Every finding on record at Elite Home Health Care, Inc

The Standard deficiencies were identified during a Medicare authorized complaint (MI00022755) investigation, conducted by the Michigan Department of Licensing and Regulatory Affairs on 9/20/22 - 9/21/22 at: The Care Team 441 South Main St., Suite 3 Standish, MI 48658 This Agency had no additional locations. At the conclusion of the investigation, the following was determined: Allegation #1: It was alleged the facility failed to come out and manage the patient’s PICC line according to the plan of care - Substantiated.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the facility failed to ensure the Physician was promptly notified of the patient's health status for 1 (MR #1) of 1 patient who required attention to her Intravenous access site and who was subsequently sent to the hospital, resulting in lack of Physician inclusion and oversight and the potential for unmet care needs. Findings include: A complaint on file alleged that the Agency's nurse failed to notify the Physician of the patient's health concerns that resulted in the patient being transferred to the hospital. . MR #1: The patient's Start of Care was 6/12/21 with diagnoses that included Encounter for adjustment and management of VAD (Vascular Access Device), Long Term use of Antibiotics and Multiple Sclerosis. On 9/21/22 during a review of the clinical record, it was noted that the Referal for home care dated 6/11/21 included additional diagnoses of Cellulitis left lower extremity and Burns involving 10-19% of body surface. The referral ordered "Home care to evaluate and admit to skill nursing..." The Plan of Care (POC) ordered Skilled Nursing (SN) services to be provided at a frequency of 1w1, 2w1, 1w7. High Tech/Special Procedure Inteventions were ordered and included: "SN Assess and Implement plans to reduce risk of hospitalization and Emergency Department visits, establish follow up visit schedule with physician to endure effective monitoring of patient's status, port dressing change weekly and PRN (as needed), change IV (intravenous) tubing every 72 hours and PRN for infiltration/infection..." The complaint on file alleged that the Registered Nurse was called and asked to come out to assess concerns with the patient's PICC line, yet the nurse refused to do so and instructed the caller to send the patient to the ER (Emergency Room). A "Case Communication" note dated 7/10/21, signed 7/12/21 acknowledged receipt of a call from the facility where the patient resided, expressing concerns regarding the patient's PICC (peripherally inserted central catheter) line site. The nurse (RN #1) instructed the caller to take the patient to ER for treatment. Further review revealed no documented evidence that the Physician had been promptly notified of the patient's health status or that the patient had been transferred to the hospital. These findings were reviewed with and acknowledged by the Regional Branch Director (RBD #1) during a telephone interview on 9/21/22 at 11:24 a.m.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the Skilled Nurse failed to provide ongoing assessments of the patient health status for 1 (MR #1) of 1 patient who required attention to her Intravenous access site, resulting in the potential for the development of infection, decline in health status and unmet care needs. Findings include: A complaint on file alleged that the Agency's nurse failed to go out and see the patient to address concerns surrounding the patient's PICC (peripherally inserted central catheter line), as instructed in the Plan of Care. MR #1: The patient's Start of Care was 6/12/21 with diagnoses that included Encounter for adjustment and management of VAD (Vascular Access Device), Long Term use of Antibiotics and Multiple Sclerosis. On 9/21/22 during a review of the clinical record, it was noted that the Referal for home care dated 6/11/21 included additional diagnoses of Cellulitis left lower extremity and Burns involving 10-19% of body surface. The referral ordered "Home care to evaluate and admit to skill nursing..." The Plan of Care (POC) ordered Skilled Nursing (SN) services to be provided at a frequency of 1w1, 2w1, 1w7. High Tech/Special Procedure Interventions were ordered and included: "SN Assess and Implement plans to reduce risk of hospitalization and Emergency Department visits, establish follow up visit schedule with physician to endure effective monitoring of patient's status, port dressing change weekly and PRN (as needed), change IV (intravenous) tubing every 72 hours and PRN for infiltration/infection..." The complaint on file alleged that the Registered Nurse was called and asked to come out to assess concerns with the patient's PICC line, yet the nurse refused to do so and instructed the caller to send the patient to the ER (Emergency Room). A "Case Communication" note dated 7/10/21, signed 7/12/21 acknowledged receipt of a call from the facility where the patient resided, expressing concerns regarding the patient's PICC line site. The nurse (RN #1) instructed the patient to take the patient to ER for treatment. Upon further review, there was no documented evidence that the nurse (RN #1) went to assess the patient's health status prior to instructing the patient go to ER. Follow up ER documents revealed the patient's PICC line merely needed to be flushed. The patient was released to home the same evening. RN #1 failed to assess the patient's health status in accordance with professional standards of practice and the Physician's orders. These findings were reviewed with and acknowledged by the Regional Branch Director (RBD #1) during a telephone interview on 9/21/22 at 11:24 a.m.

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 the Registered Nurse provided care and services as indicated in the Plan of Care for 1 (MR #1) of 1 patient who required Skilled Nursing services for management of a peripheral access line resulting in the potential for physiological health concerns and unmet care needs. Findings include: A complaint on file alleged that the Agency's nurse failed to go out and see the patient to address concerns surrounding the patient's PICC line, as instructed in the Plan of Care. MR #1: The patient's Start of Care was 6/12/21 with diagnoses that included Encounter for adjustment and management of VAD (Vascular Access Device), Long Term use of Antibiotics and Multiple Sclerosis. On 9/21/22 during a review of the clinical record, it was noted that the Referal for home care dated 6/11/21 included additional diagnoses of Cellulitis left lower extremity and Burns involving 10-19% of body surface. The referral ordered "Home care to evaluate and admit to skill nursing..." The Plan of Care (POC) ordered Skilled Nursing (SN) services to be provided at a frequency of 1w1, 2w1, 1w7. High Tech/Special Produre Interventions were ordered and included: "SN Assess and Implement plans to reduce risk of hospitalization and Emergency Department visits, establish follow up visit schedule with physician to endure effective monitoring of patient's status, port dressing change weekly and PRN (as needed), change IV (intravenous) tubing every 72 hours and PRN for infiltration/infection..." The complaint on file alleged that the Registered Nurse was called and asked to come out to assess concerns with the patient's PICC line, yet the nurse refused to do so and instructed the caller to send the patient to the ER (Emergency Room). A "Case Communication" note dated 7/10/21, signed 7/12/21 acknowledged receipt of a call from the facility where the patient resided, expressing concerns regarding the patient's PICC line site. The nurse (RN #1) instructed the patient to take the patient to ER for treatment. This was against the POC instructions to implement plans to reduce risk of hospitalization. RN #1 failed to follow the Physician's orders as written in the POC. These findings were reviewed with and acknowledged by the Regional Branch Director (RBD #1) during a telephone interview on 9/21/22 at 11:24 a.m.

This was a standard survey, a Medicare emergency preparedness survey was not conducted. The Care Team 441 S. Main Street, Suite 3 Standish, MI 48658 The agency has no branches or sub units. The agency was in compliance with COVID-19 vaccination requirements. The survey included 7 home visits with record reviews, 5 active records without home visits were reviewed, and 5 discharged records were reviewed for a total of 17 records reviewed.

A Medicare Authorized Recertification and Infection Control Survey was conducted by the Michigan Department of Licensing and Regulatory Affairs (MDLARA) from July 25, 2022 through July 28, 2022 at: The Care Team 441 S. Main Street, Suite 3 Standish, MI 48658 The survey included 7 home visits with record reviews, 5 active records without home visits were reviewed, and 5 discharged records were reviewed for a total of 17 records reviewed. The agency was found to be in compliance with staff vaccination requirements. At the conclusion of the survey the agency was found to be out of compliance with standard level deficiencies for the conditions of participation for home health agencies at: 42 CFR Part 484.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and a history of events leading to current home care needs in 17 (MR#'s 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17) of 17 records reviewed, resulting in incomplete clinical information to aid in determining the needs of the patient and determining progress towards goals. Findings included: Agency Policy: "Initial Assessment" NO.: PC2.711 (Revised 11/2020) stated, "Each patient must receive, and the home health agency must provide, a patient-specific, comprehensive assessment. MR's #1-17: During a review of the identified records, it was noted that all the patients had several admitting diagnoses within the initial comprehensive assessment. It was further noted that all the listed diagnoses had the same date of exacerbation, which was the date of admission to the Home Health Agency (HHA). Upon review, it was unclear as to which, of all the listed diagnoses, was the actual treating diagnosis/diagnoses that the patients were admitted to the HHA for. Further, when comparing onset date(s) of listed diagnoses between the initial assessment and the referral for home care, numerous discrepancies were found. In addition, review of MR's 1-17 found the comprehensive assessments failed to incorporate the current health status based on the patient's past medical history (onset dates, exacerbations, treatments with outcomes), and the ability to manage the listed diagnoses independently or through other means outside of HHA assistance. These findings were reviewed with and acknowledged by the Administrator (Adm#1), Clinical Manager (CM#1), and Regional Branch Directors (RBD #1 and #2) during an interview on 7/27/22 at 2:26 PM., and again during exit conference on 7/28/22 at 2:45 PM. The Agency failed to ensure the comprehensive assessment contained accurate clinical information and failed to collectively furnish comprehensive assessments which portrayed a clear understanding of the events that lead to home care and to what extent/involvement patient needs would be.

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 document review and interview, the Agency failed to ensure the comprehensive assessment included a review of all medications to identify any potential adverse effects and drug reactions for 2 (MR#s 9 and 13) of 7 records reviewed which included major and/or duplicative drug therapies, and failed to ensure a registered nurse performed a review of the patient's medication list in which therapy only services were ordered in 1 (MR #11) of 3 records reviewed, from a total sample of 17 records, resulting in the potential for harmful medication effects for all 1026 patients serviced by this Agency in the last 12 months. Findings include: Agency Policy: "Medication Review and Reconciliation" NO.: PC2.54 (Revised 11/2021) stated, "Qualified agency staff will conduct a review of all medications the patient is currently taking 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." MR #9: The patient was admitted on 4/25/22 with a re-certification period of 6/24/22 through 8/22/22. Patient diagnoses included pressure ulcer of right buttock-stage 3, pressure ulcer of left heel-stage 2, chronic kidney disease, and chronic obstructive pulmonary disease. Review of section M2001 of the Initial Comprehensive Assessment/Oasis dated 4/25/22, completed by Skilled Nursing indicated "No issues found during review." However, when the patient's 21 listed medications were entered into "Drugs.com" (online drug interaction checker) the following was revealed: 5 major/severe and 27 moderate drug interactions, 2 duplicative drug therapies, and 8 drug to food interactions. There was no documented evidence that the Agency notified the physician concerning the above findings. MR #7: The patient's start of care (SOC) was 9/21/21 with diagnoses that included heart disease with congestive heart failure, diabetes-type 2, and chronic obstructive pulmonary disease (COPD). Therapy only services were ordered with Physical Therapy (PT) performing the SOC comprehensive assessment with subsequent medication review on 9/21/21. During review of the clinical record on 7/26/22, no evidence was found of a registered nurse (RN) performing a follow-up medication reconciliation review as required. MR#11: The patient's SOC was 7/11/22 with diagnoses that included COPD, morbid obesity, and hypertensive heart disease with heart failure. Therapy only services were ordered with PT performing the SOC comprehensive assessment with subsequent medication review on 7/11/22. During review of the clinical record on 7/26/22, no evidence was found of a registered nurse performing a follow-up medication reconciliation review as required. These findings were reviewed with and acknowledged by the Administrator (Adm#1), Clinical Manager (CM#1), and Regional Branch Directors (RBD #1 and #2) during an interview on 7/27/22 at 2:26 PM. The Agency failed to ensure the comprehensive review of medications at the SOC identified significant potential adverse effects with physician notification of the findings and failed to provide evidence an RN had reviewed the patient's medication list at the SOC as required. MR#13: During a review of the Comprehensive Assessment dated 6/23/2022, it was noted that under the category of "M2001: Drug Regiment Review" of the Initial Comprehensive Assessment/Oasis completed by Skilled Nursing indicated "No issues found during review." However, when the patient's 7 listed medications were entered into "Drugs.com" (online drug interaction checker) it was discovered a major drug interaction between Clonidine and Metoprolol which may lower the blood pressure and slow the heart rate. Using these medications together can cause a slow heartbeat, dizziness, or result in passing out. This patient had a history of falling due to dizziness. There was no documented evidence that the Agency had notified the physician concerning this drug interaction which may have been a contributing factor to this patient's multiple falls. These finding was reviewed and acknowledged during an interview with the Administrator (ADM#1), Clinical Manager (CM#1), and Regional Branch Directors (RBD#1 and RBD#2) on 7/28/2022 at 2:30 p.m.

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, policy review, and interview, the plan of care failed to include safety parameters in which to notify the physician of worsening signs and symptoms of known diagnoses; failed to incorporate objectively measurable goals to determine the patient's progress toward achieving goals; failed to include goals that were pertinent to the patient's needs and diagnoses that required home care services; and failed to accurately document diagnoses date(s) of onset/exacerbation in 17 of 17 records reviewed. Findings included: MR #6: The patient's start of care (SOC) was 7/7/22 with diagnoses that included hydronephrosis (excess kidney fluid due to a backup of urine), hypertension, and urinary retention. Review of the patient's Plan of Care (POC) on 7/27/22, noted 22 of 22 listed goals by all ordered disciplines (Skilled Nursing, Physical Therapy, and Occupational Therapy (OT)) were not written in measurable terms. Quantitative baseline measurements used to compare with objective data collected throughout the certification period were not found within the POC goals. Examples included: "Changes in patient co-morbid status will be promptly identified and reported to the physician; Patient will demonstrate improved function in response to specific exercise(s) and/or manual therapy technique(s), as evidenced by increased independence in activities of daily living." In addition, all listed diagnoses (16 of 16) documented the dates of onset/exacerbation as 7/7/22 (admission date). However, during a scheduled home visit with OT services on 7/27/22, it was noted during an interview with the patient, that numerous primary diagnoses occurred prior to the documented dates listed on the POC. MR #7: The patient's SOC date was 9/21/21 with diagnoses that included heart disease with congestive heart failure, diabetes-type 2, and chronic obstructive pulmonary disease (COPD). Therapy only services were ordered with Physical Therapy (PT) performing the SOC comprehensive assessment with subsequent Plan of Care (POC) on 9/21/21. Review of the patient's POC on 7/27/22, found no safety reportable parameters in which to notify the physician concerning the following medical conditions: Weights or circumference measurements to monitor heart failure exacerbation (worsening); Blood sugar/glucose results for potential unstable diabetes; and oxygen saturation levels due to: "Patient has oxygen that he wears at night for COPD"-per physician referral. In addition, the patient had pain levels of 8/10 (10 being the most severe possible) at both the SOC and the following visit on 9/24/22. The SOC documented the patient exhibited moaning, grimacing, and guarding related to back pain which interfered with movement "all of the time". No pain parameters in which to notify the physician were found on the patient's POC. Further review of the POC noted 7 of 7 listed goals by all disciplines (PT/OT) were not written in measurable terms. Examples include: "Patient will demonstrate improved function in response to specific exercise(s) and/or manual therapy technique(s), as evidenced by increased independence in activities of daily living by decreased pain with mobility and improved balance test score/tinetti; Patient/Caregiver to demonstrate decreased fall risk during functional activities by 10.20.21". In addition, all (16 of 16) listed diagnoses had dates of onset/exacerbation as 9/9/21. When the listed diagnoses dates were compared to the Physician H&P (history and physical) found within the referral for homecare, numerous examples were found where the primary diagnoses had occurred prior to the documented dates listed on the POC. MR #8: The patient's SOC was 5/11/22 with diagnoses that included COPD, chronic kidney disease, and congestive heart failure. Review of the patient's POC on 7/27/22, found no safety reportable parameters in which to notify the physician concerning the following medical conditions: Weights or circumference measurements to monitor heart failure exacerbation (worsening); and oxygen saturation levels due to COPD while being on 4 Liters of oxygen continuously. In addition, it was noted during review of the patient's POC that 17 of 17 listed goals by Skilled Nursing (SN), were not written in measurable terms and all listed diagnoses (22 of 22) had documented the dates of onset/exacerbation as 5/9/22 which were found to be inaccurate. MR #9: The patient was admitted on 4/25/22 with a re-certification period of 6/24/22 through 8/22/22. Patient diagnoses included pressure ulcer of right buttock-stage 3, pressure ulcer of left heel-stage 2, chronic kidney disease, chronic obstructive pulmonary disease, and chronic pain syndrome. On 7/27/22, review of the patient's re-certification POC (dated 6/21/22) found no safety/reportable parameters in which to notify the physician concerning oxygen saturation levels (patient on 2 Liters of supplemental oxygen) and acceptable pain levels. Further documentation review of a home visit by SN on 5/17/22 noted the patient's pain level as 8 out of 10 (10 being the most severe possible). Additional review of home visits made by SN and PT services noted 15 of 15 visits (5/24/22-7/27/22) had documented the patient's pain as 10 out of 10. However, the patient's objective pain symptoms (FLACC pain scale) were documented as 0 (no pain). No documentation was found concerning pain education/insights, or a reason which explained the extreme difference in interpretation of the patient's pain levels. Physician communication or changes in pain medication were not found in the medical record. In addition, review of the patient's POC found 15 of 15 listed goals by all ordered disciplines (SN, PT, and OT) were not written in measurable terms and all listed diagnoses (13 of 13) had documented the dates of onset/exacerbation as 4/25/22 with an additional 13 of 13 diagnoses dates of 1/1/22, which were found to be inaccurate upon record/referral review. MR#10: The patient's SOC was 5/13/22 with diagnoses that included diabetes-type 2, heart disease with congestive heart failure, and COPD. On 7/27/22, review of the patient's POC (dated 5/13/22) found no safety reportable parameters in which to notify the physician concerning the following medical conditions: Weights or circumference measurements to monitor heart failure exacerbation; Blood sugar/glucose results for potential unstable diabetes; and oxygen saturation levels associated with COPD exacerbation. Review of the POC discovered the following order: "Skilled nurse to report a pattern (three or more) of blood glucose levels greater than 400 mg/dl. No upper limits for 1 or 2 consecutive readings, even if critical levels were breached, had no indication to notify the physician in the patient's POC. In addition, further review of the POC found that 31 of 31 listed goals by all disciplines (SN, PT, and OT) were not written in measurable terms. MR#11: The patient's SOC was 7/11/22 with diagnoses that included COPD, morbid obesity, and hypertensive heart disease with heart failure. On 7/27/22, POC review (dated 7/11/22) found no safety reportable parameters in which to notify the physician concerning the following medical conditions: Weights or circumference measurements to monitor heart failure exacerbation; and oxygen saturation levels associated with COPD exacerbation. Patient observed to be on oxygen continuously during a scheduled home visit with OT services on 7/27/22. The following diagnosis was noted during POC review: "Nicotine dependence, cigarettes, with other disorders - ONSET 7/11/22". No documentation was found in the medical record which alerted/educated the patient of the risk/dangers of smoking while on oxygen. No signs were observed during the home visit warning visitors of the smoking/oxygen combination potential. In addition, further review of the POC found that 20 of 21 listed diagnoses had documented the dates of onset as 7/11/22 and 8 of 8 goals by all disciplines (PT, and OT) were not written in measurable terms. These findings were reviewed with and acknowledged by the Administrator (Adm#1), Clinical Manager (CM#1), and Regional Branch Directors (RBD #1 and #2) during an interview on 7/27/22 at 2:26 PM. It was noted that all parties above agreed the POC findings above did not meet Agency expectations, and the Agency failed to ensure the patient's POC was comprehensive and appropriate in meeting the patient's medical needs. MR 12: The Start of Care (SOC) was dated 6/6/2022. The Plan of Care (POC) for the period 6/6/2022 to 8/4/2022 identified diagnoses of Wedge Compression Fracture of T11-T-12 Vertebrae, Congestive Heart Failure (CHF), non- rheumatic aortic valve stenosis, myocardial infarction (MI), and acute respiratory failure with hypoxia. Upon review of the record, it was noted the goals were not pertinent to the listed diagnoses requiring home care services, nor were the goals objectively measurable to determine the patient's progress towards achieving goals. Examples included: "A Plan of Care will be established that meets the patient's nursing needs and countersigned by physician; Patient/Caregiver will demonstrate adequate knowledge of providing a safe home setting without environmental hazards by 8 weeks; Gastrointestinal status will be evaluated and exacerbations identified with interventions implemented to minimize complications." These goals are not objectively measurable to determine the patient's achievement towards goals; and the goals were not pertinent to the listed diagnoses on the POC. The POC did not include any gastrointestinal problems or an unsafe living environment. MR13: The Start of Care was dated 6/23/2022. The Plan of Care for the period 6/23/22 to 8/21/22 identified diagnoses of Rhabdomyolysis, Acute Kidney Failure, Dementia, Heart Failure (HF), and Coronary Artery Disease (CAD). Upon review of the record, it was noted the goals were not objectively measurable to determine the patient's progress toward achieving goals. Examples included: "A Plan of Care will be established that meets the patient's nursing needs and countersigned by physician; Patient/Caregiver will demonstrate adequate knowledge of providing a safe home setting without environmental hazards by 8 weeks; Patient will demonstrate compliance with medications as prescribed; Abnormal oxygen saturation levels will be reported to the physician." These goals are not objectively measurable to determine the patient's progress towards goals. Mr#14: The Start of Care (SOC was dated 1/22/2022. The Plan of Care (POC) for the certification period 1/11/22 to 3/22/22 identified diagnoses of Aphasia (language disorder affecting the ability to communicate) following Cerebral Infarctions, Atherosclerosis, Hypertension (HTN), Diabetes type 2 (DM2), and Anxiety. Upon review of the Plan of Care it was noted the goals on the POC were not objectively measurable to determine the patient's progress toward achieving goals, nor were they specific or pertinent to the patient's health care condition. Examples included: "A Plan of Care will be established that meets the patient's nursing needs and countersigned by the physician; Patient/Caregiver will demonstrate adequate knowledge of providing a safe home setting without environmental hazards by 8 weeks; Patient/Caregiver will verbalize appropriate infection control measures to prevent infection or contamination by 8 weeks; Patient/Caregiver will verbalize/demonstrate an ability to manage cardiovascular disease as evidenced by no unplanned hospitalizations by 8 weeks." These goals are not objectively measurable to determine the patient's progress towards goals, nor are these goals specific to the patient's health care condition since the patient's primary diagnosis is aphasia, making it difficult for the patient to verbalize information. MR 15: The Start of Care (SOC) was dated 10/20/2021. The Plan of Care (POC) for the certification period 10/20/21 to 12/18/21 identified diagnoses of Congestive Heart Failure (CHF), Atrial Fibrillation, Hypoxemia, Chronic Obstructive Pulmonary Disease (COPD), and Diabetes type 2 (DM2). Upon review it was noted the goals on the POC were not objectively measurable. Findings included: "A Plan of Care will be established that meets the patient's nursing needs and countersigned by the physician; Abnormal O2 saturation levels will be reported to the physician; Respiratory exacerbations will be identified promptly and interventions initiated to minimize associated risks." These goals are not individualized or objectively measurable to determine the patient's progress towards goals. MR 16: The SOC was dated 5/26/2022. The POC for the period 5/26/2022 to 7/24/2022 identified diagnoses of Chronic Kidney Disease stage 3 (CKD3), Congestive Heart Failure (CHF), and Coronary Artery Disease (CAD). Upon review of the POC, it was noted the goals were not objectively measurable. Findings included: "A Plan of Care will be established that meets the patient's nursing needs and countersigned by physician; Patient/Caregiver will demonstrate adequate knowledge of providing a safe home setting without environmental hazards by 8 weeks; Patient will understand compliance with management of CHF as evidenced by improved endurance, decreased shortness of breath, stabilized weight, and no unplanned hospitalizations by 8 weeks." These patient goals are not specific or objectively measurable to determine the patient's progress towards achieving goals. MR 17: The Start of Care was dated 7/11/2022. The Plan of Care for the Certification period 7/11/22 to 8/9/22 identified diagnoses of Diabetes type 2 (DM2), Parkinson's Disease, Congestive Heart Failure (CHF), Coronary Artery Disease (CAD), Gastrointestinal Reflux, and Above the Right Knee Amputation. Upon review of the record, it was noted the goals were not objectively measurable to determine the patient's progress toward achieving goals. Examples included: "A Physical Therapy Plan of Care will be ordered by Physician and provided by Physical Therapy. All goals to be met in 30 days; Occupational Therapy evaluation will be completed, Plan of Care will be ordered by Physician and provided by Occupational Therapy." These goals are not objectively measurable or specific to the patient's needs to determine the patient's progress towards goals. These findings were reviewed and acknowledged during an interview with the Administrator (ADM#1), Clinical Manager (CM#1), and Regional Branch Directors (RBD#1 and RBD#2) on 7/28/22 at 2:30 p.m. MR#1: The Start of Care (SOC) was dated 3/14/22. The Plan of Care (POC) identified diagnoses of Cerebral Infarction, Falls and Weakness. During record review on 7/25/22, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient / caregiver will verbalize appropriate infection control measures to prevent infection or contamination by week 8.” Additionally, another goal stated, “Increased pain or ineffective pain control measures will be identified and promptly reported to the physician.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR#2: The Start of Care (SOC) was dated 7/9/22. The Plan of Care (POC) identified diagnoses of Bilateral Lower Limb Cellulitis, Congestive Heart Failure, Stage 2 Pressure Ulcers to Buttocks. During record review on 7/26/22, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Respiratory exacerbations will be identified promptly and interventions initiated to minimize associated risks.” Additionally, another goal stated, “Patient/caregiver will verbalize/demonstrate an ability to manage respiratory disease as evidenced by improved endurance, decreased shortness of breath, normal O2 (Oxygen) saturation levels and no unplanned hospitalizations, by 8w (8 weeks).” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Furthermore, the comprehensive assessment dated 7/9/22 documented a pain level of 8 and the patient on 2.5L of O2. The POC failed to contain pain, oxygen and weight parameters to notify the physician. MR#3: The Start of Care (SOC) was dated 7/1/22. The Plan of Care (POC) identified diagnoses of Left Knee Replacement, Osteoarthritis and Hypertension. During record review on 7/26/22, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Respiratory exacerbations will be identified promptly and interventions initiated to minimize associated risks.” Additionally, another goal stated, “Patient/caregiver will verbalize/demonstrate an ability to manage respiratory disease as evidenced by improved endurance, decreased shortness of breath, normal O2 saturation levels and no unplanned hospitalizations, by 8w (8 weeks).” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR#4: The Start of Care (SOC) was dated 7/20/22. The Plan of Care (POC) identified diagnoses of Fusion of Spine, Chronic Obstructive Pulmonary Disease and Diabetes Type 2. During record review on 7/26/22, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Respiratory exacerbations will be identified promptly and interventions initiated to minimize associated risks.” Additionally, another goal stated, “Patient/caregiver will verbalize/demonstrate an ability to manage respiratory disease as evidenced by improved endurance, decreased shortness of breath, normal O2 saturation levels and no unplanned hospitalizations, by 8w (8 weeks).” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR#5: The Start of Care (SOC) was dated 6/19/22. The Plan of Care (POC) identified diagnoses of Atrial Fibrillation, Anemia and Congestive Heart Failure. During record review on 7/28/22, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient / caregiver will verbalize appropriate infection control measures to prevent infection or contamination in 6 weeks.” Additionally, another goal stated, “Patient/caregiver will verbalize/demonstrate knowledge of management of diabetes as evidenced by decreased symptoms, stabilization of blood glucose within parameters set by physician approved parameters and no unplanned hospitalizations in 6 weeks.” there was no evidence of how these goals could be objectively measured to ascertain progress toward goals. Furthermore, the POC failed to contain blood sugar and weight parameters to notify the physician. These findings were reviewed with and acknowledged by the Administrator (Adm#1), Clinical Manager (CM#1), and Regional Branch Director (RBD#1) during an interview on 7/28/22 at 11:40 am.

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, policy review, and interview, the Agency failed to ensure Physical Therapy (PT) developed a Plan of Care that incorporated pertinent interventions concerning the patient's medical needs in 1 (MR #7) of 2 records reviewed with therapy only cases, from a total sample of 17 records, resulting in the potential for poor patient outcomes for all therapy only cases serviced by this Agency. Findings include: Agency Policy: "Physician Plan of Care" NO.: PC2.21 (Revised 6/2021) stated, "Each patient must receive an individualized written plan of care... to meet patient-specific needs... and measurable outcomes and goals. The individualized plan of care must include the following: All pertinent diagnoses... Safety measures to protect against injury..." MR #7: The patient's start of care (SOC) was 9/21/21 with diagnoses that included heart disease with congestive heart failure, diabetes-type 2, and chronic obstructive pulmonary disease (COPD). Therapy only services were ordered with Physical Therapy (PT) performing the SOC comprehensive assessment with subsequent Plan of Care (POC) on 9/21/21. On 7/26/22, review of the patient's POC found no evidence that PT had incorporated any treatment interventions, safety parameters, or goals concerning any of the patient's medical diagnoses noted above. In addition, no pain parameters in which to notify the physician were found. The patient had pain levels of 8/10 (10 being the most severe possible) at both the SOC and the following visit on 9/24/22. The SOC documented the patient exhibited moaning, grimacing, and guarding related to back pain which interfered with movement "all of the time". Review of the referral for home care noted significant history of congestive heart failure with multiple hospital admissions since 2013. The physician referral documented under "prior (history)" the following: "Patient reports that over the course of the past few months, he has had increased dyspnea (difficulty in breathing) both with exertion and at rest. He also admits that he decided he didn't like using the bathroom all the time during the day and stopped both his Bumex and Spironolactone (diuretic medications used to treat heart failure). His breathing did worsen after discontinuation of the diuretic's. Patient has oxygen that he wears at night for COPD." Review of PT's visit notes found the patient's weight went from 190 pounds at the SOC assessment (9/21/21) to 198.8 pounds on 9/29/21. The POC had no weight parameters in which to notify the physician. Subsequently, follow-up interventions or communication with the physician or other Agency team members were not found in the medical record. A request was made to review the Agency's policy regarding the management and reportable parameters concerning exacerbation (worsening) of heart failure signs and symptoms. When no policy was made available, the Administrator (Registered Nurse background) and Clinical Manager were queried on 7/27/22 at 1:50 PM., how much weight gain over a week's period would warrant physician notification. They stated anything greater than 5 pounds would be the Agency's expectation. These findings were reviewed with and acknowledged by the Administrator (Adm#1), Clinical Manager (CM#1), and Regional Branch Directors (RBD #1 and #2) during an interview on 7/27/22 at 2:26 PM. It was noted that all parties involved agreed PT services overseeing MR#7's medical needs did not meet Agency expectations, and the Agency failed to ensure the patient's POC was comprehensive and appropriate in meeting the patient's medical needs.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review, policy review, and interview, it was determined that the Agency failed to ensure the clinical record was complete, including assessments, notes, and evaluations for 2 (MR's #7 and 11) of 2 records with therapy only services ordered, from a total of 17 records reviewed, resulting in an incomplete depiction of the patient's health status, and the potential for unmet care needs. Findings include: Agency Policy: "Initial Assessment" NO.: PC2.711 (Revised 11/2020) stated, "Each patient must receive, and the home health agency must provide, a patient-specific, comprehensive assessment. MR #7: The patient's start of care (SOC) was 9/21/21 with diagnoses that included heart disease with congestive heart failure, diabetes-type 2, and chronic obstructive pulmonary disease (COPD). Therapy only services were ordered with Physical Therapy (PT) performing the SOC comprehensive assessment on 9/21/21. Review of the SOC assessment on 7/26/22 found the EMR (electronic medical record) was void of any Endocrine section which alerted the clinician to document past or current history concerning the patient's known diabetes. All major systems (i.e., heart, respiratory, skin, ...) were assessed even when no problems existed for a noted system. Subsequently, the clinical record (plan of care and visit notes) was void of having any treatments, interventions, safety parameters, or recordings concerning the patient's diabetes. MR#11: The patient's SOC was 7/11/22 with diagnoses that included COPD, morbid obesity, and hypertensive heart disease with heart failure. Therapy only services were ordered with PT performing the SOC comprehensive assessment on 7/11/22. Review of the SOC assessment on 7/27/22 found the EMR was void of any Endocrine section which alerted the clinician to assess and document any concerns relating to this major system. These findings were reviewed with and acknowledged by the Administrator (Adm#1), Clinical Manager (CM#1), and Regional Branch Directors (RBD #1 and #2) during an interview on 7/27/22 at 2:26 PM. The Agency failed to review and ensure initial comprehensive assessment had the ability to appropriately assess all major systems to be appropriately incorporated into the patient's clinical record.