Every finding on record at Sunshine Home Care of Michigan, Inc

On February 7, 2023, through February 9, 2023, an Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. During the survey, Sunshine Homecare of Michigan was found to be not in compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness. The following condition level deficiency was identified: 42 CFR §484.102 Emergency Preparedness

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness plan centered on both agency-based and community-based risk assessments (See E0006); failed to develop written emergency preparedness policies and procedures that were based on an emergency preparedness plan, risk assessment, and communication plan (See E0013); and failed to develop and maintain an Emergency Preparedness training and testing program that is based on the emergency plan, risk assessment, policies, procedures, and communication plan. These deficient practices have the potential to negatively affect the health and safety of the agency's 2 current patients. Findings include: The cumulative effect of these systemic problems results in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.102, Emergency Preparedness.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness plan centered on both agency-based and community-based risk assessments, resulting in a lack of direction and duties for agency personnel in the event of an actual disaster. This deficient practice has the potential to negatively affect the health and safety of the agency's 2 current patients. Findings include: On 2/9/23, the agency's Emergency Preparedness documentation was reviewed. The agency's policy titled, Emergency Operations Plan and Policies (revised January 2020), provides detailed instructions for the agency to follow to create a plan. There is no documentation to indicate the agency did create their own emergency plan. There is no documentation of agency-based and community-based risk assessments which is required in the development of the agency's emergency plan. The forms for facility-based and community-based hazard vulnerability analysis were blank. During an interview on 2/9/23 at 1:10 p.m., the administrator (ADM-B) reviewed the agency's Emergency Preparedness binder. ADM-B explained that the hazard vulnerability analysis forms were filled out, but she was unable to locate the documents at that time. The agency failed to develop an emergency preparedness plan based on both agency-based and community-based risk assessments.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop written emergency preparedness policies and procedures that were based on an emergency preparedness plan, risk assessment, and communication plan. Resulting in the agency's inability to implement appropriate emergency actions. This deficient practice has the potential to negatively affect the health and safety of the agency's 2 current patients. Findings include: On 2/9/23, the agency's Emergency Preparedness documentation was reviewed. During the review, it was noted that there was no documented evidence of emergency preparedness policies and procedures that were based on an emergency preparedness plan, a documented risk assessment, and communication plan. The agency's policy titled, Emergency Operations Plan and Policies (revised January 2020), provides detailed instructions for the agency to follow to create a plan. The areas in the plan that were to be filled out by the agency were blank. For example: page 2.1.3, The local community command structure is located at ____(blank)___; page 2.1.4, The Agency has transfer arrangements with the following hospital(s) or nursing home(s) ___(blank)___; and on pages 2.2A.2 and 2.2C.4 the facility-based and community-based hazard vulnerability analysis forms were blank of agency information. There is no documentation to indicate the agency developed an emergency plan. The agency's policies were not developed based on their emergency plan. During an interview on 2/9/23 at 1:10 p.m., the administrator (ADM-B) acknowledged the findings.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an Emergency Preparedness training and testing program that is based on the emergency plan, risk assessment, policies, procedures, and communication plan. Resulting in the agency's in ability to ensure staff actions align with the emergency plan. This deficient practice has the potential to negatively affect the health and safety of the agency's 2 current patients. Findings include: On 2/9/23, the agency's Emergency Preparedness documentation was reviewed. During the review, it was noted that the agency conducted fire and tornado drills on 5/13/22. Documentation of the drill states that 3 office staff (no names or sign in sheet) participated in the drills. The staff list provided by the administrator (ADM-B) indicates that the agency has 14 staff members. There was no indication that 10 field staff consisting of nurses, physical therapists, and physical therapy assistants had participated in the drills on 5/13/22, an actual emergency, or any other table-top emergency preparedness drills. During review of personnel files on 2/8/23, there was no documentation of initial training for 10 of 10 personnel files reviewed (CEO-A, ADM-B, ALTA-C (clinical manager), DON-D (registered nurse), RN-E (registered nurse), LPN-F (licensed practical nurse), PT-G (physical therapist), PT-H, PTa-K (physical therapy assistant) and PTa-M. During an interview on 2/9/23 at 1:10 p.m., the administrator (ADM-B) reviewed and acknowledged the findings.

A Medicare recertification survey was conducted from 2/7/22-2/9/22 by the Michigan Department of Licensing and Regulatory Affairs at: Sunshine Home Care of Michigan 30600 Telegraph Rd suite 3140 Bingham Farms MI 48025 The agency had no other locations at the time of this survey. COVID-19 vaccination requirements were reviewed. 3 records were reviewed with 1 home visit conducted. The agency only had 3 records available for review and only 1 home visit available. It was determined through survey findings that this agency was non-compliant with the Conditions of Participation as follows: 42 CFR §484.55: Comprehensive Assessment of Patients 42 CFR §484.65 Quality Assessment and Performance Improvement 42 CFR §484.102: Emergency Preparedness 42 CFR §484.110: Clinical Records As a result of the Condition level noncompliance, the Agency is prohibited for 2 years (from the survey date of 2/7/23) 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 record review, and interview, it was determined the Agency (HHA) failed to ensure the initial comprehensive assessment visit was made within 48 hours of the date of referral for 1 record (MR#3) reviewed (See G-514); failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs in 1 of 3 records (MR# 1) reviewed (See G-528); failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required and failed to ensure the physician was notified of potential drug interactions in 2 records (MR# 2, 3) reviewed (See G-536) and failed to ensure the update of the Comprehensive Assessment at Discharge included a summary of the patient's progress in meeting the care plan goals in 1 of 1 discharged records (MR#1) reviewed (See G-550). 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 initial assessment visit was conducted within 48 hours of referral for 1 of 2 (MR# 3) records reviewed with skilled nursing starts of care, resulting in a delay in determining the immediate care and support needs for this patient. Findings include: MR#3: This 75-year-old patient was admitted to home care on 1/19/23 with diagnoses of high blood pressure and end stage renal disease with hemodialysis on Mondays, Wednesdays, and Fridays. During record review on 2/7/23, it was noted the hospital referral for home care was fax stamped as received at the home health agency on 12/20/22. The initial assessment visit was conducted by the registered nurse on 1/19/23, which is 30 days after the agency received the referral. There was no documentation to indicate the patient's discharge from the hospital was delayed and no documentation to indicate the patient had requested a delay in home care services. The findings were reviewed with the administrator (ADM-B) during an interview on 2/9/23 at 9:30 a.m. ADM-B explained that this patient ended up going back into the hospital because the patient's arterio-venous fistula was not functioning. There was no documentation to support the 30-day delay in the initial assessment visit.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review, and interview, the Agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs in 1 of 3 records (MR#1) reviewed, resulting in incomplete and inaccurate clinical information to aide in determining the needs of the patient. Findings included: **Policy: "Initial Assessments/Comprehensive Assessments", no date. The Policy states, "Each patient admitted will receive a comprehensive assessment. The assessment will reflect the patient's current health status and include information to demonstrate the patient's progress toward achievement of desired outcomes. The Comprehensive assessment will identify the patient's need for home care and meet the patient's need for Medical, Rehabilitative, Nursing, Social and Discharge planning. The Initial Comprehensive Assessment also includes relevant diagnoses and current health status, including all active health and medical problems". MR#1: The Start of Care (SOC) was dated 11/9/2022. The Plan of Care (POC) for the certification period 11/9/2022 to 1/7/2023 identified a primary diagnosis of intertrochanteric fracture of right femur, intertrochanteric fracture of right hip, and secondary diagnoses of intertrochanteric pain in right hip, muscle weakness, difficulty walking, and abnormal gait. The POC included safety measures for Fall Precautions, Diabetes, and Use of Assistive Devices. This patient was receiving Physical Therapy Services 2xweek for 3 weeks. Upon review of the Comprehensive Assessment, the Physical Therapist (PT-N) documented the following misinformation in the Comprehensive Assessment resulting in inaccurate documentation of the patient's health condition at the Start of Care Assessment as confirmed by the Administrator (ADM-B). Examples include: Under the Category of "Potential Risk for Infection Assessment", the section was blank. This patient had surgery for a right intertrochanteric fracture of the femur and intertrochanteric fracture of the right hip. There was a choice for "post-op surgery", but it was blank, therefore the PT failed to identify the patient was at risk for infection. Under "Risk for Hospitalization," PT-N checked "Currently taking 5 or more medications", and "Currently reports Exhaustion", but failed to identify the patient had a history of falls (2 or more falls - or fall with an injury in the past 12 months). The purpose for the PT home care services was to rehab the patient after the patient fractured his right femur and hip after falling on his front porch. The PT failed to identify the patient was at risk for hospitalization. Under "Integumentary Status: Integumentary Assessment", The PT documented "No problems identified," despite the fact the patient had surgery on his upper femur and hip. Under the category of "Other Wounds", the PT documented, "NO" under "Surgical Wounds", despite the fact the patient had surgery on his right upper femur and hip. Under the category of "Endocrine", PT-N documented, "Diabetes", however, PT-N documented "Patient's Blood Sugar Status Unknown (no glucometer, paper logs, visit reports, nor patient ability to report." The SOC assessment had no information on the patient's diabetic status including, normal Blood Sugar ranges, daily blood sugar results, or any signs and symptoms the patient has experienced. There was no evidence in coordination notes or in the record that PT-N had notified the agency or physician that the patient did not have any Diabetes monitoring supplies to ensure the patient's diabetic status was stable. Under the Category of "Plan of Care: Rehabilitation Potential/Discharge Plans", the entire section was blank, resulting in no documentation of tasks or activities to be completed to allow a safe discharge for the patient from Physical Therapy. Services. These findings were reviewed and acknowledged by the Administrator (ADM-B) during an interview on 2/8/2023 at 2:30 p.m.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse conducted a review of the patient's medications for any potential adverse effects such as: side effects, drug interactions, and duplicate drug therapy for 2 of 3 (MR# 2, 3) records reviewed. This deficient practice results in the potential for unrecognized adverse effects due to medications that could affect all Agency patients. Findings include: MR#3: This patient was admitted to the agency on 1/19/23 with diagnoses of high blood pressure and end stage renal disease. The comprehensive assessment was completed by SN on 1/19/23 and indicated under M2001, "No issues found during review." During record review on 2/7/23, it was noted that the medical record contained a drug interaction report that indicates there are two major drug interactions for Allopurinol + Lisinopril and for Aspirin + Apixaban. There was no documented evidence the physician was informed of the major drug interactions. The findings were reviewed with ADM-B during an interview on 2/9/23 at 9:30 a.m. ADM-B acknowledged the findings and explained that the nurse is supposed to write a physician order to inform the physician of the medication interactions. No physician order regarding medication interactions was available for review. MR#2: This patient was admitted to the agency on 1/19/23 with a diagnosis of high blood pressure. The comprehensive assessment was completed by skilled nursing (SN) on 1/19/23 and indicated under M2001, "No issues found." During record review on 2/7/23, it was noted that the medication profile/reconciliation, not signed or dated, indicated 5 major, 8 moderate and 3 minor drug interactions. There was no documented evidence the patient's medications had been reviewed by a registered nurse and there was no evidence the findings were sent to the physician for review. During an interview on 2/9/23 at 11:00 a.m., the administrator (ADM-B) acknowledged the above findings.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on Record Review and Interview, it was determined the agency failed to ensure the comprehensive assessment at discharge included a summary of the patient's progress in meeting the care plan goals in 1 of 3 records (MR#1) reviewed resulting in the patient being discharged before the patient had met the goals on the Plan of Care. Findings included: **Agency Policy: "Discharge Criteria and Planning, no date". The Policy states, "Patient will be discharged from services as follows: The discharge is appropriate because the physician/practitioner who is responsible for the home health plan of care and the Agency agree that measurable outcomes and goals set forth in the plan of care have been achieved and the Agency and physician/practitioner responsible for the home health plan of of care agree that the patient no longer needs the Agency's services." MR#1: The Start of Care (SOC) was dated 11/9/2022. The Plan of Care (POC) for the certification period 11/9/2022 to 1/7/2023 identified a primary diagnosis of intertrochanteric fracture of right femur, intertrochanteric fracture of right hip, and secondary diagnoses of intertrochanteric pain in right hip, muscle weakness, difficulty walking, and abnormal gait. Upon review of the Discharge Summary, under the category of "Patient Goals: Goal Attainment", the Physical Therapist (PT-L) documented "Goals Unmet" for all 10 patient goals. In addition, under the Category of "Total Number of Goals", the PT documented, "10 total goals, 0 goals met, 10 goals unmet". Also, PT-L documented under "Goal Attainment Rate", "0.00%". The patient was discharged without summarizing why the patient did not meet any goals. These findings were reviewed and acknowledged by the Administrator on 2/8/2022 at 2:20 p.m.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was complete and included patient-specific interventions, measurable outcomes and goals, and the frequency and duration of visits for 3 of 3 (MR#1, 2, 3) records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes for these 3 patients. Findings include: MR#3: This 75-year-old patient was admitted to home care on 1/19/23 with diagnoses of high blood pressure and end stage renal disease with hemodialysis on Mondays, Wednesdays, and Fridays. During record review on 2/7/23, it was noted the 1/19/23 POC included the following goals: patient's activity level will improve due to effective pain control, demonstrate measures to prevent skin breakdown, remain free of sepsis, and will have optimal bowel evacuation. The goals were not stated in measurable terms that would enable nursing staff to accurately perform an objective evaluation of the patient's progress toward her goals. The findings were reviewed with and acknowledged by ADM-B during an interview on 2/9/23 at 9:30 a.m. MR#2: This patient was admitted to the agency on 1/19/23 with a diagnosis of high blood pressure. The plan of care (POC) was completed by skilled nursing (SN) on 1/19/23 and failed to document under the "Frequency" section, a frequency and duration of clinician visits. The frequency section was blank. During an interview on 2/9/23 at 11:00 a.m., the administrator (ADM-B) acknowledged the above findings. **Agency Policy: "Plan of Care - CMS#485 and Physician/Practitioners Orders." The policy states, "The individualized Plan of Care must include the following: All pertinent diagnoses, the type of services required, the frequency and duration of visits to be made, patient-specific interventions and education, measurable outcomes and goals. MR#1: The Start of Care (SOC) was dated 11/9/2022. The Plan of Care (POC) identified diagnoses for the certification period 11/9/2022 to 1/7/2023 of fracture of right femur, pain in right hip, muscle weakness, difficulty walking, and abnormal gait. The POC included safety measures for Fall Precautions, Diabetes, and Use of Assistive Devices. This patient was receiving Physical Therapy Services, however there were no orders on the Plan of Care for frequency and duration of physical therapy services. In addition, there were no interventions or goals on the Plan of Care to address the patient's diagnosis of Diabetes such as monitoring daily blood glucose results, or signs and symptoms to report to the physician. These findings were reviewed and acknowledged with the Administrator (ADM-B) during an interview on 2/8/2022 at 2:30 p.m.

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 physical therapy and occupational therapy services were provided as ordered by the physician for 2 of 3 records (MR# 2, 3) reviewed, resulting in the potential for physical decline and unmet care needs for these patients. Findings include: MR#2: This patient was admitted to the agency on 1/19/23 with a diagnosis of high blood pressure. The plan of care (POC) was completed by skilled nursing (SN) on 1/19/23 and documented SN, PT, and OT services to be provided with no frequency or duration of visits. A physician order dated 2/7/23, had skilled nursing ordered for 1 time a week for 3 weeks, and for PT and OT to evaluate and treat. During record review on 2/7/22, it was discovered that no PT or OT visits were documented in the record. There was no evidence in the record that PT and OT services had been discontinued or the patient declined the services. There was no documentation in the record that the physician was notified of PT or OT services not being provided. During an interview on 2/9/23 at 11:00 a.m., the administrator (ADM-B) acknowledged the above findings. MR#3: This patient was admitted to the agency on 1/19/23 with diagnoses of high blood pressure and end stage renal disease with hemodialysis on Mondays, Wednesdays, and Fridays. The 1/19/23 plan of care ordered the agency to provide skilled nursing, physical therapy (PT), occupational therapy (OT), and home health aide services. During record review on 2/7/23, it was noted that the patient declined aide services. There was no documentation to indicate that PT and OT services had been provided to this patient. There was no documentation to indicate the patient had declined PT and OT services and no documentation to indicate the physician was informed that therapy services were not provided as ordered. The findings were reviewed with and acknowledged by the administrator (ADM-B) during an interview on 2/9/23 at 9:30 a.m.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on record review and interview, the physical therapist failed to provide a written copy of the home exercise program prescribed by the physical therapist to aid the patient in performing the prescribed physical therapy exercises between scheduled physical therapy visits in 1 of 3 records reviewed (MR#1) in which Physical Therapy services were provided of a total of 3 records reviewed, resulting in the inability for the patient to perform the exercises on the days in which the Physical Therapist's was not scheduled for home visits. Findings included: MR#1:The Start of Care (SOC) was dated 11/9/2022. The Plan of Care (POC) for the certification period 11/9/2022 to 1/7/2023 identified a primary diagnosis of intertrochanteric fracture of right femur, intertrochanteric fracture of right hip, and secondary diagnoses of intertrochanteric pain in right hip, muscle weakness, difficulty walking, and abnormal gait. The POC included safety measures for Fall Precautions, Diabetes, and Use of Assistive Devices. This patient was receiving Physical Therapy Services twice a week for 3 weeks that included prescribed therapeutic exercises. It was noted that the Therapeutic Physical Therapy Program was not included in the patient record. A review of the patient's record revealed that the Physical Therapist only performed the Initial Assessment and Re-Assessment; and the Physical Therapy Assistant (Pta) performed the remaining 10 visits between the PT Evaluations. However, a copy of the prescribed physical therapy exercises was not included in the patient's record, which would be needed for the Pta to assist the patient in performing the exercises. During an interview with the Administrator on 2/8/2023 at 2:30 p.m., the Administrator was advised of this finding and the response was, "we usually require a copy of the prescribed exercise program to be included as part of the medical record and that a copy be left in the patient home. It would also be needed for access by the Physical Therapy Assistant." The Administrator stated she "did not know if a copy of the prescribed exercise program had been left in the patient home." These findings were reviewed and acknowledged by the Administrator (ADM-B) during an interview on 2/8/2023 at 2:30 p.m.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review, policy review, and interview, the agency failed to select the indicators that it will utilize in its QAPI program based upon identified adverse or negative patient outcomes or agency processes that the HHA wishes to monitor and measure (Refer to G- 642); failed to provide evidence of data collected to use to monitor the effectiveness of services and quality of care and to identify opportunities for improvement (Refer to G-644); 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 (Refer to G-648); the Governing Board failed to approve the agency's 2022 and 2023 Performance Improvement Projects (Refer to G-660). The cumulative effect of these systemic problems results in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.65, Quality Assessment and Performance Improvement.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review, policy review, and interview, the agency failed to select the indicators that it will utilize in its QAPI program based upon identified adverse or negative patient outcomes or agency processes that the HHA wishes to monitor and measure. Each indicator must be measurable through data to evaluate any HHA change in procedure, policy or intervention. The HHA QAPI program must include procedures for measurement and analysis of indicators and address the frequency with which such measurement and analysis will occur. **Agency Policy: Quality Assessment and Performance Improvement (QAPI) Plan and Program, Revised February 2021. The Policy states, "The Agency must measure, analyze, and track quality indicators, including adverse patient events and other aspects of performance that enable the Agency to assess processes of care, services, and operations. Upon review of the agency QAPI program on 2/8/23, it was noted there was no data for the QAPI program to review, no chart review data was included that identified adverse or negative patient outcomes. The agency's program consisted of data on late notes submitted by staff, and only included percentages. but no specific data and how the late notes would affect the patients. There were no procedures included in the QAPI program that included agency procedures for measurement and analysis of indicators, and there was no frequency of which the measurements and analysis would occur. This finding was reviewed and acknowledged by the Administrator during an interview on 2/8/23 at 2:30 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 record review, policy review, and interview, the agency failed to provide evidence of data collected to use to monitor the effectiveness of services and quality of care and to identify opportunities for improvement. **Agency Policy: Quality Assessment and Performance Improvement (QAPI) Plan and Program, Revised February 2021. The Policy states, "The Agency will establish an ongoing, Agency-wide, data-driven program of quality assessment and performance improvement and maintain documentary evidence of its program. The purpose is to continuously collect and analyze data is to improve Agency's performance of clinical and other processes as follows: "Continuously improve processes of patient care services as well as outcomes of care; and use a systematic approach to problem identification and resolution." Based on record review and interviews, the agency failed to provide evidence of collected data to identify opportunities for improvement. Findings included: Upon review of the QAPI report, it was noted the report did not include any Data, only percentages. There was no quality indicator data or data collected from OASIS. The program consisted of percentages regarding late notes submitted by the staff. There was no data included regarding patient services. It was also noted upon review of the Governing Board Meeting Notes, that there was no Governing Board approval of the frequency and detail of data collection. These findings were reviewed and acknowledged by the Administrator during an interview on 2/8/23 at 2:30 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 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: **Agency Policy: "Quality Assessment and Performance Improvement (QAPI) Plan and Program", no date. The policy states, "The Agency program will 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. The program must utilize quality indicator data including measures derived from OASIS and other relevant data in the design of its program. The agency will use the data collected to monitor the effectiveness and safety of services and quality of care and identify opportunities for improvement." During an interview on 2/8/23 at 1:00 p.m., the Administrator (ADM-B) was queried about the Performance Improvement Program (PIP) activities the agency was conducting. The response was, "we are concentrating on late notes submitted by our staff." When asked if the agency had decided what needed to be monitored and improved for the agency's patients, the response was, "we are looking at the timeframe in which the staff submit their visit notes, late notes affect our operation." ADM-B was asked if information from the patient complaint logs was used to come to an agreement of how to improve the agency's services for patients? "I'm not sure, our Director of Nursing is in charge of QAPI, and she is not in the office this week". At the conclusion of the interview, ADM-B was unable to present evidence or voice a current Performance Improvement Project that the agency had chosen to improve services for patients. The agency failed to develop a Performance Improvement Project to improve patient care services provided by the agency. The agency created a performance improvement program to benefit issues identified as late notes submitted by staff.

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: 660 Based on documents reviewed and interview, the Governing Body failed to approve a Performance Improvement Program for the year 2023. Findings included: **Agency Policy: "Quality Assessment and Performance Improvement (QAPI) Plan and Program." The Policy states, "The agency will establish an ongoing, Agency-wide, data-driven program of quality assessment and performance improvement and maintain documentary evidence of its program. The program will be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes." On 2/8/2023 at 11:00 a.m., the Administrator (ADM-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. These findings were reviewed and acknowledged by the Administrator (ADM-B) during an interview on 2/8/23 at 2:30 p.m.

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 that 1 of 1 staff (PTa-M) granted a vaccine exemption agreed to the agency's contingency plans, resulting in the potential to spread the COVID-19 virus to any of the agency's 4 patients in the past 12 months that received physical therapy assistant services. Findings include: The agency's COVID-19 vaccination record was reviewed on 2/9/23. Review of the record indicates that one employee (PTa-M) was granted a vaccine exemption on 3/4/21. During an interview on 2/9/23 at 10:20 a.m., the administrator (ADM-B) was queried regarding the agency's policy or practice for staff granted a vaccine exemption. ADM-B explained that PTa-M should have signed a form certifying that he was educated on COVID-19, will complete pre-screening of all patients, self-monitor symptoms prior to home health care visits, and will use personal protective equipment throughout every visit. ADM-B was unable to provide documentation that PTa-M signed the agency's document and agreed to the agency's contingency plan for unvaccinated employees.

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 2 (MR# 2, 3) records reviewed with multiple disciplines, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes for these 2 patients. Findings include: MR#3: This patient was admitted to home care on 1/19/23 with diagnoses of high blood pressure and end stage renal disease. The 1/19/23 plan of care orders skilled nursing, physical therapy (PT), and occupational therapy (OT) services for this patient. During an interview on 2/7/23 at 10:15 a.m., the administrator (ADM-B) explained that after the patient is admitted to home care the agency expects other disciplines (such as PT and OT) to conduct their assessments within 48 hours of admission to home care. Record review on 2/7/23 indicates that PT and OT assessments had not been conducted or documented in the past 19 days since the patient was admitted to home care. ADM-B acknowledged the findings during an interview on 2/9/23 at 9:30 a.m. MR#2: This patient was admitted to the agency on 1/19/23 with a diagnosis of high blood pressure. The plan of care (POC) was completed by skilled nursing (SN) on 1/19/23 and documented SN, PT, and OT services to be provided with no frequency or duration of visits. A physician order dated 2/7/23, with an effective date of 1/19/23, had skilled nursing ordered for 1 time a week for 3 weeks, and for PT and OT to evaluate and treat. During record review on 2/7/22, it was discovered that no PT or OT assessments were documented in the record, 19 days after the start of care. During an interview on 2/9/23 at 11:00 a.m., the administrator (ADM-B) acknowledged the above findings.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on record review and interview, the physical therapist failed to ensure the patient had a copy of the prescribed exercises the patient was to perform daily in 1 of 3 records reviewed, resulting in the possibility of the patient not performing the therapeutic exercises on a daily basis to ensure an improvement of the patient's recovery from surgery. Findings included: MR#1: The Start of Care (SOC) was dated 11/9/2022. The Plan of Care (POC) for the certification period 11/9/2022 to 1/7/2023 identified a primary diagnosis of intertrochanteric fracture of right femur, intertrochanteric fracture of right hip, and secondary diagnoses of intertrochanteric pain in right hip, muscle weakness, difficulty walking, and abnormal gait. Physical Therapy visits were scheduled for this patient 2 x week x 3 weeks. Upon review of the record, it was noted that there was no copy of the Prescribed Physical Therapy Exercise Program the patient was to perform on a daily basis to ensure progress of the patient's physical health and healing status. This could possibly result in hinderance of the patient performing the daily exercises as prescribed, thus affecting the progress of the patient's physical recovery. This finding was reviewed and acknowledged by the Administrator (ADM-A) on 2/8/2022 at 2:30 p.m.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals prepared clinical notes for 2 of 3 (MR# 2, 3) records reviewed, resulting in a lack of information regarding the health status of these 2 patients. Findings include: MR#3: This patient was admitted to home care on 1/19/23 with diagnoses of high blood pressure and end stage renal disease. The 1/19/23 plan of care orders skilled nursing, physical therapy (PT), and occupational therapy (OT) services for this patient. During record review on 2/7/23, it was noted that there were no physical therapy clinical notes for review. It was unclear if PT services were provided or not documented. During an interview on 2/9/23 at 9:30 a.m., the administrator (ADM-B) explained that PT services were provided, but the PT had not documented the clinical notes within 5 days per agency practice. MR#2: This patient was admitted to the agency on 1/19/23 with a diagnosis of high blood pressure. The plan of care (POC) was completed by skilled nursing (SN) on 1/19/23 and documented SN, PT, and OT services to be provided with no frequency or duration of visits. A physician order dated 2/7/23, had skilled nursing ordered for 1 time a week for 3 weeks, and for PT and OT to evaluate and treat. During record review on 2/7/22, it was discovered that no PT or OT visit notes were documented in the record. There was no evidence in the record that PT or OT services had been provided. During an interview on 2/9/23 at 11:00 a.m., the administrator (ADM-B) acknowledged the above findings.

Participate in HHA-sponsored in-service CFR(s): 484.75(b)(9) Participation in HHA-sponsored in-service training. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure skilled professionals participated in agency-sponsored in-service training, resulting in a lack of training and educational opportunities for 12 skilled professionals employed by the agency or under arrangement. Findings include: During review of the agency’s binder titled, HHA In-Service Book, on 2/9/23, it was noted that the documentation of the monthly in-service education in 2022 failed to include documentation of participation by the 12 skilled professionals working at/for this agency. The sign-in sheets were blank. The findings were reviewed with the administrator (ADM-B) during an interview on 2/9/23 at 11:05 a.m. ADM-B reviewed the In-Service binder and explained that staff come to the office monthly for in-service education and they're supposed to sign in on the sheet. There was no documented evidence that skilled professionals participated in agency sponsored in-service training in 2022.

Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Physical Therapist performed oversite and routine evaluations of the physical therapy assistant's performance and effectiveness of patient care during the provision of home visits provided by physical therapy assistants in 1 of 3 records reviewed (MR#1) in which physical therapy services were provided. Findings included: MR#1: The Start of Care (SOC) was dated 11/9/2022. The Plan of Care (POC) for the certification period 11/9/2022 to 1/7/2023 identified a primary diagnosis of intertrochanteric fracture of the right femur, intertrochanteric fracture of the right hip, and secondary diagnoses of intertrochanteric pain in right hip, muscle weakness, difficulty walking, and abnormal gait. This patient was receiving Physical Therapy Services 2 x week for 3 weeks. The patient received 10 visits from the Physical Therapy Assistant (PTa-L) over a 3-week period, however, there was no documentation found in the record that certified the Physical Therapist (PT-N) had reviewed and evaluated any of the services provided to the patient by PTa-L during that 3-week period. It was noted the only visits performed by PT-N was the Initial Evaluation and a Re-Evaluation. The agency failed to evaluate services provided by Physical Therapy Assistants. This finding was reviewed and acknowledged with the Administrator (ADM-B) during an interview on 2/8/2022 at 2:30 p.m.

Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to maintain a valid Clinical Laboratory Improvement Amendment certificate of waiver, resulting in the potential for the agency to be performing unauthorized laboratory tests on all 4 patients admitted in the past 12 months. Findings include: On 2/8/23, the administrator (ADM-B) presented the agency's CLIA (Clinical Laboratory Improvement Amendment) certificate of waiver for review. The CLIA certificate was issued to Sunshine Home Care of Michigan located in Davison, Michigan. The agency was purchased by the current owner in June of 2022. The agency relocated to the new address in Troy, Michigan. The laboratory director listed on the certificate is no longer associated with Sunshine Home Care of Michigan. During a phone interview on 2/9/23 at 11:18 a.m., the manager (SOM-O) of the State of Michigan's CLIA program explained that an agency has a 30-day grace period to update their CLIA certificate to reflect the new address and laboratory director. SOM-O checked the Federal data base and confirmed that Sunshine Home Care of Michigan did not have a valid CLIA certificate of waiver for the Troy location. The finding was reviewed with and acknowledged by ADM-B during an interview on 2/9/23 at 9:30 a.m.

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight of all patient care services to ensure the coordination of referrals for physical and occupational therapy services for 2 of 2 (MR# 2, 3) records reviewed in which therapy services were ordered, resulting in the potential for physical decline and unmet care needs for these 2 patients. Findings include: MR#2: This patient was admitted to the agency on 1/19/23 with a diagnosis of high blood pressure. The plan of care (POC) was completed by skilled nursing (SN) on 1/19/23 and documented SN, PT, and OT services to be provided with no frequency or duration of visits. A physician order dated 2/7/23, had skilled nursing ordered for 1 time a week for 3 weeks, and for PT and OT to evaluate and treat. During record review on 2/7/22, it was discovered that no OT visits were provided to the patient. There was no evidence in the record that OT services had been discontinued or the patient declined the services. There was no documentation in the record that the physician was notified of OT services not being provided. There was no documentation to indicate the clinical manager provided oversight of all patient care services and personnel to ensure the referrals for PT and OT services were coordinated and provided as ordered by the physician. During an interview on 2/9/23 at 11:00 a.m., the administrator (ADM-B) acknowledged the above findings. MR#3: This 75-year-old patient was admitted to home care on 1/19/23 with diagnoses of high blood pressure and end stage renal disease with hemodialysis on Mondays, Wednesdays, and Fridays. The 1/19/23 plan of care ordered the agency to provide skilled nursing, physical therapy (PT), occupational therapy (OT), and home health aide services. During record review on 2/7/23, it was noted that the patient declined aide services. There was no documentation to indicate that PT and OT services had been provided to the patient nor declined by the patient. There was no documentation to indicate the clinical manager provided oversight of all patient care services and personnel to ensure the referrals for PT and OT services were coordinated and provided as ordered by the physician. The findings were reviewed with the administrator (ADM-B) during an interview on 2/9/23 at 9:30 a.m. ADM-B explained that PT services were provided, but they were not documented and that OT services were declined by the patient and the nurse failed to document the declination.

Primary HHA is responsible for patient care CFR(s): 484.105(e)(3) The primary HHA is responsible for patient care, and must conduct and provide, either directly or under arrangements, all services rendered to patients. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to retain overall responsibility for all services provided, resulting in the potential for inappropriate care or unmet care needs for Agency patients. Findings include: During an interview on 2/7/23 at 11:30 a.m., when asked what service was provided only by the agency and not contracted, the administrator (ADM-B) stated, "All of our services are contracted." When asked who supervises the contracted staff ADM-B stated, "The staffing agency supervises the contracted staff. We do not have anyone to supervise them." During review of Agency records, it was discovered that no supervision or oversight by the Agency, of contracted staff, was documented. On 2/8/22, during review of the Agency's contracts, it was discovered that the staffing agency contract (PRS) dated 7/2/22 stated on page 1, "Clent (Home health agency) shall neither have nor exercise any control or direction of the methods by which PRS work is performed, except that PRS agrees to perform at all times in strict accordance with the currently approved methods of the PT, OT, ST." This contract language potentially eliminates any supervisory or oversight responsibility by the Agency over contracted staff. During an interview on 2/9/23 at 11:00 a.m., ADM-B acknowledged the above findings.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to have one service provided only by the agency and not contracted, resulting in all agency services provided with contracted staff. During an interview on 2/7/23 at 11:30 a.m., when asked what service was provided only by the agency and not contracted, the administrator (ADM-B) stated, "All of our services are contracted. We have a nurse in the office, but she does not see patients." During review of patient records throughout the survey it was confirmed that all services were provided by contracted staff. During an interview on 2/9/23 at 11:00 a.m., ADM-B acknowledged the above findings.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the clinical record contained assessments, plans of care, and clinical notes for 2 of 3 (MR# 2, 3) records reviewed (refer to G1012), and failed to ensure that 25 clinical records were safeguarded against loss or unauthorized use (refer to G1028). 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 § 484.110: Clinical Records.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained assessments, plans of care, and clinical notes for 2 of 3 (MR# 2, 3) records reviewed, resulting in a lack of information for the physician and all agency staff caring for these 2 patients. Findings include: MR#3: This patient was admitted to home care on 1/19/23 with diagnoses of high blood pressure and end stage renal disease with hemodialysis on Mondays, Wednesdays, and Fridays. The 1/19/23 plan of care ordered the agency to provide skilled nursing, physical therapy (PT), occupational therapy (OT), and home health aide services. During record review on 2/7/23, it was noted that the physical therapy assessment was blank of information. There was no documentation of a PT plan of care. The PT clinical notes for 1/30/23 and 2/1/23 were blank of information. During an interview on 2/9/23 at 9:30 a.m., the administrator (ADM-B) acknowledged the findings and explained that documentation is to be in the clinical record within 5 days of the visit per agency practice. MR#2: This patient was admitted to the agency on 1/19/23 with a diagnosis of high blood pressure. The plan of care (POC) was completed by skilled nursing (SN) on 1/19/23 and documented SN, PT, and OT services to be provided with no frequency or duration of visits. A physician order dated 2/7/23, had skilled nursing ordered for 1 time a week for 3 weeks, and for PT and OT to evaluate and treat. During record review on 2/7/22, it was discovered that no PT or OT visit notes, assessments, or care plans were documented in the record. During an interview on 2/9/23 at 11:00 a.m., the administrator (ADM-B) acknowledged the above findings.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure that clinical records were safeguarded against loss or unauthorized use, resulting in the potential compromise of protected health information for 25 patients. Findings include: On 2/7/23 the agency provided a room for the survey team. At 1:20 p.m., it was observed that 5 patient files were unsecured and free-standing on a desk top shelf. The patient files contained the following protected health information: past medical histories, consents for care, and plans of care. The room provided for the surveyors contained 4 file cabinets with keys inserted in the key locks. One file cabinet drawer labeled "Jan-1-2022-till-Dec.31-2022" contained 20 patient records in manila file folders with protected health information. During an interview on 2/7/23 at 4:15 p.m., the administrator (ADM-B) was queried regarding cleaning of the office. The agency suite is in a multi-story office building. ADM-B explained that the office is cleaned every evening by a cleaning crew managed by the office building. On 2/8/23, the surveyor arrived at the agency at 8:30 a.m. and entered the agency with ADM-B who arrived at 8:45 a.m. and unlocked the door. Upon entry to the survey room, it was observed that the same 5 patient files were unsecured and free-standing on a desk top shelf. The 4 file cabinets were observed with keys inserted in the key locks. The 20 patient records were unsecured. ADM-B was queried if the office had been cleaned by the cleaning crew the previous evening. ADM-B replied yes, it's cleaned every night, see the waste baskets have been emptied. During an interview at 9:30 a.m. the findings were reviewed with and acknowledged by ADM-B.