HospitalInspections.org

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:

1. Resources and oversight were not provided to ensure the hospital provided care in a safe setting and ensured the patient's right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) as well as his/her physical safety for eight of 11 sampled patients (Pt 2, Pt 17, Pt 25, Pt 41, Pt 42, Pt 43, Pt 44, and Pt 45) by providing services in the Emergency Department (ED) after obtaining physician order for inpatient care instead of moving them into an appropriate inpatient room which deprived Pt 2, Pt 17, Pt 25, Pt 41, Pt 42, Pt 43, Pt 44, and Pt 45 of the amenities (something that helps to provide comfort, convenience, or enjoyment (such as a private or semi-private room, private or semi-private bathroom, showers, call bell system, inpatient hospital bed, television, smoking etc.) available on the inpatient units (Refer A115, Finding 1 and A-0144).

2. Resources and oversight were not provided to ensure two patients were free from all forms of abuse or harassment when a Patient Care Technician (PCT) slapped Pt 92 and a Doctor of Osteopathy (DO, licensed physician with a unique focus on the muscles and bone systems) 1, who was not assigned to provide care for Pt 8, entered Pt 8's hospital room and conducted an inappropriate physical exam that included touching without gloves her breasts, back, buttocks and genitals on 5/6/25 at 5:11 a.m. (Refer to A115, Finding 2 and A-0145, Finding 1 and 2).

3. Resources and oversight were not provided to ensure the hospital maintained an effective, comprehensive, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI-is a systematic approach to improving the quality of care and services delivered to patients) program when the program did not implement effective actions to address the ongoing concerns of inpatients in the ED receiving all or most of their care in the ED instead of having the care provided in the appropriate inpatient unit. (Refer to A263, Finding 1, A309 and A115, Finding 1)

4. Resources and oversight were not provided to ensure the hospital nursing staff developed and maintained individualized care plans reflecting the needs of the patients and care to be provided for the patients when five of 30 patients' (Patient [Pt] 11, Pt 12, Pt 14, Pt 25, and Pt 49) care plans did not contain patient specific problems and interventions. (Refer to A-396)

5. Resources and oversight were not provided to ensure an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of hospital acquired infections (infection one gets while receiving treatment in a healthcare facility) and other infectious diseases. (Refer to A747 and A749, all Findings).

6. Resources and oversight were not provided to ensure an organized food and nutrition service when the Senior Food Service Director (SFSD)/Registered Dietitian did not provide regularly scheduled oversight and guidance to the Food Services Director (FSD 2) to effectively analyze the scope and complexity of the FANS department at one of the three campuses (Surgical Campus 2) which resulted in ineffective systems and monitoring to ensure staff competency for a cook and was not aligned with the hospital's organizational chart; and The Clinical Registered Dietitian (RD 1) was not evaluated by staff with the appropriate skill set and the hospital's organizational chart and job description were not aligned at Surgical Campus 2. (Refer to A0618, Finding 1 and A-0619)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner for all patients.

Based on observation, interview and record review, the hospital failed to protect and promote each patient's rights when:


1. The hospital failed to ensure care was provided in a safe setting and failed to ensure the patient's right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) as well as his/her physical safety and quality care for eight of 11 sampled patients (Pt 2, Pt 17, Pt 25, Pt 41, Pt 42, Pt 43, Pt 44, and Pt 45) by providing services in the Emergency Department (ED) after physician's order to provide inpatient care instead of moving them into an appropriate inpatient room which deprived Pt 2, Pt 17, Pt 25, Pt 41, Pt 42, Pt 43, Pt 44, and Pt 45 of the amenities (something that helps to provide comfort, convenience, or enjoyment (such as a private or semi-private room, private or semi-private bathroom, showers, call bell system, inpatient hospital bed, television, smoking etc.) available on the inpatient units (Refer to A-0144).

2. The hospital failed to ensure two patients were free from all forms of abuse or harassment when a Patient Care Technician (PCT) slapped Pt 92 and a Doctor of Osteopathy (DO, licensed physician with a unique focus on the muscles and bone systems) 1, who was not assigned to provide care for Pt 8, entered Pt 8's hospital room and inappropriately conducted a physical exam touching breasts, back, buttocks and genitals without gloves and without consent of Pt 8 on 5/6/25 at 5:11 a.m. (Refer to A-0145, Finding 1 and 2).

3. The hospital failed to follow their policy and procedure on grievances for one patient, Patient (Pt) 6, when hospital staff were made aware of Pt 6's request to file a grievance related to his care in the Emergency Department and no grievance or follow up was made of Pt 6's concerns (Refer to A-0118).

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe and quality setting.

Based on observation, interview and record review, the hospital failed to ensure an active, effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance Improvement (QAPI-is a systematic approach to improving the quality of care and services delivered to patients) program had been developed, implemented, and adjusted in order that the hospital could achieve sustainable regulatory compliance, quality care and safe standards of care when:

1. The hospital failed to ensure 2 of twenty-four (24) patients were free from surgical procedure errors when Pt 19 experienced a wrong-side procedure (nerve block) and Pt 30 experienced a retained foreign object (RFO- a patient safety incident in which a surgical object is accidentally left in a body cavity or operation wound following a procedure) that went unreported to the California Department of Public Health (CDPH). (Refer to A-0951).

2. The hospital failed to have a QAPI program that effectively tracked and monitored adverse events (AE- a harmful and negative outcome that happens to a patient provided medical care), and implement preventive measures when the hospital did not conduct a root cause analysis (RCA - a structured process for investigating incidents to determine the cause or causes) to determine the cause, and implement measures to ensure future incidences would not occur. (Refer to A-0286)

3. The hospital failed to preserve the patient's right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) as well as his/her physical safety for seven of 11 sampled patients (Pt) (Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45) by holding them in the Emergency Department (ED) instead of moving them into an inpatient room which deprived Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45 of the amenities (something that helps to provide comfort, convenience, or enjoyment (such as a private or semi-private room, private or semi-private bathroom, showers, call bell system, inpatient hospital bed, television, smoking etc.) available on the inpatient units. (Refer to A-0144)

The cumulative effect of these systemic deficiencies resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment and professional manner that promotes reporting and investigating adverse patient events and to analyze their causes, and to implement preventive actions and mechanisms that include feedback and learning throughout the hospital to maintain patient safety.

Based on observation, interview and record review, the facility failed to have a well-organized and effective nursing service when:

1. The hospital failed to ensure nursing staff developed and maintained individualized care plans reflecting the needs of the patients and care to be provided for the patients when five of 30 patients' (Patient [Pt] 11, Pt 12, Pt 14, Pt 25, and Pt 49) care plans did not contain patient specific problems and interventions. (Refer to A-396)

2. External supplies on the Triage Labor and Delivery Unit (unit where women in labor are assessed) crash cart (mobile medical cart equipped with essential supplies and equipment to manage life-threatening emergencies) were not checked for their presence or expiration in accordance with the P&P titled, " Code Blue - Medications & Crash Carts (CB)" for four of six days on 5/6/25. (Refer to A 398)

3. Licensed nurses did not create a wound Lines, Drains and Assessment (LDA) in Patient (Pt) 92's electronic medical record (EMR) when a coccyx (tailbone) wound was identified, in accordance with the hospital policy titled, "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", dated 9/13/24. (Refer to A 398)

4. Licensed nurses did not place a pressure redistribution waffle mattress (an overlay placed over hospital mattress to evenly distribute weight and keep patients cool and dry) for one of 3 sampled patients (Pt 2) in the Emergency Department (ED) according to hospital P&P titled," Pressure Injury Risk Assessment, Prevention, Staging, and Treatment". (Refer to A 398)

5. Licensed Nurses (LNs) failed to ensure critical laboratory values for one (1) of twelve (12) sampled patients (Pt 27) was repeated after intravenous (IV-into a vein) fluid resuscitation (the medical practice of replacing fluids lost by the body, usually through IV administration) was ordered to stabilize Pt 27's critically elevated lactic acid level (LA- a buildup of lactic acid in your bloodstream) in accordance with hospital P&P titled "Provider Notification Regarding Patient Status" dated 11/14/23 and professional practice standards. (Refer to A 398)

6. Hospital staff failed to document the indication (reason) for the order and administration of Quetiapine (an antipsychotic medication that treats several kinds of mental health conditions by balancing the levels of hormones (chemicals that coordinate different functions in your body) that help regulate your mood, behaviors and thoughts) for 1 of 12 sampled Pts (Pt 22) per hospital P&P titled "Medications - Orders, Administration, Storage, Documentation", dated 12/19/23, and P&P titled "Documentation in the Health Record", dated 6/14/18. (Refer to A 398)

7. LNs did not take actions according to hospital P&P titled "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", dated 9/13/24, prevent the development of a hospital acquired injury from a skin tear. (Refer to A 398)

8. Pt 98 was administered the incorrect amount of high-risk/high-alert medication (Medications that have a heightened risk of causing significant patient harm when they are used in error). (Refer to A 398)

9. The dose of Patient 78's propofol (a medication used for the induction and maintenance of anesthesia or sedation) was not adjusted as prescribed according to Patient 78's Richmond Agitation-Sedation Scale (RASS, a medical scale used to measure the agitation or sedation level). (Refer to A 405)

10. The dose of Patient 63's insulin (a medication used to lower blood sugar level) was not adjusted as prescribed according to Patient 63's insulin order. (Refer to A 405)


The cumulative effect of these system problems resulted in the hospital's inability to provide nursing services in a safe setting.

Based on observation, interview and record review, the hospital failed to ensure an organized food and nutrition services when:

1. The Senior Food Service Director (SFSD)/Registered Dietitian did not provide regularly scheduled oversight and guidance to the Food Services Director (FSD 2) to effectively analyze the scope and complexity of the FANS department at one of the three campuses (Surgical Campus 2) which resulted in ineffective systems and monitoring to ensure staff competency for a cook and was not aligned with the hospital's organizational chart; and The Clinical Registered Dietitian (RD 1) was not evaluated by staff with the appropriate skill set and the hospital's organizational chart and job description were not aligned at Surgical Campus 2. (Refer to A-0619)

2. One of five cooks (Cook 1) was not competent in the day-to-day duties of meal preparation and the competencies completed for Cook 1 did not reflect the depth and scope of the position at one of three campuses (Surgical Campus 2). (Refer to A-0622)

3. Nutritional needs were not met in accordance with recognized dietary practices for three of ten patients who were provided care in the Emergency Department (ED) at Campus 1 as inpatients, Patient (Pt) 2, Pt 17 and Pt 44 when hospital staff failed to follow physician diet orders ensuring patients received meals. Pt 2 and Pt 44 were diagnosed and admitted as inpatients related to complications of cancer and were not provided meals on multiple occasions and meal intake was not documented; each stayed in the ED for multiple days. Pt 44 was admitted to the ED for complications of developmental delay and mental health and did not have documented evidence of meal intake. The ED did not have a system in place to ensure timely delivery of meals, meals were provided per physician order, and a monitoring system to ensure meals and/or snacks were offered. (Refer to A-0629)

4. Therapeutic diet orders were not followed when nutrition supplements initiated by the Registered Dietitians lacked clear parameters within the prescribed diet order in the hospital's approved diet manual. (Refer to A-0630)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of dietetic services for the health and safety needs of patients in compliance with the Condition of Participation for Food and Dietetic Services.

Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of hospital acquired infections (infection one gets while receiving treatment in a healthcare facility) and other infectious diseases, when:

1. The hospital failed to ensure food preparation equipment and storage for food preparation equipment were in sanitary condition for one of two kitchens located in the main hospital (Refer to A750 finding 1).

2. An ice machine located in the main kitchen of the main campus was not clean in accordance with professional standards (Refer to A750 finding 2).

3. One of one Neonatal intensive care unit (NICU) nurses at the main hospital campus did not perform hand hygiene between glove changes during NICU milk preparation and one of five cooks on campus B of the hospital did not perform hand hygiene between glove changes during food preparation in accordance with the hospital's policy on hand hygiene (Refer to A750 finding 3).

4. The physical environment in the NICU of the main hospital did not support the preparation of milk and the addition of modulars (nutritional supplementation) to minimize cross contamination in accordance with professional standards. Nursing staff did not don personal protective equipment (PPE) and did not adhere to infection control standards in the preparation of milk for newborns (Refer to A750 finding 4).

5. Nursing staff in the Emergency Department (ED) did not keep the door closed in the isolation room for Patient (Pt) 39 in accordance with recommendations for the CDC (spell out) for transmission-based droplet precautions. Pt 39 was diagnosed with Rhinovirus and worsening respiratory symptoms and had a physician order for respiratory droplet precautions on 5/4/25 (Refer to A750 finding 5).

6. Registered Nurse (RN) 20 did not wear a mask during a bedside procedure for Pt 100. Pt 100 was admitted to Neurology ICU (Intensive Care Unit) on 5/6/2025 and required a ventricular drain and central venous line and RN 20 did not wear a mask while assisting providers during the procedures in accordance with infection control standards (Refer to A750 finding 6).

7. Two placenta specimens were stored in clear plastic containers in an open untied bag in the Labor & Delivery Unit's soiled utility room and not stored in a sealed biohazard container in accordance accepted professional standards (Refer to A750 finding 7).

8. An unlabeled and undated container with half a sandwich was stored in the patient nourishment room on the High-Risk Ante Partum (before and after birth) Unit and should have either been thrown away or labeled and dated in accordance with the hospital's policy on safe food storage titled, "Storage" (Refer to A750 finding 8).

9. Soiled adhesive from labels was left on communication boards in patient rooms on 5West, supply bins and cupboards in the clean utility room, nutrition room and medication rooms of the Rehabilitation Unit and should have been discarded in accordance with the with infection control standards (Refer to A750 finding 9).

10. two of ten patients, Pt 17 and Pt 98, the intravenous tubing was not labeled and dated in accordance with hospital policy and procedure (P&P) titled, "Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites" (Refer to A750 finding 10).

11. Outpatient clinic staff did not flush weekly an eye wash station in the outpatient clinic as per P&P titled, "Emergency Shower and Eye Wash Station Policy" (Refer to A750 finding 11).

12. Three of six hospital supply rooms in outpatient clinics stored patient care supplies on dirty, contaminated floor and were not stored in accordance with infection control standards (Refer to A750 finding 12).

13. Staff of on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties did not clean and sanitize a glucometer (a medical device used to test blood for the levels of glucose or sugar) in accordance with the hospital's policy titled, "BRAND NAME] Glucose Meter," and was visibly dirty with a dark, reddish brown spot at the entrance where the blood is sampled (Refer to A750 finding 13).

14. Clean supplies were stored under the sink in four of 50 cabinets and not in accordance with hospital policy titled, "Environmental Cleaning and Disinfection Policy", and infection control standards in the following areas: auxiliary pathology lab, outside the entrance to the Operating Room (OR), Campus B; second floor, East Plaza of the outpatient clinic, Neuro Rehab Center; second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties (Refer to A750 finding 14).

15. One of one sampled endoscopic (a thin flexible tube with a camera and light at the tip, used to visualize the internal parts of the body) storage cabinets were observed with four endoscopes touching each other and allowing for possible damage and cross contamination and not stored in accordance with the manufacturer's guidelines titled, "[BRAND NAME] Reprocessing Manual" (Refer to A750 finding 15).

16. Garlic aioli was not monitored and part of the temperature cooling process in the bistro café kitchen and did not follow Food Code requirements (Refer to A750 finding 16).

17. Scrambled eggs that were previously cooked were above 41 degrees Fahrenheit (F) and were not monitored for temperature cooling process in the café kitchen in the main hospital in accordance with Food Code (Refer to A750 finding 17).

18. Previously cooked food items stored in the refrigerator in the bistro café kitchen were above 41 degrees F. and did not follow Food Code requirements (Refer to A750 finding 18).

19. Staff failed to ensure biohazardous waste containers (a regulated container storing needles, glass, medication, and sharp objects) were closed between operating room (OR) cases in accordance with national guidelines for two of four sampled biohazardous waste containers (Surgical Services 1, OR T-9) (Refer to A750 finding 19).

20. Staff failed to ensure clean and dirty equipment in the high-level disinfection (HLD - the process used for the destruction of all germs except for low levels of bacterial spores) cardiology (relating to the heart) decontamination (to remove dangerous germs from objects) workroom was separated in a manner to prevent cross-contamination according to national standards (Refer to A750 finding 20).

21. Hand hygiene was not performed after donning and doffing gloves for three of three sampled glove removals in accordance with hospital's P&P titled, "Hand Hygiene" and nationally accepted standards (Refer to A750 finding 21).

22. Employees did not have access to a handwashing sink that was separated from the decontamination sink in accordance with the CDC and OSHA regulatory regulations in the cardiology decontamination workroom (Refer to A750 finding 22).

23. There was no documented evidence that the hospital followed the manufacturer's instructions for use (IFU) for daily cleaning of 1 of 1 sampled transesophageal echocardiogram (TEE - a heart test using a camera, a flexible tube) machine, located in the Cardiology Outpatient Department, second floor of the main hospital (Refer to A750 finding 23).

24. Terminal cleaning was not done in accordance with the hospital's P&P, titled, "Procedural Area Terminal Cleaning," and nationally accepted standards and yellow spots were scattered throughout a wall vent for one of two sampled wall vents. (Surgical Services 2, OR 3) (Refer to A750 finding 24).

25. The heart-lung machine (Extracorporeal -- a machine that takes over the functions of the heart and lungs during surgery) was observed with brown and orange substances streaking down the side of the machine, (Surgical Services 2, OR 3) and not cleaned as per the hospital's P&P, titled "Medical Extracorporeal Life Support Guidelines" (Refer to A750 finding 25).

26. A fluid warmer in OR 3 had a brownish ring round the bottom of the basin and the basin case had several areas of chipped paint and rough brownish discoloration (Surgical Services 2) and not cleaned according to the hospital's P&P titled, "Procedural Area Terminal Cleaning," and nationally accepted standards (Refer to A750 finding 26).

27. 18 of 21 sampled surgical instrument case carts did not have clean/biohazardous (a biological substance that poses a threat to the health of living organisms) labels in accordance with the hospital's P&P titled, "Instrument Transport" and nationally accepted standards (Refer to A750 finding 27).

28. two of two sampled instrument loading carts (specialized heat-resistant cart used for steam sterilization) and two of two sampled autoclaves (machines used to sterilize patient reusable surgical instruments) (SPD 2nd floor) in accordance with the manufacturer's IFUs and nationally accepted standards for cleaning were followed (Refer to A750 finding 28).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe setting.

Based on interview and record review, the hospital failed to provide surgical services in accordance with acceptable standards of practice and did not ensure prevention of surgical errors for two (2) of twenty-four (24) patients sampled (Patient (Pt) 19 and Pt 30) when:

1. Pt 19 was consented for a right arm fistula creation [a connection between two parts of your body that do not normally connect. It often takes the form of a tunnel or passageway] by Medical Doctor 1 (MD1) and MD1 ordered a right arm nerve block (a procedure that numbs the nerves in the shoulder and arm area, providing pain relief) and did not verify the correct surgical site in accordance with the hospital's policy and procedure (P&P) titled "Universal Protocol - Procedural Areas" before performing a left shoulder nerve block. (Refer to A-0951, 3)

2. Pt 30 experienced a retained foreign object (RFO- a patient safety incident in which a surgical object is accidentally left in a body cavity or operation wound following a procedure) after a vaginal delivery surgical repair and during which the provider lost the suture needle used to repair a tear made during the birthing process. (Refer to A-0951, 1)

These failures led to Pt 19 receiving the wrong-side nerve block to the left shoulder and avoidable pain and suffering and temporary non-use of the left shoulder and Pt 30 experiencing a RFO, resulting in an imbedded surgical needle to Pt 30's right-sided vulva (the external (outer) female genital organs) causing pain and suffering, delayed healing, and repeated surgical procedures to remove the surgical needle.

The cumulative effect of these systemic deficiencies resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to promptly report a stage 3 pressure ulcer (a skin injury resulting from prolonged pressure, friction, or shear, leading to tissue damage) on Patient 92 in accordance with reporting requirements for CCR Title 22, Division 5, Chapter 1, Article 11.

This failure had the potential to result in skin and tissue injuries to not be reported timely.

Findings:

During a review of Patient (Pt) 92's "History & Physical (H&P)", dated 3/26/25, the "H&P" indicated Pt 92 was admitted on 3/26/25 for cellulitis (a common bacterial infection of the underlying tissues) of the right arm.

During a review of Pt 92's electronic medical record (EMR), the EMR indicated Pt 92 was placed in two-point (both wrists) Non-Violent restraints (devices that limit a person's freedom of movement) to prevent the patient from pulling on medical equipment on 3/27/25 at 4:30 a.m. until 3/29/25 at 12:54 p.m.; on 3/29/25 at 1:30 p.m. until 4/3/25 at 10:00 a.m.; and on 4/3/25 at 7:30 p.m. until 4/10/25 at 6:09 a.m. The EMR indicated Pt 92 was placed in four-point (both wrists and both ankles) Violent restraints (used to manage violent or self-destructive behavior) due to agitation on 4/10/25 at 10:15 p.m. until 4/11/25 at 10:23 a.m. The EMR indicated Pt 92 was placed in two-point restraints on 4/17/25 at 4:58 p.m. until 4/18/25 at 7:02 a.m. The EMR indicated Pt 92 was placed on four- point restraints on 4/23/25 at 9:00 p.m. until 4/24/25 at 10:48 a.m.; and on 4/24/25 at 11:55 p.m. until 4/28/25 at 4:17 p.m. The EMR indicated Pt 92 was placed in two-point restraints on 4/30/25 at 5:25 a.m. until 5/6/25 at 10:32 a.m. and on 5/6/25 at 5:25 p.m. until 5/9/25 at 12:40 a.m.

During a review of Pt 92's "Wound Specialist Note (WSN)", dated 5/3/25 at 10:12 a.m., the "WSN" indicated, " ...Wound consult received for 'left knee skin tear, pressure injury to coccyx' ... The buttock wound has skin breakdown ... It is important to note that any moisture associated concerns place this tissue is at higher risk for pressure injury ...Sacral/buttocks [coccyx area] denuded, partial and full thickness wound ...".

During a concurrent interview and record review on 5/14/25 at 8:48 a.m. with the Director of Critical Care (DCC) and the Wound Specialist Nurse Educator (WSNE), Pt 92's "Wound Line Drains and Assessment (LDA)" was reviewed. The WSNE stated the first time Pt 92's coccyx was noted on the "LDA" was on 5/3/25 at 5:17 p.m. (more than seven hours after the "WSN") and noted to be a stage 2 pressure injury (a partial-thickness loss of skin that extends into the first two layers of skin but not to the muscle). The DCC stated nursing staff should create an LDA for any skin injury as soon as it is identified even if they don't know what type of injury to call it. The DCC stated Pt 92's coccyx injury was moisture related and not a pressure injury, and thus not reportable. The DCC stated Pt 92's coccyx injury was both a partial and full-thickness injury.

During an interview on 5/15/25 at 12:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated if Pt 92's coccyx injury was a full-thickness skin loss, then it is a stage 3 pressure injury (into the fat tissue).

During a review of the hospital's policy and procedure (P&P) titled, "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", dated 9/13/24, the P&P indicated, " ... POLICY ... Upon identification of a suspected pressure injury, whether present on admission or hospital-acquired, the RN [Registered Nurse] shall photograph, describe and document the injury location on the appropriate section of the electronic health record (EHR) ... Staging/Treatment ... Stage 3 Pressure Injury - Full-thickness skin and loss with exposed muscle ...".

During a review of the hospital policy and procedure (P&P) titled, "Adverse Event Reporting to the California Department of Health Services", dated 1/3/22, the P&P indicated, " ... PURPOSE ... to comply with the mandated reporting requirements of Health and Safety Code §1279>1(b) ... Adverse event includes any of the following ... A stage 3 or 4 ulcer, acquired after admission ...".

During the review of a professional reference titled, "Prevention and Treatment of Pressure Ulcers/Injuries (P&T)", dated 2025, the "P&T" indicated, " ... individuals at risk of pressure injuries, especially when moisture and heat at the skin-surface interface are contributing factors ...".

During a review of a professional reference titled, "Classification of Pressure Injuries (CPI)", dated 10/2020, " ...Over the decades, PIs [Pressure Injuries] have had alternate naming conventions such as decubitus ulcers, pressure sores, and pressure ulcers. In 2016, the National Pressure Injury Advisory Panel (NPIAP), formerly the National Pressure Ulcer Advisory Panel, updated the definition of PI and the staging system to classify each PI type.1 The updated definition of PI reads 'A pressure injury is localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by microclimate, nutrition, perfusion, co-morbidities an condition of the soft tissue' ...".

During a review of a professional reference, California Code of Regulations (CCR), the CCR indicated, " ... Stage 3 pressure ulcer" means a full-thickness loss of skin ...".

Based on interview and record review, the hospital failed to follow their policy and procedure on grievances for one Patient (Pt) 6, when hospital staff were made aware of Pt 6's request to file a grievance related to his care in the Emergency Department and no grievance or follow up was made of Pt 6's concerns.

This failure resulted in not esuring Pt 6's request and right to have his grievance filed, addressed, and promptly resolved and the potential for other patients' grievances not to be filed, addressed and resolved.

Findings:

During a review of Pt 6's "Face sheet (FS)", dated 4/20/25, the "FS" indicated Pt 6 was Spanish speaking.

During a review of Pt 6's "Emergency Patient Timeline (EDTL)", dated 4/20/25 to 4/22/25, the "EDTL" indicated Pt 6 was brought in by ambulance on 4/20/25 for issues with his urinary catheter (a flexible tube used to drain urine from the bladder). The "EDTL" indicated Pt 6 had a history of congestive heart failure (CHF, a condition where the heart's pumping ability is impaired) and his oxygen saturation (percentage of oxygen in the circulating blood) was low. The "EDTL" indicated Pt 6 had blood drawn on 4/20/25 at 9:05 p.m., on 4/21/25 at 10:08 a.m. and 4:04 p.m. The "EDTL" indicated Pt 6 refused a blood draw on 4/22/25 at 4:01 a.m. and had blood drawn at 9:11 a.m.

During a review of "Intake Information (II, an online complaint for to the California Department of Public Health [CDPH])" dated 4/23/25, the "II" indicated Complainant (CO) 1 was a representative for the Program of All-Inclusive Care for the Elderly (PACE) of which Pt 6 was his client. "II" indicated on 4/22/25 at approximately 2:44 p.m., Pt 6 reported to him that he was currently in the hospital and stated on 4/21/25 in the afternoon medical staff wanted to draw blood a third time from him causing him concern. The "II" indicated, " ... My client [Pt 6] further reported that he clearly told the medical staff that he didn't feel comfortable with them drawing more blood a 3rd time, in such a short amount of time, so he panicked and resisted, and noted that medical staff still physically forced him to comply, to where he felt they were almost going to break one of his arms and were really hurting him during the process. My client, [Pt 6] reported that while medical staff were trying to restrain him, out of frustration, one of the medical staff stated 'Stupid, we're just trying to help you'. However, my client, Mr. [Pt 6] noted he already told medical staff "no", and that he did not feel comfortable with them drawing more blood from him, but that they didn't care to listen to him, and proceeded to draw his blood by force. My client, [Pt 6] reported that the medical staff there did not explain things clearly to him, and he was afraid to get more blood drawn as noted. My client, [Pt 6] also reported that medical staff advised him that he needed to fast today, but he noted he was very hungry, and that medical staff did not clarify to him for how long he needed to fast for. My client, [Pt 6] also reported that the medical staff there tending to him have and continue to be very unprofessional and rude, so he voiced wanting to file a grievance against the medical staff who treated him poorly ... I explained ... he would need to file a grievance there at the hospital, but that he can ask to speak to the Medical Social Worker [MSW] there to further assist him. My client, [Pt 6] then stated to me that he had already asked the medical staff at different times, that he wanted to speak to the Medical Social Worker there, but no one has came by to speak to him yet, and so he expressed that he felt medical staff are not taking him seriously and are ignoring his requests. I noted to my client, [Pt 6] that as soon as I ended the call, I would notify my client's assigned Primary Care Doctor and assigned RN [Registered Nurse] at my agency called [name of city] PACE on what my client shared with him, and will also call [name of hospital], and ask to speak to a Medical Social Worker for follow up, and will advocate for my client as needed. My agency medical staff and I have reached out to to [sic] the Medical Social Worker and Case Manager there at [name of hospital] and asked that they tend to our client's concerns and needs, and assisting him in filing a grievance against the medical staff who he reported mistreated him by using physical force ...".

During an interview on 5/8/25 at 1:39 p.m. with the Manager of Licensing and Accreditation (MLA), the MLA stated Risk Management was unable to locate a grievance for Pt 6.

During the review of "PACE Email Trail (Email)", dated 5/22/25, the "Email" indicated PACE RN Laison (RNL) wrote, " ... I called CM [CM 1] and informed her of all of his concerns/grievances and requested Spanish speaking staff. I also informed her to have a SW see him to address concerns as well and that he has been waiting ...". The "Email" indicated CO 1 wrote, " ... I just got off the phone with assigned SW [LCSW 1], to introduce myself, and to advocate for our [Pt 6's] need and his concerns regarding his treatment from medical staff ...".

During a review of Pt 6's "Case Manager Note (CMN)", dated 4/22/25, the "CMN" indicated, " ... Received a call from [RNL] @ [name of city] PACE. States patient is [sic] called there [sic] SW. States patient is upset regarding multiple lab draws and requesting to speak to SW. secure messages sent via [electronic message system name] to [RN 28] to follow up regarding above. Secure message sent via [electronic message system name] to [LCSW 1] requesting to follow up regarding above ...".

During a review of Pt 6's Social worker note (SWN), dated 4/22/25, the "SWN" indicated LCSW 1 wrote, " ... Received secure message from case manager requesting follow up with patient due to patient calling PACE upset about multiple lab draws ... Writer also received call from [CO 1] ... He stated that called their office with complaints of not being fed and having too many lab draws. He asked for someone to follow up with him. Writer reviewed chart and noted that patient has been nothing by mouth since midnight for possible procedure. Also noted that he has been refusing lab draws. Writer went by patient's room. He was eating and did not appear to be in any distress. Social worker will follow up with patient tomorrow morning due to time constraints today ... Addendum: Patient moved to 8th floor. Handoff sent to unit social worker via secure chat ... [Revision History 4/23/25] ...".

During a concurrent interview and record review on 5/13/25 at 11:09 with LCSW 1 and the Social Work Supervisor (SWS), Pt 6's SWN and CMN were reviewed. LCSW 1 stated she was not aware Pt 6 wanted to file a grievance. LCSW 1 stated she went by Pt 6's isolation room (a specialized hospital room designed to isolate patients with contagious disease or to protect those with weakened immune systems, preventing spread of infection) at the end of her shift, saw that he was eating, and did not make contact with Pt 6. LCSW 1 stated she intended to come back in the morning to see Pt 6. LCSW 1 stated in the morning Pt 6 had been moved to a new floor and she sent a message to LCSW 2 who covers the new unit. SWS stated LCSW 2 never wrote a note in pt 6's medical record and therefore, did not make contact with Pt 6. The SWS stated there was a discharge note by Discharge Navigator on the day of discharge, 4/28/25 and it did not address food, lab draws or staff behavior. The SWS stated if case management/social work do not follow up on patient concerns, it can be detrimental to their health and this incident was an opportunity to improve communication.

During an interview on 5/15/25 at 11:30 a.m. with the Chief Nursing Officer (CNO), the CNO stated if patient concerns are not dealt with there could be, " ... a bad experience overall ...".

During a concurrent interview and record review on 5/22/25 at 9:55 a.m. with CO 1, "II" was reviewed. Referring to his notes, CO 1 stated he spoke to Licensed Clinical Social Worker (LCSW) 1, expressed concerns, asked for assistance to Pt 6 in filing a grievance and later spoke to LCSW 1 again who stated Pt 6 was then assigned to LCSW 2. CO 1 stated Case Manager (CM) 1 was also aware of the complaint.

During a review of the hospital's policy and procedure (P&P) titled, "Patient and Patient's Representative complaint & Grievance", dated 10/30/24, the P&P indicated, " ... PURPOSE ... To meet patients' reasonable expectations of care and service in a timely, reasonable and consistent manner ... DEFINITIONS ... Complaint: Any concern expressed by the patient or patient's representative concerning care or service that can be resolved as soon as possible by the staff or managers present while hospitalized. A complaint is considered resolved when the patient or patient's representative is satisfied with the actions taken on their behalf ... POLICY ... Issues that qualify as grievances include ... Complaints that involve allegations of abuse or neglect ... Situations where the patient or patient's representative requests the complaint be handled as a formal complaint or grievance ... PROCEDURE ... If the concern cannot be resolved by the person receiving the complaint, the chain of command is followed until the complaint can be addressed. The supervisor on duty for the point of service (POS) is contacted. If the supervisor is not available, contact the manager; if the manager is not available contact the director ... If the situation endangers or potentially endangers the patient, such as neglect or abuse, Risk Management is to be contacted immediately ... DOCUMENTATION ...All complaint and grievances will be reported and documented in the IRIS [Incident Reporting Intranet System, the hospital's secure incident reporting system] system ..."

Based on observation, interview and record review, the hospital failed to ensure care was provided in a safe setting for seven of 11 sampled Emergency Department (ED) patients (Patient (Pt) Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45) when:

The hospital failed to ensure the patient's right to emotional health and safety (the components of an emotionally safe environment: respect, dignity, and comfort) as well as his/her physical safety and quality of care for seven of 11 sampled patients (Pt) (Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45) by providing services to them in the Emergency Department (ED) instead of appropriately moving them into an inpatient room which deprived Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45 of the amenities (something that helps to provide comfort, convenience, or enjoyment (such as a private or semi-private room, private or semi-private bathroom, showers, call bell system, inpatient hospital bed, television, smoking etc.) available on the inpatient units. Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44 and Pt 45 each were assessed and treated in the ED, determined to require inpatient care and were provided all or most of their care in the ED, rather than the appropriate inpatient unit.

These failures resulted in a violation of Pts Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45) (hallway patients) rights to privacy and dignity when they remained in a hallway bed (a gurney/stretcher), out in plain view of other patients, staff, and visitors in a very busy and crowded ED while they waited for many hours up to several days for an inpatient admission bed. Pt 2 was admitted and held in the ED in a room. The wait time (or TT) required both hall and room patients to share access to a limited number of available ED restrooms (no showers available). Pts in ED hallway beds did not have access to call bells to request staff assistance, they did not have privacy while eating, or toileting (if incontinent (unable to voluntarily control retention of urine or feces in the body), etc.). Pts admitted and held in the ED hallway beds, or room beds were not provided with hygiene care, meals, did not benefit from a quiet healing space, the use of a telephone, and television available to Pts on the inpatient units.

Findings:

During a telephone interview on 5/1/25 at 3:49 p.m. with Complainant (CO) 3, CO 3 stated her family member, Pt 2, was admitted to the hospital as an inpatient on 4/24/25 but remained in the ED for 110 hours before being moved to an inpatient room. CO 3 stated Pt 2 endured the discomfort of a gurney during her long stay in the ED. CO 3 stated she requested a regular hospital bed for Pt 2, and staff informed CO 3 only bariatric (wider and longer for larger bodies) beds were allowed for the ED, but none were available. CO 3 stated Pt 2 did not receive her meal on several occasions throughout the time she was held in the ED. CO 3 stated Pt 2's hospital gown, underclothes, sheets, or pillowcases where not changed and new items were not provided for the entire length of the ED stay. CO 3 stated Pt 2 was moved to the Medical Oncology Unit (a specialized hospital unit where patients with cancer receive treatment and care) on 4/29/25 in the afternoon. CO 3 stated Pt 2 did not receive the same level of care in the ED as in the inpatient unit. CO 3 stated on the inpatient unit Pt 2's care included hygiene, meals, and a wound nurse consultation. CO 3 stated on the inpatient unit Pt 2 had a bathroom in the room, had a quiet and restful environment, and had a much more comfortable bed.

During a concurrent observation and interview on 5/6/25 at 10:30 a.m., with the Director of the Emergency Department (DED), and the ED Managers (MEDs), MED 1 and MED 2 in the ED unit, observation of the ED included a tour of the unit. The ED was observed to be very busy, with many patients of all ages on gurneys or hallway beds as well as in rooms. MED 1 stated there were 205 patients in the ED with a total of 128 patients admitted and held in the ED waiting for an inpatient bed assignment. During the tour, patients were observed to be waiting, eating, sitting on gurneys interacting with the one visitor allowed at bedside or receiving infusions of IV medications, throughout the three zones in the ED, Red, Yellow, Green, and in the overflow East Hall/South Hall areas. The DED stated patients were provided with privacy screens upon request. Privacy screens observed, while providing patient privacy, contributed to the already cluttered state of the hallways and made visualization of patients without a means to alert staff for help (there are no call bells available to hallway bed patients) was difficult. The DED stated nursing staff were in the hallways to watch and listen to patients calling out for assistance, because no call bells were available for any hallway patients.

During a concurrent observation and interview on 5/6/25 at 10:40 a.m. with Pt 45 in the ED East Hall Overflow area, Pt 45 was observed lying in a hallway gurney in a hospital gown, with disheveled (untidy) hair, and noticeable body odor. Pt 45 did not have a call light, a television, or a telephone near him. Pt 45 stated he had been at the hospital for three days. Pt 45 stated he had not been "cleaned up (shower, clean gown, or sheets)" or brushed his teeth since he had been in the hospital. Pt 45 stated he would like to clean up and he would like to hurry the process along so he can go home.

During a concurrent observation and interview on 5/6/25 at 1:31 p.m. with the Director of Critical Care (DCC), Pt 2, and CO 3 in Pt 2's inpatient hospital room, Pt 2 was observed in a clean hospital gown, with neatly combed hair, sitting upright in a wheelchair, next to her hospital bed, with family member (CO 3) at bedside. Pt 2 had healing wounds with scabbing on both hands. Pt 2 had a type of medical boot on both feet with toes exposed, and scabbing was observed on the toes. Pt 2's lips were observed with healing wounds. Pt 2 stated she did not like the care she received in the ED. Pt 2 stated she believed the nurses in the ED could not give the kind of care they do on the inpatient unit, because they seemed too busy. Pt 2 stated she did not have her gown or bed sheets changed while in the ED. Pt 2 stated she was not given a bath, or oral care, and no one cleaned her hands prior to eating. Pt 2 stated the inpatient unit was restful, she was bathed, the bed was more comfortable, and she felt more cared for than when she was in the ED.

During an interview on 5/6/25 at 1:40 p.m., with the Manager (M) of the Cardiac Progressive Care Unit (CPCU- a specialized hospital unit that provides care for patients with heart conditions who require more intensive monitoring and treatment than a regular medical ward), on the CPCU, the MCPCU stated they were staffed for 58 beds, total capacity [on the unit] was 64 beds. The MCPCU stated she was not aware of how many ED holds were waiting for a bed assignment and transfer to the CPCU, since she last checked earlier "this morning." The MCPCU explained the unit was divided into 2 sections- East and Central each assigned a Clinical Supervisor (CS). The MCPCU stated both CSs were free of a patient assignment.

During an observation and interview on 5/6/25 at 2:31 p.m. with Pt 44 and RN 11 in Pt 44's ED hospital room in the Green Zone, Pt 44 stated he was agreeable to an interview. Pt 44 was a frail elderly patient with disheveled hair, in a hospital gown, lying flat on a gurney. Pt 44 stated he came to the hospital five days ago and was first placed in the hallway by an elevator. Pt 44 stated it was noisy, and he didn't sleep. Pt 44 stated he was in the hall for two nights and was in a room for three days. Pt 44 stated he had not showered since arriving at the hospital. Pt 44 stated he also had no gown change, linen (bed sheets, pillowcases, and blankets) change, or toothbrush provided. Pt 44 stated he was going to ask today, because no one had offered any hygiene supplies. RN 11 stated she would provide the hygiene supplies he needed. Pt 44 stated meals were on time in the room, but in the hall sometimes food did not come at all.

During an interview on 5/6/25 at 2:36 p.m. with RN 11, in the ED Green Zone, RN 11 stated, Patients should have hygiene supplies, clean gowns, linens... to feel human while they were in the hospital." RN 11 stated patients should be asked about hygiene and should be cleaned up every day, and the hygiene should be documented in the medical record.

During an interview on 5/6/25 at 2:51 p.m. with RN 12, in the ED Yellow Zone, RN 12 stated the difference in care from admitted ED patients versus ED patients were skin assessments were more through, completing medication reconciliation, and providing an air mattress to prevent skin breakdown. RN 12 stated ensuring the patient and linen were clean was important because it helped to prevent skin breakdown and reduced infection risks. RN 12 stated the hospital used to have call bells in the hall, but "I don't know where they are now". RN 12 stated, patients called out when they needed help. RN 12 stated, patients were at a higher risk for falls without a call bell, because they could try to get up without help if they needed to go to the bathroom or if they were confused.

During a concurrent observation and interview on 5/6/25 at 3:40 p.m. with the Director of Capacity Operations (DCO) and Pt 42 in the Discharge Lounge (an area in the hospital where patients can wait while the final steps of their discharge processes are being completed.), Pt 42 was observed in street clothes, sitting in a recliner chair, with intravenous (IV- medical technique that administers fluids, medications and nutrients directly into a person's vein) antibiotics (medication to destroy germs) infusing into the right wrist. Pt 42 stated he wanted to talk about his experiences in the ED. Pt 42 stated he arrived at the ED on 5/1/25 at around 8 p.m. and the ED was very busy. Pt 42 stated he was on a gurney in the hallway for the first few days, then moved to an area in the green zone with curtains around the gurney. Pt 42 stated he had never been admitted to the hospital before and he did not know what to expect, but he expected basic human care and did not receive that. Pt 42 became tearful and stated he was not offered hygiene supplies, a shower, a clean gown or his linens changed while he was held in the ED. Pt 42 stated he had to ask for a toothbrush and some bath wipes (pre-moistened cloths used for bathing patients without water) to clean himself a few days after admission, but he did not feel clean without a shower. Pt 42 stated cleanliness was important to him. Pt 42 stated he had to request socks from the staff. Pt 42 stated he got one pair but was expected to walk across the dirty ED floor to go to the bathroom. Pt 42 stated the bathroom was filthy and was shared with all the patients in the zone he was in so it was often occupied. Pt 42 stated he felt dehumanized and did not feel taken care of while in the ED. The DCO stated patients should feel cared for when in the hospital no matter what unit they were in. The DCO stated the level of care for admitted patients should be the same for ED and inpatient units.

During a concurrent observation and interview on 5/6/25 at 3:55 p.m. with the DCO and Pt 43 in the Discharge Lounge, Pt 43 was sitting in a recliner chair, dressed in street clothes, with a family member at the chairside. Pt 43 stated she was agreeable to an interview. Pt 43 stated she was in the ED for two days. Pt 43 stated she was admitted as an inpatient and discharged from the ED. Pt 43 never moved to an inpatient unit. Pt 43 stated no one changed her sheets or her gown during her admission, and she had to get her bath wipes from a cart because no one offered them to her. Pt 43 stated the bathroom in the green zone was filthy, so she would go down to the yellow zone because it wasn't as dirty.

During an interview on 5/7/25 at 9:25 a.m. with Nurse Supervisor (NS) 1 on the 7th floor Medical Oncology (dedicated area within the hospital that focuses on the diagnosis, treatment, and care of patients with cancer) and Progressive Care Unit (PCU- offer a higher level of monitoring and intervention than standard medical-surgical floors). NS 1stated staff on the inpatient unit used the bath wipes to clean patients after a bowel movement (BM) but used wash cloths with water and soap to clean the patients every day. NS 1 stated patients were wiped with chlorhexidine (CHG-antiseptic [a chemical agent to prevent the growth of germs]) wipes everyday as well. NS 1 stated patients received a clean gown and clean bedding every day. NS 1 stated ensuring the patients were clean and on clean linens helped to prevent infection.

During a concurrent observation and interview on 5/7/25 at 11:30 a.m. with the DED in the main ED Green, and Yellow Zones, the ED was observed to be busy with patients of all ages in the halls on gurneys. The ED census was 102 admitted patients. There was very little room to move through the hall between patients, staff, and visitors. No call bells were again observed with the patients in the hallways. The DED stated the patients in the halls do not have call bells, and to "think of the environment". The DED stated the bells would be very loud and distracting to other patients in the area. The DED stated the nurses could see the patients and the patients could call out for help. When asked about hospital beds for comfort for the admitted and held patients, the DED stated hospital beds did not work in the ED halls because there was no room for them due to the size of the bed (too large). The DED stated the ED rooms could house the bed, but the patients were moved in and out of the rooms frequently and the beds were cumbersome (large, heavy difficult to move). The DED stated the hall patients obviously did not get the same level of care as the patients moved to the inpatient units, and there was no private bathroom for any of the patients. The DED stated he believed the hospital care was the same because the patients received consultations, case management and discharge planning as the patient would on the inpatient unit. The DED stated his expectation was for the patients to get daily care and for nursing staff to respond to patient needs when doing patient rounding. The DED stated oral care, and changing gowns was a part of daily care. The DED stated his expectation was nursing staff would ensure patient hygiene was taken care of.

During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the DED, Pt 2's "History & Physical [H&P- an assessment from physician including medical history and exam]," dated 4/24/25, Admission Transfer Discharge (ADT), and "Daily Care Flowsheet (DCF)", dated 4/24/25 to 4/29/25, were reviewed. The DED stated Pt 2 arrived at the ED on 4/24/25 at 5:10 p.m. The "H&P" indicated, Pt 2 was 80-years old with a past medical history (PMH) of lung cancer (abnormal cell growth) on immunotherapy (utilizes medications to boost the body's immune system to target and destroy cancer cells). The "H&P" indicated Pt 2 had open sores to mouth, lips, hands, feet, and other areas of the body. The "ADT" indicated Pt 2 was admitted to the hospital on 4/24/25 at 8:39 p.m. The DED stated Pt 2's admitting diagnosis was an allergic reaction. Pt 2 was held in the ED as an inpatient from 4/24/25 until 4/29/25. Pt 2 was moved to the inpatient Medical Oncology Unit on 4/29/25 at 11:06 a.m. Pt 2's total time spent in the ED was 138 hours. The "DCF" indicated on 4/25/25 at 9:59 a.m. Pt 2 ate "25%" of the meal. The "DCF" indicated, on 4/25/25 no lunch, dinner or snacks were provided, on 4/26/25, 4/27/25, and 4/28/25 no breakfast, lunch, dinner or snacks were provided. The "DCF" indicated, on 4/29/25 at 6:56 p.m. "0%" diet eaten. The DED stated nutrition should be documented, and when patients refuse meals, the refusal should be documented. The "DCF" indicated, Pt 2 did not have any hygiene care (bath, linen change, hair wash), or oral care provided from 4/24/25 to 4/29/25 at 2 p.m. The DED stated if the nursing staff provided daily care, it should be documented. The DED stated, daily care interventions such as hygiene, and oral care were a part of all patient's plan of care. The DED stated that all patients had a right to cleanliness and hygiene. The DED stated, assuring patients' hygiene needs were met decreased the risk of infections.

During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the Director of Emergency Department (DED), Pt 2's "Daily Care Flowsheet (DCF)", dated 4/24/25 to 4/29/25 and "Physician Orders (PO)," dated 4/25/25 to 4/29/25, were reviewed. The "PO" dated 4/24/25 at 10:27 p.m. indicated, Regular Diet. On 4/25/25 at 9:59 a.m. The "DCF" indicated on 4/25/25 at 9:59 a.m. Pt 2 ate "25%" of the meal. The "DCF" indicated, on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no breakfast, lunch, dinner or snacks were provided. The "DCF" indicated, on 4/29/25 at 6:56 p.m. "0%" diet eaten. The DED stated nutrition should be documented, and when patients refuse meals, the refusal should be documented.

During an interview on 5/8/25 at 11:38 a.m. with MED 1, MED 1 stated, the mattresses in the ED were the same as the inpatient beds, just smaller to fit in the ED. MED 1 stated, the inpatient hospital beds electronic adjustable movements, for the knees and feet were "just for comfort".

During an interview on 5/8/25 at 11:02 a.m. with the DED and MED 1 Pt 45's "ED Pt Care Timeline (EDCT)", and "DCF" dated 5/4/25 to 5/6/25, were reviewed. The "EDCT" indicated, " ...Arrival ...5/4/25 at 1:48 p.m. ...TT [time spent in the ED before being moved to the inpatient bed] 54:58 [hours:minutes] ... 1:52 p.m. Start Triage Initiated ...2:02 p.m. ED Notes Addendum Chief Complaint Patient presents with Pain Chest x [for] 2 days ... brought in by ambulance from home for CP [chest pain], on right side radiates [spread] with stomach ... Wheelchair Bound [confined to a wheelchair] ... 2:05 p.m. Patient roomed in ED To room EAST H [number] [hallway gurney] ... 5/5/25 11:44 a.m. Admission Information ... Patient Admit Service: Medicine ... Requested Bed Type ... CPCU Tele [Cardiac Progressive Care Unit a telemetry unit is a floor in a hospital where patients undergo continuous cardiac (heart) monitoring], ... Precautions ... Aspiration Precautions ... Fall precautions ... Nursing - Cardiac monitoring, progress mobility as tolerated ...". Care was provided to Pt 45 in the ED in an overflow hallway bed from 5/4/25 through 5/6/25 at 8:46 p.m. when he was moved to an inpatient CPCU Pt 45's "DCF" indicated no hygiene, or nutrition were provided to Pt 45 for 5/4/25 and 5/5/25. The DED stated the patient should have his daily care and meals documented.

During an interview on 5/8/25 at 11:18 a.m. with the DED Pt 44's "H&P", "ADT" and, and "DCF" dated 5/4/25 to 5/7/25, were reviewed. The H&P indicated Pt 44 was an 85-year-old male who arrived in the ED on 5/4/25 by ambulance for fever and chills. The DED stated Pt 44 was admitted as an inpatient on 5/4/25 at 12:48 p.m. The DED stated Pt 44 was admitted as an inpatient for Systemic Inflammatory Response Syndrome (SIRS- widespread pain, swelling, throughout the body). The "ADT" indicated Pt 44 was held in the ED as an inpatient from 5/4/25 to 5/6/25. Pt 44 was held in the ED for 52 hours and 35 minutes. The "ADT" indicated Pt 44 was in a hallway bed as an inpatient for 25 hours and 35 minutes, Pt 44 was in an ED room for 27 hours. Pt 44 was transferred to an inpatient hospital room on 5/7/25 at in the ED observation unit for 18 hours and 2 minutes and was transferred to a progressive care unit (PCU) on 5/7/25 at 9:07 p.m. The "DCF" indicated Pt 44 had no hygiene care documented from 5/4/25 to 5/6/25. The DED stated Pt 44 had no meal documentation on 5/4/25 or 5/6/25. The DED stated Pt 44 should have all daily care activities and all meals documented in the medical record.

During a concurrent interview and record review on 5/8/25 at 2:05 p.m. with the DED and MED 1, Pt 43's "EDCT", and "DCF" dated 5/4/25 to 5/6/25 were reviewed. The "EDCT" indicated, " ...Arrival 5/4/25 at 10:02 a.m. Depart 5/6/25 2:47 p.m. TT 52:45 ..." The DED stated Pt 43 was never moved to an inpatient unit, Pt 43 was admitted as an inpatient, held, and was discharged from the ED. The "EDCT" indicated, " ... 5/4/25 10:05 a.m. ...To room R-04 [room Red Zone] ...5/4/25 10:06 a.m. Chief Complaints Updated difficulty breathing ... 5/4/25 12:33 p.m. Decision to Admit ... 5/4/25 Admission Information Patient Admit Service: Medicine ... Bed Requested ... Medicine ... 5/4/25 Patient Transferred from room R-04 to YH [Yellow Zone Hall] ...5/5/25 3:48 a.m. Transfer to Green [Green Zone] ...5/6/25 at 2:47 p.m. To department DC [discharge] Lounge ...". The DED stated the "DCF" had no documentation indicating nursing staff provided Pt 43 with daily care (hygiene, bathing, oral care, gown or linen changes from 5/4/25 to 5/6/25. The DED stated daily care should have been provided to and documented for Pt 43 during her ED admission.

During a concurrent interview and record review on 5/8/25 at 2:18 p.m. with the DED and MED 1, Pt 42's "EDCT", and "DCF" dated 5/1/25 to 5/3/25 were reviewed. The "EDCT" indicated, " ...Arrival 5/1/25 at 8:27 p.m. Depart 5/3/25 8:56 p.m. TT 48:29 ..." The DED stated Pt 43 was moved to an inpatient unit on 5/3/25. The "EDCT" indicated, " ... 5/1/25 8:28 p.m. Triage Started ...5/1/25 8:30 p.m. Chief Complaints Updated Jaundice [a yellow discoloration of eyes and skin] (Pt presented to [other hospital] for abdominal pain and yellow eyes for 3 days ...) ...5/1/25 10:48 p.m. decision to admit for observation ...5/2/25 12:21 a.m. ...Admit to Inpatient ...Bed Requested ... Medicine ...5/3/25 8:53 p.m. Transport to: 4C CPCU ...". The DED stated the "DCF" had no documentation indicating nursing staff provided Pt 42 with daily care from 5/1/25 to 5/3/25. The DED stated nursing notes indicated on 5/3/25 at 4:52 Pt 42 received toiletries.

During an interview on 5/9/25 at 10:53 a.m. with MED 1 and the DED, MED 1 stated ED leadership want to make sure the patients in the ED were comfortable. MED 1 stated he recognized the patients may not be as comfortable as on the inpatient units, but he believed the care was equitable (fair). The DED stated ED staff were able to give comparable care at the level "we are able to" (since the unit does not have all things the inpatient units have). The DED stated the ED staff were providing the standard of care by the policy. When asked about a patient's right to hygiene, the DED stated he did not know if they were providing the standard of comfort the inpatient departments had, but the ED staff were attempting to provide what they could knowing the environment they work with. The DED stated he believed the ED was meeting the standard of care.

During a review of hospital Policy and Procedure (P&P) titled, "Standard of Practice for Emergency Department", dated 9/23/24, indicated, " ...Maintain and/or improve skin integrity during hospitalization through appropriate nursing interventions. Promote patient comfort, cleanliness, and sense of well being by assisting with activities of daily living (ADL's) ...". According to hospital P&P the ED nursing staff were not following the Standard of Practice.

During a concurrent observation and interview on 5/9/25 at 1:39 p.m. with the DED and MED 1 in the main ED, staring in the Green Zone, the area was loud and busy with patients lining the walls in gurneys. MED 1 stated the census was 200 ED patients and 107 admitted patients. The DED stated bed control determined which patients went up first to the inpatient units. The DED stated the ED did not have a specific area for admitted patients and the ED nurses adapted to the patients coming into the ED. The DED stated nursing staff were assigned to a geographic area and were assigned to the patient in the area. The DED stated the charge nurse gave patient assignments. The Yellow Zone was busy with patients lining the halls and was comparable to the noise and congestion of the Green Zone. The Red Zone was calm, and quiet, without nurses rushing around, and with only one patient in a hall bed.

During an interview on 5/9/25 at 1:47 with LVN1, RN 2 (charge nurse) and the DED, LVN 1 stated she was assigned to the Green Zone areas Q, R, S, T for the day. LVN 1 stated she had four patients assigned to her and all four patients were admitted inpatients. LVN 1 stated one of her duties was to help patients with their meals. LVN 1 stated when the patient had a special diet, she would call the kitchen to get the meal. LVN 1 stated hot foods were microwaved for the patients in the ED, because they came from the kitchen cold the night before. LVN 1 stated the patients usually had two choices of a heated meal or a cold sandwich. LVN 1 stated some of the inpatient units had a menu the patients could choose from but not in the ED. LVN 1 stated the Green Zone had one microwave, and the yellow zone had two microwaves to heat the meals. The DED stated the Red Zone did not have a microwave. The DED stated the ED had one shower and patients were not taken upstairs to any inpatient units to shower. When asked if the patients were able to get out of bed and stretch their legs or walk, especially the hallway patients. RN 2 stated the staff tried to limit circulatory ambulation (patients walking around the unit) around the unit to prevent the patients from engaging in other patient's care. RN 2 stated, "We do our best create privacy". When asked if there was a place for patients to go to receive sensitive medical news or treatments, RN 2 stated the staff could utilize the treatment rooms for privacy if the patient was in a hall bed. RN 2 stated, in his experience staff utilizing the treatment rooms was infrequent. LVN 1 stated, she never witnessed staff utilizing the treatment rooms for privacy to speak with patients.

During an interview on 5/9/25 at 2:13 with the DED, RN 2, and Patient Care Technician (PCT) 1, PCT 1 stated she liked the "fast pace" of the ED. PCT 1 stated, if the patient was "just ED" the patient came in and received care right away. PCT 1 stated "just ED" meant the patient would be in and out of the ED quickly. PCT 1 stated her role was to assist patients with activities of daily living (ADLs-feeding, bathing, toileting, drinking, oral care, mobility). PCT 1 stated her role was about the same for admitted patients as ED patients. PCT 1 stated she worked 12-hour shifts and worked from 7 a.m. to 7:30 p.m. When asked if she could speak to one of her patients and ask if surveyors could speak with them for a moment, PCT 1 stated she did not really know any of them. PCT 1 stated she had not spoken to them today and stated they had been "calm" today. PCT 1 stated it was typical (usual) not to talk to the patients.

During an interview and record review on 5/9/25 at 3:10 p.m., with RN 27, on the CPCU RN 27 stated "Daily Cares (Toileting, bathing/showering, hand cleansing, assisting with drinking and eating, etc.)" are offered daily as a routine on the unit.

During a concurrent interview and record review on 5/9/25 at 3:18 p.m. with the Director of Critical Care (DCC), Pt 2's "DCF", dated 4/24/25 to 4/29/25, was reviewed. The DCC stated Pt 2's first hygiene documentation began on 4/29/25 at 2 p.m. The DCC stated Pt 2 was moved to the inpatient unit on 4/29/25 at 11:06 a.m. The DCC stated there should be the same level of care provided to patients in the ED as on the inpatient units, meals, hygiene, wound care, and comfort. The DCC stated gurneys were not the same as the inpatient hospital beds. The DCC stated gurneys were not as comfortable as inpatient hospital beds.

During an observation and interview on 5/9/25 at 3:35 p.m., with Registered Nurse (RN) 1 and Pt 25, in Pt 25's room, Pt 25 was observed to be lying on his left side, head on his left shoulder. Pt 25 was wearing a hospital gown hair disheveled, with eyes closed. Pt 25 consented to be interviewed about his admission. Pt 25 stated he was not helped in toileting/shower or bed bath, "was down there [in ED] three (3) days, bed was not comfortable, was in a hallway, stated he requested a shower and was not provided one."

During an interview on 5/9/25 at 3:42 p.m., with PCT 3, on the CPCU, PCT 3 stated, with a new patient, she makes sure to get the room ready by placing toiletries and other patient care items (soap, toothbrush, etc.) so when the patient comes to the unit, they are ready to offer toileting if needed. PCT 3 stated on the new admission patient arrival she checks Vital Signs (VS- Blood pressure, Heart Rate, etc.) and reports any abnormal VS to the primary nurse. PCT 3 stated she has only floated to the ED as a sitter (1:1 observation for safety), stated completed PCT daily cares as needed only for the patient she is sitting with.

During a review of hospital document titled, "History and Physical (H&P-define)" dated 5/2/25, the document indicated Pt 17 was a 41-year-old male with history of seizure disorder (seizure - a sudden burst of electrical activity in the brain. It can cause changes in behavior, movements, feelings and levels of consciousness), autism spectrum disorder (a condition that affects a person's ability to communicate, interact socially, and understand the world around them), schizophrenia (a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions), and developmental delay. He arrived at the hospital through the Emergency Department (ED) on 5/2/25 and was discharged on 5/6/25.

During a concurrent interview and record review on 5/12/25 at 3:00 p.m. with the Manager of unit 1 East (M1E), M1E reviewed Pt 17's chart and stated Pt 17 was admitted as an inpatient on 5/2/25 and stayed in the ED for 4 days. M1E stated Pt 17 was transferred to an inpatient bed on 1 East on 5/6/25, the same day he was discharged home. The hospital document titled, "Flow Sheet" was reviewed, which showed that on 5/2/25, 5/3/25, and 5/4/25, Pt 17 was not provided meals or snacks. On 5/5/25 at 11:00 a.m., the flowsheet indicated Pt 17 drank 111 ml (Milliliters - a unit of liquid measure. 111 ml is a little less than ½ cup.) At 2:35 p.m., the flowsheet indicated Pt 17 ate "50%" of his meal. M1E was unable to find any other documentation indicating Pt 17 ate or drank anything else during his 4-day stay. M1E stated, "he may have been refusing meals, but if he was, they didn't document it." M1E stated Pt 17 was not receiving any fluids intravenously (fluid going directly into a vein to keep patient hydrated.) The hospital document titled, "Care Plan Details," dated 5/6/25 indicated, " ... Intervention Details: REMINDER(s): Eating environment enhancement. Encourage self-feeding. Ensure dentures available. Provide verbal encouragement ..." The document titled, "Physician Orders" dated 5/2/25 indicated, "Diet: Regular." M1E stated, "He didn't receive the same level of care that he would have if he had been transferred to our unit (1 East) on the day he was admitted. We would have had more time to assess his needs, and we would have noticed if he wasn't eating.

During a review of the hospital document titled, "Diet Manual & Enteral Nutrition Formulary 2025," the manual indicated, " ...Patients who refuse the foods served will be offered substitutes of equal nutritional value. This may include oral nutrition supplements ..."

During an interview on 5/15/25 at 11:25 a.m., with the Chief Nursing Officer (CNO), the CNO stated, "this should never happen. If the patient was eating, it should be documented. If the patient wasn't eating, that should be documented as well, and the doctor should be notified. A hard reset is needed. These things should never happen." The CNO stated his expectation was for nursing staff to provide patients with daily care activities (hygiene, oral care, meals, linen changes, etc.) regardless of the patient being admitted, in the ED, or a patient on the inpatient units.

During a review of the hospital's P&P titled, "Patient's Rights and Responsibilities", dated, 3/14/25, indicated, " ...the hospital shall provide processes to support the following patient rights: 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting ..."

During a review of the hospital's P&P titled, "Oral Care", dated 2/15/22, indicated, " ...PURP

Based on interview and record review the hospital failed to ensure two of eight sampled patients (Patient [Pt] 8 and Pt 92) were free from all forms of abuse and harassment when:

1. Doctor of Osteopathy (DO, licensed physician with a unique focus on the Muscles and bone systems) 1, who was not assigned to provide care for Pt 8, entered Pt 8's hospital room and sexually assaulted Pt 8, including fondling her breasts and genitals without gloves on 5/6/25 at 5:11 a.m. Doctor of Osteopathy (DO) 1 entered a restricted area of the Emergency Department, and was not assigned to any patient in the area, entered Pt 8's hospital room without turning on the lights and without introducing himself to Pt 8 as a physician and did not obtain permission from Pt 8 and examined Pt 8's back, breasts, buttocks and genitals in a manner where she "felt completely violated [fail to respect (someone's peace, privacy, or rights)] by the way he was touching me". DO 1 was not assigned as a physician for Pt 8 and after examining Pt 8 left the room without turning on the light or documenting in Pt 8's electronic medical record.

These failures resulted in Pt 8 feeling afraid, anxious, angry and feeling as if she was sexually assaulted. These failures resulted in Pt 8's right to be free from abuse and her right to have care in a safe setting. All patients cared for by DO 1 were and are at risk of harm as a result of these failures.

2. Staff were aware of Pt 92's aggressive and combative behavior and history of confusion and alcohol withdrawal, Pt 92 kicked Patient care Technician (PCT) 2 and PCT 2 immediately and inappropriately responded by slapping Pt 92. Pt 92's physical abuse was not self-reported by the hospital and should have been.

This failure resulted in a probable avoidable physical abuse of Pt 92.

Findings:

1. During a concurrent interview and record review on 5/8/25 at 3:28 p.m. with the Director of the Emergency Department (DED) and Manager of the Emergency Department (MED) 1, Pt 8's "Emergency Department Patient Care Timeline (EDCT)," "Nursing Notes (NN)", "Provider Notes (PN)", "Social Work Notes (SWN)", dated 5/3/25 to 5/6/25, and "Discharge Summary", dated 5/6/25 were reviewed. The "EDCT" indicated, Pt 8 arrived in the ED on 5/3/25 at 10:56 p.m., and the chief complaint was all-terrain vehicle (ATV) accident, with pain and deformity to left arm and elbow. Pt 8 reported wearing no helmet and driving 20 miles per hour. The "EDCT" indicated, Pt 8 was admitted to ED observation (a specific area within an ED where patients requiring extended monitoring and evaluation are cared for) on 5/4/25 at 8:18 a.m. and was transferred to the ED Observation Unit at 9:17 a.m. The "EDCT" indicated, Pt 8 transferred to the surgery department on 5/4/25 at 2:29 p.m., and transferred back to the ED Observation Unit after an open reduction internal fixation of the left elbow surgery (ORIF- procedure to repair a severe broken bone by realigning the broken bone and using screws, plates, or rods to secure the bone while it heals) at 7:40 p.m. The "PN" dated 5/5/25 at 7:19 a.m. written by the Orthopedic (physician that specializes in the diagnosis, treatment, and prevention of injuries and diseases of the bones, muscles, joints, ligaments, and tendons) physician indicated, " ... Seen and examined ...complaining of severe left elbow pain about the left elbow ... Patient has poorly controlled postoperative pain ..." The "EDCT" indicated, Pt 8 remained in the ED Observation Unit on 5/5/25, and received pain medications. The "EDCT" indicated on 5/6/25 at 5 a.m. Pt 8's primary nurse, Registered Nurse (RN) 15 documented "Hourly Observation Status: Observation Continues" The "EDCT" indicated, RN 15 administered two medications to Pt 8 on 5/6/25 at 5:20 a.m. The "NN" created on 5/5/25 at 8:39 p.m. by RN 15 had an addendum was added on 5/6/25 at 5:30 a.m. " ...Patient states that one male wearing green scrub with badge came to her room without introducing himself in the dark without turning light on. He started to listen to her heart touching her inappropriately. He also asked [her] to lay flat and started to examine her private area touching her inappropriately. He stayed 5-10 min and left per patient ...".

The "EDCT" indicated, Pt 8's attending physician documented a "Significant Event Addendum" on 5/6/25 at 6:47 a.m., " ...I was alerted by nursing staff that the patient states someone came into her room and touched her chest inappropriately without consent. Appropriate notifications made to hospital security and supervisors. Social work consulted for APS [Adult Protective Services] report ...". The "NN" from 5/6/25 at 7:02 a.m. written by Nursing Supervisor (NS) 3 indicated, " ...0620 [6:20 a.m.] Risk Management Notified at this time ... patient's complaints this morning of being inappropriately touched by a [physical description] male, dressed in mint-colored scrubs ...". The "PN" indicated, Pt 8 was evaluated by the orthopedic physician on 5/6/25 at 7:35 a.m. with no mention of the incident. The "EDCT" indicated, Social Worker (SW) 1 documented on 5/6/25 at 8:42 a.m., " ... 0800 (8a.m.) Informed by OBS (Observation Unit) RN Supervisor - Patient sexually assaulted by medical staff member this morning at 0530 (5:30 a.m.) ... SW placed a call to [city] PD (police department) ...will come to bedside unknown ETA (estimated time of arrival) ...". The "EDCT" indicated the PD did not come to the hospital to speak with Pt 8, Pt 8 wanted to be discharged and have the police go to her home. The "EDCT" indicated Pt 8 was discharged from the hospital on 5/6/25 at 5:55 p.m. The "Discharge Summary" indicated, Pt 8 was "OK to d/c [discharge] per ortho [orthopedic physician]". The "Discharge Summary" indicated, Pt 8 remained in ED Observation pending PD report but wished to "d/c to f/u [follow up] with PD at a later date".

The DED stated, there were "a lot of people consulting" (meaning the patient had other specialties besides orthopedic physicians advising and recommending treatments to her primary physician), and you can see "someone" going into the patient's room on the surveillance video, the "person" came out, but the "person" has a mask on, so they did not know who the "person" was. The Patient came out as soon as the "person" left the room and reported someone inappropriately touched her. The DED stated Risk Management, and Social Workers were involved. The DED stated leadership and Risk Management interviewed staff and pieced the information together. The DED stated there were no interactions between the nursing staff and "person" wearing a "mask, badge and some scrubs", who went into the room then right back out. The DED stated the "person" was in the room "less than five or 10 minutes". The DED stated the hospital still had one more staff member to interview, and stated the Surveyor would need to speak to Risk Management for the results of investigation. Pt 8's record review indicated no documented entries from anyone during the time of the incident, 5/6/25 between 5:11 a.m. and 5:17 a.m. the time the alleged perpetrator was in the room with the alleged victim. Pt 8's record had no documented entries on 5/6/25 from any consulting physicians. Pt 8's record had one assessment documented by her Orthopedic physician at 7:35 a.m. and a discharge summary written by her attending physician at 5:17 p.m.

During a telephone interview on 5/12/25 at 9:27 a.m. with Pt 8 at home, Pt 8 stated, she arrived at the ED on Saturday for an accident she was in. Pt 8 stated she had surgery on her elbow on Sunday, and the plan was to go home the following day, Monday (5/5/25), but she was in so much pain the physicians decided for her to stay one additional day and discharge her Tuesday (5/6/25) morning. Pt 8 stated her parents went to the hospital to eat dinner with her on Monday night, because she was no longer in pain. Pt 8 stated she told her mother she did not have to stay the night with her because she "was in good hands", and "she's not a baby". Pt 8 stated on Monday morning 5/6/25 around 5 a.m.-5:10 a.m. a man came into her room, and she was just coming out of her sleep. Pt 8 stated she twisted over and looked up at him. Pt 8 stated she thought the man was a doctor coming to do an exam. Pt 8 stated the man said to her, "oh I am going to do an exam". Pt 8 stated, the man explained to her he was going to check her heart, and he put the stethoscope against her chest, then he began touching her breast in "weird ways". Pt 8 stated the man put his hands on both sides of her breasts, pushed them together and said, "oh this is nice", then released them. Pt 8 stated the man checked her arms and then asked her to roll to her left to check her back, Pt 8 stated she told him she could not turn to the left due to the surgery on the left elbow, so he told her to turn to the right. Pt 8 stated the man began checking her back and spine. Pt 8 stated she was unaware what he was doing, then he pulled her pants down from behind lifted her bottom and separated her buttocks. Pt 8 stated she felt something from behind and squirmed, flinched and made a noise, and the man said, "oh you are fine", then went behind her head. Pt 8 stated the man began snapping his fingers and asked if she could hear, and she responded yes, he asked her to open her mouth and stick out her tongue, then went around to the front of the bed. Pt 8 stated, the man asked her if she was on her mensural cycle (Menstrual cycle is the regular discharge of blood and mucosal tissue from the inner lining of the womb) and she said no, her knees were bent up on the bed and he tried to push her knees apart then pulled down the front of her pants exposing her genitals (private parts). Pt 8 stated the man then said she was going to be discharged that day, and left the room, closing the curtain behind him. Pt 8 stated the man was whispering, and did not turn on the lights, the only light was the dim light from the hall. Pt 8 stated the man did not introduce himself, or wear gloves. Pt 8 stated the man did not have a mask on in the room. Pt 8 thought it was weird because everyone else had introduced themselves. Pt 8 stated "right when he left" she (Pt 8) went out of the room and asked staff sitting near her room who the person was, because she felt something was wrong by the way he was touching her. Pt 8 stated her nurse RN 15 said take your meds, just calm down. Pt 8 gave a detailed description of the man who came into her room, Pt 8 stated the room was too dark to read the name badge. Pt 8 stated the man was not anyone she had seen during her stay.

During a concurrent observation and interview on 5/12/25 at 10:27 a.m. with MED 1 in the ED Observation Unit, security badge access was required for entry. The unit was calm and quiet, shaped like a horseshoe with the nursing station at the front of the horseshoe's closed end. The patient areas were off the unit's hall and hospital staff called the area's "pods", there were four pods in each area with a bathroom in the pod area at the back wall center location. The unit had four pods with four beds each for a total of 16 beds. The beds were separated by a curtain that hung from the ceiling and surrounded the hospital bed. The area where Pt 8's room was located was directly to the right of the nurse's station (when facing the nurses' station from the front) and against the wall nearest the building's windows. A monitor technician was seated on the far right of the nursing station. There were computers at the nursing station and a nurse, and a nursing supervisor were seated at the station typing on the computer. Pt 8's room was approximately 10 to 12 feet away from the nurse's station, directly in the line of sight from the nurse's station. MED 1 stated the RNs were often in and out of the rooms, but the monitor tech and the nursing supervisor sit at the desk.

During an interview on 5/12/25 at 10:32 with Monitor Technician (MT) 3 on the ED Observation Unit, MT 3 stated, only people with badge access could enter the unit, and visitors had to call into the unit for staff to let them in. MT 3 stated the unit only allowed two visitors per patient at a time, so she watched to make sure people did not have too many because there was not a lot of room in the pods. MT 3 stated she would feel comfortable asking someone if they needed help or what they were doing on the unit if they looked lost. MT 3 stated, she would probably not stop someone who looked like a physician, because she would assume they know where they are going and what they were doing.

During an interview on 5/12/25 at 10:39 a.m. with NS 2 on the ED Observation Unit, NS 2 stated, if she saw someone coming to the floor in scrubs with a badge and a stethoscope, she was likely to follow them. NS 2 stated, "I am kinda nosy about that stuff", and NS 2 stated she preferred to listen to physicians for a while to update the patient notes. NS 2 was not aware of allegations submitted by Pt 8.

During an interview on 5/12/25 at 10:43 a.m. with RN 14 on the ED Observation Unit, RN 14 stated, if a patient came out of their room and reported someone assessed them but they did not know who or why, he would first look through the patient's medical record to see if the patient had any consultations pending. RN 14 stated he would notify his supervisor. RN 14 stated he felt comfortable asking people to identify themselves. RN 14 was not aware of the allegations submitted by Pt 8.

During a concurrent surveillance video review and interview on 5/12/25 at 2:48 p.m. with the Interim Security Director (ISD), Pt 8's surveillance video from 5/6/25 beginning at 5:11 a.m. to 5:17 a.m. was reviewed. The ISD agreed with the following sequence of events. The video began on 5/6/25 at 5:11 a.m. with a west facing view of the hallway of the ED Observation Unit. At 5:11 a.m. a male (DO 1) of medium height in mint green jogger scrubs with greenish yellow tennis shoes with a stethoscope around his neck was walking up the hall, away from the camera. DO 1's face could not be seen. DO 1 was walking at a normal pace. A female staff member (RN 15) was sitting at a computer workstation on wheels at the top of the camera frame, the computer was located near the far wall at the end of the unit, about four feet from where Pt 8's pod was located. RN 15 was looking at the computer screen. DO 1 crossed in front of RN 15 and turned left into a pod area, out of the camera frame. DO 1's face was not visible. The ISD stated the area DO 1 entered was the area of Pt 8's room. Shadows indicating movement could be seen on the floor to the right of the screen, directly across from where the man turned left. The ISD stated the nurse's station was on the right of the screen. At 5:14 a.m. a different female staff member (RN16) was observed walking in the hall with a computer workstation on wheels. RN 16 crossed the frame of the video into the pod area pushing the computer workstation on wheels, at 5:16 a.m. RN 16 walked out of Pt 8's pod area with the workstation on wheels and stood by the nursing station looking at the computer screen. At 5:17 a.m. DO 1 walked out of Pt 8's pod area. DO 1 turned to the right and walked up the hall, toward the camera, at a noticeable faster pace than when he walked onto the unit. RN 16 was standing at the workstation on wheels near the nurses' station when DO 1 left Pt 8's pod area. RN 16 could be seen turning her head quickly to the left to look towards DO 1. DO 1 did not speak with any of the staff on the unit and no staff stopped DO 1. DO 1's face was seen on the camera; DO 1 was wearing a surgical mask. DO 1 had a badge on the left side of his scrub top. The surveillance video ended prior to Pt 8 alerting staff of her concerns. The ISD stated he believed Pt 8 reported her concerns shortly after DO 1 walked down the hall and out of the ED Observation Unit. DO 1 entered Pt 8's Pod at 5:11 a.m. and exited at 5:17 a.m.

During an interview on 5/12/25 at 2:56 p.m. with the RMD, the RMD stated the Risk Management Department was notified of the incident with Pt 8 on 5/6/25, the same day as the allegation. Nursing notes indicated Risk Management was notified on 5/6/25 at 6:20 a.m. The RMD stated the hospital initiated immediate investigation including staff interviews, requesting surveillance video, chart reviews, and security badge access reports. The RMD stated the hospital did identify someone who met the description of the person Pt 8 said examined her, a physician at the hospital (DO 1). The RMD stated someone who matched DO 1's description went into Pt 8's hospital room. The RMD stated DO 1 used his security badge in different areas and security was able to follow him on the cameras and through the security badge report. The RMD stated DO 1 was not Pt 8's physician, or part of Pt 8's care team (a group of healthcare members who work together to provide care for a patient). The RMD stated DO 1 was not assigned other patients on the unit on 5/6/25 and was not assigned to examine any patient on the unit at the request of another physician. The RMD stated DO 1 was a [specialty] hospitalist. The RMD stated, DO 1 did not document anything in Pt 8's medical record. The RMD stated there was no need for this physician to examine Pt 8 because he was not a part of her care team.

The RMD stated on 5/6/25 the date Pt 8 reported the incident with DO 1, nursing staff notified the clinical supervisor (NS 3), primary physician, house supervisor, and risk management. The RMD stated, risk management called the on-call administrator. The RMD stated the social worker notified the PD, and Adult Protective Services (APS). The RMD stated all notifications were on 5/6/25.The RMD stated no other complaints were reported to the Risk Management Department to indicate DO 1 had any other allegations like Pt 8 at the hospital. The RMD stated Risk Management then notified their leadership and the Peer Review (physician experts in a specific field who evaluate physician conduct) Committee. The RMD stated on 5/6/25 DO 1 was summarily (immediately) placed on administrative leave. The RMD stated the Risk Management Department's investigation was completed and turned over to Medical Staff for peer review (further investigation). When asked about DO 1 allegedly performing breast, buttock and a genital exam on Pt 8 the RMD stated physicians could have a chaperone with them during assessments, especially if there was a private area to be assessed, but the hospital had no current policy indicating a chaperone was needed for exams. The RMD stated a policy was in progress but was not yet approved for implementation. The RMD stated that a chaperone during an exam was good for both the patient and the care provider. The RMD stated nurses did not stop DO 1because they did not know if he was coming in to examine her, and if he was a consultant physician. RMD stated a root cause analysis (RCA-a systematic process used to identify the underlying causes of a problem, rather than just addressing the surface symptoms) had not yet been decided or discussed.

During a hospital document review titled, "Badge Access Audit (BAA)", dated 5/6/25, the "BAA" indicated, 5/6/25 at 5:06 a.m. DO 1 entered the parking lot. The "BAA" indicated, at total of five different badge "card admitted" uses. The "BAA" indicated at 5/6/25 at 5:09 a.m. DO 1 entered the hallway to the ED Observation unit. The "BAA" indicated on 5/6/25 at 5:17 a.m. leaving the ED observation unit.

During a telephone interview on 5/13/25 at 9:11 a.m. with RN 15, RN 15 stated she was the primary nurse for Pt 8 the morning of the incident on 5/6/25, and she recalled the incident between Pt 8 and DO 1. RN 15 stated she works the night shift from 7 p.m. to 7:30 a.m. RN 15 worked the night of 5/5/25 and the morning of 5/6/25, with her shift ending at 7:30 a.m. RN 15 stated Pt 8 reported to her on the morning of 5/6/25 after 5 a.m. someone with a stethoscope, went to Pt 8's room without turning on the light, or introducing themselves and listened to Pt 8's chest area, then inappropriately touched her chest and breasts, was told to lay on her side, and the man touched Pt 8's buttocks, then Pt 8 was told to lay flat, and the man touched her "private area". RN 15 stated Pt 8 also reported the man snapped his fingers around Pt 8's ears, and said can you hear. RN 15 stated she did not remember seeing the man on the unit. RN 15 stated she did not recall the last time she saw Pt 8 before the incident, but it was at least thirty minutes or more, because she administered pain medications to Pt 8. RN 15 stated physicians generally came and left the ED Observation Unit without telling nursing staff. RN 15 stated the physician would only inform nursing staff if the nurse was needed for something. RN 15 stated only the orthopedic physicians would round (assess the patients) in the morning. RN 15 stated usually one or two physicians went and checked on the surgery site (cut area from surgery) and then left. RN 15 stated she did not have any means to check on physicians to determine if they were licensed or credentialed. RN 15 stated Pt 8 was very frightened and was crying when she reported the incident. RN 15 stated Pt 8 wanted the security footage to be checked right away. RN 15 stated she told her supervisor right away, and the primary physician was notified. RN 15 stated the primary physician said "ok". RN 15 stated she had "no idea" of any way to prevent something like this incident from re-occurring. RN 15 stated she should keep an eye on the physicians going into the patients' rooms, but it would be difficult because the nursing staff are in many different rooms.

During an interview on 5/13/25 at 9:47 a.m. with the DED, the DED stated he was aware of Pt 8's experience and the alleged conduct of DO 1 and stated several risk mitigation measures (the process of planning for and lessening the negative impact of potential risks) proved problematic (difficult). In the ED the security logs were reviewed to ensure only active personnel had access and the hospital removed access for people who should not have it. The ED Observation Unit had access granted to most physicians due to consulting services. The DED stated nurses should have some awareness about who was entering the patient's rooms. The DED stated in the ED Observation Unit, there may be Orthopedic physicians, or Surgeons getting consents signed, or physicians rounding on patients. The DED stated DO 1 should not have been on the ED Observation Unit in Pt 8's room. The DED stated the PD had to authorize a sexual assault examination of a patient, and the patient was not interviewed by the PD until Pt 8 was discharged. The DED stated the ED Observation Unit was a closed unit and required a security badge for entry.

During an interview on 5/13/25 at 2:53 p.m. with the RMD, the RMD stated DO 1 had no patient complaints at any other hospitals he previously worked to her knowledge. The RMD stated, information about DO 1's background check was completed through the Medical Staff Office. The RMD stated DO 1's security badge access was removed on 5/6/25, the same day DO 1 was placed on administrative leave. The RMD stated Risk Management did not interview DO 1. DO 1 was not interviewed by hospital staff.

During an interview on 5/14/25 at 7:38 a.m. with the DED and Patient Care Technician (PCT) 4, PCT 4 stated she recalled the incident with Pt 8 from the morning of 5/6/25. PCT 4 stated she worked the night shift on 5/5/25 and was working the morning of 5/6/25 when Pt 8's incident occurred. PCT 4 stated the morning of the incident she was sitting at the computer in the pod where Pt 8's bed was located. PCT 4 stated she heard someone walk past her, turned her head and saw a tall man wearing scrubs peeking through the curtain into Pt 8's bed area. PCT 4 stated she turned back to the computer to finish her work and did not see the man go in, but PCT 4 stated she saw the man pull apart the curtain. PCT 4 stated, the next thing she saw was him leaving. PCT 4 stated minutes after he left, the patient walked out of her room and asked who the man was in her room and told PCT 4 she was uncomfortable with him. PCT 4 stated RN 15 went into the pod, and the patient came out of the curtain and spoke to RN 15. PCT 4 stated security came to the unit. PCT 4 stated the patient was upset, became emotional and began crying. PCT 4 stated the incident made her feel uncomfortable, that something like this could have happened. PCT 4 stated she did not realize DO 1 was there, and wished she could have helped Pt 8 more.

During an interview on 5/14/25 at 7:52 a.m. with NS 3, NS 3 stated, he recalled the incident with Pt 8 from the morning of 5/6/25. NS 3 stated he was the Nursing Supervisor for the night of 5/5/25 and morning of 5/6/25. NS 3 stated RN 15 approached him and told him Pt 8 was distraught, because a man wearing mint green scrubs, came into her room never turned on the light, never introduced himself, inappropriately touched her and she felt violated. NS 3 reported the incident to leadership and got orders from the physician for the SW consult. NS 3 was at the nurse's station and did not see the man come on the unit. NS 3 stated Pt 8 went out of her room and spoke to RN 15, but RN 15 was speaking faintly so NS 3 did not hear the conversation. NS 3 stated he (NS 3) did not speak to the patient at all, but RN 15 described in detail what Pt 8 reported. NS 3 stated he felt devastated, Pt 8 came to the hospital to get better and something like this happened.

During an interview on 5/14/25 at 7:58 a.m. with RN 16, RN 16 stated she recalled the incident with Pt 8 from the morning of 5/6/25. RN 16 stated she was working the night shift from 5/5/25 to 5/6/25. RN 16 stated while passing medications for a patient directly across from Pt 8's bed in the same four bed pod, RN 16 heard a man's voice with Pt 8. RN 16 stated, a male walked out of Pt 8's room area, but she was focused on the computer. RN 16 stated, the gentleman passed by and walked to the side of her. RN 16 stated she did not look at his face and RN 16 stated the man walked quickly causing RN 16 to see movement, so RN 16 turned around. RN 16 stated the thought was, "who is walking by so fast?" RN 16 stated the man was bald and in scrubs, so she figured the man was a doctor or something. RN 16 stated shortly after the man walked down the hall Pt 8 walked out of her room and spoke to PCT 4. RN 16 stated Pt 8 said the man did not introduce himself and asked her about her last menstrual cycle RN 16 stated Pt 8 seemed upset, and RN 16 knew "something was not right". RN 16 stated physicians should document patient assessments. RN 16 stated she never had an experience where a physician examined a patient and did not document the exam.

During an interview on 5/14/25 at 11:49 a.m. with the Director of the Neurological Hospitalist Department (DNH), the DNH stated he (the DNH) was DO 1's Supervisor. The DNH stated, his (DNH) role was to provide a safe environment for patients and physicians, and he set clear expectations for his physicians. The DNH stated he was now aware of the allegations Pt 8 made against DO 1. The DNH stated he was not involved in the investigation. The DNH stated he received a phone call on 5/6/25 at 6 p.m. from the hospital's Medical Executive Committee (oversee the peer review process to ensure the quality of medical care provided by the medical staff) President and was informed about the action taken with DO 1 not the details for the action. The DNH stated DO 1 was removed from the schedule. The DNH stated on 5/13/25 Pt 8's medical record was given to him to review. The DNH stated after a chart review, he determined no physicians from his service, including DO1, were involved in Pt 8's care, so the DNH closed Pt 8's medical record, concluding his investigation as to whether DO 1 was part of Pt 8's care team. DO 1 was not part of Pt 8's care team. The DNH stated the team of physicians he directs provides care for neurological cases (brain, spinal cord, nerves). The DNH stated Pt 8 was an orthopedic case. The DNH stated a neurological assessment would include an assessment of the head area and cognition (how well someone is able to think, learn, remember, and use judgment and language). The DNH stated the physicians he supervised had a template to document in the patient's record and all assessments were supposed to be documented. The DNH stated, as far as he was aware DO 1 had no other complaints against him. The DNH stated Pt 8 was not one of the neuro group's patients and was not a neuro case. The DNH stated DO 1 was not scheduled to work on Tuesday 5/6/25. The DNH stated the transition of teams' assignment change was on Wednesday's at 7 am. The DNH stated the transition would have occurred on 5/7/25. The DNH stated Pt 8's allegations would indicate moral and ethical behaviors not in line with that of a physician.

During a review of hospital document titled "Call Schedule", dated 5/1/25 to 5/31/25, the "Call Schedule" indicated DO 1 was not scheduled to work from 5/1/25 to 5/7/25.

During a concurrent interview and record review on 5/14/25 with Director of Medical Staff Department (DMS), DO 1's credentialing (process that establishes the qualifications of licensed professionals and assesses their background and legitimacy to provide services) documents, "Reappointment Approval Form" dated 10/31/24, "Peer References", dated 6/14/24, and "Background Screening Report", dated 6/14/24. The DMS stated DO 1 had active status as a member of Medical Staff at the hospital. The DMS stated DO 1 had no restrictions (no limitations or conditions) on his medical license. The "Background Screening Report" indicated, "County Court Search", "Nationwide Criminal Search", and "State Sex Offender" results were complete and clear of any negative reports. The two "Peer Review" documents indicated DO 1's peers rated him "above standard" for "Ethical Practice [acting in a manner that is morally right and fair, adhering to principles of honesty, integrity, and respect for others]", "Responsibility toward patients", "Responsibility toward their profession", and "Responsibility toward society". The "Reappointment Approval Form" indicated, on 10/10/24 the Credentials Committee agreed with department recommendation and DO 1 was reappointed with Medical Staff status. The DMS was aware of allegations by Pt 8 against DO 1 and stated DO 1 was "summarily suspended- decision made by the MEC or president of the MEC." The DMS stated DO 1's EMR access, badge access, any access to all campuses where DO 1 might have privileges were suspended on 5/6/25.

During an interview on 5/14/25 at 3:14 p.m. with the Director of Medical Staff Department (DMS) the DMS stated, DO 1 was suspended on 5/6/25 by Medical Staff. The DMS stated on 5/8/25 the Medical Staff Department contacted an outside investigation firm. The DMS stated on 5/12/25 the firm was approved. The DMS stated she did not know if anyone investigated DO 1's electronic medical record usage to determine which patients were accessed by DO 1 and not assigned to him.

During an interview on 5/15/25 at 11:30 a.m. with the Chief Nursing Officer (CNO) the CNO stated, he was aware of the incident involving Pt 8 and the sequence of events that led to the report of alleged misconduct by DO 1. The CNO stated, the facility identified a medical staff member as the male person Pt 8 identified entering her room and allegedly touching her inappropriately. The CNO stated, the medical staff member was suspended, and a third-party vendor would be completing the investigation. The CNO stated nursing staff should have some awareness of who was seeing the patient (physicians). The CNO stated nursing and medical staff should slow down and be engaged in the patient's care, to communicate. The CNO stated when physicians assess patients the documentation should be in the patient's medical record.

During an interview on 5/15/25 at 2:42 p.m. with Risk Management Analyst (RMA) 1, RMA 1 stated DO 1 had remote access (ability to access electronic medical records off site) prior to 5/6/25. RMA 1 stated on 5/6/25 DO 1's remote access, and security badge access were removed at the time administrative leave started. RMA 1 brought in the contact number for DO 1's legal counsel when the surveyor requested DO 1's telephone number and the information of the third-party investigation company.

During a review of the hospital's policy and procedure (P&P) titled, "Standard of Practice for Emergency Department", dated 9/23/24, indicated, " ... Intervene appropriately

Based on interview and record review, the hospital failed to have an effective Quality Assurance and Performance Improvement (QAPI-is a systematic approach to improving the quality of care and services delivered to patients) program that tracked and monitored adverse events (AE- a harmful and negative outcome that happens to a patient provided medical care) and implement preventive measures when:

1. The QAPI committee failed to monitor and track the use of the "Universal Protocol" in the pre-operative area where nerve blocks are sometimes performed. Patient (Pt) 19 was consented for a right arm fistula creation [a connection between two parts of your body that don't normally connect. It often takes the form of a tunnel or passageway] by Medical Doctor 1 (MD1) and MD1 ordered a right arm nerve block (a procedure that numbs the nerves in the shoulder and arm area, providing pain relief) and did not verify the correct surgical site in accordance with the hospital's policy and procedure (P&P) titled "Universal Protocol - Procedural Areas" before performing a left shoulder nerve block. Pt 19's nerve block was performed in the pre-operative area. (cross reference A-0951,3).

This failure resulted in no time-out being performed, which was part of the hospital Universal Protocol, which may have prevented the wrong side nerve block in Pt 19.

2. Hospital staff failed to submit an adverse event report (IRIS-Incident Reporting Intranet System) at the time of Pt 30's "lost" suture needle event, in accordance with hospital P&P titled "Adverse Event Reporting" dated 1/3/22 and within 45 days.

This failure resulted in the QAPI committee not investigating the incident and not performing a root cause analysis (RCA-is a method used to identify the main cause of an issue), for 77 days, the RFO (suture needle) after vaginal delivery on 2/21/25, to determine the cause and implement measures to ensure future incidences would not occur. (Refer to A-0951, 2).

Findings:

1. During an interview on 5/14/25 at 2:45 p.m. with the DRM, the DRM explained how the hospital responded after they learned of the wrong side nerve block. The DRM stated they did a root cause analysis (RCA - a structured process for investigating incidents to determine the cause or causes) and found that the education regarding timeouts before nerve blocks may not have reached the providers. DRM stated they have now completed education with the anesthesia group and with the surgeons. Anesthesia Leadership reinforced "Universal Protocol - Procedural Areas" to make sure that anesthesia providers (medical doctors who specialize in anesthesia and CRNAs) know that a separate timeout is required for regional blocks (such as nerve blocks on arms or legs), spinals (Spinal blocks are injected directly into the spinal fluid through a needle in the patient's back, providing immediate and complete pain relief) , or epidurals (epidurals are injected into the space outside the spinal fluid sac, allowing for continuous pain relief and greater control of pain levels without taking away all feeling.) DRM stated they also trained all staff that a nurse must be present for the timeout, and the timeout must be documented in the procedure record.

During an interview on 5/15/25 at 11:00 a.m. with the Chief Nursing Officer (CNO) the CNO stated the root cause of the wrong side nerve block was the failure to do a timeout before the nerve block. The CNO described a timeout as. "A period to validate everything in the room. Everything before you cut."

During a review of hospital Policy and Procedure (P&P) titled, Universal Protocol - Procedural Areas" dated 12/19/22, the P&P indicated, " ... I. PURPOSE: A. To provide guidance to peri-procedural personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures. B. To provide guidance for improving team communication through a culture of safety in order to reduce the incidence of medical errors. II. DEFINITION: A. Provider: A person who is authorized to provide care as determined by privilege or competency through the Medical Staff and the Board of Trustees - including the following: 1. Medical Staff Member: Physicians and others granted membership on the Medical Staff and, for purposes of this policy, includes individuals with temporary clinical privileges. 2. Advanced Practice Professional (APP): Physician assistants and advance practice nurses including nurse practitioners, certified nurse midwives, certified registered nurse anesthetists and other non-physician providers who provide direct patient care services under a defined degree of supervision by a physician Medical Staff Member. 3. Learner: A student, resident or fellow who does not have privileges or credentials on the Medical Staff of [name of health system] for their academic program ... III POLICY: A. The Universal Protocol must be followed on all procedures that require an informed consent. This includes all invasive/operative procedures, and all procedures done under Procedural Sedation whether invasive or noninvasive. B. The Universal Protocol must be followed in all areas of the organization where the procedure is performed (e.g., Operating Room (OR), Cardiac Catheterization Laboratory (CCL), lnterventional Radiology (IR), Nuclear Medicine, Endoscopy, etc.). C. The Universal Protocol must be practiced whether the provider is doing the procedure alone (e.g., insertion of central line), or as part of a greater team (e.g., in the OR or CCL). D. The Universal Protocol is composed of the following elements: Pre-Procedure verification; Marking the site, when applicable; Procedural Briefing; Time Out; Debriefing ....D. Timeout: 1. The Time Out is a standardized process that is performed with the healthcare team and used throughout the hospital before all operative/invasive procedures. The healthcare team involved in the procedure must pause to conduct a final verbal and audible verification of all safety elements listed below. This pause is referred to as a Time Out. 2. The Time Out involves the immediate members of the procedure team, including the individual performing the procedure and other active participants who will be participating in the procedure from the beginning. A. Conduct the Time Out immediately before the procedure begins with the patient properly positioned, prepped and draped ...All activities are to be suspended for the duration of the Time Out, to the extent possible, without compromising the safety of the patient so that all members of the team are focused on elements of the Time Out. Each team member will play a role in the process ... D. Time Out addresses and verbally confirms among all team members the following elements: ... Correct procedure and laterality (when applicable) as consented. Ill. Site marked (when applicable).

2. During an interview on 5/9/25 at 10:54 a.m., with DWC, DWC stated her preliminary investigative findings in the matter of Pt 30's RFO event, were that staff failed to submit an IRIS report on the day the RFO was detected (2/21/25). DWC stated to her knowledge, the only IRIS report submission was the report submitted by the DRM on 5/9/25. DWC stated her expectation was for staff to submit an IRIS report per hospital P&P, and as soon as possible once the adverse event occurs.

During an interview on 5/16/25 at 11:02 a.m. with CNO, the CNO stated his expectation was for staff to report events such as the RFO incident on Pt 30 and that "what goes in should come out pre and post [areas] should be preparing the patient and all counts are done/accounted for and appropriately tracked to prevent RFO events.

During a review of the facility's policy and procedure (P&P) titled, "Adverse Event Reporting to the California Department of Health Services," dated 1/3/22, the P&P indicated, "To comply with the mandated reporting requirements of Health and Safety Code 1279.1 (b). To support the improvement of patient safety and quality improvement initiatives ... Adverse event includes any of the following: Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient ... It shall be the policy of [hospital name] to report an adverse event, as define within Health Safety Code 1279.1, to the CDPH no later than five days after the event has been detected; or, if the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients ... not later than twenty-four (24) hours after the adverse event has been detected ... In addition, the regulations specify the hospital is subject to an onsite investigation when CDPH determines that an adverse event or complaint is an ongoing threat of imminent danger of death or serious bodily harm. It is also our policy to investigate the source of the event, initiate any mitigation actions that may be indicated and cooperate fully with the CDPH throughout the process. All adverse events which may be considered reportable as defined by this policy shall be reported to the Supervisor/Manager immediately by involved staff and an Incident Reporting Intranet System (IRIS) completed within 24 hours ...It will be the responsibility of the Risk Manager to develop and submit the initial report to the CDPH..."

Based on observation, interview and record review, the governing body (GB), medical staff and administrative officials failed to implement effective actions to address the known problem of a high number of inpatients provided care in the Emergency Department (ED). The hospital and Quality Assurance and Performance Improvement (QAPI-is a systematic approach to improving the quality of care and services delivered to patients) Committee submitted an acceptable Plan of Correction (POC) in response to a Centers for Medicare and Medicaid Services (CMS- a federal agency that administers the Medicare, Medicaid, and other health insurance programs) authorized federal survey findings in August 2024 related to patients seen in the ED, admitted to an inpatient unit and remained in the ED for their entire inpatient stay; patients did not experience the benefits of inpatient unit care. The current survey found seven of eleven sampled patients (Pt [Pt 2, Pt 17, Pt 25, Pt 42, Pt 43, Pt 44, and Pt 45]) were brought into the ED, determined to require admission to an inpatient unit and remained in the ED. The QAPI actions were not sufficient to address the high number of inpatients in the ED. (cross reference A144, finding 1)

These failures resulted in not evaluating on an ongoing basis the effectiveness of improvement actions and denied patients the benefit and services that inpatient unit can provide and the ED does not provide. From January 2025 to May 2025 these failures resulted 2,206 total number of patients denied the benefit of services of inpatient units.

Findings

During a concurrent interview and record review on 5/12/25 at 3:00 p.m. with the Manager of unit 1 East (M1E), M1E reviewed Pt 17's chart and stated Pt 17 was admitted as an inpatient on 5/2/25 and stayed in the ED for 4 days. M1E stated Pt 17 was transferred to an inpatient bed on 1 East on 5/6/25, the same day he was discharged home. The hospital document titled, "Flow Sheet" was reviewed, which showed that on 5/2/25, 5/3/25, and 5/4/25, Pt 17 was not provided meals or snacks. On 5/5/25 at 11:00 a.m., the flowsheet indicated Pt 17 drank 111 ml (Milliliters - a unit of liquid measure. 111 ml is a little less than ½ cup.) At 2:35 p.m., the flowsheet indicated Pt 17 ate "50%" of his meal. M1E was unable to find any other documentation indicating Pt 17 ate or drank anything else during his 4-day stay. M1E stated, "he may have been refusing meals, but if he was, they didn't document it." M1E stated Pt 17 was not receiving any fluids intravenously (fluid going directly into a vein to keep patient hydrated.) The hospital document titled, "Care Plan Details," dated 5/6/25 indicated, " ... Intervention Details: REMINDER(s): Eating environment enhancement. Encourage self-feeding. Ensure dentures available. Provide verbal encouragement ..." The document titled, "Physician Orders" dated 5/2/25 indicated, "Diet: Regular." M1E stated, "He didn't receive the same level of care that he would have if he had been transferred to our unit (1 East) on the day he was admitted. We would have had more time to assess his needs, and we would have noticed if he wasn't eating."

During a review of hospital document titled, "History and Physical (H&P- an assessment from physician including medical history and exam)" dated 5/2/25, the H&P indicated Pt 17 was a 41-year-old male with history of seizure disorder (seizure - a sudden burst of electrical activity in the brain. It can cause changes in behavior, movements, feelings and levels of consciousness), autism spectrum disorder (a condition that affects a person's ability to communicate, interact socially, and understand the world around them), schizophrenia (a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions), and developmental delay. He arrived at the hospital through the Emergency Department (ED) on 5/2/25 and was discharged on 5/6/25.

During a concurrent observation and interview on 5/6/25 at 3:55 p.m. with the Director of Capacity Operations (DCO) and Pt 43 in the Discharge Lounge, Pt 43 was sitting in a recliner chair, dressed in street clothes, with a family member at the chairside. Pt 43 stated she was agreeable to an interview. Pt 43 stated she was in the ED for two days. Pt 43 stated she was admitted as an inpatient and discharged from the ED. Pt 43 never moved to an inpatient unit. Pt 43 stated no one changed her sheets or her gown during her admission, and she had to get her bath wipes from a cart because no one offered them to her. Pt 43 stated the bathroom in the green zone was filthy, so she would go down to the yellow zone because it wasn't as dirty.

During an interview on 5/8/25 at 11:18 a.m. with the DED Pt 44's "H&P", "ADT" and, and "DCF" dated 5/4/25 to 5/7/25, were reviewed. The H&P indicated Pt 44 was an 85-year-old male who arrived in the ED on 5/4/25 by ambulance for fever and chills. The DED stated Pt 44 was admitted as an inpatient on 5/4/25 at 12:48 p.m. The DED stated Pt 44 was admitted as an inpatient for Systemic Inflammatory Response Syndrome (SIRS- widespread pain, swelling, throughout the body). The "ADT" indicated Pt 44 was held in the ED as an inpatient from 5/4/25 to 5/6/25. Pt 44 was held in the ED for 52 hours and 35 minutes. The "ADT" indicated Pt 44 was in a hallway bed as an inpatient for 25 hours and 35 minutes, Pt 44 was in an ED room for 27 hours. Pt 44 was transferred to an inpatient hospital room on 5/7/25 at in the ED observation unit for 18 hours and 2 minutes and was transferred to a progressive care unit (PCU) on 5/7/25 at 9:07 p.m. The "DCF" indicated Pt 44 had no hygiene care documented from 5/4/25 to 5/6/25. The DED stated Pt 44 had no meal documentation on 5/4/25 or 5/6/25. The DED stated Pt 44 should have all daily care activities and all meals documented in the medical record.

During a concurrent interview and record review on 5/8/25 at 2:05 p.m. with the Director of the ED (DED) and the Manager of the ED (MED) 1, Pt 43's "ED Pt Care Timeline (EDCT)," and "Daily Care Flowsheet (DCF)", dated 5/4/25 to 5/6/25 were reviewed. The "EDCT" indicated, " ...Arrival 5/4/25 at 10:02 a.m. Depart 5/6/25 2:47 p.m. TT 52:45 ..." The DED stated Pt 43 was never moved to an inpatient unit, Pt 43 was admitted as an inpatient, held, and was discharged from the ED. The "EDCT" indicated, " ... 5/4/25 10:05 a.m. ...To room R-04 [room Red Zone] ...5/4/25 10:06 a.m. Chief Complaints Updated difficulty breathing ... 5/4/25 12:33 p.m. Decision to Admit ... 5/4/25 Admission Information Patient Admit Service: Medicine ... Bed Requested ... Medicine ... 5/4/25 Patient Transferred from room R-04 to YH [Yellow Zone Hall] ...5/5/25 3:48 a.m. Transfer to Green [Green Zone] ...5/6/25 at 2:47 p.m. To department DC [discharge] Lounge ...". The DED stated the "DCF" had no documentation indicating nursing staff provided Pt 43 with daily care (hygiene, bathing, oral care, gown or linen changes from 5/4/25 to 5/6/25. The DED stated daily care should have been provided to and documented for Pt 43 during her ED admission.

During an interview on 5/13/25 at 9:32 a.m., with hospital Vice President of Quality and Senior Vice President (DRQ) and Chief Financial Officer (CFO) and Senior Vice President Community Health Systems, CFO stated hospital clinical leaders are aware of the bed capacity challenges. Leadership's focus has been on throughput. CFO stated he would have to defer to hospital leaders with a clinical background/focus on some of the patient care issues that have risen to his level of attention. CFO stated he is an active part of discussions at the governance level with daily reports reviewed by several levels of management. CFO stated the Board (BOD- are responsible for making strategic decisions, overseeing operations, and ensuring the hospital's financial health and compliance with regulations. Essentially, they act as the hospital's stewards, entrusted with its overall well-being)) is well aware of situation [inpatients boarding in the ED) and they are focused on initiatives to alleviate the volumes [in the ED]. CFO stated the hospital is actively renovating and looking to reopen a SNF location to move pts to that unit to help free up beds to reduce volumes hospital wide. CFO stated leaders acknowledge the ED volumes are increased over this last few years. Challenge with addressing it with anticipated addition of 154 licensed beds slated to open at end of calendar year 2025. CFO stated departmental quality reviews are occurring. CFO stated the ED "scorecard- Scorecards provide a high-level, one-page overview of a health system's long-term, strategic outcomes improvement goals)" reviewed with the Chief Executive Officer (CEO) and that the facility BOD sees a general view not the actual ED score card. CFO stated the BOD has been provided the ED capacity and the inpatient boarding data is shared with them. CFO stated the hospital is always trying to get better. CFO stated the hospital has conducted a cost benefit study with a goal to staff all of the [licensed] beds. CFO stated the hospital made a compensation adjustment in July 2024. CFO stated ED care and ED inpatient care reimbursement is different in that outpatient is at a different reimbursement than inpatient reimbursement.
During an interview on 5/13/25 at 12:30 p.m. with Vice-Chair Integrated Medical Staff and Interim CMO (DR1), and VPQ, DR1 stated [patient clinical] as a physician, he "hasn't noted any outcomes concerns" however, as an administrator he is aware of the differences in the care in ED vs in-patient unit. DR1 stated some of the concerns he is aware of are ED RNs were having adaptation issue to pts with inpatient needs i.e.: intake and output monitoring/documentation. DR1 stated this resulted in educating the RNs in the ED on how to care for the inpatient they were caring for in the ED. DR1 stated he has seen better care as a result of the education. DR1 stated the Hospitalist was expected to come to the ED and drive the care of the inpatient. The Hospitalist is the point person for the inpatient care team.

During an interview on 5/6/25 at 2:36 p.m. with RN 11, in the ED Green Zone, RN 11 stated, Patients should have hygiene supplies, clean gowns, linens... to feel human while they were in the hospital." RN 11 stated patients should be asked about hygiene and should be cleaned up every day, and the hygiene should be documented in the medical record.
During an interview on 5/6/25 at 2:51 p.m. with RN 12, in the ED Yellow Zone, RN 12 stated the difference in care from admitted ED patients versus ED patients were skin assessments were more thorough, completing medication reconciliation, and providing an air mattress to prevent skin breakdown. RN 12 stated ensuring the patient and linen were clean was important because it helped to prevent skin breakdown and reduced infection risks. RN 12 stated the hospital used to have call bells in the hall, but "I don't know where they are now". RN 12 stated, patients called out when they needed help. RN 12 stated, patients were at a higher risk for falls without a call bell, because they could try to get up without help if they needed to go to the bathroom or if they were confused.
During an interview and record review on 5/9/25 at 2:05 p.m., with the Manager (M) of the (CPCU and RN 27 indicated that while Pt 25 was in the ED, the care plan should be focused on the problem of altered mental status and was not.
During an interview on 5/15/25 at 11:02 a.m. with the Chief Nursing Officer (CNO), CNO stated it is his expectation that [Pt 25's] CP include the chief complaint. CNO stated syncope/AMS should have been addressed in [Pt 25's] CP.
During a review of the hospital's P&P titled "Interdisciplinary Plan of Care" dated 10/12/23, the P&P indicated, "... initiate the Plan of Care based on the patient's comprehensive assessment and medical care of the provider responsible for the patient ... Document the Interdisciplinary/Nursing Interventions when identified ... Activate interventions for the problems identified based on patient assessment ... For outcomes not met, develop and document an action plan such as notification of provider, change in interventions, or new orders."

During a concurrent observation and interview on 5/7/25 at 11:30 a.m. with the DED in the main ED Green, and Yellow Zones, the ED was observed to be busy with patients of all ages in the halls on gurneys. The ED census was 102 admitted patients. There was very little room to move through the hall between patients, staff, and visitors. No call bells were again observed with the patients in the hallways. The DED stated the patients in the halls do not have call bells. The DED stated the bells would be very loud and distracting to other patients in the area. The DED stated the nurses could see the patients and the patients could call out for help. When asked about hospital beds for comfort for the admitted and held patients, the DED stated hospital beds did not work in the ED halls because there was no room for them due to the size of the bed (too large). The DED stated the ED rooms could house the bed, but the patients were moved in and out of the rooms frequently and the beds were cumbersome (large, heavy difficult to move). The DED stated the hall patients obviously did not get the same level of care as the patients moved to the inpatient units, and there was no private bathroom for any of the patients. The DED stated he believed the hospital care was the same because the patients received consultations, case management and discharge planning as the patient would on the inpatient unit. The DED stated his expectation was for the patients to get daily care and for nursing staff to respond to patient needs when doing patient rounding. The DED stated oral care, and changing gowns was a part of daily care. The DED stated his expectation was nursing staff would ensure patient hygiene was taken care of.

During an interview on 5/9/25 at 10:53 a.m. with MED 1 and the DED, MED 1 stated ED leadership want to make sure the patients in the ED were comfortable. MED 1 stated he recognized the patients may not be as comfortable as on the inpatient units, but he believed the care was equitable (fair). The DED stated ED staff were able to give comparable care at the level "we are able to" (since the unit does not have all things the inpatient units have). The DED stated the ED staff were providing the standard of care by the policy. When asked about a patient's right to hygiene, the DED stated he did not know if they were providing the standard of comfort the inpatient departments had, but the ED staff were attempting to provide what they could knowing the environment they work with. The DED stated he believed the ED was meeting the standard of care.

During an interview on 5/8/25 at 11:38 a.m. with MED 1, MED 1 stated, the mattresses in the ED were the same as the inpatient beds, just smaller to fit in the ED. MED 1 stated, the inpatient hospital beds electronic adjustable movements, for the knees and feet were "just for comfort".

During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the Director of Emergency Department (DED), Pt 2's "Daily Care Flowsheet (DCF)", dated 4/24/25 to 4/29/25 and "Physician Orders (PO)," dated 4/25/25 to 4/29/25, were reviewed. The "PO" dated 4/24/25 at 10:27 p.m. indicated, Regular Diet. On 4/25/25 at 9:59 a.m. the DCF indicated Pt 2 ate "25%" of the meal. The DCF indicated, on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no breakfast, lunch, dinner or snacks were provided. The DCF indicated, on 4/29/25 at 6:56 p.m. "0%" diet eaten. The DED stated nutrition should be documented, and when patients refuse meals, the refusal should be documented.

During a concurrent interview and record review on 5/9/25 at 3:18 p.m. with the Director of Critical Care (DCC), Pt 2's DCF, dated 4/24/25 to 4/29/25, were reviewed. The DCC validated in Pt 2's DCF no documentation for diet eaten on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no diet eaten documentation for any meal, and 4/29/25 the only documentation was "0%" at 6:56 p.m. The DCC stated there should be some form of documentation for meals. The DCC stated there should be the same level of care provided to patients in the ED as on the inpatient units, meals, hygiene, wound care, and comfort.
During an interview on 5/14/25 at 11:08 a.m. with two members of the Governing Body, Governing Body Member 2 (GBM2) stated he has been to the ED to do tours a few times, and he encounters people who have been patients or who have friends and family members who have been patients in the ED in the community. He stated patients do not want to be kept in the ED when they are admitted, "they want a bed." GBM2 stated he understands that the hospital is receiving payment for patients to be on nursing units, but they are being kept in the ED because there are no beds available. GBM2 stated the Governing Body has been told that the patients in the ED are receiving care that is comparable to what they would receive if they were on an inpatient nursing unit.
The Joint Commission Journal on Quality and Patient Safety article titled, titled "No More Useless Band-aids that Fail to Solve America's Emergency Department Boarding Crisis," dated 12/2023 retrieved 2/19/25 from https://www.jointcommissionjournal.com/article/S1553-7250(23)00234-9/fulltext indicated, "The causes of boarding as well as many proposed solutions have been well described. However, the suggestions are band-aid solutions such as changing ED workflow, surgical schedule smoothing, and alternate care sites, and none of them will alleviate boarding and its harms. Boarding is the manifestation of a dysfunctional health care system with misaligned financial incentives. It is a direct consequence of the United States' patchwork, profit-driven health care system, not attributable to any single hospital or health care organization.
While daily admissions from the ED will vary somewhat, the typical number can be easily determined from the ED's historical records. Beds could easily be reserved for these anticipated admissions, and remaining beds could be allocated to elective admissions. Predicting the daily admission needs for the ED to function and serve the community is not a difficult task. We lack the will to do this, not the ability to make it happen. The lack of will arises from hospital administrators having no incentive to reserve space for ED admissions when they can allocate beds to elective admissions that generate higher profit. In both for-profit and not-for-profit ..." hospitals-which account for the overwhelming majority of annual acute inpatient admissions in the United States-the C-suite is tasked with remaining fiscally solvent. To do so, they favor patients with the kinds of insurance and the kinds of medical conditions that provide lucrative reimbursement for short lengths of stay. In following this strategy, admitted ED patients are queued up in the ED, occupying rooms and halls that need to be available to the patients in the ED waiting room. Consequently, our healthcare system caters better to a regional patient in need of advanced oncology therapy, organ transplant, or complex surgery than a local community member who presents to the ED with pneumonia or congestive heart failure who may find that emergency medical services cannot take them to their preferred hospital because its ED is diverting due to saturation. Boarding is a driver of ambulance diversion and leads to further inequities and disparities.15-21 Our healthcare system does not value care of the most vulnerable.22 While many factors contribute to the lack of acute inpatient psychiatric stabilization beds, a reimbursement system that undervalues such care is a major factor.23 Individuals suffering a mental health crisis experience some of the most egregious prolonged boarding in EDs awaiting acute inpatient psychiatric beds.24-27

The American College of Emergency Physicians policy statement titled, "Boarding of Admitted and Intensive Care Patients in the Emergency Department," revised February 2023, retrieved 2/19/25 from https://www.acep.org/siteassets/new-pdfs/policy-statements/boarding-of-admitted-and-intensive-care-patients-in-the-emergency-department.pdf, indicated, " ... Optimal utilization of the emergency department (ED) includes the timely evaluation, management, and stabilization of all patients. Once admitted, patient care is most effectively and safely delivered on inpatient units. Boarding of admitted patients in the ED represents a hospital-wide failure and contributes to lower quality of care, decreased patient safety, reduced timeliness of care, reduced patient satisfaction, an increased number of patients leaving without being seen, and increased mortality. Additionally, it directly contributes to ED crowding due to the resultant loss of bed and resource capacity. ED crowding and its negative impacts on patients are due to misaligned health care economics and financial pressures on hospitals ..."

The Journal of Academic Emergency Medicine article titled, "The Association Between Length of Emergency Department Boarding and Mortality" retrieved 2/19/25 from https://onlinelibrary.wiley.com/doi/full/10.1111/j.1553-2712.2011.01236.x, indicated, " ...ED boarding occurs when insufficient hospital capacity is available for admitted patients to be transferred to inpatient beds. The result is that admitted patients remain in the ED, sometimes for long periods. The concern is that due to competing demands by other patients and general system overload, boarders do not receive the same level of care that they would in inpatient beds. Several recent articles have identified safety issues with boarding, including adverse events, higher rates of ventilator-associated pneumonia, higher mortality rates for intensive care unit (ICU) patients per se, and for admissions overall. There are also higher rates of medication errors and preventable adverse events ..."

Based on observation, interview and record review, the hospital failed to ensure nursing staff developed and maintained individualized care plans reflecting the needs of the patients and care to be provided for the patients when five of 30 patients' (Patient [Pt] 11, Pt 12, Pt 14, Pt 25, and Pt 49) care plans did not contain patient specific problems and interventions.

These failures had the potential for inconsistent care delivery for patients (Pt 11, Pt 12, Pt 14, Pt 25, and Pt 49) and the potential for not receiving nursing care to reflect their individual needs and goals which could negatively affect patient well-being.

Findings:

During a concurrent observation and interview, on 5/6/25 at 10:50 a.m., Pt 11 was lying in bed on a medical unit, finger wrapped in gauze. Pt 11 was alert and able to discuss his injury. Pt 11 stated he cut his finger "about a month ago" and it got infected, and he had to have a surgical procedure to drain it. Pt 11 stated he was in a lot of pain the first few days after he was admitted, but the pain in his finger was better now, but his back was hurting now from lying in bed for so long.

During a concurrent interview and record review with the Manager of 1 East Medical Unit (M1E), M1E reviewed the Electronic Medical Record (EMR) for Pt 11. The hospital document titled, "History and Physical" dated 4/27/25 indicated, " ... History of Present Illness: [Pt 11] is a 37-year-old man with h/o HLD (history of high cholesterol), who presents for worsening L (left) index finger pain and swelling after accidentally cutting himself with brass ammunition casing on 4/7(2025). He went to urgent care on 4/14 (2025) and was prescribed prednisone (a medication to reduce swelling) and Amoxicillin/Clavulanate Potassium(an antibiotic) which he completed on 4/24 (2025). He underwent I&D (incision and drainage - opening the wound to allow pus to come out) at urgent care on 4/17 (2025). He has noticed worsening pain, swelling, redness and purulent discharge (pus) from the finger. Reports the tip of the finger is numb ...". Reviewed hospital document titled, "Care Plan" which listed one of Pt 11's needs as pain control. The Care Plan titled "Pain" was not individualized to indicate where Pt 11 was experiencing pain. The only notations were that the patient was "progressing." M1E stated, " ... the care plan should be more specific. They [the nurses] could have included what interventions seemed to help, whether that was elevating the arm, applying ice, etc. ...". M1E stated that Pt 11 could possibly been having pain other than just his finger.

During a concurrent interview and record review with M1E, M1E reviewed the EMR for Pt 12. The hospital document titled, "History and Physical" dated 3/26/25 indicated Pt 12 " ... is a 63 y.o. (year old) female With past medical history of stage IV (4) colon cancer with liver mets (metastasis - spreading to other organs, in this case, the liver)." The document titled, "Progress note" dated 5/9/25 indicated patient's health was "worsening". On 5/06/25 a meeting was held with Pt 12's family, and the family agreed to pursue hospice care (specialized form of healthcare that provides comfort and support to individuals who are terminally ill). The clinical record indicated Pt 12 had an order for "do not resuscitate." The hospital document titled, "Care Plan" was reviewed which listed one of Pt 12's needs as "Adapt to Life Changes." The Care Plan "Adapt to life changes" had no further detail listed and was not individualized to indicate what kind of life changes Pt 12 was experiencing, and did not include her adjustment to her end-of-life diagnosis or going home with hospice care. M1E stated, " ... the care plan should be more specific. I would expect to see something related to how she was adjusting to the fact that she was dying and going home with hospice care ...".

During a concurrent interview and record review of the EMR for Pt 14 with M1E the hospital document titled, "History and Physical" dated 4/5/25 indicated Pt 14 came to the emergency department on 4/5/25, brought in by ambulance after being found near a canal with no clothes on and was severely dehydrated. He was a 61-year-old male with past medical history of diabetes, hypertension (high blood pressure), hyperlipidemia (high cholesterol), coronary artery disease (heart disease), urinary tract infection, and other long-term illnesses, and brought to the hospital for altered mental status (confused and dazed.) A CT (computed tomography, a test that uses X-rays and a computer to see what's happening inside of the body) was done of his chest, which showed a "left lateral 6 rib fracture with overriding of the fracture fragments" (one of his ribs was broken, and half of the rib was pushed down below the other half.) Review of the document titled, "Pain Monitoring" indicated Pt 14 was having pain on 4/8/25 at 4 a.m. at a pain level of 7 (pain scale of 1-10, with 1-3 being mild pain, 4-6 being moderate pain, and 7-10 being severe pain) and Pt 14 described the pain as hip pain in both hips. At 8:00 a.m. the same day, he described his pain as level 8, and the location was his left hip. At 9:00 p.m. on 4/8/25 he described his pain level as level 8, in his back at that time. Pt 14 continued to report pain throughout his stay, and on 5/1/25 at 2:00 p.m., Pt 14 described his pain level as level 4, in his lower back. M1E reviewed the document titled, "Care Plan" which included a care plan for "Pain" started on 4/8/25 at 9:13 a.m. The plan included "Control of acute pain," and "Reduced pain sensation." The plans were not individualized and did not indicate the locations of the pain or what interventions were helpful in reducing pain for Pt 14. M1E stated the care plan was incomplete, and it needed to be individualized to address Pt 14's specific needs.

During a review of Pt 25's record review on 5/9/25 at 2:05 p.m., of Pt 25s "Face Sheet" the document indicated Pt 25 is a 68-year-old admitted to the hospital as an inpatient on 5/1/25 after coming to the Emergency Department (ED) for "Syncope." (a temporary loss of consciousness)


During a review of Pt 25's EMR on 5/9/25 at 2:05 p.m., the "History and Physical (H&P)" indicated Pt 25 " ... presented to the ED via EMS (Emergency Response) for AMS (altered mental status) and two witnessed episodes of syncope ... Assessment & Plan ... A. ... was very hypotensive (low blood pressure) with EMS...suspect the cause possible dehydration vs other ... P. ... keep on tele (Telemetry- Telemetry is used as an observation tool to monitor cardiac rhythm and rate, respiratory rate and oxygen level) ... BP (blood pressure) improved after fluids, will continue ... Past Medical History: Diagnosis Arthritis, Back pain, Back problem...Dizziness frequently - uses cane...Heart abnormality ...".

During a review of Pt 25's EMR the "Plan of Care" dated 5/2/25 indicated, " ... Problem: Risk of Impaired Skin Integrity ... Problem: Pain ... Problem High Risk for Skin Integrity Impairment ... Problem: Falls, Risk of ...".

During a concurrent interview and record review of Pt 25's EMR with the Manager of the Cardiovascular Progressive Care Unit (MCPCU) and RN 27, the MCPCU and RN 27 stated the EMR did not include a Care Plan for Pt 25's admission diagnosis. MCPCU stated it was her expectation that CPs are initiated, updated once per shift and completed per hospital policy. MCPCU stated CPs should be patient-specific and that Pt 25's CP did not include a focus or plan for the management of the patient's AMS. RN 27 stated she is assigned to care for Pt 25 today. RN 27 stated [for nurse care planning] depending on the [patient's] chief complaint she does an assessment for care plan and her goals are to remove any barriers to progressing to a safe discharge. RN 27 reviewed Pt 25's care plans and stated she did not find an active CP for AMS or syncope, but after her assessment of the patient, she agreed this focus should have been active and she would be adding AMS to her CP by the completion of her shift.

During a concurrent interview and record review on 5/9/25 at 10:10 a.m. with the Nurse Manager of Behavioral Health (NMBH) and the Nurse Supervisor of Behavioral Health (NSBH), Pt 49's "History & Physical (H&P)", dated 4/30/25, was reviewed. The "H&P" indicated Pt 49 had a history of substance induced (substance abuse causing) psychosis (a mental disorder where an individual experiences a loss of touch with reality) and schizophrenia (a chronic brain disorder that affects a person's ability to think clearly, manage emotions, and relate to others) and methamphetamine (a psychostimulant) use disorder (abuse). The "H&P" indicated Pt 49 uses methamphetamines seven times per week.

During a concurrent interview and record review on 5/9/25 at 10:25 a.m. with the NMBH and the NSBH, Pt 49's "Care Plan (CP)" dated 4/30/25 to 5/1/25, was reviewed. CP indicated, active problems of " ... Risk for violence/aggression towards others ...suicide, Risk of ... Potential for injury related to falls ...". When asked why there were no problems addressing Pt 49's diagnosis of psychosis and substance abuse in the CP, the NMBH stated, " ... good question ... should probably be some in there ...". The NMBH stated when diagnoses are not addressed in the CP there was a potential for not treating the patient appropriately.

During an interview on 5/15/25 at 11:15 a.m. with the Chief Nursing Officer (CNO), the CNO stated a patient's major diagnoses and chief complaints should be addressed in each patient's care plan and the care plans for Pt 11, Pt 12, Pt 14, Pt 25, and Pt 49 were not individualized. The CNO stated care plans should have had interventions that were individualized to meet the needs of the patients.

During a review of the hospital's Policy and Procedure (P&P) titled, "Interdisciplinary Plan of Care", dated 10/12/23, the "P&P indicated, " ... PURPOSE ... C. To promote interdisciplinary collaboration in order to develop a Plan of Care that is individualized, age and developmentally appropriate, and takes into consideration the physical, psychosocial, spiritual, and cultural needs of the patient and their family ... PROCEDURE ... 3. Initiate the Plan of Care based on the patient's comprehensive assessment and medical care of the provider responsible for the patient ... Document the Interdisciplinary/Nursing Interventions when identified ... Activate interventions for the problems identified based on patient assessment ... For outcomes not met, develop and document an action plan such as notification of provider, change in interventions, or new orders ...".

During a review of a professional reference titled, "Integrating Personalized Care Planning into Primary Care (IPC)", dated 10/24/19, the "IPC" indicated, " ... Personalized [individualized] care planning, a process to collaboratively develop care plans tailored to patient priorities and social contexts, is increasingly important to providing high-quality, patient-centered care ... Often used with medically complex patients, personalized care plans have been effective in improving outcomes when integrated into the routine care and are now mandated by the Centers for Medicare and Medicaid Services for chronic care management reimbursement ..."

Based on observation, interview and record review, the hospital failed to ensure all licensed nurses adhered to the hospital's policies and procedures (P&P) and followed physician's orders when:

1. Licensed Nurses did not check for the presence or expiration of external supplies on the Triage Labor and Delivery Unit (unit where women in labor are assessed) crash cart (mobile medical cart equipped with essential supplies and equipment to manage life-threatening emergencies) in accordance with the P&P titled, " Code Blue - Medications & Crash Carts (CB)" for four of six days in May 2025.

These failures placed potential patients on the unit (10) at risk for inadequate resuscitation.

2. Licensed nurses failed to document Pt 92's coccyx skin wound when first identified in accordance with the hospital policy titled, "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", dated 9/13/24.

This failure resulted in potential delay in addressing and providing care to Pt 92's full-thickness skin loss on his coccyx.

3. Licensed nurses did not place a pressure redistribution waffle mattress (an overlay placed over hospital mattress to evenly distribute weight and keep patients cool and dry) for one of three sampled patients (Pt 2) in the Emergency Department (ED) according to hospital P&P titled," Pressure Injury Risk Assessment, Prevention, Staging, and Treatment".

This failure had the potential to result in harm to Pt 2 by increasing the risk for skin breakdown leading to pressure injuries (PI -damage to the skin and underlying tissue caused by prolonged pressure) and had the potential to worsen Pt 2's wounds.

4. Licensed Nurses (LNs) failed to ensure critical laboratory values for one of twelve sampled patients (Pt 27) was repeated after intravenous (IV-into a vein) fluid resuscitation (the medical practice of replacing fluids lost by the body, usually through IV administration) was ordered to stabilize Pt 27's critically elevated lactic acid level (LA- a buildup of lactic acid in your bloodstream) in accordance with hospital P&P titled "Provider Notification Regarding Patient Status" dated 11/14/23 and professional practice standards.

This failure had the potential to result in Pt 27's continued and unresolved lactic acidosis with the potential to result in decline in medical condition up to and including death.

5. Hospital staff failed to document the indication (reason) for the order and administration of Quetiapine (an antipsychotic medication that treats several kinds of mental health conditions by balancing the levels of hormones (chemicals that coordinate different functions in your body) that help regulate your mood, behaviors and thoughts) for one of twelve sampled Pts (Pt 22) per hospital P&P titled "Medications - Orders, Administration, Storage, Documentation", dated 12/19/23, and P&P titled "Documentation in the Health Record", dated 6/14/18.

This failure had the risk for Pt 22 to be administered an unnecessary psychotropic medication leading to unwanted and/or adverse side effects of unnecessary medication(s).

6. LNs did not take actions on Pt 21's skin tear in accordance with hospital P&P titled "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", dated 9/13/24, to prevent the development of a hospital acquired injury from a skin tear.

This failure delayed identification and treatment of the pressure ulcer and had the potential for infection, pain, and prolonged recovery.

7. Pt 98 was administered the incorrect amount of high-risk/high-alert medication for sedation (Medications that have a heightened risk of causing significant patient harm when they are used in error).

These failures placed Patient 98 at risk for not receiving the desired patient therapeutic medication goals (meaningful outcome for patients).


Findings:

1. During a concurrent interview and record review on 5/6/25 at 11:06 a.m. with Registered Nurse (RN) 6 in the Labor and Delivery Triage Unit, the "Crash Cart Check Sheet (CCC)", date 5/2025, was reviewed. "CCC" indicated the check list column titled, " ... External Supplies Stocked Per List ... Clovis Only - Rad 97 [unknown equipment] present & operational ..." had a line drawn down the center of the column forming two columns. The left column indicated check marks on 5/4/25 and 5/6/25 and no check marks on 5/1/25, 5/2/25, 5/3/25 and 5/5/25. The right column indicated no check marks 5/1/25 through 5/6/25. RN 6 stated she was unsure what the split column indicated. RN 6 stated the combined columns had no checks on 5/1/25, 5/2/25, 5/3/25 and 5/5/25.

During a concurrent interview and record review on 5/6/25 at 11:10 a.m. with Licensed Vocational Nurse (LVN) 2 in the Labor and Delivery Triage Unit, LVN 2 reviewed the "CCC", date 5/2025. LVN 2 stated she along with other unit nurses performed crash cart checks on the unit. LVN 2 stated the "CCC" divided column, " ... External Supplies Stocked Per List ... Clovis Only - Rad 97 present & operational ..." indicated the left side was for checking the external supplies on the unit crash cart while the right column indicated checking a particular piece of equipment at another sister hospital site and not applicable to this hospital. LVN 2 stated the "CC" indicated the external supplies on the cart for this hospital were not checked on 5/1/25, 5/2/25, 5/3/25 and 5/5/25. LVN 2 stated if external supplies on the cart, such as the resuscitation bag (a bag/mask device used to force air into the lungs of a patient) were not checked for their presence daily, a patient's emergent resuscitation could be at stake.

During an interview on 5/15/25 at 11:25 a.m. with the Chief Nursing Officer (CNO), the CNO stated crash cart equipment should have been checked for presence and expiration because it is needed to resuscitate patients.

During a review of the hospital policy and procedure titled, "Code Blue - Medications & Crash Carts (CB)", dated 3/14/25, "CB" indicated, " ... Purpose ... To set the standard for appropriate supplies, medications and equipment necessary to initiate advance life support measures and to ensure uniformity of crash cart contents ... outline the process for securing and checking Code Blue Crash Carts ... Policy ... External crash cart checks ... are to be completed at least every 24 hours ... Document crash cart checks on the Crash Cart Check Sheet ...".

2. During a review of Pt 92's "History & Physical (H&P, an assessment from physician including medical history and exam)", dated 3/26/25, the "H&P" indicated Pt 92 was admitted on 3/26/25 for cellulitis (a common bacterial infection of the underlying tissues) of the right arm.

During a review of Pt 92's "Wound Specialist Note (WSN)", dated 5/3/25 at 10:12 a.m., the "WSN" indicated, " ...Wound consult received for 'left knee skin tear, pressure injury to coccyx' ... The buttock wound has skin breakdown ... It is important to note that any moisture associated concerns place this tissue is at higher risk for pressure injury ...Sacral/buttocks [coccyx area] denuded, partial and full thickness wound ...".

During a concurrent interview and record review on 5/14/25 at 8:48 a.m. with the Director of Critical Care (DCC) and the Wound Specialist Nurse Educator (WSNE), P 92's "Wound Line Drains and Assessment (LDA)" was reviewed. The WSNE stated the first time Pt 92's coccyx was noted on the "LDA" was on 5/3/25 at 5:17 p.m. (more than seven hours after the "WSN") and noted to be a stage 2 pressure injury (a partial-thickness loss of skin that extends into the first two layers of skin but not to the muscle). The DCC stated nursing staff should create an LDA for any skin injury as soon as it is identified even if they don't know what type of injury to call it. The DCC stated Pt 92's coccyx injury was moisture related and not a pressure injury, and thus not reportable. The DCC stated Pt 92's coccyx injury was both partial and full-thickness injury.

During an interview on 5/15/25 at 12:20 p.m. with the Chief Nursing Officer (CNO), the CNO stated if Pt 92's coccyx injury is a full-thickness skin loss, then it is a stage 3 pressure injury (into the fat tissue).

During a review of the hospital's policy and procedure (P&P) titled, "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", dated 9/13/24, the P&P indicated, " ... POLICY ... Upon identification of a suspected pressure injury, whether present on admission or hospital-acquired, the RN [Registered Nurse] shall photograph, describe and document the injury location on the appropriate section of the electronic health record (EHR) ... Staging/Treatment ... Stage 3 Pressure Injury - Full-thickness skin and loss with exposed muscle ...".

During the review of a professional reference titled, "Prevention and Treatment of Pressure Ulcers/Injuries (P&T)", dated 2025, the "P&T" indicated, " ... individuals at risk of pressure injuries, especially when moisture and heat at the skin-surface interface are contributing factors ...".

3. During a telephone interview on 5/1/25 at 3:49 p.m. with Complainant (CO) 3, CO 3 stated her family member, Pt 2, was admitted to the hospital as an inpatient on 4/24/25 but remained in the ED for 110 hours before being moved to an inpatient room. CO 3 stated Pt 2 was forced to endure the discomfort of a gurney during her long stay in the ED. CO 3 stated she requested a regular hospital bed for Pt 2, and staff informed CO 3 only bariatric (wider and longer for larger bodies) beds were allowed for the ED, but none were available. CO 3 stated Pt 2 did not receive a waffle mattress for the first 30 hours on the gurney.

During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the Director of the Emergency Department (DED) and Manger of Emergency Department (MED) 1, Pt 2's "H&P", dated 4/24/25, "Admission Transfer Discharge (ADT)", and "Daily Care Flowsheet (DCF)", dated 4/24/25 to 4/29/25, were reviewed. The DED stated Pt 2 arrived at the ED on 4/24/25 at 5:10 p.m. The "H&P" indicated, Pt 2 was 80-years old with a past medical history (PMH) of lung cancer (abnormal cell growth) on immunotherapy (utilizes medications to boost the body's immune system to target and destroy cancer cells). The "H&P" indicated Pt 2 had open sores to mouth, lips, hands, feet, and other areas of the body. The "ADT" indicated Pt 2 was admitted to the hospital on 4/24/25 at 8:39 p.m. The DED stated Pt 2's admitting diagnosis was an allergic reaction. Pt 2 was held in the ED as an inpatient from 4/24/25 until 4/29/25. Pt 2 was moved to the inpatient Medical Oncology Unit on 4/29/25 at 11:06 a.m. Pt 2's total time spent in the ED was 138 hours. The "DCF" indicated, no special mattress was documented on the "DCF" until 5/2/25 at 7:55 p.m. The DED stated if the nursing staff provided daily care, and placed a special mattress, it should be documented. MED 1 stated a pressure reduction mattress overlay helped to prevent skin breakdown and reduce the risk of pressure injuries.

During a review of the hospital's P&P titled, "Pressure Injury Risk Assessment, Prevention, Staging, and Treatment", dated 9/13/24, indicated, " ...Use the Braden Scale Risk Assessment tool to identify patients at risk for pressure injury as part of the initial admission patient assessment. Subsequent Braden Risk assessments are completed each shift. The initial skin assessment upon admission and/or transfer from another unit will be conducted by an RN and a secondary licensed staff member. .... if the risk stems from immobility, address turning, positioning, and the support surface. If the risk is from malnutrition, address this problem, etc.".

During a review of the hospital's P&P titled, "Documentation in the Health Record", dated 6/14/18, indicated, " ...PURPOSE A. To provide a complete record of patient care and patient progress. B. To facilitate communication among care providers and enhance continuity of care. ...All patient care and activities are to be documented at the time care is provided.

4. During a concurrent interview and record review of Pt 27's Face Sheet (FS) dated 5/8/25, the FS indicated, Pt 27's "... Admit Reason(s): Newborn/C/S [Cesarian Section- used to deliver a baby through surgical incisions {cut made in skin} to the abdomen {stomach} and uterus {womb}] ... Delivery [at] 15:09 [3:09 p.m.]...Admit Source Newborn [born inside this hospital]...".

During a review of a document provided by the hospital indicated, Pt 27's "EPOC Lactate ... 5/7/25 [at] 15:29 [3:29 p.m.] [of] 2.4 [in red] ... Latest Reference Ranges & Units 0.5 - 2.2 mmol/L [millimoles per liter- a unit of measurement used to measure the concentration of a substance in a fluid] ...". No further lactic acid results documentation was provided by the hospital.

During a review of Pt 27's "Neonatal Resuscitation" note dated 5/7/25 16:04 (4:04 p.m.), the note indicated, "... Indication: Requested to be present...for 33-week twin preterm delivery ... Brief Description: ... Placed on bubble CPAP [bCPAP, bubble continuous positive airway pressure, a noninvasive respiratory support modality used to manage newborns with respiratory distress] and transferred to NICU [Neonatal Intensive Care Unit-a specialized hospital unit that provides critical care for premature, sick, or critically ill newborn infants] ... Disposition: Transferred to NICU in critical condition ...".

During a review of Pt 27's H&P dated 5/9/25, the H&P indicated, "... Current Diagnoses: Preterm (28.0-33.6 wks [weeks]), Gestational Age: 33w3d week female infant ... METABOLIC/RENAL [body system]: 1-Lactic acidosis [physiologic-of or relating to normal healthful functioning] resolved. There was an initial lactate level of 2.4 mmol/L which is likely physiologic for a fetus [a young human being or animal before birth) where metabolism is anaerobic with low oxygen saturation tensions]. Clinically, perfusion appears excellent with brisk capillary refill (the amount of time it takes for the capillaries [tiny blood vessels] in the skin to refill with blood after pressure is applied) on exam on 5/9/25 ...".

During a concurrent interview and record review on 5/9/25 at 10:00 a.m., of Pt 27's Electronic Health Record (EHR- is an electronic version of a patient's medical history, that is maintained by the provider over time, and may include all of the key administrative clinical data relevant to that persons care under a particular provider) with the Manager of Neonatal Intensive Care Unit (MNICU) the EHR indicated Pt 27's lactic acid level was elevated, with no documentation present of a discussion between the LN and attending (primary physician) of repeating a lactic acid level after IV Fluid resuscitation. MNICU stated the expectation is that staff follow the hospital P&P and at minimum a repeat LA level should have been completed to ensure the IV Fluid resuscitation ordered corrected the lactic acidosis.

During an interview on 5/15/25 at 11:02 a.m., with the hospital Chief Nursing Officer (CNO), the CNO stated his staff had made him aware of the failure to repeat a LA for a neonate (a newborn child). The CNO stated appropriate follow up and a repeat LA laboratory test is expected and should have been done.

During a review of the hospital "Provider Notification Regarding Patient Status" P&P dated 11/14/23, the P&P indicated, "...I. PURPOSE To provide staff with guidelines for keeping the resident, attending physician, consulting physician and/or advanced Practice Professional (APP) informed of the patient's status. ... III. POLICY...B. The attending physician/APP is to be notified by the RN: ...3. Regarding abnormal laboratory results or critical values... VI. DOCUMENTATION A. Document in the EHR each time there is a discussion with and/or a call placed to a physician/APP concerning a patient, even if only the exchange is reached documentation should include the name of the physician/APP, the time, the reason, and the outcome of each discussion or call. B. Document the patient's condition change, physician notification, actions taken, and the patient's response in the EHR...".

During a review of the hospital "Critical Results Communication and Documentation" P&P dated 12/12/24, the P&P indicated, "... I. PURPOSE To ensure immediate reporting of the critical results of tests and diagnostic procedures to the appropriate care providers to enable provision of timely and appropriate treatment of patients...II. DEFINITIONS A. Critical Results: Results that require rapid clinical attention to aver significant patient morbidity or mortality [M&M-Morbidity is the state of being unhealthy for a particular disease or situation, whereas mortality is the number of deaths that occur in a population] ... All critical results must be communicated within defined time frames to the nurse caring for the patient or the provider. Documentation of the call including date, time and who received the critical result(s) must be made as a permanent part of the patient's electronic health record [EHR] ...".

According to the National Library of Medicine "StatPearls" electronically retrieved on 5/20/25, from https://www.ncbi.nlm.nih.gov/books/NBK470202/#article-24002.s9, StatPearls indicated, "... Lactic acidosis is a common cause of metabolic acidosis [here is too much acid in the body fluids] in hospitalized and critically ill patients, serving as both a clinical marker of disease severity and a contributor to multiple organ dysfunction and mortality ... Diagnosis involves measuring serum lactate, ... and analyzing arterial blood gases. Prompt recognition and treatment-focused on the underlying cause-are essential. Management strategies include fluid resuscitation ... Serum lactate serves as both a marker of risk and a therapeutic target; the higher the level and the longer it remains elevated, the greater the risk of mortality [death] ...".

5. During a concurrent interview and record review on 5/8/25 at 2:11 p.m., of Pt 22's EMR, with the Director of Critical Care Services (DCC), the EMR indicated an order for quetiapine to be administered to Pt 22. DCC stated, after record review, Pt 22's EMR did not indicate a reason for why the Quetiapine was ordered. DCC stated expects that staff and providers document the reason for the medication in the patient's EMR.

During a concurrent interview and record review of Pt 22's FS, dated 5/12/25, indicated, Pt 22 was a "... 55-year-old [y.o.] ...Admit Reason(s): Mvc [Motor Vehicle Collision] ... Admit Event Date/Time: 4/22/25 ...".

During a review of Pt 22's H&P, dated 4/23/25, the H&P indicated, "... 66 y.o. ... Trauma activation @ 2009 [8:00 p.m.] ... Chief Complaint ... Found pinned in truck, traveling at highway speeds, +seatbelt, flail chest [happens when three or more ribs located next to each other are fractured in two or more places] on left side, Glasgow coma scale [a neurological assessment tool used to measure a patient's level of consciousness after a brain injury or other neurological insult] 3 [indicates the lowest possible level of consciousness, signifying deep unconsciousness or coma] upon arrival ... chest needled [a needle used in medical procedures to access the pleural space {the space between the lung and the chest wall}] with positive blood and air with EMS ... no reported medical history brought in by [third party air ambulance] ... intubated by [EMS] ... was initially stable, but became hypotensive with a positive FAST [stands for Focused Assessment with Sonography in Trauma, and it's a rapid, bedside ultrasound examination] and was taken emergently to the operating room...Service to Admit: TICU [Trauma ICU], Inpatient Admission ...".

During a review of Pt 27's order for Quetiapine dated 5/15/25, the order indicated, "... Ordered Dose: 25 mg [milligrams- unit of measurement] ... Route: Oral [by mouth] ... Frequency: 2 times daily...Scheduled Start Date/Time: 5/4/25 1200 [12:00 p.m.] ...".

During a review of Pt 22's "Medication Administration Record (MAR)", dated 5/8/25, indicated Pt 22 was given a dose of Quetiapine 25 mg at 8:33 a.m. on 5/8/25.

During an interview on 5/15/25 at 11:02 a.m., with hospital CNO, CNO stated the indication for the medication should be documented in the order and with documentation in the EMR to indicate why the provider considered starting the medication [Quetiapine].

During a review of hospital P&P titled "Documentation in the Health Record", dated 6/14/18, the P&P indicated, "... PURPOSE A. To provide a complete record of patient care and patient progress. B. To facilitate communication among care providers and enhance continuity of care. C. To provide a legal record of patient care... II. POLICY A. All care providers caring for the patient are to document within their scope of practice/job description. B. All patient care and activities are to be documented at the time care is provided ... 1. Documentation of assessments, completion of notes from interviews and history taking, medication administration ...".

The California Code of Regulations, Title 22, Section 70215 stated " ... a registered nurse shall directly provide: ongoing patient assessment as defined in the Business and Professions Code, Section 2725(d). Such assessments shall be performed and the findings documented in the patient's medical record, for each shift, and upon receipt of the patient when he/she is transferred to another patient care area ...".

The California Nursing Practice Act, Business and Professions Code Chapter 6, Section 2725(d), defined an assessment as an observation of signs and symptoms of illness, reactions to treatment, general behavior, or general physical condition, and determination of whether the signs, symptoms, reactions, behavior, or general appearance exhibit abnormal characteristics, and implementation, based on observed abnormalities, of appropriate reporting, or referral, or standardized procedures, or changes in treatment regimen in accordance with standardized procedures, or the initiation of emergency procedures.

6. During a concurrent interview and record review on 5/8/25 at 1:26 p.m. with DCCS of Pt 21's EMR, the EMR indicated Pt 21 developed a wound (also known as HAPI- hospital acquired pressure injury) to his buttocks. DCCS stated the nurse's documentation in Pt 21's EMR indicates Pt 21 developed a "skin tear" discovered on 5/5/25, in the setting of moisture-associated skin damage (MASD-caused by prolonged exposure to moisture sources like urine, stool, and/or sweat, causing the skin to soften and become more susceptible to damage. Moisture lesions and pressure injuries are skin conditions that can lead to damage or breakdown). DCCS stated the EMR indicated Pt 21's Braden Scale Score (BSS- is a tool used to assess and categorize a person's risk for developing pressure ulcers, with lower scores indicating a greater likelihood of developing a pressure injury) on 5/8/25 was 12 (High Risk: Total score of 10-12). DCCS stated was unable to locate nursing documentation was not present DCCS stated MASD is not recognized as a pressure injury (pressure injuries, or pressure ulcers, are caused by prolonged pressure on the skin, often over bony prominences, leading to reduced blood flow and tissue damage) by hospital P&P. DCCS stated as Director assigned oversight of the Wound nurses, she believes hospital P&P is in alignment with the position of the professional references [NDNQI, Journal of Wound, Ostomy and Continence Nursing (JWOCN), National Pressure Injury Advisory Panel (NPIAP)] used when developing wound care policy/ies. DCCS stated the monitoring and tracking of MASD wounds differs from the HAPI monitoring and tracking process. DCCS explained that because MASD skin injuries are not pressure injuries, they do not meet hospital policy criteria for reporting to state and other regulatory agencies as a HAPI or an adverse outcome/event.

During a concurrent interview and record review of Pt 21's FS dated 5/12/25, indicated, Pt 21 "... 47-year-old [y.o.] ... Admit Reason(s): Burn (Any Degree) Involving 20-29% of body surface ... Admit Event Date/Time: 4/16/25 ...".

During a review of Pt 21's H&P dated 4/16/25, the "Burn Surgery" H&P indicated, "... 50 y.o. ... with no known medical history who presented as a burn activation [anticipated critical burn patient arrival]. Pt in significant distress and had difficulty answering any questions ... SUBJECTIVE: Unable to gather history given patient was severely agitated, in pain, and subsequently intubated [the process of inserting a tube called an endotracheal tube {ET} into the mouth or nose and then into the airway {trachea} to hold it open] ... Patient admitted to Burn ICU ...".

During a review of Pt 21's "Wound Care Order" dated 5/9/25, the order indicated "... Order Date/Time 5/9/25 ... Frequency Every shift ... Comments To gluteal cleft wound [a wound that occurs in the intergluteal cleft, which is the space between the buttocks. It is a common site for skin breakdown due to factors like moisture, friction, and pressure], apply foam daily ...".

During an interview on 5/15/25 at 11:02 a.m., with hospital CNO, CNO stated HAPIs continued to be a process improvement focus with nurse leaders working on the deep tissue injuries (DTIs, a type of PI that involves damage to underlying tissues, but the skin may not be broken) and how moisture affects skin breakdown. CNO stated he expects LNs to go into "preventive mode" by making sure interventions to control moisture, (cleansing after stool, urine), applying lotions and creams as indicated to reduce moisture, friction, and sheer and ongoing assessments are done daily, incorporating the wound team. CNO stated it is his expectation that LNs document moisture, not as a HAPI but expect that it is being tracked, treated, and prevented as it can lead to a HAPI especially if over a bony prominence.

The facility policy and procedure titled "Pressure Injury Risk Assessment, Prevention, Staging and Treatment" dated 9/13/24 indicated, " ... I. PURPOSE...D. To implement wound management strategies to optimize the healing potential and prevent deterioration of existing pressure injuries... III. POLICY .... C. Patients with a subscale identified as a score of 1 or 2 are considered at risk for developing pressure injuries. The nurse will identify and implement an individualized plan of care that addresses the interventions appropriate to reduce the risk factors ... IV. PROCEDURE ... B. Prevention ...1. Skin Care ... e. Cleanse the skin promptly after an episode of incontinence (inability to control the flow of urine from the bladder (urinary incontinence) or the escape of stool from the rectum (fecal incontinence)) f. Use skin cleansers that are pH balanced for the skin...3. Moisture Control a. Control incontinence and minimize skin exposure by using under-pads, and barrier creams ... 4. Pressure Reduction-Positioning... e. Consider the level of immobility, exposure to shear, skin moisture... g. Use breathable incontinent pad when using microclimate management surfaces...k. If the patient cannot be moved or is positioned with the head of the bed elevated over 30 degrees, place a sacral border dressing on the sacrum (coccyx/buttocks) ... 5. Friction and Sheering Reduction a. Minimize friction injury with creams, skin sealants, or protective padding...C. Prevention by Risk Levels ... 3. If the patient scores a 1 or 2 in the moisture subscale, implement the following interventions as appropriate: a. Cleanse with incontinent wipes with each episode and pat dry. b. Apply appropriate skin protectant cream. c. Use briefs only for ambulating/sitting in chair. d. Apply incontinent pad on surface as appropriate. e. Offer toileting assistance every 2 hours. f. Consider fecal collection device. g. Consider low air loss mattress/overlay per protocol ... 7. If the patient scores a 1 or 2 in the friction and shear subscale, implement the following interventions as appropriate: a. Use a lift sheet to move patient. Consider trapeze on bed frame. b. Apply moisturizers to affected area(s) to reduce friction. c. Head of bed up 30 degrees or less except for meals/care/feeding. d. Avoid massaging bony prominences ... VI. DOCUMENTATION ... B. Document the following as appropriate with every reassessment in the EHR: 1. Braden Scale score. 2. Assessment, interventions and patient response. 3. Location of any changes in skin condition and erythema (redness of the skin). 4. Pain assessment and interventions. 5. provider notification of any changes. 6. Patient/family education. 7. Nutrition consumed ...".

According to Friction and Shear Considerations in Pressure Ulcer Development, Hanson, Darlene RN, MS; Langemo, Diane K. PhD, RN, FAAN; Anderson, Julie PhD, RN, CCRC; Thompson, Patricia RN, MS; Hunter, Susan RN, MSN, Author Information, Advances in Skin & Wound Care 23(1):p 21-24, January 2010. | DOI: 10.1097/01.ASW.0000363489.38996.13 electronically retrieved from https://journals.lww.com/aswcjournal/citation/2010/01000/friction_and_shear_considerations_in_pressure.11.aspx on 5/22/25, "... the National Pressure Ulcer Advisory Panel (NPUAP) indicated Friction abrades (to rub or wear away especially by friction) the skin of the epidermis (he outermost layer of skin) and dermis (the middle layer of skin), thereby decreasing the amount of pressure needed to create a pressure ulcer. A successful ulcer prevention program will address contributing factors such as pressure, shear forces, friction and moisture ...".

According to Lumbers M. Moisture-associated skin damage: cause, risk and management. Br J Nurs. 2018 Jun 27;27(Sup12):S6-S14. doi: 10.12968/bjon.2018.27.Sup12.S6. PMID: 29944429 electronically retrieved from https://pubmed.ncbi.nlm.nih.gov/29944429/ on 5/22/25, indicated "...Understanding the differential diagnosis (process is used to help make a final diagnosis when you have symptoms that don't have one clear cause.) between moisture-associated skin damage (MASD) and pressure ulcers (PU) ensures appropriate management and interventions are instigated at the earliest opportunity. Most damage occurring to the buttocks or sacrum is attributed to pressure, shear, excessive moisture or a combination of these factors. MASD caused by excessive moisture to the sacrum/buttock area is recognized as incontinence-associated dermatitis (IAD); its occurrence is an identified risk factor in the development of PUs. Treatment for IAD should therefore focus on both IAD management and pressure ulcer prevention. ...".

According to Nora Warshawsky, Ph.D., R.N., NEA-BC, CNE, FAAN in the "The value of nursing preventative strategies in reducing hospital-acquired pressure injuries" dated 20 October 2023 electronically retrieved from https://info.pressganey.com/patient-workforce-safety/the-value-of-nursing-preventative-strategies-in-reducing-hospital-acquired-pressure-injuries on 5/22/25, "...Several evidence-based nursing interventions currently exist to prevent HAPIs from developing and to reduce the severity of the pressure injury stage. The first step in HAPI prevention is to routinely assess patients, beginning with admission, to identify those likely to develop pressure injuries. Preventative strategies-like routine repositioning, nutritional support, moisture management, and pressure redistribution-should be initiated as soon as at-risk patients are identified ...".

According to Yusuf S, Okuwa M, Shigeta Y, Dai M, Iuchi T, Rahman S, Usman A, Kasim S, Sugama J, Nakatani T, Sanada H. Microclimate and development of pressure ulcers and superficial skin changes. Int Wound J. 2015 Feb;12(1):40-6. doi: 10.1111/iwj.12048. Epub 2013 Mar 12. PMID: 23490303; PMCID: PMC7950852...electronically retrieved on 5/20/25, " ... In conclusion, difference in skin temperature seems to be a predictor for pressure ulcer development and superficial skin changes, while synthetic fiber sheets are able to maintain a beneficial microclimate (refers to the heat and humidity at the intersection of the patient's skin/body and the surface on which the patient is laying) ...".

7. During a concurrent interview and record review, on 5/12/25, at 1:00 p.m., with the Manager of Neurology Intensive Care Unit (MN ICU), and Nurse Educator for Neurology ICU (NE 1), Pt 98's EMR was reviewed. Pt 98's H&P, dated 4/28/25, "MAR", dated 5/9/25, and "Flow Sheet", dated 5/9/25, were reviewed. Pt 98's H&P indicated Pt 98 was a 41-year-old male, admitted on 4/28/25 with a history of hemorrhagic (a blood vessel in the brain ruptures and bleeds, causing damage to brain tissue) stroke. NE 1 stated Pt 98 had had a decompressive hemicraniectomy (surger

Based on observation, interview, and record review, the hospital failed to ensure medications were administered in accordance with the Physician Orders, facility policies, and accepted standards of practice when:

1. The dose of Patient 78's propofol (a medication used for the induction and maintenance of anesthesia or sedation) was not adjusted as prescribed according to Patient 78's Richmond Agitation-Sedation Scale (RASS, a medical scale used to measure the agitation or sedation level).

This failure resulted in Patient 78 experiencing excessive sedation.

2. The dose of Patient 63's insulin (a medication used to lower blood sugar level) was not adjusted as prescribed according to Patient 63's insulin order.

This failure resulted in Patient 63 experiencing excessive sugar levels in the blood.

Findings:

1. A review of Patient 78's clinical record showed that Patient 78 was a 72-year-old patient admitted to the facility for traumatic aortic dissection (serious condition where the aorta, the body's main artery, tears or ruptures due to trauma).

A review of Patient 78's Physician Orders dated 4/14/25, indicated, an order for propofol intravenous (IV) drip with starting dose of 10 mcg/kg/min (microgram per kilogram per minute, unit of measure) or current infusing dose ...increase infusion by 5 mcg/kg/min every 5 minutes to goal ...once patient is stable at goal RASS, may decrease infusion by 5 mcg/kg/min every 5 minutes. Goal sedation: RASS -1 to 0 (The RASS is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm").

During a concurrent interview and clinical record review on 5/7/25 at 3:40 p.m. with the Director of Critical Care/Burn/Wound Services (DOCC), the DOCC stated, according to Patient 78's Medication Administration Records (MAR), Patient 78's propofol was administered with a dose of 15 mcg/kg/min at 10:42 a.m. on 4/14/25. The dose of 15 mcg/kg/min was kept the same at 7:41 p.m. on 4/14/25. The dose was increased to 20 mcg/kg/min at 12:39 a.m. on 4/15/25. The dose of 20 mcg/kg/min was kept the same at 5:34 a.m. and 8:20 a.m. and ended at 12:16 p.m. on 4/15/25. Patient 78's RASS score was measured and documented thirty-seven times from 10:42 a.m. on 4/14/25 to 12:15 p.m. on 4/14/25. The RASS documentation indicated that Patient 78's RASS score was at -5 (no response to voice or physical stimulation) with every RASS documentation when the propofol dose was kept the same or increased instead of lowering the dose as ordered by the physician.

During a continued interview on 5/7/25 at 3:45 p.m. with the DOCC, the DOCC stated, the RASS goal of -1 to 0 should have been followed while Patient 78's RASS was at -5. The nursing notes say ventilation compliance, but RASS was kept at -5. If the RASS needed to be at -5, the order should have been changed to be aligned with how the patient was doing.

During an interview on 5/9/25 at 10:35 a.m. with the Director of Pharmacy (DOP), the DOP stated, the nurses did not follow propofol's Physician Orders. If there was a question or concern, the physician should have been contacted for clarification and adjustments accordingly.

During a review of the facility's policy and procedure (P&P) titled, "Medications - Orders, Administration, Storage, Documentation," dated of 12/19/23, the P&P indicated, "It is the responsibility of the person administering the medication to verify the following ...The right dose ...The patient's response to medication will be monitored for effectiveness and side effects. Information such as vital signs, laboratory values, clinical signs and symptoms, as well as the patient's perception, will be evaluated ...A medication order must be clear, legible and include the following ...Dosage ...Frequency ...Orders to titrate medications must indicate starting rate, titration parameters and maximum rate. These orders may include ...sedation scale."

2. A review of Patient 63's clinical record showed that Patient 63 was a 61-year-old patient admitted to the facility for cardiogenic shock (a life-threatening condition where the heart can't pump enough blood to meet the body's needs, leading to inadequate blood flow to vital organs).

A review of Patient 63's Physician Orders dated 4/13/25, indicated an order for insulin regular in 0.9% (percent, unit of measure) NaCl (a type of IV fluid) 100 u/100 ml (units per milliliter, unit of measure), start infusion at 0.1 u/kg/hr (units per kilogram per hour, unit of measure), target Blood Glucose (BG): 150-250 mg/dL (milligram per deciliter, unit of measure) until resolution of DKA/HHS (diabetic ketoacidosis and hyperosmolar hyperglycemic state are both serious complications of diabetes).
The Physician Order further stated for BG greater than 250 mg/dL:
- if BG increased from previous value: increase insulin infusion by multiplying by 1.5;
- if BG decreased by less than 50 mg/dL from previous value: increase insulin infusion by multiplying by 1.5;
- if BG decreased by 50-75 mg/dL from previous value: continue same infusion rate. No change;
- if BG decreased by 76-100 mg/dL from previous value: decrease insulin infusion by multiplying by 0.75;
- if BG decreased by more than 100 mg/dL from previous value: decrease insulin infusion by multiplying by 0.5

During a concurrent interview and clinical record review on 5/7/25 at 3:21 p.m. with the DOCC, the DOCC stated, according to Patient 63's MAR, Patient 63's insulin dose on 4/14/25 was increased to 0.15 u/kg/hr at 1:31 a.m., and increased to 0.225 u/kg/hr at 3:54 a.m., increased to 0.34 u/kg/hr at 7:53 a.m., decreased to 0.255 u/kg/hr at 10:03 a.m., decreased to 0.13 u/kg/hr at 11:04 a.m., increased to 0.2 u/kg/hr at 12:08 p.m., and increased again to 0.3 u/kg/hr at 2:03 p.m.

During a continued interview on 5/7/25 at 3:21 p.m. with the DOCC, the DOCC stated, on 4/14/25, Patient 63's BG levels were recorded at 590 mg/dL at 8:25 a.m., increased to over 600 mg/dL at 8:55 a.m., and again measured at 624 mg/dL at 9:08 a.m., but the dose of insulin was not adjusted. BG reduction from 624 mg/dL at 9:08 a.m. to 580 mg/dL at 10 a.m., 44 mg/dL reduction from previous value, should have increased insulin infusion by multiplying by 1.5, but the nurses reduced the infusion rate to 0.255 at 10:03 a.m. on 4/14/25. Furthermore, the DOCC stated, "we should not have decreased the insulin dose and we were unable to find any notes regarding the dose decrease."

During an interview on 5/9/25 at 10:35 a.m. with the Director of Pharmacy (DOP), the DOP stated, the nurses did not follow propofol's, Physician Order. If there was a question or concern, the physician should have been contacted for clarification and adjustments accordingly.

During a review of the facility's P&P titled, "Medications - Orders, Administration, Storage, Documentation," dated of 12/19/23, the P&P indicated, "It is the responsibility of the person administering the medication to verify the following ...The right dose ...The patient's response to medication will be monitored for effectiveness and side effects. Information such as vital signs, laboratory values, clinical signs and symptoms, as well as the patient's perception, will be evaluated ...A medication order must be clear, legible and include the following ...Dosage ...Frequency ...Orders to titrate medications must indicate starting rate, titration parameters and maximum rate."

Based on observation, interview, and record review, the facility failed to ensure pharmaceutical products were stored and monitored properly according to the facility's policies and procedures or manufactures' specifications and requirements for a census of 810 patients, when:

1. Seventeen injectable vials of ceftazidime, a medication to treat bacterial infection, were not protected from light in accordance with the manufacturer's storage requirements.
2. The room temperature was not monitored and recorded in five medication storage areas

These failures had the potential for medication degradation and administration of potentially ineffective or expired medications.

Findings:

1. During an inspection of the Neonatal Intensive Care Unit (NICU), satellite pharmacy on 5/6/25 at 3:30 p.m., seventeen injectable vials of ceftazidime 1g per vial (gram, unit of measure) were observed outside of manufacture's box in a clear bag in a bin on the shelf in the pharmacy room. The storage bin did not have any "protect from light" labels on the outside and the seventeen vials were exposed to light.

During an interview on 5/6/25 at 3:34 p.m. with the Pharmacist in Charge (PIC) 1, the PIC 1 stated, "drug efficacy could be decreased over time ...the ceftazidime vials should be protected from light."

During an inspection of the ceftazidime manufacturer's label in the pharmacy on 5/6/25 at 3:35 p.m. with the PIC 1, the manufacture label on the vial indicated, "Protect from light."

During an interview on 5/9/25 at 10:30 a.m. with the Director of Pharmacy (DOP), the DOP stated, medications need to be stored according to the manufacture requirements to ensure ongoing potency and effectiveness.

During a review of the facility's policy and procedure (P&P) titled, " Guidelines for Procurement of Pharmaceuticals," dated of 4/2025, the P&P indicated, "All medications shall be stored at appropriate conditions that follow the manufacturer's guidelines and is directed by pharmacy."

2. During an inspection of an Emergency Department, ED, medication storage area (Pat1) on 5/6/25 at 11:10 a.m., with the ED Manager (MED), the medication room was observed to not have a thermometer or any room temperature logs.

During an interview on 5/6/25 at 11:20 a.m. with the Registered Pharmacist (RPh) 1, the RPh 1 stated that there was no thermometer in the room to record the room temperature.

During an inspection of another ED medication storage area (Yellow) on 5/6/25 at 11:40 a.m. with the MED, the medication room was observed to not have a thermometer or any room temperature logs.

During an interview on 5/6/25 at 11:45 a.m. with the PIC 1, the PIC 1 stated, there was no thermometer/temperature logs in the medication room.

During an inspection of a medication storage area (Oxygen/medication storage) in the radiology department on 5/6/25 at 3:15 p.m., with the director of imaging, the medication room was observed to not have a thermometer or any room temperature logs.

During an interview on 5/6/25 at 3:15 p.m. with the PIC 1, the PIC 1 stated, there was no thermometer in the room to record the room temperature.

During an inspection of a medication storage area in the dialysis unit on 5/7/25 at 9:25 a.m., with the RPH 2, the medication room was observed to not have a thermometer or any room temperature logs.

During an interview on 5/7/25 at 9:25 a.m. with the RPH 2, the RPH 2 stated, the medication room temperature was not monitored and there was no thermometer in the room.

During an inspection of a pharmacy in the Community Behavioral Health Center on 5/7/25 at 10:25 a.m., with the PIC 2, the pharmacy was observed to not have any temperature logs.

During an interview on 5/7/25 at 10:25 a.m. with the PIC 2, the PIC 2 stated, that there was no temperature logs in the pharmacy.

During an interview on 5/8/25 at 1:18 p.m. with the Director of Facilities (DOF), the DOF stated, facility and pharmacy teams are responsible for maintaining temperature in the medication storage areas. The DOF acknowledged that the temperature was not monitored in some of the medication storage areas.

During an interview on 5/8/25 at 1:20 p.m. with the PIC 1, the PIC stated, if medications are stored out of temperature range required by the manufacture, it can affect the integrity of the medications stored in the medication room.

During an interview on 5/9/25 at 10:30 a.m. with the Director of Pharmacy (DOP), the DOP stated, medications need to be stored according to the manufacture requirements to ensure ongoing potency and effectiveness.

During a review of the facility's policy and procedure (P&P) titled, " Guidelines for Procurement of Pharmaceuticals," dated 4/2025, the P&P indicated, "All medications shall be stored at appropriate conditions that follow the manufacturer's guidelines and is directed by pharmacy...All medications shall be stored under appropriate temperatures ...room temperature shall be between 59°F to 86°F."

Based on observation, interview, and record review, the hospital failed to ensure medications were kept in a secured area when intravenous bags (a liquid solution to allow medications to go through the vein) fentanyl (a potent synthetic opioid drug used for pain relief) and propofol (a medication used to put patients asleep and keep them unconscious during medical procedures) were observed unattended and unsecure in an empty patient room of the Neurology Intensive Care Unit (Neuro ICU) in accordance with the hospital's policies and procedures (P&P) titled, "Medications - Orders, Administration, Storage, Documentation" and "Controlled Substances [a drug that has been classified by a government agency as having potential for abuse and addiction] ...".

These failures had the potential to result for medications to be diverted by unauthorized patients, staff and visitors.

Findings:
During a concurrent observation and interview on 5/6/25, at 11:04 a.m., with Manager of Neurology ICU (MN ICU), Director of Neuroscience (DN), Registered Nurse (RN) 18, and RN 19, while touring Neuro ICU, in empty room 1009, two medications of intravenous (IV) liquids were observed hanging from the IV pole. One bag was labeled fentanyl 250 ml (milliliter - unit of measurement) and the other medication was a full bottle, labeled propofol 100 ml vial. RN 19 stated, he was responsible for the medications and a patient had left to go to surgery. RN 19 stated, he had thought the staff had taken the medications with him to surgery. RN 19 stated, the medications should not be left unattended, should be in a secure room or drawer or discard. MN ICU stated, both medications are considered controlled substances and should be handled as per policy and not be hanging unattended in an empty patient room. MN ICU stated, she expected nurses who are working with controlled substances follow the policies associated with the handling of controlled substances.

During an interview on 5/15/25 at 11:01 a.m. with the Chief Nursing Officer (CNO), the CNO stated, the medications should not have been left in an empty room and should have been discarded. The CNO stated, nurses should not leave controlled substance medication unattended and follow the policies associated with securing the medications.

During a review of the hospital's facility's P&P titled, "Medications - Orders, Administration, Storage, Documentation", dated 12/19/23, the policy indicated, "PURPOSE ... To provide guidelines for the safe and accurate ordering, transcribing, labeling, administration, storage and documentation of medications. ... C. Medication Storage ... 9. Medications will be securely stored at all times and at the appropriate temperature. ..."

During a review of the hospital's facility's P&P titled, "Controlled Substances - Storage", dated 12/6/24, the policy indicated, "PURPOSE ... To ensure that all Drug Enforcement Administration (DEA) defined controlled substances are managed in compliance with State and Federal laws pertaining to proper storage of controlled substances within the hospital. ... B. General Storage ... 4. In patient care areas of [BRAND] hospitals. medication storage is primarily maintained in a medication room. ADC [Automated Dispensing Cabinet] equipment are located in the medication room and are under video surveillance. ... 5. Controlled substances requiring refrigeration will be kept in a locked drawer secured to the refrigerator. ... 6. Those ADS [Automated Dispensing System] not in designated medication rooms are located in full view of licensed personnel and under video surveillance. C. Restricted Access ... C. Medication rooms are under security lock that requires badge access ... D. Only personnel authorized by hospital policy and applicable state laws have access to the ADS ..."

Based on observation, interview, and record review, the facility failed to ensure unwrapped and undated IV bags were not available for patient use according to the facility's policies and procedures. This failure had the potential for patients to receive unsafe or ineffective IV fluids.

Findings:

During an inspection of an Emergency Department (ED) medication storage area (green) on 5/6/25 at 11:39 a.m. with the ED Manager (MED), four 1000 ml (milliliter, unit of measure) intravenous (IV) bags, were found unwrapped and undated among other IV bags on the shelf.

During an interview on 5/6/25 at 11:40 a.m. with the Pharmacist in Charge (PIC) 1, the PIC 1 stated, the four IV bags should not have been there without a date ...when the IV bags were unwrapped, they needed to be dated and used within 30 days.

During an interview on 5/6/25 at 11:42 a.m. with the MED, the MED stated, there was risk of infection if the IV bags were unwrapped with no date.

During an interview on 5/9/25 at 10:35 a.m. with the Director of Pharmacy (DOP), the DOP stated, the IV bags needed to have their outer wrap.

During an interview on 5/9/25 at 10:36 a.m. with PIC 1, the PIC 1 stated, "we have posted laminated signs in medication room to stress the importance of removing from overwrap and discarding it if not used."

During a review of the facility's policy and procedure (P&P) titled, " Guidelines for Procurement of Pharmaceuticals," dated 4/2025, the P&P indicated, "All medications shall be stored at appropriate conditions that follow the manufacturer's guidelines and is directed by pharmacy... All pharmaceutical products Pharmacy procures shall meet the following criteria: 1. Meet or exceed USP, NF or FDA requirements for potency and labeling."

Based on observation, interview, and record review, the facility failed to ensure proper safety precautions in accordance with the manufacturer's instructions when one of three sampled lead aprons was observed folded and hanging.

This failure had the potential to compromise the integrity of the lead apron which increases the risk of exposing patients, staff and visitors to unnecessary radiation.

Findings
During a concurrent observation and interview, on 5/9/25 at 11:15 a.m., with Outpatient Manager (OP M) 2, and Registered Nurse (RN) 25, on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties, one lead apron of three aprons was observed folded and hanging over the hanger. RN 25 stated, the apron was not hanging correctly and should be hanging using the straps on the apron. RN 25 unfolded the apron and correctly hung the apron. RN 25 stated, if the lead apron is not hung correctly, it can compromise the safety of the apron. The OP M 2 observed and did not state anything.
During an interview on 5/15/25 at 11:01 a.m. with the Chief Nursing Officer (CNO), the CNO stated, he expects the nurse leaders of the different areas to own their areas and ensure they are in compliance during the rounds. The CNO stated, he expected the nurses to follow the policies about the use lead aprons.

During a review of the manufacturer's guidelines provided by the hospital titled, "[BRAND NAME] Safety, Cleaning & Storage Tips," date 2025, indicated, " ... ONGOING INSPECTIONS ... Buckles, Velcro, and straps position the garments for proper coverage. ... Garments with broken or damaged features that prohibit correct positioning should be removed from service and repaired or replaced ... STORING YOUR APRON AND PROTECTIVE APPAREL ... Radiation protection aprons should be hung by the shoulders or straps on an apron hanger. ... X-ray aprons should be rolled, not folded, when traveling. ... Avoid folding, stacking, or sitting while wearing aprons. ... Proper use, cleaning, and storage of radiation protection garments directly affect their integrity. ... ".

During a professional reference review retrieved from https://research.columbia.edu/lead-aprons titled, "Columbia Research --Lead Aprons," no date, the professional reference indicated, " ... After using a lead apron, make sure to hang the apron so that it is not creased to avoid damage to the lead. Do not store the aprons folded or crinkled on a counter or table. This can cause cracks in the lead and can compromise the effectiveness of the apron. ..."

Based on observation, staff interviews and review of hospital documents, the hospital failed to ensure the Food and Nutrition Services (FANS) department was effectively organized and managed effectively when:

1. The Senior Food Service Director (SFSD)/Registered Dietitian did not provide regularly scheduled oversight and guidance to the Food Services Director (FSD 2) to effectively analyze the scope and complexity of the FANS department at one of the three campuses (Surgical Campus 2) which resulted in ineffective systems and monitoring to ensure staff competency for a cook and was not aligned with the hospital's organizational chart; and

2. The Clinical Registered Dietitian (RD 1) was not evaluated by staff with the appropriate skill set and the hospital's organizational chart and job description were not aligned at the Surgical Campus 2.

The lack of organization, supervision, and oversight of the food and dietetic services department resulted in deficient practices in multiple areas related to safe food practice, sanitation, storage, and staff competency (Cross-reference A-0622 and A-0750).

Findings:

1a. During a review of the hospital document titled Amendment to No. 1 to Food Services Management Agreement, dated 5/31/19 and effective date 1/16/20 between the Vendor and the hospital. The agreement listed a section "Compliance with law" that stated the Vendor shall comply with any and all applicable laws of governmental authorities concerning the provision of services contemplated herein, including without limitation, sanitation, safety and health related laws, and shall procure and maintain all necessary licenses and permits. The agreement also listed a section "Quality Assurance" the vendor agrees to perform the services in compliance with all applicable governmental laws and regulations and in accordance with all applicable standards and comply with all accrediting organizations' standards, including state and federal laws and regulations.

During the survey from 5/6/25 to 5/13/25, the survey team identified one cook (Cook 1) was not competent in the day-to-day duties of meal preparation and the competencies completed for Cook 1 did not reflect the depth and scope of the position at one of three campuses (FHSH). Cross Reference A-0622 and A-0750.

During a review of the hospital's untitled document of the Organizational Structure for FANS for Surgical Campus 2, dated 3/31/25, showed FSD 2 was above the Retail and Patient Sous Chefs and RD 1.

During an interview with SFSD on 5/8/25 at 4:11 p.m., the SFSD stated that she was the RD with oversight to the FSD 2 and they had provided an updated FANS org chart that showed her position.

During a review of the hospital document, untitled, FANS organizational structure, the document was not dated and not on hospital letterhead, showed SFSD with a solid line to the FSD 2. The FSD 2 had a solid line to the VP and a dotted line from SFSD to the VP.

During an interview with SFSD, FSD 1, and Executive Chef on 5/9/25 at 9:07 a.m., SFSD stated she does a standards audit twice a year, and that audit consists of looking at the cleanliness, temperature logs, looking at uniform policy, hygiene, menus. SFSD stated weekly manager walk throughs are done by FSD 2 and the patient and retail chefs. SFSD confirmed she did not do those at the hospital. SFSD stated the infection control preventionist does rounds quarterly.

1b. During an interview with FSD 1 on 5/7/25 at 11:11 a.m., FSD 1 stated all the FSD job descriptions were the same for each hospital location.

During a review of the FSD 2 job description, undated, indicated FSD 2 reports to the SFSD. It showed FSD 2 overall responsibility for the direction and guidance for FANS in collaboration with Clinical Nutrition Manager. FSD 2 is granted authority and delegated responsibility by the hospital's governing body and medical staff for the operation of FANS. Surgical Campus 2 where FSD 2 worked did not have a Clinical Nutrition Manager position.

During a review of SFSD job description, indicated "job summary" the SFSD in conjunction with the district manager provides oversight and is responsible for the contractual relationship and executive of the Vendor services in healthcare facilities ... attaining full regulatory compliance, adhering to ...applicable laws and regulations." The SFSD job description indicated under primary duties and responsibilities the leadership and supervision are to supervise district team and hold regular in-person or virtual touch bases with unit leadership teams and conduct two-unit visits per year.

During an interview with SFSD, FSD 1, FSD 2 on 5/13/25 at 11:13 a.m., SFSD stated she did the standard audit twice a year at all campuses, which consisted of observing Trayline and food production on the day she would complete the audit. SFSD stated that she would observe kitchen and retail while doing the audit and after she would meet with the FSD 2 about it. SFSD stated that she also did quarterly hospital visits in addition to the twice a year audits. SFSD stated that she does meet with FSD 2 more often however there is no formal documentation to validate the regular oversight and guidance.

2. During an interview with RD 1 on 5/8/25 at 3:15 p.m., RD 1 stated she had worked under the hospital and in August it will be two years. RD 1 stated she will collaborate with the FSD 2 and provide in-services to the kitchen staff. RD 1 stated she does not do any audits or oversight in the kitchen and she only works clinical.

During a review of the hospital's untitled document of the Organizational Structure for FANS at Surgical Campus 2, dated 3/31/25, showed FSD 2 was above the Retail and Patient Sous Chefs and RD 1. The RD 1 position had a straight line to the Retail and Patient Sous Chefs. The RD 1 position had a dotted line up to the VP of Nursing.

During a review of RD 1 job description, dated last review 11/19/21, indicated the reporting to Manager or Supervisor. It did not state what Manager or Supervisor was the report, just listed the titles more generally.

Review of the hospital document, titled "FY24 Annual Appraisal" for RD 1, performance review period dated 8/23/23-8/27/24, indicated the Supervisor title was Manager of the Bariatric Program (BPM). The evaluation indicated under "Essential Accountabilities", that RD 1 consistently exceeded expectations for "conducts a nutrition assessment for patients within required time frames. Including screening for malnutrition, formulating a nutrition diagnosis based on collected data while utilizing evidence-based standards, and collaborating with the multidisciplinary team".

During an interview with SFSD, FSD 2 and RD 1 on 5/8/25 at 4:16 p.m., RD 1 stated since she has been a hospital employee there has not been any chart reviews or competencies done on her by a RD. SFSD stated since RD 1 was not part of the contracted service they do not do those on her but do them on all other RDs on all the other campuses. RD 1 stated her supervisor is over the bariatric program.

During an interview with the Bariatric Program Manager (BPM) on 5/13/25 at 10:41 a.m., BPM stated that he has worked for three years at Bariatric Program. He stated his background is project management with recruiting. BPM stated he has a law degree, Master of Business Administration, was a medic in the past and had a biology degree. The BPM stated he is the person that does the evaluation on RD 1. The BPM stated he collaborates with nursing from the hospital to complete her evaluation. BPM acknowledged he does not have the skill set to evaluate RD 1 for clinical nutrition competency.

Based on observation, interview and record review, the hospital failed to ensure one of five cooks (Cook 1) at one of three hospital campuses (Surgical Campus 2) was competent in the day-to-day duties of meal preparation. One of 51 patients, Patient (Pt) 90, had physician ordered pureed diet and Cook 1 did not prepare the puree chicken in accordance with the recipe specifications and was not knowledgeable of the correct temperature for the puree chicken. Cook 1 did not follow hand hygiene requirements in accordance with the hospital's policy and procedure on hand hygiene.

These failures had the potential to result in serving undercooked chicken to inpatients and visitors which could result in foodborne illness for a highly susceptible population, not following recipes for puree food items can result in food not being nutritious and palatable leading to decreased nutritional status and not having proper hand hygiene can result in the growth of microorganisms and leading to food borne illness. The Surgical campus 2 census was 51.

Findings:

During a review of the hospital document titled Entrée, Pureed Grilled Chicken Breast dated 2025 showed, three ounces Boneless Herbed Chicken Breast, two ounces U.H. Sauce, Chicken Stock - Low Sodium Fortified, .14-ounce thickener. Method: 1 Removed entrée from the oven when an internal temperature of 165 degrees Fahrenheit (F) is reached, rough chop and add to blender. 2. Bring stock to a boil, add to blender. 3. Puree for 1 ½ minutes or until entrée is smooth in consistency. 4. Place pureed entrée in a stainless-steel bowl and mix while added thickener a little at a time until fully incorporated. 5. Using a #8 scoop place puree entrée evenly into mold. 6. Place mold on to a sheet pan and place into freezer for a minimum of two hours. 7. Remove puree from freezer and remove puree from mold and place into a freezer bag, label and date and store in freezer. 8. To reheat- pull puree from freezer, place onto a plate, wrap plate with plastic wrap, microwave for three minutes or place in a steamer for 15 minutes until puree has reached 165 degrees F.

During a review of the hospital document titled U.H. Sauce, Chicken Stock - Low Sodium Fortified dated 2025 showed, ingredients included low sodium chicken base, water, onion, celery, carrot, garlic, parsnip, turnip, bay leaf, parsley, rosemary and thyme.
During a review of the medical record for Patient 90, showed Patient 90 was admitted to the hospital on 4/24/25 with diagnosis of coronary artery disease. A pureed low sodium, low fat diet was ordered by the Physician on 5/3/25.

During an observation of the lunch meal of Cook 1 on 5/8/25 at 12:00 PM, Cook 1 placed one 5-ounce cooked chicken breast and an unmeasured quantity of water into a blender and blended the product. The product was a thin runny consistency. Cook 1 added an unmeasured amount of thickener to the chicken mixture. Cook 1 tested the temperature of the blended chicken with a dial thermometer. The temperature of the chicken was 152 degrees Fahrenheit (F). When asked if the temperature of the chicken was ok, Cook 1 stated as long as the food was above 135 degrees F it was fine. The Patient Sous Chef (PSC) intervened and stated the chicken would be reheated to reach 165 degrees F for meal service.

During an interview with the Senior Food Service Director (SFSD), Food Service Director (FSD 1) and FSD 2 On 5/12/25 at 11:15 AM, the SFSD agreed Cook 1 did not follow the puree chicken recipe when he added an unmeasured quantity of water in place of two ounces U.H. Sauce, Chicken Stock- Low Sodium and did not measure the thickener per the recipe. The SFSD added it was her expectation that cooks follow all recipes. The SFSD also confirmed all cooks should be knowledgeable of proper cooking temperatures for foods.

During a review of the hospital document titled Cook Job Description undated showed the cook was responsible to follow standard recipes and ensure safety of food prepared by following safe sanitary food handling practices- hot food hot and cold food cold.
During a review of Cook 1's personnel file, the competency evaluation signed and dated by Cook 1 on 6/24/19 showed Cook 1 was competent in reading and understanding recipes and food temperature control.

Competency evaluations for Cook 1 did not include reading and understanding recipes and food temperature control.

During a review of the hospital Policy and Procedure titled, Hand Hygiene dated 4/12/2025 showed, Purpose: to establish clear guidelines and procedures for proper hand washing, aiming to prevent the spread of germs and infections by ensuring healthcare workers and individuals consistently clean their hands at critical moments, ultimately protecting patients and staff from healthcare-associated infections. D. Glove Use: 2. Perform hand hygiene before donning after doffing gloves.

During an observation of the lunch meal preparation on 5/8/25 at 12:00 PM, Cook 1 was observed to use gloved hands to place cooked chicken into a blender. Cook 1 then changed his gloves but failed to wash his hands then returned to food preparation. Cook 1 was observed to change his gloves a second time without washing his hands.

During an interview with SFSD on 5/8/25 at 12:15 PM, SFSD confirmed hands should be washed between glove changes.
During a review of the hospital document titled Cook Job Description, undated, showed the cook was responsible for handling food and equipment in accordance with sanitation and safety practices.
Cross Reference to A-0750, Finding 3a.

During a review of the Cook 1 competency evaluation signed and dated by Cook 1 on 8/27/24, showed Cook 1 was competent in proper glove use.

During an interview with SFSD, FSD 1 and FSD 2 on 5/13/25 at 10:12 a.m., FSD 2 stated on an annual basis they do three to five competencies on the employees that pertain to their position duties. FSD 2 confirmed he did not do competencies of all of the different specific responsibilities for the position.

During a review of the hospital policy and procedure titled "Competency Assessment Validation Program", dated 12/1/22, indicated "Each employee is to achieve and maintain competence according to his/her role and responsibilities as outlined in the Job Description/Performance Evaluation and unit specific skills checklist."

Based on observation, interview and record review, the hospital failed to ensure nutritional needs were met in accordance with recognized dietary practices for three of ten patients who were provided care in the Emergency Department (ED) as inpatients, Patient (Pt) 2, Pt 17 and Pt 44 when hospital staff failed to follow physician diet orders ensuring patients received meals. Pt 2 and Pt 44 were diagnosed and admitted as inpatients related to complications of cancer and were not provided meals on multiple occasions and meal intake was not documented; each stayed in the ED for multiple days. Pt 44 was admitted to the ED for complications of developmental delay and mental health and did not have documented evidence of meal intake. The ED did not have a system in place to ensure timely delivery of meals, meals were provided per physician order, and a monitoring system to ensure meals and/or snacks were offered.

These failures had the potential to result in weight loss, reduced immune system (body's ability to fight infection) function, leading to higher risk of infections, poor wound healing, and a worsening of medical conditions.

Findings:

During a review of the hospital documents titled "History & Physical [H&P- an assessment from physician including medical history and exam]," dated 4/24/25, and Admission Transfer Discharge (ADT), dated 4/24/25 to 4/29/25, the H&P indicated, Pt 2 arrived in the ED on 4/24/25. The H&P indicated, Pt 2 was 80-years old with a past medical history (PMH) of lung cancer (abnormal cell growth) on immunotherapy (utilizes medications to boost the body's immune system to target and destroy cancer cells), and chronic kidney disease (CKD- kidneys are damaged and cannot filter blood properly). The H&P indicated Pt 2 was advised to go to the ED by her primary cancer treatment physician, for diffuse (widespread) dermatitis (inflammation on skin) suspected to be from the immunotherapy. The H&P indicated Pt 2 had open sores to mouth, lips, hands, feet, and other areas of the body. The "ADT" indicated, Pt 2 arrived at the hospital's ED on 4/24/25 and was admitted to the hospital on 4/24/25 at 8:39 p.m. for allergic reaction. Pt 2 was held in the ED as an inpatient from 4/24/25 until 4/29/25, about 4.5 days. Pt 2 was moved to the inpatient Medical Oncology Unit (dedicated area within the hospital that focuses on the diagnosis, treatment, and care of patients with cancer) on 4/29/25 at 11:06 a.m.

During a telephone interview on 5/1/25 at 3:49 p.m. with Complainant (CO) 3, CO 3 stated her family member Patient (Pt) 2 was admitted to the hospital as an inpatient on 4/24/25 and was held in the Emergency Department (ED) for 110 hours (4.5 days) before being moved to an inpatient room. CO 3 stated Pt 2 did not receive her meal on several occasions throughout the time she was held in the ED.

During a concurrent observation and interview on 5/6/25 at 1:32 p.m. with Pt 2, CO 3, and the Director of Critical Care, in Pt 2's hospital room on the Medical Oncology Unit, Pt 2 was sitting in a wheelchair at the side of her hospital bed talking with CO 3 and was agreeable to an interview. Pt 2 had scabbing on both hands, Pt 2 had a type of boot on both feet, but the toes were exposed, and scabbing was observed on the toes of both feet. Pt 2's lips were observed with healing wounds. Pt 2 stated she did not like the care she received in the ED. Pt 2 stated she remembered in the ED she did not get a meal a few times. CO 3 stated she visited Pt 2 on one occasion in the late afternoon and asked Pt 2 what she had for lunch, and Pt 2 said no one ever brought lunch. CO 3 stated she then asked the nurse for food. Pt 2 stated she believed the nurses in the ED could not give the kind of care they do on the inpatient unit, because they seemed too busy.

During a concurrent interview and record review on 5/8/25 at 9:49 a.m. with the Director of Emergency Department (DED), Pt 2's "Daily Care Flowsheet (DCF)", dated 4/24/25 to 4/29/25 and "Physician Orders (PO)," dated 4/25/25 to 4/29/25, were reviewed. The "PO" dated 4/24/25 at 10:27 p.m. indicated, Regular Diet. On 4/25/25 at 9:59 a.m. the DCF indicated Pt 2 ate "25%" of the meal. The DCF indicated, on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no breakfast, lunch, dinner or snacks were provided. The DCF indicated, on 4/29/25 at 6:56 p.m. "0%" diet eaten. The DED stated nutrition should be documented, and when patients refuse meals, the refusal should be documented.

During a concurrent interview and record review on 5/9/25 at 3:18 p.m. with the Director of Critical Care (DCC), Pt 2's DCF, dated 4/24/25 to 4/29/25, were reviewed. The DCC validated in Pt 2's DCF no documentation for diet eaten on 4/25/25 no lunch, dinner or snacks were provided to Pt 2, on 4/26/25, 4/27/25, and 4/28/25 no diet eaten documentation for any meal, and 4/29/25 the only documentation was "0%" at 6:56 p.m. The DCC stated there should be some form of documentation for meals. The DCC stated there should be the same level of care provided to patients in the ED as on the inpatient units, meals, hygiene, wound care, and comfort.
During a review of hospital document titled "History and Physical" dated 5/2/25, the document indicated Pt 17 was a 41-year-old male with history of seizure disorder (seizure - a sudden burst of electrical activity in the brain. It can cause changes in behavior, movements, feelings and levels of consciousness), autism spectrum disorder (a condition that affects a person's ability to communicate, interact socially, and understand the world around them), schizophrenia a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions), and developmental delay. He arrived at the hospital through the Emergency Department (ED) on 5/2/25 at 6:51 p.m. and was admitted as an inpatient to a medical/surgical unit (an inpatient unit where patients with medical conditions that are not considered life threatening are admitted) on 5/2/25 at 10:44 p.m., but stayed in a bed in the ED. For 4 days after the admission order was written.

During a concurrent interview and record review on 5/12/25 at 3:00 p.m. with the Manager of unit 1 East (M1E), M1E reviewed Pt 17's chart and stated Pt 17 was admitted as an inpatient on 5/2/25 and stayed in the ED for 4 days. M1E stated Pt 17 was transferred to an inpatient bed on 1 East on 5/6/25, the same day he was discharged home. The hospital document titled, "Flow Sheet" was reviewed, which showed that on 5/2/25, 5/3/25, and 5/4/25, Pt 17 was not provided meals or snacks. On 5/5/25 at 11:00 a.m., the flowsheet indicated Pt 17 drank 111 ml (Milliliters - a unit of liquid measure. 111 ml is a little less than ½ cup.) At 2:35 p.m., the flowsheet indicated Pt 17 ate "50%" of his meal. M1E was unable to find any other documentation indicating Pt 17 ate or drank anything else during his 4-day stay. M1E stated, "he may have been refusing meals, but if he was, they didn't document it." M1E stated Pt 17 was not receiving any fluids intravenously (fluid going directly into a vein to keep patient hydrated.) The hospital document titled, "Care Plan Details," dated 5/6/25 indicated, " ... Intervention Details: REMINDER(s): Eating environment enhancement. Encourage self-feeding. Ensure dentures are available. Provide verbal encouragement ..." The document titled, "Physician Orders" dated 5/2/25 indicated, "Diet: Regular." M1E stated, "He didn't receive the same level of care that he would have if he had been transferred to our unit (1 East) on the day he was admitted. We would have had more time to assess his needs, and we would have noticed if he wasn't eating."

During a review of the hospital document titled, "Diet Manual & Enteral Nutrition Formulary 2025," the manual indicated, " ...Patients who refuse the foods served will be offered substitutes of equal nutritional value. This may include oral nutrition supplements ..."

During an interview on 5/15/25 at 11:15 a.m., the Chief Nursing Officer stated, "this should never happen. If the patient was eating, it should be documented. If the patient wasn't eating, that should be documented as well, and the doctor should be notified. A hard reset is needed. These things should never happen."

During a review of the hospital documents titled H&P, dated 5/4/25, and Admission Transfer Discharge (ATD), dated 5/4/25 to 5/7/25, the H&P indicated, Pt 44 arrived by ambulance in the ED on 5/4/25. The H&P indicated, Pt 44 was 85-years old with a PMH of metastatic (cancer that spread from the original location) adenocarcinoma (type of cancer starting in the glands lining the body's internal organs) of the sigmoid (part of intestines closest to rectum) colon, with lung metastasis (cancer spread to lungs). Pt 44 presented to the ED with fever and chills. Pt 44 was admitted to the hospital as an inpatient on 5/4/25 at 4:32 p.m. for systemic inflammatory response syndrome (SIRS-a serious condition in which there is inflammation [redness, swelling, heat, pain and loss of function] throughout the whole body), sigmoid colon cancer. Pt 44was moved to the Progressive Care Unit (PCU- inpatient unit for Pts too ill for general medical surgical but not critically ill) 5/7/25 at 9:07 p.m.

During a concurrent observation and interview on 5/6/25 at 2:31 p.m. with Registered Nurse (RN) 11 and Pt 44 in Pt 44's ED hospital room in the Green Zone, Pt 44 was frail and lying on his back in his hospital gurney with the lights off in his room, and Pt 44 stated he was agreeable to an interview. Pt 44 stated, first he was placed in the hallway by an elevator, and it was noisy, and he didn't sleep. Pt 44 stated, he spent two nights outside in the hallway and three nights in a room. Pt 44 stated, the food was on time when he was in the room, but when his bed was in the hall sometimes food did not come at all. Pt 44 stated, his complaints about care in the ED were, no sleep, no food, and no help with hygiene.

During a concurrent interview and record review on 5/8/25 at 11:18 a.m. with the DED and the Manager of Emergency Department (MED) 1, Pt 44's DCF dated 5/4/25 to 5/9/25 and "PO", dated 5/4/25 was reviewed. The "PO" dated 5/4/25 at 4:26 p.m. indicated, Diet Gastrointestinal (GI-stomach and intestines) Bland/low fiber. The DCF indicated Pt 44 was not provided meals or snacks on 5/4/25. The DCF indicated, Pt 44 was not provided meals or snacks on 5/5/25 after 4 p.m. The DED stated nutrition should be documented. The DCF indicated Pt 44 was not provided meals or snacks on 5/6/25. The DED stated all meals and snacks should be documented.
During an interview on 5/14/25 at 8:18 a.m. with the Director of Emergency Department (DED), the DED stated, heating meals in the ED was a huge undertaking and required a lot of staff time. The DED stated that the ED has three microwaves to heat meals and could probably use more. The DED stated his expectation was for staff to document meals. The DED stated ED staff were doing a better job documenting, but there was room for improvement. The DED stated staff documenting patient's eating their meals was important to ensure the patients were getting the nutrition they require. The DED stated documenting patient's intake, and output was a way to ensure the patients were meeting their basic needs, including nutrition and hydration..

During an interview on 5/15/25 at 11:28 a.m. with the Chief Nursing Officer (CNO), the CNO stated, patient's food should be warm and delivered, for all the ED patients not just the admitted and held patients. The CNO stated, documentation should be in the medical record for both intake and output.

During a review of facility Policy and Procedure (P&P) titled, "Documentation in the Health Record," dated 6/14/18, indicated, " ... All care providers caring for the patient are to document within their scope of practice/job description. ...Electronic Health Record (EHR) 1. Documentation of assessments, completion of notes from interviews and history taking, medication administration (bar coding), vital signs, intake and output collection are recorded at the patient's bedside ...".

Based on observation, interview and record review, the hospital failed to ensure therapeutic diet orders were followed when nutrition supplements initiated by the Registered Dietitians lacked clear parameters within the prescribed diet order in the hospital's approved diet manual.

This failure can result in patients having an increase in adverse clinical status.

Findings:

During a clinical record review of Patient 109, the patient was admitted to the hospital on 4/3/25 with a past medical history that included diagnoses of Diabetes Mellitus (DM - a disorder characterized by difficulty in blood sugar control and wound healing), follicular lymphoma stage IV (cancer has spread to multiple sites outside of the lymph nodes, such as the liver, lungs, or bone marrow) with an admitting diagnosis of Neutropenic fever (fever in a patient with reduced neutrophil counts -neutropenia, which can be a complication of cancer treatments). The Nutrition Assessment dated 4/10/25, initiated after a consult ordered on 4/9/25 relating to poor oral intake and a new diagnosis of AML (Acute Myeloid Leukemia- a type of blood cancer that affects the bone marrow and blood, causing an overproduction of abnormal white blood cells). Diet order was a Diabetic Diet and po intakes were documented to be 44%. The Registered Dietitian documented 52% of the calorie needs were being met and 68% of the protein needs. The intervention documented was to add Glucerna shake (nutrition supplement designed for people with DM) twice daily. Review of the physician's orders dated 4/10/25, Glucerna shake, 8 ounces, two times daily. The Nutrition Follow-Up note dated 4/14/25, the RD documented Patient 109 has had no oral intakes since 4/11/25 and has an appetite but dislikes the food and likes the oral nutrition supplement. The RD documented to continue diabetic diet and increase Glucerna shake to three times a day, and add Ensure Max protein once daily, and may have outside food to promote food intake. The next Nutrition Follow-Up note dated 4/22/25, which was 8 days after the last note.

During a clinical record review of Patient 109 with a concurrent interview with Registered Dietitian (RD 2) on 5/7/25 at 9:30 a.m., RD 2 stated the hospital's nutrition assessment policy. RD 2 stated nutrition supplements are part of a protocol within the current diet order. RD 2 stated the RD may individualize the dietary treatment plan within the parameters of the prescribed diet order as outlined in the diet manual. The diet order has an option that the physician must answer yes or no and can modify snacks, preferences, portion sizes or oral nutrition supplements. RD 2 stated they follow up on high risk in two to four days for ICU patients, patients who are not eating, malnourished, wounds, unstable tube feeding or feeding by vein. RD 2 stated for moderate risk they follow up in five to seven days when patient is eating okay, stable tube feeding, low RD needs and low risk they see patients in eight to 10 days when patient is stable.

During a review of the hospital document titled Diet Manual and Enteral Nutrition Formulary 2025, revision dated 11/24, indicated "All Diet orders include the option of an Oral Nutrition Supplement (ONS). A Registered Dietitian, upon further assessment, may add, change, or discontinue an ONS based on the guidelines set forth in the facility diet manual. All diet orders may be individualized by modifying the distribution, type, and quantity of food and nutrients to meet the patient's individual healthcare needs based on the parameters defined in the diet manual. If a physician does not want the dietitian to make changes to the patient's nutrition care utilizing one or more of the outlined order entry modes, the physician indicates within the diet order a nutrition communication that expressly states the dietitian's restrictions to ordering per protocol." The ONS protocol in the diet manual showed all the diets that can be ordered at the hospital and what types of oral nutrition supplements were allowed for each diet type.

During a review of hospital policy and procedures titled Patient Diet Orders and Menus, dated 10/7/24, indicated diet orders will be ordered and produced in accordance with the guidelines referenced in the diet manual and RDs may make dietary alterations, modifications and/or substitutions, within the diet order parameters, to achieve desired patient outcomes.

During an interview with the Senior Food Services Director (SFSD) and Food Services Director (FSD 1) on 5/13/25 at 12:28 p.m., FSD 1 stated the Registered Dietitians (RDs) initiate a physician's order in the electronic medical record for a nutrition supplement when the patient is not eating well. FSD 1 stated the menu for diabetic diet provides 4-5 carbohydrates per meal. FSD 1 acknowledged that adding nutrition supplements even though for diabetic patients would be in addition to the amount of carbohydrates allowed in the physician ordered diabetic diet. FSD 1 acknowledged that at times, the RDs may not follow up for reassessment or to see how the patient is tolerating the nutritional supplement for a few days depending on how they determined their risk level. SFSD and FSD 1 acknowledged there were no specific parameters within the table that indicated the circumstances/criteria, quantity, frequency and duration for the supplements within the therapeutic diet order.

Based on observation, interview, and record review, the hospital's infection prevention and control program (IPCP) failed to ensure a clean and sanitary environment in accordance with hospital policies and procedures and national standards of practice for infection control to prevent and control infections among patients, personnel, and visitors when:

1. The hospital failed to ensure food preparation equipment and storage for food preparation equipment were in sanitary condition for one of two kitchens located in the main hospital.

2. An ice machine located in the main kitchen of the main campus was not clean in accordance with professional standards

3. One of one Neonatal intensive care unit (NICU) nurses at the main hospital campus did not perform hand hygiene between glove changes during NICU milk preparation and one of five cooks on campus B of the hospital did not perform hand hygiene between glove changes during food preparation in accordance with the hospital's policy on hand hygiene.

4. The physical environment in the NICU of the main hospital did not support the preparation of milk and the addition of modulars (nutritional supplementation) to minimize cross contamination in accordance with professional standards. Nursing staff did not don personal protective equipment (PPE) and did not adhere to infection control standards in the preparation of milk for newborns.

5. Nursing staff in the Emergency Department (ED) did not keep the door closed in the isolation room for Patient (Pt) 39 in accordance with recommendations for the CDC (spell out) for transmission-based droplet precautions. Pt 39 was diagnosed with Rhinovirus and worsening respiratory symptoms and had a physician order for respiratory droplet precautions on 5/4/25.

6. Registered Nurse (RN) 20 did not wear a mask during a bedside procedure for Pt 100. Pt 100 was admitted to Neurology ICU (Intensive Care Unit) on 5/6/2025 and required a ventricular drain and central venous line and RN 20 did not wear a mask while assisting providers during the procedures in accordance with infection control standards.

7. Two placenta specimens were stored in clear plastic containers in an open untied bag in the Labor & Delivery Unit's soiled utility room and not stored in a sealed biohazard container in accordance accepted professional standards.

8. An unlabeled and undated container with half a sandwich was stored in the patient nourishment room on the High-Risk Ante Partum (before and after birth) Unit and should have either been thrown away or labeled and dated in accordance with the hospital's policy on safe food storage titled, "Storage".

9. Soiled adhesive from labels was left on communication boards in patient rooms on 5West, supply bins and cupboards in the clean utility room, nutrition room and medication rooms of the Rehabilitation Unit and should have been discarded in accordance with the with infection control standards.

10. Two of ten patients, (Pt 17 and Pt 98) Intravenous tubing was not labeled and dated in accordance with hospital policy and procedure (P&P) titled, "Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites,"

11. Outpatient clinic staff did not flush weekly an eye wash station in the outpatient clinic as per P&P titled, "Emergency Shower and Eye Wash Station Policy".

12. Three of six hospital supply rooms in outpatient clinics stored patient care supplies on dirty, contaminated floor and were not stored in accordance with infection control standards.

13. Staff of on the second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties did not clean and sanitize a glucometer (a medical device used to test blood for the levels of glucose or sugar) in accordance with the hospital's policy titled, "BRAND NAME] Glucose Meter," and was visibly dirty with a dark, reddish brown spot at the entrance where the blood is sampled.

14. Clean supplies were stored under the sink in four of 50 cabinets and not in accordance with hospital policy titled, "Environmental Cleaning and Disinfection Policy", and infection control standards in the following areas: auxiliary pathology lab, outside the entrance to the Operating Room (OR), Campus B; second floor, East Plaza of the outpatient clinic, Neuro Rehab Center; second floor of the outpatient clinic, North Plaza, Oral and Maxillofacial Surgery and Plastics Specialties.

15. One of one sampled endoscopic (a thin flexible tube with a camera and light at the tip, used to visualize the internal parts of the body) storage cabinets were observed with four endoscopes touching each other and allowing for possible damage and cross contamination and not stored in accordance with the manufacturer's guidelines titled, "[BRAND NAME] Reprocessing Manual",

16. Garlic aioli was not monitored and part of the temperature cooling process in the bistro café kitchen and did not follow Food Code requirements.

17. Scrambled eggs that were previously cooked were above 41 degrees Fahrenheit (F) and were not monitored for temperature cooling process in the café kitchen in the main hospital in accordance with Food Code.

18. Previously cooked food items stored in the refrigerator in the bistro café kitchen were above 41 degrees F. and did not follow Food Code requirements.

19. Staff failed to ensure biohazardous waste containers (a regulated container storing needles, glass, medication, and sharp objects) were closed between operating room (OR) cases in accordance with national guidelines for two of four sampled biohazardous waste containers (Surgical Services 1, OR T-9).

20. Staff failed to ensure clean and dirty equipment in the high-level disinfection (HLD - the process used for the destruction of all germs except for low levels of bacterial spores) cardiology (relating to the heart) decontamination (to remove dangerous germs from objects) workroom was separated in a manner to prevent cross-contamination according to national standards.

21. Hand hygiene was not performed after donning and doffing gloves for three of three sampled glove removals in accordance with hospital's P&P titled, "Hand Hygiene" and nationally accepted standards.

22. Employees did not have access to a handwashing sink that was separated from the decontamination sink in accordance with the CDC and OSHA regulatory regulations in the cardiology decontamination workroom.

23. There was no documented evidence that the hospital followed the manufacturer's instructions for use (IFU) for daily cleaning of 1 of 1 sampled transesophageal echocardiogram (TEE - a heart test using a camera, a flexible tube) machine, located in the Cardiology Outpatient Department, second floor of the main hospital.

24. Terminal cleaning was not done in accordance with the hospital's P&P, titled, "Procedural Area Terminal Cleaning," and nationally accepted standards and yellow spots were scattered throughout a wall vent for one of two sampled wall vents. (Surgical Services 2, OR 3).

25. The heart-lung machine (Extracorporeal -- a machine that takes over the functions of the heart and lungs during surgery) was observed with brown and orange substances streaking down the side of the machine, (Surgical Services 2, OR 3) and not cleaned as per the hospital's P&P, titled "Medical Extracorporeal Life Support Guidelines".

26. A fluid warmer in OR 3 had a brownish ring round the bottom of the basin and the basin case had several areas of chipped paint and rough brownish discoloration (Surgical Services 2) and not cleaned according to the hospital's P&P titled, "Procedural Area Terminal Cleaning," and nationally accepted standards.

27. 18 of 21 sampled surgical instrument case carts did not have clean/biohazardous (a biological substance that poses a threat to the health of living organisms) labels in accordance with the hospital's P&P titled, "Instrument Transport" and nationally accepted standards.

28. Two of two sampled instrument loading carts (specialized heat-resistant cart used for steam sterilization) and two of two sampled autoclaves (machines used to sterilize patient reusable surgical instruments) (SPD 2nd floor) in accordance with the manufacturer's IFUs and nationally accepted standards for cleaning were followed.

As a result of these failures all patients and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses.

Findings:

1. According to the United States Department of Agriculture (USDA) Food Code 2022 Section 4-601.11 Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces and Utensils A. Equipment, food-contact surfaces and utensils shall be clean to sight and touch, C. Nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris.

On 5/6/25 at 12:30 PM an observation of the food preparation area of the cafe kitchen was conducted with the Executive Chef of Food Services (Ex Chef) and the Senior Food Service Director (SFSD). Multiple bins located on shelves in various areas of the kitchen were observed to hold dry food, food service utensils and equipment. The shelves and bins were not clean with noticeable and excessive food debris, and a sticky brown substance. The can opener was observed with excessive sticky debris on the blade. The Ex Chef and SFSD confirmed the findings and agreed food preparation areas that were not clean could attract pests. The Ex Chef confirmed the can opener was not clean and would have it cleaned.
2. According to the USDA Food Code 2022 Section 4-601.11 Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces and Utensils A. Equipment, food-contact surfaces and utensils shall be clean to the sight and touch.

On 5/6/25 at 3:12 PM, an observation of the ice machine located in the main kitchen of the main hospital and concurrent interview was conducted with the Plant Operations Supervisor (POS). The ice chute, the part of the ice machine that directed ice to the ice storage bin was observed with a gray residue. The POS confirmed the finding and stated the ice machine chutes were cleaned monthly.

Review of the hospital document titled Engineering Order # 110520 showed the ice machine located in the main kitchen was last cleaned on April 5, 2025.

3. On 5/7/25 at 1:37 PM an observation of RN 3 performing NICU milk preparation in the critical care NICU was conducted with the Clinical Nutrition Manager (CNM) present. RN 3 was adding a fortifier (a nutritional additive) to a NICU infant's bottles. RN 3 dropped the bottle top on the ground. RN 3 used her gloved hand to pick up the bottle top then discarded the bottle top in the trash. RN 3 changed her gloves but failed to wash her hands then proceeded with the milk preparation process.

On 5/8/25 at 9:34 AM, an interview was conducted with the Director of NICU (DNICU) and the Director of Pediatrics (DPEDs). Both the DNICU and DPEDs confirmed hands should be washed between glove changes.

a. During the lunch meal preparation on 5/8/25 at 12:00 PM, Cook 1 used gloved hands to place cooked chicken into a blender. Cook 1 then changed his gloves but failed to wash his hands then returned to food preparation. Cook 1 was observed to change his gloves a second time without washing his hands.

On 5/8/25 at 1215 PM, an interview was conducted with SDFS (Senior Director of Food Service). The SDFS confirmed hands should be washed between glove changes.
Review of the hospital Policy and Procedure titled, Hand Hygiene dated 4/12/2025 showed, Purpose: to establish clear guidelines and procedures for proper hand washing, aiming to prevent the spread of germs and infections by ensuring healthcare workers and individuals consistently clean their hands at critical moments, ultimately protecting patients and staff from healthcare-associated infections. D. Glove Use: 2. Perform hand hygiene before donning after doffing gloves.

4. A review of the professional reference titled Infant and Pediatric Feedings, Third Edition, Academy of Nutrition and Dietetics, 2019 showed,
"Providing a separate designated space for the preparation and handling of human milk (HM) and formula is recommended. This space should have physical separation from direct patient care areas; be divided from the storage and anteroom areas and be used solely for the purpose of preparing HM and formulas by aseptic technique. The purpose of an anteroom is to serve as a buffer zone between the HM and formula preparation room and the rest of the health care hospital. The anteroom provides an area where personnel can practice appropriate hand hygiene and put on gowns and bonnets or hairnets before entering the preparation area. A sink used exclusively for hand hygiene is imperative in the anteroom or the identified buffer zone to the preparation area. The sink should have controls for water that do not require the use of hands.

"Office space is necessary for the operation of the preparation room. If space does not allow for a separate anteroom or office, a designated buffer zone within the preparation room that is away from feeding preparation is necessary for hand hygiene and clerical duties to ensure aseptic technique.

"A covered laundry hamper should be placed in the anteroom, office area or designated area away from feeding preparations may be used for depositing reusable gowns after they have been worn.

"The handling of HM and feeding containers should be carried out using aseptic technique and in a location where there is little risk of contamination with pathogenic microorganisms or undesirable environmental substances. Feeding should not be prepared at bedside or in any patient care areas. Preparation requires a clean room with restricted access and healthy personnel. During the time designated for feeding preparation, only authorized personnel should enter the preparation room, and no other activity should be permitted in the room.

"All work surfaces must be cleaned with an antimicrobial sanitizing solution that is appropriate for food contact surfaces.

"The uniform worn into the feeding preparation area should not be street clothing that is worn regularly outside the health care hospital. Ideally a clean uniform should be donned in a locker room inside the health care hospital.

"Personal protective equipment should be donned for feeding preparation, including a bonnet or hairnet, gloves and gowns as well as a beard cover if needed.

"Modulars are most appropriately added in the feeding preparation room at the time of milk preparation. It is of vital importance to consider clinical indications when choosing modulars and additives. Proper handling and storage are imperative to ensure patient safety, as any manipulation of feedings increases the risk of contamination. Facilities should implement policies and procedures outlining the handling and distribution of modulars and additives.

On 5/7/25 at 1:20 PM an interview was conducted in the critical care NICU with RN 4. RN 4 stated each NICU nurse was responsible for preparing feedings for their patients. RN 4 stated liquid fortifiers or modulars were added to the feeding bottles. Powdered formulas were mixed with sterile water in the kitchen by trained kitchen staff.

On 5/7/25 at 1:37 PM, an observation of milk preparation located in the critical care NICU was conducted with RN 3 and the CNM present. RN 3 was preparing critical care NICU feedings on a counter that was located in the middle of the critical care NICU unit. There was no designated separate space for the milk preparation; visitors and staff were free to walk through the area where the milk preparation was performed. The counter had approximately six inches of space to prepare the feedings. On the preparation counter was a plastic bin, a container of sanitizing wipes labeled "Sani-Cloth" germicidal disposable wipes and 12 bottle warmers. On one side of the preparation counter was a covered trash bag used for soiled laundry. The preparation counter was approximately six feet across from a large hand sink that was accessible to visitors and staff. As RN 3 prepared the milk by adding a modular, she wore street clothes and a large vest-type jacket. RN 3 wore gloves but had no hair covering. During the milk preparation, two visitors washed their hands in the hand sink directly across from the milk preparation area. The CNM was asked if the sanitizing wipes were appropriate for food contact surfaces. The CNM confirmed the sanitizing wipes were not appropriate for food contact surfaces. The CNM stated the sanitizing wipes were only used to wipe the milk preparation counters.

On 5/7/25 at 1:50 PM, an observation of the milk preparation area for the 3rd floor NICU and concurrent interview was conducted with RN 5. RN 5 stated each NICU room held between four to eight NICU beds. The milk preparation area was a small counter on top of a refrigerator approximately three feet by one foot. On the milk preparation counter were four bottle warmers and a plastic basket which contained pens and labels. Approximately two feet from the milk preparation counter was a hand sink. The hand sink did not have a splash guard, a barrier to prevent cross contamination from the spread of infection and maintaining a safe environment for patients. The milk preparation counter had a container of sanitizing wipes labeled "Sani-Cloth" germicidal disposable wipes which were attached to the side of the milk preparation counter. RN 5 stated the milk preparation counter was sanitized using the "Sani-Cloth" wipes and allowed to air dry.

On 5/8/25 at 9:34 AM, an interview was conducted with the Director of NICU (DNICU) and the Director of Pediatrics (DPEDs). When asked what professional standards of practice were followed for the NICUs, neither the DNICU nor DPEDs were sure which professional standards of practice were followed. The DNICU and DPEDs were not aware of the professional standards of practice referred to in professional reference specifically for infant and pediatric feedings published by the Academy of Nutrition and Dietetics. The competency of the NICU nurses in regard to milk preparation was discussed with the DNICU and DPEDs. The DNICU and DPEDs confirmed NICU nurses were trained on hire but did not receive annual training on NICU milk preparation. The DNICU and DPEDs stated the hospital was only adding modulars to milk. The DPEDs agreed that the present set up in the critical NICU and NICU for milk preparation was a contamination risk being that anyone could enter the milk preparation area. The DPEDs agreed the hand sink accessible by visitors and staff directly across from the milk preparation counter in the critical NICU, the hand sink in the NICU without a splash guard, the dirty linen bin next to the milk preparation counter in the critical NICU, and office supplies on the milk preparation counter in the NICU were a concern.
On 5/12/25 at 1:00 PM, a phone interview was conducted with NICU Infection Preventionist (NICUIP) and the Director of Accreditation, Licensing, Infection Preventionist. The NICUIP confirmed she did rounds in the NICU but did not have a specific schedule or audit for the milk preparation in NICU units. If she had a concern, she would address it at the time she noticed the problem. The NICUIP confirmed aseptic technique should be followed during milk preparation in the NICUs such as a clean space, PPE (protective personal equipment) and hand hygiene in a specific space. The NICUIP stated breast milk is fortified at bedside. When asked about the milk preparation areas located in the infant rooms and the fact that anyone is allowed in those rooms, the NICUIP stated it was fine because the milk was fortified breast milk and was not sterile. When asked if the sanitizing wipes used in the milk preparation areas should be food safe, the NICUIP stated the sanitizing wipes were a level 4 meaning the least toxic and she would expect that to be food safe. The NICUIP added once the sanitizing solution was dry it was ok to use with food. When asked about the soiled linen container next to the milk preparation counter in the critical NICU, the NICUIP stated it was fine since the soiled linen container was closed. The NICUIP stated the milk preparation space may be splashed with the hand sink location so close in the NICU rooms but that was ok since the nurses would wipe the milk preparation counter with the sanitizing wipe.
Review of the hospital document titled Week 2 Expectations and Evaluation signed by RN 3 on 5/15/2023 showed RN 3 met standards for correctly demonstrates labeling, thawing, fortification and storage of breast milk. Correctly verifies and administers breast milk.
Review of the P/P titled Breast Milk Management effective 1/13/2023 showed aseptic technique must be used in breast milk preparation and handling.

5. During a concurrent observation and interview on 5/6/25 at 2:02 p.m. with Manager of the Emergency Department (MED)1, and the Director of the Emergency Department (DED) in the ED's Yellow Zone, Pt 39's transmission-based droplet precautions room door was left open, and the patient was in the room without a mask. The DED stated doors to isolation rooms should remain closed to prevent the spread of infection. MED 1 closed the patient's ED room door.

During a concurrent interview and record review on 5/6/25 at 2:14 p.m. with Registered Nurse 10, Patient (Pt) 39's "History & Physical (H&P- an assessment from physician including medical history and exam)," dated 5/4/25, "Microbiology Results," dated 5/4/25, and "Isolation and Infection Instructions", dated 5/4/25, were reviewed. RN 10 stated he was the primary nurse for Pt 39. The "H&P" indicated Pt 39 was a 77-year-old with worsening of shortness of breath over the last week, with difficulty breathing with exertion. The "H&P" indicated Pt 39 had an oxygen saturation (percentage of oxygen in blood) of 76% (normal 95%-100%) on room air. RN 10 stated Pt 10 went to the ED by ambulance and was admitted for acute respiratory failure with hypoxia on 5/4/25 at 7:26 a.m. The "Isolation and Infection Instructions" indicated, droplet precautions were ordered on 5/4/25. RN 10 stated Pt 39 was on droplet precautions for Rhinovirus (respiratory virus) and has pneumonia (an infection of the air sacks in the lungs). RN 10 stated, he did not know the door was left open to Pt 39's hospital room. RN 10 stated the door to the isolation room should remain closed to prevent the spread of the virus to other patients, visitors and staff.

During an interview on 5/14/25 at 2:30 p.m. with the Director of Infection Prevention (DIP) and the Infection Prevention Registered Nurse (IPRN), the DIP stated, his expectations from an infection control standpoint for isolation rooms was to ensure the right signage was up, and the personal protective equipment (PPE- Specialized clothing or equipment worn by an individual to protect them from various hazards in the workplace or other environments) matched the type of isolation. The DIP stated his expectation was everyone who entered the isolation room wore the correct PPE. The DIP stated his expectation was to limit the number of people in isolation rooms to reduce the risk of introducing additional microorganisms to the patient.

During an interview on 5/15/25 at 11:30 a.m. with the Chief Nursing Officer (CNO), the CNO stated, the door to droplet precaution isolation room should be closed, and appropriate PPE should be worn in the room.

During a review of professional reference titled, "Infection Control Summary of Recommendations" (retrieved from https://www.cdc.gov/infection-control/hcp/isolation-precautions/summary-recommendations.html), dated 11/27/2023, indicated " ...in acute care hospitals, place patients who require Droplet Precautions in a single-patient room when available ... Ensure that patients are physically separated ...".

6. During a concurrent observation and interview on 5/6/25 at 11:49 a.m., with Manager of Neurology ICU (MN ICU), Director of Neuroscience (DN), and RN 18 in the Neurology ICU, RN 20 was observed assisting Physician Assistant (PA) 1 inserting an External Ventricular drain (EVD) (a tube inserted into the brain to reduce excess fluids and/or monitor pressures in the brain) in Pt 100's head and simultaneously, Nurse Practitioner (NP) 1 was inserting a central venous line (a large IV tube usually put into the vein in the groin or neck for fluids and/or monitoring) into the right groin. NP 1 and PA 1 were observed in gown, sterile gloves, cap, and eye protection during the procedure. RN 20 was observed documenting care, following the orders given by PA 1 and NP 1, monitoring Pt 100's vital signs/response to the procedures and administering medications to Pt 100. RN 20 was observed wearing a cap, and no mask. MN ICU stated, RN 20 should be wearing a mask during the procedure to protect the patient from possible infection.

During a review of Pt 94's,"History & Physical [H&P]," dated 5/6/25, the "H&P" indicated, Pt 100 was admitted on 5/4/25, she was an 80-year-old female who complained of Headache at home and called Emergency Transport Services. In route, Pt 100 lost consciousness and had seizures. Pt 94 had a history of high blood pressure, heart disease and atrial fibrillation (an irregular heart beat). Pt 94 was found to more than likely have a hemorrhagic (a blood vessel in the brain ruptures and bleeds, causing damage to brain tissue) stroke due to brain aneurysm (a weakness in a blood vessel wall.

During an interview record review, on 5/14/25, at 2:30 p.m., with the Director Infection Prevention (DIP), and the Infection Prevention Nurse (IPRN), the IPRN stated, standard precautions face/eye shield, mask, gloves, gown are expected for anyone doing the procedure or are ready to help during the procedure. The IPRN stated, the staff should limit the number of people in the room to reduce the risk of introducing additional microorganisms to the patient.

During an interview on 5/15/25 at 11:30 a.m. with the Chief Nursing Officer (CNO), the CNO stated, the staff should have had masks during the procedure as it is important to prevent infection. The CNO stated, the staff should work as a team and everyone should check each other.

According to the CDC (Centers for Diseases Control and Prevention - an agency that works to protect people from health threats) reference titled "CDC's Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings" (https://www.cdc.gov/infection-control/hcp/core-practices/index.html) dated 4/12/24, " ...standard precautions (basic level of infection control that is used in patient care) include: ...hand hygiene ...environmental cleaning and disinfection ...risk assessment with use of appropriate personal protective equipment (e.g., gloves, gowns, face masks) based on activities being performed ..."

7. During a concurrent observation and interview on 5/6/25 at 10:50 a.m. in the Labor & Delivery Unit's soiled utility room with Obstetric (OB, the field of study concentrated in pregnancy, childbirth and post birth period) Technician (OBT) 1, two placenta specimens in liquid were stored in clear plastic tubs inside unsealed clear plastic bags. OBT 1 stated the specimen bags should have been sealed to avoid spillage and the risk of transmission of infection.

During an interview on 5/15/25 at 11:10 a.m. with the Chief Nursing Officer (CNO), the CNO stated laboratory specimens should be sealed in a plastic biohazard (marked as a potential disease producing pathogens) bag to avoid cross-contamination both to and from the specimen and the handler of the specimen.

During the review of a professional reference titled, "A Comprehensive Guide to Biohazard Specimen Bags (CG)", dated 2/2/24, the "CG" indicated, " ... Biohazard specimen bags are also known as biohazard bags or specimen transport bags. They are specifically designed containers for the safe and secure transportation of biological materials posing a threat to human health. These materials include blood samples, tissues, cultures, and other potentially infectious substances ... Closure Mechanism: Secure closure mechanisms, such as zip-lock seals or adhesive strips, prevent exposure to the contents ... reducing the risk of contamination ...".

8. During a concurrent observation and interview on 5/6/25 at 2:10 p.m. in the patient nourishment room on the High-Risk Ante Partum (before and after birth) Unit with Registered Nurse (RN) 7, an unlabeled container contained half a sandwich. RN 7 stated the sandwich was sent up for a patient and was held but should have been thrown out if not eaten. RN 7 stated the sandwich should not have been saved as they had dated sandwiches in the refrigerator.

During an interview on 5/15/25 at 11:30 a.m. with the CNO, the CNO stated patient food should be labeled with an expiration date because expired food could make a patient ill.

During a review of facility's P&P for Nutrition/Dining Services titled, "Storage," dated 11/13/24, the policy indicated, " ... PURPOSE ... Proper storage of food is essential to preserve its quality, prevent contamination and deter bacterial growth. Maintenance of proper storage procedures is a responsibility shared by receiving, store room, ingredient room, preparation and service personnel. ... All opened foods will be kept in containers that prevent contamination. Such containers will be clearly labeled with the common name of the food and dated with date food was opened and expiration date. ... "

9. During a concurrent observation and interview on 5/6/25 at 1:27 p.m. on the Rehabilitation Unit with the Manager of the Rehabilitation Unit (MRU) in the clean utility room, nutrition room, and medication room, labels on the supply bins and cupboards were peeling off, exposing dirty adhesive. MRU stated peeling labels are an infection risk because the adhesive can trap organisms, and the labels can't be properly cleaned.

During a concurrent observation and interview on 5/6/25 at 2:01 p.m. on 5 West Unit with M1E in the clean utility room, labels on the edges of shelves were peeling off, exposing dirty adhesive. M1E stated the labels needed to be replaced because they can cause the spread of infection.

During a concurrent observation and interview on 5/6/25 at 2:31 p.m. on 5 West Unit with the Supervisor (S5W) in room 587, surveyor noted "Contact Isolation" sign outside door of room. S5W stated this patient (Pt 15) is in isolation for VRE (Bacteria known as vancomycin-resistant enterococci (VRE) are resistant to some powerful antibiotics), CRE (Carbapenem-resistant Enterobacter (CREs) are certain kinds of bacteria that carbapenems (commonly used antibiotics) aren't effective against.), and C.diff (Clostridium difficile (C. diff) is a bacterium that can cause inflammation of the colon (colitis). It is a common cause of antibiotic-associated diarrhea.) Surveyor and S5W, put on gowns and gloves and entered Pt. 15's room. The communication board (a white board that provides information about the patient and the names of nurses caring for the patient) had been altered with a patch to change the name of the unit, using a piece of material approximately 1/8" thick, which was stuck on top of the old unit name, creating a raised edge around the patch. The same type of patch was used to change the room number on the communication board. On the edges of the patches, black residue was stuck around all sides. S5W stated the dirt around the edges is concerning, especially since Pt. 15 was in isolation for very resistant organisms, and the whiteboard could not be cleaned properly to protect staff and the next patient who is admitted to this room.

During an interview on 5/15/25 at 11:28 a.m. with the Chief Nursing Officer (CNO), the CNO reviewed a photograph that had been taken of the dirt around the patch and stated, "That is unacceptable. It is an infection control risk for everybody who goes in the room, and it is unacceptable."

During a review of facility's policy titled, "Infection Prevention Plan," effective date 2/27/25, the policy indicated, " ... HAZARD SURVEILLANCE TOURS/ENVIRONMENTAL ROUNDS ... A multidisciplinary team with representation from Infection Prevention Department, Plant Services, Envi

Based on interview and record review, the hospital failed to implement interventions meant to support the effectiveness of hospital policies and procedures (P&Ps) to assure the achievement and maintenance of high standards of medical practice and care when:

1. On 5/8/25, the hospital self-reported to the California Department of Public Health (CDPH), a suture needle had been "lost" during a laceration repair procedure on a Labor and Delivery (L&D) patient (Patient (Pt) 30), after a vaginal delivery, on 2/21/25.

This failure resulted in Pt 30 suffering unnecessary pain, delayed healing, and an additional procedure to retrieve the retained foreign object (RFO- a patient safety incident in which a surgical object is accidentally left in a body cavity or operation wound following a procedure).

2. Hospital staff failed to submit an adverse event report (IRIS-Incident Reporting Intranet System) at the time of Pt 30's "lost" suture needle event, in accordance with hospital P&P titled "Adverse Event Reporting" dated 1/3/22.

This failure had the potential to place future L&D patients at risk of a RFO event and to experience unnecessary effects of a RFO such as pain, injury, and additional surgery/procedures.

3. On 3/28/25, the hospital self-reported to CDPH, staff failed to follow hospital P&P titled "Universal Protocol" dated 12/19/23 and performed a surgical procedure (nerve block) on Pt 19's left arm (instead Pt 19's right arm (correct arm).

This failure resulted in Pt 19 suffering unnecessary pain, delayed healing, and an additional procedure.

Findings:

1. During a concurrent interview and record review on 5/9/25 at 10:54 a.m., with the Director of Women and Children's Services (DWC), DWC stated Doctor of Obstetrics/Gynecologist (OB/GYN) 1, approached her on the unit on the morning of 5/7/25 to report a RFO event. DWC stated OB/GYN 1 reported his colleague, OB/GYN 2, notified him Pt 30 presented to their private practice with a complaint of vaginal pain. OB/GYN reported he discovered and removed a retained suture needle after a physical exam was performed. DWC stated a preliminary investigation indicated Pt 30 delivered vaginally on 2/21/25 by a Certified Nurse Midwife (CNMW- an Advanced Practice Registered Nurse who specializes in the care of women's reproductive health and childbirth) while Pt 30's OB/GYN (OB/GYN 1) was in the Labor and Delivery (L&D) Operating Room (OR) with another patient. DWC stated an IRIS report was submitted by the Director of Risk Management and Pt Relations (DRM) on 5/9/25.

During a telephone interview on 5/12/25 at 10:53 a.m., with Pt 30, Pt 30 stated she "tore- refers to perineal tearing, a common injury that occurs when the skin and tissues between the vaginal opening and anus (the perineum) stretch and tear during delivery) during delivery and the hospital midwife was doing the sewing. Pt 30 stated "lost needle" was announced in the room, but cannot recall who stated it. Pt 30 stated staff and CNMW searched and searched to locate the needle without success. Pt 30 stated CNMW "stated she was 95% sure it was not left" in the patient. Pt 30 stated her support persons, mother and significant other were the support persons in the room. Pt 30 stated there were two (2) nurses and an Emergency Medical Technician student present during the announcement and helped search for the missing suture needle. Pt 30 statedher mother told the staff that she wanted an x-ray to see if the needle could be found. Pt 30 stated an X-ray was done but results were not given to her, she asked for a follow up for a better view and another x-ray was done. Pt 30 stated she had discomfort, but since she had never given birth before, she did not know if the discomfort was normal or not. Pt 30 stated the discomfort and pain in the area was concerning and when she touched the area she felt a sharp surface. Pt 30 stated she had no other signs or symptoms of infection. Pt 30 stated she made an appointment with her doctor who completed a physical examination on 5/2/25 with a follow up appointment scheduled for 5/5/25 to remove the needle in the doctor's office. Pt 30 stated the OB/GYN 2 numbed the area, removed it [the needle], with a small incision (cut) and added one (1) stitch. Pt 30 stated she was given a prescription for pain medication and reports is still uncomfortable, with stitch to be removed on 5/13/25.

During a review of Pt 30's "Delivery Note (DN)" dated 2/21/25, the DN indicated "...Delivery done for [OB/GYN])...he is involved with a c/s (c/s- Cesarian Section- the surgical delivery of a baby through a cut (incision) made in the birth parent's abdomen and uterus) at present...[Pt 30] is a 21 y.o. (year old) G1P0 (describes a woman who is pregnant for the first time and has not yet delivered a baby) at 40w3d [40 weeks and 3 days] admitted for Labor...Laceration: 2nd...Repair: with edges well approximated and hemostatis achieved using 3-0 vicryl...Final instrument and lap count correct. NOTE: 3-0 Vicryl used to suture laceration- needle popped off spontaneously when re-grasping for next stitch, unable to account for needle. All drapes and bags searched. Pt tissue examined manually and not identified. [OB/GYN 1] aware and will manage follow up..."

During a review of Pt 30's "Office Visit" progress note dated 5/5/25, the note indicated "...Reason for Visit: Follow-up Visit... Comments Removal of the needle... Comments: 1 cm (centimeter-a unit of measurement) incision...of right vulva (the external (outer) female genital organs). Mass was grasped and bluntly removed intact. Appears to be a curved needle. Skin reapproximated with 2-0 vicryl..."

2. During an interview on 5/9/25 at 10:54 a.m., with DWC, DWC stated her preliminary investigative findings in the matter of Pt 30's RFO event, were that staff failed to submit an IRIS report on the day the RFO was detected (2/21/25). DWC stated to her knowledge, the only IRIS report submission was the report submitted by the DRM on 5/9/25. DWC stated her expectation was for staff to submit an IRIS report per hospital P&P, and as soon as possible once the adverse event occurs.

During an interview on 5/16/25 at 11:02 a.m. with CNO, the CNO stated his expectation was for staff to report events such as the RFO incident on Pt 30 and that "what goes in should come out pre and post [areas] should be preparing the patient and all counts are done/accounted for and appropriately tracked to prevent RFO events.

During a review of hospital Policy and Procedure (P&P) titled, "Adverse Event Reporting to the California Department of Health Services" dated 1/3/22, the P&P indicated, " ...I. PURPOSE A. To comply with the mandated reporting requirements of Health and Safety Code §1279.1(b). B. To support the improvement of patient safety and quality improvement initiatives... II. DEFINITIONS A. Adverse event includes any of the following: 1. Surgery performed on a wrong body part that is inconsistent with the documented informed consent for that patient. A reportable event does not include a situation requiring prompt action that occurs in the course of surgery or a situation that is so urgent as to preclude obtaining informed consent. 2. Surgery performed on the wrong patient. 3. The wrong surgical procedure performed on a patient that is inconsistent with the documented informed consent for that patient. A reportable event does not include a situation requiring prompt action that occurs in the course of surgery, or a situation that is so urgent as to preclude the obtaining of informed consent. 4. Retention of a foreign object in a patient after surgery or other procedure, excluding objects intentionally implanted as part of a planned intervention and objects present prior to surgery that are intentionally retained. ... III. POLICY A. It shall be the policy of Community Medical Centers (CMC) to report an adverse event, as defined within Health and Safety Code §1279.1, to the California Department of Public Health (CDPH) no later than five days after the event has been detected; or, if the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than twenty-four (24) hours after the adverse event has been detected. ... IV. PROCEDURE
A. Investigation 1. All adverse events which may be considered reportable as defined by this policy shall be reported to the Supervisor/Manager immediately by involved staff and an Incident Reporting Intranet System (IRIS) completed within 24 hours..."

During a review of hospital P&P "Universal Protocol (UP- a set of guidelines for healthcare professionals that aims to prevent surgical errors) - Procedural Areas" dated 12/19/23, the P&P indicated " ...I. PURPOSE: A. To provide guidance to [hospital] personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures ... B. To provide guidance for improving team communication through a culture of safety in order to reduce the incidence of medical errors ... III. POLICY: B. The Universal Protocol must be followed in all areas of the organization where the procedure is performed (e.g., Operating Room (OR) ...Interventional Radiology (IR) ...etc.) ... D. The UP is composed of the following elements: 1. Pre-Procedure verification. 2. Marking the site, when applicable ... V. PROCEDURE: ... B: Site Marking... 7. For procedures on a lateralized internal organ via a minimally invasive approach (a surgical technique that uses smaller incisions and specialized equipment to perform procedures), whether percutaneous (a medical procedure or method that involves accessing tissue or inner organs by puncturing the skin with a needle, instead of making a large incision) or through a natural orifice (an opening in the body that can be used to access the abdominal cavity for surgery), mark the intended side at or near the insertion site that will remain visible after completion of the skin prep[aration] and sterile draping... C. Procedural Briefing...b. Correct procedure and laterality as consented. c. Site marked... D. Time Out 1. The Time Out is a standardized process that is performed with the healthcare team and used throughout the hospital before all operative/invasive procedures. The healthcare team involved in the procedure must pause to conduct a final verbal and audible verification of all safety elements listed below. This pause is referred to as a Time Out... 2. ... b. ... i. The written consent will be utilized as a guide for the patient's identification and procedure... d. Time Out addresses and verbally confirms among all team members the following elements:... II. Correct procedure and laterality (when applicable) as consented... VI. DOCUMENTATION... C. If provider cannot mark a site that requires marking, ensure that a verification of the site/side with patient/substitute decisionmaker is documented in the EHR (Electronic Health Record)..."

3. A report dated 3/28/25 sent to CDPH from the hospital indicated, "On 3/26/25, a 70-year-old male patient with past medical history of end-stage renal disease [ESRD - kidneys were failing] presented to [name of hospital] for a right arm fistula creation [a connection between two parts of your body that don't normally connect. It often takes the form of a tunnel or passageway]. Prior to surgery, the patient was to undergo a right (correct) arm peripheral nerve block for anesthesia. Informed consent (got written permission from the patient) performed for right (correct) arm peripheral nerve block. Positioning was interrupted prior to nerve block placement as RN briefly left room to gather medications. CRNA (Certified Registered Nurse Anesthetist - an RN trained to do anesthesia) and resident physician entered room and completed the nerve block on left (incorrect) arm without a timeout per universal protocol. The surgeon [Medical Doctor - MD1] entered [operating]room and immediately noticed the nerve block had been placed on the left (incorrect) arm. Local anesthetic injection was then performed on right (correct) arm and a right fistula creation was performed without further complications. The patient was transferred to PACU [post-anesthesia care unit]. Disclosure was done [patient was told what happened.] Patient was discharged [sent home] the same day ..."

During a concurrent interview and record review on 5/12/25 at 3:30 p.m. with the Manager of Inpatient Surgery (MIS), MIS accessed the Electronic Medical Record (EMR) for Pt 19. The document titled History and Physical dated 3/26/25 indicated Pt 19 had end-stage renal disease (his kidneys were failing) and needed hemodialysis (a medical treatment that replaces the function of the kidneys when they are no longer working properly.) The reason for the surgery was for a procedure to "create a right brachial artery to upper arm basilic vein transposition fistula" (a surgical procedure to create a route for hemodialysis treatments.) The MIS reviewed the EMR and stated there is no documentation of a timeout for a nerve block in the patient's chart. The document titled "H&P" dated 3/26/25 at 9:05 a.m. signed by MD 1 indicated, "COMPLICATIONS: Inadvertent anesthesia wrong site block (left instead of right)

During an interview on 5/8/25 at 10:20 a.m. with the Vice-Chair of Integrated Medical Staff physician (DRI), the DRI stated he was familiar with the case because he had been part of the quality review process that investigated the event after it occurred. The DRI stated, "There should have been a timeout (a surgical timeout is a brief pause in the surgical procedure to verify critical information before the procedure starts to ensure patient safety), but the hospital didn't do a timeout. The anesthesia provider (CRNA 1) proceeded with the nerve block without doing a timeout." DRI stated that nerve blocks are "not without risks. Complications could include nerve injury, infection, and bleeding." The patient received a nerve block that wasn't needed, because they used another form of anesthesia to do the surgery on the correct side.

During an interview on 5/9/25 at 11:00 a.m. with the Registered Nurse (RN 17) who was in the room at the time of the nerve block incident, RN 17 stated, "I went to short-stay (an area where patients are held while waiting for surgery) and brought him (Pt 19) back to the [operating] room. During that time, I had started to position the patient, but anesthesia needed to put on leads (wires to monitor heart rate) so I took that opportunity to leave the room and get the medications that would be needed. While I was out of the room, he (CRNA1) started on the nerve block. I usually initiate the timeout, but I wasn't ready for that yet. I finished what I was working on, and MD1 came in and immediately saw what was happening. He said, "Which arm did you block?" RN 17 stated she hadn't finished positioning the patient when the nerve block was started by CRNA1. RN 17 stated, "Anyone can call for a timeout. If he (CRNA 1) called for a timeout, I didn't hear him and I didn't participate. We do at least two timeouts, one before the nerve block and one before the surgical incision. I always do a timeout, but I wasn't in the room and wasn't ready to do the timeout." RN 17 stated that when she oriented to her role as a surgical nurse, "Universal Protocol" was taught, which includes a timeout is done before every procedure and everyone has to stop and participate in the timeout. RN 17 stated, "The RN in the operating room calls for the timeout and makes sure everyone in the room is involved." RN 17 stated MD1 had met with Pt 19 in the pre-operative area and had made a mark on the right arm to indicate on which side of the body they would be doing the procedure. RN 17 stated they also put a pink wrist band on the arm that they will be working on to show which side. The right arm had the surgeon's mark indicating he would be doing the procedure on the right arm, and the right arm also had the pink wristband. RN 17 stated they were not short-staffed that day.

During an interview on 5/9/25 at 11:30 a.m. with CRNA 1, he described the incident and stated that when he came into the operating room , Pt 19 was already in the room on the surgical table. The nurse was "in and out of the room" and she had a nurse with her that she was training. CRNA 1 stated, "I did the nerve block on the left side [wrong side], then MD 1 walked in and saw that it was the wrong side. Ultimately we did a MAC (Monitored Anesthesia Care is used for uncomfortable procedures or minor surgeries that do not usually require general anesthesia) with nerve block on the wrong side." CRNA 1 stated a nerve block can last for up to 24 hours, so they didn't do a nerve block on the right side because Pt 19 would not have been able to use either arm, so they did the MAC instead. CRNA 1 stated a pink arm band was placed on Pt 19's right arm in the pre-op area, and the right arm had been marked in ink by the surgeon (MD 1) prior to the patient going into the operating room to indicate "laterality" (laterality refers to the side of the body where a specific condition or procedure is located.) CRNA 1 stated, "I didn't look for the mark. I don't always look for the mark on the arm." CRNA 1 stated his normal pre-anesthesia evaluation included asking the patient questions, doing a physical assessment, reviewing the history and physical report, making sure the correct procedure as stated by the patient, and confirming laterality. CRNA stated, "In the computer there is a note from the surgeon showing what the surgery will be. The order was for the right side." CRNA 1 stated the bed wasn't in the orientation that he would expect for a right arm fistula. "We have standard timeouts that are done before incision, we have room verification process, and procedural timeouts before nerve blocks. At least two people participate, at least me and the nurse. We check the consent, verify it's the right person, etc. In this case, we didn't do that. The nerve block was done before the surgeon saw the patient in the room." CRNA 1 stated nerve blocks, "have complications and risks, including infection risk and nerve damage." CRNA stated he has reviewed the policy and now does a timeout 100% of the time. CRNA 1 stated, "I should have checked to see which arm the doctor had marked for laterality. I will do that every time in the future, for sure."

During an interview on 5/14/25 at 2:45 p.m. with the DRM, the DRM explained how the hospital responded after they learned of the wrong side nerve block. The DRM stated they did a root cause analysis (RCA - a structured process for investigating incidents to determine the cause or causes) and found that the education regarding timeouts before nerve blocks may not have reached the providers. DRM stated they have now done education with the anesthesia group and with the surgeons. Anesthesia Leadership reinforced "Universal Protocol - Procedural Areas" to make sure that anesthesia providers (medical doctors who specialize in anesthesia and CRNAs) know that a separate timeout is required for regional blocks (such as nerve blocks on arms or legs), spinals (Spinal blocks are injected directly into the spinal fluid through a needle in the patient's back, providing immediate and complete pain relief) , or epidurals (epidurals are injected into the space outside the spinal fluid sac, allowing for continuous pain relief and greater control of pain levels without taking away all feeling.) DRM stated they also trained all staff that a nurse must be present for the timeout, and the timeout must be documented in the procedure record.

During an interview on 5/15/25 at 12:30 p.m. with the surgeon (MD 1) who performed the surgery on Pt 19, MD 1 stated he remembered the surgery well. MD 1 stated that before any surgery is done, he evaluates the patient in the pre-operative area, does an interval H&P (talks to the patient to make sure nothing has changed since the patient was last examined) and then he marks the site by using an ink pen to show which side the surgery will be done. MD 1 stated he is the supervisor over the CRNAs, and "They are supposed to do a timeout before their procedure." MD 1 stated that on the day of the surgery for Pt 19, "I walked in and immediately noticed it was the wrong arm. I positioned the patient as we normally would. I was trying to prevent harm to the patient, I didn't want to have to reschedule. A fistula can be done under local anesthesia, so that's what we did instead of doing a block on the right arm, which would have left him without the use of both arms for up to a day. MD 1 stated the anesthesia timeout is mandatory, and this was not a new process.

During an interview on 5/15/25 at 11:00 a.m. with the Chief Nursing Officer (CNO) the CNO stated the root cause of the wrong side nerve block was the failure to do a timeout before the nerve block. The CNO described a timeout as. "A period to validate everything in the room. Everything before you cut."

During a review of hospital Policy and Procedure (P&P) titled, Universal Protocol - Procedural Areas" dated 12/19/22, the P&P indicated, " ... I. PURPOSE: A. To provide guidance to peri-procedural personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures. B. To provide guidance for improving team communication through a culture of safety in order to reduce the incidence of medical errors. II. DEFINITION: A. Provider: A person who is authorized to provide care as determined by privilege or competency through the Medical Staff and the Board of Trustees - including the following: 1. Medical Staff Member: Physicians and others granted membership on the Medical Staff and, for purposes of this policy, includes individuals with temporary clinical privileges. 2. Advanced Practice Professional (APP): Physician assistants and advance practice nurses including nurse practitioners, certified nurse midwives, certified registered nurse anesthetists and other non-physician providers who provide direct patient care services under a defined degree of supervision by a physician Medical Staff Member. 3. Learner: A student, resident or fellow who does not have privileges or credentials on the Medical Staff of [name of health system] for their academic program ... III POLICY: A. The Universal Protocol must be followed on all procedures that require an informed consent. This includes all invasive/operative procedures, and all procedures done under Procedural Sedation whether invasive or non¿invasive. B. The Universal Protocol must be followed in all areas of the organization where the procedure is performed (e.g., Operating Room (OR), Cardiac Catheterization Laboratory (CCL), lnterventional Radiology (IR), Nuclear Medicine, Endoscopy, etc.). C. The Universal Protocol must be practiced whether the provider is doing the procedure alone (e.g., insertion of central line), or as part of a greater team (e.g., in the OR or CCL). D. The Universal Protocol is composed of the following elements: Pre-Procedure verification; Marking the site, when applicable; Procedural Briefing; Time Out; Debriefing ....D. Timeout: 1. The Time Out is a standardized process that is performed with the healthcare team and used throughout the hospital before all operative/invasive procedures. The healthcare team involved in the procedure must pause to conduct a final verbal and audible verification of all safety elements listed below. This pause is referred to as a Time Out. 2. The Time Out involves the immediate members of the procedure team, including the individual performing the procedure and other active participants who will be participating in the procedure from the beginning. A. Conduct the Time Out immediately before the procedure begins with the patient properly positioned, prepped and draped ...All activities are to be suspended for the duration of the Time Out, to the extent possible, without compromising the safety of the patient so that all members of the team are focused on elements of the Time Out. Each team member will play a role in the process ... D. Time Out addresses and verbally confirms among all team members the following elements: ... Correct procedure and laterality (when applicable) as consented. Ill. Site marked (when applicable).

The Anesthesia Patient Safety Foundation Newsletter article titled "Safety Considerations in Peripheral Nerve Blocks," dated 2/2025, retrieved 5/27/25 from https://www.apsf.org/article/safety-considerations-in-peripheral-nerve-blocks/ indicated, " ...Prevention of Wrong-Sided Blocks ... Wrong-sided procedures are considered "Never Events" ... The term "Never Event" was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), in reference to egregious medical errors that should never happen. There are certain characteristics identified in most wrong-sided blocks... Prior to starting the nerve block, visual confirmation of the correct procedure location is performed by both the patient and nurse using institution-specific standards, which can include placing a wristband marked with the word "yes" on the side corresponding to the surgery or marked clearly by the surgeon or provider performing the procedure. Involving the patient in the process prior to receiving sedation or anesthesia leads to decreased error and may enhance patient satisfaction as patients may feel they are active participants in the process and gain confidence in their providers ..."