Every finding on record at New Era Home Health Agency

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey from 10/17/2023 to 10/21/2023. Federal Intake Number: 101762 Representing the Department of Public Health: Surveyor ID # 43979 -RN - HFEN Surveyor ID # 43929 -RN - HFEN Census: 23 Sample Size: 7 Home Visits: 3 Closed Record review: 2 The following Conditions of Participation (COP) not met: 484.55 Condition of Participation: Comprehensive Assessment of Patients 484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care 484.75 Condition of Participation: Skilled Professional Services 484.80 Condition of Participation: Home Health Aide Services 484.105 Condition of Participation Organization and Administration of Services 484.110 Condition of Participation: Clinical Records 484.115 Condition of Participation: Personnel Qualifications On 10/20/2023 at 3:22 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) in the presence of the facility’s Administrator/Licensed Vocational Nurse 2 (ADM/LVN 2) for the facility’s failure to conduct the comprehensive assessments for Patient 4 and Patient 5 within five days of admission, and had potential to cause delay of patient care and undetected signs of physical and emotional needs for Patient 4 and Patient 5. On 10/20/2023 at 3:29 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) in the presence of the facility’s Administrator/Licensed Vocational Nurse 2 (ADM/LVN 2) for the facility’s failure to follow the plan of care for Patient 2 to treat and assess PIs and monitor blood glucose levels On 10/21/2023 at 3 p.m., the survey team completed the survey tasks, and exited the facility with the IJ situation not removed.

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to ensure three of seven sampled patients (Patient 3, Patient 4, and Patient 5) received information regarding the State toll free home health complaint telephone hotline, its contact information, its hours of operation, and its purpose. This deficient practice resulted in a violation of the patient’s (Patient 3, Patient 4, and Patient 5) rights due to not having the information necessary to make a complaint regarding the agency’s care. Findings: 1. A review of Patient 3’s “Patient Profile,” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including closed left femur (upper leg/thigh bone) fracture (broken). During a concurrent observation and interview of the home visit on 10/18/2023, at 1:54 p.m., Patient3’s Caregiver (CG 2) had the agency folder with her. The contents of the folder were observed with CG 2 who stated she did not know how to call the State Department to report concerns about the HHA care. 2. A review of Patient 4’s “Patient Profile,” indicated a start of care date (SOC) of 10/7/2023 with diagnoses including systolic congestive heart failure (weak contracture from the left side of heart). During an observation of the home visit on 10/17/2023, at 10:10 a.m., Patient 4 was observed looking for the agency folder (a folder that is provided by the HHA with all the information on resources) in his living space. During an interview at the home visit on 10/17/2023, at 10:20 a.m., Patient 4 stated he did not have the information on how to call the State Department to verbalize concerns with the HHA care. 3. A review of Patient 5’s “Patient Profile,” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During a record review on 10/18/2023 at 12 p.m., of Patient 5’s HHA patient folder, folder did not contain information on the State complaint/information hot line phone number. During a concurrent interview and record review on 10/18/2023 at 12:55 p.m., with Licensed Vocational Nurse 1 (LVN1) of Patient 5’s HHA patient folder, LVN 1 stated the folder did not contain information on the State complaint/information hot line phone number. During an interview on 10/18/2023 at 1 p.m., with LVN1, LVN1 stated the HHA needed to provide the documents so Patient 5 and the family would be educated. LVN1 stated that patients needed the phone numbers to place complaints. During an interview on 10/19/2023 at 11:35 a.m., with the Director of Patient Care Services (DPCS), DPCS stated they needed to provide the State complaint toll free number to all their patients in case the patients needed to place a complaint. DPCS stated the patients had the right to make complaints. A review of facility’s policy and procedure titled “Admission Criteria and Process” undated, indicated “If eligibility criteria are met, the patient and family/caregiver will be provided with an organization brochure and various educational materials providing sufficient information on: Complaint/grievance process. A review of facility’s policy and procedure titled “Patient Bill of Rights and Responsibilities” revised 3/2019, indicated “Patients have the right: to be advise of the telephone number and hours of operation of the State’s Home Health Agency hotline, that receives complaints or questions about local home health agencies.”

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure one of seven sampled patients (Patient 5) received information on the Federal and State funded entities available in their areas of residence. This deficient practice had the potential to prevent Patient 5 to be familiar with the services that were available to Patient 5. Findings: A review of Patient 5’s “Patient Profile,” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During a record review on 10/18/2023, at 12 p.m. of Patient 5’s HHA patient folder, the folder did not contain information on the Federal and State funded entities. During a concurrent interview and record review on 10/18/2023, at 12:55 p.m., with Licensed Vocational Nurse 1 (LVN1) of Patient 5’s HHA patient folder, the folder did not contain information on the Federal and State funded entities. During an interview on 10/18/2023, at 1 p.m., with LVN1, LVN1 stated that the documents were needed for the family to be educated on the risk and benefits. LVN1 stated the patients (in general) needed the community information. During an interview on 10/19/2023 at 11:35 a.m., with the Director of Patient Care Services (DPCS), DPCS stated he was not aware of what or who the State and Federal funded entities were. DPCS stated without the entity’s numbers, the patients (in general) would not be aware of the resources available to them. A review of facility’s policy and procedure titled “Admission Criteria and Process” undated, indicated “If eligibility criteria are met, the patient and family/caregiver will be provided with an organization brochure and various educational materials providing sufficient information on: Available community resources. A review of facility’s policy and procedure titled “Patient Bill of Rights and Responsibilities” revised 3/2019, indicated “Patients have the right: Be advised of the names, addresses and telephone numbers of the following federally funded and state funded entities that serve the area where the patient resides -agency of aging, center for independent living, protection and advocacy agency, aging and disability resource center, and quality improvement organization.”

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1.Perform a comprehensive assessment for Patient 4 and Patient 5, within five days of admission in order to develop and implement an individualized plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) to address the care needs of the patients. Ensure the Director of Patient Care Services (DPCS) and or the Clinical Manager (CM) oversaw the overall patient care services which included the completion of comprehensive assessments of Patient 4 and Patient 5 within five days of admissions. (Refer to G520). 2. The HHA failed to ensure a Registered Nurse completed the initial assessment within 48 hours of the start of care, for two seven sampled patients (Patient 5 and Patient 6). This deficient practice had the potential to result in decline in health status by not assessing the patient’s needs. (Refer to G514). 3. The HHA failed to review and document all the medications and treatments the patient was currently using for two of seven sampled patients (Patient 4 Patient 5). This deficient practice placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. This failure resulted in patients not having an accurate and comprehensive medical list that could place the patients at risk for medication errors and adverse drug reactions. (Refer to G536). 4. The HHA failed to ensure a Registered Nurse updated the comprehensive assessment for the recertification period for one of seven sampled patients (Patient 1). This deficient practice had the potential to result in decline in health status by not assessing the patient’s needs. (Refer to 546). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal regulations for Comprehensive Assessment of patients to ensure home health care benefits are verified for eligibility to patients provided home health services. Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities]) for Comprehensive Assessment (a tool used by nurses to evaluate a patient's complete health status) of Patients as follows: 1. The HHA failed to perform a comprehensive assessment for two of seven sampled patients (Patient 4 and Patient 5) within five days of admission in order to develop and implement an individualized plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) to address the care needs of the patients. (Refer G520) 2. Ensure the Director of Patient Care Services (DPCS) and or the Clinical Manager (CM) oversaw the overall patient care services which included the completion of comprehensive assessments of two of seven sampled patients (Patient 4 and Patient 5) within five days of admission. (Refer to G520) These deficient practices had the potential to cause delay of patient care and undetected sign of physical and emotional needs for Patient 4 and Patient 5. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (a state law) compliance with the Federal regulations for Comprehensive Assessment of patients to ensure home health care benefits are verified for eligibility to patients provided home health services.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure a Registered Nurse completed the initial assessment within 48 hours of the start of care for two of seven sampled patients (Patient 5 and Patient 6). This deficient practice had the potential to result in decline in health status of (Patient 5 and Patient 6) by not assessing the patients' needs. Findings: a. A review of Patient 5’s “Patient Profile” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During an interview on 10/17/2023 at 2:55 p.m., the Administrator/Licensed Vocational Nurse 2 (ADM/LVN2) stated there was no initial nursing assessment or plan of care (POC – an individualized plan for the care of a patient) for Patient 5 because the nurse (unidentified) had not completed the documentation. During a joint home visit on 10/18/2023 at 12:45 p.m., with Licensed Vocational Nurse 1 (LVN1), LVN1 looked at Patient 5’s medication list from an online source (OS), LVN1 stated the medications listed look like the list they had in the HHA office. LVN1 asked Care Giver 1 (CG1) if Patient 5’s nebulizer (a device for producing a fine spray of liquid, used for example for inhaling a medication) was used as needed. CG1 stated she was under the impression the nebulizer was supposed to be used twice a day. During an interview on 10/18/2023, at 1:20 p.m., the ADM/LVN2 stated Patient 5’s initial nursing assessment and POC were not completed. During an interview on 10/19/2023, at 11:35 a.m., with the DPCS, DPCS stated he was not aware Patient 5’s initial assessment or POC were not completed. During an interview on 10/19/2023, at 11:48 a.m., with the DPCS, DPCS stated a patient’s initial assessment (in general) was “usually” done within 24 hours of admission and did not know the timeline for completion. DPCS stated an initial comprehensive assessment was a head-to-toe assessment, in collaboration with the Registered Nurse, Licensed Vocational Nurse, certified home health aide, social worker, physical therapy, and occupational therapy. DPCS stated they would include other disciplines if the patient required them. DPCS stated that all were involved, so all staff were aware of the patients' needed visits and their care needs. DPCS stated the initial comprehensive assessment needed to be completed to prevent patients from going back to the hospital. During an interview on 10/19/2023, at 2:20 p.m., with the ADM/LVN2, ADM/LVN2 stated Patient 5’s initial assessment and POC were not completed. ADM/LVN2 stated the initial comprehensive assessment needed to be completed within seven to 14 days. ADM/LVN2 stated the Clinical Manager (CM) called the admitting nurse to complete, but as far as he knew they all had other primary jobs. During an interview on 10/20/2023 at 11:12 a.m., with the CM, CM stated an initial comprehensive assessment was a detailed background of the patient and that it should be completed within three days of admission, before the nurses’ visit patients. CM stated Patient 5’s initial comprehensive assessment was not completed. b. A review of Patient 6’s “Patient Profile” indicated a start of care date (SOC) of 12/10/2022 with diagnoses including rhabdomyolysis (breakdown of damage muscle into the blood stream). A record review of Patient 6’s medical record form titled “OASIS – Start of Care” dated 12/10/2022, indicated “dare assessment completed 10/10/2022.” It also indicated it was electronically signed by the Clinical Manager (CM) on 12/10/2022 4:07 PM.” A review of CM’s form titled “HHA - Application for Employment” dated 2/1/2023, indicated CM had a hired date of 2/3/2023. During a concurrent interview and record review on 10/19/2023, at 3:05 p.m., with the Administrator/License Vocational Nurse 2 (ADM/LVN2) of Patient 6’s medical record form titled “OASIS start of care” dated 12/10/2022, ADM/LVN2 stated Patient 6’s initial assessment was completed on 12/10/2022. ADM/LVN2 stated it was electronically signed by the Clinical Manager (CM) on 12/10/2022 at 4:07 p.m. ADM/LVN2 stated CM started her employment with the HHA in February 2023. ADM/LVN2 was unable to state why CM’s electronic signature was on Patient 6’s start of care OASIS. During a concurrent interview and record review on 10/20/2023 at 2:18 p.m. with the Clinical Manager (CM) of Patient 6’s Electronic Medical Record (EMR) medical record form titled “OASIS start of care”, CM stated Patient 6’s initial assessment was completed on 12/10/2022. CM stated the medical record indicated it was signed by her but was unable to explain how since she was not on staff at the HHA during that time. CM stated, “I really don’t know how that was signed by me; I was not working here at that time.” A review of facility’s policy and procedure titled “Initial Assessments/Comprehensive Assessments” revised 3/2019, indicated “The Clinical Supervisor will assign clinical organization personnel to conduct assessments of eligibility for services within 48 hours of acceptance of referral information and/or discharge from a referring facility. The initial visit must be performed either within 48 hours of the referral, within 48 hours of the patient's return home, or on the start of the care date ordered by the physician (or other authorized licensed independent practitioner). The patient's most critical needs for home health services must be identified during the initial assessment and met in a timely fashion.”

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 observation, interview, and record review, the Home Health Agency (HHA) failed to perform a comprehensive assessment (a tool used by nurses to evaluate a patient’s complete health status) for two of seven sampled patients (Patient 4 and Patient 5) by failing to: 1. Perform a comprehensive assessment for Patient 4 and Patient 5, within five days of admission in order to develop and implement an individualized plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) to address the care needs of the patients. 2. Ensure the Director of Patient Care Services (DPCS) and or the Clinical Manager (CM) oversaw the overall patient care services which included the completion of comprehensive assessments of Patient 4 and Patient 5 within five days of admissions. These deficient practices had the potential to cause delay of patient care and undetected sign of physical and emotional needs for Patient 4 and Patient 5. On 10/20/2023 at 3:22 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) in the presence of the facility’s Administrator/Licensed Vocational Nurse 2 (ADM/LVN 2) for the facility’s failure to conduct the comprehensive assessments for Patient 4 and Patient 5 within five days of admission, and had potential to cause delay of patient care and undetected signs of physical and emotional needs for Patient 4 and Patient 5. On 10/21/2023 at 3 p.m., the survey team completed the survey tasks, and exited the facility with the IJ situation not removed. Findings: a. During a review of Patient 4’s Patient Profile, Patient 4’s Patient Profile indicated a start of care date (SOC) of 10/7/2023 with a diagnosis of systolic congestive heart failure (occurs when the heart does not pump blood effectively). During a concurrent observation and interview of the home visit on 10/17/2023, at 9:20 a.m., the ADM/LVN2 arrived to Patient 4’s residence. ADM/LVN2 stated there was no POC for Patient 4. The DPCS stated the POC needed to be completed prior seeing Patient 4 and for staff (in general) to know what Patient 4’s needs were and for the staff to know what to do. During an interview on 10/17/2023, at 2:55 p.m., with ADM/LVN2, ADM/LVN2 stated there was no comprehensive assessment for Patient 4. During an observation of the home visit on 10/18/2023, at 9:25 a.m., Patient 4 greeted ADM/LVN2 at the door. Patient 4 walked slow and was observed using oxygen with an extended nasal cannula (a tubing delivering oxygen through the nose) tubing that dragged on the floor and surrounding areas. During an interview on 10/18/2023 at 9:27 a.m., with Patient 4, Patient 4 stated he was concerned about the swelling on his legs and had requested “socks for swelling,” from the previous visiting nurse (unidentified nurse). During an observation of the home visit on 10/18/2023 at 9:30 a.m., ADM/LVN2 checked Patient 4’s blood pressure. The blood pressure was 151/91 (normal is less than 130/80, according to the American Heart Association). ADM/LVN2 checked Patient 4’s colostomy (an opening through the abdomen creating a passage from the large intestine to the outside of the body, so stool and gas can leave the body) site during the home visit. During an interview on 10/18/2023, at 9:55 a.m., with Patient 4, Patient 4 stated his nebulizer (a small machine that turn liquid medicine into a mist that can be easily inhaled [breathe]) was not working sufficiently. The ADM/LVN2 told Patient 4 he (ADM/LVN2) was not sure how the process of getting a nebulizer to work, but the agency would figure it out. The ADM/LVN2 stated he would call Patient 4’s doctor to get an order. During an interview on 10/18/2023, at 10:11 a.m., with Patient 4, Patient 4 stated he had diabetes and stated his morning blood sugar level was “156,” (normal ranges 80 and 130 milligrams per deciliter (mg/dL). Patient 4 stated a doctor (unidentified) prescribed insulin (help the body turn food into energy and controls your blood sugar levels) for him, but he was not taking the insulin. Patient 4 stated he did not like how insulin made him feel. Patient 4 stated he was taking care of his diabetes by controlling his diet. During an interview on 10/19/2023, at 11:48 a.m., with the Director of Patient Care services (DPCS), the DPCS stated the purpose of the initial comprehensive assessment was to evaluate the patient to see what they would need. The DPCS stated the comprehensive assessment involved a head-to-toe assessment. The DPCS stated the comprehensive assessment was used to develop the Plan of Care (POC). The DPCS stated if the initial assessment was not done, the patient would not receive the care needed or ordered. The DPCS stated if the patients (in general) did not receive the care needed, the patients would get sick, end up back in the hospital. During an interview on 10/19/2023, at 11:48 a.m., with the DPCS, the DPCS stated the comprehensive assessment covered all the needs of the patient. The DPCS stated it was important to complete the comprehensive assessment because the comprehensive assessment was for the HHA staff to know the needs of the patients and what the priority needed to be done for the patient to get better and be able to manage their disease at home and not end up back in the hospital. During an interview on 10/19/2023, at 11:48 a.m., with the DPCS, the DPCS stated the outcome of not completing the comprehensive assessment was the patient might get sick because the agency was not doing what they were supposed to do, and the agency was not complying with guidelines. The DPCS stated the patients (in general) would not get the care they needed and might end up in the hospital. During an interview on 10/19/2023, at 11:48 a.m., with the DPCS, the DPCS stated the POC needed to be completed prior of seeing Patient 4 because the staff (in general) needed to know what the needs of the patient were and needed to know what to do. During an interview on 10/19/2023, at 2:17 p.m., with the ADM/LVN2, ADM/LVN2 stated the OASIS (Outcome and Assessment Information Set – data set, that measures quality and outcome) was used for the initial comprehensive assessment was not done. During an interview on 10/19/2023, at 2:18 p.m., with the ADM/LVN2, The ADM/LVN 2 stated Patient 4’s POC should include information about managing his oxygen saturation levels (amount of oxygen level circulating in the blood) colostomy status, education with medication, management including parameters for his blood sugar, education on taking diabetes medication, education on fall prevention. The ADM/LVN2 stated Patient 4 did not have a POC to address the risk for falls due to the long oxygen cord, diabetes management, medication management, colostomy care, and oxygen saturation. The ADM/LVN2 stated Patient 4 was at a very high risk of falls. The ADM/LVN 2 stated if the nurses (in general) were not observant or critically thinking about his long oxygen cord, Patient 4 could trip and fall. The ADM/LVN2 stated poor medication management, as a result of not actively reviewing at Patient 4’s medications. The ADM/LVN2 stated Patient 4’s colostomy care or lack of care could result in surrounding skin breakdown and infection of the stoma (opening in the body). The ADM/LVN2 stated Patient 4 was at risk for constipation (a condition in which there is difficulty in emptying the bowels), and the HHA staff (in general) needed to check to ensure the colostomy was draining. The ADM/LVN2 stated nurses had up to 14 days to complete the comprehensive assessment. The ADM/LVN2 stated the nurse would take14 days to complete the comprehensive assessment that was how long it would take to make the POC. Patient 4 could experience hypoglycemia (low blood sugar levels) resulting in a fall. During an interview on 10/19/2023, at 2:23 p.m., with the ADM/LVN2, the ADM/LVN2 stated the comprehensive assessment needed to be completed within seven to 14 days. During an interview on 10/19/2023, at 2:18 p.m., with the ADM/LVN2, the ADM/LVN2 stated the Clinical Manager (CM) was waiting for the initial comprehensive assessment to be completed so she could generate the POC. The ADM stated the CM would review the OASIS once it was completed she would generate the POC from the OASIS. During an interview on 10/20/2023, at 11:12 a.m., with the CM, the CM stated the OASIS was used on the first visit to document the comprehensive assessment. The CM stated the comprehensive assessment should be completed within three days of the visit. The CM stated the agency did not have a set time frame for completion of the comprehensive assessment because the nurses who completed the comprehensive assessment had other full-time jobs and no time frame was given. The CM stated the comprehensive assessment was used to create a plan of care for the patient. The CM stated the POC was not done for Patient 4. During an interview on 10/20/2023, at 11:12 a.m., with the CM, the CM stated Patient 4’s comprehensive assessment was not done because the nurse who did the assessment did not have access to the electronic medical record (EMR). During an interview on 10/20/2023, at 11:35 a.m., the CM was asked how the nurses are aware of what they are supposed to do during the visit, when the POC is not done. The CM stated she provided direction based on the diagnosis. For P4, who had a diagnosis of congestive heart failure, nurses are supposed to review medication, make sure patient is compliant with taking medication, assess for wounds, vital signs, check their blood sugar levels, home safety check and document it. The CM stated these actions were not best practice, but she was aware that the agency needed to work on improving communication and being more efficient, so everyone can follow the same guidelines. b. During a review of Patient 5’s Patient Profile, Patient 5’s Patient Profile indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During an interview on 10/17/2023, at 2:55 p.m., with the ADM/LVN 2, the ADM/LVN2 stated there was no comprehensive nursing assessment or POC for Patient 5. During a joint home visit on 10/18/2023, at 12 p.m., with LVN1 inside Patient 5’s home, Patient 5 was laying on a hospital bed with eyes open. Tracheostomy (opening in front of neck to facilitate breathing) noted, open to air and a suction machine (a medical device that is primarily used for removing obstructions) by bedside. Gastrostomy (GT – Tube inserted through the abdominal wall into the stomach to facilitate feedings) feeding machine at the side of the bed. During an interview on 10/18/2023, at 12:30 p.m., with Patient 5’s Care Giver 1(CG1), CG1 stated Patient 5 had a wound in the buttocks area that was healed and the healed skin looked pink. During a joint home visit on 10/18/2023, at 12:45 p.m., with LVN1, LVN1 reviewed at Patient 5’s medication list from an online source (OS), LVN1 stated the medications listed looked like the list they have in the HHA office. LVN1 asked CG1 if Patient 5’s nebulizer was used as needed. CG1 stated she was under the impression that it was supposed to be used twice a day. During an interview on 10/18/2023, at 1 p.m., with LVN1, LVN1 stated she reviewed Patient 5’s POC and medication list in the office yesterday and that is how she was able to perform her assessments and tasks. During an interview on 10/18/2023, at 1:20 p.m., with the ADM/LVN2, ADM/LVN2 stated Patient 5’s comprehensive nursing assessment and POC were not completed. During an interview on 10/19/2023, at 10:54 a.m., with the ADM/LVN 2, the ADM/LVN2 stated the DPCS duties and responsibilities included discussing patient care, assess for nursing concerns, call the doctors and overlooking the CM by guiding her. The ADM/LVN 2 stated the CM was responsible in overseeing the nurses to make sure doctor’s orders were followed and the comprehensive assessments and POCs were done. The ADM/LVN2 stated oversight over the nurses was important to make sure the care was being provided. During an interview on 10/19/2023 at 11:02 a.m., with the ADM/LVN2. AMD/LVN2 stated CM needed to oversee the patients POCs were completed. ADM/LVN2 stated the DPCS was unable to oversee the nurses right now because “he is all over the place.” During an interview on 10/19/2023, at 11:34 a.m., with the DPCS, the DPCS stated his responsibilities included overlooking the nurses, reviewing charts to make sure what the staff was supposed to do. The DPCS stated the ADM/LVN2 and CM called him if they needed support or ideas. The DPCS stated he came to the agency once or twice a week, stayed four to six hours to review documents and the budget. The DPCS stated he was not aware the POCs and the comprehensive assessments for Patient 4 and Patient 5 were not done. During an interview on 10/19/2023, at 11:35 a.m., with the DPCS, the DPCS stated he was not aware that Patient 5’s comprehensive assessment or POC were not completed. During an interview on 10/19/2023, at 11:48 a.m., with the DPCS, the DPCS stated a patient’s (in general) initial comprehensive assessment was “usually” done within 24 hours of admission before the completion of a POC to address the patients’ needs. The DPCS stated that it was important to complete a POC for the patients (in general) to know their needs to be able to manage their lives in their homes. The DPCS stated she did not know the timeline for completion. DPCS stated a comprehensive assessment was a head-to-toe assessment, in collaboration with the Registered Nurse, licensed vocational nurse, certified home health aide, social worker, physical therapist, and occupational therapist. The DPCS stated they would include other disciplines if the patient required them. DPCS stated all the staff were involved to be aware of the patients’ needed visits and their care needs. DPCS stated the comprehensive assessments needed to be completed to prevent patients from going back to the hospital. During an interview on 10/19/2023, at 2:20 p.m., with the ADM/LVN2, ADM/LVN 2 stated Patient 5’s comprehensive assessment and POC were not completed. ADM/LVN2 stated the comprehensive assessment needed to be completed within seven to 14 days. The ADM/LVN2 stated Registered Nurse 1 (RN1) did not complete Patient 5’s initial comprehensive assessment. ADM/LVN2 stated CM needed to review the initial comprehensive assessment to be able to formulate a POC. ADM/LVN 2 stated that as soon as the OASIS was completed, the POC was completed. ADM/LVN2 stated that if a visiting nurse was not “attentive or visual they can skip out on suctioning him which can lead to respiratory distress and back to the hospital. As well, everybody overlooks the fact that the patient needs to be turned. Without the plan of care there is no guidance.” During an interview on 10/20/2023, at 11:12 a.m., with the CM, the CM stated a comprehensive assessment was a detailed background of the patient and should be completed within three days of admission, before the nurses’ visits patients. The CM stated Patient 5’s comprehensive assessment was not completed. During an interview on 10/20/2023, at 11:12 a.m., the CM stated the purpose of the POC was to set guidelines on what staff are going to do with the patient. A lot of it is education, how to manage medication, how to manage their disease. When asked about the timeline of completing the POC, the CM state there was no timeline set for completion of the POC. The CM stated she tried to have the POC completed before the nurse saw the patients. The CM stated the ADM/LVN2 and her were the ones responsible in completing the POC. During an interview on 10/20/2023, at 11:12 a.m., with the CM, the CM stated if she noticed the comprehensive assessment was not done in a week, she would follow up with the nurse, before the next visit. The CM stated a follow up was important because that was the assessment, the baseline information for the next visit. During an interview on 10/20/2023, at 11:15 a.m., with the CM, the CM stated Patient 5’s comprehensive assessment was not completed. The CM stated she generated a POC based on the nursing assessment. CM stated the POC was a guideline of the patient’s needs. CM stated she did not have a set timeline for completing a POC. A review of the HHA’s policy and procedure titled, “Coordination of Patient Care”, dated March 2019, indicated, “Procedure…2. The Director of Clinical Services provides oversight of all patient care services. Oversight includes: Coordinating patient care…ensuring that patient needs are continually assessed. Ensuring the development, implementation, and updates of the individualized plan of care. A review of the HHA’s policy and procedure titled, “Coordination of Patient Care”, dated March 2019, indicated, “Procedure…2. The Director of Clinical Services provides oversight of all patient care services. Oversight includes…Ensuring the development, implementation, and updates of the individualized plan of care. A review of the HHA’s policy and procedure titled, “Coordination of Patient Care”, dated March 2019, indicated, “Procedure…2. The Director of Clinical Services provides oversight of all patient care services. Oversight includes…ensuring that patient needs are continually assessed. A review of the HHA’s policy and procedure titled, “Admission Criteria and Process” revised 3/2018, indicated “The Clinical Supervisor will assign clinical organization personnel to conduct assessments of eligibility for services within 48 hours… the initial written assessment will be completed within 24 hours of the original assessment/admission visit.” It also stated, “A comprehensive assessment must be completed within five (5) calendar days of the patients start of care… Each patient must receive a patient-specific, comprehensive assessment that identifies the need for home health care and that meets the patients’ medical, nursing, rehabilitative, social and discharge planning needs.” A review of the HHA’s policy and procedure titled, “Initial Admission/Comprehensive Assessment” revised 3/2019, indicated “Each patient admitted by (HHA) will have appropriate initial assessments performed and documented… Each patient admitted will receive a comprehensive assessment.” It also indicated “Completion of the comprehensive assessment must be completed in a timely manner consistent with the patients need, but no later than five (5) calendar days after the start of care. A review of the HHA’s policy and procedure titled, “Care Planning Process”, dated March 2018, indicated, “Policy: In order to assure that care provided is appropriately planned to meet each patient’s specific needs and problems…will utilize data/information gathered during assessments in the care planning process.”

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 Home Health Agency (HHA) failed to review and document all the medications and treatments the patients were currently using for two of seven sampled patients (Patient 4 and Patient 5). This deficient practice placed Patient 4 and Patient 5 at risk of drug-to-drug interaction (occur when two or more drugs react with each other) and harm by not knowing which medications the patients were taking. Findings: a. A review of Patient 4’s “Patient Profile,” indicated a start of care date (SOC) of 10/7/2023 with diagnoses including systolic congestive heart failure (weak contracture from the left side of heart). During an interview on 10/17/2023, at 9:20 a.m., the Administrator/Licensed Vocational Nurse (ADM/LVN 2) stated he did not have a medication list with him for the home visit because the nurse had not completed the documentation. During a concurrent observation, interview, and record review on 10/17/2023 at 9:35 a.m., Patient 4’s record titled, “Patient Medication Profile”, for episode period: 10/7/2023 to 12/5/2023, was used to observe the medication review done by the ADM/LVN 2 at Patient 4’s home. The ADM/LVN 2 reviewed Patient 4’s medication bottles. The following medications were at Patient 4’s home and not listed on the medication profile: Lasix/Furosemide (water pill, to get rid of excess water in the body) 40 mg (mg-milligram, unit of measurement), to be taken every day. Colace (stool softener) 100 mg capsule, one by mouth to be taken daily as needed for constipation (a condition in which there is difficulty in emptying the bowels). Atrovent (for the lungs, helps breathe easier) 17 mcg (mcg-micrograms, unit of measurement) one puff by mouth every 4 hours as needed. Further review of the document indicated “Carvedilol (for high blood pressure) 3.125 mg by mouth daily for 14 days”. Patient 4 stated his doctor had discontinued the medication. b. A review of Patient 5’s “Patient Profile” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During a joint home visit on 10/18/2023 at 12 p.m., with Licensed Vocational Nurse 1 (LVN1) to Patient 5’s home, Patient 5 noted laying on a hospital bed, with eyes open. Tracheostomy (opening in front of neck to facilitate breathing) noted, open to air. Suction machine noted by bedside. Gastrostomy (GT – Tube inserted through the abdominal wall into the stomach to facilitate feedings) feeding machine noted at side of bed. During a joint home visit on 10/18/2023 at 12:45 p.m. with LVN1, LVN1 looked at Patient 5’s medication list provided by Care Giver 1 (CG1) that was sent from an online source (OS), LVN1 stated the medications listed looked like the list they had in the HHA office. LVN1 asked CG1 if Patient 5’s nebulizer was used as needed. CG1 stated that she was under the impression that it was supposed to be used twice a day. LVN1 did not have the HHA medication list to reconcile/compared to the one CG1 provided. During an interview on 10/18/2023 at 1 p.m. with LVN1, LVN1 stated the patient’s medication were conciliated monthly, beginning on the first visit. LVN1 stated the medications needed to be reconcile (compared) so everyone knew Patient 5's current medications and to make sure the patient had the medications needed. During an interview on 10/19/2023 at 11:55 a.m. with the Director of Patient Care Services (DPCS), DPCS stated the admitting nurse (unidentified) collected information from the patient’s medication bottles and a list, which was placed in the patient’s profile. DPCS stated the medications were reconciled on admission and when there was a new medication ordered, which was communicated from the family and/or the doctor. DPCS stated the patients had the possibility of taking medications that were not needed and could get sick if the medications were not reconciliated. During an interview on 10/19/2023 at 2:20 p.m., with the Administrator/License Vocational Nurse 2 (ADM/LVN2), the ADM/LVN2 stated they reconciliated the medications on admission and recertification. ADM/LVN2 stated medication reconciliation should be ongoing. ADM/LVN2 stated nurses should ask the patient or their family if there are any new or discontinued medications to report. A review of facility’s policy and procedure titled “Medication Reconciliation” revised 3/2018, indicated “The agency will reconcile patients’ medication at time of admission and on an ongoing basis 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.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure a Registered Nurse updated the comprehensive assessment for the recertification period for one of seven sampled patients (Patient 1). This deficient practice had the potential to result in decline in Patient 5's health status. Findings: A review of Patient 1’s “Patient Profile” indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels) and foot ulcer (open wound or sore). During an interview on 10/17/2023 at 1:35 p.m., the Administrator/Licensed Vocational Nurse (ADM/LVN 2), stated the HHA had not been able to get a hold of Patient 1. The ADM/LVN 2 stated Patient 1 needed to be recertified for home health and the recertification assessment was due. The ADM/LVN 2 stated the HHA was planning to send a nurse to the home to check on Patient1’s wellness. The ADM/LVN 2 stated the HHA normally waited about two weeks when they were unable to get a hold of the patients, before doing a well visit. During an interview on 10/20/2023, at 12:23 p.m., the Clinical Manager (CM) stated Patient 1 was due for a recertification assessment on 10/10/2023. The CM stated the HHA had not notified Patient1’s doctor they were unable to get a hold of Patient 1. The CM stated the HHA did not know the status of the patient and Patient1 was on her list to follow up and go to the home to find out what happened. A review of the HHA’s undated policy and procedure titled, “Reassessments/Recertification”, indicated, “Procedure…2. For each new episode of care, a comprehensive assessment will be completed no earlier than five (5) days before and no later than one (1) day before the calendar day on which the new episode of care began.”

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Care Planning, Coordination, Quality of Care was met as follows: 1. The HHA failed to ensure the plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was followed for one of seven sampled patients (Patient 2) by failing to: a. Assess and monitor Patient 2’s sacral (tailbone) Pressure Injury (PI, localized damage to the skin as well as underlying soft tissue) Stage 1 (abnormal redness of the skin that does not turn white when pressed) every visit as indicated in the plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services (Refer to G572). b. Assess and monitor the unstageable (depth unknown) PIs to the right great toe and right second toe, every visit as indicated in the POC (Refer to G572). c. Ensure to have a physician order for PI treatment for Patient 2’s sacral PI Stage I and the right great toe and right second toe unstageable PIs (Refer to G572). d. Monitor Patient 2’s blood sugar levels every visit as indicated in the POC (Refer to G572). These deficient practices had the potential for Patient 2’s PIs to get infected or worsen and delay in healing These deficient practices also had the potential for Patient 2 to experience undetected serious complications of hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar), that could lead to blurred vision, difficulty concentrating, confused thinking, slurred speech, numbness, and drowsiness and that could lead to hospitalization and/or death. 2. The HHA failed to include information required in the plan of care for two of seven sampled patients (Patient 4 and Patient 7), P7’s current medication list was not documented. This failure had the potential to result in patients not receiving the identified needs and services, and have a decline in health status, that could affect their quality of care and well-being. (Refer to G574). 3. The HHA failed to ensure physician medical orders were received/transcribed by a licensed or registered nurse for two of seven sampled patients (Patient 2 and Patient 4). This failure resulted in not knowing who received/transcribed the medical doctor order, which had the potential to result in providing the wrong care for the patients. (Refer to G584). 4. The HHA failed to provide Gastrostomy tube (GT, a soft tube inserted through the abdominal wall into the stomach to facilitate feeding) feeding machine education for one of seven sampled patients (Patient 5) Care Giver 1 (CG1). This failure had the potential to result in Patient 5 not receiving the appropriate amount of nutrients needed. (Refer to G610). 5. The HHA failed to provide written information regarding the plan of care for three of seven sampled patients (Patient 3, Patient 4 and Patient 5). This deficient practice resulted in patients and their representatives not knowing their care team or their treatment course or what medications were ordered. (Refer to G612). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services. .

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was followed for one of seven sampled patients (Patient 2) by failing to: 1. Assess and monitor Patient 2’s sacral (tailbone) Pressure Injury (PI, localized damage to the skin as well as underlying soft tissue) Stage 1 (abnormal redness of the skin that does not turn white when pressed) every visit as indicated in the POC. 2. Assess and monitor the unstageable (depth unknown) PIs to the right great toe and right second toe, every visit as indicated in the POC. 3. Ensure to have a physician order for PI treatment for Patient 2’s sacral PI Stage I and the right great toe and right second toe unstageable PIs. 4. Monitor Patient 2’s blood sugar levels every visit as indicated in the POC. These deficient practices had the potential for Patient 2’s PIs to get infected or worsen. This deficient practice had the potential for Patient 2 to experience undetected serious complications of hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar), that could lead to blurred vision, difficulty concentrating, confused thinking, slurred speech, numbness, and drowsiness. On 10/20/2023 at 3:29 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was identified in the presence of the facility’s Administrator/Licensed Vocational Nurse 2 (ADM/LVN 2) for the facility’s failure to follow the plan of care for Patient 2 to treat and assess PIs and monitor blood glucose levels. On 10/21/2023 at 3 p.m., the survey team completed the survey tasks, and exited the facility with the IJ situation not removed. Findings: During a review of Patient 2’s Patient Profile, Patient 2’s Patient Profile indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain), left side hemiplegia (one sided muscle paralysis or weakness) and Type 2 diabetes (a medical condition characterized by the body's inability to regulate blood sugar levels). During a review of Patient 2’s Home Health Certification and Plan of Care notes, dated for certification period 8/4/2023 to 10/2/2023, the Home Health Certification and Plan of Care indicated the skilled nurse (SN) to visit Patient 2 once a week for nine weeks. The notes indicated for the SN to assess and observe Patient 2’s body systems including the integumentary (skin) system on every visit. The notes indicated Patient 2’s goals included “the patient/pcg (primary care giver) will demonstrate knowledge on prevention of pressure injury, will follow wound care as ordered by MD (doctor) and know when to report signs of exacerbation/infection within 4 weeks.” The Home Health Certification and Plan of Care indicated the SN was to assess and monitor the body systems to include the endocrine (body parts responsible for blood sugar levels) system, obtain and record blood sugar levels, and notify the doctor if blood sugar levels were too high or too low based on the ordered parameters. The Home Health Certification and Plan of Care notes indicated the SN was to educate Patient 2 about diabetes, its management and control through medicine and complication such as foot ulcers and gangrene (is death of body tissue due to a lack of blood flow or a serious bacterial infection). During a review of Patient 2’s Nursing Progress Notes, dated 8/16/2023, 8/23/2023, 9/1/2023, 9/8/2023, 9/12/2023, and 9/21/2023, Nursing Progress Notes indicated “Additional SN notes:…Cleansed right great toe and right second toe with ns (normal saline), patted dry, painted with betadine. Covered with betadine (cleaning solution) dressing and wrapped with kerlix (gauze dressing).” The nurse administered wound treatment to the right toes without a doctor’s order. During a review of Patient 2’s Progress Note, dated 8/17/2023, the Progress Note indicated a wound assessment was done by a wound consultant (unidentified). The record indicated “Site 1 right plantar 1st toe, foot, gangrene, measurement 4.0 x 3.5 cm. Site 2 right plantar 2nd toe foot, gangrene, 2.1 x 1.3 cm.” The wounds on the right foot had increased in size. During a review of Patient 2’s Reason for Assessment undated notes, Reason for Assessment notes indicated Patient 2 was hospitalized on 9/26/2023. During an interview on 10/20/2023, at 12:33 p.m., with the Clinical Manager (CM), the CM stated Patient 2 was hospitalized at a General Acute Care Hospital (GACH) because her PI wounds on her foot were worsening. The CM stated a wound assessment was supposed to be done on admission and during the SN visits. The CM stated the wound assessment entailed measuring the wound and taking a picture. The CM stated wound assessments were documented in the form titled “Wound Care Worksheet,” if the wound was changing or there was a change of condition. During a concurrent interview and record review, on 10/20/2023, at 12:41 p.m., with the CM, Patient 2’s Wound Care Worksheet notes, dated 8/4/2023 were reviewed. The CM stated this was the assessment of the sacral wound that was documented when Patient 2 recertified for home health on 8/4/2023. The record indicated Patient 2 had a sacral wound PI Stage 1. During a concurrent interview and record review, on 10/20/2023, at 12:43 p.m., with the CM, Patient 2’s Wound Care Worksheet, dated 8/11/2023 was reviewed. The CM stated the record did not have documentation and/or assessment about the sacral wound. During a concurrent interview and record review on 10/20/2023, at 12:43 p.m., with the CM Patient 2’s Wound Care Worksheet, dated 8/11/2023 was reviewed. The CM stated the record indicated Patient 2 developed wounds on the right foot. Wound number one was on the right great toe, described as a deep tissue (persistent non-blanchable [discoloration of the skin that does not turn white when pressed deep] red, maroon or purple discoloration injury), unstageable, and measured 3.3 x 3.5 cm (cm-centimeter, unit of measurement). PI Wound number two was on the right second toe, described as deep tissue injury, unstageable, and measured 1.5 x 1.0 cm. During a concurrent interview and record review, on 10/20/2023, at 12:46 p.m., with the CM, Patient 2’s Wound Care Worksheet, dated 8/14/2023 was reviewed. The CM stated the record did not have documentation and/or assessment about the sacral wound. During a concurrent interview and record review on 10/20/23, at 12:46 p.m., with the CM, Patient 2’s Wound Care Worksheet notes, dated 8/14/2023 were reviewed. The CM stated the record indicated PI wound number one on the right great toe had gangrene and the measurements were 3.8 x 3.3 cm. PI Wound number two on the right second toe was necrotic (dead skin) and the measurements were 2.0 x 1.0 cm. Further review of the record indicated the right great toe and right second toe both had gangrene and were necrotic (dead tissue). During a concurrent interview and record review on 10/20/2023, at 12:53 p.m., with the CM, Patient 2’s Wound Care Worksheet, dated 8/4/2023 was reviewed. The record indicated Patient 2 had a Stage 1 sacral PI wound, and the treatment order read “Cleanse with sterile wound cleanser, pat dry, apply zinc ointment, and leave open to air.” The CM stated there was no doctor order for the treatment documented. The CM stated the treatment for Stage 1 was to monitor Patient 1’s Stage 1 for signs of worsening, provide education for the patient because Stage 1 wounds are easier to heal. During a concurrent interview and record review on 10/20/2023, at 1 p.m., with the CM, Patient 2’s Home Health Certification and Plan of Care (POC), for certification period 8/4/2023 to 10/2/2023 was reviewed. The CM stated the POC did not have PI wound treatment instructions. The CM stated the POC needed to include PI wound treatment instructions so the nurses can follow the treatment order and know the objectives of Patient 2. During a concurrent interview and record review on 10/20/2023, at 1:01 p.m., with the CM, Patient 2’s Nursing Progress Note, dated 8/9/2023 was reviewed. The CM stated there was no assessment of the sacral PI wound. The CM stated the document did not indicate the PI wound was improving or worsening. During a concurrent interview and record review on 10/20/2023, at 1:02 p.m., with the CM, Patient 2’s Nursing Progress Note, dated 8/16/2023 was reviewed. The CM stated there was no assessments of Patient 2’s sacral and right toes PIs on 8/16/2023. The CM stated the document did not indicate the status of the wounds. During a concurrent interview and record review on 10/20/2023, at 1:15 p.m., with the CM, Patient 2’s Nursing Progress Note, dated 8/23/2023 was reviewed. The CM stated there were no assessments of Patient 2’s PIs of the sacral and right toes on 8/23/2023. During a concurrent interview and record review on 10/20/2023, at 1:15 p.m., with the CM, Patient 2’s Nursing Progress Note, dated 9/1/2023 was reviewed. The CM stated there was no assessment of Patient 2’s PIs of the sacral and right toes on 9/1/2023. During a concurrent interview and record review on 10/20/2023, at 1:15 p.m., with the CM, Patient 2’s record titled, Nursing Progress Note, dated 9/8/2023 was reviewed. The CM stated there was no assessment of Patient 2’s PIs of the sacral and right toes on 9/8/2023. During a concurrent interview and record review on 10/20/2023, at 1:16 p.m., with the CM, Patient 2’s Nursing Progress Note, dated 9/12/2023 was reviewed. The CM stated there was no assessment of Patient 2’s PIs of the sacral and right toes on 9/12/2023. During a concurrent interview and record review on 10/20/2023, at 1:16 p.m., with the CM, Patient 2’s Nursing Progress Note, dated 9/21/2023 was reviewed. The CM stated there was no assessment of Patient 2’s PIs of the sacral and right toes on 9/21/2023. During an interview on 10/20/2023, at 1:28 p.m., with the CM, the CM stated wounds should always be assessed. The CM stated the last time the sacral wound was assessed was on 8/4/2023. The CM stated the last time the wound of the right toes was assessed by the SN was on 8/14/2023. During a concurrent interview and record review on 10/20/2023, at 1:29 p.m., with the CM, Patient 2’s Communication Note, dated 8/17/2023 was reviewed. The record indicated, “Comments…Will follow up and ensure proper nursing interventions and care is in place.” The CM stated proper interventions included monitoring the wound to determine if it was healing or not and assessing the wound. The CM stated the SN did not monitor the wound. The CM stated it was important to monitor the wound because it could lead to complications such as infection and amputation (surgical removal of a limb) if its not monitored. The CM stated she did not know why the wound assessments and monitoring were not done. During a concurrent interview and record review on 10/20/2023, at 2:15 p.m., with the ADM/LVN2, Patient 2’s Nursing Progress Note, dated 8/9/2023, 8/16/2023, 8/23/2023, 9/1/2023, 9/8/2023, 9/12/2023, and 9/21/2023 were reviewed. The notes indicated there were no blood sugar levels monitored. The ADM/LVN2 stated the nurses (in general, unidentified) should have asked Patient 2 to check his blood sugar levels and to document Patient 2 was able to check his blood sugar levels. The ADM/LVN2 stated the nurse should have checked Patient 2’s blood sugar levels and document. The ADM/LVN2 stated it was important to make sure Patient 2 was able to check his blood sugars, to make sure the blood sugar levels were not out of parameters. If blood sugar is out of parameters, it could cause complications. The documentation just said endocrine “no problems.” During a concurrent interview and record review on 10/20/2023, at 2:52 p.m., with the ADM/LVN2, Patient 2’s Wound Care Worksheet note, dated 8/14/2023 was reviewed. The note indicated “treatment order right great toe gangrene: pain in betadine and cover in betadine-soaked gauze, apply ABD (a type of dressing) pad, and warp in kerlix (a type of dressing). Right 2nd toes gangrene: Pain in betadine and cover in betadine-soaked gauze, apply ABD pad, and wrap in kerlix”. The ADM stated there was no doctor’s order for any of Patient 2’s wound treatments documented. During an interview on 10/20/2023, at 2:56 p.m., with the ADM/LVN2, the ADM/LVN2 stated the HHA did not have any information, education, or policies and procedures on how to manage PI wound care. A review of the HHA’s policy and procedure titled “Patient Bill of Rights and Responsibilities” revised 3/2019, indicated, “Be free from neglect… receive all services in the plan of care.” A review of the HHA’s policy and procedure titled “Plan of Care – CMS #485 and Physician Orders” revised 3/2019, indicated, “Each patient must receive the home health services that are written in an individualized plan of care that identifies patient – specific measurable outcomes… Patient – specific measurable outcome is a change in health status... which occurs over time in response to a health care intervention…Care and services provided will be provided according to physician orders. Orders are current and updated. Drugs, services, and treatments are administered by staff only as ordered by physician. Changes in the patients condition that require a change in the Plan of Care must be documented in the patients’ clinical record. The patient’s physician orders for treatments and services are the foundation of the plan of care.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to include a complete medication list in the Plan of Care (POC) for two of seven sampled patients (Patient 4 and Patient 7). This failure had the potential to result in patients not receiving the identified needs and services, and decline in health status that could affect their quality of care and well-being. Findings: a. A review of Patient 4's “Patient Profile” indicated a start of care date (SOC) of 10/7/2023 with diagnoses including systolic congestive heart failure (weak contracture from the left side of heart). During an interview on 10/19/23, at 2:29 p.m., the Administrator/Licensed Vocational Nurse (ADM/LVN 2) stated Patient 4’s POC was not completed because the nurse had not completed the comprehensive assessment. The ADM/LVN 2 stated Patient 4’s POC should include information on managing his oxygen saturation (amount of oxygen in the blood), how to manage his colostomy (an opening through the abdomen creating a passage from the large intestine to the outside of the body, so stool and gas can leave the body) status, education about his medications, diabetic management, and education on fall prevention. During an interview on 10/19/23 at 2:55 p.m., the ADM/LVN 2 stated physical therapy (PT) are not included in the POC because the physical therapists included it in the PT assessment. The ADM/LVN 2 stated it was important to include PT goals in the POC so the nurses are informed on what the goal is for PT. b. A review of Patient 7’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 and end of care (EOC) of 9/26/2023 with diagnoses including Diabetes Meletus II (high blood sugar) and chronic kidney disease (kidneys unable to filter blood well). A review of Patient 7’s medical record form titled “(Hospital– HO) History and Physical (H&P) Reports” dated 8/26/2023, indicated Patient 7’s home medications included “amlodipine (high blood pressure medication), lovastatin (high cholesterol medication), metformin (high blood sugar medication), omeprazole (stomach acid reducer medication), and zolpidem (insomnia medication). A review of Patient 7’s medical record form titled, “Start of Care” dated 9/20/2023 to 11/18/2023, indicated “Currently taking 5 or more medications”. A review of Patient 7’s medical record form titled, “Home Health Certification and Plan of Care” dated from 9/20/2023 to 11/18/2023, indicated there were two medications listed under “Medications: Oxycodone – APAP (narcotic pain medication) Zolpidem (insomnia medication)”. During an interview on 10/20/2023 at 11:15 a.m., with the CM, CM stated that a patient’s comprehensive assessment is a detailed assessment that it is used to develop their POC. CM stated that the POC is a guideline of what needs to be done for the patients. During a concurrent interview and record review on 10/20/2023 at 1:32 p.m., with the Clinical Manager (CM) of Patient 7’s Electronic Medical Record (EMR), medical record forms (all), CM stated on admission the admitting nurse goes over the patient’s medication to make sure there are no duplicates and contacts the patient’s primary physician if there are any concerns. CM stated the medication list is based on the patients H&P. CM stated that Patient 7’s medication reconciliation was not completed by the admitting nurse. CM stated medication needs to be reconciliated because that is how the patient’s conditions are managed. A review of facility’s policy and procedure titled, “Plan of Care – CMS #485 and Physician Orders” dated 3/2019, indicated, “The individualized plan of care must include the following: All medications and treatments.” A review of facility’s policy and procedure titled, “Medication Reconciliation” dated 3/2018, indicated, “The Agency will reconcile patient's medications at time of admission and on an ongoing basis 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 non-compliance with drug therapy.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure physician's verbal orders were received/transcribed by a licensed or registered nurse for one of seven sampled patients (Patient 2 and Patient 4). This failure has the potential to result in services will be furnished to the patients without the written physician's orders, signed, and dated by authorized personnel jeopardizing the health and safety of the patients. Findings: a. A review of Patient 2’s “Patient Profile” indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). During a concurrent interview and record review on 10/20/23, at 12:53 p.m., the CM reviewed services are furnished based on a physician's verbal order, the order must be put into writing by personnel authorized to do so. Patient 2’s record titled, “Wound Care Worksheet”, dated 8/4/23. The record indicated Patient 2 had a stage 1 sacral wound, and the treatment order read “Cleanse with sterile wound cleanser, pat dry, apply zinc ointment, and leave open to air”. The CM stated there was no doctor order for the treatment documented. The CM stated the treatment for stage 1 was to monitor it for signs of worsening, provide education for the patient because stage 1 wounds are easier to heal. During a concurrent interview and record review on 10/20/23, at 1:00 p.m., the CM reviewed Patient 2’s record titled, “Home Health Certification and Plan of Care” (POC), for certification period 8/4/2023 to 10/2/2023. The CM stated the POC did not have wound treatment instructions. The CM stated the POC needed to include wound treatment instructions so the nurses can follow the treatment order and know the objectives of the patient. During a concurrent interview and record review on 10/20/23, at 2:52 p.m., the administrator (ADM) reviewed Patient 2’s record titled, “Wound Care Worksheet”, dated 8/14/23. The record indicated, “treatment order right great toe gangrene: pain in betadine and cover in betadine soaked gauze, apply ABD (a type of dressing) pad, and warp in kerlix (a type of dressing). Right 2nd toes gangrene: Pain in betadine and cover in betadine soaked gauze, apply ABD pad, and wrap in kerlix”. The ADM stated there was no doctor’s order for any of the wound treatments documented. A record review of Patient 2’s document titled, “Nursing Progress Note”, dated 8/16/23, 8/23/23, 9/1/23, 9/8/23, 9/12/23, and 9/21/23 indicated, “Additional SN notes:…Cleansed right great toe and right second toe with ns (normal saline), patted dry, painted with betadine. Covered with betadine dressing and, wrapped with kerlix.” The nurse administered wound treatment to the right toes without a doctor’s order. b. A review of Patient 4’s “Patient Profile” indicated a start of care date (SOC) of 10/7/2023 with diagnoses including systolic congestive heart failure (weak contracture from the left side of heart). During a concurrent interview and record review on 10/19/23 at 2:59 p.m., the ADM/LVN 2 reviewed Patient 4’s record titled, “Order/Telephone Order”, dated 10/7/23. The ADM/LVN stated the order was not complete because the name of the nurse who took the order did not sign and the order did not indicate who took the order. During a concurrent interview and record review on 10/19/23 at 3:02 p.m., the ADM/LVN 2 reviewed Patient 4’s record titled, “Order/Telephone Order”, dated 10/6/23. The record indicated, “Referred for Admission: 10/6/23 1:41 p.m.”. The ADM/LVN 2 stated the record did not indicate the nurse who got the order and the method of how the order was obtained. The ADM/LVN 2 stated the document was not considered an order because the order was incomplete. A review of the HHA’s policy and procedure titled, “Plan of Care-CMS #485 and Physician Orders”, dated March 2019, indicated, “Procedure:...5. All patient care orders, including verbal orders, must be recorded in the plan of care. The plan will be revised to reflect any verbal order received during the 60-day certification period so that all Agency staff are working from a current plan…”

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on observation and interview, the Home Health Agency (HHA) failed to provide gastrostomy tube (GT, a soft tube inserted through the abdominal wall into the stomach to facilitate feeding) feeding machine education and training to the caregiver (CG1) for one of seven sampled patients (Patient 5). This failure had the potential to result in the patient not receiving the required nutrients needed to meet the nutritional needs of the patient. Findings: A review of Patient 5’s “Patient Profile” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). A review of Patient 5’s medical record form titled “Start of Care”, dated 10/4/2023 to 12/2/2023, indicated it was not completed. A review of Patient 5’s medical record form titled “Order/Telephone Order – Admission Order” dated 10/4/2023, indicated “Enteral Feed: Fiber source HN (feeding formula with fiber) 1.2 set pump at 90 ml (milliliters, a unit of capacity)/hr. (hour) x (for) 16 hours. SN (skilled nurse) to teach caregiver management of G-tube (gastrostomy tube) feeding and water flushes.” During an interview on 10/17/2023 at 2:55 p.m., the Administrator/Licensed Vocational Nurse 2 (ADM/LVN2) stated there was no initial nursing assessment or POC for Patient 5 because the nurse had not completed the documentation. ADM/LVN2 stated that the nurse was aware of it and will complete it by tonight. During a joint home visit on 10/18/2023, at 12:45 p.m., with Licensed Vocational Nurse 1 (LVN1) and Care Giver 1 (CG1), CG1 stated that she turns on Patient 5’s feeding pump from 6:00 p.m. to 6:00 a.m. LVN1 asked CG1 if she was taught on how to use Patient 5’s feeding pump. CG1 stated that no one taught her how to use the pump (a medical device used to deliver feeding at a controlled rate), and that she “figured it out” by herself. During an interview on 10/18/2023 at 1:00 p.m., with LVN1, the LVN1 stated that she reviewed Patient 5’s plan of care (POC, an individualized care plan) at the HHA yesterday, 10/17/2023. The LVN1 stated the POC was the plan for the patients care, which included the goals and the interventions for completing those goals. During an interview on 10/18/2023 at 1:20 p.m., the ADM/LVN2 stated that Patient 5’s initial nursing assessment and POC were not completed as planned and will provide the documents tomorrow on 10/19/2023. During an interview on 10/19/2023, at 11:35 a.m., with the Director of Patient Care Services (DPCS), the DPCS stated he was not aware that Patient 5’s initial assessment or POC was not completed. During an interview on 10/19/2023, at 11:48 a.m., with the DPCS, the DPCS stated, an initial comprehensive assessment included a head-to-toe assessment, in collaboration with the registered nurse, licensed vocational nurse, certified home health aide, social worker, physical therapy, and occupational therapy. DPCS stated that the initial comprehensive assessment needed to be completed to prevent patients from going back to the hospital. During an interview on 10/19/2023 at 2:20 p.m., with the ADM/LVN2, ADM/LVN2 stated Patient 5’s initial assessment and POC were not completed. ADM/LVN2 stated that RN1 was “getting caught up”. ADM/LVN2 stated that the initial comprehensive assessment needs to be completed in seven to 14 days. ADM/LVN2 stated that the Clinical Manager (CM) calls the admitting nurse to complete, but as far as he knew they all had other primary jobs. During an interview on 10/20/2023 at 11:15 a.m., with the CM, CM stated, an initial comprehensive assessment included a detailed background of the patient and that it should be completed within three days of admission, before the nurses visit patients. CM stated that Patient 5’s initial comprehensive assessments was not completed yet because RN1 was having a hard time getting access to the HHA’s Electronic Medical Record (EMR) system. CM stated that RN1 was given access to their EMR system on 10/17/2023. A review of facility’s policy and procedure titled “Plan of Care – CMS # 485 and Physician Orders” dated 3/2019, indicated, “Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment…The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. The individualized plan of care must include the following: patient and caregiver education and training to facilitate timely discharge. Care and services provided will be provided according to physician orders.”

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to provide a copy of written information of the Plan of Care (POC) and current list of medications for three of seven patients (Patient 3, Patient 4, and Patient 5). This deficient practice resulted in patients and their family/caregiver not aware and did not fully understand their care, treatment, and services being provided by the HHA. Findings: 1. A review of Patient 3’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including closed left femur (upper leg bone) fracture (broken). During a concurrent observation and interview on 10/18/23, at 1:54 p.m., Patient 3’s Caregiver (CG 2) had the agency folder with her. The contents of the folder were observed with CG 2 who stated she did not have a copy of P3’s plan of care and medication list. 2. A review of Patient 4’s “Patient Profile” indicated a start of care date (SOC) of 10/7/2023 with diagnoses including systolic congestive heart failure (weak contracture from the left side of heart). During a concurrent observation and interview of the home visit on 10/17/2023, 9:20 a.m., at Patient 4's residence the ADM stated, there was no POC because the nurse still had not completed the documentation. The ADM/LVN 2 stated he did not have a medication list with him for the home visit because the nurse had not completed the documentation. During an observation of the home visit on 10/17/2023, at 10:10 a.m., Patient 4 was observed looking for the agency folder (a folder that was provided by the HHA with all the information on resources) in his living space. Patient 4 stated he did not have the HHA folder. There was no POC and Medication list in Patient 4’s home. 3. A review of Patient 5’s “Patient Profile” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). A record review on Patient 5’s medical record form titled “Start of Care” initial nursing assessment dated 10/4/2023 to 12/2/2023, indicated it was not completed. During an interview on 10/17/2023, at 2:55 p.m., the Administrator/License Vocational Nurse 2 (ADM/LVN2) stated there was no initial nursing assessment or POC for Patient 5 because the nurse had not completed the documentation. ADM/LVN2 stated that the nurse was aware of it and will complete it by tonight. During a joint home visit on 10/18/2023, at 1 p.m., with License Vocational Nurse 1 (LVN1), LVN1 was unable to locate Patient 5’s POC or medication list in his HHA home folder. LVN1 stated that both the POC and the medication list needed to be at the patient's home to provide education and information on the staff’s schedule. LVN1 stated the family need the POC to be aware and agree with the plan of care. During an interview on 10/18/2023 at 1 p.m. with LVN1, LVN1 stated that she reviewed Patient 5's POC yesterday, 10/17/2023. LVN 1 stated the POC was the plan of care which included the goals and interventions for meeting these goals. During an interview on 10/18/2023 at 1:20 p.m., the ADM/LVN2 stated that Patient 5’s initial nursing assessment and POC were not completed as planned and will provide documents tomorrow on 10/19/2023. During an interview on 10/19/2023 at 2:20 p.m., with the ADM/LVN2, ADM/LVN2 stated Patient 5’s initial assessment and POC were not completed. ADM/LVN2 stated that RN1 was “getting caught up”. ADM/LVN2 stated that the initial comprehensive assessment needed to be completed in 7 to 14 days. ADM/LVN2 stated that the Clinical Manager (CM) called the admitting nurse to complete, but as far as he knew they all had other primary jobs. During an interview on 10/20/2023, at 11:12 a.m., with the CM stated, an initial comprehensive assessment included a detailed background of the patient and that it should be completed within three days of admission, before the nurses’ visit patients. CM stated that Patient 5’s initial comprehensive assessments was not completed yet because RN1 was having a hard time getting access to the HHA’s EMR system. CM stated that RN1 was given access to their EMR system on 10/17/2023. A review of facility’s policy and procedure titled “Patient Rights and Responsibilities” revised 3/2019, indicated “Patients have the right: To be informed of: Visit schedule and frequency. Patient medication schedule/instructions. Treatments to be administered by Agency staff. Other pertinent instructions related to care.” A review of facility’s policy and procedure titled “Medication Reconciliation” revised 3/2018, indicated “The agency provides the patient and/or caregiver with written patient medication schedule/instructions…”

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Skilled Professional Services as follows: 1. The HHA failed to ensure three of seven sampled patients received treatments and/or services in accordance with their written plan of care by not: Monitoring Patient 1's and Patient 7’s blood sugar levels. Patient 3 did not receive the wound treatment as indicated in the POC. This failure had the potential to result in placing the patients at risk of being hospitalized. (Refer to G710). 2. The HHA failed to provide Gastrostomy tube (GT, a soft tube inserted through the abdominal wall into the stomach to facilitate feeding) feeding machine education for one of seven sampled patient's (Patient 5) Care Giver 1 (CG1). This failure had the potential to result in Patient 5 not receiving the appropriate amount of nutrients needed. (Refer to G714). 3. The HHA failed to perform supervisory visits for their Licensed Vocational Nurse (LVN) services for one of seven sampled patients (Patient 3). This failure had the potential to result in patients being taken care of by an unqualified staff. (Refer to G726). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure four of seven sampled patients (Patient 1, Patient 2, Patient 3, and Patient 7) received treatments and/or services in accordance with the written plan of care. - Patient 1's, Patient 2's, and Patient 7's blood sugar levels were not monitored as ordered on the POC (Plan of Care). - Patient 3's surgical wound treatment was not performed as ordered in the POC. This failure had the potential to result in placing the patients at risk for hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar), and slow healing process or decline of the patient's wound that could lead to infection of the surgical wound. Findings: A review of Patient 1's “Patient Profile” indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Meletus II (high blood sugar) and foot ulcer (open wound or sore). During a concurrent interview and record review on 10/20/2023, at 12:20 p.m., the Clinical Manger (CM) reviewed Patient 1’s record titled, “Nursing Progress Note”, dated 9/13/2023, 9/22/2023, 9/28/2023, and 10/6/2023. The CM stated according to the plan of care, the skilled nurse was to obtain and record blood sugar levels every visit. The CM stated the skilled nurse did not obtain and record blood sugar levels for the nursing visits made on 9/13/2023, 9/22/2023, 9/28/2023, and 10/6/2023. The CM stated it was important to check Patient 1’s blood sugar levels to make sure the levels were not too low or too high because complications can occur such as coma (a period of long unconsciousness due to illness or injury) and ketoacidosis (body produces excess blood acids caused by high blood sugar levels). 2. A review of Patient 2’s “Patient Profile” indicated an SOC date of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). A review of Patient 2’s record titled, “Home Health Certification and Plan of Care” (POC), for certification period 8/4/2023 to 10/2/2023, indicated the Skilled Nurse (SN) was to assess and monitor the body systems to include the endocrine (body parts responsible for blood sugar levels) system, obtain and record blood sugar levels, and notify the doctor if blood sugar levels were too high or too low based on the ordered parameters. The record also indicated the SN was to educate Patient 2 about diabetes, its management and control through medicine and complication such as foot ulcers and gangrene. During a concurrent interview and record review on 10/20/2023, at 2:15 p.m., the Administrator (ADM) reviewed Patient 2’s records titled “Nursing Progress Note” dated, 8/9/2023, 8/16/2023, 8/23/2023, 9/1/2023, 9/8/2023, 9/12/2023, and 9/21/2023. The ADM stated the nurses should have asked the patient to check the blood sugar levels and at the very least document the patient was able to take their blood sugar. The nurse should have checked the values with the patient and document it in the record. The ADM stated it was important to make sure the patient was able to check his blood sugars, to make sure the ranges were not out of parameters. If blood sugar is out of parameters, it could cause complications. 3. A review of Patient 3's “Patient Profile” indicated an SOC date of 9/20/2023 with diagnoses including closed left femur (upper leg bone) fracture (broken). During the home visit on 10/18/2023, at 2:01 p.m., the Licensed Vocational Nurse 1 (LVN 1) was observed providing wound treatment to Patient 3’s surgical incision (a cut made through the skin to facilitate an operation). LVN 1 cleansed the left knee wound with normal saline (salt water), dried the area using a gauze, and applied triple antibiotic (medicine that fight bacterial infections) ointment on the wound. During the wound treatment, LVN 1 used clean gloves (not sterile (sterile means free from germs) and gauzes stored in a Zip-lock bag. During an interview on 10/20/2023, at 11:51 a.m., the CM stated surgical wound treatments could be done using a clean technique because it is hard to keep a sterile technique. The CM stated a clean or sterile gauze needed to be kept in its original packaging and taken to the patient’s house, because that was the best practice. A review of Patient 3’s document titled, “Home Health Certification and Plan of Care”, for certification period 9/20/2023 to 11/18/2023, indicated, “Wound care as follows: using aseptic technique (using sterile equipment and barriers to prevent germs from getting inside the body) cleanse left lateral knee surgical incision with NSS (normal saline), pat dry, and leave open to air”. The record did not indicate to apply triple antibiotic ointment to the surgical incision. LVN 1 did not perform the surgical wound treatment as indicated in the POC. 4. A review of Patient 7’s “Patient Profile” indicated an SOC date of 9/20/2023 and end of care (EOC) date of 9/26/2023 with diagnoses including Diabetes Meletus II (high blood sugar) and chronic kidney disease (kidneys unable to filter blood well). During a record review on 10/17/2023 at 5:08 p.m., of Patient 7’s Electronic Medical Record (EMR) form titled “Parameter Graph – FBS/RBS (Fasting Blood Sugar/Random Blood Sugar)” dated from 9/20/2023 to 9/25/2023, indicated there were no values documented. A review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated from 9/20/2023 to 11/18/2023, indicated “Certified for skill nursing assessment/observation of… endocrine… Obtain and record vital signs, and notify MD if … FBS (fasting blood sugar) > (more than) 250 mg (milligram, a unit of mass)/dl (deciliter, a metric unit of capacity) or During an interview on 10/20/2023, at 11:15 a.m., with the CM, CM stated that a patient’s comprehensive assessment is a detailed assessment that it is used to develop their POC. CM stated that the POC is a guideline of what needs to be done for the patients. During a concurrent interview and record review on 10/20/2023, at 1:32 p.m., with the CM of Patient 7’s EMR, medical record form titled “Comprehensive Assessment” dated 9/20/2023, CM stated Patient 7’s blood sugar was not being assessed. CM stated that Patient 7’s blood sugar needed to be assessed/monitored to prevent patient from being hospitalized. A review of facility’s policy and procedure titled “Plan of Care – CMS #485 and Physician Orders” dated 3/2019, indicated Skilled nursing and other home health services will be in accordance with a Plan of Care based on the patient's diagnosis and assessment of immediate and long-range needs and resources. Each Plan of Care must be signed and dated by the physician. Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed (every 60 days or more frequently when indicated by changes in the patient's condition) and signed by a Doctor of Medicine, osteopathy (a branch of medical practice) or podiatry (a branch of medical practice) acting within the scope of his or her state license, certification, or registration. A review of facility’s policy and procedure titled “Physician Orders and Tracking System” revised 10/2017, indicated “HHA will designate a person to be responsible for sending out orders, maintaining a tracking file and receiving the signed orders. A "back­ up" person exists for vacations, sick days, etc. These orders include: all CMS Plans of Care. The tracking file is checked every day and if there are overdue orders in the file, the physician's office is called to verify if indeed the order was received and if a second copy needs to be sent… When following up on a late order, document the action taken including the name of the person following up, the date and to whom spoken. All authenticated (signed) physician orders are maintained in the patient's medical record.”

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 and interview, the Home Health Agency (HHA) failed to provide Gastrostomy tube (GT, a soft tube inserted through the abdominal wall into the stomach to facilitate feeding) feeding machine education to the patient's caregiver (CG1) for one of seven sampled patient (Patient 5). This failure had the potential to result in Patient 5 not receiving the appropriate amount of nutrients needed. Findings: A review of Patient 5’s “Patient Profile” indicated a start of care (SOC) date of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). A review of Patient 5’s medical record form titled “Start of Care” dated 10/4/2023 to 12/2/2023, indicated it was not completed. A review of Patient 5’s medical record form titled “Order/Telephone Order – Admission Order” dated 10/4/2023, indicated “Enteral Feed: Fiber source HN (tube feeding formula) 1.2 set pump at 90 ml (milliliters, a unit of capacity)/hr. (hour) x (for) 16 hours. Skilled Nurse (SN) to teach caregiver management of G-tube (gastrostomy tube) feeds and water flushes.” During an interview on 10/17/2023 at 2:55 p.m., the Administrator/Licensed Vocational Nurse 2 (ADM/LVN2) stated there was no initial nursing assessment or POC for Patient 5 because the nurse had not completed the documentation. ADM/LVN2 stated that the nurse is aware of it and will complete it by tonight. During an observation of the joint home visit on 10/18/2023, at 12:45 p.m., with Licensed Vocational Nurse 1 (LVN1) and CG1 stated that she turns on Patient 5’s feeding pump from 6:00 p.m. to 6:00 a.m. LVN1 asked CG1 if she was taught on how to use Patient 5’s feeding pump. CG1 stated that no one taught her how to use the pump (a medical device used to deliver feeding tube at a controlled rate), and that she “figured it out” by herself. During an interview on 10/18/2023, at 1:00 p.m., with LVN1, the LVN1 stated that she reviewed Patient 5’s plan of care (POC, an individualized care plan) at the HHA yesterday, 10/17/2023. LVN1 stated the POC was the plan for the patients care, which included the goals and the interventions for completing those goals. During an interview on 10/18/2023, at 1:20 p.m., the ADM/LVN2 stated that Patient 5’s initial nursing assessment and POC were not completed as planned and will provide documents tomorrow, 10/19/2023. During an interview on 10/19/2023, at 11:35 a.m., with the Director of Patient Care Services (DPCS), the DPCS stated that he was not aware that Patient 5’s initial assessment or POC were not completed. During an interview on 10/19/2023, at 11:48 a.m., with the DPCS, the DPCS stated an initial comprehensive assessment is a head-to-toe assessment, in collaboration with the registered nurse, licensed vocational nurse, certified home health aide, social worker, physical therapy, and occupational therapy. DPCS stated that all are involved, so that all are aware of the patients needed visits and their care needs. DPCS stated that the initial comprehensive assessment needed to be completed to prevent patients from going back to the hospital. During an interview on 10/19/2023, at 2:20 p.m., with the ADM/LVN2, the ADM/LVN2 stated Patient 5’s initial assessment and POC were not completed. ADM/LVN2 stated that RN1 is “getting caught up”. ADM/LVN2 stated that the initial comprehensive assessment needs to be completed in seven to 14 days. ADM/LVN2 stated that the Clinical Manager (CM) calls the admitting nurse to complete, but as far as he knew, they all had other primary jobs. During an interview on 10/20/2023 at 11:15 a.m., with the CM, CM stated an initial comprehensive assessment is a detailed background of the patient and that it should be completed within three days of admission, before the nurses visit patients. CM stated that Patient 5’s initial comprehensive assessment was not completed yet because RN1 was having a hard time getting access to the HHA’s Electronic Medical Record (EMR) system. CM stated that RN1 was given access to their EMR system on 10/17/2023. A review of facility’s policy and procedure titled “Plan of Care – CMS #485 and Physician Orders” dated 3/2019, indicated “Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment…The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. The individualized plan of care must include the following: patient and caregiver education and training to facilitate timely discharge. Care and services provided will be provided according to physician orders.”

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to perform License Vocational Nurses (LVN) supervisory visits for services for one of seven sampled patients (Patient 3), provided LVN services. This failure had the potential to result in patients being taken care of by an unqualified staff. Findings: A review of Patient 3’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including closed left femur (upper leg bone) fracture (broken). During a concurrent observation and interview of the home visit on 10/18/2023, at 2:01 p.m., Licensed Vocational Nurse 1 (LVN 1) was observed providing wound treatment to Patient 3’s surgical incision (a cut made through the skin to facilitate an operation). LVN 1 stated Patient 3’s incision was oozing (slowly trickling fluid). LVN 1 left to her car to bring gauze she had forgotten. LVN 1 returned, and she immediately donned a pair of gloves. No hand washing/sanitizing was observed. LVN 1 cleaned Patient 3’s left knee wound with normal saline (salt water) and was observed squeezing the skin in an area. LVN 1 described as “hard” and “with a small blister”. LVN 1 took the used gauze used to clean Patient 3’s incision, placed it on the side, and took a gauze from the Zip-lock bag she brought from the car. No change of gloves was observed. LVN 1 then applied tripe antibiotic (a medicine that fight bacterial infections) ointment on top of the incision using the same gloves used at the start of the wound treatment. LVN 1 stated there was a blister on the incision she had popped and there was no more oozing. During an interview on 10/18/2023, at 2:33 p.m., LVN 1 stated, “right, I did not hand sanitize when I came back from the car” and was supposed to remove the glove and hand sanitize after the wound was cleaned. LVN 1 stated she had not done that and had placed Patient 3 at risk for cross contamination and getting an infection. During an interview on 10/19/2023, at 10:51 a.m., the Administrator/Licensed Vocational Nurse (ADM/LVN 2) stated he had never completed a clinical competency checklist for LVN 1, and there was no job description signed. The ADM/LVN 2 stated it was important to have a clinical competency list completed to make sure the nurse is capable and knowledgeable for the specific task. The ADM/LVN 2 stated if a nurse did not have knowledge about wound care, the HHA would not assign a wound care patient to the nurse. During an interview on 10/19/2023 at 11:07 a.m., with the ADM/LVN2, ADM/LVN2 stated they have not done any supervisory visits. During an interview on 10/19/2023 at 11:55 a.m., with the Director of Patient Care Services (DPCS), the DPCS stated he supposed to do the LVN supervisory visits. DPCS stated he has not completed an onsite visit with the LVNs. DPCS stated they needed to do onsite LVN visits to provide them with orientation go over the patients POC. DPCS stated LVN supervisory visits were important to make sure the patients are receiving the care they are supposed to. During an interview on 10/20/23, at 11:44 a.m., the Clinical Manager (CM) stated hand hygiene/washing was supposed to be done before wound care was started. Once the wound was cleaned, gloves were supposed to be removed, hands sanitized again, and apply clean gloves to apply a clean dressing to the wound. The CM stated the risks of not doing hand hygiene were introducing germs and bacteria to the patient. As a result, the patient can get an infection, which can be deadly if it's bad, causing hospitalization. The CM stated blisters on wounds should not be popped or squeezed because by breaking the skin, it’s another opportunity to get an infection. A review of facility’s undated policy and procedure titled “Responsibilities/Supervision of Clinical Services”, indicated “Licensed practical/vocational nurses will be supervised by a registered nurse making a visit to the home with or without the LPN/LVN every thirty (30) days unless state regulation requires more frequently. Supervisory visits will be documented, dated, and signed by the supervising professional and included in the clinical record.” The HHA failed to supervise LVN 1 to ensure wound care was done correctly.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities]) for Home Health Aide Services was met as follows: 1. The HHA failed to ensure the acting Certified Home Health Aide (CHHA) was qualified to provide direct patient care services for three of seven sampled patient (Patient 1, Patient 2, and Patient 5). This deficient practice placed Patient 1, Patient 2, and Patient 5 at risk for injury and or harm. (Refer to G784). 2. The HHA failed to create a care plan with instructions for two of seven sampled patients (Patient 1 and Patient 2) for the Certified Home Health Aide (CHHA1) to follow when providing services to Patient 1 and Patient 2. This deficient practice had the potential not to meet Patient 1 and Patient 5’s care needs and placed the patients at risk for injury. (Refer to G798). 3. The HHA failed to conduct supervisory visits for Certified Home Health Aide (CHHA) services for three of seven sampled patients (Patient 1, Patient 2, and Patient 5). This deficient practice resulted in the CHHA not be evaluated for patient care and services and placed Patient 1, Patient 2, and Patient 5 at risk for injury. (Refer to G808). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of a quality health care in a safe environment.

Noncompliance with training requirements CFR(s): 484.80(f)(1) Was out of compliance with the requirements of paragraphs (b), (c), (d), or (e) of this section; or This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure the acting Certified Home Health Aide (CHHA) was qualified to provide direct patient care services for three of seven sampled patient (Patient 1, Patient 2, and Patient 5). This deficient practice placed Patient 1, Patient 2, and Patient 5 at risk for injury and or harm. Findings: a. During a review of Patient 1’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels) and foot ulcer (open wound or sore). During a record review of the facility’s form titled “Employment Application,” dated 5/1/2023, indicated CHHA1 had experience working at a care center with the job title of “Dietary Aid.” During a record review of Patient 1’s Home Health Certification and Plan of Care, dated for certification period from 8/12/2023 to 10/10/2023, the Home Health Certification and Plan of Care indicated the CHHA was to visit Patient 1 twice a week for eight weeks. During a record review of Patient 1’s Home Health Aide Record, dated 9/21/2023, the Home Health Aide Record indicated CHHA 1 took Patient 1’s blood pressure, respiration, pulse, and temperature readings. The Home Health Aide Record CHHA 1 performed a bath, hygiene care, and activity procedures. During a record review of Patient 1’s document Home Health Aide Record, dated 9/28/2023, the Home Health Aide Record indicated CHHA 1 took Patient 1’s blood pressure, respiration, pulse, and temperature readings. Home Health Aide Record indicated CHHA 1 performed a bath, hygiene care, and activity procedures. b. During a record review of Patient 2’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). During a record review of Patient 2’s Home Health Certification and Plan of Care dated for certification period 8/4/2023 to 10/2/2023 indicated the CHHA was to visit Patient 2 twice a week for eight weeks. c. During a review of Patient 5’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During a record review of Patient 5’s Order/Telephone Order – Admission Order, dated 10/4/2023, indicated the Order/Telephone Order-Admission Order, indicated for the CHHA to visit once for one week. During a record review of Patient 5’s Home Health Aide Visit Record dated 10/12/2023, indicated CHHA 1 provided care for Patient 5. During an interview on 10/17/2023, at 10:50 a.m., with the Administrator/Licensed Vocational Nurse 2 (ADM/LVN2), the ADM/LVN2 stated the HHA had only one CHHA (CHHA1). During an interview on 10/18/2023 at 12 p.m., with Patient 5’s Caregiver 1 (CG1), CG1 stated CHHA1 conducted a visit on the morning of 10/18/2023 (unidentified time) to bathe Patient 5. During an interview on 10/20/2023, at 11:15 a.m., with the ADM/LVN2, the ADM/LVN2 stated he did not request CHHA1’s certificate or BLS (basic life support, generally refers to the type of care that first-responders, healthcare providers and public safety professionals provide to anyone who is experiencing cardiac arrest, respiratory distress, or an obstructed airway) card because he needed someone to work. ADM/LVN2 stated he did not complete CHHA1’s background check (screening process to determine whether an applicant may be unqualified for a position due to a record of criminal conviction). During a concurrent interview and record review, on 10/20/2023, at 12:48 p.m., with the ADM/LVN2, CHHA1’s employee file was reviewed. The ADM/LVN2 stated the CHHA 1’s file did not contain CHHA1’s BLS card, picture identification, or a background check. ADM/LVN2 stated CHHA1 was hired in May 2023. ADM/LVN2 stated he hired CHHA1 because she had experience working at a care center and thought she was a Certified Nurse Assistant (CNA) and was attending school for CHHA. ADM/LVN2 stated he did not recall if CHHA1 told him she was a CNA. ADM/LVN2 stated he did not verify CHHA1’s schooling and had not provided CHHA1 competencies or in services. ADM/LVN2 stated HHA census was 22 with three patients (Patient 1, Patient 2, and Patient 5) who received CHHA services. During a review online at https://cvl.cdph.ca.gov/SearchPage.aspx, of form titled “L&C Verification Search Page” (a government site where licenses or certificates can be verified) indicated CHHA1 was not listed as having a CHHA or a CNA certificate. During a record review of facility’s form titled “Job Description – Home Health Aide (HHA)” revised 3/2018, indicated “A paraprofessional person who is specifically trained, competent and performs assigned functions of personal care to the patient in their residence under the direction, instruction, and supervision of the registered nurse (RN). Qualifications: Must meet Medicare Conditions of Participation for Home Health Aide training program and competency.” During a record review of facility’s form titled “Job Description – Administrator” revised 3/2018, indicated “Recruits employees and retains qualified personnel to maintain appropriate staffing levels by employing qualified staff.” A record review of facility’s policy and procedure titled “Personnel Records” revised 3/2018, indicated “Personnel files will be established and maintained for all staff. The personnel record or personnel information for an employee will include, but not be limited to, the following: Employment application/resume. Observed competencies: initial during orientation and ongoing (minimally every 3 years) for all patient care staff. Hom Health Aide competency evaluation: initially and annually. CPR, if required. Performance appraisal/evaluation forms. Verification of education, certification and/or licensure. Agency employee orientation. Inservice education record. Criminal history check, if required by law. Certification for specialty areas of practice, if applicable.”

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 Home Health Agency failed to create a care plan with instructions for two of seven sampled patients (Patient 1 and Patient 2) for the Certified Home Health Aide (CHHA) to follow when providing services to Patient 1 and Patient 2. This deficient practice had the potential not to meet Patient 1 and Patient 2’s care needs and placed the patients at risk for injury. Findings: a. During a review of Patient 1’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels) and foot ulcer (open wound or sore). During a record review of Patient 1’s Home Health Certification and Plan of Care, dated for certification period from 8/12/2023 to 10/10/2023, the Home Health Certification and Plan of Care indicated the CHHA was to visit Patient 1 twice a week for eight weeks. During a record review of Patient 1’s Home Health Aide Record, dated 9/21/2023, the Home Health Aide Record indicated CHHA 1 took Patient 1’s blood pressure, respiration, pulse, and temperature readings. The Home Health Aide Record CHHA 1 performed a bath, hygiene care, and activity procedures. During a record review of Patient 1’s document Home Health Aide Record, dated 9/28/2023, the Home Health Aide Record indicated CHHA 1 took Patient 1’s blood pressure, respiration, pulse, and temperature readings. Home Health Aide Record indicated CHHA 1 performed a bath, hygiene care, and activity procedures. During an interview on 10/20/23, at 12:15 p.m., with the Clinical Manger (CM), the CM stated there was no CHHA care plan and did not know the reason there was no care plan with instructions for Patient 1 for CHHA1 to follow. The CM stated the purpose of the care plan was to have guidelines on what CHHA1 needed to do for the patient. The CM stated she was supposed to ensure there was a care plan completed before the CHHA saw Patient 1. b. During a record review of Patient 2’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). During a record review of Patient 2’s Home Health Certification and Plan of Care dated for certification period 8/4/2023 to 10/2/2023 indicated the CHHA was to visit Patient 2 twice a week for eight weeks. During an interview on 10/20/2023, at 12:29 p.m., with the CM, the CM stated there was no CHHA care plan for Patient 2. During a record review of facility’s form titled “Job Description – Home Health Aide (HHA)” revised 3/2018, indicated “A paraprofessional person who is specifically trained, competent and performs assigned functions of personal care to the patient in their residence under the direction, instruction, and supervision of the registered nurse (RN). Qualifications: Must meet Medicare Conditions of Participation for Home Health Aide training program and competency.”

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 Home Health Agency (HHA) failed to conduct supervisory visits for Certified Home Health Aide (CHHA) services for three of seven sampled patients (Patient 1, Patient 2, and Patient 5). This deficient practice resulted for the HHA not to evaluate CHHA services for patient care and services and placed Patient 1, Patient 2, and Patient 5 at risk for injury. Findings: a. During a review of Patient 1’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels) and foot ulcer (open wound or sore). During a record review of Patient 1’s Home Health Certification and Plan of Care, dated for certification period from 8/12/2023 to 10/10/2023, the Home Health Certification and Plan of Care indicated the CHHA was to visit Patient 1 twice a week for eight weeks. During a record review of Patient 1’s Home Health Aide Record, dated 9/21/2023, the Home Health Aide Record indicated CHHA 1 took Patient 1’s blood pressure, respiration, pulse, and temperature readings. The Home Health Aide Record CHHA 1 performed a bath, hygiene care, and activity procedures. During a record review of Patient 1’s document Home Health Aide Record, dated 9/28/2023, the Home Health Aide Record indicated CHHA 1 took Patient 1’s blood pressure, respiration, pulse, and temperature readings. Home Health Aide Record indicated CHHA 1 performed a bath, hygiene care, and activity procedures. During an interview on 10/19/2023, at 11:07 a.m., with the Administrator/Licensed Vocational Nurse 2 (ADM/LVN2), ADM/LVN2 stated they had not done any supervisory visits for CHHA1 who provided care for Patient 1. b. During a record review of Patient 2’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). During a record review of Patient 2’s Home Health Certification and Plan of Care dated for certification period 8/4/2023 to 10/2/2023 indicated the CHHA was to visit Patient 2 twice a week for eight weeks. c. During a review of Patient 5’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During a record review of Patient 5’s Order/Telephone Order – Admission Order, dated 10/4/2023, indicated the Order/Telephone Order-Admission Order, indicated for the CHHA to visit once for one week. During a record review of Patient 5’s Home Health Aide Visit Record dated 10/12/2023, indicated CHHA 1 provided care for Patient 5. During an interview on 10/18/2023, at 12 p.m., with Patient 5’s Caregiver 1 (CG1), CG1 stated CHHA1 conducted a visit on 10/18/2023 in the morning (unidentified time) and bathed Patient 5. During an interview on 10/19/2023, at 11:07 a.m., with ADM/LVN2, ADM/LVN2 stated the HHA did not conduct any supervisory visits for CHHA1. During an interview on 10/19/2023, at 11:55 a.m., with the Director of Patient Care Services (DPCS), DPCS stated he did not go with CHHA1 to a patient home (in general). The DPCS stated CHHA supervisory visits were important to complete to ensure the patients (in general) received the care they needed and to ensure CHHA1 complied with her hours. DPCS stated if the CHHA supervisory visits were not completed the patients (in general) were at risk of going to the hospital due to not receiving the care ordered. During a concurrent interview and record review, on 10/20/2023, at 12:05 p.m., with the Clinical Manager (CM), CHHA 1’s employee file was reviewed. The CM stated the HHA did not have CHHA 1’s skills, knowledge, and competency. The CM stated it was important to check the clinical competency of CHHA 1 because the HHA had to see if she could perform the skills. The CM stated she did not supervise CHHA 1. During an interview on 10/20/2023 at 12:29 p.m., with CM, CM stated there was no supervision visits done for CHHA 1 when CHHA1 would provide care for Patient 2. A review of facility’s policy and procedure titled “Responsibilities/Supervision of Clinical Services” undated, indicated “Home health aide supervisory visits will be conducted on-site at least every fourteen (14) days by skilled personnel. Supervisory visits can be made in conjunction with the home health aide or in his/her absence. A direct observation supervisory visit will be made at least every six (6) months. Supervisory visits will be documented, dated, and signed by the supervising professional and included in the clinical record.” A review of facility’s policy and procedure titled “Home Health Aide Supervisory Visits” undated, indicated “The frequency of supervisory visits will be based upon the needs of the patient after the plan of care is established. They must be conducted no less frequently than every 14 days if the patient is receiving skilled services. Supervisory visits will be documented on a supervisory visit form. Each supervisory visit shall contain documentation to ensure that the aide is furnishing care in a safe and effective manner...” During a record review of facility’s form titled “Job Description – Administrator” revised 3/2018, indicated “Recruits employees and retains qualified personnel to maintain appropriate staffing levels by employing qualified staff.”

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: This CONDITION is NOT MET as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Organization and Administration or Services was met as follows: 1. The HHA failed to ensure there was a governing body to provide agency oversight to ensure services were provided to five of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, and Patient 5). This failure resulted in lack of staff oversight to ensure services were provided according to federal guidelines. (Refer to G942). 2. The HHA failed to ensure a Clinical Manager was available during all operating hours of the HHA to oversee the nursing care provided to five of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, and Patient 5). This failure resulted in lack of nursing oversight, to ensure services were provided according to accepted standards of care and federal guidelines. (Refer to G950). 3. The HHA failed to ensure the acting Certified Home Health Aide (CHHA) met the qualifications for that title while performing personal patient care to three of seven sampled patients (Patient 1, Patient 2, and Patient 5). This failure resulted in patients being taken care of by an uncertified person, which had the potential to cause the patients harm by being mistreated and/or not performing tasks as ordered by a doctor. (Refer to G952). 4. The HHA failed to ensure the Clinical Manager ensured five of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 5, and Patient 7) plans of care were developed. This failure had the potential to result in patients not being provided the care as ordered by their doctors by assigned HHA staff. (Refer to G968). 5. The HHA failed to ensure there was a written agreement and/or contract with the acting Physical Therapy (PT) and Occupational Therapy (OT) company being used for patient care. This failure resulted in not knowing if the PT or OT had the qualifications to take care of patients as ordered by their doctors or the time frame of an agreed time of services. (Refer to G978). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of a quality health care in a safe environment.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to ensure there was a governing body to assume full legal responsibility and overall management and operation to ensure services were provided to five of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, and Patient 5). This failure resulted in lack of staff oversight to ensure services were provided according to federal guidelines. Findings: A review of Patient 1’s “Patient Profile” indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Meletus II (high blood sugar) and foot ulcer (open wound or sore). A record review of Patient 1’s document titled, “Home Health Certification and Plan of Care”, for certification period 8/12/23 to 10/10/23 indicated the Certified Home Health Aid (CHHA) was to visit twice a week for 8 weeks. During an interview on 10/19/2023, at 11:07 a.m., with the Administrator/License Vocational Nurse 2 (ADM/LVN2), ADM/LVN2 stated they had not done any supervisory visits. During an interview on 10/20/23, at 12:05 p.m., the Clinical Manager (CM) stated CHHA 1 had not been supervised by the CM. The CM stated she was not sure if another nurse had supervised her. 2. A review of Patient 2’s “Patient Profile” indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). A record review of Patient 2’s document titled, “Home Health Certification and Plan of Care”, for certification period 8/4/23 to 10/2/23 indicated the CHHA was to visit P2 twice a week for 8 weeks. During an interview on 10/20/23 at 12:29 p.m., the Clinical Manager (CM) stated there was no supervision visits done for CHHA 1. 3. A review of Patient 3’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including closed left femur (upper leg bone) fracture (broken). During a concurrent observation and interview of the home visit on 10/18/23, at 2:01 p.m., Licensed Vocational Nurse 1 (LVN 1) was observed providing wound treatment to Patient 3’s surgical incision (a cut made through the skin to facilitate an operation). During the wound treatment, LVN 1 did not wash her hands prior to starting wound care. During an interview on 10/18/23, at 2:33 p.m., LVN 1 stated, “right, I did not hand sanitize when I came back from the car” and was supposed to remove the glove and hand sanitize after the wound was cleaned. LVN 1 stated she had not done that and had placed Patient 3 at risk of cross contamination (process germs pass from one object to another) and getting an infection. During an interview on 10/19/23, at 10:51 a.m., the Administrator/Licensed Vocational Nurse (ADM/LVN 2) stated he had never completed a clinical competency checklist for LVN 1, and there was no job description signed. The ADM/LVN 2 stated it was important to have a clinical competency list completed to make sure the nurse is capable and knowledgeable for the specific task. During an interview on 10/19/2023 at 11:07 a.m. with the Administrator/License Vocational Nurse 2 (ADM/LVN2), ADM/LVN2 stated they had not done any supervisory visits. During an interview on 10/19/2023 at 11:55 a.m., with the Director of Patient Care Services (DPCS), DPCS stated he is supposed to do the LVN supervisory visits. DPCS stated he has not completed an onsite visit with the LVNs. DPCS stated they needed to do onsite LVN visits to provide them with orientation go over the patients Plan of Care (POC). DPCS stated LVN supervisory visits were important to make sure the patients are receiving the care they are supposed to. 4. A review of Patient 4's “Patient Profile” indicated a start of care date (SOC) of 10/7/2023 with diagnoses including systolic congestive heart failure (weak contracture from the left side of heart). During an interview on 10/17/23 at 2:55 p.m., the administrator (ADM) stated there was no initial nursing assessment for Patient 4 because the nurse had not completed the documentation. During an interview on 10/19/23, at 2:29 p.m., the Administrator/Licensed Vocational Nurse (ADM/LVN 2) stated Patient 4’s POC was not completed because the nurse had not completed the comprehensive assessment. 5. A review of Patient 5’s “Patient Profile” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During an interview on 10/17/23 at 2:55 p.m., the ADM stated there was no comprehensive nursing assessment or POC for Patient 5 because the nurse had not completed the documentation. ADM stated that the nurse is aware of it and will complete it by tonight. During an interview on 10/19/23 at 10:54 a.m., the ADM stated the DPCS duties and responsibilities included discussing patient care, assess for nursing concerns, call the doctors and overlooking the CM by guiding her. When asked to provide examples of DPCS tasks the ADM stated the CM had been managing clinical operations. The ADM stated the CM was responsible in overseeing the nurses to make sure doctor’s orders are followed and the comprehensive assessments and POC’s were done. The ADM stated oversight over the nurses was important to make sure the care is being provided: that nurses are up to speed with the POC, and that there are no patient complaints. During an interview on 10/19/23 at 11:34 a.m., the DPCS stated the CM was the one running most of the things. The DPCS stated his responsibilities included overlooking the nurses, reviewing charts to make sure what the staff is supposed to do is done. The DPCS stated the ADM and CM called him if they needed support or ideas. The DPCS stated he came to the agency one or twice a week, stay 4 to 6 hours to review documents and the budget. The DPCS stated he was not aware the POC’s and comprehensive assessments were not done. During an interview on 10/20/23 at 11:12 a.m., the CM stated if she noticed the comprehensive assessment was not done in a week, she followed up with the nurse, before the next visit. The CM stated a follow up was important because that is the assessment, the baseline information for the next visit. During an interview on 10/19/2023 at 10:54 a.m. with the Administrator/License Vocational Nurse 2 (ADM/LVN2), ADM/LVN2 stated he was a License Vocational Nurse for 15 years with case management experience. ADM/LVN2 stated he did not have an associate or baccalaureate degrees or has not taken courses in health care administration or managerial. During an interview on 10/19/2023 at 11 a.m. with the ADM/LVN2, ADM/LVN2 stated “I am the secretary, CEO, everything.” ADM/LVN2 stated that he used to make decisions with the Director of Patient Care Services (DPCS), but now “any nursing stuff” he talks it over with the Clinical Manager and informs the DPCS. ADM/LVN2 stated he appointed himself as the ADM/LVN2 because he started the company. During an interview on 10/19/2023 at 11:07 a.m. with the Administrator/License Vocational Nurse 2 (ADM/LVN2), ADM/LVN2 stated they had not done any supervisory visits. During an interview on 10/19/2023 at 11:55 a.m. with the DPCS stated he is supposed to do the LVN supervisory visits. DPCS stated he has not completed an onsite visit with the LVNs. DPCS stated they needed to do onsite LVN visits to provide them with orientation go over the patients POC. DPCS stated LVN supervisory visits were important to make sure the patients are receiving the care they are supposed to. A review of facility’s policy and procedure titled “Governing Body” revised 3/2018, indicated “Purpose to ensure lines of authority are established and to ensure appropriate quality services are provided to patients. The Governing Body is comprised of individuals with relevant expertise, business knowledge and professional relationships specific to Agency's philosophy, mission, and purpose. For each member of the Governing Body New Era Home Health Agency maintains the name, address, credentials, and professional/business affiliation. The Governing Body meets at least annually to review the operation of New Era Home Health Agency and documents all meetings by minutes. The Governing Body appoints a qualified Administrator or approves an Administrator selected by the corporation or another group and annually evaluates the Administrator's performance.”

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure a Clinical Manager was available during all operating hours of the HHA to oversee the nursing care provided to five of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, and Patient 5). This failure resulted in lack of nursing oversight, to ensure services were provided according to accepted standards of care and federal guidelines. Findings: During an interview on 10/17/23, at 10:15 a.m., the Administrator/Licensed Vocational Nurse 2 (ADM/LVN 2) stated the Director of Patient Care Services (DPCS) was not available to come to the HHA because he had a full-time job at the General Acute Care Hospital (GACH). On 10/18/23, the DPCS was not available during the survey process. During an interview on 10/19/23, at 10:10 a.m., the ADM/LVN 2 stated the DPCS was going to come to the HHA but only for 3 hours because he had to go back to the GACH. During an interview on 10/19/23 at 10:54 a.m., the ADM stated the DPCS duties and responsibilities included discussing patient care, assess for nursing concerns, call the doctors and overlooking the CM by guiding her. When asked to provide examples of DPCS tasks the ADM stated the Clinical Manager (CM) had been managing clinical operations. The ADM stated the CM was responsible in overseeing the nurses to make sure doctor’s orders are followed and the comprehensive assessments and POC’s were done. The ADM stated oversight over the nurses was important to make sure the care is being provided: that nurses are up to speed with the POC, and that there are no patient complaints. During an interview on 10/19/23, at 11:34 a.m., the DPCS stated the CM was the one running most of the things. The DPCS stated his responsibilities included overlooking the nurses, reviewing charts to make sure what the staff is supposed to do is done. The DPCS stated the ADM and CM called him if they needed support or ideas. The DPCS stated he came to the agency one or twice a week, stay 4 to 6 hours to review documents and the budget. The DPCS stated he was not aware the POCs and comprehensive assessments were not done. During an interview on 10/20/23, at 11:12 a.m., the CM stated if she noticed the comprehensive assessment was not done in a week, she followed up with the nurse, before the next visit. The CM stated a follow up was important because that is the assessment, the baseline information for the next visit. During an interview on 10/19/2023 at 11:55 a.m. with the DPCS stated he is supposed to do the LVN supervisory visits. DPCS stated he has not completed an onsite visit with the LVNs. DPCS stated they needed to do onsite LVN visits to provide them with orientation go over the patients POC. DPCS stated LVN supervisory visits were important to make sure the patients are receiving the care they are supposed to. During an interview on 10/20/23, at 11:38 a.m., the CM stated her working hours were Monday through Friday 10:00 a.m. to 1:50 p.m. The CM stated she was responsible in the day-to-day operation of nursing care. 1. A review of Patient 1’s “Patient Profile” indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Meletus II (high blood sugar) and foot ulcer (open wound or sore). A record review of Patient 1’s document titled, “Home Health Certification and Plan of Care”, for certification period 8/12/23 to 10/10/23 indicated the CHHA was to visit Patient 1 twice a week for 8 weeks. During an interview on 10/19/2023 at 11:07 a.m., the (ADM/LVN2), stated the HHA had not done any supervisory visits. During an interview on 10/20/23, at 12:05 p.m., the CM stated Certified Home Health Aide (CHHA 1) had not been supervised by the CM. The CM stated she was not sure if another nurse had supervised her. 2. A review of Patient 2’s “Patient Profile” indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). A record review of Patient 2’s document titled, “Home Health Certification and Plan of Care”, for certification period 8/4/23 to 10/2/23 indicated the CHHA was to visit Patient 2 twice a week for 8 weeks. During an interview on 10/20/23 at 12:29 p.m., the CM stated there was no supervision visits done for CHHA 1. 3. A review of Patient 3’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including closed left femur (upper leg bone) fracture (broken). During a concurrent observation and interview of the home visit on 10/18/23, at 2:01 p.m., Licensed Vocational Nurse 1 (LVN 1) was observed providing wound treatment to Patient 3’s surgical incision (a cut made through the skin to facilitate an operation). During the wound treatment, LVN 1 did not wash her hands prior to starting wound care. During an interview on 10/18/23, at 2:33 p.m., LVN 1 stated, “right, I did not hand sanitize when I came back from the car” and was supposed to remove the glove and hand sanitize after the wound was cleaned. LVN 1 stated she had not done that and had placed P3 at risk of cross contamination and getting an infection. During an interview on 10/19/23, at 10:51 a.m., the Administrator/Licensed Vocational Nurse (ADM/LVN 2) stated he had never completed a clinical competency checklist for LVN 1, and there was no job description signed. The ADM/LVN 2 stated it was important to have a clinical competency list completed to make sure the nurse is capable and knowledgeable for the specific task. During an interview on 10/19/2023 at 11:07 a.m., the ADM/LVN2 stated the HHA had not done any supervisory visits. During an interview on 10/19/2023 at 11:55 a.m., the DPCS stated he is supposed to do the LVN supervisory visits. DPCS stated he has not completed an onsite visit with the LVNs. DPCS stated they needed to do onsite LVN visits to provide them with orientation go over the patients POC. DPCS stated LVN supervisory visits were important to make sure the patients are receiving the care they are supposed to. 4. A review of Patient 4’s “Patient Profile” indicated a start of care date (SOC) of 10/7/2023 with diagnoses including systolic congestive heart failure (weak contracture from the left side of heart). During an interview on 10/17/23, at 2:55 p.m., the ADM/LVN 2 stated there was no initial nursing assessment for Patient 4 because the nurse had not completed the documentation. During an interview on 10/19/23, at 2:29 p.m., the ADM/LVN 2 stated Patient 4’s POC was not completed because the nurse had not completed the comprehensive assessment. 5. A review of Patient 5’s “Patient Profile” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During an interview on 10/17/23, at 2:55 p.m., the ADM stated there was no comprehensive nursing assessment or POC for Patient 5 because the nurse had not completed the documentation. ADM stated that the nurse is aware of it and will complete it by tonight. A record review of the HHA’s policy and procedure titled, “Coordination of Patient Care”, dated March 2019, indicated, “Procedure…2. The Director of Clinical Services provides oversight of all patient care services. Oversight includes: Coordinating patient care…ensuring that patient needs are continually assessed. Ensuring the development, implementation, and updates of the individualized plan of care.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure the acting Certified Home Health Aide (CHHA) met the qualifications for that title while performing personal patient care to three of seven sampled patients (Patient 1, Patient 2, and Patient 5). This failure resulted in patients being taken care of by an uncertified person, which had the potential to cause the patients harm by being mistreated and/or not performing tasks as ordered by a doctor. During an interview on 10/17/2023 at 10:50 a.m. with the Administrator/License Vocational Nurse 2 (ADM/LVN2), ADM/LVN2stated that they have one CHHA at this time, but that they are in the process of hiring another. During an interview on 10/20/2023 at 11:15 a.m. with Clinical Manager (CM), CM stated that there is one CHHA employed at the HHA at this time, CHHA1. During an interview on 10/20/2023 at 11:15 a.m. with the Administrator/License Vocational Nurse 2 (ADM/LVN2), ADM/LVN2 stated he did not request CHHA1’s certificate or BLS (basic life support) card because he needed someone to work. ADM/LVN2 stated he did not complete CHHA1’s background check. During a concurrent interview and record review on 10/20/2023 at 12:48 p.m. with the ADM/LVN2 or CHHA1’s employee file, the file contained an application. ADM/LVN2 stated the file did not contain CHHA1’s CHHA certificate, BLS card, picture identification, or a background check. ADM/LVN2 stated CHHA1 was hired in May 2023. ADM/LVN2 stated that he hired CHHA1 because she had experience working at a care center and thought she was a Certified Nurse Assistant (CNA) and was attending school for CHHA. ADM/LVN2 stated he does not recall if CHHA1 told him she was a CNA. ADM/LVN2 stated he did not verify CHHA1’s schooling and has not provided CHHA1 competencies or in services. ADM/LVN2 stated HHA census was 22 with two patients receiving CHHA services. During a record review of facility’s form titled “Employment Application” dated 5/1/2023, indicated CHHA1 had experience working at a care center with the job title of “Dietary Aid”. During a record review online at https://cvl.cdph.ca.gov/SearchPage.aspx, of form titled “L&C Verification Search Page” indicated CHHA1 was not listed as having a CHHA or a CNA certificate. 1. A review of Patient 1 (P1)’s “Patient Profile” indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Meletus II (high blood sugar) and foot ulcer (open wound or sore). A record review of P1’s document titled, “Home Health Certification and Plan of Care”, for certification period 8/12/23 to 10/10/23 indicated the CHHA was to visit P1 twice a week for 8 weeks. A record review of P1’s document titled, “Home Health Aide Record”, dated 9/21/23, indicated the CHHA 1 took P1’s blood pressure, respiration, pulse, and temperature readings. Further review of the record indicated CHHA 1 performed bath, hygiene, and activity procedures. A record review of P1’s document titled, “Home Health Aide Record”, dated 9/28/23, indicated the CHHA 1 took P1’s blood pressure, respiration, pulse, and temperature readings. Further review of the record indicated CHHA 1 performed bath, hygiene, and activity procedures. The HHA failed to ensure CHHA 1 was qualified to take care of P1. 2. A review of Patient 2 (P2)’s “Patient Profile” indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). A record review of P2’s document titled, “Home Health Certification and Plan of Care”, for certification period 8/4/23 to 10/2/23 indicated the CHHA was to visit P2 twice a week for 8 weeks. The HHA failed to ensure CHHA 1 was qualified to take care of P2. 3. A review of Patient 5 (P5)’s “Patient Profile” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During a record review of P5’s medical record form titled “Order/Telephone Order – Admission Order” dated 10/4/2023, indicated “CHHA visits 1 wk 1 (one visit for one week), 2 wk 6.” During a record review of P5’s medical record form titled “Home Health Aide Visit Record” dated 10/12/2023, indicated P5 was seen and cared for by CHHA1. During an interview on 10/18/2023 at 12 p.m. with P5’s Caregiver 1 (CG1), CG1 stated that CHHA1 conducted a visit that morning to bathe P5. During a record review of facility’s form titled “Job Description – Home Health Aide (HHA)” revised 3/2018, indicated “A paraprofessional person who is specifically trained, competent and performs assigned functions of personal care to the patient in their residence under the direction, instruction, and supervision of the registered nurse (RN). Qualifications: Must meet Medicare Conditions of Participation for Home Health Aide training program and competency.” During a record review of facility’s form titled “Job Description – Administrator” revised 3/2018, indicated “Recruits employees and retains qualified personnel to maintain appropriate staffing levels by employing qualified staff.” A record review of facility’s policy and procedure titled “Personnel Records” revised 3/2018, indicated “Personnel files will be established and maintained for all staff. The personnel record or personnel information for an employee will include, but not be limited to, the following: Employment application/resume. Observed competencies: initial during orientation and ongoing (minimally every 3 years) for all patient care staff. Home Health Aide competency evaluation: initially and annually. CPR, if required. Performance appraisal/evaluation forms. Verification of education, certification and/or licensure. Agency employee orientation. In service education record. Criminal history check, if required by law. Certification for specialty areas of practice, if applicable.”

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the Clinical Manager failed to ensure five of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 5 and Patient 7) plans of care were developed and implemented. This failure resulted in services and treatment not being provided in accordance with the plans of care. Findings: 1. A review of Patient 1’s “Patient Profile” indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Meletus II (high blood sugar) and foot ulcer (open wound or sore). During a concurrent interview and record review on 10/20/23, at 12:20 p.m., the Clinical Manger (CM) reviewed Patient 1’s record titled, “Nursing Progress Note”, dated 9/13/23, 9/22/23, 9/28/23, and 10/6/23. The CM stated according to Patient 1’s plan of care, the skilled nurse was supposed to obtain and record blood sugar levels every visit. The CM stated the skilled nurse did not obtain and record blood sugar levels for the nursing visits made on 9/13/23, 9/22/23, 9/28/23, and 10/6/23. The CM stated it was important to check Patient 1’s blood sugar levels to make sure the levels were not too low or too high because complications can occur such as coma (a period of long unconsciousness due to illness or injury) and ketoacidosis (body produces excess blood acids caused by high blood sugar levels). 2. A review of Patient 2's “Patient Profile” indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). A record review of Patient 2’s record titled, “Home Health Certification and Plan of Care” (POC), for certification period 8/4/2023 to 10/2/2023, indicated the SN was to assess and monitor the body systems to include the endocrine (body parts responsible for blood sugar levels) system, obtain and record blood sugar levels, and notify the doctor if blood sugar levels were too high or too low based on the ordered parameters. The record also indicated the SN was to educate Patient 2 about diabetes, its management and control through medicine and complication such as foot ulcers and gangrene. During a concurrent interview and record review on 10/20/23, at 2:15 p.m., the ADM reviewed Patient 2’s records titled “Nursing Progress Note”, dated 8/9/23, 8/16/23, 8/23/23, 9/1/23, 9/8/23, 9/12/23, and 9/21/23. The ADM stated the nurses should have asked the patient to check the blood sugar levels and at the very least document the patient is able to take their blood sugar. The nurse should have checked the values with the patient and document it in the record. The ADM stated it was important to make sure the patient was able to check his blood sugars, to make sure the ranges are not out of parameters. If blood sugar is out of parameters, it could cause complications. The documentation just said endocrine “no problems”. 3. A review of Patient 3’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including closed left femur (upper leg bone) fracture (broken). During an observation of the home visit on 10/18/23, at 2:01 p.m., Licensed Vocational Nurse 1 (LVN 1) was observed providing wound treatment to Patient 3’s surgical incision (a cut made through the skin to facilitate an operation). LVN 1 cleaned Patient 3’s left knee wound with normal saline (salt water), dried the area using a gauze, and applied triple antibiotic ointment on the wound. During the wound treatment, LVN 1 used clean gloves (not sterile. Sterile-no germs) and gauzes stored in a zip-lock bag. During an interview on 10/20/23, at 11:51 a.m., the CM stated surgical wound treatments could be done using a clean technique because it is hard to keep a sterile technique. The CM stated a clean or sterile gauze needed to be kept in its original packaging and taken to the patient’s house, because that was the best practice. A record review of Patient 3’s document titled, “Home Health Certification and Plan of Care”, for certification period 9/20/23 to 11/18/2023, indicated, “Wound care as follows: using aseptic technique (using sterile equipment and barriers to prevent germs from getting inside the body) cleanse left lateral knee surgical incision with NSS (normal saline), pat dry, and leave open to air”. The record did not indicate to apply triple antibiotic ointment to the surgical incision. LVN 1 did not perform the surgical wound treatment using aseptic technique. 4. A review of Patient 5’s “Patient Profile” indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During an interview on 10/17/23 at 2:55 p.m., the Administrator/License Vocational Nurse 2 (ADM/LVN2) stated there was no initial nursing assessment or plan of care (POC – an individualized plan for the care of a patient) for Patient 5 because the nurse had not completed the documentation. ADM/LVN2 stated that the nurse is aware of it and will complete it by tonight. During a joint home visit on 10/18/23 at 12:45 p.m. with License Vocational Nurse 1 (LVN1), LVN1 was unable to locate Patient 5’s POC. LVN1 stated she reviewed Patient 5’s POC in the HHA’s Electronic Medical Record (EMR) yesterday. During an interview on 10/18/23 at 1:20 p.m., the ADM/LVN2 stated that Patient 5’s initial nursing assessment and POC were not completed as planned and will provide documents tomorrow, 10/19/2023. During an interview on 10/19/23 at 11:35 a.m., with the DPCS, DPCS stated that he was not aware that Patient 5’s initial assessment or POC were not completed. During an interview on 10/19/2023 at 11:48 a.m. with the DPCS, DPCS stated that a patient’s initial assessment is “usually” done within 24 hours of admission but does not know the timeline for completion. DPCS stated an initial comprehensive assessment is a head-to-toe assessment that is used to develop the patients POC. DPCS stated that the POC needs to be completed before seeing the patient to prevent rehospitalization. During an interview on 10/19/23 at 2:20 p.m., with the ADM/LVN2, ADM/LVN2 stated Patient 5’s initial assessment and POC were not completed. ADM/LVN2 stated that RN1 is “getting caught up”. ADM/LVN2 stated that the initial comprehensive assessment needs to be completed in 7 to 14 days. ADM/LVN2 stated that the Clinical Manager (CM) calls the admitting nurse to completed, but as far as he knew they all had other primary jobs. During an interview on 10/20/23 at 11:15 a.m., with the CM, CM stated an initial comprehensive assessment is a detailed background of the patient and that it should be completed within three days of admission, before the nurses’ visit patients. CM stated that Patient 5’s initial comprehensive assessments was not completed yet because RN1 was having a hard time getting access to the HHA’s EMR system. CM stated that the comprehensive assessment is used to create the POC. CM stated that she has not completed Patient 5’s POC because the comprehensive assessment was not completed. CM stated that she told P5’s visiting nurses to review his medications, assess if there were any wounds, check his blood glucose and do a home safety check and to document that because there was no POC formulated yet. 5. A review of Patient 7’s “Patient Profile” indicated a start of care date (SOC) of 9/20/2023 and end of care (EOC) of 9/26/2023 with diagnoses including Diabetes Meletus II (high blood sugar) and chronic kidney disease (kidneys unable to filter blood well). During a record review on 10/17/2023 at 5:08 p.m. of Patient 7’s EMR medical record form titled “Parameter Graph – FBS/RBS (Fasting Blood Sugar/Random Blood Sugar)” dated from 9/20/2023 to 9/25/2023, indicated there were no values documented. A review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated from 9/20/2023 to 11/18/2023, indicated “Certified for skill nursing assessment/observation of… endocrine… Obtain and record vital signs, and notify MD if … FBS (fasting blood sugar) >250 mg/dl or During a concurrent interview and record review on 10/20/2023 at 1:32 p.m. with the CM of Patient 7’s EMR, medical record form titled “Comprehensive Assessment” dated 9/20/2023, CM stated that Patient 7’s blood sugar was not being assessed. CM stated that Patient 7’s blood sugar needed to be assessed/monitored to prevent from being hospitalized. During an interview on 10/20/2023 at 11:15 a.m. with the CM, CM stated that a patient’s comprehensive assessment is a detailed assessment that it is used to develop their POC. CM stated that the POC is a guideline of what needs to be done for the patients. A review of facility’s policy and procedure titled “Plan of Care – CMS #485 and Physician Orders” dated 3/2019, indicated “Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment…The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. The individualized plan of care must include the following: Care and services provided will be provided according to physician orders.” A record review of the HHA’s policy and procedure titled, “Coordination of Patient Care”, dated March 2019, indicated, “Procedure…2. The Director of Clinical Services provides oversight of all patient care services. Oversight includes: Coordinating patient care…ensuring that patient needs are continually assessed. Ensuring the development, implementation, and updates of the individualized plan of care.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure there was an agreement and/or contract with the acting Physical Therapy (PT) and Occupational Therapy (OT) company being used for patient care. This failure resulted in not knowing if PT or OT had the qualifications to take care of patients as ordered by their doctors or the time frame of the agreed time of service. During an interview on 10/19/2023 at 11:11 a.m. with the Administrator/License Vocational Nurse 2(ADM/LVN2), ADM/LVN2 stated that he did not have employee files for the PT or OT the HHA utilizes to treat their patients. During an interview on 10/21/2023 at 2:56 p.m. with the ADM/LVN2, ADM/LVN2 stated he did not have a PT/OT contract but is able to call PT and request for him to send one. ADM/LVN2 also stated that he did not have the employee files for PT and OT. A record review of facility’s policy and procedure titled “Contracted Staff” revised 3/2018, indicated “Contractual staff includes employees of organizations or independent individuals who contract directly with the Agency on an hourly or other basis per visit to provide services to Agency patients according to a written agreement/contract. All contractual staff are duly licensed or certified by their appropriate professional accrediting organization or licensure board prior to providing services to patients. Contracted organizations or contractual staff signs a written agreement with the Agency outlining the rules governing professional services rendered by staff and all associated charges. A copy of the contract will remain in the Agency's administrative files. Personnel files will be maintained or accessible by the Agency…” A record review of facility’s policy and procedure titled “Personnel Records” revised 3/2018, indicated “Personnel files will be established and maintained for all staff. The personnel record or personnel information for an employee will include, but not be limited to, the following: Employment application/resume. Observed competencies: initial during orientation and ongoing (minimally every 3 years) for all patient care staff. Home Health Aide competency evaluation: initially and annually. CPR, if required. Performance appraisal/evaluation forms. Verification of education, certification and/or licensure. Agency employee orientation. In service education record. Criminal history check, if required by law. Certification for specialty areas of practice, if applicable.”

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home), failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [is federal health insurance for people 65 or older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint federal and state program that helps cover medical costs for some people with limited income and resources] programs) for Clinical Records was met as follows: 1.The HHA failed to ensure clinical records accurately reflected the health status and the care and services provided, that the initial nursing assessments and plan of care (POC) were completed, filed in patients’ records, and available for review of healthcare team, for three of seven sampled patients (Patient 2, Patient 4, and Patient 5). This deficient practice had the potential for Patient 2, Patient 4, and Patient 5, not to received care and services specific to the patient care needs. (Refer to G1012). 2.The HHA failed to ensure the clinical records indicated the author of the clinical notes (in general) for two of seven sampled patients (Patient 4 and Patient 6). This deficient practice had the potential for unauthorized personnel, not involve in the patient care, modified the patient record that could result in misinformation regarding Patient 4 and Patient 6 care and services. (Refer to G1024). 3. The HHA failed to ensure patient care records that included care and services were safeguarded against unauthorized used from unauthorized staff not involved in patient's care, for one of seven sampled patients (Patient 6). The Clinical Manager (CM) modified Patient 6’s Comprehensive Assessment dated 12/10/2022, when the CM employed on 2/2023. This deficient practice resulted in Patient 6’s Comprehensive Assessment being modified by CM not involved in the patients care on 12/10/2022 and could result in patient’s information not protected from confidentiality an unauthorized use of patient health information. (Refer to G1028). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Clinical Records to ensure highest quality health care is provided to patients assessed to receive home health services.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure clinical records reflected the health status and the care and services provided, that the initial nursing assessments and plan of care (POC) were completed, filed in patients’ records, and available for review of healthcare team, for three of seven sampled patients (Patient 2, Patient 4, and Patient 5). This deficient practice had the potential for Patient 2, Patient 4, and Patient 5, not to received care and services specific to the patient care needs. A review of Patient 2 (P2)’s “Patient Profile” indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). During a concurrent interview and record review on 10/20/2023, at 12:53 p.m. the Clinical Manager (CM) reviewed Patient 2’s Wound Care Worksheet, dated 8/4/2023. The Wound Care Worksheet indicated, Patient 2 had a stage 1 sacral (located below the lumbar spine and above the tailbone) wound, (characterized by superficial reddening of the skin) and the treatment order indicated to cleanse with sterile wound cleanser, pat dry, apply zinc ointment, and leave open to air. The CM stated there was no physician’s order for the treatment documented on the Wound Care Worksheet. The CM stated the treatment for stage 1 was to monitor it for signs of worsening, provide education for the patient because stage 1 wounds were easier to heal. During a concurrent interview and record review on 10/20/2023, at 1:00 p.m. the CM reviewed P2’s record titled, “Home Health Certification and Plan of Care” (POC), for certification period 8/4/2023 to 10/2/2023. The CM stated the POC did not have wound treatment instructions documentation. The CM stated Patient 2’s POC documentation needed to include wound treatment instructions so the nurses could follow the treatment order and know the objectives of the patient. During a concurrent interview and record review on 10/20/2023, at 2:52 p.m., the administrator (ADM) reviewed Patient 2’s Wound Care Worksheet dated 8/14/2023. The record indicated a treatment order for right great toe gangrene (death of body tissue due to a lack of blood flow or a serious bacterial infection), pain in betadine and cover in betadine-soaked gauze, apply ABD (a type of dressing) pad, and warp in kerlix (a type of dressing). Right 2nd toes gangrene: Pain in betadine and cover in betadine-soaked gauze, apply ABD pad, and wrap in kerlix. The ADM stated there was no doctor’s order for any of the wound treatments documented in Patient 2’s Wound Care Worksheet dated 8/14/2023. A record review of Patient 2’sNursing Progress Note, dated 8/16/23, 8/23/23, 9/1/23, 9/8/23, 9/12/23, and 9/21/23 indicated, “Additional SN notes: Cleansed right great toe and right second toe with ns (normal saline), patted dry, painted with betadine. Covered with betadine dressing and wrapped with kerlix.” The nurse administered wound treatment to the right toes without a doctor’s order. A review of Patient 4’s Patient Profile indicated a start of care date (SOC) of 10/7/2023 with diagnoses including systolic congestive heart failure (weak contracture from the left side of heart). During an interview on 10/19/2023 at 2:29 p.m., the Administrator/Licensed Vocational Nurse (ADM/LVN 2) stated Patient 4’s POC was not completed because the nurse had not completed the comprehensive assessment. The ADM/LVN 2 stated Patient 4’s POC should include information on managing his oxygen saturation (amount of oxygen in the blood), how to manage his colostomy (an opening through the abdomen creating a passage from the large intestine to the outside of the body, so stool and gas can leave the body) status, education about his medications, diabetic management, and education on fall prevention. During a concurrent interview and record review on 10/19/2023 at 2:59 p.m., the ADM/LVN 2 reviewed Patient 4’s Order/Telephone Order dated 10/7/2023. The ADM/LVN stated the order was not complete because the name of the nurse who took the order was not signed and the order did not indicate who took the order. During a concurrent interview and record review on 10/19/2023 at 3:02 p.m., the ADM/LVN 2 reviewed Patient 4’s Order/Telephone Order dated 10/6/2023, Referred for Admission date and time 10/6/23 1:41 p.m. The ADM/LVN 2 stated, Patient 4’s Order/Telephone Order dated 10/6/2023, Referred for Admission date and time 10/6/23 1:41 p.m., did not indicate the nurse who got the order and the method of how the order was obtained. The ADM/LVN 2 stated the document was not considered an order because the order was incomplete. A review of Patient 5 Patient Profile indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During an interview on 10/17/2023 at 2:55 p.m., the Administrator/License Vocational Nurse 2 (ADM/LVN2) stated there was no records of documentation of initial nursing assessment or plan of care for Patient 5 because the nurse had not completed the documentation. ADM/LVN2 stated that the nurse was aware of it and would complete it by tonight. During an interview on 10/18/2023 at 1:20 p.m., the ADM/LVN2 stated, Patient 5’s initial nursing assessment and POC documentation were not completed as planned and will provide documents tomorrow, 10/19/2023. During an interview on 10/19/2023 at 11:35 a.m., with the DPCS, DPCS stated that he was not aware that Patient 5’s initial assessment or POC were not completed. During an interview on 10/19/2023 at 11:48 a.m. with the DPCS, DPCS stated that a patient’s initial assessment “usually” done within 24 hours of admission but did not know the timeline for completion. DPCS stated, an initial comprehensive assessment, a head-to-toe assessment used to develop the patients’ POC. DPCS stated that the POC documentation needs to be completed before seeing the patient to prevent rehospitalization. During an interview on 10/19/2023 at 2:20 p.m., with the ADM/LVN2, ADM/LVN2 stated Patient 5’s initial assessment and POC were not completed. ADM/LVN2 stated that Registered Nurse 1 (RN1) was “getting caught up”. ADM/LVN2 stated the initial comprehensive assessment needs to be completed in 7 to 14 days. ADM/LVN2 stated that the Clinical Manager (CM) calls the admitting nurse to completed, but as far as he knew they all had other primary jobs. During an interview on 10/20/23 at 11:15 a.m., with the CM, CM stated an initial comprehensive assessment is a detailed background of the patient and that it should be completed within three days of admission, before the nurses’ visit patients. CM stated Patient 5’s initial comprehensive assessments was not documented and completed yet because RN1 was having a hard time getting access to the HHA’s EMR system. CM stated in general the comprehensive assessment is used to create the POC. CM stated that she has not completed Patient 5’s POC because the comprehensive assessment was not completed. CM stated that she told Patient 5’s visiting nurses to review his medications, assess if there were any wounds, check his blood glucose and do a home safety check and to document that because there was no POC formulated yet. A review of facility’s policy and procedure titled “Plan of Care – CMS #485 and Physician Orders” dated 3/2019, indicated “Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment…The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. The individualized plan of care must include the following: Care and services provided will be provided according to physician orders.”

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the clinical records indicated the author of the clinical notes (in general) for two of seven sampled patients (Patient 4 and Patient 6). This deficient practice had the potential for unauthorized personnel, not involve in the patient care, modified the patient record that could result in misinformation regarding Patient 4 and Patient 6 care and services. A review of Patient 4’s Patient Profile indicated a start of care date (SOC) of 10/7/2023 with diagnoses including systolic congestive heart failure (weak contracture from the left side of heart). During a concurrent interview and record review on 10/19/2023 at 2:59 p.m., the ADM/LVN 2 reviewed Patient 4’s Order/Telephone Order dated 10/7/2023. The ADM/LVN stated the order was not complete because the name of the nurse who took the order was not signed and the order did not indicate who took the order. During a concurrent interview and record review on 10/19/2023 at 3:02 p.m., the ADM/LVN 2 reviewed Patient 4’s Order/Telephone Order dated 10/6/2023 and Referred for Admission date and time, 10/6/2023 1:41 p.m. The ADM/LVN 2 stated Patient 4’s Order/Telephone Order dated 10/6/2023 and Referred for Admission, did not indicate the nurse who got the order and the method of how the order was obtained. The ADM/LVN 2 stated the document was not considered an order because the order was incomplete. A record review of Patient 4’s Reason for Assessment: Start of care, for certification period 10/7/2023 to 12/5/2023, did not indicate the author of the note. A review of Patient 6 Patient Profile indicated a start of care date (SOC) of 12/10/2022 with diagnoses including rhabdomyolysis (breakdown of damage muscle into the blood stream). A review of Patient 6’s Reason for Assessment: Start of Care dated 12/10/2022, indicated form was signed by Clinical Manager (CM). During a concurrent interview and record review on 10/19/2023 at 3:05 p.m. with the Administrator/License Vocational Nurse 2 (ADM/LVN2), Patient 6’s Comprehensive Assessment dated 10/10/2023 was reviewed. ADM/LVN2 stated Patient 6’s Comprehensive Assessment dated 10/10/2023 form indicated CM electronically signed the form on 12/10/2022. ADM/LVN2 stated that CM began her employment at the HHA in February of 2023. ADM/LVN2 stated, “I couldn’t even begin to tell you; in February she started doing the admissions for us then she moved into the office.” During an interview on 10/20/2023 at 11:15 a.m. with the CM, CM stated she was hired at the HHA on 2/1/2023. During a concurrent interview and record review on 10/20/2023 at 2:18 p.m. with CM of Patient 6’s comprehensive assessment dated 12/10/2022, CM stated she did not know why her signature appeared on Patient 6’s comprehensive assessment dated 12/10/2022. CM stated she was not employed at the HHA at that time. During an interview on 10/20/2023 at 2:56 p.m. with the ADM/LVN2, ADM/LVN2 stated that the only policies and procedures for their EMR system were provided. ADM/LVN2 stated that he did not have safeguarding and authentication of documentation policies and procedures.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure patient care records that included care and services were safeguarded against unauthorized used from unauthorized staff not involved in patient's care, for one of seven sampled patients (Patient 6). The Clinical Manager (CM) modified Patient 6’s Comprehensive Assessment dated 12/10/2022, when the CM employed on 2/2023. This deficient practice resulted in Patient 6’s Comprehensive Assessment being modified by CM not involved in the patients care on 12/10/2022 and could result in patient’s information not protected from confidentiality an unauthorized use of patient health information. A review of Patient 6 Patient Profile indicated a start of care date (SOC) of 12/10/2022 with diagnoses including rhabdomyolysis (breakdown of damage muscle into the blood stream). A review of Patient 6’s “Reason for Assessment: Start of Care dated 12/10/2022, indicated form was signed by Clinical Manager (CM). During a concurrent interview and record review on 10/19/2023 at 3:05 p.m. with the Administrator/License Vocational Nurse 2 (ADM/LVN2) of Patient 6’s Comprehensive Assessment dated 10/10/2023, ADM/LVN2 stated Patient 6’s Comprehensive Assessment dated 10/10/2022 indicated CM electronically signed the form on 12/10/2022. ADM/LVN2 stated that CM began her employment at the HHA in February of 2023. ADM/LVN2 stated, “I couldn’t even begin to tell you; in February she started doing the admissions for us then she moved into the office.” During an interview on 10/20/2023 at 11:15 a.m. with the CM, CM stated she was hired at the HHA on 2/1/2023. During a concurrent interview and record review on 10/20/2023 at 2:18 p.m. with CM of Patient 6’s comprehensive assessment” dated 12/10/2022, CM stated she did not know why her signature appeared on Patient 6’s comprehensive assessment dated 12/10/2022. CM stated she was not employed at the HHA at that time. On 10/20/2023 at 12:48 p.m. facility’s policy and procedure for safeguarding and authentication were requested. During an interview on 10/20/2023 at 2:56 p.m. with the ADM/LVN2, ADM/LVN2 stated that the only policies and procedures for their EMR system were provided. ADM/LVN2 stated that the agency had no safeguarding and authentication policies and procedures.

Personnel qualifications CFR(s): 484.115 Condition of participation: Personnel qualifications. HHA staff are required to meet the following standards: This CONDITION is not met as evidenced by: This CONDITION is NOT MET as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities]) regarding Personnel Qualification was met as follows: 1. The HHA failed to ensure to provide a qualified Administrator for the day-to-day operations of the HHA to ensure the safety and the quality of care for seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice had the potential for Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7 to receive unsafe and ineffective care practices. (Refer to G1052). 2. The HHA failed to ensure to provide a qualified Certified Home Health Aide to provide personal patient care for three of seven sampled patients (Patient 1, Patient 2, and Patient 5). This deficient practice placed Patient 1, Patient 2, and Patient 5 at risk for harm and injury by having an unqualified staff caring for them. (Refer to G1058). 3. The HHA failed to ensure the Occupational Therapist (OT, a healthcare provider who helps you improve your ability to perform daily tasks) met the qualifications to be able to provide safe and effective care for three of seven sampled patients (Patient 2, Patient 4, and Patient 5). This deficient practice had the potential to result for Patient 2, Patient 4, and Patient 5 to receive unsafe and ineffective care. (Refer to G1062). 4. The HHA failed to ensure the Physical Therapist (PT a person qualified to treat disease, injury, or deformity by physical methods such as massage, heat treatment, and exercise) met the qualifications to be able to provide safe and effective care to seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice had the potential for Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7 to receive inappropriate care that could be unsafe and ineffective. (Refer to G1066). 5. The HHA failed to ensure to hire a Medical Social Worker to ensure patients received information and assistance when needed for one of seven sampled patients (Patient 3). This deficient practice had the potential not to meet the needs of Patient 3 and resulted for Patient 3 not to be aware of the resources in the community. (Refer to G1076). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of a quality health care in a safe environment. Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [a federal system of health insurance for people over 65 years of age and for certain younger people with disabilities]) regarding Personnel Qualification was met as follows: 1. The HHA failed to ensure to provide a qualified Administrator for the day-to-day operations of the HHA to ensure the safety and the quality of care for seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice had the potential for Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7 to receive unsafe and ineffective care practices. (Refer to G1052). 2. The HHA failed to ensure to provide a qualified Certified Home Health Aide to provide personal patient care for three of seven sampled patients (Patient 1, Patient 2, and Patient 5). This deficient practice placed Patient 1, Patient 2, and Patient 5 at risk for harm and injury by having an unqualified staff caring for them. (Refer to G1058). 3. The HHA failed to ensure the Occupational Therapist (OT, a healthcare provider who helps you improve your ability to perform daily tasks) met the qualifications to be able to provide safe and effective care for three of seven sampled patients (Patient 2, Patient 4, and Patient 5). This deficient practice had the potential to result for Patient 2, Patient 4, and Patient 5 to receive unsafe and ineffective care. (Refer to G1062). 4. The HHA failed to ensure the Physical Therapist (PT a person qualified to treat disease, injury, or deformity by physical methods such as massage, heat treatment, and exercise) met the qualifications to be able to provide safe and effective care to seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice had the potential for Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7 to receive inappropriate care that could be unsafe and ineffective. (Refer to G1066). 5. The HHA failed to ensure to hire a Medical Social Worker to ensure patients received information and assistance when needed for one of seven sampled patients (Patient 3). This deficient practice had the potential not to meet the needs of Patient 3 and resulted for Patient 3 not to be aware of the resources in the community. (Refer to G1076). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of a quality health care in a safe environment.

Administrator CFR(s): 484.115(a) Standard: Administrator, home health agency. (1) For individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure to provide a qualified Administrator for the day-to-day operations of the HHA to ensure the safety of seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice had the potential for Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7 to receive unsafe and ineffective care practices. (Refer to G1052). Findings: During a review of Patient 1’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels) and foot ulcer (open wound or sore). During a record review of Patient 2’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). A review of Patient 3’s “Patient Profile,” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including closed left femur (upper leg/thigh bone) fracture (broken). During a review of Patient 4’s Patient Profile, Patient 4’s Patient Profile indicated a start of care date (SOC) of 10/7/2023 with a diagnosis of systolic congestive heart failure (occurs when the heart does not pump blood effectively). During a review of Patient 5’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During a review of Patient 6’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 12/10/2022 with diagnoses including rhabdomyolysis (breakdown of damage muscle into the blood stream). During a review of Patient 7’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 9/20/2023 with diagnosis of Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels). During an interview on 10/19/2023, at 10:54 a.m., with the facility’s Administrator/Licensed Vocational Nurse 2 (ADM/LVN2), the ADM/LVN2 stated he was a Licensed Vocational Nurse for 15 years with case management experience. ADM/LVN2 stated he did not have an associates or baccalaureate degree. The ADM/LVN2 stated he did not take courses in health care administration or managerial. During an interview on 10/19/2023, at 11 a.m., with the ADM/LVN2, the ADM/LVN2 stated “I am the secretary, CEO, everything.” ADM/LVN2 stated he used to make decisions with the Director of Patient Care Services (DPCS), but now “any nursing stuff,” he talked it over with the Clinical Manager (CM) and informed the DPCS. The ADM/LVN2 stated he appointed himself as the ADM/LVN2 because he started the company. During an interview on 10/19/2023, at 11:11 a.m., with the ADM/LVN2, the ADM/LVN2 stated he held the title of Human Resource (HR). During an interview on 10/19/2023, at 11:34 a.m., with the DPCS, the DPCS stated the CM was the one running most of the things. The DPCS stated his responsibilities included to supervise the nurses (in general) and review charts The DPCS stated the ADM/LVN 2, and CM called him if they needed support or ideas. The DPCS stated he came to the agency one or twice a week, stay four to six hours to review the documents and the budget. During an interview on 10/20/23, at 11:38 a.m., with the CM, the CM stated her working hours were Monday through Friday from 10 a.m., to 1:50 p.m. The CM stated she was responsible for the day-to-day operation of nursing care. A record review of facility’s form titled “Job Description – Administrator” revised 3/2018, indicated, “The Administrator ensures quality and safe delivery of home health care services; coordinates services that reflect the Agency's philosophy and standards of care; plans, develops, implements, and evaluates Agency services, programs, and activities and responsible for all day-to-day operations of Agency. Qualifications: A person who is a licensed physician, or Is a registered nurse, or Has training and experience in health services administration and at least one (1) year of supervisory or administrative experience in home health care or related health program.”

Home Health Aide CFR(s): 484.115(d) Standard: Home health aide. A person who meets the qualifications for home health aides specified in section 1891(a)(3) of the Act and implemented at §484.80. This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure to provide a qualified Certified Home Health Aide to provide personal patient care for three of seven sampled patients (Patient 1, Patient 2, and Patient 5). This deficient practice placed Patient 1, Patient 2, and Patient 5 at risk for harm and injury by having an unqualified staff caring for them. Findings: During a review of Patient 1’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels) and foot ulcer (open wound or sore). During a record review of Patient 1’s Home Health Certification and Plan of Care, dated for certification period from 8/12/2023 to 10/10/2023, the Home Health Certification and Plan of Care indicated the CHHA was to visit Patient 1 twice a week for eight weeks. During a record review of Patient 1’s Home Health Aide Record, dated 9/21/2023, the Home Health Aide Record indicated CHHA 1 took Patient 1’s blood pressure, respiration, pulse, and temperature readings. The Home Health Aide Record CHHA 1 performed a bath, hygiene care, and activity procedures. During a record review of Patient 1’s document Home Health Aide Record, dated 9/28/2023, the Home Health Aide Record indicated CHHA 1 took Patient 1’s blood pressure, respiration, pulse, and temperature readings. Home Health Aide Record indicated CHHA 1 performed a bath, hygiene care, and activity procedures. During a record review of Patient 2’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). During a record review of Patient 2’s Home Health Certification and Plan of Care dated for certification period 8/4/2023 to 10/2/2023 indicated the CHHA was to visit Patient 2 twice a week for eight weeks. During a review of Patient 5’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During a record review of Patient 5’s Order/Telephone Order – Admission Order, dated 10/4/2023, indicated the Order/Telephone Order-Admission Order, indicated for the CHHA to visit once for one week. During a record review of Patient 5’s Home Health Aide Visit Record dated 10/12/2023, indicated CHHA 1 provided care for Patient 5. During a record review of the facility’s form titled “Employment Application,” dated 5/1/2023, indicated CHHA1 had experience working at a care center with the job title of “Dietary Aid.” During an interview on 10/17/2023, at 10:50 a.m., with the Administrator/Licensed Vocational Nurse 2 (ADM/LVN2), the ADM/LVN2 stated the HHA had only one CHHA (CHHA1). During an interview on 10/18/2023 at 12 p.m., with Patient 5’s Caregiver 1 (CG1), CG1 stated CHHA1 conducted a visit on the morning of 10/18/2023 (unidentified time) to bathe Patient 5. During an interview on 10/20/2023, at 11:15 a.m., with the ADM/LVN2, ADM/LVN2 stated he did not request CHHA1’s certificate or BLS (basic life support, generally refers to the type of care that first-responders, healthcare providers and public safety professionals provide to anyone who is experiencing cardiac arrest, respiratory distress, or an obstructed airway) card because he needed someone to work. ADM/LVN2 stated he did not complete CHHA1’s background check (screening process to determine whether an applicant may be unqualified for a position due to a record of criminal conviction). During a concurrent interview and record review, on 10/20/2023, at 12:48 p.m., with the ADM/LVN2, CHHA1’s employee file was reviewed. The ADM/LVN2 stated the CHHA 1’s file did not contain CHHA1’s BLS card, picture identification, or a background check. ADM/LVN2 stated CHHA1 was hired in May 2023. ADM/LVN2 stated he hired CHHA1 because she had experience working at a care center and thought she was a Certified Nurse Assistant (CNA) and was attending school for CHHA. ADM/LVN2 stated he did not recall if CHHA1 told him she was a CNA. ADM/LVN2 stated he did not verify CHHA1’s schooling and had not provided CHHA1 competencies or in services. ADM/LVN2 stated HHA census was 22 with three patients (Patient 1, Patient 2, and Patient 5) who received CHHA services. During a record review online at https://cvl.cdph.ca.gov/SearchPage.aspx, of form titled “L&C Verification Search Page” indicated CHHA1 was not listed as having a CHHA or a CNA certificate. During a record review of facility’s form titled “Job Description – Home Health Aide (HHA)” revised 3/2018, indicated “A paraprofessional person who is specifically trained, competent and performs assigned functions of personal care to the patient in their residence under the direction, instruction, and supervision of the registered nurse (RN). Qualifications: Must meet Medicare Conditions of Participation for Home Health Aide training program and competency.” During a record review of facility’s form titled “Job Description – Administrator” revised 3/2018, indicated “Recruits employees and retains qualified personnel to maintain appropriate staffing levels by employing qualified staff.” A review of facility’s policy and procedure titled “Patient Bill of Rights and Responsibilities” revised 3/2019, indicated “Patients have the right: to be admitted by (HHA) only if it has the resources needed to provide the care safely and at the required level of intensity, as determined by a professional assessment. (HHA) with less than optimal resources may nevertheless admit the patient if a more appropriate provider is not available, but only after fully informing the patient of (HHA)'s limitations and the lack of suitable alternative arrangements.”

Occupational Therapist CFR(s): 484.115(f) Standard: Occupational therapist. A person who- (1)(i) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the state in which practicing, unless licensure does not apply; (ii) Graduated after successful completion of an occupational therapist education program accredited by the Accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA), or successor organizations of ACOTE; and (iii) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). (2) On or before December 31, 2009- (i) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the state in which practicing; or (ii) When licensure or other regulation does not apply- (A) Graduated after successful completion of an occupational therapist education program accredited by the accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA) or successor organizations of ACOTE; and (B) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc., (NBCOT). (3) On or before January 1, 2008- (i) Graduated after successful completion of an occupational therapy program accredited jointly by the Committee on Allied Health Education and Accreditation of the American Medical Association and the American Occupational Therapy Association; or (ii) Is eligible for the National Registration Examination of the American Occupational Therapy Association or the National Board for Certification in Occupational Therapy. (4) On or before December 31, 1977- (i) Had 2 years of appropriate experience as an occupational therapist; and (ii) Had achieved a satisfactory grade on an occupational therapist proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. (5) If educated outside the United States, must meet both of the following: (i) Graduated after successful completion of an occupational therapist education program accredited as substantially equivalent to occupational therapist entry level education in the United States by one of the following: (A) The Accreditation Council for Occupational Therapy Education (ACOTE). (B) Successor organizations of ACOTE. (C) The World Federation of Occupational Therapists. (D) A credentialing body approved by the American Occupational Therapy Association. (E) Successfully completed the entry level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT). (ii) On or before December 31, 2009, is licensed or otherwise regulated, if applicable, as an occupational therapist by the state in which practicing. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Occupational Therapist (OT, a healthcare provider who helps you improve your ability to perform daily tasks) met the qualifications to be able to provide safe and effective care for three of seven sampled patients (Patient 2, Patient 4, and Patient 5). This deficient practice had the potential to result for Patient 2, Patient 4, and Patient 5, Patient 6, to receive unsafe and ineffective care. Findings: a. During a record review of Patient 2’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). b. During a review of Patient 4’s Patient Profile, Patient 4’s Patient Profile indicated a start of care date (SOC) of 10/7/2023 with a diagnosis of systolic congestive heart failure (occurs when the heart does not pump blood effectively). c. During a review of Patient 5’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During an interview on 10/19/2023, at 11:11 a.m., with the Administrator/Licensed Vocational Nurse 2 (ADM/LVN2), the ADM/LVN2 stated the HHA did not have an employee file for the OT. During an interview on 10/21/2023, at 2:56 p.m., with the ADM/LVN2, the ADM/LVN2 stated he did not have an OT contract. ADM/LVN2 stated he did not have the employee file for the OT to show evidence of the OT’s qualifications. A record review of facility’s policy and procedure titled “Contracted Staff” revised 3/2018, indicated “Contractual staff includes employees of organizations or independent individuals who contract directly with the Agency on an hourly or other basis per visit to provide services to Agency patients according to a written agreement/contract. All contractual staff are duly licensed or certified by their appropriate professional accrediting organization or licensure board prior to providing services to patients. Contracted organizations or contractual staff signs a written agreement with the Agency outlining the rules governing professional services rendered by staff and all associated charges. A copy of the contract will remain in the Agency's administrative files. Personnel files will be maintained or accessible by the Agency…” A record review of facility’s policy and procedure titled “Personnel Records” revised 3/2018, indicated “Personnel files will be established and maintained for all staff. The personnel record or personnel information for an employee will include, but not be limited to, the following: Employment application/resume. Observed competencies: initial during orientation and ongoing (minimally every 3 years) for all patient care staff. Home Health Aide competency evaluation: initially and annually. CPR, if required. Performance appraisal/evaluation forms. Verification of education, certification and/or licensure. Agency employee orientation. In service education record. Criminal history check, if required by law. Certification for specialty areas of practice, if applicable.”

Physical Therapist CFR(s): 484.115(h) Standard: Physical therapist. A person who is licensed, if applicable, by the state in which practicing, unless licensure does not apply and meets one of the following requirements: (1)(i) Graduated after successful completion of a physical therapist education program approved by one of the following: (A) The Commission on Accreditation in Physical Therapy Education (CAPTE). (B) Successor organizations of CAPTE. (C) An education program outside the United States determined to be substantially equivalent to physical therapist entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or an organization identified in 8 CFR 212.15(e) as it relates to physical therapists. (ii) Passed an examination for physical therapists approved by the state in which physical therapy services are provided. (2) On or before December 31, 2009- (i) Graduated after successful completion of a physical therapy curriculum approved by the Commission on Accreditation in Physical Therapy Education (CAPTE); or (ii) Meets both of the following: (A) Graduated after successful completion of an education program determined to be substantially equivalent to physical therapist entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or identified in 8 CFR 212.15(e) as it relates to physical therapists. (B) Passed an examination for physical therapists approved by the state in which physical therapy services are provided. (3) Before January 1, 2008 graduated from a physical therapy curriculum approved by one of the following: (i) The American Physical Therapy Association. (ii) The Committee on Allied Health Education and Accreditation of the American Medical Association. (iii) The Council on Medical Education of the American Medical Association and the American Physical Therapy Association. (4) On or before December 31, 1977 was licensed or qualified as a physical therapist and meets both of the following: (i) Has 2 years of appropriate experience as a physical therapist. (ii) Has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service. (5) Before January 1, 1966- (i) Was admitted to membership by the American Physical Therapy Association; (ii) Was admitted to registration by the American Registry of Physical Therapists;or (iii) Graduated from a physical therapy curriculum in a 4-year college or university approved by a state department of education. (6) Before January 1, 1966 was licensed or registered, and before January 1, 1970, had 15 years of fulltime experience in the treatment of illness or injury through the practice of physical therapy in which services were rendered under the order and direction of attending and referring doctors of medicine or osteopathy. (7) If trained outside the United States before January 1, 2008, meets the following requirements: (i) Was graduated since 1928 from a physical therapy curriculum approved in the country in which the curriculum was located and in which there is a member organization of the World Confederation for Physical Therapy. (ii) Meets the requirements for membership in a member organization of the World Confederation for Physical Therapy. This STANDARD is not met as evidenced by: Based on interview and record review, the HHA failed to ensure the Physical Therapist (PT a person qualified to treat disease, injury, or deformity by physical methods such as massage, heat treatment, and exercise) met the qualifications to be able to provide safe and effective care to seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This deficient practice had the potential for Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7 to receive inappropriate care that could be unsafe and ineffective. Findings: During a review of Patient 1’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 2/13/2023 with diagnoses including Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels) and foot ulcer (open wound or sore). During a record review of Patient 2’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 4/6/2023 with diagnoses including cerebrovascular accident (disruption of blood flow to the brain) and left side hemiplegia (one sided muscle paralysis or weakness). A review of Patient 3’s “Patient Profile,” indicated a start of care date (SOC) of 9/20/2023 with diagnoses including closed left femur (upper leg/thigh bone) fracture (broken). Findings: During a review of Patient 4’s Patient Profile, Patient 4’s Patient Profile indicated a start of care date (SOC) of 10/7/2023 with a diagnosis of systolic congestive heart failure (occurs when the heart does not pump blood effectively). During a review of Patient 5’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 10/4/2023 with diagnoses including multiple sclerosis (progressive of brain and spinal cord nerves) and chronic (long term) respiratory failure (difficulty breathing). During a review of Patient 6’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 12/10/2022 with diagnoses including rhabdomyolysis (breakdown of damage muscle into the blood stream). During a review of Patient 7’s Patient Profile, the Patient Profile indicated a start of care date (SOC) of 9/20/2023 with diagnosis of Diabetes Type 2 (a medical condition characterized by the body's inability to regulate blood sugar levels). During an interview on 10/19/2023, at 11:11 a.m., with the Administrator/Licensed Vocational Nurse 2 (ADM/LVN2), the ADM/LVN2 stated he did not have employee files for the PT. During an interview on 10/21/2023, at 2:56 p.m., with the ADM/LVN2, the ADM/LVN2 stated he did not have a PT/OT contract. ADM/LVN2 also stated he did not have the employee files to show the PT was qualified to provide PT services for the patients (in general). A record review of facility’s policy and procedure titled “Contracted Staff” revised 3/2018, indicated “Contractual staff includes employees of organizations or independent individuals who contract directly with the Agency on an hourly or other basis per visit to provide services to Agency patients according to a written agreement/contract. All contractual staff are duly licensed or certified by their appropriate professional accrediting organization or licensure board prior to providing services to patients. Contracted organizations or contractual staff signs a written agreement with the Agency outlining the rules governing professional services rendered by staff and all associated charges. A copy of the contract will remain in the Agency's administrative files. Personnel files will be maintained or accessible by the Agency…” A record review of facility’s policy and procedure titled “Personnel Records” revised 3/2018, indicated “Personnel files will be established and maintained for all staff. The personnel record or personnel information for an employee will include, but not be limited to, the following: Employment application/resume. Observed competencies: initial during orientation and ongoing (minimally every 3 years) for all patient care staff. Hom Health Aide competency evaluation: initially and annually. CPR, if required. Performance appraisal/evaluation forms. Verification of education, certification and/or licensure. Agency employee orientation. Inservice education record. Criminal history check, if required by law. Certification for specialty areas of practice, if applicable.”

Social Worker CFR(s): 484.115(m) Standard: Social worker. A person who has a master's or doctoral degree from a school of social work accredited by the Council on Social Work Education, and has 1 year of social work experience in a health care setting. This STANDARD is not met as evidenced by: Based on interview and record review the HHA failed to ensure to hire a Medical Social Worker to ensure patients received information and assistance when needed for one of seven sampled patients (Patient 3). This deficient practice had the potential not to meet the needs of Patient 3 and resulted for Patient 3 not to be aware of the resources in the community. Findings: A review of Patient 3’s Patient Profile indicated a start of care date (SOC) of 9/20/2023 with diagnoses including closed left femur (upper leg bone) fracture (broken). During an interview on 10/17/2023, at 10:50 a.m., with the Administrator/Licensed Vocational Nurse 2 (ADM/LVN2), the ADM/LVN2 stated the HHA did not have a Medical Social Worked (MSW) employed. During an interview on 10/18/2023, at 1:50 p.m., Patient 3’s caregiver (CG 2) stated she needed a social worker to help her get resources about getting help at home for Patient 3. CG 2 stated she was interested in home support care services as well as other services such as getting a sit/stand walker (a type of mobility aid that offers stability and support while walking) for Patient 3 and did not know who could help her. During an interview on 10/19/2023, at 12:32 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated he thought the ADM/LVN2 had hired a MSW, and he did not know if there was a MSW employed at the HHA. The DPCS stated MSW needed to assist patients with referrals and community resources. The DPCS stated it was important to have a MSW to prevent patients from getting frustrated from not having a resource person. A review of facility’s Admission Folder indicated “Services we provide: Social Services”. A review of facility’s Public Facility Brochure indicated “(HHA) services include… Medical social services…” A review of facility’s policy and procedure titled “Admission Criteria and Process” undated, indicated “Patients will be accepted for care based on the adequacy and suitability of organization personnel, resources to provide required services, and the reasonable expectation that the patient's… social needs can be adequately met in the patient's place of residence.” A review of facility’s policy and procedure titled “Assessment and Reassessment Guidelines” revised 3/2018, indicated “The Medical Social Worker (MSW) will provide initial and ongoing reassessments for social work services.”