Every finding on record at Family First Home Care, LLC

A recertification survey for Emergency Preparedness was conducted by the Michigan Department of Licensing and Regulatory Affairs, Bureau of Community and Health Systems from 8/3/21-8/10/21. Family First Home Care LLC. 3155 W. Big Beaver Rd. suite 108 Troy, MI 48084 At the time of the survey, the agency did not operate any branch offices or subunits. At the survey's conclusion, the agency was found to be in substantial compliance with the requirements for participation in Medicare/Medicaid at 42 CFR §484.102, Emergency Preparedness.

A Medicare recertification and infection control survey was conducted on 8/3/21 through 8/10/21 by the Michigan Department of Licensing and Regulatory Affairs at: Family First Home Care LLC. 3155 W. Big Beaver Rd. suite 108 Troy, MI 48084 At the time of the survey, the agency did not operate any branch offices or subunits. Clinical records reviewed for this survey included 3 records with home visits, and 7 records without home visits, for a total of 10 records reviewed. The following Condition level deficiencies were identified at: 42 CFR 484.55 Comprehensive Assessment. 42 CFR §484.75: Skilled Professional Services. As a result of the Condition level noncompliance, the agency is prohibited for 2 years from offering a home health aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.36 (a)(2)(i).

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, it was determined the Agency failed to ensure the registered nurse conducted the initial assessment visit within 48 hours of referral, to determine the immediate care needs of the patient, including homebound status in 3 records, from a total of 10 records reviewed (MR #6, 7 and 9), resulting in the potential for unidentified patient needs (G514); failed to document baseline data for future assessments, in 2 of 10 records reviewed (MR #3 and 5), resulting in the potential for unmet care needs (G526); failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status, past medical history, history of events leading to home care, and ascertained the patient's immediate care needs in 9 records from a total of 10 records reviewed (MR # 1, 2, 3, 4, 5, 6, 7, 8 and 9), resulting in the potential for unmet care needs (G528); failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; and failed to document the findings of the drug regime review as required in 1 record, from a total of 10 sampled records reviewed (MR #6), resulting in the potential for harmful medication effects for all patients serviced by this Agency (G536). The cumulative effects of this systemic problem resulted in the Home Health 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.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse conducted the initial assessment visit within 48 hours of referral to determine the immediate care needs of the patient, including homebound status, for 3 of 10 (MR# 6, 7, and 9 ) records reviewed in which Skilled Nursing services were ordered, resulting in a delay of needed care and services which has the potential to negatively affect the health and well-being of patients. Findings include: **Agency policy "Initial Assessments/Comprehensive Assessments (no date) stated, "Each patient admitted by the Agency will have appropriate initial assessments performed and documented...A RN, PT or SLP must conduct the initial assessment visit within 48 hours of referral..." MR#6: This 87-year-old patient was admitted to the agency on 7/20/21 with diagnoses of metabolic encephalopathy, altered mental status, and repeat falls. During record review on 8/4/21, it was noted that the referral for home care services came from a skilled nursing facility and was dated on 7/15/21. The patient was discharged on 7/16/21 (caregiver interview during joint survey home visit on 8/4/21 at 1130 hours). On 7/20/21, DCS-B (director of clinical services-registered nurse) documented the start of care assessment visit, which was 5 days after the agency had received the referral. There was no documentation to indicate what had happened with this patient in the past 4 days. There was no documentation to indicate when the patient was discharged from the skilled facility. It was unclear whether the agency had attempted to contact the patient between the dates of 7/15/21 through 7/20/21. There was no documentation to indicate the patient had declined or delayed home care services. There was no documented evidence the physician was informed of the 4-day delay in care. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours. MR#7: This 61-year-old patient was admitted to the agency on 7/21/21 with diagnoses of left knee joint replacement on 6/21/21. During record review on 8/4/21, it was noted that the referral for home care services came from a rehabilitation facility and was dated 7/13/21. The patient was discharged on 7/13/21 (patient interview during joint survey home visit on 8/4/21 at 1230 hours). On 7/21/21, DCS-B documented the start of care assessment visit, 8 days after the agency received the referral. There was no documentation to indicate what had happened with this patient in the past 8 days. There was no documentation to indicate when the patient was discharged from the rehabilitation facility. It was unclear whether the agency had attempted to contact the patient between the dates of 7/13/21 through 7/21/21. There was no documentation to indicate the patient had declined or delayed home care services. There was no documented evidence the physician was informed of the 8-day delay in care. The findings were reviewed with and acknowledged by Admin-A and DCS-B during an interview on 8/10/21 at 1400 hours. MR#9: This 50-year-old patient was admitted to the agency on 4/19/21 with diagnoses of diabetes mellitus type 2 with foot ulcer, surgical amputation of 5th toe (requiring daily dressing changes), and end stage renal disease with dialysis. During record review on 8/5/21, it was noted that the referral for home care services came from a hospital and was dated on 4/16/21. On 4/19/21, DCS-B documented the start of care assessment visit, 3 days after the agency received the referral. There was no documentation to indicate what had happened with this patient in the past 3 days. There was no documentation to indicate when the patient was discharged from the hospital. It was unclear whether the agency had attempted to contact the patient between the dates of 4/16/21 through 4/19/21. There was no documentation to indicate the patient had declined or delayed home care services. There was no documented evidence the physician was informed of the 3-day delay in care. The findings were reviewed with and acknowledged by Admin-A and DCS-B during an interview on 8/10/21 at 1400 hours.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to document baseline data for future assessments, in 3 of 10 records (MR# 3, 4, and 5) out of a total of 10 records reviewed, resulting in the potential for unmet care needs. Findings included: **Agency policy "Initial Assessments/Comprehensive Assessments (no date) stated, "Each patient admitted by the Agency will have appropriate initial assessments performed and documented...The assessment will reflect the patient's current health status and include information to demonstrate the patient's progress toward achievement of desired outcomes..." MR#3: The SOC date was on 7/20/21, with diagnoses of malnutrition, type 2 diabetes mellitus and sepsis. During review of the comprehensive assessment on 8/5/21, it was discovered that the director of clinical services-registered nurse (DCS-B) failed to document a baseline blood sugar for a diagnosis of type 2 diabetes mellitus. MR#4: The SOC date was on 7/22/21, with diagnoses of chronic obstructive pulmonary disease (COPD), heart failure, hypertension and falls. During review of the comprehensive assessment on 8/5/21, it was discovered that DCS-B documented within normal limits (WNL) under the cardiac assessment for diagnoses of heart failure, coronary artery disease and hypertension. DCS-B failed to document a baseline O2 saturation on the comprehensive assessment with a primary diagnosis of COPD and continuous oxygen (O2) at 3L. DCS-B also documented the SOC comprehensive assessment as a non-OASIS assessment. A non-OASIS comprehensive assessment is less detailed than an OASIS assessment. MR#5: The SOC date was on 7/22/21, with diagnoses of heart failure, end stage renal disease and weakness. During review of the comprehensive assessment on 8/6/21, it was discovered that DCS-B failed to document a baseline weight or measurements with a primary diagnosis of heart failure. The findings were reviewed with and acknowledged by Admin-A and DCS-B during an interview on 8/10/21 at 2:00 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: MR#1: The start of care (SOC) date was on 7/14/21, with diagnoses of heart disease, Neoplasm of breast and dehydration. During review of the comprehensive assessment on 8/3/21, it was discovered that the clinical services-registered nurse (DCS-B), failed to document the patient's past medical history with dates of onset, exacerbations, treatments and outcomes, baseline data, and what happened to require admission to home health services. MR#2: The SOC date was on 7/14/21, with diagnoses of sepsis, hypotension and weakness. During review of the comprehensive assessment on 8/4/21, it was discovered that DCS-B failed to document the patient's past medical history with dates of onset, exacerbations, treatments and outcomes, baseline data, and what happened to require admission to home health services. MR#3: The SOC date was on 7/20/21, with diagnoses of malnutrition, type 2 diabetes mellitus and sepsis. During review of the comprehensive assessment on 8/5/21, it was discovered that DCS-B failed to document the patient's past medical history with dates of onset, exacerbations, treatments and outcomes, baseline data, and what happened to require admission to home health services. MR#4: The SOC date was on 7/22/21, with diagnoses of chronic obstructive pulmonary disease (COPD), heart failure and falls. During review of the comprehensive assessment on 8/5/21, it was discovered that DCS-B failed to document the patient's past medical history with dates of onset, exacerbations, treatments and outcomes, baseline data, and what happened to require admission to home health services. MR#5: The SOC date was on 7/22/21, with diagnoses of heart failure, end stage renal disease and weakness. During review of the comprehensive assessment on 8/6/21, it was discovered that DCS-B failed to document the patient's past medical history with dates of onset, exacerbations, treatments and outcomes, baseline data, and what happened to require admission to home health services. The findings were reviewed with and acknowledged by Admin-A and DCS-B during an interview on 8/10/21 at 2:00 p.m. Based on observation, record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected patients current health status for 9 of 10 (MR# 1, 2, 3, 4, 5, 6, 7, 8, and 9) records reviewed, resulting in incomplete clinical information to aid in determining the needs of patients and for measuring patient progress toward goals/outcomes. Findings include: **Agency policy "Initial Assessments/Comprehensive Assessments (no date) stated, "Each patient admitted by the Agency will have appropriate initial assessments performed and documented...The assessment will reflect the patient's current health status and include information to demonstrate the patient's progress toward achievement of desired outcomes..." MR#6: This 87-year-old patient who lives alone, was admitted to the agency on 7/20/21 with diagnoses of metabolic encephalopathy, altered mental status, and repeat falls. During record review on 8/4/21, it was noted the DCS-B (director clinical services-registered nurse) completed the comprehensive assessment on 7/20/21. DCS-B documented the patient's past medical history included heart disease with a recent short-stay in an acute hospital and a skilled nursing facility. During the joint survey home visit with LPN-C (licensed practical nurse) on 8/4/21 at 1130 hours, the caregiver stated that the patient was found on the floor with confusion and was sent by ambulance to the hospital. DCS-B failed to document in the comprehensive assessment, the patient's past surgeries, medical history, and what happened to require admission to home health services presently. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours. MR#7: This 61-year-old patient was admitted to the agency on 7/21/21 with diagnoses of left knee joint replacement on 6/21/21. During record review on 8/4/21, it was noted that the DCS-B completed the comprehensive assessment on 7/21/21. DCS-B documented the patient's past medical history included arthritis and total knee replacement with a recent short-stay in an acute hospital and a rehabilitation facility. During the joint survey home visit with physical therpaist (PT-E) the patient stated that she had hypertension, chronic obstructive pulmonary disease, and the right knee joint replaced 5 years previously. DCS-B failed to document the patient's past surgeries, medical history, and what happened to require admission to home health services presently. The findings were reviewed with and acknowledged by Admin-A and DCS-B during an interview on 8/10/21 at 1400 hours. MR#8: This 58-year-old patient was admitted to the agency on 6/16/21 with diagnoses of type 2 diabetes mellitus, congestive heart failure, acute/chronic respiratory failure, and pleural effusion. During record review on 8/4/21, it was noted the DCS-B completed the comprehensive assessment on 6/16/21. DCS-B documented the patient's past medical history included chf (congested heart failure), endocrine disease, and heart disease with a recent short-stay in an acute hospital. DCS-B failed to document the patient's past surgeries, medical history, and what happened to require admission to home health services presently. DCS-B failed to document the length of the patient's diagnosis of diabetes mellitus and past and current treatment. The patient was on 5 L of oxygen and DCS-B failed to document the length of time of oxygen use and the reason for its use. In the Narrative section DCS-B documented, "Patient is A and OX3 (alert and oriented X3), VS (vital signs) stable. No Pain. DC (discharge) on 6-15-21 due to pleural effusion. PMH (past medical history) of Renal transplant, hypoxic, ascites, DM2 (diabetes), Htn (hypertension)..." There was no documentation of the patient's chest tube, its locations, drainage requirements, and drain dressing. The findings were reviewed with and acknowledged by Admin-A and DCS-B during an interview on 8/10/21 at 1400 hours. MR#9: This 50-year-old patient was admitted to the agency on 4/19/21 with diagnoses of diabetes mellitus type 2 with foot ulcer, surgical amputation of 5th toe (requiring daily dressing changes), and end stage renal disease with dialysis. During record review on 8/5/21, it was noted the DCS-B completed the comprehensive assessment on 4/19/21. DCS-B documented the patient's past medical history included anemia, renal disease, and heart disease with a recent short-stay in an acute hospital. DCS-B failed to document the patient's past surgeries, medical history, and what happened to require admission to home health services presently. DCS-B failed to document the length of the patient's diagnosis of anemia, heart disease, and renal disease. The patient was on dialysis 3 times a week, which was not documented in the comprehensive assessment. In the Narrative section DCS-B documented, "Patient is A and OX3 (alert and orient X3), VS (vital signs) stable. No Pain. DC (discharge) on 4-16-21 due to 5th toe amputated on right foot. Patient educated on signs and symptoms of infection. PMH (past medical history) of ESRD (end stage renal disease), HTN, and anemia..." The findings were reviewed with and acknowledged by Admin-A and DCS-B during an interview on 8/10/21 at 1400 hours.

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 observation, document review, and interview it was determined that the agency failed to ensure the registered nurse performed a complete and accurate review of the medications the patient was taking at the time of the comprehensive assessments in 1 out of 3 records reviewed in which a surveyor home visit was conducted (MR# 6), which resulted in the potential for adverse patient outcomes or patient injury from inaccurate medication administration. Findings include: MR#6: This 87-year-old patient was admitted to the agency on 7/20/21 with diagnoses of metabolic encephalopathy, altered mental status, and repeat falls. On 7/20/21, DCS-B (director of clinical services-registered nurse) documented the initial comprehensive assessment, which included a drug review. During a joint survey home visit with LPN-C (licensed practical nurse) on 8/4/21 at 1130 hours, the caregiver was asked if the medication list on the plan of care dated 7/20/20 was correct. The caregiver went to the cupboard and pulled out 2 additional vials of medication: 1) Atorvastatin 40 mg one daily (dated 6/10/21) 2) Sertraline Hcl 50 mg one daily at night (dated 6/10/21). LPN-C failed to acknowledge the additional medication during the home visit. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours.

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, it was determined the Home Health Agency (HHA) failed to ensure the goals on the Plan of Care (POC) were measurable in 4 of 10 records reviewed (M.R.#s 1, 2, 4, 5), resulting in the potential for a plan of care not meeting the patient's needs. Findings include: **Agency policy: Care Planning Process. The agency's policy did not address parameters or measurable goals. MR#1: The start of care (SOC) date was on 7/14/21, with diagnoses of heart disease, Neoplasm of breast and dehydration. During record review on 8/3/21, it was discovered that the goals on the POC were not measurable, for example, one goal stated, "Verbalize/demonstrate measures to prevent falls." Another stated, "Abnormal O2 saturations will be reported to the physician." There were no oxygen (O2) parameters on the POC to indicate when to report to the physician. There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR#2: The SOC date was on 7/14/21, with diagnoses of sepsis, hypotension and weakness. During record review on 8/4/21, it was discovered that the goals on the POC were not measurable, for example, one goal stated, "Patient will demonstrate compliance with medications as prescribed." Another stated, "Abnormal O2 saturations will be reported to the physician." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR#4: The SOC date was on 7/22/21, with diagnoses of chronic obstructive pulmonary disease (COPD), heart failure and falls. During record review on 8/5/21, it was discovered that the goals on the POC were not measurable, for example, one goal stated, "Abnormal O2 saturations will be reported to the physician." Another stated, "Cardiovascular exacerbations will be identified promptly and interventions to minimize risks." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR#5: The SOC date was on 7/22/21, with diagnoses of malnutrition, type 2 diabetes mellitus and sepsis. During record review on 8/6/21, it was discovered that the goals on the POC were not measurable, for example, one goal stated, "Abnormal O2 saturations will be reported to the physician." Another stated, "Patient will verbalize/demonstrate techniques needed for safe use of walker by 8/21/21." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1345 hours.

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 Home Health Agency (HHA) failed to ensure individualized interventions and parameters were documented on the plan of care (POC) for 4 of 10 records reviewed (MR's 1, 2, 4 and 5), resulting in the potential for negative patient outcomes. Findings include: MR#1: The start of care (SOC) date was on 7/14/21, with diagnoses of heart disease, Neoplasm of breast and dehydration. During record review on 8/3/21, it was discovered that the POC documented as needed (PRN) orders for O2 saturations to be performed for signs and/or symptoms of possible respiratory complications. The POC did not have oxygen (O2) parameters documented to indicate when to report to the physician. MR#2: The SOC date was on 7/14/21, with diagnoses of sepsis, hypotension and weakness. During record review on 8/4/21, it was discovered that the POC documented PRN orders for O2 saturations to be performed for signs and/or symptoms of possible respiratory complications The POC did not have O2 parameters documented to indicate when to report to the physician. MR#4: The SOC date was on 7/22/21, with diagnoses of chronic obstructive pulmonary disease (COPD), heart failure and falls. During record review on 8/5/21, it was discovered that the POC documented PRN orders for O2 saturations to be performed for signs and/or symptoms of possible respiratory complications. This patient has a primary diagnosis of COPD with continuous O2 at 3 liters. The POC did not have O2 parameters documented to indicate when to report to the physician. MR#5: The SOC date was on 7/22/21, with diagnoses of malnutrition, type 2 diabetes mellitus and sepsis. During record review on 8/6/21, it was discovered that the POC documented PRN orders for O2 saturations to be performed for signs and/or symptoms of possible respiratory complications. The POC did not have O2 parameters documented to indicate when to report to the physician. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1:45 p.m.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency (HHA) failed to ensure all patient skilled nursing intervention orders were recorded in the plan of care (POC) in 1 record (MR# 8) of 10 sampled records reviewed, resulting in a lack of physician oversight and input regarding the patient's plan of care and the potential for services not provided as ordered. Findings included: **Agency policy "Physician Orders-Verbal Orders" (no date) stated, "Drugs and treatments are administered by the Agency staff only as ordered by the physician." MR#8: This 58-year-old patient was admitted to the agency on 6/16/21 with diagnoses of type 2 diabetes mellitus, congestive heart failure, acute/chronic respiratory failure, and pleural effusion. During record review on 8/4/21, it was noted that the referral dated 6/15/21 signed by the physician specified, "Pleur-X care and drainage every 5-7 days as needed for shortness of breath." Review of the plan of care dated 6/16/21 failed to contain the Pleur-X care and drainage (drainage system used for the chest tubes so fluid can be drained from lungs) every 5-7 days as needed for shortness of breath. During record review on 8/4/21, the LPN-C documented drainage of the chest tubes on 6/21/21, 6/25/21, 6/28/21, and 7/2/21. There was no documented evidence that the drainage of the chest tubes was completed on the initial comprehensive assessment on 6/16/21, and skilled nursing visit dates 6/18/21, 7/6/21 and 7/9/21 . The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review, and interview, it was determined the Agency failed to ensure skilled nursing, occupational therapy, social work, and physical therapy services were provided as ordered by the physician for 3 of 10 (MR# 6, 7, and 8) records reviewed and failed to provide the frequency of services ordered by the physician in 3 of 10 (MR# 8, 9 and 10) records reviewed in which nursing services were ordered (G710), resulting in the potential for poor patient outcomes for these patients; failed to ensure the RN (registered nurse) supervised the care provided by the LPN (licensed practical nurse) in 1 of 7 records reviewed in which LPN services were provided for more than 30 days (MR# 9), from a total sample of 10 records reviewed, resulting in a lack of clinical supervision and oversight and the potential for unmet care needs (G726); failed to ensure the Registered Nurse (RN) prepared complete written instructions for patient safety needs in 2 of 2 records in which aide services were provided (MR# 9 and 10), from a total of 10 records reviewed, resulting in the potential for unsafe, substandard care and unmet care needs (G798). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality care for the condition of participation at 42 CFR §484.75: Skilled Professional Services.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that skilled nursing, occupational therapy, social work, and physical therapy services were provided as ordered by the physician for 3 of 10 (MR# 6, 7, and 8) records reviewed and failed to provide the frequency of services ordered by the physician in 3 of 10 (MR# 8, 9 and 10)records reviewed in which nursing services were ordered, resulting in the potential for poor patient outcomes for these patients. Findings include: **Agency policy "Physician Orders" (no date) stated, "Drugs and treatments are administered by the agency staff only as ordered by the physician." MR#6: This 87-year-old patient was admitted to the agency on 7/20/21 with diagnoses of metabolic encephalopathy, altered mental status, and repeat falls. During record review on 8/4/21, it was noted that the referral dated 7/15/21 for home care services included nursing, physical therapy, occupational therapy, and home health aide services. On 7/20/21, DCS-B (director of clinical services-registered nurse) documented the start of care assessment visit. The physical therapist evaluated the patient on 7/22/21 for services. Home health aide services were not provided as ordered. There was no evidence documented why the service was not provided. The occupational therapist documented the patient evaluation on 8/4/21, there was no evidence that the patient had refused or requested the delay in evaluation. The agency failed to provide the services that were ordered in the referral. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours. MR#7: This 61-year-old patient was admitted to the agency on 7/21/21 with diagnoses of left knee joint replacement on 6/21/21. During record review on 8/4/21, it was noted that the referral for home care services came from a rehabilitation facility, dated on 7/13/21 and specified nursing, physical therapy, occupational therapy, and social work. On 7/21/21, DCS-B documented the start of care assessment visit. Physical therapy evaluated the patient on 7/21/21. Occupational therapy evaluated the patient on 8/2/21, there was no documentation if the patient requested, the late evaluation or the agency wasn't able to provide earlier. There was no documentation that MSW (master social work) was refused by patient, or the service was provided. The findings were reviewed with and acknowledged by Admin-A and DCS-B during an interview on 8/10/21 at 1400 hours. MR#8: This 58-year-old patient was admitted to the agency on 6/16/21 with diagnoses of type 2 diabetes mellitus, congestive heart failure, acute/chronic respiratory failure, and pleural effusion. During record review on 8/4/21, it was noted that the referral dated 6/15/21 signed by the physician specified nursing, occupational therapy, and physical therapy services. DCS-B completed the patient initial comprehensive assessment on 6/16/21. Physical therapy evaluated the patient 7 days (late evaluation) after the nurse opened the patient. There was no evidence that the occupational therapist evaluated or provided the services ordered in the referral. Also, the PT (physical therapy) evaluation was completed on 6/23/21 and the plan of care dated 6/16/21 stated, "2W4 for the week of 6/20/21." The PT provided only 1 visit week 2 on 6/23/21, the PT failed to provide 2 visits week 1 as specified by the plan of care. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours. DCS-B stated, "I should have notified the physician of the missed visits and got an order to change the visit frequency." MR#9: This 50-year-old patient was admitted to the agency on 4/19/21 with diagnoses of diabetes mellitus type 2 with a foot ulcer, surgical amputation of 5th toe (requiring daily dressing changes), and end stage renal disease with dialysis. During record review on 8/5/21, it was noted the DCS-B completed the comprehensive assessment on 4/19/21. The plan of care dated 4/19/21 specified skilled nursing, physical therapy, and home health aide services. The patient was transferred to the hospital with chest pain on 4/28/21, a ROC (resumption of care) was completed on 5/5/21. Updated physician orders on 5/5/21 specified skilled nursing at, "1W7." The skilled nursing failed to provide weekly visits for week 7 (5/30/21) and week 9 (week 6/13/21). Physical therapy frequency on 5/5/21 was ordered, "2W3." The physical therapist failed to document 2 visits week 4 (5/9/21), no documentation was found for the services not provided The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours. MR#10: This 67-year-old patient was admitted to the agency on 3/31/21 and recertified on 5/30/21 with diagnoses of atrial fibrillation, peripheral vascular disease, and urinary tract infection with a catheter. Skilled nursing services were ordered, "1W1, 1every4W4, 1W1" to complete catheter change every 4 weeks. The skilled nurse changed the catheter on 5/27/21, 6/29/21 and it was due to be changed 6/27/21. The skilled nurse failed to document a visit for catheter change, there was no physician order or reason documented for not completing the catheter change. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on policy review, record review and interview, the agency failed to ensure the RN (registered nurse) supervised the care provided by the LPN (licensed practical nurse) in 1 of 7 records reviewed in which LPN services were provided for more than 30 days (MR# 9), from a total sample of 10 records reviewed, resulting in a lack of clinical supervision and oversight and the potential for unmet care needs. Findings include: **Agency policy "Nursing Services" (no date) stated, "The LPN/LVN will be supervised by the RN as required by applicable state rules and regulations." MR#9: This 50-year-old patient was admitted to the agency on 4/19/21 with diagnoses of diabetes mellitus type 2 with foot ulcer, surgical amputation of 5th toe (requiring daily dressing changes), and end stage renal disease with dialysis. During record review on 8/5/21, it was noted the DCS-B completed the comprehensive assessment on 4/19/21. The plan of care dated 4/19/21 specified skilled nursing with a frequency, "2W1, 1W2, 2W1." The patient was transferred to the hospital with chest pain on 4/28/21, a ROC (resumption of care) was completed on 5/5/21. Updated physician orders on 5/5/21 specified skilled nursing at, "1W7." The DCS-B (director of clinical services-registered nurse) provided the resumption of care on 5/5/21(week 2), no LPN supervision was documented on that visit. The LPN-C (licensed practical nurse) provided visits 4/21/21 (week 1), 4/26/21 (week 2), 5/12/21 (week 4), 5/20/21 (week 5), 5/24/21 (week 6), no visit week 7, and 6/9/21 (week 8), with no supervision documented by the registered nurse. The agency failed to provide LPN supervision every 30 days as required by their policy. During an interview Consultant-E stated, "LPN supervision is required every 30 days." The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure the Registered Nurse (RN) prepared complete written instructions for patient safety needs in 2 of 2 records in which aide services were provided (MR# 9 and 10), from a total of 10 records reviewed, resulting in the potential for unsafe, substandard care and unmet care needs. Findings include: MR#9: This 50-year-old patient was admitted to the agency on 4/19/21 with diagnoses of diabetes mellitus type 2 with foot ulcer, surgical amputation of 5th toe (requiring daily dressing changes), and end stage renal disease with dialysis. The plan of care dated 4/19/21 specified skilled nursing, physical therapy, and home health aide services. The plan of care specified functional limitations of endurance and ambulation. Safety measures were adequate lighting, anticoagulant precautions, clean technique, clear pathways, disposal of medical waste, emergency plan, fall preventions, med precautions, and universal precautions. The HHa (home health aide) care plan dated 5/5/21 failed to include safety precautions and functional limitations to ensure the safety of the patient while the aide was providing care. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours. MR#10: This 67-year-old patient was admitted to the agency on 3/31/21 and recertified on 5/30/21 with diagnoses of atrial fibrillation, peripheral vascular disease, and urinary tract infection with a catheter. The plan of care dated 5/30/21 specified functional limitations of bowel/bladder (incontinence), endurance, and ambulation. The safety measures were adequate lighting, clean technique, clear pathways, disposal of medical waste, emergency plan, infection prevention, fall preventions, med precautions, and universal precautions. The HHa care plan dated 5/30/21 failed to include safety precautions and functional limitations to ensure the safety of the patient while the aide was providing care. The findings were reviewed with and acknowledged by Admin-A (administrator) and DCS-B during an interview on 8/10/21 at 1400 hours.