Every finding on record at Focus Health

The following reflects the findings of the California Department of Public Health, during the Partial Extended Recertification Survey conducted on 6/2/25 to 6/12/25. Representing the California Department of Public Health. Record Review with Home Visits :7 Record Review without Home Visits: 5 Closed Record Review: 5 Total sample size :17

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 observation, interview and record review, the agency failed to involve the patient and their caregivers to participate in the development and ongoing updates of their plan of care (POC-a written document that describes the home health services and items that a patient needs, how often they will receive them, and what outcomes are expected from the treatment) for four of seven patients with home visits (Patients, 2, 3, 4 and 5) when the patients and their caregivers were unable to locate their admission booklet (the booklet outlines the rights of patients receiving home health services, such as the right to privacy, informed consent, and the right to be involved in care decisions). This failure resulted in a lack of informed consent and compromised patient and caregiver participation in care decisions throughout the episodes of care. During a concurrent observation and interview on 6/4/25 at 3:03 p.m., with Occupational Therapy (OT) 1, in Patient 2’s bedroom, OT 1 evaluated Patient 2's ability to get in and out of bed in her bedroom. Patient 2 stated she could manage on her own but had to exert effort and endure pain when placing her swollen legs above the pillow. OT 1 recommended that Patient 2 order a "bed caddy" to assist with getting in and out of bed and share the purchase site with Patient 2. OT 1 did not update Patient 2’s admission booklet with her findings and recommendations in writing. During a concurrent interview and record review on 6/4/25 at 3:15 p.m., following the completion of a home visit by OT 1. Patient 2 was in her living room and attempted to locate the admission booklet. Patient 2 stated she had received the booklet but was unable to find it. Patient 2 stated the agency did not explain which services and supplies were covered and which were not prior to her giving consent for treatment. A review of Patient 2’s Plan of Care (POC), which is a written comprehensive and individualized roadmap outlining the specific treatments and support services needed while receiving care at home, dated May 25, 2025, to July 26, 2025, indicated that the start of care (SOC) was on May 28, 2025. Since the SOC date, three other visits were made by PT (Physical Therapy), PTA (Physical Therapy Assistant), and OT. During a concurrent observation and interview on 6/5/25 at 12:05 p.m., with Licensed Vocational Nurse (LVN) 1, in Patient 3’s living room. After finishing her visit, LVN 1 received a verbal order from Patient 3's physician to change the medication dose. LVN 1 instructed Patient 3’s caregiver to give Warfarin (a medication that helps prevent blood from clotting) 5 milligrams (mg-unit of measurement) daily and 7.5 mg on Fridays. LVN 1 did not ask the caregiver to write down this change in the admission booklet. During an interview on 6/5/25 at 12:55 p.m., with Patient 3's caregiver following the completion of a home visit by LVN 1, Patient 3’s caregiver stated, Patient 3’s coagulation levels (the ability of the blood to coagulate) remained unstable, and she was unaware of when Patient 3 would be discharge from the agency. Patient 3’s caregiver stated she received an admission booklet at the beginning of the first episode of care but was unable to locate it at the time of the interview. During a review of Patient 3’s POC dated 5/21/25 to 7/19/25, the POC indicated Start of Care (SOC) began on 3/22/25. There were multiple visits conducted by SN (skilled nursing) staff, but there was no evidence the admission booklet was used to review Patient 3’s rights or to support the ongoing involvement of Patient 3 and the caregiver in updates to the POC during the second episode of care. During a concurrent observation and interview on 6/5/25 at 3 p.m., with LVN 2, in Patient 4’s living room, LVN 2 was observed completing the wound care on Patient 4’s right leg. LVN 2 praised Patient 4 for increased protein intake to support wound healing and informed Patient 4 that her wound was healing well, with no signs of redness or drainage. LVN 2 did not reference or requested the admission booklet to initiate or discuss discharge planning with Patient 4. During an interview on 6/5/25 at 3:53 p.m., with Patient 4, Patient 4 stated she recalled RN 5 conducting the initial visit and providing the admission booklet. Patient 4 stated she was unable to locate the admission booklet. Patient 4 stated no one had requested or referenced the admission booklet since the start of care. During a review of Patient 4’s POC dated 5/11/25 to 7/9/25, the POC indicated the Start of Care began on 3/12/25. There were multiple visits conducted by SN (skilled nursing) staff, but there was no evidence the admission booklet was used to review Patient 4’s rights or to support the ongoing involvement of Patient 4 and the caregiver in updates to the POC during the second episode of care. During a concurrent observation and interview on 6/9/25 at 9:30 a.m. with RN 1, in assisted living facility, RN 1 informed Patient 5 it was time to change the urinary catheter (a sterile, flexible tube inserted into the bladder to drain the urine). RN 1 stated Patient 5’s sister was the designated Responsible Party (RP) and had previously requested to be notified prior to any procedures or change in the Plan of Care. RN 1 stated she did not contact the RP prior to the visit since Patient 5 was familiar with her. During a review of Patient 5’s POC dated 5/6/25 to 7/4/25, the SOC was 11/7/24. The POC indicated the urinary catheter to be changed every 5 weeks. During a phone interview on 6/10/25 at 8:45 a.m., with Patient 5’s RP, Patient 5’s RP stated she received the admission packet on 11/6/24 but did not recall discussion regarding billing or financial matters. The RP stated she had requested agency staff to contact her prior to SN visit, since Patient 5 has consistently refused catheter changes. The RP stated agency staff had not followed up with her or made the requested calls prior to visits. During an interview on 6/12/25 at 2:24 p.m., with the Director of Patient Care Services (DPCS)/ Vice President (VP), the DPCS/VP stated, patients should receive a Start of Care booklet, and the clinician initiating the case was responsible for completing the admission process. The DPCS/VP stated this includes informing the patient and family about the complaint process, reviewing consent and financial responsibilities, and setting expectations at the SOC. The DPCS/VP stated clinicians should document updates in the admission booklet during visits unless they have confirmed patient was actively using "Family Link-provider's website” as outlined in the admission booklet. During a review of the agency’s admission booklet, the section for “Plan of Care”, the plan of care section indicated, “we involve you, your caregiver, your representative (if any), key professionals and other staff members in developing your individualized plan of care and identifying your specific measurable outcomes and goals. Your plan of care is based upon identified problems, needs, physician orders and medications, care, treatment and services, timeframes, our specific measurable outcomes and goals. Your plan of care your environment and your personal goals whenever possible. The plan of care is designed to increase your ability to care for yourself and may include the following interventions: nursing care, personal care, medication management, rehabilitation therapy, pain management, psychosocial needs and discharge planning…You have access to this plan through our electronic medical record system, “Family Link” or you may request the plan to be provided on paper…we will notify you, your representative (if any), your caregiver and all physicians involved in your pan of care of any revisions to the plan of care due to a change in your health status…”

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on observation interview and record review the agency failed to ensure one of seven sample patients with home visits ( Patient 3) received all services according to the plan of care (POC- a written document that describes the home health services and items that a patient needs, how often they will receive them, and what outcomes are expected from the treatment) when education was not provided for management of fluid restriction and cardiac (heart) diet. This failure had the potential to place Patient 3 at risk for fluid overload (too much fluid in the body) exacerbating his congestive heart failure(CHF- a heart disorder which causes the heart to not pump the blood efficiently to meet the body's needs), which could lead to severe complications such as pulmonary edema (fluid build up in the lungs), cardiogenic shock (a life-threatening condition leading to inadequate blood flow to vital organ) and hospital admission . During an interview and record review on 6/5/25 at 12:47 p.m. with License Vocational Nurse (LVN) 1, LVN 1 stated, she was not aware Patient 3 was on a 1.5 Liters (L- unit of measurements) fluid restriction and cardiac diet. LVN 1 stated she should have educated Patient 3 on 1.5 L fluid restriction. LVN 1 stated it was important to educate Patient 3 on his fluid restriction and diet to prevent edema (swelling). LVN 1 stated Patient 3 could have increased swelling and could have developed open sores. LVN 1 stated nurses were responsible for educating patients about their fluids and diet. LVN 1 stated increasing fluid intake could result in increased swelling in Patient 3’s legs and possible hospital admission. During an interview on 6/5/25 at 1 p.m. with Patient 3, Patient 3 stated, the home health staff never discussed her fluid restriction and diet orders. Patient 3 stated he was on fluid restriction during the time he was in the nursing home for rehabilitation, but was never informed by the home health agency he will continue the fluid restriction at home. During an interview on 6/5/25 at 1:08 p.m. with Family Member (FM) 1, FM 1 stated the home health nursing staff did not provide education on Patient 3’s fluid restrictions. FM 1 stated it was important for the home health nursing staff to provide education on Patient 3’s fluid restrictions to prevent complications and avoid potential hospital admission. During an interview and record review on 6/11/25 at 4:04 p.m. with Clinical Manager (CM) 2, CM 2 stated Patient 3 was on a cardiac diet with 1.5 liters fluid restrictions. CM 2 stated nurses should be teaching Patient 3 about everything regarding his diet and fluids. CM 2 stated Patient 3 should be expected to learn and limit his fluids to 1.5 liter from all food sources. Patient 3 should have been checking his weight daily. CM 2 stated Patient 3 could have increase in fluid and could have fluids overload (condition where there's too much fluid in the body, potentially leading to increased blood pressure, swelling, and breathing difficulties). CM 2 stated Patient 3’s CHF could have been could have exacerbated and Patient 3 could have return to the hospital. CM 2 stated “It is the responsibility of the nurses to educate and monitor and informed the patients and family about their diet and fluids.” During an interview and record review on 6/11/25 at 4:04 p.m. with Clinical Manager (CM) 2, CM 2 stated that Patient 3 was on a cardiac diet (a meal plan designed to reduce the risk of heart disease) with 1.5 liters fluid restrictions. CM 2 stated home health nurses should have provided education to Patient 3 and his family member on Patient 3’s diet and fluid intake and helped Patient 3’s understands to limit his fluid intake. CM 2 stated Patient 3’s increase fluid intake could lead to fluid overload (a medical condition where there is too much fluid in the body) and exacerbation of Patient 3’s CHF which could result in hospitalization. CM 2 stated it was the responsibility of the home health nurses to provide education to the patients, families and caregivers regarding the care provided. During an interview on 6/12/25 at 2 p.m. with the Director of Patient Care Services (DPCS)/Vice President (VP), the DPCS/VP stated LVN 1 should have review Patient 3’s diet POC during visits. The DCPS/VP stated LVN 1 should have educated Patient 3 about his diet and fluids restriction according to the POC. The DCPS/VP stated nurses were expected to educate patients, families and their caregivers according to the POC. DCPS/VP stated LVN 1 did not follow their policy. During an interview on 6/12/25 at 2:20 p.m. with Registered Nurse (RN), RN 3 stated she was one of the nurses who provided care to Patient 3. RN 3 stated Patient 3 should have been educated on fluid restriction and cardiac diet according to his POC. RN 3 stated Patient 3 could have experienced fluid overload and increased the risk of hospitalization. RN 3 stated, she should have documented when she educated Patient 3 on his fluid restriction and cardiac diet. RN 3 stated, “It should have been documents and it was not.” RN 3 stated Patient 3 and FM 1 did not receive services according to the POC. During a review of Patient 3’s “ Plan of Care” dated 5/19/25, the POC indicated, "Diagnoses...atrial fibrillation (type of irregular heartbeat or arrhythmia), congestive heart failure, pressure ulcers (injuries to the skin and underlying tissue caused by prolonged pressure or friction) gout (a type of arthritis characterized by sudden, severe attacks of pain, swelling, redness, and tenderness in the joints), use of anticoagulants…[line]skilled nurse to provide instructions/reinforcement of management of cardiac disease in home setting, including diet...” During a review of the facility’s policy and procedure (P&P) dated 4/2021, the P&P indicated, “Orders are review for appropriateness and accuracy before treatment and services are provided…” During a review of the agency’s admission booklet, the section for “Plan of Care”, the plan of care section indicated, “we involve you, your caregiver, your representative (if any), key professionals and other staff members in developing your individualized plan of care and identifying your specific measurable outcomes and goals. Your plan of care is based upon identified problems, needs, physician orders and medications, care, treatment and services, timeframes, our specific measurable outcomes and goals. Your plan of care your environment and your personal goals whenever possible. The plan of care is designed to increase your ability to care for yourself and may include the following interventions: nursing care, personal care, medication management, rehabilitation therapy, pain management, psychosocial needs and discharge planning…You have access to this plan through our electronic medical record system, “Family Link” or you may request the plan to be provided on paper…we will notify you, your representative (if any),, your caregiver and all physicians involved in your pan of care of any revisions to the plan of care due to a change in your health status…”

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to conduct a comprehensive assessment within five days of referral for three of 17 sampled patients (Patients, 2, 11 and 16). This failure resulted in patients not receiving their assessment by the skilled professional in a home setting in a timely manner to develop the necessary plan of care (POC- a written document that describes the home health services and items that a patient needs, how often they will receive them, and what outcomes are expected from the treatment). During an observation on 6/3/25 at 2:30 p.m., with Occupational Therapist (OT) 1 in Patient 2’s home, Patient 2 lives alone in an assisted living facility. Patient 2 was struggling to manage daily tasks independently and expressed frustration over the lack of assistance from the staff, particularly when preparing for bed. Elevating her swollen legs onto a pillow was especially difficult and painful for her. During a review of Patient 2’s “POC”, dated 5/28/25 to 7/26/25, the POC indicated, the start of care (SOC) was 5/28/25. During a review of Patient 2’s “Referral”, dated 5/20/25 , the referral indicated, Patient 2 needed SN (skilled nursing), PT (physical therapy) and OT (occupational therapy-healthcare profession that focuses on enabling people to do the things they want and need to do in their everyday lives) services from home health agency when Patient 2 was discharged from the skilled nursing facility. During a review of Patient 2’s “Client Coordination Note” dated 5/29/25 entered by RN (Registered Nurse) 4, the coordination note indicated Patient 2 needed PT and OT evaluation. During a review of Patient 2’s visit notes involving all disciplines, the visit note indicated OT 1’s evaluation visit was done on 6/4/25 (eight days from SOC). The agency’s coordination note did not contain the reason or notification to the physician for the delay of the OT evaluation. During a review of Patient 11’s “Referral” dated 4/22/25, the referral indicated Patient 11’s physician ordered home health to provide SN, PT and MSW (Master of Social Work). The POC dated from 4/24/25 to 6/22/25 indicated the SOC was 4/24/25. Patient 11’s visit notes indicated PT and MSW evaluation were done on 4/29/25. The comprehensive assessment by all discipline ordered was supposed to be conducted within five days from SOC. The evaluation assessment by PT and MSW were delayed for one day without justification. Patient 11’s primary diagnosis was orthostatic hypotension (a form of low blood pressure that happens when standing after sitting or lying down) and in need of community resources to receive proper care. During a review of Patient 16’s “Referral” dated 9/4/24, Patient 16’s physician ordered home health to provide SN, PT, OT and HHA (home health aide). The POC dated from 9/9/24 to 11/7/24 indicated the SOC was 9/9/24. Patient 16’s visit notes indicated PT’s evaluation was done on 9/26/24. The comprehensive assessment by all discipline ordered was supposed to be conducted within five days from SOC which were due on 9/13/24. The evaluation assessment by PT was delayed for 13 days without justification. Patient 16’s primary diagnosis was encounter for orthopedic aftercare following surgical amputation (toe amputation). During an interview on 6/12/25 at 9:28 a.m., Clinical Manager (CM) 2 stated PT 2 was expected to evaluate Patient 16 within five days to prevent any falls. CM 2 stated other disciplines had noted difficulties in contacting Patient 16 to schedule visits, but there were no notes from PT 2. CM 2 stated there was no evidence that PT 2 had made any effort to conduct the necessary evaluation. During a phone interview on 6/12/25 at 9:34 a.m., PT 2 stated she was unaware the visit was for a comprehensive assessment. PT 2 stated the agency’s standard practice was for her to make home visits when the scheduler notified her of their availability. PT 2 stated she was not informed that the visit required a comprehensive assessment to be completed within five days of the SOC when she received the notification from the scheduler. During an interview on 6/12/25 at 9:50 a.m., with the Intake Coordinator (IC), The IC stated referrals came through fax or AE. The IC stated she reviewed the necessary documents and started email threads to all involved disciplines once verified. The IC stated she was responsible for scheduling the SOC (start of care) visit and notifying the Case Manager (CM) within 48 hours if delayed, including a reason for the delay. The IC stated if additional disciplines were needed, she would add them within five days. The IC stated if a discipline could not visit, she would inform the clinical supervisor of their unavailability. The IC stated when a clinician scheduled a visit, they had to note if the patient refused the visit, and the scheduler would reschedule it. The IC stated the scheduler should inform clinicians whether the visit was rescheduled or not. The scheduler was not available for an interview during the survey. During a review of the agency’s policy and procedure (P&P) titled, “Initial and Comprehensive Assessment” dated 04/21, the P&P indicated, “A comprehensive patient assessment will be completed within five (5) calendar days of the patient's start of care."

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 observations, interviews, and record reviews the home health agency failed to ensure one of seven patients with homes visits (Patient 3) was provided notification of a change in prescribed medications dosage in his admission booklet (a document provided during the start of care, that contains important information for patients and their families/caregivers for the home health agencies) when home health agency staff did not notify Patient 3 of a change in prescribed anticoagulant (a medication used to prevent blood clot) dosage. This failure placed Patient 3 at potential risk for adverse drug events (harm caused by inappropriate or appropriate use of a drug), including bleeding. During an interview on 6/5/25 at 1 p.m. with Patient 3, Patient stated he was not informed about a change in his anticoagulant medication dosage. Patient 3 stated he should have been notified of the changes for him to take the correct dose. During an interview on 6/5/25 at 1:08 p.m. with Family Member (FM) 1, FM 1 stated the home health nursing staff did not provide her a written instructions regarding the schedule and change of dosage of the anticoagulant medication. FM 1 stated she was responsible for giving Patient 3 his medication. FM 1 stated having written instructions would help her stay updated and make it easier to manage any changes in Patient 3’s medication. During an interview on 6/12/25 at 2:25 p.m. with the Director of Patient Care Services (DPCS)/Vice President (VP), the DPCS/VP stated clinician should be writing medication changes in the admission booklet. The DCPS/VP stated, “The booklet is the center for all communication.” The DCPS/VP stated nurses should have printed the forms and placed them in the booklet so the patient and family could have them. The DCPS/VP stated, the clinicians should have been checking the admission booklet regularly. The DPCS/VP stated, “We did not provide the patient and family written documents. We should have brought it out there.” The DPCS/VP stated the agency did not follow their policy and procedure. During a review of the agency's policy and procedure (P&P), titled “Medication Profile” dated 3/2021, the P&P indicated, “Each patient will receive appropriate written material for specific medications/he she is receiving. The material will contain information on actions of the medication, potential side effects, contraindications the patients should be aware of and any special instructions when taking the specific medication.”

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, interview and record review the agency failed to follow standards of practice for one of seven sampled home visit patients (Patient 3) when License Vocational Nurse (LVN) 1 did not disinfect prothrombin (PT -a blood test that measures how long it takes for blood to clot/ International Normalized Ratio (INR- standardized way to measure how long it takes for a person's blood to clot) meter, Registered Nurses (RN 1, RN 2, RN 3) and Director or Patient Care Services (DPCS)/Vice President (VP) were not able to verbalized disinfected equipment reprocess according to the manufacturer guideline. This failure put Patient 3 and other patients who used the meter at risk for blood-borne (infectious microorganisms in human blood that can cause disease in humans) pathogen (bacterial or virus) infections and cross-contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect). During an observation on 6/5/25 at 12: 00 p.m. in Patient 3’s living room, License Vocational Nurse (LVN) 1 took a Pt/INR blood sample. LVN 1 use a [brand name] disinfect wipe to cleaned the PT/INR meter and placed the Pt/INR meter into her bag. There was no contact time (the time taken for the disinfectant to bind to the microorganism to kill it). During an interview on 6/5/25 at 12:47 p.m. with LVN 1, LVN 1 stated she used [brand name] disinfect wipes to cleanse the PT/INR meter after obtaining blood sample from patients.. LVN 1 stated, “I wipe and put it away.” LVN 1 stated, “It was normal for her to clean the PT/INR meter by wiping and putting it away without no contact time. LVN 1 stated she was not sure how long the contact time was to safely disinfect the PT/INR meter. LVN 1 stated it was important to cleanse and disinfect the PT/INR meter correctly to prevent cross-contamination. LVN 1 stated improperly cleaning of the PT/INR meter had the potential for blood borne pathogen and infection. LVN 1 stated the PT/INR meter was use for different patients. LVN 1 stated she was not sure when the last time she had an in-service on disinfecting the PT/INR meter. During an interview on 6/9/25 at 2:22 p.m. with the Director of Patient Care Services/Vice President (DCPS/VP), the DPCS/VP stated, the agency used 70 percent alcohol wipes or [brand name] disinfected wipes to cleanse and disinfect the PT/INR meter. The DCPS/VP stated, “I expected it to be wiped and cleanse and put away.” The DCPS stated she expected the staff to use the same disinfected reprocess for other medical equipment such as blood pressure cuffs, stethoscopes the same way as the PT/INR meter. . The DCPS/VP stated there were no amount of contact time needed to disinfect the PT/INR meter. During an interview on 6/10/25 at 11:45 a.m. with Registered Nurse (RN) 1, RN 1 stated she cleanse the area where the strips went into with alcohol wipes. She stated the alcohol wipes should be on there for 30 seconds. RN 1 stated, “We use alcohol pad. We clean the PT/INR meter using alcohol pads.” RN 1 stated, “I am not sure how long [the contact time] should be on there.” RN 1 stated, “It is important to clean [PT/INR meter] correctly, it can be a mode of transmission, of microorganism, bloodborne pathogen.” RN 1 stated, “Patients can get HIV (human immunodeficiency virus-a virus that attacks the body's immune system), Hep C (Hepatitis C - a viral infection that causes liver swelling) and any bloodborne blood pathogen. RN 1 stated patients were at risk to get infections. RN 1 stated she did not remember any in-services on disinfection of PT/INR meter. During an interview on 6/10/25 at 12:10 p.m. with RN 2, RN 2 stated she used the [brand name] wipes to disinfect the PT/INR meter. RN 2 stated “I wiped the machine with [brand name] wipes. I wipe it down, allowed it to dry and put away. I will let it sit for 30 seconds and put it away.” RN 2 stated it was important to clean the PT/INR meter correctly to prevent cross-contamination of blood borne pathogens. RN 2 stated patients were at risk to get infections. During an interview on 6/10/25 at 4:30 p.m. with RN 3, RN 3 stated, “I will use [brand name] wipes, let it come dry for 30 or 60 seconds then put away.” RN 3 stated, “ I use the purple top wipes for any blood product.” RN 3 stated, “It was important to cleanse and sanitize the PT/INR meter correctly with correct contact time to prevent infection.” RN 3 stated improperly disinfecting the PT/INR meter could have transmitted bloodborne pathogens among patients. RN 3 stated he did not remember the last in services for PT/INR meter cleaning techniques. During an interview on 6/12/25 at 2:15 p.m. with the DCPS/VP, the DCPS/VP stated we did not follow the manufacture guideline for cleaning and disinfecting the PT/INR meter. We did not follow the professional standard of practice. During a review of Patient 3’s “ Plan of Care (POC -document outlining the specific medical, rehabilitative, and supportive care a patient)” dated 5/19/25, the POC indicated ”.I want my INR to get between 2-3…” During a review of the manufacturer’s guidelines titled, “Cleaning/Disinfecting the Meter” dated “no date”, the manufacturer’s guideline indicated, “It is important to follow the procedures below to clean and disinfect the meter…use only the following items for cleaning/disinfecting the [brand name meter] housing for a contact time of > [greater] 1 minute…70% isopropyl alcohol…10% sodium hypochlorite solution (1 part bleach to 9 pars deionized water, made fresh every 24 hours)…wipe the meter’s exterior clean…wipe away residual moisture and fluids after cleaning the housing…Allow to wiped areas to dry for at least 10 minutes before performing a test…”

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on observation, interview and record review the agency failed to ensure one of seven sampled patients with home visits (Patient 3) was provided education on the Physician Order (PO-instructions written by a physician to other healthcare professionals regarding a patient's care plan) for 1.5 liters (L-units of measurement) of fluid restriction and cardiac (heart) diet. This failure had the potential to place Patient 3 at fluid overload (too much fluid in the body) exacerbating his congestive heart failure (CHF- heart disorder which causes the heart to not pump the blood efficiently resulting in leg swelling) and returning to the hospital. During an interview and record review on 6/5/25 at 12:47 p.m. with License Vocational Nurse (LVN) 1, LVN 1 stated, she was not aware Patient 3 was on fluid restriction and cardiac diet. LVN 1 stated she did not provide education on his fluid restrictions and cardiac (heart) diet. LVN 1 stated it was important to educate Patient 3 on his fluid restriction and cardiac (heart) diet to prevent edema (swelling). LVN 1 stated Patient 3 could have increase in swelling in his legs which could have contributed to open sores. LVN 1 stated Patient 3's CHF could have gotten worse and he could have return to the hospital. LVN 1 stated nurses were responsible for educating patients regarding their physician orders. During an interview on 6/5/25 at 1:00 p.m. with Patient 3, Patient 3 stated, “They [nurses] never went over the fluid restriction and diet with me.” Patient 3 stated, he was not aware of his current diet and fluids restriction. Patient 3stated he would like to know if he was on fluids restriction but was never informed During an interview on 6/5/25 at 1:08 p.m. with Family Member (FM) 1, FM 1 stated nursing staff asked about the amount of fluids Patient 3 drank. FM 1 stated nurses did not education her on 1.5 liters fluids restriction or cardiac diet for Patient 3. FM 1 stated she would like to be education on Patient 3 fluid restriction to prevent him from returning to the hospital. During an interview and record review on 6/11/25 at 4:04 p.m. with Clinical Manager (CM) 2, CM 2 stated Patient 3 was on a cardiac diet with 1.5 liters (amount of measurement) fluid restriction. CM 2 stated nurses should have education Patient 3 about his cardiac diet and fluid restriction. CM 2 stated Patient 3 should have known about limiting his fluids to 1.5 liters from all food sources. CM 2 stated Patients 3 should have been checking his weights daily. CM 2 stated Patient 3 could have drank more fluids beyond the PO leading to fluid overload. CM 2 stated Patient 3’s CHF could have been could have exacerbated and Patient 3 could have returned to the hospital. CM 2 stated “It is the responsibility of the nurses to educate and monitor and informed the patients and family about their diet and fluids.” During an interview on 6/12/25 at 2:00 p.m. with the Director of Patient Care Services DPCS/Vice President (DPCS/VP), the DPCS/VP stated LVNs should have access to the diet and should have update the patient about their diet and fluids restriction. The DCPS/VP stated nurses should have educated patients about daily weights. The DCPS/VP stated nurse should have provided education to the patient and family. During an interview on 6/12/25 at 2:20 p.m. with Registered Nurse (RN) 3, RN 3 stated, “I did not document.” RN 3 stated, “It should have been documents and it was not.” RN 3 stated, Patient 3 should have been educated on fluid restrictions and diet. RN 3 stated Patient 3 could have fluid overload and return to the hospital. During a review of Patient 3s “ Plan of Care (POC- a written document that describes the home health services and items that a patient needs, how often they will receive them, and what outcomes are expected from the treatment))” dated 5/19/25, the POC indicated, "[line] diagnoses... atrial fibrillation (type of irregular heartbeat or arrhythmia), congestive heart failure, pressure ulcers (injuries to the skin and underlying tissue caused by prolonged pressure or friction) gout (a type of arthritis characterized by sudden, severe attacks of pain, swelling, redness, and tenderness in the joints), use of anticoagulants…[line]skilled nurse to provide instructions/reinforcement of management of cardiac disease in home setting, including diet…” During a review of the agency’s Admission Booklet, titled, “Home Health Admission Booklet (HHAB)” dated 12/24, the HHAB indicated, “Services…Skilled Nursing is provided by an RN and LVN…services may include evaluation of patient needs…education of patient…” During a review of the agency’s Job Description, titled, “Licensed Vocational Nurse” dated no date, the JD indicated, “Provides care as ordered…provide instructions to patient/CG’s [caregiver] and staff in a timely manner…”

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure Certified Occupational Therapy (COTA) /Home Health Aide (HHA) receive 12 hours in-service training during each 12 month period for two of 17 sampled patients (Patient 8 and Patient 9). This failure placed the patients at risk for receiving care by incompetent COTA/HHA. During an interview on 6/9/25 at 2:20 p.m., with the Director of Patient Care Services (DPCS)/Vice President (VP), the DPCS/VP stated, "Home Health Aide we have two patients. We use COTA. We have no HHA. We do not have any new patients with HHA services. When patient comes on services we can and will accept them using COTA. In the past the COTA was able to do it based on their competency. We did not meet the 12 hrs. It is new for me and I am learning." During a review of COTA /HHA" s personnel file, the job description for COTA and HHA met the requirements. The date of hire was 10/25/22. The personnel file did not contain any in-service training. During a review of the agency's policy and procedure (P&P) titled, "Training/Inservice Education" dated 4/21, the P&P indicated, "Aides (CNA {certified Nursing assistant}s HHAs) must receive at least 12 hours of in-service training per calendar year. This may be provided while the aide is furnishing care to patients."

The following reflects the findings of the Department of Public Health-Licensing & Certification during a recertification survey.Representing the Department of Public Health: Health Facilities Evaluator Nurse 40030 RN, Health Facilities Evaluator Nurse.Sample Patients with Home Visits: 7Sample Patients without Home Visits: 10Total sampled patients: 17The agency was found to be in substantial compliance with the Conditions of Participation

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to complete a comprehensive assessment for four of 17 sampled patients (Patients 3, 9, 10, and 17) when the agency did not provide: Physical Therapy (PT-treatment of injury by physical methods such as exercise rather than drugs or surgery) as ordered within five days of the start of care date (SOC-initial visit in where a clinical assessment is done to identify the needs of the patient that will be addressed by a home health agency) for Patients 3, 9, and 17.Occupational Therapy (OT-form of therapy for those recuperating from physical or mental illness that encourages rehabilitation through the performance of activities required in daily life) as ordered within five days of the SOC for Patients 10 and 17. This failure had the potential for PT and OT services to not be given in a timely manner that could lead to Patients 3, 9, 10 and 17 going to the hospital due to care needs not being met. 1. During a review of Patient 3’s “SOC Visit Note Report”, dated 7/21/22, the “SOC” indicated, “…Visit Type RN ADMISSION…” During a review of Patient 3’s “Plan of Care” (PC), dated 7/21/22, the PO indicated, “…Frequency/Duration of Visits…Physical Therapy 1wk1 (one visit for one week)…” During a review of Patient 3’s clinical record on 8/11/22 a “PT Evaluation” had still not been completed for Patient 3. During a concurrent interview and record review, on 8/11/22, at 10:10 a.m., with the Clinical Manager (CM) and Executive Director (ED), Patient 3’s SOC, PC, and PT evaluation were reviewed. The ED stated the SOC was on 7/21/22. The ED stated the PT evaluation had still not been completed by PT 1 and was outside the window of five days to complete the comprehensive assessment of Patient 3. The ED stated the delay may have been from a scheduling issue. The ED stated she did not know why the PT evaluation was not done on the first week of SOC. The ED and there was no coordination note nor change of order indicating the need for a new PT evaluation date for week 7/25/22. During a review of Patient 9’s “SOC”, dated 6/16/22, the “SOC” indicated, “…Visit Type RN ADMISSION…” During a review of Patient 9’s “Plan of Care” (PC), dated 6/16/22, the PO indicated, “…Frequency/Duration of Visits…Physical Therapy effective 6/19/22 1wk1, 2wk3, 1wk1 (one visit for one week; two visits for three weeks; one visit for one week)…” During a review of Patient 9’s “PT Evaluation”, dated 6/22/22, the PT Evaluation indicated, “…PT ADD-ON EVALUTION…” During a concurrent interview and record review, on 8/11/22, at 11:08 a.m., with the CM and ED, Patient 9’s SOC, PC, and PT evaluation were reviewed. The ED stated Patient 9’s SOC was on 6/16/22. The ED stated the PT evaluation was on 6/22/22 (6 days from SOC) and was outside of the five day window to complete the comprehensive assessment for Patient 9. The ED stated there was no coordination note indicating why the PT evaluation was outside of the five days from SOC. During a review of Patient 17’s “SOC”, dated 5/27/21, the “SOC” indicated, “…Visit Type RN ADMISSION…” During a review of Patient 17’s “Plan of Care” (PC), dated 5/27/21, the PO indicated, “…Frequency/Duration of Visits…Physical Therapy effective 5/30/21 1wk1…” During a review of Patient 17’s “PT Evaluation”, dated 6/2/21, the PT Evaluation indicated, “…PT ADD-ON EVALUTION…” During a concurrent interview and record review, on 8/11/22, at 12:57 p.m., with the CM and ED, Patient 17’s SOC, PC, and PT evaluation were reviewed. The ED stated Patient 17’s SOC was on 5/27/22 and the PT evaluation was on 6/2/22 (6 days after SOC) which was outside the five day window of completing the comprehensive assessment. 2. During a review of Patient 10’s “SOC”, dated 7/7/22, the “SOC” indicated, “…Visit Type RN ADMISSION…” During a review of Patient 10’s “Plan of Care” (PC), dated 7/7/22, the PO indicated, “…Frequency/Duration of Visits…Occupational Therapy effective 7/10/22 1wk1…” During a review of Patient 10’s “Physician Order” (PO), dated 7/14/22, the PO indicated, “…OT evaluation the week of 7/18/22 per patient request…” During a review of Patient 10’s “Physician Order” (PO), dated 7/21/22, the PO indicated, “…Due to OT availability OT evaluation week of 7/25/22…” During a review of Patient 10’s “OT Evaluation”, dated 7/25/22, the PT Evaluation indicated, “…OT ADD-ON EVALUTION…” During an interview on 8/10/22, at 3:15 p.m., with OT 1, OT 1 stated OT evaluations should not be moved due to her availability. OT 1 stated if she could not have completed an OT evaluation for Patient 10, another OT could have performed the OT evaluation. OT 1 stated the OT evaluation for Patient 10 needed to be done within five days of the SOC to ensure Patient 10 received the therapy services in timely manner. During a concurrent interview and record review on 8/11/22, at 11:15 a.m., with the CM and ED, Patient 10’s SOC, PC, POs and PT evaluation were reviewed. The ED stated Patient 10’s SOC was on 7/7/22. The ED stated Pt 10’s OT evaluation was moved from the week of 7/10/22 to the week of 7/18/22 per Patient 10’s request, but was not carried out due to OT 1 being ill. The ED stated she would have needed to have another OT do the evaluation but had no other OT available. The ED stated the OT evaluation on 7/25/22 was outside the five day window of Pt 10’s request of having it performed on 7/18/22 (7 days later). The ED stated it was nearly two weeks from the Patient 10’s SOC (7/7/22) to the OT evaluation (7/25/22). During a review of Patient 17’s “SOC”, dated 5/27/21, the “SOC” indicated, “…Visit Type RN ADMISSION…” During a review of Patient 17’s “Plan of Care” (PC), dated 5/27/21, the PO indicated, “…Frequency/Duration of Visits…Occupational Therapy effective 6/6/21 1wk1…” During a review of Patient 17’s “OT Evaluation”, dated 6/11/21, the OT Evaluation indicated, “…OT ADD-ON EVALUTION…” During an interview, on 8/11/22, at 8:25 p.m., with RN 2, RN 2 stated once the SOC was completed with a patient, all other evaluations such as PT and OT should have been completed within five days of the SOC. RN 2 stated the PT and OT evaluations did not always happen due to patient delaying home visits or scheduling conflicts. During a concurrent interview and record review, on 8/11/22, at 12:57 p.m., with the CM and ED, Patient 17’s SOC, PC, and OT evaluation were reviewed. The ED stated Patient 17’s SOC was on 5/27/22 and the OT evaluation was on 6/11/22 (15 days after SOC) which was outside the five day window of completing the comprehensive assessment. The ED stated there were no coordination notes indicating why the OT evaluation was completed over two weeks after the SOC. The ED stated the comprehensive assessment of patients was important to be done within the five days of SOC to identify what every patients’ needs were and to deliver the appropriate care for each patient. During a review of the agency’s policy and procedure (P&P) titled, “Initial and Comprehensive Assessment”, dated April 2021, the P&P indicated, “…A comprehensive patient assessment will be completed within five calendar days of the patient’s start of care…5. The comprehensive assessment should determine: A. Patient problems/needs/strengths…H. Plan of care, including type of services, frequency, and duration…”

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to review all the medications and update the medication profile for four of seven sampled patients with home visits (Patient 1, 3, 4 and 6), when: Patient 1 had three medications with different dosages: Metoprolol (used to treat high blood pressure and chest pain), Furosemide (used to treat fluid retention cause by liver disease, kidney disease or heart disease), Vitamin D3 (supplement used to absorb other chemicals in the body) and one supplement Vitamin C (used to grow and develop all body tissues such as bone, and teeth) was not on the medication list. Patient 3 had two medications with different dosages: Atorvastatin (used to treat high fat content levels in the blood), Acetaminophen-Codeine (used to treat moderate to severe pain) in the home. Patient 4 had one supplement: Coenzym (used to treat conditions such as heart failure and fluid buildup in the body, chest pain and high blood pressure) with a different dosage in the home. Patient 6 had two medications with a different dosages: Insulin glargine (long acting insulin or hormone used to control sugar levels in the blood), Insulin aspar (rapid acting medications used to control sugar levels in the blood), four medications and one supplement in the home not on the list: Naproxe (used to treat inflammation caused by swelling and joint pain), Losartan (used to treat high blood pressure), Montekulast (used to treat allergies), Cetirizine (use to treat allergies, hives, and itching), Lutein (used to prevent eye disease). These failures had the potential to put the patients at risk for ineffective drug therapy, potential adverse effects, and drug reactions. 1. During an interview on 8/1/22, at 3:45 p.m., with Registered Nurse (RN) 1, RN 1 stated she would update medications on Patient 1’s medication list by asking if any changes had occurred since her last visit. RN 1 stated there had been no changes to Patient 1’s medications since her last visit. RN 1 stated it was important to know all the medications patients were taking to ensure medication safety and compliance. During an observation on 8/1/22, at 4:20 p.m., in Pt 1’s home, there was a medication bottle that indicated, “Metoprolol take ½ tablet (12.5 mg-milligrams) every day.” There was a medication bottle that indicated, “Furosemide 20 mg tablet.” There was a medication bottle that indicated, “Vitamin D3 Supplement 125 mcg (micrograms) per soft gel”. There was a medication bottle that indicated “C (vitamin C) 500 mg.” During a review of Patient 1’s “Medication List” (ML), dated 8/1/22, indicated, “…Metoprolol 25 mg tablet…1.5 tablet…Daily…Furosemide 40 mg tablet…Vitamin D3 25 mcg…” 2. During an observation on 8/2/22, at 3:53 p.m., in Patient 3’s home, there was a medication bottle that indicated, “Atorvastatin 80 mg tablet take 1 tablet by mouth every day.” There was a medication bubble pack that indicated “Acetaminophen-Codeine Give 1 tablet by mouth every 8 hours as needed for moderate to severe pain.” During a review of Patient 3’s ML, dated 8/1/22, indicated, “… [Atorvastatin] 20 mg tablet… Acetaminophen 300 mg-Codeine 30 mg Tablet…every 6 hours take only as needed…” 3. During an observation on 8/3/22, at 11 a.m. in Patient 4’s home, there was a supplement bottle that indicated, “CoQ (Coenzyme) 200 mg per soft gel.” During a review of Patient 4’s ML, dated 8/1/22, indicated, “…Coenzyme Q10 100 mg Capsule 2mg Daily…” 4. During an interview on 8/4/11, at 10:05 a.m., with RN 3, RN 3 stated Patient 6 was taking 15 units of Insulin Glargine at bedtime and 7 units of Insulin Aspart twice a day. RN 3 stated she knew to update medications on the ML if any changes had occurred. RN 3 stated she would ask Patient 6 about changes in medications. During a concurrent observation and interview on 8/4/11, at 10:30 a.m., in Patient 6’s home, with Patient 6, there was a prescription card that indicated, “Insulin Aspart 100 un/ml (units/milliliter-unit of measurement for insulin)…inject 12 units subcutaneously (under the skin) with breakfast and inject 18 units of 100 un/ml with dinner for blood control.” Patient 6 stated that his primary care physician (PCP) had changed the Insulin Aspart to 15 units for the morning and 15 units at bedtime. Patient 6 indicated he had not gotten a new prescription but had spoken to his PCP about the change and had been doing it for a while. Patient 6 stated he did not know if the agency had updated the change on his list. Patient 6 stated he took 20 units of long lasting Insulin Glargine at bedtime as oppose to 15 units on the ML. There was a medication bottle that indicated, “Naproxen 500 mg tab take one tablet once every day as needed for pain or inflammation.” There was a medication bottle that indicated, “Losartan 25 mg tab take one tablet by mouth every day for blood pressure control.” There was a medication bottle that indicated, “Montekulast 10 mg tablet take one tablet by mouth every day for allergies/asthma.” There was a medication bottle that indicated, “Cetirizine 10 mg tab take one tablet by mouth every day for allergy symptoms.” There was supplement bottle that indicated, “Lutein 40 mg.” During a review of Patient 4’s ML, dated 8/2/22, indicated, “[Insulin Aspart] 100 unit/ml 7 units 2 times daily…Insulin Glargine 100 unit/ML (3ML) 15 units bedtime…” During an interview on 8/11/22, at 9:10 a.m., with the Clinical Manager (CM) and the Executive Director (ED), the ED stated it was important for all clinicians to review patients’ medications in the home from prescribed medications, over the counter, and supplements to ensure patients were compliant with medication administration and medication safety. The ED stated old medications needed to be disposed by the patient to ensure the clinician knew what medications were taken by the patient, and which medications were discontinued. The ED stated the clinician should notify the patients’ PCP for any medications that may have been changed, or discontinued. The ED stated she acknowledged there were discrepancies on Patient’s 1, 3, 4 and 6 MLs that did not reflect what was in their homes. During a review of the agency’s policy and procedure (P&P) titled “Administration and Documentation of Medications”, dated April 2017, indicated, “…1. As part of the assessment process, a drug history will be taken, including prescribed and over-the-counter medications, and herbal and nutritional supplements. A comparison will be made between the physician’s order and the current medications the patient is taking. Any discrepancies or contradictions should be reported to the physician for resolution. 2. The nurse will provide instruction to the patient on a continuing basis. This instruction will include medication administration, route, how medication relates to disease process, contraindications, side effects, and adverse reactions…”

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 interview and record review, the agency failed to provide treatment as ordered by the primary care physician (PCP) for seven of 17 sampled patients (Patient 1, 3, 5, 7, 10, 12, and 16) when: Skilled Nursing (SN) visit frequencies were not followed per PCP orders for Patients 3, 7, and 16. Physical Therapy (PT) visit frequencies were not followed per PCP orders for Patient 7. Home Health Aide (HHA) visit frequencies were not followed PCP orders for Patients 1, 5, 7, 10, and 12. These failures had the potential to have the needs of the patients go unmet and led to the patients’ poor prognosis and re-hospitalization. 1. During a review of Patient 3’s “Plan of Care” (PC), dated 7/21/22, the PC indicated, “…SN 1wk1, 2wk1, 1wk3 (one visit for one week; two visits for one week; one visit for three weeks)…” During a review of Patient 3’s “SOC (start of care) Visit Note Report”, dated 7/21/22, the “SOC” indicated, “…Visit Type RN ADMISSION…” During an interview on 8/11/22, at 8:25 a.m., with RN 2, RN 2 stated she had done the SOC on 7/21/22. RN 2 stated Patient 3’s visit schedule was not on her tablet to visit her for the week of 7/25/22. RN 2 stated she did not know why Patient 3 had missed visits for the second week (7/25/22) following the SOC. During a concurrent interview and record review on 8/11/22, at 10:10 a.m., with the Clinical Manager (CM) and the Executive Director (ED), the Patient 3’s clinical record was reviewed. The ED stated Patient 3’s SN visit frequency was for two visits on the second week of the episode (7/25/22). The ED stated there were no coordination notes indicating why SN visits were missed. The ED stated Patient 3’s calendar did not indicate there were scheduled SN visits for the week of 7/25/22. The ED stated she did not know why SN visits were missed. During a review of Patient 7’s PC, dated 7/16/22, the PC indicated, “…SN 1wk1, 2wk4, 1wk2 (one visit for one week; two visits for four weeks; one visit for two weeks)…” During a review of Patient 7’s SOC, dated 7/16/22, the SOC indicated, “…Visit Type RN ADMISSION…” During a concurrent interview and record review on 8/11/22, at 10:45 a.m., with the CM and the ED, the Patient 3’s clinical record was reviewed. The ED stated Patient 7’s SN visit frequency was for two visits on the third week of the episode (7/25/22). The ED stated there was one SN visit done on 7/26/22, but no second visit was done for SN. The ED stated there was no coordination note indicating why a second visit on the week of 7/25/22 was missed. During a review of Patient 16’s PC, dated 6/23/21, the PC indicated, “…SN 2wk1, 3wk1 (two visits for one week; three visits for one week)…” During a review of Patient 16’s SOC, dated 6/23/21, the SOC indicated, “…Visit Type RN ADMISSION…” During a concurrent interview and record review on 8/11/22, at 12:36 p.m., with the CM and the ED, the Patient 16’s clinical record was reviewed. The ED stated Patient 16’s SN visit frequency was for three visits on the second week of the episode (6/27/21). The ED stated there were two SN visits done on the week of 6/27/21 (6/29/21, 7/1/21) but no third visit for that week. The ED stated there was no coordination note and no visit scheduled on Patient 16’s calendar to indicate a missed SN visit. 2. During a review of Patient 7’s PC, dated 7/16/22, the PC indicated, “…PT effective 7/17/22 2wk3, 1wk1 (two visits for three weeks, one visit for one week)…” During a review of Patient 7’s “PT Evaluation”, dated 7/19/22, the PT Evaluation indicated, “…PT ADD-ON EVALUTION…” During a concurrent interview and record review on 8/11/22, at 10:45 a.m., with the CM and the ED, the Patient 7’s clinical record was reviewed. The ED stated Patient 7’s PC indicated PT visit frequency was to have two visits for the week of 7/17/22. The ED stated Patient 7 had a PT evaluation on 7/19/22, but did not have a second PT visit for that week. The ED stated there was no coordination note and not PT visit scheduled on Patient 7’s calendar indicating the reason for the missed visit. 3. During a review of Patient 1’s PC, dated 7/13/22, the PC indicated, “…HHA effective 7/17/22 1wk1, 2wk2 (one visit for one week, two visits for two weeks)…” During a concurrent interview and record review on 8/11/22, at 9:50 a.m., with the CM and the ED, the Patient 1’s clinical record was reviewed. The ED stated Patient 1 had an order for two HHA visits on the week of 7/25/22. The ED stated there were no HHA visits done on the week of 7/25/22. The ED stated there were no coordination notes indicating HHA visits were missed. During a review of Patient 5’s “Physician Order” (PO), dated 7/25/22, the PO indicated, “…HHA effective 7/31/22 2wk1, 1wk1 (two visits for one week; one visit for one week)…” During a concurrent interview and record review on 8/11/22, at 10:30 a.m., with the CM and the ED, the Patient 5’s clinical record was reviewed. The ED stated Patient 5 had an order for two HHA visits for the week of 7/31/22. The ED stated there was an HHA visit done on 8/3/22, but no other visit for that week. The ED stated there was no coordination note indicating a missed visit for Patient 5. During a review of Patient 7’s PC, dated 7/16/22, the PC indicated, “…HHA effective 7/17/22 1wk1, 2wk1 (one visit for one week; two visits for one week)…” During a concurrent interview and record review on 8/11/22, at 10:45 a.m., with the CM and the ED, the Patient 7’s clinical record was reviewed. The ED stated the HHA order for Patient 7 was for two visits for the week of 7/25/22. The ED stated there were no HHA visits scheduled for Patient 7 for the week of 7/25/22, and no coordination notes indicating why HHA visits were missed. During a review of Patient 10’s PO, dated 7/20/22, the PO indicated, “…HHA 2wk3 (two visits for three weeks) effective week of 7/18/22 for bathing assistance…” During a concurrent interview and record review on 8/11/22, at 11:15 a.m., with the CM and the ED, the Patient 10’s clinical record was reviewed. The ED stated Patient 10 was ordered to have two HHA visits for the week of 7/25/22. The ED stated there were no HHA visits done on the week of 7/25/22, nor were there coordination notes indicating HHA visits were missed. During a review of Patient 12’s PO, dated 7/15/22, the PO indicated, “…HHA effective 7/17/22 1wk2 (one visit for two weeks)…” During a concurrent interview and record review on 8/11/22, at 11:50 a.m., with the CM and the ED, the Patient 12’s clinical record was reviewed. The ED stated Patient 12’s order on 7/15/22 indicated Patient 12 was to have one HHA visit for the week of 7/25/22. The ED stated there was no HHA visit done for the week of 7/25/22 and there were no coordination notes indicating a missed HHA visit. During an interview on 8/10/22, at 4:25 p.m., with the HHA, the HHA stated she was the only HHA in the agency. The HHA stated she was off from work the week of 7/25/22 due to being ill. The HHA stated if she missed visits, she would need to put in a coordination note as to why visits were missed. The HHA stated if there were undue visits on her schedule, the agency would get orders to change the frequency of the HHA visits. The HHA stated if she was not able to work, the patients with HHA services do not get seen since there was no other HHA to cover for her. The HHA stated she did not know what happened to the missed HHA visits during the week of 7/25/22. During an interview on 8/11/22, at 9:10 a.m., with the CM and ED, the ED stated it was important to follow the PCP orders for home visit frequencies in order to meet the needs of the patients. The ED stated if clinicians were not following the ordered frequencies of the patients’ schedule, the goals of the patients may not have been met and could have led to patients not being safe at home and potentially transferring to the hospital. The ED stated there were scheduling issues with the HHA due to her being ill the week of 7/25/22. The ED stated her expectation was for the need for better coordination with the clinicians for scheduling home visits as ordered by the PCPs. During a review of the policy and procedure (P&P) titled, “Care/Service Coordination”, dated April 2021, indicated, “…Timely and ongoing communication is the responsibility of each team member and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. The clinician/technician will be responsible for facilitating communications about changes in the patient’s status among the assigned personnel…4. Care coordination will include, but not be limited to…J. Coordination of care deliver to meet the patient’s needs and involve the patient representative, and caregivers, as appropriate, in the coordination of care activities…5. It will be the responsibility of the primary clinician to facilitate communication about changes in the patient’s status among all assigned disciplines. 6. Organization personnel will communicate changes in a timely manner via telephone, one-on-one meetings, case conferences, and home visits. Documentation of all communications will be included in the clinical record on a communication note, case conference summary, or clinical note. Documentation will include: the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication… During a review of the P&P titled, “Physician Participation in Plan of Care”, dated April 2017, indicated, “…A physician will direct the care of every home health care patient admitted for service…1. Physician orders will be individualized, based on patient’s needs, and include…B. Treatments and/or procedures needed, including type, frequency, duration, and goals…”

Revisions communicated to patient and MDs CFR(s): 484.60(c)(3)(i) (i) Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and all physicians or allowed practitioner's issuing orders for the HHA plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to communicate with the Primary Care Physician (PCP) revisions to the plan of care for one of 17 sampled patients (Patient 14), when Registered Nurse (RN) 3 did not inform the PCP of the updated frequency order for Skilled Nursing visits (SN) on the Start of Care (SOC). This failure had the potential of Patient 14 not achieving the SN goals needed for reaching the highest attainable levels of functioning. During a review of Patient 14’s “Referral Order” (RO), dated 6/7/22, the RO indicated, “…Nursing: Incisional care/dressing changes 2 times a week for 2 weeks…” During a review of Patient 14’s “Plan of Care” (PC), dated 6/15/22, the PC indicated, “…SN 1wk4 (one visit for four weeks)…” During a review of Patient 14’s “Start of Care Visit Note Report” (SOC), dated 6/15/22, the SOC indicated, “…Assessment…Skin check is done. Incision noted RLE (right lower extremity) with staples intact, and no active drainage…Patient (14) agrees with weekly nursing visits for 4 weeks…” During a concurrent interview and record review on 8/11/22, at 12:07 p.m., with the Clinical Manager (CM) and the Executive Director (ED), the Patient 14’s clinical record was reviewed. The ED stated the RO was for Patient 14 to have SN visits for two times for two weeks. The ED stated when RN 3 assessed Pt 14 on the SOC visit, RN 3 determined that Patient 14 did not need wound treatment and required less visits for medication education, and assessment of incision. The ED stated RN 3 should have notified the PCP of the change in visit frequency to one visit for four weeks in order to have the correct order of visit frequency. The ED stated Patient 14’s PC did not follow the PCP orders on RO. During a review of the policy and procedure (P&P) titled, “Care Planning Process”, dated April 2017, indicated, “…4. The care planning decisions will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet the individualized patient problems and goals…10. Clinicians will inform the patient’s physician of any changes that suggest a need to alter the plan of care. Changes must be written, dated, and signed by the professional making the changes…” During a review of the P&P titled, “Physician Participation in Plan of Care”, dated April 2017, indicated, “…A physician will direct the care of every home health care patient admitted for service…1. Physician orders will be individualized, based on patient’s needs, and include…B. Treatments and/or procedures needed, including type, frequency, duration, and goals…”

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 interview and record review, the agency failed to communicate the discharge plans for one of 17 sampled patients (Patient 12), when Registered Nurse 2 did not communicate the discharge visit to the agency and a Skilled Nursing (SN) visit was done by a Licensed Vocational Nurse (LVN) after discharge. This failure had the potential for discharge plans to go unnoticed and lead to miscommunication of Patient 12’s plan of care. During a review of Patient 12’s “DC (discharge) of SN Services Visit Note Report” (DC), dated 7/29/22, the DC indicated, “…Care Coordination…What discipline did you communicate with: Clinical Manager…LVN…” During a review of Patient 12’s “SN Visit Note” (SN), dated 7/30/22, the SN indicated, “…Agent Name [LVN name]…” During a concurrent interview and record review with the Clinical Manager (CM) and the Executive Director (ED), the Patient 12’s clinical record was reviewed. The ED stated Patient 12’ DC visit was on 7/29/22 with RN 2 and Patient 12 had met their goals for DC. The ED stated there was an SN visit done on 7/30/22 by an LVN, but did not know why it was carried out. The ED stated RN 2 should have inputted a coordination note indicating Patient 12 was DC from SN services. The ED stated there was a lack of communication between RN 2 and the Clinical Manager as to the discharge plans for Patient 12. During a review of the policy and procedure (P&P) titled, “Discharge Criteria and Process”, dated April 2021, indicated, “…7. If more than one discipline is providing care, the discipline being discontinue will be specified on the interim order…10. The clinician will update the comprehensive assessment…11. All discharge paperwork will be due in the office within 72 hours of the discharge date. This will include the discharge order, discharge summary, plan of care, medication profile…” During a review of the P&P titled, “Care/Service Coordination”, dated April 2021, indicated, “…Timely and ongoing communication is the responsibility of each team member and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. The clinician/technician will be responsible for facilitating communications about changes in the patient’s status among the assigned personnel…4. Care coordination will include, but not be limited to…K. The organization shall provide training, as necessary, to ensure a timely discharge…5. It will be the responsibility of the primary clinician to facilitate communication about changed in the patient’s status among all assigned disciplines. 6. Organization personnel will communicate changes in a timely manner via telephone, one-on-one meetings, case conferences, and home visits. Documentation of all communications will be included in the clinical record on a communication note, case conference summary, or clinical note. Documentation will include: the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication…

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 observation, interview, and record review, the agency failed to integrate services for pain management for one of seven sampled patients with home visits (Patient 4), when Occupational Therapist (OT-clinician who practices a form of therapy for those recuperating from physical or mental illness that encourages rehabilitation through the performance of activities required in daily life) 1 implemented exercises for Patient 4 while in pain and pain medication was not available in the home. This failure had the potential to affect patient safety and treatment effectiveness that could lead to the inability of Patient 4 reaching their highest attainable level of functioning. During an observation on 8/3/22, at 10 a.m., in Patient 4’s home, OT 1 asked Patient 4 to rate any level of pain from 0-10 (numerical pain scale; 0 being no pain; one to three meaning mild pain; four to seven being moderate pain; eight and above being severe pain) while bearing weight on her left knee. Patient 4 stated she had pain of 6/10 in her left knee when she beared weight on it. OT 1 assisted Patient 4 to the restroom to practice transfers from toilet to standing. Patient 4 stated she did not want to do other exercises besides toilet transfers because she was not in the mood during the home visit. During a review of Patient 4’s “OT Visit Note” (OTV), dated 8/3/22, the OTV indicated, “…Narrative…Assessment…6/10 pain in L (left) knee upon weight bearing. Patient declined demonstrating ADLs (activities of daily living) with use of hip kit tools, but agreeable to verbal training…Patient tolerated only one toilet transfer to standard toilet and required minimal assistance to stand due to pain in left knee…” During an interview on 8/10/22, at 3:15 p.m., with OT 1, OT 1 stated Patient 4 was in 6/10 pain to her left knee during the home visit on 8/3/22. OT 1 stated if she knew a patient had pain while bearing weight, she would want patients to take their pain medication about 30 minutes before an OT visit to facilitate interventions during exercises. OT 1 stated Patient 4 did not have anything prescribed by her Primary Care Physician (PCP) for pain management. OT 1 stated she was able to notify the PCP of any pain medication that could be ordered. OT 1 stated it was important to control a patient’s pain level during OT home visits so that the patient could perform exercises such as transfers to the toilet and bed and achieve their goals to reach the highest level of functioning. During an interview on 8/11/22, at 8:10 a.m., with Registered Nurse (RN) 1, RN 1 stated she was the case manager for Patient 4. RN 1 stated she did not know if Patient 4 had pain medication to manage pain during OT exercises. RN 1 stated if a patient did have pain during weight bearing exercises, it would be beneficial for patients to control their pain with pain medications before the OT would perform her home visit. RN 1 stated she could notify the PCP if Patient 4 had problems with pain during home visits. RN 1 stated if she could not get a hold of the PCP’s office for order on pain medication, she could have the patient hand deliver an order request for pain medication as she had done before with other patients. During a review of Patient 4’s “Medication List” (ML), dated 8/1/22, the ML indicated no pain medication prescribed for Patient 4. During a concurrent interview and record review on 8/11/22, at 10:20 a.m., with the Clinical Manager (CM) and the Executive Director (ED), the Patient 4’s clinical record was reviewed. The ED stated Patient 4’s ML did not indicate any prescribed pain medication. The ED stated there was no documentation about clinicians speaking to Patient 4’s PCP about the need for prescribing any medication for pain. The ED stated if Patient 4 had any pain during weight bearing exercises, RN 1 or OT 1 could have notified the PCP of the need for pain medication. The ED stated Patient 4 should have been as comfortable as possible during exercises and not be in pain. The ED stated it was important for patients to be able to perform OT exercises according to the plan of care and reach their goals of reaching their highest level of functioning. During a review of the policy and procedure (P&P) titled, “Pain Management Education”, dated April 2021, indicated, “…1. Clinicians will identify patients with pain or who are at risk for pain during initial and ongoing patient assessment. 2. The patient and family/caregiver will receive verbal and written instructions, as appropriate, regarding…D. The importance of effective pain management E. Methods for pain management, when identified as part of treatment…” During a review of the P&P titled, “Care Planning Process”, dated April 2017, indicated, “…1. At the time of the initial assessment, the clinician, along with other involved disciplines, will develop the patient plan of care based upon the patient’s identified needs and will review it with the patient and family/caregiver…D. Pain and symptom management, as appropriate…” During a review of the P&P titled, “Care/Service Coordination”, dated April 2021, indicated, “…Timely and ongoing communication is the responsibility of each team member and will be appropriate to the needs and abilities of the patient, and relevant to the care/service provided. The clinician/technician will be responsible for facilitating communications about changes in the patient’s status among the assigned personnel…4. Care coordination will include, but not be limited to…5. It will be the responsibility of the primary clinician to facilitate communication about changes in the patient’s status among all assigned disciplines. During a review of the P&P titled, “Physician Participation in Plan of Care”, dated April 2017, indicated, “…A physician will direct the care of every home health care patient admitted for service…1. Physician orders will be individualized, based on patient’s needs, and include…C. Medications to be administered or monitored…”

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, interview, and record review, the agency failed to follow standard precautions to prevent the transmission of infectious diseases for five of seven sampled patients with home visits (Patients 1, 4, 5, 6 and 7), when: 1. Registered Nurse (RN) 1 used a torn glove during wound treatment for Patient 1. 2. Occupational Therapist (OT) 1 did not perform appropriate hand hygiene in Patient 4’s home. 3. Physical Therapist (PT) 1 did not perform hand hygiene in between glove use in Patient 5’s home. 4. RN 3 did not perform hand hygiene after a home visit with Patient 6. 5. Physical Therapist Assistant (PTA) 1 did not perform appropriate hand hygiene in Patient 4’s home. These failures had the potential to increase the transmission of infections to other patients. 1. During an observation on 8/1/22, at 3 p.m., in Patient 1’s home, RN 1 was preparing to do a wound treatment to Patient 1’s right heel. RN 1 tore one glove while attempting to place it on her right hand. RN 1 continued to use the torn glove while performing the wound treatment to Patient 1’s right heel. During an interview on 8/1/22, at 3:45 p.m., with RN 1, RN 1 stated she did not notice her glove was torn until she had taken it off. RN 1 stated she should have replaced the torn glove before performing the wound treatment on Patient 1. RN 1 stated the torn glove was not appropriate to use since it was compromised and could potentially cause cross contamination (transfer of harmful bacteria from one person, object or place to another) between patients in other home visits. 2. During an observation on 8/3/22, at 10:12 a.m., in Patient 4, OT 1 had performed vital signs (medical signs that indicate the status of the body’s vital functions) for Patient 4 with gloves on, and then proceeded to apply hand sanitizer over her gloved hands. During an interview on 8/3/22, at 10:40 a.m., with OT 1, OT 1 stated she should not have performed hand hygiene with the hand sanitizer over her gloves. OT 1 stated she should have removed her gloves and then used the hand sanitizer over her hands. OT 1 stated it was important to use proper hand hygiene to prevent from any germs to cross over to other patients in other home visits. 3. During an observation on 8/3/22, at 2 p.m., in Patient 5’s home, PT 1 had gloves on and was performing passive range of motion exercises (space in which a part of the body can move when someone or something is creating the movement) with Patient 5. PT 1 removed her gloves and put on new gloves without performing hand hygiene with the hand sanitizer. During an interview on 8/3/22, at 2:45 p.m., with PT 1, PT stated she should have used the hand sanitizer in between glove use to ensure her hands were clean after touching Patient 5. PT 1 stated it was important to use the hand sanitizer after removing gloves to ensure she did not take any germs from Patient 5’s home to other home visits. 4. During an observation on 8/4/22, at 10 a.m., outside of Patient 5’s home, RN 3 removed her N95 mask (particulate-filtering face piece that filters at 95% of airborne particles), disinfected her face shield, and removed her gloves and did not perform hand hygiene with the hand sanitizer. During an interview on 8/4/22, at 10:05 a.m., RN 3 stated she would have needed to perform hand hygiene with the hand sanitizer after removal of N95 mask, and gloves when she left Patient 5’s home. RN 3 stated it was important to perform hand hygiene after a patient’s visit to prevent taking any germs to other patients’ home visits and getting patients ill. 5. During an observation on 8/4/22, at 2:20 p.m., in Patient 7’s home, PTA 1 had gloves on during the home visit and then proceeded to apply hand sanitizer over her gloved hands. During an interview on 8/4/22, at 2:35 p.m., with PTA 1, PTA 1 stated she would have needed to remove her gloves before applying the hand sanitizer over her hands. PTA 1 stated it was important to ensure proper hand hygiene in a patient’s home to prevent the spread of any germs between patient’s home visits. During an interview on 8/11/22, at 9:10 a.m., with the Clinical Manager (CM), and Executive Director (ED), the ED stated clinicians needed to use the hand sanitizer in between gloves and over their hands to perform proper hand hygiene. The ED stated it was not appropriate to use a torn glove during wound treatments as it would compromise the integrity of the glove and would need to replace it with a new glove. The ED stated it was important to perform proper hand hygiene and glove use in patients’ homes to ensure that no germs get transferred from home to home and prevent from any patient becoming ill. During a review of the policy and procedure (P&P) titled, “Hand Hygiene”, dated April 2021, indicated, “…Personnel providing care in the home setting will regularly wash their hands, per the most recently CDC guidelines (Centers for Disease Control and Prevention-the national public health agency) for hand hygiene in healthcare settings…When hands are not visibly soiled, they should be washed using an alcohol-based hand rub for routinely decontaminating hands…Procedure…1. Apply alcohol-based hand rub product to palm of one hand and rub hands together, covering all surfaces of hands and fingers until hands are dry…3. Hand decontamination using an alcohol-based hand rub should be performed…G. After removing gloves…”

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 observation, interview, and record review, the agency failed to implement policies and procedures to ensure adherence to COVID-19 (a contagious serious respiratory infection transmitted from person to person cause by a virus) guidelines for one of two unvaccinated clinicians, when Physical Therapist Assistant (PTA) 1 did not use an N95 mask (particulate-filtering face piece that filters at 95% of airborne particles) during Patient 7’s home visit. This failure had the potential of exposing Patient 7 to the COVID-19 virus and lead to serious illness or even death. During an observation on 8/4/22, at 1:52 p.m., outside of Patient 7’s home, PTA 1 had a surgical mask (are made of a combination of paper and plastics) on and entered Patient 7’s home for the PTA home visit. During an interview on 8/4/22, at 2:35 p.m., with PTA 1, PTA 1 stated she was not vaccinated for the COVID-19 vaccine. PTA 1 stated she would normally would wear an N95 mask during patient home visits, but did not wear one due to being a hot day outside and did not feel like she could breathe as well in an N95 mask. PTA 1 stated the agency would leave it up to clinicians whether they wanted to wear an N95 mask during home visits regardless of COVID-19 vaccination status. During a review of the agency’s “Worker HR Log Report” (LR), dated 8/10/22, the LR indicated, “… [PTA 1] COVID 19 Vaccine Exempt Comments: Declination Received 1/22/21…” During a concurrent interview and record review on 8/10/22, at 1:30 p.m., with the Executive Director (ED) and the Director of Clinical Operations (DCO), the policy and procedure (P&P) titled “Pandemic Infectious Disease”, dated 8/1/22 was reviewed. The “Home Health Agency Attachment QSO-22-07 (Quality Safety and Oversight for State Agencies) was reviewed. The QSO-22-07 indicated, “…The policy HHAs must have a process for ensuring all staff have received at least a single-dose, or the first dose of a multi-dose COVID-19 vaccine series prior to providing any care, treatment, or other services for the facility and/or its patients… The policy must also ensure those staff who are not yet fully vaccinated, or who have been granted an exemption or accommodation as authorized by law, or who have a temporary delay, adhere to additional precautions that are intended to mitigate the spread of COVID-19. There are a variety of actions or job modifications a facility can implement to potentially reduce the risk of COVID-19 transmission including, but not limited to… Requiring staff who have not completed their primary vaccination series to use a NIOSH approved N95 or equivalent or higher-level respirator for source control, regardless of whether they are providing direct care to or otherwise interacting with patients…” The DCO stated it was the agency’s expectation for clinicians to wear N95 masks in situations that presented to wear an N95 mask during a patient home visit, such as the patient or family with confirmed COVID-19 infection. The DCO stated it was up to the clinician if they wanted to wear an N95 mask during a patient’s home visit that was not confirmed to have COVID-19 regardless of the clinician’s COVID-19 vaccination status. The DCO if the requirement in the QSO-22-07 was for unvaccinated clinicians to wear an N95 mask at all times in patient’s home, then it would need to be implemented into the agency’s policy on COVID-19 precautions. The ED stated the guidance in the QSO-22-07 would require the agency to educate unvaccinated clinicians to wear an N95 during home visits. The P&P titled “Pandemic Infectious Disease” did not indicate the need for unvaccinated clinicians for COVID-19 to wear an N95 mask.

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 interview, and record review, the agency failed to provide services in the plan of care for two of seven sampled patients with home visits (Patient 4 and 5) when: Occupational Therapist (OT) 1 did not perform an oxygen saturation (O2 sat-referrers to the percentage of oxygen in a person’s blood) check during a home visit for Patient 4.Physical Therapist (PT) 1 did not perform a respiratory rate (a person’s respiratory rate is the number of breaths taken per minute) during a home visit for Patient 5. These failures had the potential for the PT and OT to no report any vital signs (medical signs that indicate the status of the body’s vital functions such as O2 sat, and respiratory rate) out of range that could lead to unachieved goals and re-hospitalization. 1. During a review of Patient 4’s “Plan of Care” (PC), dated 7/26/22, the PC indicated, “…Licensed Professional (OT 1) may check O2 sats using a pulse oximeter (device used to measure O2 sats) PRN (as needed) for SOB (shortness of breath), signs/symptoms of hypoxia (deficiency in the amount of oxygen reaching the body organ tissue), or for assessment of tolerance to treatment…Licensed Professional to report vital signs falling outside the following established parameters…O2 sat 100…” During a review of Patient 4’s “OT Visit Note Report” (OTV), dated 8/3/22, the OTV indicated no documentation of an O2 sat reading. During an interview on 8/10/22, at 3:15 p.m., with OT 1, OT 1 stated she needed to check Patient 4’s O2 sat to ensure Patient 4 was getting enough oxygen to her lungs so that the patient did not get dizzy and have enough energy to perform the exercises. OT 1 stated if Patient 4’s O2 sat was below a certain number she notified the Primary Care Physician of the abnormal reading for further evaluation. OT 1 stated she did not document the O2 sat for Patient 4 during the home visit on 8/3/22 because it was not out of range. 2. During a review of Patient 5’s PC, dated 7/18/22, the PC indicated, “…Licensed Professional to report vital signs falling outside the following established parameters…Resp (respiratory rate) 21…” During a review of Patient 5’s “PT Visit Note Report” (PTV), dated 8/3/22, the PTV indicated, “…Respirations…Reading… [Blank]…” During an interview on 8/10/22, at 2:27 p.m., with PT 1, PT 1 stated she needed to assess Patient 5’s respiratory rate to see whether Patient 5 was breathing appropriately. PT 1 stated if Patient 5 had an increased respiration rate that indicated shortness of breath, the patient would not be able to perform the PT exercises needed to improve their highest function. PT 1 stated she did not document Patient 5’s respiration rate on the PTV note. During an interview on 8/11/22, at 9:10 a.m., with the Clinical Manager (CM), and Executive Director (ED), the ED stated it was important to take all vitals signs of patients during home visits to ensure they were stable to perform any PT or OT exercises. The ED stated all vital signs should be documented in the visit notes to ensure all patients were stable. The ED stated OT 1 and PT 1 were licensed professionals that could take vital signs during home visits. During a review of the undated job description titled, “Occupational Therapist”, indicated, “…Performs occupational therapy procedures, measurements, evaluations and diagnostic tests on patients in the home for whom they have been medically prescribed to aid in establishing or revising specifics of treatment program and communicates results with physician appropriately…” During a review of the undated job description titled, “Physical Therapist”, indicated, “…Performs physical therapy procedures, measurements, evaluations and diagnostic tests on patients in the home for whom they have been medically prescribed to aid in establishing or revising specifics of treatment program and communicates with physician appropriately…”

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on interview, and record review, the agency failed to provide competency evaluations for one of one Home Health Aide (HHA) and one of one Licensed Vocational Nurse (LVN) 1 when: The agency did not verify documentation of a successfully completed competency testing for the HHA. The agency used LVN 1 to perform HHA duties for Patient 16 without having competencies to carry out HHA duties. This failure had the potential for the patients (Patient 16) receiving HHA services to be at risk for injury, and re-hospitalization. 1. During a concurrent interview and record review on 8/11/22, at 2:30 p.m., with the Executive Director (ED), the HHA’s personnel file was reviewed. The personnel file had no evidence of a competency evaluation done upon hire of the HHA. The ED stated the expectation was for a Registered Nurse (RN) to do an onsite competency check list with the HHA upon hire and every year after. The ED stated it was important to verify the competencies of the HHA to ensure the duties of an HHA were being done in a safe and competent manner for the patients. 2. During a review of Patient 16’s “Plan of Care” (PC), dated 6/23/21, the PC indicated, “…HHA effective 6/27/21 2wk3 (two visits for three weeks)…” During a review of Patient 16’s “Aide Visit Note Report” (AVN), dated 6/29/21, the AVN indicated, “…Agent Name [LVN 1]…” During a review of Patient 16’s AVN, dated 7/1/21, the AVN indicated, “…Agent Name [LVN 1]…” During an interview on 8/10/22, at 3:50 p.m., with LVN 1, LVN 1 stated she had performed HHA duties a year ago when the agency did not have a HHA to carry out HHA services. LVN 1 stated did perform HHA visits for Patient 16 from 6/29/21 to 7/1/21 and had been doing HHA visits since the end of 2021. LVN 1 stated she did not have HHA competency evaluations done at the time to indicate she was trained to do the duties of an HHA. During an interview on 8/11/22, at 9:10 a.m., with the Clinical Manager (CM), and Executive Director (ED), the ED stated the agency had used LVN 1 to perform HHA duties up until the time they hired the HHA in September 2021. The ED stated the agency needed to hire more HHA to ensure there was enough personnel to carry out the services of the HHA. The ED stated LVN 1 did not have a competency check list of HHA duties in her personnel file to indicate she was competent to carry out all the duties of an HHA. During a review of LVN 1’s personnel file, there was no evidence of a competency evaluation done during the time LVN 1 was performing HHA duties. During a review of the undated policy and procedure (P&P) titled, “Orientation of Assigned Home Health Aide”, indicated, “…2. The home health aide will review the duties to be performed and the arrangements for providing services as stated in the plan of care, and he/she will discuss this with the nurse or therapist. A. An orientation or placement visit is scheduled in the patient’s home by the clinician, whenever feasible. B. 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. Return demonstration will be requested, as appropriate. During a review of the undated job description titled, “Home Health Aide”, the job description indicated, “…Adequate performance at this level requires the knowledge and ability to perform as a health care professional. The duties of a HHA are varied and complex… Minimum 1-year experience as a Home Health Aide…Current certification as a Certified Home Health Aide by the State of California required…”

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 interview and record review, the agency failed to develop an updated Home Health Aide (HHA) care plan for one of 17 sampled patients (Patient 12) when Registered Nurse (RN) 2 did not update Patient 12’s aide care plan to reflect the change from shower to bed bath. This failure had the potential to place Patient 12 at risk for improper bathing technique from the HHA that could lead to injury. During a review of Patient 12’s “Client Coordination Note Report” (CN), dated 6/15/22, the CN indicated, “…HHA give pt (patient) with the assistance of a caregiver...Shower is not safe for pt HHA notified RN (2) about the situation and she will change the plan of care to sponge bath…” During a review of Patient 12’s “Aide Visit Note Report” (AVN), dated 6/21/22, the AVN indicated, “…Service: Bathing (Shower)…Note: HHA provided a sponge bath by pt request. RN (2) aware…” During a review of Patient 12’s AVN, dated 6/29/22, the AVN indicated, “…Service: Bathing (Shower)…” During a review of Patient 12’s AVN, dated 7/7/22, the AVN indicated, “…Service: Bathing (Shower)…Note: HHA give pt a sponge bath with nurse (RN 2) approval…” During a review of Patient 12’s AVN, dated 7/13/22, the AVN indicated, “…Service: Bathing (Shower)…” During a review of Patient 12’s AVN, dated 7/18/22, the AVN indicated, “…Service: Bathing (Shower)…” During a review of Patient 12’s “Aide Care Plan” (ACP), dated 8/10/22, the ACP indicated, “…ADL (activities of daily living)…Bathing (shower)…every visit…” During an interview on 8/10/22, at 4:25 p.m., with the HHA, the HHA stated she had done an HHA visit with Patient 12 on 6/15/22, and felt that doing a shower was unsafe for Patient 12. HHA stated she had informed RN 2 about changing the ACP to indicate to do a bed bath for Patient 12. HHA stated RN 2 was responsible for creating the ACP and updating it as needed. The HHA stated ensuring the correct bathing technique for Patient 12 was important to maintaining the patient safe during home visits. During an interview on 8/11/22, at 8:25 p.m., with RN 2, RN 2 stated the HHA had informed her about the need to change Patient 12’s ACP due to safety issues for showering. RN 2 stated she had called the Clinical Manager (CM) to update the ACP, but the documentation did not indicate an update was made. RN 2 stated it was important to update the ACP to ensure the HHA was performing the correct bathing technique to maintain Patient 12’s safety and prevent any injury. During a concurrent interview and record review on 8/11/22, at 11:50 a.m., with the CM, and Executive Director (ED), Patient 12’s record was reviewed. The ED stated there was a coordination note made by the HHA to RN 2 to update the ACP, but the ACP on 8/11/22 did not indicate an update from shower to bed bath. The ED stated it was important to ensure the safety of Patient 14 by implementing the correct bathing technique and prevent any injury. During a review of the policy and procedure titled “Home Health Aide Plan of Care” dated April 2017, indicated, “…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 any time the patient’s change of condition warrants revision. 5. The Case Manager, or other appropriate skilled professional and aide will initial the plan to indicate this review has occurred...”

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on interview, and record review, the agency failed to provide supervision of Home Health Aides (HHA) by Registered Nurses (RN) for four of 17 sampled patients (Patients 1, 3, 5, and 16) every 14 days when: RN 1 did not provide oversight of the HHA during supervisory visits for Patient 1.RN 2 did not provide oversight of the HHA during supervisory visits for Patient 3, 5, and 12 These failures lead to a lack of RN oversight that had the potential for Patients 1, 3, 5 and 12 to experience improper HHA care and the risk of injury. 1. During a review of Patient 1’s PC, dated 7/13/22, the PC indicated, “…HHA effective 7/17/22…” During a review of Patient 1’s “RN Visit + Sup (supervisory) Note” (RNSN), dated 7/26/22, the RNSN indicated, “…Supervisory Functions…Indicate discipline of employee being evaluated…Licensed Practical Nurse (LPN)…” The RNSN had no documentation of HHA services being supervised. During an interview on 8/11/22, at 8:10 a.m., with RN 1, RN 1 stated she was to be doing supervisory of the HHA every two weeks (14 days). RN 1 stated the RNSN had questions to indicate what clinician was to be supervised during the home visit. RN 1 state she believed she needed to accompany the HHA during a home visit, but had not occurred since she had been working for the agency. RN 1 stated her supervisory visit consisted of speaking to the patients about the HHA services and looking at documentation. 2. During a review of Patient 3’s “Plan of Care” (PC), dated 7/21/22, the PC indicated, “…HHA effective 7/24/22…” During a review of Patient 3’s clinical record, there was no indication of a RNSN was performed to supervise the HHA. During a review of Patient 5’s “Physician Order” (PO), dated 7/25/22, the PO indicated, “…HHA effective 7/31/22…” During a review of Patient 5’s RNSN, dated 7/26/22, the RNSN indicated, “…Supervisory Functions…Were supervisory functions performed…No…Indicate reason supervisory functions not performed: Not applicable to today’s visit…” The RNSN had no documentation of HHA services being supervised. During a review of Patient 12’s PC, dated 6/13/22, the PC indicated, “…HHA 1wk3 (one visit for three weeks)…” During a review of Patient 12’s RNSN, dated 6/22/22, the RNSN indicated, “…Supervisory Functions… Indicate discipline of employee being evaluated…Licensed Practical Nurse (LPN)…” The RNSN had no documentation of HHA services being supervised. During a review of Patient 12’s RNSN, dated 7/15/22, the RNSN indicated, “…Supervisory Functions… Indicate discipline of employee being evaluated…Licensed Practical Nurse (LPN)…” The RNSN had no documentation of HHA services being supervised. During an interview on 8/11/22, at 8:25 a.m., with RN 2, RN 2 stated she would supervise the HHA by asking patients how the HHA services were going, and speaking to the HHA about what ADLs (activities of daily living) she was performing during home visits. RN 2 stated supervisory visits for HHAs were to be done every two weeks. RN 2 stated supervisory documentation would be in the notes. During an interview on 8/11/22, at 1 p.m., with the Executive Director (ED), the ED stated the HHA needed to be supervised every 14 days by an RN. The ED stated an RNSN visit would be scheduled for RN 1 and RN 2 to perform every 14 days. The ED stated if patients only had HHA visits for only one week due to a patient declining further HHA visits, the RNs would still need to do supervisory oversight of the HHA. The ED stated RNSNs for Patients 1, 3, 5 and 12 did not contain supervisory visits for the HHA. The ED stated it was important for RNs to supervise the HHA to ensure competent duties were being carried out and ensure the safety of patients receiving HHA services. During a review of the policy and procedure (P&P) titled, “Home Health Aide Plan of Care”, dated April 2017, indicated, “…The Case Manager or other appropriate clinician will supervise the home health aide at least every fourteen days to ensure care is provided according to plan…” During a review of the undated job description titled “Registered Nurse”, the job description did not include HHA supervision as part of the RN job duties.