Adventist Health Hanford

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 40644 Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment in accordance with hospital policy and procedures and clinical standards of practice for infection control when: 1. “Brand name” analyzer machine (a portable, point-of-care (medical diagnostic tests that are performed at or near the site where the patient is receiving care) that provides rapid, comprehensive testing of patient blood samples to aid in critical care decisions) on multiple units in the hospital were visibly soiled with splatter marks, dark red in color, on the machine surface(s). 2. Medication, clean and dirty utility rooms (rooms designated to prepare and/or store clean supplies/medications and waste products separately) cabinets, on several units in the hospital had peeling labels and residual adhesive with built up debris stuck onto the adhesive. 3. Patient medication storage bins in the Intensive Care Unit (ICU- a specialized hospital department that provides critical care to critically ill or injured patients who require constant monitoring and intensive medical intervention) were visibly soiled with sticky, amber-colored substances. 4. Hot meals, breakfast trays containing scrambled eggs were stored in the Emergency Department (ED) nutrition pantry room counter and did not have a delivery date and time or a use by date and time label to warn of expiration. These failures resulted in the potential risk of cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) to patients, visitors, and staff which could lead to infection and diseases. Findings: 1. During a concurrent observation and interview on 11/4/25 at 9:53 a.m., during a tour of the Emergency Department (ED) with the ED Manager (MED) and Registered Respiratory Therapist (RRT) 1, the “brand name” analyzer machine in the medication room had dark red splash stains on multiple surfaces of the machine. RRT 1 stated the machine was used by Respiratory Therapists and the expectation was the surface of the machine should be wiped down with “brand name” wipes (disinfecting wipes) after each use. RRT 1 stated the machine needed to be cleaned. During a concurrent observation and interview on 11/4/25 at 11:09 a.m. with the ICU Director (DICU), the ICU unit “brand name” analyzer machine had dark red splash stains on multiple surfaces of the machine. The DICU stated the machine needed to be cleaned. 2. During a tour on 11/4/25 at 9:53 a.m. on 2 South Medical/Surgical unit (Med/Surg - nursing units in the hospital where patients who are not critically ill are cared for) with the Director of Med/Surg (Dir M/S) and the Interim Manager (IM) of 2 South Med/Surg, the Medication Room was observed. The lower cabinet doors had a white substance that had dripped down the cabinet. The IM stated she did not know what the substance was, but the door did not look clean. The sink was observed to have a layer of white residue. The inside of the upper cabinet doors had multiple stickers that were peeling off, leaving a sticky adhesive residue. The IM stated the doors needed to be cleaned for infection control. During a tour on 11/4/25 at 10:30 a.m. on 3 Med/Surg with Nurse Manager (NM) 1 and Dir M/S, the Medication Room was observed. The inside of the upper cabinet doors had multiple stickers that were peeling off, leaving a sticky adhesive residue. NM 1 stated the stickers should not be there and it was an infection control risk because it could not be cleaned. The dirty utility room (the room where equipment and supplies are stored after use and before being cleaned) was observed, and there were brown spots along the edge of the ceiling where the ceiling met the wall. Streaks were noted that appeared to be from something dripping down the wall. NM1 stated the wall needed to be cleaned. During a concurrent observation and interview on 11/4/25 at 11:09 a.m., during a tour of the ICU, with the DICU, in the medication room, the inside of the upper cabinet doors had multiple stickers that were peeling off, leaving a sticky adhesive residue. The DICU stated the stickers were being removed and were to be replaced with new stickers, and it appeared the project was incomplete. The DICU stated his expectation was that the cabinets should be clean and free of debris to prevent cross-contamination. 3. During a concurrent observation and interview on 11/4/25 11:15 a.m. during a tour of the ICU medication room, with the DICU, patient medication storage bins had sticky debris collected on them. The DICU stated his expectation was the bins should be clean to prevent cross-contamination. 4. During a tour on 11/4/25 at 10:00 a.m. with the Director of ED (DED), the Emergency Department Nutrition Pantry room was observed to have a tray containing two (2) hot breakfast meals, intended for patient use, were stored on the counter. The breakfast trays did not have a use by or expiration date label or delivery date and time label. The DED stated without labeling to confirm the date and time of delivery, it was not possible to determine if the trays were safe to provide to patients. The DED stated the trays should have been thrown away. During an interview on 11/5/25 at 1:53 p.m. with the Director of Infection Prevention (DIP), the DIP reviewed pictures taken during tours of hospital patient care units. The DIP stated the rooms were not clean and the stickers on the cabinets were not acceptable. The DIP stated the tape and stickers could not be cleaned and could cause cross contamination. The DIP stated her expectation was unit leaders should ensure staff were following policy and procedure (P&P) to maintain a sanitary environment. The DIP stated the analyzer machines and patient medication bins should be cleaned routinely and as per manufacturer recommendation. During a review of the hospital’s P&P titled, “Infection Prevention and Control Plan/Program (ICP Plan),” dated 6/18/25, the P&P indicated, “...PLAN: COMPLIANCE - KEY ELEMENTS...F. ICP Plan...1...The IPC Plan reflects:...l. Clean and sanitary environment that includes: ...iv. Medical equipment and medical devices...” During a review of the hospital’s P&P titled, “Sanitary Environment in Healthcare Facilities,” dated 4/18/16, the P&P indicated, “ ...POLICY SUMMARY/INTENT: The organization will maintain a sanitary environment to avoid sources of infection and communicable disease [define]. ...B....1. The methods of cleaning and/or decontamination [define] will be appropriate, effective and shall be appropriate for the: a. Location b. Type of surface or equipment c. Type of soil or contamination...3. Equipment and environment will be decontaminated between patients and after contact with blood or other potentially infections materials (OPIM), immediately or as soon as feasible, but no later than at the end of the shift this applies to: a. Surfaces that are overtly contaminated b. Spills of blood or OPIM c. When procedures are completed and d. At the end of the work shift if the surface may have become contaminated since the last cleaning... C....D. Manufacturer’s instruction for use (IFU) for cleaning and maintaining medical equipment will be followed...L. Bins, pails, cans and similar receptacles intended for reuses shall be inspected and decontaminated regularly...” During a review of the hospital’s P&P titled, “Entity Plan: Bloodborne Pathogens [define] Exposure Control Plan,” dated 3/19/25, the P&P indicated, “ ...C. Methods of Compliance 1. Standard Precautions:... 5. Housekeeping: Environmental Services and Safety Management:...iii. a. Environment: i. Maintaining a safe, clean and sanitary environment for patients, visitors, and staff if part of the mission statement of the Environmental Services Department, as well as an important aspect of the Bloodborne Pathogens Standard...” During a review of a professional reference from the Agency for Healthcare Research and Quality (AHRQ), an article titled, “Infection Prevention (IP),” (undated), the article indicated, “ ... Providing a sanitary environment ... There is a clear separation of clean and dirty work areas. Clean areas are used for storage and preparation of medications and unused supplies; dirty areas are used for contaminated equipment ...” During a review of the professional reference from Current Opinion in Infectious Diseases titled, “The role of the surface environment in healthcare-associated infections,” dated August 2013, the article indicated, “ ...Hospital surfaces are frequently contaminated with important healthcare-associated pathogens (bacteria). Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider’s hands or gloves that may result in patient-to-patient transmission of nosocomial (originating from the hospital) pathogens ...” During a review of the professional reference retrieved from https://www.who.int/publications/m/item/trs-1025-annex-7, an article titled, “Good Storage and Distribution Practices for Medical Products,” dated 6/17/20, the article indicated, “ ...Storage and distribution are important activities in the supply chain management of medical products ... Storage areas should be of sufficient capacity to allow orderly storage of the various categories of medical products ... Storage areas should be appropriately designed, constructed, maintained or adapted. They should be kept clean and there should be sufficient space and lighting ... Materials and medical products should be stored off the floor, away from walls and ceilings, protected from direct sunlight and suitably spaced, to permit ventilation, cleaning and inspection ... Materials and medical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination...””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 42118 Based on observation, interview and record review, the hospital failed to have an effective governing body (GB) legally responsible for the conduct of the hospital when the GB did not provide sufficient oversight and resources to ensure the Medical Executive Committee (MEC - define) followed up and completed an investigation related to serious allegations of misconduct of a physician (MD 1). MD 1 was alleged to routinely perform vaginal and rectal examinations on women patients prior to performing colonoscopy without first obtaining informed consents for the vaginal and rectal exams. The MEC placed MD 1 on administrative leave, began an investigation into the allegations and stopped the investigation once MD 1 resigned. The GB failed to ensure a full investigation was completed to determine the extent of the practice and the effect on the quality of care to patients and the effect on patients’ right to have informed consents for vaginal and rectal exams. (Refer to A049) The cumulative effect of this systemic problem resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe setting.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 42118 Based on interview and record review, the hospital failed to protect and promote patients’ rights when: 1. The facility failed to ensure one of five sampled patients (Patient (Pt) 1) received care in a safe setting when the Radiologist Technologist (RT) mislabeled the portable x-ray (a medical imaging device used to get pictures of the inside of the body) leading to the misplacement of the chest tube (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully) by the medical doctor. This failure resulted in Pt 1 unnecessarily having bilateral (affecting two sides) chest tubes placed which extended Pt 1’s recovery time and placed Pt 1 at risk for worsened health conditions and infections. (Refer to A - 0144) 2. Rectal and/or vaginal examinations were performed on three of four patients (Patient (Pt) 3, Pt 4, and Pt 25) during colostomy procedures, without informed consent, while patients were under anesthesia; in addition, one of two patients (Pt 25) had an observer present during her procedure and a consent form was not documented to have the observer present. These failures had the potential to negatively affect the health and safety of all patients and violated patients’ rights when patients were not fully informed of invasive procedures performed on them while under anesthesia and were not given the opportunity to consent or refuse the procedure. (Refer to A - 0131). The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe setting.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 42118 Based on observation, interview and record review, the hospital failed to have an organized medical staff that operates under bylaws approved by the governing body (GB), and which is responsible for the quality of medical care provided to patients when the GB did not provide sufficient oversight and resources to ensure the Medical Executive Committee (MEC - define) followed up and completed an investigation related to serious allegations of misconduct of a physician (MD 1). MD 1 was alleged to routinely perform vaginal and rectal examinations on women patients prior to performing colonoscopy without first obtaining informed consents for the vaginal and rectal exams. The MEC placed MD 1 on administrative leave, began an investigation into the allegations and stopped the investigation once MD 1 resigned. The GB failed to ensure a full investigation was completed to determine the extent of the practice and the effect on the quality of care to patients and the effect on patients’ right to have informed consents for vaginal and rectal exams. (Refer to A0347) The cumulative effect of this systemic problem resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and responsible manner.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 42118 Based on observation, interview, and record review, the facility failed to ensure surgical services were provided in accordance with acceptable standards of practice when: 1. Rectal and/or vaginal examinations were performed on three of four sampled patients (Patient (Pt) 3, Pt 4, and 25) during colonoscopy procedures without informed consent (the process by which each patient is informed by the performing surgeon/practitioner, in a language they could understand of the risks and benefits of a procedure and authorized for it to be performed), while these patients were under anesthesia (the use of medicines to prevent pain during surgery or other procedures). (Refer to A - 0955) 2. The Radiologist Technician (RT) mislabled an x-ray film while performing a portable x-ray (a medical imaging device used to get pictures of the inside of the body) on one of five sampled patients (Patient (Pt) 1), leading to the misplacement of the chest tube (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully) by the medical doctor. (Refer to A - 0951) These cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe setting.”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 42118 Based on observation, interview, and record review, the hospital failed to ensure the medical staff was accountable to the governing body for the quality of care provided, when the subgroup of the Medical Executive Committee (MEC) placed Medical Doctor (MD) 1 on administrative leave while they investigated allegations that he routinely performed vaginal and rectal examinations on patients during colonoscopies (medical procedure where the doctor inspects the inside of the largest part of the large intestines, using a long, flexible tube with a camera and light), without obtaining informed consent (the process by which each patient is informed by the performing surgeon/practitioner, in a language they can understand, of the risks and benefits of a procedure and authorizes for it to be performed); then, they stopped the investigation when MD 1 resigned, without determining the full extent of the practice of routine sensitive examinations being performed without informed consent on patients during colonoscopies at locations under the hospital’s license and failed to indicate ongoing practice. This failure resulted in the lack of determining the full extent of sensitive examinations performed during colonoscopies without informed consent, as described above, and had the potential to negatively affect the provision of quality care and safety to all patients receiving colonoscopies at locations under this hospital’s license and to deprive patients from their right to be informed about the procedure and authorize it to be performed, as well as their rights to privacy. FINDINGS: When it came to the hospital’s attention that a social media post was made on 3/21/25 claiming that a physician at a local hospital was known to be “molesting patients with nothing being done about it,” senior management/administration immediately began an internal investigation. The hospital soon discovered that some staff who worked with MD 1 during colonoscopies for extended periods of time had knowledge that MD 1 routinely performed vaginal and rectal exams and some physicians at the facility routinely conducted rectal exams on their patients during colonoscopies, without obtaining and documenting informed consents prior to the procedure. A sub-committee of the MEC was formed to investigate MD 1’s practice. MD 1 resigned from the facility after being suspended pending investigation and the investigation into MD 1’s practice ended. The hospital notified their assigned (Name of State) Department of Public Health of the social media post and the details of their internal investigation. Of the four medical records of colonoscopy patients randomly audited at the main hospital and at other sites under the hospital’s license, between 8/22/24 and 6/03/25, sensitive examinations were not documented on any of their informed consents, not even those whose operative records indicated the physician documented having a discussion with the patient that rectal exams would be done during the procedure. At the time the state Department of Public Health conducted their investigation, it was discovered that the hospital had not fully investigated the extent of this deficient practice or implemented effective strategies to prevent it from happening again. During an interview on 5/28/25 at 2:33 p.m. with Endoscopy Technician (ET) 2, with the Director of Regulatory Compliance (DRC) in attendance, ET 2 stated he worked in this role at this hospital for over ten years. ET 2 stated the last time he worked with MD 1 was “maybe four months ago.” When asked if he noticed anything “out of line” when working with MD 1, ET 2 stated when he first started working at the facility, he was informed by a previous nurse who trained him that, when MD 1 performed colonoscopies, he always performed vaginal and rectal exams to look for “fistulas [an abnormal opening or passage between two organs or between an organ and the surface of the body].” ET 2 stated everything he knew about MD 1 looking for fistulas was hearsay (define), and he had not heard anything about it in the last four years. ET 2 stated he never observed MD 1 examining for fistulas because of the way he and MD 1 were positioned in the operating room. ET 2 stated he was always out of the direct line-of-sight to observe what MD 1 was doing, ET 2 stated he never observed MD 1 or any other physician doing something inappropriate with patients and if he did, he would report it to the “circulating nurse (a member of the surgical/procedural team responsible for ensuring a safe environment).” During an interview on 5/28/25 at 3:30 p.m. with Registered Nurse (RN) 1 from the Gastrointestinal Department (GI -department which performs procedures involving the stomach and intestines), with the DRC in attendance, RN 1 stated she had been at the facility in the role of circulating nurse since January 2024. RN 1 stated the last time she participated in a colonoscopy with MD 1 was approximately January 2025. RN 1 stated, when she was in the colonoscopy procedure, she was standing at the computer and all she could see was “the patient facing me, my role was mainly charting.” RN 1 stated, she “heard MD 1 checked for vaginal fistulas [unusual openings that form between the vagina and another organ].” RN 1 stated, if she observed MD 1 performing vaginal exams, checking for fistulas, she probably would not have questioned it, “since it had already been reported and was his standard of practice.” RN 1 stated she had not seen MD 1 for “about a month.” During an interview on 5/29/25 at 10:29 a.m. with the Manager of Patient Scheduling/Radiology (MPS), the MPS stated she was on (name of social media site) on 3/21/25 and read an article from a local news station and a post responding to the article that indicated “there was a situation at a [name of city] hospital where a provider was molesting patients”. The MPS said she shared this information with Director of Administrative Operations (DAO). The MPS stated the article from the local newspaper was regarding another physician in the area who reportedly molested patients in his private office. The MPS stated she did not know what the DAO did with the information she reported (to the DOA). The MPS stated she had abuse training at least annually and if anyone at the hospital had reported abuse to her, she would fill out the required form and report the incident to Risk Management immediately. During a concurrent interview and record review on 5/29/25 at 11:30 a.m., with the Director of Medical Staff (DMS) and the Senior Director/Central California Network (SDCCN), the files for MD 1 and MD 8 which included education, credential processes, and personnel files were reviewed. The files indicated, no issues were noted for MD 1 or MD 8. The file for MD 1 indicated, no records of disciplinary actions, except the current issue with informed consent. The DMS and the SDCCN stated they were members of the MEC subgroup that investigated the social media post which indicated a doctor at this hospital was molesting patients and nothing was being done about it. The DMS and the SDCCN both stated they were not aware of any issues with MD 1’s practice. The DMS and the SDCCN stated neither one of them had ever been informed about MD 1’s practice of vaginal and rectal exams during his patients’ colonoscopies. The DMS and the SDCCN stated MD 1 was interviewed and admitted he was trained to perform vaginal and rectal exams during colonoscopies. The DMS and the SDCCN stated, after MD 1 resigned, the investigation related to him “stopped.” The DMS returned a few hours later and stated the MEC did not make a final determination if vaginal and rectal exams should be considered routine parts of a colonoscopy. During an interview on 5/29/25 at 2:12 p.m. with the DAO, with the DRC in attendance, the DAO stated the MPS reported to her what she saw on a social media post regarding a local physician “touching patients and nothing was being done about it.” The DAO stated she asked the MPS to send her a text regarding this post. The DAO stated she then forwarded this text to the Chief Operating Officer (COO) of the hospital. The DAO stated she did not know how it was determined that the social media post was related to MD 1. During an interview on 5/29/23 at 2:25 pm with the Medical Director of the Gastrointestinal Service Line (MD 2), with the SDCCN, the DMS, and the DRC in attendance, MD 2 stated he had been in his position at the hospital since March 2024. MD 2 stated he was part of the MEC subgroup investigating MD 1 and was familiar with the allegations made regarding MD 1’s practice of vaginal and rectal examinations during colonoscopies. MD 2 stated the colonoscopy procedure was indicated for colon cancer screening, previous polyps (a small clump of cells that form on the lining of the large intestines or rectum), bleeding in GI track, and for changes in bowel habits. MD 2 stated, after the bowel preparation (the process of emptying and cleaning the large intestines), a rectal exam was performed to feel for hemorrhoids (swollen and inflamed veins located in the lower rectum and anus), fistulas, and/or enlarged prostates (a gland surrounding the neck of the bladder in males), the colonoscopy scope was introduced into the rectum and then slowly withdrawn, looking for abnormalities. MD 2 stated vaginal exams were not the standard of practice for colonoscopies. MD 2 stated it first came to his attention that MD 1 was routinely performing vaginal exams during colonoscopies when MD 1 was suspended. MD 2 stated, if he observed MD 1’s practice of performing vaginal examinations prior to colonoscopies, he would have asked MD 1 why he was performing vaginal exams on females and what was he looking for. MD 2 stated rectal exams were performed on all patients during colonoscopies and would not be alarming, but he would discuss the practice of vaginal exams with peers. MD 2 stated, “We’re in a rural area ... practices are different in rural areas.” MD 2 stated he would look into whether the informed consent for colonoscopy covers rectal exams. During an interview on 5/29/25 at 2:30 p.m., with the DAO, with the SDCCN, MSD, and DRC in attendance, the DAO stated the MPS reported to her what she saw on the social media posting regarding a local physician “touching patients and nothing was being done about it.” The DAO stated she asked the MPS to send her a text regarding this posting, which she did; the DAO stated she then forwarded this text to the Chief Operating Officer (COO) of the hospital. The DAO stated she does not know how it was determined that the social media posting was related to MD 1. The SDCCN stated she was part of the Administrative Team that investigated this case; she stated, “We went to the Operating Room Director [DOR] who said she was aware.” The SDCCN stated she participated in the review of 10 patient charts and the Peer Review Committee, who did the initial review of this incident and reviewed about “40 charts.” The MDS stated the investigation was pulled out of MEC to an ad hoc committee of the MEC; she stated, “We summararily suspended MD 1 and he resigned. The SDCCN stated an education on informed consent was given to the general medical staff. During an interview on 5/29/25 at 3:09 pm with the Chief Operating Officer (COO),with the DRC in attendance, the COO stated the DAO sent him a screen shot of the social media post, dated “3/21/25 at 7:05 a.m.,” which indicated a doctor had been molesting patients at (name of city) hospital and nothing was being done about it and the first and last name of the person who posted this message. The COO stated, with this information, he recognized the last name to match an employee which was the Director of Sterile Processing (DPS), and the COO asked the DPS if his partner’s first name was the first name of the individual who posted. The COO stated the DPS stated his partner’s first name was the first name of the individual who posted but was not aware of the post. The COO stated he called the Director of the Operating Room (DOR) and the DOR stated she had no knowledge related to the post. The COO stated he then called the Chief Executive Officer (CEO) to inform him of the post. The COO stated the DOR later told him MD 1 conducted vaginal exams during colonoscopies. The COO stated the DOR shared there “was a concern that was raised a year and a half ago” and at that time, it was determined to be part of MD 1’s standard of practice. The COO stated an informal investigation was opened on 3/21/25. The COO stated the DOR was placed on administrative leave and she resigned, after giving a two-week notice. The COO stated it was his understanding that the Peer Review investigation had stopped. The COO stated a “Rapid Module Based Training related to Consents” was given to the “procedural staff” and “safety stand down training” on escalating staff concerns were given to key physicians, surgeons, and preop [before surgery]/ post op [after surgery] staff. The DRC agreed to forward the training that was given to their assigned state Department of Public Health office. During an interview on 5/29/25 at 3:45 p.m. with the Chief Medical Officer (CMO), with the DRC in attendance, the CMO stated he had been in his position since January 2024. The CMO stated he received notification on 3/21/25 regarding a social media post regarding allegations of sexual abuse by a physician in (name of city) hospital. The CMO stated he called the DOR who advised him of MD 1’s practice during colonoscopies which was brought to her attention eight months prior but she thought it was a standard of practice. The CMO stated, when he found out MD 1 was still on staff performing colonoscopies, he informed the MEC. The CMO stated the MEC reviewed the case and found it was unusual to perform pelvic exams during colonoscopies. The CMO stated the DOR should have notified medical staff and leadership of MD 1’s practice of performing rectal and vaginal exams without informed consent and should not have made a decision on her own. The CMO stated MD 1 was suspended pending investigation and MD 1 was reported to the medical board. The CMO stated he was not involved in the peer review process (where experts in a similar field evaluate the work of others for quality, accuracy, and relevance) related to MD 1. The CMO stated, “It’s hard to see how this was normalized.” The CMO stated yearly updates were given to the medical staff using (the name of the online educational program) and various other ways of training. The CMO stated, in response to the allegation made of MD 1’s practice, “standdowns; educational meetings; medical staff training on informed consent; ‘Just Culture’ training [a culture that encourages open communication and learning from errors, rather than solely focusing on blame] for the last 18 months; and ‘Stopping-the-Line’ training, if any physician was doing something they should not be doing.” The CMO stated physicians should follow the hospital’s informed consent policy. The CMO stated the organization had not received any complaints or grievances related to MD 1’s practice from patients and was not aware of any related allegations. During a concurrent interview and record review on 5/30/25 at 2:56 p.m., with the Manager of GI (MGI) and the Manager of Regulatory Compliance (MRC), the document in Pt 3’s medical record titled, “History and Physical [H & P]”, dated 9/24/24, was reviewed. The MGI concurred that this document indicated, “... Chief Complaint: Colon cancer screen... Actions/Plans: Colonoscopy...” Then, the document titled, “Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures (Consent),” dated 9/24/24 was reviewed. The MGI concurred that the consent indicated Pt 3, a female, consented for a “Colonoscopy” by MD 1 and the type of anesthesia to be used was “IV [into the vein] Sedation.” Next, the document in Pt 3’s clinical record titled, “Surgery and Procedure Report,” dated 9/24/24 was reviewed. This document indicated, “Preoperative Diagnosis: Screening for colon cancer... Surgeon: [MD 1]... Procedure in Detail: Perianal inspection [part of a rectal exam; involves examining the skin and surrounding area around the anus] was unremarkable. Digital palpation [a manual examination technique where a health professional used their finger to assess soft tissues, muscles, and organs]” revealed no palpable abnormality...” Pt 3’s Consent form did not indicate a perianal digital palpation would be conducted, nor did it indicate a vaginal exam was done. During a concurrent interview and record review on 5/30/25 at 3:32 p.m., with the MGI and the MRC, the document in Pt 4’s medical record titled, “H & P”, dated 8/22/24, was reviewed. The MPA concurred that this document indicated Pt 4 was a male, “... Chief Complaint: Screen for colon cancer... Actions/Plans: Colonoscopy...” Then, the document titled, “Consent,” dated 8/22/24 was reviewed. The MGI concurred that the consent indicated Pt 4 consented for a “Colonoscopy... Anesthesia...General [a medically induced state of unconsciousness used during surgery or other medical procedures to eliminate pain and other sensations]” by MD 1, his document indicated, “Preoperative Diagnosis: Colon cancer screening...Operation: Colonoscopy...Postoperative diagnosis: no abnormalities seen... Surgeon: [MD 1]... Procedure... Perianal inspection was unremarkable. Digital palpation revealed no palpable abnormality...” Pt 4’s Consent form did not indicated a perianal digital palpation would be conducted. During a concurrent interview and record review on 6/3/25 at 10:23 a.m. with the DRC, Pt 7’s medical record titled, “Operative Report - Colonoscopy (Report),” dated 5/30/25 was reviewed. The DRC stated the Report indicated MD 7 performed the procedure and it did not indicate a rectal exam was performed. During an observation on 6/3/25 at 11 a.m. in the pre-operative (Pre-Op) department, Pt 25 was dressed in a hospital gown and sitting up in the hospital bed. Consent for observer was conducted via video interpreter with RN 9, Program Specialist (PS) and Regulatory Specialist (RS) present and Pt 25 consented. During an observation on 6/3/25 at 11:26 a.m. in the Pre-Op department, MD 2, with the assistance of a video interpreter, reviewed Pt 25’s chief complaint of abdominal pain, the EGD and colonoscopy procedures, as well as risks and benefits, and explained the need for a rectal examination prior to the colonoscopy to check for masses. Pt 25 asked if MD 2 would be taking any samples during the procedure. MD 2 informed Pt 25, if any polyps were identified, they would be removed and if there were any tumors or inflammation, MD 2 would take samples to biopsy. Pt 25 consented to the procedure with a signature on the consent form. During an observation on 6/3/25 at 11:30 a.m., in the Pre-Op department, Pt 25’s “Consent,” dated 6/3/25 was reviewed. The Consent indicated, “Esophagogastroduodenoscopy and Colonoscopy with intervention ...print name (physician): [MD 2] ...” The Consent form did not indicate a rectal examination would be performed. During an interview on 6/03/25 at 2:30 p.m. with the CEO, with the DRC in attendance, the CEO stated there were two Governing Boards (GB) in the regional network where this facility was located, and these boards met in-person quarterly. The CEO stated he functioned as the CEO “for this area.” In response to the question “How does the Governing Body become aware of issues at this facility”, the CEO stated the GB were made aware of issues at the facility when the GB met monthly which oversaw quality. The CEO stated the previous DOR admitted the concerns regarding MD 1 were brought to her attention and she did not escalate them. The CEO stated, when the allegations related to MD 1 came about, the information was distributed to the “system board, [local] Department of Public Health” and their fiduciary.” The CEO stated when the allegations were shared with the GB, “There was a desire for the truth,” because MD 1 had practiced at this facility for 40 years. The CEO stated the Medical Staff conducted their own investigation, and the GB was not aware of the results of the Medical Staff’s investigation. The CEO stated upon learning of the allegations and being notified of MD 1’s practice, the GB did not agree with MD 1 going back into practice. The CEO stated his expectations were the Medical Staff should have followed their process, completed the investigation, and made the final determination related to the “standard of practice.” The CEO stated the GB will be updated on what was learned from the survey by the local Department of Public Health and ensure necessary changes were made. The CEO stated he was not aware of any allegations made by patients regarding MD 1. During a concurrent interview and record review on 6/4/25 at 4 p.m. with the Director of Surgery Service Line (DSS), Pt 25’s “Gastroenterology Procedure Final Report (Report),” dated 6/3/25 was reviewed. The DSS stated the Report indicated, “ ...Procedures Performed: EGD with biopsy ...Colonoscopy-screening ...Indication: 1. Abdominal pain 2. Colon cancer screening ...Attending: [MD 2] ...Procedure details for EGD and colonoscopy: Informed consent was obtained for the procedure, including sedation ...After completion of EGD endoscope was switched to a colonoscope. A rectal exam was performed. The standard colonoscope was inserted into the rectum ...Impression ...Colonoscopy revealed moderate to severe left-sided diverticulosis [a condition in which small, bulging pouches develop in the digestive tract], internal hemorrhoids ... unremarkable examination of terminal ileum [final section of the small intestines] ...” During an interview on 6/04/25 at 4:43 p.m. with the Patient Care Executive/ Chief Nursing Officer (PCE), the PCE stated she had been in her role with the current “Network” since 1/2024. The PCE stated prior to this role she was the PCE at another hospital with the same company since 2012. The PCE stated she learned about the social media post involving MD 1 from the Network President. The PCE stated the DOR did not share her knowledge of MD 1’s practice during colonoscopies with her. The PCE stated the DOR should have escalated what she knew about MD 1’s practice of vaginal and rectal exams. The PCE stated it had not been her experience that vaginal exams are performed during colonoscopies. The PCE stated, “We’ve done a lot of get-togethers with staff and management, and we have done considerable work to make sure we have a culture that people can speak up, even with hard conversations.” During a review of an untitled document of a social media post, dated 3/21/25, the document indicated, “Wish I could post anonymously because there’s a known doctor at a (name of city) hospital that has been seen molesting his patients when they are under. Many have complained and nothing has been done. Many staff know about it but don’t speak up.” During a review of the facility’s policy and procedure (P & P) titled, “Consent and Informed Consent”, dated 6/20/2022, this document indicated, “DEFINITIONS: ... 8. Informed consent - Agreement or permission accompanied by full notice about the care, treatment, or service that is the subject of the consent. A patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course. After receiving this information, the patient then either consents to or refuses such a procedure or treatment. POLICY: COMPLIANCE - KEY ELEMENTS - A. Identifying Who May Give Consent: a. A patient may give a valid consent only if they have “capacity”, which means they are able to understand the nature and consequences of a decision and to make and communicate the decision. b. To give consent, the person must have ALL of the following:... ii. Physical capacity - I. Patient is conscious. II. Patient is able to communicate a decision regarding consent to care... E. Treatments/Procedures That Require Informed Consent: 1. Complex treatment/procedures: ... c. Typically, informed consent must be obtained for: i. All treatments/procedures performed in the: I. Operating Room... III Gastrointestinal lab... 3. The topics that must be addressed in the informed consent discussion are: a. The nature of the operation or procedure, including other care, treatment, services... 4. Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient’s legal representative with the information that is necessary to allow an ‘informed decision’ to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to the performance of the procedure... c. the role of the health care facility in the informed consent process is to verify that the proceduralist(s) is/are permitted to perform the procedure/tests or that an exception (such as the emergency exception) applies that allows the treatment to proceed. F. Documentation: ... 2. Consent to Surgery or Special Procedure Form: a. The consent form should include: i. The name of the patient... ii. The medical terminology for the procedure... vi. Ensure where signature is applied that it is accompanied with a date and time... 4. The nursing staff shall be responsible for verifying that the documentation has been included in the chart PRIOR to the surgery/procedure and checking this off the surgical checklist. If these conditions are not met, the proceduralist performing the procedure must be contacted to obtain the required documentation...” During a review of the facility’s P&P titled, “Patient Rights”, dated 1/10/23, the P&P indicated, “... POLICY: Compliance - Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting... 4. Information: a. The hospital supports the provision of information to patients or designated representative which enables the making of healthcare decisions. Patients will receive information about their illness, health status, course of treatment, prospects for recovery and outcomes of care in terms you can understand... 5. Informed Consent: a. The patient will receive as much information about any proposed treatment or procedure as needed, in order to give informed consent or to refuse the course of treatment... The responsibility to obtain informed consent rests with the physician who provides service...” During a review of a professional reference from the Association of American Medical Colleges, an article titled, “CMS Clarifies Informed Consent Required for ‘Sensitive Examinations’,” dated 4/5/24, the article indicated, “On April 1, the Centers for Medicare and Medicaid Services (CMS) revised its Hospital Interpretive Guidelines to clarify that informed consent from patients is required prior to allowing supervised medical, advanced practice provider, or other applicable students to perform training and education-related sensitive examinations (such as breast, pelvic, prostate, and rectal examinations), particularly on patients under anesthesia. Along with the changes in guidelines ... “it is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent.” ...if hospitals don’t obtain consent, they would be violating the conditions of participation under Medicare and Medicaid and may be subject to fines and investigations for violations of patient privacy laws ...””

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 45580 Based on observation, interview, and record review, the facility failed to ensure patients were fully informed of their plan of care for: a. Three of four patients (Patient (Pt) 3, Pt 4, and Pt 25) when rectal and or vaginal procedures were performed while patients were under anesthesia (the use of medicines to prevent pain during surgery or other procedures) and the consent form did not indicate the invasive procedure being performed. b. One of two patients (Pt 25) when Pt 25 had an observer present during her procedure and a consent form was not documented to address her informed consent to have the observer present. These failures had the potential to negatively affect the health and safety of all patients and violated patients’ rights when patients were not fully informed of invasive procedures performed on them while under anesthesia and were not given the opportunity to consent or refuse the procedure. Findings: During a review of an untitled document of a social media post, undated, the document indicated, “Wish I could post anonymously because there’s a known doctor at a [name of city] hospital that has been seen molesting [to make unwanted or improper sexual advances towards someone] his patients when they are under. Many have complained and nothing has been done many staff know about it but don’t speak up.” During an interview on 5/28/25 at 2:34 p.m. with Endoscopy Technician (ET) 2, ET 2 stated when he first started over 10 years ago, his preceptor (someone who trains others on how to do their job) informed him MD 1 performed rectal and or vaginal examinations on his patients prior to their colonoscopy (a medical procedure that allows a doctor to examine the inside of the large intestine (colon) using a flexible tube called a colonscope) to check for fistulas (an abnormal passageway that forms between two normally separate areas). ET 2 stated his preceptor no longer worked at the facility. ET 2 stated about four years ago, a new ET had asked about MD 1’s practice and ET 2 informed her what he was taught but he encouraged her to use the chain of command if she was concerned about the practice. ET 2 stated he was not sure if the new ET used the chain of command to report her concern. ET 2 stated when he was in the operating room (OR) with MD 1, he could not see what MD 1 was doing as he was situated near the head of the bed and MD 1 sat when he performed colonoscopies; ET 2 could not see if MD 1 performed vaginal or rectal examinations on the patients. During an interview on 5/28/25 at 3:21 p.m. with Registered Nurse (RN) 1, RN 1 stated she had been in the OR when MD 1 performed colonoscopies on his patients. RN 1 stated while in the OR she sat at the computer, and the patient was positioned towards her, so she was unable to see what MD 1 was doing. RN 1 stated she had worked at the facility for close to a year and heard MD 1 examined the vagina of female patients, but she had not observed or verified MD 1’s practice. RN 1 stated she asked other staff why MD 1 examined the vagina of his female patients, and she was informed MD 1 checked for fistulas during the vaginal examinations. RN 1 stated if she observed MD 1 examining his patient’s vagina prior to colonoscopies, she would not have questioned it as she was taught it was his standard of practice. RN 1 stated MD 1 was the only physician she heard who practiced examining of his female patients for fistulas and there were no other allegations of inappropriate behavior by staff or other physicians. During an interview on 5/29/25 at 10:29 a.m. with the Manager of Patient Scheduling (MPS), the MPS stated on 3/21/25 she was scrolling through a social media website and saw a post from the local news station. The MPS stated the news station posted about another physician who had sexually abused his patient, and she could not recall the exact wording but from what she remembered, the comment stated, “There was a similar situation happening at the [name of Hospital A] where a provider was molesting his patients.” The MPS stated after she read the comment, she screened shot the comment and shared it with the Director of Administrative Operations (DAO). The MPS stated the comment did not mention a name of a physician and she had not heard of any allegations of sexual abuse by physicians. During an interview on 5/29/25 at 11:45 a.m. with the Senior Director for Central California Network (SDCCN), the SDCCN stated at the administrative level, she gathered information that would support the allegations and provided this information to the Medical Executive Committee for evaluation. The SDCCN stated MD 1 resigned during the investigation, so a final determination of his practice of examining his patient’s rectum and vagina prior to their colonoscopies was not determined. The SDCCN stated the Medical Staff was not able to determine if MD 1’s practice was out of his scope of practice or if it was inappropriate. The SDCCN stated during an interview with MD 1, MD 1 stated vaginal and rectal examinations prior to colonoscopies were his standard of practice and how he was taught. The SDCCN stated a physician should not perform vaginal examinations without an informed consent from the patient. The SDCCN stated both vaginal and rectal examinations prior to colonoscopies were not found to be the standard of practice but exceptions in some cases where the patient’s diagnosis and informed consents for both examinations were obtained. The SDCCN stated during their investigation, it was determined there were no other physicians who routinely examined their patient’s vagina and rectum prior to colonoscopies. During an interview on 5/29/25 at 2:25 p.m. with MD 2, MD 2 stated he was a part of the Ad Hoc Committee (a temporary group of people who are brought together to perform a specific task) and was familiar with the allegations made of MD 1’s practice of performing rectal examinations as well as vaginal examinations on all female patients prior to their colonoscopy. MD 1 stated the process of colonoscopy started when there was an indication for the colonoscopy such as a colon cancer screening, previous polyps (a growth in the body), bleeding in the lower gastrointestinal tract (the portion of the digestive system that includes he small intestine, the large intestine, rectum, and anus), and changes in bowel pattern depending on the age group. MD 2 stated prior to the colonoscopy a rectal exam was taught to fellows (a doctor who has completed their initial residency training and pursuing additional training) to feel for fissures (a small tear in the lining of the anus) and for males to feel for nodules (a small growth of tissue) of the prostate gland (a small, walnut-shaped gland located in the male reproductive system). MD 2 stated he did not perform vaginal examinations on his female patients prior to their colonoscopy as this was not the standard of practice. MD 2 stated he was not aware of MD 1’s practice until MD 1 was suspended. MD 2 stated when he explained the colonoscopy procedure it was implied a rectal exam would be conducted prior to the colonoscopy and the informed consent should cover the rectal exam along with the colonoscopy procedure. During an interview on 5/29/25 at 3:44 p.m. with MD 4, MD 4 stated he received a text message around mid-day from the Chief Operating Officer (COO) referring to an article about a physician in [name of nearby city] was suspended and in the post there was a comment where a physician was molesting patients in [name of Hospital A]. MD 4 stated he called the Director of the Operating Room (DOR), and she said the allegation was brought to her attention eight months ago, she did her own research which found it was the standard of practice for vaginal examinations to be performed with the colonoscopy. MD 4 asked the DOR if she escalated to the Medical Staff and she said, “No.” MD 4 stated to his knowledge, vaginal examinations were not routinely performed unless the patient had prolapse (the falling down of an organ from its normal position) or other issues. MD 4 stated the DOR should have informed the Medical Staff and himself and should not have taken it upon herself to investigate the allegation. MD 4 stated any sensitive examinations performed under anesthesia should have an informed consent. MD 4 stated physicians should know and comply with informed consents for sensitive procedures. During a concurrent interview and record review on 5/30/25 at 2:56 p.m. with the Manager of Gastrointestinal (MGI) and the Manager of Regulatory Compliance (MRC) present, Patient (Pt) 3’s “History and Physical (H&P),” dated 9/24/24 was reviewed. The MGI stated the H&P indicated, “ ...Chief Complaint: Colon Cancer Screen ...Action/Plans: Colonoscopy ...” During a concurrent interview and record review on 5/30/25 at 3 p.m. with the MGI and the MRC present, Pt 3’s “Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures (Consent),” dated 9/24/24 was reviewed. The MGI stated the Consent indicated Pt 3 was consented for “Colonoscopy” by MD 1 and the type of anesthesia to be used was “IV Sedation.” The MGI stated there was no indication for a separate consent for anesthesia as the anesthesia used was conscious sedation (a level of sedation in which a person is asleep but wakes when spoken to or touched). The Consent did not indicate a rectal examination would be performed. During a concurrent interview and record review on 5/30/25 at 3:15 p.m. with the MGI and the MRC present, Pt 3’s “Surgery and Procedure Reports (Report),” dated 9/24/24 was reviewed. The MGI stated the Report indicated, “Preoperative Diagnosis: Screening for colon cancer ...Operation: Colonoscopy ...Postoperative Diagnosis: Normal colon ...Surgeon: [MD 1] ...Procedure in Detail: Perianal inspection [visual examination of the skin around the anus] was unremarkable. Digital palpation [feeling a body part with your fingers] revealed no palpable abnormality ...” The consent form and the Report did not indicate a rectal and vaginal examination would be conducted prior to the colonoscopy per MD 1’s standard of practice. During a concurrent interview and record review on 5/30/25 at 3:32 p.m. with the MGI and the MRC present, Pt 4’s “H&P,” dated 8/22/24 was reviewed. The MGI stated the H&P indicated, “ ...Chief Complaint: Screen for colon cancer ...Action/Plans: Colonoscopy ...” During a concurrent interview and record review on 5/30/25 at 3:40 p.m. with the MGI and the MRC present, Pt 4’s “Consent,” dated 8/22/24 was reviewed. The MGI stated the Consent indicated, “ ...Colonoscopy ...Anesthesia ...General ...MAC ...[MD 1] ...” During a concurrent interview and record review on 5/30/25 at 3:45 p.m. with the MGI and the MRC present, Pt 4’s “Report,” dated 8/22/24 was reviewed. The MGI stated the Report indicated, “ ...Preoperative Diagnosis: Colon cancer screening ...Operation: Colonoscopy ...Postoperative Diagnosis: No abnormalities seen. Poor prep [bowels were not clear of bowel movement] ...Surgeon: [MD 1] ...Procedure ...Perianal inspection was unremarkable. Digital palpation revealed no palpable abnormality ...” The Consent did not indicate a rectal examination would be performed. During an observation on 6/3/25 at 11:26 a.m. in the Pre-Op department, MD 2 with the assistance of a video interpreter, reviewed Pt 25’s chief complaint of abdominal pain, the esophagogastroduodenoscopy (EGD-a medical procedure were a doctor uses a thin, flexible, lighted tube called an endoscope to examine the lining of the esophagus (a muscular tube that connects the mouth to the stomach), stomach, and duodenum (first part of the small intestine)) and colonoscopy procedures as well as risks and benefits, and explained the need for a rectal examination prior to the colonoscopy to check for masses. Pt 25 asked if MD 2 would be taking any samples during the procedure. MD 2 informed Pt 25 if any polyps were identified, they would be removed and if there were any tumors or inflammation, MD 2 would take samples to biopsy (a procedure where a small sample of tissue is removed from the body for examination under a microscope). Pt 25 consented to the procedure with a signature on the consent form. During an observation on 6/3/25 at 11:30 a.m. in the Pre-Op department, Pt 25’s “Consent,” dated 6/3/25 was reviewed. The Consent indicated, “Esophagogastroduodenoscopy and Colonoscopy with intervention ...print name (physician): [MD 2] ...” The Consent did not indicate a rectal examination would be performed. During a concurrent interview and record review on 6/4/25 at 4 p.m. with the Director of Surgery Service Line (DSS), Pt 25’s “Gastroenterology Procedure Final Report (Report),” dated 6/3/25 was reviewed. The DSS stated the Report indicated, “ ...Procedures Performed: EGD with biopsy ...Colonoscopy-screening ...Indication: 1. Abdominal pain 2. Colon cancer screening ...Attending: [MD 2] ...Procedure details for EGD and colonoscopy: Informed consent was obtained for the procedure, including sedation ...After completion of EGD endoscope was switched to a colonoscope. A rectal exam was performed. The standard colonoscope was inserted into the rectum ...Impression ...Colonoscopy revealed moderate to severe left-sided diverticulosis, internal hemorrhoids on retroflexion rectum. Otherwise unremarkable examination of terminal ileum ...” During a review of the facility’s policy and procedure (P&P) titled, “Consent and Informed Consent-California,” dated 3/6/25, the P&P indicate, “Policy Summary/Intent: Address when consent and informed consent must be obtained as well as to describe the process for obtaining consent and documenting it was given ...Treatments/Procedures That Require an Informed Consent: 1. Complex treatments/procedures: a. Informed consent must be obtained for treatments/procedures that are “complex” in that they involve material risks that are not commonly understood. b. The determination of which procedures are “complicated” or “complex,” and therefore, require informed consent, is medical in nature. Medical staff rules and regulations and/or policies should address which procedures and treatments require written informed consent, and should be approved by the medical staff executive committee. c. Typically, informed consent must be obtained for: i. All treatments/procedures/services performed in the: I. Operating room ... The topics that must be addressed in the informed consent discussion are: a. The nature of the operation or procedure, including other care, treatment, services or medications. b. Potential benefits, material risks, or side effects of the operation or procedure, including potential problems that might occur during recuperation. c. The likelihood of achieving the patient’s goals. d. Reasonable alternatives and the relevant material risks, benefits and side effects related to such alternatives, including the possible results of not receiving the proposed care, treatment and services ... Authorization and consent to the performance of important tasks related to the surgery or examinations or invasive procedures ... Examinations or invasive procedures conducted for educational and training purposes included, but are not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law ... Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient’s legal representative with the information that is necessary to allow an “informed decision” to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to performance of the procedure ... The role of the health care facility in the informed consent process is to verify that the practitioner(s) obtained the patient’s informed consent before the practitioner(s) is/are permitted to perform the procedure/tests ... Documentation: Consent to Surgery or Special Procedure Form: a. The consent form should include: i. The name of the patient, and when appropriate the patient’s legal representative. ii. The medical terminology for the procedure (without abbreviation) and the type of anesthesia to be used if applicable. iii. Name or names of practitioners who will perform important parts of the procedure/treatment/service. iv. Signature of witness. v. Name and signature of interpreter and an attestation that the consent has been translated, if applicable. vi. Ensure where signature is applied that it is accompanied with a date and time. b. If signed by the patient, the consent form should be signed while the patient has capacity ... The nursing staff shall be responsible for verifying that the documentation has been included in the chart PRIOR to the surgery/procedure and checking this off the surgical checklist ...” b. During an observation on 6/3/25 at 11 a.m. in the pre-operative (Pre-Op) department, Pt 25 was dressed in a hospital gown and sitting up in the hospital bed. Consent for observer was conducted via video interpreter with RN 9, Program Specialist (PS) and Regulatory Specialist (RS) present and Pt 25 consented. During a review of Pt 25’s “Authorization For and Consent for Observer or Product Representative in the Operating Room (Consent for Observer),” undated was reviewed. The Consent for Observer was not provided by the facility. During an email response on 6/12/25 at 3:30 p.m. regarding Pt 25’s missing “Consent for Observer” form with the MRC, the MRC stated, “Turns out that for Patient 25, the pre-op nurse only obtained verbal consent for [Surveyor] to observe. The form wasn’t filled out and there’s no other documentation that spells out that the patient consented for [Surveyor] to observe ...” During a review of the facility’s policy and procedure (P&P) titled, “Consent and Informed Consent-California,” dated 3/6/25, the P&P indicated, “Consent for Observers or Other Non-hospital Personnel Who Are Not an Essential Part of the Health Care Team During a Procedure: 1. All patients have the right to refuse the presence or participation of any person who is not a health care facility employee or essential part of the health care team during a procedure. 2. The practitioner is to obtain the patient’s approval for observers or non-health care facility personnel (who are not an essential part of the health care team during a procedure) to be present. The patient’s approval for these persons to be present and observe the procedure performed is to be documented in the medical record by the practitioner prior to the procedure ...” During a review of the facility’s document titled, “Consolidated Medical Staff of the Central Valley Network Consolidated Medical Staff Rules & Regulations 2019,” dated 11/27/19, the document indicated, “An informed consent must be obtained for all surgical, therapeutic, and invasive procedures and for the administration of anesthesia ... It is the treating practitioner’s exclusive responsibility to obtain and document informed consent. Informed consent must include the name of the licensed independent practitioner and any assistants, medical information regarding the nature of the treatment, its expected benefits or effects, its possible risks and complications, and any alternatives to the proposed treatment and their possible risks and complications. The treating practitioner’s must document in the patient’s medical record that a discussion of the planned procedure and anesthesia was held with the patient and that informed consent was obtained. Evidence of informed consent (copy of signed surgery permit from physician’s office, documented in pre-operative history & physical, or documented by handwritten note in the patient’s medical record) will be required before commencing with the intervention ...” During a review of a professional reference from the Association of American Medical Colleges, an article titled, “CMS Clarifies Informed Consent Required for “Sensitive Examinations”,” dated 4/5/24, the article indicated, “On April 1, the Centers for Medicare and Medicaid Services (CMS) revised its Hospital Interpretive Guidelines to clarify that informed consent from patients is required prior to allowing supervised medical, advanced practice provider, or other applicable students to perform training and education-related sensitive examinations (such as breast, pelvic, prostate, and rectal examinations), particularly on patients under anesthesia. Along with the changed in guidelines ... “it is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent.” ...if hospitals don’t obtain consent, they would be violating the conditions of participation under Medicare and Medicaid and may be subject to fines and investigations for violations of patient privacy laws ...””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 32946 Based on interview and record review, the facility failed to ensure one of five sampled patients (Patient (Pt) 1) received care in a safe setting when the Radiologist Technologist (RT) mislabeled the portable x-ray (a medical imaging device used to get pictures of the inside of the body) leading to the misplacement of the chest tube (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully) by the medical doctor. This failure resulted in Pt 1 unnecessarily having bilateral (affecting two sides) chest tubes (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully) placed which extended Pt 1’s recovery time and placed Pt 1 at risk for worsened health conditions and infections. FINDINGS: During a review of an untitled facility document dated 4/23/2025, this document indicated, “On 4/11/25 a radiation technician (rad tech) went to [Pt 1’s] beside to perform a portable CXR [chest x ray]. [Pt 1] was uncomfortable and unable to lay back in the bed [CXR usually taken from the front of the patient]. To promote comfort, the rad tech performed the CXR with [Pt 1] sitting up right (from the back of the patient). The rad tech failed to adjust the digital marker which led to the mislabeling of the image...Based on the discussion between the Interventional Radiologist [Medical Doctor] and Intensivist [Medical doctor] the intensivist inserted a chest tube into the left side per the mislabeled image. After placement of the left chest tube the patient continued to decompensate [ worsening of symptoms]. A stat CXR was performed at this time showing a right pleural effusion [a buildup of fluid between the tissues that line the lungs and the chest]. A right sided chest tube was then placed, and the patient’s condition improved.” During a review of Patient 1’s “Critical Care Consultation Note (CCN)”, dated 4/12/2025 at 1:00p.m., the CCN indicated, “58-year-old female was admitted for respiratory failure and was noted to have pneumonia [infection in the lungs] and was given antibiotics. Patient developed worsening dyspnea [shortness of breath] since last night and developed hypoxic [low oxygen levels in the body] respiratory failure.” During an interview on 6/2/25 at 10:00 a.m. with the RT, the RT stated, when she went into the patient’s room, Pt 1 was seated at the edge of the bed. The RT stated she had asked Pt 1 if she could lay back on the gurney and Pt 1 stated “No.” The RT stated she asked Pt 1 to hold the x-ray film cassette [Pt 1 held the x-ray film cassette in front of the body]. The RT stated she took the image. The RT stated she did not realize, if she took the image in post anterior (PA - x-ray beam passes from the back to the front of the body) view, and the image was going to be reversed. The RT stated, “Normally when we shoot [the portable CXR [AP], and the x-ray source is in the front [of the body] and the x-ray film cassette is in the back of the patient, and what happened was the opposite, the x-ray film cassette was in the front and the portable [CXR] machine was in the back of the patient. I checked the image, and it was like the image I usually take, and I sent it.” The RT stated she had entered the left x-ray maker identifier into the portable x-ray machine computer herself. The RT stated, “You just type the initials for right or left [sides].” The RT stated she did not place the marker on the x-ray film cassette because the patient was holding the x-ray film cassette. During an interview on 6/2/25 at 10:28 a.m. with Radiology Supervisor (RS) 1, RS 1 stated, “She [RT} mismarked it [X-ray].” During a review of Patient 1’s “Chest 1Vw [view] portable” dated 4/11/2025 at 6:32 a.m., Performed by [RT 1] the Chest 1 Vw indicated, “ ...TECHNIQUE: Single portable frontal view of the chest.” During a review of Pt 1’s “Critical Care/Intensivist Procedure”, dated 4/12/25 at 3:32 p.m., the “Critical Care/Intensivist Procedure” indicated, “Left chest tube CHEST TUBE PLACEMENT indication for procedure - Pneumothorax [occurs when air leaks into the space between the lung and chest wall] ...CXR ordered. X-ray showed left chest tube in place; however patient has a large right tension pneumothorax [a life-threatening condition where air accumulates in the pleural space, causing a pressure build-up and potentially collapsing the lung].” During a concurrent interview and record review on 6/2/25 at 11:23 a.m. with Physician 1, Physician 1 stated, when the film was loaded it looked like it was on the left side pneumothorax when he saw the patient in the room and from the x-ray film he saw on 5/12/25, he decided to place a chest tube in the patient’s left chest wall. During a review of Pt 1’s “Critical Care/Intensivist Procedure”, dated 4/12/25 at 3:32 p.m., the “Critical Care/Intensivist Procedure” indicated, “right chest tube CHEST TUBE PLACEMENT-- indication for procedure - Pneumothorax Location-Right pleural space.” During a review of Pt 1’ “Critical Care Consultation Note (CCCN)”, dated 4/12/25 at 3:27 p.m. The CCCN indicated, “[P1] admitted respiratory failure and was noted to have pneumonia [infection in the lungs] and was given antibiotic [medication to treat infections]. [Pt 1] developed worsening dyspnea [shortness of breath] since last night and developed hypoxia [insufficient oxygen to the body] respiratory failure ... patient has left pneumothorax and [MD 2] scheduled chest tube placement ... I [MD 2] received a call from [Medical Doctor] that the patient was having worsening respiratory distress at the x-ray table while getting ready to do a chest tube ...Initial plan was to place emergent left chest tube since a quick needle compression [procedure in which a needle is introduced into pleural space to provide temporary relief for a patient suffering a tension pneumothorax (life threatening condition where air leaks into the space between the lung and chest wall, creating pressure that can collapse the lung)] was not possible ...Left chest tube was then emergently placed via Seldinger pressure that can collapse the lung] technique [is a medical procedure to obtain safe access to blood vessels and other hollow organs] ... [CXR] was then emergently obtained. Endotracheal [tube into the windpipe] placed. [Pt 1] is now noted to have large right tension pneumothorax. [Pt 1] was repositioned, and emergent right chest tube was placed and noted to have lung expansion ...[Pt 1] then underwent left chest tube and air bubbles noted on chamber, however oxygen saturation only minimally improved. Emergent [CXR] was done which showed right large tension pneumothorax and emergent right-sided chest tube was then placed. Unfortunately, the morning x-ray was reversed ... noted to left pneumothorax - however actually patient has right pneumothorax. Unfortunately, patient underwent 2 chest tubes ...” During a concurrent interview and record review on 6/2/25 at 11:31 a.m. with MD 2, MD 2 stated, “Xray showed left pneumothorax on the left side. Pt 1 was sitting up ...having distress ... [Pt 1] ... was not improving. Second x-ray showed the right pneumothorax, left chest tube was removed the following day.” During a review of the RT’s personnel file, it was noted that he was currently certified by the American Registry of Radiologic Technologist (ARRT), with an expiration date of 4/30/2026. The RT cleared his background check on 5/22/24 and started working at the hospital on 6/10/24. The RT’s last performance appraisal was on 5/24/25 with no performance issues noted. During a review of the facility’s P & P titled, “Patient Rights”, dated 1/10/23, this document indicated, “... POLICY: COMPLIANCE - Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting...””

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 42118 Based on observation, interview, and medical/administrative record review, the hospital failed to ensure the medical staff is accountable to the governing body for the quality of care provided, when the subgroup of the Medical Executive Committee (MEC) placed Medical Doctor (MD) 1 on administrative leave while they investigated allegations that he routinely performed vaginal and rectal examinations on patients during colonoscopies, without obtaining informed consent (the process by which each patient is informed by the performing surgeon/practitioner, in a language they can understand, of the risks and benefits of a procedure and authorizes for it to be performed); then, they stopped the investigation when MD 1 resigned, without determining the full extent of the practice of routine sensitive examinations being done, without informed consent, on patients during colonoscopies at locations under their license and failed to indicate ongoing practice. This failure resulted in the lack of determining the full extent of sensitive examinations performed during colonoscopies without informed consent, as described above, and had the potential to negatively affect the provision of quality care and safety to all patients receiving colonoscopies at locations under this hospital’s license and to deprive patients from their right to be informed about the procedure and authorize it to be performed, as well as their rights to privacy. FINDINGS: When it came to their attention that a social media post was made on 3/21/25 claiming that a physician at a local hospital was known to be “molesting patients with nothing being done about it,” senior management/administration immediately began an internal investigation. They soon discovered that some staff who worked with MD 1 during colostomies for extended periods of time had knowledge that MD 1 routinely performed vaginal and rectal exams and some of other physicians at the facility routinely performed rectal exams on their patients during colonoscopies, without obtaining and documenting informed consents prior to the procedure. A sub-group of the MEC was formed to investigate MD 1’s practice; MD 1 resigned from the facility after being suspended and the related investigation ended. At the time the state Department of Public Health conducted their investigation, it was discovered that the hospital had not fully investigated the extent of this deficient practice or implemented effective strategies to prevent it from happening again. During an interview on 5/28/25 at 2:33 p.m. with Endoscopy Technician (ET) 2, with the Director of Regulatory Compliance (DRC) in attendance, ET 2 stated he worked in this role at this hospital for over ten years. ET 2 stated the last time he worked with MD 1 was “maybe four months ago.” When asked if he noticed anything “out of line” when working with MD 1, ET 2 stated when he first started working at the facility, he was informed by a previous nurse who trained him that, when MD 1 performed colonoscopies, he always performed vaginal and rectal exams to look for “fistulas [an abnormal opening or passage between two organs or between an organ and the surface of the body].” ET 2 stated everything he knew about MD 1 looking for fistulas was hearsay (rumor), and he had not heard anything about it in the last four years. ET 2 stated he never observed MD 1 examining for fistulas because of the way he and MD 1 were positioned in the operating room. ET 2 stated he was always out of the direct line-of-sight to observe what MD 1 was doing, ET 2 stated he never observed MD 1 or any other physician doing something inappropriate with patients and if he did, he would report it to the “circulating nurse [a member of the surgical/procedural team responsible for ensuring a safe environment].” During an interview on 5/28/25 at 3:30 p.m., with Registered Nurse (RN) 1 from the Gastro-intestinal (GI) Laboratory (GI Lab - location devoted to disorders of the digestive system), with the DRC in attendance, RN 1 stated she has been at the facility in the role of circulating nurse since January 2024. RN 1 stated the last time she participated in a colonoscopy with MD 1 was approximately January 2025. RN 1 stated that, when she is in the colonoscopy procedure, she is standing at the computer and all she can see is “the patient facing me; my role is mainly charting”. RN 1 stated, she “heard that MD 1 checks for vaginal fistulas”; she further stated, if she observed MD 1 performing vaginal exams, checking for fistulas, she probably would not have questioned it, “since it had already been reported.” RN 1 stated she has not seen MD 1 for “about a month.” During an interview on 5/29/25 at 10:29 a.m. with the Manager of Patient Scheduling/ Radiology (MPS), the MPS stated she was on (name of social media site) on 3/21/25 and read an article from a local news-station and a post responding to the article that indicated “there was a situation at a [name of city] hospital where a provider was molesting patients. The MPS said she shared this information with the Director of Administrative Operations (DAO). The MPS stated the article from the local newspaper regarded another physician in the area who reportedly was molesting patients in his private office. The MPS stated she does not know what the DAO did with the information that she reported (to the DOA). The MPS stated she had abuse training at least annually and, if anyone at the hospital had reported abuse to her, she would fill out the required form and report the incident to Risk Management immediately. During a concurrent interview and record review on 5/29/25 at 11:30 a.m., with the Director of Medical Staff (DMS) and the Senior Director/Central California Network (SDCCN), the files for MD 1 and MD 8, which included education, credential processes, and personnel files were reviewed. The files indicated no issues were noted for MD 1 or MD 8. The file for MD 1 indicated no records of disciplinary actions, except the current issue with informed consent. The DMS and the SDCCN stated they were members of the MEC subgroup that investigated the social media post which indicated a doctor at this hospital was molesting patients and nothing was being done about it. The DMS and the SDCCN both stated they were not aware of any issues with MD 1’s practice. The DMS and the SDCCN stated neither one of them had ever been informed about MD 1’s practice of vaginal and rectal exams during his patients’ colonoscopies. The DMS and the SDCCN stated MD 1 was interviewed and admitted he was trained to perform vaginal and rectal exams during colonoscopies. The DMS and the SDCCN stated, after MD 1 resigned, the investigation related to him “stopped.” The DMS returned a few hours later and stated the MEC did not make a final determination if vaginal and rectal exams should be considered routine parts of a colonoscopy. During an interview on 5/29/23 at 2:25 pm with the Medical Director of the Gastrointestinal Service Line (MD 2), with the SDCCN, the DMS, and the DRC in attendance, MD 2 stated he had been in his position at the hospital since March 2024. MD 2 stated he was part of the MEC subgroup investigating MD 1 and was familiar with the allegations made regarding MD 1’s practice of vaginal and rectal examinations during colonoscopies. MD 2 stated the colonoscopy procedure was indicated for colon cancer screening, previous polyps (a small clump of cells that form on the lining of the large intestines or rectum), bleeding in GI track, and for changes in bowel habits. MD 2 stated, after the bowel preparation (the process of emptying and cleaning the large intestines), a rectal exam was performed to feel for hemorrhoids (swollen and inflamed veins located in the lower rectum and anus), fistulas, and/or enlarged prostates (a gland surrounding the neck of the bladder in males), the colonoscopy scope was introduced into the rectum and then slowly withdrawn, looking for abnormalities. MD 2 stated vaginal exams were not the standard of practice for colonoscopies. MD 2 stated it first came to his attention that MD 1 was routinely performing vaginal exams during colonoscopies when MD 1 was suspended. MD 2 stated, if he observed MD 1’s practice of performing vaginal examinations prior to colonoscopies, he would have asked MD 1 why he was performing vaginal exams on females and what was he looking for. MD 2 stated rectal exams were performed on all patients during colonoscopies and would not be alarming, but he would discuss the practice of vaginal exams with peers. MD 2 stated, “We’re in a rural area ... practices are different in rural areas.” MD 2 stated he would look into whether the informed consent for colonoscopy covers rectal exams. During an interview on 5/29/25 at 2:30 p.m., with the DAO, with the SDCCN, MSD, and DRC in attendance, the DAO stated the MPS reported to her what she saw on the social media posting regarding a local physician “touching patients and nothing was being done about it.” The DAO stated she asked the MPS to send her a text regarding this posting, which she did; the DAO stated she then forwarded this text to the Chief Operating Officer (COO) of the hospital. The DAO stated she does not know how it was determined that the social media posting was related to MD 1. The SDCCN stated she was part of the Administrative Team that investigated this case; she stated, “We went to the [DOR] who said she was aware.” The SDCCN stated she participated in the review of 10 patient charts and the Peer Review Committee, who did the initial review of this incident and reviewed about “40 charts.” The MSD stated the investigation was pulled out of MEC to an ad hoc committee of the MEC; she stated, “We summarily suspended MD 1, and he resigned.” The SDCCN stated an education on informed consent was given to the general medical staff. During an interview on 5/29/25 at 3:09 pm with the Chief Operating Officer (COO), with the DRC in attendance, the COO stated the DAO sent him a screen shot of the social media post, dated “3/21/25 at 7:05 a.m.,” which indicated a doctor had been molesting patients at (name of city) hospital and nothing was being done about it and the first and last name of the person who posted this message. The COO stated, with this information, he recognized the last name to match an employee which was the Director of Sterile Processing (DPS), and the COO asked the DPS if his partner’s first name was the first name of the individual who posted. The COO stated the DPS stated his partner’s first name was the first name of the individual who posted but was not aware of the post. The COO stated he called the DOR, and the DOR stated she had no knowledge related to the post. The COO stated he then called the Chief Executive Officer (CEO) to inform him of the post. The COO stated the DOR later told him MD 1 conducted vaginal exams during colonoscopies. The COO stated the DOR shared there “was a concern that was raised a year and a half ago” and at that time, it was determined to be part of MD 1’s standard of practice. The COO stated an informal investigation was opened on 3/21/25. The COO stated the DOR was placed on administrative leave and she resigned, after giving a two-week notice. The COO stated it was his understanding that the Peer Review investigation had stopped. The COO stated a “Rapid Module Based Training related to Consents” was given to the “procedural staff” and “safety stand down training” on escalating staff concerns were given to key physicians, surgeons, and preop [before surgery]/ post op [after surgery] staff. The DRC agreed to forward the training that was given to their assigned state Department of Public Health office. During an interview on 5/29/25 at 3:45 p.m. with the Chief Medical Officer (CMO), with the DRC in attendance, the CMO stated he had been in his position since January 2024. The CMO stated he received notification on 3/21/25 regarding a social media post regarding allegations of sexual abuse by a physician in (name of city) hospital. The CMO stated he called the DOR who advised him of MD 1’s practice during colonoscopies which was brought to her attention eight months prior, but she thought it was a standard of practice. The CMO stated, when he found out MD 1 was still on staff performing colonoscopies, he informed the MEC. The CMO stated the MEC reviewed the case and found it was unusual to perform pelvic exams during colonoscopies. The CMO stated the DOR should have notified medical staff and leadership of MD 1’s practice of performing rectal and vaginal exams without informed consent and should not have made a decision on her own. The CMO stated MD 1 was suspended pending investigation and MD 1 was reported to the medical board. The CMO stated he was not involved in the peer review process (where experts in a similar field evaluate the work of others for quality, accuracy, and relevance) related to MD 1. The CMO stated, “It’s hard to see how this was normalized.” The CMO stated yearly updates were given to the medical staff using (the name of the online educational program) and various other ways of training. The CMO stated, in response to the allegation made of MD 1’s practice, “standdowns; educational meetings; medical staff training on informed consent; ‘Just Culture’ training [a culture that encourages open communication and learning from errors, rather than solely focusing on blame] for the last 18 months; and ‘Stopping-the-Line’ training, if any physician was doing something they should not be doing.” The CMO stated physicians should follow the hospital’s informed consent policy. The CMO stated the organization had not received any complaints or grievances related to MD 1’s practice from patients and was not aware of any related allegations. During a concurrent interview and record review on 5/30/25 at 2:56 p.m., with the Manager of GI (MGI) and the Manager of Regulatory Compliance (MRC), the document in Pt 3’s medical record titled, “History and Physical [H & P]”, dated 9/24/24, was reviewed. The MGI concurred that this document indicated, “... Chief Complaint: Colon cancer screen... Actions/Plans: Colonoscopy...” Then, the document titled, “Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures (Consent),” dated 9/24/24 was reviewed. The MGI stated the consent indicated Pt 3, a female, consented for a “Colonoscopy” by MD 1 and the type of anesthesia to be used was “IV [into the vein] Sedation.” Next, the document in Pt 3’s clinical record titled, “Surgery and Procedure Report,” dated 9/24/24 was reviewed. This document indicated, “Preoperative Diagnosis: Screening for colon cancer... Surgeon: [MD 1] ... Procedure in Detail: Perianal inspection [part of a rectal exam; involves examining the skin and surrounding area around the anus] was unremarkable. Digital palpation [a manual examination technique where a health professional used their finger to assess soft tissues, muscles, and organs]” revealed no palpable abnormality...” Pt 3’s Consent form did not indicate a perianal digital palpation would be conducted, nor did it indicate a vaginal exam was done. During a concurrent interview and record review on 5/30/25 at 3:32 p.m., with the MGI and the MRC, the document in Pt 4’s medical record titled, “H & P”, dated 8/22/24, was reviewed. The MPA concurred that this document indicated Pt 4 was a male, “... Chief Complaint: Screen for colon cancer... Actions/Plans: Colonoscopy...” Then, the document titled, “Consent,” dated 8/22/24 was reviewed. The MGI concurred that the consent indicated Pt 4 consented for a “Colonoscopy... Anesthesia...General [a medically induced state of unconsciousness used during surgery or other medical procedures to eliminate pain and other sensations]” by MD 1, his document indicated, “Preoperative Diagnosis: Colon cancer screening...Operation: Colonoscopy...Postoperative diagnosis: no abnormalities seen... Surgeon: [MD 1]... Procedure... Perianal inspection was unremarkable. Digital palpation revealed no palpable abnormality...” Pt 4’s Consent form did not indicate a perianal digital palpation would be conducted. During a concurrent interview and record review on 6/3/25 at 10:23 a.m. with the DRC, the document in Pt 7’s medical record titled, “Operative Report - Colonoscopy,” dated 5/30/25 was reviewed. The DRC concurred that this document indicated MD 7 performed the procedure and it did not indicate a rectal exam was done. During an observation on 6/3/25 at 11 a.m. in the pre-op department, Pt 25 was dressed in a hospital gown and sitting up in the hospital bed. The unsigned “Consent” for an observer to be in the operating room was reviewed. During an observation at 11:26 a.m., MD 2, with the assistance of a video interpreter, reviewed Pt 25’s chief complaint of abdominal pain, the esophagogastroduodenoscopy [EGD -a procedure where a doctor examines the lining of the throat, stomach and first part of the small intestines using a thin, flexible tube with a camera; used to diagnose and treat issues in the upper gastrointestinal tract] and colonoscopy procedures, as well as risks and benefits, and explained the need for rectal examination prior to the colonoscopy to check for masses. Pt 25 asked if MD 2 would be taking any samples during the colonoscopy procedure. MD 2 informed Pt 25, if any polyps were identified, they would be removed and, if there were any tumors or inflammation, MD 2 would take samples to biopsy. Pt 25 consented to the procedure with a signature on the Consent form. Pt 25’s Consent form indicated, “[EGD] and Colonoscopy with intervention” to be done by MD 2; however, the Consent form did not indicate that a rectal exam would be done. During an interview on 6/03/25 at 2:30 p.m. with the Chief Executive Officer (CEO) of hospital, with the DRC in attendance, the CEO stated there are two Governing Boards in the regional network where this facility is located, and these boards meet in-person quarterly; he further stated that he functions as the CEO “for this area.” In response to the question “How does the Governing Body become aware of issues at this facility”, the CEO responded that a group meets monthly that oversees quality. The CEO stated that the previous DOR admitted the concerns regarding MD 1 were brought to her attention and she did not escalate them. The CEO stated, when the allegations related to MD 1 came about, the information was distributed to the “system board, [local] Department of Public Health” and their fiduciary. The CEO stated, when the allegations were shared with the Governing Body, “There was a desire for the truth,” because MD 1 had practiced at this facility for 40 years. The CEO stated that Medical Staff conducted their own investigation, and the Governing Body was not aware of the results of the Medical Staff’s investigation. The CEO stated, upon learning of the allegations and being notified that MD 1 was practicing the way he was trained, the Governing Board did not agree with MD 1 going back into practice. The CEO stated his expectations were that the Medical Staff should have followed their process, completed the investigation, and made the final determination related to the “standard of practice.” The CEO stated the Governing Body will be updated on what is learned from the survey by the local Department of Public Health and ensure necessary changes are made. The CEO stated he was not aware of any allegations made by patients regarding MD 1. During a concurrent interview and record review on 6/04/25 at 4 p.m., with the Director of the Surgery Service Line (DSS), the document in Pt 25’s medical record titled, “Gastroenterology Procedure Final Report”, dated 6/3/25, was reviewed. The DSS concurred that this document indicated “... Procedures Performed: EGD with biopsy... Colonoscopy: Informed consent was obtained for the procedure, including sedation... After completion of EGD, endoscope was inserted into the rectum... Impression... Colonoscopy revealed moderate to severe left-sided diverticulosis [a condition in which small, bulging pouches develop in the digestive tract], internal hemorrhoids... Otherwise, unremarkable examination of terminal ileum [final section of the small intestines] ...” During an interview on 6/04/25 at 4:43 p.m. with the Patient Care Executive/ Chief Nursing Officer (PCE), the PCE stated she had been in her role with the current “Network” since 1/2024. The PCE stated prior to this role she was the PCE at another hospital with the same company since 2012. The PCE stated she learned about the social media post involving MD 1 from the Network President. The PCE stated the DOR did not share her knowledge of MD 1’s practice during colonoscopies with her. The PCE stated the DOR should have escalated what she knew about MD 1’s practice of vaginal and rectal exams. The PCE stated it had not been her experience that vaginal exams are performed during colonoscopies. The PCE stated, “We’ve done a lot of get-togethers with staff and management, and we have done considerable work to make sure we have a culture that people can speak up, even with hard conversations.” During a review of an untitled document of a social media post, dated 3/21/25, the document indicated, “Wish I could post anonymously because there’s a known doctor at a (name of city) hospital that has been seen molesting his patients when they are under. Many have complained and nothing has been done. Many staff know about it but don’t speak up.” During a review of the facility’s policy and procedure (P & P) titled, “Consent and Informed Consent”, dated 6/20/2022, this document indicated, “DEFINITIONS: ... 8. Informed consent - Agreement or permission accompanied by full notice about the care, treatment, or service that is the subject of the consent. A patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course. After receiving this information, the patient then either consents to or refuses such a procedure or treatment. POLICY: COMPLIANCE - KEY ELEMENTS - A. Identifying Who May Give Consent: a. A patient may give a valid consent only if they have ‘capacity’, which means they are able to understand the nature and consequences of a decision and to make and communicate the decision. b. To give consent, the person must have ALL of the following... ii. Physical capacity - I. Patient is conscious. II. Patient is able to communicate a decision regarding consent to care... E. Treatments/Procedures That Require Informed Consent: 1. Complex treatment/procedures: ... c. Typically, informed consent must be obtained for: i. All treatments/procedures performed in the: I. Operating Room... III Gastrointestinal lab... 3. The topics that must be addressed in the informed consent discussion are: a. The nature of the operation or procedure, including other care, treatment, services... 4. Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient’s legal representative with the information that is necessary to allow an ‘informed decision’ to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to the performance of the procedure... c. the role of the health care facility in the informed consent process is to verify that the proceduralist(s) is/are permitted to perform the procedure/tests or that an exception (such as the emergency exception) applies that allows the treatment to proceed. F. Documentation: ... 2. Consent to Surgery or Special Procedure Form: a. The consent form should include: i. The name of the patient... ii. The medical terminology for the procedure... vi. Ensure where signature is applied that it is accompanied with a date and time... 4. The nursing staff shall be responsible for verifying that the documentation has been included in the chart PRIOR to the surgery/procedure and checking this off the surgical checklist. If these conditions are not met, the proceduralist performing the procedure must be contacted to obtain the required documentation...” During a review of the facility’s P & P titled, “Patient Rights”, dated 1/10/23, this document indicated, “... POLICY: COMPLIANCE - Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting... 4. Information: a. The hospital supports the provision of information to patients or designated representative which enables the making of healthcare decisions. Patients will receive information about their illness, health status, course of treatment, prospects for recovery and outcomes of care in terms you can understand... 5. Informed Consent: a. The patient will receive as much information about any proposed treatment or procedure as needed, in order to give informed consent or to refuse the course of treatment... The responsibility to obtain informed consent rests with the physician who provides service...” During a review of a professional reference from the Association of American Medical Colleges, an article titled, “CMS Clarifies Informed Consent Required for “Sensitive Examinations”,” dated 4/5/24, the article indicated, “On April 1, the Centers for Medicare and Medicaid Services (CMS) revised its Hospital Interpretive Guidelines to clarify that informed consent from patients is required prior to allowing supervised medical, advanced practice provider, or other applicable students to perform training and education-related sensitive examinations (such as breast, pelvic, prostate, and rectal examinations), particularly on patients under anesthesia. Along with the changed in guidelines ... “it is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent.” ...if hospitals don’t obtain consent, they would be violating the conditions of participation under Medicare and Medicaid and may be subject to fines and investigations for violations of patient privacy laws ...””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 42148 Based on interview and record review, the facility failed to develop and implement a person-centered plan of care for four of four patients (Patient (Pt) 8, Pt 9, Pt 11, and Pt 13). This failure had the potential for Pt 8, Pt 9, Pt 11, and Pt 13 to not have their individualized care needs met. Findings: a. During a concurrent interview and record review on 6/2/25 at 11:08 a.m. with RN 10, Patient 8’s “ Care Plans (CPs),” were reviewed. RN 10 stated Patient 8 was on a ventilator (machine to help patient breathe) and should have had an “impaired gas exchange” care plan implemented and was unable to find one was developed. b. During a concurrent interview and record review on 6/2/25 at 11 a.m. with RN 10, Patient 9’s “CPs” were reviewed. RN 10 stated Patient 9 was in restraints and should have had a “restraint care plan” implemented and was unable to find one was developed. c. During a concurrent interview and record review on 5/30/2025 at 10:13 a.m. with Registered Nurse (RN 3), Patient 11 ‘s “electronic medical record (eMAR),” was reviewed. RN 3 stated she was unable to provide evidence of any patient centered plan of care was developed and initiated for Patient 11. RN 3 stated, “They’re just not there, somebody just forgot.” RN 5 stated they (plans of care) should have been completed. d. During a concurrent interview and record review on 5/30/2025 at 10:31 a.m. with RN 3, Patient 13 ‘s “eMAR,” was reviewed. RN 3 was unable to provide evidence of any patient centered plan of care was developed and initiated for Patient 13. RN 3 stated, “No care plans [plans of care], there’s no intrapartum or postpartum care plans. Yes, she [staff] should have did them.” During a review of the facility’s policy and procedure (P&P) titled, “Interdisciplinary Clinical Documentation,” dated 12/21/2015, the P&P indicated, “Policy Summary/Intent: To guide the user in the completion of clinical documentation consisting of Patient Data Profile (PDP), Assessment/Reassessment, Plan of care, Interventions, and Treatments ... A. All patients receiving care will have an assessment of their physical, psychosocial, and social needs performed by licensed members for the health care team utilizing the following: 1. Patient Data Profile (PFP) will be utilized for initial assessment in all clinical departments. The PDP is to be completed on admission for all patients admitted to inpatient units. Outpatients will complete the PDP as appropriate to the patient needs ... 3. The Patient Assessment/Reassessment will provide a comprehensive mechanism for the documentation of patient assessments utilizing a problem-oriented systems approach, which emphasizes a focus on deviation from defined parameters. This will be utilized for initial assessments and reassessment ... a. All data collected in the PDP, Assessment/Reassessment, and H&P/Diagnosis provides the information to develop an ongoing, individualized interdisciplinary plan of care throughout the hospital stay for patients and family through the use of focused charting using the nursing process. The care plan facilitates interdisciplinary communication and continuity of care by identifying patient problems, prioritization of needs, goals, interventions, and patient response to interventions ... e. Time Frame: i. Patient shall have a plan of care initiated within 24 hours of admission ...” 32946”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 32946 Based on interview and record review, the facility failed to ensure one of five sampled patient’s (Patient (Pt) 1) portable x-ray (a medical imaging device used to get pictures of the inside of the body) was performed in an accurate manner, when the Radiologist Technician (RT) mislabeled an X-ray film, leading to the misplacement of the chest tube (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully). This failure resulted in Pt 1 having bilateral (affecting two sides) chest tubes placed, which extended Pt 1’s recovery time and placed Pt 1 at risk for worsened health conditions and infection. FINDINGS: During a review of an untitled facility document, dated 4/23/2025, this document indicated, “On 4/11/25 an [RT] went to [Pt 1’s] bedside to perform a portable chest X-ray [CXR]. [Pt 1] was uncomfortable and unable to lay back in the bed [CXR usually taken from the front of the patient]. To promote comfort, the [RT] performed the [CXR] with Pt 1 sitting up right [from the back of the patient]. The [RT] failed to adjust the digital marker which led to the mislabeling of the image...Based on the discussion between the Interventional Radiologist [Medical Doctor] and Intensivist [Medical doctor], the intensivist inserted a chest tube into the left side per the mislabeled image. After placement of the left chest tube the patient continued to decompensate [worsening of symptoms]. A stat [CXR] was performed at this time, showing a right pleural effusion [abnormal collection of fluid in the space between the right lung and the chest wall]. A right sided chest tube was then placed, and the patient’s condition improved.” During a review of Pt 1’s “Critical Care Consultation Note (CCN)”, dated 4/12/2025 at 1:00 p.m., the CCN indicated, “ ...a female was admitted for respiratory failure and was noted to have pneumonia [infection in the lungs] and was given antibiotics [medications that kill bacteria and prevent them from multiplying]. Patient developed worsening dyspnea [shortness of breath] since last night and developed hypoxic [low oxygen levels in the body] respiratory failure.” During an interview on 6/2/25 at 10:00 a.m. with Radiologist Technologist (RT), RT stated when she went into the patient room Pt 1 was seated at the edge of the bed. RT stated she had asked Pt 1 if she could lay back on the gurney and Pt 1 stated “No”. RT stated she asked Pt 1 to hold the x-ray film cassette [Pt 1 held x-ray film cassette in front of the body]. RT stated she took the image. RT stated she did not realize if she took the image in PA (posteroanterior - x-ray beam passes from the back to the front of the body) view, and the image is going to be reversed. RT stated, “Normally when we shoot AP [anteroposterior] x-ray source [portable x-ray] in the front [of the body] and the x-ray film cassette is in the back of the patient, and what happened was the opposite, the x-ray film cassette was in the front and the portable x-ray machine was in the back of the patient. I checked the image, and it was like the image I usually take, and I sent it, the image.” RT stated she had entered the left x-ray maker identifier into the portable x-ray machine computer herself. RT stated, “You just type the initials for right or left [sides].” RT stated she didn’t place the marker on the x-ray film cassette because the patient was holding the x-ray film cassette. During an interview on 6/2/25 at 10:28 a.m. with Radiology Supervisor (RS) 1, RS 1 stated, “[RT} mismarked it [X-ray].” During a review of Pt 1’s “Chest 1Vw [view] portable” dated 4/11/2025 at 6:32 a.m., performed by [RT 1] the Chest 1 Vw indicated, “ ...TECHNIQUE: Single portable frontal view of the chest.” During a review of Pt 1’s “Critical Care/Intensivist Procedure”, dated 4/12/25 at 3:32 p.m., this document indicated, “Left ... CHEST TUBE PLACEMENT indication for procedure - Pneumothorax [occurs when air leaks into the space between the lung and chest wall] ...CXR ordered. X-ray showed left chest tube in place however patient has a large right tension pneumothorax [a life-threatening condition where air accumulates in the pleural space, causing a pressure build-up and potentially collapsing the lung].” During a concurrent interview and record review on 6/2/25 at 11:23 a.m. with Physician 1, Physician 1 stated, when the film was loaded it looked like it was on the left side pneumothorax; when he saw the patient in the room and from the x-ray film, he saw on 5/12/25, he decided to place a chest tube in the patient left chest wall. During a review of Pt 1’s “Critical Care/Intensivist Procedure”, dated 4/12/25 at 3:32 p.m., the “Critical Care/Intensivist Procedure” indicated, “Right ... CHEST TUBE PLACEMENT-- indication for procedure - Pneumothorax Location-Right pleural space.” During a review of Pt 1’ “Critical Care Consultation Note (CCCN)”, dated 4/12/25 at 3:27 p.m. The CCCN indicated, “[P1] admitted respiratory failure and was noted to have pneumonia [infection in the lungs] and was given antibiotic [medication to treat infections]. [Pt 1] developed worsening dyspnea [shortness of breath] since last night and developed hypoxia [insufficient oxygen to the body] respiratory failure ... patient has left pneumothorax and [MD 2] scheduled chest tube placement ... I [MD 2] received a call from [Medical Doctor] that the patient was having worsening respiratory distress at the x-ray table while getting ready to do a chest tube ...Initial plan was to place emergent left chest tube since a quick needle compression [procedure in which a needle is introduced into pleural space to provide temporary relief for a patient suffering a tension pneumothorax (life threatening condition where air leaks into the space between the lung and chest wall, creating pressure that can collapse the lung)] was not possible ...Left chest tube was then emergently placed via Seldinger pressure that can collapse the lung] technique [is a medical procedure to obtain safe access to blood vessels and other hollow organs] ... [CXR] was then emergently obtained. Endotracheal [tube into the windpipe] placed. [Pt 1] is now noted to have large right tension pneumothorax. [Pt 1] was repositioned, and emergent right chest tube was placed and noted to have lung expansion ...[Pt 1] then underwent left chest tube and air bubbles noted on chamber, however oxygen saturation only minimally improved. Emergent [CXR] was done which showed right large tension pneumothorax and emergent right-sided chest tube was then placed. Unfortunately, the morning x-ray was reversed ... noted to left pneumothorax - however actually patient has right pneumothorax. Unfortunately, patient underwent 2 chest tubes ...” During a concurrent interview and record review on 6/2/25 at 11:31 a.m. with MD 2, MD 2 stated, “Xray showed left pneumothorax on the left side. Pt 1 was sitting up ...having distress ... [Pt 1] ... was not improving. Second x-ray showed the right pneumothorax, left chest tube was removed the following day.” During a review of the facility’s P & P titled, “Patient Rights”, dated 1/10/23, this document indicated, “... POLICY: COMPLIANCE - Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting...””

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 42118 Based on observation, interview, and record review, the facility failed to ensure properly executed informed consent forms were in the medical records for three of four sampled patients (Patient (Pt) 3, Pt 4, and Pt 25) when rectal and or vaginal examinations (exams) were performed during colonoscopy procedures (a medical procedure that allows a doctor to examine the inside of the large intestine (colon) using a flexible tube called a colonoscope) while these patients were under anesthesia (the use of medicines to prevent pain during surgery or other procedures) and their procedural consent form did not include these sensitive exams. These failures had the potential to negatively affect the provision of quality care and safety to all patients receiving colonoscopies at locations under this hospital’s license and to deprive patients from their right to refuse or consent to the procedure and their right to privacy. FINDINGS: During a review of an untitled document of a social media post, undated, the document indicated, “Wish I could post anonymously because there’s a known doctor at a [name of city] hospital that has been seen molesting his patients when they are under. Many have complained and nothing has been done; many staff know about it but don’t speak up.” During an interview on 5/28/25 at 2:34 p.m. with Endoscopy Technician (ET) 2, ET 2 stated when he first started over 10 years ago, his preceptor (someone who trains others on how to do their job) informed him MD 1 performed rectal and or vaginal examinations on his patients prior to their colonoscopy to check for fistulas (an abnormal passageway that forms between two normally separate areas). ET 2 stated his preceptor no longer worked at the facility. ET 2 stated about four years ago, a new ET had asked about MD 1’s practice and ET 2 informed her what he was taught but he encouraged her to use the chain of command if she was concerned about the practice. ET 2 stated he was not sure if the new ET used the chain of command to report her concern. ET 2 stated when he was in the operating room (OR) with MD 1, he could not see what MD 1 was doing as he was situated near the head of the bed and MD 1 sat when he performed colonoscopies therefore ET 2 could not see if MD 1 performed vaginal or rectal examinations on the patients. During an interview on 5/28/25 at 3:21 p.m. with Registered Nurse (RN) 1, RN 1 stated she had been in the OR when MD 1 performed colonoscopies on his patients. RN 1 stated while in the OR she sat at the computer, and the patient was positioned towards her, so she was unable to see what MD 1 was doing. RN 1 stated she had worked at the facility for close to a year and heard MD 1 examined the vagina of female patients, but she had not observed or verified MD 1’s practice. RN 1 stated she asked other staff why MD 1 examined the vagina of his female patients, and she was informed MD 1 checked for fistulas during the vaginal examinations. RN 1 stated if she observed MD 1 examining his patient’s vagina prior to colonoscopies, she would not have questioned it as she was taught it was his standard of practice. RN 1 stated MD 1 was the only physician she heard practiced the examining of his female patients for fistulas and there were no other allegations of inappropriate behavior by staff or other physicians. During an interview on 5/29/25 at 10:29 a.m. with the Manager of Patient Scheduling (MPS), the MPS stated on 3/21/25 she was scrolling through a social media website and saw a post from the local news station. The MPS stated the news station posted about another physician who had sexually abused (the act of making someone take part in sexual activities against their wishes) his patient, and she could not recall the exact wording but from what she remembered, the comment stated, “There was a similar situation happening at the [name of Hospital] where a provider was molesting his patients.” The MPS stated after she read the comment, she screened shot the comment and shared it with the Director of Administrative Operations (DAO). The MPS stated the comment did not mention a name of a physician and she had not heard of any allegations of sexual abuse by physicians. During an interview on 5/29/25 at 11:45 a.m. with the Senior Director for Central California Network (SDCCN), the SDCCN stated, on the administrative level, she gathered information which would support the allegations and provided this information to the Medical Executive Committee for evaluation. The SDCCN stated MD 1 resigned during the investigation, so a final determination of his practice of examining his patient’s rectum and vagina prior to their colonoscopies was not determined. The SDCCN stated the Medical Staff was not able to determine if MD 1’s practice was out of his scope of practice or if it was inappropriate. The SDCCN stated during an interview with MD 1, MD 1 stated vaginal and rectal examinations prior to colonoscopies were his standard of practice and how he was taught. The SDCCN stated a physician should not perform vaginal examinations without an informed consent from the patient. The SDCCN stated both vaginal and rectal examinations prior to colonoscopies were not found to be the standard of practice but exceptions in some cases where the patient’s diagnosis and informed consents for both examinations were obtained. The SDCCN stated during their investigation, it was determined there were no other physicians who routinely examined their patient’s vagina and rectum prior to colonoscopies. During an interview on 5/29/25 at 2:25 p.m. with MD 2, MD 2 stated he was a part of the Ad Hoc Committee (a temporary group of people who are brought together to perform a specific task) and was familiar with the allegations made of MD 1’s practice of performing rectal examinations as well as vaginal examinations on all female patients prior to their colonoscopy. MD 2 stated the process of colonoscopy started when there was an indication for the colonoscopy such as a colon cancer screening, previous polyps (a growth in the body), bleeding in the lower gastrointestinal tract (the portion of the digestive system that includes he small intestine, the large intestine, rectum, and anus), and changes in bowel pattern, depending on the age group. MD 2 stated, prior to the colonoscopy, a rectal exam was taught to fellows (a doctor who has completed their initial residency training and pursuing additional training) to feel for fissures (a small tear in the lining of the anus) and for males to feel for nodules (a small growth of tissue) of the prostate gland (a small, walnut-shaped gland located in the male reproductive system). MD 2 stated he did not perform vaginal examinations on his female patients prior to their colonoscopy as this was not the standard of practice. MD 2 stated he was not aware of MD 1’s practice until MD 1 was suspended. MD 2 stated when he explained the colonoscopy procedure it was implied a rectal exam would be conducted prior to the colonoscopy and the informed consent should cover the rectal exam along with the colonoscopy procedure. During an interview on 5/29/25 at 3:44 p.m. with MD 4, MD 4 stated he received a text message around mid-day from the Chief Operating Officer (COO) referring to an article about a physician in [name of nearby city] was suspended and in the post there was a comment where a physician was molesting patients in [name of Hospital]. MD 4 stated he called the Director of the Operating Room (DOR), and she stated the allegation was brought to her attention eight months ago and she did her own research which found it was the standard of practice for vaginal examinations to be performed with the colonoscopy. MD 4 stated he asked the DOR if she escalated to the Medical Staff and she said, “No.” MD 4 stated to his knowledge, vaginal examinations were not routinely performed unless the patient had prolapse (the falling down of an organ from its normal position) or other issues. MD 4 stated the DOR should have informed the Medical Staff and himself and should not have taken it upon herself to investigate the allegation. MD 4 stated any sensitive examinations performed under anesthesia should have an informed consent. MD 4 stated physicians should know and comply with informed consents for sensitive procedures. During a concurrent interview and record review on 5/30/25 at 2:56 p.m. with the Manager of Gastrointestinal (MGI) with the Manager of Regulatory Compliance (MRC) present, Pt 3’s “History and Physical (H&P),” dated 9/24/24, Pt 3’s “Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures (Consent),” dated 9/24/24, and Pt 3’s “Surgery and Procedure Reports (Report),” dated 9/24/24 were reviewed. The MGI stated the H&P indicated, “ ...Chief Complaint: Colon Cancer Screen ...Action/Plans: Colonoscopy ...” The MGI stated the Consent indicated Pt 3 was consented for “Colonoscopy” by MD 1 and the type of anesthesia to be used was “IV Sedation”. The Consent indicated there was no indication a rectal or vaginal examination would be performed with the colonoscopy, which was MD 1’s practice. The MGI stated the Report indicated, “Preoperative Diagnosis: Screening for colon cancer ...Operation: Colonoscopy ...Postoperative Diagnosis: Normal colon ...Surgeon: [MD 1] ...Procedure in Detail: Perianal inspection [visual examination of the skin around the anus] was unremarkable. Digital palpation [feeling a body part with your fingers] revealed no palpable abnormality ...” During a concurrent interview and record review on 5/30/25 at 3:32 p.m. with the MGI and the MRC present, Pt 4’s “H&P,” dated 8/22/24, Pt 4’s “Consent,” dated 8/22/24, and Pt 4’s “Procedure Report,” dated 8/22/24 were reviewed. The MGI stated the H&P indicated, “ ...Chief Complaint: Screen for colon cancer ...Action/Plans: Colonoscopy ...” The MGI stated the Consent indicated,” ...Colonoscopy ... Anesthesia ... General ...MAC ...[MD 1] ...” The MGI stated the Report indicated, “ ...Preoperative Diagnosis: Colon cancer screening ...Operation: Colonoscopy ...Postoperative Diagnosis: No abnormalities seen. Poor prep [bowels were not clear of bowel movement] ...Surgeon: [MD 1] ...Procedure ...Perianal inspection was unremarkable. Digital palpation revealed no palpable abnormality ...” The Consent did not indicate a rectal examination would be performed. During an observation on 6/3/25 at 11:26 a.m. in the Pre-Op department, MD 2 with the assistance of a video interpreter, reviewed Pt 25’s chief complaint of abdominal pain, the esophagogastroduodenoscopy (EGD-a medical procedure were a doctor uses a thin, flexible, lighted tube called an endoscope to examine the lining of the esophagus (a muscular tube that connects the mouth to the stomach), stomach, and duodenum (first part of the small intestine)) and colonoscopy procedures as well as risks and benefits, and explained the need for a rectal examination prior to the colonoscopy to check for masses. Pt 25 asked if MD 2 would be taking any samples during the procedure. MD 2 informed Pt 25 if any polyps were identified, they would be removed and if there were any tumors or inflammation, MD 2 would take samples to biopsy (a procedure where a small sample of tissue is removed from the body for examination under a microscope). Pt 25 consented to the procedure with a signature on the consent form. The Consent, dated 6/3/25, was reviewed. The Consent indicated, “Esophagogastroduodenoscopy and Colonoscopy with intervention ...print name (physician): [MD 2] ...” The Consent did not indicate a rectal examination would be performed. During a concurrent interview and record review on 6/4/25 at 4 p.m. with the Director of Surgery Service Line (DSS), Pt 25’s “Gastroenterology Procedure Final Report (Report),” dated 6/3/25 was reviewed. The DSS stated the Report indicated, “ ...Procedures Performed: EGD with biopsy ...Colonoscopy-screening ...Indication: 1. Abdominal pain 2. Colon cancer screening ...Attending: [MD 2] ...Procedure details for EGD and colonoscopy: Informed consent was obtained for the procedure, including sedation ...After completion of EGD endoscope was switched to a colonoscope. A rectal exam was performed. The standard colonoscope was inserted into the rectum ...Impression ...Colonoscopy revealed moderate to severe left-sided diverticulosis, internal hemorrhoids on retroflexion rectum. Otherwise unremarkable examination of terminal ileum ...” During a review of the facility’s policy and procedure (P&P) titled, “Consent and Informed Consent-California,” dated 3/6/25, the P&P indicated, “Policy Summary/Intent: Address when consent and informed consent must be obtained as well as to describe the process for obtaining consent and documenting it was given ...Treatments/Procedures That Require an Informed Consent: 1. Complex treatments/procedures: a. Informed consent must be obtained for treatments/procedures that are “complex” in that they involve material risks that are not commonly understood. b. The determination of which procedures are “complicated” or “complex,” and therefore, require informed consent, is medical in nature. Medical staff rules and regulations and/or policies should address which procedures and treatments require written informed consent, and should be approved by the medical staff executive committee. c. Typically, informed consent must be obtained for: i. All treatments/procedures/services performed in the: I. Operating room ... The topics that must be addressed in the informed consent discussion are: a. The nature of the operation or procedure, including other care, treatment, services or medications. b. Potential benefits, material risks, or side effects of the operation or procedure, including potential problems that might occur during recuperation. c. The likelihood of achieving the patient’s goals. d. Reasonable alternatives and the relevant material risks, benefits and side effects related to such alternatives, including the possible results of not receiving the proposed care, treatment and services ... Authorization and consent to the performance of important tasks related to the surgery or examinations or invasive procedures ... Examinations or invasive procedures conducted for educational and training purposes included, but are not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law ... Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient’s legal representative with the information that is necessary to allow an “informed decision” to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to performance of the procedure ... The role of the health care facility in the informed consent process is to verify that the practitioner(s) obtained the patient’s informed consent before the practitioner(s) is/are permitted to perform the procedure/tests ... Documentation: Consent to Surgery or Special Procedure Form: a. The consent form should include: i. The name of the patient, and when appropriate the patient’s legal representative. ii. The medical terminology for the procedure (without abbreviation) and the type of anesthesia to be used if applicable. iii. Name or names of practitioners who will perform important parts of the procedure/treatment/service. iv. Signature of witness. v. Name and signature of interpreter and an attestation that the consent has been translated, if applicable. vi. Ensure where signature is applied that it is accompanied with a date and time. b. If signed by the patient, the consent form should be signed while the patient has capacity ... The nursing staff shall be responsible for verifying that the documentation has been included in the chart PRIOR to the surgery/procedure and checking this off the surgical checklist ...” During a review of the facility’s document titled, “Consolidated Medical Staff of the Central Valley Network Consolidated Medical Staff Rules & Regulations 2019,” dated 11/27/19, the document indicated, “An informed consent must be obtained for all surgical, therapeutic, and invasive procedures and for the administration of anesthesia ... It is the treating practitioner’s exclusive responsibility to obtain and document informed consent. Informed consent must include the name of the licensed independent practitioner and any assistants, medical information regarding the nature of the treatment, its expected benefits or effects, its possible risks and complications, and any alternatives to the proposed treatment and their possible risks and complications. The treating practitioner’s must document in the patient’s medical record that a discussion of the planned procedure and anesthesia was held with the patient and that informed consent was obtained. Evidence of informed consent (copy of signed surgery permit from physician’s office, documented in pre-operative history & physical, or documented by handwritten note in the patient’s medical record) will be required before commencing with the intervention ...” During a review of the facility’s P&P titled, “Patient Rights”, dated 1/10/23, the P&P indicated, “... POLICY: E Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting... 4. Information: a. The hospital supports the provision of information to patients or designated representative which enables the making of healthcare decisions. Patients will receive information about their illness, health status, course of treatment, prospects for recovery and outcomes of care in terms you can understand... 5. Informed Consent: a. The patient will receive as much information about any proposed treatment or procedure as needed, in order to give informed consent or to refuse the course of treatment... The responsibility to obtain informed consent rests with the physician who provides service...” During a review of a professional reference from the Association of American Medical Colleges, an article titled, “CMS Clarifies Informed Consent Required for “Sensitive Examinations”, dated 4/5/24, the article indicated, “On April 1, the Centers for Medicare and Medicaid Services (CMS) revised its Hospital Interpretive Guidelines to clarify that informed consent from patients is required prior to allowing supervised medical, advanced practice provider, or other applicable students to perform training and education-related sensitive examinations (such as breast, pelvic, prostate, and rectal examinations), particularly on patients under anesthesia. Along with the changed in guidelines ... “it is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent.” ...if hospitals don’t obtain consent, they would be violating the conditions of participation under Medicare and Medicaid and may be subject to fines and investigations for violations of patient privacy laws ...””

“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: 37529 Based on observation, interview and record review, the hospital failed to comply with EMTALA regulations at CFR 489.24(b) and CFR 489.24 when: 1. Hospital A did not provide an appropriate medical screen examination (MSE, an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether or not an emergency medical condition [EMC] exists) within the capability and capacity of the hospital’s emergency department for two of 20 patients, Pt 1 and Pt 5. a. Pt 1 was brought in by ambulance with head trauma and other injuries as result of domestic violence and the hospital did not conduct appropriate triage and prioritization and medical screen exam and ensure the safety of Pt 1 upon arrival. Pt 1 was witnessed to leave the ED by hospital staff and no efforts were made to follow up with Pt 1. Pt 1 subsequently suffered an avoidable accident of motorcycle vs pedestrian and was hospitalized at a local hospital for traumatic wounds. (refer to A2406, finding 1) b. Pt 5, a 36-year-old male, presented to the Emergency Department with suicidal ideation and eloped five minutes later. Pt 5 chief complaint was ’ Danger to Self ’, and was observed by an Emergency Department [ED] tech running out of the hospital. The QMP was not notified, and the hospital did not initiate follow-up actions such as a welfare check or notification to law enforcement in accordance with hospital policy. No medical screening exam was done or attempted. (refer to A2406, finding 2) Because of the serious actual harm to Pt 1 and potential harm to Pt 5 resulting from not performing an appropriate MSE, determining whether an EMC existed and not providing stabilizing measures, an Immediate Jeopardy (IJ) situation was called under CFR 489.24(a), A2406, at 12:50 p.m. on 10/29/24 with the Chief Medical Officer, Chief Nursing Executive, and the Director of Accreditation and Regulatory. The hospital submitted an acceptable IJ Plan of Removal (Version 3) on 11/01/24. The IJ Plan of Removal included but was not limited to the following: 1. Staff contact local PD when a patient elopes and is a danger to self or others, is altered/confused, or a victim of abuse/assault. 2.Staff prioritize room assignments for victims of abuse/assault. 3. RNs appropriately assign ESI level. 4. Abuse screening and CSSRS (suicide risk) screen for all patients 5. 24/7 security was stationed at the ED EMS entrance mitigating risk of patients who are a danger to themselves or others (i.e. altered, confused) from eloping, On 11/1/24 the components of the IJ Plan of Removal were validated onsite through observations, interviews, and record review. The IJ was removed on 11/1/24 at 4:10 p.m. with the Director of of Accreditation and Regulatory and the Associate Chief Nursing Executive. 2. The hospital failed to provide stabilizing measures for identified emergency medical conditions (EMC) within the capability and capacity of the hospital for 4 of 20 patients (Pt 2, Pt 3, Pt 6, and Pt 19). a. Pt 2 arrived with her son to the hospital emergency department (ED) following a police report of physical assault of domestic violence. Pt 2 had traumatic injuries including neck abrasion, three left temporal hematomas and was reported to have been choked. The qualified medical professional (QMP) conducted an appropriate medical screen and stabilized the physical injuries of the EMC. The hospital failed to provide stabilizing measures for the psycho-social components of the traumatic injuries. Social work consult was not provided. Home environment was not evaluated for safety. The hospital failed to determine if Pt 2 benefited to be placed in a shelter meant to keep domestic violence victims safe. (refer to A2407, finding 1). b. Patient 3 came to ED on 10/10/24 at 12:06 p.m. at 34 weeks and 5 days pregnant with complaints of abdominal pain, chest pain, palpitations (skipped, extra, or irregular heartbeats), and vomiting for a week. Hospital staff were aware Pt 3 had Type 1 diabetes mellitus (a chronic condition in which the body makes little or no insulin, which leads to high blood glucose [sugar] levels) and took daily insulin (a hormone that allows your body to use glucose for energy), and hospital staff were aware Pt 3 had a history of diabetic ketoacidosis (DKA--a serious, potentially life-threatening complication of diabetes that develops when a lack of insulin leads to uncontrolled hyperglycemia, inability to use glucose for energy, causing the liver to breakdown fat for fuel producing ketones [acids] which build up to dangerous levels in the blood). On arrival to the ED Pt 3 ’ s heart rate was 138-155 beats per minute (bpm- normal 60-100 bpm). Pt 3 was examined by a Qualified Medical Person (QMP) and determined not to be in labor, a non-stress test was reactive, Pt 3 ’ s glucose level was 200 mg/dl, and Pt 3 was moved back to the ED at 1:13 p.m. In ED, blood tests at 3 p.m. indicated low sodium, chloride, magnesium and calcium, carbon dioxide, and glucose 127 mg/dL, and beta-hydroxybutyric acid (BHB- a ketone) 3.69 mmol/L (HIGH- greater than 3 is associated with DKA) and a urinalysis indicated many ketones and glucose. Pt 3 was given intravenous (IV) fluid boluses, and IV calcium and magnesium, and medications for nausea and vomiting. During her almost 12 hour ED stay, blood glucose was recorded just once at 3 p.m., no output (urine or vomit) or oral intake (fluids or food) were recorded, no insulin was given, lab tests were not repeated, and fetal well-being was not assessed prior to discharge on 10/11/24 at 12:45 a.m. Tachycardia (heart rate greater than 100 bpm) continued throughout ED stay and the discharge heart rate was 132 bpm. These failures resulted in Pt 3 being discharged without the emergency medical condition being stabilized and led to harm to Pt 3 and her unborn baby. Pt 3 returned to the ED on 10/11/24 at 7 p.m. with worsening abdominal pain and tachycardia, blood sugar 303 mg/dl and lab tests indicated DKA. Fetal distress resulted in an emergency cesarean section on 10/11/24 at 10:52 p.m., and the baby required resuscitation with chest compressions and intubation. The baby was transferred to a children ’ s hospital (Hospital C) and Pt 3 was admitted to the intensive care unit of Hospital A. (refer to A2407, finding 2). c. Pt 6 arrived in the ED on 8/13/24 at 11:24 p.m. as walk in patient with chest pain, shortness of breath, high heart rate and low blood pressure and severe pain described as 10/10. Pt 6 was incorrectly assigned an ESI level 3, and left in the lobby to wait. The MSE was initiated at 11:57 p.m. and a Chest X-ray and EKG were done, and Pt 6 remained in the lobby to wait. The QMP failed to provide stabilizing measures for the emergency medical condition of CP, SOB and severe pain and Pt 6 left before the MSE was completed after two hours of waiting. These failures resulted in Pt 6 returning to the ED approximately ten hours later on 8/14/24 at 11:30 a.m., with chest pain, abdominal pain, dizziness, HR of 95, BP of 73/57, and a pain level of 10/10 requiring over eight hours of treatment in ED that included imaging and intravenous fluids. (refer to A2407, finding 3) d. Patient (Pt) 19 was first brought in by ambulance on 10/7/24 at 2:59 p.m. with chief complaint of three days of worsening leg pain and swelling. Hospital staff were aware Pt 19 was homeless. Following triage and initiation of the medical screen exam by ED physician (MD 2), Pt 19 left sometime between 4 p.m. and 5 p.m. without further services being provided. No labs or medications were administered. On 10/7/24 at 8 p.m. Pt 19 returned to the ED with the same chief complaint of three days of worsening leg pain and swelling. ED physician (MD 3) diagnosed deep vein thrombosis (DVT-a blood clot [thrombus] in one or more of the deep veins in the body), following an ultrasound. Pt 19 was discharged with prescription for medication to treat the DVT and instructions to return to her Primary Care Physician (PCP) for follow up. No social work consult was obtained in accordance with hospital policy and procedure. Pt 19 did not have a PCP. Hospital staff did not determine if Pt 19 could obtain the medication from the pharmacy and did not determine if Pt 19 could follow the instructions. These failures resulted in Pt 19 being unable to obtain the prescription for medication to treat the DVT and led to Pt 19 ’ s return to ED by ambulance for shortness of breath within fourteen hours of discharge. Pt 19 required additional work up and a two day hospital stay. (refer to A2407, finding 4) Because of the serious potential harm to Pt 2, serious actual harm to Pt 3 and Pt 3 ’ s baby, and serious potential harm to Pt 6, due to not providing stabilizing measures to address the emergency medical conditions, an immediate jeopardy situations (IJ) was called under CFR 489.24(d)(3), A2407, on 10/29/24 at 12:50 p.m. with the Chief Nursing Executive, the Chief Medical Officer, and the Director of Accreditation and Regulatory. The IJ template was provided to the hospital and instructed to submit in writing an acceptable Plan of Removal for the IJ. The hospital submitted an acceptable IJ Plan of Removal (Version 3) on 11/01/24. The IJ Plan of Removal included but was not limited to the following: 1. Nurses assign ESI level appropriately. 2. Nurses screen all patients for abuse and suicide risk 3. Nurses acknowledge clinical alarms and escalate to the provider. 4. Nurses escalate any patient safety concerns not addressed by the provider, prior to discharge. 5. Social worker referrals are made for victims of assault/abuse. 6. Local law enforcement is notified if a patient elopes who may be a danger to self or others, is confused, or altered. 7. OB and ED physicians review plan of care together for any OB pt in ED longer than four hours. 8. Patients with complaints of assault or abuse are prioritized for placement an ED room. The team verified by observations, interviews, and record review the actions of the IJ Removal Plan were implemented and the IJ was removed on 11/1/24 at 4:10 p.m. with the Associate Chief Nursing Executive and the Director of Accreditation and Regulatory. 3. Hospital A failed to meet its Recipient Hospital Responsibilities for 6 of 7 requested patient transfers (Patients A, B, C, D, E, and F). a. Hospital D contacted Hospital A on 7/3/24 requesting to transfer Patient A who had a diagnosis of ascites (the abnormal build-up of fluid in the abdomen), and needed a higher level of care. Hospital A declined to accept Pt A due to physician refusal and otherwise had the capacity and capability to accept the transfer. b. Hospital B contacted Hospital A on 7/20/24 requesting to transfer Pt B who had a diagnosis of sepsis and needed a higher level of care. Hospital A declined to accept Pt B due to physician refusal and otherwise had the capacity and capability to accept the transfer. c. Hospital B contacted Hospital A on 7/20/24 requesting to transfer Pt C who had a diagnosis of kidney stone and needed a higher level of care. Hospital A declined to accept Pt C due to physician refusal and otherwise had the capacity and capability to accept the transfer. d. Hospital E contacted Hospital A on 7/30/24 requesting to transfer Pt D who had a diagnosis of kidney stone and needed a higher level of care. Hospital A declined to accept Pt D due to physician refusal and otherwise had the capacity and capability to accept the transfer. e. Hospital E contacted Hospital A on 8/14/24 requesting to transfer Pt E who needed urologist and a higher level of care. Hospital A declined to accept Pt E due to physician refusal and otherwise had the capacity and capability to accept the transfer. f. Hospital B contacted Hospital A on 8/16/24 requesting to transfer Pt F who had a gastrointestinal bleed (GIB) and needed a higher level of care. Hospital A declined to accept Pt F due to physician refusal and otherwise had the capacity and capability to accept the transfer. (refer to A2411) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the statutory requirements for EMTALA and provide for patient care in a safe setting.”

“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: 37529 Based on interview and record review, Hospital A failed to provide an appropriate medical screening examination (MSE, an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether or not an emergency medical condition [EMC] exists) within the capability of the hospital’s Emergency Department (ED) for two of 20 sampled patients (Patient [Pt] 1 and Pt 5) when: 1. Pt 1 came to the ED on 9/7/24 at 11:09 p.m. by ambulance accompanied by a police officer after being punched in the face multiple times and choked by her husband, sustaining cuts and bruises to her face and head. Pt 1 ’ s triage vital signs were abnormal, and an assessment indicated her verbal response to questions was confused. The triage nurse indicated Pt 1 had no signs of abuse, denied being assaulted or having pain. Pt 1 was triaged as Emergency Severity Index level 3 (ESI- a 5-level acuity scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed in order to prioritize care; ESI 1 is the most serious) and was assigned a bed in the ED hallway. Pt 1 was observed leaving the ED out the ambulance entrance at 11:38 p.m., twenty-nine minutes after arrival to the ED, before the MSE was initiated. The hospital did not notify the police department or call Pt 1 ’ s family despite it being almost midnight and the hospital being aware Pt 1 was a victim of domestic violence, was injured, and confused, and an emergency medical condition had not been ruled out. These failures resulted in Pt 1 suffering an avoidable accident by running into the street and being struck by a motorcycle sustaining life-threatening injuries within fourteen minutes of leaving the ED. Pt 1 spent three weeks at Hospital B. 2. Patient (Pt) 5, a 36-year-old male, presented to the Emergency Department with suicidal ideation and eloped five minutes later. Pt 5 chief complaint was ’ Danger to Self, ’ and was observed by an Emergency Department [ED] tech running out of the hospital. The QMP was not notified, and the hospital did not initiate follow-up actions such as a welfare check or notification to law enforcement in accordance with hospital policy. No medical screening exam was done or attempted. These failures resulted in Pt 5 not receiving an appropriate MSE and the benefit of stabilizing measures for a probable emergency condition and could have led to Pt 5 causing self-harm or injury. Because of the serious actual harm to Pt 1 and potential harm to Pt 5 resulting from not performing an appropriate MSE, determining whether an EMC existed and not providing stabilizing measures, an Immediate Jeopardy (IJ) situation was called under CFR 489.24(a), A2406, at 12:50 p.m. on 10/29/24 with the Chief Medical Officer, Chief Nursing Executive, and the Director of Accreditation and Regulatory. The hospital submitted an acceptable IJ Plan of Removal (Version 3) on 11/01/24. The IJ Plan of Removal included but was not limited to the following: 1. Staff contact local PD when a patient elopes and is a danger to self or others, is altered/confused, or a victim of abuse/assault. 2.Staff prioritize room assignments for victims of abuse/assault. 3. RNs appropriately assign ESI level. 4. Abuse screening and CSSRS (suicide risk) screen for all patients 5. 24/7 security was stationed at the ED EMS entrance mitigating risk of patients who are a danger to themselves or others (i.e. altered, confused) from eloping, On 11/1/24 the components of the IJ Plan of Removal were validated onsite through observations, interviews, and record review. The IJ was removed on 11/1/24 at 4:30 p.m. with the Director of of Accreditation and Regulatory and the Associate Chief Nursing Executive. Findings: 1. During a review of Pt 1 ’ s medical record, the Patient Care Record (PCR- Record of prehospital care provided by Emergency Medical Services [EMS] personnel) dated 9/7/24, indicated on 9/7/24 at 10:41 p.m. the paramedics responded to the location of a reported assault. The PCR indicated, “ ...Arrived on scene to find Pt [Pt 1] laying on the floor post assault surrounded by PD [police department] and bystanders. Pt presented with multiple hematomas [abnormal collections of blood outside of a blood vessel] to her left forehead, and a laceration to her left temple. Pt was GCS 14 [Glasgow Coma Scale- a tool used to assess a patient ’ s level of consciousness. Scores range from 3 (worst) to 15 (alert and oriented)]. The PCR indicated Pt 1 ’ s score for verbal response was determined as “ confused. “ The PCR indicated, “ ...Unable to determine if she suffered LOC [loss of consciousness] ...Reported by [name of city] PD that patient was punched in the face multiple times and was choked by the assailant. Pt reports [her] only pain was from the obvious injuries to her head. Pain level 10 [on a scale of 0 (no pain) to 10 (worst pain)] ... “ During a review of the triage record dated 9/7/24 at 11:16 p.m., the record indicated Pt 1 arrived to the ED at 11:09 p.m. and was triaged by RN 1 at 11:16 p.m. Triage vital signs: temperature 98.5 degrees Fahrenheit (F), pulse 123 beats per minute (bpm- normal range 60-100 bpm), respirations 18/minute, blood pressure (BP) 164/109 millimeters of mercury (mmHg- normal is less than 120/80 mmHg), oxygen saturation 98 %. The triage record indicated on 9/7/24 at 11:16 p.m. RN 1 documented Pt 1 ’ s reason for visit, “ Assaulted by husband, loc? No vomiting. Presented with head injury, multiple laceration of the face and scalp. Patient denied assault and denied pain, paramedic stated that PD was on scene. PD came in with the patient to ED, “ and assigned an ESI of 3 (urgent). GCS was 14, verbal response “ confused. “ RN 1 completed the abuse screen (adult/elderly/domestic), indicating “ No signs of abuse. “ RN 1 indicated Pt 1 ’ s pain as acute and constant, however Pt 1 ’ s pain level was assessed as 0 (no pain). Pt 1 was assigned to a gurney in the ED hallway. The triage record indicated at 11:28 p.m., RN 1 changed the ESI level from 3 to ESI 2. The record indicated at 11:38 p.m., “ Pt walked to the back door and ran off. MD made aware Pt eloped. “ There was no evidence in the record the hospital notified the police department or Pt 1 ’ s family that Pt 1 eloped prior to being seen by the physician. On 9/9/24 at 7:28 a.m., RN 1 amended the medical record, changing the ESI 2 to ESI 3, changing “ no signs of abuse “ to “ according to accompanying PD, the patient had been assaulted by husband, patient said nobody assaulted her when I asked. “ During a review of Pt 1 ’ s PCR dated 9/7/24-9/8/24, the PCR indicated on 9/7/24 at 11:51 p.m. 911 was called after Pt 1 was hit by a motorcycle while walking in the middle of the street. When the ambulance arrived on scene Pt 1 was laying in the middle of the street unconscious, with a GCS of 3 and hypotensive, blood pressure 63/31 mmHg. The PCR indicated, “ ...According to PD [police] patient had recently left hospital without prior notification or formal release and was reported to be altered [a change in mental status] ... “ Pt 1 was transported to Hospital B for trauma care. Review of the Pt 1 ’ s medical record from Hospital B indicated Pt 1 required intubation on arrival to the ED due to respiratory compromise. Imaging revealed Pt 1 ’ s injuries included a subarachnoid hemorrhage (bleeding in the area between the brain and one of the three protective layers surrounding it), a subdural hematoma (an abnormal collection of blood under the dura mater, one of the protective layers surrounding the brain), acute right second, third, fourth, 11th and 12th rib fractures, transverse process fractures (a break in the wing-like sides at the back of the vertebrae [bones]) of the lumbar spine (lower back), and multiple areas of scalp hematoma. The record indicated Pt 1 was discharged from Hospital B on 9/28/24, three weeks after the accident. During an interview on 10/24/24 at 11:30 a.m. with the Director of ED (DED), the DED stated he had reviewed Pt 1 ’ s record and had interviewed staff. The DED stated he did not know what happened to Pt 1 until a couple of days after the ED visit on 9/7/24. The DED stated he identified some things the staff could have done differently such as determining the correct ESI level. The DED stated Pt 1 should have been triaged as an ESI level 2, instead of 3. An ESI 2 may have resulted in prioritization of the MSE for Pt 1. The DED stated Pt 1 was assigned to hallway bed 3 which is near the ambulance entrance which was unsupervised and not monitored. . The DED stated an ED tech saw Pt 1 leave and informed the Lead Nurse (LN) 1. The DED stated he does not know what prompted Pt 1 to leave but since Pt 1 was assessed as GCS 14 and was a victim of an assault, the lead nurse should have alerted the police right away so they could try to find Pt 1. The DED stated the nurse should not ask the physician whether or not to call the police if there is a concern the patient is altered or at-risk, the notification of the police should occur as well as informing the physician. The DED stated when he spoke to LN 1, LN 1 had acknowledged that he should have notified the police department and said it was “ a lapse in judgment. “ The DED stated since this incident occurred, there is a security guard scheduled at the ambulance entrance around the clock. During an interview on 10/28/24 at 3:15 p.m. with the ED Lead Nurse (LN) 1, LN 1 stated he was working the night shift in ED on 9/7/24. LN 1 stated patients who come in by ambulance to the ED are triaged by the lead nurse to determine whether they should go to a bed or out to the lobby to wait. LN 1 stated if the lead nurse is with another patient, then another RN can triage the patient. LN 1 stated he asked RN 1 to assist with triage on 9/7/24 when Pt 1 arrived in ED. LN 1 stated he was aware of Pt 1 ’ s chief complaint and noticed there was a police officer with Pt 1 when she arrived, but LN 1 stated he does not know how long the officer stayed before leaving the ED. LN 1 stated Pt 1 was assigned to a hallway bed. LN 1 stated he was told by one of the nurses that Pt 1 left the ED, going out the ambulance entrance which was near Pt 1 ’ s hallway bed. LN 1 stated he asked the nurse who witnessed Pt 1 leaving if Pt 1 looked impaired, and the nurse said no. LN 1 stated he also asked an ED tech if Pt 1 looked impaired, and the ED tech said no. LN 1 stated Pt 1 did not appear impaired to him (LN 1). LN 1 acknowledged he did not interview or assess Pt 1 and the nurse who saw Pt 1 leave did not interview or assess Pt 1. LN 1 stated he looked at the chart and it stated she (Pt 1) was alert, but LN 1 stated he did not look at the GCS 14. LN 1 stated he informed the physician on duty that Pt 1 had eloped. LN 1 stated the physician had not seen Pt 1 yet. LN 1 stated Pt 1 ’ s family showed up to the ED after Pt 1 had eloped, and LN 1 stated he told them Pt 1 had left and suggested they look for her. LN 1 stated he did not call the police department or make a social services referral to follow up. LN 1 stated, “ My confusion was whether she was altered or not, whether she was of right mind, I should have called the police. “ During an interview on 10/28/24 at 3:30 p.m. with RN 1, RN 1 stated he was working the night of 9/7/24. RN 1 stated he was not working as the triage nurse that night but was asked to help LN 1. RN 1 stated he triaged Pt 1 and that was the extent of his involvement with Pt 1 ’ s care, and had no idea what happened to Pt 1 after she left the hospital until the manager told him days later. RN 1 was asked about the screening of Pt 1 for suicide risk, and RN 1 stated Pt 1 did not need to be screened because she was there for a medical issue. RN 1 was asked about the changes he made to Pt 1 ’ s medical record on 9/9/24, two days after Pt 1 ’ s ED visit. Regarding the ESI change from ESI 2 to 3, RN 1 stated the ESI was 3, and was not changed to 2. RN 1 stated the ED manager asked him about the ESI and when he looked at it he corrected it to ESI 3. RN 1 stated he never changed it to 2 and doesn ’ t know why the medical record indicated he had changed it on 9/7/24 to 2. As far as the change to the abuse screening, RN 1 stated “ it was a miss-click, “ referring to charting in the electronic health record (EHR). During an interview on 10/28/24 at 9:45 a.m. with the social worker (SW) 1, SW 1 stated on 9/9/24 she was made aware of Pt 1 ’ s elopement and suspected domestic violence by the ED manager. SW 1 stated she reviewed the record which indicated Pt 1 had a seven year-old child and because of this a referral to Child Protective Services (CPS) was required, and due to the allegation of domestic violence, a referral to Adult Protective Services was required which is what she did on 9/9/24. SW 1 stated the nursing staff can make the referrals also. During an interview on 11/1/24 at 2:20 p.m. with the medical director of the ED (EDMD), the EDMD stated he was working in the ED the night of 9/7/24. He did not see Pt 1, but the lead nurse (LN 1) informed him that Pt 1 had eloped and asked him if he had seen Pt 1 yet. The EDMD stated he recalled LN 1 saying Pt 1 may have been intoxicated. The EDMD stated LN 1 asked him if he should call the police, and EDMD stated he asked LN 1 what the policy says. The EDMD stated he did not think the physicians are aware of the details of the policy regarding notifying the police for patients who elope and are altered. The EDMD stated he was aware a physician ’ s order was not required for the staff to notify the police. The EDMD stated triaging patients appropriately is important since the physician sees the ESI level on the ED board and that information along with any other pertinent information about the patient determined which patient is seen next. During an interview on 11/4/24 at 10:55 a.m. with the Manager of ED (EDM) 1, EDM 1 stated she was told about Pt 1 on 9/9/24. EDM stated had reviewed the record and asked RN 1 about the initial ESI 3 in triage on 9/7/24 at 11:16 p.m. that was changed to ESI 2 on 9/7/24 at 11:28 p.m. EDM 1 stated she was aware that RN 1 changed the ESI back to ESI 3 on 9/9/24, but did not ask him to change that documentation. EDM 1 stated she would never ask a nurse to change an ESI level. EDM 1 stated she was aware RN 1 documented “ no signs of abuse “ despite the report from the paramedics describing Pt 1 ’ s injuries and the presence of a police officer with Pt 1 on arrival to ED. EDM 1 stated RN 1 was not very thorough in his assessment of Pt 1. EDM 1 stated nurses must “ use critical thinking and should not be on autopilot. “ During a review of the hospital ’ s policy and procedure (P&P) titled “ Standards Of Care, Emergency Department, “ dated 6/27/24, the P&P indicated, “ ...All patients will be screened for Assault/Abuse Screenings, Screening for Suicidal/Homicidal ideations, Fall Risk, Advanced Directive, and Homelessness ... “ During a review of the reference titled, “ Comprehensive Accreditation Manual for Hospitals, CAMH Update, “ dated 7/1/24, the reference indicated, “ ...The Joint Commission considers the following list of events, though not comprehensive, to be sentinel events if they occur under any Joint Commission-accredited health care organization: ... Any elopement (that is, unauthorized departure) of a patient from a staffed around the-clock care setting (including the ED), leading to death, permanent harm, or severe harm to the patient ... “ During a review of an article in American College of Emergency Physicians (ACEP) Now: Vol 39 No 03, March 2020, titled, “ Don ’ t Overlook Traumatic Brain Injury in Intimate Partner Violence, “ dated 3/17/20, the article indicated, “ ...While IPV is often associated with traumatic brain injury (TBI), TBI often goes unrecognized and undiagnosed among its victims. Even mild TBI may cause chronic disability without appropriate rehabilitation. Emergency physicians are in a unique position to prevent long-term sequelae by diagnosing TBI and providing appropriate referrals .... Victims of IPV may suffer repeat episodes of TBI within a similar timeframe, as they are at high risk of multiple violent encounters. Also, while strangulation causing anoxic brain injury is uncommon among other patients at risk of TBI, it is disturbingly common among victims of IPV. These patients may experience headaches, dizziness, memory issues, sleep problems, poor judgment, and emotional lability. Often these symptoms are incorrectly chalked up to substance abuse, mental illness, or the psychological trauma of IPV ... Victims of IPV are often discharged from the emergency department without adequate information about lasting symptoms and without appropriate follow-up ... “ During a review of an article in ACEP Now: Vol 37 No 08, August 2018, titled, “ How to Help Victims of Intimate-Partner Violence, “ dated 8/14/18, the article indicated, “ ...Emergency department staff have a unique opportunity to identify victims of intimate partner violence [IPV] and to provide safety planning and community referrals. Multiple organizations, including the American College of Emergency Physicians (ACEP) and The Joint Commission, recommend universal screening for IPV. For IPV screening to be done routinely, it must be built into the workflow of the emergency department. If the screen is positive, the patient requires a safety plan prior to discharge ... “ During a review of the Brain Sciences journal article titled, “ Update on Domestic Violence and Traumatic Brain Injury: A Narrative Review, “ dated 1/17/22, retrieved from <https://doi.org/10.3390/brainsci12010122>, the article indicated, “ ...Victims of domestic violence are unlikely to report their abuse. These patients are afraid to come forward for several reasons including fear of retaliation from their partner and losing custody of their children. There is a general mistrust of healthcare professionals in this population, due to fear of being judged, or even being blamed themselves for allowing someone to be violent towards them ...Traumatic brain injuries (TBI) are categorized by the Glasgow Coma Scale, with scores of 13-15 being mild, 9-12 being moderate, and less than 8 being severe TBI. Despite 80% of all reported TBIs being mild, the incidence of mild TBIs [mTBI] is very underreported, likely because mTBI can present as a transient feeling of being dazed, disoriented, or confused. Without proper treatment, there is a risk for repetitive injuries which can have a cumulative result, leading to detrimental outcomes such as chronic traumatic encephalopathy, depression, suicidality, and Alzheimer ’ s-like syndromes ... “ 2. During a concurrent interview and record review on 10/24/24 at 2:53 p.m. with the Emergency Room Director (DED), Manager Regulatory Team (MRT), and Regulatory Specialist (RS) 2, Pt 5 ’ s Electronic Medical Record (EMR)” was reviewed for the Emergency Department (ED) visit on date 8/1/24. The “ EMR “ indicated, that Pt 5 arrived at the ED on 8/1/24 at 9:46 p.m. Five minutes later, at 9:51 p.m., the patient was documented as eloped on depart summary from the emergency department. The EMR indicated ... “ Visit Reason: Danger to self ...Arrival Mode Walk-in “ . The EMR indicated patient left without being seen before MSE was initiated. The DED stated Pt 5 was registered with chief complaint of ’ Danger to Self, ’ and was observed by an ED staff running out of the hospital. The DED stated Pt 5 ’ s EMR does not reflect safety sitter was initiated. The DED stated he was unable to find any documentation that the QMP was notified about Pt 5 ’ s chief complaint and elopement after registering the chief complaint of danger to self. The hospital did not initiate follow-up actions such as a welfare check or notification to law enforcement in accordance with hospital policy according to DED. The DED stated Pt 5 “ clearly notified registration “ upon arrival of his intent to hurt himself and was registered as a “ Danger to self “ . The DED stated he expected that emergency department staff members were upholding the hospital ’ s policies and procedures, and in this case failed to escalate to the charge nurse, or provider or notify law enforcement for a welfare check. The DED stated the only documentation he was able to find for the entire visit was a note written by a patient access team member (person that registers patient in main lobby upon arrival to ED) on 8/1/24 at 9:51 p.m. stating “ Pt ran out “ . The DED stated Pt 5 was seen in ED twelve hours before the visit of 8/1/24 at 9:46 p.m. for the chief complaint of suicidal thoughts. The DED stated Pt 5 had a history of schizophrenia (a serious mental health condition that affects how people think, feel, and behave. It may result in a mix of hallucinations, delusions, and disorganized thinking and behavior) as well as methamphetamine use (powerful, highly addictive stimulant drug that affects the central nervous system) and was discharged after being cleared by mental health team for outpatient follow up for mental health or return to ED if unable to follow up as outpatient within 72 hours. The DED stated regardless of the previous visit, Pt 5 returned in 12 hours seeking help for suicidal ideation and should have received a medical screening exam and evaluation of mental health. The DED stated Pt 5 had the potential to hurt himself with suicidal ideation and stated it was not acceptable that staff failed to escalate and follow up. The DED stated he was glad to see that Pt 5 did return to ED for the third time on 8/1/24 at 11:16 p.m. (one hour and twenty-five minutes after elopement) seeking help for suicidal ideation. Pt 5 was evaluated upon return by the mental health team and was offered resources. The DED stated that MSE was started, the mental health team cleared the patient, and physician assessment was done, however, Pt 5 eloped again before additional workup could be completed. The DED stated the provider called the patient to return to ED and the patient refused to return to the ED. The DED stated on the 3rd visit hospital policy was followed as Pt 5 was evaluated by the mental health team and deemed safe before elopement. Pt 5 also received information on resources from the mental health team prior to elopement and the provider called the patient after elopement. The DED stated his staff should have followed the same process when Pt 5 eloped before MSE on the second visit on 8/1/24 at 9:51 p.m. with active suicidal ideation. During an interview on 11/1/24 at 2:21 p.m. with the ED Medical Director (EDMD), the EDMD stated he had been the ED medical director for a year and three months. The EDMD stated it was his expectation that staff was following the hospital policies. The EDMD stated for patients who are dangerous to themselves and elope from ED, he expected that staff members follow the elopement process outlined in the facility policy. The EDMD stated staff usually will escalate these types of elopement situations to him and he would escalate to law enforcement authorities if it had not been escalated as needed. The EDMD stated he has called law enforcement in the past for patients who were danger to themselves when it was appropriate for the patient ’ s condition. The EDMD stated he was not familiar with Pt 5, but the expectation would be the same that staff follow the facility ’ s process and policies. During an interview on 11/4/24 at 9:24 a.m. with the Manager Social Services (MSS), the MSS stated she had been working at the hospital for nine years and had been promoted to manager in September of this year. The MSS stated patients who are a danger to themselves and others, an ED social worker may get notified. The MSS stated they are limited in what social work team can do. The MSS stated the social work team makes sure they work with [local county name] crises team and provide resources as needed for the outpatient follow-up and continuity of care. The MSS stated if the patient elopes while they are a danger to self and others, and the social worker is notified, their process is to notify law enforcement and request a welfare check. The MSS stated usually nursing staff or Provider take care of that and the social worker does not get notified of an elopement in the ED. During a review of the facility ’ s policy and procedure (P&P) titled, “ EMTALA - Patient LWBS, Elopement, AMA, LABS “ , with an effective date 6/6/19, the P&P indicated “ ...POLICY SUMMARY/INTENT: To ensure all departments of the Hospital that provide Emergency Services and Care take appropriate steps to follow up on patients who leave the Hospital prior to receiving the Medical Screening Examination (MSE) and/or completing the necessary Stabilizing treatment ... Left Without Being Seen (LWBS) - Before MSE: The patient leaves before receiving the initial Medical Screening Examination ... All patients leaving the Emergency Department (and/or add all Dedicated Emergency Departments) before completion of the Medical Screening Examination will be offered the Medical Screening Examination and encouraged to remain in the Department to receive Emergency Services and Care ...Patient Does Not Notify Staff Before Leaving ...Patient in the Waiting Room. If a patient is not in the Dedicated Emergency Department waiting room ...when called for service, Hospital staff will call the patient two (2) additional times to escort the patient to the treatment area ...Each time a patient is called, the time of the call will be noted on the patient record indicating “ patient name called, no response. “ The note will be documented by the staff signature or initial with the corresponding time. Other efforts to locate the patient who is not in the waiting area should be noted in the patient ’ s chart ...Patient in a Treatment Room. If the patient leaves after being placed in a treatment room, a search for the patient will be conducted within the immediate area of the Department ...Efforts to locate the patient will be recorded on the patient record. The note will be documented by the staff signature or initial with the corresponding time ...If the patient is or may be a danger to self or others, local law enforcement will be notified if a psychiatric evaluation and hold may be necessary ... “”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 37529 Based on observation, interview and record review, the hospital failed to provide stabilizing measures for identified emergency medical conditions (EMC) within the capability and capacity of the hospital for 4 of 20 patients (Pt 2, Pt 3, Pt 6, and Pt 19) when: 1. Pt 2 arrived with her son to the hospital emergency department (ED) following a police report of physical assault of domestic violence. Pt 2 had traumatic injuries including neck abrasion, three left temporal hematomas and was reported to have been choked. The qualified medical professional (QMP) conducted an appropriate medical screen and stabilized the physical injuries of the EMC. The hospital failed to provide stabilizing measures for the psycho-social components of the traumatic injuries. Social work consult was not provided. Home environment was not evaluated for safety. The hospital failed to determine if Pt 2 benefited to be placed in a shelter meant to keep domestic violence victims safe. These failures had the potential for Pt 2 to return to an unsafe environment and experience further assault. 2. Patient 3 came to ED on 10/10/24 at 12:06 p.m. at 34 weeks and 5 days pregnant with complaints of abdominal pain, chest pain, palpitations (skipped, extra, or irregular heartbeats), and vomiting for a week. Hospital staff were aware Pt 3 had Type 1 diabetes mellitus (a chronic condition in which the body makes little or no insulin, which leads to high blood glucose [sugar] levels) and took daily insulin (a hormone that allows your body to use glucose for energy), and hospital staff were aware Pt 3 had a history of diabetic ketoacidosis (DKA--a serious, potentially life-threatening complication of diabetes that develops when a lack of insulin leads to uncontrolled hyperglycemia, inability to use glucose for energy, causing the liver to breakdown fat for fuel producing ketones [acids] which build up to dangerous levels in the blood). On arrival to the ED Pt 3 ’ s heart rate was 138-155 beats per minute (bpm- normal 60-100 bpm). Pt 3 was examined by a Qualified Medical Person (QMP) and determined not to be in labor, a non-stress test was reactive, Pt 3 ’ s glucose level was 200 mg/dl, and Pt 3 was moved back to the ED at 1:13 p.m. In ED, blood tests at 3 p.m. indicated low sodium, chloride, magnesium and calcium, carbon dioxide, and glucose 127 mg/dL, and beta-hydroxybutyric acid (BHB- a ketone) 3.69 mmol/L (HIGH- greater than 3 is associated with DKA) and a urinalysis indicated many ketones and glucose. Pt 3 was given intravenous (IV) fluid boluses, and IV calcium and magnesium, and medications for nausea and vomiting. During her almost 12 hour ED stay, blood glucose was recorded just once at 3 p.m., no output (urine or vomit) or oral intake (fluids or food) were recorded, no insulin was given, lab tests were not repeated, and fetal well-being was not assessed prior to discharge on 10/11/24 at 12:45 a.m. Tachycardia (heart rate greater than 100 bpm) continued throughout ED stay and the discharge heart rate was 132 bpm. These failures resulted in Pt 3 being discharged without the emergency medical condition being stabilized and led to harm to Pt 3 and her unborn baby. Pt 3 returned to the ED on 10/11/24 at 7 p.m. with worsening abdominal pain and tachycardia, blood sugar 303 mg/dl and lab tests indicated DKA. Fetal distress resulted in an emergency cesarean section on 10/11/24 at 10:52 p.m., and the baby required resuscitation with chest compressions and intubation. The baby was transferred to a children ’ s hospital (Hospital C) and Pt 3 was admitted to the intensive care unit of Hospital A. 3. Pt 6 arrived in the ED on 8/13/24 at 11:24 p.m. as walk in patient with chest pain, shortness of breath, high heart rate and low blood pressure and severe pain described as 10/10. Pt 6 was incorrectly assigned an ESI level 3, and left in the lobby to wait. The MSE was initiated at 11:57 p.m. and a Chest X-ray and EKG were done, and Pt 6 remained in the lobby to wait. The QMP failed to provide stabilizing measures for the emergency medical condition of CP, SOB and severe pain and Pt 2 left before the MSE was completed after two hours of waiting. These failures resulted in Pt 6 returning to the ED approximately ten hours later on 8/14/24 at 11:30 a.m., with chest pain, abdominal pain, dizziness, HR of 95, BP of 73/57, and a pain level of 10/10 requiring over eight hours of treatment in ED that included imaging and intravenous fluids. 4. Patient (Pt) 19 was first brought in by ambulance on 10/7/24 at 2:59 p.m. with chief complaint of three days of worsening leg pain and swelling. Hospital staff were aware Pt 19 was homeless. Following triage and initiation of the medical screen exam by ED physician (MD 2), Pt 19 left sometime between 4 p.m. and 5 p.m. without further services being provided. No labs or medications were administered. On 10/7/24 at 8 p.m. Pt 19 returned to the ED with the same chief complaint of three days of worsening leg pain and swelling. ED physician (MD 3) diagnosed deep vein thrombosis (DVT-a blood clot [thrombus] in one or more of the deep veins in the body), following an ultrasound. Pt 19 was discharged with prescription for medication to treat the DVT and instructions to return to her Primary Care Physician (PCP) for follow up. No social work consult was obtained in accordance with hospital policy and procedure. Pt 19 did not have a PCP. Hospital staff did not determine if Pt 19 could obtain the medication from the pharmacy and did not determine if Pt 19 could follow the instructions. These failures resulted in Pt 19 being unable to obtain the prescription for medication to treat the DVT and led to Pt 19 ’ s return to ED by ambulance for shortness of breath within fourteen hours of discharge. Pt 19 required additional work up and a two day hospital stay. Because of the serious potential harm to Pt 2, serious actual harm to Pt 3 and Pt 3 ’ s baby, and serious potential harm to Pt 6, due to not providing stabilizing measures to address the emergency medical conditions, an immediate jeopardy situations (IJ) was called under CFR 489.24(d)(3), A2407, on 10/29/24 at 12:50 p.m. with the Chief Nursing Executive, the Chief Medical Officer, and the Director of Accreditation and Regulatory. The IJ template was provided to the hospital and instructed to submit in writing an acceptable Plan of Removal for the IJ. The hospital submitted an acceptable IJ Plan of Removal (Version 3) on 11/01/24. The IJ Plan of Removal included but was not limited to the following: 1. Nurses assign ESI level appropriately. 2. Nurses screen all patients for abuse and suicide risk 3. Nurses acknowledge clinical alarms and escalate to the provider. 4. Nurses escalate any patient safety concerns not addressed by the provider, prior to discharge. 5. Social worker referrals are made for victims of assault/abuse. 6. Local law enforcement is notified if a patient elopes who may be a danger to self or others, is confused, or altered. 7. OB and ED physicians review plan of care together for any OB pt in ED longer than four hours. 8. Patients with complaints of assault or abuse are prioritized for placement an ED room. The team verified by observations, interviews, and record review the actions of the IJ Removal Plan were implemented and the IJ was removed on 11/1/24 at 4:10 p.m. with the Associate Chief Nursing Executive and the Director of Accreditation and Regulatory. Findings: 1. During a concurrent interview and record review on 10/28/24 at 10:00 a.m. with the Emergency Department Director (DED), patient (Pt)2 ’ s electronic medical record (EMR) was reviewed for the Emergency Department (ED) visit on 9/1/24. The EMR indicated Pt 2 arrived at ED on 9/1/24 at 2:30 a.m. with scalp hematoma, neck abrasion, and left-hand injury due to physical assault. The document titled “ ED Triage and Initial Assessment “ was reviewed and Indicated Pt 2 ’ s preferred language was Spanish, and Pt 5 ’ s son was used as interpreter. The initial vitals on 9/1/24 at 2:51 a.m. indicated HR 101 beats per minute (bpm-normal 60-100), Respiratory rate 17 breaths per minute (normal 12-20), Blood pressure 144/80 millimeters of mercury (mmHg - Unit of measurement-normal less than 120/80), Pain intensity level of 8 (on a scale of 0 [no pain] to 10 [worst possible pain], 8 and above is severe pain). The “ ED Triage and Initial Assessment “ indicated, “ ...ED SOCIAL HISTORY ...CSSRS Suicide screening ED: Not Screened: Clinical Judgement and Non-BH ...Abuse Screen, adult/elderly/domestic: No signs of abuse ... “ The DED stated Pt 2 needed language assistance services, and he was unable to find any documentation in the medical record that indicated the patient was provided language assistance services or was made aware of the available resources per hospital policy. The DED stated the Triage documentation indicated Pt 2 ’ s son was used as an interpreter, and the waiver form to use family member instead of language assistance service was not completed in accordance with the hospital policy. The DED stated he was unable to comment on why Pt 2 ’ s son was used for translation, and he was unsure if Pt 2 ’ s son was old enough to translate. The DED stated the Triage documentation was inaccurate as it indicates no signs of abuse, while Pt 2 presented with a chief complaint of scalp hematoma, neck abrasion, and left-hand injury due to physical assault. The DED stated the nurse who completed the “ ED Triage and assessment “ was not a qualified certified interpreter, and without the use of language assistance service, the assessment was not completed appropriately accordance with the facility policy. The DED also stated the patient was assigned incorrect emergency severity index (ESI) level 4 (ESI- a 5-level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed in order to prioritize care, ESI 1 being the most serious) and should have been assigned higher ESI (ESI level 2) based on presentation and abuse as stated in chief compliant in Triage. The DED stated assigning incorrect ESI in Triage could have the potential to cause delays in medical care. During a concurrent interview and record review on 10/28/24 at 10:10 a.m. with the DED, Pt 2 ’ s “ ED Physician note “ dated 9/1/24 was reviewed. The “ ED Physician note “ indicated, “ ...History of present illness ...38 Year-old female ...emergency department for evaluation after an assault ...Physical Exam: Spanish speaking ... [Head Eyes Nose Throat] ...She has 3 left temporal hematomas ...SKIN Abrasion/contusion to zone 3 of neck ... Psychiatric ... Tearful ... Communication altered due to language ...Medical Decision Making: Patient reports that she was at her mother’s house and her boyfriend was drunk ...all of a sudden assaulted her. She says that he pulled her hair and was choking her at 2 different occasions during this altercation. She further says that she is having pain to her left wrist as he yanked her from there during assault... [Police Department] was involved in the incident and report has been filed ...Patient reporting pain to her left temporal region as well as pain to her left wrist ...On presentation, [Pt 2 ’ s] Glasgow Coma Scale 15 [GCS- a system to “ score “ or measure how conscious a person is. Scores range from 3-15, 15 is alert and oriented] and appropriately protecting her airway on room air ...Results of x-ray do not demonstrate any bony fracture nor dislocation or foreign body. Patient felt better after treatment emergency department. Results of workup were shared with the patient. [pain medication prescription] sent to pharmacy of choice. Pain management discussed with patient. Instructed to follow-up with PCP within 72 hours of discharge. Patient expresses understanding and is amenable to outpatient follow-up. At this time, patient be discharged home ... “ The DED stated patient received Acetaminophen (medication to treat minor aches and pains, and reduces fever) and Methocarbamol (muscle relaxant) on 9/1/24 at 3:34 a.m. and was discharged on 9/1/24 at 5:26 a.m. The DED stated although the discharge instructions were provided in Spanish, there was no documentation indicating that a certified interpreter or language assistance services were used by the provider. The DED reported no documentation within the entire medical record on for the 9/1/24 ED visit indicating that a social worker had been consulted before discharge. According to the DED, both the ED physician ’ s notes and medical record indicated police involvement before Patient 2 ’ s arrival. However, the medical record lacks evidence that Pt 2 received a social worker consultation, psychosocial assessment, safe discharge planning, or follow-up resources for abuse victims before discharge. The DED emphasized that, as a known victim of abuse, Pt 2 should have undergone an assessment for a safe discharge location and received referrals for appropriate follow-up support. Additionally, the DED found no physician documentation verifying that language assistance services were used, nor was it confirmed if the ED physician was a certified interpreter, as per hospital policy. The DED stated physician ’ s note, which documented “ communication altered due to language, “ highlighted the importance of using a certified interpreter to ensure a thorough discharge assessment and to identify any barriers to a safe discharge with necessary outpatient resources for abuse victims. The DED also stated that Pt 2 had an inaccurate abuse screen completed during triage, lacked a social worker referral and evaluation, and did not receive documented resource evaluation before discharge, resulting in an unsafe discharge. The DED expressed an expectation for ED staff to complete abuse assessments accurately and involve a social worker to evaluate patients presenting to the ED as potential abuse victims. During a concurrent interview and record review on 10/28/24 at 10:15 a.m. with the DED, Pt 2 ’ s EMR was reviewed. Review of the document titled “ ED Depart “ dated 9/1/24, indicated Pt 2 was discharged on 9/1/24 at 0527 by Licensed Vocational Nurse (LVN) 2. The “ ED Depart “ indicated, “ ...Preferred language: Spanish ... Interpreter/Translator name, if used: Staff ... Location Information: Nurse Unit- ED Hallway. New Medications ...methocarbamol ... “ The DED stated while discharge instructions were provided in Spanish, there was no documentation indicating that a certified Spanish interpreter was used by the nurse discharging the patient, nor did the instructions contain abuse-related information or resources for the patient. The DED confirmed that LVN 2, who provided the discharge instructions, was not a certified interpreter and should have used language assistance services in accordance with hospital policy to ensure the patient ’ s comprehension of the discharge instructions. The DED expressed that, without a certified interpreter, it is unclear whether Pt 2 fully understood the discharge process and follow-up care. The DED stated that he would have expected the patient to be provided with resources for abuse victims and to undergo a safety assessment facilitated by language assistance services before discharge. Additionally, the DED noted the absence of documentation regarding the age of Patient 2 ’ s son and stated an assessment should have been done to ensure the safety of any minors in the household who may be at risk. The DED stated it was inappropriate for Pt 2 to be left in the ED hallway and that abuse victims should be placed in a more private, secure area within the ED. During an interview on 11/1/24 at 2:30 p.m. with the EDMD, the EDMD stated he was the medical director for the ED. The EDMD stated for patients presenting to the ED with domestic abuse, the ED provider and staff were expected to inquire if the patient had filled out a police report. The EDMD stated it was important to ensure that they have a safe place to go after discharge. The EDMD stated additionally, if the patient was elderly or pediatric, they were obligated to report to Adult Protective Services (APS) or Child Protective Services (CPS). The EDMD stated that the ED provider completes the full assessment and documents it in the medical record, assessed for signs of abuse, asked patients where they are hurting, and used a certified interpreter or language assistance service for patients with a language barrier. The EDMD stated that, at times, these cases are very emotional, and the patient only wants the family to translate, and in those cases, they have a process in place. The EDMD stated if a patient presents with a significant other, they make every attempt to separate them and interview the patient. The EDMD stated before discharge, patient functionality gets assessed, and they make sure the patient has a safe place to go and resources. The EDMD stated he would expect all of this to be documented. The EDMD stated that a social worker consult is ordered as needed, however, they do have limited resources at night. The EDMD stated he had not reviewed Pt 2 ’ s chart, but the expectation would be the same for any patient presenting with domestic abuse. During an interview on 11/4/24 at 9:24 a.m. with the Manager of Social Services (MSS), the MSS stated her team gets calls and referrals from ED for all types of patients, such as homeless, child abuse, and difficult discharges. The MSS stated currently, the social worker is assigned to ED during weekdays until 11:00 p.m. and on weekends on site until 4:30 p.m. The MSS states for victims of domestic violence; their role is to speak with the patient, do screening, which consists of assessing for domestic violence, if children are involved, ensure a CPS report is filed, and, most importantly, offer domestic violence resources. The MSS stated even if the patient denied, their team provides the resources in case the victim later needs it. If the victim does not want to go home, their team provides the shelter resources. The MSS stated social workers are certified in Spanish. If the social worker does not speak Spanish, they are required to use translation services and document that in the medical record. The MSS stated regarding Pt 2, she ideally the doctor would have made a referral to social work, and her team would have come in to do an assessment. The MSS stated part of their assessment is to ensure no children are in the home and at risk where domestic abuse occurred. If the children are present, they would like to make sure the children are safe along with the patient. The MSS stated social workers always provide resources in case patients need to use them in the future, even if the patient refuses them for the visit. The MSS stated that victims of domestic violence are not ready to leave and need to prepare therefore, these resources are critical. The MSS stated her team has packets ready that prepare the victims of domestic violence to leave and make them aware of the available resources. The MSS stated they also do not have any social worker available for ED at night after 11 p.m., and if the social worker consult is ordered and the patient is discharged before the morning shift, the social worker team would not get any notification and order would fall off where her team is not able to track. The MSS stated if Pt 2 arrived after 11:00 p.m. and was discharged before the day shift, her team would not be aware, and currently, they do not have a way to track this or our patient follow-up. The MSS stated ED nurses have been made aware of these packets, have access to them after hours, and expected to provide these to patients after hours. During a review of the hospital ’ s policy and procedure (P&P) titled, “ Language Assistance Program - Interpretation and Hearing Impaired, “ dated 6/20/24, the P&P indicated, “ ...[Hospital A] will take reasonable steps to ensure that persons requiring language assistance services (such as oral language assistance or written translation) and who have Limited English Proficiency (LEP) will have meaningful access and an equal opportunity to participate and understand services, activities, programs and other benefits involving medical conditions and treatment. Assistance will be offered for the communication of information contained in vital documents, including but not limited to, waivers of rights, consent to treatment forms, financial and insurance benefit forms, etc. Patients/clients and their families will be informed of the availability of such assistance free of charge. Language assistance will be provided using competent bilingual staff, providers, staff interpreters, contracts or formal arrangements with local organizations providing interpretation or translation services, or technology and telephonic interpretation services ... OBTAINING A QUALIFIED INTERPRETER ...A qualified staff interpreter must pass the competency exam as outlined in the instructions on CVN Interpreter Services Connect ...Note: Sites may choose not to use staff for translating or interpreting, unless during an emergency involving an imminent threat to the safety or welfare of an individual or the public...Maintaining an accurate and current list showing the name, language, phone number and hours of availability of competent bilingual staff - located on CVN Interpreter Services Connect ] ...Contacting the appropriate competent bilingual staff member to interpret, in the event that an interpreter is needed, if an employee who speaks the needed language is available and is qualified to interpret ...Site staff who have a limited familiarity (not deemed competent or qualified) with sign language or language/interpreter skills should interpret only in emergency situations for a brief time until a qualified interpreter can be present ...Obtaining an outside interpreter if a competent bilingual staff or qualified staff interpreter is not available or does not speak the needed language ...[[Company name] Language Solutions, (866) 745 - 5010, is available 24 hours per day, 7 days per week. [Company name] Interpreting (559) 636 - 3294, is available for live ASL interpreting between the hours of 8am to 5pm Monday - Friday] ... Some LEP persons may prefer or request to use a family member or friend as an interpreter. However, family members or friends of the LEP person will not be used as interpreters unless specifically requested by that individual and after the LEP person has understood that an offer of an interpreter at no charge to the person has been made by the facility. Such an offer and the response will be documented with the waiver of rights form, in the patient’s medical/health record. The waiver of rights must include a statement giving the LEP person the right to request an interpreter at any time ... Children and other clients/patients/residents will not be used to interpret, in order to ensure confidentiality of information and accurate communication ... “ During a review of the facility ’ s P&P titled, “ ABUSE, REPORTING OF “ , with a review date of 8/6/2023, the P&P indicated “ ...POLICY INTENT ... To provide directions to staff in the mandatory reporting of child abuse, elder / dependent adult abuse, and the victims of domestic violence ... Domestic Violence: Abuse committed against an adult or fully emancipated minor who is ...Spouse or former spouse ...Cohabitant or former cohabitant ...Person with whom the suspect has had a child ... Physical Abuse: Physical injury that results in substantial harm to the person, or the genuine threat of substantial harm from physical injury to the person, including an injury that is at variance with the history or explanation given and excluding an accident or reasonable discipline by a parent, guardian or conservator that does not expose the person to a substantial risk of harm ... POLICY COMPLIANCE - KEY ELEMENTS ...Staff of the hospital and its associated facilities and clinics will adhere to the mandatory reporting requirements for victims of elder / dependent / child abuse and / or neglect and domestic violence ...If allegations of abuse or neglect are raised, reporting must take place ...If the staff, either medical practitioner or other staff, suspects or sees possible abuse / neglect, reporting is mandatory ...Appropriate forms will be completed and notifications of appropriate law enforcement agencies will be made ...incident reporting system file should be completed and a copy of the reporting form forwarded to Risk Management ... Domestic Violence ...Upon suspicion of domestic violence, initiate a verbal report via telephone call to the law enforcement agency of jurisdiction ...Complete the “Domestic Violence Report” (Form No. 8756F1210) and distribute per instructions at the bottom of the page ...Encourage the victim to call the Domestic Violence Hotline and if in immediate danger, ask for assistance to enter the shelter ...Document assessment findings, treatments, pertinent statement of victim and others in the medical record ... “ During a review of the facility ’ s P&P titled, “ STANDARDS OF CARE EMERGENCY DEPARTMENT “ , with a review date of 6/27/24, the P&P indicated “ ...Assessments/Reassessments ...All patients will be triaged by a registered nurse (RN) ... All patients will be screened for Assault/Abuse Screenings, Screening for Suicidal/Homicidal ideations, Fall Risk, Advanced Directive, and Homelessness ... Discharge ...The ED physician will determine if the patient meets discharge criteria, needs to be transferred to another facility or higher level of care, or requires hospital admission. For patients who are discharged, all patients will receive after care instructions in the form of discharge instructions upon completion of their treatment. Medication instructions and educational handouts are provided as appropriate. Patients identified as homeless will be offered resources ... “ During a professional reference review retrieved from (https://pmc.ncbi.nlm.nih.gov/articles/PMC4393790/ ), dated Dec 2014, titled “ Managing Intimate Partner Violence in the Emergency Department “ , the reference indicated, “ ... Intimate partner violence (IPV) is a pattern of assaultive or coercive behaviors, perpetrated by someone who was or is in an intimaterelationship with the person ....The ED provider should seek to encourage and empower patients to speak to health care providers and to overcome any reluctance to seek help for their abuse, both during the current visit and in the future. Patients may be divulging abuse for the first time, and may experience it as emotional, embarrassing, and frightening .... Assessing the immediate safety concerns of the patient for themselves and for any children in the household will determine the next critical steps ...Patients should be asked if they feel safe to leave the ED; a brief formal danger assessment tool may be used as a follow up to a positive screen to calculate risk of severe future IPV and may perform better than self-assessment of risk ...If the patient does not feel safe to go home, they will need to be linked to domestic violence agencies to seek alternative housing ...Given the shortage of domestic violence shelter beds, patients may need to consider alternative housing through friends or family for the short term; some hospitals will admit a patient in danger of violent victimization who do not feel safe to go home and have no other options ... Child protective services must be consulted if there is concern for the safety of children in the household ... Patients experiencing abuse should be offered the opportunity to receive assistance contacting law enforcement to make a report and initiate the process of obtaining a restrain orders. If they do not wish to initiate this process while in the ED, they should be given information on how to do so, and made aware that domestic violence agencies’ services include navigating law enforcement and legal aid ... Child abuse and elder abuse, in contrast, must be reported; if these are revealed to coexist with partner violence, providers cannot assure confidentiality. In the vast majority of cases, patients will be returning home, rather than to a shelter. Anticipating and understanding this, remaining supportive and encouraging, and avoiding responses of frustration, disbelief, or disapproval will ensure the patient does not feel judged or looked down upon, and may increase the possibility that they will seek help from health care providers in the future. It can take many attempts at leaving before someone leaves an abusive relationship permanently ... Ideally, patients should be instructed in a variety of steps they can take to keep themselves and their children safe and to allow them to leave the home quickly in case violence should escalate ... the patient should be encouraged to learn more about safety behaviors with domestic violence agencies as an outpatient ... Patients experiencing IPV should receive, at the minimum, referrals to local or national domestic violence hotlines... “ 2. During a concurrent interview and record review on 10/28/24 at 10:55 a.m. with the Director of Obstetrics (OBD) and the Manager of Obstetrics (OBM), Pt 3 ’ s medical record was reviewed. Review of the record indicated Pt 3 came to the ED on 10/10/24 at 12:06 p.m. with complaints of abdominal pain, chest pain and palpitations, was triaged and assigned an ESI level 2. Pt 3 ’ s heart rate was 138-155 bpm. The ED triage nurse ’ s note dated 10/10/24 indicated Pt 3 was 34 weeks, 5 days pregnant and had a history of Type 1 diabetes and DKA and was initially going to be put into an ED room but because she was pregnant and had abdominal pain she was sent to labor and delivery (L&D) after an EKG was done. On 10/10/24 at 1 p.m. Pt 3 ’ s heart rate was 127 bpm, and a non-stress test was performed and was reactive with a baseline fetal heart rate of 155 bpm. Pt 3 ’ s vaginal exam indicated her cervix was closed, and there were no regular contractions noted. The L&D record indicated at 12:56 p.m. the obstetrician was notified of, “ edc [estimated date of confinement, due date], gestational age, fetal heart rate, complaint of chest pain, walked over by ED, feeling generally bad, Type 1 DM, having trouble controlling bs [blood sugar], current BS 200. “ The record did not indicate how that blood sugar was obtained since it did not show up on the lab report. The OBD called the L&D nurse (RN 6) who stated Pt 3 was wearing a continuous glucose monitor (CGM) and RN 6 read the glucose level off of the CGM. At 1:13 p.m., Pt 3 was transported back to the ED. Review of the “ ED Physician Notes, “ dated 10/10/24 at 2:16 p.m., indicated the MSE was initiated by the nurse practitioner (NP 1) at 1:28 p.m. The note indicated, “ ...27 year-old female who is 34 weeks and 5 days pregnant with a history of Type 1 diabetes ...Patient reports she has been experiencing palpitations with simple movements like sitting up in the bed. The palpitations are associated with shortness of breath. States she can only walk a few steps before started feeling short of breath and feeling like her heart is racing. Patient also reports that she has been experiencing vomiting and heartburn and has not been eating or drinking as much for the past week ... “ Blood and urine tests, and a chest x-ray were ordered, and two IV fluid bolus of 1000 milliliters normal saline each, medication for vomiting, and IV magnesium were given. Review of the lab results dated 10/10/24 at 2:58 p.m., indicated sodium 124 mmol/L (range; 136-144), chloride 93 mmol/L (101-111), CO2 19 mmol/L (22-32), Anion Gap 12mmol/L (5-15), random glucose 127 mg/dl (70-110), Osmolality 249 (275-295), calcium 8.6 mg/dL (8.9-10.3), Magnesium 1.1 mg/dL (1.8-2.4), Beta-Hydroxybutyric Acid (BHB) 3.69 mmol/L. Urinalysis indicated Glucose-150 mg/dL (Negative is the normal value), protein-30 mg/dL (negative is normal) and Ketones-Many (negative is normal). Review of the medical decision-making part of NP 1 ’ s note indicated, “ ...Upon reevaluation, patient ’ s heart rate at rest is between 105-120s and with activity such as sitting up or walking heart rate goes up to the 140s. Given patient continues to experience tachycardia with shortness of breath with simple movements after receiving 2 L of fluid, I discussed with the patient the possibility of PE [pulmonary embolism-a blood clot in the lungs] ...CT ordered ...I have transitioned care to [name of ED Physician] [MD 1] , we have discussed the clinical presentation, work up, and ED course course thus far ... “ NP 1 indicated she spoke to the obstetrician [OB 1] about Pt 3. The note indicated, “ Diagnosis: Vomiting, Tachycardia, Shortness of Breath on exertion. Condition: Guarded ... “ Review of MD 1 ’ s ED Physician Note dated 10/11/24 at 12:16 a.m., indicated, “ ...complains of 10 days of weakness, palpitations and abdominal pain, vomiting followed by diarrhea constipation ...Pt took a laxative followed by diarrhea and vomiting ...She was seen here by the midlevel who initially diagnosed dehydration started IV fluids as well as additional work-up which all came back unremarkable except for hyponatremia with a sodium of 124 ...Patient was turned over to my care at change of shift awaiting the results of the CT and final disposition. CT did come back showing no evidence of PE ...01:00 still tachycardic by feels markedly improved, would like to go home ...no further vomiting, tolerating oral fluids quite well, lab work significant only for mild hyponatremia ...Healthy young female presented with weakness and dehydration consistent with gastroenteritis ... “ There was no mention in MD 1 ’ s note that Pt 3 had Type 1 diabetes, or that the BHB was 3.69 (greater than 3 is associated with DKA), or that there was glucose and many ketones in Pt 3 ’ s urinalysis. The record did not indicate the discharge was discussed with Pt 3 ’ s obstetrician. Review of the intake and output record for the entire ED stay from 10/10/24 at 1:18 p.m. until 10/11/24 at 12:45 a.m. when Pt 3 was discharged, indicated only the IV fluid was recorded on the intake record. There was no intake of oral fluids for the shift or food intake documented in the record. There was no output (urine or vomit) documented for the stay. Review of the medication administration record (MAR) dated 10/10/24 at 1:18 p.m. until 10/11/24 at 12:45 a.m. indicated no insulin was given. Review of the nurses notes and the lab results records indicated no blood glucose testing was done in ED except for at 3 p.m. as part of a metabolic panel. Point of care fingerstick blood glucose tests were not done and there was no mention of Pt 3 ’ s CGM. The record indicated Pt 3 ’ s unborn baby was not monitored during the ED stay. The OBD stated L&D staff were not aware Pt 3 stayed in the ED for almost twelve hours after Pt 3 had an NST. The OBD stated there is no record of the ED calling them to monitor the patient or perform another NST. The OBD stated if there is a patient in the ED that needs to be checked once or monitored continuously, the ED staff notify the L&D staff. Review of the document “ ED Depart Summary, “ dated 10/11/24 at 1:01 a.m. indicated discharge vital signs were temperature 97.6 degrees F, heart rate 132 bpm, respiratory rate 22 breaths per minute, and blood pressure 108/66 mmHg. During a concurrent interview and record review on 10/28/24 at 1:30 p.m. with the OBD and the regulatory specialist (RS 1), Pt 3 ’ s medical record dated 10/11/24 at 7:07 p.m., indicated Pt 3 returned to the ED on 10/11/24 at 7:07 p.m. with complaints of worsening chest pain and vomiting. Triage vital signs are Temp 98.2 F, heart rate 143 bpm, respirations 24 breaths per minute, and BP 130/72 mmHg. Fingerstick blood glucose was 285mg/dL. Blood tests were done at 8 p.m. and indicated CO2 less than 8 (critical test result), glucose 303 mg/dL, wbc 20.7 (4.5-11.0), BHB 8.39 mmol/L, venous blood gas pH 7.06 (critical result). The record indicated Pt 3 had a CT to rule out abdominal aortic aneurysm at 8:30 p.m. which was negative. A biophysical profile (BPP-a test to evaluate fetal well-being) without a non-stress test (NST) was done and results were 2 (out of 8 [no NST]) and indicated a need to deliver the baby. An emergency cesarean section was performed, and the baby was born at 10:52 p.m. The baby was not breathing and did not have a heart rate at birth and required resuscitation with intubation, and was transferred to the neonatal intensive care unit and then to Hospital C for a higher level of care. Apgars were 0/6/7 at one minute, five minutes, and ten minutes. During an interview on 11/1/24 at 2:25 p.m. with the ED Medical Director (EDMD), EDMD stated after Pt 3 was discharged and then returned to ED a co-worker approached him with concerns about the discharge and EDMD stated he referred this case to peer review. EDMD stated he had reviewed the record and had a hard time understanding the discharge of a patient with a heart rate of 132 bpm. EDMD stated he had not spoken to the physician who discharged the patient yet, they will discuss it at the peer review meeting. EDMD stated the physicians, and the nursing staff work as a team and if the nurse has a patient care concern they should communicate that to the physician. During an interview on 11/4/24 at 11 05 a.m. with the manager of ED (EDM 1), EDM 1 stated monitoring and documenting Pt 3 ’ s intake and output is very important, especially since Pt 3 had nausea and vomiting and decreased oral intake, and fluid boluses were part of Pt 3 ’ s treatment plan. EDM 1 stated they also re-educated staff on the policy for responding to clinical alarms that alert the staff to abnormal vital signs. Pt 3 ’ s heart rate was elevated which would have caused the alarm to alert. EDM 1 stated they do not know what happened with the alarm in this case, whether anyone heard it or what was done in response to the alarm because nothing is documented. EDM 1 stated as far as Pt 3 ’ s discharge with a heart rate of 132 bpm, her expectation was for the nurse to notify the physician, and to document that in the record. EDM 1 stated if the physician did not evaluate the patient, then at that point she would expect the nurse to follow their chain of command and notify the lead nurse. EDM stated the nurse is the last person to see the patient before discharge and the nurse is indicating the patient is ok to be discharged as far as the vital signs and assessment. EDM 1 stated it doesn ’ t matter if the physician wrote a discharge order, if the vital signs or assessment are abnormal the nurse must follow up with the physician. During a review of the reference article, “ Managing Preexisting Diabetes for Pregnancy: Summary of evidence and consensus recommendations for care, “ Diabetes Care 1 May 2008 retrieved from https://doi.org/10.2337/dc08-9020, the article indicated, “ ...Managing Diabetes Complications ...Pregnancy profoundly affects the management of diabetes ... Providers should have a high index of suspicion for DKA in diabetic pregnant women with nausea, vomiting, abdominal pain, fever, and poor oral intake. The marked increase in insulin resistance and enhanced lipolysis/ketosis associated with pregnancy account for the greater risk of DKA during gestation. Predisposing factors include vomiting and dehydration, omission of insulin doses, infection. DKA jeopardizes both maternal and fetal wellbeing. In pregnancy, 10-30% of cases of DKA have been reported to occur with moderately elevated glucose levels (<250 mg/dl). Diabetic pregnant women with nausea, vomiting, and persistent and even moderate hyperglycemia should be evaluated for ketoacidosis. Treatment protocols for DKA are based on correcting volume depletion, supplying insulin by infusion, carefully monitoring and correcting electrolyte imbalances, and identifying and treating precipitating factors. Continuous fetal heart rate monitoring and biophysical tests are used to assess fetal wellbeing in cases occurring after 24 weeks ’ gestation ... “ During a review of The Journal of Clinical Endocrinology & Metabolism, 2022, Vol.107, No.11 article titled “Diabetic Ketoacidosis in Pregnancy: Clinical Risk Factors, Presentation, and Outcomes,” the article indicated, “...Diabetic ketoacidosis [DKA] in pregnancy is an obstetrical emergency associated with an increased maternal and fetal mortality risk if not promptly identified and treated. DKA complicates 5% to 10% of all pregnancies with pre-gestational and gestational diabetes, and while maternal mortality is rare, fetal mortality rate is estimated to be between 10% and 35%. Pregnancy is characterized by progressive insulin resistance, particularly throughout the second and third trimesters. The altered metabolic milieu during pregnancy means that DKA can develop more rapidly and at lower plasma glucose concentrations than observed outside of pregnancy...In addition, pregnancy is considered a state of accelerated starvation with enhanced lipolysis and ketone body production even with relatively short periods of fasting (5). Pregnant women also experience increased minute alveolar ventilation leading to respiratory alkalosis with compensatory increased renal excretion of bicarbonate and a lower buffering capacity (6). These features, in com¿bination with a relative or absolute insulin deficiency, pre¿dispose to DKA development ... “ During a review of the professional reference titled, “ Hyperglycemic Crises in Adults With Diabetes: A Consensus Report, “ dated 6/2022, retrieved from <https://diabetesjournals.org/care/article/47/8/1257/156808/Hyperglycemic-Crises-in-Adults-With-Diabetes-A> the reference indicated, “ ...Although hyperglycemia remains a key diagnostic criterion of DKA, a wide range of plasma glucose concentrations can be present on admission. Approximately 10% of patients with DKA present with euglycemic DKA, which is defined as plasma glucose levels <200 mg/dL [11.1 mmol/L] in the presence of ketosis ( â-Hydroxybutyrate concentration =3.0 mmol/L OR urine ketone strip 2+ or greater) and metabolic acidosis (pH <7.3 and/or bicarbonate concentration <18 mmol/L) criteria of DKA. In recognition of the wider range of glucose levels at presentation with DKA, the criteria for diagnosis of DKA have been changed to encompass a lower glucose value of >200 mg/dL (11.1 mmol/L) or a prior history of diabetes (irrespective of the glucose level) ...A substantial proportion of individuals hospitalized with DKA experience recurrent episodes, underscoring the importance of engaging patients experiencing these events to identify triggers and prevent recurrence ... “ 3. During a concurrent interview and record review on 10/24/24 at 9:30 a.m. with the Emergency Room Director (DED), Manager Regulatory Team (MRT), and Regulatory Specialist (RS) 2, Pt 6 ’ s “ Electronic Medical Record (EMR) “ was reviewed for the Emergency Department (ED) visit on date 8/13/24. The EMR indicated Pt 6 arrived at ED on 8/13/24 at 11:22 p.m. and was triaged at 11:46 p.m. The document titled “ ED Triage and Initial Assessment “ dated 8/13/24 indicated “ ...Reason for visit history: Pt c/o chest pain, itchiness and rib pain X 9 days...Tracking acuity control: 3 [Emergency severity index (ESI) or acuity - 5 level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed in order to prioritize care, ESI 1 being the most serious ] ...Triage ...Peripheral Pulse Rate 105 [breaths per minute (bpm), normal 60-100], Systolic BP...83 [Millimeters of mercury (mmHg- unit of measurement), normal 120 or less but greater than 90], Diastolic BP 60 mmHg [normal 60-80], Pain intensity level 7 [numeric scale asks the person in pain to assign a number, from zero to ten, to the severity of their pain, 0 means you have no pain; one to three means mild pain; four to seven is considered moderate pain; eight and above is severe pain] ... “ The DED stated Pt 6, with a chief complaint of Chest pain, Heart rate of 105, Blood pressure of 83/60, and pain level of 7 should have been assigned acuity score of 2. The review of document titled “ ED Physician Note “ indicated, “ ...MD Time patient seen face to face at 11:57 p.m. ...Medical Decision Making ...39 year old Female who presents for chief complaint of chest pain x9 days at triage. Vitals signs reviewed which showed mild tachycardia 105 with hypotension 80/60 ...Patient was called for initial interview and was ambulatory to triage room without issue. Upon sitting down, patient began rocking back and forth, crying and yelling “ I can ’ t take it anymore “ . When attempting to clarify her symptoms patient became more agitated and continued yelling as she pointed to her chest and throughout abdomen. Patient was able to answer yes or no to some question ...EKG overall nonischemic without lethal arrhythmia [no significant concerns] ...Patient was noted to be seating comfortably in the ED waiting room shortly after. Labs ordered and drawn; however, patient eloped prior to resulting ...Diagnosis Chest Pain ...Disposition Eloped ... “ The review of a document titled “ Orders “ indicated acetaminophen (pain medication) was administered on 8/14/24 at 12:57 a.m. EKG was ordered at 11:25 p.m. and was signed by a provider at 11:53 p.m. Lab tests including a complete blood count (CBC - a blood test that provides information about the cells in a person’s blood), comprehensive metabolic panel (CMP- a blood test that measures substances in the blood such as protein and electrolytes) and troponin level (troponin is a protein found in the blood when the heart muscle is damaged) were ordered on 8/14/24 at 12:18 a.m., however patient left before labs resulted. The review of a document titled “ Nursing Documentation- Flowsheet “ on 8/14/24 at 1:33 a.m. indicated, “ ...Pt was yelling profanities at staff and security from [waiting room]. PT had been asked multiple times by security and staff to please be patient. Pt started yelling profanities and then left the ER stating that she was going to Fresno and that she no longer ...waiting care at this [hospital]. Pt escorted out to the benches by security. “ The DED stated that Pt 6 should have been assigned an ESI of 2 and brought directly into the ED after triage, as it was inappropriate to keep a patient of this acuity level in the main lobby. The DED stated that while the medical screening examination (MSE) was initiated, it was not completed prior to Pt 6 ’ s elopement. He stated that the medical record does not indicate that the provider was notified of the patient’s distress or intention to leave. The DED further stated that this outcome might have been avoided had the patient been correctly triaged at acuity level 2 (rather than 3) and placed in the ED, in alignment with protocol for patients of this acuity. Additionally, there was no documentation showing that the provider attempted to reach out to the patient post-elopement to encourage a return to the ED. The DED highlighted the lack of sufficient documentation regarding the involvement of security and noted that security personnel escorted the patient out. He stated that the patient ’ s pain level was documented as 10 out of 10 at 12:57 a.m. on 8/14/24, at which time acetaminophen was administered; however, there was no documentation indicating reassessment or resolution of the pain before the patient’s departure. The DED stated Pt 6 reportedly eloped at 1:32 a.m., approximately two hours and ten minutes after arrival, and had remained in the waiting room with complaints of chest pain, low blood pressure, and an elevated heart rate. Given the patient ’ s chief complaint of chest pain, high pain level, and low blood pressure, the DED stated that he would have expected the triage nurse to escalate the situation to the provider, allowing the provider to discuss the risks of leaving without a complete MSE. The DED also noted that the “ leaving against medical advice “ (AMA) form should have been completed in this instance after Pt 6 was provided the opportunity to speak with the provider instead of being escorted out by security. During a concurrent interview and record review on 10/24/24 at 9:45 a.m. with the DED, MRT, and RS 2, Pt 6 ’ s EMR was reviewed for an Emergency Department (ED) visit on date 8/14/24. The EMR indicated Pt 6 returned to the ED on 8/14/24 at 11:30 a.m. (nine hours and fifty-two minutes later) and was triaged at 11:49 a.m. Pt 6, upon arrival in Triage, had a BP of 73/57, Pulse rate of 95, and Pain level intensity level of 10. Pt’s Chief complaint indicated, “ Pt [complaint of] rib, abdominal pain, [Nausea/Vomiting] and dizziness x 9 days. Pt states she was seen this morning but only given Tylenol. Pt smokes marijuana daily “ . The review of EMR for the second ED visit on 8/14/24 indicated MSE was started at 12:06 a.m. and patient work up required bolus of lactate ringer (fluid replacement therapy that’s used to treat low blood volume or low blood pressure), chest X-ray (an imaging test that creates picture of the inside of the chest), CT scan (a non-invasive imaging procedure that uses X-rays to create detailed cross-sectional pictures of the body) of chest and abdominal/Pelvis, electrocardiogram (EKG- a test that records the electrical activity of your heart), Labs that includes CBC, CMP, Troponin, BNP (a test which helps to diagnose or rule out heart failure), blood culture (diagnostic blood test that can help identify the type of microorganism causing an infection, which can help determine the best treatment), lipase level (to check for pancreatic disease or other conditions), lactic acid (A lactic acid test can help diagnose lactic acidosis, a serious condition that can be life-threatening), respiratory panel (to check for bacteria and virus in respiratory tract) and received medications that includes Morphine (strong pain medication), Diphenhydramine (treat pain and itching), Ondansetron (prevent nausea & vomiting), and Ceftriaxone (antibiotics). The review of “ ED provider notes “ dated 8/14/24 indicated, “ Medical Decision Making ...[Pt 6] initially was hypotensive although that resolved after she received IV fluid ...Patient has since been normotensive here. Her labs do show some mild demargination on her white count without any underlying finding of infection. She was also hemoconcentrated with an elevated hemoglobin and hematocrit. I do feel that her IV fluid that has been given to her has improved her status. She says that she now no longer has any symptoms and would like to go home. Her abdomen is soft, nontender nonacute and she is feeling well at this time. Her chest x-ray and the rest of her labs also are normal. Patient will follow-up with her doctor and return with any persistent or worsening symptoms. It is unclear what the etiology is of her initial symptoms. It is possible that she became dehydrated or that she has a viral syndrome that required hydration ...Patient was also complaining of hemoptysis initially and I was concern for underlying pneumonia (lung infection) or pulmonary embolism (blood clot in the lung). A CT angio (CT scan with a special dye to create pictures of blood vessels and tissues) of the chest was negative, and the patient had resolution of her symptoms here in the ER ...Disposition Discharge to Home ... “ The EMR indicated the patient was discharged on 8/14/24 at 8:02 p.m. The DED stated although Pt 6 received timely MSE and care on this visit, the acuity was still not assigned correctly. The DED stated it was important to assign correct acuity as it helps the provider to determine which patient to see next, and the frequency of nursing assessment, vitals, and patient placement also depends on the acuity. The DED stated that the assignment of correct acuity in triage has been identified as a gap since the last survey and his team had been working on reeducation of staff. The DED stated although Pt 6 has a history of elopement, it was not acceptable to place a patient in a lobby with active chest pain and have them wait two hours, which potentially led to elopement. The DED stated Pt 6 returned with hypotension and a pain score of 10. The DED agreed Pt 6 elopement on the first visit had the potential for adverse outcomes with hypotension and severe pain. The DED stated that the charge nurse should have been notified, and the provider should have been made aware of the patient ’ s concerns before elopement and immediately after elopement. The DED stated he was not able to find any documentation where Pt 6 ’ s concerns were escalated before or after the elopement. During an interview on 11/1/24 at 2:31 p.m. with the ED Medical Director (EDMD), the EDMD emphasized the importance of assigning the correct triage acuity to patients. The EDMD explained that ED providers rely on the assigned acuity, along with other clinical information, to prioritize which patients to see next. The acuity level also helps determine the frequency of patient assessments, and an incorrect ESI scoring could lead to delays in care. The EDMD also stated that staff are generally effective at escalating any concerns to providers. Additionally, the EDMD stated that the hospital has an established policy on patient elopement and that he expected the ED staff to follow these hospital policies. During an interview on 11/4/24 at 10:56 a.m. with the ED Manager (EDM 1), EDM 1 stated that she was informed about Pt 6 ’ s case and confirmed that the assigned acuity was inaccurate; it should have been an acuity level of 2 instead of 3. EDM 1 stated that her team has been reeducating staff on the importance of accurate acuity assignment, as it helps prioritize and expedite patient care in the ED. She emphasized that accurate acuity is essential to ensure patients receive appropriate assessments and timely interventions. EDM 1 stated she could not comment on why the charge nurse or provider was not informed when the patient became upset in the lobby and began to leave the ED. EDM 1 stated security had been re-educated on the need to notify the charge nurse if they encounter a distressed patient in the ED lobby. During a review of the facility ’ s policy and procedure (P&P) titled, “ EMTALA - Patient LWBS, Elopement, AMA, LABS “ , with an effective date 6/6/2019, the P&P indicated “ ...POLICY SUMMARY/INTENT: To ensure all departments of the Hospital that provide Emergency Services and Care take appropriate steps to follow up on patients who leave the Hospital prior to receiving the Medical Screening Examination (MSE) and/or completing the necessary Stabilizing treatment ... Left Without Being Seen (LWBS) - Before MSE: The patient leaves before receiving the initial Medical Screening Examination ... All patients leaving the Emergency Department (and/or add all Dedicated Emergency Departments) before completion of the Medical Screening Examination will be offered the Medical Screening Examination and encouraged to remain in the Department to receive Emergency Services and Care ...Patient Does Not Notify Staff Before Leaving ...Patient in the Waiting Room. If a patient is not in the Dedicated Emergency Department waiting room ...when called for service, Hospital staff will call the patient two (2) additional times to escort the patient to the treatment area ...Each time a patient is called, the time of the call will be noted on the patient record indicating “ patient name called, no response. “ The note will be documented by the staff signature or initial with the corresponding time. Other efforts to locate the patient who is not in the waiting area should be noted in the patient ’ s chart ...Patient in a Treatment Room. If the patient leaves after being placed in a treatment room, a search for the patient will be conducted within the immediate area of the Department ...Efforts to locate the patient will be recorded on the patient record. The note will be documented by the staff signature or initial with the corresponding time ...If the patient is or may be a danger to self or others, local law enforcement will be notified if a psychiatric evaluation and hold may be necessary During a review of the facility ’ s policy and procedure (P&P) titled, “ STANDARDS OF CARE, EMERGENCY DEPARTMETN “ , with a revision date of 6/27/2024, the P&P indicated, “ ...Vital sign assessment to be completed at triage, with any change in the patient ’ s condition, in response to a treatment, and at discharge along with the minimum routine frequency based on acuity ... ESI Level 2: Every hour for the first 4 hours, then every 2 hours if clinically stable. ESI Level 3: Patient with normal vitals should be reassessed no less frequently than every 4 hours. Patients with abnormal vital signs should be reassessed no less frequently than every 2 hours for the first 4 hours, then every 4 hours if clinically stable ... Patient care is prioritized based on the Emergency Severity Index ... The RN evaluates the effectiveness of care through assessment and observation of the patient ’ s physical condition and behavior, signs and symptoms of illness, and response to treatment and care. The RN ’ s findings are communicated to the ED provider and documented ... “ 4. During a review of Patient (Pt) 19 ’ s “ Ambulance Report “ dated 10/7/24 at 2:59 p.m., the “ Ambulance Report “ indicated, “ ...Incident address [restaurant name] ... Response: 911 Response ...upon initial EMS contact patient found walking to ambulance from nearby restaurant. Patient presents as the middle-aged female who reports she has had worsening and progressive pain within both her legs. Patient reports pain as sharp and pulsating in nature. Patient reports no history with liver or heart disease. Patient report this has been persistent for 3 days. Patient denies any medical history. Patient denies any recent trauma ... “ During a review of Pt 19 ’ s “ ED Triage and Initial assessment “ document dated 10/7/24 at 3:27 p.m. indicated, “ ...Reason for Visit: Brought in by ambulance [BIBA] from [restaurant name] parking lot for bilateral leg pain and swelling that has been getting progressively worse over last 3 days. Pt is currently homeless, denies any shortness of breath [SOB], is still able to ambulate. Pt denies any Past Medical History [PMH] ...Emergency Severity Index (ESI- a 5-level scale used by triage nurses to indicate the seriousness of the patient’s condition and the resources needed, ESI 1 being the most serious)] 3 ...Triage ...Peripheral Pulse Rate 79 [beats per minute - bpm (normal 60-100)], Respiratory rate 16 [breaths per minute (normal 12-20)], BP 109/73 millimeters of mercury [mmHg - Unit of measurement, normal less than 120/80] ...Pain intensity level: 8 ... “ During a concurrent interview and record review with the Director of Special Projects (DSP) and Regulatory Specialist (RS 2) on 10/29/24 at 3:45 p.m., Pt 19 ’ s EMR was reviewed for the ED visits of 10/7/24 & 10/8/24. The EMR indicated the patient had three visits between 10/7/24 to 10/8/24. The EMR indicated Pt 19 was brought into ED via ambulance on 10/7/24 at 3:25 p.m. with the chief complaint of bilateral leg swelling that has been getting progressively worse, and homeless was also listed as the chief complaint. The review of the document titled “ ED Physician Notes “ dated 10/7/24 at 4:06 p.m. indicated MSE was started at 3:25 p.m. and “ ...Patient seen in hallway ...vitals reassuring ...will get labs, pain meds and [antibiotics] ...Re-evaluation 4:00 p.m. ED RN reports that the patient has left the lobby. 4:56 p.m. Multiple attempts to reach patient. Not successful. Patient has left during the treatment ...Medical Decision Making ... [Pt 19] has eloped from emergency department lobby. Labs, Imaging, and antibiotics were not able to administered ... “ . The DSP stated that the last known contact with the patient was at 3:25 p.m. The EMR indicated Pt 19 returned to ED on 10/7/24 at 8:00 p.m. The review of a document titled “ ED Physician Notes “ dated 10/7/24 at 9:37 p.m. indicated “ ...MD ...Time Patient Seen face to face ...10/7/2024 9:06 p.m. ... Chief complaint Walked to triage for bilateral leg and feet swelling and pain for the past 3 days ...Walk in ...Physical Exam ...2+ bilateral lower extremity pitting edema past the knee ...bilateral feet with open blister wounds to the medial aspects of the feet ...ED course ...Ultra sound [U/S- Imaging test that uses sound waves to make pictures of organs, tissues, and other structures inside your body] lower extremity-Acute deep Venous thrombosis left lower extremity ...Medical Decision Making ... Patient is a 53-year-old female with history of Deep vein thrombosis [DVT - a serious condition that occurs when a blood clot forms in a deep vein, usually in the leg or pelvis] presenting due to bilateral lower extremity edema and discomfort worsening over the past 3 days. She does note that she traveled here from Washington about 2 weeks ago ...She does have 2+ bilateral lower extremity pitting edema ...She also does have 2 open blister wounds to the medial aspects of the feet ...Patient will be discharged home with [Apixaban- medication to prevent blood clot] starter pack for DVT. She should follow-up with her PCP for re-evaluation. Additionally, will discharge with prescription for Keflex or concerns of soft tissue infection given her bilateral foot wounds. The skin appears irritated surrounding the wounds, and given that they are open wounds at this time concerned that they may be predisposing patient to more severe infection. Patient requesting fluconazole for yeast infection as she is being discharged with antibiotics, stating that she generally develops yeast infection with antibiotic use. Diagnosis...Bilateral lower extremity edema ...Left leg DVT ...Soft tissue infection ...Disposition Discharge to Home ...Prescribed Medication ... [Apixaban] Starter pack ... cephalexin [antibiotic] ...Follow up with primary care provider ...within 1-2 days ... “ . The DSP stated she was unable to find any social worker consult in the patient EMR for this visit. The DSP stated unable to find any resources were offered prior to discharge. The EMR indicated Pt 19 was discharged on 10/8/24 at 1:46 a.m. and was prescribed Apixaban and Cephalexin. The DSP stated that she was unable to locate any documentation indicating that resources were offered to Pt 19 or that any attempt was made to assess Pt 19 ’ s ability to access the prescribed medications. She noted that the discharge instructions recommended follow-up with a primary care provider (PCP) within one to two days; however, no PCP was listed, and the ED provider ’ s note indicated that Pt 19 had moved to the area less than two weeks prior. The DSP further highlighted that Pt 19 was documented as homeless, having initially been brought in from a restaurant parking lot, eloped, and returned approximately four and a half hours later seeking treatment. Pt 19 was listed as homeless during registration and should have been evaluated for appropriate resources. The DSP stated that she would defer to ED leadership regarding processes for homeless discharges but expressed concern that Pt 19 ’ s chief complaint during the initial visit was homelessness. The DSP was unable to find any documentation in the EMR reflecting efforts to ensure Pt 19 could access critical medications or receive resources for outpatient management. During a concurrent interview and record review with the Director of Special Projects (DSP) and Regulatory Specialist (RS 2) on 10/29/24 at 3:55 p.m., Pt 19 ’ s EMR was reviewed for the ED visits of date 10/8/24. The review of “ Ambulance Report “ dated 10/8/24 at 3: 12 p.m. indicated “ ...Address: Homeless ...911 Response ...Found 53 Year [old] Female. Patient had a chief complaint (s) of Shortness of breath ...Pt states that she was just discharged from [Hospital Name]. Pt states that she has blood clots in her legs ... and that she could not pick up her meds. Pt requesting to go back to [Hospital Name] for further evaluation ... “ . The review of the document titled “ ED Physician Notes “ dated 10/8/24 at 3:45 p.m. indicated “ ...Chief Compliant Shortness of breath ... Medical Decision Making ...This is an irritated appearing 53-year-old female with a reported past medical history from EMS of blood clots that were diagnosed today, although I do see on her record a diagnosis of an acute DVT diagnosed yesterday on the left side who states that she has been unable to fill her prescription ...On exam the patient appears somewhat frustrated, however, once she and I start talking she warms up a bit. She is not in any acute distress, she is resting comfortably on the EMS gurney. She states that she needs to be “looked at thoroughly”. I discussed with the patient that while her vital signs appear to be reassuring today, she does have the risk factors for the development of a thromboembolic event [the formation of a blood clot in a vein or artery] specifically to the lungs. Therefore, given her new symptoms and acute onset in nature, we will evaluate a CT scan (medical imaging procedure that uses X-rays to create detailed cross-sectional pictures of the inside of the body) of the chest as this would be the safest plan ...Chronic Medical Conditions Impacting Care: DVT Consideration of Hospitalization/Escalation or De-escalation of Care: Pending at time of sign out ... “ The review of the document titled “ ED Physician note “ dated 10/8/24 at 10:31 p.m. indicated “ ... Plan of care ... patient is taken over at shift change pending CT results ... Medical Decision Making ...Patient CT scan returns with no major abnormalities ...patient continues to saturate well on room air ....no large pulmonary embolisms are noted. Patient is stable for discharge, return precautions have been given ...Disposition discharge home ... “ The ED Physician note dated 10/9/24 at 3:27 a.m. indicated “ ...No pulmonary embolism on CT scan but when going to discharge patient ...patient states that she cannot afford any medications and does not feel that she can care for self at home or shelter ... Medical Decision Making Patient has required no further medical management on my part during my shift. They will be handed off at shift change pending case management evaluation ... “ The Document titled “ Case management “ dated 10/9/24 at 11:00 a.m. indicated “ ... [Social worker (SW)] completed introduction, stated role and reasons for encounter. Patient presents alert and oriented and was appropriately responsive ...Patient was reluctant to verify information and stated she was ready to be discharged. Patient noted, personal/home demographics identified on the face sheet are correct ...Patient stated she is “relocating” as she moved to CA from WA three weeks ago and is still trying to get situated. Patient stated she has her spouse ... and her father who will be coming to the area for her ...Patient does not have a PCP or preferred clinic as she is “relocating” ...Patient denies any current alcohol or other drug use. She stated she smokes cigarettes and vapes, declined to specify frequency and declined resources. SW inquired regarding access to medications. Patient stated she is unemployed and does not have any income of her own. She stated she was unaware she still needed blood thinners as she had been told otherwise, but stated regardless her insurance does not cover it. SW advised [Case Manager will f/u with patient regarding medications. SW offered homeless resources and patient declined ...SW administered depression screening with patient at bedside and patient scored negatively ...Living Situation ...Homeless ... reports she located from WA 3 weeks ago ...Anticipated discharge disposition: Homeless ...Homeless Discharge ... Residence : Refused ... Patient Provided Medication for Discharge: Other: Pending ...Discharge planning notes ....[company name] pharmacy on Campus, they will deliver patient ’ s cephalexin and apixaban prescription to the Emergency Department tomorrow ... Anticipated discharge disposition: Homeless ... “ . The Review of the document titled “ ED Depart “ dated 10/9/24 at 11:30 p.m. indicated Pt was discharged at 12:02 a.m., 10/10/24. During an interview with the ED Medical Director (EDMD) on 11/1/24 at 2:21 p.m., the EDMD provided insight into the care of Pt 19. The EDMD confirmed his awareness of the case and recalled personally managing Pt 19 during her third visit to the ED. He stated that the patient was evaluated and discharged with an appropriate care plan on the second visit but could not explain why a homeless discharge screening was not conducted. The EDMD acknowledged that discharge instructions recommending follow-up with a primary care provider (PCP) are ineffective when no PCP is identified, or no additional resources are provided to the homeless patient. The EDMD stated upon Pt 19 ’ s return to the ED, her symptoms, including shortness of breath, had escalated in severity, prompting a comprehensive workup. The EDMD identified medication accessibility as a critical issue and noted that the patient remained in the ED until case management secured her medications for discharge on the third visit. The EDMD stated the hospital maintains established policies and procedures for discharging homeless patients, expressing his expectation that these protocols be adhered to in all cases. During an interview on 11/4/24 at 9:24 a.m. with the Manager of Social Services (MSS), the MSS stated she had been working at the hospital for nine years. The MSS stated her team gets referrals from the ED for various patient needs, including homelessness, child abuse, and complex discharges. Currently, a social worker is assigned to the ED on weekdays until 11:00 p.m. and on weekends until 4:30 p.m. The MSS explained that the team has a structured process in place for homeless patient discharges, wherein ED staff contact the on-duty social worker if available. Staff are trained to address essential needs such as clothing, meals, and transportation. Additionally, a homeless discharge packet is provided, containing information about services for showers, meals, and other necessities. Nurses assist with discharges in the absence of a social worker and are knowledgeable about available resources. On-duty social workers meet with patients to assess their needs, offer shelter options, and provide a list of local resources. While social workers do not manage medication or placement, they refer patients requiring these services to Case Management. Case Management then assists with medication and placement needs. If a homeless patient requires medication or further care, the social worker ensures a referral is made to Case Management. The MSS emphasized the collaborative efforts of the team to ensure patients receive appropriate resources and support tailored to their specific situation. The MSS stated that the homeless Pt with DVT requiring outpatient support should have been evaluated by a social worker and case management prior to discharge. During an interview on 11/4/24 at 9:52 a.m. with the Manager of Case Management (MCM), the MCM stated she had reviewed the medical record for case management involvement. The MCM noted that case management was not involved during Pt 19 ’ s second visit and if they had, efforts would have been made to secure the patient ’ s medications before discharge, which might have prevented the subsequent return to the ED due to medication inaccessibility. The MCM stated Pt 19 required resources and should not have been discharged if staff were aware of the patient ’ s homelessness. The MCM stated that it is expected for the ED case manager to be notified in such situations and explained that case management typically coordinates with local pharmacies to secure medications for patients who cannot access them. Medications are generally delivered to bedside nurses, often the charge nurse, who documents the receipt, but in this case (the third ED visit), there was no documentation in the EMR indicating that the prescribed medications (Apixaban and Cephalexin) were delivered, who received them, or that Pt 19 was provided with instructions before discharge even on the third visit. The MCM stated while the discharge summary indicated medications were given, no supporting documentation was found. The MCM stated the hospital ’ s processes require improvement to ensure that homeless patients receive medications prior to discharge. During an interview on 11/4/24 at 10:30 a.m. with the Director of Emergency Department (DED), the DED stated that he had reviewed) the EMR for Pt 19 ’ s ED visits on 10/7/24 and 10/8/24. The DED validated that, during the second visit, there was no documentation indicating that resources were offered to the patient despite Pt 19 being homeless, presenting with active deep vein thrombosis (DVT), and requiring antibiotics and anticoagulation therapy. He expressed an inability to explain why a social work consult or a list of resources was not provided in accordance with facility policy and emphasized that addressing these needs could have prevented the patient ’ s subsequent return to the ED. The DED stated that it was unacceptable to discharge homeless patients with instructions to follow up with a primary care provider (PCP) when no PCP was on file. He further noted that Pt 19, who lacked resources, had an open foot wound, and was diagnosed with active DVT, should not have been discharged back to the streets without involvement from social work and case management in the middle of the night. The patient was discharged at 1:46 a.m. during the second visit, with no outpatient resources arranged, a practice the DED deemed unacceptable. The DED stated he had identified a potential contributing factor of the unavailability of social workers during nighttime hours. He acknowledged this as a significant gap in care and stated that the ED plans to collaborate with hospital leadership to develop solutions to support the ED team in the absence of social workers during night shifts. During an interview on 11/4/24 at 10:56 a.m. with the ED Manager (EDM 1), EDM 1 stated that it is the responsibility of the nurse discharging the patient to confirm that appropriate follow-up resources are in place. This includes instructing patients without a primary care provider to return to the ED for further assistance. Additionally, EDM 1 highlighted the importance of alerting social workers, who may facilitate care continuity evaluations to help connect patients with a primary care physician in case they do not have access to one. The EDM stated in cases where EMS provides reports that indicate barriers such as homelessness or abuse, EDM 1 stressed the necessity of ensuring that these issues are communicated from the triage nurse to any nurse receiving the report. The discharge nurse is also required to review essential resources, including food, clothing, and shelter, with homeless patients prior to discharge. The EDM 1 stated regarding the specific case of Pt 19, if documentation is absent to confirm that these resources were offered, and if the patient lacked the necessary resources to access a doctor or obtain medication, it would be deemed an unsafe discharge. Furthermore, EDM 1 expressed a preference that a care continuity evaluation be completed prior to discharge in cases such as the second visit for Pt 19, during which the social worker would have coordinated outpatient follow-up and resource and referrals. During a review of the facility ’ s P&P titled, “ STANDARDS OF CARE EMERGENCY DEPARTMENT, “ with a review date of 6/27/24, the P&P indicated “ ...Assessments/Reassessments ...All patients will be triaged by a registered nurse (RN) ... All patients will be screened for Assault/Abuse Screenings, Screening for Suicidal/Homicidal ideations, Fall Risk, Advanced Directive, and Homelessness ... Discharge ...The ED physician will determine if the patient meets discharge criteria, needs to be transferred to another facility or higher level of care, or requires hospital admission. For patients who are discharged, all patients will receive after care instructions in the form of discharge instructions upon completion of their treatment. Medication instructions and educational handouts are provided as appropriate. Patients identified as homeless will be offered resources ... “ During a review of the facility ’ s P&P titled, “ Unhoused Patient Discharge Planning “ , with a review date of 6/27/24, the P&P indicated “ ...It is the policy of Adventist Health to manage the care of its unhoused patients with the same dignity and respect that all patients should expect to receive, both as an inpatient and while in the Emergency Department ... The hospital will develop an individual discharge plan for an unhoused patient that helps prepare the unhoused patient for return to the community by connecting the patient with available community resources, treatment, shelter, and other supportive services. The discharge planning shall be guided by the best interests of the unhoused patient, their physical and mental condition, and the unhoused patient ’ s preferences for the placement. The unhoused patient shall be informed of available placement options ... Documentation ...The hospital shall document all of the following prior to discharging a unhoused patient ...The provider has determined the unhoused patient ’ s clinical stability for discharge, including, but not limited to, an assessment as to whether the patient is alert and oriented to person, place, and time, and the provider or designee has communicated post discharge medical needs to the unhoused patient ...The unhoused patient has been offered a meal, unless medically indicated otherwise ....If the unhoused patient ’ s clothing was inadequate, the hospital has offered the unhoused patient weather-appropriate clothing ...The unhoused patient has been referred to a source of follow up care, if medically necessary ...The unhoused patient has been provided with a prescription, if needed, and, for a hospital with an onsite pharmacy licensed and staffed to dispense outpatient medication, an appropriate supply of all necessary medication, if available ... “”

“RECIPIENT HOSPITAL RESPONSIBILITIES CFR(s): 489.24(f) A participating hospital that has specialized capabilities or facilities (including, but not limited to, facilities such as burn units, shock-trauma units, neonatal intensive care units, or (with respect to rural areas) regional referral centers, which, for purposes of this subpart, means hospitals meeting the requirements of referral centers found at §412.96 of this chapter) may not refuse to accept from a referring hospital within the boundaries of the United States an appropriate transfer of an individual who requires such specialized capabilities or facilities if the receiving hospital has the capacity to treat the individual. This requirement applies to any participating hospital with specialized capabilities, regardless of whether the hospital has a dedicated emergency department. This Standard is not met as evidenced by: 37529 Based on interview and record review, Hospital A failed to meet its Recipient Hospital Responsibilities for 6 of 7 requested patient transfers (Patients A, B, C, D, E, and F) when: 1. Hospital D contacted Hospital A on 7/3/24 requesting to transfer Patient A who had a diagnosis of ascites (the abnormal build-up of fluid in the abdomen), and needed a higher level of care. Hospital A declined to accept Pt A due to physician refusal and otherwise had the capacity and capability to accept the transfer. 2. Hospital B contacted Hospital A on 7/20/24 requesting to transfer Pt B who had a diagnosis of sepsis and needed a higher level of care. Hospital A declined to accept Pt B due to physician refusal and otherwise had the capacity and capability to accept the transfer. 3. Hospital B contacted Hospital A on 7/20/24 requesting to transfer Pt C who had a diagnosis of kidney stone and needed a higher level of care. Hospital A declined to accept Pt C due to physician refusal and otherwise had the capacity and capability to accept the transfer. 4. Hospital E contacted Hospital A on 7/30/24 requesting to transfer Pt D who had a diagnosis of kidney stone and needed a higher level of care. Hospital A declined to accept Pt D due to physician refusal and otherwise had the capacity and capability to accept the transfer. 5. Hospital E contacted Hospital A on 8/14/24 requesting to transfer Pt E who needed urologist and a higher level of care. Hospital A declined to accept Pt E due to physician refusal and otherwise had the capacity and capability to accept the transfer. 6. Hospital B contacted Hospital A on 8/16/24 requesting to transfer Pt F who had a gastrointestinal bleed (GIB) and needed a higher level of care. Hospital A declined to accept Pt F due to physician refusal and otherwise had the capacity and capability to accept the transfer. These failures had the potential to result in a delay in care and could have led to injury or harm to Pts A, B, C, D, E, and F. Findings: During a review of the inbound transfer request log dated 6/18/24 through 10/22/24, the log indicated: 1. On 7/3/24 at 1:34 a.m., Hospital D (a rural hospital without specialists) contacted Hospital A to request to transfer Pt A, a 52 year-old with a diagnosis of ascites who needed a gastroenterologist ’ s care. The log indicated the case transfer reason was a higher level of care (HLOC) and the patient type was “ emergency. “ The transfer was declined due to physician refusal. The log did not have any information regarding why the physician refused, or whether the decision to refuse was escalated to anyone. 2. On 7/20/24 at 5:54 p.m., Hospital B contacted Hospital A to request to transfer Pt B, a 70 year-old with a diagnosis of sepsis (a life-threatening complication of an infection) who needed a urology specialist. The log indicated the case transfer reason was a higher level of care (HLOC) and the patient type was “ emergency. “ The transfer was declined due to physician refusal. The log did not have any information regarding why the physician refused, or whether the decision to refuse was escalated to anyone. 3. On 7/20/24 at 3:19 p.m., Hospital B contacted Hospital A to request to transfer Pt C, a 42 year-old with a kidney stone, who needed a urology specialist. The log indicated the case transfer reason was a higher level of care (HLOC) and the patient type was “ emergency. “ The transfer was declined due to physician refusal. The log did not have any information regarding why the physician refused, or whether the decision to refuse was escalated to anyone. 4. On 7/30/24 at 11:42 a.m., Hospital E contacted Hospital A to request to transfer Pt D, a 55 year-old with a diagnosis of “ Other “ who needed a urology specialist. The log indicated the case transfer reason was a higher level of care (HLOC) and the patient type was “ emergency. “ The transfer was declined due to “ Outpatient Follow-up. “ The log did not have any information regarding the reason the transfer was declined, or whether the decision to refuse was escalated to anyone. 5. On 8/14/24 at 10:45 p.m., Hospital E contacted Hospital A to request to transfer Pt E, a 53 year-old with a diagnosis of “ Other “ who needed a urology specialist. The log indicated the case transfer reason was a higher level of care (HLOC) and the patient type was “ emergency. “ The transfer was declined due to “ capacity-specialist. “ The log did not have any information explaining the reason the transfer was declined, or whether the decision to refuse was escalated to anyone. 6. On 8/17/24 at 10:33 a.m., Hospital B contacted Hospital A to request to transfer Pt F, a 79 year-old with a diagnosis of GIB who needed a GI specialist. The log indicated the case transfer reason was a higher level of care (HLOC) and the patient type was “ emergency. “ The transfer was declined due to “ capacity-specialist. “ The log did not have any information explaining the reason the transfer was declined, or whether the decision to refuse was escalated to anyone. During an interview on 11/4/24 at 2:20 p.m. with the transfer center manager (TCM), information regarding the six transfer requests was reviewed. The TCM stated the transfer center had been handling transfer requests for Hospital A since April. The TCM stated she does not have much information regarding the individual transfers other than what is on the log already. For Pt A, the TCM stated the reason for the physician refusal was the gastroenterologist indicated he was “ at capacity for the day. “ The TCM stated there is no indication Hospital A was at capacity, and there is no additional information regarding this transfer request, and she does not know if this refusal was escalated to anyone at Hospital A, or what was meant by at capacity for the day at 1:30 a.m., or if there was any effort to accommodate the transfer at a later time. The TCM stated for Patient B, the physician refused the patient and indicated the labs were within normal limits, there was no obstruction, and the current facility can treat a complicated urinary tract infection. The TCM stated there is no information regarding the patient ’ s diagnosis other than sepsis, or what labs were within normal limits. The TCM stated she does not have any information about whether this refusal was escalated to be reviewed by anyone else at Hospital A. The TCM stated for Pt C, the physician refused the patient and indicated interventional radiology (IR) should place a nephrostomy tube and the patient can follow up as an outpatient. The TCM stated she does not know whether this refusal was escalated at Hospital A or whether the sending hospital (Hospital B) had the capability or staff available for IR. The TCM stated for Pt D, there is no further information on the patient ’ s diagnosis in addition to “ other. “ The physician refused the transfer and indicated the patient did not have a fever and labs were normal. The physician indicated interventional radiology should put a nephrostomy tube and the patient can follow up as an outpatient. The TCM did not know whether this refusal was escalated at Hospital A, or whether the sending hospital (Hospital E) had the service of IR, or the availability of an interventional radiologist. The TCM stated for Pt E, there is no further information regarding Pt E ’ s diagnosis of “ other. “ The reason the transfer was declined was physician refusal and the urologist indicated he was “ at capacity for the day. “ The TCM stated there is no indication Hospital A was at capacity, there is no additional information regarding this transfer request, and she does not know if this refusal was escalated to anyone at Hospital A, or what is meant by capacity for the day at 10:45 p.m., or if there was any effort to accommodate the transfer at a later time. The TCM stated for Pt F, the reason the transfer was declined was physician refusal and the gastroenterologist indicated he was “ at capacity for the day. “ The TCM stated there is no indication Hospital A was at capacity, there is no additional information regarding this transfer request, and she does not know if this refusal was escalated to anyone at Hospital A, or what is meant by capacity for the day at 10:33 a.m., or if there was any effort to accommodate the transfer at a later time. The TCM stated the physicians don ’ t submit the information in writing, it is in their head. The decisions might have been escalated to someone, but she does not have a good record of that. If the physician declines then they will look at another hospital. The TCM stated this is a new process and they are figuring out how to document. During a review of the hospital ’ s policy and procedure (P&P) titled, “ EMTALA-Acceptance of Emergency Transfers, “ dated 8/23, the P&P indicated, “ ...If the transfer center determines that the request is an appropriate transfer, the transfer center will assess the capability and capacity of the hospital ...If the hospital has the capacity to accept the patient, the transfer center will contact the appropriate on-call specialist or emergency department physician to determine acceptance of the patient ...Reporting of Denial of Transfer Request. If the receiving physician declines a transfer, he/she will immediately report the denial of the transfer to the house nursing supervisor on duty. If a physician and/or house nursing supervisor refuses a transfer, he/she will submit a written report to the Transfer Center within 24 hours. The written report will include the name of the patient condition and need for care, the reason given for the transfer and the reason that the physician or house nursing supervisor declined the transfer ... “”

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 27000 Based on interviews and record review, the hospital failed to establish a Controlled Substance Diversion Prevention Program (CSDPP) committee or task force and its charter (a structured organization which includes goals, scope of service, membership, commitment, etc.) to oversee, provide leadership and directions, and develop policies and procedures for the CSDPP as in accordance with the current professional standards of practice. The failure resulted in the hospital not having an effective CSDPP to readily identify and minimize controlled drug (medications that can be easily abused and are under strict government control)diversion. CS diversion can lead to serious patient safety issues including impaired healthcare worker performance, medication errors, and inadequate pain relief for patients. Findings: A review of the “ASHP [American Society of Health System Pharmacists, a national organization advocating and supporting the professional practice of pharmacists in hospitals, health systems, and other settings spanning the full spectrum of medication use] Guidelines on Preventing Diversion of Controlled Substances,” dated July 28, 2022, indicated: “Controlled substances (CS) diversion in health systems can lead to serious patient safety issues, harm to the diverter, and significant liability risk to the organization. Diversion puts patients at risk of harm, directly or indirectly, including inadequate relief of pain, inaccurate documentation of their care in the medical record, exposure to infectious diseases from contaminated needles and drugs, and impaired healthcare worker (HCW) performance.” On 6/28/24, the California Department of Public Health received an Entity Reported Incident where a Certified Registered Nurse Anesthetist (CRNA, a licensed advanced practice nurse who administers anesthesia and related care to patients before, during, and after surgery) was brought into the Emergency Department after being in a car accident. While at the scene, the police found one 2-milliLiter (mL, unit of measurement) vial of hydrocodone (a potent narcotic for pain) injection 2 milligrams/mL, two 2-mL vials of midazolam (a controlled medication for induction of anesthesia) injection 1 mg/mL, and one 1-mL vial of diphenhydramine (a sedative to produce sleep) injection 50 mg/mL in her possession. During the survey entrance conference on 8/19/24 at 1:20 p.m., the hospital was requested to provide the CSDPP committee charter and its policy and procedures. In an interview on 8/20/24 at 4:30 p.m., the Director of Pharmacy (DOP) stated the hospital had processes in place for accountability and monitoring of CS use throughout the hospital but did not have a CSDPP committee or charter. During a follow-up interview and record review on 8/21/24 at 9:20 a.m., the DOP provided the document named “Controlled Substance Diversion Prevention Program Committee Charter,” dated 7/29/24 (3 weeks before the survey date). He stated the charter is “still in draft” and “has not been approved yet because we are still getting feedback from individuals involved.” He also stated, “We have the process but this [referring to the CSDPP committee charter] will provide more structure.” On 8/21/24 at 10:10 a.m., in an interview and record review with the Pharmacy Operations Manager (POM) and the Manager of Risk Management (MRM), the POM stated the hospital investigation discovered the CRNA in question removed three 2-mL vials of midazolam 1 mg/mL (6 mg total) for Patient 45’s surgery but only charted 4 mg in the anesthesia (surgery) record as being given on 6/24/24 (two days before the car accident). The POM stated he discovered this discrepancy on 6/27/24 and filed the incidence report the same day. The MRM showed the photos of the medications found by the police on the day of the accident. The POM stated the found medications’ lot numbers (unique identifier assigned to a batch of products during manufacturing to track and trace them throughout the supply chain) matched the ones the pharmacy carried. During a group interview with multiple hospital administration staff members on 8/22/24 at 2:06 p.m., the Chief Medical Office (CMO) confirmed the CSDPP Committee had not been put in place yet and stated, “We haven’t been taking this as seriously as it should be. The plan is to activate it right away. This will provide more structured process.” A review of the above-mentioned ASHP Guidelines on Preventing Diversion of Controlled Substances indicated: “It is imperative that organizations establish a CSDPP that discourages diversion and strengthens accountability, rapidly identifies suspected diversion and responds to known or suspected diversion incidents, and continually seeks to improve controls. Strong organization oversight with broad HCW [healthcare worker] participation and a clear accountability structure provides a framework for a capable program... “The pharmacy executive, whose central role is responsibility for the organization’s medication use system, will be an essential resource for a successful CSDPP. Key elements for organization oversight and accountability include... The organization establishes an interdisciplinary CSDPP committee to provide leadership and direction for developing policies and procedures and for overseeing the CSDPP. The CSDPP committee is proactive in its prevention efforts and addresses prevention control, diversion detection, incident investigation, reporting procedures, and quality improvement activities... “The CSDPP committee... Establishes a charter that includes membership composition, roles and responsibilities, reporting structure, and meeting frequency... Is proactive in its prevention efforts and actively addresses prevention control, diversion detection, incident investigation, and reporting procedures... “The functions of the CSDPP committee are integrated with existing compliance management programs, and the committee reports at least quarterly directly to the senior leadership of the organization.””

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 27000 Based on interview and record review, the hospital failed to reconcile a control drug (medication that can be easily abused and are under strict government control) discrepancy promptly as in accordance with the hospital policy and procedures for one of 6 patients (Pt 44). The failure had the potential to result in hospital staff diverting controlled drugs, which could place patients at risk for potential adverse outcomes including inadequate pain relief and impaired healthcare worker performance. Findings: During the survey, the controlled substance discrepancy for 6 patients was selected for review. On 8/21/24 at 9:32 a.m., a review of Pt 44’s clinical record with the Director of Pharmacy (DOP), the Pharmacy Operations Manager (POM), and the Pharmacy Automation Specialist (PAS) indicated Pt 44 was admitted to the hospital for hip fracture and choledocholithiasis (common bile duct stone). On 2/29/24, she underwent a surgical procedure called ERCP (endoscopic retrograde cholangiopancreatography, a procedure that uses an endoscope and X-rays to examine the liver, gallbladder, bile ducts, and pancreas). A review of the automated dispensing cabinet (ADC, where medications are stored and electronically tracked) activity report indicated, on the day of the surgery, the CRNA (a licensed advanced practice nurse who administers anesthesia and related care to patients before, during, and after surgery) removed one 2-mL vial of midazolam (a controlled medication to induce anesthesia, or the temporary loss of consciousness/awareness, during a procedure) 1 milligram per milliliter (mg/mL) at 2:06 p.m., and another vial at 3:39 p.m. (4 mg total). However, a review of the anesthesia record indicated the CRNA only documented she administered 2 mg during the procedure, resulting a discrepancy of 2 mg. During the interview and review above, on 8/21/24 at 9:42 a.m., the POM and the PAS stated the pharmacy staff audits all anesthesia records a day or two after the procedures were complete to reconcile controlled medication use versus the ADC activities. Any discrepancy would be sent to the Medical Director of Anesthesia (MDA) for forwarding to the anesthesia provider for response, and the pharmacy would send again if there is no response within 7 days. Further review of Pt 44’s clinical record indicated the CRNA corrected the anesthesia record by manually crossing out “2 mg” and replacing it with “4 mg” in the entry of midazolam use, on 3/25/24 at 3:33 p.m. (25 days after the discrepancy was made). Both the POM and PAS acknowledged the discrepancy report was not reconciled and responded to timely. During a group interview with the hospital administration staff members including the MDA on 8/21/24 at 2:03 p.m., the MDA stated he would work on the discrepancy reports sent by the pharmacy as soon as they are given to him but some anesthesia providers are not on regular schedule so he had to wait for when they come back for their next case. When advised that the CRNA worked the following week (first week of March) after the discrepancy was made, the MDA confirmed and stated a 25-day response for the controlled drug discrepancy report was too long. A review of the surgery schedule, provided by Director of Accreditation (DA), indicated the CRNA was on the schedule every day, Monday through Friday, during the month of March 2024. A review of the hospital’s policy and procedures titled “THE MANAGEMENT OF CONTROLLED SUBSTANCES,” revision date 3/14/24, indicated, “Diversion monitoring reports will be sent to the Nursing Manager (or Designee) for investigation and follow up. The Nurse Manager will review and investigate and report all findings to the Director of Pharmacy or designee within 7 days (if no findings report as none).””

“PHARMACIST SUPERVISION OF SERVICES CFR(s): 482.25(b)(1) §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. This Standard is not met as evidenced by: 27000 Based on observation, interview, and record review, the hospital failed to correctly store and label Lorazepam (a controlled medication to treat anxiety and seizures) Injection Carpujects (syringe device for the administration of injectable fluid medication) as in accordance with the manufacturer’s specifications. They were labeled with a 90-day expiration date while the manufacturer indicated they were good for up to 30 days when stored at room temperature (temp). The failure had the potential for the medication to be used past the date it would be effective for patient use. Findings: During a visit to the pharmacy on 8/19/24 at 2:15 p.m., the Pharmacy Operations Manager (POM) stated lorazepam injection products are stored in the medication refrigerator until they are dispensed to the nursing units; the products would be short-dated (given a shorter expiration date than that on the product) when stored at room temp. A visit to the Emergency Department’s (ED) Green Zone Medication Room was conducted with the POM, the Director of Pharmacy (DOP), and the Manager of Intensive Care Unit (MICU) on 8/20/24 at 9:02 a.m. Four 1-milliliter (mL) Lorazepam Injection Carpujects 2 milligrams per mL (mg/mL), made by Manufacturer A, were observed stored at room temp in the automatic dispensing cabinet (ADC, where medications are stored and electronically tracked). Each had yellow expiration date sticker on its body; three indicated they expire on 11/11/24, and one had 11/13/24 expiration date (86 days from survey date). The POM stated the pharmacy short-date lorazepam injection products based on the manufacturer; most products are good (stable) for 30 days, but those made by Manufacturer A, would be good for 90 days at room temp. He was asked to provide Manufacturer A’s supporting literature for this storage. On 8/20/24 at 9:20 a.m., during the visit to the ED’s Red Zone Medication Room with the POM, the DOP, and the MICU, 11 Lorazepam Injection Carpujects 2 mg/mL, by Manufacturer A, were observed in the ADC. They all had expiration date of various dates in November 2024. On 8/20/24 at 10:15 a.m., a visit was made to the 2North Medical/Surgical Unit with the DOP, the MICU, and the Pharmacy Automation Specialist (PAS). Five Manufacturer A’s Lorazepam Injection Carpujects 2 mg/mL were observed stored at room temp in the ADC. Each had an expiration label of various dates in November 2024. On 8/20/24 at 10:35 a.m., a visit was made to the 3North Medical/Surgical Unit with the DOP, the MICU, and the PAS, inspection of the ADC showed it had two lorazepam 2 mg/mL vials with 30-day expiration dating, and three Manufacturer A’s Lorazepam Injection Carpujects 2 mg/mL with 90-day expiration dating, expiring in November 2024. During a concurrent interview and record review on 8/20/24 at 12:55 p.m., the DOP provided a letter, dated 12/2/2011, from Manufacturer A’s representative indicating that stability testing showed its lorazepam injection product could be stored for up to 3 months at room temperature. However, this information was 13 years old. The DOP was asked to provide more current information on room temp stability of lorazepam injection by Manufacturer A. During a follow-up interview and record review with the DOP and the POM on 8/22/24 at 10:20 a.m., the DOP stated a clinical pharmacist reached out to Manufacturer A and was given the information that all its Lorazepam Injection Carpujects are good (or stable) up to 30 days at room temp. The DOP provided the “Medical Information,” last updated 5/16/24, from a drug company that owns Manufacturer A. Its review with the DOP indicated to store the lorazepam injection products under refrigeration, and internal study by the company showed its Lorazepam Injection Carpujects 2 mg/mL with the specified NDC (National Drug Code, a unique identifier for each drug), could be stored for “a period of 1 month” at room temp. The DOP confirmed the NDC addressed on this medical information matched the products the pharmacy carried. Both the DOP and POM confirmed they had been assigning the wrong expiration date for Manufacturer A’s Lorazepam Injection Carpujects 2 mg/mL, which had the potential for them to be given past the period for which they are stable. A review of the hospital’s policy and procedures titled “MEDICATION MANAGEMENT (STORAGE OF MEDICATIONS),” revised 6/27/24, indicated medications requiring refrigeration will be stored in a refrigerator, and those requiring storage at room temp will be maintained at room temp. However, the policy did not address the short-dating of refrigerated products when stored at room temp.”

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 27000 Based on observation, interview, and record review, the hospital failed to ensure an expired medication was removed from active stock to avoid it being given to the patients; and intravenous fluid bags were kept in the protective outerwrap until used to maintain the fluid concentration as labeled. Findings: A visit to the Emergency Department’s (ED) Green Zone Medication Room was conducted with the Pharmacy Operations Manager (POM), the Director of Pharmacy (DOP), and the Manager of Intensive Care Unit (MICU) on 8/20/24 at 9:16 a.m. Random inspection of the medications in the automatic dispensing cabinet (ADC, where medications are stored and electronically tracked) identified one of two ketamine (an anesthetic used for induction and maintenance of anesthesia, temporary loss of sensation or awareness) 50 milligrams/5 milliliter syringes with the expiration date of 8/7/24. The POM verified that one syringe had expired and should not be kept in the ADC. On 8/20/24 at 9:53 a.m., during a visit to the ICU’s medication room with the DOP, the MICU, and the Pharmacy Automation Specialist (PAS), a 1-liter bag of 5% dextrose and 0.9% sodium chloride (hydration solution) injection solution was identified on a shelf without the outerwrap and without the date it was opened. The DOP stated it should be stored in the outerwrap until used to maintain its concentration. On 8/20/24 at 10:15 a.m., a visit to the 2North Medical/Surgical Unit’s medication room with the DOP, the MICU, and the PAS identified a 1-liter bag potassium chloride 20 milliEquivalent (unit of measurement) in 5% dextrose and 0.45% sodium chloride solution (for fluid and electrolyte replenishment) was identified on the shelf without the outerwrap and the date it was opened. The staff present verified this finding. A review of the hospital’s policy and procedure titled “MEDICATION MANAGEMENT (STORAGE OF MEDICATIONS),” revised 6/27/24, indicated in part: “5. Medications will not be removed from their containers and/or protective wrapping until it is time to dispense and/or administer the medications... Expired...medications shall be stored separate from other medications...””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 40644 Based on observation, interview, and record review, the hospital failed to maintain a clean environment to avoid sources of transmission of infection when: 1. Three of three microwave ovens in patient pantries were visibly dirty in 2 South, 2 North, and the Emergency Department. 2. Dusty supplies were found in one of two clean utility rooms on 2 South. 3. A bin in a patient medication refrigerator had brown/black substance on the inner bottom of bin, underneath the medication and stains on the bottom shelf. These failures had the potential to allow for the spread of infectious organisms to patients and staff. Findings: 1. During an observation and interview on 8/19/24 at 3:39 p.m. on 2 North medical unit with the Manager of the Intensive Care Unit (MICU) and the Manager of Risk Management (MRM), the microwave oven in the patient pantry had discolorations that appeared to be dried on food spatters on the interior sides and top. The MICU stated, “It needs to be cleaned. It’s gross.” The MICU stated the dried on food on the top could drop on the food that was being warmed for another patient and contaminate the food. During an observation and interview on 8/19/24 at 4:26 p.m. on 2 South with MICU, MRM, and Director of Infection Prevention (DIP), the microwave in the patient pantry had discolorations that appeared to be dried on food splatters inside the microwave on sides and on top. The MICU stated it appeared to be food in the corners and on the sides of the microwave. The DIP stated a dirty microwave can be a source of contamination and could allow for the spread of infection. During an observation and interview on 8/20/24 at 10:40 a.m. in the Emergency Department with the Manager of the Emergency Department (MED) and the DIP, the microwave oven in the patient pantry had discolorations that appeared to be dried on food spatters on the interior sides and top. The MED stated it needed to be cleaned. The MED stated there was potential for bacteria buildup and that it was an infection control issue. The DIP stated the microwave was dirty and needed to be cleaned. The DIP stated housekeeping was responsible to clean the microwave. 2. During an observation and interview on 8/19/24 at 4:26 p.m. on 2 South with MICU, MRM, and DIP, the Clean Utility Room (a room for clean supplies and equipment) had a wire shelving unit, approximately 6 feet tall and 2 feet deep. The shelving unit held medical supplies. The MICU removed an item from the top shelf and identified it as a “wound vac dressing pack” (a package that contains sterile supplies for a piece of equipment used for treating patient wounds.) The wound vac dressing pack had a layer of dust on it that filled the air in the room with dust when lightly brushed with MICU’s hand. The MICU stated staff clean the room every day, but “obviously they aren’t cleaning on top of the racks.” The MICU stated the clean utility room is expected to be clean, and dust could be a source for the spread of infection. 3. During an observation and interview on 8/20/24 at 10:15 a.m. on 2 North Medical/Surgical Unit with the Director of Pharmacy (DOP), the Manager of Intensive Care Unit (MICU), and the Pharmacy Automation Specialist (PAS) a medication refrigerator inside the medication room was observed. Inspection of the medication refrigerator identified six 2-milliliter vials of famotidine (to treat or prevent ulcers of the stomach and intestines) 20 milligrams per 2 milliliter injection solution inside a medication bin. The entire inner bottom of the bin was observed with black and brown stains. When shown to the PAS, she stated, “Not good!” The bottom shelf of the medication refrigerator was also observed with yellow and brown dusty stains. The pharmacy staff present acknowledged medications should be stored in clean and sanitary condition to avoid contamination. A review of the hospital’s policy and procedure titled “MEDICATION MANAGEMENT (STORAGE OF MEDICATIONS),” revised 6/27/24, indicated in part: “Medications are stored in such a manner as to prevent...contamination, mold growth, or spoilage.” During a review of hospital policy titled, “Sanitary Environment in Healthcare Facilities” revised 6/20/23, the policy indicated, “ ...COMPLIANCE - KEY ELEMENTS ... B. Written cleaning methods and schedules for routine cleaning will be maintained by Environmental Services ... 2. This will include regular disinfection of all restrooms, counter tops, elevators, surfaces in patient rooms and nursing stations, and on-patient care areas.” In a research article from Frontiers in Microbiology dated 8/7/24 titled, “The Microwave Bacteriome: Biodiversity of Domestic and Laboratory Microwave Ovens” retrieved from https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2024.1395751/full, the article indicated, “Thirty microwave ovens (10 from domestic use, 10 of domestic shared-use, and 10 of laboratory use) were sampled and used to culture microbial strains on Columbia agar, TSA, YM, R2A, and NA. This yielded a collection of 101 isolates dominated by strains belonging to the genera Bacillus, Micrococcus, and Staphylococcus, followed by Brachybacterium, Paracoccus, and Priestia. Members of the genera Acinetobacter, Bhargavaea, Brevibacterium, Brevundimonas, Dermacoccus, Klebsiella, Pantoea, Pseudoxanthomonas, and Rhizobium were found only in domestic microwaves.””

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 37529 Based on interview and record review, the hospital failed to provide medical examination and treatment to stabilize the emergency medical condition (EMC) for 2 of 18 patients, Patient (Pt) 5, and Pt 6, when: 1. Pt 5 came to the ED by ambulance on 3/24/24 with a chief complaint of allergic reaction to shrimp. Pt 5 was given epinephrine IM and oral Benadryl by family at home and given another dose of Benadryl in the ambulance due to wheezing. In ED Pt 5 was initially given steroids, an H2 blocker (antihistamine), and intravenous (IV) fluids and then 45 minutes after arrival Pt 5 began wheezing again and required another dose of epinephrine IM, and an inhaled dose of epinephrine (racemic). Pt 5 was discharged two and one-half hours after arrival and was not evaluated to determine the need for additional medical support. The physician did not consider the risk of rebound anaphylaxis prior to discharge. This failure resulted in Pt 5 experiencing chest pain and shortness of breath at home, becoming unresponsive the next day, returning to the hospital and being admitted. 2. Pt 6 came to the ED on 4/17/24 at 9:45 p.m. with complaints of severe pain and a non-functional nephrostomy tube (a tube inserted through the skin into the kidney to allow urine to drain) following replacement earlier that day. The patient reported a pain level of 9/10, was triaged as an ESI 2 and sent to the lobby to wait. The MSE was initiated and a difference in the appearance of the hub (connector) on the nephrostomy tubes between the right and the left was noted by the Nurse Practitioner (NP) during the exam. Labs and a CT scan were ordered at 10:45 p.m. and the physician saw the patient on 4/18/24 at 12:03 a.m., over two hours from the time first arrived in the ED. Pt 6 remained in the lobby for over five and a half hours, did not have vital signs reassessed, and was not provided fluids or pain medication. By 3:16 a.m. the CT scan still had not been done and Pt 6 could not wait any longer and left. These failures resulted in not stabilizing and treating extreme pain level, in delay in diagnosing a retained stylet in the nephrostomy tube from the procedure on 4/17/24, an unnecessary hospitalization on 4/18/24, and a delay in removal of the stylet two days later on 4/19/24. Findings: 1. During a record review the hospital’s report of returns to ED within 48 hours (of a previous ED visit) was reviewed. The report indicated Pt 5 was a 25 year-old woman who came to the ED by ambulance on 3/24/24 at 9:57 p.m. with a chief complaint of allergic reaction and had returned to the ED by ambulance on 3/25/24 at 7:10 p.m. with a chief complaint of altered mental status. During a record review on 5/14/24 at 10:20 a.m. with the ED manager (EDM), Pt 5’s medical record dated 3/24/24 at 9:57 p.m. was reviewed. Review of the triage nurses notes dated 3/24/24 at 10:06 p.m. indicated, “Reason for Visit: Hx [history] of shrimp allergy. Ate shrimp today, family gave epi [epinephrine- medication given to treat severe allergic reactions] pen at home and gave oral Benadryl [an antihistamine medication given for allergy symptoms] for rash, Emergency Medical Services [EMS- service that responds to emergencies and provides pre-hospital medical care] gave 50 mg of Benadryl intramuscularly [IM]. Hx of depression, anxiety, Attention Deficit Hyperactive Disorder [ADHD], Post traumatic Stress Disorder [PTSD, seizure disorder.” Vital signs were temperature 98.5 degrees Fahrenheit (F), pulse 113 beats per minute (bpm- normal 60-100), respirations 18 respirations per minute (rpm), blood pressure 165/97 millimeters of mercury (mmHg). Assigned an ESI of 2. Review of the ED Physician Note indicated the MSE was started at 10:07 p.m. The note indicated, “History of Present Illness: Apparently she is allergic to shrimp and ate something she did not know had shrimp in it. She started having facial swelling, and redness and shortness of breath...family members gave her some oral Benadryl and her Epi pen but did not feel like it was improving. EMS arrived and she was fairly tachypneic and wheezing throughout all lung fields. She was given a shot of IM Benadryl as well by EMS...They state that she steadily improved on the way here. She is now fairly somnolent [sleepy] with all of the Benadryl she received. Entirety of history obtained from EMS as patient is too somnolent to answer questions...” Review of the medication administration record (MAR) indicated at 10:15 p.m. an intravenous (IV-into a vein) fluid bolus was started, and Pt 5 received a dose of IV steroids and IV Pepcid (a kind of antihistamine [H2 blocker]). At 10:31 p.m. Pt 5 received a dose of epinephrine IM, and at 10:38 p.m., Pt 5 received a dose of racemic epinephrine (inhaled). At 11:47 p.m. Pt 5 received Toradol 15 mg IV for headache and Zofran 4 mg IV for nausea. Review of the record indicated at 11 p.m. a chest x-ray was completed and indicated low lung volumes, pulmonary vascular crowding vs congestion. Review of the ED Physician’s Note indicated, “...Medical Decision Making- ED Course: Patient is pretty significantly somnolent now with the amount of Benadryl she received. Have added on some Solumedrol [a steroid] and Pepcid. She already received epinephrine. She is really having minimal wheezing now. Will give her some fluids as well but we will just monitor her for a while... She started wheezing again, required another dose of epinephrine and gave her some racemic epi. She is doing much better after this. She is asking for something for headache and nausea. I [have] given her some Toradol and Zofran. I [have] written her for some prednisone for home. Pt stable for discharge, return precautions have been given...” The ED Physician’s note was signed on 3/24/24 at 11:26 p.m. by MD 3. The record indicated a discharge order was placed at 11:20 p.m. Vital signs prior to discharge were temp 98.5 F Pulse 89 bpm, respirations 18, BP 145/100 mmHg. Pt 5 was discharged on 3/25/24 at 12:15 a.m. Diagnosis: Anaphylaxis (An acute, life-threatening systemic allergic reaction). During a record review on 5/14/24 at 10:35 a.m. with the EDM, Pt 5’s medical record dated 3/25/24 was reviewed. The medical record indicated Pt 5 was brought to the ED by ambulance on 3/25/24 at 7:10 p.m. Review of the Patient Care Record (PCR- Emergency Medical services [EMS] record of prehospital care) dated 3/25/24 indicated at 6:42 p.m., “Family advised pt had an anaphylaxis event yesterday...Pt has been complaining of chest pain with sob [shortness of breath] since waking up thismorning. Family advised at 6:30 p.m. Pt became unresponsive, so family administered two doses of epi pens [epinephrine] with no improvements. Upon EMS contact pt had audible wheezes bilaterally with no visible airway swelling...Pt had equal pupils at 3 mm...” The PCR indicated at 6:43 p.m. Pt 5’s Glasgow Coma Scale (GCS- describe the extent of impaired consciousness) score was 8 (unresponsive, range is 3-15, 15 being completely alert and oriented) and at 6:52 p.m. the GCS score was 7. Pt 5 was given a dose of Benadryl IM and a dose of epinephrine IM at 6:44 p.m. Vital signs at 6:52 p.m. were pulse 120 bpm, respirations 19, BP 154/88 mmHg, oxygen saturation 99% on oxygen 15 liters via non-rebreather mask. The PCR indicated the ambulance arrived at the ED at 7:07 p.m. Review of the triage nurses notes indicated Pt 5 was triaged at 7:28 p.m. and assigned an ESI of 1 (Immediate). Reason for visit: “Altered level of consciousness with possible allergic reaction. Per EMS patient was here yesterday of allergic reaction to shrimp,” Triage vital signs were temperature 99.4 F, pulse 123 bpm, resp 16, BP 193/114 mmHg, and oxygen saturation 100% on 15L oxygen non-rebreather mask. Review of the respiratory therapist’s note dated 3/25/24 at 7:40 p.m., indicated, “...Assisted with intubation...pt switched to vent...” Review of the ED Physician’s note dated 3/25/24 at 7:49 p.m. indicated, “...biba [brought in by ambulance] from home for decreased consciousness and anaphylaxis...She received two doses of epi IM, 3 prednisone and 1 dose of diphenhydramine [Benadryl] IV, as well as 1 dose Narcan IM...the decision was made to intubate after patient became apneic...History was collected from patient’s mother. Last night she [Pt 5] ingested 3 shrimp and had an allergic reaction. Her mother administered an epi pen and the patient was brought to the ED. She was discharged last night. Upon returning home today she was complaining of chest pressure...Last seizure was last night...” The record indicated Pt 5 was admitted to ICU. During an interview on 5/14/24 at 12:57 p.m. with the ED medical director (EDMD), the EDMD stated there is a risk of rebound anaphylaxis after epinephrine is given and patients should be observed for at least two and a half to 3 hours after receiving epinephrine. The EDMD stated Pt 5 may have benefited from a longer period of observation. During a review of the reference American Family Physician Volume 102, Number 6 September 15, 2020 article titled “Anaphylaxis: Recognition and Management,” the article indicated, “...Patients should be monitored for a biphasic reaction (i.e., recurrence of anaphylaxis without reexposure to the allergen) for four to 12 hours, depending on risk factors for severe anaphylaxis A minimum observation period of four hours supports current guidelines, with longer observation periods recommended based on individualized factors such as previous biphasic reaction, severity of initial presentation, treatment with multiple doses of epinephrine, a previously protracted anaphylactic reaction, unknown anaphylactic trigger, or presence of risk factors for severe or fatal anaphylaxis...” During a review of the reference article titled “Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis,” in The Journal of Allergy and Clinical Immunology volume 145, issue 4 April 2020, the article indicated, “... After diagnosis and treatment of anaphylaxis, all patients should be kept under observation until symptoms have fully resolved. We suggest that a clinician incorporate severity of anaphylaxis presentation and/or the administration of >1 dose of epinephrine for the treatment of initial anaphylaxis as a guide to determining a patient’s risk for developing biphasic anaphylaxis. We suggest extended clinical observation in a setting capable of managing anaphylaxis (to detect a biphasic reaction) for patients with resolved severe anaphylaxis and/or those who need >1 dose of epinephrine...” During a review of the Allergy and Asthma Network reference “Anaphylaxis,” retrieved from https://allergyasthmanetwork.org/anaphylaxis/ , the reference indicated, “...Symptoms normally peak within a half-hour of exposure, but they can last for several hours. About 20% of the time, you can get your symptoms under control with treatment, but they may come back. This is what is known as a biphasic reaction - a second reaction. This is why it is important to seek emergency care after using epinephrine...” During a review of the Food Allergy Research and Education [FARE] Field Guide, the guide indicated,”...Transport person to the emergency room (ER), even if symptoms resolve. The person should remain in the ER for at least 4 hours because symptoms may return...” 2. During a review of the ED log dated 4/17/24, the log indicated Pt 6 came to the ED on 4/17/24 at 9:45 p.m. with a chief complaint of left sided abdominal pain and left against medical advice (AMA) at 3:18 a.m. on 4/18/24. Review of the ED log dated 4/18/24 indicated Pt 6 came back to the ED on 4/18/24 at 12:50 p.m. with a chief complaint of catheter issues. and was admitted to the hospital. During an interview on 5/14/24 with the interventional radiology manager (IRM), the IRM stated Pt 6 underwent bilateral nephrostomy tube replacement in the afternoon of 4/17/24. The IRM stated it was discovered later that the stylet was not removed from one of the nephrostomy tubes (the left) after placement. The IRM stated initially when Pt 6 came back to the hospital the cause of the problem was not known so Pt 6 was scheduled to undergo another procedure on 4/19/24. However, when they were preparing for the procedure the tech noticed the stylet and it was removed correcting the problem. The IRM stated when the stylet is left in, there is a yellow hub (connector) that is visible. The IRM stated verifying the stylet has been removed from the nephrostomy tube after placement is a shared responsibility between the physician placing the nephrostomy tube and the staff in IR taking care of the patient. During a review of Pt 6’s medical record dated 4/17/24, the record indicated Pt 6 was a 61 year old patient with a history of ovarian cancer, currently undergoing treatment. The triage record indicated Pt 6 came to the ED by car on 4/17/24 at 9:45 p.m. and was triaged at 9:54 p.m. The triage RN’s note indicated, “Patient had nephrostomy tubes bilateral since Dec 2023. Today [in the] morning she had them changed. Patient coming now stating that the left nephrostomy tube is not draining, and she has severe pain.” Pt 6’s vital signs were taken and indicated, temperature 99.1 degrees Fahrenheit (F), pulse 113 beats per minute (bpm- normal 60-100)), respirations 16 per minute, blood pressure 130/71 millimeters of mercury (mmHg), oxygen saturation 96% on room air. Pt 6 reported acute left flank (area on side of back below rib cage) pain, pain level of 9/10 (severe pain; 0 is no pain, 10 is the worst pain), was assigned an ESI of 2 (very urgent) and was sent to the lobby to wait. Review of the record indicated Pt 6’s medical screening examination (MSE) was started by the nurse practitioner (NP 1) on 4/17/24 at 10:38 p.m. Review of NP# ‘s “ED RME Note” dated 4/17/24, indicated, “...Pt states that she got both nephrostomy bags replaced today here at Interventional Radiology [IR] but mentions that the left nephrostomy bag is not working at all since it was placed...Pt stated that nephrostomy bag was first placed back in December of 2023...Pt states she is on chemotherapy and will start a new one on Monday 4/22/2024...Physical Exam: Gastrointestinal- Left nephrostomy bag not working and yellow connector on the left nephrostomy bag is present but not on the right one...” The record indicated lab tests and a CT scan were ordered and Pt 6 remained in the lobby. Review of Pt 6’s record indicated labs were drawn at 11:54 p.m., were resulted on 4/18/24 at 12:20 a.m. and indicated wbc 20.8 (normal range 4.5-11), neutrophil percent 87.3 (high), absolute neutrophil 18.1 (high), BUN/creatinine ratio 27 (10-20). Review of Pt 6’s record indicated MD 3 saw Pt 6 on 4/18/24 at 12:02 a.m. Review of the ED Physician Notes dated 4/18/24 at 12:03 a.m. indicated, “...HISTORY OF PRESENT ILLNESS: 61 year old with ovarian cancer. Underwent PCNT [percutaneous nephrostomy tube] exchange with IR this afternoon here at [name of hospital]. Pt states there has been no output from the left nephrostomy tube since then and she is having pain at the site, that is not relieved with Norco. Last took one Norco at 6/6:30 p.m... PHYSICAL EXAM: Mild distress, ill-appearing...Abdomen: Distended, firm abdomen, bilateral percutaneous nephrostomy tubes with 100 ml [milliliters- unit of measure] serosanguinous fluid in right, no output in left, left flank tender to palpation with voluntary guarding...” Medical Decision Making: “...CT abdomen was ordered to rule out possible tube dislodgement...Patient’s lab work returns with leukocytosis [high wbc] and neutrophil predominance. May just be postsurgical but do think she will require a CT scan. She is pending CT at this time. Urinalysis looks fairly benign...” The record indicated Pt 6 continued to wait in the lobby. Review of Pt 6’s record indicated Pt 6 remained in the lobby since triage at 9:54 p.m. on 4/17/24. There were no further nurses notes after triage until 3:18 a.m. on 4/18/24, no vital signs, no pain reassessment and no pain medication given. On 4/18/24 at 3:18 a.m. the triage nurse’s notes indicated “Patient decided to leave and does not want to wait further, stated she will come back in the morning...got MD who explained the risk of leaving, pt signed AMA and left...” Review of the ED Physician Notes dated 4/18/24 starting at 12:03 a.m. indicated, “was called back to triage as patient is wanting to leave. I did discuss at length with her and understand her frustration at the long wait times but did let her know that I think she still needs to get the CT scan...I discussed with her that I cannot guarantee her safety without her staying...her plan is to come back in the morning when IR is present so maybe she can be seen faster...She would like to leave against medical advice...” Review of the form titled “leaving against medical advice dated 4/18/24 was signed by Pt 6 at 3:16 a.m. and at 3:23 a.m. by MD # who indicated, “Discussed Risk of Morbidity and Mortality.” Review of Pt 6’s medical record dated 4/18/24 indicated Pt 6 returned to the ED at 12:50 p.m. and was triaged at 1:12 p.m. The triage nurses note indicated, “Pt states she was here yesterday to have her nephrostomy tubes replaced, and pt states that her left one has not functioned since it was replaced. Pt states she has ovarian cancer and is getting treatment for the cancer...” Vital signs obtained, pain level assessed as 5/10 (moderate) left flank pain. Assigned an ESI of 3. Review of the ED physician assistant note dated 4/18/24 at 1:49 p.m., indicated Pt 6’s left nephrostomy collection bag was empty. There was no mention of the appearance of the nephrostomy sites. An ultrasound was performed and indicated the tube was positioned appropriately within the kidney. The IR physician was contacted, and indicated he would replace the left nephrostomy tube the next day (4/19/24). Pt was admitted by the hospitalist on 4/18/24 at 4:33 p.m. Review of the IR report dated 4/19/24 indicated Pt 6 was in IR on the procedure table at 10:13 a.m. At 10:23 a.m. the report indicated, “Dr determined L nephro tube working properly, procedure cancelled.” On 4/23/24 (four days after the procedure) IR MD’s documented “...1 plastic insert was left in patient...The patient returned, and the stylet was removed. Malfunctioning catheter was then fully functional. No foreign body remains in this patient...” During a concurrent interview and record review on 5/15/24 at 2:50 p.m. with the Assistant Patient Care Executive (APCE- formerly the ED director) and the ED manager (EDM), the APCE stated patient’s with an ESI of 2 should not wait in the lobby. The EDM manager stated she was unable to find any vital signs had been taken after triage and does not have an explanation for why Pt 6’s severe pain was not addressed. The APCE stated this was a busy night in ED but that does not explain why this patient remained waiting in the lobby for over five and a half hours without having her vital signs checked or pain medication. The APCE stated they had adequate nursing staff on that night. The APCE indicated they have been having issues with getting CT scans read at night but that should not affect the scan being done. There is no indication in the record as to why the scan was not done by 3:15 a.m. on 4/18/24 when it had been ordered on 4/17/24 at 10:45 p.m. During a concurrent interview and record review on 5/15/24 at 3:10 p.m. with the APCE, the “ED RME Note” dated 4/17/24 at 10:38 p.m. was reviewed. The NP’s assessment regarding the nephrostomy tubes indicated, “ Left nephrostomy bag not working and yellow connector on the left nephrostomy bag is present but not on the right one...” The APCE stated this assessment indicated the yellow connector (stylet) was noted during that first ED visit on the day of the procedure (4/17/24). There was no indication in the record that the difference in the appearance of the left and right nephrostomy tubes was communicated to anyone or that the sites were assessed, or difference noticed by anyone else caring for Pt 6. Review of the Policy and Procedure (P&P) titled, “Standards of Care , Emergency Department,” dated 3/5/24, indicated, “...Vital sign assessment to be completed at triage, with any change in the patient’s condition, in response to a treatment, and at discharge along with the minimum routine frequency based on acuity: ESI Level 2: every hour for the first 4 hours, then every 2 hours if clinically stable... All patients will be triaged by a registered nurse. All patients will have an inital assessment and prioritized treatment per Emergency Severity Index Level 1-Immediate, Level 2 Very Urgent, Level 3- Urgent... Initial pain level will be assessed, and if the patient has pain, reassessment will be recorded a minimum of every 2 hours...Nurses will perform the skills required to meet the patient’s needs, including education and communication regarding treatments and care...” During a review of the professional reference titled,” Emergency Severity Index, A triage Tool for Emergency Department Care, Version 4,” dated 2020, the reference indicated, “...When the patient is categorized as ESI level 2, the triage nurse has determined that it would be unsafe for the patient to remain in the waiting room for any length of time. While ESI does not suggest specific time intervals, ESI level-2 patients remain a high priority, and generally, placement and treatment should be initiated rapidly. ESI level-2 patients are very ill and at high risk. The need for care is immediate and an appropriate bed needs to be found...””

“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: 39795 Based on interviews, policy review, and record review, the hospital failed to comply with the regulatory requirements for EMTALA when: 1. Patient (Pt) 1, a pediatric patient with special needs (physical, medical, developmental, or cognitive conditions that require special consideration), was brought to Hospital A’s emergency department (ED) on 11/30/23 at 1:09 a.m. with a chief complaint (a concise statement describing the symptom, problem, and/ or condition for seeking emergent care) of abdominal pain and possible constipation. Pt 1 was not appropriately screened and prioritized per emergency severity index (ESI- a tool used in the ED to prioritize patients based on the stability of vital signs, degree of distress, expected staff response, and time to disposition), nor provided a medical screening examination (MSE) 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 (EMC) existed. The Qualified Medical Person (QMP- a healthcare professional designated by the hospital’s governing body to perform an MSE) on 11/30/23 (Family Nurse Practitioner [FNP] 1) did not conduct a physical examination and failed to identify Pt 1’s emergency medical condition (EMC) according to laboratory results completed on 11/30/23 at 2:24 a.m. that indicated Pt 1 had a high white blood cell count (WBC- 24,000 K/mm3) and blood glucose level (BG- 275 mg/dl). Pt 1 was discharged home with family on 11/30/23 at 04:41a.m. The patient returned to the ED at 08:39 a.m. on 11/30/23 via emergency medical services in cardiac arrest. Several rounds of advanced cardiopulmonary life support were completed but were unsuccessful and Pt 1 was pronounced on 11/30/23 at 09:09 a.m. (Refer to 2406) Because of the serious actual harm (death) that occurred with the care of Patient 1 not receiving an appropriate and timely Medical Screening Exam (MSE) to determine an emergency medical condition (EMC) and the serious potential harm to all patients related to not receiving an appropriate and timely MSE, an Immediate Jeopardy (IJ- a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for CFR 489.24 - A2406 on 12/14/23 at 3:35 p.m. with the President Central California Network, Chief Medical Officer, Patient Care Executive, Interim Patient Care Executive, Director Regulatory Compliance, Executive Operations, Director of Quality and Risk, Incoming Patient Care Executive, System Director Accreditation and Licensing, and Emergency Department Director on 12/14/23 at 3:35 p.m. The hospital submitted an acceptable IJ Plan of Removal (Version 3) on 12/18/23. The IJ Plan of Removal included but was not limited to the following: 1) RNs appropriately triage, prioritize and establish an accurate ESI and to obtain vital signs upon admission, 2) RNs appropriately determine the next steps following an accurate ESI, 3) The QMP always conducts an appropriate MSE that includes a physical assessment, differential diagnoses and determine stabilizing measures when an EMC is identified, 4) Follow up on all critical and abnormal laboratory results 5) RNs and all ED staff appropriately address ED and EMTALA requirements for special need children. On 12/18/23 the components of the IJ Plan of Removal were validated onsite through observations, interviews, and record review. The IJ was removed on 12/18/23 at 4:37 p.m. with the facility Chief Medical Officer, Director of Quality and Risk, Director of Regulatory Compliance, and Regulatory Specialist. The cumulative effect of these systemic failures resulted in the inability of the hospital to provide care in a safe and quality manner in the Emergency Department and was not in compliance with the statutory requirement of EMTALA.”

“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: 39795 Based on observation, interview, and record review the hospital failed to provide an appropriate medical screening examination (MSE- an assessment performed by Qualified Medical Personnel [QMP] for the purpose of determining whether an emergency medical condition [EMC] exists) within the capability of the hospital’s emergency department (ED) for one of 23 patients (Patient 1) when: 1. Patient 1 was admitted to the Emergency Department (ED) on 11/30/23 at 1:09 a.m. for abdominal pain and possible constipation. No physical assessment was conducted and vital signs (blood pressure [BP], heart rate [HR], respirations [R], temperature [T], and oxygen saturation [O2sats]) were incomplete. The hospital did not appropriately assess, prioritize, and provide medical and/or emotional support to Pt 1, a pediatric patient with special needs (physical, medical, developmental, or cognitive conditions that require special consideration) and nurses permitted the family to take Pt 1 to the car to wait. The Qualified Medical Person (QMP- a healthcare professional designated by the hospital’s governing body to perform an MSE) on 11/30/23 (Family Nurse Practitioner [FNP] 1) failed to identify Pt 1’s emergency medical condition (EMC) according to laboratory results completed on 11/30/23 at 2:28 a.m. that indicated Pt 1 had a high white blood cell count (WBC- 24,000 K/mm3) and blood glucose level (BG- 275 mg/dl). The hospital had knowledge of grievances filed against FNP 1 and continued to permit FNP 1 to work in the ED triage area. Pt 1 was discharged home with family on 11/30/23 at 4:41a.m. The patient returned to the ED at 8:39 a.m. on 11/30/23 via emergency medical services in cardiac arrest (no heart function). Several rounds of advanced cardiopulmonary life support (ACLS) were completed but were unsuccessful and Pt 1 was pronounced dead on 11/30/23 at 9:09 a.m. Because of the serious actual harm (death) that occurred with the care of Patient 1 not receiving an appropriate and timely Medical Screening Exam (MSE) to determine an emergency medical condition (EMC) and the serious potential harm to all patients related to not receiving an appropriate and timely MSE, an Immediate Jeopardy (IJ- a situation in which the provider’s noncompliance with one or more conditions of participation has caused or is likely to cause serious injury, harm, impairment, or death to a patient) situation was called for CFR 489.24 - A2406 on 12/14/23 at 3:35 p.m. with the President Central California Network, Chief Medical Officer, Patient Care Executive, Interim Patient Care Executive, Director Regulatory Compliance, Executive Operations, Director of Quality and Risk, Incoming Patient Care Executive, System Director Accreditation and Licensing, and Emergency Department Director on 12/14/23 at 3:35 p.m. The hospital submitted an acceptable IJ Plan of Removal (Version 3) on 12/18/23. The IJ Plan of Removal included but was not limited to the following: 1) RNs appropriately triage, prioritize and establish an accurate ESI and to obtain vital signs upon admission, 2) RNs appropriately determine the next steps following an accurate ESI, 3) The QMP always conducts an appropriate MSE that includes a physical assessment, differential diagnoses and determine stabilizing measures when an EMC is identified, 4) Follow up on all critical and abnormal laboratory results 5) RNs and all ED staff appropriately address ED and EMTALA requirements for special need children. On 12/18/23 the components of the IJ Plan of Removal were validated onsite through observations, interviews, and record review. The IJ was removed on 12/18/23 at 4:37 p.m. with the facility Chief Medical Officer, Director of Quality and Risk, Director of Regulatory Compliance, and Regulatory Specialist. Findings: 1. During concurrent observation and interview, on 12/12/23, at 10 a.m. in Hospital A’s ED main lobby waiting room (WR), with the Emergency Department Director (EDD) and Medical Director Emergency Department (MED), an escorted tour of the ED was conducted. The WR had a large desk with two staff persons registering patients. The EDD stated the registration desk was staffed with a receptionist and a “quick look” nurse whose primary function was to monitor the WR and take vital signs of patients. The WR had three triage (the initial assessment of patients to determine the urgency of their need for treatment, and the treatment required) rooms. The EDD stated triage was monitored and operated by registered nurses (RN) and qualified medical providers (QMPs also referred to as Advanced Practice Providers [APP] e.g., physician assistant, family nurse practitioner, etc.). The EDD stated the process was for patients who “walked in” the ED to stop at the reception desk to provide the reason for ED visit (chief complaint), have vital signs checked by the “quick look” nurse, and wait in WR until triaged. During triage, patients were evaluated by a RN and QMP, and provided a history of their medical condition, allergies, and prescribed medications. The EDD stated the RN assigned an emergency severity index (ESI- a tool used to categorize patients from level one, the most critically ill, to level five, the least critically ill and resource intensive) score based on the patient’s presentation to help to prioritize care. The EDD stated patients with ESI score one, two, or three were directed to an ED room and those who scored four or five returned to WR. The EDD stated all ED patients’ vital signs were checked every two hours or more frequently based on the needs of patients and underlying medical conditions. The MED stated the MSE was performed concurrently during triage and completed after the QMP completed the initial face to face evaluation. During a review of Pt 1’s “Registration Record (RR- form that contains essential demographic, financial, and medical information)”, dated 11/30/23, the “RR” indicated Pt 1 was an eight-year-old male who arrived in the hospital emergency department on 11/30/23 at 1:09 a.m. Initial Diagnosis was constipation, abdominal pain. (First visit to ED on 11/30/23) During a review of Pt 1’s “Emergency Department Reports (EDR)” dated 11/30/23, the “EDR” indicated Pt 1 was triaged on 11/30/23 at 1:23 a.m. The FNP initiated the face-to-face medical screening exam (performed by a qualified medical professional to determine whether a patient has an emergency medical condition [EMC]) on 11/30/23 at 1:15 a.m. and “completed” at 1:19 a.m. the same day. An ultrasound (an imaging test that uses sound waves to make pictures of organs, tissues, and other structures inside your body) of the appendix (a small pouch attached to the large intestine) was performed on 11/30/23 at 2:38 a.m. and laboratory studies at 2:24 a.m. Pt 1 was discharged from the ED on 11/30/23 at 4:48 a.m. to “Home or Self Care.” During a review of Pt 1’s “ED Physician Notes *Final Report*,” dated 11/30/23 at 1:28 a.m., the “ED Physician Notes” indicated, “ ... Pt is a 8 yo male who was brought in by mom c/o [complained of] abd [abdominal] pain x [times] today Mom states he is having associated viral illness (diagnosed earlier by pmd [primary medical doctor] but was not having abdominal pain at that time) Mom states pt has hx [history] constipation and gave him benefiber, apple juice and stool softener Mom states they did not give him anything for pain PMH [past medical history] autism [a spectrum disorder with a broad range of conditions characterized by challenges with social skills, repetitive behaviors, speech and nonverbal communication]... Triage Vital Signs ... 01:22 [a.m.] T [temperature]: 97.8 F [Fahrenheit] HR [heart rate]: 82 RR [respiratory rate] 20 SPO2 [oxygen reading]: 96%... General ... autistic with verbal outbursts ... Cardiovascular [related to heart and blood]: Regular rate and rhythm, Normal peripheral perfusion Respiratory [movement of air through lungs]: Lungs are clear to auscultation [listening for sounds], respirations are non-labored ... Gastrointestinal [stomach and intestines]: Soft, nontender, Normal bowel sounds ... Lab Results Date 11/30/23 02:24 a.m. ... Neutrophil [part of the immune system (defends against infection) Absolute [total] 15.3 K/mm3 [thousand cells per cubic meter] (HIGH) ... Lymphocyte [part of the immune system] Absolute 6.0 K/mm3 (HIGH) ... Monocyte [part of immune system] Absolute 1.9 K/ mm3 (HIGH) ... WBC [white blood cell, protects against infection) 24.00 K/ mm3 (HIGH) ... RBC (red blood cell, component of blood that carries oxygen) 5.16 M / mm3 [millions per cubic millimeter] (HIGH) ... ... HGB [hemoglobin, oxygen carrying protein in RBC] 13.8 gm/ dl [grams per deciliter] (HIGH) ... HCT [hematocrit, percent of RBC in blood] 42.0% (HIGH) ... Glucose [sugar], Random 275 mg/ dl [milligrams per deciliter- unit of measure] (HIGH) ... 11/30/23 02:40 a.m ... UA [urinalysis, examination of urine] - Specific Gravity [chemical particles in the urine] 1.09 (HIGH) ... UA - Glucose >= 500 mg/ dl (ABNORMAL) ... UA - WBC 7/HPF [high power field] (HIGH) ... UA- Crystals CA oxalate [calcium] small (ABNORMAL) ... US [ultrasound- imaging test that uses sound waves to make pictures of structures within the body] Appendix [muscular structure attached to the large intestine] November 30, 2023 02:28 [a.m.] ... Impression: Nonvisualization of the appendix with no evidence of free fluid or rebound tenderness during scanning ... Medical Decision Making Problems addressed: Patient is 8 Years old Male with no significant medical history including hypertension, diabetes mellitus, recent antibiotic use, or immunodeficiency ... This patient did not have any chronic illnesses which impacted care ... Patient remained medically stable throughout their ED stay and review of the physical examination/ vital signs have demonstrated that there is no acute medical nor surgical emergency that requires admission or transfer to a higher level of care and that this patient is stable and appropriate for outpatient management ... No escalation of hospital level care at this point in time ... No discussions of [with] other providers took place ... No discussions or tests were done with any external or internal providers ... Notes: Diagnosis and treatment consistent with Nurse Practitioner standardized procedures ... Condition ... Stable ...” No discharge vital signs were documented. During a review of Pt 1’s second “RR”, dated 11/30/23, the “RR” indicated Pt 1 was brought back to the ED by emergency medical services (EMS- ambulance) on 11/30/23 at 8:38 a.m., 230 minutes after being discharged from the ED at 4:48 a.m. on 11/30/23. During review of Pt 1’s ambulance run sheet (medical record for ambulance services) document “Ambulance Report,” dated 11/30/23, the document indicated, “ ... AOS to home of 8/o [year old] male in cardiac arrest [sudden, unexpected loss of heart function, breathing, and consciousness]. Patient was found lying supine [horizontal with face up] with compressions [the act of applying pressure to someone’s chest to help blood flow through the heart in an emergency] being performed by fire on scene. Per family member on scene, pt was taken into the hospital last night for severe abdominal pain but was discharged with a virus. Pt now in cardiac arrest first rhythm reading PEA [pulseless electrical activity]. Pt placed on cardiac monitor and moved to backboard for stat [immediate] transport to hospital... During transport, pt is cold to touch now in asystole [no heartbeat], remains apneic [not breathing], no improvement. Unable to establish vascular [in a vein] access x 2/ Unable to establish IO [intraosseous- in a bone] access. ETA [estimated time of arrival] call in is made, continuous compressions/ ventilations [circulation of air] are done en route, no change in cardiac rhythm. Pt is GCS 3 [Glasgow coma scale- tool used to measure level of consciousness, score 3 = deep coma or death] remains in cardiac arrest as patient is moved over to hospital bed for continuity of care ... First CPR [cardiopulmonary resuscitation] 08:16:23 [a.m.] ...Primary Impression: Cardiac arrest- Non- traumatic ...08:26:32 [a.m.] BP [blood pressure] Exam Finding Not Present ... Pulse [HR] 0 ... Rhythm Absent ... Resp [respirations] Exam Finding Not Present ... Effort Apneic ... 08:26:42 [a.m.] Oxygen ... Bag valve mask (BVM) [handheld device to mechanically ventilate a patient not breathing] ... 1.5 Liters Per Minute (LPM [gas]) ... 08:32:45 [a.m.] ... No eye movement when assessed ... No Motor Response ... No verbal/ vocal response ... Transfer of Care: 11/30/23 08:37:45 [a.m.] ...” During a review of Pt 1’s “ED Triage and Initial Assessment”, dated 11/30/23, the “ED Triage and Initial Assessment” indicated, “ ... Reason for visit history: Code in progress on EMS arrival. Abd pain x 2 days per EMS. Possible down time of 8-10 minutes pre ems arrival, per family report/ ems report,. No family at bedside on EMS arrival. Dry dark brown vomitus like residue on face ... Triage ... Temperature (F): 94.3 DegF ... (<LLOW) ... Temp [temperature] site: Rectal ... Assess/ Monitor level of consciousness: Unresponsive ... Completely immobile ...” During a review of Pt 1’s “Clinical Note ED”, dated 11/30/23, the “Clinical Note ED” indicated, “ ... Pediatric pt BIBA [brought in by ambulance] from home CC [chief complaint] Cardiac Arrest. Per report family checked on pt and he had vomit on self and was unresponsive. 911 was called, Fire arrived first and initiated compressions approx 10 minutes s/p [status post] found down. Per EMS patient had “dark vomit” was “cold to touch” and showed PEA on the monitor, they did a “load and go” and the code was worked enroute, Fire had previously placed OPA [oropharyngeal tube- used to maintain airway open] and pt was being compressed and ventilated the whole trip .... Pt arrived in ED at 0838 [8:38 a.m.] ... Upon arrival patient was moved to our gurney, compressions immediately continued and pt was bagged. Pt placed on pads and asystole showed on the monitor. EMS IO [intraosseous] removed IO placed here by another RN to L [left] shin [front of leg between knee and foot], IV [intravenous- in a vein] established by this RN to L AC [antecubital- bend of elbow] (22 g [gauge- size]) @ 0842 [8:42 a.m.] and first round of EPI [epinephrine- medicine used to restore heart rhythm] given through this line, see code sheet. LR [Lactated Ringer’s solution- fluid used to treat dehydration and restore fluid balance in the body] was connected to IO and slowly dripped in, additional IV place to R [right] AC ... Fluids connected to this line and pressure bagged in ... no labs were obtained during the code. Cardiac activity was checked with each pulse by palpation, doppler, monitor and US throughout the code, and compressions were promptly resumed. TOD [time of death] called at 0909 [9:09 a.m.] after confirmation of no cardiac activity shown on US ... Coroner spoke to MD [medical doctor] on oficers [Officer’s] phone and asked for CT scans [computed tomography- diagnostic imaging procedure], scans ordered and patient taken to CT ...” During a review of Pt 1’s “Cardiac Respiratory Code (CRC) Record”, dated 11/30/23, the “CRC Record” indicated, “ ... Time initiated: 0838 [8:38 a.m.] Arrest Type: Cardiac [heart] ... AIRWAY/ VENTILATION ... Type: ETT [endotracheal tube- placed through the mouth to the windpipe to help assist breathing] ... Intubation: Time 0845 [8:45 a.m.] Size 5 ... BLOOD GLUCOSE LEVELS 0839 [8:39 a.m.] ... Value: 443 ...” Epinephrine 0.33 mg [milligrams- unit of measure] was administered to Pt 1 at 8:42 a.m., 8:44 a.m., 8:47 a.m., 8:50 a.m., 8:53 a.m., 8:56 a.m., 8:59 a.m., 9:02 a.m., 9:05 a.m., and 9:08 a.m. Sodium bicarbonate (medicine to counteract acid build up in the body) 33 mEq (milliequivalents- unit of measure) was administered to Pt 1 at 8:46 a.m., 8:51 a.m., and 8:57 a.m. and Calcium Chloride (medicine used during a code to increase heart contractions and electrical activity) 600 mg at 8:55 a.m. Advanced cardiac life support measures in the ED continued for 31 minutes, return of spontaneous circulation (ROSC- restart of a sustained heart rhythm after cardiac arrest) was not achieved. Pt 1 was pronounced dead at 9:09 a.m. During a concurrent interview and record review, on 12/13/23 at 9:30 a.m. with the Emergency Department Manager (EDM) and Emergency Room Director (EDD), Pt 1’s “Electronic Medical Record (EMR- electronic version of a patient’s medical history)” dated 11/30/23, the EDM validated the sequence of events during Pt 1’s visits to the ED on 11/30/23. Upon further review, the EDM stated Pt 1, a pediatric patient accompanied by his parents and with a history of autism, was admitted to the ED on 11/30/23 for abdominal pain and constipation and triaged by RN 1 at 1:22 a.m. The EDM stated there was no blood pressure or gastrointestinal assessment (relating to stomach and intestines) documented in Pt 1’s EMR and Pt 1’s home medication list was incomplete. The EDM stated the pain level documented for Pt 1 was 10/10 on the “Numeric Pain Scale” (a simple pain scale that grades pain levels from 0 [no pain], 1,2, and 3 [mild], 4,5, and 6 [moderate], 7,8, and 9 [severe] to 10 [worst pain possible]) to his abdomen for which Pt 1 was administered Motrin 250 mg once at 2:18 a.m. and no pain reassessment was documented. The EDM stated Pt 1 was assigned an ESI score 4, therefore directed to wait further workup in the WR. The EDM stated laboratory studies and ultrasound were ordered and reviewed by FNP 1. Notable were Pt 1’s elevated WBCs (24,000 K/ mm3) and blood glucose levels (275 mg/ dl) indicated in the laboratory results. The EDM stated Pt 1 was discharged home from the ED on 11/30/23 at 4:48 a.m. There was no documented evidence that Pt 1’s vital signs were documented throughout the ED visit nor were vital signs taken prior to Pt 1’s discharge. The EDM stated RN 1 did not follow hospital policy and procedure for abnormal laboratory values and patient follow up. The EDM stated the expectation was that patients evaluated in the ED had a complete set of vital signs (BP, HR, R, T, and oxygen saturation [O2sats]) 30 minutes prior to discharge. The EDM stated a point-of-care test (POCT- a portable device is used to test blood glucose at bedside) for blood glucose should have been done prior to Pt 1 leaving the ED to ensure Pt 1 was stable. The EDM stated Pt 1 did not have a history of diabetes and elevated glucose in blood and urine was abnormal. The EDD stated she did not agree with the ESI score assigned to Pt 1. The EDD stated Pt 1 should have been prioritized ESI score 3 based on age, behavior, and pain level. The EDD stated Pt 1’s presentation and laboratory results should have prompted RN 1 to reassess Pt 1 and ask about the appropriateness of Pt 1’s discharge from the ED. During an interview on 12/13/23 at 4:44 p.m., with RN 1 and the EDD, RN 1 confirmed she worked the night shift on 11/29/23 (7 p.m. to 7 a.m. on 11/30/23) and was assigned to triage patients. RN 1 stated the triage area was usually staffed with two to three nurses in the “green zone” (fast track area), however the ED was short staffed that night and the “green zone” was closed; patients were directed to wait in WR until triaged. RN 1 stated the WR was staffed with an ED technician (EDT1) who assisted with vital signs and reported changes in the patients’ conditions. RN 1 stated a “medical surg” (medical surgical) nurse (RN 2) was also “floated” to the ED to assist her with the patients. RN 1 stated Pt 1 arrived at the ED on 11/30/23 “around 1:00 a.m.” RN 1 stated she did not immediately triage Pt 1 upon his arrival because there were four patients that still needed to be triaged. RN 1 stated Pt 1 yelled “so loud” in pain, which prompted her to leave the triage area and check the WR. RN 1 stated she saw that Pt 1 was a young boy “guarding” (involuntary reaction to protect an area of pain) the “middle area” of his stomach. RN 1 stated she triaged Pt 1 at 1:22 a.m. and was informed by Pt 1’s mother that Pt 1 had a history of autism and chronic constipation. RN 1 stated Pt 1’s vital signs were “normal” (SpO2, HR, T, and R), however she could not obtain Pt 1’s blood pressure “because the cuff kept squeezing his arm and reading 200.” RN 1 stated the ED provider (FNP 1) was stationed right next to her in the triage area. RN 1 stated FNP 1 asked Pt 1’s mother for the reason for the ED visit and informed Pt 1’s mother that she would order laboratory studies and an ultrasound, then walked away from the triage area. RN 1 stated FNP 1 did not conduct a physical assessment of Pt 1. RN 1 stated, “[FNP 1] did not touch him” and felt FNP 1 “dismissed” the mother’s concerns and reason for the visit. RN 1 stated she had witnessed this practice before, FNP 1 not completing a medical screening exam with other ED patients but had not reported it to management. RN 1 stated Pt 1 was directed after triage back to WR to wait for laboratory and ultrasound procedures. RN 1 stated Pt 1’s father requested Pt 1 be given pain medication while Pt 1 waited for tests. RN 1 stated this “alerted” her since she had “clinical knowledge” of “autistic children” having high pain tolerance and was concerned Pt 1 “may have been in a lot of pain.” RN 1 stated Pt 1’s father was also “surprised” Pt 1 complained of pain. RN 1 stated Pt 1 was medicated for the pain and sent to a private ED room to have labs drawn. RN 1 stated Pt 1 was held down by his father and staff for labs to be collected. RN 1 stated Pt 1 was directed back to WR to wait after his blood was collected. RN 1 stated Pt 1 continued “yelling” in the WR and Pt 1’s father requested that they be allowed to wait in their car. RN 1 stated the WR was full, and the family was allowed to wait in the car. RN 1 stated this was appropriate since the family parked outside the ED entrance and sat with their window rolled down. RN 1 stated the car was visible to the ED technician stationed in the WR. RN 1 stated “around 3 a.m.” FNP 1 updated the “[ED] tracker board” (enables staff to track ED patients, pending orders, care being provided, and status of diagnostics studies and their results) to indicate Pt 1 was ready for discharge. RN 1 stated she had several patients to discharge so she tasked EDT 1 to print Pt 1’s discharge instructions and RN 2 to complete Pt 1’s discharge from the ED. RN 1 stated she “heard” RN 2 discharge Pt 1 and felt RN was a “newer nurse” with less ED experience. RN 1 stated she did not have time to “educate” RN 2 on ED protocols. RN 1 stated FNP 1 did not reevaluate Pt 1 nor discuss laboratory studies with Pt 1’s family. RN 1 stated she did not review Pt 1’s labs or ultrasound and assumed Pt 1 was stable for discharge since FNP 1 wrote discharge orders and Pt 1 “appeared to look better.” RN 1 stated Pt 1’s vital signs were not rechecked prior to discharge. RN 1 stated she was not aware of Pt 1’s elevated WBC counts, elevated blood glucose, and glucose in urine. RN 1 stated she did not review Pt 1’s laboratory and ultrasound results at any time on 11/30/23. RN 1 stated she was made aware of the “abnormal” results the next morning when she was notified by the EDM. RN 1 stated patients with Pt 1’s similar symptoms and presentation would have been placed in a room and cared for in the “green zone” by two to three RNs; laboratory, radiological studies, and vital signs would have been assessed and documented more frequently. RN 1 stated in this case (Pt 1’s visit) it was not done. FNP 1 was placed on administrative leave effective 11/30/23 and was not available for interview. RN 2 was not interviewed as she was on personal leave to care for a critically ill relative. During an interview on 12/14/23, at 7:45 a.m., with the ED Charge Nurse (RN 3), RN 3 confirmed she was the charge nurse (oversee the operations of their specific nursing unit during a set period while working alongside the team) in the ED on 11/30/23. RN 3 stated the ED technician working on 11/30/23 informed her an “8- or 9-year-old-boy” with history of autism was in the WR and needed to be restrained to have labs drawn. RN 3 stated it was reported to her that Pt 1 had abdominal pain and was being worked up for an “Appy” (appendicitis- a pouch on the colon that becomes inflamed and filled with pus, causing pain). RN 3 stated she arranged a private room in the ED to have Pt 1’s labs drawn. RN 3 stated it was not reported to her that Pt 1 was in distress. RN 3 stated she followed Pt 1 on the ED “tracker board” and confirmed Pt 1’s labs and ultrasound were completed. RN 3 stated she reviewed Pt 1’s labs, ultrasound, and vital signs and they were “nothing of concern.” RN 3 stated she was not aware of what priority status (ESI score) was given to Pt 1 on 11/30/23. RN 3 stated it was not her practice to look at patients’ ESI scores since the “number [score]” was for “billing and reimbursement” purposes. RN 3 stated she prioritized care based on the time and type of orders entered on the “tracker board.” RN 3 validated RN 2 (medical surgical nurse) was “floated” to the ED department on 11/30/23 to assist RN 1 with assigned duties. RN 3 stated it was Hospital A’s practice to “float” nurses to the ED during staff shortages. RN 3 stated RN 2 was instructed to medicate and discharge patients (within scope of practice) on 11/30/23. RN 3 stated RN 2 did not have access to the ED computer system and required assistance to access patient information. During an interview on 12/14/23, at 8:15 a.m., with the EDD, the EDD acknowledged FNP 1 documented a MSE for Pt 1 on 11/30/23 and stated she was not aware FNP 1 did not conduct a physical examination on Pt 1. The EDD stated she was not aware that FNP 1 had a practice of not conducting physical examination of patients. EDD stated she was unaware RN 1 had observed FNP 1 not conduct physical examination on ED patients. The EDD stated the ED department had received two complaints from patients who came to the ED seeking emergent care alleging FNP 1 was “rude” and “did not do anything”. The EDD stated “not doing anything” was interpreted by her as FNP 1 not meeting the expectations of the complainants. The EDD stated at the time she did not interpret the complaint to mean the FNP 1 did not conduct physical examinations. The EDD stated both complaints were escalated to the MED on 9/5/23. During an interview on 12/14/23, at 8:50 a.m., with Pt 1’s family member ( Mother), Mother stated she took Pt 1 to the ED on 11/30/23 to be evaluated for abdominal pain and constipation. Mother was tearful and stated, “They didn’t do anything for him [Pt 1].” Mother stated Pt 1 was not evaluated by an ED physician and FNP 1 “never touched him [Pt 1].” Mother stated staff did not “listen” to her when she explained Pt 1 had history of autism and would require sedation for the ultrasound procedure. Mother stated Pt 1 was “screaming in excruciating pain” during the ultrasound and she voiced concerns to staff that a complete and accurate test would not be obtained. Mother stated Pt 1 remained in pain the entire ED visit. Mother stated he was medicated with “Motrin” when his blood and urine were collected but was not reassessed by the nurse nor offered additional pain medication during the visit. Mother stated Pt 1 was being loud because of his pain and they requested to wait in the car to avoid upsetting other children in the ED. Mother stated, while waiting in the car, staff did not assess Pt 1 nor reattempt taking vital signs. Mother stated she returned to the WR to inquire about lab results and was notified Pt 1 would be discharged. Mother stated she was told Pt 1 was stable to go home and to continue with fiber for constipation, no other instructions were provided. Mother stated she did not speak to FNP 1, and labs results were not reviewed with her. MOM stated after discharge, Pt 1 continued to have pain but fell asleep in a recliner next to his grandmother. Mother stated Pt 1 woke up sometime later stating his stomach hurt and requested water. Mother stated Pt 1 was given water and she returned to bed. Mother stated she was abruptly awakened to Pt 1’s grandmother screaming and went to check Pt 1. Mother stated, “he had everything coming out of his mouth ... he was already gone ... I had just talked to him ... it happened so fast.” Mother stated family in the home called emergency services, fire and police departments arrived within 10 minutes. Mother stated the police kept her in a separate room while emergency personnel attempted resuscitation and transported Pt 1 back to the ED. Mother stated Pt 1 was deceased by the time they arrived at the hospital. Mother stated she was informed by the sheriff coroner’s office that Pt 1 had a “twisted intestine.” Mother stated, “I didn’t know,” Pt 1 acted like he was constipated and so that’s what was reported to the ED nurse when she sought emergent care for Pt 1. Mother stated she went to the ED on 11/30/23 and asked that Pt 1 be evaluated by an ED physician because Pt 1 was in pain and not getting better. Mother stated, “I tried.” During an interview on 12/14/23, at 9:45 a.m., with the Assistant Investigator of the County Coroner’s Office (AICCO), the AICCO stated cause of death has not been established, however findings for Pt 1 included “Intestinal Volvulus” (a medical emergency that occurs when part of the colon or intestine twists, causing bowel obstructions that may cut off the blood supply and requires surgical treatment. Symptoms include abdominal pain and chronic constipation). During an interview on 12/14/23, at 11:30 a.m., with the MED and the EDD, the MED stated he assumed the Medical Director ED role in August 2023. The MED stated, on 9/5/23, the EDD informed him of a patient who complained FNP 1 did not examine her daughter. The MED stated concerns (FNP 1’s behavior and attitude) were discussed at that time with the ED physician’s group regional leader and FNP 1. The MED stated it was decided to “start a paper trail” and develop a “PIP” (performance improvement plan) for FNP 1. The MED stated a second complaint was reported to him on 10/19/23 in which FNP 1 “was dismissive” of the patient’s signs and symptoms during their ED visit. The MED stated FNP 1’s dismissiveness was concerning to him and a meeting with human resources, physician group regional leader and manager took place on 11/8/23. The MED stated he was waiting for the “PIP” to be approved when the incident with Pt 1 occurred. The MED stated FNP 1 was immediately placed on administrative leave as a result and the leave was extended an additional 12 weeks. The MED stated he did not consider removing FNP 1 from the ED until 11/30/23. The MED stated he reviewed Pt 1’s EMR and “overall [Pt 1] looked well” to all parties (FNP 1, RN 1, and MOM) during the first ED visit on 11/30/23 at 1:09 a.m. and Pt 1 was allowed to be discharged home. The MED stated FNP 1 had ordered “a good set of labs” and the ultrasound exam was “largely unimpressive.” However, the MED stated Pt 1’s WBC count (24,000 K/mm3) was concerning, and most concerning was Pt 1’s blood glucose level (275 mg/dl). The MED stated clearly glucose was “spilling” into Pt 1’s urine (UA- glucose > 500 mg/dl). The MED stated FNP 1 “missed” the elevated glucose levels and other symptoms that should have kept Pt 1 in the ED for further observation. The MED stated blood glucose level over 200 mg/ dl was abnormal and FNP 1 should have called (name of local Children’s Hospital) for further instruction and possible transfer. The MED stated he did not agree with FNP 1’s assessment of Pt 1 and decision to discharge Pt 1 from the ED on 11/30/23. The MED stated although pediatric patients were often discharged from the ED with elevated WBCs, the provider must discuss the weighted risks and benefits with parents and document the discussion in the EMR. The MED stated FNP 1’s disposition was based on the department’s “observation” of Pt 1 and not clinical findings. The MED stated FNP 1 did not follow the physician’s group “Clinical APP [advanced practitioner provider] Guidelines” when Pt 1 was discharged from the ED on 11/30/23 with labs inconsistent with findings; Pt 1 “appeared well” but lab results did not coincide, therefore it was not clear, with certainty, whether Pt 1 had an emergency medical condition in need of immediate medical attention or stable enough to go be discharged home. The MED stated FNP 1 did not consult the supervising physician on 11/30/23 per guidelines. During an interview on 12/14/23, at 3:35 p.m., with the EDM, the EDM stated she was in the ED when Pt 1 was brought in by ambulance in cardiac arrest. The EDM stated the call from EMS came into the ED as an 80-year-old male in cardiac arrest, not 8-year-old child. The EDM stated this surprised the critical care team but did not delay care. The EDM stated she learned after the code Pt 1 was evaluated in the ED on 11/30/23, earlier that morning. The EDM stated she would not have expected Pt 1 to return to ED in cardiac arrest based on how he “presented” at discharge. The EDM stated Pt 1’s mother reported that “Colace [stool softener] and fiber” were administered to Pt 1 at home and Pt 1 had sustained a “fall” prior to his cardiac arrest. The EDM stated MD 1 was made aware. During an interview on 12/18/23, at 9:05 a.m., with Nurse Practitioner (NP) 3, NP 3 stated she worked as a NP in the ED for 1 ½ years. NP 3 stated hospital practice was for patients to be triaged and screened by a provider as soon as possible after arriving to the ED. NP 3 stated patients could not be appropriately prioritized and medically screened without having a complete set of vital signs checked and physical assessment as it related to a patient’s chief complaint. NP 3 stated the purpose of a MSE was to identify any emergency medical condition (EMC) that required immediate treatment and was completed when the EMC was ruled out. NP 3 stated it was the responsibility of all providers to physically assess every patient, review vital signs, laboratory, and diagnostic studies before determining whether an ED patient has been stabilized, and to discuss findings with patients prior to their discharge. During an interview on 12/18/23, at 11:05 a.m., with EDT 1, EDT 1 stated Pt 1 was brought in by family to the ED on 11/30/23. EDT 1 stated it was evident Pt 1 was in pain when he arrived. The EDT 1 stated she heard Pt 1 say “ouch mom my stomach.” EDT 1 stated Pt 1 was triaged and returned to the WR to wait. EDT 1 stated Pt 1 continued to yell in pain “my stomach hurts” while he waited and was unable to obtain Pt 1’s vital signs because of the pain. EDT 1 stated she was able to secure a private room to draw Pt 1’s labs, “many hands” held Pt 1 down so she could collect his blood. The EDT 1 stated she was not sure if Pt 1 returned to the WR to wait further testing. EDT 1 stated Pt 1 was “walking normal” after the lab draw but continued to yell and act out. EDT 1 stated Pt 1’s mom asked to wait in the car because she could not manage Pt 1 in the WR. EDT 1 stated the triage nurse agreed and the family went to the car to wait. EDT 1 stated she did not recall if Pt 1 was medicated because “I was in the lobby.” EDT 1 stated when Pt 1 was ready for discharge, she went to Pt 1’s car parked outside and instructed them to return to the WR to be discharged. EDT 1 stated she did not print ED discharge instructions and was uncertain who provided the discharge instructions to Pt 1. EDT 1 stated there was a “float” nurse that evening assisting triage with medication administration and discharges. EDT 1 stated Pt 1 was a “completely different kid” at time of discharge. EDT 1 stated Pt 1 was walking next to mom and notyelling in pain. EDT 1 stated she did not reattempt vital signs during Pt 1’s ED visit or at discharge. EDT 1 stated she did not observe the QMP [FNP 1] assess Pt 1 at discharge. During an interview on 12/19/23, at 9 a.m., with ED Physician (MD) 1, MD 1 stated she was on shift when Pt 1 was brought by EMS to the ED in full cardiac arrest on 11/30/23 at 8:37 a.m. MD 1 stated EMS reported Pt 1 had a history of an upper respiratory infection and had been evaluated by his pediatrician on 11/29/23. MD 1 stated Pt 1 had dry vomit on his face, and she thought Pt 1 may have possibly ingested something “as children often do.” MD 1 stated she called the family who confirmed Pt 1 had been “sick” for several days and was evaluated in the ED on 11/30/23, earlier that morning. MD 1 stated she did not know much about Pt 1’s case however the family stayed on the phone to answer questions while resuscitative measures were performed. MD 1 stated Pt 1 was hypothermic (below normal body temperature), and his blood glucose was in “400’s.” MD 1 stated bedside ultrasound was used during the code to monitor for any cardiac response however ROSC was never achieved. MD 1 stated she pronounced Pt 1 at 9:09 a.m. MD 1 stated Pt 1’s death was reported to the county coroner’s office per protocol. MD 1 stated the coroner’s office ordered for CT scans of Pt 1’s body which were completed. MD 1 stated CT scans showed Pt 1 with pneumoperitoneum (the presence of air/ gas in the peritoneum [a thin layer of tissue that surrounds the abdomen]). MD 1 stated she reviewed the record of Pt 1’s ED visit on 11/30/23 at 1:09 a.m. after the debriefing. MD 1 stated she did not know how Pt 1 presented to FNP 1 and it was not fair to evaluate her medical decision-making solely based on what was explained, however stated Pt 1’s elevated WBC and blood glucose counts justified Pt 1 staying in the ED for further testing and evaluation. During a review of Pt 1’s “CT Brain WO [without] Contrast [dye]” dated 11/30/23 at 10:29 a.m., the “CT scan Brain” indicated, “ ... No acute [sudden] intracranial [inside the skull] process ...” During a review of Pt 1’s “CT Cervical Spine [neck region] WO Contrast Trauma” dated 11/30/29 at 10:29 a.m., the “CT scan Cervical Spine” indicated, “ ... Sagittal study [an anatomical plane that divides the body into right and left sections] demonstrates normal alignment. Facets align normally. Canal is patent. Patient is intubated [has breathing tube inserted]. Coronal images [an anatomical plane that divides the body into dorsal (back portion) and ventral (front portion) sections] demonstrate intact ring of C1 and odontoid (projection of the vertebrae). Axial images demonstrate severe air space disease upper lungs. Lungs are incompletely imaged. Central spinal canal appears patent...” During a review of Pt 1’s “CT Chest/ Abdomen/ Pelvis WO Contrast” dated 11/30/23 at 10:29 a.m., the “CT scan Chest/ Abdomen/ Pelvis” indicated, “ ... OVERALL IMPRESSION ... dense miliary process [ innumerable, small 1-4 mm nodules (firm lumps) scattered throughout the lungs] throughout the lung fields bilaterally [both sides]. ARDS is not entirely excluded... Status post intubation ... Air present within the right ventricle [chamber of the heart] query history of vascular penetrating type injury or air embolus [gas bubble] ... Pneumobilia [presence of air in biliary system]... Ascites [fluid collection in the abdomen]... distended loops of small bowel with fluid consistent with ileus [blockage] although infectious etiology is not excluded... possible pneumotosis... high density material within the bladder query blood products...” During a review of Pt 1’s “CT Lower Extremities Bilateral WO Contrast” dated 11/30/23 at 10:29 am., the “CT scan Lower Extremities Bilateral” indicated, “ ... there is no evidence of fracture or malalignment. Ossicular [bone structure] development is consistent with patient stated age... bone mineralization is within normal limits... No evidence of joint effusions [swelling]... IMPRESSION... Subcutaneous emphysema [air underneath layers of skin] left mid [middle] calf [lower leg] extending to the deeper fascial planes [connective tissue that holds nerves, muscles, and blood vessels] with associated soft tissue edema [swelling] ... fluid present within the deeper fascial planes ... Necrotizing fasciitis is not excluded ...” During a review of the hospital’s policy and procedure (P&P) “Medical Screening Examination (MSE) and Stabilization” dated 6/5/19, the P&P indicated, “... To ensure that all individuals who Come to the Hospital (as defined in the Compliance with EMTALA policy) seeking or in need of Emergency Services and Care receive an appropriate Medical Screening Examination... the Dedicated Emergency Department, or other Department of the Hospital... must provide an appropriate Medical Screening Examination within the Capability of the Dedicated Emergency Department, including ancillary services routinely available to Dedicated Emergency Department, to determine whether or not an individual has an Emergency Medical Condition... Triage is a sorting process to determine the order in which individuals will be provided a Medical Screening Examination by a physician or Qualified Medical Person. Triage is not the equivalent of a Medical Screening Examination and does not determine the presence or absence of any Emergency Medical Condition ... The Triage assessment and classification of prioritization for the Medical Screening Examination will be performed in accordance with hospital policies and procedures... A Medical Screening Examination is the process required to reach, within reasonable clinical confidence, the point at which it can be determined whether an individual is, or is not experiencing an Emergency Medical Condition ... the scope of the Medical Screening Examination must be tailored to the presenting complaint and the medical history of the individual... the Medical Screening Examination must be the same examination that the hospital would perform on any individual who Comes to the Emergency Department with the same or similar signs and symptoms... The medical staff bylaws or rules and regulations, as approved by the hospital governing body, will designate the categories of Qualified Medical Persons in each Dedicated Emergency Department who are authorized to perform the medical screening examination... a qualified medical person who is authorized to perform a Medical Screening Examination must... demonstrate his her current competence in the performance of Medical Screening Examinations within the authorized scope of his her health profession... perform the Medical Screening Examination in accordance with protocols, standardized procedures or other policies as may be required by law or approved by the hospital governing body and the medical staff...” The hospital did not have a written P&Ps for “Triage” or “Assessments” of the ED patient. During a review of the hospital’s “[Network] Consolidated Medical Staff Rules and Regulations 2019” indicated, “ ... An “Allied Health Professional” (AHP) shall have the same meaning as in Definition 1 of the Medical Staff Bylaws ... AHPs are permitted to render services offered and the needs of the hospital. Current categories approved AHP’s are ... Certified Nurse Practitioner ... Hospital employed midlevel practitioners shall be required to meet the same professional qualifications as members of the allied health staff, and shall be subject to annual competency review by their supervising physician and departmental director ... AHP’s will consult with the supervising physician or their designee whenever a patient’s condition warrants consultation as defined in the delineated clinical privileges... Abide by the medical staff bylaws, and all other rules, regulations, policies and procedures of the medical staff and hospital...” During review of the hospital’s “Consolidated Medical Staff Bylaws- 2019”, indicated, “ ... Allied Health Staff are those Allied Health Practitioners (AHPs) who are neither employees of the hospital or, pursuant to the terms of these bylaws, eligible for medical staff membership, but have been granted clinical privileges or approved to provide patient care within their approved scope of practice. “Clinical Privileges” means the permission granted to an allied health staff member to provide specified patient care services within his or her qualifications and scope of practice... AHP services must be consistent with the clinical privileges/scope of practice granted and within the scope of the AHP’s licensure or certification. Provision of specified clinical privileges/ scope of practice is subject to a medical staff members responsibility for the patient’s general medical condition. Where the AHP does not practice independently, he/she must be under the supervision and direction of a member of the active medical staff, who has been granted specific privileges to supervise the category of an AHP... The medical staff shall be organized along key service lines... Emergency medicine... The general functions of each key service line shall include... conducting patient care reviews for the purpose of analyzing and evaluating the quality and appropriateness of care and treatment provided to patients within the service line... taking appropriate action an important problems in patient care and clinical performance are identified...” During a review of “[Name of ED Physician Group] Emergency medicine Advanced Provider Clinical Supervision Guidelines” dated March 2023, indicated, “ ... physicians must supervise physician assistants and nurse practitioners (advance providers) at each [Name of ED Physician Group] site in accordance to state regulations and state practice requirements ... sites are expected to review and augment these guidelines for site practice specificity as needed... the supervising physician should document in- person evaluations of the patient in the medical record... the advanced provider should document discussions with their supervising physicians even in cases where an in- person evaluation by the supervising physician was not necessary... Advanced providers should consult the supervising physician in patient encounters involving... Patients whose history, physical, or lab findings are inconsistent with the clinical picture... any condition which the advanced provider feels exceeds his her level of confidence or has uncertainty of diagnosis or treatment...” During a review of the hospital’s P&P “STANDARD PROCEDURE: NURSE PRACTITIONER IN THE EMERGENCY DEPARTMENT” dated 9/28/22, indicated, “ ... nurse practitioners may perform the following functions within their training and consistent with their experience and credentialing: perform medical screening exams, perform assessments ordering and interpreting laboratory procedures, X-rays... Physician consultation will be obtained as specified in the individual protocols and under the following circumstances... history, physical, or lab findings inconsistent with the clinical picture... HEALTH CARE MANAGEMENT: EMERGENCY CARE ... this protocol covers the management of emergency care conditions where there is a risk of significant or permanent morbidity or mortality to the patient. Such conditions include, but are not limited to ... abdominal pain ... Diagnosis ... consistent with subjective and objective findings... Treatment ... consultation and referral as appropriate ...” During a review of the professional reference retrieved from https://journals.lww.com/pec-online/abstract/2022/07000/medical_management_of_children_with_autism_in_the.6.aspx , titled “Pediatric Emergency Care Medical Management of Children with Autism in the Emergency Department” dated July 2022, indicated “ ... Autism spectrum disorder (ASD) is an increasingly prevalent diagnosis characterized by impairment of social communication and behavioral regulation. Children with ASD seek care more frequently in the emergency department (ED) than their neurotypical peers and the approach to medical evaluation of this population requires heightened attention to a variety of factors. Communication with caregivers, attention to environmental stimulation, identification of accommodation needs, and understanding frequently associated medical conditions are important considerations in ED encounters. Gastrointestinal problems, seizure disorders, and metabolic disease are common causes for ED presentation in children with ASD. A high index of suspicion for underlying medical issues must be maintained, even when children with ASD present primarily for behavioral concerns ...” During a review of the professional reference retrieved from https://www.ncbi.nlm.nih.gov/books/NBK441836/, titled, “National Library of Medicine Volvulus”, dated 9/12/22, the professional reference indicated, “ ... Volvulus occurs when a loop of intestine twists around itself and the mesentery that supports it ... Symptoms include abdominal distension, pain, vomiting, constipation, and bloody stools. The onset of symptoms may be insidious or sudden. The mesentery becomes so tightly twisted that blood supply becomes cut off, resulting in an ischemic bowel ...In children, the small intestine and stomach are more commonly involved. Diagnosis is mainly clinical, however, characteristic radiological findings on plain radiograph, ultrasound, and upper GI series help in differentiating from other differentials ... Patients presenting to the hospital after a significant delay may have features such as diffuse tenderness, guarding, and rigidity suggesting perforation peritonitis. In the presence of severe abdominal distension, patients often develop hemodynamic instability and respiratory compromise. In contrast, newborns with midgut volvulus have sudden onset bilious emesis, upper abdominal distension, hematochezia, inconsolable cry, etc. Older children with midgut volvulus may also present with features including episodic abdominal pain, diarrhea, and failure to thrive ... radiological investigations are often required for diagnostic confirmation due to an overlap of clinical features with other diseases. The first investigation to be performed is a plain radiograph of the abdomen. Specific signs including “bent inner tube” or a “coffee bean” sign are characteristic for sigmoid volvulus. These refer to the appearance of the air-filled closed loop of the colon which forms the volvulus revealing a thick inner and a thin outer wall. Similarly, plain radiographs of patients with cecal volvulus reveal distended small bowel and large bowel ... in children with midgut volvulus, radiological features include paucity of gas throughout the intestine with few scattered air-fluid levels on plain radiograph, and an abnormally placed duodenojejunal junction (DJ) with the small bowel looping entirely on the right side of the abdomen on upper GI series. [5] Laboratory studies including complete blood count (CBC) and serum biochemistry may show a left shift with leucocytosis and electrolyte abnormalities respectively, however, these are non-specific ... In all the cases of volvulus, patients need to be resuscitated prior to surgery. Broad-spectrum antibiotics should also be administered in these patients preoperatively. Vitals monitoring including measurement of the urine output should be done ... Any delay in the diagnosis of cecal or sigmoid volvulus can be associated with high morbidity and mortality ... If untreated, volvulus can cause bowel strangulation, gangrene, perforation, and peritonitis ... Patients with volvulus often present to the emergency department. While the diagnosis is not difficult, the management is not always straight forward. Thus, it is important to involve an interprofessional team that includes the emergency department physician, intensivist, nurse practitioner, general surgeon, gastroenterologist, and internist. It is also vital to involve the radiologist right from the beginning so that a diagnosis can be made urgently. The monitoring of the patient, before and after the surgery, is exceedingly important and must be done in ICU or HDU under the care of an intensivist. Immediate consultation with a surgeon is necessary to plan for surgery. The role of a gastroenterologist is also vital, as immediate treatment of sigmoid volvulus is detorsion utilizing the sigmoidoscopic reduction technique ...” During a review of the professional reference retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5774593/, titled “Managing acute abdominal pain in pediatric patients: current perspectives” dated 6/29/17, indicated, “ ... Acute abdominal pain [AP] in pediatric patients has been a challenge for providers because of the nonspecific nature of symptoms and difficulty in the assessment and physical examination in children ... The most practical approach is to make the distinction between medical and surgical causes by initially relying on a thorough history and physical examination ... The physical examination of a child with acute AP [abdominal pain] should begin with an overall assessment of the child’s appearance (lethargy, eye contact, comforted by family member, and interactive), hydration status, activity level, and vital signs ... Abdominal examination should be performed gently with careful hands-off inspection being the first step. Distracting the child while palpating the abdomen is very helpful. A young child is best examined in a parent’s arms or lap ... Peritoneal signs including localized tenderness, rebound tenderness, and involuntary or voluntary guarding are indicative of an acute surgical abdomen ... pain <48 hours in duration followed by vomiting, guarding, and rebound tenderness on physical examination, particularly if there is a history of a prior surgical procedure, indicates a patient with high risk of an acute surgical abdomen ... Examination of all body systems is mandated, including throat, ears, skin, and genitals ... Although appropriate diagnostic laboratory testing varies based on the clinical situation, a complete blood count (CBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and urinalysis can be considered as initial laboratory tests as suggested by American Family Physician recommendations for evaluating patients with acute AP ... When a clinically nonurgent condition is suspected but the CRP is above 100 mg/L or the WBC count is above 15×109/L, the possibility of an urgent surgical condition should be reconsidered and additional imaging may be warranted ... laboratory tests do not sufficiently differentiate between surgical and nonsurgical cases, they may be helpful in identifying associated morbidity. For example, in the setting of a possible bowel obstruction, electrolytes should be obtained as acidosis may indicate impending decompensation or sepsis ... A blood glucose check is recommended if AP is associated with polyuria or polydipsia or with changes in metal status, to rule out diabetic ketoacidosis, an urgent medical condition... The sensitivity of ultrasonography is decreased in centers where it is used less often, when the appendix is not clearly visualized, and when there is shorter duration of pain ... Providers in EDs, therefore, may need additional diagnostic tools after consulting with a radiologist when doubt exists about the need for surgical intervention ... Treatment should be directed at the underlying cause when it can be identified. While the treatment of each specific condition is beyond the scope of the current manuscript, some general points deserve discussion. In patients with a high suspicion of a surgical condition, urgent consultation with a specific specialty such as surgery, gynecology, or urology is mandated while the patient is getting stabilized with adequate hydration and pain control. After surgical and urgent medical conditions have been excluded, discharge from the ED or acute care clinic with education regarding worrisome signs and symptoms and very close follow-up is generally a safe approach with children ... Children who are discharged should be in stable condition with normal vital signs and oxygen saturations and with adequate pain relief. Children who do not meet these criteria or appear more than mildly ill should be admitted to the hospital to allow continuous monitoring and frequent reevaluation ... The most important and most attainable initial goal in the evaluation of acute AP is to differentiate surgical and nonsurgical conditions with each further categorized as urgent versus nonurgent. This can often be achieved by a thorough history and physical examination, laboratory testing to primarily assess comorbidity, and imaging studies. In an ill-appearing patient, work-up and management decisions should involve collaboration between the acute setting provider, a surgeon, and a radiologist. Once an urgent condition is excluded, serial reevaluation and symptomatic treatment with close follow-up are the mainstays of management ...” During a concurrent interview and record review on 12/13/23 at 11:30 a.m., with the EDM, Patient 1’s “comparator patient (Pt 3)” EMR, dated 8/15/23, was reviewed. Pt 3’s EMR indicated Pt 3, a nine-year-old female, presented to the ED on 8/15/23 at 12:58 p.m. with chief complaint of abdominal pain (6/10 on numeric pain scale). Pt 3 was triaged at 1:16 p.m. and given ESI score 3 (vital signs T 100.1 F, HR 134, R 20, BP 115/72, SpO2 97% on RA). Laboratory and diagnostic studies collected on 8/15/23 included the following results: CRP (c-reactive protein, checks inflammation in the body) 8.515 mg/ dL (HIGH) WBC 33.00 K/mm3 (HIGH) RBC 5.13 M/mm3 (HIGH) HGB 14.3 gm/ dL (HIGH) HCT 40.7% (HIGH) Blood Glucose 111 mg/dL (HIGH) Total protein 8.9 dm/dL (HIGH) UA- Protein 30 mg/ dL (ABNORMAL) During a review of Pt 3’s “ED Physician Notes *Final Report*,” dated 8/15/23 the “ED Physician Notes” indicated, “ ... Abdomen 2 Vw (view) ... 2:09 p.m ... there is no evidence of free intraperitoneal air... impression non obstructed gas pattern... US Appendix ... 2:05 p.m ... multiple images were obtained ... Impression: mildly dilated non compressible tubular right lower quadrant structure suspicious for acute appendicitis...” Pt 3 was transferred to Hospital B on 8/15/23 at 6:18 p.m. for higher level of care.”