Vanderbilt University Medical Center

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 19001 Based on hospital policy review, medical record review, hospital document review, and interview, the hospital failed to ensure staff followed its policy for reporting abuse and failed to maintain communication within the care team to ensure allegations of sexual abuse were thoroughly investigated for 1 of 4 (Patient #1) sampled patients. The findings included: 1. Review of hospital policy, “Identification and Reporting of Abuse and/or Neglect-Child” effective May 2024 revealed, “Purpose: To appropriately identify and report cases of suspected child maltreatment, including ...child sexual abuse ...in accordance with Tennessee law ...Definitions: ...Child sexual abuse: The involvement of adults, older children, or adolescents in intentional sexual acts or activities with children who cannot legally consent to such acts and that produce sexual arousal and/or gratification for the perpetrator or sexual behaviors/situations in which there is a sexual component. Under TN [Tennessee] law, this includes also the commission of any act involving the unlawful sexual abuse, molestation, fondling or carnal knowledge of a child under thirteen (13) years of age that constitutes a criminal offense... Specific Information A. In some situations, there are indicators that child maltreatment is occurring. A partial list of potential indicators of child maltreatment includes: 1. Disclosure from patient, caregiver or other that child abuse ...may have occurred... Reporting Procedure: Any person, including physicians, nurses, and other [named Hospital #1] employees, who have reasonable cause to suspect a child has been a victim of child abuse, child sexual abuse... shall report these concerns immediately to the child’s attending physician and Social Work. The appropriate Social Worker will work with the concerned party and/or attending physician to assist and verify that Child Protective Services is contacted in a timely fashion... 2. [named Hospital #1] Social Work is notified in all cases of suspected child abuse, child sexual abuse... whether reported by [named Hospital #1], an outside hospital, or other third party. After hours, a Social Worker is available on call through the [named Hospital #1] Operator...” Review of hospital policy, “Occurrence Reporting: Patient and Visitor” effective January 2025 revealed, “Purpose: To identify, evaluate, and take appropriate action to address serious or significant Events... that involve patients... to track patient safety data trends... Policy: When a serious or significant Event occurs that involves a patient... immediately notify the Office of Risk and Insurance Management and the Administrative Coordinator or Administrator on- Call via telephone or pager... the report may be made through: 1. [named online occurrence reporting system] and/or 2. Telephone call to a risk manager... Definitions: A. Abuse- is the willful infliction or injury, unreasonable confinement, intimidation or punishment with resulting physical harm, pain or mental anguish... Event for the purposes of the policy is any of the following:... Incidents of Abuse...Event analysis is a process to identify basic or fundamental causal factors that underlie variation in performance, including the occurrence or possible occurrence of a Sentinel Event, Serious Reportable Event., or Serious Safety Event. An Event Analysis focuses on systems, processes, and human factors. The analysis progresses from specific causes in clinical processes to common causes in organizational systems to determine how to decrease the likelihood of such Events in the future or to determine that no such improvement opportunities exist...When a Department Manager or Designated Reviewer receives a [named occurrence reporting system] report involving a Sentinel Event, Serious Reportable Event or Serious Safety Event, the Department Manager or the medical leader assists the Office of Risk and Insurance Management with the investigation, as appropriate...” 2. Medical record review for Patient #1 revealed a female preschooler (as defined by age according to the American Academy of Pediatrics) accompanied by her parents presented to Hospital #1’s Children’s Hospital Emergency Department (ED) on 5/18/2026 with complaints of fever, neck pain, fast breathing and neck swelling. The Patient had significant posterior pharynx erythema (redness and inflammation at the back of the throat, often indicating an underlying infection or irritation), exudates (pus like materials) and edema (swelling at the back of the throat) and was found on Computed Tomography scan (CT) a scan using a combination of multiple X-ray images taken from different angles to produce detailed 3D images) to have a significant retropharyngeal abscess (an abnormal accumulation of fluid in the deep pocket of tissue located at the back of the throat), large necrotic cervical (neck) lymph node (a lymph node in the neck which has become enlarged and contains dead tissue) and moderate to severe airway narrowing. Patient #1 was successfully treated under consultation with Ear Nose and Throat (ENT) using Intravenous (IV) antibiotics, Incision and Drainage procedure (I&D) a medical procedure used to treat abscesses and localized infections by making an incision to allow pus or fluid to drain, promoting healing and relieving pain) and subsequent VATS (Video-assisted thoracic surgery is a minimally invasive surgical technique used to diagnose and treat various conditions in the chest) to address mediastinal involvement . On 6/2/2026, Patient #1 was discharged home in stable condition with her parents. Review of a Nursing communication/event note for Patient #1 documented by Registered Nurse (RN) #2 dated 5/23/2026 at 5:30 PM, revealed “RN called to bedside by family with patient safety concern, elevated to charge RN, AC [Administrative Coordinator- also referred to as House Supervisor] and MD [medical doctor]...” Review of Social Work (SW) #2’s progress note dated 5/24/2026 at 9:00 AM revealed, “...SW support requested by medical team due to Patients [Patient #1] disclosure of sexual assault... SW received handoff from on call SW [SW #1]. On call SW informed that a detective presented to pt’s [patient’s] bedside. SW met with pt’s mother at bedside to gather information. Pt’s mother reports teaching her daughter body safety awareness. Pt disclosed “inappropriate touch by hospital staff.” SW encouraged mother in the fact that Patient [Patient #1] trusted parents with this information and felt safe to tell her parents ...SW advised DCS [Department of Children’s Services]/SIU [Special Investigations Unit] and LE [Law Enforcement] will continue their investigation. SW to liase [liaise - to exchange information between different people] with DCS/LE as necessary. SW apprised on call attorney, hospital leadership, risk management, SW director, and charge RN with disclosure. Risk Management and hospital leadership have already been involved and updated...” 3. During an electronic interview on 6/2/2026 at 9:30 AM, Associate Nurse Officer (ANO) #1 stated her role was to support all nursing roles within Hospital #1’s Children’s hospital. ANO #1 stated on the evening of 5/23/2026 at 5:44 PM, she was the Administrator on Call (AOC) and she was informed by the House Supervisor, Patient #1’s mother had reported to RN #2 an allegation of inappropriate sexual touch by a male nurse who had woke her up on the night of 5/22/206 and inserted a finger into her vagina. ANO #1 stated based on review of the schedule, it was determined one male nurse, RN #3, had cared for Patient #1 in the Pediatric Intensive Care Unit (PICU) on 5/22/2026. RN #3 was identified as a nurse in Hospital 1’s float pool. ANO #1 stated float pool employees were employees of the hospital that support all of Hospital #1 areas for acute care staffing. ANO #1 stated she contacted the Interim Float Pool Manager (ANO #2), who determined RN #3 was scheduled to return to work at 7:00 PM on 5/23/2026. ANO #1 stated the Float Pool Manager contacted RN #3 and instructed him he was being placed on administrative leave with pay, pending an investigation related to patient safety. ANO #1 stated she and ANO#2/Interim Float Pool Manager spoke on 5/23/2026 around 6:08 PM. ANO #1 stated RN #3 remained on administrative leave pending the police investigation. ANO #1 stated the following were notified of the allegation of abuse: Attending Physician, Hospital’s police department, Department of Children’s Services, Risk Manager, Social Worker, Medical Chief of Staff, and the Medical Director for the PICU. ANO #1 stated the Hospital police department reported the incident to the local Metro Police department, per their reporting protocol. ANO #1 stated that around 7:30 or 8:00 PM, Patient #1’s mother reported to staff the incident might have occurred earlier in the hospital stay and it might have been a female. When asked if the hospital had an internal abuse team that would review/investigate, the ANO #1 stated, “We do, but for these type situations, we do an external, because it’s an internal allegation.” ANO #1 stated the local police department would investigate because the allegations were against a hospital employee. ANO #1 stated the local police department met with Patient #1’s mother at the bedside on the night of 5/23/2026. ANO #1 stated a virtual chaperone was initiated for Patient #1 beginning on 5/24/2026. She stated this was a camera in the patient room that was monitored at all times by a Mental Health Technician, as an increased safety precaution. During an interview on 6/2/2026 at 11:21 AM, RN #1 stated she was the Relay Staff Leader in the PICU on 5/23/2026. RN #1 verified RN #2 reported to her the allegation of abuse by a male nurse, made by the family of Patient #1. RN #1 stated she reported this information to her Administrator on Call (AOC) #1 and reported the incident to the patient’s attending physician. RN #1 stated she instructed RN #2 not to discuss the incident with Patient #1. RN #1 stated she met with Patient #1’s mother and informed her the abuse concerns had been reported to hospital management and hospital police. AOC #1 was on personal leave and was not available for interview during the investigation. During an electronic interview on 6/2/2026 at 2:35 PM, ANO #2 verified she was the Interim Float Pool Manager. ANO #2 stated she was notified on the evening of 5/23/2026 that one of the float pool nurses, RN #3, had been named in an incident. ANO #2 stated ANO #1 contacted her to ask her to notify RN#3 he was being placed on paid administrative leave pending a patient safety investigation. ANO #2 stated there had been no issues with RN #3 prior to this alleged incident. During an electronic interview on 6/3/2026 at 8:30 AM, Social Worker (SW) #1 stated she was the on call at Hospital #1 on 5/23/2026. SW #1 stated her only involvement was she received a page through the internal paging system from a nurse that stated a Detective wanted the SW’s contact information. SW #1 stated she was not aware of the reason the police Detective was on-site. SW #1 stated the Nurse did not tell her why the Detective wanted the SW’s contact information. SW #1 stated the nurse did not share any information about alleged abuse. SW #1 stated she did not have a name of the nurse, only a phone number came up for her to call the pager. SW #1 stated she sent an email to the weekend SW (SW #2) on 5/24/2026 at 7:00 AM because her on-call duty ended at 8:00 AM. When asked what the process was for notifying SWs when there was an allegation of child sexual abuse, SW #1 stated, “I don’t know, I would assume someone would tell us if there was sexual abuse if it was someone in community ...if sexual assault by staff member that might go above us [the SWs].” SW#1 was not informed of the allegation of sexual abuse of Patient #1 by a staff member on 5/23/2026 in accordance with hospital policy. During an electronic interview on 6/3/2026 at 9:45 AM, RN #2 verified she was caring for Patient #1 on 5/23/2026 on the day shift. RN #2 stated Patient #1’s mother pressed the call light, and when RN #2 entered the room at approximately 5:30 PM, Patient #1’s mother reported Patient #1 had told her she had been sexually abused during the hospitalization by a nurse who woke her up in the early morning on 5/22/2026 and the nurse had touched Patient #1’s vagina, and vulva and stuck a finger inside her vagina. RN #2 verified the information was reported by Patient #1’s mother. RN #2 stated she informed Patient #1’s mother she had to report the allegation to her supervisor. RN #2 stated she immediately reported the allegation to RN #1, her onsite supervisor. RN #2 stated she entered an incident report into the internal occurrence reporting system. During an electronic interview on 06/03/2026 at 1:15 PM, SW #2 was asked about the alleged sexual abuse incident with Patient #1. SW #2 stated she was first made aware of the alleged incident via an email sent from the overnight on-call SW #1. SW #2 stated she met with Patient #1’s mother on 5/24/2026 while a Department of Child Services (DCS) representative was meeting with Patient #1’s father. SW #2 stated the mother confirmed Patient #1 told her that a male staff member had come into her room and touched her inappropriately the night before. Later that same day, SW #2 had a conversation with a representative from DCS and the mother. The DCS representative stated to SW #2 that Patient #1 had changed the story. The DCS representative stated Patient #1 now said it was a female staff member instead of a male staff member [named a female name]. Patient #1’s parents then stated it could have happened on another floor a few days earlier. SW #2 stated Patient #1 did not provide any details about the inappropriate touching. During an interview on 06/03/2026 at 2:00 PM, the Director of Risk Management was asked about the alleged incident with Patient #1 and the facility investigation. The Director of Risk Management stated, “...I’m not going to be able to discuss individual investigation details because that information is privileged and confidential ...internally, I will only say that I can tell you the process that we followed, but I can’t discuss anything else that we may or may not have done ...we will notify the medical team ...secondly we will notify social work ...we will notify ...police ...we notify [Named organization that provides expert medical evaluations and crisis counseling to children who have experiences sexual abuse] ...We notify our hospital leadership ...It is my understanding that [Named Hospital #1] Police does not investigate this type of allegation so they always turf [redirect a responsibility] it over to [named local police department] to investigate and they take over those types of investigations ...we are ...from that point hands off because we don’t want to do anything that would compromise their ...investigation ...those are the steps we took for this case in particular ...” During an interview on 6/4/2026 at 10:26 AM, the hospital’s Accreditation and Regulatory Specialist #1 verified the first time she learned of the potential name of a female employee as the alleged abuser of Patient #1 was during the electronic interview conducted by the survey team with SW #2 on 6/3/2026. During a second interview by telephone on 6/4/026 at 12:25 PM, SW #2 stated on 5/24/2026, DCS had informed her Patient #1’s story had changed from a male nurse to a female nurse and the patient provided a purported female staff member’s name. When asked if she had informed the nursing staff of the new allegation, SW #2 stated she called the on-call Attorney, who directed her to contact the on-call Risk Manager (RM) #1. SW #2 stated she did share with on-call RM #1 about the change in the allegation from a male to a female staff member. During an electronic interview on 6/9/2026 at 1:30 PM, RM #1 verified he was the on-call RM on 5/23/2026 and 5/24/2026. RM #1 verified he was initially notified by AOC #1 of the allegation of a male staff member sexually abusing Patient #1 on 5/23/2026, and stated he elevated the concern to his supervisor, the Director of RM. RM #1 verified he received a message from SW #2 on 5/24/2026, returned her call the same day and was informed by SW #2 that Patient #1 was now stating it was potentially a female staff member and potentially happened on an earlier day or evening in the hospital stay, not on 5/22/2026. RM #1stated SW #2 did not share a name with him. RM #1 stated he documented the call from SW #2 in the internal occurrence reporting system. During an electronic meeting on 6/9/2026 at 1:50 PM, ANO #1 stated they learned of the allegation on 5/23/2026 at about 5:45 PM, of a male nurse who cared for Patient #1 on the night of 5/22/2026. ANO #1 verified the hospital was not aware of the potential name of the female staff member until the survey team interviewed SW #2 on 6/3/2026. ANO #1 verified that the female staff member’s name should have been shared by SW #2. ANO #1 stated, “We would have liked for that to be shared ...” ANO #1 stated since they had learned about the name of the female staff member during the surveyor’s interview with SW #2, they have since determined there was no staff member employed by the hospital with this name. The hospital failed to follow their own policy/procedure to ensure timely communication of vital information about the change in allegations of sexual abuse among the care team investigating the allegations to ensure a thorough investigation into potential abuse. 4. Review of the forensic interview notes at the local District Attorney’s office of Patient #1’s interview conducted on 6/4/2026, revealed Patient #1 denied making a disclosure of sexual abuse at Hospital #1, and denied telling her mother that she had been abused at Hospital #1. The sexual abuse allegation was found to be unsubstantiated. During a telephone interview on 6/4/2026 at 11:23 AM, with Patient #1’s mother, Patient #1’s mother stated, “At this time we are not going to speak with anyone else.” Patient #1’s Mother declined to be interviewed by the survey team.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 33763 Based on document review, observation, and interview, Nursing Services failed to ensure aseptic technique to decrease the risks of infection were followed by 1 of 1 (Registered Nurse (RN) #1) nurses observed administering medications. The findings included: 1. Review of hospital document, “Standing Operating Procedure Standard Precautions” effective January 2022 revealed, “...Isolation - Infection Precautions to Prevent Transmission of Contagious Infections...Safe injection practices...Medication containers...are entered with a new needle and new syringe, even when withdrawing additional doses for the same patient...Disinfect the medication container with alcohol for each access...” 2. Observations in Random Patient (RP) #1’s room on 3/17/2026 at 9:25 AM, revealed RN #1 preparing to administer Kytril, a medication used to treat nausea to RP #1. RN #1 performed hand hygiene, donned gloves, removed the cap from the vial of Kytril, inserted the needle and withdrew the medication. RN #1 proceeded with the medication administration. RN #1 failed to clean the rubber septum of the medication vial prior to inserting the needle and withdrawing the medication. 3. During an interview on 3/17/2026 at 10:04 AM, the Nurse Manager confirmed staff should clean the rubber septum prior to inserting the needle and withdrawing medication.”

“DISCHARGE PLANNING EVALUATION CFR(s): The discharge planning evaluation must be included in the patient’s medical record for use in establishing an appropriate discharge plan and the results of the evaluation must be discussed with the patient (or the patient’s representative). This Standard is not met as evidenced by: 35244 Based on policy review, medical record review and interview, the facility failed to document discharge plan instructions and post-surgical care education for 1 of 3 (Patient #1) sampled patients reviewed. The findings included: 1. Review of the facility’s “Spine Center SOP [Standard Operating Procedure]-Spine Surgery Same-Day Discharge Criteria” policy (August 2025) revealed, “ ...The surgical team is ultimately responsible for assessment of discharge readiness and entry of discharge home orders ...” Review of the facility’s “Patient and Family Education” policy (July 2024) revealed, “ ...Instructions for discharge or at transition of care given to the patient and family are provided to the individual or organization responsible for the continuing care of the patient ...Education (teaching, learning and assessment) is documented in the electronic health record ...” 2. Medical record review revealed Patient #1 was admitted to the facility’s outpatient surgery center on 2/23/2026 for left L5-S1 (joint where the lumbar spine meets the sacrum) lateral recess decompression (procedure to relieve pressure on spinal nerve roots) with discectomy (procedure to remove herniated disc). Review of “Care Timeline” revealed surgery at 1:16 PM and Patient discharged at 3:56 PM. An “After Visit Summary” with post-operative instructions was found in the Patient’s record. There was no documentation the Patient was provided the instructions, no documentation surgery center staff went over the instructions with the Patient and no documentation the Patient understood the post-operative instructions. In an interview on 3/5/2026 at 11:00 AM, RN #1 verified she had printed off Patient #1’s discharge paperwork, but never did one on one teaching. RN #1 verified discharge teaching was normally done while a patient was still in the Post Anesthesia Care Unit (PACU). RN #1 stated RN #2 was going to give the Patient the paperwork as he left the surgery center parking lot. In an interview on 3/5/2026 at 12:30 PM, RN #2 verified she attempted to give the discharge paperwork to Patient #1, but the Patient refused to take the paperwork. In an email correspondance on 3/5/2026 at 3:43 PM, Accreditation and Regulatory Specialist #1 verified there was no documentation in Patient #1’s medical record related to discharge instructions or refusal to accept discharge paperwork.”

“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: 49570 Based on review of facility policy, medical record review, review of facility documents, and interview, the facility failed to ensure nursing staff secured medications after removal from the medication storage room and maintained control of medications prior to patient administration. Nursing staff left a vial of insulin (medication used to regulate blood sugar) and a syringe unattended at the nurses ’ station, accessible to patients. A psychiatric patient (Patient #19) obtained the insulin prior to staff intervention. This failure placed 1 of 1(Patient #19) patients at risk for serious harm, including inappropriate self-administration of insulin, which could have resulted in hypoglycemia (low blood sugar), altered level of consciousness (temporary sudden loss of awareness), seizure (sudden, uncontrolled disruption of the brain ’ s electrical activity), or death. The findings revealed: 1. Review of facility policy titled “Medication Storage and Handling” effective May 2024, revealed, “ ...Medications are stored and handled in a manner that: ...D. Reduces the potential for medication error ...IV. Specific Information ...S. Medications are obtained from locked medication storage areas...1. Once removed, medications are not left unattended...” 2. Review of facility medical record for Patient #19 revealed an admission date of 12/05/2025 to the facility Psychiatric Unit with diagnoses which included: Psychosis (symptoms indicating a loss of contact with reality) and Type 1 Diabetes Mellitus (chronic condition causing high blood sugar) with hyperglycemia (increased blood sugar). Documentation reflected Patient #19 was unable to safely manage his diabetes and demonstrated poor judgement choices throughout his facility stay such as poor eating habits that increased his blood sugar levels, and attempting to self-medicate with insulin. 3. Review of facility document “Medication Incident Report” dated 12/11/2025, revealed an incident for “unsecured medication” on the Adult 3 floor. The report stated a vial of insulin and needle was found in Patient #19 ’ s jacket after he reportedly picked up the two items because he felt facility staff was not able to effectively manage his diabetes, and he believed he could “do better”. At the time of discovery, Patient #19 had a blood glucose level of over 400 (normal range 160-180) indicating hyperglycemia (high blood sugar). Review of facility investigation revealed no documentation was provided by the facility that reflected an internal investigation had occurred and no documentation was provided that reflected staff had been re-educated on the handling of medications once removed from the medication storage room. 4. During an interview on 02/19/2026 at 12:15 PM, the Chief Nursing Officer was unable to provide details regarding the 12/11/2025 incident in which Patient #19 obtained unsecured insulin, including actions taken to investigate the event or prevent recurrence. See A-0405”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 49570 Based on review of facility policy, review of facility documents, medical record review, and interview, the facility failed to ensure nursing staff prepared, secured, and maintained control of medications in accordance with facility policy. Nursing staff prepared medications for multiple patients at one time and left the prepared medications unattended in 1 of 2 (Adult 3 medication room) medication storage rooms. Additionally, nursing staff failed to maintain control of medications after removal from the medication storage room when a vial of insulin and a needle were left unattended at the nurses ’ station and accessible to patients. A psychiatric patient (Patient #19) obtained the insulin and insulin syringe with needle prior to staff intervention. These practices did not ensure the integrity, security, or accurate administration of medications and created the potential for medication errors, accidental ingestion, diversion, or inappropriate self-administration. The findings revealed: 1. Review of facility policy titled “Medication Storage and Handling” effective May 2024, revealed, “ ...Medications are stored and handled in a manner that: A. Maintains medication integrity...C. Minimizes the risk of diversion; and D. Reduces the potential for medication error ...IV. Specific Information ...S. Medications are obtained from locked medication storage areas (e.g., ADS [automated dispensing systems]) or containers immediately prior to administration of the product and for one patient at a time. 1. Once removed, medications are not left unattended. 2. If the medication has been obtained, but unable to be given to the patient immediately, the medication is returned to the appropriate storage area as soon as possible...” 2. Review of facility medical record for Patient #19, revealed an admission date of 12/05/2025 to the facility Psychiatric Unit with diagnoses which included: Psychosis (symptoms indicating a loss of contact with reality) and Type 1 Diabetes Mellitus (chronic condition causing high blood sugar) with hyperglycemia (increased blood sugar). Documentation revealed Patient #19 suffered a traumatic brain injury (disruption in normal brain function) 3.5 years ago that resulted in episodes of illogical thoughts and poor judgement. In order to manage his Diabetes, he had been prescribed 1.0 to 1.5 units of insulin for home use and had been prescribed 1.0 to 6.0 units of insulin at the facility. However, documentation reflected Patient #19 was unable to safely manage his diabetes independently at home and further demonstrated that lack of accountability and poor judgement throughout his facility stay with blood sugar ranges consistently higher than normal blood glucose levels, poor eating habits, and attempting to self-medicate with insulin. 3. Review of facility document “Medication Incident Report” dated 09/21/2025, revealed medications that had been prepared for a patient who refused administration were later found stored improperly. The report indicated the medications were located in a drawer in a cup labeled with patient initials and room number and had not been returned to appropriate medication storage. The incident report did not include documentation that identified the staff member who found the medications or the specific location as to where the medications were located upon discovery. Review of facility document “Medication Incident Report” dated 12/11/2025, revealed an incident for “unsecured medication” occurred on the Adult 3 floor. The report stated a vial of insulin and needle was found in Patient #19 ’ s jacket after he reportedly picked up the two items because he felt facility staff was not able to effectively manage his diabetes and he believed he could “do better”. At the time of discovery, Patient #19 had a blood glucose level of over 400 (normal range 160-180) indicating hyperglycemia. Review of facility investigation revealed no documentation could be provided by facility that reflected an internal investigation had occurred and no documentation could be provided that reflected staff had been re-educated on the handling of medications once removed from the medication storage room. 4. During an interview on 02/18/2026 at 2:45 PM, Registered Nurse #1 stated she had witnessed multiple cups of patient ’ s medication being left unattended in the medication room. She denied reporting the unattended medications to a supervisor or placing the medication back into the Medication Dispensing System. During an interview on 02/18/2026 at 3:15 PM, Registered Nurse #2 stated he had witnessed multiple cups of patient ’ s medication being left unattended in the medication room. She denied reporting the unattended medications to a supervisor or placing the medication back into the Medication Dispensing System. During an interview on 02/19/2026 at 9:30 AM, Registered Nurse #3 stated she had witnessed multiple cups of patient ’ s medication being left unattended in the medication room. She denied reporting the unattended medications to a supervisor or placing the medication back into the Medication Dispensing System. During an interview on 02/19/2026 at 12:00 PM, the Manager of Patient Care Services for Adult Unit 2 stated she had followed up with nursing staff regarding medication incidents with either education or a verbal warning. However, she could not provide any documentation to confirm the education was provided and/or the verbal warnings were administered. She confirmed facility policy was to only pull medications for one patient at a time and to not leave medications unattended once they had been pulled. During an interview on 02/19/2026 at 12:15 PM, the Chief Nursing Officer (CNO) confirmed it was not facility policy for nurses to pull medications for multiple patients at the same time or to leave them unattended once pulled. The CNO was unable to provide details regarding the 12/11/2025 incident in which Patient #19 obtained unsecured insulin, including actions taken to investigate the event or prevent recurrence. During an online interview on 2/20/2026 at 1:30 PM, the CNO stated Patient #19 managed to get the insulin and needle to his room. The CNO stated the nurses then identified the medication was missing, and the nursing staff located the medication in Patient #19 ’ s jacket pocket while he was in his room.”

“Evacuation and Relocation Plan CFR(s): NFPA 101 Evacuation and Relocation Plan There is a written plan for the protection of all patients and for their evacuation in the event of an emergency. Employees are periodically instructed and kept informed with their duties under the plan, and a copy of the plan is readily available with telephone operator or with security. The plan addresses the basic response required of staff per 18/19.7.2.1.2 and provides for all of the fire safety plan components per 18/19.2.2. 18.7.1.1 through 18.7.1.3, 18.7.2.1.2, 18.7.2.2, 18.7.2.3, 19.7.1.1 through 19.7.1.3, 19.7.2.1.2, 19.7.2.2, 19.7.2.3 This Standard is not met as evidenced by: 50784 Based on document review and interview, the facility failed to follow the adopted emergency plan and include all required components in the plan. The finding includes: Interview with facility staff and administration on 01/06/2026 between 10:30 AM and 12:30 PM, revealed that during the fire emergency that occurred on 12/21/2025, the facility failed to follow their associated fire and emergency policies, including activation of the fire alarm system and notification of the emergency. Document review conducted on 01/08/2026 between 8:00 AM and 12:00 PM, revealed the facility timeline of the event showed the fire was discovered at 07:10 AM, the fire alarm did not activate until 07:19 AM, and the fire department was not contacted until 07:28 AM. It also revealed that the fire was discovered and extinguished by staff without calling a red alert or manually activating the fire alarm pull station in the vicinity of the fire. NFPA 101, 19.7.2.1.2 (2012 Edition) Document review on 01/08/2026 between 8:00 AM and 12:00 PM, revealed the facility’s fire alarm response procedure and fire safety red alert procedure do not include transmission of alarms to the fire department and an emergency phone call to the fire department. NFPA 101, 19.7.2.2 (2)&(3) (2012 Edition) This finding was acknowledged by the Accreditation and Regulatory Specialist during the phone exit conference on 01/15/2026.”

“Gas and Vacuum Piped Systems - Maintenance Pr CFR(s): NFPA 101 Gas and Vacuum Piped Systems - Maintenance Program Medical gas, vacuum, WAGD, or support gas systems have documented maintenance programs. The program includes an inventory of all source systems, control valves, alarms, manufactured assemblies, and outlets. Inspection and maintenance schedules are established through risk assessment considering manufacturer recommendations. Inspection procedures and testing methods are established through risk assessment. Persons maintaining systems are qualified as demonstrated by training and certification or credentialing to the requirements of AASE 6030 or 6040. 5.1.14.2.1, 5.1.14.2.2, 5.1.15, 5.2.14, 5.3.13.4.2 (NFPA 99) This Standard is not met as evidenced by: 50784 Based on interview and document review, the facility failed to maintain their medical gas equipment. The finding includes: Interview with the Senior Director of Facilities Management on 01/06/2026 between 11:30 AM and 12:00 PM, revealed the facility failed to maintain the medical gas equipment. During the interview, the Senior Director of Facilities Management stated that the technician responsible for changing the filters on the medical gas vacuum pump was unaware that the exhaust filters existed, and therefore did not change them. The Senior Director of Facilities Management further stated that the facility believed the fire was caused due to overheating of the pump from obstructed exhaust filters. Document review between 01/08/2026 and 01/09/2026, revealed the facility’s Inspection Work Order dated 10/31/2025 states in part, to change the exhaust filter every 6 months or 2000 hours of operation. This work order was marked as completed by the technician on 11/25/2025. The associated procedure instructions for this task did not mention inspecting or changing intake or exhaust filters. Further document review revealed the vacuum pump manufacturer’s instructions include changing the exhaust filter every 6 months or 2000 hours of operation. NFPA 99, 5.1.14.2.2.4 (2012 Edition) NFPA 99, 5.1.14.2.2.5 (2012 Edition) This finding was acknowledged by the Accreditation and Regulatory Specialist during the phone exit conference on 01/15/2026.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 37530 Based on review of hospital documents, policy review, medical record review, and interview, the facility failed to ensure patient rights were protected and patients received care in a safe setting for 2 of 6 (Patient #10 and #44) sampled patients reviewed for falls. The findings included: 1. Review of the undated “Targeted Toileting Scripting Examples,” revealed “ ...Your safety is a priority for us as we work together to help you heal during your stay. We will keep you safe from falling by always escorting you to and from the bathroom. We will provide you with as much privacy as possible while in the bathroom, but your safety is most important. So, we will remain within arm’s reach or line of sight to keep you safe from falling ...” Review of the “Let Us Help You Stay Safe Signage,” revealed “ ...Don’t go to the bathroom alone. Let a nurse or caregiver help you get back to the bathroom, stay close by while you go, and help you back to bed. This is very important to make sure you don’t fall ...” 2. Review of the policy titled “Falls Prevention Policy,” dated February 2024, revealed “ ...Fall ... A patient fall is a sudden, unintentional descent, with or without injury to the patient, that results in the patient coming to rest on the floor, on or against some other surface ... ( ...a counter), on another person, or on an object ( ...a trash can). This includes all types of falls, whether they result from physiologic reasons ( ...fainting) or environmental reasons ( ...slippery floor) ...Medications with High Potential for Contributing to Patient Falls ...Consider medications with high potential for contributing to patient falls ...hypnotics and sedatives ...Fall Prevention Reference Chart ...HIGH FALL RISK Maintain low interventions, moderate interventions AND do the following ...Education family/patient every shift about high fall risk status and why they need to call for assistance, Closely monitor/protect/engage the patient, Remain with patient during toileting, Provide bedside toileting devices if needed, Assist with ambulation and transfers, Bed alarms/chair alarms where appropriate, Toileting schedule (individualized or per unit protocol), Provide yellow non-skid footwear, Laminated high fall risk sign, if feasible, Yellow high fall risk armband, For patients/families unable or unwilling to participate in the fall prevention program, consider a sitter ( ...virtual sitter or in-person sitter) ...” 3. The hospital failed to ensure care was provided in a safe setting for Patient #10 and Patient #44 out of 6 sampled patients. Patient #10 was found on the floor at a friend’s house on 4/15/2023 and was taken to an outside hospital where she was found to have a subdural hematoma (a pool of blood between the brain and its outermost covering) with a midline shift (a life-threatening condition that occurs when brain tissue is displaced across the brain’s center line). Patient #10 was intubated at the outside hospital and transferred to Hospital #1 for a higher level of care. Patient #10 was assessed as a high fall risk and was placed on fall precautions and remained a high fall risk until discharge. On 4/25/2023 at approximately 11:53 AM, Patient #10’s bed alarm sounded, and Registered Nurse (RN) #2 entered the room to find Patient #10 standing halfway to the bathroom while still connected to telemetry, pulse oximetry and the blood pressure monitor. RN #2 disconnected the monitors from Patient #10 and assisted her to the commode. After Patient #10 urinated, she stood up next to RN #2 and asked to wash her hands. Patient #10 then fell away from RN #2 and landed on her hip on the bathroom floor and hit her forehead on the floor. Immediately after the fall, Patient #10 was alert and oriented X4, and neurological checks were unchanged. RN #2 assisted Patient #10 back to bed, and Patient #10 was assessed to be hypertensive on subsequent vital sign checks. RN #2 administered 2 doses of intravenous hydralazine (blood pressure medication), and a stat computerized tomography (CT) was ordered. The CT scan revealed Patient #10 had a new right subdural hematoma. Upon arriving back on the floor following the CT, Patient #10 became more somnolent, had snoring respirations, and her pupils became dilated. Patient #10 was intubated and transferred to the operating room for an emergent craniotomy (removal of portion of the skull for brain surgery). RN #2 failed to ensure Patient #10 safety by assisting Patient #10 to the bathroom alone and failed to use the bedside commode as recommended. Patient #44 was admitted to the hospital on 3/28/2025, with diagnoses including Syncope and Idiopathic Intracranial Hypertension (increased pressure in fluid surrounding brain). Patient #44 was assessed as a high fall risk and was placed on fall precautions. Review of the “Medication Administration Record,” revealed Patient #44 received Benadryl on 3/30/2025 at 11:00 PM. Benadryl (sedative) is considered a high-risk drug for falls. Review of the “Significant Event Note,” dated 3/31/2025 at 4:56 AM revealed Care Partner (CP #3) instructed Patient #44 to wait while she got help from the nurse in order to move her safely given her baseline weakness. When CP #3 left the room, Patient #44 fell out of the bed and landed on her shoulder on the floor. CP #3 failed to ensure Patient #44’s safety by leaving Patient #44 alone in her room to get the nurse. Refer to A-144”

“PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION CFR(s): 482.13(a)(2)(iii) At a minimum: In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. This Standard is not met as evidenced by: 32777 Based on policy review, medical record review, My Health at (Named Hospital #1) review and interview, the facility failed to follow its policy for resolution of grievances related to time frames for patient termination for 1 of 3 (Patient #45) sampled patients. The findings include: 1. Review of a facility policy titled, “Termination of Clinician-Patient Relationship: Patient Discharge Process” dated September, 2023 revealed, “...Circumstances that may justify ending the Clinician-Patient relationship include...Persistent patterns of not showing up to appointments and not following prescribed treatments or recommended care when non-adherence is a risk to the patient’s health...Patient Notification...For Level 1 and Level 2 terminations, 30 days’ notice from the date of the letter is the minimum notification period...The patient termination letter includes...Level 1 and Level 2 termination letters specify whether the patient has any appointment in the next 30 days, and, if so, the Clinician or a member of the Clinician’s department will meet with the patient to discuss transition plans...” 2. Review of the closed medical record revealed Patient #45 was seen as an outpatient at Hospital #1 Dermatology Clinic multiple times beginning in July, 2022 through March 2024 for a diagnosis of melanoma and Basal Cell Carcinoma (BCC) lesions. There was a gap in treatment from Hospital #1 Dermatology Clinic from September, 2022 until November, 2023 with no documentation any treatment was done at any facility for the melanoma and the other BCC lesions identified in the medical record. Review of the My Health at (Named Hospital #1) communication dated July, 2022 through August, 2022 revealed 6 communication entries from Patient #45 to different staff members at Hospital #1. There was documentation of 7 communication entries from multiple staff members to Patient #45 during the same time period regarding surgical appointments and the need for treatment for the melanoma and BCC lesions. A note from staff member #1 dated 8/12/2022 revealed, “...I have you scheduled Tuesday August 16, 2022@ 10 am with [Named Physician #1] for a consult and to answer any and all questions you have...” A note dated 8/19/2022 titled, “SURGERY SCHEDULED” revealed, “Would you be able to come in on 10/19 @9:00 for your surgery...Please let me know if the above date and time will work for you...” On 8/19/2022, Patient #45 responded, “...I need FT [Full Time] professional work with a living wage and medical benefits with an employer that recognizes my credentials. [Named Hospital #1] does not recognize my credentials...and neither do the other TN [Tennessee] employers. I’m told that in TN, jobs are secured by WHO you know, not WHAT you know. Therefore, I need to get work in a place that hires based on qualifications. For the record, I need Mohs, [A specialized surgical procedure used to remove skin cancer. This technique allows for precise removal of cancerous tissue while sparing healthy tissue, leading to a high cure rate and minimal scarring.] melanoma care...But because [Named Hospital #1] and other employers in TN will not hire me, I am unable to preserve and restore my health without an income.” There was a gap in treatment for Patient #45 from September, 2022 until November, 2023 with no communication documented in My Health at (Named Hospital #1). Review of the My Health at (Named Hospital #1) communication from November, 2023 through March, 2024 revealed approximately 20 communication entries from Patient #45 to different staff members at Hospital #1. Review of the My Health at (Named Hospital #1) communication from November, 2023 through March, 2024 revealed communication entries from multiple staff members to Patient #45 during the same period regarding the continued need for treatment for the melanoma and BCC lesions. There were multiple communication entries between physicians and other staff members regarding Patient #45’s need for treatment and how that treatment and surgeries could be accomplished. Review of the My Health at (Named Hospital #1) note from Physician #2 revealed, “12/05/23...Please reschedule pt [patient] for the procedures we planned on when we saw her last in 2022-she canceled the scheduled procedure an did not follow up. The melanoma is in [Named Physician #3’s] territory And please confirm with [Named Physician #2] what else he wants us to schedule for tx [treatment] in Mohs [a specialized surgical procedure for removing skin cancer].” Review of the My Health at (Named Hospital #1) note from Physician #3 revealed, “12/20/23...seen in July, 2022. I discussed options for management including wide excision and wide excision with sentinel node [the first lymph node that cancer cells from a primary tumor are likely to spread to] biopsy. The patient had multiple...social issues and was living in her car at that time. She was offered Social Work...but the patient declined those interventions. At the completion of our discussion, she elected to proceed with wide excision in clinic. Multiple attempts were made to schedule this but the patient failed to respond. She was counseled that melanoma is a malignancy with potential to spread and is therefore life threatening...PLAN: The patient has a history of melanoma of the right calf. I reviewed the diagnosis with the patient and clearly articulated again that this is a life threatening malignancy which requires treatment I discussed the options for surgical management again...I favored wide excision for local control. WE also discussed the recurrent skin lesion of the chest which is consistent with basal cell carcinoma. I recommended conservative excision for this local control. After considering the risks and benefits for surgery, the patient declined to schedule surgery. Her rational for this was illogical in inconsistent. She stated that her major concerns were the fact that she did not have a job or health insurance and felt that she was being discriminated against for several reasons. I explained that she was approved for care through OORA [Office of Outpatient Referral Assistance] and that I was happy to perform the procedure free of charge if she would simply schedule it. She declined to do so stating that she did not have money for gas to get to the procedure. When I asked her how she was able to come to the appointment today, she stated that a church gave her a gas card...When I offered to help her obtain a gas card through [Named Hospital #1’s] Social Work, she declined this stating that the state of TN and [Named Hospital #1] were “trying to keep her on welfare”. I again offered to provide care free of charge, but she declined stating that she was unwilling to do so until “her other needs were met” by obtaining a job and heath insurance. This circular discussion was repeated three times over a span of at least 15 minutes. the end of the discussion, I wished the patient well and told her that I would be happy to perform the surgical procedure if she reconsidered decision in the future. No additional Surgical Oncology follow up was scheduled, but I would be happy to see her again if she is willing to proceed with surgery...” Review of the My Health at (Named Hospital #1) note from Nurse #2 to Physician #1 revealed, “1/19/24...She is scheduled for Mohs to treat BCC [Basal Cell Carcinoma] on chest on 2/8/24...” Review of the My Health at (Named Hospital #1) note from Nurse #3, “1/23/24...Patient called...for lodging left a message. I have called back, we talked about hotels, missions. Per patient is living in her car and homeless...” Review of the My Health at (Named Hospital #1) note from Licensed Social Worker #1 to Patient #45 revealed, “1/24/24...I wanted to encourage you to use the services at the Women’s Shelter at the Rescue Mission. Their number is...and the address is...I hope you use their services. Their new facility sounds really nice.” Review of the My Health at (Named Hospital #1) response note from Patient #45 to Licensed Social Worker #1 revealed, “1/24/24...I’ve notified my medical team that you expressed unfamiliarity with my background and an inability to make recommendations for my situation...I would like to formally request the removal of any shelter recommendations from my...record, as these were not discussed or agreed upon during our conversation. I am in need of professional assistance that takes into account my unique background, education, skills, and needs to develop an individualized care plan...It is crucial for me to work with professionals who understand the importance of market-rate solutions rather than focusing solely on FPL [Federal Poverty Level] low-income programs. It is unacceptable to be directed towards Low-income programs...” Review of the My Health at (Named Hospital #1) note from Patient #45 to Physician #1 revealed, “1/25/24...I received unsolicited advice that has nothing to do with my immediate needs. I asked that only my medical doctors and nurses have access to my chart. I kindly ask that you remove your notes from my chart. We did not discuss any of this, My file notes mention that social workers only offer FPL temporary, unsafe low-income solutions that do not match my market rate needs and don’t acknowledge my advanced education and professional experience...” Review of the My Health at (Named Hospital #1) note from Patient #45 to Physician #1 revealed, “2/05/24...I am very grateful for your time and kindness to help me with my very painful basal cell carcinoma...no one on my medical team is offering me help with my post-operative accommodation needs. I had to reach up higher to advocate for myself because I care about my health and desire to work...” Review of the My Health at (Named Hospital #1) note from Patient #45 to Physician #1 revealed, “2/08/25 [date of scheduled surgery] Regarding my scheduled surgery for basal cell skin cancer at the Mohs clinic on Thursday, 2/8/24, I was unable to proceed as planned. [Named Director of Patient Services] informed me on 2/7/2024 that [Hospital #1] had no provisions for my outpatient post-operative care. He stated that there were no resources available to assist me during this critical period...” Review of the My Health at (Named Hospital #1) note from staff member #1 revealed, “2/14/24...spoke with [Named Patient #45]...She was needing help with appts. [appointments]. I was able to call over to the MOHS clinic and get her 3/5/24 apt with [Named Physician #1] rescheduled to this Friday 2/16/24 at PM. She was aware of this appt and where to go, as well as her appt tomorrow 2/15/24 with [Named Physician #5] She is also aware after confirming with FC [Financial Counseling] that her FA [Financial Assistance] has been approved thru early July [2024]. She discussed multiple things with me voicing many frustrations she has had in the past with [Named Hospital #1] including patient relations as well. I told her I would try to look into some outside resources for her that could be beneficial to her.” Review of the My Health at (Named Hospital #1) note from Patient #45 to Physician #1 revealed, “2/25/24...The vulnerable deserve genuine support, not exploitation. I refuse to be treated as a commodity for the enrichment of nonprofits and state agencies. I will continue to share my experiences publicly, both within and outside Tennessee, in the hope of exposing the unethical and unjust circumstances I have faced as a competent, capable, and ethical woman...” Review of an email sent from the Director of Patient Relations to Patient #45 on February 28, 2024 at 8:38 AM revealed, “... Dear [Named Patient #45], Thank you for responding to my messages. No, [Named Hospital #1] is unable to provide you with hotel accommodations after your procedure. While we are not at all unsympathetic to your plight, please accept this as I have communicated this with you on several occasions and it will not change. I believe our social workers have provided you with information regarding services in the community. Do you need me to resend that information? Additionally, I need to know by 9:00 am this Friday, March 1 if you plan to keep the appointment for this procedure on March 5. Another no-show is unfair to the other patients we ’ re attempting to serve and will result in discontinuation of all services from [Named Hospital #1] Dermatology. Review of an email sent from Patient #45 to the Director of Patient Relations and Tennessee Legislators on February 28, 2024 at 8:03 PM revealed, “I am deeply troubled by the unprofessional behavior I have experienced from...the Director of Patient Relations. On February 7, 2024, just one day before my scheduled medical procedure, [Named Director of Patient Relations] informed me that [named Hospital #1] had no postoperative solutions available to meet my needs. This lack of communication and last-minute notification left me with no time to find an alternative solution and ultimately led to the cancellation of my surgery...I request Named Hospital #1] to work with me to find an appropriate discharge planning option that addresses my needs and protects my health and safety...” Review of the My Health at (Named Hospital #1) note from Physician #1 to staff member #4 revealed, “2/29/24...Send patient our notes on post op wound care. If she wants to speak with me, make her an appointment but tell her I will not get involved in her political agenda...” Review of the My Health at (Named Hospital #1) note from Patient #45 to Physician #1 revealed, “2/29/24...I very much need the surgery...[Named Social Worker #1] entered unauthorized notes into my chart stating she discussed discharge planning with me which wasn’t true...As a middle aged woman, [Named Hospital #1] and most of all TN employers self-fund their medical insurance plans and refuse to hire me at [age] so I can have both an income and insurance. The state wants people unemployed & dependent on govt [government] programs & nonprofit social services to general Federal aid for its funding budgets. I need to be working. I need discharge planning accommodations. [Named Social Worker #1] wrote notes in my chart unrelated to my discharge needs. No one at [Named Hospital #1] will discuss that with me. Can you call me so I can discuss my discharge planning needs with you before the 3/5/24 surgery...” Review of an email sent from the Director of Patient Relations to Patient #45 on March 1, 2024 at 12:01 PM revealed, “Good Afternoon...We sincerely regret the need to cancel your appointment next week with [Named Physician #1]. You will receive a letter from the department in the mail. Thank you...” Review of a termination letter dated 3/01/2024 from the Chair of Named Hospital #1 Dermatology to Patient #45 revealed, “I write to inform you that [Named Physician #1] and the clinicians of Vanderbilt Dermatology are unable to continue as your health care providers. Your appointment with [Named Physician #1] on March 5, 2024 has been canceled and no future appointments or procedures will be scheduled unless you have an urgent need for care in the next thirty days...Please note [Named Physician #2’s] discussion with you on February 27, 2024 in which he emphasized the importance of seeing surgical oncology for definitive surgical treatment of the malignant melanoma on your right calf. Failing to treat this malignancy is against our best medical advice...Also note the untreated basal cell skin cancers that were biopsied in the summer of 2022 on the left forearm, right shoulder, and left neck, and discussed with [Named Physician #1] on Dec 2023. At that time you declined to schedule further follow-up for these cancers except for the chest lesion. We would recommend that you have these lesions evaluated...” The facility did not follow the “Termination of Clinician-Patient Relationship: Patient Discharge Process” which stated a 30 day notice from the date of the termination letter is the minimum notification period. Patient #45’s scheduled surgery for 3/5/24 was canceled by the facility 5 days after the date of the termination letter dated 3/1/24 and was within the 30 day minimum notification period. Review of the My Health at (Named Hospital #1) note from Patient #45 to Physician #1 revealed, “3/02/24...On 2/8/24 I was denied Mohs surgery that was scheduled. It was rescheduled for 3/1/24, but I was denied once again by [Named Physician #1] (as per [Named Director of Patient Relations] due to a lack of discharge planning support...” Review of the My Health at (Named Hospital #1) note from Patient #45 to Physician #2 revealed, “3/04/24...My Mohs surgery was scheduled on 3/5/24 and [Named Director of Patient Relations] called 3/1/24 to cancel it. Despite these challenges, my primary concern lies with the dismissal of my requests for suitable and private discharge planning accommodations that can facilitate my medical care...” Review of the My Health at (Named Hospital #1) note from Physician #2 to Patient #45 revealed, “3/05/24...Unfortunately, [Named Physician #1] has decided to remove you from the [Named Hospital #1] Dermatology clinic. I think a letter has been sent to you that should detail the reasons for this decision...I strongly recommend that you get ALL of these treated as soon as you can. I am sorry things have gone this way...” Review of the My Health at (Named Hospital #1) note from Patient #45 to Physician #2 revealed, “3/05/24...[Named Hospital #1] approved my surgery under charity care and then rescinded it simply because I requested assistance with discharge planning,..” During a telephone interview on 4/22/25 beginning at 1:30 PM, Patient #45 stated, “... I’m speaking up for myself because I have to so the only solution for me to get out of my situation is market rate living wage income...I know how to solve my problem I know how to solve homelessness but nobody will allow me to work in those positions and exercise my knowledge including experiential because they don’t want to solve the the homeless problem. I was pushed into poverty. I didn’t come to Tennessee like this I was pushed down into it and denied health care so they engineered poverty in this state by doing exactly what they’ve done to me, and the reason why I’m being silenced is because if anybody speaks to me whether it’s the media or anybody and they see a lucid sober sane non drug addicted non mentally ill person with a masters degree from private schools homeless, then that means the system does not work. when I was scheduled to have my surgery [Director of Patient Relations] created interference so that I couldn’t communicate with my medical team...I’m in my car, I couldn’t have surgery and then go back to my car...I wrote [Named Previous Board Member at Hospital #1] a letter and I said, “I did volunteer work at your upscale [Named Senior Living facility] and I said, would you help me get into a Marriott a Hyatt or Hilton Hotel for one to two months so I can recover from my surgeries and heal and get back in the workforce. That’s all I want. You know that costs them [Hospital #1] nothing. Corporate hotel rates...that’s not going to break them or bankrupt them I said, but could you put me up in a respectful hotel because I can’t be in a shelter with people that have mental health problems, their own trauma and addictions. That’s not suitable for me because that’s not my background”... why am I being treated this way. It’s inhumane, it makes no sense to me. I’m in a very unusual situation, probably something you’ve never come across. I’m actually a [named age] year old woman who’s never married and child free and not from here originally, and I’m denied employment because of my pre-existing health issues that are not disabling so nobody will hire me with these conditions to work and earn the money to pay for the medical care not even [Named Hospital #1] would hire me...I said why don’t you do an MRI [Magnetic Resonance Imaging is a technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body] or PET scan [Positron Emission Tomography diagnostic imaging test that uses radioactive tracers to show how the body’s tissues and organs are functioning] or you know some sort of standing evaluation before you cut open my leg, can we do that. There is a step before that wide open excision that you can do, you can either take my blood or you know do a PET scan, CT scan [Computed Tomography imaging test that detects diseases and injuries] or MRI, one of those things on my leg and they didn’t want to do that because that doesn’t generate enough money, so I said, how about this my body my choice. I spoke their liberal language, my body my choice and I said I want to get back to work so why don’t we focus on the MOHS surgeries first, it’s cheaper and on my face and my neck and my left temple, because I have another basal cell my left temple they have biopsied...And I said let’s do that so that I can get back to work put me in a hotel for a month or two so I can recover, because I’m a professional and I’ve histoplasmosis [a lung infection]. I can’t be around other immunocompromised homeless speaking intelligently and using my education, so I said I don’t authorize that because I deserve better. I do, so they retaliated against me because I challenged their malignant Melanoma diagnosis, they did...Then I would go to the emergency room with my untreated medical conditions, they trained their medical team to threaten me with death; you know if you don’t get your wide open excision to have [Named Physician #3] look at your lymph node to see if it’s cancer you could die. I said really you don’t think I know anything about this, you’re not asking me what I know that I think and what I need, because...you’re talking at me. I said remember we are in Nashville and this is liberal my body my choice. I’m speaking your language here, I want my Mohs skin cancer done so that I can be presentable to go back in the workforce and then I can contribute to the cost of my medical care. I come from the conservative background and that’s what we do and and then I can worry about my malignant Melanoma diagnosis later. My body my choice, it’s a bipartisan issue so they don’t get it and I’m really not that impressed with [Named Hospital #1]...” During a TEAMS (virtual audio and/or video conferencing to communicate and have conversations) interview on 4/24/2024 beginning at 1:45 PM, the Associate Director of Patient Relations stated, “...I understand [Director of Patient Relations] had communication with [Named Patient #45] for several years and has done a lot to try to help help her unique situation and leading up to the case in dermatology he was able to help encourage her to reach out to our financial assistance department and work together with them to get her some financial assistance with some of the needs that she had. [Named Director of Patient Relations] did a lot of work to help help...the dermatology situation. [Named Patient #45] was asking for help with things outside of our scope so she was asking for discharge planning care which included a hotel stay for her recovery, gas cards, employment so that she could eventually pay for all of these things, and on several occasions [Named Director of Patient Relations] was able to say that’s something that’s beyond our scope and aren’t able to help with that, but here are some resources that you can tap into to help...Her messages started to escalate and got continual and persistent and there was nothing that was clinical in nature, it was all always about how she was being kept down and how she needed to have a hotel stay and gas cards and employment in order to have her clinical needs met...I do know that between January 20th and March 2nd she sent us 19 different lengthy e-mail messages all asking for the same thing. I know of at least 5 responses that were documented from [Named Director of Patient Relations] reiterating each time that we could not accommodate her requests for hotel stays and gas cards...so [Named Patient #45] didn’t show up for her MOHS procedure on February 8th after several conversations letting letting her know that we couldn’t accommodate the recovery process that she wanted. She did not show up for the MOHS procedure... They did reschedule that for the next month and there was condition that she not ask continually or vent continually about her situation and her unique needs that [Named Hospital #1] wasn’t providing. It was from that point on that the emails started being lengthier...repetitive and persistent and it got to the point where that just degraded the relationship between the physician and the patient and at that point the physician no longer felt comfortable offering care and asked to move forward with the dismissal...we felt it was appropriate to pursue a dismissal from the clinic... During a TEAMS interview on 4/28/25 beginning at 9:00 AM, Physician #2 stated, “...So I met her first in clinic. I do general dermatology as well as dermatopathology so I saw her in the general dermatology clinic...she had several skin cancers biopsied at that visit some with basal cell carcinomas and then she had a a melanoma biopsy from her leg. We referred her both to the MOHS [a specialized surgical procedure for removing skin cancer] micrographic surgery team for the basal cell carcinomas and then the for the melanoma we sent her to surgical oncology. I followed her from a chart perspective just to make sure I have the melanoma was taken care of. She was sent to [Named Physician #3] oncology. She refused therapy to have it excised...she was lost to follow up... [Patient #45] came back and again not have them treated. At that point, so we tried to impress upon her the danger of letting the melanoma just kind of hang around to her general health and then she had some biopsies of some basal cell carcinomas we encouraged her to go back to surgical oncology...she was so anti treatment for whatever reason...the next thing I heard was that she was being dismissed from our clinic...I didn’t know why that was happening...so then I had to tell her you need to get all this treated, unfortunately you’re going to have to seek treatment outside of [Named Hospital]. These are serious conditions though. You need to find another clinic to do it. At that point I didn’t know everyone has tried to get her insurance coverage or get someone to help with this. I didn’t know where she stood when she left [Named Hospital] in terms of treatment so it’s kind of on her to try to find that other provider to to help because I feel like we had done quite a bit at [Named Hospital]. I know I had my nurse and I had talked to her...like war and peace level emails, and didn’t seem like we’d gotten anywhere...it’s an unfortunate case...””

“PATIENT RIGHTS: PERSONAL PRIVACY CFR(s): 482.13(c)(1) The patient has the right to personal privacy. This Standard is not met as evidenced by: 37530 Based on review of hospital documents, policy review, medical record review, and interview, the facility failed to ensure patient rights were protected and patients received care in a safe setting for 2 of 6 (Patient #10 and #44) sampled patients reviewed for falls. The findings included: 1. Review of the undated “Targeted Toileting Scripting Examples,” revealed “ ...Your safety is a priority for us as we work together to help you heal during your stay. We will keep you safe from falling by always escorting you to and from the bathroom. We will provide you with as much privacy as possible while in the bathroom, but your safety is most important. So, we will remain within arm’s reach or line of sight to keep you safe from falling ...” Review of the “Let Us Help You Stay Safe Signage,” revealed “ ...Don’t go to the bathroom alone. Let a nurse or caregiver help you get back to the bathroom, stay close by while you go, and help you back to bed. This is very important to make sure you don’t fall ...” 2. Review of the policy titled “Falls Prevention Policy,” dated February 2024, revealed “ ...Fall ... A patient fall is a sudden, unintentional descent, with or without injury to the patient, that results in the patient coming to rest on the floor, on or against some other surface ... ( ...a counter), on another person, or on an object ( ...a trash can). This includes all types of falls, whether they result from physiologic reasons ( ...fainting) or environmental reasons ( ...slippery floor) ...Medications with High Potential for Contributing to Patient Falls ...Consider medications with high potential for contributing to patient falls ...hypnotics and sedatives ...Fall Prevention Reference Chart ...HIGH FALL RISK Maintain low interventions, moderate interventions AND do the following ...Education family/patient every shift about high fall risk status and why they need to call for assistance, Closely monitor/protect/engage the patient, Remain with patient during toileting, Provide bedside toileting devices if needed, Assist with ambulation and transfers, Bed alarms/chair alarms where appropriate, Toileting schedule (individualized or per unit protocol), Provide yellow non-skid footwear, Laminated high fall risk sign, if feasible, Yellow high fall risk armband, For patients/families unable or unwilling to participate in the fall prevention program, consider a sitter ( ...virtual sitter or in-person sitter) ...” 3. Review of the closed medical record revealed Patient #10 was admitted to the facility on 4/15/2023 with diagnoses including Ischemic Stroke, Subdural Hematoma and Brain Herniation. Review of the “Flowsheet,” dated 4/15/2023, revealed, “ ...Per reports, the Patient #10 was found down while at friend’s house earlier this afternoon ...She [Patient #10] was taken to [named] OSH [Outside Hospital] where she was found to have a 2 cm [centimeter] left convexity SDH [Subdural Hematoma] with 1 cm midline shift. The patient was intubated and transferred to our institution for higher level of care ...” Review of the “Clinical Note,” dated 4/16/2023, revealed, “ ...CTH [Computed Tomography of Head] confirmed acute left lateral convexity SDH with 10 mm [millimeters] MLS [Midline Shift] and left uncal herniation. Patient was taken to the OR [Operating Room] emergently by Neurosurgical team for left decompressive craniotomy and subdural hemorrhage evacuation. She was brought to the ICU [Intensive Care Unit] from the OR still intubated. She has been admitted to the NCU [Neuro-intensive Care Unit] for close post-operative hemodynamic and neurological monitoring and ventilator weaning and management ...” Review of the “Flowsheet,” dated 4/15/2023, Patient #10 was considered a high fall risk and was placed on fall precautions and remained a high fall risk until discharge. Review of the “Flowsheet,” dated 4/24/2023, revealed, “ ...Patient #10 is at a heightened risk of falls ...impaired cognition with delayed processing, unclear if Patient #10 understands education provided ...recommended use of bedside commode ...2-person level of assistance ...” Review of the “Clinical Note”, dated 4/25/2023 at 11:53 AM, revealed “ ...Responded to bed alarm at approximately 0800 [8:00 AM] to find patient [Patient #10] standing out of bed, all four side rails raised, halfway to the bathroom with telemetry, pulse oximetry, and blood pressure monitors still tethered to patient. Monitors were detached to prevent further entanglement and patient was assisted into restroom and down onto toilet. Patient urinated and then stood up with RN #2 next to patient the entire time. Patient then asked to wash hands and abruptly fell away from RN #2 back into the bathroom, I [RN #2] was unable to break patients fall. She [Patient #10] landed on her hip and then hit her forehead on the floor ...Patient was alert and oriented X [times] 4 and neuro [neurological] checks were unchanged. Patient insisted on trying to stand repeatedly saying, “I need to go home”. At this time, I [RN #2] stabilized the patient and got her to get back into the bed safely. I immediately notified my charge nurse and NP [Nurse Practitioner] on the primary care team. Patient was found to be hypertensive on subsequent vitals checks and I administered 2 doses of 10mg [10 milligrams] IV [intravenous] hydralazine [used to treat high blood pressure]. STAT [immediately] CT [computed tomography] was ordered and department was contacted .... transported patient to CT on monitor. Upon transport back to room patient became more somnolent, had snoring respirations, and patient’s pupils became equal but dilated ...RRT [Rapid Response Team] was initiated, patient was intubated and transferred to OR [Operating Room] 1 for further surgical intervention ...” RN #2 failed to ensure Patient #10’s safety by assisting Patient #10 to the bathroom alone and failed to use the bedside commode as recommended. Review of the “Clinical Communication,” dated 4/25/2023, revealed “ ...Got paged by RN that patient had gotten out of bed and fell in the bathroom hitting her head. At the time of the fall patient had no changes in mental status, a non-contrast head CT was ordered and patient assessed. Patient became more and more sleepy and hypertensive ...notified patient attending...Patient given Hydralazine 10mg [10 milligrams] IV [intravenous] x [times] 2 prior to going to CT scan. Went with patient to scan and reviewed the CT immediately after it was completed and notified [Named Medical Doctor #1] about new right subdural hematoma. Patient went back to the neuro [Neurology] stepdown and at this time stopped following commands, a rapid response was called since no open neuro ICU [Intensive Care Unit] bed. Patient intubated by anesthesia then we brought [Name Patient #10] down to OR [Operating Room] 1 for emergent craniotomy [removal of portion of the skull for brain surgery]. [Named APRN #2] ...Clinical Communication Name ... Received a call from [Named Doctor #1] regarding patient fall. Requesting trauma to review traumatic mechanism, which happened on 4/25/2023 morning. Reviewed chart. Repeat HCT [Head Computed Topography] was ordered appropriately and plan of care was implemented ...” Review of the “Operative Report,” dated 4/25/2023, revealed “ ...Pre-operative Diagnoses ...Traumatic subdural hemorrhage ...with loss of consciousness ...Procedure performed ...Craniotomy, with evacuation of hematoma ...Location ...Subdural On the right side ...reportedly fell to right side and hit head, witnessed by patient’s RN. Was responsive after however our team evaluated and got CT [computed tomography] head showing new R [right] SDH [subdural hemorrhage] with MLS [midline shift], she also was progressively declining mental status and was intubated in ICU. She was taken emergently for right craniotomy for subdural evacuation ...” Review of the “Physical Medicine & Rehabilitation Consultation” dated 5/2/2023, revealed, “ ...Per the daughter at bedside Patient #10 was living by herself ...she [Patient #10] had 8 steps to get in her building...She was independent in all of her ADLs [Activities of Daily Living] ...Patient #10 has been more sleepy and sedated since her second surgery...over the last couple days she has been responding more to external stimuli ...now fairly consistently following commands and nodding her head yes and no to questions ...has not started to respond with words consistently yet ...There was concern for seizure activity yesterday and she is currently on a continuous EEG [Electroencephalogram, records brain activity] ...” Review of the “Social Worker Notes” dated 5/25/2023, revealed, “ ...SW [Social Worker] discussed the extensive efforts that CM [Case Management] /SW have made to identify IPRs [Inpatient Rehabs] that may offer a charity bed and/or self- pay options, but there was no facility able to take Patient #10 under charity and family declined self-pay options...Family inquired about a 24hr home health aide and SW provided education and informed Patient #10 and family this would be self-pay ...Ongoing concerns were expressed by Patient #10s family ...discussed with Patient #10 and family that Patient #10 could receive PT/OT [Physical Therapy/Occupational Therapy] if they applied for [Named] Indigent Program and the steps needed to take to pursue this...” Review of the medical record reveal Patient #10 was discharged home with family on 5/25/2023. RN #2 was a contract employee amd unavailable for surveyor to conduct an interview. 4. Review of the closed medical record revealed Patient #44 was admitted to the hospital on 3/28/2025, with diagnoses including Syncope and Idiopathic Intracranial Hypertension (increased pressure in fluid surrounding brain). Review of the “Emergency Department Care Timeline,” dated 3/28/2025, revealed Patient #44 was considered a high fall risk and was placed on fall precautions. Review of the “Medication Administration Record,” revealed Patient #44 received Benadryl on 3/30/2025 at 11:00 PM. Benadryl (sedative) is considered a high-risk drug for falls. Review of the “Significant Event Note,” dated 3/31/2025 at 4:56 AM revealed “ ...APRN [advanced practice Registered Nurse] #1 ...Patient [Patient #44] sustained a fall out of bed tonight ...Care Partner [CP #3] instructed patient to wait while she [CP #3] got help from RN [Registered Nurse] in order to move her [Patient #44] safely given her baseline weakness. Care Partner was out of the room for less than 3 minutes and when she returned with RN ...Patient [Patient #44] reports that she fell out of bed onto her left shoulder while reaching for the bucket. Patient states she did not hit her head upon fall. Xray [Radiographic Imaging] of left shoulder order and fall precautions in place ...” Review of the “Nursing Flow Sheet,” dated 3/31/2025 at 4:43 AM revealed “ ...Pt [Patient #44] had alleged fall from bed, unwitnessed by staff ...” CP #3 failed to ensure Patient #44’s safety by leaving Patient #44 alone in her room to get the nurse. 5. Review of the Competency Training for hospital employees revealed there was no documentation RN #1, RN #2, RN #3 and CP #3 received Fall Risk Assessment or Fall Prevention training in 2024. Review of the “Fall Prevention Committee” meeting minutes revealed there were a total of 207 patient falls in the hospital from 1/1/2025-3/31/2025. 6. During a telephone interview on 4/21/2025 at 7:35 PM, Family Member #1 stated, “ ...I received a telephone call informing me my mother had a fall ...she had to be rushed into surgery...The nurse [RN #2] stated he helped her to bathroom ...while she was washing her hands ...she fell and hit her head on toilet ...He [RN #2] said he was not required to stand by her to make sure she didn’t fall...” During an interview on 4/22/2025 at 11:20 AM, Care Partner (CP) #4 was asked if high fall risk patients were left alone while toileting. CP #4 stated “ ...If a patient is a high fall risk, patients are assisted to the bedside commode. Once they are on the bedside commode you are not to leave the room ...a nurse must be within arm’s reach ...” During a Zoom interview on 4/29/2025 at 11:30 AM, the Director of Adult Management and Improvement Team was asked about high fall risk patient precautions. The Director of Adult Management and Improvement Team stated, “ ...nurses are reminded they should be remaining with all high-risk patients in the bathroom ...however we know that there are patients that refuse for that to happen ...the best practice is staying in the bathroom with the patient ...” When asked what should happen after a fall is reported, the Director of Adult Management and Improvement Team stated, “ ...We do a daily fall email if an event has been reported...that goes into a fall report...I will review them, then reach out to Patient Quality and Safety Advisor and the unit manager. Level of review is based with unit...Some may review them at a staff meeting, sometimes it’s a one on one ...May be at weekly huddles like a reminder to staff at shift change ... The Director of Adult Management and Improvement Team was asked if there was a fall with harm, how does the hospital follow up. She stated, “ ...It’s up to the unit level ...units have different meetings so they don’t all have one standard meeting ...some of them may review those at a staff meeting ...” During a Zoom interview on 4/30/2025 at 7:45 AM, CP #3 was asked to tell me about the incident. CP #3 stated, “ ...I heard a bed alarm going off, so I went to her [Patient #44] room. She [Patient #44] was trying to get out of bed, stating she had to use the bathroom. I told her [Patient #44] to stay in the bed until I came back with help ...” CP #3 was asked should she have left Patient #44’s bedside. CP #3 stated, “ ...I should have just stayed ...” CP #3 was asked if she was aware of the hospital policy regarding high fall risk patients. CP #3 stated, “ ...Yes, I’m aware ...I have been with the hospital [Hospital #1] for 2 years and have had fall prevention training...” When asked about fall prevention meetings, CP #3 stated, “ ...we have daily unit meetings regarding updates on patients that are a fall risk and patients that get turned every 2 hours. CP #3 stated she did not receive any additional training following the incident. During a Zoom interview on 4/30/2025 at 8:00 AM, RN #1 stated, “ ...I was charting at the nurse’s station ...heard a bed alarm going off ...then I didn’t hear it anymore ....moments later [CP #1] told me a patient needed help going to bathroom...[CP #1] turned off the bed alarm ...told the patient [Patient #44] to please stay until she came back with help ...We [RN #1 and CP #1] got back into the patient’s [Patient #44] room and she [Patient #44] was on the floor ... I assessed her vital signs and we helped her back to bed ...then I notified attending [physician] to come and assess her ...” During a Zoom interview on 5/1/2025 at 2:20 PM, Registered Nurse (RN) #3 was asked if high fall risk patients were left alone while toileting. RN #3 stated, “ ...you would not just leave them if their a high fall risk ...always stay within arm’s reach ...” During an interview on 5/6/2025 at 11:30 AM, the Senior Director Accreditation and Standards stated, “ ...there was no Fall Competency Training in 2024 for existing staff, only new staff received training during orientation...” When asked about annual competency training, the Senior Director Accreditation and Standards stated, “ ...there are certain units that have falls as an issue ... if a unit is meeting their goals and falls are not an issue then we’re going to focus on something where there is an issue ...a competency package is built for each unit based upon their quality scores and data ...each unit has specified competency training depending on what unit they’re on and what the units quality goals are...” When asked if nurses floated to different areas in the hospital even if they had received competency training for that specific unit, the Senior Director Accreditation and Standards stated, “yes” ...” The facility failed to ensure its vulnerable patient population received care in an environment that a reasonable person would consider safe. The facility failed to provide physical safety to Patient #10 and Patient #44 by failing to monitor, provide protection, and ensure patient rights to physical safety by ensuring the staff members followed hospital policies related to fall preventions and failed to appropriately implement fall precautions.”

“Cooking Facilities CFR(s): NFPA 101 Cooking Facilities Cooking equipment is protected in accordance with NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, unless: * residential cooking equipment (i.e., small appliances such as microwaves, hot plates, toasters) are used for food warming or limited cooking in accordance with 18.3.2.5.2, 19.3.2.5.2 * cooking facilities open to the corridor in smoke compartments with 30 or fewer patients comply with the conditions under 18.3.2.5.3, 19.3.2.5.3, or * cooking facilities in smoke compartments with 30 or fewer patients comply with conditions under 18.3.2.5.4, 19.3.2.5.4. Cooking facilities protected according to NFPA 96 per 9.2.3 are not required to be enclosed as hazardous areas, but shall not be open to the corridor. 18.3.2.5.1 through 18.3.2.5.4, 19.3.2.5.1 through 19.3.2.5.5, 9.2.3, TIA 12-2 This Standard is not met as evidenced by: 50784 Based on observation, document review, and interview, the facility failed to maintain the cooking equipment. The findings include: 1. Observation on 05/12/2025 at 10:54 AM, revealed two (natural gas) deep fat fryers under the kitchen hood that were equipped with castors and did not have an approved method to return the equipment to the approved location after moving for cleaning or maintenance. NFPA 101, 19.3.2.5.1 (2012 Edition) NFPA 101, 9.2.3 (2012 Edition) NFPA 96, 12.1.2.3.1 (2011 Edition) 2. Interview with the Executive Chef on 05/12/2025 at 11:03 AM, revealed there have been approximately 4 or 5 previous fires due to build up of grease in the exhaust of the deep fat fryers. The Executive Chef stated that the deep cleaning and maintenance of that equipment is performed by facilities management, and that these events were reported to the facilities staff responsible for the kitchen. NFPA 101, 19.3.2.5.1 (2012 Edition) NFPA 101, 9.2.3 (2012 Edition) NFPA 96, 11.7.2 (2011 Edition) NFPA 96, 4.1.3.1 (2011 Edition) 3. Interview with the Director of Nutrition on 05/12/2025 at 11:05 AM, revealed staff failed to activate the fixed hood suppression system before using the portable class K extinguisher, and initially attempted to extinguish the fire with salt. NFPA 101, 19.3.2.5.1 (2012 Edition) NFPA 101, 9.2.3 (2012 Edition) NFPA 96, 10.5.7 (2011 Edition) 4. Document review on 05/12/2025 between 11:08 AM and 3:00 PM, revealed the facility could not provide records of inspection, cleaning (other than cleaning of the cooking oil and cooking surfaces), or maintenance of the cooking equipment. NFPA 101, 19.3.2.5.1 (2012 Edition) NFPA 101, 9.2.3 (2012 Edition) NFPA 96, 11.7.1 (2011 Edition) The Accreditation & Regulatory Specialist was present when these findings were identified and acknowledged them during the telephone exit conference on 05/15/2025.”

“Utilities - Gas and Electric CFR(s): NFPA 101 Utilities - Gas and Electric Equipment using gas or related gas piping complies with NFPA 54, National Fuel Gas Code, electrical wiring and equipment complies with NFPA 70, National Electric Code. Existing installations can continue in service provided no hazard to life. 18.5.1.1, 19.5.1.1, 9.1.1, 9.1.2 This Standard is not met as evidenced by: 50784 Based on observation, the facility failed to maintain gas cooking equipment equipped with castors. The finding includes: Observation on 05/12/2025 at 10:54 AM, revealed two deep fat fryers equipped with castors that were not equipped with a restraint device. NFPA 101, 19.5.1.1 (2012 Edition) NFPA 101, 9.1.1 (2012 Edition) NFPA 54, 10.12.6 (2012 Edition) The Accreditation & Regulatory Specialist was present when these findings were identified and acknowledged them during the telephone exit conference on 05/15/2025.”

“Fire Alarm System - Notification CFR(s): NFPA 101 Fire Alarm - Notification 2012 EXISTING Positive alarm sequence in accordance with 9.6.3.4 are permitted in buildings protected throughout by a sprinkler system. Occupant notification is provided automatically in accordance with 9.6.3 by audible and visual signals. In critical care areas, visual alarms are sufficient. The fire alarm system transmits the alarm automatically to notify emergency forces in the event of a fire. 19.3.4.3, 19.3.4.3.1, 19.3.4.3.2, 9.6.4, 9.7.1.1(1) This Standard is not met as evidenced by: 50784 NFPA 101 2012 Edition 39.3.4.3 Occupant Notification. During all times that the building is occupied (see 7.2.1.1.3), the required fire alarm system, once initiated, shall perform one of the following functions: “ (1) It shall activate a general alarm in accordance with 9.6.3 throughout the building, and both of the following also shall apply: o (a) Positive alarm sequence in accordance with 9.6.3.4 shall be permitted. o (b) A presignal system in accordance with 9.6.3.3 shall be permitted. “ (2) Occupant notification shall be permitted to be made via a voice communication or public address system in accordance with 9.6.3.9.2. Based on document review and interview, the facility failed to provide occupant notification of the fire alarm. The findings included: Document review and interviews with facility administrative staff on 04/09/2025, revealed a fire was discovered in the pediatric emergency room on 04/02/2025. Fire alarm log data shows 3 pull station activations and 3 smoke detector activations. Interview with facility administrative staff revealed that the audio/visual notification devices did not activate. Document review of the fire alarm log shows the fire alarm system was bypassed at the time of this incident. Subsequent document review revealed at the time of the shut down of the fire alarm notification appliances no fire watch or Interim Life Safety Measures were being conducted. NFPA 101, 39.3.4.3 (2012 Edition) The Accreditation & Regulatory Specialist acknowledged these findings during the telephone exit conference on 02/07/2025.”

“Fire Alarm System - Out of Service CFR(s): NFPA 101 Fire Alarm - Out of Service Where required fire alarm system is out of services for more than 4 hours in a 24-hour period, the authority having jurisdiction shall be notified, and the building shall be evacuated or an approved fire watch shall be provided for all parties left unprotected by the shutdown until the fire alarm system has been returned to service. 9.6.1.6 This Standard is not met as evidenced by: 50784 Based on document review and interview, the facility failed to provide occupant notification of the fire alarm. The findings included: Document review and interview with facilities administration on 04/09/2025 at 10:30 AM, revealed the facility had a fire at the nurses station in the pediatric emergency room at approximately 7:20 PM. At the time of the fire the fire alarm system was placed on “test” and fire alarm notification devices were bypassed for unknown reasons. Document review of facility provided event time line and fire alarm log shows 3 pull stations were activated by staff, and 3 smoke detectors also activated in the emergency department. Interview with facility administration revealed the audio/visual notification devices did not activate at any time during this event. Subsequent document review of fire alarm log shows the fire alarm was bypassed for a total of 13 hours, 50 minutes, and 55 seconds on 04/02/2025, including during the incident time. Interview with the Senior Accreditation Regulatory Specialist and subsequent review of the provided documentation from the facility revealed that at the time of the shut down of the fire alarm notification appliances no fire watch or Interim Life Safety Measures were being conducted. NFPA 101, 9.6.1.6 (2012 Edition) The Accreditation & Regulatory Specialist acknowledged these findings during the exit conference on 04/09/2025.”

“Fire Alarm System - Notification CFR(s): NFPA 101 Fire Alarm - Notification 2012 EXISTING Positive alarm sequence in accordance with 9.6.3.4 are permitted in buildings protected throughout by a sprinkler system. Occupant notification is provided automatically in accordance with 9.6.3 by audible and visual signals. In critical care areas, visual alarms are sufficient. The fire alarm system transmits the alarm automatically to notify emergency forces in the event of a fire. 19.3.4.3, 19.3.4.3.1, 19.3.4.3.2, 9.6.4, 9.7.1.1(1) This Standard is not met as evidenced by: 36006 NFPA 101 2012 Edition 39.3.4.3 Occupant Notification. During all times that the building is occupied (see 7.2.1.1.3), the required fire alarm system, once initiated, shall perform one of the following functions: “ (1) It shall activate a general alarm in accordance with 9.6.3 throughout the building, and both of the following also shall apply: o (a) Positive alarm sequence in accordance with 9.6.3.4 shall be permitted. o (b) A presignal system in accordance with 9.6.3.3 shall be permitted. “ (2) Occupant notification shall be permitted to be made via a voice communication or public address system in accordance with 9.6.3.9.2. Based on document review and interview, the facility failed to provide occupant notification of the fire alarm. The findings included: Document review and interview with the Director of Facilities Management on 02/05/2025 at 11:54 AM, revealed the facility had a fire that started in an office next to the kitchen in the basement of The Vanderbilt Clinic building. At the time of the fire the fire alarm system was placed on “test” and fire alarm notification devices were bypassed due to a renovation project in the area. Interview with staff members #4 and #5 between 12:47 PM and 1:05 PM, revealed during the fire incident staff member #5 pulled the fire alarm but neither staff member heard any fire alarms going off. Both staff members proceeded to manually notify others in the area of the fire and started assisting in evacuations of the area. Interview with the Construction Coordinator and Director of Facilities Management, at the time of the shut down of the fire alarm notification appliances no fire watch or Interim Life Safety Measures were being conducted. NFPA 101, 39.3.4.3 (2012 Edition) The Accreditation & Regulatory Specialist acknowledged these findings during the telephone exit conference on 02/07/2025.”

“Fire Alarm System - Out of Service CFR(s): NFPA 101 Fire Alarm - Out of Service Where required fire alarm system is out of services for more than 4 hours in a 24-hour period, the authority having jurisdiction shall be notified, and the building shall be evacuated or an approved fire watch shall be provided for all parties left unprotected by the shutdown until the fire alarm system has been returned to service. 9.6.1.6 This Standard is not met as evidenced by: 36006 Based on document review and interview, the facility failed to provide occupant notification of the fire alarm. The findings included: Document review and interview with the Director of Facilities Management on 02/05/2025 at 11:54 AM, revealed the facility had a fire that started in an office next to the kitchen in the basement of The Vanderbilt Clinic building. At the time of the fire the fire alarm system was placed on “test” and fire alarm notification devices were bypassed due to a renovation project in the area. Interview with staff members #4 and #5 between 12:47 PM and 1:05 PM, revealed during the fire incident staff member #5 pulled the fire alarm but neither staff member heard any fire alarms going off. Both staff members proceeded to manually notify others in the area of the fire and started assisting in evacuations of the area. Interview with the Construction Coordinator and Director of Facilities Management at the time of the shut down of the fire alarm notification appliances no fire watch or Interim Life Safety Measures were being conducted. NFPA 101, 9.6.1.6 (2012 Edition) The Accreditation & Regulatory Specialist acknowledged these findings during the telephone exit conference on 02/07/2025.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 30070 Based on policy review, hospital document review, medical record review, and interview, the hospital failed to ensure staff abided by the hospital’s policy and necessary care and services were provided to prevent potential mental anguish and physical harm to all patients for 3 of 3 (Patient #1, #2, and #3) sampled patients. The findings included: 1. Review of the hospital policy, “Occurrence Reporting: Patient and Visitor,” dated March 2022, revealed, “ ...Purpose: To identify, evaluate, and take appropriate action to address serious or significant Events, Near-Miss Events, or Hazards involving patients and visitors, to track patient safety data trends, and report Events in accordance with applicable law ...Definitions ...Neglect means the failure to provide goods and services necessary to avoid physical harm, mental anguish or mental illness of a patient. An occurrence which is unrelated to the reason for the patient’s hospitalization or the ordinary course of the patient’s underlying condition and which results in death, permanent harm or significant temporary harm to the patient may be identified as “Neglect,” following a review of relevant facts and circumstances (including, but not limited to, whether the occurrence arose from a significant or repeated deviation from an established or prescribed plan of care or treatment by one or more clinicians). Review of the hospital policy, “Exposure to Communicable Diseases for Patients and Visitors,” dated January 2023, revealed, “ ...Purpose: To outline the process used when a patient or visitor has been exposed to a communicable disease and establish guidelines that determine follow-up ...Bloodborne pathogen exposure: An event in which blood or other potential infectious body fluid comes in direct contact with a person’s blood, mucous membranes, or non-intact skin ...Communicable disease exposure: Unprotected exposure to contagious pathogens that require chemoprophylaxis, furlough, and/or symptom monitoring of the person exposed ...Patients or visitor exposure to communicable disease, bloodborne pathogen, sharps injury ...If an exposure event has occurred for the patient, the following actions are taken ...In consultation with Risk Management, the primary attending physician or designee discloses to the patient and appropriate family members the exposure circumstances and the need for testing ...” 2. Review of the hospital document, “GI [Gastrointestinal] Tech [Technician] Specialist ...Job Summary,” dated 9/19/2024, revealed, “Assists GI Endoscopy Services Unit with the coordination of the daily patient endoscopy schedule with occasional guidance from the charge nurse, physician, or staff nurse. Facilitates patient care by assisting physician/nursing staff before, during and after endoscopy procedures by providing the instruments and supplies required by the proceduralist according to established plan for patient care with occasional guidance. GI Tech is able to perform competently most of the cases in a given service/shift. Cleans, disinfects and sterilize all flexible bronchoscopes, video scopes and related Endoscopy instruments for all areas ...Job Description ...Maintains the work environment in a safe, clean, orderly manner ...Prepares instrumentation and equipment according to recommended procedures and techniques in preparation for high-level disinfection and sterilization to support all perioperative areas and clinics. Operates all departmental equipment safely and effectively ...Departmental Policies & [and] Procedures (Novice): Possesses sufficient fundamental proficiency to successfully demonstrate knowledge of departmental policies and procedures in practical applications of moderate difficulty. Is attentive to existing departmental policies and procedures, and may recommend improvements to existing departmental policies and procedures within the work area ...” Review of the hospital document, “Endoscopy Event Timeline,” last updated 10/9/2024 (The hospital developed this document as a result of the identified potential exposure to bloodborne pathogens/communicable diseases during endoscopic procedures), revealed the following: “ ...Sep. [September] 17, 2024 ...Incident identified by RN [Registered Nurse] and escalated to manager ... Sep. 18, 2024 ... Manager confirmed inappropriate practice isolated to one GI [Gastrointestinal] Tech [Technician] ... Sep. 21, 2024 ...Began analysis of potentially exposed patients ... Sep. 22, 2024 ...Determined time frame of potential exposures and identified source/exposed patients ... Sep. 23, 2024 ...Validated analysis of potentially exposed patients ... Sep. 24, 2024 ...Analysis of potentially patients completed ... Sep. 27, 2024 ...Patient notification plan created ... Oct. [October] 3, 2024 ...Began notifying patients and ordering/scheduling appropriate labs ...Total Completed Patient Notifications: 109 ...Total % [percent] of Patients Notified: 14%... Oct. 4, 2024 ...Total Completed Patient Notifications: 271 ...Total % of Patients Notified: 34%... Oct. 5, 2024 ...Total Completed Patient Notifications: 398 ...Total % of Patients Notified: 50%... Oct. 6, 2024 ...Total Completed Patient Notifications: 517 ...Total % of Patients Notified: 65%... Oct. 7, 2024 ...Total Completed Patient Notifications: 586 ...Total % of Patients Notified: 74%... Oct. 8, 2024 ...Total Completed Patient Notifications: 617 ...Total % of Patients Notified: 78%...” Review of the hospital document, “Disclosure Outline for Call to Source Patient,” (undated) (The hospital developed this document as a result of the identified potential exposure to bloodborne pathogens/communicable diseases during endoscopic procedures), revealed, “ ...May I speak to [SOURCE PATIENT NAME]?...I need to speak with you for a few moments about your recent endoscopy procedure ...We recently become aware of an issue in how a solution was administered during certain endoscopy procedures at the [Hospital #1 Clinic]. Because you recently had an endoscopy procedure, we are calling to discuss this. During approximately half of endoscopy procedures, a solution can be administered into the scope to reduce air bubbles and make it easier for the physician to see. Because of an error in how the solution was administered, there is a risk that the bottle of solution used each day may have become contaminated, which may place patients at risk for infection ...We are recommending that you be tested for Hepatitis B and C and for HIV [Human Immunodeficiency Virus] ...Results will come to you through [Hospital #1’s electronic health information portal], or you will get a phone call from one of our clinicians ...I’m sure this is a lot to process, and I am sorry if this information raises any concerns ...” Review of the hospital document, “Frequently Asked Questions-Adult Endoscopy,” (undated) (The hospital developed this document as a result of the identified potential exposure to bloodborne pathogens/communicable diseases during endoscopic procedures), revealed, “What happened? We recently discovered that a solution was improperly administered during some adult endoscopy procedures. We are investigating this issue extensively and have reported it to the Tennessee Department of Health. Specifically, in approximately half of adult endoscopy procedures, a solution called simethicone is used to decrease air bubbles to more clearly see the gastrointestinal (GI) tract through the scope. A sterile syringe with a needle attached is used to withdraw simethicone from a bottle, and the solution is then administered to the patient through the scope using a port at the end of the scope held by the physician ...We became aware that in certain endoscopy rooms when simethicone was administered, the needle used to withdraw simethicone from the bottle was re-inserted into the same bottle if more than one dose was needed for that patient. If the needle came in contact with biological material from the scope during any administration of simethicone and was reinserted into the bottle, it could have contaminated the bottle for subsequent patient examinations on that day and that used simethicone. If the bottle of simethicone used each day in that room was contaminated, it may place the patient at risk for infection. Since the administration of simethicone during an endoscopy is not documented in the medical record, we cannot verify with certainty which patients received it during their examination ...we are notifying every patient who had an endoscopy in the specific location during the period of risk ...Why am I being notified?...if you received simethicone during an endoscopy, and if the bottle of simethicone used in your procedure was contaminated, there are some viruses that could be transmitted, including HIV and hepatitis B and C. We are notifying patients who received endoscopy procedures at the [Hospital #1 Clinic] within the last four months and recommending testing for these viruses ...How will I know what the results are? If you have your testing done at [Hospital #1] and are enrolled in ...our electronic health information portal, your test results will post there. Otherwise, we will inform you of your lab results after the testing has been processed. Our team will reach out to you by phone for any results that require follow up testing or additional workup. It will take several days to get results back, so please be patient ...Will I need to come back for additional testing? It is likely that you will need to have follow-up lab testing over the next six months so that we can monitor for infection ...[A testing schedule is included: patients who have been exposed greater than or equal to 10 weeks should have a baseline test and 6 month test; patients who have been exposed between 4 to 10 weeks should have a baseline test, 12 week test, and 6 month test; patients who have been exposed less than 4 weeks should have a baseline test, 6 week test, 12 week test, and 6 month test] ...What if the lab test reveals something?...If you would benefit from additional testing or treatment based on the lab results, [Hospital #1] will help connect you with a medical team to guide the next best steps ...How long has this been going on?...Cases with possible exposure occurred during May-September 2024 ...Am I contagious to other people? Do I need to take any precautions? While the likelihood of a hepatitis or HIV infection is very low, we cannot rule out infection until testing is complete now and after six months. Hepatitis and HIV are spread through blood or body fluid. To reduce the risk of transmission during this period of time, it is recommended that you: cover cuts or open wounds; clean up blood or body fluid with alcohol or bleach-based solutions; avoid sharing personal care products, such as razors or nail clippers; and use barrier precautions during sexual activity ...Am I going to die from an infection that you gave me?...The risk of infection from this possible exposure is very low. In the case that a hepatitis C infection occurs, this is a curable infection that should not impact your long-term health. While hepatitis B and HIV are not yet curable, most people live full lives with well-tolerated treatment that can be taken as one pill once per day. The reason that we recommend laboratory testing now and in the future is to ensure that you receive the care that you need ...” Review of the hospital document, “Current Data as of 10/9/24” (The hospital developed this document as a result of the identified potential exposure to bloodborne pathogens/communicable diseases during endoscopic procedures) revealed, “Total patients involved (source only and exposed) = 796 ...As of this morning, 631 contacted (~ [approximately] 80%) ...Original Source: By procedure room and date, a patient who was the first case where the tech assisted. This patient does not need any testing beyond baseline ...Reclassified Source: A patient who was originally classified as Exposed but can be reclassified as a source due to negative baseline BBP [Bloodborne Pathogens] testing in all patents [patients] preceding the patient that day in that room beginning from the first case in the room(s) where the tech assisted. This patient does not need any additional testing beyond baseline ...Solo source: A patient who was the only case in that room where the tech assisted. This patient does not need any testing beyond baseline. If the Solo Source is baseline lab negative (or only HBV [Hepatitis B Virus] Surface Antibody positive [indicates immunity against the hepatitis B virus either through a past infection or from receiving the hepatitis B vaccine]), this will clear all subsequent patients in that room for that day ...Permanently Exposed: An exposed patient who had a procedure in a room where the tech had worked that day and who follows either a) a deceased patient, b) a patient with a history of BBP as defined by IP [Infection Prevention], or c) a patient with baseline lab testing positive for any test except HBV Surface Antibody (Ab) with or without positive HBV Core Antibody (Ab). These patients must be followed for the full 6 months with the entire complement of testing, as we will not have enough baseline data to clear the patients who were in the room before them.” 3. Medical record review for Patient #1 revealed a procedure date for an esophagogastroduodenoscopy (EGD) on 9/9/2024 with a preoperative diagnosis of Dysphagia. Medical record review for Patient #2 revealed a procedure date for an upper GI endoscopy on 8/6/2024 with a preoperative diagnosis of Cirrhosis Rule out Esophageal Varices. Medical record review for Patient #3 revealed a procedure date for a colonoscopy on 7/3/2024 with a preoperative diagnosis of High Risk Colon Cancer Surveillance, Personal History of Colonic Polyps. 4. During an interview on 10/7/2024 at 9:27 AM, the Chief Hospital Epidemiologist stated that on 9/17/2024, nursing personnel identified that one staff member (GI Tech #1) was reusing the same needle and syringe to draw up simethicone, and there was a chance that the simethicone and saline solution could become contaminated. The Chief Hospital Epidemiologist stated that if the physician could not get a good visual during an endoscopic procedure, the physician may use simethicone through the scope. The Chief Hospital Epidemiologist stated the simethicone was mixed with sterile saline and injected through the scope with a 60 cubic centimeter (cc; equal to 1 milliliter) syringe. The Chief Hospital Epidemiologist stated they (hospital investigation team) had identified that the syringe was discarded after each patient, but one GI Tech (GI Tech #1) used the dirty syringe to draw up the simethicone mix which contaminated it. The Chief Hospital Epidemiologist stated that there was no documentation in the patient’s medical record whether simethicone was used or not. The Chief Hospital Epidemiologist stated that the identified staff member started working on 5/22/2024 as a GI Tech in Endoscopy Center #1, and the hospital identified 680 patients who could have possibly been exposed to a communicable disease due to the error in practice. The Chief Hospital Epidemiologist stated that 20 of those patients have passed away, so the hospital will attempt to contact the remaining 660 patients to inform them of the potential exposure and recommend testing for hepatitis B and C and HIV. During an interview on 10/7/2024 beginning at 9:27 AM with the Chief Hospital Epidemiologist, the Chief Medical Officer (CMO) of Adult Clinics, the Vice President and Chief Nursing Officer (CNO) of Ambulatory Nursing, the Senior Quality and Patient Advisor, and Accreditation and Standards Specialist #1, it was stated the hospital had travel staff working for the previous 18 months. The hospital gave the travel staff a prolonged training, but “we failed to give [GI Tech #1] that training ...in the training program ...we had a lot of management changeout ...this was his [GI Tech #1] first endo [endoscopy] job. He had a short amount of training ...cut short due to leadership being short at that time ...We had an appropriate training plan ...it just wasn’t followed ...” During an interview on 10/7/2024 at 4:16 PM, the Senior Quality and Patient Advisor confirmed the Board of Directors for the hospital were notified of the incident on 10/4/204. The Senior Quality and Patient Advisor stated the Risk Management Body met (date not stated) and discussed the incident and decided the incident did not meet the definition of “Neglect.” The Senior Quality and Patient Advisor confirmed the hospital did not report the incident to the state agency. During an interview on 10/8/2024 at 12:30 PM, the Executive Vice President (VP) of Quality Safety stated that the incident with the potential exposure during endoscopic procedures was reported to the Risk Management Committee, and the Committee made the decision whether to report the incident to the state agency. The Executive VP of Quality Safety stated they had an agreement with the state on “Neglect” that told them what needed to be reported. The Executive VP of Quality Safety confirmed the incident was not reported to the state, but it would have been if one of the patients was found to be newly infected with the HIV or hepatitis virus. The Executive VP of Quality Safety stated that situation would clearly be viewed by the hospital as neglect and would then be reportable. During a virtual interview on 10/9/2024 at 11:46 AM, GI Tech #1 confirmed he was hired as a GI Tech at Hospital #1 on 5/20/2024 and had training on the job. GI Tech #1 stated he had multiple preceptors and had hands on training with a check sheet. When asked what he was taught during orientation about the use of simethicone during an endoscopic procedure, GI Tech #1 stated, “ ...draw it up out of the jug [simethicone mix] when the provider asks for it ...after each patient ...throw away the needle and syringe and get a fresh one ...” When asked about the simethicone mix, GI Tech #1 stated, “ ...we use the same jug. We would discard the jug at the end of the day ...” GI Tech #1 stated Registered Nurse (RN) #4 told him he was not drawing up the simethicone mix correctly and showed him the correct way to draw it up. During an interview on 10/9/2024 at 12:10 PM, RN #4 stated that she had prepared two 60 cc syringes with the simethicone mix, but the physician requested more. RN #4 stated GI Tech #1 used one of the dirty syringes to draw the simethicone mix from the jug and pushed the plunger up and down in the mix. RN #4 stated she told GI Tech #1 that he cross contaminated the mix, and he told her that he had been following that same process. RN #4 stated she reported the incident to Nurse Manager #1. During an interview on 10/9/2024 at 1:34 PM, the Vice President and Chief Nursing Officer (CNO) of Ambulatory Nursing stated the hospital had an extended orientation period of 3 months. The Vice President and CNO of Ambulatory Nursing stated GI Tech #1 was the first person in the program for the extended orientation, but he received 3 weeks of orientation instead of 3 months. The Vice President and CNO of Ambulatory Nursing stated the nurse educator was not doing a weekly check in with the employee. During an interview on 10/9/2024 at 1:55 PM, the Director of Risk Management stated the hospital would only report an incident as “Neglect” if actual harm was identified for a patient. During a phone interview on 12/23/2024 at 10:46 AM, Patient #1’s husband stated he spoke with the representative from Hospital #1 by phone when the hospital called to inform Patient #1 about the potential exposure from contaminated equipment during an endoscopy procedure. Patient #1’s husband stated that Patient #1 had a laryngeal procedure, and she had difficulty talking on the phone. Patient #1’s husband stated Patient #1 had been tested once for hepatitis and HIV, and the results were negative. When asked about how the incident affected them, Patient #1’s husband stated, “I was shocked ...hepatitis and HIV ...pretty bad sounding infections ...it’s kind of scary ...you get a phone call out of the blue. We’re getting older and trying to hold on to the days we have left ...it scared us.” During a phone interview on 12/23/2024 at 11:01 AM, when asked about the incident with the potential exposure from the endoscopy procedure, Patient #2 stated, “ ...I don’t think that was appropriate. No one should ever have to go through that.” When asked how she responded to the information when she received the phone call from Hospital #1, Patient #2 stated, “Shock and despair. I was scared.” During a phone interview on 12/23/2024 at 11:06 AM, when asked about the incident with the potential exposure from the endoscopy procedure, Patient #3 stated, “It scared me plumb to death. I’ve lost a lot of sleep because of this. I have other health issues, and my liver couldn’t take HIV or hepatitis ...I’ve been tested once at the Health Department. I went back to get tested again, but I panicked. I got so anxious, I just put the clipboard down at the Health Department and walked out ...I plan to go back after Christmas and get tested again. The woman at the Health Department that I would have to get tested up to a year. I have to go through this whole thing for a year before I am in the clear. I’m still losing sleep over this.” 5. The hospital failed to provide goods and services necessary to avoid the mental anguish of patients. The hospital failed to provide adequate training and monitoring of a new employee which resulted in the potential exposure of multiple patients to communicable diseases. The hospital notified 631 patients at the time of the investigation that they may have been exposed to hepatitis B, hepatitis C, or HIV, and recommended the patients get tested for these viruses. This deficient practice has the possibility of causing mental anguish for the patients. Although some of the patients were recommended the need for only baseline testing, many were recommended testing for up to 6 months which can cause and can continue to cause further mental anguish for the patients.”

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 30070 Based on policy review, email review, observation, and interview, the hospital failed to ensure all drugs and biologicals were kept in a secure area for 2 of 3 (Endoscopy Procedure Center #1 and #3) Endoscopy Procedure Centers. The findings included: 1. Review of the hospital policy, “Medication Storage and Handling,” dated May 2024, revealed, “ ...Medications are stored and handled in a manner that ...Maintains medication integrity ...Authorized Staff - For the purposes of this policy, authorized staff refers to those staff members involved in procurement, delivery, dispensing, or administration of medications ...Medications are stored ...In locked storage areas or containers unless they are under constant surveillance by an authorized individual ...Medications are obtained from locked medication storage areas ...or containers immediately prior to administration of the product and for one patient at a time ...Once removed, medications are not left unattended ...Procedural areas are restricted to authorized staff and are considered secure when authorized staff are actively providing care to patients or are present in the procedural room preparing to receive patients. Medication storage in these areas is considered to be secure when these criteria are in place. Medication storage in these areas is secured by locking medication carts or locked cabinet when these criteria are not in place ...” 2. Review of an email dated 10/7/2024 at 6:26 PM, revealed the Director of Anesthesia Advanced Practice Nursing sent an email to [Hospital #1] Nurse Anesthesia, “We have consistently provided reminders on the importance of proper medication preparation, storage, and disposal. While our recent focus has been on end-of-shift clean-up and secure storage, we must also remain vigilant with our medication preparation processes. Medications and syringes should not be prepared in advance. They must only be opened, spiked, and ready for use immediately before the imminent patient arrives in the OR [Operating Room] or procedural setting. This protocol appiles to every patient, case, and procedure, regardless of turnover times. If there is any production pressure from anesthesia, nursing, surgery, proceduralists, or other team members, do not compromise best practices. Instead, please report the situation to your CRNA [Certified Registered Nurse Anesthetist] leaders so that we can address it appropriately.” Review of an email dated 10/9/2024 at 2:43 PM, revealed Pharmacy Manager #1 responded, “ ...When propofol [Diprivan] vial is spiked, it should be immediately administered. We utilize USP [United States Pharmacopeia; non-profit organization that establishes standards for the quality, purity, and identity of medications and dietary supplements] to define what immediate administration means, which says the product needs to be administered within 4 hours ...While a BUD [Beyond Use Date] of 4 hours can be used to define how long a propofol vial is spiked in the procedural area, I’ve asked that staff only prep [prepare] one case in advance. This is to limit the amount of propofol being spiked, decrease the potential for drug waste, and decrease the potential for medication errors. Also, the propofol should only be used on a single patient ...” 3. Observations in Endoscopy Center #1 on 10/7/2024 at 2:39 PM, revealed two bottles of Diprivan (medication used for the induction of general anesthesia) 500 milligrams/50 milliliters which were spiked and stored in the bottom of the Certified Registered Nurse Anesthetist (CRNA) medication cart in Procedure Room #18. The CRNA medication cart was unlocked and unattended, and the Diprivan was not labeled with the date or time the medication was spiked. Observations in Endoscopy Center #1 on 10/7/2024 at 3:00 PM, revealed a 2 ml syringe of vasopressin (medication which raises arterial blood pressure and increases the amount of solute-free water reabsorbed back into circulation) and a 10 ml syringe of nicardipine (medication used to treat high blood pressure and chest pain) were stored on the CRNA medication cart in Procedure Room #20. The CRNA medication cart was unlocked, and the medications were left unattended. There were several, partially filled bottles of Diprivan discarded in a blue plastic biohazard box. The box had a large opening in the lid which allowed easy access to the discarded bottles of Diprivan. Observations in Endoscopy Center #3 on 10/8/2024 at 2:29 PM, revealed a glycopyrrolate (medication used to decrease mouth, throat, or stomach secretions) injection 0.2 mg/1 ml and a single use vial of acetaminophen (medication used to treat pain) injection 1000 mg/100 ml stored on the CRNA medication cart. The acetaminophen injection vial was spiked, and both medications were left unattended. 4. During an interview on 10/7/2024 at 3:11 PM, when asked about the CRNA medication carts being left unlocked and unattended, Pharmacy Manager #2 stated, “ ...the gold standard is to lock the cart ...” When asked about the Diprivan discarded in the blue plastic biohazard box, Pharmacy Manager #2 confirmed this was the accepted practice to discard used bottles of Diprivan.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 30070 Based on review of the Food and Drug Administration (FDA) standards of practice, facility policy review, observation and interview, the hospital failed to ensure infection control measures were followed by staff to prevent and control the transmission of infections within the hospital. The hospital failed to adhere to the manufacture’s guideline for the storage and usage of expired supplies in 3 of 3 (Endoscopy Center #1, #2, and #3) Endoscopy Procedure Centers. The hospital failed to ensure staff followed appropriate hand hygiene measures for 4 of 4 (Registered Nurse (RN) #3, Gastrointestinal (GI) Technician (Tech) #1, and #2, and Certified Surgical Technologist (CST) #1) staff members observed during an endoscopic procedure. The findings included: 1. Review of the FDA’s recommendations dated 7/25/2024, revealed “A medical product is typically labeled by the manufacture with an expiration date. This reflects the time period during which the product is expected to remain stable or retain its identity, strength quality and purity...Medical Countermeasures (MCMs) that have reached their expiration date in most cases cannot be used...” 2. Observations in Endoscopy Center #1 on 10/7/2024 beginning at 2:10 PM, revealed the following supplies stored open, undated or past their expiration dates: a. The Adult Emergency Crash Cart had an opened suction yankauer (a rigid, curved, plastic suction tip used in medical procedures to remove fluids and debris from the body) attached to suction tubing, opened to air and had dust on the tubing, packaging, and suction canister sitting on top of the Emergency Crash Cart. Multifunction Defibrillator Pads (disposable sensors that can detect and correct irregular heartbeats) were stored on the Emergency Crash Cart with an expiration date of 4/24/2022. During an interview on 10/7/2024 at 2:15 PM, RN #1 confirmed the Multifunction Defibrillator pads had expired, and the opened suction yankauer hooked to suction had dust on the tubing, packaging, and suction canister. b. The Procedure Room #18 nurses’ cart had a Suction Catheter Kit with an expiration date of 6/30/2024. During an interview on 10/7/2024 at 2:24 PM, RN #2 verified the Suction Catheter Kit was stored past the expiration date. c. Procedure Room #20 had an Endotracheal (ET) tube 7.5 millimeters (mm) stored opened with an opened syringe attached. During an interview on 10/7/2024 at 2:36 PM, RN #2 verified the ET tube with a syringe attached was stored while opened. 3. Observations in Endoscopy Center #2 on 10/8/2024 beginning at 9:38 AM, revealed the following stored opened, undated or past their expiration dates: a. Procedure Room #4 had four small oval flexible single use polyepectomy (polyp removal) snares (a wire loop to remove polyps) in single use packages with an expiration date of 10/4/2024 stored in a Technician Cart. There were three suction tubings stored opened and unpackaged in the bottom drawer of the supply cabinet. During an interview on 10/8/2024 at 9:42 AM, the Associate Operating Officer (AOO) verified the four polypectomy snares were stored past the expiration date, and the three suction tubings were stored opened and unpackaged. b. The Clean Supply Room had seven Multiple Band Ligator bands (used to place band to halt the blood flow) stored with a use by date of 7/26/2024. During an interview on 10/8/2024 at 10:32 AM, the AOO verified the 7 bands were stored past the use by date. c. The Crash Cart at the nurses’ station had six, 10 milliliter (ml) syringes with 18 G (Guage) 1 ½ (inch) blunt fill needle stored with expiration dates of 5/31/2024. Adult/(and)Child Multifunction Defibrillator Pads were stored in the Crash Cart with an expiration date of 7/1/2024. A Chest Tube Tray was stored in the Crash Cart with an expiration date of 9/30/2024. During an interview on 10/8/2024 at 11:19 AM, Accreditation and Standards Specialist #1 verified the syringes with needles and defibrillator pads were stored past the expiration date. During an interview on 10/8/2024 at 11:25 AM, RN #2 confirmed the Chest Tube Tray was stored past the expiration date. d. The Post-Anesthesia Care Unit (PACU) Crash Cart had the following supplies: Non-conductive suction tubing with an expiration date of 12/1/2022 Electrodes with an expiration date of 8/31/2023 Two carbon dioxide detectors with an expiration date of 2/14/2024 Three-3 lumen (allows for multiple treatments to be administered at once) central venous catheters with an expiration date of 4/30/2024 two pairs of sterile surgical gloves with an expiration date of 4/30/2024 During an interview on 10/8/2024 at 11:30 AM, Accreditation and Standards Specialist #1 verified the supplies listed above were stored in the PACU Crash Cart past the expiration date. 4. Observations on 10/8/2024 beginning at 1:30 PM, revealed Endoscopy Center #3 had the following stored opened, undated or past their expiration dates: The Special Procedure Room #1 supply cart had eleven catheter tip (syringe without a needle) 50 ml syringes with an expiration date of 8/31/2024. The Gastrointestinal (GI) cart had a disposable transducer (a medical device used to provide accurate measurements) with an expiration date of 5/31/2024. During an interview on 10/8/2024 at 3:06 PM, Infection Preventionist #1 verified the supplies listed above were stored past the expiration date. 5. Review of the hospital’s “Standard Precautions” policy effective date 1/2022 revealed, “...Standard precautions are a set of infection control practices used to prevent transmission of diseases that can be acquired by contact with blood body fluids, non-intact skin...mucous membranes... Hand hygiene is performed before entry and after exit of the patient environment... Gloves are worn when touching blood, bodily fluids, or items potentially contaminated with blood or body fluids, regardless of the presence of visible blood...” Review of the hospital’s “Hand Hygiene” policy effective date 3/2024 revealed, “...provide guidelines to promote hand hygiene practices...Hand hygiene measures are an essential prevention strategy to avoid healthcare associated infections (HAI).All faculty and staff who enter a patient’s environment adhere to the hand hygiene practice guidelines that are consistent with the Centers for Disease Control and Prevention (CDC) recommendations... Decontaminate hands at the following times...Each patient contact [“Before and After”] ...Gloving [“Before”]...Glove removal [“After”]...Handling contaminated objects [“After”]...” 6. Observations in Procedure Room #16 on 10/7/2024 at 11:53 AM, revealed RN #3 donned gloves and assisted in positioning the patient for a procedure, removed gloves, donned a new pair of gloves without preforming hand hygiene, RN #3 used a computer at the nurses cart, gloves were removed, no hand hygiene was performed, and a new pair of gloves was donned to assist in position patient after the procedure, removed the gloved and used alcohol-based hand rub. Observations in Procedure Room #16 on 10/7/2024 at 12:30 PM, revealed GI Tech #1 cleaned the GI cart and equipment with disinfecting wipes and his bare hands after an endoscopic procedure. GI Tech #1 did not wear gloves while cleaning the GI cart. Observations in Room #1420 on 10/21/2024 at approximately 12:15 PM, revealed CST #1 removed gloves and failed to perform hand hygiene before a new pair of gloves were donned. Observations in the Decontamination Room on 10/21/2024 at 12:41 PM, revealed GI Tech #2 removed gloves and donned new gloves without performing hand hygiene.”

“Evacuation and Relocation Plan CFR(s): NFPA 101 Evacuation and Relocation Plan There is a written plan for the protection of all patients and for their evacuation in the event of an emergency. Employees are periodically instructed and kept informed with their duties under the plan, and a copy of the plan is readily available with telephone operator or with security. The plan addresses the basic response required of staff per 18/19.7.2.1.2 and provides for all of the fire safety plan components per 18/19.2.2. 18.7.1.1 through 18.7.1.3, 18.7.2.1.2, 18.7.2.2, 18.7.2.3, 19.7.1.1 through 19.7.1.3, 19.7.2.1.2, 19.7.2.2, 19.7.2.3 This Standard is not met as evidenced by: 36006 Based on document review and interview, the facility failed to follow the procedures in case of fire. The findings included: Interview with staff member #1 on 08/19/2024 at 12:41 PM, revealed the facility experienced a fire in patient room 10627 and the building’s fire alarm was not activated. Document review of unit specific fire response plan (Department Disaster Response Sub-Plan Department 10CCT) state “Persons discovering the fire.... 2. Activate nearest fire alarm pull station.” Interview with staff member #3 on 08/20/2024, revealed the staff member responded to room 10627 and discovered smoke in the room. Further interview revealed the staff member evacuated the room and called the on-call Administrative Coordinator and Facilities Management to report the fire. NFPA 101 19.7.2.1.2 (2012 Edition) The Senior Director Accreditation and Standards acknowledged this finding during the telephone exit conference on 08/26/2024.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 35244 Based on medical record review and interview, the hospital failed to ensure all patients presenting to the hospital’s Emergency Department (ED) seeking care for an emergency medical condition (EMC) received an appropriate and on-going medical screening examination (MSE), monitoring and treatment for one of 20 (Patient #1) sampled patients who were eighteen years of age or younger. The findings included: Medical record review revealed Patient #1 was an 8-year-old male who presented to the Hospital #1 Emergency Department (ED) on 12/14/2023 at 9:46 PM with a chief complaint of Seizures. Patient #1 had a medical history of Trisomy 21, Epilepsy, and Gastrostomy Tube (G-tube) Dependence. Patient #1 started having seizures approximately every 5 to 10 minutes on the afternoon of 12/14/2023. The seizures lasted for approximately 10 seconds. The patient had stiffening of the body. Patient #1 was seen by ED Physician #3 who documented Patient #1 had two brief seizures during triage and another brief seizure during the physical examination, but the physical exam was otherwise unremarkable. ED Physician #3 ordered a basic metabolic panel (checks for the levels of glucose, calcium, bun-urea-nitrogen, creatinine, sodium, potassium, chloride, and carbon dioxide in the blood) which revealed a glucose level of 56 (normal fasting blood sugar level is 60 to 90). There was no documentation of interventions to treat Patient #1’s low blood sugar level . There was no documentation the blood glucose level was reassessed while Patient #1 was in the ED. Patient #1’s hypoglycemia was not fully and appropriately re-assessed. ED Physician #3 did not order a urinalysis to check for possible occult infection. Refer to A 2406”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 35244 Based on medical record review and interview, the hospital failed to ensure all patients presenting to the hospital’s Emergency Department (ED) seeking care for an emergency medical condition (EMC) received an appropriate and on-going medical screening examination (MSE), monitoring and treatment for one of 20 (Patient #1) sampled patients who were eighteen years of age and under. The findings included: Medical record review revealed Patient #1 was an 8-year-old male who presented to the Hospital #1 Emergency Department (ED) on 12/14/2023 at 9:46 PM with a chief complaint of Seizures. Patient #1 was brought to the Hospital #1 ED by his parents by private vehicle. Patient #1 had a medical history of Trisomy 21, Epilepsy, and Gastrostomy Tube (G-tube) Dependence. Patient #1 was triaged at 9:53 PM and was assigned a patient acuity of 2 (high risk situation). Patient #1’s parents reported Patient #1 had a baseline of 1-2 seizures per month, but Patient #1 started having seizures approximately every 5 to 10 minutes since earlier that afternoon (12/14/2023). The seizures lasted for approximately 10 seconds with stiffening of the body. The parents reported Patient #1 had been more tired today (12/14/2023) and had not been sleeping well but was otherwise at his baseline. Patient #1 had been tolerating tube feedings through his G-tube without vomiting. Patient #1 was seen by ED Physician #3 at 10:08 PM. ED Physician #3 (5th year resident) documented Patient #1 had 2 brief seizures during triage and another brief seizure during the physical examination. The seizure during the physical examination was tonic in nature with full body stiffening and lasted approximately 10 seconds. ED Physician #3 documented the parents reported that Patient #1 appeared somewhat tired but was otherwise at his neurologic baseline. ED Physician #3 documented Patient #1’s physical exam was otherwise unremarkable. ED Physician #3 ordered a basic metabolic panel (BMP), complete blood count with differential, and a hepatic (liver) function panel at 10:29 PM. The BMP was resulted at 11:57 PM with a glucose level of 56 (reference range was 60-90). The ED Physician #2 signed on 12/16/2023 at 6:54 AM that he saw and evaluated Patient #1, and he discussed the care with ED Physician #3 and agreed with the findings and plan. There was no documentation Patient #1’s below normal glucose level was ever reassessed or treated. There was no documentation Patient #1 was given any food or feedings through the G-tube to address the low blood sugar. Patient #1’s hypoglycemia was not fully and appropriated assessed. ED Physician #3 did not order a urinalysis to check for possible occult infection. ED Physician #3 documented Patient #1 was discharged home, with the parents, on 12/14/2023 at 1:02 AM and documented she had a detailed discussion with the patient/parents about Patient #1’s symptoms, workups, what to look out for, and when to return to the emergency department. Review of an Internet search revealed the patient lived 131.3 miles from Hospital #1 (over 2 hours travel time). This would have made it difficult for Patient #1 to return to the ED quickly and seek care. There was no documentation by ED Physician #3 or Pediatric Neurologist #1 that they were aware of the distance Patient #1 would have to travel to return and seek care. Patient #1 returned to the Hospital #1 ED on 12/15/2023 at 12:26 PM with the chief complaint of continuing seizures every 3-5 minutes lasting approximately 8-10 seconds each. Patient #1 was admitted to Hospital #1 for further evaluation and treatment. The parents reported that they were unable to pick up the Keppra medication since the local pharmacy was out of stock. The parents reported Patient #1 started having seizures at some time after 9:00 AM (12/15/2023), and they brought him back to the Hospital #1 ED. Patient #1’s respiratory pathogen panel was positive for rhinovirus/enterovirus. Patient #1’s hospital course was complicated by Strep pneumoniae and Methicillin-resistant Staphylococcus aureus (MRSA) tracheitis requiring antibiotics. Patient #1 continued to have seizures during his hospital stay. The Rapid Response Team (team of medical providers who intervene when a patient demonstrates signs of imminent clinical deterioration) responded to Patient #1 demonstrating near continuous seizure activity on 12/16/2023 at 9:03 PM. Patient #1 was then transferred to the Pediatric Intensive Care Unit for closer observation and treatment. On 12/18/2023, Patient #1 began to demonstrate increased work/difficulty in breathing and was intubated with pressure regulated volume control. Patient #1 gradually improved and was extubated on 12/24/2023. Patient #1 continued to improve and was discharged home on 12/26/2023. In an interview on 1/10/2024 at 10:55 AM, Registered Nurse (RN) #2 confirmed she was the primary nurse for Patient #1 during his ED visit on 12/14/2023. RN #2 stated Patient #1 was still altered from the medications he received at home when he was placed on the monitor (cardiac). RN #2 stated the parents reported Patient #1’s seizure activity had increased, and he was having seizures approximately every 5 minutes. RN #2 stated neurology was consulted, and they ordered a loading dose of Keppra. RN #2 stated there were no further seizures witnessed or reported after Patient #1 received the Keppra medication. RN #2 stated she accompanied the ED physician into Patient #1’s room to go over the discharge plans. RN #2 stated the parents were comfortable with the return instructions given and the discharge home. RN #2 denied that Patient #1 exhibited any signs or symptoms of infection or other illness. In an interview on 1/10/2024 at 11:53 AM, RN #4 confirmed she was the triage nurse for Patient #1 during his ED visit on 12/14/2023. RN #4 stated she recognized Patient #1’s name, and his triage, “was a very short interaction. The parents brought him in with seizures, and the parents had already given him 3 prns [as needed medication for seizures]. He did have a seizure in triage area, so I called my charge nurse and told her we needed to get him to the back pretty quickly ...” In an interview on 1/10/2024 at 12:32 PM, ED Physician #2 confirmed he was the medical provider for Patient #1 when he presented to the Hospital #1 ED on 12/14/2023. ED Physician #2 stated Patient #1 had a complex medical history most notable for seizure activity. ED Physician #2 stated the reported history and what was observed in the ED were very short cluster seizures. ED Physician #2 stated Patient #1 “had no fever, no symptoms reported on exam, there was no evidence of an illness.””