Every finding on record at Advisacare Healthcare Solutions, Inc

On 3/4/24 through 3/7/24, an Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. During the survey, AdvisaCare was found to be in compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness.

An unannounced Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 3/4/24 to 3/7/24 at: AdvisaCare 3290 W. Big Beaver Rd, Suite 501 Troy, MI 48084 This agency has no branch sites. Records Reviewed: 4 records with home visits, 3 active records without home visits and 3 discharged records, for a total of 10 records reviewed. On 3/7/24 at 11:25 a.m., an Immediate Jeopardy was approved due to the agency's failure to ensure the registered nurse promptly alerted the physician to changes in the patient's condition, resulting in hospital admission and intravenous antibiotics. The following Immediate Jeopardy Condition Level citations were out of compliance: 42 CFR §484.60 Care planning, coordination of services, and quality of care. The agency's Administrator was notified of the Immediate Jeopardy at 11:28 a.m. The Immediate Jeopardy was removed at 3:50 p.m., after review and approval of the agency's immediacy Plan of Correction. As a result of the Condition level non-compliance on 3/7/24, the agency is prohibited from offering Home Health Aide training and competency program for 2 years as specified in 42 CFR §484.80(f)(3).

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was completed within 5 calendar days of the start of care in 3 (P-4, 5, 6) of 10 records reviewed, resulting in a delay in determining the immediate care and support needs for these patients. P-4: This 91-year-old patient was admitted to home care on 2/2/24 with diagnoses of atrial fibrillation, hypertensive chronic kidney disease and osteoarthritis. During record review on 3/4/24, it was noted that the order for home care included skilled nursing, physical therapy (PT), and occupational therapy (OT). The OT evaluation was conducted on 2/7/24, six days after the start of care. There was no evidence that the physician had been notified of the reason for delay. P-5: This 94-year-old patient was admitted to home care on 11/3/23 with diagnoses of tibia fracture, muscle weakness, malnutrition, and congestive heart failure. During record review on 3/5/24, it was noted that the order for home care included skilled nursing, physical therapy (PT), occupational therapy (OT), home health aide (HHa), and medical social work (MSW). The PT evaluation was conducted on 11/9/23, seven days after the start of care. The MSW evaluation was conducted on 11/16/23, 14 days after the start of care. There was no evidence that the physician had been notified of the reasons for delay. P-6: This 89-year-old patient was admitted to home care on 2/9/24 with diagnoses of hypertensive heart disease, chronic congestive heart failure, and diabetes mellitus. During record review on 3/6/24, it was noted that the order for home care included skilled nursing, physical therapy (PT), occupational therapy (OT), and home health aide (HHa). This patient has been receiving home care services for 28 days and there is no evidence that the occupational therapy assessment has been conducted or that the physician has been notified of the reason for delay. These findings were reviewed and acknowledged by the administrator (Staff A) and the clinical manager (Staff B) during an interview on 3/7/24 at 3:25 p.m.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment contained an accurate, complete picture of the patient’s current health, psychosocial, functional, and cognitive status in 2 (P-8, 10) of 10 records reviewed, resulting in the potential for unmet care needs. Findings include: P-8: This 91-year-old patient was admitted to this agency on 1/28/24 with the diagnoses of a laceration (wound) on the left lower extremity and edema (swelling). During record review on 3/5/24, it was noted the physical therapy evaluation dated 2/23/24 quoted the patient stating, “My legs and L knee hurts a lot along with I feel tightness in my upper and mid back causing disturbances in sleep.” Upon further review of the physical therapy evaluation, it was determined the “Pain Assessment” section on page 3 identified both legs and the left shoulder as areas with pain but did not report objective pain measurements to further assess the patient’s current status. During an interview on 3/7/24 at 11:00 AM, the Regional Director of Rehabilitation (Staff C) was asked if she was able to locate an assessment of the patient’s current pain levels in the physical therapy evaluation. Staff C reported it did not appear that the physical therapist addressed the patient’s pain levels at that time. She acknowledged the findings. P-10: This 80-year-old patient was admitted to this agency on 2/7/24 with the diagnoses of chronic obstructive pulmonary disease (COPD), hypertensive heart disease with heart failure, and type II diabetes. During record review on 3/6/24, it was determined the physical therapist and occupational therapist both evaluated the patient on 2/7/24. Upon further review of the documentation, it was noted there was a significant difference in the evaluation of the patient’s transfer status. The physical therapist noted the patient required the assistance of 2 people for transfers and required maximum assistance for the activities of sit to stand, stand to sit, and from bed to wheelchair. The occupational therapist noted the patient was a “supervision” level assist for the above activities – meaning the patient could complete the task without physical assistance but may require cuing or supervision to be safe. Staff C was queried during an interview on 3/7/24 at 11:00 AM on how there could be such a significant difference in evaluation of these activities. Staff C stated the occupational therapist was new to the agency and that could be why. Staff C also later reported she spoke to the physical therapist who performed the evaluation and confirmed that he believed the patient required maximum assistance at that time. Staff C was unable to contact the occupational therapist during the survey. Staff C acknowledged this significant difference would make it very difficult to identify the patient’s specific needs and to make accurate goals for treatment as it does not show an accurate representation of the patient’s status. Staff A and the Alternate Administrator (Staff B) were also present during the interview and acknowledged the findings.

Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment contained goals identified by the patient with measurable outcomes in 3 (P-7, 8, 9) of 10 records reviewed, resulting in the potential for a lack of individualized care and unmet care needs. Findings include: P-7: This 77-year-old patient was admitted to this agency on 2/10/24 with the diagnoses of Parkinson’s Disease and repeated falls. During record review on 3/6/24, the following goal was noted by physical therapy on the Plan of Care dated 2/10/24: “Patient Stated Outcome to be achieved within this episode of care is: PATIENT WANTED TO GET MORE STRONGER AND WANTED TO FALL FREE DURING TRANSFER AND AMBULATION.” [sic] This goal does not contain measurable outcomes to detect progress or changes in the patient’s health status. P-8: This 91-year-old patient was admitted to this agency on 1/28/24 with the diagnoses of a laceration (wound) on the left lower extremity and edema (swelling). During record review on 3/6/24, the following goal was noted by skilled nursing on the Plan of Care dated 1/28/24: “Patient Stated Outcome to be achieved within the episode of care is: ‘I want you to make sure my leg gets better.’” This goal does not contain measurable outcomes to detect progress or changes in the patient’s health status. P-9: This 79-year-old patient was admitted to this agency on 12/27/23 with the diagnoses of an unspecified fracture of the first lumbar vertebra, type II diabetes, high blood pressure, and chronic kidney disease. During record review on 3/5/24, the following goal was noted by skilled nursing on the Plan of Care dated 12/27/23: “Patient Stated Outcome to be achieved within this episode of care is: to understand how to take medications and decrease in pain.” This goal does not contain measurable outcomes to detect progress or changes in the patient’s health status. The Administrator (Staff A) was queried regarding these goals during an interview on 3/7/24 at 10:00 AM. Staff A reported they are required by corporate to put a goal identified by the patient in the Plan of Care, however acknowledged the above findings are not measurable and therefore are unable to show the patient’s progress towards achievement.

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 prescribed to the patient, and include those medications in the patient's medication profile in its entirety for possible adverse effects or drug interactions in 1 (P-2) of 10 records reviewed and failed to have skilled nursing perform a comprehensive drug review for possible significant drug interactions or duplicate drug therapy in 5 (P-4, 6, 7, 8 and 10) of 10 records reviewed, resulting in the potential for undetected harmful medication side effects or interactions. Findings include: Agency policy titled, “ADVISACARE III.17 MEDICATION MANAGEMENT”, (undated), was reviewed on 3/7/24. On page 1., it stated “A Medication Profile comprised of a list of all medications… shall be completed for each patient at the time of admission by the admitting clinician... and sent to the physician as part of the patient’s plan of care… The medications will be reviewed for potential adverse effects, drug reactions, ineffective drug therapy, significant drug interactions, duplicate drug therapy, and for patient non-compliance with drug therapy. The admitting clinician or the nurse reviewing the profile will contact the patient’s physician immediately if there are any questions or concerns regarding the medications a patient is taking. P-2: This 89-year-old was admitted to the agency on 3/2/24 with diagnoses which included, heart failure; diabetes; and Chronic Obstructive Pulmonary Disease (progressive lung disease). The medical record was reviewed on 3/5/24. On 3/5/24 at 10:30 a.m., a joint home visit was made with the registered nurse (RN). A surveyor interview was conducted with the patient at 11:30 a.m. to compare the patient’s medications listed in the agency profile with the medication list in the home. The patient stated that she had been taking Lasix (a diuretic) and Farxiga (a blood sugar reducer) since discharge from the hospital on 2/29/24. The patient also stated that she used another medication long term, Albuterol inhaler (opens airways in lungs to ease breathing). Those 3 medications were not found on the agency “Patient Medication Record” signed by the admitting RN on 3/4/24 and were also not found on an additional “Patient Medication Record” signed by the Administrator (Staff A) on 3/5/24. There was no evidence in the medical record that the RN assessed the above medications for potential interactions or duplicate therapy. These findings were reviewed and acknowledged during interview on 3/7/24 at 1:30 p.m. with Staff A and the Alternate Administrator (Staff B). P-4: This 91-year-old patient was admitted to home care on 2/2/24 with diagnoses of atrial fibrillation, hypertensive chronic kidney disease and osteoarthritis. During record review on 3/4/24, it was noted that there were three major medication interactions noted on the Drugs.com medication review conducted by the agency between amiodarone and warfarin, warfarin and fenofibrate, and atorvastatin and fenofibrate. This report was faxed to the physician on 2/13/24, 11 days after the start of care. Additionally, the start of care assessment, dated 2/2/24, stated there were no issues found during review (M2001 Drug Regimen Review), and the medication follow up (M2003) was blank. P-6: This 89-year-old patient was admitted to home care on 2/9/24 with diagnoses of hypertensive heart disease, chronic congestive heart failure, and diabetes mellitus. During record review on 3/6/24, it was noted there was one major medication interaction noted on the Drugs.com medication review conducted by the agency between calcitriol and ergocalciferol. This report was faxed to the physician on 2/13/24, four days after the start of care. Additionally, the start of care assessment, dated 2/9/24, stated there were no issues found during review (M2001 Drug Regimen Review), and the medication follow up (M2003) was blank. These findings were reviewed and acknowledged by the administrator (Staff A) and the clinical manager (Staff B) during an interview on 3/7/24 at 3:25 p.m. P-7: This 77-year-old patient was admitted to this agency on 2/10/24 with the diagnoses of Parkinson’s Disease and repeated falls. During record review on 3/6/24, it was noted there was a medication duplication identified by the Drugs.com medication review conducted by the agency between “MiraLAX (polyethylene glycol 3350)” and “senna”. During further review, it was noted the form labeled “Patient Medication Record” dated 2/10/24 stated there were no medication discrepancies or severe interactions to contact the physician about. Furthermore, the OASIS (Outcome and Assessment Information Set) form from the Start of Care (SOC) dated 2/10/24 noted there were “No issues found during review.” P-8: This 91-year-old patient was admitted to this agency on 1/28/24 with the diagnoses of a laceration (wound) on the left lower extremity and edema (swelling). During record review on 3/5/24, it was noted there was 1 major medication interaction noted on the Drugs.com medication review conducted by the agency between “aspirin” and “apixaban”. During further review, it was noted the form labeled “Patient Medication Record” dated 1/28/24 stated there were no medication discrepancies or severe interactions to contact the physician about. Furthermore, the OASIS (Outcome and Assessment Information Set) form from the Start of Care (SOC) dated 1/28/24 noted there were “No issues found during review.” P-10: This 80-year-old patient was admitted to this agency on 2/7/24 with the diagnoses of chronic obstructive pulmonary disease (COPD), hypertensive heart disease with heart failure, and type II diabetes. During record review on 3/6/24, it was noted there was a medication duplication identified by the Drugs.com medication review conducted by the agency between “albuterol” and “wixela inhub (fluticasone/salmeterol)”. During further review, it was noted the form labeled “Patient Medication Record” dated 2/7/24 stated there were no medication discrepancies or severe interactions to contact the physician about. Furthermore, the OASIS (Outcome and Assessment Information Set) form from the Start of Care (SOC) dated 2/7/24 noted there were “No issues found during review.” The Administrator (Staff A) was queried regarding why the interactions and duplications noted above were not reported to the physician during an interview on 3/7/24 at 10:00 AM. Staff A reported the agency does not report duplicative therapies and that corporate said they did not need to report major interactions with long-standing medications. Staff A was asked to provide a policy outlining how the clinicians are to know which types of interactions should be reported to the physician. Policy titled “III.17 MEDICATION MANAGEMENT” (undated) stated, “The medications will be reviewed for potential adverse effects, drug interactions, ineffective drug therapy, significant drug interactions, duplicate drug therapy, and for patient non-compliance with drug therapy. The admitting clinician or the nurse reviewing the profile will contact the patient’s physician immediately if there are any questions or concerns regarding the medications a patient is taking.” Staff A and the Alternate Administrator (Staff B) agreed the policy is not specific as to what should be reported and would need to be revised. They acknowledged the findings at the time of the interview.

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 patient received the services outlined in the plan of care in 3 (P-5, 6, and 10) of 10 records reviewed, resulting in the potential for unmet care needs ( see G572), failed to ensure the plan of care included individualized, patient-specific, interventions, and measurable outcomes and goals in 8 (P-1, 4, 5, 6, 7, 8, 9, and 10) of 10 records reviewed, resulting in the potential for poor patient outcomes and unmet care needs (see G574), and failed to ensure the registered nurse promptly alerted the physician to changes in the patient's condition for 1 (P-5) of 10 records reviewed. This resulted in Immediate Jeopardy (IJ) to the health and safety of P-5, with new onset of pain and burning with urination, resulting in a six-day hospitalization requiring intravenous antibiotics (see G590). 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 of services, and quality of care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient received the services outlined in the plan of care in 3 (P-5, 6, and 10) of 10 records reviewed, resulting in the potential for unmet care needs. Findings include: P-10: This 80-year-old patient was admitted to this agency on 2/7/24 with the diagnoses of chronic obstructive pulmonary disease (COPD), hypertensive heart disease with heart failure, and type II diabetes. During record review on 3/6/24, it was noted the Plan of Care dated 2/7/24 included orders for Occupational Therapy (OT) 2 times a week for 6 weeks. During further review of the record, it was noted there were no OT visits the week of 2/19/24. According to the “Missed Visit Form” on 2/20/24, the visit was canceled due to the clinician feeling ill. The note reported the physician was not notified and there was no new order generated to reflect the change. According to the “Missed Visit Form” on 2/22/24, the patient’s spouse canceled the visit due to another appointment. The note reported the physician was not notified and there was no new order generated to reflect the change. The Administrator (Staff A) was interviewed on 3/6/24 at 2:00 PM regarding the agency’s policy for missed visits. According to Staff A, the agency does not have a specific policy regarding the procedure for missed visits, but offered a policy that directly references the regulations regarding this. **Policy titled “III.6 Physician’s Plan of Treatment/Change Orders” (undated) stated, “Per the State Operations Manual Interpretive Guidance……G572: …..If the HHA misses a treatment or services as required by the plan of care, which results in any potential for clinical impact upon the patient, then the HHA must notify the responsible physician of such missed treatment or service.” Staff A acknowledged the findings during a follow-up interview on 3/7/24 at 10:00 AM. Additionally, the Plan of Care dated 2/7/24 included orders to report to the physician: “Respirations greater than (>) 24 or less than () 160 or less than (Upon review of the treatment records, it was noted the OT note dated 2/13/24 recorded the systolic blood pressure as 179 during treatment and 174 post treatment. There was no indication this was reported to the physician. On the OT note dated 2/15/24, it was noted there were no documented values for respiration during the entire visit. Findings were reviewed with and acknowledged by Staff A and the Alternate Administrator (Staff B) during an interview on 3/7/24 at 10:00 AM. P-5: This 94-year-old patient was admitted to home care on 11/3/23 with diagnoses of tibia fracture, muscle weakness, malnutrition, and congestive heart failure. During record review on 3/5/24, it was noted that the plan of care ordered skilled professionals to notify the physician of diastolic (bottom number) blood pressure greater than 90 or less than 60, variation of weight of 2 pounds in 24 hours or 5 pounds in 7 days, and pain level greater than 7 on a scale of 1-10. This patient received skilled nursing visits for 8 weeks, and a weight was documented on the start of care on 11/3/23. There was no evidence of weight documentation on the following 13 skilled nursing visits to monitor potential worsening of congestive heart failure. On 11/16/23, the skilled nurse documented a blood pressure reading of 95/54. There was no evidence the physician was notified. On 12/20/23 and 12/22/23, skilled nursing documented the patient’s pain as an “8” on a scale of 1-10. There was no evidence the physician was notified of pain level. P-6: This 89-year-old patient was admitted to home care on 2/9/24 with diagnoses of hypertensive heart disease, chronic congestive heart failure, and diabetes mellitus. During record review on 3/6/24, it was noted that the plan of care ordered skilled professionals to measure bilateral lower extremity edema and notify the physician of changes of 2 cm or greater, and to notify for pain level greater than 7 on a scale of 1-10. The registered nurse obtained baseline measurements during start of care assessment on 2/9/24. On 2/13/24, the right ankle measurements were 2 cm greater than baseline. On 2/17/24, the left ankle was 2 cm greater than baseline. On 2/23/24, the right calf measured 3.1 cm greater than baseline and remained the same for the next three skilled nursing visits. Additionally, the patient reported a pain level of 8 on a scale of 1-10 on 2/23/24. There was no evidence the physician was notified of the extremity measurements or pain. These findings were reviewed and acknowledged by the administrator (Staff A) and the clinical manager (Staff B) during an interview on 3/7/24 at 3:25 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 and interview, the agency failed to ensure the plan of care included individualized, patient-specific, interventions and measurable outcomes and goals in 8 (P-1, 4, 5, 6, 7, 8, 9 and 10) of 10 sampled records reviewed potentially resulting in insufficient information to adequately assess patient progress. Findings include: P-1: This 78-year-old was admitted to the agency on 2/9/24 with diagnoses which included, Ataxia (poor muscle control) following a stroke; paralysis of the right side of body; and high blood pressure. The medical record was reviewed on 3/4/24. During review of the plan of care dated 2/9/24, the following skilled nursing (SN) goals were noted: Patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization; and Patient stated goal is to increase strength and improve memory. There were no other SN goals for care. It was unclear how these goals were specific to this patient’s diagnoses, and how they would be measured in terms that would enable nursing staff to accurately perform an objective evaluation of the patient's progress toward the goals. This finding was reviewed and acknowledged during interview on 3/7/24 at 1:30 p.m. with the Administrator (Staff A) and the Alternate Administrator (Staff B). P-7: This 77-year-old patient was admitted to this agency on 2/10/24 with the diagnoses of Parkinson’s Disease and repeated falls. During record review on 3/6/24, it was noted the occupational therapy (OT) treatment interventions on 2/22/24 were recorded as follows: “UB (upper body) strengthening; yellow theraband, 2 sets of 10, all planes” and “Performed UB strengthening HEP (home exercise program)." It is unclear what patient-specific exercises were performed by the patient. The Regional Director of Rehabilitation (Staff C) was interviewed on 3/7/24 at 11:00 AM regarding how to know which exercises were performed by the patient. Staff C stated the specific exercises should be documented and acknowledged it was not clear what exercises this patient had performed on this day. P-8: This 91-year-old patient was admitted to this agency on 1/28/24 with the diagnoses of a laceration (wound) on the left lower extremity and edema (swelling). During record review on 3/5/24, it was noted the Plan of Care dated 1/28/24 did not have any goals set regarding wound size or edema, although both had been measured and evaluated at the start of care. It was also noted on the Plan of Care dated 1/28/24 under “SN (skilled nursing) Interventions” to, “Report to the physician if patient experiences pain level not acceptable to the patient, pain level greater than 7/10 with objective data…”. Further down under “SN Interventions” it stated, “Report to physician…...unrelieved pain >5 on a 0-10 scale…”. It is unclear which intervention to follow, therefore these interventions are not patient-specific. P-9: This 79-year-old patient was admitted to this agency on 12/27/23 with the diagnoses of an unspecified fracture of the first lumbar vertebra, type II diabetes, high blood pressure, and chronic kidney disease. During record review on 3/5/24, the following interventions were noted under orders on the Plan of Care dated 12/27/24: SN (Skilled Nursing) Interventions: “Instruct pt/cg to maintain daily weights and report any weight gain of >3 lbs in any 24 hour period or 3-5 lbs in a week to SN or MD.” and, PT (Physical Therapy) Interventions: “Instruct Pt/Caregiver to weigh daily and to report variations of 2 lb/24 hours or 5 lb/7 days to MD. Instruct pt to log weights daily, clinicians to monitor. If unable to weigh, measure BLE edema and report changes of 2 cm or greater to the MD.” It is unclear which order should be followed, therefore these interventions are not patient-specific. Staff A was queried regarding the conflicting interventions during an interview on 3/7/24 at 10:00 AM. Staff A reported the interventions are generated based on diagnoses and acknowledged it is unclear which intervention to follow. Staff A stated the clinician should be reviewing these to ensure they are specific to the patient and not conflicting. She acknowledged the findings. P-10: This 80-year-old patient was admitted to this agency on 2/7/24 with the diagnoses of chronic obstructive pulmonary disease (COPD), hypertensive heart disease with heart failure, and type II diabetes. During record review on 3/6/24, the following SN goal was noted on the Plan of Care dated 2/7/24: “Patient will be free from signs and symptoms of respiratory distress during the episode.” This goal contains no measurable data. Staff A acknowledged the findings. Additionally, the following goal was noted in records for P-7, 8, 9, and 10: “Patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” Staff A was questioned about this goal being located in every record reviewed during an interview on 3/7/24 at 10:00 AM. Staff A reported corporate instructed them to use this goal for everyone as it would “cover” the goal requirements. However, Staff A admitted that this is goal is not measurable or patient-specific and acknowledged the findings. The Alternate Administrator (Staff B) was also present during the above interviews and acknowledged the findings. P-4: This 91-year-old patient was admitted to home care on 2/2/24 with diagnoses of atrial fibrillation, hypertensive chronic kidney disease and osteoarthritis. During record review on 3/4/24, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. The plan of care contained the following goals, “Patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization,” and “Patient/caregiver will state understanding of measures to manage hypertension and identify signs and symptoms to report throughout episode of care.” There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. P-5: This 94-year-old patient was admitted to home care on 11/3/23 with diagnoses of tibia fracture, muscle weakness, malnutrition, and congestive heart failure. During record review on 3/5/24, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. The plan of care contained the following goals, “Patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization.” There were no patient specific skilled nursing goals related to admitting diagnoses of tibia fracture, muscle weakness, malnutrition, or congestive heart failure. P-6: This 89-year-old patient was admitted to home care on 2/9/24 with diagnoses of hypertensive heart disease, chronic congestive heart failure, and diabetes mellitus. During record review on 3/6/24, it was noted that the plan of care failed to include measurable nursing goals that are individualized to address patient needs. The plan of care contained the following goals, “Patient will have diagnosis specific interventions throughout this episode of care to monitor co-morbidities and potential adverse events, to reduce the risk of acute hospitalization,” and “patient and caregiver will verbalize an understanding of factors that contribute to shortness of breath.” There was no evidence of how these goals could be objectively measured to determine progress toward meeting the goals. These findings were reviewed and acknowledged by the administrator (Staff A) and the clinical manager (Staff B) during an interview on 3/7/24 at 3:25 p.m.

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, the agency failed to ensure the registered nurse promptly alerted the physician to changes in the patient's condition for 1 (P-5) of 10 records reviewed, resulting in increased pain, and burning with urination, resulting in a six-day hospitalization requiring intravenous antibiotics. Findings include: Policy III.7 – Professional/Ancillary Care Plans (no date) states care coordinator (RN who opened the case) shall be responsible for informing the physician of changes in the patient’s condition. No time frame was noted in the agency policy. P-5: This 94-year-old patient was admitted to home care on 11/3/23 with diagnoses of Tibia fracture, muscle weakness, malnutrition, congestive heart failure, and history of frequent urinary tract infections. The plan of care, dated 11/3/23, contained orders to notify physician of temperature greater than 99.6 degrees. During review of the skilled nursing visit notes on 3/5/24, the following was noted: 12/1/23 – Registered Nurse (RN) documented, Temperature of 99.9, "Received call from daughter Wendy that the patient wasn’t feeling well. Upon arrival patient was drowsy and fatigue. Vitals was WNL (within normal limits) besides the temperature," [sic] there was no evidence the physician was notified. 12/5/23 – New onset of pain, rated as 5 out of 10, and RN documented, “patient having burning while urinating. Patient already on Keflex daily. This is a huge problem as patient ends up in hospital over bladder infection. Will call daughter Wendy to discuss intervention to staying out of hospital.” [sic] 12/6/23 - Pain level of 7 out of 10 and RN documented, “burning with urination” and "Daughter stated if we don’t get medical attention patient will end up in hospital. Burning is usually the first signs before things take a turn for the worse. Wendy will take mother to ER tomorrow morning. Hopefully we can avoid long stay in hospital since the doctor can’t see the patient until 12/18/23." P-5 was hospitalized from 12/7/23 to 12/12/23, required intravenous antibiotics for dysuria and UTI with hematuria, and returned home with home care. The patient was discharged from home care and admitted to hospice on 12/25/23. The administrator was interviewed on 3/6/24 at 2:30 p.m., who acknowledged the record failed to include documentation that the RN notified the physician of temperature, new onset of pain, or burning with urination. When queried what is the expectation, the administrator replied, clinicians must report changes to the physician. The RN (Staff-D) was interviewed on 3/7/24 at 12:05 p.m. and stated, “On December 1, I was there with the patient’s daughter when she called and left a message for the doctor.” When queried if she had attempted to contact the physician, she replied that she did not as the daughter had a good relationship with the physician. When queried if she was aware of the agency policy to inform the physician of changes in patient condition, she replied, “Yes, I am aware of the policy. I should have documented.” The nurse failed to notify the physician of the elevated temperature, new onset of pain, and burning with urination, with patient who has a history of frequent urinary tract infections.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure care was coordinated between disciplines to assure identification of patient needs, safety and treatment effectiveness in 2 (P-7, 9) of 10 records reviewed, resulting in the potential for poor patient outcomes and unmet care needs. Findings include: P-7: This 77-year-old patient was admitted to this agency on 2/10/24 with the diagnoses of Parkinson’s Disease and repeated falls. During record review on 3/6/24, the following occupational therapy (OT) intervention was noted under orders on the Plan of Care dated 2/10/24: “Instruct Pt/Caregiver to weigh daily and to report variations of 2 lb / 24 hours or 5 lb / 7 days to MD. Instruct pt to log weights daily, clinicians to monitor.” During review of the OT notes from 2/15/24, 2/22/24, and 2/29/24, it was determined that no weight measurements were recorded or reviewed on those days. The Administrator (Staff A) was queried where to find weight measurements on an OT note during an interview on 3/7/24 at 10:00 AM. Staff A reported there is not a spot for it on the OT notes, but the nurse should be doing it since there was one involved in the care of this patient. She was unsure why OT would pick that intervention. Upon further review of the nursing notes, it was determined that no weight was recorded or reviewed by nursing on the visits dated 2/20/24 and 2/28/24. Staff A then reported there should be a list of daily weights in the patient’s home for the clinician to review but was unable to provide evidence that this was the case or any evidence that the patient’s weight was being monitored. Care was not coordinated between OT and nursing to determine who would monitor the patient's weight. Staff A acknowledged the findings. P-9: This 79-year-old patient was admitted to this agency on 12/27/23 with the diagnoses of an unspecified fracture of the first lumbar vertebra, type II diabetes, high blood pressure, and chronic kidney disease. During record review on 3/5/24, the following interventions were noted under orders on the Plan of Care dated 12/27/24: SN (Skilled Nursing): “Instruct pt/cg to maintain daily weights and report any weight gain of >3 lbs in any 24 hour period or 3-5 lbs in a week to SN or MD.” PT (Physical Therapy): “Instruct Pt/Caregiver to weigh daily and to report variations of 2 lb/24 hours or 5 lb/7 days to MD. Instruct pt to log weights daily, clinicians to monitor. If unable to weigh, measure BLE edema and report changes of 2 cm or greater to the MD.” As above, Staff A was asked where to find weights on the physical therapy notes. Staff A reported there is not a place on the PT notes, but the nurse should be doing it since there was one involved in the care of this patient. She was unsure why PT would pick that intervention. Upon further review of the nursing notes, it was noted that it was documented on 1/2/24 that the patient is unable to stand on a scale. The skilled nursing notes did not contain edema measurements on 1/2/4/24 or 1/4/24. As a result, the patient’s weight/edema was not being monitored by any clinician at that time. Care was not coordinated between OT and nursing to determine who would monitor. Staff A and the Alternate Administrator acknowledged the findings during the interview on 3/7/24 at 10:00 AM.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the skilled professionals provided services as ordered by the physician in the plan of care for 1 (P-5) of 10 records reviewed, resulting in the potential for physical decline and unmet care needs for this patient. Findings include: P-5: This 94-year-old patient was admitted to home care on 11/3/23 with diagnoses of tibia fracture, muscle weakness, malnutrition, and congestive heart failure. During record review on 3/5/24, it was noted that the patient was ordered physical therapy once a week for 7 weeks, and occupational therapy once a week for 6 weeks. During the week of 12/11/23, there was no evidence the patient received physical therapy or occupational therapy visits. There was no evidence of missed visit documentation or that the physician was notified. This finding was reviewed and acknowledged by the administrator (Staff A) and the clinical manager (Staff B) during an interview on 3/7/24 at 3:25 p.m.

Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse supervised the care of the licensed practical nurse for 1 (P-5) of 10 records reviewed, resulting in a lack of oversight regarding the services provided by the licensed practical nurse. Findings include: During the entrance conference on 3/4/24 at 10:10 a.m., the administrator (Staff A) stated that licensed practical nurses (LPN) are supervised by a registered nurse (RN) and this is documented in the skilled nursing visit notes every 30 days. P-5: This 94-year-old patient was admitted to home care on 11/3/23 with diagnoses of tibia fracture, muscle weakness, malnutrition, and congestive heart failure. During record review on 3/5/24, it was noted that the plan of care ordered skilled nursing visits once week one, twice a week for five weeks, and once a week for four weeks. The LPN provided a skilled nursing visit on 11/20/24. There was no documented evidence of supervision by the RN. This finding was reviewed and acknowledged by the administrator (Staff A) and the clinical manager (Staff B) during an interview on 3/7/24 at 3:25 p.m.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure home health aides reported changes in the patient’s condition to a registered nurse or other appropriate skilled professional in 2 (P-6 and 9) of 4 records reviewed with home health aide services, resulting in the potential for unmet care needs and poor patient outcomes. Findings include: P-9: This 79-year-old patient was admitted to this agency on 12/27/23 with the diagnoses of an unspecified fracture of the first lumbar vertebra, type II diabetes, high blood pressure, and chronic kidney disease. During record review on 3/5/24, it was noted the home health aide note dated 1/4/24 stated, “Bruising on back. Small skin tear on forehead. Left foot is swelling up a little.” There was no indication in the record this had been reported to the nurse. During further record review, it was noted the home health aide note dated 1/11/24 documented the patient’s systolic blood pressure (top number) to be 167. According to the parameters on the Plan of Care dated 12/27/23 and the daily aide notes, a systolic blood pressure over 160 should be reported to the nurse and ultimately to the physician. There was no indication in the record this had been reported to anyone. The Administrator (Staff A) and Alternate Administrator (Staff B) acknowledged the findings during an interview on 3/7/24 at 10:00 AM. P-6: This 89-year-old patient was admitted to home care on 2/9/24 with diagnoses of hypertensive heart disease, chronic congestive heart failure, and diabetes mellitus. During record review on 3/6/24, it was noted that the plan of care ordered home care staff to notify physician of diastolic blood pressure (bottom number) greater than 90 or less than 60. On 2/16/24, the home health aide documented a blood pressure of 113/57. There was no evidence the blood pressure finding was reported to the nurse. This finding was reviewed and acknowledged by the administrator (Staff A) and the clinical manager (Staff B) during an interview on 3/7/24 at 3:25 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 a completed transfer summary was sent to the physician within 2 business days of becoming aware of an unplanned transfer in 2 (P-4, and 9) of 3 records reviewed with a transfer, resulting in the potential for unmet patient care needs. Findings include: P-4: This 91-year-old patient was admitted to home care on 2/2/24 with diagnoses of atrial fibrillation, hypertensive chronic kidney disease and osteoarthritis. During record review on 3/4/24, it was noted that the patient was admitted to the hospital on 2/8/24 with hematuria and discharged home on 2/12/24. There was no documented evidence that a transfer summary was sent to the receiving agency within 2 business days of becoming aware of transfer. This finding was reviewed and acknowledged by the administrator (Staff A) and the clinical manager (Staff B) during an interview on 3/7/24 at 3:25 p.m. **Policy titled "III.10 TRANSFER/ TRANSFER OASIS” (undated) was reviewed stated, "The patient’s physician will be notified of any transfer and a transfer summary sent to the physician within 2 days of the patient’s transfer, or within 2 days of the Agency becoming aware of the transfer.” P-9: This 79-year-old patient was admitted to this agency on 12/27/23 with the diagnoses of an unspecified fracture of the first lumbar vertebra, type II diabetes, high blood pressure, and chronic kidney disease. During record review on 3/5/24, it was noted a patient transfer summary was completed for this patient on 1/26/24 following an unplanned transfer due to a fall. During an interview on 3/7/24, the Administrator (Staff A) was queried whether the transfer summary was sent to the doctor. Staff A reported there should be a completed fax transmission form scanned with the document after it is sent. Staff A was unable to locate one for this patient. Staff A then noted she typically hand delivers notes to this physician once per week. Staff A was asked how the agency keeps track of which records are hand delivered. Staff A acknowledged that the agency does not keep a list of what records are hand delivered, so there would be no evidence of it being done. She acknowledged the findings at the time of the interview.

The following standard level deficiencies were identified during the Medicare Emergency Preparedness survey conducted by the Michigan Department of Licensing and Regulatory Affairs from 3/9/21 to 3/12/21 at: AdvisaCare Home Health & Hospice 3290 W. Big Beaver Rd., Suite 501 Troy, MI 48084.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years.] At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to incorporate an individual Emergency Preparedness Plan into the Comprehensive Patient Assessment for 3 of 10 records reviewed (MR #8, 9 and 10) for Emergency Preparedness from a total of 7 sampled records reviewed, resulting in the potential for negative patient outcomes in the event of an actual emergency for the agency's current 79 patients. Findings include: MR's #1-3: During record review on 3/9/21 through 3/12/21, it was noted that there was no individualized Emergency Preparedness Plan or triage designation in the charts reviewed. DON#1 (director of nursing) was questioned on 3/12/21 at 11:30 a.m., and confirmed the findings stating, "We need to complete the patient's emergency preparedness plan better." The agency failed to incorporate an individual Emergency Preparedness Plan into the Comprehensive Patient Assessment.

The following standard and condition level deficiencies were identified during an authorized Medicare recertification survey conducted on 3/9/2021 through 3/12/2021 by the Michigan Department of Licensing and Regulatory Affairs at: AdvisaCare Home Health & Hospice 3290 W. big Beaver Rd., Suite 501 Troy, MI 48084 At the time of the survey, the agency did not operate any branch locations. The services the agency provides are: Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW) and Speech Therapy (ST). Clinical records reviewed for this survey included: 4 records with home visits and 6 records without home visits, for a total of 10 records reviewed. Condition level deficiencies were identified at: 42 CFR§484.55 Comprehensive Assessment of Patients 42 CFR §484.60 Care Planning, Coordination, Quality of Care 42 CFR §484.65 Quality Assessment/Performance Improvement 42 CFR§484.110 Clinical Records As a result of the Condition level noncompliance, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to inform the patient in advance of the disciplines that will furnish care in 1 of 10 records reviewed (MR#8) from a total sample of 10 records reviewed, resulting in the patient not having knowledge of the plan for treatment. Findings include: Agency policy: Referral and Acceptance of Patients (undated) states, "To accept referrals, information regarding a patient's ...services needed ...will be taken in order to make the initial determination of whether the patient's needs can be met..." MR#8: The Start of Care (SOC) was dated 4/2/20. The Plan of Care (POC) identified diagnoses of Myocardial Infarction, Acute Kidney Failure and Chronic Obstructive Pulmonary Disease (COPD). During record review on 3/9/21, the referral dated 3/31/20 documented, "Order Summary: Discharge with PT (Physical therapy), OT (Occupational Therapy), ST (Speech Therapy), SN (Skilled Nursing), SW (Social Worker)." There were no documented visits made by the ST. Additionally, there was no documentation of the patient refusing ST services within the comprehensive assessment dated 4/2/20. The Adm#1 was questioned on 3/12/21 at 9:30 am and confirmed the findings stating, "I am not sure why the speech therapist never made an evaluation visit."

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 comprehensive assessment included baseline information detailing the patient's current health at the time of admission for 6 of 10 (MR# 5, 6, 7, 8, 9 and 10) records reviewed (See G528); failed to ensure the patient's Activity of Daily Living needs were adequately met in the patient's home for 1 (MR #2) of 3 patients assessed as needing assistance with ADLs; and failed to ensure 1 (MR #2) of 1 patient's Medical Social Work needs were met, resulting in the potential for poor hygiene, psychological decline, injury, lack of resources, and unmet care needs (G534); failed to ensure the registered nurse conducted a review of the patient's medications for any potential adverse effects such as: side effects, drug interactions, and duplicate drug therapy for 10 of 10 sampled records reviewed (MR's #1, 2, 3, 4, 5, 6, 7, 8, 9 and 10) (See G536); and failed to ensure that the comprehensive assessment was updated and revised in 1 (MR #2) of 2 records in which the patient was transferred and admitted to an inpatient facility related to unknown causes, resulting in the lack of information in determining the care and support needs of the patient (G544). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR§484.55 Comprehensive Assessment of Patients.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on 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, outcomes, baseline information and history of events leading to current home care needs and fails to reflect the patient's current health status in 6 of 10 records reviewed (MR#s 5, 6, 7, 8, 9 and 10) resulting in incomplete clinical information to aide in determining the needs of the patient. Findings included: MR #5: The start of care (SOC) was dated 2/20/20, with diagnoses that included atrial fibrillation, chronic obstructive pulmonary disease (COPD) and type 2 diabetes. During a review of the Comprehensive Assessment on 3/9/21, it was discovered that under the category of (M1021): "Significant past health history," the only information provided was a list of diagnoses and the same date of onset, 2/20/20, for all diagnoses. There was no information providing individual dates of onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. On the SOC under M1023, diabetes is documented as a diagnosis. Under M1028, diabetes is checked as an active diagnosis, comorbidity or co-existing condition. Under the endocrine system section, the within normal limits (WNL) box is checked and the box asking if he patient is a diabetic is checked no. On the plan of care (POC) dated 2/20/20, diabetes was listed as a diagnosis. The SOC also failed to have a baseline blood sugar documented. MR #6: The SOC was dated 11/12/2020, with diagnoses that included pressure ulcer, COPD and type 2 diabetes. During review of the SOC on 3/10/21, it was discovered that under the category of (M1021): "Significant past health history," the only information provided was a list of diagnoses and the same date of onset, 11/12/20, for all diagnoses. There was no information providing individual dates of onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. MR #7: The start of care (SOC) was dated 2/8/21, with diagnoses that included osteoarthritis, hypertension and dizziness. During review of the SOC on 3/10/21, it was discovered that under the category of (M1021): "Significant past health history," the only information provided was a list of diagnoses and the same date of onset, 2/8/21, for all diagnoses. There was no information providing individual dates of onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. During an interview on 3/12/21 at 9:25 a.m., Admin#1 agreed with the above findings. MR#8: The Start of Care (SOC) was dated 4/2/20. The Plan of Care (POC) identified diagnoses of Myocardial Infarction, Acute Kidney Failure and Chronic Obstructive Pulmonary Disease (COPD). During record review on 3/9/21, it was noted that the SOC comprehensive assessment dated 4/2/20, documented under "Primary Diagnosis and Other Diagnoses", all 8 diagnoses were blank under onset/exacerbation and date of the onset/exacerbation. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#9: The Start of Care (SOC) was dated 2/12/21. The Plan of Care (POC) identified diagnoses of Stasis Ulcers, Diabetes Type 2 and Chronic Obstructive Pulmonary Disease (COPD). During record review on 3/10/21, it was noted that the SOC comprehensive assessment dated 9/3/20, documented under "Primary Diagnosis and Other Diagnoses", all 18 diagnoses had the same date of exacerbation, 2/12/21. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. Additionally, under the endocrine system section, "no" is marked for the following questions: Insulin dependent, is patient independently able to draw up correct dose of insulin and is patient able to properly administer own insulin. The medication profile documents the patient taking Lantus subcutaneous (injection) 100unit/mL 15 units every evening. During the home visit on 3/10/21, the patient was questioned regarding medication administration and doses. The patient stated, "I draw up and administer my own insulin." The agency failed to assess the patient's ability of medication administration. MR#10: The Start of Care (SOC) was dated 2/10/21. The Plan of Care (POC) identified diagnoses of Scoliosis and Post-Polio Syndrome. During record review on 3/11/21, it was noted that the SOC comprehensive assessment dated 2/10/21, documented under "Primary Diagnosis and Other Diagnoses", all 3 diagnoses had the same date of exacerbation documented, 2/10/21. No prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. Additionally, the comprehensive assessment dated 2/10/21 documented, "Unable to take medication unless administered by another person" was selected under M2020 "Management of Oral Medications." During the home visit on 3/10/21, the patient was questioned regarding medication administration and doses. The patient stated, "I always have set up my own medications. After I take my morning pills, I set up my evening pills, then after my evening pills, I setup my morning pills." The agency failed to assess the patient's ability of medication administration. The Adm#1 was questioned on 3/12/21 at 9:45 am and confirmed the findings stating, "The comprehensive assessment was not completed accurately."

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined the Agency failed to ensure the patient's Activity of Daily Living needs were adequately met in the patient's home for 1 (MR #2) of 3 patients assessed as needing assistance with ADLs; and failed to ensure 1 (MR #2) of 1 patient's Medical Social Work needs were met, resulting in the potential for poor hygiene, psychological decline, injury, lack of resources, and unmet care needs. Findings include: MR #2: The patient's start of care (SOC) was 1/22/21 with diagnoses that included Hypotension due to drugs, chronic kidney disease and diabetes mellitus. The Plan of Care (POC) dated 1/22/21 revealed the following: "Functional limitations: Paralysis, bowel/bladder incontinence, contracture; Safety Measures: slow position change, stairs, use of assistive devices, safety in ADLs, proper position during meals, Fall precautions, Hoyer lift with transfers." Section M1800/Grooming, of The initial Comprehensive Assessment dated 1/22/21 revealed: "Patient depends entirely upon someone else for grooming needs, to dress upper and lower body, unable to participate effectively in bathing, depends entirely upon another person to maintain toileting hygiene." There were no home health aide (HHa) services offered. Additionally, the section, "Community resource info needed to manage care" indicated, "Yes" however, no Medical Social Work services were provided or offered. These findings were reviewed with the Administrator (Adm #1) during an interview on 3/10/21 at 11:49 a.m. who reported, "I don't know why a HHa wasn't offered." When queried about the need for MSW services, Adm #1 responded, "An MSW should have been put in place." During a subsequent interview on 3/11/21, when queried about the provision of Home Health Aide services, Adm #1 stated, "If a patient needs home health aide services, the service is provided by our private duty side......We should be offering the service at the start of care if there is a need."

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency (HHA) failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required, failed to have a registered nurse review the medications, and failed to ensure the physician was notified of potential drug interactions in 10 of 10 sampled records reviewed (MR's #1, 2, 3, 4, 5, 6, 7, 8, 9 and 10), resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: **Agency policy: III.17, Medication Management, "The medications will be reviewed for potential adverse effects, drug reactions, ineffective drug therapy, significant drug interactions, duplicate drug therapy, and for patient non-compliance withdrug therapy. The admitting clinician or the nurse reviewing the profile will contact the patient's physician immediately if there are any questions or concerns regarding the medications a patientis taking." MR #5: The start of care (SOC) was dated 2/20/20, with diagnoses that included atrial fibrillation, chronic obstructive pulmonary disease (COPD) and type 2 diabetes. During review of the SOC assessment on 3/9/21, it was documented under M2001, drug regimen review, "No issues found during review." The agency's Medication Profile form dated 2/20/20, has "yes" documented under section E, "Have potential adverse effects, significant drug interactions, duplicate/ineffective drug therapy and potential contraindications been identified?" The agency's Medication Record form dated 2/20/20, has no discrepancies and no interactions documented. The agency's drug interaction report dated 3/9/21, documented 1 major, 6 moderate and 4 food interactions. During an interview on 3/12/21 at 9:25 a.m., the administrator (Adm#1) was asked if the physician was notified of the drug regime results. Admin#1 stated, "No, the physician would not have been notified." MR #6: The SOC was dated 11/12/2020, with diagnoses that included pressure ulcer, COPD and type 2 diabetes. During review of the SOC on 3/10/21 it was discovered under M2001, drug regimen review, "No issues found during review." was documented. The agency's drug interaction report dated 3/9/21, documented 1 major, 2 moderate, 1 minor and 2 food interactions. During an interview on 3/12/21 at 9:25 a.m., the administrator (Adm#1) was asked if the physician was notified of the drug regime results since the SOC assessment indicated no issues found. Admin#1 stated, "No, the physician would not have been notified." MR #7: The start of care (SOC) was dated 2/8/21, with diagnoses that included osteoarthritis, hypertension and dizziness. During review of the patient's record on 3/11/21, it was discovered there was no documented evidence a registered nurse (RN) reviewed the patient's medications for this record when physical therapy (PT) and occupational therapy (OT) were the only services ordered. During an interview on 3/12/21 at 9:25 a.m., the administrator (Adm#1) was asked if an RN reviewed the medications for this record, Admin#1 stated, "An RN does not review the medications if they are not on the case." An RN is required to review all medications for every case, even if skilled nursing was not ordered. MR#8: The Start of Care (SOC) was dated 4/2/20. The Plan of Care (POC) identified diagnoses of Myocardial Infarction, Acute Kidney Failure and Chronic Obstructive Pulmonary Disease (COPD). During record review on 3/9/21, section M2001 of the "Comprehensive Assessment" dated 4/2/20 and completed by the registered nurse (RN), documented "No issues found during review." The electronic medical record (EMR) medication profile contained 10 medications for this patient. It was unclear as to how the medication reconciliation had been performed. The drug interaction report was uploaded to the EMR on 3/9/21, more than 11 months after the SOC. The drug interaction report indicated there was 1 major medication interaction between Allopurinol and Lisinopril and 1 major medication and food interaction between Ranexa and grapefruit/grapefruit juice. There was no documented evidence that a drug interaction review had in fact been conducted to identify any adverse reactions or effects, or documented evidence that the physician had been notified of the above findings. MR#9: The Start of Care (SOC) was dated 2/12/21. The Plan of Care (POC) identified diagnoses of Stasis Ulcers, Diabetes Type 2 and Chronic Obstructive Pulmonary Disease (COPD). During record review on 3/10/21, section M2001 of the "Comprehensive Assessment" dated 2/12/21 and completed by the registered nurse (RN), documented "No issues found during review." The electronic medical record (EMR) medication profile contained 18 medications for this patient. It was unclear as to how the medication reconciliation had been performed. The drug interaction report was uploaded to the EMR on 3/9/21, 25 days after the SOC. The drug interaction report indicated there was 2 major medication interactions between Timolol Ophthalmic and Formoterol, and Albuterol and Timolol Ophthalmic. Additionally, there is 1 major medication and food interaction between Metformin and Alcohol. There was no documented evidence that a drug interaction review had in fact been conducted to identify any adverse reactions or effects, or documented evidence that the physician had been notified of the above findings. Additionally, during the home visit on 3/10/21, the patient was questioned regarding medication doses. The patient stated, "I take 10 units in the am and 40 units in the evening of Lantus subcutaneous." Metformin 1000mg is taken two times a day instead of daily that is documented on the POC. Lasix 40mg a day was started "about a week ago" was not listed on the POC. The agency failed to reconcile the patient's medications. MR#10: The Start of Care (SOC) was dated 2/10/21. The Plan of Care (POC) identified diagnoses of Scoliosis and Post-Polio Syndrome. The plan of care dated 2/4/20, ordered physical therapy services. During record review on 3/11/21, section M2001 of the "Comprehensive Assessment" dated 2/10/21, completed by the physical therapist (PT), documented "No issues found during review." The medication profile was signed by the PT. There was no documented evidence that the patient's medications had been reviewed by a registered nurse for possible drug interactions and duplicate drug therapy. The Adm#1 was questioned on 3/12/21 at 9:45 am and confirmed the findings stating, "The medication interaction report was not completed at the start of care. A registered nurse did not review the medication profile for patient. A medication reconciliation is to be done every visit." MR #1: The patient's start of care (SOC) was 3/10/20 with diagnoses that included Urinary Tract Infection, Parkinson's Disease and Repeated Falls. On 3/9/21 at 1:11 p.m., during the clinical record review, section M2001 of the "Initial Comprehensive Assessment" dated 12/16/19, completed by the Physical Therapist, documented, "No - No issues found during (medication) review." At the time of the review, a document, dated 3/9/21, had been uploaded by the facility. Further review revealed that the document that had been uploaded was the patient's "Drug Interaction Report" from "Drugs.com" (online medication interaction checker). The report revealed 11 moderate drug interactions,and 4 drug to food interactions. There was no documented evidence that a drug review had been conducted at the SOC to determine any untoward reactions. MR #2: The patient's SOC was 1/22/21 with diagnoses that included Hypotension due to drugs, chronic kidney disease and diabetes mellitus. On 3/9/21 at 6:17 p.m., during the clinical record review, section M2001 of the Initial Comprehensive Assessment dated 1/22/21 completed by the Registered Nurse, stated, "No issues found during review." The patient's "Drug Interaction Report", uploaded on 3/9/21, revealed that of the patients 11 prescribed medications, there were 6 moderate drug to drug interactions, and 6 drug to food interactions. There was no documented evidence that a drug review had been conducted at the SOC to determine any untoward reactions. MR #3: The patient's SOC was 1/26/21 with diagnoses that included Urinary Tract Infection, Muscle Weakness and diabetes mellitus. On 3/10/21 at 9:45 a.m., during the clinical record review, section M2001 of the Initial Comprehensive Assessment dated 1/22/21 completed by the Physical Therapist, stated, "No issues found during review." Drugs.com Drug Interaction Report revealed: of the patient's 13 prescribed medications, there was 1 major drug to drug interaction, 15 moderate drug to drug interactions, 9 drug to food interactions and 1 duplicate drug. Further review revealed agency uploaded the drug interaction report, dated 3/9/21, at the time of the survey. Additionally, there was no documented evidence that a Registered Nurse provided oversight of the drug review process as per this requirement. There was no evidence that a drug review had been conducted at the SOC. MR #4: The patient's SOC was 1/27/21 with diagnoses that included Pain related to prosthetic graft, Failure to thrive and difficulty Walking. On 3/11/21 at 8:55 a.m., during the clinical record review, section M2001 of the Initial Comprehensive Assessment dated 1/27/21 completed by the Physical Therapist, stated, "No issues found during review." A Drugs.com Drug Interaction Report uploaded by the Agency on 3/9/21 revealed: of the patient's 7 prescribed medications, there was 1 moderate drug to drug interaction, 2 drug to food interactions and 2 duplicate drugs. Additionally, there was no documented evidence that a Registered Nurse provided oversight of the drug review process as per this requirement. There was no evidence that a drug review had been conducted at the SOC. The above findings were reviewed with and confirmed by the Administrator (Adm #1) during the following interview: 3/10/21 11:26 a.m., Adm #1 acknowledged skilled nurse does not sign off on the drug review conducted by the Physical Therapist and stated, "I know it hasn't been done, because I'd be the one to do it." 3/10/21 11:49 a.m., Adm #1 reported, "A staff person uploaded the drug interaction reports on all the records yesterday (3/9/21) because they hadn't been done. I guess (the staff person) was just trying to help."

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that the comprehensive assessment was updated and revised in 1 (MR #2) of 2 records in which the patient was transferred and admitted to an inpatient facility related to unknown causes, resulting in the lack of information in determining the care and support needs of the patient. Findings include: Policy: III.10 "TRANSFER/ TRANSFER OASIS" stated, "A Transfer OASIS will be completed within 2 days of the transfer, or immediately upon the Agency becoming aware of the transfer." MR #2: The patient's Start of Care (SOC) was 1/27/21 with diagnoses that included Hypotension related to drugs, chronic kidney disease and End Stage Renal Disease. On 3/9/21 at 6:17 p.m., during the clinical record review, it was noted that the patient was transferred to the hospital on 2/27/21. No reasons had been documented in the clinical record as to why the patient was transferred out. The screen which displays the patient's visit notes indicated that the Oasis Transfer document, dated 2/27/21, was "not started." On 3/12/21 at 10:10 a.m., a telephone interview was conducted with the Registered Nurse (RN #1) who was assigned to care for the patient. The Administrator (Adm #1) was present during the interview. When queried about the incomplete Comprehensive Oasis Transfer Summary, RN #1 reported, "I haven't had time to do it because I have a heavy work schedule." The Agency failed to ensure that the comprehensive assessment was updated and revised to reflect the patient's transfer to an inpatient facility.

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 document review and interview, it was determined that the agency failed to ensure the Plan of Care included objectively measurable and individualized goals in 4 of 5 records reviewed (MR#s 5, 6, 8 and 9) with skilled nursing ordered out of a total of 10 records reviewed, resulting in a potential for failure to measure progress toward achievement of desired outcomes (G572); failed to ensure the plan of care included safety measures, and pain parameters in 3 of 7 records (MR# 5, 6 and 7) from a total of 10 records reviewed, resulting in the potential for injury and unmet care needs (G574); failed to ensure that all drugs, care and services were provided only in accordance with Physician's orders for 1 (MR #1) of 3 discharged records, from a total of 10 records reviewed, resulting in the potential for the provision of unsafe, unauthorized care and unmet care needs (G580); and failed to ensure the Physician was promptly notified, as ordered in the plan of care, of vital signs outside the reportable parameters, for 1 (MR #2) of 1 patient with elevated blood pressure readings, from a total of 10 sample records reviewed, resulting in the potential for unidentified, untreated health concerns and unmet care needs (G590). 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 42 CFR §484.60 Care Planning, Coordination, Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to ensure the Plan of Care included objectively measurable and individualized goals in 4 of 5 records reviewed (MR#s 5, 6, 8 and 9) with skilled nursing ordered out of a total of 10 records reviewed, resulting in a potential for failure to measure progress toward achievement of desired outcomes. Findings include: **Agency Policy: Professional/Ancillary Care Plans (Undated) states, "An individualized plan of care shall be developed and implemented by each professional discipline providing service ...Each plan will include: Specific, individualized, measurable goals and interventions, including goals related to patient/caregiver education and training." MR#8: The Start of Care (SOC) was dated 4/2/20. The Plan of Care (POC) identified diagnoses of Myocardial Infarction, Acute Kidney Failure and Chronic Obstructive Pulmonary Disease (COPD). During record review on 3/9/21, it was noted that the goals on the POC were not measurable, for example the Skilled Nursing goals stated, "PT (patient) will verbalize understanding of Covid19 precautions and s/s to report to physician and when to call 911. PT will verbalize understanding of medication regimen, dose, route, frequency, identification, and side effects by EOE (end of episode). Patient will be free from signs and symptoms of respiratory distress during the episode." There was no evidence of how these goals could be quantitatively measured. MR#9: The Start of Care (SOC) was dated 2/12/21. The Plan of Care (POC) identified diagnoses of Stasis Ulcers, Diabetes Type 2 and Chronic Obstructive Pulmonary Disease (COPD). During record review on 3/10/21, it was noted that the goals on the POC were not measurable, for example the Skilled Nursing goals stated, "Patient will verbalize understanding of proper use of pain medication by 4/11/21. Patient skin integrity will remain intact during this episode." There was no evidence of how these goals could be quantitatively measured. The Adm#1 was questioned on 3/12/21 at 9:40 am and confirmed the findings stating, "Yes, the goals are not measurable." MR #5: The start of care (SOC) was dated 2/20/20, with diagnoses that included atrial fibrillation, chronic obstructive pulmonary disease (COPD) and type 2 diabetes. During review of the Plan of Care (POC) on 3/9/21, it was discovered that skilled nursing (SN) goals on the POC were not measurable, "Patient and care giver will verbalize an understanding of factors that contribute to shortness of breath by 3/5/20. The patient and care giver will verbalize an understanding of symptoms of cardiac complications and when to call 911 by 3/5/20." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR #6: The SOC was dated 11/12/2020, with diagnoses that included pressure ulcer, COPD and type 2 diabetes. During review of the POC on 3/10/21, it was found that skilled nursing (SN) goals on the plan of care were not measurable, "Patient's blood pressure will remain within established parameters during the episode. Assess for pain at every skilled nurse visit." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. During an interview on 3/12/21 at 9:25 a.m., when asked about measurable goals, the administrator (Adm #1) stated, "I agree, the goals are not measurable."

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, it was determined the agency failed to ensure the plan of care included safety measures, and pain parameters in 3 of 7 records (MR# 5, 6 and 7) from a total of 10 records reviewed, resulting in the potential for injury and unmet care needs. Findings include: **Agency policy: Advisacare, III.7, Professional and ancillary care plans. "Each plan will include safety measures including use of specific equipment." MR #5: The start of care (SOC) was dated 2/20/20, with diagnoses that included atrial fibrillation, chronic obstructive pulmonary disease (COPD) and type 2 diabetes. During review of the Plan of Care (POC) on 3/9/21, it was discovered there were no pain parameters documented. During review of the SOC assessment dated 2/20/20, pain was documented at 5 out of 10 and a goal for pain to be 0-2. MR #6: The SOC was dated 11/12/2020, with diagnoses that included pressure ulcer, COPD and type 2 diabetes. During review of the POC on 3/10/21, it was documented that the patient was a diabetic and there were no diabetic safety precautions on the POC. MR #7: The start of care (SOC) was dated 2/8/21, with diagnoses that included osteoarthritis, hypertension and dizziness. During review of the Plan of Care (POC) on 3/11/21, it was discovered there were no pain parameters documented. During review of the SOC assessment dated 2/8/20, pain was documented at 4 out of 10 and a goal for pain to be 0. During an interview on 3/12/21 at 9:25 a.m., when asked about the absence of diabetic precautions and pain parameters, the administrator (Adm #1) stated, "I agree, there should be diabetic safety precautions and pain parameters on the POC."

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that all drugs, care and services were provided only in accordance with Physician's orders for 1 (MR #1) of 3 discharged records, from a total of 10 records reviewed, resulting in the potential for the provision of unsafe, unauthorized care and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 3/10/2020 with diagnoses that included Urinary Tract Infection, Parkinson's Disease and Repeated Falls. The plan of care (POC) dated 3/10/20, was digitally signed by the Physical Therapist and ordered Home Health Aide (HHa) services at a frequency of 2w4, Physical Therapy 1w1, 2w4, and Occupational Therapy (OT) 1w1, 2w3, 1w1. Further review revealed the patient discharged from the agency's services on 3/26/20. At the time of this clinical record review (1 year after the date of admission), the POC still had not been signed by the Physician. The agency failed to ensure that all care and services were provided only in accordance with Physician's orders. A fax cover sheet with a send date of 4/13/20, was addressed to a Physician and documented, "Please sign the enclosed orders and return as soon as possible." These findings were reviewed with and confirmed by the Administrator (Adm #1) during an interview on 3/10/21 at 11:44 a.m. who reported, "I don't have an explanation as to why it took until 4/13/20 to request a Physician's signature. I thought we sent it out for signature sooner than that. I don't see that we did and I don't see that the plan of care was ever signed."

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, it was determined the Agency failed to ensure the Physician was promptly notified, as ordered in the plan of care, of vital signs outside the reportable parameters, for 1 (MR #2) of 1 patient with elevated blood pressure readings, from a total of 10 sample records reviewed, resulting in the potential for unidentified, untreated health concerns and unmet care needs. Findings include: MR #2: The patient's start of care (SOC) was 1/22/21 with diagnoses that included Hypotension related to drugs, chronic kidney disease and End Stage Renal Disease. A review of the clinical record conducted on 3/9/21 revealed the following: The Plan of Care (POC) ordered, "Notify Physician of: Systolic BP (blood pressure) greater than (>) 150 or less than () 100 or less than (

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: This Condition of Participation has not been met. Based on interview, it was determined the Agency failed to measure, track and analyze it's quality indicators in order to assess processes of care and services, resulting in the inability to determine the scope of services provided (G642); failed to develop Performance Improvement activities, as part of the Agency's QAPI (Quality Assessment Performance Improvement) program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for substandard care and unmet care needs (G654); and failed to develop a Quality Assessment Performance Improvement program that documented the quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2018, 2019 and 2020 calendar years, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance (G658); and the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all 79 patients currently receiving services and all 349 patients admitted over the past year (G660). 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 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 interview and record review, it was determined the Agency failed to provide evidence of its efforts to measure, track and analyze it's quality indicators in order to assess processes of care and services, resulting in the inability to determine the scope of services provided and the potential unmet care needs for all 79 patients currently serviced by this agency. Findings include: On 3/10/21 at 3:45 p.m., during an interview, the Administrator (Adm #1) was queried about the Agency's QAPI (Quality Assessment Performance Improvement) program. When asked to define the agency's QAPI, Adm #1 responded, "It's a program gauged toward monitoring the effectiveness and safety of services and quality of care. We're supposed to look at processes that would improve patient care." Upon review of the agency's QAPI data with Adm #1, it was noted that there was no data to review for the calendar years 2018, 2019 and 2020 that showed the agency's efforts to measure, track and analyze indicators in order to determine if care and services have been provided safely and appropriately. These findings were reviewed with and confirmed by Adm #1 at the time of discovery.

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 interview and record review, it was determined the Agency failed to develop Performance Improvement activities, as part of the Agency's Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: On 3/10/2021 at 3:45 p.m., during an interview, the Administrator (Adm #1) was queried about the Agency's QAPI (Quality Assessment Performance Improvement) program. When asked to review the agency's Performance Improvement Projects, Adm #1 reported, I don't see that there are any."

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 interview and record review, it was determined the Agency failed to develop a Quality Assessment Performance Improvement program that documented the annually quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2018, 2019 and 2020 calendar years, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: On 3/10/21 at 3:45 p.m., during an interview, the Administrator (Adm #1) was queried about documentation of the Agency's QAPI (Quality Assessment Performance Improvement) program and Performance Improvement Projects, reasons for conducting the projects along with measurable progress achieved. Adm #1 was unable to provide the requested data and stated, "I don't see that there are any projects underway."

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 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 program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all 79 patients currently receiving services and all 349 patients admitted over the past year. Findings include: During an interview on 3/10/21 at 3:45 p.m., a request was made to review the agency's Quality Assessment Performance Improvement (QAPI) report and Governing Body meeting minutes for 2018, 2019 and 2020. Upon receipt and review of the agency's QAPI data, there was no data made available for review that determined or affirmed the Governing Body's oversight of the QAPI program. These findings were reviewed with and acknowledged by Adm #1 at the time of discovery.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review, and interview, it was determined the Agency (HHA) failed to provide documented evidence that infection control education was provided to any of the 37 employees of the agency including those granted clinical privileges, resulting in the potential for the development and spread of infection. Findings include: **Agency Policy: AdvisaCare X.3 Infection Control Program (Undated), "Educating staff in the prevention and control of infections initially and at least annually thereafter, or as needed per change in policies....." On 3/11/21, during review of the agency's infection control binder, there was no documentation of any agency employees educated on infection control. During an interview on 3/12/21 at 9:25 a.m., the administrator (Adm #1) was asked about infection control education for employees and stated, "There is no documentation that any employees were educated on infection control. I call them and observe them on home visits at times, but there is no documentation."

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Registered Nurse (RN) failed to prepare clearly written patient care instructions and include safety precautions on the aide's care plan, in 2 of 4 records in which Home Health Aide (HHa) services were provided (MR# 1, 5) from a total sample of 10 records reviewed. Resulting in the potential for the provision of unsafe care and unmet care needs. Findings included: **Agency policy: Advisacare, III.7, Professional and ancillary care plans. "For home health aides, the case manager will prepare an assignment or plan of care specific to the patient. Each plan will include safety measures, including use of specific equipment." M.R. #5: The start of care (SOC) was dated 2/20/20, with diagnoses that included atrial fibrillation, chronic obstructive pulmonary disease (COPD) and type 2 diabetes. During review of the Home Health Aide (HHa) POC dated 2/20/20, it was discovered that no safety precautions were documented. The RN failed to follow the agency's policy and ensure the plan of care included "Safety measures, including the use of specific equipment." During an interview on 3/12/21 at 9:25 AM, after a review of the aide's care plan, the administrator (Adm #1) stated, "I agree, the safety precautions should be on the aide's care plan." MR #1: The patient's start of care (POC) was 3/10/20 with diagnoses that included Urinary Tract Infection, Parkinson's Disease and Repeated Falls. During a review of the clinical record on 3/9/21 at 1:11 p.m., it was noted that the POC ordered Home Health Aide services at a frequency of 2x/wk. x 4 wks. The POC revealed the following, "DME (durable medical equipment) and supplies: Hospital bed; Safety Measures: Proper position during meals, Fall precautions, support during transfer; Functional Limitations: Bowel/bladder Incontinence." The "Aide Care Plan" dated 3/10/20 completed by the Physical Therapist, was void of the above mentioned DME, Safety Measures and Functional Limitations. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 3/10/21 at 11:45 a.m. who reported, "No, I don't see that the precautions are on here (Aide Care Plan). They should have been added because those are safety things for the patient and the Aide."

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 the Clinical Manager coordinated patient care in 1 of 4 (MR#'s 7) home visits where State surveyors were scheduled, from a total sample of 10 records reviewed. Resulting in the lack of oversight and coordination of clinicians. Findings include: On 3/11/21, upon arriving at a joint surveyor/clinician home visit scheduled for 4:00 p.m., it was observed that no clinician was onsite. A call was placed with the clinician 5 minutes after the scheduled visit was to begin. The clinician answered the call and was asked what time she would arrive. The clinician then asked me where I was. After giving her the address, she stated, "I already did that visit. I left a few minutes ago. I called the Clinical manager/Administrator (Adm#1) about an hour ago and told her the patient needed the visit moved up." Adm#1 did not communicate with the surveyor regarding the home visit time change, resulting in over an hour of wasted survey time and the need to schedule another visit the next day.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was complete and included clinical notes, transfer summaries and comprehensive assessments for 2 (MR#'s 2, 9) of 10 records reviewed, resulting in the physician not having a clear and concise clinical picture of the patient's health status and progression towards goals, and incomplete clinical record and the potential for unmet care needs (G1012); and, failed to ensure that discharge and transfer summaries were complete, provided the patient's current health status at the time of discharge and transfer, documented progress toward goals, and were sent to the physician in 3 of 3 records (MR# 2, 5 and 8) who were discharged/transferred from a total of 10 records reviewed (1022), resulting in the potential for unidentified continuing health care concerns and unmet care needs. 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§484.110 Clinical Records.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was complete and included clinical notes, transfer summaries and comprehensive assessments for 2 (MR#'s 2, 9) of 10 records reviewed, resulting in the physician not having a clear and concise clinical picture of the patient's health status and progression towards goals, and incomplete clinical record and the potential for unmet care needs. Findings include: **Agency Policy: Clinical Record Contents and maintenance (Undated) states, "The patient's clinical record will contain data including but not limited to: A complete physical assessment including vital signs, height, and weight as applicable, systems review, and other relevant information as well as ongoing assessments and reassessments." MR#9: The Start of Care (SOC) was dated 2/12/21. The Plan of Care (POC) identified diagnoses of Stasis Ulcers, Diabetes Type 2 and Chronic Obstructive Pulmonary Disease (COPD). The POC contained a goal of "Patient's random blood sugar will remain between 80 mg/dL and 250 mg/dL during the episode. During record review on 3/10/21, it was noted that the clinical record failed to document a blood sugar level for all 8 skilled nursing visits completed, including the comprehensive assessment on 2/12/21. The Adm#1 was questioned on 3/12/21 at 9:45 am and confirmed the findings stating, "The skilled nurse should have documented the blood sugars every visit." MR #2: The patient's start of care (SOC) was 1/22/21 with diagnoses that included Hypotension related to drugs, Chronic Kidney Disease and End Stage Renal Disease. On 3/9/21 at 6:17 p.m., the clinical record review was conducted. During the review, it was noted that the patient transferred to an inpatient facility on 2/27/21 for undocumented reasons. There was no documented evidence that a transfer summary or transfer oasis had been completed. Additionally, there were no documented visit notes in the patient's record after the date of transfer (2/27/21). On 3/12/21 at 10:10 a.m., a joint interview was conducted with the Administrator (Adm #1) and the assigned Registered Nurse (RN #1). When queried about the status of the patient, Adm #1 alleged no knowledge and was unable to give account for the patient's whereabouts, the reason for the transfer, or the absence of documentation. RN #1, who participated in the interview via telephone, was queried about the current status of the patient and reported, "The patient transferred to Beaumont Hospital on 2/27/21 due to nausea and vomiting. She (patient) returned home on 3/5/21 and went back to the hospital on 3/6/21." When asked why there was no documentation of the patient's transfer, transfer summary and Oasis, current status and why there were no further visit notes after the date of the transfer, RN #1 reported, "There's no reason. I just haven't had time because I have a heavy work schedule."

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 that discharge and transfer summaries were complete, provided the patient's current health status at the time of discharge and transfer, documented progress toward goals, and were sent to the physician in 4 of 4 records (MR# 1, 2, 5 and 8) who were discharged/transferred from a total of 10 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: **Agency Policy: Advisacare. III.11, Discharge planning, discharge summary and discharge OASIS. "All discharge summaries shall be sent to the patient's physician within 5 days of the patient's discharge from services. The discharge summary will include but is not limited to: -Admission and discharge dates. -Physician responsible for the home health plan of care. -Reason for admission. -Reason for discharge. -Status of problems throughout the course of care. -Types of care/services provided, including frequency of such services. -Laboratory data, if applicable. -Medications patient is on at time of discharge. -The progress or lack of toward established goals. -The patient's overall status at time of discharge. -Any continuing care needs, instructions, or referrals regarding the needs. ** Agency Policy: III.10 "Transfer/Transfer Oasis" When a patient is transferred to another facility or level of care, relevant information regarding the patient's condition and care requirements will be provided in writing to the transferring facility. Relevant information includes..., Date of admission and transfer, Physician responsible for the home health plan of care, Reason for admission to home health, Reason for transfer and conditions under which the transfer occurred, The patient's physical and psychosocial status at the time of transfer, Types care/services provided, frequency of services, and progress toward goals, Laboratory data, if applicable, Medications the patient is taking at time of transfer, Existence of infection in the patient that requires monitoring, treatment, and/or additional precautions in response to the way the infection spreads, Instructions and referrals / community resources provided to the patient, Existence of advanced directives..." MR#5: The start of care (SOC) was dated 2/20/20, with diagnoses that included atrial fibrillation, chronic obstructive pulmonary disease (COPD) and type 2 diabetes. During record review, it was discovered that no discharge or transfer summary was documented in the patient's record by skilled nursing (SN) or physical therapy (PT). The agency failed to document a discharge and transfer summary, and send it to the physician as stipulated by agency policy. During an interview on 3/12/21 at 9:25 a.m., the Administrator (Adm #1) agreed that a discharge summary should have been documented and sent to the physician. MR#8: The Start of Care (SOC) was dated 4/2/20. The Plan of Care (POC) identified diagnoses of Myocardial Infarction, Acute Kidney Failure and Chronic Obstructive Pulmonary Disease (COPD). The Skilled Nurse (SN) completed a discharge OASIS (outcome and assessment information set) on 4/24/20. During record review on 3/9/21, it was noted that there was no documented evidence a discharge summary was sent to the physician within 5 business days of the patient's discharge. The Adm#1 was questioned on 3/12/21 at 9:45 am and confirmed the findings stating, "Yes, the discharge summary was not sent to the physician within 5 business days." MR #1: The patient's start of care (SOC) was 3/10/20 with diagnoses that included Urinary Tract Infection, Falls and Parkinson's Disease. During the clinical record review on 3/9/21 at 1:11 p.m., it was noted that the patient received Occupational Therapy (OT), Physical Therapy (PT) and Home Health Aide (HHa) services and was discharged from the the agency's services on 3/26/20. Further review revealed the patient discharged from OT on 3/23/20 and discharged from PT on 3/26/21. Both, OT and PT discharge summaries documented, "Physician notified of discharge summary availability." There was no documented evidence that the discharge summaries had been sent to the Physician within 5 days of the patient's discharge. These findings were reviewed with and confirmed by the Administrator (Adm #1) during an interview on 3/10/21 at 11:46 a.m. who reported, "Since that time, as of the first part of June 2020, we started sending them (discharge summaries) out because I noticed we hadn't been doing it." MR #2: The patient's SOC was 1/22/21 with diagnoses that included hypotension related to drugs, chronic kidney disease and end stage renal disease. On 3/9/21 at 6:17 p.m., during the clinical record review, it was noted that the patient was transferred to an inpatient facility. There was no transfer summary available for review that detailed the reason for the patient's transfer. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the assigned Registered Nurse (RN #1) during a joint interview on 3/12/21 at 10:10 a.m. During the interview, RN #1 reported, "She (patient) transferred to Beaumont Hospital on 2/27/21 due to nausea and vomiting. I haven't had time to complete the paperwork because I have a heavy work schedule."

Physical Therapist Assistant CFR(s): 484.115(i) Standard: Physical therapist assistant. A person who is licensed, registered or certified as a physical therapist assistant, if applicable, by the state in which practicing, unless licensure does not apply and meets one of the following requirements: (1)(i) Graduated from a physical therapist assistant curriculum approved by the Commission on Accreditation in Physical Therapy Education of the American Physical Therapy Association; or if educated outside the United States or trained in the United States military, graduated from an education program determined to be substantially equivalent to physical therapist assistant entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or identified at 8 CFR 212.15(e); and (ii) Passed a national examination for physical therapist assistants. (2) On or before December 31, 2009, meets one of the following: (i) Is licensed, or otherwise regulated in the state in which practicing. (ii) In states where licensure or other regulations do not apply, graduated before December 31, 2009, from a 2-year college-level program approved by the American Physical Therapy Association and after January 1, 2010, meets the requirements of paragraph (h)(1) of this section. (3) Before January 1, 2008, where licensure or other regulation does not apply, graduated from a 2-year college level program approved by the American Physical Therapy Association. (4) On or before December 31, 1977, was licensed or qualified as a physical therapist assistant and has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that 1 of 1 Physical Therapy Assistants, who was granted clinical privileges, maintained an active and current license when providing care, resulting in the potential for the provision of unsafe care and unmet care needs. Findings include: On 3/10/21 at 2:00 p.m., during a review of the Agency's personnel files, it was noted that the Agency's contracted Physical Therapy Assistant (PTA) did not have a current/active license on file. The license in the PTA's personnel file indicated the license expired 7/31/2020. These findings were reviewed with and confirmed by the Alternate Administrator (Adm #2) at the time of discovery.