet included a consent form, admission agreement, Beneficiary notice, patient rights and responsibilities forms and Emergency Preparedness documents. Upon review, it was noted that there was no contact information for the Agency's current Clinical Manager. These findings were reviewed with and confirmed by the Administrator during an interview on 7/25/23 at 2:49 p.m.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined the home health agency failed to develop a Quality Assessment and Performance Improvement (QAPI) program that measures, tracks and analyzes it's quality indicators in order to assess the processes of care and services provided by the agency, resulting in the inability to improve patient care with positive outcomes (refer to G 0642); the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, to ensure the effectiveness and safety of services and quality of care to the patients and to identify opportunities for improvement, and there was no documented evidence the governing body approved the QAPI frequency and data collection process (refer to G0644); failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program that focused on high risk, high volume or problem prone areas (See G0648); failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program that considered incidence, prevalence, and severity of problems in identified areas of focus (See G0650); failed to track adverse patient events, analyze their causes, and implement preventative actions within their Quality Assessment Performance Improvement (QAPI) program (See G0654); failed to conduct any performance improvement projects within their Quality Assessment Performance Improvement (QAPI) program (See G0658); failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section, that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness (See G0660). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to provide evidence of its efforts to measure, track and analyze its quality indicators in order to assess processes of care and services, resulting in the inability to determine the scope of services provided and potential unmet care needs for all agency patients. Findings include: During review of the agency's Quality Assessment and Performance Improvement (QAPI) program on 7/27/23, it was discovered that the agency had no documented QAPI information or QAPI activities for 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program to ensure the effectiveness and safety of services, quality of care to patients, and to identify opportunities for improvement. In addition, there was no documented evidence the governing body approved the QAPI frequency and data collection process. During review of the agency's Quality Assessment and Performance Improvement (QAPI) program on 7/27/23, it was discovered that the agency had no documented QAPI information or QAPI activities for 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency (HHA) failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program that focused on high risk, high volume or problem prone areas, resulting in the potential for agency issues to go unresolved and could negatively affect all patients served by the agency. Findings include: During review of the agency's QAPI program on 7/27/23, it was discovered that the agency had no documented QAPI information or QAPI activities for 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined the Agency (HHA) failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program that considered incidence, prevalence, and severity of problems in identified areas of focus, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: During review of the agency's QAPI program on 7/27/23, it was discovered that the agency had no documented QAPI information or QAPI activities for 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency (HHA) failed to track adverse patient events, analyze their causes, and implement preventative actions within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for patient issues to go unresolved and negatively affect all patients served by the agency. Findings include: During review of the agency's QAPI program on 7/27/23, it was discovered that the agency had no documented QAPI information or QAPI activities for 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency (HHA) failed to conduct any performance improvement projects within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for patient and agency issues to go unresolved and affect all patients served by the agency. Findings include: During review of the agency's QAPI program on 7/27/23, it was discovered that the agency had no documented QAPI information or QAPI activities for 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Governing Body failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section, that addressed priorities for improved quality of care and patient safety and was evaluated for its effectiveness, resulting in the potential to adversely affect the quality of care to all patients receiving services. Findings include: During review of the agency's QAPI program on 7/27/23, it was discovered that the agency had no documented QAPI information or QAPI activities for 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined the agency failed to document any infection control meeting minutes or infection control activities for 2023 (G-684). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR§484.70, Infection Control.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the agency's Quality Assessment Performance Improvement program, resulting in the potential spread of infections between patient care staff and the agency's patients. Findings include: During review of the agency's QAPI and infection control program on 7/27/23, it was discovered that the agency had no documented infection control information or activities incorporated into their QAPI program for 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the assigned Therapists assisted the physician in evaluating the patient's level of function and helped to develop the plan of care for 2 (P's #6, 9) patients of which Therapy services were ordered, from a total sample of 10 sampled records reviewed, resulting in the potential for decline in physical functioning and unmet care needs (G708); failed to ensure that Medical Social Work, Occupational Therapy and Physical Therapy services were provided as ordered for 5 (P's #1, 2, 6, 7, 9) patients who required the services, from a total of 10 sampled records reviewed, resulting in the potential for psychological decline, lack of resources, physiological decline, and unmet care needs (G710); failed to ensure the clinical record was completed and included detailed Physical Therapy and Skilled Nursing notes for 4 (P's #2, 4, 5, 6) records with the ordered services, from a total of 10 sampled records reviewed, resulting in the potential for lack of continuity of care, undocumented, unidentified health concerns, and unmet patient needs (G716); failed to ensure all of the agency's staff, including contracted staff, participated in the agency's Quality Assessment and Performance Improvement (QAPI) program (G720); failed to have all agency staff, including contracted staff, participate in agency sponsored in-services (G722). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.75 Skilled Professional Services.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the assigned Therapists assisted the physician in evaluating the patient's level of function and helped to develop the plan of care for 2 (P's #6, 9) patients of which Therapy services were ordered, from a total sample of 10 sampled records reviewed resulting in the potential for decline in physical functioning and unmet care needs. Findings include: P-6: The patient's start of care (SOC) was 6/12/23 with diagnoses that included Acute Kidney Failure and Diabetes Mellitus. The referral for home care ordered Physical Therapy (PT), Occupational Therapy (OT), Skilled Nursing (SN) and Home Health Aide (HHa) services to be provided. At the time of this record review on 7/27/23 at 4:30 p.m., no OT services had been provided. Additionally, there was no documented evidence that the patient refused/declined services. These findings were reviewed with and confirmed by the Administrator (Adm #1) and Assistant Administrator (Adm #2) during an interview on 7/28/23 at 11:35 a.m. P-9: The patient's SOC was 6/1/23 with diagnoses that included Lactic Acidosis and Aspiration Pneumonia. The referral for home care dated 5/22/23 ordered SN and PT services to be provided. At the time of this record review, no PT services had been provided. There was no documented evidence that the patient refused services. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 7/28/23 at 12:30 p.m. The Agency failed to ensure the Occupational Therapist and Physical Therapist assisted the physician in evaluating the patient's level of function and helped to develop the plan of care.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that Medical Social Work, Occupational Therapy and Physical Therapy services were provided as ordered for 5 (P's #1, 2, 6, 7, 9) patients who required the services, from a total of 10 sampled records reviewed, resulting in the potential for psychological decline, lack of resources, physiological decline, and unmet care needs. Findings include: P-1: The patient's start of care (SOC) was 11/2/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure. The referral for home care dated 11/1/22 ordered Occupational Therapy (OT) services to be provided. Further review of the record on 7/26/23 at 10:15 a.m., revealed that OT began services 15 days after the SOC. The agency failed to provide services as ordered. These findings were reviewed with and confirmed by the Administrator (Adm #1) and Assistant Administrator (Adm #2) during an interview on 7/26/23 at 12:58 p.m. P-2: The patient's SOC was 7/26/22 with diagnoses that included Cancer of the Brain. During the record review on 7/26/23 at 11:25 a.m., it was noted that the referral for home care ordered Skilled Nursing (SN), Physical therapy (PT), OT and Home Health Aide services to be provided. The plan of care (POC) ordered Medical Social Work (MSW) services to be provided to evaluate for resources. At the time of this review, no MSW services had been provided. Additionally, no OT services had been provided until the 4th week of care. The agency failed to ensure that services were provided in accordance with the Physician's order and the POC. These findings were reviewed with and acknowledged by Adm #2 during an interview on 7/26/23 at 1:29 p.m. P-6: The patient's SOC was 6/12/23 with diagnoses that included Acute Kidney Failure and diabetes Mellitus. The referral for home care dated 5/17/23 ordered PT, OT and SN services to be provided. At the time of this review on 7/27/23 at 4:30 p.m. OT services had not been provided. Additionally, SN made one visit during the 3rd week of service and a 2nd visit during the 5th week of service. No additional SN visits had been made as ordered. Further review revealed that PT made no further visits after 7/8/23. The agency failed to ensure services were provided as ordered. These findings were reviewed with Adm #1 and Adm #2 during an interview on 7/28/23 at 11:35 a.m. P-9: The patient's SOC was 6/1/23 with diagnoses that included Lactic Acidosis and Aspiration Pneumonia. The referral for home care dated 5/22/23 order SN and PT services to be provided. At the time of this review on 7/28/23, no PT services had been provided. Additionally, there was no documented evidence that the patient refused services. The agency failed to ensure services were provided as ordered. These findings were reviewed with and confirmed by Adm #1 and Adm #2 during an interview on 7/28/23 at 12:30 p.m. P-7: The start of care (SOC) was dated 5/6/23 with diagnoses that included chronic obstructive pulmonary disease (COPD) and anemia. Record review on 7/27/23 showed the plan of care (POC) ordered skilled nursing (SN), physical therapy (PT), and occupational therapy services. At the time of survey, there were no OT visits documented in the record, or an order from the physician to discontinue OT services. During an interview on 7/28/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the clinical record was completed and included detailed Physical Therapy and Skilled Nursing notes for 4 (P's #2, 4, 5, 6) records with the ordered services, from a total of 10 sampled records reviewed, resulting in the potential for lack of continuity of care, undocumented, unidentified health concerns, and unmet patient needs. Findings include: On 7/25/23 at 2:15 p.m., during the entrance conference, the Administrator (Adm #1) was queried regarding the agency's expectation for the completion and submission of visit notes and responded, "Our policy is 24 to 48 hours, but there is need for improvement." P-2: The patient's start of care (SOC) was 7/26/22 with diagnoses that included Cancer of the Brain. The plan of care (POC) ordered Physical Therapy (PT) at a frequency of 1w1, 2w2, 1w3. During the record review on 7/26/23 at 11:25 a.m., it was noted that PT saw the patient on 8/4/22 and again on 8/11/22. There was a documented missed visit on 8/11/22. At the time of this review, there were no further PT notes available after the 8/11/22 missed visit. These findings were reviewed with and confirmed by the Assistant Administrator (Adm #2) during an interview on 7/26/23 at 1:29 p.m., who reported, "The visits were plotted (scheduled) but I don't see any actual notes. They haven't been put in yet." P-4: The patient's SOC was 7/3/23 with diagnoses that included Diabetes Mellitus and Unsteady Gait. The POC ordered PT at a frequency of 2w2, 1w3. During the record review on 7/26/23 at 3:10 p.m., it was noted that there were no PT notes available for review during the week of 7/16/23. These findings were reviewed with and confirmed by Adm #2 during an interview on 7/27/23. P-5: The patient's SOC was 7/12/23 with diagnoses that included Bilateral Knee Replacement. The POC ordered PT at a frequency of 2w1, 3w1, 2w1. During the record review on 7/26/23 at 3:45 p.m., it was noted that there were no PT visit notes available for the week of 7/16/23 (3 visit notes missing). These findings were reviewed with and confirmed by Adm #2 during an interview on 7/27/23 at 5:18 p.m. P-6: The patient's SOC was 6/12/23 with diagnoses that included Acute Kidney Failure and Diabetes Mellitus. The POC ordered PT at a frequency of 1w6. During the record review on 7/27/23 at 4:30 p.m., it was noted that there were no PT visit notes for the weeks of 7/9/23 and 7/16/23 (2 missing visit notes). These findings were reviewed with and acknowledged by the Adm #1 and Adm #2 during an interview on 7/28/23 at 11:35 a.m. The Agency failed to ensure the clinical record was completed and included detailed Physical Therapy and Skilled Nursing notes.

Participate in the HHA's QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA's QAPI program; and This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure all 16 of the agency's staff, including contracted staff, participated in the agency's Quality Assessment and Performance Improvement (QAPI) program, resulting in the potential for unaddressed agency issues and missed opportunities for agency performance improvement. Findings include: During review of the agency's QAPI program on 7/27/23, it was discovered that the agency had no documented QAPI information or QAPI activities for 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Participate in HHA-sponsored in-service CFR(s): 484.75(b)(9) Participation in HHA-sponsored in-service training. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to have all agency staff, including contracted staff, participate in agency sponsored in-services, resulting in the potential for poor patient outcomes. Findings include: During review of the agency's employee files on 7/27/23, it was discovered that from a sample of 8 agency employees, including one contracted employee, three of the employees, including one contracted employee, did not have any yearly in-services documented for 2022 or 2023. During an interview on 7/27/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Registered Nurse and Physical Therapist prepared clear written patient care instructions for the home health aide regarding client needs, prior to providing care in 3 (P's #1, 2, 6) of 4 records in which Home Health Aide services were ordered, from a total of 10 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs (G798); failed to ensure the Home Health Aide provided care in accordance with the written plan of care for 1 (P-2) of 4 patients ordered to receive Home Health Aide services, from a total of 10 sampled records resulting in the patient not receiving care and services as ordered and unmet care needs (G800). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.80 Home Health Aide Services.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Registered Nurse and Physical Therapist prepared clear written patient care instructions for the home health aide regarding client needs, prior to providing care in 3 (P's #1, 2, 6) of 4 records in which Home Health Aide services were ordered, from a total of 10 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs. Findings include: Policy: Home Health Aide Plan of Care, 4/2020, 2-023.1 stated, "Each patient receiving home health aide services will have an individualized plan developed and utilized to direct care performed by the assigned aide..., and will include at least: Frequency of visits, Safety measures, Instructions for completion of documentation, reporting changes in patient's condition and needs." P-1: The patient's start of care (SOC) was 11/1/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure. A Physician's order ordered Physical Therapy, Occupational Therapy and Home Health Aide services to be provided. At the time of this review on 7/26/23 at 10:15 a.m., no Aide care plan had been created to direct the care of the patient. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Assistant Administrator (Adm #2) during an interview on 7/26/23 at 12:58 p.m. P-2: The patient's SOC was 7/26/22 with diagnoses that included Cancer of the Brain. The referral for home care dated 7/18/22 ordered Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT) and HHa services to be provided. During the record review on 7/26/23 at 11:25 a.m., it was noted that the "Aide Care Plan" failed to include the Aide visit frequency and the safety precautions as indicated in the Plan of Care /485 such as, Neutropenic Precautions, Medical Equipment (Walker, Bedside Commode), Prone to skin breakdown, Support during transfer and ambulation. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 7/26/23 at 1:29 p.m. P-6: The patient's SOC was 6/12/23 with diagnoses that included Acute Kidney Failure and Diabetes Mellitus. The referral for home care dated 5/19/23 ordered PT, OT, SN and HHa services to be provided. At the time of this record review on 7/27/23 at 4:30 p.m., there was no Aide Care Plan available for review. These findings were reviewed with and acknowledged by Adm #1 and Adm #2 during an interview on 7/28/23 at 11:35 a.m.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Home Health Aide provided care in accordance with the written plan of care for 1 (P-2) of 4 patients ordered to receive Home Health Aide services, from a total of 10 sampled records resulting in the patient not receiving care and services as ordered and unmet care needs. Findings include: Policy: Home Health Aide Plan of Care, 4/2020, 2-023.1 stated, "Each patient receiving home health aide services will have an individualized plan developed and utilized to direct care performed by the assigned aide." P-2: The patient's start of care (SOC) was 7/26/22 with diagnoses that included Cancer of the Brain. During the record review on 7/26/23 at 11:25 a.m., it was noted that the patient was ordered to receive Home Health Aide (HHa) services. The Aide Care Plan instructed the HHa to weigh the patient every visit. The record revealed the HHa saw the patient 2x/wk. x 5 wks. for a total of 10 visits made in the patient's home. Upon review of the Aide visit notes, there was no documented evidence that the Aide weighed the patient as instructed in the plan of care. These findings were reviewed with and acknowledged by the Assistant Administrator (Adm #2) during an interview on 7/26/23 at 1:29 p.m.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation and interview, it was determined the Administrator failed to ensure the Clinical Manager was available at all times during operating hours, resulting in the lack of clinical supervision and oversight and the potential for unmet care needs for the agency's existing patients. Findings include: On 7/25/23 at 2:15 p.m., during the Entrance Conference, the Administrator (Adm #1) was queried about the Agency's Clinical Manager (CM #1) and reported, "She won't be in today because she has other obligations. She has another job." When asked if CM #1 would be available any time during the survey, Adm #1 reported, "She should be here tomorrow (7/26/23)." On 7/26/23, a person introduced as the Clinical Manager arrived at the agency at 9:00 a.m. The Clinical Manager left the Agency around 1:00 p.m. When queried as to her whereabouts, the Assistant Administrator reported, "She (CM #1) is going to see patients." It was not clear if the CM was seeing the agency's patients. On 7/28/23, the Administrator (Adm #1) was asked if the CM would be present and available for interviews and replied, "I'm not sure. She should be, but I have to admit, she's (CM) having some other problems." The Administrator failed to ensure the Clinical Manager was available at all times during operating hours. These findings were reviewed with Adm #1 and Adm #2 at the time of discovery.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to ensure the plan of care was implemented and that all patients received services as ordered by the Physician for 4 (P's #1, 2, 6, 9) patients who required medical and therapeutic management of their disease process, from a total of 10 patients reviewed, resulting in patients not receiving care and services based on their individualized needs and the potential for poor patient outcomes. Findings include: P-1: The patient's start of care (SOC) was 11/2/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure. The referral for home care dated 11/1/22 ordered Occupational Therapy (OT) services to be provided. Further review of the record on 7/26/23 at 10:15 a.m., revealed that OT began services 15 days after the SOC. The Clinical Manager (CM #1) failed to ensure the plan of care (POC) was implemented as per this requirement. These findings were reviewed with and confirmed by the Administrator (Adm #1) and Assistant Administrator (Adm #2) during an interview on 7/26/23 at 12:58 p.m. Adm #1 reported, "I can't lie, she (CM #1) has some other problems going on." P-2: The patient's SOC was 7/26/22 with diagnoses that included Cancer of the Brain. During the record review on 7/26/23 at 11:25 a.m., it was noted that the referral for home care ordered Skilled Nursing (SN), Physical therapy (PT), OT and Home Health Aide services to be provided. The POC ordered Medical Social Work (MSW) services to be provided to evaluate for resources. At the time of this review, no MSW services had been provided. Additionally, no OT services had been provided until the 4th week of care. CM #1 failed to ensure the POC was implemented as per this requirement. These findings were reviewed with and acknowledged by Adm #2 during an interview on 7/26/23 at 1:29 p.m. P-6: The patient's SOC was 6/12/23 with diagnoses that included Acute Kidney Failure and diabetes Mellitus. The referral for home care dated 5/17/23 ordered PT, OT and SN services to be provided. At the time of this review on 7/27/23 at 4:30 p.m. OT services had not been provided. Additionally, SN made one visit during the 3rd week of service and a 2nd visit during the 5th week of service. No additional SN visits had been made as ordered. Further review revealed that PT made no further visits after 7/8/23. CM #1 failed to ensure the POC was implemented as per this requirement. These findings were reviewed with Adm #1 and Adm #2 during an interview on 7/28/23 at 11:35 a.m. P-9: The patient's SOC was 6/1/23 with diagnoses that included Lactic Acidosis and Aspiration Pneumonia. The referral for home care dated 5/22/23 order SN and PT services to be provided. At the time of this review on 7/28/23, no PT services had been provided. Additionally, there was no documented evidence that the patient refused services. CM #1 failed to ensure the POC was implemented as per this requirement. These findings were reviewed with and confirmed by Adm #1 and Adm #2 during an interview on 7/28/23 at 12:30 p.m.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the transfer/discharge summaries were complete, provided the patient's current health status at the time of transfer/discharge, progress toward goals, and forwarded to the receiving facility and the Physician in 3 (P's #1, 2 and 7) records in which the patient was discharged/transferred from the agency's services, from a total of 10 sampled records reviewed, resulting in the potential for unidentified continuing health concerns and unmet care needs. Findings include: Policy: Transfer Summary, 4/2020, 2-041.1 stated, "Within 48 hours of transfer, the clinician will complete a transfer summary that includes: reason for transfer, physical and psychosocial status at the time of transfer, symptom management needs, medication profile, summary of care provided, existence of advanced directives, post discharge goals of care, treatment preferences to the receiving facility..." A policy regarding Discharge Summaries was requested but was not provided during the survey. P-1: The patient's start of care (SOC) was 11/1/22 with diagnoses which included Hypertensive Heart Disease with Heart Failure, Chronic Kidney Disease and Hypertension. During the record review on 7/26/23 at 10:15 a.m., it was noted that the patient received Physical Therapy (PT) and Occupational Therapy (OT) services. The patient was discharged from PT services on 12/8/22 and discharged from OT services on 12/15/22. The PT Discharge Summary was dated 12/8/22 and upon review, the sections titled "Physical Assessment, Gait Analysis and W/C Mobility" were all left blank. There was no summary that detailed the course of care provided with responses, status at the time of discharge, which goals were met vs not met, and any continuing needs. Additionally, there was no evidence that the summary had been sent to the Physician within 5 days of the date of discharge. The OT Discharge Summary was dated 12/15/22 and upon review, there was no summary of care that detailed the course of care provided with responses to treatment, which goals were met vs not met and any continuing needs. The section titled "condition of discharge - include vital signs, blood sugar functional and overall status" was incomplete. The summary documented "Physician notified." There was no documented evidence that the OT discharge summary was sent to the Physician within 5 days of the date of discharge. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Assistant Administrator (Adm #2) during an interview on 7/26/23 at 12:58 p.m. P-2: The patient's SOC was 7/26/22 with diagnoses which included Cancer of the Brain. During the record review on 7/26/23 at 11:25 a.m., it was noted that the patient was transferred to the hospital on 9/9/22. Upon review of the "Transfer summary" dated 9/9/22, it was noted to be void of the required elements as per this requirement such as a detailed course of care provided with responses, list of medications, and documented evidence that the summary was sent to the Physician. These findings were reviewed with and acknowledged by Adm #2 during an interview on 7/26/23 at 1:29 p.m. Policy: Transfer Summary, 4/2020, 2-041.1 stated, "Within 48 hours of transfer, the clinician will complete a transfer summary that includes: reason for transfer, physical and psychosocial status at the time of transfer, symptom management needs, medication profile, summary of care provided, existence of advanced directives, post discharge goals of care, treatment preferences to the receiving facility..." P-7: The start of care (SOC) was dated 5/6/23 with diagnoses that included chronic obstructive pulmonary disease (COPD) and anemia. Record review on 7/27/23 showed the patient received skilled nursing (SN), and physical therapy (PT) services. The patient was transferred to the hospital on 5/19/23. There was an OASIS transfer, but no transfer summary documented in the record. During review of the transfer OASIS on 7/27/23, it was discovered that no reason for the transfer, no patient history related to the transfer and no medication information was documented for the receiving facility. There was also no documented evidence in the record that the patient's physician was notified of the hospital transfer. During an interview on7/28/23 at 12:45 p.m., the Assistant Administrator/Vice president (Adm #2) acknowledged the above findings.