Children’s Hosp of Los Angeles

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 36206 Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation (CoP) for Patient Rights was met, as evidenced by: 1. The facility failed to provide medical record within the facility’s required timeframe (15 days) for one of 33 sampled patients (Patient 17), in accordance with the facility’s policy for medical record request, when Patient 17’s parent (FM 17) submitted Patient 17’s medical record request on 6/12/2024 and 8/7/2024. The facility completed FM 17’s medical record request on 8/6/2024 and 11/13/2024. This deficient practice resulted in a delay of Patient 17’s parent (FM 17) receiving the requested medical record for Patient 17. (Refer to A-0129) 2. The facility failed to provide information of “Experimental Subject’s Bill of Rights (a list of rights as required by [the state] law for anyone participating in a medical experiment)” to one of 33 sampled patients (Patient 18), when obtaining consent from Patient 18 and Patient 18’s parents, in accordance with the facility’s Institutional Review Board (IRB, a committee that ensures the ethical treatment, safety, and welfare of human subjects in research, approving and monitoring research studies) requirement when consenting Patient 18 and Patient 18’s parents to participate in research study (Study B) on 4/29/2015. This deficient practice had the potential to result in Patient 18 and Patient 18’s parents not being fully aware, understand and exercise their rights when participating in a research study. (Refer to A-0129) 3. The facility failed to ensure that the facility’s emergency department (ED, the hospital department that provides immediate treatment for acute illness or injury) physician communicated pertinent medical information for one of 33 sampled patients (Patient 7) in their preferred language, Spanish, as was requested by Patient 7’s family member on admission in the emergency department (ED), in accordance with the facility’s policy regarding communication assistance. This deficient practice had the potential for Patient 7’s (who is a minor) family member not to understand the communicated information, violating Patient 7’s rights to be able to make informed decisions in a language that a patient can understand (the legal and ethical entitlements that ensure patients receive safe, respectful care, including the right to receive information in a language they understand to make informed healthcare decisions). (Refer to A-0129) 4. The facility failed to ensure that visitation restrictions were applied in a reasonable, consistent, and patient?centered manner during a period of significant medical decline for one of 33 sampled patients (Patient 5), when the visitation by the father (Patient 5’s father) was not allowed despite Patient 5’s worsening medical condition, in accordance with the facility’s policy regarding visitation. This deficient practice resulted in the violation of Patient 5’s rights to allow visitation of any person living in the household and any support person pursuant to federal law (federal law require hospitals to allow patients to receive visitors of their choosing without discrimination, including family members, household members...). (Refer to A-0129) 5. The facility failed to ensure timely access to Patient Relations (the hospital department that helps patients and families with complaints, concerns, care coordination issues, and communication support to resolve problems during hospitalization) for one of 33 sampled patients (Patient 8). In addition, Patient 8’s parents attempted multiple times to voice concerns about the treatment and care of Patient 8, but the facility did not support the family in understanding, participating in, and exercising their rights regarding care decisions, in accordance with the facility’s policy regarding grievance resolution management including patient and patient’s family’s rights. This deficient practice resulted in the violation of Patient 8’s rights to participate in the development and implementation of the plan of care and to make informed decisions about care. In addition, this failure had the potential to result in Patient 8’s parents’ concerns to remain unaddressed and hindered their ability to participate in the care plan, which could negatively affect Patient 8’s postoperative recovery. (Refer to A-0129) 6. The facility failed to ensure the completion of an investigation and disclose the results of the investigation about left arm swelling, for one of 33 sampled patients (Patient 8), to Patient 8 and to Patient 8’s family, in accordance with the facility’s policy regarding patient and patient’s family’s rights. This deficient practice violated Patient 8’s right to be informed of their health status, including the right to receive information necessary to understand the cause of symptoms, participate in care decisions, and make informed choices about treatment. In addition, this deficient practice had the potential to result in delayed identification of vascular compromise for Patient 8, untreated arterial injury, or worsening swelling and pain. (Refer to A-0129) 7. The facility failed to ensure that a provider (a licensed healthcare professional such as a physician, nurse practitioner, or other qualified clinician who is authorized to evaluate a patient’s understanding and make decisions about their participation in medical care or research) determined the capacity (a person’s ability to understand information, think it through, and make an informed decision) of all minors (individuals under the age of legal adulthood) enrolled in Study C, to provide assent (affirmative agreement from a child who is not legally able to give full consent) during consent conferences for participation in the clinical study C. Instead, the Clinical Research Coordinator (CRC, a trained professional who manages and organizes the daily activities of a clinical trial) independently assessed and documented minors’ capacity to assent without involvement or consultation with the Principal Investigator (PI, the doctor or qualified expert who is responsible for the overall conduct and safety of the clinical study) or a qualified provider, which was not in accordance with the facility’s policy. This deficient practice had the potential to affect all minors enrolled in Study C, as their ability to provide meaningful assent was not assessed or documented by a qualified clinician, in accordance with the facility’s policy for determining capacity. (Refer to A-0131) 8. The facility failed to ensure staff immediately notified security and hospital leadership after receiving reports of concerning behavior by a visitor/family member for one of 33 sampled patients (Patient 30), placing patients, visitors, and staff at risk for an unsafe environment. For Patient 30, staff received information regarding concerning behavior involving a visitor/family member; however, security personnel and hospital leadership were not immediately notified. The failure to promptly escalate the concern had the potential to prevent a timely assessment and intervention to address potential safety risks within the care environment, which may lead to patient harm for Patient 30 and other patients at the facility. (Refer to A-0144) 9. The facility failed to provide requested medical records (documents containing a patient’s health information) to one (1) of 33 sampled patients (Patient 10), within the 3-5 business day timeframe stated on the facility’s public website. Instead, the facility’s actual processing time was 15 business days, which conflicted with the website’s stated timeframe. This deficient practice resulted in delays for Patient 10’s mother and father when attempting to obtain copies of the patient’s medical records. (Refer to A-0148) The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality healthcare in a safe environment.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 36206 Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation (CoP) for Nursing Services was met, as evidenced by: 1. The facility failed to ensure nursing staff in the Emergency Department (ED) assessed and reassessed pain for one of 33 sampled patients (Patient 1), in accordance with the facility’s policy regarding pain management and assessment of pain. This deficient practice had the potential to result in unmanaged pain, delayed recognition of worsening conditions, and compromised patient outcomes. (Refer to A-0395) 2. The facility failed to ensure nursing staff notified the physician when one of 33 sampled patient’s (Patient 32), heart rate (HR-the number of times the heart beats per minute), fell below the physician - ordered notification parameter of less than 57 beats per minute (bpm- the number of times your heart beats each minute while you are awake, calm and not moving). Documentation showed that Patient 32’s HR dropped to 52 bpm on 4/15/206 at 1:00 a.m.; however, there was no documented evidence the provider was notified as ordered. This deficient practice had the potential to delay medical evaluation and treatment of symptomatic bradycardia (a slower than typical heartbeat) for Patient 32, which may result in worsening cardiac status, decreased cardiac output (an inadequate volume of blood pumped by the heart to meet the metabolic demands of the body), hypotension (low blood pressure) arrythmias (a problem with the rate or rhythm of the heartbeat) or cardiac arrest (when the heart suddenly and unexpectedly stops pumping). (Refer to A-0395) 3. The facility failed to ensure that nursing staff developed and maintained a current nursing care plan (a written document outlining patient goals and nursing interventions) addressing pain management for one of 33 sampled patients (Patient 10), as required by facility policy and federal regulation regarding care plans. This deficient practice created the potential for unmet pain management needs and incomplete documentation of care planning. (Refer to A-0396) 4. The facility failed to ensure Nursing staff notified the physician and the charge nurse of an abnormal PEWS (Pediatric Early Warning Signs, a tool used in hospitals to identify potential clinical deterioration in children) score for one of 33 sampled patients (Patient 5). In addition, the abnormal PEWS was not reassessed within 1 - 2 hours, in accordance with the facility’s policy and procedure regarding PEWS. This deficient practice placed Patient 5 at risk of clinical staff not identifying and treating Patient 5’s potential clinical deterioration. (Refer to A-0398) 5. The facility failed to ensure Nursing staff notified the physician when one of 33 sampled patients (Patient 5) had abnormal vital signs (temperature, blood pressure, heart rate, and respiratory rate, oxygen saturation), in accordance with the physician’s order. This deficient practice resulted in a delay in addressing Patient 5’s abnormal vital signs for approximately seven (7) hours until Patient 5’s parent (Parent 1) initiated a RRT (Rapid Response Team, a team of healthcare professionals with critical care expertise prepared to respond and meant to assist in stabilizing a patient’s condition before a cardiac or respiratory arrest or other adverse event occurs) and placed Patient 5 at risk of deterioration. (Refer to A-0398) 6. The facility failed to ensure that one of 33 sampled patients (Patient 2), received adequate education and discharge instructions regarding the care and management of an indwelling Foley catheter(a thin, flexible tube inserted through the urethra into the bladder to continuously drain urine into an external collection bag) that had been placed in the facility’s urology clinic. Specifically, the facility failed to provide instruction regarding catheter hygiene, infection prevention measures, signs and symptoms of complications, and when to seek medical attention. This deficient practice had the potential to result in Patient 2’s inability to appropriately manage the indwelling urinary catheter after discharge, which could contribute to the development of catheter-associated urinary tract infection (CAUTI), progression of infection, sepsis, hospitalization, and other serious adverse outcomes. For Patient 2, the lack of documented education and instruction regarding Foley catheter care had the potential to contribute to the development of a urinary tract infection and subsequent sepsis (a life-threatening medical emergency caused by the body’s extreme, overactive response to an infection). (Refer to A-0398) The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality healthcare in a safe environment.”

“PATIENT RIGHTS: EXERCISE OF RIGHTS CFR(s): 482.13(b) Patient Rights: Exercise of Rights This Standard is not met as evidenced by: 48212 Based on interview and record review, the facility failed to: 1. Provide medical record within the facility’s required timeframe (15 days) for one of 33 sampled patients (Patient 17), in accordance with the facility’s policy for medical record request, when Patient 17’s parent (FM 17) submitted Patient 17’s medical record request on 6/12/2024 and 8/7/2024. The facility completed FM 17’s medical record request on 8/6/2024 and 11/13/2024. This deficient practice resulted in a delay of Patient 17’s parent (FM 17) receiving the requested medical record for Patient 17. 2. Provide information of “Experimental Subject’s Bill of Rights (a list of rights as required by [the sate] law for anyone participating in a medical experiment)” to one of 33 sampled patients (Patient 18), when obtaining consent from Patient 18 and Patient 18’s parents, in accordance with the facility’s Institutional Review Board (IRB, a committee that ensures the ethical treatment, safety, and welfare of human subjects in research, approving and monitoring research studies) requirement when consenting Patient 18 and Patient 18’s parents to participate in research study (Study B) on 4/29/2015. This deficient practice had the potential to result in Patient 18 and Patient 18’s parents not being fully aware, understand and exercise their rights when participating in a research study. 3. Ensure that the facility’s emergency department (ED, the hospital department that provides immediate treatment for acute illness or injury) physician communicated pertinent medical information for one of 33 sampled patients (Patient 7) in their preferred language, Spanish, as was requested by Patient 7’s family member on admission in the emergency department (ED), in accordance with the facility’s policy regarding communication assistance. This deficient practice had the potential for Patient 7’s (who is a minor) family member not to understand the communicated information, violating Patient 7’s rights to be able to make informed decisions in a language that a patient can understand (the legal and ethical entitlements that ensure patients receive safe, respectful care, including the right to receive information in a language they understand to make informed healthcare decisions). 4. Ensure that visitation restrictions were applied in a reasonable, consistent, and patient-centered manner during a period of significant medical decline for one of 33 sampled patients (Patient 5), when the visitation by the father (Patient 5’s father) was not allowed despite Patient 5’s worsening medical condition, in accordance with the facility’s policy regarding visitation. This deficient practice resulted in the violation of Patient 5’s rights to allow visitation of any person living in the household and any support person pursuant to federal law (federal law require hospitals to allow patients to receive visitors of their choosing without discrimination, including family members, household members...). 5. Ensure timely access to Patient Relations (the hospital department that helps patients and families with complaints, concerns, care coordination issues, and communication support to resolve problems during hospitalization) for one of 33 sampled patients (Patient 8). In addition, Patient 8’s parents attempted multiple times to voice concerns about the treatment and care of Patient 8, but the facility did not support the family in understanding, participating in, and exercising their rights regarding care decisions, in accordance with the facility’s policy regarding grievance resolution management including patient and patient’s family’s rights. This deficient practice resulted in the violation of Patient 8’s rights to participate in the development and implementation of the plan of care and to make informed decisions about care. In addition, this failure had the potential to result in Patient 8’s parents’ concerns to remain unaddressed and hindered their ability to participate in the care plan, which could negatively affect Patient 8’s postoperative recovery. 6. Ensure the completion of an investigation and disclose the results of the investigation about left arm swelling, for one of 33 sampled patients (Patient 8), to Patient 8 and to Patient 8’s family, in accordance with the facility’s policy regarding patient and patient’s family’s rights. This deficient practice violated Patient 8’s right to be informed of their health status, including the right to receive information necessary to understand the cause of symptoms, participate in care decisions, and make informed choices about treatment. In addition, this deficient practice had the potential to result in delayed identification of vascular compromise for Patient 8, untreated arterial injury, or worsening swelling and pain. Findings: 1. During a review of Patient 17’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 3/30/2022, the “H&P” indicated, Patient 17 was a 13-year-old patient admitted to the facility due to pelvic (lower part of the body between abdomen and thigh) mass for work up and management. During a review of Patient 17’s facility’s clinic visit note titled, “Hematology (specialized branch of medicine focused on the study, diagnosis, treatment, and prevention of blood-related disease, and blood cells disorders)-Oncology (specialized branch of medicine focused to the diagnosis, treatment and prevention of cancer) OP (outpatient) MD (medical doctor) note (an examination note with patient’s history and physical prepared by the patient’s provider),” dated 5/9/2022, the clinical visit note indicated, Patient 17 had pelvic (lower part of the body between abdomen and thigh) Ewing sarcoma (a group of cancers that occurs in bone, muscle, organs or nerves) and receiving chemotherapy (cancer treatment) at the facility’s infusion center (outpatient clinic providing outpatient treatment including chemotherapy). During a review of Patient 17’s medical record request form titled, “Authorization of Release Health Information,” dated 6/11/2024, the “Authorization of Release Health Information” indicated, Patient 17’s parent (FM 17) completed the medical record request form on 6/11/2024 requesting Patient 17’s medical record including emergency department (ED, hospital department provides unscheduled outpatient services to patients whose condition requires immediate care), history and physical, immunization (record of vaccine), laboratory results, discharge summary, clinic notes, radiology reports, radiology images, pathology reports (a medical document that provides a report on tissue, cells, or body fluids removed during a biopsy, surgery or other procedure) and operative (surgery) reports from 3/25/2022 to 6/11/2024. During a concurrent interview and record review on 4/17/2026 at 11:04 a.m. with the Director (DIR 4) of Health Information Management (HIM, hospital department handles retaining and releasing patient’s medical record), the facility’s internal medical record request management program (HIM program, facility’s medical record request tracking system), was reviewed. The HIM program indicated, the facility received a medical record request on 6/12/2024 from Patient 17’s parent (FM 17). The HIM program also indicated, FM 17’s request was completed on 8/6/2024. DIR 4 stated typically, the turn-around time for medical record release, was 15 days. DIR 4 further stated there was a delay in processing FM 17’s request because there was a backlog (a collection of unfinished work, pending orders). During a review of Patient 17’s medical record request form titled, “Authorization of Release Health Information,” dated 8/7/2024, the “Authorization of Release Health Information” indicated, Patient 17’s parent (FM 17) completed the medical record request form on 8/7/2024 requesting Patient 17’s medical record including emergency department, history and physical, immunization, laboratory results, discharge summary, clinic notes, radiology reports, radiology images, pathology reports and operative reports from 6/27/2008 to 8/7/2024. During a concurrent interview and record review on 4/17/2026 at 11:15 a.m. with the Director (DIR 4) of Health Information Management (HIM, hospital department handles retaining and releasing patient’s medical record), the facility’s internal medical record request management program (HIM program), was reviewed. The HIM program indicated, the facility received medical record request on 8/7/2024 from Patient 17’s parent (FM 17). The HIM program also indicated, FM 17’s request was completed on 11/13/2024. DIR 4 stated there was a delay in completing FM 17’s request because additional time was needed to retrieve the record from storage and radiology department. DIR 4 further stated communication took place when the requestor called the HIM department to check on the request status. DIR 4 stated the HIM department did not have the resources to reach out to the requestor to provide update on the record request status. During a concurrent interview and record review on 4/20/2026 at 3:38 p.m. with the Manager of Performance Improvement (MPI), the facility’s policy and procedure (P&P) titled, “Privacy - Individual Rights: Access to PHI (Protected Health Information),” dated 7/2021, was reviewed. The P&P indicated, “[the facility] is committed to protecting the privacy of patients and their health information while carrying out hospital services and operations. The purpose is to implement the applicable state and federal laws that provide patients, on a written request, with a right of access to inspect and/ or obtain a copy of their Protected Health Information (PHI), maintained in one or more designated record set(s) ... Responding to Request ... Health Information Management will respond to an individual’s request to access their Protected Health Information within the established time frame set forth in the applicable laws.” MPI stated the timeframe was 15 days. During a review of the facility’s policy and procedure (P&P) titled, “Privacy - Individual Rights: Access to PHI (Protected Health Information),” dated 7/2021, the P&P indicated, “[the facility] is committed to protecting the privacy of patients and their health information while carrying out hospital services and operations. The purpose is to implement the applicable state and federal laws that provide patients, on a written request, with a right of access to inspect and/or obtain a copy of their Protected Health Information (PHI), maintained in one or more designated record set(s) ... [the facility] patients and/or their personal representative(s) are entitled to inspect and/or obtain a copy of their Protected Health Information maintained in a designated set by [the facility] ... Responding to Request ... Health Information Management will respond to an individual’s request to access their Protected Health Information within the established time frame set forth in the applicable laws.” 2. During a review of Patient 18’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 7/6/2014, the “H&P” indicated, Patient 18 was admitted to the facility for new onset of leukemia (a type of blood cancer). During a review of the cancer research study’s (Study B’s) informed consent form titled, “[the facility] Parental Permission to Participate in a Research Study [research study name],” dated 4/29/2015, the informed consent indicated, Study B involved collecting patient’s demographic information, disease information, diagnostic laboratory report, and permitting future contact. During an interview on 4/17/2026 at 12:06 p.m. with the Director (DIR 5) of Research Office, DIR 5 stated each research study would require the facility’s Institutional Review Board (IRB, a committee that ensures the ethical treatment, safety, and welfare of human subjects in research, approving and monitoring research studies) review and approval. DIR 5 stated IRB would issue an approval letter listing what informed consent documents were required when enrolling a participant in the research study. During a review of the facility’s IRB approval letter issued for the cancer research study (Study B) titled, “Notice of Facilitated Review of Acceptance with Stipulation (requirement),” dated 4/28/2008, the IRB approval letter for Study B indicated, “one copy of the signed informed consent document and “Experimental Subject’s Bill of Rights (a list of rights as required by [the state] law for anyone participating in a medical experiment)” and the HIPAA (Health Insurance Portability and Accountability Act. Federal regulations that govern the privacy and confidentiality of medical information maintained by healthcare providers) Authorization Form for Research, should be placed in the subject’s [the facility] medical record.” During a review of Patient 18’s “Informed Consent Conference,” dated 4/29/2015, the “Informed Consent Conference” indicated, the Clinical Research Coordinator (CRC 4) conducted an informed consent conference regarding Study B with Patient 18 and Patient 18’s parents. The “Informed Consent Conference” also indicated, “The subject (Patient 18)/family was given adequate time to review the informed consent/assent and HIPAA documents. All questions and/or concerns were addressed and the subject (Patient 18)/ family voluntarily agreed to participate in study. Signatures were obtained on all necessary documents ...” The “Informed Consent Conference” did not indicate the “Experimental Subject’s Bill of Rights” was discussed or reviewed during the informed consent conference on 4/29/2015. During an interview on 4/20/2026 at 4:25 p.m. with DIR 5, DIR 5 stated after patient and patient’s parent(s) had signed all required documents per IRB approval letter, there should be a second reviewer to review and make sure the informed consent packet was complete before enrolling the patient into the research study. During a concurrent interview and record review on 4/20/2026 at 4:27 p.m. with DIR 5, Patient 18’s informed consent packet for Study B, dated 4/29/2015, was reviewed. The consent packet indicated there was no “Experimental Subject’s Bill of Rights” copy found for Patient 18. DIR 5 confirmed there was no “Experimental Subject’s Bill of Rights” copy found in Patient 18’s medical record. During an interview on 4/20/2026 at 4:32 p.m. with physician (MD 3), MD 3 stated during the consent conference for a research study, the person conducting the consent conference should provide information of the “Experimental Subject’s Bill of Rights” to the patient and patient’s parents. The “Experimental Subject’s Bill of Rights” talked about patient’s rights including the right of knowing the risks and benefits of participating the research study, the right of asking questions about the research study, and the right of withdrawing from the research study at any time. During a review of the facility’s “Experimental Subject’s Bill of Rights,” dated 10/28/2016, the “Experimental Subject’s Bill of Rights” indicated, “You have been asked to participate as a subject in a medical experiment. Before you decide whether you want to participate in the experimental procedure, you have a right to the following information. [the state] Law Requires that You Must Be Informed About: 1. The nature and purpose of the study; 2. The procedures in the study and any drug or device to be used; 3. Discomforts and risks reasonably to be expected from the study; 4. Benefits reasonably to be expected from the study; 5. Alternative procedures, drugs or devices that might be helpful and their risks and benefits; 6. Availability of medical treatment should complications occur; 7. The opportunity to ask questions about the study or the procedure; 8. The ability to withdraw from the study at any time and discontinue participation without affecting your future care at this institution; 9. Be given a copy of the signed and dated written consent form of the study; and 10. The opportunity to consent freely to the study without the use of coercion.” During a review of the facility’s policy and procedure (P&P) titled, “Patient and Family Rights and Responsibilities,” dated 8/4/2025, the P&P indicated, “Patient rights should be promoted and protected by all hospital and medical staff... 5. Made decisions regarding medical care and receive as much information about any proposed treatment or procedure as may be needed in order to give informed consent or to refuse a course of treatment... 14. Be advised if the hospital or licensed healthcare practitioner acting within the scope of his or her professional licensure proposes to engage in or perform human experimentation affecting care or treatment. The patient has the right to refuse to participate in such research projects.” During a review of the [state] regulation “Health and Safety Code § 24173 (a),” dated 1/1/202024, the [state] regulation indicated, “The subject or subject’s conservator or guardian, or other representative, as specified in Section 24175, is provided with a copy of the experimental subject’s bill of rights, prior to consenting to participate in any medical experiment, containing all the information required by Section 24172, and the copy is signed and dated by the subject or the subject’s conservator or guardian, or other representative, as specified in Section 24175.” 3. During a review of Patient 7’s Emergency Department note, dated 8/25/2025, the note indicated that Patient 7 was brought in by his (Patient 7) mother into the Emergency Department (ED), for abdominal pain, multiple soft stools throughout the day, and blood in the stool. During a concurrent interview and record review on 4/14/2026 at 2:00 p.m. with Registered Nurse-Clinical Practice Leader (RN 2), Patient 7’s physician orders, placed into the EMR (Electronic Medical Record, a digital version of a patient’s medical chart used to store and track medical information) on 8/25/2025, were reviewed. The order indicated that an “ED Language/Culture Request (In-person, an in-person request for a qualified interpreter to assist with communication between medical staff and the patient/family when English is not their preferred language), was placed on 8/25/2025 at 10:27 p.m. RN 2 also verified that a Spanish translation request/order was placed for Spanish-speaking families. During an interview on 4/14/2026 at 2:50 p.m. with Registered Nurse-Clinical Practice Leader (RN 2), RN 2 stated that she (RN 2) was unable to locate documentation indicating that a translator/interpreter (a qualified individual who converts spoken or signed information from one language to another to ensure the patient or family can understand medical information), was used during Patient 7’s visit on 8/25/2025. During further review of Patient 7’s Emergency Department note, dated 8/25/2025, the note indicated the following: “I (ED physician [MD 13]) have confirmed all elements of the history, personally performed the physical examination, and reviewed the plan of care with the caregiver ...” During an interview on 4/15/2026 at 12:07 p.m. with the Emergency Department physician (MD 13), MD 13 stated that they (the facility staff) recalled that Patient 7’s mother was very frustrated with the medical system. MD 13 stated that she (Patient 7’s mother) was upset about the ED wait time and that MD 13 spent a significant amount of time speaking with the mother (Patient 7’s mother), who left the ED abruptly without receiving discharge instructions. MD 13 then confirmed that no translator/interpreter was used during this conversation and stated, “I recall speaking English and she (Patient 7’s mother) spoke English with me. If it says Spanish [interpreter was ordered/requested], we don’t have the interpreter at that hour [after 10 p.m.], and we would use the phone interpreter, and they typically provide an ID (a unique identification number issued by the interpreter service to document who provided the language assistance and to verify that a qualified interpreter was used), but I don’t see it documented ... and I don’t recall using the phone interpreter ... I spoke English to mom ... she spoke English to me ...” During a review of the facility’s policy and procedure (P&P) titled, “Communication Assistance,” dated 8/2023, the policy indicated that patients with limited English proficiency (LEP) may require additional support to meet this goal. The policy further indicated that this is accomplished by delivering care that is language-concordant and adaptive to individual communication needs. To assist in facilitating effective communication between patients/research subjects/families and care providers/researchers, the language-concordant services include interpretation and the use of Language-Proficient Bilingual Employees (BE), as well as communication resources such as Speech-Language Pathologists, other professionals, or assistive devices. The policy indicated the following: “I. Oral Interpreting Services and/or Assistive Devices: A. All patients/families with limited English proficiency (LEP), vision, speech, hearing or cognitive impairments, shall be advised of their right to receive healthcare information in a manner that meets the patient’s needs, either directly in their primary spoken language, through a qualified interpreter or through auxiliary aids provided by CHLA within a reasonable time, and at no charge. B. CHLA shall provide meaningful access to all patient services, including access to information, signage, appointments, financial services, and ancillary services for all patients/families with LEP, or who have vision, speech, hearing or cognitive impairments. Services shall be provided to LEP patients/families either directly in their preferred primary language or through interpreter services within a reasonable time and at no cost to the patient or family...” During a review of the facility’s policy and procedure (P&P) titled, “Patient Rights and Responsibilities,” dated 2/2024, the policy indicated, “Patient rights should be promoted and protected. The policy is applicable to all patients and families, clinical services, patient family experiences, and social work... Patients have the right to receive information about their health status, diagnosis, prognosis, and course of treatment ...in a language the patient can understand...” 4. During a review of Patient 5’s History and Physical (H&P, a medical document that provides a comprehensive summary of the patient’s medical history, current condition, and findings from the physical examination), dated 3/3/2021, the H&P indicated that Patient 5 was a minor with a history of brain stem lesions (abnormal areas of damaged tissue located in the brain stem, the part of the brain responsible for vital functions such as breathing, heart rate, and coordination) without tissue diagnosis (no biopsy or sample analysis was performed to confirm the exact type or nature of the lesion) and with progressive neurologic decline (a gradual worsening of nervous system function, such as movement, coordination, cognitive ability, or strength over time), who presented for the management of weight loss and malnutrition (a condition resulting from insufficient intake of nutrients needed for normal growth, healing, and body function). During a review of Patient 5’s Social Work progress note, dated 3/15/2021, the note indicated that the mother (Patient 5’s mother) reported that she (Patient 5’s mother) and her husband (Patient 5’s father) decided that they wanted the mother (Patient 5’s mother) and the paternal grandmother to be Patient 5’s two (designated) caregivers. The note also indicated that the mother was informed that once this visitation restriction allowance was made, it would apply for the duration of the hospitalization, and the mother agreed to it. The record was reviewed with Clinical Nurse Specialist (CNS 1) on 4/15/2026. During a review of Patient 5’s Social Work progress note, dated 3/17/2021, the note indicated that the mother asked if the father of Patient 5 could visit Patient 5 in the hospital because the child’s (Patient 5) birthday was on 3/18/2021. The note further indicated that the request was denied due to the current pandemic protocol (rules the hospital used during COVID?19 to limit visitors) and because the mother (Patient 5’s mother) had previously agreed to switch Patient 5’s father’s visitation with the paternal grandmother. The note also indicated that patient 5’s mother said that a cousin (Patient 5’s) was allowed to visit that day, and questioned why, if the pandemic protocol was in place, he (the father) was denied visitation while the cousin was allowed to visit. This information was verified with Clinical Nurse Specialist (CNS 1) on 4/15/2026. During a review of Patient 5’s Social Work progress note. dated 3/18/2021, the note indicated that Social Worker (SW 2) was advised by Social Worker (SW 3) to not allow any changes to the visitation arrangement (the only approved visitors for this hospital stay, as previously agreed, were the mother and the grandmother). SW 2 declined the request for the father to visit Patient 5 on the patient’s birthday (3/18/2021) to have cake with him [Patient 5]. The note indicated that per current policy, no visitor changes were allowed. The record was reviewed with Clinical Nurse Specialist (CNS 1) on 4/15/2026. During a review of Patient 5’s Social Work progress note, dated 3/18/2021, the note indicated that Patient 5’s condition deteriorated and RRT (Rapid Response Team, a hospital team that responds immediately when a patient’s condition worsens) was called twice. The note also indicated that the mother of Patient 5 was again updated that due to the pandemic visitor-allowance protocol (hospital rules limiting visitors during COVID-19 for the safety of Patient 5 and other patients), the father of Patient 5 would not be allowed to be present at Patient 5’s bedside. The record was reviewed with Clinical Nurse Specialist (CNS 1) on 4/15/2026. During a review of Patient 5’s Social Work progress note, dated 3/19/2021, the note indicated that Social Worker (SW 3) reviewed the visitor-allowance policy, reviewed CDC (Centers for Disease Control and Prevention, the national public health agency that provides safety guidelines) visitation guidelines, consulted with the charge nurse and Social Worker (SW 2), and updated the mother (Patient 5’s mother) that no changes could be made to the visitor allowance, even though the mother (Patient 5’s mother) expressed the following: “Mom stated she is unsure she can handle the current situation emotionally without dad (Patient 5’s father) being present.” The record was reviewed with Clinical Nurse Specialist (CNS 1) on 4/15/2026. During a review of the Social Worker note, dated 3/22/2021, the note indicated that the child protective services case worker recommended that Patient 5’s “father be authorized as the second caregiver visitor so that he can participate in medical decision making and ongoing conversations at bedside. (This means the case worker wanted the father to be officially allowed as a visitor so he could help make medical decisions and stay informed about the patient’s care).” The record was reviewed with Clinical Nurse Specialist (CNS 1) on 4/15/2026. During a review of Patient 5’s discharge summary (a medical document that describes the patient’s hospital course, treatment provided, and plan for care after leaving the hospital), dated 3/29/2021, the record indicated that on 3/26/2021, Patient 5 was discharged back home with hospice care (a type of care focused on comfort and quality of life for patients with a life-limiting illness, usually provided at home). During a concurrent interview and record review on 4/20/2021 with the Vice President of Quality and Patient Safety (VPQ), the facility’s policy titled “Changes to Visitation Policy,” dated 10/29/2020, was reviewed. The record indicated that starting 11/1/2020, the updated visitation policy “restricted inpatient visitors to two designated caregivers per patient, who had to be free of symptoms ... Two visitor passes were issued to these designated caregivers, and the passes could not be shared with other family members.” The VPQ did not provide a comment as to why two members of the same household could not alternate as the designated caregivers, especially given that Patient 5’s medical condition was worsening. The VPQ only stated, “We had the policy for a reason. If every family asked for exceptions, it would be impossible to enforce the policy.” During a review of the facility’s policy and procedure (P&P) titled “Changes to Visitation Policy,” dated 10/29/2020, the policy indicated that as of 11/2/2020, two designated caregivers were allowed per patient. Inpatient visitors were restricted to two designated caregivers per patient who did not have symptoms. During a review of the facility’s policy and procedure (P&P) titled “Patient and Family Rights and Responsibilities,” dated 2/2024, the policy indicated that the hospital may establish reasonable restrictions on visitation, including limits on visiting hours and the number of visitors. 5. During a review of Patient 8’s History and Physical (H&P, a medical document that summarizes the patient’s medical history, current condition, physical exam findings, and the plan of care), dated 3/16/2026, the H&P indicated that Patient 8, an 8 year-old, was admitted for tracheoesophageal fistula repair (a surgery to close an abnormal connection between the trachea [windpipe] and the esophagus [food pipe]) and for post-operative management (medical care provided after surgery to monitor healing, prevent complications, and manage pain and nutrition). During a review of Patient 8’s Social Work Confidential Note, dated 3/17/2026, the note indicated that “Mother and Father [Patient 8’s parents] spoke at length regarding their concerns, and Social Worker (SW 1) provided empathetic support (meaning the social worker listened with understanding, acknowledged their feelings, and offered emotional reassurance). Parents reported that some of their concerns have been alleviated over the past few days...” During a review of Patient 8’s Social Work Confidential Note, dated 3/24/2026, the note indicated that “a family conference is planned for tomorrow (3/25/2026) to discuss barriers to care. Today (3/24/2026), the parents refused physical therapy goals, and also refused nursing goals (including turning, assessing dressings, and following monitoring as ordered...).” During a review of Patient 8’s Social Work Confidential Note, dated 3/25/2026, the note indicated that a team consisting of the social worker, pediatric surgery, pain management, the primary registered nurse, and the floor manager met and agreed that Patient 8’s parents had been presenting refusal and disruption of care. The note further indicated, “Please refer to chart for details...” The note indicated that the same team met with the mother at the bedside, while the father participated by speakerphone, “The mother reported that she did not agree with the refusal of care. SW 1 informed the parents that if refusal and disruption of care continued, one or both parents might be asked to leave the hospital for a cooling-off period (a short time away from the situation to allow emotions to settle and prevent further conflict) overnight, and DCFS (Department of Children and Family Services, the agency that investigates concerns about child safety) might be consulted. During an interview on 4/17/2026 at 1:51 p.m. with the manager of 6 East (NM 3), NM 3 stated, “We had issues with the family not following the care plan. We brought together all the care providers so we could compare notes, make sure everyone was on the same page, and then meet with the family. The barriers to care included refusing care items, delaying antibiotics, and refusing many of the recommendations made by the treatment team. Vital signs and antibiotics were often pushed off the schedule because the family said they did not want them at that time, and they did not give a clear reason. Their refusals did not match the patient’s [Patient 8] medical needs. They also refused for the patient [Patient 8] to walk at times, even though the attending physician said the lung had healed and the patient needed to get back on schedule and follow the care plan. The patient’s pain scores did not show high levels of pain, and the plan was to reduce the pain medication and have her [Patient 8] walk.” During the same interview on 4/17/2026 at 1:51 p.m. with the manager of 6 East (NM 3), NM 3 also stated that patient relations (the hospital department that helps patients and families resolve concerns or complaints) was the parents’ responsibility to contact if they had concerns. NM 3 said there was no medical reason for the child to refuse to walk, because the patient’s pain scores were good. NM 3 explained that the family did not agree with the medication regimen and other treatment methods, and they did not want the patient to walk but confirmed that patients do have the right to refuse treatments, as required under patient rights (the legal protections that allow patients or their representatives to make decisions about their care). During an interview on 4/17/2026 at 11:51 a.m. with the social worker (SW 1), SW 1 stated: -“The meeting held on 3/25/2026 was about getting the pediatric surgeon and the team together to discuss the parents’ (Patient 8’s parents) refusal of care. There were many refusals. The parents refused turning, refused assessments of the dressing, refused pulse ox (oximeter) monitoring, and there were many times they refused or delayed medications. The pediatric surgery team initiated the conference. -My role as the social worker was to provide psychosocial support. This was the first and only meeting with the family so far. -The mother (Patient 8’s mother) reported that she did not agree that she had been refusing care. She denied refusing anything. I don’t think the father said that he was refusing care. The father did participate in discussing the goals for recovery.” -SW 1 also said that parents “can be asked to leave the hospital if refusal and disruption of care continue, may be asked to leave for a cooling-off period (a short time away from the unit to allow emotions to settle and reduce conflict). This could initially be for a weekend. DCFS (Department of Children and Family Services, a government child welfare agency) can be contacted if the physician determines that the parents’ actions are causing medical harm to the patient. This was not meant as a threat; it was a plan. If the parents’ refusal becomes harmful to the child, decisions would be made with the provider. Many steps are taken before reaching that point.” -“I had seen the family before this meeting, and many refusals of care had been documented. During the meeting, the parents expressed many concerns, including disagreements with the medical plan and concerns about how staff approached the care. Their concerns included not agreeing with the plan for turning, dressing changes, and other care that they felt the patient could not tolerate.” -“The parents’ refusals were documented as interfering with care. I do not remember all of them, but everything is documented in the chart.” During a review of Patient 8’s Physical Therapy (PT) Evaluation, dated 3/16/2026, the note indicated the following: “Behavior observed: Patient 8 was able to answer simple questions and follow simple 1-2 step directions; however, there was frequent refusal throughout the session. Patient 8 required 3?person assist (meaning three staff members were needed to safely help the patient move in bed) with bed mobility, and use of a draw sheet (a large sheet placed under the patient that allows staff to lift or reposition the patient more easily). Patient 8 refused to move the right lower extremity (RLE) (the right leg) into hip and knee extension with reports of pain when moving, and fear of pain at the PIV in the RLE (PIV meaning a peripheral intravenous line placed into a vein of the right leg to give fluids or medications).” During a review of Patient 8’s Physical Therapy (PT) note, dated 3/17/2026, the note indicated that treatment was not provided because the patient (Patient 8) and (Patient 8’s) family refused. The bedside registered nurse (RN) also requested that PT hold the session at that time. The note further indicated that Patient 8 required supplemental oxygen (extra oxygen given to help a patient breathe better) via a face mask (a mask placed over the nose and mouth to deliver oxygen) and had consistent tachycardia (a fast heart rate). The RN requested holding the PT session due to Patient 8’s “increased pain and increased respiratory needs.” During a review of Patient 8’s Physical Therapy (PT) note, dated 3/18/2026, the note indicated the following: “Treatment not given: Patient/family refused. Additional comments: Spoke with bedside RN who reports Patient 8 is scheduled for an esophagram (a diagnostic test in which X-ray images are taken while the patient swallows contrast dye to evaluate the esophagus) at this time and possible PICC line placement (Peripherally Inserted Central Catheter, a procedure in which a long, thin catheter is inserted into a large vein to provide long?term IV access) following.” -The note also indicated that Patient 8 refused to do physical therapy in the afternoon after undergoing the procedures. The note further indicated, “Patient (Patient 8) continues to be on 5 L/min (a flow rate indicating five liters of oxygen delivered each minute to support breathing) supplemental oxygen via face mask (a mask placed over the nose and mouth to deliver oxygen) with poor ability to clear secretions independently (meaning she was unable to cough up mucus on her own).” During a review of the Physical Therapy (PT) progress note, dated 3/20/2026, the note indicated that Patient 8 had undergone transesophageal fistula (TEF) ligation (a surgery to close an abnormal connection between the esophagus and the airway) and cryoablation (a procedure that uses extreme cold to destroy or numb tissue) through a right thoracotomy (a surgical opening made on the right side of the chest). The record was reviewed with Clinical Nurse Specialist (CNS 1) on 4/17/2026. The note also indicated that “...the family had been trying to raise the head of the bed (HOB) while patient (Patient 8) was lying on her back, but patient (Patient 8) reported feeling dizzy. PT (Physical Therapy) and the father attempted to raise the HOB again, but Patient 8 refused and became upset. PT and the family tried to encourage her [Patient 8] to participate in therapy by sitting up in bed, but Patient 8 strongly refused. She was anxious around occupational therapy (OT) and wanted to work only with her parents ...patient (Patient 8) had audible chest congestion and an increased respiratory rate, described as being in the 30s. (A normal respiratory rate for an 8 year old is usually around 18-30 breaths per minute, so a rate in the 30s is slightly above normal).” The note was reviewed with Clinical Nurse Specialist (CNS 1) on 4/17/2026. During a review of Patient 8’s Clinical Services confidential note, dated 3/22/2026, the note indicated, “Patient 8 was irritable and crying. The registered nurse (RN) educated the mother about the need for frequent assessment of the old chest tube site (the area on the chest where the drainage tube had been removed, which must be checked for redness, swelling, drainage, or other changes). The RN reinforced information that had already been provided by the day-shift RN. The RN looked at the chest tube site and asked the mother to notify staff if there were any changes, since the patient [Patient 8] was often resistant to nursing interventions.” During a review of Patient 8’s Pulmonary (pulmonary meaning relating to the lungs and breathing) progress note, dated 3/30/2026, the note indicated the following: “Parents reported that patient (Patient 8) had significant right-sided pain and cried when attempted to auscultate near the incision site (auscultate meaning to listen with a stethoscope; incision site meaning the area where the chest tube had previously been inserted and later removed). Parents also had concerns about thick, milky yellow green drainage from the right side. The parents also expressed many frustrations with patient’s (Patient 8’s) care during this admission.” This record was reviewed with Clinical Nurse Specialist (CNS 1) on 4/17/2026. During a review of Patient 8’s Pediatrics Progress note (pediatrics meaning the medical specialty that cares for infants, children, and adolescents), dated 4/2/2026, the note indicated that Patient 8 required placement of a chest tube on 4/1/2026 for empyema (a collection of pus inside the chest cavity, usually caused by infection). During an interview on 4/17/2026 at 11:51 a.m. with the social worker (SW 1) regarding documentation of Patient 8’s parents’ refusal of care, SW 1 was asked about patient rights and whether patients or family members could refuse care and treatment. SW 1 stated that patients and families do have the right to refuse care, consistent with patient-rights requirements under federal regulations. -In the same interview, when SW 1 was asked about the inability to find many notes indicating refusals of care initiated by the parents prior to 3/25/2026, SW 1 did not provide a comment. SW 1 further stated that connecting families with concerns to patient relations was not something social workers did and reported that Patient 8’s parents had opportunities to contact patient relations but did not do so. During an interview on 4/17/2026 at 2:04 p.m. with the manager of Patient Relations (MN 4), MN 4 described the role of patient relations as responding to patient and family complaints, concerns, and grievances. MN 4 stated that families had multiple ways to contact patient relations, including by phone, email, or by asking staff for assistance. MN 4 also stated that social services could contact patient relations, and that patient relations could proactively reach out to patients and families afterwards. During an interview on 4/17/2026 at 2:18 p.m., Patient Relations (PR) stated that the father of Patient 8 contacted Patient Relations on 3/31/2026 regarding the family meeting held on 3/25/2026 with the attending physician and the social work team. PR reported that this was the first time the PR team became aware of Patient 8’s parents’ concerns or complaints. PR stated that the father expressed concerns about the attitude and behavior of staff during the meeting, noting that approximately ten people were present, with the mother (Patient 8’s mother) at the bedside and the father participating by phone. According to PR, the father reported that the family was told they were interfering with care, that the recovery should have taken only 3-5 days, that the team planned to begin tapering the patient’s pain medication and start aggressive laxatives (stool softeners), and that if the family continued to impede care, they might be escorted out of the hospital. PR stated that a letter acknowledging the receipt of a grievance was sent to the family of Patient 8. PR further stated that the goal of the PR team was to have a clarifying conversation with the family, which they had not yet been able to complete but were working toward as of 4/17/2026. During an interview on 4/20/2026 at 11:24 a.m. with the Chief Medical Officer (CMO), the CMO stated that if the family expressed concerns to the social services, either the social worker or the family could request involvement from patient relations to ensure that the family felt heard and that their concerns were addressed. During a review of the scope of service for clinical social work, the description indicated that clinical social work provided support to patients and their families or caregivers to meet their social and emotional needs. Major areas of support included, but were not limited to, reviewing any concerns related to interpersonal conflict (meaning conflict between people caused by misunderstandings, communication issues, or differing expectations). During a review of the facility’s policy and procedure (P&P) titled, “Grievance Resolution Management,” dated 4/2025, the policy indicated that the hospital’s grievance mechanism was designed to solicit, investigate, and resolve patient and parent/legal guardian complaints and grievances regarding care and services. The policy indicated that complaints were to be addressed in a timely manner and handled in a way that did not compromise a patient’s right to receive respectful and supportive care. The policy further indicated that attempts should be made to resolve a complaint informally as soon as possible after it was noted. -The policy indicated that verbal complaints regarding patient care, when resolved at the time of the complaint by staff present, were considered addressed by the staff involved during the stay or visit. Grievances were identified by or referred to Patient Relations from multiple sources, and all hospital team members were encouraged to alert Patient Relations about any patient grievances. -The policy also indicated that while the hospital was required to provide a written response to each grievant, Patient Relations staff and the Grievance Committee could use additional methods to resolve the grievance, such as meeting with the patient or the patient’s family or requesting additional resources to collaborate on a plan of action. During a review of the facility’s policy and procedure (P&P) titled, “Patient and Family Rights and Responsibilities,” dated 2/27/2024, the policy indicated that patient rights were to be promoted and protected by all hospital and medical staff. The policy indicated that it applied to all patients and families, clinical services, patient and family experience, and social work. -The policy indicated that patients had the right to receive considerate and respectful care, to be kept comfortable, and to receive information about their health status, diagnosis, prognosis, and course of treatment. The policy further indicated that patients had the right to receive reasonable responses to reasonable requests for service. -Regarding children’s rights, the policy indicated that children had the right to maintain as normal a schedule as possible, including allowing parents or family members to comfort them; to have tests and procedures scheduled so that they were not hungry or thirsty longer than necessary and physical discomfort was minimized; and to expect sensitivity to their feelings, including recognizing that children may cry because they are lonely, afraid, or in pain. -The policy also outlined patient and family responsibilities, including taking responsibility for the consequences of refusing recommended treatment or not following the practitioner’s instructions, and recognizing the effect of their lifestyle on their personal health. 6. During a review of Patient 8’s History and Physical (H&P, a medical document that summarizes the patient’s medical history, current condition, physical exam findings, and the plan of care), dated 3/16/2026, the H&P indicated that Patient 8, an 8 year-old, was admitted for tracheoesophageal fistula repair (a surgery to close an abnormal connection between the trachea [windpipe] and the esophagus [food pipe]) and for post-operative management (medical care provided after surgery to monitor healing, prevent complications, and manage pain and nutrition). During a review of the complaint received by the Department of Public Health (DPH, the state agency responsible for reviewing and investigating complaints about healthcare facilities), the complaint alleged that “on 3/18/2026, an OR (operating room) nurse and CRNA (certified registered nurse anesthetist) expressed concern that Patient 8’s left-hand IV (a small tube placed into a vein to give fluids or medications), which was removed while Patient 8 was under anesthesia (sedation), sprayed blood and may have been improperly placed, yet no clear explanation was provided afterward.” During an interview on 4/20/2026 at 10:56 a.m. with the Certified Registered Nurse Anesthetist (CRNA), the CRNA stated that she [CRNA) recalled that on 3/18/2026, the peripheral IV line she removed from Patient 8 began squirting blood immediately toward her (CRNA). The CRNA stated that it was possible the PIV in the left arm (of Patient 8) had been inserted into an artery instead of a vein. The CRNA said the line was documented as a peripheral IV, but the entire arm was very swollen, and the child (Patient 8) did not allow anyone to touch it. The CRNA stated, “When we took it out, it was shooting blood out... and it was inserted in the Operating Room only a few days prior.” The CRNA further explained that visually, when the line was capped, there was no way to distinguish between a peripheral IV line and an arterial line (an arterial line is a catheter placed into an artery to monitor blood pressure continuously or obtain blood samples; it is not used for regular IV fluids). The CRNA stated that although the line was used as a PIV, it “appeared to actually be in an artery.” The CRNA also stated that this information was shared with Patient 8’s mother, who was present with the patient at the time. The CRNA added, “We had plastics (the plastic surgery team, which evaluates soft?tissue injuries and swelling) come look at the arm; it was very tight and swollen. The event was reported as an adverse event.” During an interview on 4/20/2026 at 11:04 a.m. with the Chief Medical Officer (CMO), who was also part of Patient 8’s surgical team, the CMO stated that they were unaware of any peripherally inserted intravenous catheter that had possibly been inserted into an artery. During a concurrent interview and record review on 4/20/2026 at 1:37 p.m. with the Clinical Nurse Specialist (CNS), Patient 8’s peripheral IV (a small tube placed into a vein to give fluids or medications) assessment, dated 3/18/2026, was reviewed. The record indicated the following: -“Location: Left-hand angiocath gauge 20 (a type of IV catheter; the gauge number refers to the size of the catheter) - Site condition: infiltration/extravasation (the leakage of blood or other fluid, such as an anticancer drug, from a blood vessel or tube into the tissue around it ), swelling measurement 70% (meaning the swelling was estimated to be 70% larger than normal tissue size). Infiltration/extravasation symptoms included swelling of 60% or more and diminished pulses distal to the PIV (meaning the pulse below the IV site was weaker).” In the peripheral IV comments section, the documentation indicated: “Removed in OR; Plastics (plastic surgery) ... assessed arm in Operating Room (OR); pediatric surgery team ‘ultrasounded’ (used ultrasound imaging to check) the pulses.” -CNS 1 verified that there was no documentation from the plastic surgery team, the surgical team, or any other team regarding the results of an ultrasound to assess Patient 8’s diminished pulses, swelling, or the possible complication of an IV line being inserted into an artery instead of a vein. CNS 1 also confirmed that there was no documentation of any discussion with Patient 8’s family regarding the incident. During an interview on 4/20/2026 at 2:10 p.m. with the Quality and Patient Safety (QPS), QPS stated that because there was no formal consultation completed by the plastics team or other teams (as referenced in the CRNA’s note), the teams were not required to document their findings in a progress note. During an interview on 4/20/2026 at 2:19 p.m. with the Patient Safety Manager (MPS), MPS stated that an incident report had been received regarding the event, but no full investigation was completed because the initial document review did not show anything that suggested concern for an arterial line, and the event was not rated as a serious PIV infiltration. The Patient Safety Manager did not provide any additional comments. During a review of the facility’s policy and procedure (P&P) titled, “Patient and Family Rights and Responsibilities,” dated 2/27/2024, the policy indicated that patient rights were to be promoted and protected by all hospital and medical staff. The policy indicated that it applied to all patients and families, clinical services, patient and family experience, and social work. The policy indicated that patients had the right to receive considerate and respectful care, to be kept comfortable, and to receive information about their health status, diagnosis, prognosis, and course of treatment. The policy further indicated that patients had the right to receive reasonable responses to reasonable requests for service.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 46333 Based on interview and record review, the facility failed to ensure that a provider (a licensed healthcare professional such as a physician, nurse practitioner, or other qualified clinician who is authorized to evaluate a patient’s understanding and make decisions about their participation in medical care or research) determined the capacity (a person’s ability to understand information, think it through, and make an informed decision) of all minors (individuals under the age of legal adulthood) enrolled in Study C to provide assent (affirmative agreement from a child who is not legally able to give full consent) during consent conferences for participation in the clinical study C. Instead, the Clinical Research Coordinator (CRC, a trained professional who manages and organizes the daily activities of a clinical trial) independently assessed and documented minors’ capacity to assent without involvement or consultation with the Principal Investigator (PI, the doctor or qualified expert who is responsible for the overall conduct and safety of the clinical study) or a qualified provider, which was not in accordance with the facility’s policy. This deficient practice had the potential to affect all minors enrolled in Study C, as their ability to provide meaningful assent was not assessed or documented by a qualified clinician, in accordance with the facility’s policy for determining capacity. Findings: During an interview on 4/17/2026 at 10:41 a.m. with CRC 1 (Clinical Research Coordinator, a trained professional who manages and organizes the daily activities of a clinical trial), CRC 1 stated that if the child was older than 7 years old and had the capability (the ability to understand information and make decisions), she would explain the study to them at a level they could understand and had them sign the assent form (a document indicating agreement from a child who is not legally able to give full consent). CRC 1 stated that she then determined if the patient (child participant) was able to understand her explanation or not. CRC 1 also stated that she was trained and could determine if a child was capable of understanding what was being said. CRC 1 further stated that the children were seen by neuropsychology (a specialty that assesses brain function and behavior), cognitive function was evaluated (the ability to think, learn, and remember), and she also reviewed their medical chart (the official record of a patient’s health information). During an interview on 4/21/2026 at 10:02 a.m., with CRC 2, CRC 2 stated that they (the CRCs) conducted consent conferences (meetings to discuss and obtain agreement for research participation) for Study C enrollment with the patient and parent(s)/legal guardian(s) alone, without a provider or the Principal Investigator (PI, the doctor or qualified expert who is responsible for the overall conduct and safety of the clinical study) present. CRC 2 reported completing the consent process without communicating with the PI or a provider regarding the patient’s capacity (the ability to understand and make decisions) to assent (affirmative agreement from a child who is not legally able to give full consent). CRC 2 further stated that they would check the box on the consent form indicating, “The subject cannot give assent because their capacity is so limited that they cannot reasonably be consulted,” based on the parent’s description and their own observation of the patient. During an interview on 4/21/2026 at 11:45 a.m. with the DIRB (Designated Institutional Review Board representative, a person responsible for research oversight), DIRB stated that if the CRC (Clinical Research Coordinator) decided to check the box indicating the minor did not have the capacity to assent, the CRC must have a discussion with the PI (Principal Investigator). DIRB further stated that the PI had the ultimate responsibility to determine whether the minor had the capacity to assent. During an interview on 4/21/2026 at 11:45 a.m. with the Vice President of Center for Blood Disease Institute (VPCB, a senior leader overseeing the research program), VPCB stated, “it is not in the scope of CRC to determine capacity to assent.” During a review of CRC 2’s job description for Clinical Research Coordinator I (CRC I, a staff member responsible for research study logistics), dated 11/1/2022, the job description indicated that the CRC assisted principal investigators or other study team members with research studies, including subject recruitment, data collection, scheduling, and follow-up. The CRC helped ensure the consent process was performed and documented in compliance with federal, sponsor, and institutional requirements, but was not authorized to independently determine capacity to assent. During a review of the facility’s policy and procedure (P&P) titled, “Informed Consent,” dated 10/29/2024, the P&P indicated, “A person may give valid consent only if he or she has “capacity” (determined by the provider obtaining consent), which means that the person is able to understand the nature and consequences of a decision and to make and communicate the decision ...Provider should strive to solicit asset and involve a minor patients in decisions as a measure of respect for the minor and the minor patients in developing autonomy.” During a review of the facility’s policy and procedure (P&P) titled, “Assent policy,” dated 9/26/2024, the P&P indicated, “In the event of dissent/disagreement, respect the minor patient’s personhood, while their best interests ... if there are no reasonable alternatives to a necessary treatment, the minor patient should be informed in a developmentally appropriate manner, with assurance that their best interests are the primary focus and that the treatment chosen is based on the team’s best clinical judgment and the decisions of the minor patient’s parents/guardians. This discussion should aim to help the minor patient understand the situation and the rationale for treatment, know what to expect and how they will be cared for, and have an opportunity to ask questions. If the patient does not agree with a treatment for which a reasonable alternative is available, the minor patient’s wishes should be respected.””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 52001 Based on interview and record review, the facility failed to ensure staff immediately notified security and hospital leadership after receiving reports of concerning behavior by a visitor/family member for one of 33 sampled patients (Patient 30), placing patients, visitors, and staff at risk for an unsafe environment. For Patient 30, staff received information regarding concerning behavior involving a visitor/family member; however, security personnel and hospital leadership were not immediately notified. The failure to promptly escalate the concern had the potential to prevent a timely assessment and intervention to address potential safety risks within the care environment, which may lead to patient harm for Patient 30 and other patients at the facility. Findings: During a review of Patient 30’s History and Physical (H&P), dated 1/11/2026, the H&P indicated that Patient 30 was admitted on 1/11/2026 for cough, congestion, increased oxygen to maintain O2 saturations (amount of oxygen circulating in the blood), vomiting, and diarrhea (loose stools). During an interview on 4/13/2026 at 10:00 a.m. with Patient 30’s family member (FM 2), FM 2 stated that on 1/13/2026 at around 1:30 a.m., they (FM 2) were awakened by a man (identified as the visitor of another patient from a different patient room next to Patient 30’s room) standing in their room with his genitals exposed. FM 2 stated that the man who had come into the patient’s (Patient 30) room, also urinated on the floor of their room. FM 2 stated that staff were notified but the staff failed to escalate the matter right away. FM 2 stated that they (FM 2) felt scared at the time of the incident. FM 2 stated that they (FM 2) called LAPD (Los Angeles Police Department) to report the incident. During a review of the “Social Worker Process Note,” titled “Suspected Child Abuse and Neglect,” dated 1/13/2026 at 6:10 p.m., the note indicated “SW (social worker) responded to page from Charge Nurse (CN) for SW support at 3:05 a.m. SW consulted with CN who reports mother notified staff that father of another patient in the room next door had entered their room unannounced around 1:30 a.m., while patient (Patient 30) and mother were asleep .... SW met with security at bedside ... mother expressed frustrations with parent in room next door ... Mother reports that she contacted LAPD non-emergency line for support and was informed that LAPD would respond to the hospital ...” During an interview on 4/14/2026 at 12:15 p.m. with Registered Nurse 3 (RN 3), RN 3 stated that if there were reports of concerning behavior by a family member, involving another visitor or family member, the process would be to immediately report to management, investigate the incident and immediately involve social work. During an interview on 4/14/2026 at 2:47 p.m. with the Manager of Patient Care Services (MPCS 1), MPCS 1 stated that if there were reports of concerning behavior by a family member, involving another visitor or family member, the nurse should go up the chain of command to report the incident and security should be called to speak with the family to determine if a police report should be filed. MPCS 1 also stated that the House Supervisor, social work and security should be immediately notified. During an interview on 4/15/2026 at 12:00 a.m. with the Chief Risk Manager (CRO), The CRO stated that typically security was notified if there were reports of concerning behavior, and the security department would call LAPD. During an interview on 4/16/2026 at 11:27 a.m. with the Supervisor of Clinical Services (MMS 1), MMS 1 stated that when there was a report of concerning behavior, the process would be for the nurse to first notify the charge nurse, secure the environment to ensure patient safety, notify the chain of command, notify the House Supervisor, Director, social worker, and security as soon as possible. MMS 1 also stated that after the staff became aware that Patient 30’s FM called LAPD, the staff then called the facility’s security team. During an interview on 4/17/2026 at 9:59 a.m. with the Manager of Safety and Security (MSS), MSS stated that they rely on their team members to be the front line. MSS stated that it was surprising that the security team was not called right away. MSS also stated it was the expectation that everyone ensured safety, the staff ensured safety by sending the parents back to their separate rooms. During an interview on 4/17/2026 at 10:15 a.m. with the Manager of patient safety (MPS), MPS stated that if staff were unsure of how to handle the situation, then all team members should have been involved. MPS stated that security was not called right away because Patient 30’s family member (FM 2) did not ask for additional support at the time of the incident. During a review of the facility’s policy and procedure (P&P) titled “Workplace Violence Policy,” dated 12/24/2025, the P&P indicated ... “PURPOSE: To provide a safe, accessible, and effective Environment of Care (EC), consistent with our mission, services and applicable government mandates. Our commitment includes the provision of a physical and social environment that minimizes hazards and risks to patients, family members, visitors, team members (staff, employees, contractors) and vendors. [Name of Facility] maintains a written Workplace Violence Management Plan describing the processes it implements to effectively manage the safety of patients, team members, and other people visiting the organization’s facilities .... PROCEDURE: When [name of facility] team members recognize violations of [name of facility] House Rules involving incidents of workplace violence, they should follow the appropriate behavioral response category actions below. These incidents may apply to patients, parents, caregivers, and/or visitors ... Situations that may warrant an Early Crisis Response include, but are not limited to: ... -Hostile or threatening body language -Behaviors that acutely impede or interfere with care delivery ... 4. Roles that respond to an Early Crisis Response may include: a. Patient care team members b. Unit leadership (Charge Nurse or designee) and Social Work may provide immediate oversight and additional de-escalation efforts. c. Patient Relations may also be consulted to assist in addressing concerns or grievances that may be contributing to distress and help facilitate communication between the care team and individual or family ...” During a review of the facility’s policy and procedure (P&P) titled” Disruptive Behavior,” dated 11/20/2025, the P&P indicated: “PURPOSE: The purpose of this policy is to ensure high quality patient care by promoting a safe, cooperative and professional healthcare environment and to prevent or eliminate, to the extent possible, conduct that: -Creates a hostile work environment for hospital employees or staff members. -Affects the ability of others to do their jobs; and -Disrupts and/ or adversely affects patient care ... POLICY: It is the goal of [name of facility] that all individuals within its facilities be treated Vith courtesy, respect, and dignity. To that end, all physicians, employees, and licensed non-medical staff practitioners, vendors, and visitors are expected to conduct themselves in a professional and cooperative manner in the hospital. If an employee fails to exhibit appropriate behavior and conduct, the matter will be dealt with in accordance with the Management of Human Resource Policy HR - 049.0 Disciplinary Counseling Procedures. ln dealing with incidents of inappropriate conduct that are determined to have merit, the orderly operation, protection of patients, employees, and other licensed non-medical staff practitioners in the Hospital are paramount concerns. This Policy shall be enforced in a firm, fair, and equitable manner ... b. Physical Harassment: ... Threatening Position or posture ... PROCEDURE: ... All reports of disruptive behavior will be investigated in a timely manner, with due regard to the privacy of the RAEPORTING Party as well as the Respondent ...””

“PATIENT RIGHTS: ACCESS TO MEDICAL RECORD CFR(s): 482.13(d)(2) The patient has the right to access their medical records, including current medical records, upon an oral or written request, in the form or format requested by the individual. If it is readily producible in such form and format (including in an electronic form or format when such medical records are maintained electronically); or if not, in a readable hard copy form or such other form or format as agreed by the facility and the individual, and within a reasonable timeframe. The hospital must not frustrate the legitimate efforts of individuals to gain access to their own medical records and must actively seek to meet these requests as quickly as its record keeping system permits. This Standard is not met as evidenced by: 46333 Based on observation, interview and record review, the facility failed to provide requested medical records (documents containing a patient’s health information) to one (1) of 33 sampled patients (Patient 10), within the 3-5 business day timeframe stated on the facility’s public website. Instead, the facility’s actual processing time was 15 business days, which conflicted with the website’s stated timeframe. This deficient practice resulted in delays for Patient 10’s mother and father when attempting to obtain copies of the patient’s medical records. Findings: During a review of Patient 10’s “Physician IP (Inpatient) Medical Progress Note (a physician’s documentation describing the patient’s condition, treatment, and progress while hospitalized),” dated 12/26/2019, the record indicated Patient 10 was 8 years old with Autism (a neurodevelopmental condition that affects communication, social interaction, and behavior). The record indicated symptoms including leg pain radiating up the body, fevers, vomiting blood, and nosebleeds, with laboratory tests concerning for leukemia (a cancer of blood-forming tissues). During a review of Patient 10’s “Bone Marrow Transplant Inpatient (IP) Progress Note,” dated 9/16/2024, the note indicated Patient 10 was 13 years old with Autism (a neurodevelopmental condition affecting communication, social interaction, and behavior) and had a history of SR-BALL, meaning Standard Risk B-Acute Lymphoblastic Leukemia (a fast-growing cancer of the blood and bone marrow that begins in immature B-cells, a type of white blood cell) that was CNS-negative (Central Nervous System negative, meaning no leukemia cells were found in the fluid surrounding the brain and spinal cord). During a review of Patient 10’s medical record request form titled, “Authorization of Release Health Information,” dated 10/13/2023, the “Authorization of Release Health Information” indicated, Patient 10’s mother completed the Authorization of Release Health Information on 10/13/2023. During a concurrent interview and record review on 4/17/2026 at 11:00 a.m. with the Director (DIR 4) of Health Information Management (HIM)-the department responsible for retaining and releasing patient medical records-the facility’s internal medical records request program (“HIM program”), was reviewed. The HIM program indicated the hospital received the mother’s request on 10/13/2023 and completed it on 10/26/2023. DIR 4 stated the hospital’s typical turnaround time was 15 business days. DIR 4 stated the delay occurred due to a backlog (collection of unfinished or pending work). During a review of Patient 10’s medical record request form titled “Authorization of Release of Health Information,” dated 8/15/2025, the form showed that Patient 10’s father completed the request on this date. During a concurrent interview and record review on 4/17/2026 at 11:05 a.m., the HIM program indicated the hospital received the father’s request on 8/15/2025 and completed it on 9/2/2025 (Request was completed 18 days after the date the request was made). DIR 4 stated there was no documented reason for the delay in processing this medical record request. During a concurrent observation and interview on 4/17/2026 at 9:53 a.m. with the Patient Liaison (PL 1)-a staff member who assists patients and legal representatives with obtaining medical records-the facility’s public website titled, “Request Medical Records [facility name],” was reviewed. PL 1 stated that when patients or family members requested records in person, they were handed an iPad and directed to complete the “Authorization to Release Health Information” form on this website. The front page of the website displayed the message: “Current estimated wait time for records is 3-5 business days.” During a concurrent interview and record review with DIR 4 on 4/17/2026 at 11:08 a.m., the same website page, was reviewed. DIR 4 stated the message indicating “3-5 business days” may have remained on the website for approximately five years. DIR 4 stated the message did not reflect the facility’s current policy and practice, which indicated a 15 business day processing timeframe. During a concurrent interview and record review on 4/17/2026 at 3:38 p.m. with DIR 4, the facility’s policy and procedure (P&P) titled, “Privacy - Individual Rights: Access to PHI (Protected Health Information),” dated 7/2021, the P&P indicated, “[the facility] is committed to protecting the privacy of patients and their health information while carrying out hospital services and operations. The purpose is to implement the applicable state and federal laws that provide patients, on a written request, with a right of access to inspect and/ or obtain a copy of their Protected Health Information (PHI), maintained in one or more designated record set(s) ... Responding to Request ... Health Information Management will respond to an individual’s request to access their Protected Health Information within the established time frame set forth in the applicable laws.” DIR 4 stated the timeframe was 15 business days.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 46333 Based on interview and record review, the hospital failed to ensure that the Quality Assessment and Performance Improvement program (QAPI, a facility-wide program used to identify, monitor, and correct quality and safety problems) monitored, measured, and tracked the effectiveness of corrective actions taken to address an identified research consent process error in Research Study (a structured and IRB-approved project designed to answer a specific scientific or clinical question) D. The facility failed to assign QAPI oversight responsibility for the corrective action plan addressing the unauthorized consent process conducted by CRC 1. QAPI did not evaluate whether the corrective actions, submitting an amendment to authorize CRC 1 to obtain consent and re?consenting all affected participants were effective, and did not track whether compliance with the IRB-approved consent process was sustained for all 203 of 203 participants requiring re-consent (Patients 12, 13, 21, 26, 27, 28, and 34-197). This deficient practice created the potential for recurrence of unauthorized consent activities without detection or intervention. Findings: During a concurrent interview and record review on 4/17/2026 at 4:10 p.m., the Clinical Practice Leader (RN 2) reviewed Patient 12’s medical record titled Documentation of Informed Consent Conference, dated 5/22/2025. The record indicated that CRC 1 (Clinical Research Coordinator; research staff who coordinates study activities) discussed the informed consent information required for participation in Research Study D (a clinical and molecular characterization of Autism Spectrum Disorder and related neurodevelopmental disorders, meaning a research study that documents participants’ medical and behavioral features through examinations and testing [clinical] and analyzes their genetic material, such as DNA, through laboratory techniques like whole?genome sequencing [molecular], to better understand Autism Spectrum Disorder and other developmental conditions [neurodevelopmental disorders]) with the research subject (Patient 12) and the subject’s family. RN 2 confirmed that CRC 1 conducted the consent conference, even though CRC 1 was not IRB-authorized to obtain consent for Study D. During a review of Patient 12’s signed consent form for Research Study D, the form showed the “person obtaining consent” signature, was completed by CRC 1, on 5/19/2025. During a concurrent interview and record review on 4/21/2026 at 8:29 a.m., the Clinical Nurse Specialist (CNS 1) reviewed Patient 13’s medical record titled, Documentation of Informed Consent Conference, dated 11/12/2024. The record indicated that CRC 1 (Clinical Research Coordinator; research staff who coordinates study activities) discussed informed consent information with the research subject and the subject’s family. CNS 1 confirmed CRC 1 conducted the consent conference. During a review of Patient 13’s signed consent form for Study D, the form showed the “person obtaining consent” signature, was completed by CRC 1 on 11/12/2024. During a concurrent interview and record review on 4/16/2026 at 10:47 a.m., the Clinical Partner Leader (CPL 3) reviewed Patient 26’s medical record titled Documentation of Informed Consent Conference, dated 9/18/2025. The record indicated that CRC 1 conducted and discussed informed consent information with the research subject (Patient 26) and the subject’s family. During a review of Patient 26’s signed consent form for Study D, the form showed the “person obtaining consent” signature, was completed by CRC 1 on 9/18/2025. During a review of Patient 21’s signed consent form for Study D, the form showed the “person obtaining consent” signature, was completed by CRC 1 on 11/12/2024. During a concurrent interview and record review on 4/16/2026 at 11:13 a.m., the Clinical Partner Leader (CPL 3) reviewed Patient 27’s medical record titled Documentation of Informed Consent Conference, dated 11/12/2025. The record indicated that CRC 1 conducted and discussed informed consent information with the research subject (Patient 27) and the subject’s family. During a concurrent interview and record review on 4/16/2026 at 09:45 a.m., the Clinical Partner Leader (CPL 3) reviewed Patient 28’s medical record titled Documentation of Informed Consent Conference, dated 9/18/2025. The record indicated that CRC 1 (Clinical Research Coordinator; research staff who coordinates study activities) discussed informed consent information with the research subject (Patient 28) and the subject’s family (Patient 28). CPL 3 confirmed CRC 1 conducted the consent conference. During a review of Patient 28’s signed consent form for Study D, the form showed the “person obtaining consent” signature, was completed by CRC 1 on 9/18/2025. During an interview on 4/17/2026 at 2:30 p.m., the Director of Research (DIR 1) stated that each clinical study must follow the Institutional Review Board (IRB, a committee that reviews and approves research involving human subjects)-approved protocol, and only personnel approved by the IRB with specific designated roles may conduct participant interactions, including the consent process. During an interview on 4/21/2026 at 11:20 a.m., the Director of IRB (DIRB) stated that the facility reported a continuing noncompliance issue to the Office for Human Research Protections (OHRP, a federal oversight agency for human subjects research) in April 2025. The noncompliance involved an individual (CRC 1) conducting consent for Study D without authorization. DIRB further stated that Study D was paused until the research team resubmitted corrective action materials and a new IRB application authorizing CRC 1 to obtain consent was approved. The corrective action included re-consenting all 203 affected participants and adding another CRC with proper consenting privileges. During a review of Research Study D’s approved protocol, dated 6/20/2025, the protocol indicated that for CRC 1, the field for “obtained consent” was marked “No.” During a review of Research Study D’s approved protocol, dated 2/13/2026, the protocol indicated that for CRC 1, the field for “obtained consent” was marked “Yes.” During a concurrent interview and record review on 4/21/2026 at 11:45 a.m., the Manager of Research (MRS) reviewed the document titled Events and Problems that Require Prompt Reporting to the IRB, dated 4/6/2026. The report indicated that when the research team submitted a protocol amendment, CRC 1 was still in training and had not yet been approved to perform consent. After completing the facility’s consent obtaining requirements and internal training, the research team neglected to submit an additional amendment requesting that CRC 1’s study activities be updated to include consenting participants. The corrective action section indicated: - The facility submitted a personnel change amendment requesting consenting privileges for CRC 1. - A newly hired Clinical Research Coordinator was added to assist with re-consenting the 203 participants. - The research team would “attempt to re-consent all participants consented by CRC 1.” -MRS stated the team began performing quarterly checks to ensure protocol adherence; however, MRS was unable to provide documentation of audits for other studies to show that personnel conducting consent were qualified, IRB-approved, and listed with consent privileges in the protocol. During a review of the list of 203 participants consented by CRC 1, the list indicated that the consent dates ranged from October 2021 through March 2026. During an interview on 4/21/2026 at 1:05 p.m., the Program Manager of Quality Assessment and Performance Improvement (PMQ) stated that QAPI was aware that Study D had been paused due to CRC 1 lacking authorization but said, “No, we were not involved, IRB scope is out of our program,” and “We do not have scope over the research program.” PMQ confirmed QAPI had no role in monitoring compliance, measuring effectiveness, or tracking whether corrective actions for this incident were sustained. During a review of the facility’s policy and procedure (P&P) titled, “Quality Assessment & Performance Improvement (QAPI) Plan,” dated 2026, the P&P indicated the Quality Management System (QMS) encompasses all QAPI and patient safety activities across the enterprise and applies to all hospital departments and services, including contracted services. The QMS uses risk?based methodology to: -determine risks and opportunities, -plan actions to address risks and opportunities, and -implement and evaluate the effectiveness of actions. The policy further indicated that corrective action plans must define monitoring parameters to evaluate action effectiveness and ensure sustained improvement. During a review of the facility’s program plan titled “Human Research Protection Program Plan,” dated 5/1/2025, the program plan indicated that the institution was “committed to protecting the rights and welfare of subjects in Human Research.” The plan indicated that its purpose was to describe how the institution complied with ethical and legal requirements for the conduct and oversight of human research. The plan further indicated that the Human Research Protection Program (HRPP) was a comprehensive system designed to ensure the protection of the rights and welfare of participants in human research and was dependent on all individuals, committees, and departments fulfilling their described responsibilities. The plan also indicated that “Investigators and research staff have the responsibility to follow the Human Research Protection Program requirements described in HRP-103 - Investigator Manual.” During a review of the facility’s “Investigator Manual,” dated 8/12/2024, the manual indicated that investigators and staff conducting human research must complete the CHLA Collaborative Institutional Training Initiative (CITI) human subjects training program. The manual indicated that training was valid for three years and must be renewed, and that all members of the research team involved in the design, conduct, or reporting of research must complete required human research protections training. The manual further indicated that individuals who have not completed the required training “may not take part in aspects of the research that involve human subjects.””

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 52001 Based on interview and record review, the facility failed to: 1. Ensure nursing staff in the Emergency Department (ED) assessed and reassessed pain for one of 33 sampled patients (Patient 1), in accordance with the facility’s policy regarding pain management and assessment of pain. This deficient practice had the potential to result in unmanaged pain, delayed recognition of worsening conditions, and compromised patient outcomes. 2. Ensure nursing staff notified the physician when one of 33 sampled patient’s (Patient 32), heart rate (HR-the number of times the heart beats per minute), fell below the physician - ordered notification parameter of less than 57 beats per minute (bpm- the number of times your heart beats each minute while you are awake, calm and not moving). Documentation showed that Patient 32’s HR dropped to 52 bpm on 4/15/206 at 1:00 a.m.; however, there was no documented evidence the provider was notified as ordered. This deficient practice had the potential to delay medical evaluation and treatment of symptomatic bradycardia (a slower than typical heartbeat) for Patient 32, which may result in worsening cardiac status, decreased cardiac output (an inadequate volume of blood pumped by the heart to meet the metabolic demands of the body), hypotension (low blood pressure) arrythmias (a problem with the rate or rhythm of the heartbeat) or cardiac arrest (when the heart suddenly and unexpectedly stops pumping). Findings: 1. During a review of Patient 1’s “Triage (the process of sorting patients based on the severity of their condition to prioritize care, ensuring those with life-threatening issues are treated first) Note,” dated 9/25/2025 at 1:37 a.m., the note indicated ... “Reason for Visit: Upper Extremity Pain/Injury. Chief Complaint/Patient Story: Fall from bed approx. (approximately) 3ft (feet) at 2330 (11:30 p.m.). Unsure if hit head, denies LOC (loss of consciousness). Now not wanting to move L (left) arm ...Tracking Acuity: 3 Urgent ...Recommended ESI (Emergency Severity Index, a 5-level triage algorithm used to determine acuity level of patients presenting to the emergency department and prioritize resources) level: 3 ... Face: Occasional Grimace (a twisted, distorted facial expression that signals pain, strong disgust, disapproval, or sometimes wry humor) or Frown, withdrawn, Disinterested ...Cry: Crying Steadily, Screams or Sobs, Frequent Complaints ... FLACC (Face, Legs, Activity, Cry, Consolability- is an observational pain assessment tool used for patients who cannot verbally communicate their pain. It is primarily used for infants and children [ages 2 months to 18 years] as well as adults with cognitive impairments) Pain Assessment in Intensity: 4 (indicates moderate pain).” During a concurrent interview and record review on 4/16/2026 at 9:22 a.m. with the ED Clinical Practice Leader (RN 2), RN 2 stated that Patient 1 received Tylenol 272 mg (milligrams, a unit of measurement) by mouth at 1:47 a.m. on 9/25/2025, for a pain level of 4, based on FLACC. During a review of Patient 1’s “medication administration flow sheet,” titled “MAR (Medication Administration Record) Summary,” dated 9/25/2025, the summary indicated that Ibuprofen (treats mild to moderate pain, reduces fever, and decreases inflammation) 200 mg, given by mouth, was administered to Patient 1 at 4:04 a.m. During a review of Patient 1’s “assessment flow sheet,” titled “ED Vital Sign,” dated 9/25/2025 at 4:05 a.m., the document indicated that vital signs (essential, objective measurements of the body’s most basic functions used to assess physical health, detect medical problems, and monitor recovery) were taken, but no assessment of Patient 1’s pain (before and after pain medication administration), was documented. During a concurrent interview and record review on 4/16/2026 at 9:25 a.m. with RN 2, Patient 1’s “assessment flowsheet,” dated 9/25/2025, was reviewed. RN 2 verified that there was no pain assessment documented prior to the administration of Ibuprofen at 4:04 a.m., and there was no reassessment documented after the medication was given. RN 2 stated that nurses should document pain assessments before and after medication was given to ensure that the pain medication was effective. During a review of Patient 1’s “X-Ray (a high-energy type of electromagnetic radiation used in medicine to take pictures of the inside of the body. It allows doctors to look at bones, organs, and tissues without needing surgery) results,” titled, “XR Forearm AP (Anterior Posterior- [front and back])/Lateral (the side located away from the midline or center of the body) Lt [left] Final Report,” dated 9/25/2025 at 4:20 a.m., the note indicated “Reason for exam: 3 year old s/p (status post/following) fall, complaints of forearm pain ... Findings: There is large elbow joint effusion (the abnormal accumulation of excess fluid in, or around, a joint), with concern for a misplaced supracondylar humeral (a common elbow injury, primarily in children, where the lower part of the upper arm bone [humerus] breaks just above the elbow joint and the bone fragments have shifted out of their normal alignment) and proximal ulnar buckle fracture (an incomplete, stable bone break in the ulna-the forearm bone on the pinky finger side) ... Impression: Findings concerning for nondisplaced supracondylar humeral and proximal ulnar buckle fractures (a break in the arm bone [humerus] just above the elbow joint) ...” During a review of Patient 1’s “X-Ray results,” titled, “XR Elbow Minimum e-View Lt Final Report,”, dated 9/25/2025 at 4:42 a.m., the note indicated “Impression: Findings concerning for nondisplaced supracondylar humeral and proximal ulnar buckle fractures ...” During a review of the facility’s policy and procedure (P&P) titled “Pain Management and Assessment of Pain in Infants, Children, Adolescents, and Young Adults,” dated 9/4/2025, the P&P indicated ... “POLICY STATEMENTS: 1. It is the obligation of every health care provider (HCP) at [this hospital] to anticipate, relieve, minimize, or avoid pain, agitation, and anxiety for all our patients. 2. HCPs ensure that patients are adequately and accurately assessed for pain, anxiety, agitation, and sedating effects of pain medication. a. HCPs should assess physiological changes such as heart rate, blood pressure, respiratory-rate, skin mottling, splinting, arching, rigidity of muscles, etc. b. HCPs should assess pain before any intervention to treat an increase in pain ...” 2. During a review of Patient 32’s history and physical (H&P), dated 4/11/2026, the H&P indicated that Patient 32 was admitted to the Medical Surgical Unit (Med-Surg- specific area of a hospital or other healthcare facility where patients recover from operations or receive treatment for various illnesses) on 4/11/2026 for seizure (sudden, uncontrolled surge of electrical activity in the brain) in the setting of likely Xanax (medication used to quickly calm severe anxiety and panic attacks) withdrawal (Medication withdrawal happens when the body has adapted to a medication and reacts negatively when the patient suddenly stops taking it or lower the dose. In simple terms, the body and brain have grown dependent on the drug to function and are struggling to adjust to its absence). During a review of Patient 32’s “provider order information,” titled “Notify Prescriber If,” dated 4/11/2026, the order indicated “Heart Rate (bpm, beats per minute) < 57 ...” During a concurrent interview and record review on 4/15/2026 at 11:30 a.m. with the Supervisor of Medical Surgical (MMS 2), Patient 32’s medical records were reviewed. The following was noted: -MMS 2 verified that there was no documentation that the doctor was notified when Patient’s 32’s HR (heart rate) dropped below 57. -MMS 2 stated when a patient’s HR dropped below normal parameters, the process was to document that the provider was notified of the drop in HR. -MMS 2 stated that it was important to notify the provider when the HR dropped below 57 so that the provider was aware of the Patient’s status. During an interview on 4/17/2026 at 11:45 a.m. with the Supervisor of Clinical Services (MMS 1), MMS 1 stated that Patient 32’s nurse should have notified the doctor when the HR dropped below 57 to ensure the patient’s safety. MMS 1 stated that the nurse should have documented that the doctor was notified. During a review of the facility’s policy and procedure (P&P) titled, “Acute Care Nursing Assessment Documentation Standards of Practice,” dated 3/25/2026, the P&P indicated the following: “Definition of Terms ...Vital Signs: Essential measurements that indicate a patient’s basic physiological functions ...Additional Measurements to Include in Documentation: Vital signs: on admission, as ordered, and as clinically indicated ...””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 46333 Based on interview and record review, the facility failed to ensure that nursing staff developed and maintained a current nursing care plan (a written document outlining patient goals and nursing interventions) addressing pain management for one of 33 sampled patients (Patient 10), as required by facility policy and federal regulation regarding care plans. This deficient practice created the potential for unmet pain management needs and incomplete documentation of care planning. Findings: During a review of Patient 10’s medical record (MR, a detailed, systematic account of your personal health history and healthcare journey) document titled, “Bone Marrow Transplant IP (in-patient) Progress Note (a clinical documentation entry made by healthcare providers),” dated 9/8/2024, the progress note indicated, (Patient 10) was “having more mouth and throat pain today with limited mouth opening due to pain and decreased oral intake.” The MR further indicated “Patient (Patient 10) family is open to starting PCA (Patient-Controlled Analgesia, a method that lets patients press a button to give themselves a small, safe dose of pain medicine through a machine) today so that was started late morning and has provided additional relief.” During a review of Patient 10’s MR document titled, “Bone Marrow Transplant Inpatient (IP) Progress Note,” dated 9/16/2024, the document indicated Patient 10 was a minor with Autism (a neurodevelopmental condition affecting communication, social interaction, and behavior) and had a history of SR-BALL, meaning Standard Risk B-Acute Lymphoblastic Leukemia (a fast-growing cancer of the blood and bone marrow that begins in immature B-cells, a type of white blood cell). During a concurrent interview and record review on 4/22/2026 at 8:18 a.m. with a Clinical Practice Leader (CNS 1), Patient 10’s medical record documents titled “Pain” assessment flowsheet (a chart tracking pain scores), dated from 9/7/2024 through 9/10/2024, were reviewed. The medical record indicated that Patient 10 reported mouth pain on 9/7/2024, with a pain level of 9 out of 10 (on a scale of 0-10, where 0 is no pain and 10 is the worst pain). On 9/7/2024 at 8:12 p.m., Patient 10 continued to report pain at 6 out of 10. On 9/8/2024 at 8:22 a.m., the pain level was 7 out of 10. On 9/9/2024 at 6:43 a.m., the pain level was at 7 out of 10. On 9/9/2024 at 11:20 p.m., Patient 10 reported pain at 10 out of 10. CNS 1 confirmed that Patient 10’s medical record indicated ongoing pain despite receiving pain medications. During a concurrent interview and record review on 4/22/2026 at 9:20 a.m. with CNS 1, Patient 10’s physician orders for PCA Hydromorphone (a prescribed pain medication) dated 9/8/2024, were reviewed. The order indicated the physician ordered 0.2 mg (milligrams, a unit of measure)/mL (milliliters, a unit of measure) PCA. CNS 1 confirmed that the PCA Hydromorphone was started on 9/8/2024. CNS 1 confirmed that despite PCA being started, Patient 10 continued to have intermittent pain. During a concurrent interview and record review on 4/22/2026 at 9:45 a.m. with CNS 1, Patient 10’s “Care Plan (a written document outlining patient goals and nursing interventions),” dated from September to October 2024, was reviewed. CNS 1 stated that no care plan was created for the month of September 2024, and no care plan addressing pain management, goals, or interventions was created for Patient 10. CNS 1 confirmed that facility policies and procedures (P&P, written rules and guidelines) required nursing staff to create a care plan for pain management when a patient was experiencing pain. During a concurrent interview and record review on 4/22/2026 at 10:15 a.m. with RN 2, the facility’s policy and procedure (P&P) titled, “Pain Management and Assessment of Pain in Infants, Children, Adolescents, and Young Adults,” dated 12/2/2025, was reviewed. The P&P indicated, “It is the obligation of every health care provider (HCP, a person licensed to provide health care services) at (facility name) to anticipate, relieve, minimize, or avoid pain, agitation, and anxiety for all our patients ...The patient and family play an integral role when formulating and evaluating the plan for managing the patient’s pain. If inadequate pain management is identified as an actual or potential problem, an interprofessional plan of care (IPOC, a coordinated plan developed by multiple health care professionals) will be initiated (for inpatient areas).” RN 2 stated that according to the facility’s policy and procedure, the patient should have a plan of care developed to help manage ongoing pain. During a record review of the facility’s policy and procedure (P&P) titled, “Interdisciplinary Care Planning - General,” dated 3/31/2025, the P&P indicated, “The Registered Nurse (RN, a licensed professional nurse) is responsible for overseeing and supervising the patient’s IPOC (interprofessional plan of care), as well as initiating, updating, and discontinuing all plans of care ... Other disciplines involved in the patient’s care may also document any relevant interventions and progress in accordance with their scope of practice within the IPOC. Interprofessional Plans of Care (IPOC) will be initiated by the RN within 24 hours of admission. Additional IPOCs should be initiated as the plan of care develops and patient needs change. Nurses should consider relevant co-morbidities (other existing health conditions) when creating the plan of care.” During a record review of the facility’s policy and procedure (P&P) titled, “Patient and Family Rights and Responsibilities,” dated 2/27/2025, the P&P indicated, “Patients have a right to: Appropriate assessment and management of pain, information about pain, pain relief measures, and to participate in developing a pain management plan.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 52001 Based on interview and record review, the facility failed to: 1. Ensure Nursing staff notified the physician and the charge nurse of an abnormal PEWS (Pediatric Early Warning Signs, a tool used in hospitals to identify potential clinical deterioration in children) score for one of 33 sampled patients (Patient 5). In addition, the abnormal PEWS was not reassessed within 1 - 2 hours, in accordance with the facility’s policy and procedure regarding PEWS. This deficient practice placed Patient 5 at risk of clinical staff not identifying and treating Patient 5’s potential clinical deterioration. 2. Ensure Nursing staff notified the physician when one of 33 sampled patients (Patient 5) had abnormal vital signs (temperature, blood pressure, heart rate, and respiratory rate, oxygen saturation), in accordance with the physician’s order. This deficient practice resulted in a delay in addressing Patient 5’s abnormal vital signs for approximately seven (7) hours until Patient 5’s parent (Parent 1) initiated a RRT (Rapid Response Team, a team of healthcare professionals with critical care expertise prepared to respond and meant to assist in stabilizing a patient’s condition before a cardiac or respiratory arrest or other adverse event occurs) and placed Patient 5 at risk of deterioration. 3. Ensure that one of 33 sampled patients (Patient 2), received adequate education and discharge instructions regarding the care and management of an indwelling Foley catheter (a thin, flexible tube inserted through the urethra into the bladder to continuously drain urine into an external collection bag) that had been placed in the facility’s urology clinic. Specifically, the facility failed to provide instruction regarding catheter hygiene, infection prevention measures, signs and symptoms of complications, and when to seek medical attention. This deficient practice had the potential to result in Patient 2’s inability to appropriately manage the indwelling urinary catheter after discharge, which could contribute to the development of catheter-associated urinary tract infection (CAUTI), progression of infection, sepsis, hospitalization, and other serious adverse outcomes. For Patient 2, the lack of documented education and instruction regarding Foley catheter care had the potential to contribute to the development of a urinary tract infection and subsequent sepsis (a life-threatening medical emergency caused by the body’s extreme, overactive response to an infection). Findings: 1. During a review of Patient 5’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 3/03/2021, the H&P indicated the following: “Patient (Patient 5), a four (4) year-old male, with known brain stem lesion (an area of damage or abnormal tissue in the brain stem-the critical stalk-like part of the brain that connects your brain to your spinal cord) without tissue diagnosis with progressive neurologic decline (the gradual loss of brain and nervous system function- This leads to a decline in thinking, physical movements, or senses), who presents for inpatient management of weight loss and malnutrition (deficiencies, excesses, or imbalances in a person’s intake of energy and nutrients ) ...Patient (Patient 5) has also had progressive symptoms of seizures (sudden, uncontrolled surge of electrical activity in the brain)/‘abnormal movements’ ...L (left) hemiparesis (weakness on one side of the body), behavioral changes after initially presenting to Ophthalmologist (specialty focused on diagnosing and treating eye diseases) clinic with esotropia (when one or both eyes turn inward, or ‘cross eyes’) and ptosis (drooping of upper eyelid ) ...Of note, he (Patient 5) did not a fever (elevation in core body temperature, generally above 38 degrees Celsius or 100.4 degree Fahrenheit) 2 days ago and was seen in the ED (Emergency Department) for this, however, parent (Parent 1, parent of Patient 5) and patient (Patient 5) left before they were formally evaluated ...decided to take him (Patient 5) to a different ED instead. Assessment and plan include continuous vital sign monitoring, close clinical monitoring under the direct supervision of a physician, and counseling caregivers about the plan of care.” During a review of Patient 5’s “PEWS Scale (Pediatric Early Warning Signs, a tool used in hospitals to identify potential clinical deterioration in children)” results, dated 3/4/2021, the PEWS Scale results indicated the following: -“At 8 a.m., Behavior PEWS: 3. Lethargic (drowsy, sluggish, lack of energy or mental alertness), Cardiovascular (refers to the heart and blood vessels) PEWS: 1. Pale (loss of color in skin or mucous membranes, often caused by reduced flow) or Dusky (skin tones of medium to deep brown in color), Respiratory PEWS: 0. No Retraction, Medical History PEWS: 0. N/A (not applicable), PEWS Score: 4. -At 12 p.m., Behavior PEWS: 3. Lethargic, Cardiovascular PEWS: 1. Pale or Dusky, Respiratory PEWS: 0. No Retraction, Medical History PEWS: 0. N/A (not applicable), PEWS Score: 4. -At 3 p.m., Behavior PEWS: 0. Appropriate, Cardiovascular PEWS: 1. Pale or Dusky, Respiratory PEWS: 0. No Retraction, Medical History PEWS: 0. N/A (not applicable), PEWS Score: 1.” During a concurrent interview and record review on 4/14/2026 at 2:38 p.m. with Registered Nurse Clinical Practice Leader (RN 1), RN 1 stated the following: “Patient (Patient 5) was admitted on 3/3/2021 for weight loss and malnutrition. Patient (Patient 5) had a brain stem lesion with progressive decline. Patient (Patient 5) was admitted to the Hematology (specialized branch of medicine focused on the study, diagnosis, treatment, and prevention of blood-related disease, and blood cells disorders)/Oncology (specialized branch of medicine focused to the diagnosis, treatment and prevention of cancer) unit on 3/3/2021 at 4:01 p.m. PEWS scale score upon admission was zero (0, normal).” RN 1 stated the PEWS assessment purpose was to detect pediatric early warning signs, which gave staff an idea if the patient had acute changes in condition and the need to keep a closer eye on the patient. RN 1 said that Patient 5’s PEWS score was Zero upon admission and continued to be 0 until the PEWS score changed on 3/4/2021 at 8 a.m. and at 12 p.m., the PEWS score was 4. RN 1 also stated that Patient 5 was lethargic and the skin was dusky. RN 1 verified that there was no documentation in the medical record indicating that the charge nurse or the physician had been notified of the abnormal PEWS score, nor that Patient 5 had been reassessed within 1-2 hours, as indicated in the facility’s policy and procedure regarding PEWS. RN 1 also stated that per policy, the nurse could have initiated a RRT (Rapid Response Team, a specialized group of healthcare professionals who are called to a patient’s bedside when early signs of clinical deterioration occur) to address the abnormal PEWS. RN 1 stated that the charge nurse and physician should have been notified to determine the plan of care for Patient 1, in addition, the PEWS should have been reassessed within 1 - 2 hours, per the facility’s policy and procedure. During a review of the facility’s policy and procedure (P&P) titled, “Pediatric Early Warning Signs,” dated 10/02/2026, the P&P indicated the following: Purpose: To have a means to gather data to assist in earlier recognition of patient deterioration in areas utilizing the Rapid Response Team (RRT) process. Procedure: 1. PEWS will be taken upon admission and every four (4) hours. 2. If PEWS is 0-2, reassess every 4 hours as per routine. 3. If PEWS is 4, notify the Charge Registered Nurse (RN) and MD (Physician) to determine the plan of care, reassess in 1 -2 hours, and consider RRT. 2. During a review of Patient 5’s physician’s order titled, “Notify Prescriber If,” dated 3/05/2021 at 5:19 p.m., the physician’s order indicated the following: Notify the prescriber if: -Temperature (deg. C [Celsius]) > (greater than) 38 (100.4 Fahrenheit, indicates possible fever) or < (less than) 36 (low temperature, normal is 37 deg. C or 98.6 F) -Heart Rate (bpm, beats per minute) > 130 or < 80 -Respiratory Rate (breaths/minute) > 40 or < 20 -Blood Pressure Systolic (mm/Hg) > 105 or < 85 -Blood Pressure Diastolic (mm/Hg) > 70 or < 55 During a review of Patient 5’ flowsheet titled, “Emergency Documentation Flowsheet,” dated 3/18/2021 at 2:45 p.m., the flowsheet indicated the following: “Patient’s (Patient 5’s) diagnosis: brain tumor. Type of Emergency: increase posturing (involuntary, ridged body positions) and tachycardia (elevated heart rate) ...Vital signs at the time of the Emergency: Heart rate (HR): 188, Respiratory rate (RR): 35, Blood pressure (BP): 91/58 (normal), SpO2 (oxygen saturation): 98 % (normal) on room air. Breathing: spontaneous and equal chest rise. Breath sounds were clear and equal bilaterally. Circulation: HR and rhythm regulator, capillary refill 1 second ...Extremities were warm and pink ...Patient (Patient 5) remained on the unit. The event ended at 3:15 p.m.” During a concurrent interview and record review on 4/14/2026 at 2:38 p.m. with Registered Nurse Clinical Practice Leader (RN 1), RN 1 stated the following: Vital signs were ordered every four (4) hours for Patient 5. The physician wrote order for vital sign parameters and when to notify the provider. Per orders, nursing staff should notify the provider if the temperature was greater than 38 degrees Celsius or less than 36 degrees C; heart rate was greater than 130 or less than 80; respiratory rate was greater than 40 or less than 20; systolic blood pressure (the top number in a blood pressure reading. It measures the maximum force the blood exerts against the artery walls when the heart beats and actively pumps blood) was greater than 105 or less than 85; diastolic blood pressure (the bottom number in a blood pressure reading. It measures the pressure in the arteries when the heart muscle is resting between beats and refilling with blood) was greater than 70 or less than 55. During the same interview on 4/14/2026 at 2:38 p.m. with Registered Nurse Clinical Practice Leader (RN 1), RN 1 stated Patient 5’s vital signs on 3/18/2021 at 7:47 a.m., were as follows: Temperature was 39.5 C, heart rate was 157, respiratory rate was 27, and blood pressure was 104/45. Patient 5’s vital signs on 3/18/2021 at 11:35 a.m., were as follows: Temperature was 39.5 C, heart rate was 154, respiratory rate was 31, blood pressure was 149/94. RN 1 verified there was no documentation in Patient 5’s medical record indicating that Patient 5’s provider was notified of the abnormal vital signs, per the physician’s order. RN 1 stated the heart rate usually become elevated when there was an increase in temperature and there may be concerns for possible infection and may need additional treatment. RN 1 stated that on 3/18/2021 at 2:45 p.m., a RRT was initiated by Patient 5’s parent (Parent 1). RN 1 stated parents were “partners in care” and should be empowered to initiate a RRT if they had any concerns. RN 1 stated after the RRT, Patient 5 remained on the unit, however, Patient 5 was transferred to the Pediatric Intensive Care Unit (PICU, specialized hospital department that provides the highest level of care and monitoring for seriously ill or injured infants, children, and teenagers) a few hours later, for stabilization of vital signs. During a review of the facility’s policy and procedure (P&P) titled, “Acute Care Nursing Assessment Documentation Standards of Practice,” dated 3/25/2026, the P&P indicated the following: “Definition of Term s ...Vital Signs: Essential measurements that indicate a patient’s basic physiological functions ...Additional Measurements to Include in Documentation: Vital signs: on admission, as ordered, and as clinically indicated ...” 3. During a review of Patient 2’s “Urology OP Consult,” dated 8/15/2025, the note indicated that Patient 2 presented to the Urology Clinic (which was under the facility’s license) with ESRD (End Stage Renal Disease, the final stage of long-term kidney disease) secondary to CAKUT (Congenital Anomalies of the Kidney and Urinary Tract) with renal dysplasia (a congenital disorder where one or both kidneys do not develop properly in the fetus, resulting in non-functional, malformed tissue) associated with a solitary functioning obstructed right Kidney (only one functioning kidney [the right one], and it is currently blocked, preventing urine from draining properly) s/p(status post) cutaneous ureterostomy (a surgical procedure that redirects the tubes carrying urine from kidneys to a new opening on the skin of the abdomen, bypassing the bladder), presented to the urology clinic for evaluation in the setting of worsening hydronephrosis of the transplanted kidney. The note also indicated the following: “Given the patient’s (Patient 2) history of small, contracted bladder and decreased compliance, I suspect the worsening hydronephrosis (the swelling of one or both kidneys that occurs when urine cannot drain properly and builds up, stretching the organ) may be secondary to delayed/poor emptying from the bladder ... I placed a 14 French foley catheter (a thin, flexible tube inserted through the urethra into the bladder to continuously drain urine into an external collection bag) in patient for continuous urinary drainage.” During an interview on 4/13/2026 at 11:14 am with Patient 2’s legal guardian (FM 1), FM 1 stated the following: -FM 1 stated that when Patient 2’s foley catheter was placed on 8/15/2025 by the provider, no education was provided on how to care for the foley catheter while at home. -FM 1 stated that on October 9, 2025, Patient 2 began urinating less than usual and was observed to be sleepier and had a fever with vomiting. FM 1 stated Patient 2 was then taken to the Emergency Department at another facility where he (Patient 2) was diagnosed with sepsis (a life-threatening medical emergency caused by the body’s extreme, overactive response to an infection) and UTI (Urinary Tract Infection, an infection caused by bacteria entering the urinary system. It primarily affects the bladder and urethra, leading to inflammation and discomfort) due to the catheter being in place. During a review of Patient 2’s urology phone message titled, “Phone/Consumer Message Sign Information,” dated 10/14/2025, the note indicated “Mom (Patient 2’s mother) called to inform us (the facility staff) that patient (Patient 2) was hospitalized on Friday 10/10/2025. Patient began to feel uncomfortable, and per caregiver, patient was a bit fatigued. Patient (Patient 2) was sent to the nearest ED, where he (Patient 2) was found to have a UTI (urinary tract infection) ...” During a concurrent interview and record review on 4/15/2026 at 2:54 p.m. with the Urology RN (RN 2), Patient 2’s medical records, were reviewed. RN 2 verified that there was no documentation indicating that education was provided to Patient 2’s FM (Family Member) about how to care for Patient 2’s indwelling foley catheter. RN 2 stated that it was important to provide education about how to care for the foley catheter to prevent infection and to know what signs and symptoms of infection to be aware of. During an interview on 4/17/2026 at 11:01 a.m. with the Manager of Urology Clinic (NM 1), NM 1 stated that it was important to provide education about catheter care because the patient and their family were on their own while at home and they needed the education to be able to take care of the patient, and to know which symptoms to watch for that may indicate an infection. The patient and family also needed to know “when to call us if there are any concerns.” During a review of the facility’s policy and procedure (P&P) titled”Urinary Catheterization, dated 12/18/2025, the P&P indicated ... “Education: A. Education on urinary catheter care and infection prevention should be provided to the patient/family ...””

“CONTENT OF RECORD: INFORMED CONSENT CFR(s): 482.24(c)(4)(v) [All records must document the following, as appropriate:] Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent. This Standard is not met as evidenced by: 48212 Based on interview and record review, the facility failed to retain written assent (affirmative agreement) form for one of 33 sampled patients (Patient 17), in accordance with the facility’s Institutional Review Board (IRB, a committee that ensures the ethical treatment, safety, and welfare of human subjects in research, approving and monitoring research studies) requirement when enrolling Patient 17 to a research study (Study A) on 5/9/2022. This deficient practice resulted in Patient 17 enrolled into a research study (Study A) without a written assent to confirm Patient 17’s agreement to participate in the research study. Findings: During a review of Patient 17’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 3/30/2022, the “H&P” indicated, Patient 17 was a 13-year-old patient admitted to the facility due to pelvic (lower part of the body between abdomen and thigh) mass for work up and management. During a review of Patient 17’s facility’s clinic visit note titled, “Hematology (specialized branch of medicine focused on the study, diagnosis, treatment, and prevention of blood-related disease, and blood cells disorders)-oncology (specialized branch of medicine focused to the diagnosis, treatment and prevention of cancer) OP (outpatient) MD (medical doctor) note (an examination note with patient’s history and physical prepared by the patient’s provider),” dated 5/9/2022, the clinical visit note indicated, Patient 17 had pelvic (lower part of the body between abdomen and thigh) Ewing sarcoma (a group of cancers that occurs in bone, muscle, organs or nerves) and receiving chemotherapy (cancer treatment) at facility’s infusion center (outpatient clinic providing outpatient treatment including chemotherapy). During a review of the cancer research study’s (Study A’s) informed consent form titled, “Research Informed Consent/Parental Permission Form: Part B [research study name],” dated 5/9/2022, the informed consent indicated, Study A involved collecting patient’s treatment information, demographic information, and permitting future contact. During an interview on 4/17/2026 at 12:06 p.m. with Director (DIR 5) of Research Office, DIR 5 stated each research study would require facility’s Institutional Review Board’s (IRB, a committee that ensures the ethical treatment, safety, and welfare of human subjects in research, approving and monitoring research studies) review and approval. DIR 5 stated IRB would issue an approval letter listing what informed consent documents were required when enrolling a participant in the research study. During a review of the facility’s IRB approval letter issued for the cancer research study (Study A) titled, “Notice of Facilitated Review Acceptance of Amendment,” dated 3/9/2016, the IRB approval letter for Study A indicated, an IRB approved consent document, a written assent (affirmative agreement) of children age seven (7) years and older, the “Experimental Subject’s Bill of Rights (a list of rights as required by [the sate] law for anyone participating in a medical experiment),” and facility’s Research HIPAA (Health Insurance Portability and Accountability Act. Federal regulations that govern the privacy and confidentiality of medical information maintained by healthcare providers) authorization documents, were required as part of informed consent packet. During a concurrent interview and record review on 4/20/2026 at 4:23 p.m. with DIR 5, the facility’s IRB approval letter for Study A, dated 3/9/2016, was reviewed. The IRB approval letter for Study A indicated a written assent of children age 7 years and older was necessary for participating in the research study. DIR 5 stated the investigator would need to follow the instructions in the IRB approval letter and collect the written assent (a participant’s affirmative agreement to participate in a study) during the informed consent process with Patient 17 and Patient 17’s parents prior to enrolling Patient 17 in Study A. During a review of Patient 17’s “Informed Consent Conference (documentation of a meeting with patient and/or patient’s representative to discuss treatment plan, risk, benefits and alternatives),” dated 5/9/2022, the “Informed Consent Conference” indicated the Clinical Research Assistant (CRA 1) conducted an informed consent conference regarding Study A with Patient 17, Patient 17’s parent, and a facility’s in person interpreter. The “Informed Consent Conference” also indicated, “The subject (Patient 17)/ family was given adequate time to review the “Experimental Research Subject’s Bill of Rights”/informed consent/assent and HIPAA documents. All questions and/or concerns were addressed and the subject (Patient 17)/family voluntarily agreed to participate in study. Signatures were obtained on all necessary documents ...” During a concurrent interview and record review on 4/20/2026 at 4:25 p.m. with DIR 5, Patient 17’s informed consent packet for Study A, dated 5/9/2022, was reviewed. The consent packet indicated there was no assent form for Patient 17. DIR 5 stated the investigator failed to obtain the written assent per IRB requirement. DIR 5 further stated that the process should have been, after the patient and parent had signed all required documents, there should be a second reviewer to review and make sure the informed consent packet was complete before enrolling the patient into the research study. DIR 5 further stated the facility’s research study system indicated Patient 17 had enrolled in Study A. During a review of the facility’s policy and procedure (P&P) titled, “SOP (standard operating procedure): Informed Consent Process for Research,” dated 3/12/2020, the P&P indicated, “Purpose: This procedure establishes the process to obtain informed consent from subjects, the legally authorized representative (LAR) of adults unable to consent, or the parents or guardians of children. The process begins when an individual identifies a subject as a potential candidate for a research study. The process ends when a subject or the subject’s LAR provides legally effective informed consent or declines to do so ... Procedures ... If the subject/representative agrees to take part in the research study: If the subject is a child: Whenever possible explain the research to the extent compatible with the child’s understanding. Request the assent (affirmative agreement) of the child unless ... The IRB determined that assent was not a requirement.””

“PHARMACIST SUPERVISION OF SERVICES CFR(s): 482.25(b)(1) §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. This Standard is not met as evidenced by: 28851 Based on observations, interviews, and record review, the hospital: 1. Failed to ensure their sterile compounding (a process in compounding germ-free intravenous [IV, into the vein] medications) policy and procedures included diagrams (maps) of their microbiological air and surface sampling locations. This failure had the potential of exposing patients requiring IV medications to preventable contamination that may affect patients’ health and safety. 2. Failed to ensure the pharmacy personnel had documented work order and action plan for the recurring high humidity excursions at two (2) of 6 IV compounding areas. This failure had the potential of exposing patients requiring IV medications to preventable contamination that may affect patients’ health and safety. 3. Failed to ensure four (4) of 6 IV compounding areas were clean, not cluttered, had smooth and impervious surfaces, free of cracks and crevices, and that staff were able to clean around the primary engineering controls (PEC [a specialized device or enclosure used in pharmacy compounding to provide an ISO Class 5 or cleaner environment], HEPA [High Efficiency Particulate Air]-filtered ventilated devices [devices used for indoor air purification] that provide a certified ISO Class 5 [a standard of a highly controlled and low-particulate air quality]) for sterile compounding. This failure had the potential of exposing patients requiring IV medications to preventable contamination that may affect patients’ health and safety. 4. Failed to develop, and implement, a policy and procedure regarding the fit-testing and training of pharmacy staff in proper respirator use (masks that protect both the sterile product and the wearer, offering fluid resistance while filtering out 95% of airborne particles) during the deactivating, decontaminating, and cleaning of four (4) of 4 sampled biological safety cabinets (BSCs, a type of primary engineering control or PEC, which are HEPA [High Efficiency Particulate Air]-filtered ventilated devices [devices used for indoor air purification] that provide a certified ISO Class 5 [a standard of a highly controlled and low-particulate air quality] work environment [extreme level of air cleanliness] for the process of sterile [germ-free] compounding hazardous drugs [HD, such as chemotherapy drugs] that will be directly injected or infused into the vein) work trays (the removable stainless steel surface located at the base of the BSC’s interior, designed to hold spills of hazardous drugs, aka HD). The hospital also failed to document the monthly cleaning of the BSC work trays. This deficient practice had the potential to increase risk of hazardous drugs exposure to staff. Findings: 1. During an interview on 4/14/2026 at 3:10 p.m. with the pharmacy supervisor (Pharm 1), Pharm 1 stated the hospital followed the guidance of US Pharmacopeia (USP) chapter 797 (USP 797 is a chapter of the United States Pharmacopeia that provides guidelines and standards for compounding [the process of mixing, altering, or combining ingredients to create a custom medication tailored to a specific patient’s needs] sterile preparations [CSPs] in healthcare settings, ensuring patient safety by preventing harm from microbial contamination, endotoxins, and other errors. It covers various aspects of sterile compounding [a process in compounding germ-free intravenous [IV, into the vein] medications’, including personnel training, facility requirements, and quality control procedures) as standard of practice. During a review of the certification reports and microbiological air and surface sampling results and a concurrent interview on 4/14/2026 at 3:28 p.m., the surveyor asked what “AS2” meant in the second floor IV room (2AP) viable sampling results, the pharmacy supervisor (Pharm 1) stated AS2 referred to an air sample collected in the biological safety cabinet (a type of PEC [Primary Engineering Control], a specialized device or enclosure used in pharmacy compounding to provide an ISO Class 5 or cleaner environment) located in the hazardous drugs (HD) buffer room (a certified cleanroom for sterile compounding). However, Pharm 1 was unable to verify the specific location within the BSC where the sample was collected, and the certification report lacked a map indicating the sampling locations. Pharm 1 further stated the hospital policy did not include diagrams that indicated microbiological air and surface sampling locations. During a review of the current edition of USP 797 (2023), the standard was that the microbiological air and surface monitoring program must be clearly described in the facility’s procedures, which must include a diagram of the sampling locations. 2. During an interview on 4/14/2026 at 3:45 p.m., the director of pharmacy (DOP) stated the hospital had 6 areas for sterile compounding, which included 4 cleanroom suites (classified area that consists of both anteroom and buffer room) and 2 segregated compounding areas (SCAs, designated space, areas, or rooms that are not required to be classified but must contain a PEC suitable for compounding sterile products). During a concurrent observation and interview at the cleanroom suite located in the infusion center satellite pharmacy (IC) on 4/15/2026 at 2:31 p.m., in the presence of DOP and 2 pharmacy supervisors (Pharm 1 and 2), the pass-through chamber connecting the anteroom to the HD buffer room was made of laminated wood particles with visible gaps or crevices along the edges and corners. This pass-through chamber appeared to block access to the left side of the PEC. When asked to demonstrate how to clean the exterior of the PEC, the pharmacy technician could not reach an area on the side of PEC next to, and almost touching, the right side of the pass-through chamber. The technician also could not reach around to clean the back side of the PEC and the back wall. Pharm 2 stated the limited space around the PEC did not allow cleaning of the back wall. Also, there was no demarcation line in the HD buffer room for doffing (safely remove) personal protection equipment (PPE) before exiting the HD buffer room. The anteroom was crowded with large storage racks, chemo trace bins (specialized yellow receptacles used in hospitals to dispose of medical items that have come into contact with chemotherapy drugs), and pharmaceutical waste bins (specialized containers used for the safe disposal of materials that have come into contact with chemotherapy or cytotoxic drugs, but contain only microscopic or residual amounts of the medication). During a concurrent observation and interview on 4/15/2026 at 3 p.m., at the IV cleanroom suite inside the “Main Gateway Pharmacy,” (MGW) in the presence of DOP, Pharm 1 and Pharm 2, there were crevices and uneven surfaces observed on the floor and walls of the anteroom. Pharm 2 stated the cabinet above the sink was made of laminated wood with edges exposed to form crevices. There were dark brownish gray residues underneath the bench. During a concurrent observation and interview at the IV cleanroom suite inside the 2nd floor Anderson Pharmacy (2AP) on 4/15/2026 at 3:27 p.m., in the presence of DOP, Pharm 1 and Pharm 2, there were dents, paint chips on the wall, residues on the floor inside the anteroom, which indicated staff did not move the carts and storage racks to clean the area underneath. Pharm 2 confirmed there were crevices that needed caulking. Also, there was a refrigerator located in an alcove on the left of the non-HD buffer room entrance. Pharm 1 stated pharmacy staff could not clean the back of the refrigerator and the wall behind. During an interview on 4/15/2026 at 3:54 p.m., DOP stated the HD buffer rooms in the IC, 2AP and 4AP did not have demarcation lines in the HD buffer room. During a concurrent observation and interview at the fourth floor Anderson Pharmacy (4AP) IV cleanroom suite, on 4/15/2026 at 3:59 p.m., the ante room had dents and paint chips on the walls. There was a backpack hung on a storage rack in the clean area. DOP stated the backpack belonged to a pharmacy staff and personal items as such should not be stored in the cleanroom. During an interview on 4/15/2026 at 4:08 p.m., DOP agreed the aforementioned IV cleanroom suites were cluttered and crowded with supplies. During a review of the hospital’s policy and procedures (P&P) titled Compounding Sterile Products (revised on 10/10/2025), the policy indicated the hospital would ensure compliance with USP 797. During a review of the current edition of USP 797 (2023), the USP 797 indicated that the standard was that, the placement of the PEC must allow for cleaning around the Primary engineering control (PEC): A device or zone that provides an ISO Class 5 air quality environment for sterile compounding. The standard also indicated after compounding HD, PPE must be disposed of in accordance with USP 800 (a chapter of USP that describes practice and quality standards for handling HDs to promote patient safety, worker safety, and environmental protection). Furthermore, the standard indicated that design or installation of furniture, equipment, and other materials, in a classified area must not impact environmental air quality and must promote effective cleaning and disinfecting. During a review of the current edition of USP 800 (2019), the standards indicated a line of demarcation must be defined within negative-pressured buffer room for donning and doffing PPE. 3. During a review of the humidity records from the continuous monitoring system, the record indicated the humidity in the MGW (Main Gateway pharmacy) IV cleanroom suite between 4/8/2026 around 4 p.m. and through 4/9/2026 at around 10 a.m., was above the threshold of 60 percents (%). During an interview on 4/15/2026 at 11:22 a.m., the pharmacy supervisors (Pharm 1 and 2) confirmed that there was a period of approximately 18 hours that the aforementioned recorded humidity was above the threshold, with the highest over 75% humidity. During an interview on 4/15/2026 at 2 p.m., DOP stated there was no record of a facility work order submission for the aforementioned humidity excursion. DOP and the regulatory pharmacist (Pharm 3) stated humidity inside IV rooms had been an ongoing issue in recent years due to recent rain, warmer climate, aging mechanicals, and structural designs. During a review of the humidity records for MGW IV cleanroom, there were 2 reported excursions (humidity above threshold) in January 2026, 3 in February 2026, and 4 in April 2026 (not including the excursion happened between 4/8/2026 and 4/9/2026). For the IC (Infusion Center satellite pharmacy) IV cleanroom, there were 4 reported excursions in February 2026, 7 in March 2026, and 2 in April 2026. Also, there was 1 reported excursion in January 2026 for 4AP IV room. During a concurrent review of the work order history related to temperature, humidity, and pressure differential excursions that occurred in the IV clean room suites, the record indicated there had been recurring excursions dated as far back as January 2024. During an interview on 4/16/2026 at 10:33 a.m. with the director of facilities operation (DIR 3), in the presence of DOP and Pharm 3, DIR 3 stated the current IV cleanroom suites were built around 2010-2011 to different building codes and standards. DIR 3 stated the MGW and IC IV cleanrooms were serviced by the central HVAC (Heating, Ventilation, and Air Conditioning. It refers to the interconnected systems used to regulate temperature, humidity, and air quality) chillers and none of the IV cleanrooms had dedicated air handlers. DIR and Pharm 3 indicated it had been challenging to maintain the temperature, humidity, and pressure relationship of the IV rooms at times during weather changes. During a review of the hospital policy and procedures (P&P) titled Compounding Sterile Products (revised 10/10/2025), the policy indicated if the humidity goes out of range, notify the Pharmacy Manager immediately; if proper conditions have not been restored within 4 hours, Pharmacy to place a work order with Facilities and documented in pharmacy cleaning/monitoring system. During a review of the current edition of USP 797 (2023), the USP 797 indicated that the standards was that, the cleanroom suite should be maintained at a relative humidity of 60% or below to minimize the risk of microbial proliferation. 4. During an interview on 4/14/2026 at 3:10 p.m., the pharmacy supervisor (Pharm 1) stated the hospital followed the guidance of US Pharmacopeia (USP) chapter 797 (USP 797, is a chapter of the United States Pharmacopeia that provides standards for compounding sterile preparations [CSPs] in healthcare settings, ensuring patient safety by preventing harm from microbial contamination, endotoxins, and other errors. It covers various aspects of sterile compounding, including personnel training, facility requirements, and quality control procedures) as standard of practice. During an interview on 4/14/2026 at 3:45 p.m., the director of pharmacy (DOP) stated the hospital had 4 BSCs located in different compounding areas that are used to make intravenous (IV, into the vein) HDs (Hazardous Drugs). During an interview on 4/16/2026 at 2:48 p.m., the pharmacy supervisor (Pharm 2) stated the cleaning of the BSC work trays (the removable stainless steel surface located at the base of the cabinet’s interior, designed to hold spills of hazardous drugs) were performed monthly as part of the monthly terminal clean procedures. Concurrently, Pharm 2 stated pharmacy staff were expected to utilize P95 respiratory masks (respirator that can filter at least 95% of airborne particles and is resistant to oil-based mists, ideal for HD PEC cleaning) for protection during the cleaning of the HD work trays. However, when surveyor asked about the annual P95 respiratory fit-test (procedure that verifies the mask seals properly to the wearer’s face is required by the Occupational Safety and Health Standards [OSHA] 1910.134), Pharm 2 stated there was no documented respirator training and evaluation for their pharmacy staff. Pharm 2 stated improper fitting of the respirator would not protect staff from the risk of handling HD and acknowledged the OSHA requirements. During a review of the hospital policy and procedures (P&P) titled Compounding Sterile Products (revised on 10/10/2025), the policy indicated the hospital would ensure compliance with USP 797 and OSHA. This policy also indicated cleaning activity is documented in pharmacy cleaning/monitoring system. During an interview on 4/16/2026 at 3:01 p.m., Pharm 2 stated the monthly cleaning of BSC work trays was implied to be performed by pharmacy staff assigned to certain work shift. Pharm 2 stated their cleaning log did not document the work tray cleaning. Pharm 2 further stated the current hospital policy did not include the cleaning procedure of BSC work trays. During a review of the current edition of USP 797 (2023), the guidance indicated the minimum frequency for cleaning the work tray was monthly.”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 36206 Based on observation, interview, and record review, the facility failed to post written notice or signage informing patients of their right to receive a medical screening examination, stabilizing treatment and an appropriate transfer, regardless of their ability to pay, in the Ambulance Entrance of the Emergency Department (ED, the department of a hospital that provides immediate treatment for acute illnesses and trauma). This deficient practice had the potential for patients who arrive to the ED via ambulance, not knowing their rights when they visit the ED seeking treatment for a medical condition. Findings: During an observation on 12/16/2024 at 3:06 p.m. in the Emergency Department (ED), no signage informing patients of their right to a medical screening, stabilizing treatment ...regardless of their ability to pay, was posted in the ambulance entrance or in the hallway, where patients, who are brought by ambulance wait to be seen by a physician. Concurrently, on 12/16/2024 at 3:06 p.m., the Director of the Emergency Department (DED) verified that the signage, informing patients of their rights to be seen regardless of their ability to pay, was not posted in the Ambulance Entrance or in the hallway where patients, who arrive by ambulance, wait to be examined. The DED stated patients who arrive by ambulance can wait in the hallway, near the ambulance entrance, or are taken directly to a room, in which case, the patients would be unable to see the signage. The patients could only see the signage if the patients wait in the waiting area of the Main Entrance. Concurrently, on 12/16/2024 at 3:06 p.m., the Clinical Practice Leader (CPL) stated that most patients arriving by ambulance are taken directly to a room or wait in the hallway, next to the ambulance entrance and would not be able to visualize any sign. The CPL also verified there was no signage posted in the Ambulance Entrance and adjacent hallway, used as a waiting area for patients who arrive by ambulance. During an interview on 12/18/2024 at 2:22 p.m., Manager of Accreditation (MOA) reviewed the facility ’ s policy regarding EMTALA and stated that the signage should be visible to all patients entering the emergency department, both through the Main Entrance and the Ambulance Entrance, to ensure that patients were aware of their rights to receive care regardless of payment. During a review of the facility ’ s policy and procedure (P&P) titled, “EMTALA (Screening, Stablization, and Management of Emergency Transfers),” dated 3/12/2024, the P&P indicated the following: Signage means the signs posted by the Hospital in its Dedicated Emergency Department(s) and in a place or places likely to be noticed by all individuals entering the Dedicated Emergency Department(s) (including waiting room, admitting area, entrance and treatment areas), that inform individuals of their rights under EMTALA.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 36206 Based on observation, interview and record review, the facility failed to ensure the Condition of Participation (CoP) for Nursing Services was met as evidenced by: 1. For one of 30 sampled patients (Patient 1), with a physician’s order for cardio-respiratory monitoring to track heart rate (number of heartbeats per minute), heart rhythm (pattern of movement), respiratory rate (number of breaths per minutes), and pulse oximetry (percentage of oxygen saturation in the blood), the facility failed to: 1.a. Ensure Registered Nurse (RN 1, a licensed nurse who has graduated from an accredited nursing program and has passed a national licensing exam) assessed Patient 1 immediately after Care Partner (CP 1, also known as Certified Nursing Attendant, an entry-level role that provides vital support to both patients and nurses) reported that Patient 1 was in the bathroom and disconnected from the Cardio-Respiratory monitor, with an IV (intravenous- through the vein) pump (a medical device used to deliver fluids into a vein) alarming. 1.b. Ensure that Patient 1 remained connected to the Cardio-respiratory monitor unless Patient 1 was confirmed stable (vital signs are within the patient’s normal range, and the patient’s condition is not changing) and appropriately supervised (under the care of an RN or qualified staff trained to detect and address signs of patient deterioration) while disconnected from a cardio-respiratory monitor. These deficient practices resulted in Patient 1 being left unmonitored during a cardiac arrest (when the heart stops beating) on 9/11/2024, which occurred inside a locked bathroom, while Patient 1 was off the Cardio-Respiratory monitor. The cardiac arrest caused an anoxic brain injury (brain damage due to lack of oxygen). Patient 1 passed away on 9/15/2024 after the family agreed to discontinue life support upon being informed of Patient 1’s poor prognosis. (Refer to A-0395) 2. The facility failed to ensure that errors made on a medical record, titled “Emergency Documentation Flowsheet,” were appropriately corrected in compliance with the facility’s policy and procedure regarding “Methods to Correct Errors in the Patient’s Medical Record,” for one of 30 sampled patients (Patient 1). This deficient practice had the potential to compromise the accuracy and reliability of the patient medical records, which may result in improper care decisions, delayed treatment, or adverse patient outcomes. (Refer to A-0398) 3. The facility failed to ensure pain assessments were completed, in accordance with its policy and procedure regarding “Pain Management and Assessment of Pain in Infants, Children, Adolescents and Young Adults,” for two of 30 sampled patients (Patient 1 and Patient 3). Patient 1 did not receive pain assessment before and after the administration of pain medication. Patient 3’s pain was not addressed, and no reassessment of the pain was documented. These deficient practices had the potential to result in inadequate pain management, impacting comfort and care outcomes for Patient 1 and Patient 3. These deficient practices also had the potential for Patient 1 and Patient 3’s pain level to worsen which may result in psychological distress or delayed recovery. (Refer to A-0398) 4. The facility failed to ensure one of 30 sampled patients (Patient 4), Patient 4’s seizure (a sudden, uncontrolled electrical disturbance in the brain which can cause uncontrolled jerking, blank stares, and loss of consciousness) precautions (refers to safety measures taken before a patient experiences a seizure) was implemented, in accordance with the facility’s policy and procedure regarding seizure management, when Patient 4 was observed not to have four side rails padded. This deficient practice had the potential for Patient 4 to suffer from pain and injury (such as fracture [broken bones]) during a seizure activity. (Refer to A-0398) 5. The facility failed to ensure one of six sampled staff members (Care Partner [CP] 1) completed the employee health requirements pertaining to Hepatitis B (a serious liver infection) titer test (a blood test that measures the level of antibodies [proteins that protect someone when an unwanted substance enter the body] in the blood to determine if someone is immune [means that the body is protected from future infection with the Hepatitis B virus] to the Hepatitis B virus) and the annual influenza vaccination (protects against the flu virus), in accordance with the facility’s policy and procedure regarding “Immunization Vaccination/Testing” and “seasonal vaccination.” This deficient practice had the potential for staff to become infected with a communicable disease and possibly spread of infection to patients, other staff, and visitors. (Refer to A-0398) 6. The facility failed to ensure one of two sampled staff (Registered Nurse [RN] 7) followed the facility’s Policy and procedure regarding isolation precautions (precautions/measures intended to prevent the spread of infectious agents) when RN 7 exited a patient’s room without removing the face mask previously worn while providing care to the patient who was placed on isolation precaution. This deficient practice had the potential to spread infection to other patients on the unit, the staff, and visitors. (Refer to A-0398) The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality healthcare in a safe environment and potentially placing patients at risk of not receiving necessary care and treatments.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a) Patients’ Rights: Notice of Rights This Standard is not met as evidenced by: 36206 Based on observation, interview, and record review the facility failed to ensure the Notice of Patient Rights (aim to empower individuals within the healthcare system, fostering a collaborative relationship between patients and their healthcare providers while upholding ethical medical practices) was posted in a place that was easily visible by patients in the Emergency Department (ED, provides immediate medical care to patients with sudden, serious illnesses or injuries), in accordance with the facility’s policy and procedure titled, “Patient and Family Responsibilities.” This deficient practice had the potential for patients or patient representatives to be unaware of their rights and of the contact information of the regulatory agency if the patient or patient representative wishes to make a complaint. Findings: During an observation on 12/3/2024 at 10:25 a.m. in the Emergency Department, the Notice of Patient Rights was not visible upon entering the ED waiting room and check-in area, which was located at the center of the waiting room. The Notice of Patient Rights was posted on the wall, across the restrooms, at the far-left corner of the waiting room, in a small hallway, that could not be visualized from the waiting room (The patient or patient representative has to get up and walk to the restrooms to be able to see and read the Notice of Patient Rights). During a concurrent interview on 12/3/2024 at 10:25 a.m. with the Director of the Emergency Department (DED), the DED stated the following: The facility was in the process of moving the Notice of Patient Rights to a prominent place in the waiting room where it would be easily noticed by patients. The DED stated that patients are only able to visualize the Notice of patient Rights, if they go to the restroom. The DED stated it was important for the Notice of Patient Rights to be easily visible so patients can be aware of their rights. During an interview on 12/3/2024 at 1:29 p.m. with the Quality Coordinator (QC) 1, QC 1 stated the Notice of Patient Rights should be posted at the entrances of the hospital, easily visible to patients. During a review of the facility’s policy and procedure (P&P) titled, “Patient and Family Responsibilities,” dated 2/1/2024, the P&P indicated the following: Patient rights should be promoted and protected by all hospital and medical staff. A list of the following rights should be posted in both English and Spanish in conspicuous (standing out) locations throughout the Hospital.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 36206 Based on interview and record review, the facility failed to ensure four (4) of 10 emergency carts (a cart stocked with emergency medical equipment [Example: oxygen tank, suction set-up which is a medical device assembly used to remove fluids or secretions from a patient’s body cavity, etc.], supplies and medications) were checked every shift, in accordance with the facility’s policies and procedures regarding emergency cart maintenance. This deficient practice had the potential for emergency medical equipment, medications, and supplies to not be readily available in the event of a medical emergency, which may result in delayed provision of patient care. Findings: During a concurrent interview and record review on 12/3/2024 at 2:40 p.m. with the Nurse Manager (NM 3) of the NICU (Neonatal Intensive Care Unit, treats dangerously ill or premature newborn babies [a baby born before 37 weeks of pregnancy]), NM 3 verified that two of five emergency carts had not been checked by a nurse on 12/2/2024 during the AM (day) shift. The nurse should check for the presence of an oxygen tank, backboard and the expiration date of the medications and supplies. The emergency cart should be checked every shift to ensure the supplies were present and ready to use in case of a code (code blue, when a patient requires resuscitation [the act of reviving someone from apparent death or from unconsciousness] or otherwise in need of immediate medical attention). During a concurrent interview and record review on 12/2/2024 at 3:48 p.m. with the Nurse Manager (NM 2) of the 5 East (Medical Surgical, a variety of medical conditions are treated) Unit, NM 2 verified that two of the five emergency carts on the unit, had not been checked for the presence of emergency equipment, oxygen tank and backboard on 12/1/2024 in the PM or evening shift. NM 2 stated that emergency carts should be checked every shift to ensure emergency equipment were present in the event of an emergency. During a review of a Log titled, “Emergency Cart/Defibrillator (a device that delivers an electric shock to the heart to restore a normal rhythm or restart a heartbeat) - Daily Shift and Weekly Code Readiness Test,” in the NICU, dated 12/2024, the Log indicated that on 12/2/2024 during the AM (morning or day) shift, there were no initials of a licensed nurse indicating that the cart was checked for the following: -The external cart contents with oxygen (O2) tank, suction (machine used to remove fluids or secretions from a patient’s body cavity), or backboard (a board that is placed between a person and a mattress in order to provide effective chest compressions when a person’s heart stops beating), present and inspected. -Code Cart Med (medication) expiration date checked. -Code cart supplies expiration date checked. During a review of a Log titled, “Emergency Cart/Defibrillator - Daily Shift and Weekly Code Shock Test,” in the 5 East Station 4, dated 12/2024, the Log indicated that on 12/1/2024 during the PM (evening) shift, there were no initials of a licensed nurse indicating that the cart (Cart #1) was checked for the following: The external cart with oxygen (O2) tank, and backboard (a board that is placed between a person and a mattress in order to provide chest compressions when a person’s heart stops beating), present and inspected. During a review of a Log titled, “Emergency Cart/Defibrillator - Daily Shift and Weekly Code Shock Test,” in the 5 East Station 1, dated 12/2024, the Log indicated that on 12/1/2024 during the PM (evening) shift, there were no initials of a licensed nurse indicating that the cart (Cart #2) was checked for the following: The external cart contents with oxygen (O2) tank, and backboard (a board that is placed between a person and a mattress in order to provide chest compressions when a person’s heart stops beating), present and inspected. During a review of the facility’s policy and procedure (P&P) titled, “Emergency Cart Maintenance,” dated 9/26/2024, the P&P indicated the following: “Purpose: To ensure that appropriate emergency cart contents and equipment are available and functioning properly ...Emergency carts will be locked. The integrity of the lock is checked every shift by a licensed provider in the units ...This check is documented on the Emergency Crash Cart/Defibrillator Check Sign-off sheet ...Checking the eternal emergency cart equipment. a. Full oxygen tank with regulator b. Suction set up. c. Backboard d. Documentation sheets e. Medication notebook for appropriate areas f. Cart content list, with the earliest expiration date of the contents in the cart ... Documentation: Record the status of the emergency equipment on the appropriate checklist per policy.””

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 46333 Based on observation, interview, and record review, for one of 30 sampled patients (Patient 1), with a physician’s order for cardio-respiratory monitoring to track heart rate (number of heartbeats per minute), heart rhythm (pattern of movement), respiratory rate (number of breaths per minutes), and pulse oximetry (percentage of oxygen saturation in the blood), the facility failed to: 1. Ensure Registered Nurse (RN 1, a licensed nurse who has graduated from an accredited nursing program and has passed a national licensing exam) assessed Patient 1 immediately after Care Partner (CP 1, also known as Certified Nursing Attendant, an entry-level role that provides vital support to both patients and nurses) reported that Patient 1 was in the bathroom and disconnected from the Cardio-Respiratory monitor, with an IV (intravenous- through the vein) pump (a medical device used to deliver fluids into a vein) alarming. 2. Ensure that Patient 1 remained connected to the Cardio-respiratory monitor unless Patient 1 was confirmed stable (vital signs are within the patient’s normal range, and the patient’s condition is not changing) and appropriately supervised (under the care of an RN or qualified staff trained to detect and address signs of patient deterioration) while disconnected from a cardio-respiratory monitor. These deficient practices resulted in Patient 1 being left unmonitored during a cardiac arrest (when the heart stops beating) on 9/11/2024, which occurred inside a locked bathroom, while Patient 1 was off the Cardio-Respiratory monitor. The cardiac arrest caused an anoxic brain injury (brain damage due to lack of oxygen). Patient 1 passed away on 9/15/2024 after the family agreed to discontinue life support upon being informed of Patient 1’s poor prognosis. On 12/4/2024 at 3:44 p.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility’s non-compliance with one or more requirements has caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Senior Vice President Chief Medical Officer (SVPCMO), Manager of Accreditation (MOA), Manager of Patient Safety (MPS), Executive Director of Patient Care Services, Quality & Safety (EDPCS), Program Manager of Accreditation & Licensing (PMAL), Vice President of Quality & Safety (VPQS), Quality Coordinator (QC) 1, QC 2, and QC 3. Patient 1 presented to the Emergency Department for sickle cell disease pain crisis (a sudden episode of severe pain when blood cells block blood flow to small blood vessels) and acute chest pain (can be a symptom of acute chest syndrome, a life-threatening complication of sickle cell disease). On 9/11/2024 at 12:49 a.m., Patient 1 was admitted to the Hematology (treat blood disease)/Oncology (treat cancer) Unit for pain management and placed on a cardiac (heart) monitor, as ordered by the physician. On 9/11/2024 at 12:59 p.m., Care Partner (CP) 1 took Patient 1’s vital signs. At 2:45 p.m., CP 1 returned to Patient 1’s room and noticed Patient 1 was not in bed. Patient 1 was disconnected from the cardiac monitor on the wall. The bathroom door was closed. The infusion pump (machine that delivers fluids or mediations through the vein) was alarming inside the bathroom. CP 1 did not visualize Patient 1 entering the bathroom. CP 1 did not knock on the bathroom door or call out to Patient 1. CP 1 notified Registered Nurse (RN) 1 that Patient 1 was in the bathroom and that the infusion pump was alarming. At 3:06 p.m., RN 1 entered Patient 1 room to give medications. Patient 1 was still in the bathroom. RN 1 knocked on the door and called Patient 1’s name. Patient 1 did not respond. The bathroom door was locked. RN 1 required the assistance from a Resource Nurse to unlock the door because there was no bathroom key. At 3:08 p.m., RN 1 and Resource Nurse unlocked the door with a coin. Patient 1 was found on the floor, unresponsive, pulseless (no pulse), apneic (not breathing), cool (lowered body temperature), and cyanotic (blue or purple color of skin due to lack of oxygen). Cardiopulmonary resuscitation (CPR, emergency treatment when someone’s breathing or heart has stopped) was initiated. Patient 1 was transferred to the Pediatric Intensive Care Unit (PICU, treat the sickest children up to 18 years old) at 3:21 p.m. Patient 1 suffered a cardiac arrest (heart stops beating) while in the locked bathroom and resulting in an anoxic brain injury (brain death due to lack of oxygen). Due to Patient 1’s poor prognosis, Patient 1’s family agreed to disconnect Patient 1 from life-support and Patient 1 expired on 9/15/2024. On 12/06/2024 at 12:59 p.m., the IJ was removed in the presence of SVPCMO, VPQS, EDPCS, MPS, MOA, QC 1, QC 2, QC 3, QC 4, PMAL, Chief Nursing Officer (CNO), Clinical Practice Leader (CPL) 1, CPL 2, Chief Quality Officer (CQO), Patient Care Services Manager (PCSM), and Clinical Informatics after the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practice). The elements of the IJ Removal Plan were verified and confirmed through observations, interviews, and record review. The IJ Removal Plan included the following: The facility inventoried patients who were on continuous cardio-respiratory monitoring and determined individual patient needs for bedside commodes (portable toilet that can be used when someone is unable to walk to the bathroom) or alternative options to maintain continuous monitoring. There will be a device to unlock restrooms in each main nursing station and crash cart. Staff education regarding compliance with alarm response policy, to ensure rapid response to all alarms. In addition, staff educated on expectations for patients on continuous cardiorespiratory monitoring; Patients ordered for continuous cardio-respiratory monitoring will require a nurse to have direct visual observation if removed from monitoring; prior to removal, patient’s heart rate and respiratory rate must be assessed and documented. If heart or respiratory rate are outside of normal range, monitoring must remain, uninterrupted, and healthcare team must be notified, promptly. Re-education included non-nursing staff regarding not removing monitoring leads. Care partners or nurses will monitor the central station and notify assigned or closest nurse of any alarms. Existing continuous cardio-respiratory monitoring orders were modified to include the option for Providers’ discretion that monitoring may be suspended during toileting and bathing. Education to Providers to assess the need for patients on continuous monitoring. Findings: 1. During a review of Patient 1’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 9/112024, the “H&P” indicated Patient 1 was an 18-year-old, who presented to the facility’s emergency department (ED, provides immediate medical care to patients with sudden, serious illnesses or injuries) with chief complaints of bilateral (both) arm pain for two days, sickle cell disease pain crisis (severe episodes of pain caused by the obstruction of blood flow due to sickle-shaped red blood cells [cells that carry oxygen from the lungs to the body’s tissues]), and acute (sudden and severe in onset) chest pain (pain in the chest due to reduced blood flow to the heart muscle). During a concurrent interview and record review on 12/3/2024 at 11:25 a.m. with Registered Nurse (RN) 8, Patient 1’s electronic medical record (EMR, digital versions of the paper charts in the hospitals) titled, “Cardio/Respiratory Monitor (device that measures the heart rate, respiratory rate, etc.),” orders, dated 9/11/2024 at 12:55 a.m., was reviewed. RN 8 confirmed that the Cardio-Respiratory monitoring was ordered. During the same interview on 12/3/2024 at 11:25 a.m., RN 8 stated the Cardio-Respiratory monitor order would stay active until the physician orders to discontinue Cardio-Respiratory monitoring. RN 8 stated on 9/11/2024 at 12:49 a.m., Patient 1 was admitted to the facility’s 4 East (Hematology [the medical specialty that studies blood] and Oncology [the study and treatment of cancer] unit) for pain management and was placed on a Cardio-Respiratory monitor as ordered by the physician. During a concurrent observation and interview on 12/2/2024 at 2:30 p.m. with Charge Nurse (CN 1, a senior RN responsible for overseeing nursing unit operations) in room 4220, the room’s bathroom locked from the inside with no external keyhole. CN 1 stated that a coin or flat screwdriver could unlock the door. However, neither was readily available on the unit. CN 1 verified that Patient 1 was found unresponsive (not reacting to verbal or physical stimuli) in room 4220’s bathroom on 9/11/2024. During a concurrent interview and record review on 12/3/2024 at 2:00 p.m. with Registered Nurse (RN) 1, Patient 1’s medical record titled, “IP (Interdisciplinary Progress) Nursing Shift Comments,” dated 9/12/2024, was reviewed. The IP nursing notes indicated the following: -On 9/11/2024 at 12:14 p.m., RN 1 notified MD (Medical Doctor) that the patient (Patient 1) was drowsy (sleepy and lethargic, appearing half-asleep) and dozes off mid-conversation but was arousable (to awake from sleep) and responsive (reacting to people or events). RN 1 also notified MD that patient’s 11:00 a.m. oxycodone (a prescribed medication used to treat moderate to severe pain) dose was held due to his (Patient 1) drowsiness (feeling more sleepy than normal during the day). MD stated they (Physician team) would come to bedside to assess (Patient 1). -At 2:45 p.m., the CP (care partner) 1 notified RN (RN 1) that Patient 1 was in the bathroom and that CP 1 was going on a meal break. -At 3:06 p.m. RN 1 entered patient’s (Patient 1) room to give meds (Medications). Patient (Patient 1) was still in the bathroom. RN 1 knocked on the door and called for the patient (Patient 1) and patient did not respond. RN 1 called Resource RN to assist with unlocking the door. The door was unlocked, patient was found unresponsive, face down on the floor. RN 1called Code Blue (when a patient requires resuscitation [the act of reviving someone from apparent death or from unconsciousness] or otherwise in need of immediate medical attention). Patient (Patient 1) had no pulse (a condition where the heart stops) and no respirations (breathing), CPR (Cardiopulmonary Resuscitation - is an emergency lifesaving procedure performed when the heart stops beating) started. Patient 1 was connected to cardiac monitor and would self-disconnect to use the restroom. During the same interview on 12/3/2024 at 2:00 p.m., RN 1 confirmed RN 1 called for the resource RN because there was no key or tool available to unlock the bathroom door. RN 1 stated the door was eventually unlocked using a coin. RN 1 verified that at 3:06 p.m. (21 minutes after CP 1 reported that Patient 1 was in the bathroom with an alarming IV pump), they entered Patient 1’s room. RN 1 did not recall being notified that the cardiac monitoring alarm had sounded when Patient 1 disconnected the cardiac monitor to go to the bathroom. During an interview on 12/3/2024 at 3:15 p.m. with Care Partner (CP) 1, CP 1 stated that after taking Patient 1’ vital signs (measure the basic functions of your body such as heart rate, blood pressure, and respiratory rate) at 12:53 p.m. on 9/11/2024, CP 1returned to find Patient 1 in the bathroom (with the door closed and locked) with the IV pump alarming (inside the bathroom). CP 1 did not knock on the bathroom door or call out to Patient 1 but reported the situation to RN 1 before leaving for break (at 2:45 p.m.). CP 1 further stated, “The patient would disconnect himself from the monitor.” CP 1 stated, “The process is if they are stable, it’s okay for them to disconnect themselves and go to the bathroom.” During an interview on 12/3/2024 at 2:30 p.m. with the Nurse Manager (NM 1), NM 1 explained the facility’s process for patients on cardiac monitoring. NM 1 stated the unit attendant must notify the RN if the cardiac monitoring alarm sounds. The RN was then responsible for checking on the patient when the cardiac monitoring alarm sounds. NM 1 stated that some patients disconnect themselves from the cardiac monitor. However, when this occurs, the alarm should sound, prompting the RN to check on the patient. During the same interview on 12/3/2024 at 2:30 p.m., NM 1 verified that the CP 1 did not knock on the bathroom door or attempt to speak to Patient 1. NM 1 stated the purpose of the cardiac monitoring was to detect abnormal heart rhythm (irregular heartbeats). These abnormalities could only be identified when the patient was connected to the monitor. NM 1 stated that there was no way to know how long the patient (Patient 1) was off the cardiac monitor because the facility does not save the cardiac monitoring strips (records of the heart’s electrical activity). During a review of Patient 1’s EMR titled, “Emergency Documentation Flowsheet,” dated 9/11/2024 at 3:08 p.m., the Flowsheet indicated the following: Type of emergency: Cardiac arrest (when the heart stops beating). HR (heart rate): 0 beats per minute. RR (respiratory rate): 0 breaths per minute. Physical condition: Patient 1 was cool to the touch, cyanotic (skin has a bluish-purple color due to lack of oxygen), and unresponsive (did not react to stimuli). At 3:21 p.m., Patient 1 was transferred to the Pediatric Intensive Care Unit (PICU, a hospital unit providing advanced care for critical ill children). During a review of Patient 1’s “Hematology-Oncology IP Progress Note,” dated 9/14/2024, the progress note indicated, “I met with the family Thursday, September 11 ... We discussed his (Patient 1) clinical course at length. I told them: 15% of patients with SCD (sickle cell disease) sudden, unexplained death and of those, 25% are felt to be due to hard (heart) rhythm disturbances (irregular heartbeats) ...” During a review of the facility’s policy and procedure (P&P) titled, “Acute Care Nursing Assessment Documentation Standards of Practice,” dated 2/1/2024, the P&P indicated, “This Nursing Documentation Standard of Practice aims to ensure all (name of the facility) patients receive consistent and timely nursing assessments. In addition, it is to streamline nursing documentation throughout all acute care inpatient units at (name of the facility). This standard of practice specifically seeks to provide nurses with: indications for patient assessment, process/ Approach for a pediatric physical assessment, differentiation and types of assessments, Structure for assessments. Assessment is a key component in nursing practice. A nursing assessment is required to plan and provide patient-centered and family-centered care... Focused Assessment: Detailed nursing assessment of a specific body system (s) relating to the presenting patient’s problem or current concerns regarding the patient. This type of assessment may include more than one body system. This assessment can be completed by either the RN or LVN.” During a review of the facility’s policy and procedure (P&P) titled, “Cardio-Respiratory Monitoring,” dated 1/24/2024, the P&P indicated, the purpose “To provide guidelines for early detection of fundamental changes in the physiological state of the patient’s cardiac and respiratory status...Cardio-Respiratory (CR) monitoring includes heart rate/rhythm, respiratory rate/patterns, and pulse oximetry. Continuous CR monitoring is indicated for all patients whose conditions place them at risk for sudden changes and respiratory patterns that must be identified and treated...The staff member who listened to central monitor alarms will notify the patient’s assigned RN or the closest RN of the alarm situation for assessment...” During a review of the facility’s policy and procedure (P&P) titled, “Clinical Alarm Safety Management,” dated 6/12/2023, the P&P indicated the following: Monitoring and Responding to Alarms: All direct care staff are responsible to respond to alarms in their patient care area promptly and intervene, as appropriate. 2. During a review of Patient 1’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” 9/11/2024, the “H&P” indicated, Patient 1 presented to the facility’s emergency department with chief complaints of bilateral (both) arm pain for two days, sickle cell disease pain crisis (periodic episodes of extreme pain, called pain crises, are a major symptom of sickle cell anemia [when the body does not have enough healthy red blood cells that carry oxygen from the lungs to the body tissues]. Pain develops when sickle-shaped red blood cells block blood flow through tiny blood vessels to the chest, abdomen and joints), and acute (sudden and severe in onset) chest pain (pain to the chest due to reduced blood flow to the heart muscle). During a concurrent observation and interview on 12/2/2024 at 2:30 p.m. with Charge Nurse (CN) 1 in the nursing station of the 4 East (Hematology and oncology) unit, where the Cardio-Respiratory (CR) central monitor (an area in the facility that monitors multiple patients’ CR status on a monitor screen) was located. CN 1 showed how the CR central monitoring (a system displaying multiple patients’ cardio-respiratory status) works. CN 1 explained that if a patient disconnects from the monitor, the screen showed a blank line, and an alarm would sound. CN 1 stated, “When the alarm goes off, the unit attendant will call a nurse to check on the patient.” CN 1 stated this was important because the patient may have dysrhythmia (an abnormal or irregular heartbeat) or changes in vitals (such as blood pressure, pulse, breathing rate, or oxygen saturation [amount of oxygen] in the blood) outside the acceptable parameters (measurements). During a concurrent interview and record review on 12/3/2024 at 11:25 a.m. with Registered Nurse (RN) 8, Patient 1’s EMR (Electronic Medical Record, a digital version of paper charting) titled, “Cardio/Respiratory Monitor,” orders, dated 9/11/2024 at 12:55 a.m., was reviewed. The orders required continuous CR monitoring starting on 9/11/2024 at 12:55 a.m. RN 8 confirmed that the CR monitor should remain active unless discontinued by a physician’s order. RN 8 stated Patient 1 was admitted to the 4 East unit on 9/11/2024 at 12:49 a.m. for pain management and placed on a CR monitor as ordered. During a concurrent interview and record review on 12/3/2024 at 2:00 p.m. with Registered Nurse (RN) 1, Patient 1’s medical record titled, “ (Interdisciplinary Progress) Nursing Shift Comments,” dated 9/12/2024, was reviewed. The nursing shift comments indicated, “At 3:06 p.m. RN (RN 1) entered patient’s (Patient 1) room to give meds (medications). Patient (Patient 1) was still in the bathroom. RN 1 knocked on the door and called for the patient (patient 1) and patient did not respond. RN 1 called Resource RN to assist with unlocking the door. The door was unlocked, patient (Patient 1) was found unresponsive (does not react to stimuli), face down on the floor. RN called Code Blue (emergency response for cardiac [heart stops beating] or respiratory arrest [patient stops breathing]). Patient 1 had no pulse (the heart had stopped)) and no respirations (breathing). CPR (Cardiopulmonary Resuscitation, a lifesaving procedure to restore heart and breathing functions) was initiated. Patient 1 was connected to cardiac monitor and would self-disconnect to use the restroom.” During an interview on 12/3/2024 at 2:45 p.m. with the Nursing Supervisor (NS 1), NS 1 confirmed that Patient 1 was found unresponsive with an IV pole nearby. The IV pole had a tray containing a torch, a circular disc container, and a plastic pipe. During an interview on 12/3/2024 at 3:15 p.m. with Care Partner (CP) 1, CP 1 stated that after taking Patient 1’ vital signs (measure the basic functions of your body such as blood pressure, heart rate, and respiratory rate) at 12:53 p.m. on 9/11/2024, CP 1 returned to find Patient 1 in the bathroom with the IV pump alarming (inside the closed bathroom). CP 1 did not knock on the bathroom door or call out to Patient 1 but reported the situation to RN 1 before leaving for break (at 2:45 p.m.). CP 1 further stated, “The patient (Patient 1) would disconnect himself from the monitor.” CP 1 said, “The process is if they are stable, it’s okay for them to disconnect themselves (from the cardiac monitor) and go to the bathroom.” During concurrent interview and record review on 12/3/2024 at 3:25 p.m. with CP 1, Patient 1’s EMR titled, “Vital Signs,” dated 9/11/2024, was reviewed. The vital signs report indicated on 9/11/2024 at 12:53 p.m., CP 1 recorded the vitals at 4:55 p.m. for vitals taken earlier at 12:53 p.m. The recorded vitals were as follows: -Heart rate: 69 beats per minute -Respiration rate: 16 breaths per minute -Missing vitals: No blood pressure, no oxygen saturation, and no temperature were recorded. During the same interview on 12/3/2024 at 3:25 p.m., CP 1 stated there was a physician order allowing blood pressure to be omitted if the vitals had been stable over the past six hours. CP1 stated the vitals were entered late because CP 1 forgot to document them (the vital signs taken at 12:53 p.m.) earlier. CP 1 explained their usual process for recording vitals: Enter the patient’s room. Place the blood pressure cuff on the patient’s arm. Press the button on the monitor to record the vitals. CP 1 stated the vitals would then be automatically recorded with the time they were taken. CP 1 confirmed that no vitals were taken before Patient 1 disconnected from the CR monitor. During a review of Patient 1’s “Hematology-Oncology IP Progress Note,” documented by MD 1, dated 9/14/2024, the progress note indicated, “I met with the family Thursday, September 11 ... We discussed his (Patient 1) clinical course at length. I told them: 15% of patients with SCD sudden, unexplained death and of those, 25% are felt to be due to hard (heart) rhythm disturbances ...” During a review of the facility’s policy and procedure (P&P) titled, “Acute Care Nursing Assessment Documentation Standards of Practice,” dated 2/1/2024, the P&P indicated, “This Nursing Documentation Standard of Practice aims to ensure all (name of the facility) patients receive consistent and timely nursing assessments. In addition, it is to streamline nursing documentation throughout all acute care inpatient units at (name of the facility). This standard of practice specifically seeks to provide nurses with: indications for patient assessment, process/Approach for a pediatric physical assessment, differentiation and types of assessments, Structure for assessments. Assessment is a key component in nursing practice. A nursing assessment is required to plan and provide patient-centered and family-centered care... Focused Assessment: Detailed nursing assessment of a specific body system (s) relating to the presenting patient’s problem or current concerns regarding the patient. This type of assessment may include more than one body system. This assessment can be completed by either the RN or LVN.” During a review of the facility’s policy and procedure (P&P) titled, “Cardio-Respiratory Monitoring,” dated 1/24/2024, the P&P indicated, the purpose “To provide guidelines for early detection of fundamental changes in the physiological state of the patient’s cardiac and respiratory status...Cardio-Respiratory (CR) monitoring includes heart rate/rhythm, respiratory rate/patterns, and pulse oximetry. Continuous CR monitoring is indicated for all patients whose conditions place them at risk for sudden changes and respiratory patterns that must be identified and treated...The staff member who listened to central monitor alarms will notify the patient’s assigned RN or the closest RN of the alarm situation for assessment...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 46333 Based on observation, interview and record review, the facility failed to: 1. Ensure that errors made on a medical record, titled “Emergency Documentation Flowsheet,” were appropriately corrected in compliance with the facility’s policy and procedure regarding “Methods to Correct Errors in the Patient’s Medical Record,” for one of 30 sampled patients (Patient 1). This deficient practice had the potential to compromise the accuracy and reliability of the patient medical records, which may result in improper care decisions, delayed treatment, or adverse patient outcomes. 2. Ensure pain assessments were completed, in accordance with its policy and procedure regarding “Pain Management and Assessment of Pain in Infants, Children, Adolescents and Young Adults,” for two of 30 sampled patients (Patient 1 and Patient 3). Patient 1 did not receive pain assessment before and after the administration of pain medication. Patient 3’s pain was not addressed, and no reassessment of the pain was documented. These deficient practices had the potential to result in inadequate pain management, impacting comfort and care outcomes for Patient 1 and Patient 3. These deficient practices also had the potential for Patient 1 and Patient 3’s pain level to worsen which may result in psychological distress or delayed recovery. 3. Ensure one of 30 sampled patients (Patient 4), Patient 4 ‘s seizure (a sudden, uncontrolled electrical disturbance in the brain which can cause uncontrolled jerking, blank stares, and loss of consciousness) precautions (refers to safety measures taken before a patient experiences a seizure) was implemented, in accordance with the facility’s policy and procedure regarding seizure management, when Patient 4 was observed not to have four side rails padded. This deficient practice had the potential for Patient 4 to suffer from pain and injury (such as fracture [broken bones]) during a seizure activity. 4. Ensure one of six sampled staff members (Care Partner [CP] 1) completed the employee health requirements pertaining to Hepatitis B (a serious liver infection) titer test (a blood test that measures the level of antibodies [proteins that protect someone when an unwanted substance enter the body] in the blood to determine if someone is immune [means that the body is protected from future infection with the Hepatitis B virus] to the Hepatitis B virus) and the annual influenza vaccination (protects against the flu virus), in accordance with the facility’s policy and procedure regarding “Immunization Vaccination/Testing” and “seasonal vaccination.” This deficient practice had the potential for staff to become infected with a communicable disease and possibly spread of infection to patients, other staff, and visitors. 5. Ensure one of two sampled staff (Registered Nurse [RN] 7) followed the facility’s Policy and procedure regarding isolation precautions (precautions/measures intended to prevent the spread of infectious agents) when RN 7 exited a patient’s room without removing the face mask previously worn while providing care to the patient who was placed on isolation precaution. This deficient practice had the potential to spread infection to other patients on the unit, the staff, and visitors. Findings: 1. During a review of Patient 1’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 9/11/2024, the “H&P” indicated, Patient 1 presented to the facility emergency department (ED, provides immediate medical care to patients with sudden, serious illnesses or injuries) with chief complaints of bilateral (both) arm pain for two days, sickle cell disease pain crisis (periodic episodes of extreme pain, called pain crises, are a major symptom of sickle cell anemia [when the body does not have enough healthy red blood cells that carry oxygen from the lungs to the body tissues]. Pain develops when sickle-shaped red blood cells block blood flow through tiny blood vessels to the chest, abdomen and joints), and acute (sudden and severe in onset) chest pain (pain to the chest due to reduced blood flow to the heart muscle). During a concurrent interview and record review on 12/3/2024 at 11:30 a.m. with Registered Nurse (RN) 8, Patient 1’s paper form “Emergency Documentation Flowsheet (a form documenting resuscitation [an emergency lifesaving procedure performed] efforts and tracks vital information during emergency situations),” dated 9/11/2024, was reviewed. The flowsheet indicated the following: -An entry was marked with an “X.” after the time entry of 3:12 p.m. indicating, “Placed on Defibrillator (devices that apply an electric charge or current to the heart to restore a normal heartbeat).” -The time entered for the administration of the first dose of epinephrine (the drug administered to increase coronary perfusion [blood flow within the heart] during resuscitation) was written on top of an earlier entry (the second written time was scribbled over or superimposed on a previous written time), rendering both times that was entered for the administration of the first dose of epinephrine illegible (difficult to read and determine the correct administration time). During the same interview on 12/3/2024 at 11:30 a.m., RN 8 stated that the correct method for correcting errors on a paper medical record, in accordance with the facility’s policy, was to: Draw a single line through the error. Write “error” above the incorrect entry. Include the name of the individual making the correction and the date. RN 8 confirmed that the corrections made on the flowsheet did not follow this method, resulting in unclear documentation. During a review of the facility’s policy and procedure (P&P) titled, “Methods to Correct Errors in the Patient’s Medical Record,” dated 4/25/2024, the P&P indicated, “In order to preserve the quality and the integrity of the patient medical record, electronic and paper, errors and corrections in the record are to be handled in the following manner. Paper Record Corrections: If error is made on a paper document: Draw a line through the information in error. Write error clearly above or below the statement. Clearly write your name and the date ...” 2.a. During a review of Patient 1’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 9/11/2024, the “H&P” indicated, Patient 1 presented to the facility’s emergency department with chief complaints of bilateral (both) arm pain for two days, sickle cell disease pain crisis (periodic episodes of extreme pain, called pain crises, are a major symptom of sickle cell anemia [when the body does not have enough healthy red blood cells that carry oxygen from the lungs to the body tissues]. Pain develops when sickle-shaped red blood cells block blood flow through tiny blood vessels to the chest, abdomen and joints), and acute (sudden and severe in onset) chest pain (pain to the chest due to reduced blood flow to the heart muscle). During a concurrent interview and record review on 12/5/2024 at 9:10 a.m. with the Clinic Practice Leader (CLP) 1, Patient 1’s Electronic Medical Record (EMR, a digital version of the paper charts in hospitals) titled, “Medication Administration Record (MAR, a report detailing the drugs administered to the patient),” dated 9/10/2024 at 8:50 p.m., was reviewed. The MAR indicated on 9/10/2024 at 8:50 p.m. Patient 1 was administered hydromorphone (a prescribed medication used to treat moderate to severe pain). The dosage was 1 mg (milligram, a unit of measurement), IV (intravenous, administered into the vein) as a one-time dose. During a concurrent interview and record review on 12/5/2024 at 9:12 a.m. with CLP 1, Patient 1’s EMR titled, “Pain Assessment Pediatric,” dated 9/10/2024, and “ED Nursing Note,” dated 9/10/24, were reviewed. CLP 1 confirmed there was no documentation of pain reassessment after pain medication administration. Hydromorphone was administered at 8:50 p.m. on 9/10/2024. CLP 1 stated, “After pain medication is administered, the patient’s pain should be reassessed within an hour.” During a concurrent interview and record review on 12/5/2024 at 9:16 a.m. with CLP 1, Patient 1’s EMR titled, “Medication Administration Record (MAR),” dated 9/10/2024 at 9:35 p.m., was reviewed. The MAR indicated on 9/10/2024 at 9:35 p.m. Patient 1 was administered hydromorphone, 1 mg dosage. During a concurrent interview and record review on 12/5/2024 at 9:19 a.m. with CLP 1, Patient 1’s EMR titled, “Pain Assessment Pediatric,” dated 9/10/2024, and “ED Nursing Note,” dated 9/10/2024, were reviewed. CLP 1 confirmed there was no documentation of pain reassessment after pain medication administration. Hydromorphone was administered on 9/10/2024 at 9:35 p.m. CLP 1 stated, “Pre-administration and post-pain administration should be reassessed for pain.” During a concurrent interview and record review on 12/5/2024 at 9:20 a.m. with CLP 1, Patient 1’s EMR titled, “Medication Administration Record (MAR),” dated 9/10/2024 at 11:04 p.m., was reviewed. The MAR indicated on 9/10/2024 at 11:04 p.m. Patient 1 was administered hydromorphone, 1 mg dosage. During a concurrent interview and record review on 12/5/2024 at 9:22 a.m. with CLP 1, Patient 1’s EMR titled, “Pain Assessment Pediatric,” dated 9/10/2024, and “ED Nursing Note,” dated 9/10/2024 were reviewed. CLP 1 confirmed there was no documentation of pain reassessment prior to the administration of hydromorphone on 9/10/2024 at 11:04 p.m. CLP 1 confirmed that the patient’s pain should be assessed and documented prior to the administration of a pain medication. During a review of the facility’s policy and procedure (P&P) titled, “Pain Management and Assessment of Pain in Infants, Children, Adolescents and Young Adults,” dated7/7/2021, the P&P indicated, “To establish guidelines for consistent, developmentally appropriate, and accurate assessment of pain. To provide adequate pain management to patients at (name of the facility). It is the obligation of every health care provider (HCP) at (name of the facility) to anticipate, relieve, minimize, or avoid pain for all of our patients ... It is our goal to provide comfort and alleviate fear for all of our patients regardless of age ...Accurate assessment is acknowledged as the foundation for adequate pain management ...Interventions for the management of pain will be multi-dimensional, taking into consideration developmental, cultural and environmental factors, and may include both pharmacologic and nonpharmacologic therapies/interventions. Interventions are strongly encouraged for any patient reporting or demonstrating pain. Pre and Post assessment of pain will be evaluated within 1 hour of any pharmacologic or nonpharmacologic intervention. interventions are then modified accordingly, in collaboration with the medical staff. The goal is that pain relief is optimized, and side effects are minimized.” 2.b. During a review of Patient 3’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 12/1/2024, the “H&P” indicated that Patient 3 was admitted with a history of Glanzmann’s thrombasthenia (a rare inherited blood clotting disorder) who presents with left ankle pain after rolling his (Patient 3) ankle yesterday. He (Patient 3) jumped off a curb yesterday evening and landed with his ankle inverted. He heard a pop and immediately began to have pain. The ankle was more swollen yesterday but started to resolve. Pain currently is a 3/10 at rest, but when he attempts to walk or place pressure on his left foot, he states the pain is 10/10.” During a concurrent interview and record review on 12/5/2024 at 2:30 p.m. with Clinic Practice Leader (CLP) 3, Patient 3’s Electronic Medical Record (EMR), titled “Pain Assessment Pediatric,” flowsheet dated 12/1/2024, was reviewed. The flowsheet indicated the following pain ratings for Patient 3 using the Faces Pain Rating Scale (a tool that shows a series of faces ranging from a happy face at 0, or “no hurt,” to a crying face at 10, which represents “hurts like the worst pain imaginable)”: -At 2:26 p.m., Patient 3’s pain was at 4. -At 4:09 p.m., Patient 3’s pain was at 2. -At 8:00 p.m., Patient 3’s pain was at 2. CLP 3 confirmed there was no documentation indicating that Patient 3’s pain at 2:26 p.m., 4:09 p.m., or 8:00 p.m., was addressed or reassessed. Under the section titled “Nonpharmacological Therapy (management of pain without medications),” CLP 3 showed that no interventions were documented. Similarly, under “Pharmacological Therapy (treatment of pain with medication),” CLP 3 confirmed that no medication was administered for any of the three times when Patient 3 reported pain. CLP 3 confirmed that Patient 3’s pain was not addressed, and no reassessment was documented. During a concurrent interview and record review on 12/5/2024 at 2:35 p.m. with CLP 3, Patient 3’s “Medication Administration Record (MAR),” dated 12/1/2024, was reviewed. The MAR indicated there was a PRN (as needed) order for acetaminophen (Tylenol, a pain reliever and fever reducer) 650 mg (milligrams, a unit of measurement) PO (oral), Q4H (every 4 hours), tablet for pain or temperature. CLP 3 stated, “The Tylenol was not given.” During a review of the facility’s policy and procedure (P&P) titled, “Pain Management and Assessment of Pain in Infants, Children, Adolescents and Young Adults,” dated7/7/2021, the P&P indicated, “To establish guidelines for consistent, developmentally appropriate, and accurate assessment of pain. To provide adequate pain management to patients at (name of the facility). It is the obligation of every health care provider (HCP) at (name of the facility) to anticipate, relieve, minimize, or avoid pain for all of our patients ... It is our goal to provide comfort and alleviate fear for all of our patients regardless of age ...Accurate assessment is acknowledged as the foundation for adequate pain management ...Interventions for the management of pain will be multi-dimensional, taking into consideration developmental, cultural and environmental factors, and may include both pharmacologic and nonpharmacologic therapies/interventions. Interventions are strongly encouraged for any patient reporting or demonstrating pain. Pre and Post assessment of pain will be evaluated within 1 hour of any pharmacologic or nonpharmacologic intervention. interventions are then modified accordingly, in collaboration with the medical staff. The goal is that pain relief is optimized, and side effects are minimized ...Documentation serves as objective evidence of the management of pain.” During a review of the facility’s policy and procedure (P&P) titled, “Acute Care Nursing Assessment Documentation Standards of Practice” dated 2/1/2024, the P&P indicated, “This Nursing Documentation Standard of Practice aims to ensure all (name of the facility) patients receive consistent and timely nursing assessments ... Assessment is a key component in nursing practice. A nursing assessment is required to plan and provide patient-centered and family-centered care ... Focused Assessment: Detailed nursing assessment of a specific body system (s) relating to the presenting patient’s problem or current concerns regarding the patient. This type of assessment may include more than one body system ... After the initial shift assessment, only document a focused assessment of your patient when ordered, when performing interventions, responses to care, or when acute changes occur ... Assessment information includes, but is not limited to: Vitals signs, pain ...” 3. During a review of Patient 4’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 11/16/2024, the “H&P” indicated, “Pt (Patient 4) was dc’d (discharge from the facility) today to (name of receiving facility) with our transport team. En route had multiple seizures (a sudden, uncontrolled electrical disturbance in the brain which can cause uncontrolled jerking, blank stares, and loss of consciousness) ...Last seizures 1850 (6:50 p.m.) lasting 20 sec (seconds).” The H&P further indicated the Patient 4 was five years old with quadriplegic cerebral palsy (congenital condition that impaired movement to all four limbs), symptomatic epilepsy (a brain condition that causes recurring uncontrolled jerking [seizures]), chronic respiratory failure (a condition that occurs when the lungs cannot get enough oxygen into the blood), trach (tube inserted into the windpipe to aid in breathing)/vent (ventilator, a device that supports or takes over the breathing process) dependence, G-tube (a gastrostomy tube, inserted through the belly that brings nutrition directly to the stomach) dependence ...” During a concurrent observation and interview on 12/2/2024 at 3:35 p.m. with Nursing Supervisor (NS) 1 in Patient 4’s room, Patient 4 was sleeping in a crib with no padding on the side rails. NS 1 stated Patient 1 was admitted to the facility due to having seizures. NS 1 stated the siderails should be padded as part of the prevention for injury to the patient who have seizures or have history of seizures. NS 1 stated nursing should pad the bedrails, it does not require a physician’s order to pad the bedrail. NS 1 stated an IPOC (Interdisciplinary Plan of Care, care plans that are customized to meet the patients care needs) for seizure precautions should be initiated by nursing, which includes padding the bed rails. During a concurrent interview and record review on 12/5/2024 at 1:15 p.m. with Clinic Practice Leader (CPL) 2, Patient 4’s EMR titled, “IPOC,” dated 12/4/2024, was reviewed. The IPOC indicated, “Intervention: Implement seizure precaution measures, outcomes: will not sustain injury secondary to seizure.” CPL 2 confirmed that part of the seizures precaution measures was to pad the bed rails. During a concurrent interview and record review on 12/5/2024 at 1:15 p.m. with Clinic Practice Leader (CPL) 2, Patient 4’s EMR titled, “Shift Activity,” dated 12/2/2024, was reviewed. The shift activity indicated, on 12/2/2024, there was no documentation of seizure precautions being implemented. CPL 2 stated, “If the nurse has started padding the side rails, it will be documented here.” During a review of the facility’s policy and procedure (P&P) titled, “Seizure Precautions/Care of the Patient with Seizures,” dated 9/27/2024, the P&P indicated, “To provide a safe environment for patients who have a neurological condition which may precipitate a seizure. Side rails must be kept raised whenever patient is in the bed or crib. Pad side rails if the patient has history of seizures ...Equipment: Bed or crib with side rails. Pads for side rails if over 1 yo (year old) ...” 4. During a concurrent interview and record review on 12/5/2024 at 9:33 a.m. with the Registered Nurse for Employee Health Services (RNEHS) and the Employee Health Services Manager (EHSM), Care Partner (CP) 1’s personnel file, was reviewed. The RNEHS and the EHSM stated the following: CP 1 was hired on 9/8/2008. CP 1 had completed the Hepatitis B vaccination series (series of two or three shots depending on the vaccine brand) on 9/2/2008 and was scheduled to return on 10/14/2008 for a Hepatitis B (a serious liver infection) titer test (a laboratory test that measures the level of antibodies [proteins that protect you when an unwanted substance enters your body] in a blood sample). CP 1 never showed up to check the Hepatitis B titer. Employee Health Services (EHS, address immunization status and health needs of employees) sent two emails to CP 1 to remind CP 1 to check her titer, on 10/21/2008 and 11/6/2008. CP 1 did not go back to EHS to check the Hepatitis B titer and EHS did not follow up any further. During the same interview on 12/5/2024 at 9:33 a.m., EHSM said CP 1 had not yet received the annual influenza (a common, sometimes deadly virus infection of the nose, throat, and lungs) vaccine or signed a request for exemption of vaccination for the current year 2024. The EHSM stated that staff who were non-compliant with employee health requirements should be suspended until they are up to date with all employee health requirements. The EHSM stated CP 1 continued to work and had not been suspended since the non-compliance began on 10/14/2008. The EHSM said the facility did not have a tracking system to identify staff who were non-compliant with employee health requirements. The EHSM stated it was important to comply with all employee health requirements to help prevent the spread of infectious diseases among staff and patients. During a review of CP 1’s “Immunization Record,” the Record indicated CP 1 received the Hepatitis B Vaccine on 8/17/1998 and 8/24/2000. During a review of the Hospital’s document titled, “Consent for Administration of Hepatitis B Vaccine,” the Consent indicated CP 1 received a Hepatitis B Vaccine at this Hospital on 9/2/2008. The document also indicated that on 10/14/2008, CP 1 was to have a planned blood draw for Hepatitis B titer. In addition, the document also indicated two emails were sent to CP 1 on 10/21/2008 and 11/6/2008 to return to EHS. During the review of the facility’s undated “Standardized Procedure,” titled, “Immunization Administration/Testing,” the Standardized Procedure indicated the following: Medical surveillance of employees shall be performed by Employee Health Services (EHS) as required by federal state laws and regulations. EHS screens Hospital employees and affiliates deemed necessary to mitigate exposure to contagious diseases ... that may pose a health and safety risk to patients and others within the facility ...Hepatitis B Vaccine Series: Administer 3 doses. Draw lab titer 30 days after the last dose. During a review of the facility’s policy and procedure (P&P) titled, “Seasonal Team Member Vaccination Policy,” dated 5/22/2024, the P&P indicated the following: Purpose: To protect patient, team members, family members, and the community from key respiratory viruses including seasonal influenza infection ...through annual immunization of all personnel subject to this policy. To comply with California Department of Public Health mandates and the Los Angeles County Department of Public Health Officer Order mandating healthcare worker vaccination ...Vaccination: As a condition of employment/performing services at the Hospital, Hospital team members must either: (a) be vaccinated and submit proof of influenza ...or (b) submit a request for accommodation / exemption from the vaccination mandates by no later than November 1st each year. Disciplinary Consequences for Non-Compliance: Failure to comply with vaccination or exemption requirements ...will result in the following: (a) For the first instance of non-compliance, the Hospital employee’s badge will be shut off until they are in compliance. (b) If non-compliance continues into the 2nd week, the Hospital employee will receive a verbal warning. (c) If non-compliance continues into a 3rd week, the Hospital employee will receive a written warning. (d) If non-compliance continues into a 4th week, the Hospital employee will receive a final written warning and suspension without pay. (e) Non-compliance for five weeks will result in the Hospital employee’s termination for violation of this policy. 5. During an observation and interview on 12/2/2024 at 4:00 p.m., on 5 East (Medical Surgical Unit), with Nurse Manager (NM) 2, Patient 18’s door was open. Registered Nurse (RN) 7 was observed removing gown and gloves while inside Patient 18’s room. RN 7 did not remove face mask, exited Patient 18’s room, and applied alcohol hand sanitizer. A sign was posted outside Patient 18’s room titled,” Combined-Droplet Precautions (precautions taken by a facility when a patient has an infection with germs that can be spread to others by speaking, sneezing, or coughing).” NM 2 and RN 7 were asked if the face mask should be removed when exiting Patien18’s room. RN 7 stated the face mask should have been removed when exiting Patient 18’s room. During an interview on 12/4/2024 at 1:35 p.m. with the Manager of Infection Prevention & Control for Quality Improvement (MIPCQI), the MIPCQI confirmed all PPE (Personal Protective Equipment- specialized clothing or equipment that protects staff or the spread of infection or illness in a hospital), gown, gloves, and mask should be removed before exiting a Patient room to prevent possible spread of infection to other Patients. During a review of the facility’s Policy and Procedure (P&P) titled, “Isolation Precautions,” dated 11/1/2023, the P&P indicated the following: combined droplet precautions (precautions taken by a facility when a patient has an infection with germs that can be spread to others by speaking, sneezing, or coughing) “are required for patients with known or suspected illness transmitted by large particle droplets. Examples included influenza (an infection of the nose, throat, and lungs), RSV (Respiratory Syncytial Virus, a common virus that infects the respiratory tract and lungs, Pertussis (a highly contagious bacterial infection that affects the respiratory system) ...” Personal Protective Equipment required: included “Surgical mask, gown and gloves...” During a review of an undated document titled “COVID-19 (respiratory illness caused by a highly infectious virus) Information Center Safety Practices, Personal Protective Equipment (PPE),” the document indicated the following: Medical mask/N95 respirator (a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles) use in Patient care: for “single Use” applies to Combined Droplet Precautions. “Discard your medical mask or N95 respirator upon leaving the patient room or after care of patients and combined droplet precautions.””

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 36206 Based on observation, interview and record review, the facility failed to ensure the Condition of Participation for Patient Rights was met as evidenced by: 1. The facility failed to ensure the Notice of Patient Rights (a document that informs patients of their rights and responsibilities in the healthcare system such as how patients can participate in decisions about their healthcare) included the correct contact information of the regulatory agency for 30 of 30 sampled patients or patient representatives to call to make a complaint. This deficient practice had the potential for the inability of patients or patient representatives to contact the regulatory agency to make a complaint which may result in inaccurate or delayed diagnosis, and preventable harm or injury to the patient. (Refer to A-0117) 2. The facility failed to use an interpreter (facilitates communication between healthcare providers and non?English speaking patients to provide the best possible quality of care) when obtaining informed consent (the process in which a healthcare provider educates a patient about the risks, benefits and alternatives, of a given procedure or intervention) for one of 30 sampled patients (Patient 11), in accordance with the facility’s policy and procedure regarding informed consent. This deficient practice had the potential for Patient 11 not receiving accurate and current information in the language Patient 11 could understand which may result in Patient 11 not understanding information regarding her (Patient 11) health status and treatment and may delay recovery from illness. (Refer to A-0131) 3. The facility failed to provide information about the condition of admission (COA - a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.) and responsibilities upon admission, including the patient’s right to make informed decisions regarding their care for three of 30 sampled patients (Patient 16, Patient 15, and Patient 13, who are considered as minors [a patient younger than 18 years old except individuals from 16 to 18 years old who have been emancipated by court]) or patient representatives, in accordance with the facility’s policy and procedure regarding admitting patients into the facility, when: 3.a. A documented blood transfusion informed consent provided in the patient’s and patient representative’s preferred language of Spanish was not completed for Patient 16. 3.b. A documented COA provided in the patient’s and patient representative’s preferred language of Mandarin was not completed for Patient 15. 3.c. A documented COA was not completed for Patient 13. These deficient practices resulted in Patient 13, Patient 15, and Patient 16, including their representatives (patient representatives) not being able to fully understand and exercise their rights as patients, as well as their responsibilities regarding billing and financial responsibility during hospitalization, which could have negatively affected the patients’ right to be involved in their own care and treatment in the facility. (Refer to A-0131) 4. The facility failed to ensure safety for patients at risk for fall (an unintentional event that results in the person coming to rest on the ground or another lower level), when using a highchair, for one of 30 sampled patients (Patient 23), per manufacturer’s instructions regarding highchair use, when Patient 23 was left unattended in a highchair (a seat raised a far distance from the ground). This deficient practice had the potential to result in Patient 23 falling off from the highchair and sustain injury such as fracture (broken bone). (Refer to A-0144) 5. The facility failed to ensure two of five sampled emergency crash carts (carts that store emergency medical equipment and medications) were inspected and verified for readiness, according to the facility’s protocol on emergency carts’ maintenance and readiness. This deficient practice had the potential to delay emergency patient care during an unexpected event requiring emergency crash cart use, due to the emergency crash cart equipment not being inspected and verified for availability and proper function, which could result in patient harm and/or death. (Refer to A-0144) 6. The facility failed to ensure patient protected health information (PHI - private identifiable patient information) was safeguarded and secured against unauthorized use for two of 30 sampled patients (Patient 18 and Patient 20), when Patient 18’s and Patient 20’s individual identification sticker labels containing their PHI were left affixed onto a workstation on wheels (WOW - a mobile computer workstation used for clinical record documentation), accessible and visible to anyone accessing the unit hallway, including visitors and staff members. This deficient practice had the potential for unauthorized individuals to access and misuse these patients’ PHI and compromise the confidentiality that was expected for these patients as they received care in the facility. (Refer to A-0146) 7. The facility failed to ensure nursing staff initiated and developed a restraint (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) care plan (provides a framework for evaluating and providing patient care needs related to the nursing process) upon restraints initiation, in accordance with the facility’s policy and procedure regarding restraints, for three of 30 sampled patients (Patients 21, 23 and 28) when the restraint care plan was initiated: 1. on 7/27/2024, two (2) days after Patient 21 was placed on mitten (a soft, padded gloves that covers a patient’s hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraints) 2. on 8/14/2024, 14 days after Patient 23 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed) 3. on 8/18/2024, four (4) days after Patient 28 was placed in an enclosed bed This deficient practice had the potential to result in unnecessary restraints use for Patients 21, 23 and 28 as there was no care plan developed for nursing staff to monitor progress and evaluate restraints use. This deficient practice also had the potential to result in complications of restraints use such as skin integrity issues, etc. (Refer to A-0166) 8. The facility failed to ensure there was a restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) renewal order from the qualified licensed practitioner (QLP, any individual permitted by state law and organization policy to order restraints and seclusion for patients), in accordance with the facility’s policy and procedures regarding restraints, for two of 30 sampled patients (Patients 21 and 23), who were both placed in restraints when: 1. Patient 21 had mitten (a soft, padded gloves that covers a patient’s hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraints. 2. Patient 23 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed). This deficient practice had the potential to result in unnecessary restraints use as Patients 21 and Patient 23 were not being evaluated by the providers for the need of continued use of restraints. This deficient practice also had the potential to result in complications regarding restraints use such as skin breakdown (damage to the skin), etc. (Refer to A-0168) 9. The facility failed to ensure staff performed ongoing assessment, monitoring and documentation of restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) use, every two (2) hours for 14 hours, for one of 30 sampled patients (Patient 28), in accordance with the facility’s policy and procedure regarding restraints, when Patient 28 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed). This deficient practice had the potential to result in Patient 28’s needs not being met and not being monitored while in the enclosed bed. (Refer to A-0175) 10. The facility failed to ensure nursing staff demonstrated satisfactory restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) application competency (ability to perform skilled learned) during onboarding in accordance with the facility’s policy and procedure regarding restraints training, when one of one sampled Registered Nurse competency record (RN 8), did not have a restraints competency record. This deficient practice had the potential to result in RN 8 not being monitored and evaluated for restraints application skills, monitoring and assessment of patients while on restraints, which may put patients at risk for harm due to improper restraints use. (Refer to A-0196) The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality healthcare in a safe environment and placing patients for patient’s rights violations, such as right to confidentiality, right to be informed of patient’s health status, and right to be free from restraints.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 36206 Based on observation, interview, and record review, the facility failed to ensure the Notice of Patient Rights (a document that informs patients of their rights and responsibilities in the healthcare system such as how patients can participate in decisions about their healthcare) included the correct contact information of the regulatory agency for 30 of 30 sampled patients or patient representatives to call to make a complaint. This deficient practice had the potential for the inability of patients or patient representatives to contact the regulatory agency to make a complaint which may result in inaccurate or delayed diagnosis, and preventable harm or injury to the patient. Findings: During a tour on 8/19/2024 at 1:17 p.m. with the Quality Coordinator (QC 2), the Patient Rights (a subset of human rights such as the right to considerate and respectful care) posting was observed in the Admitting Area (area of the hospital where patients are admitted). The Patient Rights posting indicated a telephone number to contact the regulatory agency (responsible for protecting the public’s health and safety). The telephone number was dialed in the presence of QC 2. The telephone number was not working. During a concurrent interview on 8/19/2024 at 1:17 p.m., QC 2 verified that the telephone number to the regulatory agency was incorrect and not working. QC 2 stated the facility would check and ensure to include the correct number. During an interview on 8/19/2024 at 3:25 p.m. with the Interim Manager of the Nursing Office (IMNO), the IMNO stated that the correct telephone of the regulatory agency should be available in case patients or patient representatives wish to make a complaint. During a review of the facility’s policy and procedure titled, “Patient and Family Rights and Responsibilities,” dated 2/27/2024, the P&P indicated the following: Patients have a right to ...File a complaint with the California Department of Public Health (regulatory agency) regardless of whether the hospital’s grievance (a formal or informal complaint about a patient’s care, treatment or mistreatment) process was used.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 48186 Based on interview and record review, the facility failed to: 1. Use an interpreter (facilitates communication between healthcare providers and non?English speaking patients to provide the best possible quality of care) when obtaining informed consent (the process in which a healthcare provider educates a patient about the risks, benefits and alternatives, of a given procedure or intervention) for one of 30 sampled patients (Patient 11), in accordance with the facility’s policy and procedure regarding informed consent. This deficient practice had the potential for Patient 11 not receiving accurate and current information in the language Patient 11 could understand which may result in Patient 11 not understanding information regarding her (Patient 11) health status and treatment and may delay recovery from illness. 2. Provide information about the condition of admission (COA - a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.) and responsibilities upon admission, including the patient’s right to make informed decisions regarding their care for three of 30 sampled patients (Patient 16, Patient 15, and Patient 13, who are considered as minors [a patient younger than 18 years old except individuals from 16 to 18 years old who have been emancipated by court]) or patient representatives, in accordance with the facility’s policy and procedure regarding admitting patients into the facility, when: 2.a. A documented blood transfusion (the process of receiving blood or blood products intravenously [through the vein]) informed consent provided in the patient’s and patient representative’s preferred language of Spanish was not completed for Patient 16. 2.b. A documented COA provided in the patient’s and patient representative’s preferred language of Mandarin was not completed for Patient 15. 2.c. A documented COA was not completed for Patient 13. These deficient practices resulted in Patient 13, Patient 15, and Patient 16, including their representatives (patient representatives) not being able to fully understand and exercise their rights as patients, as well as their responsibilities regarding billing and financial responsibility during hospitalization, which could have negatively affected the patients’ right to be involved in their own care and treatment in the facility. Findings: 1. During a review of Patient 11’s History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 8/11/2024 at 1:14 p.m., the H&P indicated the following: Patient 11 had a past medical history (PMH) of Pre-B-cell acute lymphoblastic leukemia (ALL, a fast growing blood cancer that occurs when the bone marrow [a soft, spongy tissue in the center of the bone] produces too many immature white blood cells [helps the body fight infection]). Patient had diagnosis of Pre-B-cell acute lymphoblastic leukemia, fever, and a viral infection (an illness caused by a virus, a small germ that uses a body’s cells to reproduce). During a review of Patient 11’s Face Sheet, the Face Sheet indicated Patient 11 was admitted to the facility on 8/11/2024 at 12:13 p.m. During a review of Patient 11’s medical record titled, “Learning Care Needs Assessment,” dated 8/11/2024 at 1:22 p.m., the medical record indicated, Patient 11’s preferred language was Spanish. During a review of Patient 11’s medical record titled, “Verification of Consent for Blood Transfusion (the process of receiving blood or blood products intravenously [through the vein]),” dated 8/12/2024, the medical record indicated, Patient 11’s Mother signed the informed consent (the process in which a healthcare provider educates a patient about the risks, benefits and alternatives, of a given procedure or intervention) for blood transfusion on 8/12/2024 at 8:41 a.m., but there was no documentation for use of an interpreter (facilitates communication between healthcare providers and non?English speaking patients to provide the best possible quality of care) when the informed consent was obtained. During a review of Patient 11’s medical record titled, “Practitioner’s Statement for Informed Consent,” dated 8/12/2024 at 8:43 a.m., the medical record indicated, Patient 11’s Practitioner signed that risks for the blood transfusion were discussed, but there was no documentation for use of an interpreter (facilitates communication between healthcare providers and non?English speaking patients to provide the best possible quality of care). During a concurrent interview and record review on 8/11/2024 at 1:14 p.m. with the Manager of Patient Safety Team (MPS), Patient 11’s medical records titled, “ Verification of Consent for Blood Transfusion,” dated 8/12/2024 and “Practitioner’s Statement for Informed Consent,” dated 8/12/2024, were reviewed. The medical record indicated, the Practitioner did not document using an interpreter for both medical records (Verification of Consent for Blood Transfusion and the Practitioner’s Statement for Informed Consent). The MPS stated the Practitioner should have provided a Spanish interpreter for non?English speaking patients and the interpreter should have documented their name, signature, date & time on the blood consent or the name of the person who acted as the interpreter should have been documented in the patient’s medical record, but this was not documented. The MPS verified the blood consent form was in English, instead of Spanish. The MPS stated the following: Consents should be obtained per policy. It is important to use an interpreter so the patient or parent/guardian can understand what they are consenting for. The consent form should also be provided in a language the patient or parent/guardian can read. During a review of the facility’s policy and procedure (P&P) titled, “Informed Consent,” dated 10/4/2023, the P&P indicated the following: “Policy: I. When Informed Consent is Required: ...B. Procedures that Require Special Consents: Informed Consent will be obtained as required by law, and consistent with special legal requirements set forth in California or federal law, in situations including but not limited to: i. Blood transfusion ... III. Procedure for Obtaining and Documenting Informed Consent ... F. Interpreters: i. Patients and/ or their legal representatives must be able to understand what they are being asked to authorize, whether it is an agreement to general terms and conditions of hospitalization or to give Informed Consent for a surgical or other procedure. If there is a communication barrier [the facility] will arrange for communication in a language or mode that can be understood by the patient or surrogate decision-maker ... iii. A person providing interpretation services to assist with obtaining Informed Consent shall indicate the date and time the interpretation services were provided on the “Interpreter Certification” portion of the Verification Form for Consent to Surgery or Special Diagnostic or Therapeutic Procedures ...” During a review of the facility’s policy and procedure (P&P) titled, “Patient and Family Rights and Responsibilities,” dated 2/27/2024, the P&P indicated the following: “ ...Procedure: Patients have the right to: (4) Receive information about their health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms and in a language (including sign language for the hard of hearing) the patient can understand ...” During a review of the facility’s policy and procedure (P&P) titled, “Communication Assistance,” dated 6/29/2023, the P&P indicated the following: “I. Oral Interpreting Services and/or Assistive Devices: A. All patients/ families with limited English proficiency (LEP) ...shall be advised of their right to receive healthcare information in a manner that meets the patient’s needs, either directly in their primary spoken language, through a qualified interpreter ...” 2.a. During a review of Patient 16’s “Face Sheet (a document containing a patient’s medical and demographic information),” (undated), the “Face Sheet” indicated, Patient 16 was admitted to the facility on 8/2/2024 at 11:27 p.m., with a medical diagnosis of severe metabolic acidosis (a condition where there is too much acid in the body’s fluid). During a concurrent interview and record review on 8/20/2024 at 2:40 p.m. with the Registered Nurse Specialist (RNS), the Clinical Informatics/Kid Specialist (CKS), and the Senior Clinical Informatics (CSI), Patient 16’s “Learning and Care Needs Assessment,” collected from Patient 16’s EHR (Electronic health Record, a digital version of paper chart), dated 8/2/2024 through 8/20/2024, was reviewed. The “Learning and Care Needs Assessment” indicated, Patient 16’s preferred parents’ language was Spanish. Patient 16’s “Verification of Consent for Blood Transfusion (the process of receiving blood or blood products intravenously [through the vein]),” dated 8/3/2024, was also reviewed. The “Verification of Consent for Blood Transfusion” document was printed in English (Patient 11’s parents’ preferred language was Spanish), with the name and identification number of the interpreter documented. Upon requesting a copy of the informed consent printed in Spanish within Patient 16’s EHR, the RNS and the CKS stated they were unable to locate one for Patient 16. The RNS and the CKS further stated, they were not aware of an informed consent policy regarding patients being provided with informed consents in their own language. During an interview on 8/21/2024 at 9:20 a.m. with the Registered Nurse Supervisor of the Clinical Neonatal Intensive Care Unit (RNCN), regarding the facility’s process of obtaining informed consent from a non-English speaking patient, the RNCN stated, the physician usually used an iPad for translation services and nurses would witness the encounter. The RNCN was unsure if two consents were signed in English and in the patient’s preferred language (Spanish). The RNCN stated, they have seen consent forms printed in other languages, including Spanish. The RNCN further stated, patients needed to understand what they were signing, and nurses needed to be re-educated regarding this facility policy. During a concurrent interview and record review on 8/21/2024 at 10:37 a.m. with the Chief Patient Safety Officer/Attending Critical Care Medical Doctor (CPSO), Patient 16’s Spanish-printed “Verification of Consent for Blood Transfusion,” was requested for review. The CPSO reviewed Patient 16’s EHR and stated they were unable to locate a documented Spanish-printed blood transfusion informed consent for Patient 16. Regarding the process of obtaining informed consent from a non-English speaking patient, the CPSO stated, they were expected to request an interpreter (ensure that patients and medical staff can communicate clearly and accurately, which is vital for patient safety), explain the procedure and treatment to the patient through the applicable interpreter, have the nurse witness the encounter, and the informed consent form would be printed in the patient’s preferred language. The CPSO further stated, if the form was not in the patient’s preferred language, then the culture department would be contacted for assistance. During a review of the facility’s policy and procedure (P&P) titled, “Informed Consent,” revised October 2023, the P&P indicated, “Patients and/or their legal representatives must be able to understand what they are being asked to authorize, whether it is an agreement to general terms and conditions of hospitalization or to give Informed Consent for Surgical or other procedure. If a non-English version of the Verification Form for Consent to Surgery or Special Diagnostic or Therapeutic Procedure is used to obtain Informed Consent, the Treating Practitioner or Authorized Designee must ensure that the name of the treatment or procedure to be performed is written in English as well as the language that the patient/legal representative speaks. During a review of the facility’s policy and procedure (P&P) titled, “Patient and Family Rights and Responsibilities,” revised in February 2024, the P&P indicated, “Patient rights should be promoted and protected by all hospital and medical staff. [ ...] For families who do not read or understand English or Spanish or who are deaf or hard of hearing an interpreter speaking the language they understand should be procured in compliance with Hospital policies and procedures.” 2.b. During a review of Patient 15’s “Face Sheet (a document containing a patient’s medical and demographic information),” (undated), the “Face Sheet” indicated, Patient 15 was admitted to the facility on 7/9/2024 at 5:25 p.m., with a medical diagnosis of congenital diaphragmatic hernia (a hole in the diaphragm [muscle that separates chest from stomach] that allows stomach organs to move into the chest during fetal [unborn baby] development, which can crowd the heart and lungs). Patient 15’s “Face Sheet” further indicated, Patient 15’s parent’s preferred language was Mandarin. During a concurrent interview and record review on 8/20/2024 at 3:14 p.m. with the Registered Nurse Specialist (RNS), the Clinical Informatics/Kid Specialist (CKS), and the Clinical Senior Informatics (CSI), Patient 15’s electronic health record (EHR - a digital version of paper chart), dated 7/9/2024 through 8/20/2024, was reviewed. The EHR indicated, Patient 15’s family’s preferred language was Mandarin. The CKS stated, admitting staff used a system to document a patient’s language and initiate their admission document process. Patient 15’s Condition of Admission (COA, a contract between the hospital and patient regarding treatment, payment for services rendered by the facility, etc.) documentation was signed on 7/11/2024 at 11:32 a.m. in English, with no interpreter (ensure that patients and medical staff can communicate clearly and accurately, which is vital for patient safety) use documented. The CKS further stated, no documentation was available to indicate an interpreter assisted Patient 15’s family to complete their COA documentation for Patient 15. During a concurrent interview and record review on 8/21/2024 at 9:06 a.m. with Supervisor Patient Access Revenue 1 (SPA 1) and the Supervisor Patient Access Revenue 2 (SPA 2), SPA 2 stated, when a patient’s preferred language was different from English, a translator was provided, and documents were presented in the respective patient’s language and copies were provided upon request. SPA 2 was requested to show the COA documentation that was provided in Mandarin for Patient 15, as well as the translator documentation for Patient 15’s COA completion. Documentation of Patient 15 being provided with COA documentation written in Mandarin, or the use of any translator being provided for Patient 15 was not found. SPA 2 stated, it was important for translators to be used for patients to understand what they were signing, and it was part of their rights, and it was part of the standard procedure to at least enter a note explaining a deviation from this process. During an interview on 8/23/2024 at 8:45 a.m. with SPA 1 and the Admitting Representative II (AR II), AR II stated, they were able to speak Spanish and English, but AR II did not speak Mandarin. AR II stated, once a patient stated their preferred language, a translator was called and used to translate for the respective patient. AR II stated, Patient 15 would have qualified for translation services, but she (AR II) did not provide translation for Patient 15. SPA 1 stated, the facility must do their part in providing translation assistance for the patients and documenting it. During a review of the facility’s policy and procedure (P&P) titled, “Patient and Family Rights and Responsibilities,” revised in February 2024, the P&P indicated, “Patient rights should be promoted and protected by all hospital and medical staff. [ ...] For families who do not read or understand English or Spanish or who are deaf or hard of hearing an interpreter speaking the language they understand should be procured in compliance with Hospital policies and procedures.” During a review of the facility’s policy and procedure (P&P) titled, “Communication Assistance,” revised in June 2023, the P&P indicated, “In situations when a vital document is not available in a non-English language, the content and intent of such document will be explained to the Limited English Proficiency (LEP) patient and family member by the health care team member involved in the encounter, in the presence of an interpreter. The interpreted encounter will then be documented in the patient’s medical record.” During a review of the facility’s policy and procedure (P&P) titled, “Admission Process: Forms Requiring Signature in Admitting,” effective May 2021, the P&P indicated, “It is the responsibility of the Admitting Department to obtain the required parent signature at pre-admission, admission or as soon as possible thereafter. The parent or guardian should be asked to sign the following documents. Condition of admission: Required under California law establishes the conditions under which a patient is admitted for in-patient services. The primary function is to document the patient’s consent to hospital and routine services and also to document financial responsibility for payment of hospital charges for services rendered.” 2.c. During a review of Patient 13’s electronic health record (EHR - a digital version of paper chart), dated 7/14/2024 through 8/20/2024, the EHR indicated, Patient 13 presented to the facility as a direct admit on 7/14/2024 at 1:22 a.m., with a diagnosis of acute respiratory failure (a condition that occurs when the lungs are unable to get enough oxygen into the blood). During a concurrent interview and record review on 8/20/2024 at 4:05 p.m. with the Registered Nurse Specialist (RNS), the Clinical Informatics/Kid Specialist (CKS), and the Clinical Senior Informatics (CSI), Patient 13’s EHR, dated 7/14/2024 through 8/20/2024, was reviewed for Condition of Admission (COA, the process in which a healthcare provider educates a patient about the risks, benefits and alternatives, of a given procedure or intervention) documentation. The COA documentation was not found for Patient 13. The RNS and CSI stated, every patient or patient’s family/representative was supposed to have a COA completed and signed, and they were unable to determine the reason for the COA not being available in Patient 13’s clinical record. During a concurrent interview and record review on 8/21/2024 at 8:35 a.m. with Supervisor Patient Access Revenue 1 (SPA 1) and the Supervisor Patient Access Revenue 2 (SPA 2), SPA 2 stated, a COA was required for every single patient that was admitted to the facility. SPA 2 stated, if the COA was missing, it would only be due to the patient being a direct transfer, then the facility would have to follow-up and make attempts to get the patient’s COA signed and documented. Patient 13’s COA was requested, but SPA 2 and SPA 1 stated Patient 13 did not have a completed COA on file, and two different attempts were made on 7/14/2024 and 7/15/2024 to obtain a signed COA document for Patient 13, but no other follow-ups were provided to Patient 13’s parents beyond 7/15/2024. SPA 1 and SPA 2 further stated, their process was to follow-up with the patient and their representatives daily to complete the outstanding COA, and allowing a month to pass without getting the COA signed was not acceptable and it was missed. During a review of the facility’s policy and procedure (P&P) titled, “Admission Process: Forms Requiring Signature in Admitting,” effective May 2021, the P&P indicated, “It is the responsibility of the Admitting Department to obtain the required parent signature at pre-admission, admission or as soon as possible thereafter. The parent or guardian should be asked to sign the following documents. Condition of admission: Required under California law establishes the conditions under which a patient is admitted for in-patient services. The primary function is to document the patient’s consent to hospital and routine services and also to document financial responsibility for payment of hospital charges for services rendered.””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 48212 Based on observation, interview and record review, the facility failed to: 1. Ensure safety for patients at risk for fall (an unintentional event that results in the person coming to rest on the ground or another lower level), when using a highchair, for one of 30 sampled patients (Patient 23), per manufacturer’s instructions regarding highchair use, , when Patient 23 was left unattended in a highchair (a seat raised a far distance from the ground). This deficient practice had the potential to result in Patient 23 falling off from the highchair and sustain injury such as fracture (broken bone). 2. Ensure two of five sampled emergency crash carts (carts that store emergency medical equipment and medications) were inspected and verified for readiness, according to the facility’s protocol on emergency carts’ maintenance and readiness. This deficient practice had the potential to delay emergency patient care during an unexpected event requiring emergency crash cart use, due to the emergency crash cart equipment not being inspected and verified for availability and proper function, which could result in patient harm and/or death. Findings: 1. During a review of Patient 23’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 8/1/2024, the H&P indicated, Patient 23 was tracheostomy (a surgically created hole through the front of the neck and into the windpipe [trachea]) dependent requiring oxygen. During a review of Patient 23’s “Face Sheet (face sheet, document provides patient’s demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance),” dated 8/20/2024, the face sheet indicated, Patient 23 was admitted to the facility with diagnosis of increased tracheal (surgically created hole through the front of the neck and into the windpipe [trachea]) secretions (fluid produced from the throat). During a concurrent observation and interview on 8/20/2024 at 12:21 p.m. with the Clinical Supervisor (CS 3) of Medical Unit, at the doorway of Patient 23’s room, Patient 23 was observed sitting in a gray color highchair (a seat raised a far distance from the ground alone, with no one in the room for supervision. CS 3 stated nursing staff made rounds to check on Patient 23. During an interview on 8/21/2024 at 11 a.m. with the Registered Nurse (RN) 6, RN 6 stated nursing staff should be with the patient (Patient 23) at all times when placing the patient (Patient 23) in a highchair. RN 6 stated someone should be in the room while patient (Patient 23) was in the highchair to supervise patient (Patient 23) for safety because patient (Patient 23) could fall off from the highchair. During a concurrent interview and record review on 8/21/2024 at 11:10 a.m. with RN 6, Patient 23’s “Fall Risk Assessment (assessment performed by nursing staff to assess patient’s risk for falling),” dated 8/14/2024, was reviewed. The fall risk assessment indicated Patient 23’s fall risk score of 14. RN 6 stated fall risk score at 12 or above would indicate Patient 23 at risk for fall. RN 6 stated putting Patient 23 in highchair would place patient 23 at risk for fall, therefore close observation was needed. During a concurrent interview and record review on 8/21/2024 at 2:22 p.m. with the Quality Coordinator (QC 1), the facility’s highchair manufacturer’s instruction titled, “The Classic Highchair Usage Instructions,” dated 4/2017, was reviewed. The “Classic Highchair Usage Instructions” indicated, “Warning: Never leave child unattended.” QC 1 stated nursing staff should follow manufacturer’s instruction when using the highchair. During a review of the facility’s policy and procedure (P&P) titled, “Patient Falls Prevention,” dated 6/2024, the P&P indicated, “To reduce the likelihood and severity of patient injury related to falls through the means of identifying those at risk, classifying the level of risk, and initiating falls prevention interventions... High Risk Standard Protocol (score 12 and above)... v. assess need for 1:1 supervision.” 2.a. During a current observation and record review on 8/19/2024 at 2:44 p.m., in the Pediatric Intensive Care Unit (a specialized unit of the hospital where the very sickest pediatric [infants, children, and adolescents] patients are admitted), three emergency crash carts (carts that store emergency medical equipment and medications) were observed on the unit. Emergency Crash Cart # 52’s log titled, “Emergency Cart/Defibrillator (a device that delivers an electric shock to the heart to restore a normal rhythm) - Daily Shift and Weekly Shock Test,” dated 8/20241, did not have an initial of the individual inspecting the cart on 8/18/2024 during the PM (afternoon) shift. During a concurrent interview and record review on 8/19/2024 at 3 p.m. with the Director of the Emergency Department (DED), the DED reviewed the emergency crash cart log titled, “Emergency Cart/Defibrillator - Daily Shift and Weekly Shock Test,” dated 8/2024 for Emergency Crash Cart # 52. The DED verified there was no documentation that the emergency crash cart was inspected for emergency medical supplies, medications, and for functioning equipment on 8/18/2024 during the PM shift. The DED stated that nursing staff should write their initials on the log after the cart has been inspected to indicate that inspection was done. The DED stated that the cart should be checked every shift to ensure all emergency supplies are available and equipment are functioning, in the event of a medical emergency. During a review of the facility’s policy and procedure (P&P) titled, “Emergency Cart Maintenance,” revised September 2023, the P&P indicated, “To ensure that appropriate emergency cart contents and equipment are available and functioning properly... 2.b. During a concurrent observation, interview, and record review on 8/20/2024 at 10:48 a.m. with the Manager of Clinical Perioperative Services (MCP) on the second floor Post Anesthesia Care Unit (PACU, a recovery room where patients are monitored after procedures that require anesthesia or sedation [medications that cause sleep]), two emergency crash carts (carts that store emergency medical equipment and medications) were observed, and the PACU’s “Emergency Cart/Defibrillator (a device that delivers an electric shock to the heart to restore a normal rhythm) -Daily Shift and Weekly Code Readiness Test” log documents, dated July 2024, were reviewed. The “Emergency Cart/Defibrillator-Daily Shift and Weekly Code Readiness Test” log document included checking the following on the emergency crash cart: locks, medication expiration dates, oxygen tank availability, supplies and defibrillator plugged into power source, peds pads (pediatric electrode pads that help deliver a lifesaving shock) plugged/ready for use, battery life and heart monitor paper in-place. During a continued concurrent observation, interview, and record review on 8/20/2024 at 10:48 a.m. with the MCP on the second floor PACU, one emergency crash cart for the month of July 2024 had a missed inspection and verification sign-off for 7/30/2024. The MCP stated, emergency crash carts were checked daily to verify everything was working properly, in case of emergency and for patient safety. The MCP further stated, the “Emergency Cart/Defibrillator-Daily Shift and Weekly Code Readiness Test” log should be completed and signed daily for all the emergency crash carts, and the facility will need to figure out which assigned Registered Nurse did not complete this daily inspection. During a review of the facility’s policy and procedure (P&P) titled, “Emergency Cart Maintenance,” revised September 2023, the P&P indicated, “To ensure that appropriate emergency cart contents and equipment are available and functioning properly... Emergency carts will be locked. The integrity of the lock is checked every shift by a licensed provider in units that are open 24hrs and daily in other areas. This check is documented on the Emergency Crash/Cart/Defibrillator Check Sign-off sheet or Emergency Crash Cart/AED Check Sign-off sheet.””

“PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS CFR(s): 482.13(d) Patient Rights: Confidentiality of Records This Standard is not met as evidenced by: 50515 Based on observation, interview, and record review, the facility failed to ensure patient protected health information (PHI - private identifiable patient information) was safeguarded and secured against unauthorized use for two of 30 sampled patients (Patient 18 and Patient 20), when Patient 18’s and Patient 20’s individual identification sticker labels containing their PHI were left affixed onto a workstation on wheels (WOW - a mobile computer workstation used for clinical record documentation), accessible and visible to anyone accessing the unit hallway, including visitors and staff members. This deficient practice had the potential for unauthorized individuals to access and misuse these patients’ PHI and compromise the confidentiality that was expected for these patients as they received care in the facility. Findings: During a review of Patient 18’s “Face Sheet (a document containing a patient’s medical and demographic information),” (undated), the “Face Sheet” indicated, Patient 18 was admitted to the facility on 8/20/2024 at 9:23 a.m., with a medical diagnosis of congenital nevus of back (a mole/birthmark). During a review of Patient 20’s “Face Sheet,” (undated), the “Face Sheet” indicated, Patient 20 was admitted to the facility on 8/20/2024 at 8:42 a.m., with a medical diagnosis of sleep apnea (disorder that causes breathing to stop or get shallow during sleep). During an observation on 8/20/2024 at 12:03 p.m. on the seventh-level Ambulatory Surgery Unit (where patients undergoing surgery have the ability to leave the hospital on the same day of the surgery without being admitted), a Workstation on Wheels (WOW, a mobile computer workstation used for clinical record documentation) was stationed in the hallway with two patient identification sticker labels, identifying Patient 18 and Patient 20, affixed to the WOW, along the table-top surface underneath the computer monitor, visible within plain sight. The sticker labels for Patient 18 and Patient 20 contained the following PHI for each patient: patient name, date of birth, medical record number (MRN), and admission date. During a concurrent observation and interview on 8/20/2024 at 12:03 p.m. with the Associate Director of Perioperative Services (ADP) and the Vice President of Perioperative Services Executive (VPPSE) on the seventh-level Ambulatory Surgery Unit, the ADP stated, when discarding medication labels, shredders were provided, and nurses were expected to log-off their WOW when away from their WOW. The ADP observed the two identification sticker labels affixed to the WOW in the hallway, identifying Patient 18 and Patient 20, and stated nursing was expected to discard patient PHI (Protected Health Information, private identifiable patient information) in the shredder, including the identification sticker labels that were observed, and the identification sticker labels should not have been attached to the WOW as observed. During a review of the facility’s policy and procedure (P&P) titled, “Safeguarding Protected Health Information,” revised June 2023, the P&P indicated, “[Abbreviated Name of Facility] Team Members are responsible for safeguarding the privacy, confidentiality, and security of PHI. The safeguards that shall be implemented by [Abbreviated Name of Facility] Team Members when handling paper and other tangible PHI includes but are not limited to: Placing unused or discard PHI in confidential shred bin.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(i) The use of restraint or seclusion must be-- (i) in accordance with a written modification to the patient’s plan of care. This Standard is not met as evidenced by: 48212 Based on observation, interview and record review, the facility failed to ensure nursing staff initiated and developed a restraint (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) care plan (provides a framework for evaluating and providing patient care needs related to the nursing process) upon restraints initiation, in accordance with the facility’s policy and procedure regarding restraints, for three of 30 sampled patients (Patient 21, 23 and 28) when the restraint care plan was initiated: 1. on 7/27/2024, two (2) days after Patient 21 was placed on mitten (a soft, padded gloves that covers a patient’s hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraints) 2. on 8/14/2024, 14 days after Patient 23 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed) 3. on 8/18/2024, four (4) days after Patient 28 was placed in an enclosed bed This deficient practice had the potential to result in unnecessary restraints use for Patients 21, 23 and 28 as there was no care plan developed for nursing staff to monitor progress and evaluate restraints use. This deficient practice also had the potential to result in complications of restraints use such as skin integrity issues (a break in the skin), etc. Findings: 1. During a review of Patient 21’s “Face Sheet (face sheet, document provides patient’s demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance),” dated 8/20/2024, the face sheet indicated, Patient 21 was admitted to the facility with diagnoses of sepsis (a body’s overwhelming and life-threatening response to infection) and hyperkalemia (high potassium level in blood). During a review of Patient 21’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 7/27/2024, the H&P indicated Patient 21 had gastrostomy (surgical opening from stomach to allow access for food fluids and medications) and ileostomy (a surgical procedure in which a part of the small bowel is brought through the abdominal wall via a surgical-created opening called a stoma to evacuate stool from body). During an observation on 8/20/2024 at 12:38 p.m. with the Nurse Manager (NM 5) of Medical Unit (an inpatient unit that provides medical and nursing care to patients with a variety of conditions) at Patient 21’s room, Patient 21 had mitten (a soft, padded gloves that covers a patient’s hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraint on his (Patient 21) left hand. NM 5 stated Patient 21 needed the mitten restraints to prevent him (Patient 21) from pulling lines and tubes. During a review of Patient 21’s “physician restraints non-violent order (physician order for restraint use),” dated 7/27/2024, the restraint order indicated, Patient 21 was placed on two-point soft mitten restraints due to pulling at tubes or lines. During a concurrent interview and record review on 8/20/2024 at 3:24 a.m. with the Registered Nurse (RN) 5, Patient 21’s “care plan (provides a framework for evaluating and providing patient care needs related to the nursing process),” dated from 7/27/2024 to 7/29/2024, was reviewed. The care plan indicated restraints care plan was initiated on 7/29/2024. RN stated the care plan for restraints was initiated two (2) days after the initiation of mitten restraints (7/27/2024). RN 5 stated care plan should be initiated upon restraints application. RN 5 stated care plan was needed to monitor Patient 21 for continual need for restraints and evaluate the earliest time for restraints removal. During a review of the facility’s policy and procedure (P&P) titled, “Restraint Policy,” dated 1/2024, the P&P indicated, “Plan of care. Upon initiation of restraints, plan of care should be initiated. Plan of care should be reviewed and modified to reflect current interventions during the shift in which the changes occurred.” 2. During a review of Patient 23’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 8/1/2024, the H&P indicated, Patient 23 was tracheostomy (a surgically created hole through the front of the neck and into the windpipe [trachea]) dependent requiring oxygen. During a review of Patient 23’s “Face Sheet (face sheet, document provides patient’s demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance),” dated 8/20/2024, the face sheet indicated, Patient 23 was admitted to the facility with diagnosis of increased tracheal (surgically created hole through the front of the neck and into the windpipe [trachea]) secretions (Fluids produced from the throat) . During a review of Patient 23’s “physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order (physician order for restraint use),” dated 8/1/2024, the restraint order indicated, “Enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed) due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow direction.” During a concurrent interview and record review on 8/21/2024 at 10:50 a.m. with the Registered Nurse (RN) 6, Patient 23’s “care plan,” dated from 8/1/2024 to 8/14/2024 was reviewed. The care plan indicated restraints care plan was initiated on 8/14/2024. RN 6 stated the restraints care plan was initiated two (2) weeks after the initial restraints were ordered and applied (8/1/2024). RN 6 stated care plan should be developed when restraint was first applied for Patient 23. RN 6 stated care plan was needed to provide nursing interventions to guide staff what to do on a daily basis to monitor and evaluate outcome while Patient 23 was on restraints. During a review of the facility’s policy and procedure (P&P) titled, “Restraint Policy,” dated 1/2024, the P&P indicated, “Plan of care. Upon initiation of restraints, plan of care should be initiated. Plan of care should be reviewed and modified to reflect current interventions during the shift in which the changes occurred.” 3. During a review of Patient 28’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 8/14/2024, the H&P indicated, Patient 28 was admitted to the facility with diagnoses including but not limited to global developmental delay (a delay in multiple developmental areas such as speech, motor [movement of the body], etc.), gastrojejunostomy tube (GJ-tube, a tube that is surgically inserted into the stomach and intestine to allow access for food, fluids and medications) feeding intolerance (difficulty to digest enteral feedings [a method of providing nutrition directly into the gastrointestinal tract]) and increased seizure (sudden surge of electrical activity in the brain when a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness) activities. During an observation on 8/20/2024 at 11:24 a.m. in Patient 28’s room, there was an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed) placed. During a review of Patient 28’s “physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order (physician order for restraint use),” dated 8/14/2024, the restraint order indicated, “Enclosed bed due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow direction.” During a concurrent interview and record review on 8/21/2024 at 3:25 p.m. with the Registered Nurse (RN) 6, Patient 28’s “care plan,” dated from 8/14/2024 to 8/18/2024, was reviewed. The care plan indicated restraints care plan was initiated on 8/18/20024. RN 6 stated the restraints care plan was initiated four (4) days after restraints application (8/14/2024). RN 6 stated restraints care plan should be initiated when restraints are started. RN 6 stated care plan was needed to monitor and evaluate Patient 28’s progress and need for restraints. During a review of the facility’s policy and procedure (P&P) titled, “Restraint Policy,” dated 1/2024, the P&P indicated, “Plan of care. Upon initiation of restraints, plan of care should be initiated. Plan of care should be reviewed and modified to reflect current interventions during the shift in which the changes occurred.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 48212 Based on observation, interview and record review, the facility failed to ensure there was a restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) renewal order from the qualified licensed practitioner (QLP, any individual permitted by state law and organization policy to order restraints and seclusion for patients), in accordance with the facility’s policy and procedures regarding restraints for two of 30 sampled patients (Patients 21 and 23), who were both placed in restraints when: 1. Patient 21 had mitten (a soft, padded gloves that covers a patient’s hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraints 2. Patient 23 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed) This deficient practice had the potential to result in unnecessary restraints use as Patients 21 and Patient 23 were not being evaluated by the providers for the need of continued use of restraints. This deficient practice also had the potential to result in complications regarding restraints use such as skin breakdown (damage to the skin), etc. Findings: 1. During a review of Patient 21’s “Face Sheet (face sheet, document provides patient’s demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance),” dated 8/20/2024, the face sheet indicated, Patient 21 was admitted to the facility with diagnoses of sepsis (a body’s overwhelming and life-threatening response to infection) and hyperkalemia (high potassium level in blood). During a review of Patient 21’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 7/27/2024, the H&P indicated Patient 21 had gastrostomy (surgical opening from stomach to allow access for food fluids and medications) and ileostomy (a surgical procedure in which a part of the small bowel is brought through the abdominal wall via a surgical-created opening called a stoma to evacuate stool from body). During an observation on 8/20/2024 at 12:38 p.m. with the Nurse Manager of the medical unit (an inpatient unit that provides medical and nursing care to patients with a variety of conditions) (NM 5), at Patient 21’s room, Patient 21 had mitten (a soft, padded gloves that covers a patient’s hands and fingers to prevent them from grabbing or dislodging tubes, catheters, or other medical equipment) restraint on his (Patient 21) left hand. NM 5 stated Patient 21 needed the mitten restraints to prevent him (Patient 21) from pulling lines and tubes. During a concurrent interview and record review of 8/20/2024 at 3:30 p.m. with the Quality Coordinator (QC 1), Patient 21’s “physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order (physician order for restraint use),” dated from 7/27/2024 to 8/3/2024, was reviewed. The physician restraints non-violent order indicated, “two-point soft mittens due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow directions and pulling at tubes or lines, with missing restraint renewal order on 8/1/2024. QC 1 stated physician restraints renewal order was needed every calendar day per facility’s policy and procedure. QC 1 stated nursing staff should not apply restraints without a physician order. During a review of the facility’s policy and procedure (P&P) titled, “Restraint Policy,” dated 1/2024, the P&P indicated, “An order written by a qualified licensed practitioner (QLP, any individual permitted by state law and organization policy to order restraints and seclusion for patients) is required for use of restraints. The order must include the following components: type of restraints, clinical rationale, date of order, start and end time ... order renewal ... non-violent: once every calendar day.” 2. During a review of Patient 23’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 8/1/2024, the H&P indicated, Patient 23 was tracheostomy (a surgically created hole through the front of the neck and into the windpipe [trachea]) dependent requiring oxygen. During a review of Patient 23’s “Face Sheet (face sheet, document provides patient’s demographic data including name, date of birth, emergency contact, admitting diagnosis and health insurance),” dated 8/20/2024, the face sheet indicated, Patient 23 was admitted to the facility with diagnosis of increased tracheal (surgically created hole through the front of the neck and into the windpipe [trachea]) secretions (fluids produced in the throat). During a concurrent interview and record review of 8/21/2024 at 10:40 a.m. with the Quality Coordinator (QC 1), Patient 23’s “physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order (physician order for restraint use),” dated from 8/1/2024 to 8/20/2024, was reviewed. The physician restraints non-violent order indicated, “enclosed bed due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow directions” with missing restraint renewal orders on 8/8/2024, 8/9/2024, 8/10/2024, 8/13/2024, 8/17/2024 and 8/18/2024 (days in which Patient 23 remained in an enclosed bed without physician restraints renewal order). QC 1 stated there were six (6) days without physician renewal orders and physician restraints renewal order was required every calendar day per facility’s policy. During a concurrent interview and record review on 8/21/2024 at 10:45 a.m. with the Registered Nurse (RN) 6, Patient 23’s “restraints flowsheet (nursing document for restraint assessment and monitoring),” dated from 8/1/2024 to 8/20/2024 was reviewed. The restraints flowsheet indicated enclosed bed was used for Patient 23 on 8/8/2024, 8/9/2024, 8/10/2024, 8/13/2024, 8/17/2024 and 8/18/2024. RN 6 stated physician order was required for use of enclosed bed on the above days. During a review of the facility’s policy and procedure (P&P) titled, “Restraint Policy,” dated 1/2024, the P&P indicated, “An order written by a qualified licensed practitioner (QLP, any individual permitted by state law and organization policy to order restraints and seclusion for patients) is required for use of restraints. The order must include the following components: type of restraints, clinical rationale, date of order, start and end time ... order renewal ... non-violent: once every calendar day.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 48212 Based on observation, interview and record review, the facility failed to ensure staff performed ongoing assessment, monitoring and documentation of restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) use, every two (2) hours for 14 hours, for one of 30 sampled patients (Patient 28), in accordance with the facility’s policy and procedure regarding restraints, when Patient 28 was placed in an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed). This deficient practice had the potential to result in Patient 28’s needs not being met and not being monitored while in the enclosed bed. Findings: During a review of Patient 28’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 8/14/2024, the H&P indicated, Patient 28 was admitted to the facility with diagnoses including but not limited to global developmental delay (a delay in multiple developmental areas such as speech, motor [movement of the body], etc.), gastrojejunostomy tube (GJ-tube, a tube that is surgically inserted into the stomach and intestine to allow access for food, fluids and medications) feeding intolerance (difficulty to digest enteral feedings [a method of providing nutrition directly into the gastrointestinal tract]) and increased seizure (sudden surge of electrical activity in the brain when a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness) activities. During an observation on 8/20/2024 at 11:24 a.m. in Patient 28’s room, there was an enclosed bed (tent-like enclosure entirely covering a hospital bed. Someone on the outside of the bed must unzip one of the tent flaps before an individual can exit the bed) placed. During a review of Patient 28’s “physician restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) non-violent order,” dated 8/14/2024, the restraint order indicated, “Enclosed bed due to cognitively (pertains to thinking, learning, remembering, or problem-solving ability) unable to follow direction.” During a concurrent interview and record review on 8/21/2024 at 3:14 p.m. with the quality coordinator (QC1), Patient 28’s “restraints flowsheet (nursing document for restraint assessment and monitoring),” dated 8/17/2024, was reviewed. The restraints flowsheet indicated there was no documentation of assessment and monitoring every 2 hours from 8/17/2024 at 5 a.m. to 8/17/2024 at 7 p.m. (14 hours). QC 1 stated nursing staff was required to document restraints assessment every two (2) hours while Patient 28 was in the enclosed bed. During an interview on 8/21/2024 at 3:20 p.m. with the Registered Nurse (RN) 6, RN 6 stated nursing assessment was required every two (2) hours while patients are on restraints to assess patients for skin and circulation, and check patient for needs for hydration and toileting to make sure patient’s needs are met. RN 6 stated nursing staff needs to monitor patients every two (2) hours to ensure patient’s safety while on restraints. During a review of the facility’s policy and procedure (P&P) titled, “Restraints Policy,” dated 1/2024, the P&P indicated, “nursing assessment documentation for non-violent restraints: the following must be monitored every two (2) hours by RN: circulation and extremity description, mental status, rational for continued restraint, criteria for release met, type of restraint and location, hydration/nutrition needs, toileting needs, skin assessment, range of motion, restraint safety. All assessment and monitoring must be documented in patient’s electronic medical record (EMR, digital version of paper chart).””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(1) Training intervals. Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion- (i) Before performing any of the actions specified in this paragraph; (ii) As part of orientation; and (iii) Subsequently on a periodic basis consistent with hospital policy. This Standard is not met as evidenced by: 48212 Based on interview and record review, the facility failed to ensure nursing staff demonstrated satisfactory restraints (any method, physical or chemical, or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move or access any part of his/her body) application competency (ability to perform skilled learned) during onboarding in accordance with the facility’s policy and procedure regarding restraints training, when one of one sampled Registered Nurse competency record (RN 8), did not have a restraints competency record. This deficient practice had the potential to result in RN 8 not being monitored and evaluated for restraints application skills, monitoring and assessment of patients while on restraints, which may put patients at risk for harm due to improper restraints use. Findings: During a concurrent interview and record review on 8/22/2024 at 2:32 p.m. with the Nurse Manager (NM 3) of the Medical Unit (an inpatient unit that provides medical and nursing care to patients with a variety of conditions), the Registered Nurse (RN) 8’s personnel file record, undated, was reviewed. The personnel file record indicated restraints use patient care service online training was completed on 8/13/2024. NM 3 stated the restraints use patient care service was an online class which served as refresher course for restraints training. NM 3 stated there should be a hands-on restraints competency (demonstration in the use of restraints) completed to validate that RN 8 could demonstrate proper restraints use. NM 3 stated it was important for nursing staff to know how to apply restraints properly to ensure patient and staff safety. NM 3 stated she (NM 3) did not have RN 8’s restraints competency record. During an interview on 8/23/2024 at 9:56 a.m. with Quality Coordinator (QC 2), QC 2 stated RN 8 was hired on 9/4/2012 and the facility could not provide record that RN 8 had completed restraints competency. During a review of the facility’s policy and procedure (P&P) titled, “Restraint Policy,” dated 1/2024, the P&P indicated, “Provide guidelines for safe and effective management of patients who required the use of violent or non-violent restraints, while preserving the dignity, safety, and rights of each individual ... training: direct patient care staff must have a working knowledge of the hospital policy regarding the use of restraints. Staff must be trained and able to demonstrate competency in the application of restraints, monitoring, assessment, and providing care for a patient in restraints before performing any of these above actions, as part of the orientation period ... training must be documented in the staff personnel records or via electronic learning module that the training and documentation of competency were successful completed.””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 48186 Based on interview and record review, the facility failed to ensure a care plan (provides a framework for evaluating and providing patient care) was developed and implemented per policy and procedure for two of 30 sampled patients (Patient 10, and 4), to include the current care and interventions when: 1. Patient 10, who was admitted for hypoxemia (condition that occurs when there is not enough oxygen in the blood, which can lead to a lack of oxygen to tissues and organs) with continuous positive airway pressure (CPAP, a machine that uses mild air pressure to keep the airways open while a person sleeps) respiratory support, did not have a care plan implemented within 24 hours of admission, to address respiratory issues. This deficient practice had the potential for Patient 10’s respiratory needs and risks to remain unidentified and unaddressed which may result in Patient 10’s respiratory status to decline, leading to respiratory distress (a serious lung condition that causes low blood oxygen). 2. Patient 4, who was admitted for pulmonary hypertension crisis (a life-threatening emergency that occurs when there is a sudden, rapid increase in lung pressure, and can lead to temporary decrease in lung blood flow and airway obstruction) and respiratory failure (inadequate gas exchange in the respiratory system), did not have a care plan relating to Patient 4’s respiratory problems, initiated in a timely manner within 24 hours of admission. This deficient practice had the potential for Patient 4’s respiratory needs and risks to remain unidentified and unaddressed which may result in a decline of Patient 4’s respiratory status. Findings: 1. During a concurrent interview and record review on 8/21/2024 at 2:09 p.m. with the Manager of Patient Safety Team (MPS), the MPS verified the following information in Patient 10’s medical record: Patient 10’s Face Sheet indicated Patient 10 was admitted to the facility on 8/6/2024 at 4:29 a.m. Patient 10’s “History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 8/6/2024, indicated Patient 10 was admitted to the facility with a diagnosis of hypoxemia (condition that occurs when there is not enough oxygen in the blood, which can lead to a lack of oxygen to tissues and organs). Patient 10’s Care Plan (provides a framework for evaluating and providing patient care) for respiratory (related to the airway and lungs) care was not initiated on admission. Patient 10’s Care Plan for respiratory care was delayed when initiated on 8/9/2024 (four days after admission date). During an interview on 8/21/2024 at 2:09 p.m. with the Manager of Patient Safety Team (MPS), the MPS stated the following: Patient 10’s respiratory Care Plan should have been initiated on admission by a member of the interdisciplinary team (IDT, a group of health care professionals with various areas of expertise who work together toward the goals of their patients). Patient 10’s care plan should have been specific to Patient 10’s admitting diagnosis (relating to respiratory issues) and should have reflected the current status of the patient. Care plans should be updated per policy. The Care Plan is a communication tool for the IDT to track goal progression. The Care Plan has patient specific interventions that supports the plan of care. The Care Plan allows the IDT to update interventions if the interventions are not effective. During a review of Patient 10’s History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 8/6/2024 at 6:20 a.m., the H&P indicated the following: Patient 10 had a past medical history of respiratory distress (a serious lung condition that causes low blood oxygen) at birth requiring continuous positive airway pressure (CPAP, a machine that uses mild air pressure to keep the airways open while a person sleeps). Patient 10 was admitted to the facility with diagnoses of hypoxemia and Trisomy 18 (a genetic disorder that can cause growth delays that are life threatening). During a review of Patient 10’s provider’s orders (a provider’s instructions for medical care and treatment), dated 8/6/2024 at 7:43am, the “Orders” indicated an order for a CPAP device. During a review of Patient 10’s nursing flowsheet, dated 8/6/2024 at 4:53 a.m., the flowsheet indicated the following: “Type of Oxygen Administration: With CPAP.” During a review of the facility’s policy and procedure (P&P) titled, “Interdisciplinary Care Planning - General,” dated 4/30/2024, the P&P indicated the following: ...The Registered Nurse (RN) is responsible for overseeing and supervising the patient’s Interprofessional Plan of Care (IPOC), as well as initiating, updating, and discontinuing all plans of care ...IPOC will be initiated by the RN within 24 hours of admission. During a review of the facility’s policy and procedure (P&P) titled, “Interdisciplinary Care Planning,” dated 4/30/2024, the P&P indicated the following: “ ...Procedure: Inpatient: A. Interprofessional Plan of Care (IPOC, provides a framework for evaluating and providing patient care) requirements: ...1) ... a) Additional IPOCs should be initiated as the plan of care develops and patient needs change ... 3) The plans of care should be updated to reflect current orders and care. a) The Registered Nurse (RN) should discontinue and/ or add goals and interventions to reflect the current plan ...” 2. During a concurrent interview and record review on 8/21/2024 at 10:49 a.m. with the Manager of Patient Safety (MPS), the MPS reviewed Patient 4’s medical record and stated the following: Patient 4 was admitted to the facility on 4/20/2024 at 2:37 a.m., for pulmonary hypertension crisis (a life-threatening emergency that occurs when there is a sudden, rapid increase in lung pressure, and can lead to temporary decrease in lung blood flow and airway obstruction). Patient 4’s biggest problem was related to the respiratory system. The MPH reviewed Patient 4’s care plan titled “Respiratory Care IPOC (Interprofessional Plan of Care, provides a framework for evaluating and providing patient care),” and verified that the care plan was not initiated within 24 hours of admission. The care plan was initiated on 4/22/2024 at 5:05 p.m. (Admission date was 4/20/2024 at 2:37 a.m.). The MPS stated the care plan should be initiated within 24 hours to ensure Patient 4 received the necessary interventions to help Patient 4 reach her (Patient 4) patient care goals. During a review of Patient 4’s History and Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 4/20/2024 at 6:24 a.m., the H&P indicated Patient 4’s chief complaint was pulmonary hypertension crisis and transferred to the facility for respiratory failure (inadequate gas exchange in the respiratory system). During a review of Patient 4’s care plan titled, “Respiratory Care IPOC,” the care plan indicated it (the care plan) was initiated on 4/22/2024 at 5:04 p.m. (two days from admission date). Goals included ...Respiratory status will improve and will tolerate increased activity. Interventions included ...Assess respiratory rate, depth, and effort. Assess breath sounds. Monitory pulse oximetry ...Perform airway suctioning ... During a review of the facility’s policy and procedure (P&P) titled, “Interdisciplinary Care Planning - General,” dated 4/30/2024, the P&P indicated the following: ...The Registered Nurse (RN) is responsible for overseeing and supervising the patient’s Interprofessional Plan of Care (IPOC), as well as initiating, updating, and discontinuing all plans of care ...IPOC will be initiated by the RN within 24 hours of admission.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 48186 Based on observation, interview and record review, the facility failed to ensure one of 30 sampled patient’s (Patient 9) enteral (a method of feeding that uses the gastrointestinal [GI, relating to the stomach and intestines] tract to deliver nutrition and calories) feeding bag was labeled, in accordance with facility policy and procedure regarding labeling of enteral feeding bags. This deficient practice had the potential for the enteral feeding bag to be expired, leading to bacterial growth within the feeding bag which may result in Patient 9 developing gastrointestinal problems such as diarrhea (loose stools). Findings: During a concurrent observation and interview on 8/19/2024 at 3:41 p.m. with Nurse Manager 1 (NM 1) and Registered Nurse 10 (RN 10), in Patient 9’s room, Patient 9 was observed in a crib with an enteral (a method of feeding that uses the gastrointestinal [GI, relating to the stomach and intestines] tract to deliver nutrition and calories) feeding bag and tubing was attached to his (Patient 9’s) gastrostomy tube (g-tube, a device that administers nutrients, fluids and medications to the gastrointestinal [GI]) site. During an interview on 8/19/2024 at 3:41 p.m. with Registered Nurse (RN 10), RN 10 verified formula was running continuously at 58 milliliter (ml, a unit of measurement) per hour from the enteral feeding bag to the g-tube, and that the enteral feeding bag was unlabeled. RN 10 stated the following: There should be a label on Patient 9’s enteral bag. The label should have included the patient’s name, time the bag was hung, type of formula, and expiration time. It is important to label the enteral feeding bag to ensure the correct formula is given to the correct patient. Also, it is important to label the enteral feeding bag with the time so you know when it will expire, so the patient does not get expired milk, which can grow bacteria. During a review of Patient 9’s History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 9/28/2023 at 5:03 p.m., the H&P indicated the following: Patient 9 was admitted to the facility with a diagnosis of congenital diaphragmatic defect (CDD, an opening in the diaphragm [muscle that separates the chest from abdomen] which allows the bowel, stomach, and liver to move upward into the chest cavity). During a review of Patient 9’s provider’s orders, dated 8/14/2024 at 10:01 a.m., the “Orders,” indicated the following: “Gentlease NeuroPro, Enfamil 22 (a type of infant formula), prepared, 58 mL (a unit of measurement) [per hour] continuous tube feeding.” During a review of Patient 9’s nursing flowsheet (a standardized tool that helps healthcare providers record patient information in a grid-like format), dated 8/19/2024 at 8:00 a.m., the nursing flowsheet indicated Patient 9 had a g-tube to the left upper quadrant of abdomen. During a review of the facility’s policy and procedure (P&P) titled, “Administration of Feeding Via an Enteral Access Device,” dated 5/15/2024, the P&P indicated the following: “ ...Definition: ...G. Continuous Feeding: Feedings delivered to either the stomach or intestine via syringe or enteral feeding pump (a device that delivers nutrient fluids into a patient’s stomach or intestines through enteral tubing) and sets at a constant rate of a period of hours, up to 24-hours per day ... D. Feeding Administration: 1. ... If the patient is a neonate or potentially immunocompromised, hang time is 4-hours ... 4. Change feeding sets every 24-hours, except in the case of the neonate... a. Neonates and potentially immunocompromised patients will have the feeding set changed consistent with the hang times ... c. Feeding bag must be labeled with patient’s name, medical record number (MRN), name of formula/feeding, rate, time formula/feeding was hung and time new feeding set was hung ...””