Every finding on record at New Start Home Health Care, Inc

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on observation, 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 coordinate with the Respiratory Therapist (RT - healthcare professional who specializes in evaluating, treating, and caring for individuals with breathing problems and other lung disorders) regarding changed to the ventilator machine for Patient 11. This deficient practice resulted in the HHA not being aware of the correct ventilator settings for Patient 11. During a review of Patient 11’s medical record titled, “Home Health Certification and Plan of Care” (POC), for the certification period of 5/3/2025 to 7/1/2025, indicated Patient 11’s diagnoses included quadriplegia (paralysis [inability to move] from the neck down, including legs, and arms, usually due to a spinal cord injury), neuromuscular dysfunction (a group of disorders that affect the nerves and muscles, impairing their communication and function) and chronic respiratory failure (condition where there is not enough oxygen or too much carbon dioxide in the body). During a review of Patient 11’s POC, for the certification period of 5/3/2025 to 7/1/2025, indicated an order for Patient 11 tracheostomy ventilator settings as followed: · Mode Control (a mode of ventilation in which the respirator delivers the preset volume or pressure regardless of the patient's own inspiratory efforts) = Assist Control (a mode where the ventilator supports the patient's breaths, either by delivering a preset number of breaths at a set rate or in response to the patient's inspiratory effort.) · Breaths per Minute (BPM, refers to the number of breaths the ventilator will deliver to the patient in one minute) = 14 BPM · Pressure-Trigger ventilation (Pt rig -the ventilator delivers a breath when it detects a drop in airway pressure caused by the patient's inspiratory effort) = 2.0 · Peep (Positive End-Expiratory Pressure, on a ventilator refers to a setting that maintains a positive pressure in the airways at the end of exhalation, even when the patient is not actively inhaling) = 0 (zero means that there is no pressure maintained in the airways at the end of exhalation. Ranges are generally between 5 and 20 cmH2O (centimeters of water) or mmHg (millimeters of mercury) · Volume (the amount of air delivered with each breath) = 800 ml (milliliter, unit of measurement) · High pressure alarm (the pressure within the patient's airway is exceeding the set limit, potentially causing damage to the lungs. This alarm is triggered when the pressure rises above a predefined threshold, indicating a problem that needs to be addressed.) = 98 · Low pressure alarm (a potential leak or disconnection in the breathing circuit, leading to insufficient pressure being delivered to the patient) = 10 cmH20 (a safety alarm designed to alert if the pressure in the patient circuit has dropped below the preset limit of 10 cmH2O clinicians to a potential problem with the patient's airway or ventilator system, such as a leak or disconnection.) · Inspiratory and Expiratory (I&E, refer to the timing and duration of the inhalation and exhalation phases of mechanical ventilation) = 1-3 During a home visit on 6/24/2025 at 11:00 a.m., with the Patient 11’s caregiver, Patient 11 was observed in the living room on his electric wheelchair. Patient 11 was observed with a tracheostomy tube and able to verbally communicate. Observed the ventilator setting for the Pt rig was 5.0. During an interview with the Director of Patient Care Services (DPCS) on 6/22/2025 at 11:52 a.m., the DPCS indicated that the HHA has no notes or documentation from the RT regarding the visits that are conducted with Patient 11. DPCS stated that the HHA does not communicate with the RT regarding Patient 11’s ventilator settings. DPCS stated that the HHA relies on what Patient 11 tells the nurses regarding the RT visits. During a review of the HHA’s Policy and Procedure (P&P) titled, “Coordination of Services with other Providers,” revised 11/2021, indicated “the Case Manager will act as a liaison with other organizations or individuals also providing care to the patient to ensure effective coordination of related services.”

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- an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to update the POC for one of three sampled patients (Patient 11). This deficient practice had the potential to cause the patient and/or the family/caregiver to not be aware of their treatment plan, the services provided and be an active participant in their care planning process. During a review of Patient 11’s medical record titled, “Home Health Certification and Plan of Care” (POC), for the certification period of 5/3/2025 to 7/1/2025, indicated Patient 11’s diagnoses included quadriplegia (paralysis [inability to move] from the neck down, including legs, and arms, usually due to a spinal cord injury), neuromuscular dysfunction (a group of disorders that affect the nerves and muscles, impairing their communication and function) and chronic respiratory failure (condition where there is not enough oxygen or too much carbon dioxide in the body). During a home visit on 6/24/2025 at 11:00 a.m., with the Patient 11’s caregiver, Patient 11 was observed in the living room on his electric wheelchair. Patient 11 was observed with a tracheostomy tube and able to verbally communicate. Observed the HHA binder that is kept at the Patient’s home to have a POC that was not updated and had a certification period of 12/1/2019 to 1/29/2020. During an interview with the Director of Patient Care Services (DPCS) on 6/25/2025 at 11:52 a.m., the DPCS indicated that the POC in the home is updated depending on the patient and if the patient wanted an updated POC. During a review of the HHA’s Policy and Procedure (P&P) titled, “Care Planning Process,” revised 11/2021, indicated “a written individualized plan of care will be initiated within five (5) days of start of care and updated at least every 60 days, or as patient’s condition warrants. The patient plan of care will be developed or revised within five (5) working days of initiation of each service or of the reassessment of the patient…The Patient and family/caregiver will participate in decisions regarding the plan of care whenever possible…5. The care planning decisions will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet individualized patient problems and goals… 6. The plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs.”

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on observation, 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 meet the Conditions of Participation (refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) for Organization and Administration of Services of patients as follows: 1. The Governing Body (or designated people so functioning) failed to assume full legal authority and responsibility for the agency's overall management and operation, failed to ensure the Administrator and Administrator Designee (ADMD) assumed responsibility for the overall management of the agency's daily operations. The ADM and ADMD did not provide oversight of the HHA’s Director of Nurses (DON) management of staff and coordination with outside entities and the skilled nurses (SN). (Refer to G942). 2. The designated Administrator (ADM) and designated Administrator Designee (ADMD) failed to be involved in the day-to-day operation of the HHA. (Refer to G948). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver mandated compliance (in a way that is decided and controlled by law) with Federal Regulations for Organization and Administration of Services to ensure a safe a secured provision of health care services were provided to patients.

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 interview and record review, the Home Health Agency (HHA) failed to ensure the Governing Body (or designated people so functioning) failed to assume full legal authority and responsibility for the agency's overall management and operation, failed to ensure the Administrator and Administrator Designee (ADMD) assumed responsibility for the overall management of the agency's daily operations. The ADM and ADMD did not provide oversight of the HHA’s Director of Nurses (DON) management of staff and coordination with outside entities and the skilled nurses (SN). Findings: During an interview with the Director of Nurses (DON), in the HHA’S office on 6/25/2023, at 12:30 p.m., the DON stated that she oversees the day-to-day operation of the HHA and that the ADM and ADMD monitor the HHA with phone calls to her (DON). During a telephone interview with the Administrator in the HHA’s office on 6/25/2025, at 1:07 p.m., she stated that she was not aware of the deficiencies identified in the three previous complaint validation surveys conducted this year and that she oversees the Director of Nurses (DON), by calling her and visiting the agency. The Administrator continued to state that she and the ADMD were members of the governing body that was responsible for overseeing the HHA. During a telephone interview with the ADMD, on 6/25/2025 at 1:16 p.m., in the HHA’s office. The ADMD stated that she comes to the office from time to time and that she talked to the DON via phone to see how things were in the agency. During an interview with the DON in the HHA’s office on 6/25/2025, at 2pm, the DON stated she is the one running the agency and that the ADM and ADMD hardly ever come to the HHA, they just communicate via telephone. During a review of the HHA’s Policy and Procedure (P&P) titled, “Leadership” revised November 2021, indicated Senior Management will meet monthly to discuss any of the following, as pertinent: Clinical operations (Assessment of care, treatment, services, coordination of care, patient and family caregiver education), including but not limited to services being provided, operational issues, new program development, utilization review issues, and patient and family/caregiver concerns.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure that their designated Administrator (ADM) and designated Administrator Designee (ADMD) assumed responsibility for the overall management of the agency's daily operations. The ADM and ADMD did not oversee and ensure corrected actions were identified, implemented and re-evaluated for the deficient practices identified in the three previous compliant validation surveys. The deficient practice has the potential to affect the quality of care to all the patients’ receiving services. Findings: During an interview with the Director of Nurses (DON), in the HHA’S office on 6/25/2023, at 12:30 p.m., the DON stated that she oversees the day-to-day operation and that the ADM and ADMD monitor the agency with phone calls to her. During a concurrent telephone interview with the Administrator in the HHA’s office on 6/25/2025, at 1:07 p.m., she stated that she was not aware of the deficiencies identified in the three previous complaint validation surveys conducted this year (2025) and that she oversaw the Director of Nurses (DON), by calling her and visiting the agency. During a telephone interview with the ADMD, on 6/25/2025, in the HHA’s office. The ADMD stated that she comes to the office from time to time and that she talked to the DON via phone to see how things were in the agency. During an interview with the DON on 6/25/2025, at 2 p.m. the DON stated She does not coordinate with the Respiratory Therapist (RT - healthcare professional who specializes in evaluating, treating, and caring for individuals with breathing problems and other lung disorders) regarding changes to the ventilator settings for patient 11.and she was not aware of the correct ventilator setting for Patient (Refer to G608). The DON continued to state that the ADM and ADMD do not come to the HHA much, they communicate with the DON via phone. The DON could not provide documentation of when the settings were changed by the RT. The DON was unable to provide documented evidence that management met monthly as indicated in the HHA’s policy and procedure titled, “Leadership”. During a review of the HHA’s Policy and Procedure (P&P) titled, “Leadership” revised November 2021, the P&P indicated “Senior Management will meet monthly to discuss any of the following, as pertinent: Clinical operations (Assessment of care, treatment, services, coordination of care, patient and family caregiver education), including but not limited to services being provided, operational issues, new program development, utilization review issues, and patient and family/caregiver concerns.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the visiting nurse failed to notify the physician of a change of condition for one of four sample patients (Patient 4) when Patient 4’s urine was assessed to be cloudy with sediments (solid material) present. This deficient practice increased the risk of infection for Patient 4, and increased the risk of Patient 4’s suprapubic catheter getting clogged (obstructed). During a review of Patient 4's Face Sheet (front page of the chart that contains a summary of basic information about the patient), the Face Sheet indicated a start of care date (SOC) date of 7/2/2025, with a diagnosis that included neuromuscular dysfunction (a wide-range of diseases affecting the peripheral nervous system, which consists of all the motor and sensory nerves that connect the brain and spinal cord to the rest of the body). During a review of Patient 4’s Home Health Certification and POC for the certification period starting from 4/6/2025 to 6/4/2025, the POC included an order for the license vocational nurse (LVN) to visit Patient 4 to assess the patients genito-urinary system (encompasses the organs of the genital [reproductive] and urinary systems) and pain management on every visits. One of the nursing interventions was to change Patient 4’s supra-pubic catheter number (#) 18 french (f-unit of measure) with 10 milliliters (ml-unit of measure) balloon every month for leakage. During a joint home visit, on 5/28/2025 at 1 p.m., conducted at Patient 4’s residence with the License Vocational Nurse 1 ( LVN 1), observed Patient 4 with an indwelling suprapubic catheter with cloudy urine and sediments present draining in the drainage bag. During an interview with LVN 1 on 5/28/2025, at 1:45 p.m., LVN 1 stated that Patient 4’s urine was cloudy with sediments. LVN 1 stated that she (LVN 1) informed Patient 4’s physician of Patient 4’s cloudy urine with sediments. During a review of Patient 4's Skilled Nurses Notes dated 5/15/2025 and 5/22/2025, the note indicated the patient's urine was assessed with sediments present. There was no documented evidence the physician was notified. During a review of Patient 4's communication notes from 4/6/2025 to 6/4/2025 indicated there was no documented evidence that the visiting nurse notified the HHA or Patient 4’s physician regarding Patient 4's cloudy urine with sediments. During an interview with the DPCS on 5/29/2025 at 12:45 p.m., the DPCS stated she did not get a report from LVN 1 regarding Patient 4's urine being cloudy and having sediments during her visits. DPCS also stated the visiting nurse should coordinate if there is any change of condition with the agency and the physician at all times. During a review of facility’s undated policy and procedure “Physician Notification Of Changes In Care”, indicated the clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. The patient’s physician will be contacted on the same day when any of the following occur: Changes in the patient’s condition. Changes that have occurred regarding diagnosis, prognosis, or treatment (including procedures, medications, precautions, and limitations).

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey, conducted from 1/28/2025 to 1/30/2025. Complaint Number: 112771 Active Patients- 15 Unduplicated admissions: 4 Sample Size - 8 Home visits – 3 The following Condition of Participation not met: 484.60 Care planning, Coordination of Services, and Quality of care

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 maintain an accurate, current medication profile for two of 8 sampled patients (Patient 2 and Patient 5). This deficient practice has the potential to place the patient at risk for medication errors and adverse drug reactions. Findings: During a review of Patient 2’s Home Health Certification and Plan of Care (POC) for the certification period from 12/12/2024 to 2/9/2025, the POC indicated a start of care date (SOC) date of 1/2/2021, with a diagnosis which included quadriplegia (paralysis from the neck down, including legs, and arms, usually due to a spinal cord injury), neurogenic bowel (loss of normal bowel function caused by a nerve problem), and acute kidney failure (a sudden and significant decline in kidney function). The POC included an order for the registered nurse (RN) to visit 2 hours per month and for the licensed vocational nurse (LVN) to visit 172 hours in 30 days to perform all skilled care, medication administration, bowel program daily, and perform catheter (a flexible tube that is inserted into the body to drain or deliver fluids) care each shift and report any change in condition to the RN. During a joint home visit, on 1/29/2025 at 10:20 a.m., at Patient 2’s residence with the licensed vocational nurse (LVN 3), Patient 2 was sitting in his wheelchair awake, alert, and oriented x 3 (to person, place, and time). During a review of Patient 2’s current medication, on 1/29/2025 at 10:37 a.m. with the LVN 3, the following medications were found: - Oxybutynin 10 milligrams (mg- metric unit of measurement, used for medication dosage and/or amount) 1 tablet by mouth twice daily with filled date on 12/9/2024, - Omeprazole 20 mg by mouth daily, filled date on 1/17/2025. However, Patient 2’s current medication profile record provided by the HHA did not indicate Patient 2 was currently taking these medications. During an interview, Patient 2 stated he started taking these two medications recently as ordered by his physician. Patient 2’s medication profile record also indicated patient was still taking famotidine 20 milligram (mg, a unit of measurement) 1 tablet daily (treat stomach ulcers). However, the bottle of famotidine could not be found. Patient 2 stated his physician stopped the medication a couple of weeks back. During an interview, on 1/30/2025 at 1:05 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated nursing staff need to review the patient’s current medication on every nurse visit and update the medication profile in the patient’s clinical record right away. During a review of the agency’s policy and procedure (P&P) titled, Medication Profile dated November 2021, the P&P indicated patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profile will be updated for each change to reflect current medications and new and/or discontinued medications. During a review of Patient 5’s Home Health Certification and Plan of Care (POC) for the certification period from 1/6/2025 to 3/9/2025, the POC indicated a start of care date (SOC) date of 11/28/2020, with a diagnosis which included quadriplegia (paralysis from the neck down, including legs, and arms, usually due to a spinal cord injury), neurogenic bowel (loss of normal bowel function caused by a nerve problem), and acute kidney failure (a sudden and significant decline in kidney function). The POC included an order for the registered nurse (RN) to visit 2 hours per month and for the licensed vocational nurse (LVN) to visit 172 hours in 30 days to perform all skilled care, medication administration, bowel program daily, and perform catheter (a flexible tube that is inserted into the body to drain or deliver fluids) care each shift and report any change in condition to the RN. During a joint home visit, on 1/29/2025 at 12 p.m., at Patient 5’s residence with the licensed vocational nurse (LVN 1), Patient 5 was observed lying in bed with a foley catheter (a thin, flexible tube inserted into the bladder to drain urine) draining yellow, clear urine in a foley bag. During a review of Patient 2’s current medication, on 1/29/2025 at 12:30 p.m. with the LVN 1, the following medications were found: - Promethazine 25 milligrams (mg- metric unit of measurement, used for medication dosage and/or amount) 1 tablet by mouth every four to six hours as needed with a fill date on 12/28/24. - Oxybutynin 10 mg one tab by mouth daily with a filled date on 12/18/2024. -Linzess 145 micrograms one tab daily with a fill date on 9/23/24. -Solifenacin 10 mg one tab daily with fill date on 1/16/25. However, Patient 5’s current medication profile record provided by the HHA did not indicate Patient 5 was currently taking these medications. During an interview with LVN 1 on 1/29/25, at 1 p.m., when asked if she was checking Patient 5's actual medications, LVN 1 she does not check the patient's actual medications regularly.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to conduct the resumption of care (ROC) assessment (in-person clinical assessment of the patient's physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency's services) for one of 8 sampled patients (Patient 1) after returning home from a hospital admission of more than 24 hours. This deficient practice had the potential to result in Patient 1’s immediate needs will not be identified which are needed to formulate the patient's resumption plan of care (POC). Findings: During a review of Patient 1’s Home Health Certification and Plan of Care (POC) for the certification period from 12/3/2024 to 1/31/2025, the POC indicated a start of care date (SOC) date of 2/7/2024, with a diagnosis which included quadriplegia (paralysis from the neck down, including legs, and arms, usually due to a spinal cord injury), and neuromuscular dysfunction(a group of disorders that affect the nerves and muscles, impairing their communication and function). The POC included an order for the licensed vocational nurse (LVN) to visit 540 hours every 30 days. The LVN was to perform observation and monitoring of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level/comfort, and patency of suprapubic catheter (a thin, flexible tube that is inserted through the abdominal wall into the bladder to drain urine). During a concurrent interview and record review on 1/30/2025 at 1:05 pm., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 3’s Nursing visit calendar and clinical record. DPCS stated Patient 1 was admitted to acute hospital on 12/15/2024 and was discharged home on 12/23/2024 and again was admitted to acute hospital on 1/1/2025 and came back home on 1/7/2025. The DPCS stated and acknowledged there was no documented evidence of an updated comprehensive assessment (Resumption of Care [ROC] assessment) was conducted and completed for Patient 1 after returning home from a hospital admission on 12/23/2024 and on 1/7/2025. DPCS stated ROC assessment should have been conducted within 48 hours when patient returned from the hospital for 24 hours or more of hospital admission, but in the case for Patient 1, the ROC assessment was not done. During a review of the agency’s policy and procedure (P&P) titled, Reassessment/Recertification dated November 2021, the P&P indicated a comprehensive assessment, including all required OASIS data elements, must be performed to measure patient progress toward outcomes. Each patient will be reassessed using a comprehensive OASIS assessment tool for the review and revision of the plan of care when…the patient returns home after an inpatient admission lasting 24 hours or longer for any purpose other than diagnostic testing.

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, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the Condition of Participation for Care Planning, Coordination of Services, and Quality of Care was met as follows: 1. The HHA failed to ensure care and services was completed in accordance with the plan of care (POC), for two of 8 sampled patients (Patient 1 and Patient 3). For Patient 1, the HHA failed to ensure frequency of visits was completed. For Patient 3, the HHA failed to check patient’s vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate). This deficient practice resulted in Patient 1 and Patient 3 not receiving the care and services as ordered. (Refer to G572) 2. The HHA failed to develop and implement an individualized plan of care for a patient receiving anticoagulant (blood thinners-to prevent and treat blood clots) medication for one of 8 sampled patients (Patients 3). This failure had the potential to cause serious complications that could affect the patients’ health status and well-being. (Refer to G574) 3. The HHA failed to ensure designated attending physician was notified and notification was documented when ordered home visit service was missed for one of 8 sampled patients (Patient 1). This failure had the potential for the patient’s condition to deteriorate with no immediate interventions due to the lack of physician notification by the HHA. (Refer to G602) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure the highest quality health care is provided to patients assessed to receive home health services. 1 1. The home health agency (HHA) failed to ensure care and services are implemented in accordance with the individualized written plans of care (POC) for three of 8 sampled patients (Patient 1, Patient 3 and Patient 4). This deficient practice resulted in Patient 1, Patient 3 and Patient 4 certified to receive home health care and services were not rendered as ordered on the POC. (Refer to G572). 2. The HHA failed to develop and implement an individualized plan of care for a patient receiving anticoagulant (blood thinners-to prevent and treat blood clots) medication for two of 8 sampled patients (Patient 3 and Patient 5). This failure had the potential to cause serious complications that could affect the patients’ health status and well-being. (Refer to G574). 3. The home health agency (HHA) failed to obtain a physician's order for a tracheostomy ventilator (a breathing machine that's connected to a tracheostomy, which is a surgical opening in the neck to help patients to breathe when they can't breathe on their own) setting for one out of eight sampled patients (Patient 6). This deficient practice placed the patient at risk for an unsafe ventilator setting will be administered to the patient that could lead to lung injury, oxygen toxicity, and or death. Refer to G580. 4. The Home Health Agency (HHA) failed to coordinate with the attending physician of the missed skilled nursing visits for one of 8 sampled patients (Patient 1). This failure had the potential for the patient’s change of condition, progress or decline will not be identified and coordinated to the physician for immediate interventions and further treatment. (Refer to G602). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure the 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 care and services are implemented in accordance with the individualized written plans of care (POC) for three of 8 sampled patients (Patient 1, Patient 3 and Patient 4). This deficient practice resulted in Patient 1, Patient 3 and Patient 4 certified to receive home health care and services were not rendered as ordered on the POC. Findings: a. During a review of Patient 1’s Home Health Certification and Plan of Care (POC) for the certification period from 12/3/2024 to 1/31/2025, the POC indicated a start of care date (SOC) date of 2/7/2024, with a diagnosis which included quadriplegia (paralysis from the neck down, including legs, and arms, usually due to a spinal cord injury), and neuromuscular dysfunction(a group of disorders that affect the nerves and muscles, impairing their communication and function). The POC included an order for the licensed vocational nurse (LVN) to visit 540 hours every 30 days to perform observation and monitoring of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level/comfort, and patency of suprapubic catheter (a thin, flexible tube that is inserted through the abdominal wall into the bladder to drain urine). During a review of Patient 1’s Nursing Clinical Notes during the week starting from 1/12/2025 to 1/18/2025, the Clinical Notes indicated Patient 1 was not visited by a skilled nurse on 1/14/2025, 1/16/2025 and 1/18/2025. During the week starting from 1/19/2025 to 1/25/2025, Patient 1 was not visited by a skilled nurse on 1/20/2025 and 1/21/2025. b. During a review of Patient 3’s Home Health Certification and POC for the certification period from 1/5/2025 to 3/5/2025, the POC indicated a SOC date of 1/11/2024, with a diagnosis which included aneurysm (a weakened and bulging section of a blood vessel), retention of urine, and immobility syndrome (a condition that occurs when someone is immobile or inactive for a prolonged period). The POC included an order for the skilled nurse (SN) to visit once a week for 9 weeks to perform skilled nursing assessment/observation of all body systems, vital signs especially blood pressure, to review patient’s compliance with prescribed treatment regimen, and to change indwelling foley catheter (a thin, flexible tube inserted into the bladder through the urethra to drain urine continuously) every week and as needed for leaking, blockage or accidental pulling out. During a review of Patient 3’s Nursing Clinical Note dated 1/4/2025, the Clinical Note indicated that Patient 3’s vital signs was not checked. On 1/18/2025, the Nursing Clinical Note indicated Patient 3’s blood pressure was not checked and documented. For Nursing Clinical Note dated 1/11/2025 and 1/25/2025, Patient 3’s temperature was not checked. During a concurrent interview and record review on 1/30/2025 at 1:05 pm with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 1 and Patient 3’s Nursing Clinical Notes. The DPCS stated and acknowledged the agency had missed visits and not meeting the required number of hours per month for skilled nursing in accordance with the plan of care for Patient 1. The DPCS also stated skilled nurse should always checked patient vital signs and then document on every nursing visit. The DPCS further stated the HHA staff should follow the plan of care to prevent a potential delay in providing care and treatment to the patient. During a review of the agency's policy and procedure (P&P) titled, Care Planning Process, dated November 2021, the P&P indicated a written individualized plan of care will be initiated within five (5) days of start of care and updated at least every 60 days, or as patient’s condition warrants. The care planning decisions will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet the individualized patient problems and goals. The plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. a. During a review of Patient 4’s Home Health Certification and Plan of Care (POC) for the certification period from 12/7/2024 to 2/4/2025, the POC indicated a start of care date (SOC) date of 7/1/2020, with a diagnosis which included neuromuscular dysfunction (disease affecting the peripheral nervous system, the neuromuscular junctions, all of which are components of the motor unit). The POC included an order for the licensed vocational nurse (LVN) to visit 136 hours every 30 days to perform observation and monitoring of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level/comfort. During a review of Patient 4’s Nursing Clinical Note dated 1/4/2025, the Clinical Note indicated that Patient 4’s vital signs was not checked. The Nursing Clinical Note dated 1/16, 1/8 and 1/23/25, indicated Patient 4’s blood pressure was not checked and documented.

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 develop and implement an individualized plan of care (POC) for two out of eight sampled patients (Patient 3 and Patient 5). For Patient 3, there was no plan of care developed for a patient receiving anticoagulant (blood thinners-to prevent and treat blood clots) medication. For Patient 5, there was no care plan developed for Foley catheter (a flexible tube inserted into the bladder to drain urine) management. This failure had the potential to cause serious complications that could affect the patients’ health status and well-being. Findings: During a review of Patient 3’s Home Health Certification and POC for the certification period from 1/5/2025 to 3/5/2025, the POC indicated a start of care date (SOC) date of 1/11/2024, with a diagnosis which included aneurysm (a weakened and bulging section of a blood vessel), retention of urine, and immobility syndrome (a condition that occurs when someone is immobile or inactive for a prolonged period). The POC included an order for the skilled nurse (SN) to visit once a week for 9 weeks to perform skilled nursing assessment/observation of all body systems, to review patient’s compliance with prescribed treatment regimen, and to change indwelling foley catheter (a thin, flexible tube inserted into the bladder through the urethra to drain urine continuously) every week and as needed for leaking, blockage or accidental pulling out. During a review of Patient 3's Medication Profile record, the Medication Profile indicated Patient 3 was taking Apixaban (Eliquis, an anticoagulant) 5 milligrams (mg, a unit of measurement) one tablet by mouth twice daily. During a further review of Patient 3's POC and clinical record indicated no care plan was developed identifying the use of the anticoagulant medication. During a concurrent interview and record review on 1/30/2025 at 1:05 pm with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 3’s POC. The DPCS stated Patients 3 was on an anticoagulant medication and no care plan was developed to monitor the patient for bleeding. The DPCS stated Patient 3’ care plan should have a care plan for the patient’s use of Eliquis so that HHA’s field nurses knew what to do to keep the patient safe in case Patient 3 had a bleeding episode. During a review of the agency’s policy and procedure (P&P) titled, Care Planning Process dated November 2021, the P&P indicated a written individualized plan of care will be initiated within five days of start of care and updated at least every 60 days, or as patient’s condition warrants. The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. b. During a review of Patient 5’s Home Health Certification and Plan of Care (POC) for the certification period from 1/6/2025 to 3/9/2025, the POC indicated a start of care date (SOC) date of 11/28/2020, with a diagnosis which included quadriplegia (paralysis from the neck down, including legs, and arms, usually due to a spinal cord injury), neurogenic bowel (loss of normal bowel function caused by a nerve problem), and acute kidney failure (a sudden and significant decline in kidney function). The POC included an order for the registered nurse (RN) to visit 2 hours per month and for the licensed vocational nurse (LVN) to visit 172 hours in 30 days to perform skilled nursing assessment/observation of all body systems, to review patient’s compliance with prescribed treatment regimen, and to change indwelling foley catheter every week and as needed for leaking, blockage or accidental pulling out. During a joint home visit, on 1/29/2025 at 12 p.m., at Patient 5’s residence with the licensed vocational nurse (LVN 1), Patient 5 was observed lying in bed with a foley catheter (a thin, flexible tube inserted into the bladder to drain urine) draining yellow, clear urine in a foley bag. During a further review of Patient 5's POC and clinical record indicated no care plan was developed for indwelling foley catheter care management. During a concurrent interview and record review on 1/30/2025 at 12:45 pm with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 5’s POC. The DPCS stated Patient 5 had an indwelling foley catheter and there should have been a care plan developed for foley care management.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to obtain a physician's order for a tracheostomy ventilator (a breathing machine that's connected to a tracheostomy, which is a surgical opening in the neck to help patients to breathe when they can't breathe on their own) setting for one out of eight sampled patients (Patient 6). This deficient practice placed the patient at risk for an unsafe ventilator setting will be administered to the patient that could lead to lung injury, oxygen toxicity, and or death. During a review of Patient 6’s Home Health Certification and Plan of Care (POC) for the certification period from 1/25/2025 to 3/25/2025, the POC indicated a start of care date (SOC) date of 2/10/2022, with a diagnosis which included acute respiratory failure (occurs when the respiratory system can't maintain normal levels of oxygen and carbon dioxide in the body). The POC included an order for the licensed vocational nurse (LVN) to visit 136 hours every 30 days. LVN was to perform skilled observation and monitoring of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level/comfort. The nursing intervention included tracheostomy care every shift and check and document ventilator setting every visit. During a review of Patient 6’s Nursing Clinical Note dated 1/26 and 1/27/25, indicated Patient 6 was on a ventilator setting as follows: -Mode Control=AC -Volume=900 -BPM Rate=16 -High Pressure Alarm=60 -Low Pressure Alarm=11 Further review of Patient 6's POC indicated there was no physician's order for the tracheostomy ventilator machine settings to be set and monitored by a qualified practitioner. During a concurrent interview and record review on 1/30/2025 at 11:45 pm., with the Director of Patient Care Services (DPCS) stated, there was no physician's orders for the settings and will call the physician for orders for the tracheostomy ventilator machine setting right away.

Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to coordinate with the attending physician of the missed skilled nursing visits for one of 8 sampled patients (Patient 1). This failure had the potential for the patient’s change of condition, progress or decline will not be identified and coordinated to the physician for immediate interventions and further treatment. Findings: During a review of Patient 1’s Home Health Certification and Plan of Care (POC) for the certification period from 12/3/2024 to 1/31/2025, the POC indicated a start of care date (SOC) date of 2/7/2024, with a diagnosis which included quadriplegia (paralysis from the neck down, including legs, and arms, usually due to a spinal cord injury), and neuromuscular dysfunction(a group of disorders that affect the nerves and muscles, impairing their communication and function). The POC included an order for the licensed vocational nurse (LVN) to visit 540 hours every 30 days. LVN was to perform observation and monitoring of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level/comfort, and patency of suprapubic catheter (a thin, flexible tube that is inserted through the abdominal wall into the bladder to drain urine). During a review of Patient 1’s Nursing Clinical Notes during the week starting from 1/12/2025 to 1/18/2025, the Clinical Notes indicated Patient 1 was not visited by a skilled nurse on 1/14/2025, 1/16/2025 and 1/18/2025. During the week starting from 1/19/2025 to 1/25/2025, Patient 1 was not visited by a skilled nurse on 1/20/2025 and 1/21/2025. There was no documented evidence Patient 1’s physician was notified of the missed visits during these dates. There was no documented evidence LVN performed skilled observation and monitoring of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level/comfort, and patency of suprapubic catheter (a thin, flexible tube that is inserted through the abdominal wall into the bladder to drain urine) as indicated on the POC. During a concurrent interview and record review on 1/30/2025 at 1:05 pm with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 1’s Nursing Clinical Notes. The DPCS stated and acknowledged the agency had missed visits and not meeting the required number of hours per month for skilled nursing in accordance with the plan of care for Patient 1. The DPCS stated that for any missed visit, patient’s attending physician should be notified promptly per the agency’s policies and procedures. DPCS stated that in the case for Patient 1, it was not done. During a review of the agency’s policy and procedure (P&P) titled, Missed Visits, dated November 2021, the P&P indicated missed visits will be communicated to the clinical supervisor and the patient’s physician. If a visit is missed and not rescheduled, the clinician will notify the physician and clinical supervisor of the missed visit and reason for missed visit.