Pacific Health Services, Inc.

“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 observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services 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 and Medicaid programs) for care planning, coordination of services, and quality of care was met as follows: 1. The HHA failed to implement 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) for Registered Nurse (RN) to perform tracheostomy (a surgical procedure that creates an opening in the neck into the windpipe [trachea] to allow for a tube to be inserted for breathing) management and was being implemented by Licensed Vocational Nurse (LVN1) for one of seven sampled patients (Patient 2), that was outside the LVN1 scope of practice. This failure placed Patient 2 at increased risk for bleeding, respiratory distress that could lead to hospitalization or death. (Refer to G572). 2. The HHA failed to ensure a physician order was obtained for tracheostomy management that included the tracheostomy tube (a curved, hollow tube inserted into a surgically created opening in the neck to provide a direct airway into the trachea [windpipe] type, size, and frequency of change for one of seven sampled patients (Patient 2). This failure placed Patient 2 at increased risk for bleeding, respiratory distress, that could lead to serious harm, hospitalization or death. (Refer to G580). 3. The HHA failed to ensure a Licensed Vocational Nurse (LVN1) did not perform the physician’s orders dated 8/7/2025 and 10/8/2025, that indicated the registered nurse (RN) to perform the following tracheostomy care for Patient 2: Performs the tracheostomy management of Patient 2, which includes changing the tracheostomy tube. Inspect Patient 2’s tracheotomy (the surgical procedure of creating an opening [incision] into the trachea [windpipe] through the neck) site daily for erythema (redness), swelling, discharge, or odor, report abnormal findings to the provider. Clean Patient 2’s stoma (opening) and peristomal (around the opening) skin with sterile saline (a purified saltwater solution that is free from microorganism [an organism that can be seen only through a microscope] making it safe for medical use like flushing wounds, irrigating eyes or rehydrating the patient) or as directed, removing all crusts and secretions. Replace Patient 2’s tracheostomy dressings and ties as ordered, ensuring secure placement without excessive tightness or risk for pressure injury (localized damage to skin and/or underlying tissue, usually over a bony prominence [a part of the body where a bone is close to the skin’s surface with little fat or muscle padding, like the elbows, heels, or sacrum], caused by intense/prolonged pressure, often combined with shear forces [when layers of tissue slide in opposite directions, like skin moving one way while deeper tissues move another, often due to gravity or movement in bed, which stretches, tears blood vessels, restricts flow, and causes severe tissue damage], leading to tissue death [necrosis] by cutting off blood flow and oxygen). Verify Patient 2’s presence of emergency airway equipment (devices used by medical professionals to quickly open and secure a patient’s airway to deliver oxygen, especially when they are unable to breathe on their own, preventing suffocation [severe deprivation of oxygen, causing the inability to breathe] and allowing for ventilation [exchange of air between the lungs and the atmosphere so that oxygen can be exchanged for carbon dioxide] in critical situations) at bedside including the following: A spare tracheostomy tube (same size and one size smaller) Obturator (a temporary, solid guide inserted into the main body [outer cannula, a tube that can be inserted into the body] of a tracheostomy tube during placement or replacement), Suction set up (system that uses negative pressure [vacuum] to mechanically remove fluids (like mucus, blood, or saliva) or debris from a patient’s airway during medical procedures or emergencies) Bag valve mask (a handheld emergency device with a self-inflating bag, one-way valve, and face mask, used to provide positive pressure breaths [rescue ventilation] to an individual who is not breathing adequately, essentially helping to breathe until advanced help arrives or if breathing returns). This failure placed Patient 2 at increased risk for bleeding, respiratory distress, that could lead to serious harm, hospitalization or death. (Refer to G580). 4. The HHA failed to ensure a physician’s order was obtained and recorded for tracheostomy management that included the tracheostomy tube type, size, and frequency of change in the Plan of Care for one of seven sampled patients (Patients 2). This deficient practice had the potential to result in Patient 2 not receiving the appropriate nursing care and services needed. (Refer to G576). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (decided and controlled by law) mandated compliance with federal regulation for care planning, coordination of services, and quality of care to ensure quality patient care was provided to certified home health patients.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to implement 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) for Registered Nurse (RN) to perform tracheostomy management but was being implemented by Licensed Vocational Nurse (LVN1) for one of seven sampled patients (Patient 2), that was outside the LVN1 scope of practice. This failure placed Patient 2 at increased risk for bleeding, respiratory distress that could lead to hospitalization or death. On 12/5/2025 at 2:05 p.m., while onsite, the Department called a 2nd 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 home health agency’s Administrator/Director of Patient Care Services (ADM/DPCS) , Administrator Designee, Case Managers and the Office Manager related to the home health agency’s failure to implement the plan of care for Registered Nurse (RN) to perform but was being implemented by LVN1 for one of seven sampled patients (Patient 2), that was outside the LVN1 scope of practice. On 12/5/2025 at 3:10 p.m., the HHA was unable to submit an IJ removal Plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). The survey team completed the survey tasks and exited the HHA with the IJ situation not removed. On 12/12/2025 the HHA submitted an IJ removal plan which was reviewed and accepted. On 12/12/2025 at 3:43 PM, the survey verified the implementation of the IJ removal during an on-site visit and the IJ was removed in the presence of the Administrator designee and Office Manager. During a review of Patient 2’s medical record titled, “Patient Profile,” the Patient Profile indicated that Patient 2, female, 23 months old, had a start of care (SOC) date on 6/18/2024, with diagnoses that included encounter for attention to tracheostomy (a surgical procedure that creates an opening in the neck into the windpipe [trachea] to allow for a tube to be inserted for breathing), stenosis of larynx (the narrowing of the airway within the larynx [voice box] and restricts the passage of air, which can make it hard to breathe, speak, and cough), acute respiratory failure with hypoxia (a sudden, severe inability of the lungs to get enough oxygen into the blood, leading to dangerously low blood oxygen levels [hypoxemia] despite breathing normal air, causing symptoms like shortness of breath, confusion, and fatigue), and dysphagia (difficulty swallowing, which can make it hard for food and liquids to move from the mouth down to the stomach). During a review of Patient 2’s medical record titled “Physician Order,” dated 8/7/2025 and 10/8/2025, the Physician Order indicated Registered Nurse (RN) to perform the following Tracheostomy Care: Perform meticulous hand hygiene and use sterile techniques (a set of strict medical practices to prevent all microorganisms (germs, bacteria, viruses) from entering a sterile field, like a surgical site or a patient’s body, ensuring it remains completely free from contamination to stop infections), during all tracheostomy care procedures to minimize infection risk. Inspect the site daily for erythema (redness), swelling, discharge, or odor and report abnormal findings to the provider. Clean the stoma and peristomal skin (referring to the skin area surrounding a surgically created opening (stoma) with sterile saline (a purified saltwater solution that is free from microorganism making it safe for medical use like flushing wounds, irrigating eyes or rehydrating the patient) or as directed, removing all crusts and secretions. Replace tracheostomy dressings and ties as ordered, ensuring secure placement without excessive tightness or risk of pressure injury. Verify the presence of emergency airway equipment at bedside, including a spare tracheostomy tube, obturator (something that blocks or closes an opening), suction set up, and bag valve mask (a crucial, hand-held device used by emergency personnel and healthcare providers to manually deliver breaths to patients who can’t breathe adequately on their own). During a review of Patient 2’s medical record titled “Home Health Certification and Plan of Care (POC, consists of different patient goals, nursing and health assessment and interventions to help attain those goals, and expected outcomes aligned with the patient’s needs),” with certification period from 10/11/2025 to 12/9/2025, the Home Health Certification and POC indicated that RN Supervisory Visit: Monthly and that the purpose of the visit included tracheostomy management and ventilator (a device that helps a deliver oxygen and removes carbon dioxide through a tube or mask to support life) management (the process of using a machine to help or completely control a patient’s breathing, adjusting settings like breath rate and air volume, and ensuring proper oxygenation [the process of supplying oxygen to the body’s tissues and cells, primarily through the lungs’ gas exchange with blood]). During a concurrent observation and interview on 12/3/2025 at 10:45 a.m., with Licensed Vocational Nurse (LVN) 1, in Patient 2’s residence in the living room, Patient 2 was observed with tracheostomy tube size 3.5 millimeters (mm, unit of length) to room air, secured by a tracheostomy tie. LVN 1 stated that he took care of Patient 2, who was 23 months old, for one and a half years now. LVN 1 stated that he performed Patient 2’s daily tracheostomy assessment, tracheostomy care, tracheostomy dressing and tie change. LVN 1 stated he changed Patient 2’s tracheostomy tubes every Monday. LVN 1 stated that RN 1 visited Patient 2 monthly to conduct head-to-toe assessment (a process that checks the health status of all major body systems of a patient), and to check proper placement of tracheostomy tube. During a concurrent observation and interview on 12/3/2025 at 10:47 a.m., at Patient 2’s residence in the living room, with LVN1, there were three (3) unopened supplies of tracheostomy tube (Bivona Silicone [a brand name of flexible tracheostomy tube used for infants and children], size 3.5 millimeters (mm, unit of length) observed. LVN 1 stated that he used the Bivona Silicone tracheostomy tube for Patient 2’s tracheostomy tube replacement. LVN 1 stated that he was unsure if supplies for Patient 2’s tracheostomy tube were delivered or picked up from the clinic. LVN 1 stated he only had the supply of tracheostomy tube with the size of 3.5 mm. During an interview on 12/3/2025 at 10:49 a.m., LVN 1 stated that he knew how to change Patient 2’s tracheostomy tube through his previous experiences. LVN 1 stated that tracheostomy tube care was within the scope of his practice, and he learned it from school and from his previous works. LVN 1 stated that he did his tracheostomy management including tracheostomy tube change skills validation and reviews on his own by watching videos online. LVN 1 stated that last month, he completed his skills revalidation regarding tracheostomy tube change, but it was from his other job and not with this HHA. LVN 1 stated that he documented tracheostomy tube change date in Patient 2’s chart. During an interview on 12/3/2025, at 10:57 a.m., with Patient 2’s Family member (FM 1). FM 1 stated that Patient 2 was 23 months old and she (FM 1) was the primary caregiver when LVN 1 was not around. FM 1 stated that LVN 1 took care of Patient 2 for eight (8) hours daily, Monday through Friday. FM 1 stated that LVN 1 replaced Patient 2’s tracheostomy tubes every Monday and as needed. FM 1 stated that Registered Nurse (RN) 1 visits Patient 2 once a month to check her but did not notice if RN 1 performs tracheostomy tube replacement for Patient 2. During a concurrent record review and interview on 12/4/2025, at 10:30 a.m., with the DPCS, Patient 2’s medical record titled “Skilled Nursing Flowsheet (a specific, standardized documentation tool used by nurses to quickly and consistently record and track essential patient data over time),” the Skilled Nursing Flowsheet indicated the following: The DPCS confirmed and stated that Patient 2’s Skilled Nursing Flowsheet dated 10/24/2025 indicated LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 10/20/2025, changed by: SN. The DPCS stated that SN (Skilled Nurse) was LVN 1 The DPCS confirmed and stated that Patient 2’s Skilled Nursing Flowsheet dated 10/27/2025 indicated LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 10/27/2025, changed by: SN. The DPCS stated that SN was LVN 1. The DPCS confirmed and stated that Patient 2’s Skilled Nursing Flowsheet dated 11/20/2025 indicated LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 11/20/2025, changed by: SN. The DPCS stated that SN was LVN 1. The DPCS confirmed and stated that Patient 2’s Skilled Nursing Flowsheet dated 11/24/2025 indicated LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 11/24/2025, changed by: SN. The DPCS stated that SN was LVN 1. During a concurrent record review and interview on 12/4/2025, at 10:55 a.m., with the DPCS, Patient 2’s medical record titled “Skilled Nursing Flowsheet,” dated from 8/1/2025 to 8/29/2025, and 9/2/2025 to 9/30/2025 were reviewed. The DPCS confirmed and stated that the Skilled Nursing Flowsheets dated from 8/1/2025 to 8/29/2025, and 9/2/2025 to 9/30/2025 indicated that LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 11/24/2025, changed by: SN. The DPCS stated that SN was LVN 1. During a telephone interview on 12/4/2025, at 11:17 a.m., with the Registered Nurse (RN 1), RN 1 stated that he was the RN that visits Patient 2 every month. RN 1 stated that he performed head-to-toe assessments including tracheostomy assessment, safety precautions, changing the tracheostomy tube if needed and checking proper tracheostomy tube placement. RN 1 stated that he was unsure if LVN is allowed to change a tracheostomy tube and if it is within the scope of practice. During an interview with the Director of Patient Care Services designee (DPCSD) on 12/4/2025, at 4 p.m., the DPCSD stated that if a skilled nurse (SN) was not well trained, inexperienced and unqualified to perform tracheostomy care including tracheostomy tube replacement, it could lead to serious harm that would result to hospitalization and/or death. During an interview with the DPCS on 12/5/2025, at 11:48 a.m., the DPCS stated that it was important that every treatment has a physician’s order to validate that it was correct and to prevent harm to patient. The DPCS stated that it was inappropriate to perform treatment with no physician order and that providing treatment without physician order could lead to serious harm, hospitalization, or death. During a review of the HHA’s P&P, titled “Physician Participation in Plan of Care,” undated, the P&P indicated that orders are reviewed for appropriateness and accuracy before care, treatment and services are provided, the organization may assist the physician in determining medical necessity and formulating an appropriate plan of care, if requested by the physician. During a review of the HA’s P&P 2, titled “Care Planning Process,” undated, P&P 2 indicated that 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. During a review of the California Board of Vocational Nursing and Psychiatric Technicians (BVNPT) regulations regarding Changes to Respiratory Care Scope of Practice, effective date of 10/1/2025, it indicated that the BVNPT would like to inform licensees, employers and educators of regulations adopted by the Respiratory Care Board (RCB) impacting the scope of practice licensed vocational nurses (LVNs) going into effect on October 1, 2025. These regulations impact the LVN scope of practice with various changes, as described below. BVNPT licensees, employers and educators are expected to comply with the regulations. Licensed Vocational Nurses (LVNs) CAN perform the following: Patient data collection. Application and monitoring of a pulse oximeter (a device used to measure the oxygen level of the blood). Medication administration by aerosol (aerosol (a method of delivering medication directly into the airways and lungs as a suspension of fine liquid or solid particles in a gas) that does not require manipulation of an invasive (a procedure that enters the body, usually by breaking the skin [incision/puncture] or through a natural opening [like mouth/nose/rectum] using instruments [needles, tubes, scopes, scalpels] to diagnose, treat, or monitor) or non-invasive (a procedure or treatment that does not break the skin or enter the body) with instruments mechanical ventilator. Heat moisture exchanger (HME) helps to reduce mucus production and coughing by humidifying and filtering the air you breathe through your stoma and oxygen tank replacement for patients who are using non-invasive mechanical ventilation. Hygiene care includes replacement of tracheostomy ties and gauze and cleaning of the stoma sites. Use of a manual resuscitation device and other cardio-pulmonary resuscitation technical skills (basic life support level) in the event of an emergency. Documentation of care provided, which includes data retrieved from performing a breath counter transcribing data from an invasive or non-invasive ventilator interface (the physical device that connects the mechanical ventilator machine to the patient’s airways). Observing and gathering data from chest auscultation. Licensed Vocational Nurses (LVNs) CANNOT perform the following: Manipulation of an invasive or non-invasive ventilator. Assessment or evaluation of observed and gathered data from chest auscultation (listening to the internal sounds of the body, usually with a stethoscope), palpation (where a healthcare provider uses their hands and fingers to feel a patient’s body to assess the size, shape, texture, consistency, location, and tenderness of organs, muscles, or other structures), and percussion (where a healthcare provider taps on the body’s surface (like the chest or abdomen) to assess underlying structures by listening to the sounds produced, revealing if tissues are solid, air-filled, or fluid-filled). Pre-treatment or post-treatment assessment. Use of medical gas mixtures (a precisely formulated combination of pharmaceutical-grade gases [like oxygen, nitrogen, nitrous oxide, carbon dioxide, helium] used for therapeutic, diagnostic, or procedural purposes) other than oxygen. Preoxygenation (delivering high-flow oxygen [usually 100%] to a patient before airway procedures) or endotracheal (the medical procedure or device for placing a tube [an endotracheal tube, or ETT] into the windpipe [trachea] through the mouth [or sometimes nose] to secure an airway for breathing support) or nasal suctioning. Initial setup, change out, or replacement of a breathing circuit (the tubing and components connecting a respiratory device) or adjustment of oxygen liter flow (the rate at which supplemental oxygen is delivered to a patient) oxygen concentration. Tracheal suctioning, cuff inflation (seals the airway for positive pressure ventilation, preventing air leaks but blocking the upper airway, hindering speech and potentially impairing swallowing/lung function)/deflation (allows airflow around the tube, restoring speech, improving swallow/respiratory mechanics, and reducing infection risk), use or removal of an external speaking valve, or removal and replacement of the tracheostomy tube or inner cannula (a thin, flexible tube inserted into the body). Important Note: The Vocational Nursing Practice Act authorizes LVNs to perform services under the direction of only licensed physicians, registered nurses (including nurse practitioners [NP]) and naturopathic doctors (a primary care provider trained in both basic sciences [like MDs] and natural, holistic therapies to support the body’s self-healing, focusing on root causes using nutrition, herbs, lifestyle). LVNs work with Respiratory Care Practitioners as part of patient care team members but shall only work under the direction of a licensed physician, registered nurse (including NPs) and naturopathic doctors. Board of Vocational Nursing & Psychiatric Technicians- https://www.bvnpt.ca.gov=Changes to Respiratory Care Scope of Practice Effective 10/1/2025.”

“Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. 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 therapeutic services to a patient’s personal residence) failed to ensure an allegation of patient neglect was reported to the Department for one of seven (Patient 1) sampled patients as required. This failure had the potential for Patient 1 to remain in an unsafe environment that could lead to serious injury and re-hospitalization. Findings: During a review of Patient 1’s Patient Profile (admission record), The Patient Profile indicated Patient 1 had a Start of Care (SOC) date of 11/07/2025, with diagnoses that included cerebral palsy (brain disorder that permanently affects body movement and muscle coordination), quadriplegia (paralysis from the neck down, including legs, and arms, usually due to a spinal cord injury), and dysphagia (difficulty swallowing). During a concurrent interview and record review on 12/2/2025 at 1:04 p.m. with the Director of Patient Care Services Designee (DPCSD), the complaint log from 12/02/2024 to 12/02/2025 was reviewed. The DPCSD stated there was only one complaint filed for the last 12 months dated 6/27/2025. The DPCSD stated the complaint report from the visiting Licensed Vocational Nurse (LVN) regarding Patient 1 did not receive appropriate oral care from another LVN. The DPCSD stated the complaint was an allegation of neglect. The DPCSD stated the allegation of neglect was not reported to local authorities. During a concurrent interview and record review on 12/2/2025 at 1:40 p.m. with Case Manager (CM) 1. The “Communication Notes: Intervention Resolution” dated 6/27/2025 was reviewed. CM 1 stated he did the investigation of the complaint and allegation, and the HHA determined neglect was unsupported. CM 1 stated he spoke to Patient 1’s primary care giver (PCG) on 6/30/2025 and was told that PCG reviewed their cameras at home and did not see any form of abuse or neglect Patient 1. CM 1 stated there were no written statements received from the involved LVNs, nor were any photograph evidence submitted to HHA. CM 1 stated all licensed nurses, and staff are mandated reporters for abuse and neglect. CM 1 stated the allegation of neglect was not reported to local authorities because they have determined that the neglect to Patient 1 did not occur. During an interview on 12/9/2025 at 2:40 p.m. with the DPCSD. The DPCSD stated he was responsible for reporting abuse and neglect to the local authorities such as Adult Protective Services (APS, a mandated program dedicated to maintaining the health and safety of elderly and dependent adults), Child Protective Services (CPS) and/or California Department of Public Health (CDPH). The DPCSD stated the investigation for this allegation was completed and deemed unsupported. The DPCSD stated verified and suspected abuse should be reported to local authorities to be thoroughly investigated. The DPCSD stated not reporting to local authorities may lead to HHA’s violation of mandatory reporting laws and patients affected may remain with unsafe care that may lead to serious injury or re-hospitalization. During a review of HHA’s policies and procedures (P&P) titled “Assessment of Possible Abuse/Neglect”, undated. The P&P indicated the following: - “Neglect: Failure of caretaker to supply patient with food, clothing, shelter, health care, or supervision” - “The organization will report all suspected cases of abuse, neglect, or exploitation in compliance with appropriate state statutes to appropriate protection organization.” - “Individual mandated to report: A professional or the professional’s delegate who is engage in the care of patients, or in education, social services, law enforcement, or in any of the related occupations, who had knowledge of the abuse or neglected, or has reasonable cause to believe that a patient is being or has been abused or neglected, or who has knowledge that a patient has sustained a physical injury that is not reasonably explained by the history of injuries provided by the caretaker or caregiver(s) of the patient.” - “The clinician will submit a verbal report of the suspected abuse/neglect to the proper authorities in accordance with state law and completed a suspected abuse and/or neglect investigation report within 24 hours of the incidents, with the addition of the following: A. Name of the alleged perpetrator B. Relationship to patient, if any C. Information regarding suspected abuse/neglect: 1. Date or occurrence 2. Witness to occurrence, if any 3. Nature of occurrence 4. Description of the abuse/neglect””

“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, interviews, and record review, the Home Health Agency (HHA, public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the plan of care (POC, a detailed summary of the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was individualized and documented all patient-specific interventions and education regarding tracheostomy (trach, surgical opening in the neck into the windpipe to allow for a tube to be inserted for breathing) care for one of seven sampled patients (Patient 7) by failing to: 1. Ensure Patient 7’s POC for respiratory care included measurable outcomes and goals identified by the HHA and the patient’s caregiver (PCG). 2. Ensure Patient 7’s POC indicated who was responsible for Patient 7’s trach tube replacements, daily cleaning, and care. 3. Ensure Patient 7’s POC reflected Patient 7’s trach manufacturer guidelines. These failures had the potential to result in Patient 7’s decline in health condition and increased risk for infections and/or lung complications related to the inconsistent POC implementation related to the trach care. Findings: During a review of Patient 7’s medical record, titled “Patient Profile,” the “Patient Profile” indicated Patient 7’s start of care (SOC) date of 10/2/2024. During a review of Patient 7’s “Physician’s Order,” dated 11/21/2025, the “Physician’s Order” indicated “Registered Nurse (RN) to perform daily trach tube cleaning, change trach ties, and check for any obstructions or buildup.” During a review of Patient 7’s medical record, titled “Home Health Recertification and Plan of Care (CMS-485)” for the period of 11/26/2025 – 1/24/2026, the CMS-485 indicated Patient 7’s multiple diagnoses that included acute and chronic respiratory failure with hypoxia and hypercapnia (sudden, severe inability of the lungs to get enough oxygen into the blood and remove carbon dioxide from the lungs, leading to dangerously low blood oxygen levels) and spastic quadriplegic cerebral palsy (CP, most severe form affecting all limbs, the trunk, and face, characterized by severe muscle stiffness, weakness, involuntary movements, and poor control). The CMS-485 indicated Patient 7 had a tracheostomy. The CMS-485 indicated the following: A. Registered Nurse (RN) supervisory visit every month for case management to evaluate patients, to develop a plan of care with PCG input, and to supervise Skilled Nurse (SN) care provided B. Shift Care Services (care provided by licensed nurses in shifts (hours) at home for complex, ongoing medical needs) for trach management C. Respiratory interventions include: -SN to assess/instruct on signs and symptoms of pulmonary (relating to the lungs) complications -SN to assess/instruct PCG on proper suctioning (procedure that uses negative pressure to mechanically remove mucus, blood, saliva, or any debris from a patient’s airway to keep it open, ensuring the patient can breathe, and preventing lung infections) technique -SN to assess/instruct PCG on all aspects of trach care and equipment -SN to perform/instruct on trach care using sterile technique (set of strict medical practices to eliminate or prevent the transfer of all microorganisms, including bacteria, fungi, and viruses, to a patient’s body, ensuring it remains completely free of contamination and infections). -SN to instruct PCG on emergency procedures for complications and dislodgement of trach tube (medical emergency wherein the trach tube comes out, potentially blocking the patient’s airway). D. Tracheostomy orders include: - Trained caregiver/SN/physician to change trach size Bivona 5.0 uncuffed using aseptic technique (set of procedural guidelines to eliminate pathogens and reduce the risk of infection) every week and as needed for dislodgement/blockage. Trach care using clean technique (focuses on reducing the overall number of germs with handwashing and clean supplies, including reusing clean parts to minimize the infection risk). -Sterile trach care procedures: The SN will meticulously demonstrate and guide the PCG through tracheostomy care, emphasizing the use of sterile techniques. This includes proper handwashing, utilization of sterile gloves, and the steps involved in cleaning and maintaining the tracheostomy site. Special consideration will be given to the frequency of tube changes, avoiding contamination, and ensuring that all equipment used is clean and sterile to prevent infections. During a concurrent observation and interview, while at Patient 7’s bedroom during a joint home visit with Licensed Vocational Nurse (LVN) 3 and Patient 7’s PCG on 12/3/2025 at 10:55 a.m., Patient 7 was asleep but easily arousable, with no signs and symptoms of pain or any respiratory distress. Patient 7 had a trach tube in place that was secured with clean trach ties with the trach stoma (surgical opening in the neck) covered with clean and intact trach dressing. Patient 7’s PCG stated Patient 7 has two backup trach supplies available as approved by the health care insurance. LVN 3 stated Patient 7’s PCG would change Patient 7’s trach ties and dressing once a week and as needed. LVN 3 stated the RN would change the trach once a month. LVN 3 stated he would mostly perform Patient 7’s oral suctioning (medical procedure to clear saliva, blood, or secretions from the mouth using a suction device to prevent aspiration [accidentally breathing food, liquid, or saliva into the windpipe and lungs] and maintain clear breathing). During a telephone interview on 12/4/2025 at 1:19 p.m., Registered Nurse (RN) 3 stated she would conduct monthly home visits to Patient 7 but did not do daily trach cleanings per the physician’s order. RN 3 stated the LVNs and PCGs (in general) could perform regular and as needed trach tube changes, trach care, and suctioning as they spend more time with Patient 7. RN 3 stated the frequency of trach tube changes and trach care varies per patient and per physician’s orders, with trach tubes commonly being changed weekly for pediatric patients (patients from infancy up to 18 years old). During a concurrent interview and record review of Patient 7’s medical records on 12/4/2025 at 2:02 p.m. with the Director of Patient Care Services Designee (DPCSD), Patient 7’s physician’s orders, POC, and nursing notes were reviewed. The DPCSD stated Patient 7’s POC for respiratory care, including trach care, included interventions but did not include measurable outcomes and goals identified by the HHA and the patient’s caregiver (PCG). The DPCSD stated the POC did not clearly indicate who was responsible for the trach tube replacement and cleaning and how often were they done. The DPCSD stated the POC did not reflect Patient 7’s trach manufacturer guidelines that indicate the trach cleaning guidelines and that Patient 7’s trach type could be cleaned, disinfected, and reused up to five times. The DPCSD stated daily trach cleaning involves removing the trach tube, washing and disinfecting per manufacturer guidelines, and putting it back on Patient 7. The DPCSD stated the standard practice for the HHA was to replace the trach tube weekly, but it could vary based on the trach tube ordered by the physician and approved by the health insurance company as in the case of Patient 7. The DPCSD stated it was important to ensure the POC for trach and respiratory care was individualized to prevent infections and/or lung complications. During a review of the HHA’s undated policy and procedures (P&P 1), titled “Care Planning Process,” “P&P 1” indicated the following: 1. The patient-specific clinical POC must include: a. Reasonable, individualized, and measurable outcomes and goals identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the POC b. Patient-specific interventions and education c. Supplies and equipment required 2. The care planning decisions must be reflected in the specific services that must be provided and the associated actions planned and implemented to meet the individualized patient problems and goals. 3. The POC must be revised as frequently as deemed necessary by the clinicians based on the ongoing assessments of the patient. Revision dates must be noted on the POC. 4. The HHA must provided the patient and PCG with a copy of written instructions outlining the following: -Visit schedule, including the day of the week, frequency of visits by personnel -Any treatments to be administered by the organization’s personnel -Any other pertinent instruction related to the patient’s care and treatments that the organization will provide, specific to the patient’s care needs During a review of the HHA’s undated policy and procedures (P&P 2), titled “Initial and Comprehensive Assessment,” “P&P 2” indicated the following: 1. The purpose of P&P 2 was to provide guidelines for the initial assessment of patients admitted to service for completing the plan of care. 2. The comprehensive assessment must reflect and determine patient care preferences; POC, including type of services, frequency, and duration; ability of the organization to adequately meet the patient’s medical, nursing, rehabilitation, social, and discharge planning needs; and any information that may be used to demonstrate the patient’s progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the organization. 3. A POC must be developed from the information gathered during the initial and comprehensive assessment. The patient’s physician is consulted for approval if additions or modifications to the POC are required after the assessment is completed. The Clinical Supervisor or designee must be responsible for the review of the POC.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, agency providing skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure the plan of care (POC, document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) reflected all patient care orders for two of seven sampled patients (Patient 2 and Patient 7) by failing to: A. Ensure a physician’s order was obtained and recorded for tracheostomy (trach, surgical opening in the neck into the windpipe to allow for a tube to be inserted for breathing) management that included the tracheostomy tube (a curved, hollow tube inserted into a surgically created opening in the neck to provide a direct airway into the trachea [windpipe] type, size, and frequency of change in the POC for Patient 2. B. Ensure Patient 7’s physician’s order for “Registered Nurse (RN) to perform daily trach tube cleaning, change trach ties, and check for any obstructions or buildup” was reflected on the active POC for the certification period from 11/26/2025 – 1/24/23026. These failures had the potential to result in the patients’ decline in health condition and increased risk for infections and/or lung complications due to possible inappropriate nursing care and services provided related to not including the physician’s order into the POC. B. During a review of Patient 7’s medical record, titled “Patient Profile,” the “Patient Profile” indicated Patient 7’s start of care (SOC) date of 10/2/2024. During a review of Patient 7’s “Physician’s Order,” dated 11/21/2025, the “Physician’s Order” indicated “Registered Nurse (RN) to perform daily trach tube cleaning, change trach ties, and check for any obstructions or buildup.” During a review of Patient 7’s medical record, titled “Home Health Recertification and Plan of Care (CMS-485)” for the period of 11/26/2025 – 1/24/2026, the CMS-485 indicated Patient 7’s multiple diagnoses that included acute and chronic respiratory failure with hypoxia and hypercapnia (sudden, severe inability of the lungs to get enough oxygen into the blood and remove carbon dioxide from the lungs, leading to dangerously low blood oxygen levels) and spastic quadriplegic cerebral palsy (CP, most severe form affecting all limbs, the trunk, and face, characterized by severe muscle stiffness, weakness, involuntary movements, and poor control). The CMS-485 indicated Patient 7 had a tracheostomy. The CMS-485 indicated the following: A. Registered Nurse (RN) supervisory visit every month for case management to evaluate patients, to develop a plan of care with PCG input, and to supervise Skilled Nurse (SN) care provided B. Shift Care Services (care provided by licensed nurses in shifts (hours) at home for complex, ongoing medical needs) for trach management C. Respiratory interventions include: -SN to assess/instruct on signs and symptoms of pulmonary (relating to the lungs) complications -SN to assess/instruct PCG on proper suctioning (procedure that uses negative pressure to mechanically remove mucus, blood, saliva, or any debris from a patient’s airway to keep it open, ensuring the patient can breathe, and preventing lung infections) technique -SN to assess/instruct PCG on all aspects of trach care and equipment -SN to perform/instruct on trach care using sterile technique (set of strict medical practices to eliminate or prevent the transfer of all microorganisms, including bacteria, fungi, and viruses, to a patient’s body, ensuring it remains completely free of contamination and infections). -SN to instruct PCG on emergency procedures for complications and dislodgement of trach tube (medical emergency wherein the trach tube comes out, potentially blocking the patient’s airway). D. Tracheostomy orders include: - Trained caregiver/SN/physician to change trach size Bivona 5.0 uncuffed using aseptic technique (set of procedural guidelines to eliminate pathogens and reduce the risk of infection) every week and as needed for dislodgement/blockage. Trach care using clean technique (focuses on reducing the overall number of germs with handwashing and clean supplies, including reusing clean parts to minimize the infection risk). -Sterile trach care procedures: The SN will meticulously demonstrate and guide the PCG through tracheostomy care, emphasizing the use of sterile techniques. This includes proper handwashing, utilization of sterile gloves, and the steps involved in cleaning and maintaining the tracheostomy site. Special consideration will be given to the frequency of tube changes, avoiding contamination, and ensuring that all equipment used is clean and sterile to prevent infections. During a concurrent observation and interview, while at Patient 7’s bedroom during a joint home visit with Licensed Vocational Nurse (LVN) 3 and Patient 7’s PCG on 12/3/2025 at 10:55 a.m., Patient 7 was asleep but easily arousable, with no signs and symptoms of pain or any respiratory distress. Patient 7 had a trach tube in place that was secured with clean trach ties with the trach stoma (surgical opening in the neck) covered with clean and intact trach dressing. Patient 7’s PCG stated Patient 7 has two backup trach supplies available as approved by the health care insurance. LVN 3 stated Patient 7’s PCG would change Patient 7’s trach ties and dressing once a week and as needed. LVN 3 stated the RN would change the trach once a month. LVN 3 stated he would mostly perform Patient 7’s oral suctioning (medical procedure to clear saliva, blood, or secretions from the mouth using a suction device to prevent aspiration [accidentally breathing food, liquid, or saliva into the windpipe and lungs] and maintain clear breathing). During a telephone interview on 12/4/2025 at 1:19 p.m., Registered Nurse (RN) 3 stated she would conduct monthly home visits to Patient 7 but did not do daily trach cleanings per the physician’s order. RN 3 stated the LVNs and PCGs (in general) could perform regular and as needed trach tube changes, trach care, and suctioning as they spend more time with Patient 7. RN 3 stated the frequency of trach tube changes and trach care varies per patient and per physician’s orders, with trach tubes commonly being changed weekly for pediatric patients (patients from infancy up to 18 years old). During a concurrent interview and record review of Patient 7’s medical records on 12/4/2025 at 2:02 p.m. with the Director of Patient Care Services Designee (DPCSD), Patient 7’s physician’s orders, POC, and nursing notes were reviewed. The DPCSD stated the POC did not reflect the physician’s order for the RN to perform daily trach tube cleaning, change trach ties, and check for any obstructions or buildup.” The DPCSD stated the DPCS/DPCSD should have paid more attention to the physician’s order and clarified with the physician if an LVN and trained PCG were also allowed to perform the trach tube cleaning, change of trach ties, and checking for obstructions or buildup, since the HHA LVNs and some PCGs were also trained to perform the tasks. The DPCSD stated daily trach cleaning involves removing the trach tube, washing and disinfecting per manufacturer guidelines, and putting it back on Patient 7. The DPCSD stated the standard practice for the HHA was to replace the trach tube weekly, but it could vary based on the trach tube ordered by the physician and approved by the health insurance company as in the case of Patient 7. The DPCSD stated it was important to ensure the POC for trach and respiratory care was individualized to prevent infections and/or lung complications. During a review of the HHA’s undated policy and procedures (P&P 1), titled “Physician Participation in Plan of Care,” “P&P 1” indicated the following: 1. The physician must direct the care of every home health patient admitted for service. 2. The attending physician must participate in the care planning process by reviewing and revising the plan of care. The care must be provided in compliance with the patient’s therapeutic and diagnostic orders and accepted standards of practice. 3. Physician orders must be individualized, based on patient’s needs and include treatment and/or procedures needed, including the type, frequency, duration, and goals. 4. Physician orders must be reviewed for appropriateness and accuracy before care, treatment, and services are provided. The organization may assist the physician in determining medical necessity and formulating an appropriate plan of care, if requested by the physician. During a review of the HHA’s undated policy and procedures (P&P 2), titled “Care Planning Process,” “P&P 2” indicated the following: 1. The patient-specific clinical POC must include: a. All patient care orders, including verbal orders b. Orders for patient-specific home health service needs identified in the comprehensive assessment and the responsible discipline(s), treatments and procedures, including the amount, frequency, and duration. 2. The POC must be based upon the physician’s orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. During a review of Patient 2’s medical record titled, “Patient Profile,” the Patient Profile indicated that Patient 2, female, 23 months old, had a start of care (SOC) date on 6/18/2024, with diagnoses that included encounter for attention to tracheostomy, stenosis of larynx (the narrowing of the airway within the larynx [voice box] and restricts the passage of air, which can make it hard to breathe, speak, and cough), acute respiratory failure with hypoxia (a sudden, severe inability of the lungs to get enough oxygen into the blood, leading to dangerously low blood oxygen levels (hypoxemia) despite breathing normal air, causing symptoms like shortness of breath, confusion, and fatigue), dysphagia (difficulty swallowing, which can make it hard for food and liquids to move from the mouth down to the stomach). During a review of Patient 2’s medical record titled “Home Health Certification and Plan of Care (POC, consists of different patient goals, nursing and health assessment and interventions to help attain those goals, and expected outcomes aligned with the patient’s needs),” with certification period from 10/11/2025 to 12/9/2025, the Home Health Certification and POC indicated that RN Supervisory Visit: Monthly and purpose of visit included tracheostomy management, ventilator management ( the process of using a machine to help or completely control a patient’s breathing, adjusting settings like breath rate and air volume to support recovery and gradually transition them back to breathing on their own, ensuring proper oxygenation while preventing lung injury. It involves monitoring the patient and machine closely, managing alarms, providing airway care, and adapting support as the patient improves, a process known as weaning), respiratory treatments (medical procedures and techniques designed to treat, manage, and prevent problems with a patient’s breathing and lung function) and suctioning (procedure that uses negative pressure (vacuum) to mechanically remove fluids (like mucus, blood, or saliva) or debris from a patient’s airway during medical procedures or emergencies). Upon further review, Patient 2’s Home Health Certification and POC, with certification period from 10/11/2025 to 12/9/2025, the Home Health Certification and POC indicated there no documented physician order related to tracheostomy tube management that included the tracheostomy tube type, size and frequency of change. During a concurrent observation and interview on 12/3/2025 at 10:45 a.m., with Licensed Vocational Nurse (LVN) 1, in Patient 2’s residence in the living room, Patient 2 was observed with tracheostomy tube size 3.5 millimeters (mm unit of length) to room air, secured by a tracheostomy tie. LVN 1 stated that he took care of Patient 2, who was 23 months old, for one and a half years now. LVN 1 stated that he performed Patient 2’s daily tracheostomy assessment, tracheostomy care, tracheostomy dressing and tie change. LVN 1 stated he changed Patient 2’s tracheostomy tubes every Monday. LVN 1 stated that RN 1 visits Patient 2 monthly to conduct head-to-toe assessment (a process that checks the health status of all major body systems of a patient), and to check proper placement of tracheostomy tube. During an observation on 12/3/2025 at 10:47 a.m., at Patient 2’s residence in the living room, there were three (3) unopened supplies of tracheostomy tube (Bivona Silicone (a brand name of flexible tracheostomy tube used for infants and children) Tracheostomy tube 3.5 mm were observed. LVN 1 stated that he used the Bivona Silicone tracheostomy tube for Patient 2’s tracheostomy tube replacement. LVN 1 stated that he was unsure if supplies for Patient 2’s tracheostomy tube were delivered or picked up from the clinic. LVN 1 stated he only had the supply of tracheostomy tube with the size of 3.5 mm. During an interview on 12/3/2025 at 10:49 a.m., LVN 1 stated that he knew how to change patient’s tracheostomy tube through his previous experiences. LVN 1 stated that tracheostomy tube care was within the scope of his practice, and he learned it from school and from his previous works. LVN 1 stated that he did his tracheostomy management including tracheostomy tube change skills validation and reviews on his own by watching videos online. LVN 1 stated that last month, he completed his skills revalidation regarding tracheostomy tube change, but it was from his other job and not with this HHA. LVN 1 stated that he documented tracheostomy tube change date into Patient 2’s chart. During a concurrent record review and interview on 12/3/2025, at 10:50 a.m., with LVN 1, Patient 2’s current medication list, for episode period dates from 10/11/2025 to 12/9/2025, and HHA folder were reviewed. LVN 1 confirmed and stated that there was no documented physician order related to tracheostomy tube management that included the tracheostomy tube type, size and frequency of change. LVN 1 stated that he was unsure why there was no standing order for tracheostomy tube set and he was unable to state where did he got the instructions to replace tracheostomy tube change every Monday and as needed. LVN 1 stated that there should be a standing physician orders to follow regarding Patient 2’s tracheostomy tube change to ensure that it was done according to physician’s directions. During an interview on 12/3/2025, at 10:57 a.m., with Patient 2’s Family member (FM 1). FM 1 stated that Patient 2 was 23 months old and she (FM 1) was the primary caregiver when LVN 1 was not around. FM 1 stated that LVN 1 took care of Patient 2 for eight (8) hours daily, Monday through Friday. FM 1 stated that LVN 1 replaced Patient 2’s tracheostomy tubes every Monday and as needed. FM 1 stated that Registered Nurse (RN) 1 visits Patient 2 once a month to check her but did not notice if RN 1 performs tracheostomy tube replacement for Patient 2. During a concurrent record review and interview on 12/4/2025, at 10:38 a.m., with the Director of Patient Care Services (DPCS), Patient 2’s Physician Order dated 8/7/2025 and 10/8/2025 were reviewed. The DPCS confirmed and stated that the Physician’s Order dated 10/8/2025 indicated that an RN must perform the following: · Perform meticulous hand hygiene and use sterile techniques, during all tracheostomy care procedures to minimize infection risk. · Inspect the site daily for erythema, swelling, discharge, or odor; report abnormal findings to the provider. · Clean the stoma and peristomal skin with sterile saline or as directed, removing all crusts and secretions. · Replace tracheostomy dressings and ties as ordered, ensuring secure placement without excessive tightness or risk of pressure injury. · Verify the presence of emergency airway equipment at bedside, including a spare tracheostomy tube (same and one size smaller) same, obturator, suction set up, and bag valve mask. The DPCS stated that Patient 2’s Physician Order dated 8/7/2025 and 10/8/2025 should have been clarified with Patient 2’s physician if an LVN can perform the orders. The DPCS confirmed and stated that the Physician’s Order dated 8/7/2025 and 10/8/2025 had no documented physician order related to tracheostomy tube management that included the tracheostomy tube type, size and frequency of change. During a concurrent record review and interview on 12/4/2025, at 10:45 a.m., with the DPCS, Patient 2’s current medication list, for episode period dates from 10/11/2025 to 12/9/2025 was reviewed. The DPCS confirmed and stated that there was no documented physician order related to tracheostomy tube management that included the tracheostomy tube type, size and frequency of change. During an interview with the Director of Patient Care Services Designee (DPCSD) on 12/4/2025, at 2:10 p.m., the DPCSD stated that he reviewed and acknowledged Patient 2’s physician orders dated 8/7/2025 and 10/8/2025. DPCSD stated that it was his responsibility to check, verify and clarify with the physician if the orders were correct, feasible, and appropriate. The DPCSD stated that he should have clarified with the physician if an RN or a skilled nurse was able to perform the tasks specified in the physician’s order to determine if a skilled nurse was able to perform the tasks that were included in the physician’s order. The DPCSD stated that it was important to follow the physician’s orders as written to ensure that correct interventions were provided to patients. During an interview with the DPCS on 12/5/2025, at 11:48 a.m., the DPCS stated that it was important that every treatment has a physician’s order to validate that it was correct and to prevent harm to patient. The DPCS stated that it was inappropriate to perform treatment with no physician order and that providing treatment without physician order could lead to serious harm, hospitalization, or death. During a review of the HHA’s Policy and Procedure (P&P), titled “Verification of Physician Orders,” with a revised date of November 2020, the P&P indicated that orders will be obtained from licensed physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients, verbal orders will be spoken to, taken and documented only by professional, licensed home health personnel (RN or qualified therapist), a qualified individual will review each order or prescription before care is provided, and a copy of the physician’s (or authorized licensed independent practitioner’s) order will be kept in the clinical record. During a review of the HHA’s P&P, titled “Physician Participation in Plan of Care,” undated, the P&P indicated that orders are reviewed for appropriateness and accuracy before care, treatment and services are provided, the organization may assist the physician in determining medical necessity and formulating an appropriate plan of care, if requested by the physician. During a review of the HHA’s P&P, titled “Care Planning Process,” undated, the P&P indicated that 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.”

“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 observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure: 1.A physician order was obtained for tracheostomy (a surgical procedure that creates an opening in the neck into the windpipe [trachea] to allow for a tube to be inserted for breathing) management that included the tracheostomy tube (a curved, hollow tube inserted into a surgically created opening in the neck to provide a direct airway into the trachea [windpipe] type, size, and frequency of change for one of seven sampled patients (Patient 2). 2. A Licensed Vocational Nurse (LVN1) did not perform the physician’s orders dated 8/7/2025 and 10/8/2025, that indicated the registered nurse (RN) to perform the following for one of seven sampled patients (Patient 2). Performs the tracheostomy management of Patient 2, which includes changing the tracheostomy tube. Inspect Patient 2’s tracheotomy site daily for erythema (redness), swelling, discharge, or odor, report abnormal findings to the provider. Clean Patient 2’s stoma (opening) and peristomal (around the opening) skin with sterile saline (a purified saltwater solution that is free from microorganism making it safe for medical use like flushing wounds, irrigating eyes or rehydrating the patient) or as directed, removing all crusts and secretions. Replace Patient 2’s tracheostomy dressings and ties as ordered, ensuring secure placement without excessive tightness or risk for pressure injury (localized damage to skin and/or underlying tissue, usually over a bony prominence, caused by intense/prolonged pressure, often combined with shear forces, leading to tissue death (necrosis) by cutting off blood flow and oxygen). Verify Patient 2’s presence of emergency airway equipment (devices used by medical professionals to quickly open and secure a patient’s airway to deliver oxygen, especially when they are unable to breathe on their own, preventing suffocation (severe deprivation of oxygen, causing the inability to breathe) and allowing for ventilation in critical situations) at bedside including the following: A spare tracheostomy tube (same size and one size smaller) Obturator (a temporary, solid guide inserted into the main body [outer cannula] of a tracheostomy tube during placement or replacement) Suction set up (system that uses negative pressure [vacuum] to mechanically remove fluids (like mucus, blood, or saliva) or debris from a patient’s airway during medical procedures or emergencies) Bag valve mask (a handheld emergency device with a self-inflating bag, one-way valve, and face mask, used to provide positive pressure breaths [rescue ventilation] to an individual who is not breathing adequately, essentially helping to breathe until advanced help arrives or if breathing returns). These failures placed Patient 2 at increased risk for bleeding, respiratory distress, that could lead to serious harm, hospitalization or death. On 12/5/2025 at 12:20 p.m., while onsite at the agency, the Department called the 1st 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 home health agency’s Administrator/Director of Patient Care Services (ADM/DPCS) , Administrator Designee, Case Managers and the Office Manager related to the home health agency’s failure as enumerated below: 1.A physician order was obtained for tracheostomy management that included the tracheostomy tube type, size, and frequency of change for one of seven sampled patients (Patient 2). 2. A Licensed Vocational Nurse (LVN1) did not perform the following physician’s orders for the Registered Nurse to perform, dated 10/8/2025, for one of seven sampled patients (Patient 2). Performs the tracheostomy management of Patient 2, which includes changing the tracheostomy tube. Inspect Patient 2’s tracheotomy site daily for erythema, swelling, discharge, or odor, report abnormal findings to the provider. Clean Patient 2’s stoma and peristomal skin with sterile saline or as directed, removing all crusts and secretions. Replace Patient 2’s tracheostomy dressings and ties as ordered, ensuring secure placement without excessive tightness or risk for pressure injury. Verify Patient 2’s presence of emergency airway equipment at bedside including a spare tracheostomy tube (same size and one size smaller), obturator, suction set up, and bag valve mask. These failures placed Patient 2 at increased risk for bleeding, respiratory distress, that could lead to serious harm, hospitalization or death. On 12/5/2025 at 3:10 p.m., the HHA was unable to submit an IJ removal Plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely). The survey team completed the survey tasks and exited the HHA with the IJ situation not removed. On 12/12/2025 the HHA submitted an IJ removal plan which was reviewed and accepted. On 12/12/2025 at 3:43 PM, the survey verified the implementation of the IJ removal during an on-site visit and the IJ was removed in the presence of the Administrator designee and Office Manager. During a review of Patient 2’s medical record titled, “Patient Profile,” the Patient Profile indicated that Patient 2, female, 23 months old, had a start of care (SOC) date on 6/18/2024, with diagnoses that included encounter for attention to tracheostomy, stenosis of larynx (the narrowing of the airway within the larynx [voice box] and restricts the passage of air, which can make it hard to breathe, speak, and cough), acute respiratory failure with hypoxia (a sudden, severe inability of the lungs to get enough oxygen into the blood, leading to dangerously low blood oxygen levels (hypoxemia) despite breathing normal air, causing symptoms like shortness of breath, confusion, and fatigue), dysphagia (difficulty swallowing, which can make it hard for food and liquids to move from the mouth down to the stomach). During a review of Patient 2’s medical record titled “Physician Order ( a doctor’s written instruction for a patient’s medical care, covering treatments, medications, tests, or general management, ensuring nurses and staff know exactly what to do, acting as the official directive for action within a healthcare setting),” dated 8/7/2025 and 10/8/2025, the Physician Order indicated Registered Nurse (RN) to perform the following Tracheostomy Care: Perform meticulous hand hygiene and use sterile techniques (a set of strict medical practices to prevent all microorganisms (germs, bacteria, viruses) from entering a sterile field, like a surgical site or a patient’s body, ensuring it remains completely free from contamination to stop infections), during all tracheostomy care procedures to minimize infection risk. Inspect the site daily for erythema, swelling, discharge, or odor and report abnormal findings to the provider. Clean the stoma and peristomal skin (referring to the skin area surrounding a surgically created opening (stoma) with sterile saline or as directed, removing all crusts and secretions. Replace tracheostomy dressings and ties as ordered, ensuring secure placement without excessive tightness or risk of pressure injury. Verify Patient 2’s presence of emergency airway equipment at bedside including a spare tracheostomy tube (same size and one size smaller), obturator, suction set up, and bag valve mask. During a review of Patient 2’s medical record titled “Home Health Certification and Plan of Care (POC, consists of different patient goals, nursing and health assessment and interventions to help attain those goals, and expected outcomes aligned with the patient’s needs),” with certification period from 10/11/2025 to 12/9/2025, the Home Health Certification and POC indicated that RN Supervisory Visit: Monthly and purpose of visit included tracheostomy management, ventilator management ( the process of using a machine to help or completely control a patient’s breathing, adjusting settings like breath rate and air volume to support recovery and gradually transition them back to breathing on their own, ensuring proper oxygenation while preventing lung injury. It involves monitoring the patient and machine closely, managing alarms, providing airway care, and adapting support as the patient improves, a process known as weaning), respiratory treatments (medical procedures and techniques designed to treat, manage, and prevent problems with a patient’s breathing and lung function) and suctioning (procedure that uses negative pressure (vacuum) to mechanically remove fluids (like mucus, blood, or saliva) or debris from a patient’s airway during medical procedures or emergencies). During a concurrent observation and interview on 12/3/2025 at 10:45 a.m., with Licensed Vocational Nurse (LVN) 1, in Patient 2’s residence in the living room, Patient 2 was observed with tracheostomy tube size 3.5 millimeters (mm unit of length) to room air, secured by a tracheostomy tie. LVN 1 stated that he took care of Patient 2, who was 23 months old, for one and a half years now. LVN 1 stated that he performed Patient 2’s daily tracheostomy assessment, tracheostomy care, tracheostomy dressing and tie change. LVN 1 stated he changed Patient 2’s tracheostomy tubes every Monday. LVN 1 stated that RN 1 visits Patient 2 monthly to conduct head-to-toe assessment (a process that checks the health status of all major body systems of a patient), and to check proper placement of tracheostomy tube. During an observation on 12/3/2025 at 10:47 a.m., at Patient 2’s residence in the living room, there were three (3) unopened supplies of tracheostomy tube (Bivona Silicone (a brand name of flexible tracheostomy tube used for infants and children) Tracheostomy tube 3.5 mm were observed. LVN 1 stated that he used the Bivona Silicone tracheostomy tube for Patient 2’s tracheostomy tube replacement. LVN 1 stated that he was unsure if supplies for Patient 2’s tracheostomy tube were delivered or picked up from the clinic. LVN 1 stated he only had the supply of tracheostomy tube with the size of 3.5 mm. During an interview on 12/3/2025 at 10:49 a.m., LVN 1 stated that he knew how to change patient’s tracheostomy tube through his previous experiences. LVN 1 stated that tracheostomy tube care was within the scope of his practice, and he learned it from school and from his previous works. LVN 1 stated that he did his tracheostomy management including tracheostomy tube change skills validation and reviews on his own by watching videos online. LVN 1 stated that last month, he completed his skills revalidation regarding tracheostomy tube change, but it was from his other job and not with this HHA. LVN 1 stated that he documented tracheostomy tube change date into Patient 2’s chart. During a concurrent record review and interview on 12/3/2025, at 10:50 a.m., with LVN 1, Patient 2’s current medication list, for episode period dates from 10/11/2025 to 12/9/2025, and HHA folder were reviewed. LVN 1 confirmed and stated that there was no documented physician order related to tracheostomy tube management that included the tracheostomy tube type, size and frequency of change. LVN 1 stated that he was unsure why there was no standing order for tracheostomy tube set and he was unable to state where did he got the instructions to replace tracheostomy tube change every Monday and as needed. LVN 1 stated that there should be a standing physician orders to follow regarding Patient 2’s tracheostomy tube change to ensure that it was done according to physician’s directions. During an interview on 12/3/2025, at 10:57 a.m., with Patient 2’s Family member (FM 1). FM 1 stated that Patient 2 was 23 months old and she (FM 1) was the primary caregiver when LVN 1 was not around. FM 1 stated that LVN 1 took care of Patient 2 for eight (8) hours daily, Monday through Friday. FM 1 stated that LVN 1 replaced Patient 2’s tracheostomy tubes every Monday and as needed. FM 1 stated that Registered Nurse (RN) 1 visits Patient 2 once a month to check her but did not notice if RN 1 performs tracheostomy tube replacement for Patient 2. During a concurrent record review and interview on 12/4/2025, at 10:30 a.m., with the DPCS, Patient 2’s medical record titled “Skilled Nursing Flowsheet (a specific, standardized documentation tool used by nurses to quickly and consistently record and track essential patient data over time),” the Skilled Nursing Flowsheet indicated the following: The DPCS confirmed and stated that Patient 2’s Skilled Nursing Flowsheet dated 10/24/2025 indicated LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 10/20/2025, changed by: SN. The DPCS stated that SN (Skilled Nurse) was LVN 1. The DPCS confirmed and stated that Patient 2’s Skilled Nursing Flowsheet dated 10/27/2025 indicated LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 10/27/2025, changed by: SN. The DPCS stated that SN was LVN 1. The DPCS confirmed and stated that Patient 2’s Skilled Nursing Flowsheet dated 11/20/2025 indicated LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 11/20/2025, changed by: SN. The DPCS stated that SN was LVN 1. The DPCS confirmed and stated that Patient 2’s Skilled Nursing Flowsheet dated 11/24/2025 indicated LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 11/24/2025, changed by: SN. The DPCS stated that SN was LVN 1. During a concurrent record review and interview on 12/4/2025, at 10:55 a.m., with the DPCS, Patient 2’s medical record titled “Skilled Nursing Flowsheet,” dated from 8/1/2025 to 8/29/2025, and 9/2/2025 to 9/30/2025 were reviewed. The DPCS confirmed and stated that the Skilled Nursing Flowsheets dated from 8/1/2025 to 8/29/2025, and 9/2/2025 to 9/30/2025 indicated that LVN 1’s signed documentation of tracheostomy tube, type: Bivona, date last changed: 11/24/2025, changed by: SN. The DPCS stated that SN was LVN 1. During a concurrent record review and interview on 12/4/2025, at 10:38 a.m., with the Director of Patient Care Services (DPCS), Patient 2’s Physician Order dated 8/7/2025 and 10/8/2025 were reviewed. The DPCS confirmed and stated that the Physician’s Order dated 10/8/2025 indicated that an RN must perform the following: Perform meticulous hand hygiene and use sterile techniques, during all tracheostomy care procedures to minimize infection risk. Inspect the site daily for erythema, swelling, discharge, or odor; report abnormal findings to the provider. Clean the stoma and peristomal skin with sterile saline or as directed, removing all crusts and secretions. Replace tracheostomy dressings and ties as ordered, ensuring secure placement without excessive tightness or risk of pressure injury. Verify the presence of emergency airway equipment at bedside, including a spare tracheostomy tube (same and one size smaller) same, obturator, suction set up, and bag valve mask. The DPCS stated that Patient 2’s Physician Order dated 8/7/2025 and 10/8/2025 should have been clarified with Patient 2’s physician if an LVN can perform the orders. During a telephone interview on 12/4/2025, at 11:17 a.m., with the Registered Nurse (RN 1), RN 1 stated that he was the RN that visits Patient 2 every month. RN 1 stated that he performed head-to-toe assessments including tracheostomy assessment, safety precautions, changing the tracheostomy tube if needed and checking proper tracheostomy tube placement. RN 1 stated that he was unsure if LVN is allowed to change a tracheostomy tube and if it is within the scope of practice. During an interview with the Director of Patient Care Services Designee (DPCSD) on 12/4/2025, at 2:10 p.m., the DPCSD stated that he reviewed and acknowledged Patient 2’s physician orders dated 8/7/2025 and 10/8/2025. DPCSD stated that it was his responsibility to check, verify and clarify with the physician if the orders were correct, feasible, and appropriate. The DPCSD stated that he should have clarified with the physician if an RN or a skilled nurse was able to perform the tasks specified in the physician’s order to determine if a skilled nurse was able to perform the tasks that were included in the physician’s order. The DPCSD stated that it was important to follow the physician’s orders as written to ensure that correct interventions were provided to patients. During an interview with the DPCSD on 12/4/2025, at 4 p.m., the DPCSD stated that if a skilled nurse (SN) was not well trained, inexperienced and unqualified to perform tracheostomy care including tracheostomy tube replacement, it could lead to serious harm that would result to hospitalization and/or death. During an interview with the DPCS on 12/5/2025, at 11:48 a.m., the DPCS stated that it was important that every treatment has a physician’s order to validate that it was correct and to prevent harm to patient. The DPCS stated that it was inappropriate to perform treatment with no physician order and that providing treatment without physician order could lead to serious harm, hospitalization, or death. During a review of the HHA’s Policy and Procedure (P&P), titled “Verification of Physician Orders,” with a revised date of November 2020, the P&P indicated that orders will be obtained from licensed physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients, verbal orders will be spoken to, taken and documented only by professional, licensed home health personnel (RN or qualified therapist), a qualified individual will review each order or prescription before care is provided, and a copy of the physician’s (or authorized licensed independent practitioner’s) order will be kept in the clinical record. During a review of the HHA’s P&P, titled “Physician Participation in Plan of Care,” undated, the P&P indicated that orders are reviewed for appropriateness and accuracy before care, treatment and services are provided, the organization may assist the physician in determining medical necessity and formulating an appropriate plan of care, if requested by the physician.”

“Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the Registered Nurse Case Manager (RN-CM) developed and evaluated the plan of care (POC, a detailed summary of the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) in partnership with the patient’s caregiver for one of seven sampled patients (Patient 7) by failing to: Ensure Patient 7’s physician’s order for tracheostomy care was implemented as ordered by the physician. This failure had the potential to result in Patient 7’s decline in health condition and increased risk for infections due to the lack of coordination of care. Findings: During a review of Patient 7’s medical record, titled “Patient Profile,” the “Patient Profile” indicated Patient 7’s start of care (SOC) date of 10/2/2024. During a review of Patient 7’s “Physician’s Order,” dated 11/21/2025, the “Physician’s Order” indicated “Registered Nurse (RN) to perform daily trach tube cleaning, change trach ties, and check for any obstructions or buildup.” During a review of Patient 7’s medical record, titled “Home Health Recertification and Plan of Care (CMS-485)” for the period of 11/26/2025 – 1/24/2026, the CMS-485 indicated Patient 7’s multiple diagnoses that included acute and chronic respiratory failure with hypoxia and hypercapnia (sudden, severe inability of the lungs to get enough oxygen into the blood and remove carbon dioxide from the lungs, leading to dangerously low blood oxygen levels) and spastic quadriplegic cerebral palsy (CP, most severe form affecting all limbs, the trunk, and face, characterized by severe muscle stiffness, weakness, involuntary movements, and poor control). The CMS-485 indicated Patient 7 had a tracheostomy. The CMS-485 indicated the following: A. Registered Nurse (RN) supervisory visit every month for case management to evaluate patients, to develop a plan of care with PCG input, and to supervise Skilled Nurse (SN) care provided B. Shift Care Services (care provided by licensed nurses in shifts (hours) at home for complex, ongoing medical needs) for trach management C. Respiratory interventions include: -SN to assess/instruct on signs and symptoms of pulmonary (relating to the lungs) complications -SN to assess/instruct PCG on proper suctioning (procedure that uses negative pressure to mechanically remove mucus, blood, saliva, or any debris from a patient’s airway to keep it open, ensuring the patient can breathe, and preventing lung infections) technique -SN to assess/instruct PCG on all aspects of trach care and equipment -SN to perform/instruct on trach care using sterile technique (set of strict medical practices to eliminate or prevent the transfer of all microorganisms, including bacteria, fungi, and viruses, to a patient’s body, ensuring it remains completely free of contamination and infections). -SN to instruct PCG on emergency procedures for complications and dislodgement of trach tube (medical emergency wherein the trach tube comes out, potentially blocking the patient’s airway). D. Tracheostomy orders include: - Trained caregiver/SN/physician to change trach size Bivona 5.0 uncuffed using aseptic technique (set of procedural guidelines to eliminate pathogens and reduce the risk of infection) every week and as needed for dislodgement/blockage. Trach care using clean technique (focuses on reducing the overall number of germs with handwashing and clean supplies, including reusing clean parts to minimize the infection risk). -Sterile trach care procedures: The SN will meticulously demonstrate and guide the PCG through tracheostomy care, emphasizing the use of sterile techniques. This includes proper handwashing, utilization of sterile gloves, and the steps involved in cleaning and maintaining the tracheostomy site. Special consideration will be given to the frequency of tube changes, avoiding contamination, and ensuring that all equipment used is clean and sterile to prevent infections. During a concurrent observation and interview, while at Patient 7’s bedroom during a joint home visit with Licensed Vocational Nurse (LVN) 3 and Patient 7’s PCG on 12/3/2025 at 10:55 a.m., Patient 7 was asleep but easily arousable, with no signs and symptoms of pain or any respiratory distress. Patient 7 had a trach tube in place that was secured with clean trach ties with the trach stoma (surgical opening in the neck) covered with clean and intact trach dressing. Patient 7’s PCG stated Patient 7 has two backup trach supplies available as approved by health care insurance. LVN 3 stated Patient 7’s PCG would change Patient 7’s trach ties and dressing once a week and as needed. LVN 3 stated the RN would change the trach once a month. LVN 3 stated he would mostly perform Patient 7’s oral suctioning (medical procedure to clear saliva, blood, or secretions from the mouth using a suction device to prevent aspiration [accidentally breathing food, liquid, or saliva into the windpipe and lungs] and maintain clear breathing). During a telephone interview on 12/4/2025 at 1:19 p.m., Registered Nurse (RN) 3 stated she would conduct monthly home visits to Patient 7 but did not do daily trach cleanings per the physician’s order. RN 3 stated the LVNs and PCGs (in general) could perform regular and as needed trach tube changes, trach care, and suctioning as they spend more time with Patient 7. RN 3 stated the frequency of trach tube changes and trach care varies per patient and per physician’s orders, with trach tubes commonly being changed weekly for pediatric patients (patients from infancy up to 18 years old). During a concurrent interview and record review of Patient 7’s medical records on 12/4/2025 at 2:02 p.m. with the Director of Patient Care Services Designee (DPCSD), Patient 7’s physician’s orders, POC, and nursing notes were reviewed. The DPCSD stated the RN-CM did not clearly specify on the POC who was responsible for the trach tube replacement and cleaning and how often they were done based on Patient 7’s ordered trach tube. The DPCSD stated the DPCS/DPCSD should have paid more attention to the physician’s order and clarified with the physician and documented on Patient 7’s medical records if an LVN and trained PCG were also allowed to perform the trach tube cleaning, change of trach ties, and checking for obstructions or buildup. The DPCSD stated the HHA LVNs and some PCGs were also trained to perform the trach care tasks. The DPCSD stated the standard practice for the HHA was to replace the trach tube weekly, but it could vary based on the trach tube ordered by the physician and approved by the health insurance company as in the case of Patient 7. The DPCSD stated it was important to ensure the POC for trach and respiratory care was individualized to prevent infections and/or lung complications. During a review of the HHA’s undated policy and procedures (P&P), titled “Provision of Care and Record Management,” P&P indicated the following: 1. Each patient must be assigned a Case Manager upon admission to the HHA to ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. A registered nurse must be assigned to a patient receiving skilled nursing. 2. Care coordination must include, but not be limited to: -Clearly outlining each clinician’s responsibilities to avoid duplication of services -Developing complementary actions and goals -Regularly occurring telephone or email communication among team members -Timely documentation of coordination of care activities -Appropriate involvement of the patient and caregivers -Coordination of care delivery to meet the patient’s needs, and involve the patient, representative, and caregivers, as appropriate, in the coordination of care activities. 3. All organization personnel involved in patient care/service, including those providing contracted services, must have access to the plan of care/service and all other relevant patient information to ensure coordination and continuity. All personnel must be knowledgeable regarding patient needs, goals of care, and services. During a review of the HHA’s RN Job Description (undated), the RN Job Description indicated the following: 1. The RN plans, organizes, and directs home care services. 2. The RN regularly reevaluates patient nursing needs. 3. The RN initiates the POC and makes necessary revisions as patient status and needs change. 4. The RN develops a POC, which establishes goals based on nursing diagnosis and incorporates therapeutic, preventive, and rehabilitative nursing actions and includes the patient and the family in the planning process. 5. The RN counsels the patient and family in meeting nursing and related needs. 6. The RN provides health care instructions to the patient as appropriate per assessment and POC. 7. The RN acts as a Case Manager when assigned by Clinical Supervisor/Nursing Supervisor and assumes responsibility to coordinate patient care for assigned caseload. 8. The RN ensures the arrangements for equipment and other necessary items and services are available.”

“Documentation of inservice training CFR(s): 484.80(d)(2) The HHA must maintain documentation that demonstrates the requirements of this standard have been met. This Element is not met as evidenced by: Based on interview and record review The Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure written policies and procedures, describing its method(s) of assessment of competency and maintaining a written description of the in-service training provided during the previous 12 months to assess the skills and competence of its home health aide (a trained professional who assists patients in their homes with daily living activities, like bathing, dressing, and meals, light household chores, all under a nurse’s direction, ensuring comfort, dignity, and safety for those needing assistance with illness, disability, or aging), furnishing care were followed. This deficient practice had the potential to affect the patients non-medical personal care and activities of daily living care and needs will not be met. Findings: During a review of the HHA’s “State License,” with an effective date of 2/24/2025 and an expiration date of 2/23/2026, the HHA’s State License indicated the following: - “In addition to Skilled Nursing (high-level medical care and therapy provided by licensed professionals (like Registered Nurses, Licensed Vocational Nurses, therapists) that requires technical skills), the following additional services have been approved which includes Home Health Aide Services.” During an interview on 12/4/2025 at 2:03 pm with Human Resources Coordinator (HR). The HR stated the HHA does not currently have an active Certified Nurse Assistant (CNA) because the licensed vocational nurses (LVN) are providing direct patient care to patients. The HR stated there is currently one inactive CNA employed in HHA but was not assigned to a patient for more than a year. The HR stated inactive staff are current employees that do not have an active patient assigned to them. The HR stated monthly in-service, and training was provided to licensed nurses, but no training provided for the CNA. During a review of HHA’s policies and procedures (P&P) titled “Training/Inservice Education”, undated. The P&P indicated the following: - “Pacific Health Services, Inc. will provide training and education to give personnel opportunities to learn new skills and improve/expand existing knowledge.” - “Aides (CNAs/HHAs [Home Health Aides]) must receive at least twelve (12) hours of inservice training per calendar year. This may be provided while the aide is furnishing care to patients.””

“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 observation, interviews and record review, the Home Health Agency (HHA, public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the documented plan of care (POC, detailed document that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was complete and accurate for one of seven sampled patients (Patient 7). For Patient 7, the POC did not include all physician orders, measurable outcomes and goals identified by the HHA and Patient 7’s caregiver (PCG), all the treatments and services related to tracheostomy (trach, surgical opening in the neck into the windpipe to allow for a tube to be inserted for breathing) care to be performed by the HHA, and trach manufacturer guidelines. This failure had the potential to result in Patient 7’s decline in health condition and increased risk for infections due to the lack of continuity of care related to the inconsistent POC implementation. Findings: During a review of Patient 7’s medical record, titled “Patient Profile,” the “Patient Profile” indicated Patient 7’s start of care (SOC) date of 10/2/2024. During a review of Patient 7’s “Physician’s Order,” dated 11/21/2025, the “Physician’s Order” indicated “Registered Nurse (RN) to perform daily trach tube cleaning, change trach ties, and check for any obstructions or buildup.” During a review of Patient 7’s medical record, titled “Home Health Recertification and Plan of Care (CMS-485)” for the period of 11/26/2025 – 1/24/2026, the CMS-485 indicated Patient 7’s multiple diagnoses that included acute and chronic respiratory failure with hypoxia and hypercapnia (sudden, severe inability of the lungs to get enough oxygen into the blood and remove carbon dioxide from the lungs, leading to dangerously low blood oxygen levels) and spastic quadriplegic cerebral palsy (CP, most severe form affecting all limbs, the trunk, and face, characterized by severe muscle stiffness, weakness, involuntary movements, and poor control). The CMS-485 indicated Patient 7 had a tracheostomy. The CMS-485 indicated the following: A. Registered Nurse (RN) supervisory visit every month for case management to evaluate patients, to develop a plan of care with PCG input, and to supervise Skilled Nurse (SN) care provided B. Shift Care Services (care provided by licensed nurses in shifts (hours) at home for complex, ongoing medical needs) for trach management C. Respiratory interventions include: -SN to assess/instruct on signs and symptoms of pulmonary (relating to the lungs) complications -SN to assess/instruct PCG on proper suctioning (procedure that uses negative pressure to mechanically remove mucus, blood, saliva, or any debris from a patient’s airway to keep it open, ensuring the patient can breathe, and preventing lung infections) technique -SN to assess/instruct PCG on all aspects of trach care and equipment -SN to perform/instruct on trach care using sterile technique (set of strict medical practices to eliminate or prevent the transfer of all microorganisms, including bacteria, fungi, and viruses, to a patient’s body, ensuring it remains completely free of contamination and infections). -SN to instruct PCG on emergency procedures for complications and dislodgement of trach tube (medical emergency wherein the trach tube comes out, potentially blocking the patient’s airway). D. Tracheostomy orders include: - Trained caregiver/SN/physician to change trach size Bivona 5.0 uncuffed using aseptic technique (set of procedural guidelines to eliminate pathogens and reduce the risk of infection) every week and as needed for dislodgement/blockage. Trach care using clean technique (focuses on reducing the overall number of germs with handwashing and clean supplies, including reusing clean parts to minimize the infection risk). -Sterile trach care procedures: The SN will meticulously demonstrate and guide the PCG through tracheostomy care, emphasizing the use of sterile techniques. This includes proper handwashing, utilization of sterile gloves, and the steps involved in cleaning and maintaining the tracheostomy site. Special consideration will be given to the frequency of tube changes, avoiding contamination, and ensuring that all equipment used is clean and sterile to prevent infections. During a concurrent observation and interview, while at Patient 7’s bedroom during a joint home visit with Licensed Vocational Nurse (LVN) 3 and Patient 7’s PCG on 12/3/2025 at 10:55 a.m., Patient 7 was asleep but easily arousable, with no signs and symptoms of pain or any respiratory distress. Patient 7 had a trach tube in place that was secured with clean trach ties with the trach stoma (surgical opening in the neck) covered with clean and intact trach dressing. Patient 7’s PCG stated Patient 7 has two backup trach supplies available as approved by the health care insurance. LVN 3 stated Patient 7’s PCG would change Patient 7’s trach ties and dressing once a week and as needed. LVN 3 stated the RN would change the trach once a month. LVN 3 stated he would mostly perform Patient 7’s oral suctioning (medical procedure to clear saliva, blood, or secretions from the mouth using a suction device to prevent aspiration [accidentally breathing food, liquid, or saliva into the windpipe and lungs] and maintain clear breathing). During a telephone interview on 12/4/2025 at 1:19 p.m., Registered Nurse (RN) 3 stated she would conduct monthly home visits to Patient 7 but did not do daily trach cleanings per the physician’s order. RN 3 stated the LVNs and PCGs (in general) could perform regular and as needed trach tube changes, trach care, and suctioning as they spend more time with Patient 7. RN 3 stated the frequency of trach tube changes and trach care varies per patient and per physician’s orders, with trach tubes commonly being changed weekly for pediatric patients (patients from infancy up to 18 years old). During a concurrent interview and record review of Patient 7’s medical records on 12/4/2025 at 2:02 p.m. with the Director of Patient Care Services Designee (DPCSD), Patient 7’s physician’s orders, POC, and nursing notes were reviewed. The DPCSD stated there was no documented evidence of the following: a. Measurable outcomes and goals identified by the HHA and the patient’s caregiver (PCG). b. Clear specification who was responsible for the trach tube replacement and cleaning and how often were they done. c. Patient 7’s trach manufacturer guidelines that indicate the trach cleaning guidelines and that Patient 7’s trach type could be cleaned, disinfected, and reused up to five times. d. Physician’s order for the RN to perform daily trach tube cleaning, change trach ties, and check for any obstructions or buildup.” The DPCSD stated the DPCS/DPCSD should have paid more attention to the physician’s order and clarified with the physician if an LVN and trained PCG were also allowed to perform the trach tube cleaning, change of trach ties, and checking for obstructions or buildup, since the HHA LVNs and some PCGs were also trained to perform the tasks. The DPCSD stated it was important to ensure the POC was individualized, detailed, and complete to ensure consistent POC implementation and continuity of care to prevent Patient 7’s increased risk for infections and/or lung complication. During a review of the HHA’s undated policy and procedures (P&P 1), titled “Clinical Record Review,” P&P 1 indicated the following: 1. Clinical records must be reviewed at least quarterly by qualified organization personnel to assure that documentation entered is reliable, timely, valid, and accurate. 2. Each clinical record must be reviewed on an ongoing basis by the Clinical Supervisor, Performance Improvement Coordinator, Clinical Director, or designees for the compliance with the established plan of care, completeness of clinical records, and accuracy of clinical records. During a review of the HHA’s undated policy and procedures (P&P 2), titled “Provision of Care and Record Management,” P&P 2 indicated the following: 1. Written evidence of care coordination must be found in the plan of care/service, case conference summary forms, clinical notes in the patient’s clinical record or interdisciplinary group meeting notes. 2. Documentation of all communications must be included in the clinical record on a communication note, case conference summary, or clinical note. Documentation must include the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication. 3. All organization personnel involved in patient care/service, including those providing contracted services, must have access to the plan of care/service and all other relevant patient information to ensure coordination and continuity. All personnel must be knowledgeable regarding patient needs, goals of care, and services.”