Every finding on record at Valerie Home Health Care Services, Inc

On January 3, through January 10, 2023, an Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. At the survey, Valerie Home Health Care Services was found to be in substantial compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness.

A Medicare recertification survey was conducted on 1/3/23 through 1/10/23 by the Michigan Department of Licensing and Regulatory Affairs at: Valerie Home Health Care Services 30445 Northwestern Highway, Suite 130 Farmington Hills, MI 48334 At the time of the survey, the agency did not operate any branch offices. For this survey, two active records were reviewed with two home visits and five discharge records were reviewed for a total of seven records reviewed. The agency had two active patients at the time of the survey. The agency was determined to not be in compliance with the Covid-19 Vaccine requirement stated at QSO-22-07-ALL Attachment G for Home Health Agencies. Condition level deficiencies were noted 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 and Performance Improvement 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).

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 observation, record review, and interview, the agency failed to ensure the initial assessment visit was conducted within 48 hours of referral for 3 of 7 (MR 2, 4, 6) records reviewed (refer to G514); failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on the patient's past medical history that included dates of onset, treatments and outcomes, history of events leading to the need for current home care services and the referral date in 3 of 7 (MR 1, 2, 3) records reviewed (refer to G528); failed to ensure the physician was informed of any potential adverse effects such as: side effects, drug interactions, and duplicate drug therapy for 1 of 7 (MR 7) records reviewed (refer to G536); failed to ensure the update to the comprehensive assessment warranted recertification for an additional episode of care for 1 of 2 (MR 7) records reviewed in which patient care was recertified for additional episodes of care (refer to G544); and failed to ensure the comprehensive assessment at discharge indicated the patient had met the care plan goals for 3 of 5 (MR 2, 4, 6) discharge records reviewed (refer to G550). The cumulative effect of these systemic problems 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 of patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initial assessment visit was conducted within 48 hours of referral for 3 of 7 (MR 2, 4, 6) records reviewed, resulting in a delay in determining the immediate care and support needs for these patients. Findings include: MR 4: The referral for skilled nursing services three times weekly for wound care was fax stamped on 5/11/22. The initial assessment visit was conducted by the registered nurse (ADM/CM-A) on 5/23/22, which is 12 days after the agency received the referral. The patient was admitted to home care on 5/23/22 with diagnoses of bilateral lower leg chronic ulcers. On 5/23/22, ADM/CM-A wrote a physician order that stated the patient had requested the delay in the start of care due to other scheduled appointments. During record review on 1/5/23, it was noted that there was no documented evidence that ADM/CM-A informed the physician, prior to 5/23/22, that there would be a 12-day delay in the initial assessment visit to determine the wound care needs of this patient. The findings were reviewed with and acknowledged by ADM/CM-A during an interview on 1/10/23 at 11:10 a.m. ADM/CM-A explained that she did inform the doctor prior to 5/23/22 but failed to document the communication. MR 6: The referral for skilled nursing, physical therapy, and occupational therapy was fax stamped as received at the agency on 8/12/22 at 5:04 p.m. The patient was medically cleared and discharged from the hospital on 8/12/22. The initial assessment visit was conducted by ADM/CM-A on 8/15/22, which is 3 days after the agency received the referral. The patient was admitted to home care on 8/15/22 with diagnoses of chest pain and acute respiratory failure with hypoxia. During record review on 1/4/23, it was noted that there was no documented evidence that the patient had requested a delay in home care services and no documentation that the physician was informed of the delay in the initial assessment visit. MR#2: The Start of Care (SOC) was dated 1/17/2022. The Plan of Care (POC) identified a primary diagnosis of Type 2 Diabetes with Hyperglycemia, and secondary diagnoses of Vascular Syndromes of Brain in Cerebrovascular Diseases (CVA), Hypertension (HTN), Muscle Weakness, Dysphagia and Facial Weakness following Cerebral Infarction. The patient was receiving Physical Therapy (PT), Occupational Therapy (OT), and Speech Therapy (ST) services. Upon review of the record, it was noted the patient was referred to Home Care Services on 1/14/2023, however, the Start of Care Assessment was dated 1/17/23, 3 days after the referral. There was no evidence found in the record that indicated the patient had requested a delay in services, nor was there any documentation that the physician had been notified of the delay in the SOC Assessment. These findings were reviewed and acknowledged by ADM/CM-A during an interview on 1/10/23 at 1:10 p.m. ADM/CM-A stated that she failed to document the physician had been notified of the delay in the Start of Care.

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 the patient's past medical history that included dates of onset, treatments and outcomes, history of events leading to the need for current home care services and the referral date in 3 of 7 records reviewed (MR#s 1, 2, 3), resulting in incomplete clinical information to aid in determining the needs of the patient, and to aid in creating individualized patient specific goals to address the patient's individualized needs. Findings included: MR#1: The Start of Care (SOC) was dated 12/30/2022. The Plan of Care (POC) for the certification period 12/30/22 to 2/27/22 identified a primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and secondary diagnoses of Allergic Rhinitis, Gastro-intestinal Reflux, Sub-clinical Iodine-deficiency, Hypothyroidism, Shortness of Breath (SOB), and Hypertension (HTN). Upon review of the Comprehensive Assessment, it was noted under "Past Medical History" the following diagnoses had check marks: "Hypertension, Osteoarthritis/Degenerative Joint Disease of bilateral knees, Chronic Obstructive Bronchitis, COPD, Hypothyroidism, Debility, Abnormality of Gait, and Chronic Pain. There was no history of the status of the above diseases including treatments for these past medical problems, and the outcomes of those treatments. There was no documented evidence of an assessment of the events that led to this specific home care referral, no date for the referral, and no assessment of the patient's specific current home care needs. During an interview on 1/10/22 at 1:00 p.m. the Administrator (ADM/CM-A) was queried why the patient needed 24 episodes of home care services from this agency. The response was "she has chronic conditions with frequent hospitalizations and requires home care services upon discharge. The patient always asks for our agency to provide the services, and her doctor sends the order to our agency." MR#2: The Start of Care (SOC) was dated 1/17/2022. The Plan of Care (POC) identified a primary diagnosis of Type 2 Diabetes with Hyperglycemia, and secondary diagnoses of Vascular Syndromes of the Brain in Cerebrovascular Diseases, Hypertension (HTN), Muscle Weakness, Dysphagia following Cerebral Infarction, Facial Weakness following other Cerebrovascular Disease. Upon review of the POC, it was noted the patient was receiving Physical Therapy (PT) and Occupational Therapy (OT) services. Upon review of the Start of Care Comprehensive Assessment it was noted under "Past Medical History" the following diagnoses had check marks: "Hypertension, Osteoarthritis/Degenerative Joint Disease of bilateral knees, Chronic Obstructive Bronchitis, COPD, pacemaker, and thoracic and lumbar spinal stenosis. There was no history of how long the patient had any of the above diseases/conditions, no dates of onset documented, or when and how the diseases occurred and if they were chronic or resolved. There was no history of the status of the above diseases including treatments for past medical problems and outcomes of those treatments. There was no documented evidence of an assessment of the events that led to the home care referral, no date for the referral, and no assessment of the patient's specific current home care needs. MR#3: The Start of Care (SOC) was dated 1/7/2022. The Plan of Care (POC) for the certification period 1/07/22 to 3/07/22 identified a primary diagnosis of Chronic Bronchitis, and secondary diagnoses of Urinary Incontinence, Allergic Rhinitis, and abnormalities of gait and mobility. There was no history of how long the patient had any of the above diseases/conditions, no dates of onset documented, or when and how the diseases occurred and if they were chronic or resolved. There was no history of the status of the above diseases including treatments for past medical problems and outcomes of those treatments. There was no documented evidence of an assessment of the events that led to the home care referral, no date for the referral, and no assessment of the patient's specific current home care needs.

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 physician was informed of any potential adverse effects such as: side effects, drug interactions, and duplicate drug therapy for 1 of 7 (MR 7) records reviewed, resulting in the potential for harmful medication effects for this patient. Findings include: MR 7: This patient was admitted to home care on 9/19/22 with diagnoses of type 2 diabetes, chronic obstructive pulmonary disease, and high blood pressure. During record review on 1/4/23, it was noted that the medical record contained a drug interaction report from Drugs.com (date unknown). The drug interaction report notes that there are 3 potential major interactions (Ibuprofen + aspirin; potassium chloride + Olmesartan; and Codeine + Gabapentin). There was no documented evidence the physician was informed of these potential major interactions. During an interview on 1/4/23 at 1:00 p.m., the finding was reviewed with the administrator/clinical manager (ADM/CM-A) who explained that she runs the drug interaction report on Drugs.com and then informs the physician by phone after the start of care assessment. ADM/CM-A then notes the date and time she informed the physician. ADM/CM-A reviewed the medical record and acknowledged there was no documentation to indicate the physician was informed of the 3 potential major interactions.

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 observation, record review, and interview, the agency failed to ensure the update to the comprehensive assessment warranted recertification for an additional episode of care for 1 of 2 (MR 7) records reviewed in which patient care was recertified for additional episodes of care, resulting in the provision of home care services to a medically stable patient. Findings include: MR 7: This 92-year-old patient was admitted to home care on 9/19/22 with a primary diagnosis of type 2 diabetes with hyperglycemia and was recertified for a second episode of care with the same primary diagnosis. The patient receives weekly skilled nursing care visits. During record review on 1/4/23, it was noted that the 9/19/22 and the 11/18/22 plans of care failed to list any oral diabetic medications or insulin for this patient. The administrator/clinical manager/registered nurse (ADM/CM-A) was queried during an interview on 1/4/23 at 1:00 p.m. regarding the lack of diabetic medications. ADM/CM-A explained that the doctor took the patient off her diabetic medications due to the patient's age and stable blood sugars. During the first certification period, the medical record indicates that ADM/CM-A made 10 patient visits between the dates of 9/19/22 through 11/17/22. The patient's fasting blood sugar level was documented at 148 on the 9/19/22 start of care assessment and it was 130 on 11/17/22 the update of the comprehensive assessment for recertification. ADM/CM-A documented the patient's blood sugar level on 2 of 10 skilled nursing visits. The patient's blood pressure was stable ranging from a high of 148/86 to a low of 128/86. The patient rated her hip pain between 3 or 5 on a scale of 1 low to 10 high. The 9/19/22 plan of care instructed the nurse to notify the physician if the patient experienced pain equal to or greater than 4, on a scale of 0 to 10. The patient rated her hip pain at a 5 in 8 of 10 visits. There was no documented evidence that ADM/CM-A notified the physician of the patient's elevated pain level that was beyond the parameter established in the plan of care. During a joint surveyor home visit with ADM/CM-A on 1/5/23 at 10:00 a.m., the patient complained of dizziness. It was observed that ADM/CM-A did not ask the patient about her blood sugar level, did not ask about meals or when the patient last ate some food, and did not suggest the patient check her blood sugar level. After ADM/CM-A departed the joint surveyor home visit, the patient was queried regarding monitoring her blood sugar levels. The patient replied she is not a diabetic and does not check her blood sugar levels. The patient's primary diagnosis is type 2 diabetes with hyperglycemia. The patient states she's not a diabetic. The nurse is not consistently monitoring the patient's blood sugar levels. The patient's blood pressure is stable. Elevated pain levels are not reported to the physician as ordered in the plan of care. It was unclear why this patient was recertified for a second episode of care with a primary diagnosis of type 2 diabetes with hyperglycemia. On 1/4/23 at 1:00 p.m., ADM/CM-A explained that the patient was recertified for a second episode care due to long term chronic health issues.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment at discharge indicated the patient had met the care plan goals for 3 of 5 (MR 2, 4, 6) discharge records reviewed, resulting in the patient being discharged from the agency before meeting the care plan goals. Findings include: MR 4: This patient was admitted to home care on 5/23/22 with primary diagnoses of bilateral lower extremity chronic ulcers. The patient received skilled nursing services for six weeks. The 5/23/22 plan of care (POC) included the following goals: wound healing without complications within 9 weeks and patient will maintain an acceptable pain level of 2 or less in 9 weeks. During record review on 1/5/23, it was noted that the patient rated his pain level at 4 (scale 1 low to 10 high) on 13 of 13 visits. On the start of care comprehensive assessment, the administrator/nurse (ADM/CM-A) documented the size of the anterior (front) right lower extremity wound at 9 centimeters (cm) length x 13 cm width x 0.1 cm depth. Two days later, on 5/25/22 ADM/CM-A documented a deterioration in the depth of the patient's wound which now measured 9 cm x 13 cm x 11.7 cm. The depth of the anterior right lower extremity wound remained the same depth of 11.7 cm for the next 11 nursing visits. The comprehensive discharge assessment on 7/4/22 indicates the anterior right lower extremity wound now measured 9 cm x 13 cm x 0.1 cm and that the patient was discharged because goals had been met. Documentation indicates the patient did experience wound healing complications and did not achieve an acceptable pain level of 2 or less. There was no indication that this patient had met the care plan goals. The comprehensive assessment at discharge did not accurately reflect the patient's status in failing to meet care plan goals. The finding was reviewed with ADM/CM-A during an interview on 1/10/23 at 11:10 a.m. ADM/CM-A explained that the Medicare advantage provider had authorized 12 skilled nursing visits and she was unable to get authorization for additional visits. The patient was discharged prior to meeting care plan goals. MR 6: This patient was medically cleared and discharged from the hospital on 8/12/22 and was admitted to home care on 8/15/22 with primary diagnoses of chest pain and acute respiratory failure with hypoxia (lack of oxygen in the tissues). The patient received physical therapy services for 4 weeks, skilled nursing care for 5 weeks, and was discharged in week 6 without a visit. During record review on 1/4/23, it was noted that the 8/15/22 plan of care ordered nursing care for nine weeks. The patient received 1 nursing visit each week for 5 weeks and was then discharged without a visit on 9/21/22. The 9/21/22 discharge summary noted that the patient was discharged because the goals had been met. There was no evidence that the following nursing goals had been met: patient will reach optimal level in provision of personal care, will demonstrate improved coping behavior, and increase endurance and strength within 9 weeks. The finding was reviewed with ADM/CM-A during an interview on 1/10/23 at 11:10 a.m. ADM/CM-A explained that the patient had requested to be discharged. There was no documentation to evidence the patient's request for discharge. The patient was discharged prior to meeting care plan goals. MR#2: The Start of Care (SOC) was dated 1/17/2022. The Plan of Care (POC) identified a primary diagnosis of Type 2 Diabetes with Hyperglycemia, and secondary diagnoses of Vascular Syndromes of the Brain in Cerebrovascular Diseases, Hypertension (HTN), Muscle Weakness, Dysphagia following Cerebral Infarction, Facial Weakness following other Cerebrovascular Disease. Upon review of the POC, it was noted the patient was receiving Registered Nursing (RN), Physical Therapy (PT), and Speech Therapy (ST) services. The POC included the following goals: "Patient and/or caregiver will reach optimal level in provision of personal care and ADL (activities of daily living) assistance within 9 weeks; Patient will demonstrate improved coping behaviors by 9 weeks; Patient and or caregiver will verbalize demonstrate pain controlled at acceptable level. There was no documentation that this patient had met these care plan goals.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included frequency and duration of visits, interventions, treatments, measurable outcomes, and goals for 7 of 7 (MR 1, 2, 3, 4, 5, 6, 7) records reviewed (refer to G574); failed to ensure the physical therapist notify the physician of findings that fell outside the parameters ordered in the patient’s plan of care in 1 of 4 (MR 6) records reviewed with physical therapy services (refer to G578); and failed to ensure the physician was notified of significant changes in the condition of the patient for 2 of 7 (MR 4, 7) records reviewed (refer to G590). The cumulative effect of these systemic problems 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 §484.60 Care Planning, Coordination of Services, and Quality of Care.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included frequency and duration of visits, interventions, treatments, measurable outcomes, and goals for 7 of 7 (MR 1, 2, 3, 4, 5, 6, 7) records reviewed, resulting in the potential for poor patient outcomes due to a lack of quantifiable measures to determine progress towards goals for these patients. Findings include: MR 4: This patient was admitted to home care on 5/23/22 with primary diagnoses of bilateral lower extremity chronic ulcers. The 5/23/22 plan of care (POC) indicates the skilled nurse is to provide three visits weekly. During record review on 1/5/23, it was noted that the POC failed to indicate the duration, or how many weeks, the nurse would be providing services. The POC also failed to include measurable skilled nursing goals and outcomes. The POC noted the following goals and outcomes: patient and/or caregiver will reach optimal level in provision of personal care, patient will demonstrate improved coping behavior, and increase endurance and strength within 9 weeks. There was no indication how the skilled nurse would determine the patient's optimal level in provision of personal care, improved coping behavior, or increased endurance or strength. It was unclear how these goals would be measured to determine the patient's progress towards discharge. The findings were reviewed with and acknowledged by the administrator/clinical manager (ADM/CM-A) during an interview on 1/10/23 at 11:10 a.m. MR 5: This patient was admitted to home care on 1/7/22 with a primary diagnosis of type 2 diabetes with hyperglycemia. The 1/7/22 POC indicates the skilled nurse is to provide weekly visits for eight weeks. During record review on 1/5/23, it was noted that the patient's medications listed on the POC included the following oral diabetic medications: Metformin Hydrochloride and Glipizide. The POC failed to include reportable parameters regarding blood sugar levels. Nursing interventions and goals were vague and did not support a primary diagnosis of type 2 diabetes with hyperglycemia. The POC included the following goals: patient will demonstrate knowledge of pathophysiology - diabetes, will prepare correct meals, and verbalize dietary instructions regarding diabetic diet. It was unclear how these goals would be measured to determine the patient's progress towards discharge. MR 6: This patient was medically cleared and discharged from the hospital on 8/12/22 and was admitted to home care on 8/15/22 with primary diagnoses of chest pain and acute respiratory failure with hypoxia (lack of oxygen in the tissues). The patient received skilled nursing and physical therapy services. During record review on 1/4/23, it was noted that the physical therapy evaluation documented the following: Patient is able to walk for 30 feet on level surface with care giver assist with cane. Patient needs to walk for 250 feet on level surface. The physical therapy goal listed on the plan of care indicates the patient can be discharged when maximum functional potential is reached. It was unclear how the goal of "maximum functional potential" would be assessed to determine the patient's progress towards discharge. The plan of care failed to include the measurable goal noted in the evaluation of walking 250 feet. MR 7: This 92-year-old patient was admitted to home care on 9/19/22 with a primary diagnosis of type 2 diabetes with hyperglycemia. During record review on 1/4/23, it was noted that the 9/19/22 POC included general nursing interventions that did not support a primary diagnosis of type 2 diabetes with hyperglycemia. The POC included one nursing goal for diabetes as follows: patient and/or caregiver will demonstrate knowledge of pathophysiology...diabetes. The goal is vague, and it is unclear how this goal would be measured to determine progress towards discharge. MR#1: The Start of Care (SOC) was dated 12/30/2022. The Plan of Care (POC) for the certification period 12/30/22 to 2/27/22 identified a primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and secondary diagnoses of Allergic Rhinitis, Gastro-intestinal Reflux, Sub-clinical Iodine-deficiency Hypothyroidism, Shortness of Breath (SOB), and Hypertension (HTN). Upon review of the Plan of Care, it was noted the goals were not objectively measurable to determine the patient's progress towards achieving the goals. Examples include: "Patient and/or caregiver will demonstrate knowledge of pathophysiology - COPD, Bronchitis, HTN, Debility, Chronic Pain, GERD, Allergic Rhinitis, Hypothyroidism, Management of and complications of disease processes, medication, purpose of medications, and medication side effects. Will also achieve maximum independence in-Home Management of Disease Processes with appropriate reporting to physician within 9 weeks; Patient and/or Caregiver will reach optimal level in provision of personal care and ADL assistance within 9 weeks; Patient will demonstrate improved coping behaviors by 9 weeks. These goals are not specific to the patient's needs, nor measurable to determine the patients progress towards achieving the goals. MR#2: The Start of Care (SOC) was dated 1/17/2022. The Plan of Care (POC) identified a primary diagnosis of Type 2 Diabetes with Hyperglycemia, and secondary diagnoses of Vascular syndromes of brain in cerebrovascular Diseases, Hypertension (HTN), muscle weakness, Dysphagia following Cerebral Infarction, Facial Weakness following other cerebrovascular Disease. Upon review of the POC, it was noted the goals were not objectively measurable to determine the patient's progress towards goals. Examples included: "Patient and/or Caregiver will demonstrate knowledge of Pathophysiology for HTN, DM, CVA, Muscle weakness, facial weakness, dysphagia; management of and complications of disease processes, medication, purpose of medications, and medication side effects; The patient will also achieve maximum independence in home management of disease processes with appropriate reporting to physician within 9 weeks. These goals are not specific or measurable to determine the patients progress towards achieving the goals. MR#3: The Start of Care (SOC) was dated 1/7/2022. The Plan of Care (POC) for the certification period 1/07/22 to 3/07/22 identified a primary diagnosis of Chronic Bronchitis, and secondary diagnoses of Urinary Incontinence, Allergic Rhinitis, and abnormalities of gait and mobility. Upon review of the POC, it was noted the goals were not objectively measurable to determine the patient's progress towards goals. Examples include: "Patient and/or caregiver will demonstrate knowledge of pathophysiology of chronic bronchitis, urinary incontinence, abnormalities of gait, and allergic rhinitis, management and complications of disease processes, medication, purpose of medications, and medication side effects; patient will demonstrate improved coping behavior by 9 weeks; Patient and/or caregiver will reach optimal level in provision of personal care and ADL assistance within 9 weeks. These goals are not specific to the patient's needs, nor are they objectively measurable to determine the patient's progress towards goals.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physical therapist notify the physician of findings that fell outside the parameters ordered in the patient’s plan of care in 1 of 4 (MR 6) records reviewed with physical therapy services, resulting in the potential for physical decline and unmet care needs for this patient. Findings include: MR 6: This patient was admitted to home care on 8/15/22 with primary diagnoses of chest pain and acute respiratory failure with hypoxia (lack of oxygen in the tissues). The 8/15/22 plan of care orders disciplines to notify the physician when the patient's pain is greater than 5 (scale 0 low to 10 high). On 8/26/22, PT-F (physical therapist) documents the patient's pain rating at 6 in both knees and the lower back. During record review on 1/4/23, it was noted that there was no documentation to indicate PT-F notified the physician of the patient's elevated pain level as ordered in the plan of care. The findings were reviewed with and acknowledged by the administrator/clinical manager (ADM/CM-A) during an interview on 1/10/23 at 11:10 a.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 and interview, the agency failed to ensure the physician was notified of significant changes in the condition of the patient for 2 of 7 (MR 4, 7) records reviewed, resulting in the potential for poor patient outcomes for these patients. Findings include: MR 4: This patient was admitted to home care on 5/23/22 with primary diagnoses of bilateral lower extremity chronic ulcers. On the start of care comprehensive assessment, the nurse (ADM/CM-A) documented the size of the anterior (front) right lower extremity wound at 9 centimeters (cm) length x 13 cm width x 0.1 cm depth. Two days later on 5/25/22 ADM/CM-A documented a deterioration in the depth of the patient's wound which now measured 9 cm x 13 cm x 11.7 cm. This is a dramatic increase in the depth of the wound and may have been a typographical error by ADM/CM-A. However, during record review on 1/5/23, it was noted that 11 of 13 visit notes throughout the episode of care (5/23/22 to 7/4/22) documented by ADM/CM-A indicate that the depth of the wound on the anterior right lower leg remained at 11.7 cm. There was no documented evidence that the physician was notified of the significant change in the status of the patient's wound. The finding was reviewed with and acknowledged by the administrator ADM/CM-A during an interview on 1/10/23 at 11:10 a.m. MR 7: This 92-year-old patient was admitted to home care on 9/19/22 with a primary diagnosis of type 2 diabetes with hyperglycemia. The 9/19/22 plan of care (POC) orders weekly nursing visits and instructs the nurse to notify the physician if the patient experiences pain equal to or greater than 4, on a scale of 0 to 10. The patient rated her hip pain at a 5 in 8 of 10 visits between 9/21/22 to 11/10/22. There was no documented evidence that ADM/CM-A notified the physician of the patient's elevated pain level that was beyond the parameter established in the plan of care.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview the agency failed to develop a Quality Assessment Performance Improvement (QAPI) program to optimize patient outcomes. Findings included: The Agency failed to develop a Quality Assessment Performance Improvement (QAPI) Program to optimize the agency's patient outcomes for the years 2022 and 2023 (G-642); The Governing Board failed to approve a Performance Improvement Program for the years 2022 and 2023 that included the manner, frequency, and detail of patient data collection as a measurement to identify improvement in patient care (G-644); failed to initiate any performance improvement activities within their QAPI program that focused on high risk, high volume, or problem prone areas (G-648); failed to initiate any performance improvement activities within their Quality Assessment Performance improvement Program (QAPI), that addressed incidence, prevalence, and severity of problems identified amongst the agency's own patient population as areas of focus to improve patient care (G-650); failed to track adverse patient events, analyze their causes, and implement preventive actions (G-654); failed to ensure a Performance Improvement Program for quality improvement and patient safety is defined, implemented, maintained, addresses priorities for improved quality of care, patient safety, and that all improvement actions are evaluated for effectiveness and approved by the Governing Board. (G660). These practices could affect all of the agency's patients. The cumulative effect of these systemic problems resulted in the agency's inability to improve patient care, health outcomes, patient safety, and the agency's overall care performance resulting in the agency not providing quality health care.

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: 0642: Based on record reviewed and Interview, the Agency failed to develop a Quality Assessment Performance Improvement (QAPI) Program to optimize the agency's patient outcomes. This practice could affect all of the agency's patients admitted to the agency. Findings included: Upon review of the agency's QAPI Program on 1/3/2023 it was discovered that the agency failed to initiate a QAPI program based on monitoring adverse or negative patient outcomes or processes the agency wishes to measure for improvements. There was no evidence that any data was collected based on the agency's own patient population and record keeping in determining a need for a coordinated agency-wide program for the surveillance investigation, identification, and prevention of future negative outcomes. These findings were reviewed and acknowledged by the Administrator/Clinical Manager (ADM/CM-A) on 1/10/2023 at 1:10 p.m.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program to ensure the effectiveness and safety of services, quality of care, and to identify opportunities for improvement. Findings included: During a review of the Agency QAPI Program on 1/3/2023, it was noted that the program included statistics from National Home Care Venues, however there was no evidence the agency had developed a QAPI program that included methods to collect and monitor its own patient data to use as a comparison to national performance, to ensure the safety of patients and the quality of care provided by this agency. There was also no indication that the Governing Board had approved the manner, frequency, and detail of patient data collection as a measurement to identify improvement in patient care. A review of the Governing Board Meeting Minutes for the year 2022 failed to reveal documentation of a discussion to approve a Quality Assessment and Performance Improvement Project for the year 2023. This finding was reviewed and acknowledged by the Administrator and Director of Operations during an interview on 1/10/2023 at 1:30 p.m.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to initiate a Performance Improvement Program (PIP) within their QAPI program that focused on high risk, high volume, or problem prone areas, resulting in the potential for agency issues with negative consequences for high risk, high volume, or problem prone areas that could affect all patients served by the agency. Findings included: During an interview on 1/10/23 at 1:00 p.m., the Administrator/Clinical Manager A/CM-A and the Director of Operations were queried about the Performance Improvement Program (PIP) activities the agency was conducting. The response was, "we do chart reviews." When asked what Performance Improvement Project was presented to the governing board and approved, there was no response. When asked if the agency had decided what needed to be monitored and improved for the agency, the response was, "we look at the complaint logs." ADM/CM-A was asked if information from the complaint logs was used to come to an agreement of a project to improve the agency's services? "Yes, we use that information". ADM/CM-A and DO-B were asked what Performance Improvement Project is the agency working on currently? DO-B responded, "we do have a Performance Improvement Project." At the conclusion of the interview, neither ADM/CM-A nor DO-B were able to present evidence or voice a current Performance Improvement Project that the agency had chosen to improve services provided by the agency. The agency failed to develop a Performance Improvement Project to improve services provided by the agency. This finding was reviewed and acknowledged by the Administrator and Director of Operations during an interview on 1/10/2023 at 1:30 p.m.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to initiate any performance improvement activities within their QAPI program that focused on high risk, high volume, or problem prone areas, resulting in the potential for agency issues with negative consequences for high risk, high volume, or problem prone areas that could affect all patients served by the agency. Findings included: During a review of the Agencies QAPI program, it was noted that there was no data collected specific to the agency's patient population. The notebook that was provided for review did have data from national home care data sources, but no data was noted that was specific to the agency. During an interview with the Administrator/Clinical Manager (ADM/CM-A) on 1/10/23 at 1:00 p.m., ADM/CM-A stated, "the national data is collected as a baseline for which to compare our own patient population's data, and I will admit, I am behind on collecting patient QAPI data for our program, but we can pull patient data sources and reports from our Electronic Medical Record that includes problem areas including high risk and high patient volume activities." The agency failed to collect data from its own patient population to compare with national statistics to determine improvements in services to the agency's patients. This finding was reviewed and acknowledged by the Administrator/Clinical Manager (ADM/CM-A) during an interview on 1/10/22 at 1:30 p.m.

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on document review and interview, the Agency failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement Program (QAPI), that addressed incidence, prevalence, and severity of problems identified amongst the agency's own patient population as areas of focus to improve patient care, resulting in the potential for rendering substandard care and unmet care needs. Findings included: During an interview with the Administrator/Clinical Manager (ADM/CM-A) on 1/10/23 at 1:00 p.m., the clinical manager was asked if the agency had tracked the agency's adverse patient events and investigated the causes in order to implement preventive actions. The response was, "No, but I can pull that information easily from our electronic medical record as a reference to obtain that information." The agency failed to collect data incidence, prevalence, and severity of problems identified amongst the agency's own patient population to use as data for the agency's Performance Improvement Program.

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 document review, and interview, the agency failed to track adverse patient events, analyze their causes, and implement preventive actions. Findings include: During an interview with the Administrator/Clinical Manager (ADM/CM-A) regarding the agency QAPI Program on 1/10/23 at 1:00 p.m., the clinical manager was queried if the agency had tracked the agency's adverse patient events and investigated the causes in order to implement preventive actions for future patients as a part of future agency QAPI programs. The response was, "No, but I can always obtain that information on the National Databases if needed." The agency failed to track agency adverse patient events to implement preventative actions as a part of their QAPI Program.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on document review and interview, the Governing Body (GB) failed to ensure a Performance Improvement Program for quality improvement and patient safety is approved by the Governing Body, defined, implemented, maintained, addresses priorities for improved quality of care, patient safety, and that all improvement actions are evaluated for effectiveness. Findings include: Based on documents reviewed and interview, the Governing Body failed to approve a Performance Improvement Program for the year 2023. Findings included: On 1/3/2023 at 11:00 a.m., the Director of Operations (DO-B) was asked to provide a copy of the agency's QAPI Program for 2023, along with Governing Board Meeting Minutes for the years 2022 and 2023. Upon review of the documents, it was noted that the Governing Board Meeting Minutes failed to have language defining and approving the agency's 2022 or 2023 Performance Improvement Projects. Upon review of the documents, it was noted that the Performance Improvement project provided to this surveyor was actually a policy, not a plan on how to implement and perform a project to improve patient care. During an interview with DO-B on 1/3/2023 at 12:00 noon, DO-B was asked to provide the documents for the 2023 Performance Improvement Project. The response was, "I already provided that to you." It was explained that he provided a policy, not a plan for a project defining implementation and goals to achieve to improve patient outcomes. DO-B was asked to explain the Performance Improvement Plan approved by the Governing Body to be performed for the year 2023. The response was, "it's there, I gave it to you, I have nothing more to give to you." The agency failed to have a Performance Improvement Project approved by the Governing Body for the year 2023.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure to document and track the COVID-19 vaccination completion, exemption, or temporary delay status for 1 of 8 (HHA-H) staff that provide patient care for the agency. This has the potential to negatively affect the health and well-being of the agency's 2 current patients. Findings include: On 1/3/23 at 11:15 a.m., the director of operations (DO-B) provided for review five envelopes containing copies of vaccine cards for five employees. The employee list provided by DO-B indicates the agency has eight staff that may furnish patient care. At 11:30 a.m., DO-B was asked to provide documentation of vaccine status or exemption for the remaining three employees. At 12 noon, additional information was received for two employees. At 12:10 p.m., an additional request was made for the information for the remaining employee HHA-H (home health aide). No documentation was received on 1/3/23 regarding HHA-H. On 1/4/23, the information for HHA-H was requested at 9:40 a.m. and 11:00 a.m. No documentation was received by the time of the survey exit on 1/10/23 at 4:00 p.m. This indicates a compliance rate of 88% for staff that may furnish patient care. The finding was reviewed with and acknowledged by the administrator ADM/CM-A during an interview on 1/10/23 at 11:10 a.m.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals performed assessments of the patient's health status and needs in 2 of 4 (MR 5, 6) records reviewed with multiple disciplines, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes. Findings include: MR 5: This patient was admitted to home care on 1/7/22 with a primary diagnosis of type 2 diabetes with hyperglycemia. The 1/7/22 POC indicates the skilled nurse is to provide weekly visits for eight weeks. During record review on 1/5/23, it was noted that the administrator/nurse (ADM/CM-A) documented a fasting blood sugar level of 136 on 1/7/22 during the comprehensive assessment and then a blood sugar level of 126 on 2/21/22 during the discharge assessment. The other seven nursing visits documented by the nurse failed to note the skilled nurse was monitoring or assessing the blood sugar levels of this patient with a primary diagnosis of type 2 diabetes with hyperglycemia. The findings were reviewed with and acknowledged by ADM/CM-A during an interview on 1/10/23 at 11:10 a.m. ADM/CM-A explained that this patient resides in a group home and the patient's blood sugar is monitored by the staff at the group home. MR 6: This patient was admitted to home care on 8/15/22 with primary diagnoses of chest pain and acute respiratory failure with hypoxia (lack of oxygen in the tissues). The 8/15/22 plan of care orders skilled nursing and physical therapy services for this patient. During an interview on 1/4/23 at 3:00 p.m., ADM/CM-A explained that after the patient is admitted to home care the agency expects other disciplines (such as therapy or social work) to complete their assessments within one week of admission to home care. During record review on 1/4/23, it was noted that the physical therapist assessed the patient on 8/26/22, which is 11 days after the patient was admitted to home care. There was no documented evidence the patient had delayed the physical therapy assessment and no documentation that the physician was informed of the delay in physical therapy services. It was noted on the 8/12/22 referral for home care services that the physician ordered skilled nursing, physical therapy, and occupational therapy (OT) services. The physician ordered OT services for activities of daily living training, assessment, and teaching of adaptive equipment. Record review indicates there was no OT assessment of this patient. There was no documentation that the patient had declined OT services and no documentation informing the doctor that OT services were not provided as ordered. During an interview on 1/10/23 at 11:10 a.m., ADM/CM-A acknowledged the findings and explained that the patient had refused OT services. ADM/CM-A was unable to find documentation of the patient's refusal of OT 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 the nurse provided services as ordered by the physician in the plan of care for 2 of 7 (MR 4, 7) records reviewed, resulting in the potential for poor patient outcomes for these patients. Findings include: MR 4: This patient was admitted to home care on 5/23/22 with primary diagnoses of bilateral lower extremity chronic ulcers. The 5/23/22 plan of care (POC) indicates the skilled nurse was to furnish three visits weekly to provide wound care. During record review on 1/5/23, it was noted that the nurse failed to provide visits in week 6 (from 6/26/22 to 7/2/22). There was no documented evidence to indicate the patient had declined visits and no evidence that the physician was informed that visits had not been provided in week 6. The findings were reviewed with the administrator/clinical manager (ADM/CM-A) during an interview on 1/10/23 at 11:10 a.m. ADM/CM-A explained that the patient had wound clinic visits that week and had declined the visits. MR 7: This 92-year-old patient was admitted to home care on 9/19/22 with a primary diagnosis of type 2 diabetes with hyperglycemia. The 9/19/22 POC orders the nurse to report blood sugar levels greater than 350 or less than 70. During record review on 1/4/23, it was noted that ADM/CM-A documented 10 nursing visits between the dates of 9/19/22 through 11/17/22 and recorded a blood sugar reading on only 2 of 10 visits. It was unclear how ADM/CM-A would be able to report blood sugar levels greater than 350 or less than 70 when blood sugar levels are not consistently monitored by the nurse for this patient with a primary diagnosis of type 2 diabetes with hyperglycemia.

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 discharge summary was sent to the physician within 5 business days of discharge for 4 of 5 (MR 3, 4, 5, 6) discharge records reviewed; and failed to include required information in the Transfer Summary in 1 of 2 (MR 3) Transfer records reviewed resulting in a lack of information to ensure continuity of care for the 17 patients discharged or transferred from the agency in the past 12 months. Findings include: MR 4: This patient was admitted to home care on 5/23/22 with primary diagnoses of bilateral lower extremity chronic ulcers. A discharge OASIS (outcome and assessment information set) was completed by the nurse on 7/4/22. During record review on 1/5/23, 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 findings were reviewed with the administrator/clinical manager (ADM/CM-A) during an interview on 1/10/23 at 11:10 a.m. ADM/CM-A explained that she personally takes the discharge summaries to the physician's offices herself however, there is no documentation to verify the physician received the discharge summary within 5 business days of discharge. MR 5: This patient was admitted to home care on 1/7/22 with a primary diagnosis of type 2 diabetes with hyperglycemia. A discharge OASIS was completed by the nurse on 2/21/22. During record review on 1/5/23, 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. MR 6: This patient was admitted to home care on 8/15/22 with primary diagnoses of chest pain and acute respiratory failure with hypoxia (lack of oxygen in the tissues). A discharge OASIS was completed by the nurse on 9/21/22. During record review on 1/4/23, 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. MR#3: The Start of Care (SOC) was dated 1/7/2022. The Plan of Care (POC) for the certification period 1/07/22 to 3/07/22 identified a primary diagnosis of Chronic Bronchitis, and secondary diagnoses of Urinary Incontinence, Allergic Rhinitis, and abnormalities of gait and mobility. Upon review of the record, a Transfer Inpatient Facility and Discharge document dated 2/9/22 was completed by the Administrator (ADM/CM-A). It was noted the document was missing the following required information to assure the receiving agency was aware of important information about this patient. The document documented the patient was transferred to an inpatient facility and discharged from the agency. However, there was no documentation on the Transfer/Discharge document that stated the type of inpatient facility, or the name of the facility in which the patient was transferred. In addition, there was no documented evidence that the physician had been notified of the transfer, or the name of the facility in which the patient had been transferred. Also, there was no evidence or documentation in the record that a discharge summary had been sent to the physician within 5 business days of the patient's transfer/discharge. This finding was reviewed with the administrator/clinical manager (ADM/CM-A) during an interview on 1/10/23 at 1:00 p.m. ADM/CM-A stated, "I personally deliver all discharge/transfer summaries to the physicians' offices to ensure the physician receives the information, however, there was no documentation in the record of time and date that the physician received the summaries within the required 5-day timeline."