Every finding on record at Prime Care Home Health Services

An Emergency Preparedness survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 4/11/2023-4/14/2023, 4/17/2023, 4/19/2023. Facility ID: 003155 At this Emergency Preparedness survey, Prime Care Home Health Services was found to not be in compliance with 42 CFR 484.102, Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and implement individualized emergency preparedness plans for the patients, which provided appropriate instructions, in the event of an emergency in 5 of 5 active clinical records reviewed. (Patient #1, #2, #3, #4, #5) The findings include: 4. Clinical record review on 4/11/2023, for patient #3, start of care 3/28/2023, evidenced a document titled “Individualized Emergency Plan” which failed to evidence emergency contact information for a person or place the patient could go to if needed to be evacuated from their home. Review of this document failed to evidence contact information to the non-emergency local police, local fire department, preferred hospital, preferred ambulance, water, electric, and gas companies. Record review failed to evidence the patient’s emergency preparedness plan was individualized to their specific geographic location, preferences, and evacuation information. 5. Clinical record review on 4/13/2023, for patient #4, start of care 3/23/2023, primary diagnosis of type 2 diabetes, evidenced a document titled “Individualized Emergency Plan” which stated the patient used “diabetic supplies” but failed to evidence what equipment and supplies were would be necessary in the event of an emergency. This document failed to evidence contact information to the non-emergency local police and non-emergency local fire department. Record review failed to evidence the patient’s emergency preparedness plan was individualized to their geographic location and specific medical supplies needed. 6. Clinical record review on 4/12/2023, for patient #5, start of care 3/20/2023, evidenced a document titled “Individualized Emergency Plan” which failed to evidence emergency contact information for a person or place the patient could go to if needed to be evacuated from their home. Review of this document failed to evidence contact information to the non-emergency local police, local fire department, preferred hospital, preferred ambulance, water, electric, and gas companies. Record review failed to evidence the patient’s emergency preparedness plan was individualized to their specific geographic location, preferences, and evacuation information. 1. Review of an agency policy revised August 2011, titled “Emergency Management Plan” stated, “… Detailed written instructions will be given to patients and/or family members to ensure an appropriate and timely response in the event of an emergent event that may cause interruptions of service….” 2. Clinical record review on 4/12/2023, for Patient #1, evidenced an agency document titled “Start of Care” dated 3/20/2023, indicated the patient had a wound to the right ankle with wound care orders and a foley catheter (a plastic tube that drains urine from the body). Review of an agency document titled “Individualized Emergency Plan” dated 3/20/2023, failed to evidence the special equipment needed to include the wound care and catheter supplies. Review failed to evidence the name and contact information for the patient’s physician and for the patient’s medical supply company. During an interview on 4/13/2023, at 9:08 AM, the patient indicated the name of the medical supply company for the catheter supplies was Entity #10. During an interview on 4/14/2023, at 11:42 AM, the clinical manager indicated all medical supplies the patient needs should be listed on the individualized emergency plan. 3. Clinical record review on 4/11/2023, for Patient #2, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 3/28/2023-5/26/2023, which indicated the patient’s primary diagnosis was diabetes (a chronic condition which affects the way the body processes blood sugar) and evidenced the parameters for when to call the physician for out-of-range blood sugar. Review of an agency document titled “Individualized Emergency Plan” dated 3/28/2023, failed to evidence the special equipment needed to check the patient’s blood sugar. During an interview on 4/13/2023, at 11:40 AM, the clinical manager indicated the individualized emergency plan should include the instructions and special equipment needed for checking the patient’s blood sugar.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the encoded OASIS (Outcome and Assessment Information Set, a comprehensive assessment data collection tool) accurately reflected the patient’s status in 3 of 6 clinical records reviewed with OASIS submissions. (Patient #1, #2, #6) The findings include: Clinical record review on 4/12/2023, for Patient #6, start of care 8/15/2022, evidenced an agency document titled, “Oasis {outcome and assessment information} -E Discharge,” for certification period 2/11/2023-4/11/2023, which indicated that the patient was independent with walking on even and uneven surfaces and negotiating stairs with and without railings. Review of the agency document titled, "Oasis-E Discharge,” indicated the stairs were not attempted due to patient medical condition or safety concerns. Review indicated patient goal to bathe independently. Review failed to evidence the patient had reached his goal of independence with bathing. During an interview with the clinical manager on 4/17/2023, at 12:25 PM, the clinical manager was unsure why the discrepancies in the oasis entries. The clinical manager was unsure and did not know why goal didn’t match at discharge. 1. Review of an agency policy revised August 2021, titled “Clinical/Service Data Collection” stated, “… Entries into the clinical/service record will be clear, concise, and specific statements of fact….” 2. Clinical record review on 4/12/2023, for Patient #1, evidenced an agency document titled “OASIS Start of Care” completed by the alternate clinical manager and dated 3/20/2023, which indicated the patient is incontinent of stool in the nurse’s narrative note. Review of the bowel incontinence frequency assessment (OASIS question M1620) indicated the patient was assessed to have bowel incontinence very rarely or never. Review of the drug regimen review (OASIS question M2001) indicated no issues were found. During an interview on 4/18/2023, at 10:50 AM, the patient’s caregiver indicated the patient was incontinent of bowel. During an interview on 4/18/2023, at 1:58 PM, the alternate clinical manager indicated the patient is incontinent of bowel and she incorrectly completed the M1620 question on the OASIS assessment. Review of an agency document titled “Medication Profile” dated 3/20/2023, indicated the patient’s medications included, but were not limited to tizanidine (muscle relaxer), Mayzent (a medication used to treat Multiple Sclerosis; a progressive autoimmune disease), dimethyl fumarate (a medication used to treat Multiple Sclerosis), and baclofen (a medication used to treat muscle spasms). Review on 4/13/2023, of an agency document titled “Drug-Drug Interactions” dated 4/13/2023, indicated major drug interactions between tizanidine and Mayzent which increased the potential for heart arrythmia and between dimethyl fumarate and Mayzent which increased the potential for immune suppression. Review indicated a moderate drug interaction between baclofen and tizanidine which increased the risk of low blood pressure, low heart rate, and dizziness. Review failed to evidence the OASIS accurately reflected the patient’s drug review. 3. Clinical record review on 4/11/2023, for Patient #2, evidenced an agency document titled “OASIS Start of Care” completed by the alternate clinical manager and dated 3/28/2023, which indicated the drug regimen review (OASIS question M2001) found no issues. Review indicated the patient did not take any injectable medications (OASIS question M2030). Review of the agency document titled “Home Health Certification and Plan of Care” for certification period 3/28/2023-5/26/2023, which indicated the patient’s medications included, but were not limited to, hydrochlorothiazide (a medication used to treat high blood pressure), lisinopril (a medication used to treat high blood pressure), ergocalciferol (dietary supplement), metformin (a medication used to lower blood sugar), amlodipine (a medication used to lower blood pressure), atorvastatin (a medication used to lower cholesterol), and Ozempic (a medication injected into the muscle to lower blood sugar) injected intramuscularly weekly. Review failed to evidence the OASIS was accurately reflected the patient’s use of injectable medication. Review of an agency document titled “Drug-Drug Interactions” dated 4/12/2023, indicated moderate drug interactions between hydrochlorothiazide and lisinopril potentially causing acute low blood pressure; hydrochlorothiazide and ergocalciferol potentially causing elevated calcium levels; lisinopril and metformin potentially causing severe low blood sugar levels; hydrochlorothiazide and metformin potentially causing increased blood sugar levels; and amlodipine and atorvastatin potentially causing liver damage. Review failed to evidence the OASIS accurately reflected the patient’s drug review. During an interview on 4/13/2023, at 12:01 PM, the clinical manager indicated the OASIS should have been correctly completed to identify the medication issues during the drug review. The clinical manager indicated the OASIS was incorrect in regards to the patient’s use of injectable medication. 4. During an interview on 4/14/2023, at 5:22 PM, the alternate clinical manager indicated the mistakes and omissions on the OASIS documents were probably due to he/she was rushing through the documentation and because the document was difficult to complete on his/her phone.

Outcomes/goals have been achieved CFR(s): 484.50(d)(3) The transfer or discharge is appropriate because the physician or allowed practitioner, who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the patient no longer needs the HHA's services; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure patient met goals for discharge in 1of 1 closed clinical records reviewed. (Patient #6) The findings include: Record review of the policy dated August 2011, titled, “Patient Education Related to Discharge Planning,” stated, “Patient will be active participant in the planning and discharge from home care services and will be verbally informed of the date and reason for discharge. Patient will receive instructions upon discharge to facilitate self-care follow-up …during subsequent visits, the patient and family/caregiver should be continually assessed as to his/her readiness to be discharged from home care, including instruction need to assure a smooth transition.…” Clinical record review on 4/12/2023, for patient #6, start of care 8/15/2022, evidenced an agency document titled “Discharge Oasis” dated 4/11/2023, which indicated the patient had met his goals at discharge. Review of an agency document dated 4/11/2023, titled “Discharge Oasis,” failed to indicate patient was safe with medication administration. Review failed to indicate patient/caregiver was able to verbalize emergency preparedness plan. Review failed to indicate information was provided to patient for continued self-management of disease process. During an interview on 4/18/2023, at 9:28 AM, Person #9 indicated they did not feel prepared for discharge. Person #9 contacted another agency to manage care. During an interview on 4/17/2023, at 3:26 PM, RN #1 indicated the patient had met their goals at time of discharge. RN #1 indicated the patient did not need agency services and met all goals. At 3:30 PM, RN #1 indicated all sections of Discharge Oasis should be filled out.

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 was completed within 48 hours of the referral in 4 of 5 active clinical records reviewed. (Patient #2, #3, #4, #5) The findings include: 4. Clinical record review on 4/11/2023, for patient #3, evidenced a document from entity #3 which electronically signed by person #1 (patient #3’s physician), on 3/2/2023, stated “Requested Home Health Services … Physical Therapy, Skilled Nursing ….” Record review evidenced a communication note from 3/9/2023, which indicated the clinical manager called person #5 (patient #3’s spouse) and stated they were “… requesting to do start of care on 03/28/2023 ….” Record review of an initial comprehensive assessment document evidenced the assessment was performed on 3/28/2023. Record review evidenced the initial comprehensive assessment occurred 26 days after the referral date. During an interview on 4/13/2023, at 9:11 AM, person #5 indicated it was not their decision to wait for the start of care. Person #5 indicated they were told by the staff at entity #3 to wait for a phone call from Prime Care Home Health and they were not given a choice. 5. Clinical record review on 4/13/2023, for patient #4, evidenced a document from entity #3 which electronically signed by person #2 (patient #4’s physician), on 2/14/2023, stated “Requested Home Health Services … Skilled Nursing, Aide, and Physical Therapy ….” Record review of an initial comprehensive assessment document evidenced the assessment was performed on 3/23/2023. Record review evidenced the initial comprehensive assessment occurred 37 days after the referral date. During an interview on 4/17/2023, at 11:23 AM, the clinical manager indicated the reason for delay in the start of care was due to waiting for the patient’s insurance to approve the prior authorization request for services. On 4/17/2023, at 9:25 AM, a prior authorization representative from entity #20 (patient #4’s insurance company), indicated once all information is received, authorization happened right away. The prior authorization representative indicated it did not take weeks or months to receive prior authorization from entity #20. 6. Clinical record review on 4/12/2023, for patient #5, evidenced a document from entity #17 and signed by person #18 (patient #5’s physician) on 3/10/2023, stated “Order: Admit to Home Health Services ….” and indicated the need for skilled nursing services and a physical and occupational therapy evaluations. Record review of an initial comprehensive assessment document evidenced the assessment was performed on 3/20/2023. Record review evidenced the initial comprehensive assessment occurred 10 days after the referral date. During an interview on 4/17/2023, at 10:54 AM, the administrator indicated the reason for delay in the start of care assessments was the patient’s insurance would not approve prior authorization requests and delays in care should be communicated with the physician. 1. Review of an undated agency policy received 4/19/2023, titled “Comprehensive Assessment and OASIS [Outcome and Assessment Information Set] Data Collection Start of Care” stated, “… The initial comprehensive assessment … should be initiated within 48 hours of the referral ….” 2. Clinical record review on 4/11/2023, for Patient #2, start of care 3/28/2023, evidenced an agency document titled “Start of Care”, dated 3/28/2023, which was identified to be the initial comprehensive visit and assessment. Review indicated the patient was referred to the agency on 3/10/2023. Review failed to evidence the initial assessment was completed within 48 hours of referral. During an interview on 4/13/2023, at 11:46 AM, the intake coordinator indicated the agency was waiting for authorization from the insurance company before they could do the initial assessment. During an interview on 4/13/2023, at 11:46 AM, the administrator indicated sometimes it takes awhile to get authorization and that it was out of the agency’s control. 3. During an interview on 4/14/2023, at 11:40 AM, the clinical manager indicated the start of care comprehensive assessment is the initial assessment.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment reflected the patient’s health status in 5 of 5 clinical records reviewed. (Patient #1, #2, #3, #4, #5) The findings include: Clinical record review on 4/12/2023 for patient #6, start of care 8/15/2022, evidenced an agency document titled, “OASIS-E Discharge,” for certification period 2/11/2023-4/11/2023, which failed to ensure all information was accurate and documentation was completed. Review evidenced an agency document titled, “OASIS-E Discharge,” failed to ensure the form was dated and signed by nurse. Review failed to evidence a completed Respiratory Assessment. Review failed to evidence a completed Cardiac Assessment. Review failed to evidence a completed Nutritional Assessment. Review failed to evidence a completed Potential Risk for Infection Assessment. Review failed to evidence a completed Patient Mood interview. Review of form indicated visit was 4/11/2023 but bowel movement date of 4/12/2023 was documented. The form failed to display accurate information for last bowel movement. During an interview with the clinical manager on 4/17/2023, at 12:21PM, the clinical manager indicated the bowel movement dates are inaccurate. At 12:25 PM, the clinical manager was unsure why the failure to complete discharge oasis form. During an interview with the intake coordinator on 4/17/2023, at 12:06 PM, the intake coordinator indicated the form should be sign and dated. During an interview with RN#1 on 4/17/2023, at 3:30 PM, RN#1 indicated she was taught to fill out all sections of the form and all sections should be filled out. RN#1 indicated she did not know why the sections are blank and they should not be. 5. Clinical record review on 4/11/2023, for patient #3, pertinent diagnosis of end stage renal disease (ESRD, when the kidneys cease to function and required dialysis to remove waste from the body), evidenced an initial comprehensive assessment from 3/28/2023, which indicated there were no problems identified during the psychosocial assessment, including but not limited to barriers to health status and community resources that were needed and/or provided. Review of the patient’s elimination status indicated there were no problems identified and failed to evidence the patient required dialysis 3 times a week. Record review failed to evidence an assessment of the patient’s cultural preferences. Record review evidenced the initial comprehensive assessment was incomplete. Record review failed to evidence a complete and accurate picture of the patient’s health status. 6. Clinical record review on 4/12/2023, for patient #4, pertinent diagnoses of type 2 diabetes and Alzheimer’s disease (deterioration of the brain and affects memory), of an initial comprehensive assessment from 3/23/2023, evidenced the patient required assistance with all ADLs (activities of daily living), required a walker to ambulate, required frequent blood sugar testing, and went to clinic to have routine blood draws to assess coumadin (warfarin, a blood thinning medication that can treat and prevent blood clots) levels. Review failed to evidence a risk assessment for infection was performed to include cofounding factors, not limited to decreased cognition, poor mobility, or an underlying disease such as diabetes. Review of the psychosocial assessment indicated there were no problems identified including but not limited to barriers to health status and community resources that were needed and/or provided. Record review failed to evidence an assessment of the patient’s cultural preferences. Record review evidenced the patient’s activities permitted/restricted stated, “Up as tolerated …” and failed to select “walker” required to ambulate. Record review evidenced the initial comprehensive assessment was incomplete and contradictory. Record review failed to evidence a complete and accurate picture of the patient’s health status. During an interview on 4/17/2023, at 11:30 AM, the clinical manager stated “I didn’t look at that OASIS [initial comprehensive assessment] very carefully” and indicated the assessments should have been completed. 7. Clinical record review on 4/12/2023, for patient #5, primary diagnosis of chronic obstructive pulmonary disease (COPD, disease that cause airflow blockage and breathing-related problems), evidenced an initial comprehensive assessment from 3/20/2023, which failed to evidence a risk assessment for infection was performed and included cofounding factors, not limited to an underlying disease such as COPD. This document indicated there were no problems identified during the psychosocial assessment, including barriers to health status and community resources that were needed and/or provided. Record review failed to evidence an assessment of the patient’s cultural preferences. Record review evidenced the initial comprehensive assessment was incomplete. Record review evidenced the patient attended an adult day program provided within the community. Record review failed to evidence a complete and accurate picture of the patient’s health status. 1. Review of an undated agency policy received 4/19/2023, titled “Comprehensive Assessment and OASIS [Outcome and Assessment Information Set] Data Collection Start of Care” stated, “… The comprehensive assessment will include: … safety and sanitization hazards … Body systems assessment ….” 2. Clinical record review on 4/12/2023, for Patient #1, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 3/20/2023-5/18/2023, which indicated normal parameters for the blood sugar. Review indicated the patient’s diagnoses included, but were not limited to, visual disturbances. Review indicated the patient’s medications included colace (a laxative medication to treat constipation) daily and amoxicillin (antibiotic used to treat infection) twice a day for 10 days. Review of a document titled “Patient Referral” from Person #6 (physician) dated 3/22/2023, indicated the patient’s diagnoses included, but were not limited to, Multiple Sclerosis (an autoimmune progressive disease that involves the brain and spinal cord), diabetes (a chronic condition which affects the way the body processes blood sugar), quadriplegia (paralysis of all 4 limbs), and legal blindness. Review of an agency document titled “Start of Care” completed by the alternate clinical manager and dated 3/20/2023, and identified as the initial comprehensive assessment, indicated the patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) to the right ankle and was at risk for pressure ulcer development. Review failed to indicate diabetic precautions and skin breakdown precaution were included in the comprehensive assessment of the patient’s safety measures. Review failed to evidence the comprehensive assessment of the patient’s endocrine system (the body system that regulates hormones which affects diabetes) included diabetes. Review indicated the patient’s vision was adequate and failed to evidence the vision impairment as part of the sensory assessment. Review indicated the Review indicated the patient had a foley catheter (a plastic tube inserted into the bladder to drain urine from the body) and failed to evidence the comprehensive assessment included the size of the catheter, the size of the balloon holding the catheter in place, the amount of urine in the drainage bag, the color and clarity of the urine, and the patency of the catheter. Review failed to evidence the assessment of the medical supplies needed and by whom they were supplied for the catheter. Review failed to evidence comprehensive assessment included the daily laxative use and failed to evidence the functional status was assessed to include an autoimmune disease affecting function. Review indicated the patient was at high risk for falls and failed to evidence the functional assessment included the patient’s high risk of falls. Review indicated the patient was chairfast and failed to evidence the functional limitations were assessed to include ambulation. Review of the infection control assessment failed to indicate the use of the antibiotic was assessed. Review of the patient strengths failed to be assessed. During an interview on 4/13/2023, at 9:08 AM, Patient #1 indicated Entity #10 was the medical supply company that managed and provided the catheter supplies. During an interview on 4/14/2023, at 11:47 AM, the clinical manager indicated diabetic precautions should have been assessed as part of the patient’s safety measures. The clinical manager indicated the vision was not assessed accurately since the patient’s vision could not be adequate if the patient had a diagnosis of legal blindness. At 11:49 AM, the clinical manager indicated the comprehensive assessment should have included the skin breakdown precautions as a safety measure. At 11:51 AM, the clinical manager indicated the comprehensive assessment should include the urinary output, urine color and amount, and size of the catheter and indicated the daily laxative use should have been included in the assessment. The clinical manager indicated the autoimmune disease affecting function should have been included in the functional status assessment. At 11:57 AM, the clinical manager indicated the comprehensive assessment should have included the patient’s high risk of falls in the functional assessment and ambulation as a functional limitation. AT 12:08 PM, the clinical manager indicated the reason for the antibiotic use was not included in the assessment and indicated the nurse should have determined the reason for antibiotic use. At 12:36 PM, the clinical manager indicated the medical supplies and supplier should have been included in the comprehensive assessment. 3. Clinical record review on 4/11/2023, for Patient #2, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 3/28/2023-5/26/2023, which indicated the patient’s medications included, but were not limited to, clopidogrel (a medication which thins the blood to prevent and/or treat blood clots). Review of an agency document titled “Start of Care” completed by the alternate clinical manager and dated 3/28/2023, and identified as the initial comprehensive assessment, failed to indicate bleeding precautions were included in the comprehensive assessment of the patient’s safety measures. Review of the endocrine assessment failed to indicate anticoagulant (a type of medication that thins the blood to prevent/treat blood clots; clopidogrel belongs to this medication class) use. During an interview on 4/13/2023, at 11:55 AM, the clinical manager indicated bleeding precautions should have been included in the comprehensive assessment. At 12:21 PM, the clinical manager indicated the comprehensive assessment should have included an assessment of the patient’s anticoagulant use. 4. During an interview on 4/14/2023, at 5:22 PM, the alternate clinical manager indicated the mistakes and omissions on the comprehensive assessment documents were probably due to he/she was rushing through the documentation and because the document was difficult to complete on his/her phone.

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included the identification of the patient’s primary caregiver, their willingness and ability to provide care, and their availability and schedule in 1 of 1 clinical record reviewed with wounds. (Patient #1) The findings include: Clinical record review on 4/12/2023, for patient #6, start of care 8/15/2022, evidence an agency document titled, “Home Health Certification and Plan of Care,” for certification period 2/11/2023-4/11/2023, which indicated patient in need of 24-hour supervision. Review of document dated 2/10/2023, titled, “OASIS [outcome and assessment information set]- E Recertification,” failed to ensure patient's primary caregiver status. During an interview with RN#1 on 4/17/2023, at 3:30PM, RN #1 indicated all sections of the form should be filled out. During an interview with the intake coordinator, on 4/17/2023, at 11:57 AM, the intake coordinator indicated the caregiver information is not completed. During an interview with the clinical manager on 4/17/2023, at 12:27 PM, the clinical manager indicated that all the sections should be filled out on the comprehensive assessment. Review of an undated agency policy received 4/19/2023, titled “Comprehensive Assessment and OASIS [Outcome and Assessment Information Set] Data Collection Start of Care” stated, “… The comprehensive assessment will include: … Family and support systems and care they are capable and willing to provide, and the amount of assistance provided ….” Clinical record review on 4/12/2023, for Patient #1, evidenced an agency document titled “Start of Care” dated 3/20/2023, and identified as the initial comprehensive assessment, indicated the patient lived with Person #7 (caregiver) around the clock. Review failed to evidence the agency assessed the caregiver’s willingness and ability to provide care and the availability of the caregiver. Review indicated the patient had a wound to the right ankle with wound care treatment ordered, was chairbound, dependent for activities of daily living, and incontinent of bowel. During an interview on 4/13/2023, at 9:05 AM, Patient #1 indicated Person #7 won’t provide the wound care to the patient’s wound and Person #7 is gone for days at a time for his/her job. Patient #1 indicated no one else lives in the home to care for the patient in the evenings. During an interview on 4/18/2023, at 10:50 AM, Person #7 indicated he is the only person that lives with the patient, and he does not know how to do the wound care for the patient. Person #7 indicated he/she sometimes can be gone for 2 or 3 days for his/her job. Person #7 indicated that if the patient had a bowel movement after the attendant left for in the evening, the patient would have to wait until the attendance arrived in the morning to have incontinent care. During an interview on 4/14/2023, at 12:45 PM, the clinical manager indicated she was unsure who was the patient’s caregiver when Person #7 was not home and stated, “We should check into that.”

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure coordination of care with the health care practitioner to ensure safe and effective transition of care for 1 of 1 discharge clinical record reviewed. (Patient #6) The findings Include: Record review of agency policy dated August 2011, titled, “Discharge Planning,” stated, “Patients will not be discharged without appropriate preparation. The patient’s continuing care needs will be assessed on an ongoing basis, as well as at discharge. Information provided to assist the patient in planning his/her discharge … Sending a post discharge letter to the patient’s physician. All communication and information regarding discharge planning will be documented in the clinical record.” Clinical record review on 4/13/2023 for patient #6, start of care 8/15/2022, evidenced an agency document titled, “Home Health Discharge Summary,” which indicated patient was discharged home due to goals met. Review of an agency document dated 4/13/2023, titled, “Home Health Discharge Summary,” failed to evidence post-discharge goals. Review failed to evidence summary was sent to physician for notification of discharge. Review failed to evidence caregiver information or emergency contact information. Review failed to evidence a discharge medications list. During an interview on 4/18/2023, at 9:28 AM, Person #9 indicated she was not given advanced notice of discharge. Person # 9 indicated another agency had taken over care of patient.

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 physical therapist provided services as ordered by the physician in the plan of care in 3 of 4 active clinical records reviewed receiving physical therapy (PT) services. (Patient #2, #3, #4) The findings include: 1. Review of an undated agency policy received 4/19/2023, titled “Physical Therapist” stated, “… The physical therapist … provides physical therapy services to clients in the home as prescribed by the attending physician….” 2. Clinical record review on 4/11/2023, for Patient #2, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 3/28/2023-5/26/2023, which indicated physical therapy was to evaluate the patient, establish a home exercise program and plan of care, and may obtain oxygen saturation as needed for signs and symptoms of respiratory distress. Review of an agency document titled “PT Plan of Care” dated 4/10/2023, failed to evidence the PT plan of care included obtaining an oxygen saturation as needed and establishing a home exercise program were included in the PT plan of care. Review failed to evidence the physical therapy plan of care included services to be provided as ordered by the physician. 3. Clinical record review on 4/11/2023, for patient #3, primary diagnosis of Parkinson’s Disease (a brain disorder that causes uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination), evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 3/28/2023 – 5/26/2023. This document indicated treatments to perform by physical therapy services included but were not limited to provide transfer mobility and pain assessments, and may obtain a pulse oximetry reading as needed for signs and symptoms of respiratory distress. Record review of an agency document titled “PT Plan of Care” electronically signed by PT #1 on 4/10/2023, evidenced a section about the patient’s medical diagnosis which was incomplete and failed to include the primary diagnosis of Parkinson’s Disease. Review of a section to describe the treatments failed to include instructions to obtain a pulse oximetry reading as needed, transfer training, and pain management as indicated on the home health plan of care. Review of this document evidenced discharge planning and care coordination with other disciplines remained incomplete. Record review failed to evidence the PT plan of care included services to be provided as ordered by the physician. 4. Clinical record review on 4/13/2023, for patient #4, pertinent diagnoses included but were not limited to unsteadiness on feet, vascular dementia (a disease where a person exhibits problems with memory, confusion, changes in behavior, and physical symptoms such as weakness/ tremors), and congestive heart failure (disease of the heart that exhibits shortness of breath and weakness), evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 3/23/2023 – 5/21/2023. This document indicated treatments to perform by physical therapy services included but were not limited to provide pain assessments and may obtain a pulse oximetry reading as needed for signs and symptoms of respiratory distress. Record review of an agency document titled “PT Plan of Care” electronically signed by PT #1 on 3/29/2023, evidenced a section about the patient’s medical diagnosis which was incomplete and failed to include the multiple comorbidities that affected the patient’s strength and mobility. Review of a section to describe the treatments failed to include instructions to obtain a pulse oximetry reading as needed and pain management as indicated on the home health plan of care. Record review failed to evidence the PT plan of care included services to be provided as ordered by the physician. 5. During an interview on 4/13/2023, at 12:24 PM, the clinical manager indicated the physical therapist should have developed the PT plan of care to include the home exercise program and oxygen saturation.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health aide (HHA) failed to report patient falls in 1 of 1 clinical record reviewed with HHA services. (Patient #2) The findings include: Review of an undated agency policy obtained 4/19/2023, titled “Home Health Aide” stated, “… Reports any change in the client’s mental or physical condition … to her immediate supervisor ….” During an interview at an observation of care for Patient #2 on 4/12/2023, at 10:30 AM, Person #19 (patient’s caregiver) indicated the patient fell on 4/10/2023 and 4/11/2023, and HHA #1 was aware of the fall on 4/10/2023, because HHA #1 was present at the time of the fall. Clinical record review on 4/12/2023, failed to evidence the HHA notified the supervising nurse of the patient’s fall. During an interview on 4/13/2023, at 11:26 AM, HHA #1 indicated he/she assisted the patient up from the floor after falling on 4/10/2023, and did not inform the agency until 4/12/2023. During an interview on 4/13/2023, at 12:45 PM, the clinical manager indicated HHA #1 did not inform the agency of Patient #2’s fall on 4/10/2023, until 4/12/2023.

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight of personnel assignments in 1 of 1 home visits with the home health aide. (#2) The findings include: Review of an agency job description revised August 2011, titled “Clinical Director” stated, “… Oversees all direct and indirect patient services provided by clinical organization personnel….” Review of an agency policy revised August 2011, titled “Availability of Services” stated, “… Additional discipline initial assessments will be provided within five (5) business days of the start of care date of date of the physician’s (or other authorized licensed independent practitioner’s) order….” Clinical record review on 4/11/2023, for Patient #2, start of care 3/28/2023, evidenced an agency document titled “Start of Care”, dated 3/28/2023, which was identified to be the initial comprehensive visit and assessment. Review indicated the patient was referred to the agency on 3/10/2023. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 3/28/2023-5/26/2023, indicated the patient was to receive skilled nursing services and physical therapy (PT) for evaluation. Review of an agency document titled “PT Evaluation” evidenced the evaluation was completed by the physical therapist on 4/10/2023. During an interview during an observation at the patient’s home on 4/12/2023, at 10:12 AM, Person #19 (patient’s caregiver) indicated he/she did not receive any communication from the agency after the referral was made from the physician until the alternate clinical manager called on 3/23/2023, to inform Person #19 the alternate clinical manager could be at the patient’s home in 1 hour for the start of care visit. Person #19 indicated he/she informed the clinical manager that he/she was not home at the time and asked if the visit could be the next day. Person #19 indicated the alternate clinical manager informed Person #19 she would be out of town the next day. Person #19 indicated PT #1 called on 3/29/2023, or 3/20/2023, to inform Person #19 that PT #1 could be at the patient’s home in 30 minutes for the first PT visit. Person #19 indicated she was not available on such short notice so PT #1 indicated he/she would come on 4/10/2023. Person #19 indicated he/she did not receive communication from the agency prior to 3/23/2023, to inform him/her of the agency’s acceptance of the referral and had not received communication in advance of the scheduling of the start of care visit for the nurse and PT. During an interview on 4/13/2023, at 12:29 PM, the clinical manager indicated there was no documentation of communication with the patient and/or Person #19 to arrange the start of care with the nurse and the PT evaluation with PT #1 prior to 3/29/2023. The clinical manager indicated she was not aware of the delay in the start of care with the nurse and with the PT evaluation. The clinical manager indicated she does not arrange the visits with the staff and indicated the administrator or the intake coordinator does. The clinical manager indicated she does not talk to the staff directly but receives information regarding the admissions and evaluations from the administrator or the intake coordinator.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to ensure the development and implementation of the plan of care in 1 of 1 clinical record reviewed with wounds. (Patient #1) The findings include: Review of an agency job description revised August 2011 titled “Clinical Director” stated, “… Essential Job Functions/Responsibilities … Provides help in … implementation and evaluation of patient and family/caregiver care ….” Clinical record review on 4/12/2023, for Patient #1, evidenced a document from Person #6 (physician) dated 2/27/2023, which indicated the patient had a wound to the right ankle. Review indicated the home health skilled nurse was to perform wound care 3 times a week. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 3/20/2023-5/18/2023, which indicated the agency was to provide skilled nursing services 2 times a week. Review failed to evidence the agency assessed a willing and able caregiver to provide wound care in absence of the skilled nurse. Review failed to evidence the agency provided skilled nursing services 2 times a week as directed in the plan of care during the weeks of 3/26/2023, 4/2/2023, and 4/9/2023. Review failed to evidence the clinical manager ensured the plan of care was developed to ensure wound care was provided as ordered by the physician and failed to evidence the plan of care was implemented to provide skilled nursing services 2 times a week as directed in the plan of care. During an interview on 4/14/2023, at 12:45 PM, the clinical manager indicated she was not sure who was taking care of the patient’s needs when the caregiver was unavailable and indicated the patient should not be left home alone because he is dependent for activities of daily living and wound care. At 12:49 PM, the clinical manager indicated she was not aware the skilled nursing visits were not provided twice a week as directed in the plan of care and indicated the skilled nurse frequency in the plan of care should be 3 times a week since that was the ordered frequency of the wound care.

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, the agency failed to ensure the skilled nurse provided wound care in accordance with current clinical practice guidelines in 1 of 1 clinical record reviewed with a wound. (Patient #1) The findings include: Review of an agency policy revised August 2011, titled “Standards of Care, Service, and Practice” stated, “… Standards of care/service and practice guidelines will guide the interventions that are to be implemented….” Clinical record review on 4/12/2023, for Patient #1, evidenced an agency document titled “Start of Care”, and completed by the alternate clinical manager/registered nurse and dated 3/20/2023, which indicated the patient had a wound to the right ankle. Review indicated the alternate clinical manager did not have wound care supplies with her and the patient did not have wound care supplies at the patient's home. Review indicated the alternate clinical manager removed the wound dressing in place to the right ankle to assess the wound and then reapplied with same dressing. During an interview on 4/14/2023, at 11:40 AM, the clinical manager indicated the alternate clinical manager should not have redressed the wound with the old dressing and this was not a acceptable standard of practice.

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 home health agency failed to review all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy in 4 of 6 clinical records reviewed. (Patient #2, #4, #5, #6) Findings include: 1. Clinical record review on 2/14/2023, for Patient #4, start of care 1/26/2023, evidenced an agency document titled “Medication Profile” for episode period 1/26/2023 – 3/26/2023. Review indicated the patient’s medications included, but were not limited to, Entresto (a medication used to treat heart failure), potassium chloride (a mineral supplement), metoprolol (a medication used to treat high blood pressure), amlodipine (a medication used to treat high blood pressure and/or heart disease), furosemide (a medication used to rid the body of excess fluid), digoxin (a medication used to treat heart failure and/or abnormal heart rhythms), aspirin (a medication used to reduce pain/fever/inflammation), and atorvastatin (a medication used to lower cholesterol). Review failed to evidence the document was signed by a registered nurse (RN). Review of an agency document titled “Drug-Drug Interactions” dated 2/14/2023, indicated a major drug interaction between potassium chloride and Entresto which could cause kidney failure, muscle paralysis, irregular heart rhythm, and cardiac arrest. Review indicated moderate interactions to include, but not limited to, metoprolol and amlodipine, potentially causing heart failure, severe low blood pressure, and chest pain; furosemide and metoprolol, potentially causing low blood pressure, slowed heart rate, and loss of blood sugar control; furosemide and digoxin, potentially causing abnormal heart rhythms; aspirin and digoxin, potentially causing digoxin toxicity; metoprolol and digoxin, potentially causing lowered heart rate; and digoxin and atorvastatin, potentially causing an increase in digoxin levels. Review failed to evidence the registered nurse reviewed the medications for potential drug interactions. Review of the initial comprehensive assessment electronically signed by the RN and dated 1/26/2023, indicated the RN reconciled the medications and found no issues. During an interview on 2/15/2023, at 2:40 PM, the clinical manager indicated there was no record the registered nurse was aware of drug interactions. 2. Clinical record review on 2/9/2023, for Patient #5, start of care 11/3/2022, evidenced an agency document titled “Recertification” and identified as the comprehensive assessment, signed by the RN and dated 12/30/2022. Review evidenced an agency document titled “Medication Profile”, which was last signed by the clinical manager on 12/1/2022. Review failed to evidence the RN reviewed the medications for potential drug interactions and adverse side effects at the time of the comprehensive assessment. 3. Clinical record review on 2/10/2023, for Patient #6, start of care 11/3/2022, evidenced an agency document titled “Recertification” and identified as the comprehensive assessment, signed by the RN and dated 12/30/2022. Review evidenced an agency document titled “Medication Profile”, which was last signed by the clinical manager on 12/1/2022. Review failed to evidence the RN reviewed the medications for potential drug interactions and adverse side effects at the time of the comprehensive assessment. 4. During an interview on 2/14/2023, at 3:44 PM, the clinical manager indicated medications should be reviewed at every recertification assessment. 1. Record review of an agency policy dated August 2011, titled, “Medication Profile,” stated, “… Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications. Upon admission to the organization, the admitting clinician will initiate a medication profile to document the current medication regimen. A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication. The review will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy … Any conclusions and findings of patient medication use or monitoring should be communicated to the pharmacist, when appropriate, and other clinicians ….” 2. Clinical record review on 02/10/2023, of patient #2, start of care 10/14/2022, evidenced an agency document titled, “OASIS (outcome and assessment information set) D-1 Recertification,” for certification period 02/11/2023-04/11/2023, indicated medication review was completed and assessed for drug interactions. The comprehensive assessment evidenced a blank box for physician contacted regarding medication review. Review of an agency document dated 02/10/2023, titled, “Drug-Drug Interactions,” indicated major drug interactions between sucralfate (medication for stomach ulcers) and cholecalciferol (vitamin D) , amlodipine (blood pressure medication) and simvastatin (cholesterol lowering medication), simvastatin and dronedarone (medication of irregular heart rhythms), and aspirin (pain reliever) and apixaban (blood thinning medication). Review of a web based source on 02/13/2023, https:drugs.com/drug-interactions.html, evidenced the following 3 major medication interactions between medications on patient #2’s medication list: Aspirin and apixaban may increase risk of bleeding, simvastatin and amlodipine may increase liver damage and may cause rare condition that breaks down the skeletal muscles and causes kidney damage, simvastatin and dronedarone may increase liver damage and may cause rare condition that breaks down the skeletal muscles and causes kidney damage. Review failed to evidence the physician was notified of the patient’s major drug interactions. During an interview on 02/15/2023, at 1:48 PM, the director of nursing indicated there is no documentation the physician was informed of the major drug interactions. The director of nursing indicated the physician should be notified of major drug interactions and going forward would notify physician of major drug interactions. 410 IAC 17-14-1(a)(1)(B)

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to implement a discharge planning process that assisted patients and their caregivers in selecting a care provider using quality measures that are applicable to the patient’s goals of care and treatment preferences in 2 of 2 clinical records with pending discharge. (Patient #5, #6) The findings include: 1. Review of an agency policy revised August 2011, titled “Discharge Planning” stated, “… Information will be provided to assist the patient in planning his/her discharge, including referral and transfer … Clinicians will assist patients regarding their discharge by: … Serving as a referral source for patient and family/caregiver in obtaining follow-up support services ….” 2. Clinical record review on 2/9/2023, for Patient #5, start of care 11/3/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/2/2023-3/2/2023, which indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks. Review indicated the patient’s diagnoses included dementia (a progressive condition which affects memory and decision making). Review indicated the patient was to discharge when the caregiver was able to demonstrate necessary skills to aid patient in managing the disease process and activity. Review indicated the patient lived with a spouse who was also a patient of the agency. Review of agency documents titled “Skilled Nurse Visit” dated 1/18/2023, 1/26/2023, and 2/8/2023, indicated the patient had muscle weakness, poor balance, shuffling unsteady gait, had difficulty breathing with minimal exertion, incontinent of bowel and bladder, and poor hydration. Review indicated the nurse assessed the patient to have poor oral and personal hygiene. Review of an agency document titled “Physician Order” dated 2/1/2023, and electronically signed by the office manager, indicated the patient was being discharged due to noncompliance. Review failed to evidence the patient’s primary caregiver/power of attorney (POA) was provided a list of providers to assist the patient with care as required. Review failed to evidence referrals for care were made for the patient’s post discharge care. During an interview on 2/10/2023, at 12:36 PM, Person J, patient’s primary contact, indicated she was the patient’s POA. Person J indicated the patient lived with spouse who was also a patient of the agency who required assistance with care. Person J stated, “[patient] has dementia in a bad way.” Person J indicated she was unaware of patient’s discharge from the agency and was not provided a list of agencies who could provide care to the patient. Person J indicated the patient required daily care. During an interview on 2/14/2023, at 4:06 PM, the administrator indicated the patient does have care needs and indicated he was unsure who would be providing the care the patient required. During an interview on 2/14/2023, at 4:06 PM, the clinical manager indicated the agency had made no other efforts to find care the patient required. The clinical manager indicated no referrals had been made and no list of other agencies had been provided to the patient’s caregiver. 3. Clinical record review on 2/10/2023, for Patient #6, start of care 11/3/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/2/2023-3/2/2023, which indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks. Review indicated the patient’s diagnoses included dementia. Review indicated the patient was to discharge when the caregiver was able to demonstrate necessary skills to aid patient in managing the disease process and activity. Review indicated the patient lived with a spouse who was also a patient of the agency. Review of agency documents titled “Skilled Nurse Visit” dated 1/18/2023, 1/26/2023, and 2/8/2023, indicated the patient was forgetful, had poor balance, shuffling gait, incontinent of bowel and bladder, and poor hydration. Review indicated the patient had an altered home environment to include caregiver burnout, cluttered/soiled living conditions, and lack of caregiver support. Review of document dated 2/8/2023, indicated the patient appears to be wearing the same clothes at every visit and has dirty hands and feet. Review of an agency document titled “Physician Order” dated 2/1/2023, and electronically signed by the office manager, indicated the patient was being discharged due to noncompliance. Review failed to evidence the patient’s primary caregiver/POA was provided a list of providers to assist the patient with care as required. Review failed to evidence referrals for care were made for the patient’s post discharge care. During an interview on 2/10/2023, at 12:36 PM, Person J, patient’s primary contact, indicated she was the patient’s POA. Person J indicated the patient lived with spouse who was also a patient of the agency who required assistance with care. Person J indicated she was unaware of patient’s discharge from the agency and was not provided a list of agencies who could provide care to the patient. Person J indicated the patient required daily care. During an interview on 2/14/2023, at 4:06 PM, the administrator indicated the patient does have care needs and indicated he was unsure who would be providing the care the patient required. During an interview on 2/14/2023, at 4:06 PM, the clinical manager indicated the agency had made no other efforts to find care the patient required. The clinical manager indicated no referrals had been made and no list of other agencies had been provided to the patient’s caregiver.

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and the patient's 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). This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to communicate discharge plans to the physician and patient’s representative in 2 of 2 clinical record reviews with medical social work (MSW) services. (Patient #5, #6) The findings include: 1. Review of an agency policy revised August 2011, titled “Discharge Planning” stated, “… Clinicians will assist patients regarding their discharge by: … Consulting with the patient and family/caregiver regarding the need for discharge from the organization … All communication and information regarding discharge planning will be documented in the clinical record….” 2. Review of an agency policy revised August 2011, titled “Monitoring Patient’s Response/Reporting to Physician” stated, “… The patient’s physician will be contacted on the same day when any of the following occur: … Patient is to be discharged from the organization ….” 3. Clinical record review on 2/9/2023, for Patient #5, start of care 11/3/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/2/2023-3/2/2023, which indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks. Review indicated the patient’s diagnoses included dementia (a progressive condition which affects memory and decision making). Review indicated the patient was to discharge when the caregiver was able to demonstrate necessary skills to aid patient in managing the disease process and activity. Review of agency documents titled “Skilled Nurse Visit” dated 1/18/2023, 1/26/2023, and 2/8/2023, indicated the patient had muscle weakness, poor balance, shuffling unsteady gait, had difficulty breathing with minimal exertion, and poor hydration. Review indicated the nurse assessed the patient to have poor oral and personal hygiene. Review of document dated 1/18/2023 indicated licensed practical nurse (LPN) #1 provided discharge notice to the patient due to noncompliance and indicated the physician was aware of plans to discharge. Review failed to evidence the LPN provided discharge notice to the patient’s caregiver/power of attorney (POA). Review of an agency document titled “Physician Order” dated 2/1/2023, and electronically signed by the office manager, indicated the nurse knocked on the patient’s door and no one answered. Review indicated the patient was being discharged due to noncompliance. Review failed to evidence the physician was contacted prior to the discharge regarding the plan to discharge. Review failed to evidence the patient’s primary contact and power of attorney (POA) was notified of the discharge. During an interview on 2/10/2023, at 12:36 PM, Person J, patient’s primary contact, indicated she was the patient’s POA. Person J indicated the patient lived with spouse who was also a patient of the agency who required assistance with care. Person J stated, “[patient] has dementia in a bad way.” Person J indicated she was unaware of patient’s discharge from the agency and of any noncompliance issues. During an interview on 2/10/2023, at 3:15 PM, LPN #1 indicated she was informed by the office manager the week prior that the patient was discharged due to noncompliance. LPN #1 indicated she was then notified this week to conduct a nurse visit and the patient would be discharged next week. LPN #1 indicated she did not provide discharge notice as documented on the visit note on 1/18/2023 because she was not aware the patient was discharging. LPN #1 indicated she added the discharge notice to the visit note on 1/18/2023 when she was informed by the office manager last week the patient was discharged since the note had yet to be completed. LPN #1 indicated she did not contact the physician regarding the plans for discharge because she assumed the office had notified the physician since the office is who told her the patient was discharged last week. During an interview on 2/14/2023, at 3:30 PM, the administrator indicated the agency was discharging the patient due to noncompliance because the family member did not answer the door for visits or took a long time to answer the door. The administrator indicated they notify the physician they are discharging but indicated there was no documentation of physician notification of the plans to discharge prior to the physician order written on 2/1/2023. During an interview on 2/14/2023, at 4:02 PM, the clinical manager indicated there was no communication documented with the physician regarding noncompliance and plans to discharge. At 4:03 PM, the clinical manager indicated the agency did not communicate discharge plans to the family member that occasionally stays with the patient or the power of attorney. During an interview on 2/15/2023, at 2:37 PM, the clinical manager indicated the office manager does not notify physician of patient changes and does not receive physician orders. The clinical manager indicated the office manager should not have documented the patient’s discharge on the physician order form but should have used a communication form. 4. Clinical record review on 2/10/2023, for Patient #6, start of care 11/3/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/2/2023-3/2/2023, which indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks. Review indicated the patient’s diagnoses included dementia. Review indicated the patient was to discharge when the caregiver was able to demonstrate necessary skills to aid patient in managing the disease process and activity. Review of agency documents titled “Skilled Nurse Visit” dated 1/18/2023, 1/26/2023, and 2/8/2023, indicated the patient was forgetful, had poor balance, shuffling gait, and poor hydration. Review indicated the patient had an altered home environment to include caregiver burnout, cluttered/soiled living conditions, and lack of caregiver support. Review of document dated 1/18/2023 indicated LPN #1 provided discharge notice to the patient due to noncompliance and indicated the physician was aware of plans to discharge. Review failed to evidence the LPN provided discharge notice to the patient’s caregiver/POA. Review of an agency document titled “Physician Order” dated 2/1/2023, and electronically signed by the office manager, indicated the nurse knocked on the patient’s door and no one answered. Review indicated the patient was being discharged due to noncompliance. Review failed to evidence the physician was contacted prior to the discharge regarding the plan to discharge. Review failed to evidence the patient’s primary contact and power of attorney POA was notified of the discharge. During an interview on 2/10/2023, at 12:36 PM, Person J, patient’s primary contact, indicated she was the patient’s POA. Person J indicated the patient lived with spouse who was also a patient of the agency who required assistance with care. Person J indicated she was unaware of patient’s discharge from the agency and of any noncompliance issues. During an interview on 2/10/2023, at 3:15 PM, LPN #1 indicated she was informed by the office manager the week prior that the patient was discharged due to noncompliance. LPN #1 indicated she was then notified this week to conduct a nurse visit and the patient would be discharged next week. LPN #1 indicated she did not provide discharge notice as documented on the visit note on 1/18/2023 because she was not aware the patient was discharging. LPN #1 indicated she added the discharge notice to the visit note on 1/18/2023 when she was informed by the office manager last week the patient was discharged since the note had yet to be completed. LPN #1 indicated she did not contact the physician regarding the plans for discharge because she assumed the office had notified the physician since the office is who told her the patient was discharged last week. During an interview on 2/14/2023, at 3:30 PM, the administrator indicated the agency was discharging the patient due to noncompliance because the family member did not answer the door for visits or took a long time to answer the door. The administrator indicated they notify the physician they are discharging but indicated there was no documentation of physician notification of the plans to discharge prior to the physician order written on 2/1/2023. During an interview on 2/14/2023, at 4:02 PM, the clinical manager indicated there was no communication documented with the physician regarding noncompliance and plans to discharge. At 4:03 PM, the clinical manager indicated the agency did not communicate discharge plans to the family member that occasionally stays with the patient or the power of attorney. During an interview on 2/15/2023, at 2:37 PM, the clinical manager indicated the office manager does not notify physician of patient changes and does not receive physician orders. The clinical manager indicated the office manager should not have documented the patient’s discharge on the physician order form but should have used a communication form.

Integrate all orders CFR(s): 484.60(d)(2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all orders were integrated into the plan of care in 1 of 1 clinical record reviewed with a hospitalization. (Patient #4) The findings include: Review of an undated agency policy on 2/15/2023, titled “Physician’s Plan of Treatment/Change Orders” stated, “… The plan of treatment shall include but not be limited to: … Medications ….” Clinical record review on 2/14/2023, for Patient #4, start of care 1/26/2023, evidenced a document titled “History and Physical” dated 1/24/2023 from Person H, nurse practitioner. Review indicated the patient’s medication orders included carvedilol (a medication used to treat high blood pressure and/or heart failure), Eliquis (a medication used to treat and prevent blood clots), Invokana (a medication used to treat high blood sugar), spironolactone (a medication used to treat fluid build-up), and digoxin (a medication used to treat heart failure and/or abnormal heart rhythms). Review indicated digoxin 62.5 micrograms (mcg) was to be taken once every 48 hours. Review of the agency document titled “Home Health Certification and Plan of Care” for certification period 1/26 /2023-3/26/2023 was signed by Person H on 1/27/2023. Review failed to evidence the patient’s medication orders included carvedilol, Eliquis, Invokana, and spironolactone. Review indicated the order for digoxin was 125 mcg daily. Review failed to evidence the medication orders were integrated into the plan of care. During an interview on 2/15/2023, at 2:55 PM, the clinical manager indicated the agency should have included the medication orders listed from the patient’s primary physician.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to coordinate care with other agencies providing services to the patient in 1 of 1 clinical record reviewed receiving services from another home care agency. (Patient #4) The findings include: Review of an agency policy revised August 2011, titled “Coordination of Services with Other Providers” stated, “… The Case Manager will be responsible for the coordination between service providers, which will include, but not be limited to: Organization personnel’s understanding of each organization’s/individual’s responsibility in providing care….” Clinical record review on 2/14/2023, for Patient #4, start of care 1/26/2023, evidenced a document from Entity E titled “After Visit Summary” dated 2/9/2023, which indicated the patient received home services from Entity F. During an interview on 2/15/2023, at 2:45 PM, the clinical manager indicated she was unaware of any other services provided to the patient by another agency. The clinical manager indicated the agency needed to have communication with Entity F. During an interview on 2/15/2023, at 3:28 PM, Person G from Entity F indicated Entity F provided 100 hours a month of attendant care and 60 hours a month of homemaker services to the patient.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on record review, and interview, the home health agency’s performance improvement activities failed to lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. Findings include: Record review of an agency policy dated August 2011, titled, “Aggregation of Data/Information,” stated, “… Data to be considered for collection to monitor performance of the organization include the following: ... Summaries of actions taken as a result of performance improvement activities, including risk management, utilization review, infection control, safety management, outcome reports regarding processes or services, and performance measures from acceptable databases ….” Review of an agency document dated 02/10/2023, titled, “Hospitalization Log,” failed to evidence the home health agency’s performance improvement activities led to an immediate correction of identified problems that directly or potentially threaten the health and safety of patients. Review of the agency's QAPI (quality assessment performance improvement) program on 02/09/2023, failed to evidence performance improvement activities led to an immediate correction of identified problems. During an interview on 02/10/2023, at 4:00 PM, the administrator indicated the hospitalization log did not lead to any immediate corrections of the identified problem. 410 IAC 17-12-2(a)

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to conduct a performance improvement project annually. Findings include: Record review of an agency policy dated August 2011, titled, “Patient Focused Performance Improvement,” stated, “… The organization’s performance improvement processes will focus on the quality of patient and program outcomes … Program, or process related performance improvement activities will focus on opportunities to improve overall organizational performance … When an opportunity to improve performance is identified, a focus study [indicator] will be developed to measure and improve associated processes. Performance improvement documentation will be maintained by the Performance Improvement Coordinator….” Review of the agency’s QAPI (quality assessment performance improvement program) on 02/09/2023, failed to evidence a performance improvement project was conducted annually. During an interview on 02/10/2023, at 4:12 PM, the administrator indicated the agency’s performance improvement project was to reduce hospitalizations but indicated there was no documentation of performance improvement project conducted. The administrator indicated he was trying to hire a nurse to assist with the QAPI program.

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 home health agency failed to implement policies and procedures to ensure the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who were not fully vaccinated; and failed to include policies and procedures that were implemented to ensure tracking of all staff vaccination status. Findings include: Record review of an undated agency policy received on 02/09/2023, identified as the Covid-19 policy by the administrator, titled, “Employee Health Requirements/Covid-19 Vaccination,” and an agency policy dated August 2011, titled, “Infection Control/Expanded Precautions,” failed to evidence the Covid-19 policy was specific to Covid-19 tracking of personnel vaccinations, or specific to Covid-19 precautions required. Review of the Covid-19 binder on 02/09/2023, failed to include contracted staff Covid-19 vaccination status tracking; failed to include N95 respiratory masks were to be worn by staff that were unvaccinated for Covid-19, and failed to include a contingency plan for unvaccinated staff to mitigate the transmission of Covid-19. During an interview on 02/10/2023, at 4:00 PM, the administrator indicated the Covid-19 policy was no specific but was included with the Hepatitis B policy. The administrator indicated all Covid-19 policies were reviewed. The administrator indicated all agency staff were vaccinated except for one that had a religious exemption. The administrator indicated unvaccinated staff must wear N95’s if unvaccinated during patient care. The administrator indicated he did not get the Covid-19 vaccination status of contracted staff until they were requested on 02/09/2023. The administrator indicated there is not a policy with a contingency plan for unvaccinated staff for Covid-19.

Participate in the HHA's QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA's QAPI program; and This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all skilled profession staff participate in the home health agency’s QAPI (quality assessment performance improvement) program. Findings include: Record review of an agency policy dated August 2011, titled, “Responsibilities In Improving Performance,” stated, “… All personnel will be active participants in the organization’s performance improvement ….” During an interview on 02/14/2023, at 3:00 PM, LPN (licensed practical nurse) #1 indicated she did not know what the QAPI program is and does not participate in the program.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to have the home health aide provide services that are ordered by the physician included in the plan of care in 1of 1 clinical records reviewed with a home health aide. (#1) Findings include: Record review of an agency policy dated August 2011, titled, “Home Health Aide Plan of Care,” stated, “… Each patient receiving home health aide services will have an individualized plan developed by an appropriate professional and utilized to direct the care performed by the assigned aide … The home health aide plan of care will be individualized to the specific patient and will include at least: Type of services/procedures to be provided ….” Record review of an agency policy dated August 2011, titled, “Orientation of Assigned Home Health Aide,” stated, “… Home health aides will receive patient information in the form of an aide assignment prior to caring for the patient … A home health aide assignment sheet is completed, reviewed with the home health aide, and signed by either the nurse or therapist and the home health aide … The home health aide assignment sheet correlates with the orders on the plan of care. The aide will complete an aide clinical note on each patient ….” Clinical record review on 02/10/2023, of patient #1, start of care 01/11/2023, evidenced an agency document dated 01/11/2023, titled, “HHA (home health aide) Care Plan,” indicated temperature, blood pressure, heart rate, and respirations were not to be completed for the patient. Review of an agency document dated 01/12/2023, titled, “Home Health Aide Assignment,” failed to evidence temperature, heart rate, or respirations were to be completed for the patient by the home health aide. Review of agency documents dated 01/16/2023, and 01/18/2023, titled, “HHA Visit,” indicated the patient’s heartrate was 80 and 86, temperature was 97.8 and 98.3, and respirations were 20 and 20; and were completed by the home health aide. During an interview on 02/14/2023, at 1:25 PM, the clinical manager indicated the home health aide should follow the aide plan of care and aide assignment sheet and should not have performed temperature, heart rate or respirations. The clinical manager indicated the home health aide should follow the aide plan of care and should perform tasks exactly as indicated, no more and no less than the plan of care directed.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the organization and management of the home health agency as follows: the administrator failed to ensure the governing body reviewed the quality assessment and performance improvement program (see tag G0942); the administrator failed to maintain the day-to-day operations of the agency (see tag G0948); the administrator failed to ensure the clinical manager was available during operating hours (see tag G0950); and the clinical manager failed to coordinate referrals (see tag G0964). The cumulative effect of these systemic problems has resulted in the home health agency's inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.105 Organization and Administration of Services. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the agency failed to set forth in writing the organizational structure to include the lines of authority and the services provided. The findings include: 410 IA 17-12-1(a)(1) Record review of an agency policy dated August 2011, titled, “Use Of Organizational Chart,” stated, “… There will be defined lines of authority, which clearly establishes responsibility and accountability for all organization personnel … The organizational chart will be reviewed, revised and dated as changes occur….” Record review of an undated agency document received on 02/09/2023, titled, “Chart Of Organization,” indicated the clinicians including registered nurse, physical therapist, medical social worker, home health aide reported to the office manager. The document failed to evidence licensed practical nurse on the organization chart. During an interview on 02/09/2023, at 3:54 PM, the administrator indicated the licensed practical nurse should be on the organizational chart and clinicians including the registered nurse, physical therapist, medical social worker, home health aide report to the director of nursing not to the office manager.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to be responsible for the day-to-day operations of the agency. The findings include: The administrator failed to ensure the day-to-day operations of the home health agency as evidenced by: The administrator failed to ensure the patient/representative was informed of and consented to services to be provided and was informed of changes in services. Please see tag G0434. The administrator failed to ensure the agency policy was followed for the review of medications. Please see tag G0536. The administrator failed to implement a discharge planning process. Please see tag G0562. The administrator failed to ensure the needs of the patient were met, the patient received an individualized written plan of care and services were provided as directed, services were coordinated with all providers, and written information was provided to the patient. Please see tags associated with federal regulation 42CFR 484.60. The administrator failed to ensure there was a Quality Assessment and Performance Improvement (QAPI) program maintained at the home health agency. Please see tags associated with federal regulation 42CFR 484.65. The administrator failed to ensure the agency maintained an infection control program. Please see tags associated with federal regulation 42CFR 484.70. The administrator failed to ensure the interdisciplinary involvement in the patient’s plan of care. Please see tag G0706. The administrator failed to ensure skilled professionals created clinical notes and/or accurate complete notes for all services provided to patients. Please see tag G0716. The administrator failed to ensure the registered nurse provided supervision of the licensed practical nurse. Please see tag G0726. The administrator failed to ensure all home health aide care plans were complete and individualized. Please see tag G0798. The administrator failed to ensure all services were provided by the home health aide as directed in the aide care plan. Please see tag G0800. The administrator failed to ensure the clinical manager was available during operating hours. Please see tag G0950. The administrator failed to ensure the clinical records contained goals in the plan of care. Please see tag G1016. The administrator failed to ensure clinical records were protected from loss and unauthorized use. Please see tag G1028. During an interview on 2/14/2023, at 3:23 PM, administrator indicated things used to be better but things haven’t been running as smoothly in the absence of the alternate administrator. 410 IAC 17-12-1(c)(1) Record review of an agency policy dated August 2011, titled, “Responsibilities In Improving Performance,” stated, “To establish patient outcomes as the primary focus of the organization’s performance improvement activities. Senior management will have the responsibility: to guide the organization’s efforts in improving organizational performance; to define expectations of the performance improvement activities; and to generate the plan and processes the organization will utilize to assess, improve, and maintain quality of care and service. Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety … The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented, and maintained … Senior management will … adopt a structured framework for performance improvement ….” Record review of the agency’s QAPI (quality assessment performance improvement) program on 02/09/2023, evidenced aggregated data from, “Medicare.gov/care-compare.” Review evidenced the data were percentages from where the agency and region measured up to the national average. Record review failed to evidence the administrator ensured an ongoing QAPI program to improve patient care with specific measurable outcomes. During an interview on 02/10/2023, at 4:00 PM, the administrator indicated the agency is not incorporating the agency’s aggregated data for the QAPI program. The administrator indicated the agency was in the process of hiring a Quality Assessment nurse to assist with the QAPI program.

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 clinical oversight of the coordination of patient referrals in 2 of 2 clinical records reviewed with referrals. (Patient #5, #6) The findings include: 1. Review of an undated agency job description on 2/15/2023, titled “Clinical Director” stated, “… Coordinates and oversees and direct and indirect patient services provided by clinical organization personnel….” 2. Clinical record review on 2/9/2023, for Patient #5, start of care 11/3/2022, evidenced an agency document titled “Medical Social Services Evaluation” dated 12/22/2022. Review indicated the medical social worker (MSW) recommended Meals On Wheels and homemaker services for the patient. Review failed to evidence follow-up on the MSW recommendations. 3. Clinical record review on 2/10/2023, for Patient #6, start of care 11/3/2022, evidenced an agency document titled “Medical Social Services Evaluation” dated 12/22/2022. Review indicated the MSW recommended Meals On Wheels and homemaker services for the patient. Review failed to evidence follow-up on the MSW recommendations. 4. During an interview on 2/14/2023, at 3:38 PM, the clinical manager indicated there was no follow-up on the MSW’s recommendations and indicated she was unaware of the MSW referral. The clinical manger indicated there should have been follow-up on the MSW recommendations.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure all clinicians performed hand hygiene to prevent the possible spread of communicable diseases for 1 of 1 home visit with a Registered Nurse (RN). (RN #1) The findings include: Record review of an undated agency policy retrieved on 12/22/2022, titled “Hand Hygiene” revised in August 2011, stated “Purpose … To prevent cross-contamination and home care-acquired infections … Policy … Personnel providing care in the home setting will regularly wash their hands, per the most recently published CDC [Center for Disease Control and Prevention] regulations and guidelines for hand hygiene in healthcare settings … Procedure … Hand decontamination with an alcohol-based hand rub … 3. Hand contamination using an alcohol-based hand rub should be performed: A. Before having direct contact with patients … C. After contact with a patient’s intact skin (when taking a pulse, blood pressure or lifting a patient) … F. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient … G. After removing gloves ….” Review of the CDC [Center for Disease Control] website on 12/29/2022, for recommendations of hand hygiene for health care providers (www.CDC.gov/handhygiene/providers) stated, “When to Perform Hand Hygiene? … Multiple opportunities for hand hygiene may occur during a single care episode. Following are the clinical indications for hand hygiene: … After touching a patient or the patient’s immediate environment … Immediately after glove removal ….” An observation of a home visit was conducted on 12/14/2022, from 11:11 AM – 12:01 PM, for patient #1, start of care 10/19/2022, with clinical manager #1. At 11:19 AM, clinical manager #1 donned a new pair of gloves and began the patient’s assessment, which included but was not limited to, blood pressure, pedal pulses, heart, lung and stomach sounds. At 11:37 AM, clinical manager #1 removed their gloves and donned a new pair failing to perform hand hygiene in between glove changes. At 11:42 AM, an assessment using an incentive spirometer (a handheld device used to expand and strengthen the lungs) was completed and clinical manager #1 removed their gloves. Clinical manager #1 added information to the patient’s home folder before the home visit was completed. Observation failed to evidence clinical manager #1 performed hand hygiene after touching inanimate objects in the patient’s home. Observation failed to evidence clinical manager #1 performed hand hygiene after removing gloves. Observation failed to evidence clinical manager #1 performed hand hygiene after patient care. During an interview on 12/21/2022, at 10:13 AM, clinical manager #1 indicated hand hygiene should be performed at the beginning of the visit with soap and water, followed by ABHR [alcohol based hand rub], and stated “The more, the better.” They indicated hand hygiene should also be performed after patient care. 410 IAC 17-12-1(m)

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure all clinical record documentation was accurate and complete for 3 of 4 active clinical records reviewed. (patient #1, #2, #4) The findings include: 1. An observation of a home visit was conducted on 12/14/2022, from 11:11 AM to 12:01 PM, for patient #1, start of care 10/19/2022, with clinical manager #1. During the visit, clinical manager #1 assessed the patient’s vital signs. At 11:22 AM, the vital signs were reported as follows: Blood pressure on left arm – 130/70 mmhg [millimeters of mercury], pulse oximetry [oxygen saturation] – 99% on room air, Temperature - 97.8 using the temporal [forehead] route. Record review evidenced an agency document titled “Skilled Nurse Visit” which was electronically signed by clinical manager #1 on 12/14/2022. This document had an area subtitled “Vital Signs” that stated, “Temperature: 98.4 … O2 [oxygen] Saturation: 98% … BP [blood pressure] ….” Record review failed to evidence the documentation of temperature and oxygen saturation accurately reflected what was observed during the home visit on 12/14/2022. During an interview on 12/21/2022, at 10:55 AM, clinical manager #1 indicated the skilled nurse visit note must have been an error and should be the same as the home visit. 2. An observation of a home visit was conducted on 12/14/2022, from 2:04 PM to 2:34 PM, for patient #2, start of care 11/3/2022, with Licensed Practical Nurse (LPN) #1. Observation during the visit evidenced the patient was saturated with urine and had not consumed food or water yet that day, confirmed by person #8. Observation evidenced one bedroom with the patient in a twin size bed on one side of the room, and person #8 in a hospital bed on the other side of the room. Observation evidenced person #7 in the living room on the couch. Clinical record review on 12/14/2022, for patient #2, pertinent diagnoses of dementia, dehydration, and history of falling, evidenced an agency document titled “OASIS-D1 Start of Care” electronically signed by clinical manager #1 on 11/3/2022. This document had an area subtitled “Caregiver Status” which stated “… lives with Grand [child] and [person #7] ….” Record review evidenced an agency document titled “Skilled Nurse Visit” electronically signed by clinical manager #1 on 11/29/2022. This document had an area subtitled “Plan of Care Review” which stated “…Caregiver Availability Grand [child] and [person #8] lives with patient .…” Record review failed to evidence consistent documentation of caregiver availability. Record review failed to evidence consistency with the observations. Record review failed to evidence accurate documentation of clinical records. During an interview on 12/21/2022, at 11:31 AM, when queried who the patient’s caregiver was, clinical manager #1 stated “[Person #9].” Clinical manager #1 indicated person #8 lived with the patient and was responsible for preparing food and water for the patient. They indicated person #7 and another relative lived there intermittently and helped with daily care. During an interview on 12/21/2022, at 11:43 AM, clinical manager #1 indicated they didn’t know who lived in the home other than the patient and person #8. 3. Clinical record review on 12/20/2022, for patient #4, start of care 9/19/2022, primary diagnosis muscular dystrophy (disease that causes progressive weakness and loss of muscle mass), evidenced an agency document titled “OASIS-D1 Recertification” electronically signed by Registered Nurse (RN) #3 on 11/14/2022. This document had an area subtitled “Hospitalization Risk Assessment Tools and Emergency Preparedness” which had an unchecked box next to the statement “Emergency Preparedness Performed…” Another area subtitled “Prognosis” which had an unchecked box next to the statement “Advance Care Plan Performed …” An area subtitled “Supportive Assistance” stated “Caregiver Availability /Type of Assistance … 24 hours ….” Record review of the skilled professionals documentation failed to evidence all safety precautions for emergency situations had been discussed with the patient/caregiver. Record review failed to evidence the type and ability for caregiver assistance. Record review failed to evidence the skilled professional completed the comprehensive assessment documentation. Record review failed to evidence an emergency preparedness plan was discussed with the patient. During an interview on 12/21/2022, at 10:24 AM, clinical manager #1 indicated the emergency preparedness plan was reviewed with the patient at every comprehensive assessment and was maintained on the front of the patient's chart. During an interview on 12/21/2022, at 1:26 PM, clinical manager #1 was queried on pertinent safety related information including but not limited to who the patient lived with, the closest evacuation shelter, any medical equipment needed in the event of an evacuation. Clinical manager #1 stated they would “have to ask the nurse” for the answer to those questions. The patient’s physical chart was reviewed in front of administrator #1, clinical manager #1, office manager #1, and intake coordinator #2, which failed to evidence the emergency preparedness plan was in the paper chart. 14 IAC 17-14-1(a)(1)(E)-RN

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all patients had a home health aide care plan for 1 of 1 active clinical record reviewed where home health aide services were provided. (patient #3) The findings include: Record review of an undated agency policy retrieved on 12/22/2022, titled “Home Health Aide Plan of Care” revised August 2011, stated “Policy … Each patient receiving home health aide services will have an individualized plan developed by an appropriate professional and utilized to direct the care performed by the assigned aide … Procedure … 2. The home health aide plan of care will be individualized to the specific patient and will include at least: … G. Nutritional requirements … L. Allergies … 4. The home health aide plan of care will be revised at least every 60 days based upon a professional reassessment of the patient and at any time the patient’s change of condition warrants revision ….” Clinical record review on 12/20/2022, for patient #3, start of care 9/7/2022, evidenced an agency document titled “HHA [home health aide] Care Plan” which stated “Episode/Period: 9/7/2022 – 11/5/2022 …” This document failed to evidence the patient’s diet and allergies. Record review failed to evidence a current HHA care plan for the episode/period of 11/6/2022 – 1/4/2022. Review failed to evidence the HHA care plan was revised for each recertification. Review failed to evidence the care plan contained all individualized information as stated on the agency policy. During an interview on 12/21/2022, at 10:14 AM, clinical manager #1 indicated the home health aide care plans were created/revised at start of care, with every recertification, and reviewed every 14 days with the supervisory visit. During an interview on 12/21/2022, at 1:30 PM, clinical manager #1 indicated the patient should have a current home health aide care plan in the clinical record. 410 IAC 17-13-2(a)

This survey was a Federal complaint and a State licensure survey for a home health agency. Survey Dates: 9/30/2022, 10/3/2022 - 10/7/2022 Facility ID: 003155 Census: 12 Complaint #: IN0093800 - Substantiated: with Federal and State deficiencies cited. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Prime Care Home Health is precluded from providing its own home health aide training and competency evaluation for a period of two years from 10/7/2022 - 10/7/2024, due to being found out of compliance with Conditions of Participation 42CFR 484.60 Care Planning, Coordination of Services and Quality of Care. Quality Review Completed 10/26/2022

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient/caregiver consented to in advance, to the frequency of services that were being furnished in 7 of 7 complete clinical records reviewed. (#1, #2, #3, #4, #5, #6, #7) The findings include: 1. An agency policy titled “Patient Bill of Rights,” revised August 2011, stated, “Each patient will be an active, informed participant in his/her plan of care….” 2. An undated agency policy obtained on 10/4/2022, titled “Home Care Patient Rights and Responsibilities/Transfer and Discharge,” stated “you have the right to participate in and be informed about … The care to be furnished … the disciplines that will furnish the care; the frequency of visits….” 3. Clinical record review for patient #1, start of care 8/23/22, evidenced a plan of care for certification period 8/23/2022 – 10/21/2022. This plan of care evidenced patient was to receive skilled nursing services once a week for nine weeks. The skilled nurse was to assess the patient, instruct on disease processes, and perform medication review and education. Clinical record review of patient #1's record failed to evidence patient #1 was informed of and consented to the treatment to be provided in the plan of care. During an interview on 10/5/22 at 3:27 PM, the clinical manager indicated the patient was informed and consented to the care to be provided. She was unsure why the document did not indicate he consented to the skilled nursing services. 4. Clinical record review for patient #2, start of care 9/7/2022, evidenced a plan of care for certification period 9/7/2022 – 11/5/2022. This plan of care evidenced patient was to receive skilled nursing services once a week for nine weeks, home health aide services twice a week for nine weeks, and physical therapy twice a week for nine weeks Clinical record review for patient #2 failed to evidence they were informed of and consented to the treatment to be provided in the plan of care. 5. Clinical record review for patient #6, start of care 5/24/2022, evidenced a plan of care for certification period 7/23/2022 – 9/20/2022. This plan of care evidenced patient was to receive skilled nursing services once a week for nine weeks. Clinical record review of patient #6's record failed to evidence the patient was informed of and consented to the treatment to be provided in the plan of care. 6. Clinical record review for patient #7, start of care 5/19/22, evidenced a plan of care for certification period 7/18/2022 – 9/15/2022. This plan of care evidenced patient was to receive skilled nursing services once a week for nine weeks. The skilled nurse was to assess the patient, instruct on disease processes, and perform medication review and education. Clinical record review for patient #7 failed to evidence the patient was informed of and consented to the treatment to be provided in the plan of care. 7. Clinical record review for patient #3, start of care 9/19/2022, evidenced a plan of care for certification period 9/19/2022 – 11/17/2022. This plan of care evidenced patient was to receive skilled nursing services once a week for nine weeks. The skilled nurse was to assess the patient and perform medication review. Clinical record review of patient #3's record failed to evidence the patient was informed of and consented to the treatment to be provided in the plan of care. 8. Clinical record review for patient #4, start of care 8/25/2022, evidenced a plan of care for certification period 8/25/2022 – 10/23/2022. This plan of care evidenced patient was to receive skilled nursing services once a week for nine weeks. Clinical record review for patient #4 failed to evidence the patient was informed of and consented to the treatment to be provided in the plan of care. 9. Clinical record review for patient #5, start of care 8/30/2022, evidenced a plan of care for certification period 8/30/2022 – 10/28/2022. This plan of care evidenced patient was to receive skilled nursing services once a week for one week as needed, and physical therapy twice a week for nine weeks. Clinical record review for patient #5 failed to evidence the patient was informed of and consented to the treatment to be provided in the plan of care. During an interview on 10/5/22 at 2:30 PM, the clinical manager indicated patients are always informed and consent to the care to be provided. 17-12-3(b)(2)(D)(ii)(AA) and (BB) 17-12-3(b)(2)(D)(iii)

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 home health agency failed to ensure: the plan of care was reviewed by the physician, individualized and followed by all agency staff (See tag G0572); the plan of care included all required information for the treatment of the patient (See tag G0574); all patient care orders were recorded in the plan of care (See tag G0576); all treatments provided by agency staff were ordered by a physician (See tag G0580); physicians were promptly notified of a change in the patient's condition (See tag G0590); patients received education and training (See tag 610); the written visit schedule was provided to patients (See tag G0614); and written instructions were provided to the patient for the patient's medication schedule and instructions (See tag G0616) patients received in writing any treatments to be administered by agency personnel. The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination of Care and Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the home health agency failed to ensure their patient's needs were being met in 4 of 5 active clinical records. (#1, #2, #3, #4, #5) The findings include: 1. Review of an updated agency policy received 10/4/2022 titled “Admission Policy,” stated “Admission criteria are standards by which a client is assessed for admission. These standards include consideration regarding the adequacy and suitability of agency personnel to me the client’s needs, the agency recourses to provide the required services, and a reasonable expectation that the client’s needs, the Agency resources to the client's needs can be adequately met in the client's place of residence…." 2. An undated agency policy obtained on 10/4/2022, titled “Home Care Patient Rights and Responsibilities/Transfer and Discharge,” stated “you have the right to … receive all services outlined in the plan of care….” 3. Clinical record review for patient #1, start of care 8/23/2022, evidenced a plan of care for certification period 8/23/2022 – 9/21/2022, which indicated patient #1 was to receive skilled nursing services once a week for nine weeks and physical therapy twice a week for nine weeks. Physical therapy was to assess for gait training, strengthening exercises, balance/coordination transfer training, and to establish a home exercise program. Review of the clinical record failed to evidence the patient received any physical therapy services. During an observation on 10/3/2022 at 10:10 AM. Patient #1 indicated he was never contacted by a physical therapist. He indicated the agency told him he would be seen by a therapist but no one ever came out. He indicated since no one had ever come out to his home for therapy, he just did some therapy for himself by walking up and down the stairs and around his home. During an interview on 10/6/2022, at 10:21 AM, the administrator indicated he was not sure why therapy did not see the patient. During an interview on 10/6/2022 at 2:00 PM. the physical therapist indicated he called the patient, and the patient did not want therapy 4. Clinical record review for patient #2 start of care 9/7/2022, evidenced a plan of care for certification period 9/7/2022 – 11/5/2022, which indicated patient #2 was to receive skilled nursing services once a week for nine weeks, home health aide services twice a week for nine weeks, and physical therapy twice a week for six weeks. Physical therapy was to assess for gait training, strengthening exercises, balance/coordination transfer training, and to establish a home exercise program. Review of the clinical record failed to evidence the patient received any physical therapy services. During an interview on 10/5/2022 at 2:01 PM, the clinical manager indicated the physical therapist had gone to the home for the initial evaluation on 10/2/2022. When queried as to why he did not see her until a month after her start of care, the administrator indicated the therapist was on vacation. During an observation of a home visit on 10/5/2022 at 10:00 AM, the patient’s daughter indicated physical therapy had not come to evaluate her mom. 5. Clinical record review for patient #3, start of care 9/19/2022, evidenced an agency document titled “Face to Face Encounter”, dated 9/20/2022 and signed by the physician. This document evidenced the patient was to receive skilled nursing and physical therapy services. Clinical record review for patient #3 failed to evidence the patient received physical therapy. During an interview on 10/6/2022 at 2:02 PM, the physical therapist indicated she did not want physical therapy. Review of the clinical record failed to evidence any documentation of the patient refusing services. 6. Clinical record review for patient #4, start of care 8/25/2022, evidenced an agency document titled “Face to Face Encounter”, dated 8/25/2022 and signed by the physician. This document evidenced the patient was to receive skilled nursing and physical therapy services. Clinical record review failed to evidence the patient received physical therapy. Clinical record review evidenced a plan of care for certification period 8/25/2022 – 10/23/2022, which indicated patient #4 was to receive skilled nursing services once a week for nine weeks. Clinical record review failed to evidence the patient received a skilled nurse visit the week of 8/18/2022. During an interview on 10/5/2022 at 2:20 PM, the clinical manager indicated she was unsure why there was no visit that week and she would look into it. During an interview on 10/5/2022, at 2:10 PM, the administrator indicated the physical therapist was on vacation. When queried as to why they did not use another therapist he indicated they had PTA (physical therapy assistant) but then would have an issue with supervisory visits. 7. Clinical record review for patient #5, start of care 8/30/2022, evidenced an agency document titled “OASIS D1- Start of Care, dated 8/30/2022 and signed by RN #4. This document indicated patient #4 needed assistance with grooming, bathing, and toileting. During an interview on 10/4/2022 at 10 AM, the patient indicated she informed the agency on 10/3/2022 that she would no longer need services as she found an agency to provide her with a home health aide. When queried as to why she did not have one with the agency she indicated the agency did not have a home health aide that would come to where she lives. Clinical record review evidenced a plan of care for certification period 8/30/2022 – 10/28/2022. This plan of care evidenced patient was to receive skilled nursing services once a week for one week and as needed, and physical therapy twice a week for nine weeks. Clinical record review evidenced a physical therapy evaluation was done on 9/3/2022, and physical therapy visits were completed on 9/10/2022 and 9/13/2022. This review failed to evidence the patient received physical therapy twice a week and failed to evidence the agency met the patient’s needs by initialing home health aide services Clinical record review evidenced skilled nurse visit notes for 8/31/2022, 8/7/2022, 8/14/2022, and 8/28/2022. Record review failed to evidence patient #5 had a physical therapy evaluation on 9/3/2022, and physical therapy visits on 9/10/2022 and 9/13/2022. The clinical record review failed to evidence she received all services outlined in the plan of care. During an interview on 10/4/2022, at 11:45 AM, the office manager indicated patient #5 was not receiving services due to the agency not having a home health aide to go to the residence. During an interview on 10/5/2022 at 2:22 PM, the administrator indicated the patient no longer wanted therapy. Clinical record review failed to evidence any documentation of patient refusal for physical therapy services. During an interview with the clinical manager on 10/6/2022 at 11:31 AM, when queried if the patient could benefit from a home health aide, the clinical manager stated “absolutely. When queried as to why she did not receive these services she indicated there was not an aide to go to that area to which the administer indicated he was not aware the aide would not go there and he would have gotten someone for her. 17-13-1(a)

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the patient received all services as ordered on the plan of care, and/or had an individualized plan of care which included patient-specific, measurable goals and outcomes in 5 of 7 clinical records reviewed. (#1. #2, #3, #4, #7) The findings include: 1. The agency policy titled "Care planning process" with a revised date of August 2011 stated, "A written plan of care will be initiated within 5 days of start of care and updated at least every 60 days or as patient's condition warrants ... the clinical plan of care included Specific procedures to be performed by the therapies, including amount, frequency, and duration, goals ... the plan of care will be based upon the physician's orders." 2. The agency's policy titled "Physician Participation in Plan of Care" dated August 2011 stated, "A physician will direct the care of every home health care patient admitted per service. The attending physician will certify that medical, skilled, rehabilitative, and social services provided by the organization are medically required for the patient. ... Physician orders will be individualized, based on patient needs, and include: A. Patient diagnoses. B. Treatments and/or procedures needed, including type, frequency, duration, and goals." 3. Clinical record review for patient #1 evidenced a plan of care, for start of care 08/23/2022, certification period 8/23/2022 – 10/21/2022. The plan of care included but was not limited to the following diagnoses, type 2 diabetes (regulation of blood sugar), hypertension (high blood pressure), prostate cancer, abnormal weight loss, and gastritis 9inflamed stomach lining). This document indicated the patient was on a regular diet. The document also indicated the skilled nurse was to assess the respiratory status, instruct on the management and self-care of lung cancer, and instruct on heart failure. The document evidenced the patient's goals were to demonstrate self-management of arthritis, patient seeks assistance with personal hygiene. The plan of care failed to be individualized to include signs/symptoms of hypo/hyperglycemia, failed to indicate teaching on the correct cancer diagnosis, and failed to have individualized goals for the patient. 4. Clinical record review for patient #2 evidenced a plan of care, for start of care 9/7/2022, certification period 9/7/2022 – 11/5/2022. The plan of care included but was not limited to the following diagnoses: Multiple Sclerosis (immune system destroys the covering of nerves), major depressive disorder, muscle weakness, morbid obesity, anxiety, bed confinement, and hyperlipidemia (high cholesterol). The document also indicated the skilled nurse was to complete an assessment with an emphasis on hypertension. This document failed to be individualized for the patient’s diagnoses During an interview on 10/5/2022 at 2:04 PM, the clinical manager indicated she would expect to see education on pertinent diagnoses for the patient. She was unsure why there would be an emphasis on hypertension when the patient does not have a diagnosis of hypertension. 5. Clinical record review for patient #7 evidenced a plan of care, for start of care 08/19/2022, certification period 7/18/2022 – 9/15/2022. The plan of care included but was not limited to the following diagnoses: heart disease, hypertension (high blood pressure), and seizures. This document failed to have individualized goals for the patient. 6. Clinical record review for patient #3 evidenced a plan of care, for start of care 9/19/2022, certification period 9/19/2022 – 11/17/2022. The plan of care included but was not limited to the following diagnoses: Lupus (disease where the immune system attacks organs and tissues), hypertension (high blood pressure), and seizures (uncontrolled electrical disturbance in the brain). This document indicated the patient's goals were to effectively manage medication regimen, and no hospitalizations and ER visits. This document failed to have individualized goals for the patient. 7. Clinical record review for patient #4 evidenced a plan of care, for start of care 8/25/2022, certification period 8/25/2022 – 10/23/2022. The plan of care included but was not limited to the following diagnoses: hypertension (high blood pressure) and seizures (an uncontrolled electrical disturbance in the brain). This plan of care failed to have any goals for the patient. During an interview on 10/6/2022 at 2:25 PM, the clinical manager indicated the computer helps create goals and assessments based on diagnoses. She indicated goals should be individualized, and there should be teaching that is appropriate for diagnosis. The clinical manager indicated she would expect to see education on blood sugars, diet, and diabetes on the patient's care plan. 17-13-1(a)

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 observation, record review, and interview, the home health agency failed to ensure the medical plan of care was complete and included medications, the indication for medications, and all diagnoses in 6 of 7 records reviewed (#1, #2, #3, #4, #6, #7) 1. The agency's policy titled "Physician Participation in Plan of Care" dated August 2011 states, "A physician will direct the care of every home health care patient admitted per service. The attending physician will certify that medical, skilled, rehabilitative, and social services provided by the organization are medically required for the patient. ... Physician orders will be individualized, based on patient needs, and include: Patient diagnoses Treatments and/or procedures needed, including type, frequency, duration, and goals. Medications, allergies, and diet.” 2. During a home visit for patient #1 on 10/3/2022 at 10:25 AM, the patient was observed to be alert and oriented. When asked for his medications he went to the bedroom and brought out a plastic tote that held his medications bottles. Patient #1 indicated he does not take Losartan or Nitrofurantoin. He indicated he started taking Culturelle and Dicyclomine on 9/14/2022. Clinical record review for patient #1, start of care 8/23/2022, evidenced agency documents titled “Skilled Nurse Visit”, dated 9/12/2022 and 9/20/2022. These documents indicated the patient was taking ibuprofen (pain reliever) for right leg pain. The plan of care failed to include ibuprofen in the medications. Clinical record review for patient #1 evidenced a plan of care, for certification period 8/23/2022 – 10/21/2022. The plan of care evidenced medications of: Pantoprazole (for stomach) Montelukast (for allergies), Nitrofurantoin (for infection), Losartan (for blood pressure) Cholecalciferol (vitamin D), atorvastatin (for cholesterol), aspirin (blood thinner), and Janumet (for regulation of blood sugar). The plan of care failed to include all current medications patient #1 was taking. During an interview on 10/5/2022 at 2:20 PM, the clinical manager indicated medications should be updated when the plan of care was revised. We update them on the medication profile until we do a new plan of care. At 2:22 PM, she indicated over-the-counter medications should be on the plan of care also but sometimes they get missed. 3. Clinical record review for patient #2, evidenced a plan of care, for start of care 9/7/2022, certification period 9/7/2022 – 11/5/2022. The plan of care evidenced medications of: Atorvastatin (for cholesterol), Norco (narcotic pain medication), iron, acetaminophen (pain reliever) 325 mg [milligram] take 2 (two) tablets every four hours as needed by mouth, Aspirin (blood thinner), Avonex pen (for treatment of multiple sclerosis), and Colace (stool softener). This document failed to evidence an accurate list of the patient’s medication, and failed to include the indication for the acetaminophen. During an interview at a home visit on 10/5/2022 at 10:00 AM, the patient’s family member indicated patient #2 was no longer taking the Avonex pen. The physician discontinued the medication in February 2022. He/She also indicated the patient was taking Metamucil (fiber supplement), calcium (supplement), vitamin D (supplement), and magnesium (supplement). Observation of the Norco medication bottle indicated the medication was prescribed every 6 hours as needed for pain. During an interview on 10/5/2022 at 2:33 PM, the clinical manager indicated the physicians should have been called and the medication list should be updated with the current medications. 4. Clinical record review for patient #6 evidenced an agency plan of care, for start of care 5/24/2022, and certification period 7/23/2022 – 9/20/2022. This plan of care evidenced medications of: Abacavir (antiviral) 300 mg (milligrams) one tablet every twelve hours, Amlodipine (for high blood pressure) 10 mg daily, hydralazine (for high blood pressure) 50 mg three times a day, ibuprofen (for pain) 400 mg every six to eight hours as needed, lisinopril (treats high blood pressure) 10 mg daily, melatonin(sleep supplement) 3 mg nightly as needed, metoprolol (for high blood pressure) 100 mg twice a day, and tramadol 50 mg as needed. This document failed to include the indications for ibuprofen, tramadol, and melatonin. During an interview on 10/5/2022 at 2:45 PM, the clinical manager indicated all as-needed medications should include the indication. 5 Clinical record review for patient #7, start of care 5/19/2022, indicated an agency document titled “Medication Profile.” This document evidenced patient #7 was taking the following medications: Phenytoin (for seizures). Folic acid (supplement) Levetiracetam (for seizures), clonidine (for high blood pressure) gabapentin (used for seizures) prednisone (steroid) clopidogrel (prevent blood clots) ibuprofen (for pain) hydrochlorothiazide (for high blood pressure), atorvastatin (for high cholesterol), amlodipine (for high blood pressure). Clinical record review for patient #7 evidenced a plan of care for certification period 7/18/2022 – 9/5/2022. This document failed to list any of the patient’s medications. During an interview on 10/6/2022 at 10:56 AM, the clinical manager indicated she was unsure why the medications were not showing on the plan of care. She indicated they should have been on there. 6. Clinical record review for patient #3, start of care 9/19/2022, evidenced a document titled "Referrals/Response Letter" dated 9/21/2022, and signed by Physician #2, which indicated the patient was taking the following medications: Acetazolamide (for seizures), pregabalin (for nerve pain), ropinirole (for restless legs), lamotrigine(for seizures), levothyroxine (for thyroid), Vimpat (for seizures), Pilocarpine (saliva production stimulator), Quetiapine (antidepressant), cyclobenzaprine (muscle relaxer), benztropine (anti tremor medication), topiramate (for seizures), Vyvanse (stimulant), Montelukast (for reducing inflammation in asthma), sertraline (antidepressant), prednisone (steroid), hydroxychloroquine (immunosuppressant for Lupus), Xarelto (prevent blood clots), folic acid (supplement), pantoprazole (for stomach acid), alendronate (for weak brittle bones), meloxicam (anti-inflammatory, and Restasis (for dry eyes). Clinical record review for patient #3 evidenced a plan of care for certification period 9/19/2022 – 11/17/2022. This plan of care failed to evidence any medications. 7. Clinical record review for patient #4, start of care 8/25/2022, evidenced a document titled “Face to Face Encounter,” dated 8/25/2022 and signed by the physician. This document indicated the patient had the following diagnoses: Impaired mobility, cerebrovascular accident (stroke), osteoarthritis (weakening of the bones) of the knees, high fall risk, chronic kidney disease, Urinary tract infection, and hypertension. Clinical record review for patient #4, start of care 8/25/2022, evidenced a plan of care for certification period 8/25/2022 – 10/23/2022. This plan of care evidenced the following diagnoses: Hypertension (high blood pressure) and Seizures. The plan of care indicated the patient was taking the following medications: Metoprolol (for high blood pressure), Carbidopa-Levodopa (changes dopamine in the brain), Atorvastatin (for high cholesterol), Aspirin (blood thinner), sertraline (antidepressant), Lisinopril (for blood pressure), Zolpidem (for sleep), Clopidogrel (prevent blood clots), Divalproex (for seizures), and Loperamide (anti-diarrheal) one tablet four times a day as needed. This document failed to evidence the indication for Loperamide and failed to include all of the patient diagnoses. During an interview on 10/5/2022 at 2:45 PM, the clinical manager indicated all as-needed medications should include the indication, and all diagnoses should be on the plan of care. 17-13-1(a)(1)(B) 17-13-1(a)(1)(C) 17-13-1(a)(1)(D)(ix)

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to record all patient care orders, including verbal orders, in the plan of care in 1 of 5 active clinical records reviewed. (#4)The findings include: Review of an agency policy, titled "Care Planning Process," revised August 2011, stated, "... The plan of care will be based upon the physician's (or other authorized licensed independent practitioner's) orders and will encompass the equipment, supplies, and services required to meet the patient's needs….” Clinical record review for patient #4, start of care date 8/25/2022, evidenced an order dated 8/25/2022, and signed by the physician. This document indicated the patient was to receive education on disease process, symptoms, and management, diet, medication compliance, safety measures, and pain management. The patient was also to receive physical therapy for assistance in improving strength, bed mobility, balance, transfer, gait and to establish a home exercise program. Clinical record evidenced a plan of care for certification period 8/25/2022 – 10/23/2022. This plan of care failed to evidence physical therapy and failed to evidence the skilled nurse was to educate the patient as indicated in the physician order. During an interview on 10/6/2022 at 10:21 AM, the administrator indicated all orders should be included on the plan of care.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to administer services and treatments only as ordered by a physician in 2 of 5 active clinical records reviewed without a home visit. (#2, #3) The findings include 1. An undated agency policy obtained on 10/5/2022, titled “Plan of Treatment/Change Orders,” stated, “ … The agency will provide care/services consistent with the plan of treatment….” 2. Clinical record review for patient #2, start of care 9/7/2022, evidenced a plan of care for certification period 9/7/2022 – 10/5/2022. This plan of care failed to evidence any wound treatment orders. Clinical record review evidenced skilled nurse visit notes dated 9/14/2022, 9/21/2022, and 9/27/2022 and signed by LPN [licensed practical nurse] #2, which stated “ … Wound care performed to right foot. Patient tolerated well … Removed previous dressing, cleansed with NS [normal saline], applied ointment, covered with gauze, wrapped with Kerlix [gauze wrap], covered with ace wrap….” During an interview on 10/5/2022 at 2:13 PM. The clinical manager indicated she did not see an order for wound care. She indicated there should be orders on the plan of care, but it must have been overlooked. 3. Clinical record review for patient #3, start of care 9/19/2022, evidenced skilled nurse visit notes dated 9/27/2022, signed by RN (registered nurse) #1, and indicated RN #1 filled the patient’s mediplanner and removed all medication still in there from the previous week. The RN then called medications into the pharmacy and reconciled medications. Clinical record review evidenced a plan of care for certification period 9/19/2022 – 11/17/2022. This plan of care failed to evidence any medications, or orders to set up medications. During an interview on 10/5/2022 at 2:42 PM, the clinical manager indicated the plan of care should include all medications and orders. 17-13-1(a)

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 promptly alert the physician to changes in the patients’ conditions which suggested outcomes were not being achieved in 2 of 5 active clinical records reviewed. (#1, #2) The findings include: 1. An agency policy titled “Monitoring Patient’s Response/Reporting to Physician,” revised August 2011, stated, “The patient’s physician will be contacted on the same day when any of the following occur: Significant changes in the patient’s condition … inability to achieve goals within the specified time frame … Changes in the patient’s expected response to treatment or medications….” 2. Clinical record review for patient #1, start of care 8/23/2022, evidenced agency documents titled, “Skilled Nurse Visit” dated 9/12/2022 and 9/20/2022. These documents indicated the patient was complaining of right leg pain. The visit note for 9/22/2022, evidenced the patient had 7/10 pain [scale of 0-10, with 0 being no pain and 10 the most severe] in the lower legs. Visit notes for 8/30/2022 and 9/12/2022, indicated the patient had bladder distention and a 5-pound weight loss for each visit. These patient changes in condition failed to be evidenced in the clinical record as reported to the physician. During an interview on 10/5/2022 at 2:24 PM, the clinical manager indicated the physician should have been notified of the bladder distention, pain, and weight loss. 3. Clinical record review for patient #2, start of care 9/7/2022, evidenced an agency document titled, “Skilled Nurse Visit” dated 9/14/2022.This document indicated the patient was complaining of right heel pain 8/10. This document failed to evidence the skilled nurse notified the physician of the pain. During an interview on 10/5/2022 at 2:45 PM, the clinical manager indicated the physician should have been notified of the patient's pain. 17-13-1(a)(2)

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient received appropriate discharge teaching in 2 of 2 discharged records reviewed (#6, #7). The findings include: 1. Record review evidenced an agency policy titled, “Discharge Planning”, revised August 2011, which stated, “ … To promote patient independence, safety, and use of community resources prior to patient discharge from the organization … All communication and information regarding discharge planning will be documented in the clinical record….” 2. Clinical record review for patient #6, start of care 5/24/2022, certification period 7/19/2022 to 9/5/2022, evidenced an agency discharge document which indicated the skilled nurse was to ensure the patient educate patient on medications, keeping a daily blood pressure log, healthy eating, management of hypertension, and home safety measures Review of the clinical record failed to evidence the nurse instructing on medications, keeping a daily blood pressure log, healthy eating, management of hypertension, and home safety measures 3. Clinical record review for patient #7, start of care 5/19/2022, certification period 7/18/2022 to 9/15/2022, evidenced an agency discharge document which indicated the skilled nurse was to ensure the patient was educated on hypertension (high blood pressure), diet, incontinent care medications and home safety. Review of the clinical record failed to evidence the nurse instructed the patient on hypertension, diet, incontinent care medications, and home safety. During an interview on 10/5/2022 at 2:33 PM, the clinical manager indicated the education was probably done, but it was not documented correctly in the chart. 17-14-1(a)(1)(G)

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure a written schedule was provided to patients in 2 of 2 home visits conducted (#1. #2) The findings include: 1. An undated agency policy obtained on 10/5/2022, titled Home Care Patient Rights and Responsibilities” stated “The patient has the right to: ... Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to ... The care to be furnished, based on the comprehensive assessment ... The frequency of visits...." 2. During an interview at a home visit for patient #1 on 09/04/2022 at 9:47 AM, the patient stated he did not have a home folder or written information from the home health agency. Observation failed to evidence the patient received a schedule of visits. 3. During an interview at a home visit for patient #2 on 09/05/2022 at 10:10 AM, the patient's family member indicated she did not have a home folder or written information from the home health agency. Observation failed to evidence the patient received a schedule of visits. During an interview on 10/5/2022 at 2:11 PM, the administrator indicated the staff called the patient the night before to confirm their visit time.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide written instructions to the patient for the patient's medication schedule and instructions in 2 of 2 home visits conducted. (#1, #2) The findings include: 1. Review of an agency policy titled “Medication Profile,” revised August 2011, stated “ … Each patient will receive appropriate written material for specific medications he/she is receiving. The material will contain information on the actions of the medication, potential side effects, contraindications, and any special instructions when taking specific medication….” 2. During a home visit for patient #1 on 10/4/2022 at 9:47 AM, the patient indicated he did not have a home folder or written information from the home health agency. Observation failed to evidence patient had received a medication schedule or instructions in writing. 3. During a home visit for patient #2 on 10/5/2022 at 10:00 AM, the patient's family member indicated she did not have a home folder or written information from the home health agency. Observation failed to evidence patient had received a medication schedule or instructions in writing. 4. During an interview on 10/5/2022 at 2:30 PM, the clinical manager indicated the patient should have a medication list in the home and it should be updated by the nurse with the current medications.

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 observation, record review, and interview, the home health agency failed to ensure patients received in writing any treatments to be administered by personnel and personnel acting on behalf of the home health agency in 2 of 2 home visits conducted (#1, #2). The findings include: 1. Review of an agency policy titled “Care Planning Process,” revised August 2011, stated, “… The organization shall provide the patient and caregiver with a copy of written instructions outlining: … Any treatments to be administered by the organization’s personnel and personnel acting on behalf of the organization, including therapy services ….” 2. During a home visit for patient #1 on 09/04/2022 at 9:47 AM, the patient indicated he did not have a home folder or written information from the home health agency. Observation failed to evidence patient had received any written information on treatments to be administered by agency personnel. 3. During a home visit for patient #2 on 09/05/2022 at 10:10 AM, the patient's family member indicated he/she did not have a home folder or written information from the home health agency. Observation failed to evidence the patient had received any written information on treatments to be administered by agency personnel. 4. During an interview on 09/5/2022 at 2:40 PM, the clinical manager indicated there should have been folders in the patient’s homes with treatment instructions. The patients may have misplaced them.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure patients received the name and contact information for the clinical manager in writing in 2 of 2 home visits conducted (#1, #2). The findings include: 1. Review of an agency policy titled “Care Planning Process,” revised August 2011, stated, “… The organization shall provide the patient and caregiver with a copy of written instructions outlining: … Name and contact information of the organization’s clinical manager ….” 2. During a home visit for patient #1 on 09/04/2022 at 9:47 AM. the patient stated he did not have a home folder or written information from the home health agency. Observation failed to evidence patient had received any written information with the clinical manager’s name or contact information. 3. During a home visit for patient #2 on 09/5/2022 at 10:00 AM, the patient's family member stated he/she did not have a home folder or written information from the home health agency. Observation failed to evidence the patient had received any written information with the clinical manager’s name or contact information. 4. During an interview on 09/5/2022 at 2:22 PM, the clinical manager indicated there should be a home folder in all the homes.

Goals in the patient's plans of care CFR(s): 484.110(a)(3) Goals in the patient's plans of care and the patient's progress toward achieving them; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record included the patient's goals and progress towards the goals in the plan of care in 1 of 2 closed clinical records reviewed. (#7) The findings include: 1. Review of an agency policy titled "Care Planning Process,” revised August 2011, stated, "... Individualized Plan of Care: The patient-specific clinical plan of care includes: Measurable outcomes and goals identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care...." 2. Clinical record review for patient #7, evidenced an agency document titled “Oasis D1 Recertification,” dated 7/19/2022. This document indicated the patient had a primary diagnosis of hypertension (high blood pressure), was incontinent (loss of control) of bladder at times, had difficulty with ambulation, had poor balance, was dependent for grooming, dressing, bathing, and toileting and was at risk for falls. Clinical record review for patient #7, start of care 5/24/2022, evidenced a plan of care for certification period 5/24/2022 – 7/22/2022. This plan of care evidenced the patient was to receive nursing care twice a week for one week and once a week for eight weeks. This document indicated the patient’s goals were to have no hospitalizations or emergency visits and to demonstrate the ability to manage medication regimen. This document failed to have patient-specific measurable goals related to nursing care. During an interview on 10/5/2022 at 2:26 PM, the clinical manager indicated there were no patient-specific goals on the plan of care, but there should be.