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Based on observation, interview and record review, the hospital failed to have an effective governing body (GB) that is legally responsible for the conduct of the hospital when:

1. 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:

a. The program did not implement effective actions to address the long-standing problem of the hospital practice to provide care to inpatients in the emergency Department (ED- an outpatient hospital department that provides immediate medical care to patient with urgent or life-threatening conditions) the QAPI program has not implemented actions to sustain improvement (refer to A-0315).

b. The hospital failed to recognize, analyze the cause, and create clear expectations related to excessive use of force against one of seventy-two patients (Patient [Pt] 1) (Refer to A-0286).

2. Resources and oversight were not provided to ensure the hospital had a well-organized and effective nursing services when the hospital failed to develop individualized care plans, follow hospital policies and procedures, follow physician orders and standards of practice (Refer to A-0396, A-0398, and A-0405).

3. Resources and oversight were not provided to ensure an active Infection Prevention and Control program 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 (Refer to A-0750).

4. Resources and oversight were not provided to ensure an organized food and nutrition services was organized in a manner appropriate to the scope and complexity of the food service operations when: the hospital policy and procedure regarding nutritional screening and assessment did not follow current standards o practice according to the Academy of Nutrition and Dietetics (Refer to A-0619). Therapeutic diet orders were not followed when the hospital's diet manual and the department's policy and procedure for nutrition supplementation did not provide clear parameters when the Registered Dietitian initiated nutrition supplements (Refer to A-0630).

5. Resources and oversight were not provided to ensure safe and effective pharmaceutical services to meet the needs of four of 72 sampled patients (Pt 6, Pt 9, Pt 16, and Pt 71) and no system was in place to accurately record receipt and disposition of all controlled substances (drugs whose manufacturing, possession and use are regulated by the federal government) including patient's own medications (POM) (Refer to A-0494 and A-0500).

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, video recording review, and record review, the hospital failed to protect and promote each patient's rights when:

1. Care was not delivered in a safe setting for all patients including the provision of respect, dignity and comfort (Refer to A-0144),

2. All patients were not given the right to make informed decisions when a surgical consent was not signed (Refer to A-0131), and

3. Language barriers were not accommodated for all identified non-English Speaking patients (Refer to A-0117).

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe and effective manner in accordance with the statutory-mandated Condition of Participation for Patient Rights.

Based on observation, interview and record review, the hospital failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program when there was no effective oversight or monitoring for the inappropriate use of excessive force on one (1) of seventy-two (72) sampled patients (Pt) 1. (Refer to A286)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide patient care in a safe and effective manner in accordance with the statutory-mandated Condition of Participation for QAPI.

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

1. The hospital failed to develop and maintain an individualized care plan (CP-a document that outlines a patient's health conditions, treatments and other information to guide their care and ensure continuity) for one of 27 patients (Pt 6) when Pt 6's CP did not include important details about her pain location, effective medications, or other pain management interventions, as required by hospital Policy and Procedure (P&P). (Refer to A-0396, Finding 1).

2. For one of five sampled patients (Pt 15) the CP did not identify her as non-English speaker or address her communication needs to ensure she fully understands her care. (Refer to A-0396, Finding 2).

3. Nursing staff failed to perform a head-to-toe assessment (thoroughly examine the body) for one of 10 patients (Pt 3) when Pt 3 was brought to the emergency department (ED- provides immediate medical care to patients with urgent or life-threatening conditions) by ambulance after a motorcycle accident and the nurse did not remove his clothing to check for injuries and did not listen to his heart, lungs, and abdominal (stomach area) sounds (an assessment using a stethoscope [a device used to listen to sounds inside the body] helps the nurse listen to the heart, lungs, and stomach to check if the body is working normally). (Refer to A-0398 Finding 1).

4. Three of three patients (Pt 2, Pt 21 and Pt 22) did not have their skin assessed and documented each shift by ED nursing staff, and Pt 21 did not have a dual nurse skin assessment (a method where two nurses work together to thoroughly assess a patient's skin for any signs of injury or potential risk factors) when transferred to another patient care area per hospital P&P titled, "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", "Admission & Ongoing Assessment - Nursing (Acute Care)", and "Documentation in the Health Record". (Refer to A-0398, Finding 2).

5. One of 10 patients (Pt 22) had an inpatient physician order and held in the ED, did not have a head-to-toe assessment completed by ED nursing staff according to hospital P&P titled, "Admission & Ongoing Assessment - Nursing (Acute Care)". (Refer to A-0398, Finding 3).

6. Two out of 10 sampled patients (Pt 2 and Pt 21) had an inpatient physician order and held in the ED were not provided hygiene care according to hospital Policy and Procedure (P&P) titled "Oral Care", and the "Patient Care Tech 1 Job Description". (Refer to A-0398, Finding 4).

7. One out of 10 sampled patients (Pt 2) did not receive a meal or snacks while admitted and held in the ED on 3/27/25 according to physician order. (Refer to A-0398, Finding 5)

8. Nursing staff failed to complete a nutritional risk screening for two of 12 patients (Pt 2 and Pt 21) or it was not completed accurately within 24 hours of admission according to the hospital's P&P titled, "Nutritional Care and Documentation in the EHR [Electronic Health Record]." (Refer to A-0398, Finding 6).

9. Nursing staff failed to ensure an enteral feeding (a method of providing nutrition directly into the gastrointestinal tract through a tube) was labeled with the date and time of change for one of two patients (Patient 65) in accordance with hospital P&P. (Refer to A-0398, Finding 7).

10. Nursing staff did not administer intravenous (IV, into the vein) magnesium (a naturally occurring mineral compound needed in the body) at the ordered time and rate and did not administer PRN (as needed) intravenous blood pressure medication according to physician's orders for one of 72 sampled patients (Pt 12). (Refer to A-0405, Finding 1).

11. Nursing staff did not administer IV vancomycin (an antibiotic to treat infection) at the scheduled time for one of 72 patients (Pt 16). (Refer to A-405, Finding 2).

12. An intramuscular (IM, into the muscle) medication administered to one of 72 patients (Pt 1), was prepared by one Licensed Nurse (LN - ANM 4, Assistant Nursing Manager 4) and administered by another LN (Registered Nurse 1) and the LNs did not follow acceptable standards of safe medication administration. (Refer to A-0405, Finding 3).

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

Based on observation, interview, and record review, the hospital failed to ensure safe and effective pharmaceutical services to meet the needs of four of 72 sampled patients (Patient 6, Patient 9, Patient 16, and Patient 71) when:

1. Patient 16's (Pt 16) vancomycin (an antibiotic to treat infection) trough (a blood level to measure the amount of antibiotic in the body) levels were not obtained in accordance with professional standards to guide dosing and monitor safety, despite Pt 16 receiving multiple doses of the antibiotic (Please refer to A-0500);

2. Multiple incomplete and unclear PRN (as needed) pain medication orders were not clarified for indication for use (e.g. mild, moderate, or severe pain) prior to administration for Pt 6 and Pt 9 (Please refer to A-0500);

3. A pain assessment was not completed before an opioid pain medication (a class of medication identified as high-risk/high-alert medications - drugs that bear a heightened risk of causing significant patient harm when used in error) was administered to Pt 9 (Please refer to A-0500); and

4. Current and accurate records were not kept for the receipt and disposition for all scheduled drugs, including patient's own medications (POM, personal belongings) categorized as controlled substances (drugs regulated by the government due to potential for abuse, misuse, or health risks) for Pt 71 in accordance with professional standards when staff stored Pt 71's POM and were not able to determine whether the POM contained controlled substances. The pharmacy did not have a system in place to accurately record receipt and disposition of POM stored in the pharmacy. (refer to A-0494)

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

Based on observation, staff interview, and review of hospital documents, the hospital failed to ensure the food and nutrition services was organized in a manner appropriate to the scope and complexity of the food service operations when:

1. Food and Nutrition Services was not organized effectively when the structure of the hospital policy and procedure regarding nutrition screening and assessment was not following current standards of practice according to the Academy of Nutrition and Dietetics. (Refer A-0619); and

2. Therapeutic diet orders were not followed when the hospital's diet manual and the department's policy and procedure for nutrition supplementation did not provide clear parameters when the Registered Dietitian initiated nutrition supplements. (Refer to A-0630).

The cumulative effect of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with practitioners' orders and acceptable standards of practice. The system problems resulted in the facility's inability to meet 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. In two of two sampled rooms (The Inpatient and Outpatient Sterile Processing Decontamination [SPD] rooms), SPD staff did not clean and maintain the floors and six of six washer conveyors (a sterile processing room conveyor system is a specialized material handling solution designed for healthcare environments like hospitals and surgical centers. Its main purpose is to automate the transportation of medical instruments and supplies throughout the sterile processing workflow, from decontamination to sterilization and storage.) in accordance with manufacturer's instructions. A white substance was found on the floor in the Inpatient Decontamination room. In six of six conveyor systems, white residue and black debris was observed (Refer to A-750, Finding 1).

2. Staff failed to ensure a biohazardous waste container (a special container to dispose of items that might have germs, blood, needles, glass, medication, and sharp objects) was closed in an ultrasound (a test using soundwaves to make pictures of the body) treatment room (Ultrasound Room 2) that was not in use, and in accordance with the hospital's policy and national guidelines (Refer to A-750, Finding 2).

3. Staff failed to ensure the hospitals policy for transporting contaminated (dirty or with germs that could make people sick) instruments was followed and there were no biohazardous labels or containers for contaminated vaginal ultrasound probe transportation (Refer to A-750, Finding 3).

4. Soiled adhesive from tape was left on the walls in in two of two sampled obstetric (OB - a branch of medicine that deals with pregnancy, childbirth) operating area rooms (C-Section 2 and Clean Supply Room) and should have been removed and cleaned in accordance with infection control standards (Refer to A-750, Finding 4).

5. Staff did not document the monitoring for cooling of potentially hazardous foods that were located in the hospital walk-in refrigerator in accordance with hospital policies and procedures and standards of practice (Refer to A-750, Finding 5).

6. Food items stored in a reach-in refrigerator in the hospital kitchen were greater than 41 degrees Fahrenheit (F) and not in accordance with standards of practice (Refer to A-750, Finding 6).

7. Areas of the kitchen and adjacent areas were not maintained in a sanitary manner in accordance with standards of practice. The cooks' tool cabinet was disorganized and had food crumbs., The catering/doctors' lounge cooking line had a build up of black grime and the cafeteria cooking line had a build-up of food on the floor under the equipment and under the counter refrigerators had food crumbs on the shelves (Refer to A-750, Finding 7).

8. In the NICU (neonatal intensive care unit), bottles were being washed in a handwashing sink and a sanitizer that is not food safe was being used to sanitize the bottle preparation counter and staff did not follow standards of practice for these items (Refer to A-750, Finding 1).

9. The hospital failed to ensure a single-use only syringe used to administer medications was discarded after use in accordance with hospital policy and procedure (Refer to A-750, Finding 1).

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 meet California Code of Regulations, Title 22. Social Security Division 5. Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies, Chapter 1. General Acute Care Hospitals, Article 3 Basic Services, §70217 (a)(1)(8)(9)(10)(11) when nurse to patient staffing ratios (N-P, refers to the number of patients a single nurse is responsible for at a given time) in:

1. The Intensive Care Units (ICU- 24-hour care for patients with life-threatening illiness or injuries) nurse to patient (N-P) ratios on 3/25/25, 3/26/25, 3/27/25, 3/28/25, and 3/29/25 were 1:3;

2. The Emergency Department (ED, a department a hospital that provides immediate medical care to patients experiencing serious or life-threatening conditions) N-P ratio on 4/10/25 were greater than 1:4;

3. The 1 North Step-down Unit (providing patient care between intensive care and acute care levels) N-P ratios on 3/24/25 to 3/28/24 and 4/20/25 to 4/21/25 were greater than 1:3;

4. The Cardiac Progressive Care Units (CPCU- a telemetry unit [where vital signs monitor that continuously transmit data, such as heart rate, breathing, and blood pressure to a nearby location] caring for patients with heart issues) N-P ratios on 3/25/25 to 3/29/25 and 4/20/25 to 4/21/25 were 1:5;

5. The Medical/Surgical (M/S-a hospital department whre patients recieve care for a wide range of conditions) units N-P ratios on 4/27/25, 4/28/25, 4/29/25, and 4/30/25 were greater than 1:5.

These failures had the potential to result in patients to receive lower quality of care, compromised patient safety, and increase medical errors which could negatively impact the health and recovery of patients.

Findings:

1. During a concurrent interview and record review on 6/10/25 at 9:37 a.m. with Nurse Manager (NM) 3, the "Medical ICU Staffing Assignment Sheets (MIS)", dated 3/25/25 to 3/29/25, were reviewed. NM 3 stated on 3/25/25 one day shift nurse was assigned three patients. NM 3 stated on 3/26/25 four day shift nurses were assigned three patients each. NM 3 stated on 3/27/25 two day shift nurses were assigned three patients each. NM 3 stated on 3/28/25 five day shift nurses and three night shift nurses were assigned three patients each. NM 3 stated on 3/29/25 four day shift nurses were assigned three patients each. NM 3 stated the required N-P (nurse to patient) ratio for the ICUs was one nurse for two patients.

During a concurrent interview and record review on 6/10/25 at 9:40 a.m. with NM 3, the "Surgical ICU Staffing Assignment Sheets (SIS)", dated 3/25/25 to 3/29/25, was reviewed. NM 3 stated on 3/25/25 two day shift nurses were assigned three patients each. NM 3 stated on 3/26/25 two day shift nurses and two night shift nurses were assigned three patients each.

2. During a concurrent interview and record review on 6/10/25 at 10:16 a.m. with Emergency Department Manager (EDM) 2, the "ED Assignment Sheet (EDA)", dated 4/10/25, and "ED Census (EDC)", dated 4/10/25, were reviewed. EDM 2 stated 30 nurses were on the EDA for day shift on 4/10/25. The EDC indicated a patient census of 139 on 4/10/25 at 3:00 p.m. EDM 2 stated the average N-P ratio for the shift was greater than 1:4 (one nurse to four patients). EDM 2 stated the N-P ratio for the ED should be less than or equal to 1:4.

During a review of a professional reference titled, "Injuries Caused by Emergency Room Understaffing (ICERU)", dated 3/9/20, the "ICERU" indicated, " ...When emergency rooms are understaffed ...patients with serious conditions may be overlooked and don't receive the care they need ... common mistakes that can occur in an understaffed emergency room include ... Failing to diagnose a patient ... patients being given the incorrect medication ... patients being given incorrect blood transfusions ... errors caused by miscommunications and failure to thoroughly read a patient's chart ... treatment of the wrong patient ... ignoring patient's concerns ... Any of these incidences can lead to a serious illness or injury that could have been prevented with proper emergency room staffing ...".

3. During a concurrent interview and record review on 6/10/25 at 9:45 a.m. with Nurse Manager (NM) 2, the "1 North Step-down Assignment Sheets (NSA)", dated 3/24/25 to 3/28/25 and 4/20/25 to 4/21/25, were reviewed. NM 2 stated nurses caring for Step-down patients should be assigned no more than three patients. NM 2 stated on 3/24/25 four day shift nurses and five night shift nurses assigned in Step-down unit had a N-P ratios of 1:4 or 1:5. NM 2 stated on 3/25/25 three day shift nurses and two night shift nurses assigned in Step-down patients had N-P ratios of 1:4 or 1:5. NM 2 stated on 3/26/25 two night-shift nurses assigned in Step-down had N-P ratios of 1:4. NM 2 stated on 3/27/25 two day shift nurses assigned in Step-down had N-P ratios of 1:4. NM 2 stated on 3/28/25 two day shift nurses assigned in Step-down had N-P ratios of 1:4. NM 2 stated on 4/20/25 two day shift nurses assigned in Step-down had N-P ratios of 1:4. NM 2 stated on 4/21/25 one day shift nurse assigned in Step-down had N-P ratios of 1:4.

4. During a concurrent interview and record review on 6/10/25 at 9:24 a.m. with Nurse Manager (NM) 1, the "Tower 2 CPCU 3rd & 4th Floor Assignment Sheets (T2AS)", dated 3/25/25 to 3/29/25 and 4/20/25 to 4/21/25, were reviewed. NM 1 stated nurses caring for telemetry patients should have a N-P ratio of no more than 1:4. NM 1 stated the T2AS accurately reflect staffing assignments on the reviewed dates. The T2AS indicated on 3/25/25 four nurses on day shift and four nurses on night shift caring for telemetry patients had a N-P ratio of 1:5. The T2AS indicated on 3/26/25 two nurses on day shift and four nurses on night shift caring for telemetry patients had a N-P ratio of 1:5. The T2AS indicated on 3/27/25 four nurses on day shift and four nurses on night shift caring for telemetry patients had a N-P ratio of 1:5. The T2AS indicated on 3/27/25 four nurses on day shift and four nurses on night shift caring for telemetry patients had a N-P ratio of 1:5. The T2AS indicated on 3/28/25 four nurses on day-shift and four nurses on night-shift caring for telemetry patients had a N-P ratio of 1:5. The T2AS indicated on 3/29/25 four nurses on day-shift and four nurses on night-shift caring for telemetry patients had a N-P ratio of 1:5. The T2AS indicated on 4/20/25 12 nurses on day-shift and four nurses on night-shift caring for telemetry patients had a N-P ratio of 1:5. The T2AS indicated on 4/21/25 four nurses on day-shift and four nurses on night-shift caring for telemetry patients had a N-P ratio of 1:5.

During a concurrent interview and record review on 6/10/25 at 9:48 a.m. with Nurse Manager (NM) 2, the "T3 3rd floor CPCU Assignment Sheets (T33AS)", dated 3/25/25 to 3/29/25 and 4/20/25 to 4/21/25, were reviewed. NM 2 stated the T33AS accurately reflect the staffing assignments on the reviewed dates. The T33AS indicated on 3/25/25 six nurses on day shift and two nurses on night shift caring for telemetry patients had a N-P ratio of 1:5. The T33AS indicated on 3/26/25 two nurses on day shift and two nurses on night shift caring for telemetry patients had a N-P ratio of 1:5. The T33AS indicated on 3/27/25 two nurses on day shift and two nurses on night shift caring for telemetry patients had a N-P ratio of 1:5. The T33AS indicated on 3/28/25 six nurses on day shift and six nurses on night shift caring for telemetry patients had a N-P ratio of 1:5. The T33AS indicated on 3/29/25 two nurses on day shift and two nurses on night shift caring for telemetry patients had a N-P ratio of 1:5. The T33AS indicated on 4/20/25 four nurses on day shift caring for telemetry patients had a N-P ratio of 1:5. The T33AS indicated on 4/21/25 three nurses on day shift caring for telemetry patients had a N-P ratio of 1:5.

5. During a concurrent interview and record review on 6/10/25 at 10:02 a.m. with Nurse Manager (NM) 11, the "2nd floor Medical Surgical Assignment sheets (2MS)" and "5th floor Medical Surgical Assignment Sheets (5MS)", dated 4/27/25 to 4/30/25, were reviewed. NM 11 stated 2MS and 5MS accurately reflect the N-P ratios for the reviewed dates. NM 11 stated the appropriate N-P ratio for M/S units was 1:5. 2MS indicated on 4/28/25, 4/29/25, and 5/30/25 five day shift nurses were assigned N-P ratios of 1:6 each. 5MS indicated on 4/27/25 four day shift nurses were assigned N-P ratios of 1:6 each and on 4/29/25 five day shift nurses were assigned N-P ratios of 1:6 each.

During a review of a professional reference titled, "How staffing shortages affect patient safety in healthcare and nursing (HSS)", dated 3/5/24, the "HSS" indicated, " ... Having appropriate and adequate nurse staffing is one of the basic elements of healthcare organization management and for good reason. Nurses not only provide care to multiple patients per shift, but nurse teams are the sentinels of healthcare safety, monitoring patients 24-hours a day and responding to their needs in real-time. Such responsibilities require constant vigilance from nurses who have the right skills to handle the kinds of patients they're caring for and their particular needs. Appropriate nurse staffing is complicated and involves many variables, from nurse skill mix to patient acuity, but at its most basic, having enough nurses at the bedside to effectively monitor and respond to patients and their needs is imperative for quality management. Because of this, it makes sense that research has tied so many safety and quality indicators to nurse staffing. Nurse-to-patient ratios and overall nurse workload are linked to safety factors like medication errors, pneumonia, and even in-hospital mortality [death] ...".

Based on observation, interview, and record review, the hospital failed to protect Patient (Pt) 15's rights when the hospital identified Pt 15 as a non-English speaker and did not provide necessary accommodation to overcome the barrier.

This failure had the potential for ineffective communication, which could have lead to miscommunication and compromising the quality of care and patient safety.

Findings:

During a concurrent interview and record review on 6/6/25 at 10:32 a.m. with Emergency Department Manager (EDM) 1, Pt 15's "Electronic Medical Record (EMR)" was reviewed. The EMR indicated Pt 15 spoke Spanish and needed an interpreter. EDM 1 stated Spanish speaking as a primary language is considered a communication barrier.

During a concurrent interview and record review on 6/6/25 at 1035 a.m. with Emergency Department Manager (EDM) 1, Pt 15's "Emergency Department Timeline (EDT)", dated 6/2/25 to 6/3/25 was reviewed. The EDT indicated Pt 15 arrived in the Emergency Department (ED) on 6/2/25 at 2:03 a.m. with a complaint of abdomen pain. The EDT indicated Registered Nurse (RN) 20 triaged (performed a preliminary assessment of the patient to determine urgency of treatment required) Pt 15. EDM 1 stated RN 20 did not speak Spanish. The EDT indicated, " ... 02:09 [2:09 a.m.] ... Risk Assessment ... Communication Barriers: None ... Domestic Violence Screening Safe in Home: Yes ... Safe in Relationship: Yes ... [RN 20] ...". EDM 1 stated RN 20 would have had the Language Service Line pad (an electronic pad that allows access to an interpreter 24 hours a day, 7 days a week) at the triage station and RN 20 " ... always ..." used the interpreter line and documented in the patient's EMR. EDM 1 stated there was no documentation of interpreter use.

During a concurrent interview and record review on 6/6/25 at 10:45 a.m. with EDM 1, Pt 15's "Interpreter Flowsheet (IFS)", dated 6/2/25 to 6/6/25, was reviewed. EDM 1 stated the IFS indicated the first use of an interpreter for Pt 15 was on 6/2/25 at 5:30 a.m.

During a review the hospital policy & procedure (P&P) titled, "Interpreters/Translation: Non-English/limited English Proficient & Deaf/Hearing Impaired", dated 6/14/24, the P&P indicated, " ... PROCEDURE ... All staff registering a patient ...who has or think may have limited English proficiency ... must identify the patient's preferred means of communication. This can be accomplished in several ways: i. Ask the patient what language she speaks or use the Language Identification Card. Ii. Access all interpreter services by dialing 15 ...".

During a review of a professional reference titled, "Safety first: The importance of interpreters & translated documents in preventing patient harm", the reference indicated, " ... When used effectively, interpreters and translated documents not only enable providers to communicate with their LEP [limited English proficiency] and NEP [non-English proficiency] patients, but also help promote patient safety by preventing medical errors and patient harm, which will minimize health disparities within this population ... open communication channels with their provider allows these patients to truly be in the center of their care ...".

Based on interview and record review, the hospital failed to ensure patient's rights to make informed decisions about care for one of 10 sampled patients (Patient 7) when Pt 7 underwent a surgical procedure for Left Lower Extremity Tendon-Achilles Lengthening via Triple Hemi Section (a surgical procedure to correct a shortened Achilles tendon in the heel), Left Midfoot Wedge Osteotomy (removal of a wedge-shaped piece bone from the foot to correct a deformity) and Application of Allograft of Bone (transplant of bone tissue from a donor) and the hospital did not have a signed consent (the process where a patient voluntarily authorizes a healthcare provider to perform a surgical procedure after being fully informed about the procedure's risks, benefits, and alternatives) for the procedures.

These failures denied Patient (Pt) 7 of his right to make informed decisions and participate in his care.

Findings:

During a review of Pt 7's "History & Physical (H&P)", dated 5/27/25, the H&P indicated, Pt 7 had a history of insulin (a medication used to managed blood sugar levels) dependent diabetes mellitus (when the body does not produce the hormone insulin to regulate blood sugar) with retinopathy (damage to small blood vessels in the eyes leading to blindness), neuropathy (damage to the nerves leading to numbness, pain and impaired function), chronic kidney disease (where the kidneys cannot filter blood properly), hypertension (high blood pressure), obesity (excessive fat accumulation) and charcot foot (a serious condition causing bone and joint damage in the foot associated with nerve damage). The H&P indicated Pt 7 came to the hospital with a worsening left foot wound with infection.

During a review of Pt 7's "Operative Report (OR)", dated 5/30/25, the OR indicated, Pt 7 underwent the following operative procedures, " ... Left lower extremity tendon-Achilles lengthening via triple hemi section ... Left midfoot wedge osteotomy ... Application of allograft of bone [transplant of bone tissue from a donor] ... left foot ... Left foot excisional operative debridement down to and including muscle [removal of dead tissue from skin to muscle to promote wound healing] ... Left foot adjacent tissue transfer/rearrangement with rotational skin plasty [moving a flap of healthy tissue form an area next to a damaged site]... Preparation of recipient site, left foot [cleaning, debriding, and ensuring the area is free of infection or dead tissue before a graft is applied] ... Application of multiplanar external fixation, left lower extremity [use of a device with pins and/or wires inserted through the skin and into the bone to stabilize and align a fracture or deformity in the leg] ... Application of 18 antimicrobial Biopatches, left lower extremity [specialized dressings to protect the insertion site of medical device from infection] ... Application of [closed-suction medical device, to drain body fluids from surgical sites] ... left foot ..." under general anesthesia [a state on controlled reversible unconsciousness, unable to feel pain].

During a concurrent interview and record review on 6/5/25 at 9:50 a.m. with Nurse Manager (NM) 2, a copy of the signed consent for Pt 7's operative procedure on 5/30/25 was requested.

During an interview on 6/9/25 at 5:05 p.m. with the Manager of Quality Outcomes (MQO), the MQO stated Pt 7's did not have a signed consent for the operative procedures on 5/30/25 in Pt 7's medical record.

During a review of the hospital policy and procedure (P&P) titled, "Consents", dated 4/13/23, the P&P indicated, " ... Verification of Consent ... The role of the hospital is limited to verifying that the physician has obtained the patients informed consent before the physician performs the procedure ... PROCEDURE ...Obtaining Consent ... Informed Consent is to be given for all invasive, complex, medical procedures such as ... All procedures performed in the operating room ... Verification of consent takes place once the physician has ordered the appropriate medical treatment. It is the responsibility of licensed personnel to verbally verify with the patient ... that a discussion has taken place between the physician ... about the procedure including the risks, benefits, and alternative ... Once the verification is complete, the patient will be asked to read and sign one of the following forms, as applicable ... Verification Consent to surgery ... Other Medical Services ...".

Based on observation, interview, review of video recording, and record review, the hospital failed to provide care in a safe setting for seven (7) of nine (9) sampled patients (Patient (Pt) Pt 1,
Pt 6, Pt 10, Pt 50, Pt 51, Pt 52, and Pt 67 when:

1. Emergency Department (ED) staff and hospital Security Officers (SOs) initiated a physical take-down (a physical maneuver or intervention to restrain or control a person, often in a potentially violent or combative situation) of Pt 1 without Pt 1 exhibiting evidence of physical escalation in behavior and not in accordance with hospital policy and procedure (P&P). Pt 1 was admitted to the Special Care Unit (SCU-a locked unit within the ED) for bizarre verbal statements. Pt 1 was assessed as cooperative and re-directable and was not assessed as a risk of exhibiting aggressive physical behavior. The inappropriate physical takedown of Pt 1 by SOs prompted the unnecessary administration of medications to chemically restrain Pt 1. The administration of medication to Pt 1 was given over Pt 1's verbal objection.

These failures violated Pt 1's right to receive care in a safe setting, which includes the provision of respect, dignity, and comfort resulting in avoidable mental anguish and suffering with the potential to cause physical injury related to the physical take-down, and use of physical and chemical restraints.

2. The hospital kept patients who had orders for admission to a hospital unit in the ED for most or all of their stay, denying them the safety and comfort of an inpatient room and bed.
These failures resulted in Pt 10, 50, 51, 52, and 67 receiving their inpatient care in the hallway of the Emergency Department where they were on gurneys rather than on the more comfortable hospital beds. Pt 10, 50, 51, 52, and 67 did not have easy access to a bathroom for toileting and hygiene, did not have the option of turning off overhead lights for comfort and sleeping. They were exposed to high foot traffic (lots of people walking around them.) Noise and talking made it difficult to relax and sleep, along with the crowded condition of the Emergency Department. Each of these patients came into the ED with various illness or injuries, and each had physicians' orders to admit to an inpatient unit of the hospital. All were kept in the ED on gurneys in the hallways, not in a room.

Findings:

1. During a review of an Entity Reported Incident (ERI) submitted to the California Department of Public Health (CDPH) on 5/13/25. The ERI indicated "...Date of Alleged Event: 5/9/25... Description of Event and additional details: During chart review on 5/12/25, documentation by ED RN on 5/10/25 found in the chart that stated the following: patient had confided in staff member that during episode when she was placed in restraints an officer had touched her breast inappropriately three times." Pt discharged on 5/11/25..."

During a review of Pt 1's "Face Sheet (FS)" dated 5/9/25, the FS indicated, "...[Pt 1] arrived at the ED on 5/9/25 at 17:27 (5:27 p.m.)... Discharge Date/Time: 5/11/25 at 21:40 (9:40 p.m.)..."

During a review of Pt 1's "ED Provider Notes (ED Note)" dated 5/9/25, the ED Note indicated, Pt 1 arrived to the ED after an alleged assault in which Pt 1 stated she was hit on the backside of her care by police. Pt 1 with complaints of headache and nausea. Pt 1 denied any type of suicidal ideations but appeared to have delusions when she was then placed on a 1799 hold (a short-term, 24-hour psychiatric detention used in California hospitals for gravely disabled [a condition in which a person is unable to provide for their basic personal needs for food, clothing, shelter, personal safety, or necessary medical care]). Pt 1 attempted to elope from the SCU and did not follow verbal redirection from staff and was placed on four-point restraints, administered diphenhydramine/haloperidol/lorazepam (antianxiety medication) via intermuscular (IM) injection. The ED note indicated Pt 1 was cleared medically but was awaiting psychiatric recommendations.

During a record review of Pt 1's "ED Timeline" dated 5/9/25 the timeline indicated Pt 1 "...18:10 (6:10 p.m.)...Transfer to SCU...18:20 (6:20 p.m.)...Patient called nurse phone, making paranoid and delusional statements. Patient refusing to lay in bed, states "You guys are hurting me in here and hurting my baby." ...MD notified, orders received. ...18:20:12 (6:20:12 p.m.) Orders Placed...New - Lorazepam... injection 2 mg... 18:24...Continuous Observation: Awake, Ambulating, Yelling, shouting, screaming at staff (pt took off the badge reader and started hitting the door with it)...18:30 (6:30 p.m.)...While waiting for medication approval by pharmacy, patient observe by patient observer to rip badge reader inside of SCCU off the wall and hit the SCU door. Security and writer entered SCU, patient escorted to bed by Security. Patient refused to sit on bed and became physically combative with Security by kicking them. Additional staff and Security entered SCU and got patient in bed. Orders received and carried out. Badge reader removed from SCU..."

During a review of the hospital document titled "SCU Door and Phone Info" undated, the document indicated the layout of the SCU in the "Green Zone" area of the ED. The SCU is a locked unit, with staff badge reader pads at 3 doors (Interior Door, SCU North (N) Door and SCU east (E) door). The SCU has 1 room (first room) where patients admitted to the SCU can change out of street clothes into paper scrubs placing items in lockers and the other room is reserved for patients requiring isolation or minor patients. The second room in the SCU is a large area where multiple patients can be admitted and placed on gurneys (a wheeled stretcher used for transporting hospital patients). These areas were under continuous observation by staff, with all hazardous risks removed. In the SCU patients communicated with staff by using a telephone located between the Interior and N doors.

During a concurrent interview and medical record review on 6/5/25 at 1:15 p.m., with RN 1 and ED Manager (EDM) 1, RN 1 confirmed she was familiar with the event involving Pt 1. RN 1 described Pt 1 was admitted to the SCU for bizarre psychiatric behavior. RN 1 described Pt 1 was at the phone and made bizarre statements, and told RN 1 she did not want to be in SCU. RN 1 stated she communicated and provided verbal reassurance with Pt 1 being directable. RN 1 explained she was with another patient when she learned Pt 1 had removed the badge reader from the wall, disconnected it, and hit the door. RN 1 stated Pt 1 was not redirectable, and Pt 1's bizarre behavior escalated. RN 1 stated she and 2 SO's responded, SO's leading the way entering the SCU through the interior door. RN 1 explained she attempted de-escalation by attempting to administer lorazepam but a pharmacy check was needed. RN 1 stated when de-escalation was unsuccessful, the team had to make physical contact. RN 1 stated Pt 1 was yelling, holding the badge reader in her hands and gesturing. RN 1 stated Pt 1 would not sit on the gurney, was struggling against the SO's hold when Pt 1 started to kick at the SO's. RN 1 stated she asked the SO's if additional help was needed, with the SO responding he had hit the "panic" button already. RN 1 responded she was aware that Pt 1 had reported she had been attacked by neighbors and police officers before this visit to the ED. RN 1 explained the team moved the bed to make room for the additional staff she had requested (2 male PCTs) come in to help. RN 1 described the physical take-down continued with one SO at each upper extremity (both arms) with PCTs holding lower extremities (both legs) and RN 1 holding both knees. RN 1 stated additional officers arrived Pt 1 became violent. RN 1 stated she went out to the desk to get locking restraints. RN 1 clarified that Security applies the locking restraints because they have special training. RN 1 stated Pt 1 was subdued and the SO's proceeded to apply the restraints. RN 1 confirmed application of 4-point locking restraints was the goal. RN 1 explained a 4th SO (SO #?) assisted at the head of the bed once arrived. RN 1 stated SO ## was not able to hold [Pt 1's] head down, so he held her down by both shoulders. RN 1 stated restraints were successfully applied with no apparent injury to either Pt 1 or hospital staff. RN 1 stated Pt 1 yelled at staff the entire time. RN 1 stated a code assessment (a process used in ED to overhead page alerting additional staff and provider to respond to a patient emergency event) was called. RN 1 stated a doctor came down (did not recall doctor name) and ordered haloperidol and diphenhydramine medications to be administered IM, and a restraint order. RN 1 state she gave lorazepam after Pt 1 was 4-point restrained and a short time after she gave the haloperidol and diphenhydramine. RN 1 explained this event occurred close to change of shift and at 7:30 p.m., when she left, Pt 1 was still agitated. RN 1 responded she did not recall if Pt 1 had a history of psychiatric or mental/behavioral health disease. RN 1 stated she did not recall seeing any inappropriate touching. A request to review surveillance video was submitted.

During an interview on 6/9/25 at 9:08 a.m., with Medical Doctor (MD) 2, MD 2 stated Pt 1 came in [to the ED] "herself" alleging assault at a property she owned while trying to collect rent from tenant. MD 2 stated after her initial exam she ordered Pt 1 be placed on a 1799 hold (lasts up to 24 hours and applies when a doctor believes someone is a danger to themselves or others due to a mental health crisis), and initiated orders for a "trauma work up" this included laboratory tests, and imaging studies (x-rays) MD 2 responded she did not order a urine sample to check for substance abuse/use because she did not believe Pt 1's bizarre behavior was caused by substance use. MD 2 stated she explained to Pt 1 that she would be moved to another secure area [SCU] while waiting for a psychiatric liaison evaluation for safety, but did not explain the details of restrictions under 1799 (such as not being able to leave, being asked to change into paper scrubs, etc.). MD 2 states she later met with Social Worker/Psychiatric Liaison (SW) 1 who assessed and determined that Pt 1 did not meet criteria and recommended the 1799 hold be lifted, MD 2 stated she was not in agreement with SW 1's recommendation. MD 2 stated she proceeded with the order to have the psychiatric assessment (done via telemedicine) due to her concern for Pt 1's psychiatric safety considering Pt 1 did not have a known past medical history of mental/behavioral disease.

During an interview and record review on 6/9/25 at 10:50 a.m., with SW 1, and Behavioral Health Supervisor, (BHS), SW1 stated her role as a Psychiatric Liaison is to perform mental health assessments in the ED, reporting to [hospital] behavioral health leadership. SW1 referred to her note dated 5/9/25 at 10:40 p.m. SW1 stated she assessed Pt 1 and recommended the 1799 hold be lifted. SW1 stated MD 2 was still concerned by Pt 1's statements and decided not to lift the 1799 hold. SW1 stated Pt 1 reported a tenant on her property had assaulted her. SW1 stated Pt 1 did not make any report to SW or staff of any abuse while in the ED. SW1 stated she was told haloperidol was administered and Pt 1 requested the restraints to be loosened. SW1 described Pt 1 to be calm cooperative, with normal cognitive abilities and appropriate behavior. SW 1 stated the primary RN coordinates the psychiatric consult. SW 1 stated she did not recall if she alerted the RN about Pt 1's request to loosen the restraints. SW 1 stated the process is the nurse is notified and documentation is completed. SW 1 stated best practice is to document, because "we say if it's not documented it wasn't done." Pt 1's EHR did not indicated SW 1 documented the event. BHS 1 stated it is fair to say that it should have been documented by SW. BHS responded "yes" there is potential harm to the with the use of restraints, if they are saying they are too tight, staff should be looking at skin. BHS stated this is definitely an opportunity to pass on to the staff (importance of documenting and communicating patient needs with clinical staff).

During a concurrent interview and surveillance video review on 6/9/24 at 11:10 a.m., with Security Operations Manager (SOM) 1, and Vice President (VP) of Regulatory, Risk, and Medical Affairs (VPR), the video recording of the incident with Pt 1 was reviewed. The date and time stamp on the video was 5/9/25 at 6:23 p.m. views of multiple cameras into the SCU were displayed. Video review begins:

At 6:23 p.m., Pt 1, in paper scrubs, was standing by the "sally port (Interior door)" and the "security door (N door)," both locked entry/exit doors into and out of the SCU area. Pt 1 was holding an emesis bag in her left hand.
At 6:23:12 p.m., - Pt 1 remained standing by the doors (interior and N). Pt 1 began to swing her right arm, and walking back and forth (pacing). Pt 1 looked at the around and focused on the badge reader to the left of the interior door.
At 6:24 p.m., Pt 1 pulled badge reader from the wall, still holding the badge reader in her right hand. Pt 1 looks at the badge reader in her right hand then looks out the windows (where staff sit at security desk), looks at the badge reader in her hand again then after a short pause Pt 1 hit the window with her right hand holding the badge reader 2 times. Pt 1 was trying to speak with staff through the windows as staff began walking into the main SCU area through the first room.
At 6:25 p.m., SOs (SO 1 and SO 2) enter the SCU through the interior door. Pt 1 remained near the interior door, did not appear to try to run past or hit the SO's. SO's immediately grabbed Pt 1 by her arms and forcibly dragged Pt 1 over to and lifted and slammed Pt 1 onto the gurney. RN 1 entered after SO's, and left the SCU shortly after. Pt 1 continued to struggle against being held down when RN 1 re-enters with restraints. Pt 1 continued to struggle with SO's, RN 1 gestures to staff waiting out in the ED. PCT1 and PCT 2 enter SCU and immediately begin to pin Pt 1's arms and legs down onto the gurney while SO's attempted to apply restraints.
At 6:27 p.m., SO 2 is possibly speaking to Pt 1, there is no audio present on video. SO 3, is positioned at the head near Pt 1's right (RT) hand, PCT 1, and PCT 2 positioned one at each leg, while locking restraints are applied to bilateral upper extremities (BUE- wrists) and bilateral lower extremities (BLE- ankles).
At 6:28 p.m., SO 4 enters the SCU. SOM 1 agreed that at point there were 4 SO's, 2 PCT's, and 1 RN, in the SCU holding Pt 1 down. SO 4 helps SO 2 apply left (LT) wrist restraint. PCTs are still holding Pt 1 down at the knees. Possible restraint readjustment by SO 2.
At 6:29:45 All 4 limbs were restrained.
At 6:30 p.m., staff released physical hold of legs and Assistant Nurse Manager (ANM) 4 handed a syringe to RN 1. Unable to view location of administration, view was obstructed.
At 6:30 p.m., Pt 1 was in 4-point restraints, and was lifting her head up and off the gurney and flailing back and forth, both gurney side rails were up.
At 6:31 p.m., ANM 4 is seated at the monitor/security station.
At 6:32 p.m., staff exit the SCU. PCT 1 remained to return Pt 1 to SCU bed 6 area. PCT 1 exits the SCU.
At 6:33 p.m., video ends. SOM 1 explained the "DVR's (Digital Video Recording- a machine used to make and watch recordings of television programs) are pulled and archived" in response to an IRIS report (hospital occurrence or adverse incident reporting system). In response to this request, security department pulled the video from the DVR focusing only on the physical take-down portion of the available recording due to the allegation of sexual abuse. SOM 1 states, yes, the surveillance video has audio recording capacity. A request to review the video including audio is made.

During a concurrent interview and video surveillance with sound/audio review on 6/9/25 at 2:04 p.m., with Patient Care Technician (PCT) 1 and SO 1, SO 1, stated he was the SO assigned to SCU on 5/9 with SO 2 responding as he rounded in the ED. SO 1 stated the SO role is to deescalate the patient and try to get the patient to comply as instructed in Crisis Prevention Intervention (CPI- a training program focused on preventing and managing challenging behaviors in a safe and respectful manner). SO 1 stated Pt 1 began to show signs of aggression, and he did not remember what Pt 1 was saying. SO 1 stated Pt 1 did not want to sit down, had just gotten changed out, and "what agitated her was that she couldn't take her necklace in the SCU. [It was] locked up with property." SO 1 explained that as soon as he and SO 2 opened the interior door, Pt 1 tried to rush through the door. SO 1 stated he may have said something to Pt 1 possibly "calm down, relax, stuff like that." PCT 1 stated his role on 5/9/25 was to assist nurses in the green zone with patient care. PCT 1 stated being a newer employee in the ED, de-escalation [techniques] were new to him, and he has received a training led by RN 1 on how to manage SCU patients. PCT 1 stated he and another PCT (PCT 2) had been standing by outside the SCU and awaiting nurse instructions or request for assistance. RN 1 signaled to the PCTs that the come into the SCU to help calm Pt 1. PCT 1 stated RN 1 called a code assessment. PCT 1 acknowledged there were 5 staff physically holding Pt 1 down, trying to get Pt 1 to lie down. PCT 1 stated SO 3 arrived and the team decided to move Pt 1 out to SCU 2 to isolate and cut down stimulation for Pt 1. PCT 1 stated after learning that another patient was expected to be roomed in SCU 2, with a greater need for the isolation, Pt 1 was moved back to bed 6. Pt 1 is heard to state she is "thirsty and hungry" at 6:32 p.m., proceeds lie down, moves about a bit then lays supine on gurney with video ending at 6:33 p.m. PCT 1 stated he did not address Pt 1's request for food and drink directly. PCT 1 stated he could not give her anything to drink or eat, so he was not comfortable giving anything to Pt 1. PCT 1 stated he did tell the nurse. PCT 1 stated he did not document the discussion he had with the nurse about Pt 1's requests for food or drink. PCT 1 stated, he believes documenting would be expected. PCT 1 stated he "just assumed [Pt 1's requests] would be brought to the doctor's attention by the RN." SO 1 stated he works at both hospital locations and at the behavioral health center. SO 1 stated differences he has noticed is they have more help there (behavioral health), clinical are staff trained differently, they have the de-escalation and CPI trainings, and other trainings (defensive tactics, classes for safe patient and staff handling). SO 1 stated behavioral health has psych techs (a healthcare professional who provides direct care to individuals with mental health conditions) who monitor the halls. PCT and SO 1 confirmed this event seemed "pretty normal" and they did not see anything of concern.

During an interview and video surveillance review (sound present) on 6/9/25 at 2:48 p.m. with ERD, and DRM, ERD stated if a patient refuses to change out (from street clothes into paper scrubs) the ED has an established process in place to accommodate the patient request. ERD explained Pt 1 could have been allowed to stay in a hallway, with an assigned patient observer for safety, if Pt 1 did not want to take off her necklace. ERD stated they do not employ psych techs in the ED/SCU. DRM stated an investigation into Pt 1's sexual abuse allegation was complete. DRM stated the investigation determined the sexual abuse allegation did not occur after a review of the archived video. DRM confirmed that an investigation and/or Root Cause Analysis (RCA- a problem-solving method used to identify the underlying reasons why a problem or event occurred) related to the concern for use of excessive force had not been conducted because the focus was on Pt 1's sexual abuse allegation.

During an interview and surveillance video (audio present) review on 6/9/25 at 5:14 p.m. with SO 2, DRM, and SOM 1, SO 2 stated he watched the video, earlier on 6/9/25. SO 2 explained he remembered the event involving Pt 1. SO 2 stated the PO told him Pt 1 had pulled the badge reader in the SCU from the wall and was holding it in her hand. SO 2 stated upon entering the SCU by door 1, he saw Pt 1 still had the badge reader in her hand. SO 2 stated he directed Pt 1 to "relax calm down, let go of the badge reader." SO 2's directive to Pt 1 was not heard on the video. It was not clear on video review if Pt 1 tried to run past the staff or if staff ran into Pt 1. SO 2 stated he pressed his panic button, right as they entered and began to grab Pt 1. SO 2 explained the panic button will dispatch additional help to the officer's location once pressed; dispatch sent more help. SO 2 stated RN 1 came in with restraints, he did not know who gave order for restraints but RN 1 told [them] she had an order for restraints . On the surveillance video, Pt 1 was held down on the gurney by SO 1, SO 2 and RN 1 with PCT 1 and PCT 2 entering to help get Pt 1 into the 4-point restraints; there was no dialogue heard until Pt 1 said [SO2] was hurting her. SO 2 explained "we were at an awkward angle;" and were not able to not able to pull the gurney out away from the wall so the process was less smooth. SO 2 was heard speaking to Pt 1 at minute marker 6:29 p.m. the on the video (was seen and heard) telling Pt 1 he would let her out of restraints as soon as possible. SO 2 said he does not recall the nurse speaking to the patient. Staff were not heard to respond to Pt 1's complaint that staff were hurting her on the surveillance video. SO 2 stated once the medication was given all hands came off Pt 1. Staff were not heard providing directives, and/or reassuring and therapeutic emotional support to Pt 1 on the surveillance video. SO 2 stated it did not seem Pt 1 understood what staff were telling her. SO 2 stated Pt 1 had not been in the SCU before and he felt Pt 1 was scared. SO 2 stated he remembered before the take down, Pt 1 repeatedly asked to see a doctor and had requested something to eat and drink. SO 2 stated he thought the nursing staff addressed Pt 1's requests. SO 2 stated he could not recall if Pt 1 saw the doctor. SO 2 explained security staff attend an in-person course in Crisis Prevention Intervention (CPI) training, where he was learned to recognize a situation for what it is, and how to resolve the problem. SO 2 stated staff must recognize when to go into to the patient in the SCU to them we are not trying to hurt them. SO 2 stated once Pt 1 became physical, hitting the window with the badge reader, Pt 1 was "going to fight." SO 2 stated, normally he assesses risks prior to reacting, but there was no time to de-escalate Pt 1 "she was going to fight; she charged to the door." SO 2 stated in this situation we "had to go hands on." SO 2 stated he did not know what patient rights were taken away when a patient is placed on a 1799 or a 5150 hold (an involuntary 72-hour psychiatric hold for individuals experiencing a mental health crisis who are deemed a danger to themselves or others). SO 2 stated one difference he has noticed when he works in the SCU versus at the behavioral health center, is that staff at the behavioral center are more hands on; they call security with the expectation that SO's follow clinical staff lead.

During an interview and video surveillance review on 6/9/25 at 6:00 p.m., with SOM 1 and DRM, SOM 1 explained a copy of the physical take down portion of Pt 1's SCU stay was available because the Risk Management team was investigating Pt 1's allegation of sexual abuse and requested video review. SOM 1 explained normally, video is stored on a DVR on a first in and first out rotation; once maximum capacity is reached and/or 10 days have passed, the DVR is overwritten. DRM stated although it is possible to save an encounter, in its entirety, staff may have decided to keep only the portion relevant to their investigation. SO 5 stated the difference between the hospital and the behavioral health center are in the hospital the SO applies restraint going into the room first, when has worked at the behavioral health center, has noticed there are more interactions with patients, here (SCU) the patients are sealed off." Staff at the behavioral health are a little more hands on; with patients often already deescalated.

During an interview and video surveillance review (sound present) on 6/10/25 at 2:42 p.m., with SOM 1 and SO 3, SO 3 stated his role is to deescalate and place hands on patients as needed observing policy in how to properly restrain, without causing further incident to the patient. SO 3 stated he has noted differences in the care of patients who are in the SCU versus patients at the behavioral health center. Some differences are in the SCU, it is like a holding tank, patients are medicated and observed, and can move if they need to use bathroom. At the behavioral health center, patients are provided with recreation and bathroom; staff are hands on and more patient focused. SO 3 stated in the SCU security is more at the forefront in SCU and act as the patient advocate, because the clinical staff is too busy. SO 3 stated patients on a hold, do not have the right to leave unit, cannot have cell phones. SO 3 stated, "no" he does not consult with clinical staff prior to entering the room or prior to engaging hands on. SO 3 stated he has watched the video of the situation with Pt 1. SO 3 explained on 5/9/25 at 6:27 p.m., he clocked in from lunch and was directed to help with restraint application. SO 3 stated when he got there, he waited for medical staff, but when he looked into the SCU and saw the activity, he ran in. SO 3 stated he "wasn't here to determine how I could help. She (pt) was in RN 1's face, best thing I could do was push down her forehead to assist with the restraint [application], SO 3 stated, "I did not speak to the patient at all." SO 3 stated after an event, they call their watch commander (shift supervisor) and report what happened by giving them details. SO 3 stated a debriefing may be done and could involve a review of the video. SO 3 stated these debriefings are done with the security team involved, clinical staff do not attend.

During an interview and video surveillance review (sound present) on 6/10/25 at 3:12 p.m., with SOM 1 and SO 4, SO 4 stated some differences between his shifts at the hospital versus the behavioral health center are in SCU it is more they are coming in from being outside, everything is going be scary for them, going through something coming off drugs. More unexpected of what could happen. Have tried to de-escalation in past. Usually we notify additional officers for restraints, usually 3, I would be primary as the SCU. Usually dispatch has eyes on camera, if officers are having trouble maintaining control dispatch will send additional officers.
SO 4 explained at the behavioral health center, security is called to prevent and to deescalate; there security makes sure patients are not harming selves or others, taking clothes off or standing next to a patient in another bed. CBHC clinical staff restrain first, here in SCU SO restrain first. SO 4 stated it is a clinical call not a security call for application of restraints or administration of chemical restraints. Sometimes patients have sitters in hallways, SCU is green (part of the green zone) and SOs are aware where they are at. SO 4 stated when he entered the SCU at 6:29 p.m., Pt 1 was yelling and screaming. SO 4 stated as the 7th person in the room, he grabbed Pt 1's left arm, to help SO 2 place the last restrain. SO 4 stated Pt 1 was calm by 6:29 p.m. SO 4 stated the nursing staff make the determination about what type of restraint (chemical, physical or both) is used. SO 4 stated the RN will order medications when they see patients pacing or something. SO 4 stated all [security] does is assist nursing staff when they ask. SO 4 stated when a patient is placed on a hold, they are not able to leave. Can't keep any belongings on them. Can use bathroom, have meals, water, make phone calls, if they are in SCU. If they are on a hold in the hallway no visitors are allowed to stay with them.

During an interview and record review, via telephone, on 6/10/25 at 4:15 p.m., with Patient Observer (PO) 1, and DRM, PO 1 stated her role is to continuously monitor SCU patient activity via video surveillance cameras and document what the patient does. PO 1 stated they log patient activity directly into the patient's Electronic Medical Record (EMR) using a codified system (letters for activity, ex: "K" means lying down; "M" is quiet). PO 1 stated Pt 1's behavior changed quickly, seemingly without provocation. PO 1 stated she did not call a code assessment, this is normally done by the nurse. After reviewing the "observation sheet," PO 1 agrees with her documentation which indicated [on 5/9/25] at 1751 (5:51 p.m.) changing out into paper scrubs with security... (6:00 p.m.) talking w staff...1815 (6:15 p.m.) ambulating and talking with staff...1824 (6:24 p.m.) awake, ambulating yelling, shouting screaming at staff, pt took off the badge reader and started hitting the door with it..." PO 1 stated Pt 1 changed out without incident or would have documented it [incident]. PO 1 stated Pt 1 spoke with SOs by phone.

During an interview, via telephone, on 6/10/25 at 4:46 p.m., with MD 2 and DRM, MD 2 stated she could not see the chart but her practice is to "do my signature below my note with details about the provider I sign out to" as it was not clear which provider had written the note due to addendums listed. MD 2 stated she could not recall generally when she gets alerts via secure chat application or "code assessments (overhead page alerting provider to the need for them to respond in person to the patient's room). MD 2 she was with another patient while Pt 1 was restrained, was informed Pt 1 was kicking staff so she said she was "fine with it [restraint application]." MD 2 stated she recommended Pt 1 be roomed in the SCU, referring to the bizarre statements as "delusions, was worried she was having a psychotic break." MD 2 stated when she told Pt 1 about being moved to the SCU, "she seemed ok with it. If there was something that agitated her, I wasn't made aware. I am not sure what made her switch [become combative]."

During an interview and video surveillance review (sound present) on 6/11/25 at 9:09 a.m., with ANM 4, ANM 4 she may have been rounding in the ED and was in the SCU area, when Pt 1's behavior escalated and she was aware that RN 1 was waiting for medications to be verified. ANM 4 stated SO's knew going in [to SCU] that medication had been ordered and needed to be given. ANM 4 stated she assisted in getting the lorazepam ordered by drawing it up at the SO desk/station. ANM stated she bypassed barcode scanning (a technology used to positively identify patients, medications, and specimens by scanning barcodes, typically on wristbands, medication packaging, and lab samples) due to the situation. The surveillance video showed ANM 4 was handling a single syringe; ANM 4 stated she could not recall if the syringe contained one or all of the medications ordered (lorazepam, haloperidol, and diphenhydramine). ANM 4 explained it is her normal practice to separate each medication into a separate syringe, so she felt confident the syringe only contained lorazepam. ANM 4 stated in this situation, she told RN 1 what she had drawn up (lorazepam). ANM 4 stated "no" she did not label the syringe. ANM 4 stated she handed the unlabeled syringe to RN 1 and scanned the medication later which documented the medication was given in Pt 1's medication administration record. ANM 4 stated, it is ideal to barcode scan and administer the medication at (patient) bedside because the nurse can verify the "5 rights (used to ensure safe and accurate medication administration- right patient, drug, dose, route, time) " and inform the patient what will be administered. ANM 4 explained her understanding of patient's rights and involuntary holds is a 1799 is a 24-hour hold and a 5150 is a 72-hour hold placed to keep the patient safe. ANM 4 stated if a patient is at the point of being held by the security guard and being restrained, the

Based on interview and record review, the hospital failed to recognize, investigate, and set clear expectations regarding the inappropriate use of excessive force on one (1) of seventy-two (72) sampled patients (Pt) 1, when Pt 1 was admitted to the special care unit (SCU- a locked unit within the Emergency Department), for evaluation for unusual verbal statements. Pt 1 was calm and was not physically aggressive when Emergency Department (ED- a hospital outpatient department that provides immediate medical care to patients with urgent or life-threatening conditions) staff and hospital Security Officers (SOs) performed a physical takedown (a physical maneuver or intervention to restrain or control a person, often in a potentially violent or combative situation) to restraint and administered medication against Pt 1's verbal refusal. The interventions was not in accordance with the hospitals policies and procedures. The hospital did not conduct an investigation into the use of excessive force and no preventative measures were implemented.

This failure resulted in the hospital's inability to recognize the inappropriate use of force, analyze the underlying causes of the incident, and implement necessary corrective actions and oversight to prevent reoccurrence and placed patients in the ED's behavioral unit at continued risk for harm from improper use of force or restraint.

Findings:

During a review of an Entity Reported Incident (ERI) submitted to the California Department of Public Health (CDPH) on 5/13/25, the ERI indicated "...Date of Alleged Event: 5/9/25... Description of Event and additional details: During chart review on 5/12/25, documentation by ED Registered Nurse (RN) on 5/10/25 found in the chart that stated the following: patient had confided in staff member that during episode when she was placed in restraints an officer had touched her breast inappropriately three times." Pt discharged on 5/11/25..."

During an interview and video surveillance review on 6/9/25 at 2:04 p.m., with Patient Care Technician (PCT) 1 and SO 1, a video dated 5/9/25 at 6:23 p.m. was reviewed. The footage was from the ED SCU, specifically area 5. The surveillance video showed Pt 1, who was not exhibiting violent physical behavior, was subjected to significant physical force when security officers forcibly grabbed her by the arms, dragged her to a gurney, and, with the help of additional staff, held her down to apply wrist and ankle restraints; despite her continued resistance and verbal objection, Pt 1 was then administered medication, all without clear evidence of de-escalation efforts from staff. SO 1 stated he was assigned to the SCU on 5/9/25, and SO 2 came to help while checking the ED. SO 1 stated that the role of security in the SCU was to calm patients down and get them to follow directions, using techniques from there crisis prevention intervention (CPI) training. SO 1 stated Pt 1 started to act aggressively, but he could not remember exactly what Pt 1 was saying. SO 1 stated Pt 1 did not want to sit down and had just finish changing her clothes. SO 1 stated he thought Pt 1 got upset because she was not allowed to keep her necklace in the SCU, and her belongings were locked away. SO 1 stated as soon as he and SO 2 opened the interior door, Pt 1 tried to rush through it. SO 1 stated he may have said something to Pt 1 like "calm down" or "relax" but the video did not capture any of this as no therapeutic communication could be heard on the audio. PCT 1 stated his job on 5/9/25 was to help nurses with patient care in the SCU. PCT 1 stated he was new to working in the ED and not yet familiar with de-escalation techniques. PCT 1 stated he had received some training from Registered Nurse (RN) 1 on how to care for SCU patients, but he had not completed the CPI course. SO 1 stated things are different when working at the ED SCU compared to the hospital's Behavioral Health Center Facility. SO 1 stated at the Behavioral Health Center Facility, there's more support; clinical staff had more training in de-escalation and CPI, and they also have their own defensive tactics training. PCT 1 and SO 1 stated in their own opinion, the incident with Pt 1 seemed routine, and they did not see anything that concerned them.

During an interview and review of surveillance video on 6/9/25 at 2:48 p.m. with the Emergency Room Director (ERD) and the Director of Risk Management (DRM), the ERD stated the hospital had completed the investigation into Pt 1's sexual abuse allegation, and the review of the video footage showed that no sexual abuse occurred. The DRM stated no investigation or root cause analysis (RCA- It's a structured method used to investigate adverse events or near misses in healthcare to identify the underlying causes and prevent recurrence) was done regarding the concern of excessive force used on Pt 1. The DRM stated the hospital's investigation focused only on the sexual abuse allegation and did not address the use of physical force during the incident.

During an interview on 6/11/25 at 9 a.m., with the quality assurance and performance improvement (QAPI) review meeting with the Interim Vice President of Operations (IVPO), the Chief Nursing Officer (CNO), The Director of Quality Outcomes (DQO) and the Emergency Department Director (ERD), the CNO stated she did not watch the video of the incident until after the survey team raised concerns about possible use of excessive force to Pt 1. The ERD stated he had reviewed the video earlier, but her focus was on Pt 1's complaint about inappropriate touching of her breast. The ERD stated the hospital determined that inappropriate touching did not occur. The ERD stated she did not initially notice the hospital staff might have use excessive force when trying to restraint Pt 1.

During an interview on 6/12/25 at 9:32 a.m., with the chief nursing officer (CNO), the CNO stated the hospital was always looking to improve, and after learning more from the staff interviews, they need to review the video including the events before and after an incident to have the full context. The CNO stated The hospital does not currently run drills to prepare for situations like physical take downs. The CNO stated after reviewing the video, she saw many areas or the hospital could improve, such as better communication with patients, and how staff handled the situations. The CNO stated there are clear opportunities to improve staff training on de-escalation techniques in the SCU.

During a review of hospital document titled, "Quality Performance Excellence Plan Fiscal Year 2025," the document indicated, " ...[hospital] aims to deliver exceptional healthcare to our patients through staff engagement, a commitment to continuous improvement, and performance excellence ...Leadership commitment, promoting a culture of safety, and application of robust performance improvement... the goals are in alignment with quality assurance performance improvement (QAPI) program, which includes, but not limited to : b. patient safety strategies ... Attachment B ...In order for an organization to become a HRO, the organization must incorporate a commitment to continuous performance improvement into its culture and operations ... Attachment C Root Cause Analysis: An RCA is a structured facilitated team process to identify root causes of an event that resulted in an undesired outcome and develop corrective actions. The RCA process gives you a way to identify system vulnerabilities so that they can be eliminated or mitigated. The purpose is to find out what happened, why it happened, and determine what changes need to be made ..."

Based on observation, interview and record review, the hospital failed to have an effective Quality Assurance and Improvement Program (QAPI-a systematic, comprehensive, and data-driven approach to maintaining and improving safety and quality in healthcare settings) to resolve the long-standing problem of the hospital practice to provide care to inpatients in the Emergency Department (ED-an outpatient hospital department that provides immediate medical care to patients with urgent or life-threatening conditions). The QAPI program has not implemented actions to sustain improvement.

This failure resulted in 1,217 patients receiving all of their inpatient care in the ED between 1/1/25 and 5/31/25 and had the potential to not meet the physician ordered inpatient needs and the comfort needs of the patients.

Findings:

During an interview on 6/11/25 at 9 a.m. with the Interim Vice President of Operations (IVPO), the Chief Nursing Officer (CNO), The Director of Quality Outcomes (DQO) and the Emergency Department Director (ERD), the QAPI goals was discussed. The IVPO stated he was ultimately responsible for the QAPI goals of reducing the number of patients who have to wait in the ED for a hospital bed after being admitted- these are called "boarding patients". The IVPO stated the goal was to have patients wait no more than eight-hours in the ED after the admission order was given. The IVPO stated the current ED average wait time for an inpatient bed was 25.4 hours after the admission orders had been received. The IVPO stated meeting the eight-hour goal for all patients could take 12 to 18 months. The CNO stated the hospital does not plan to add more beds but instead plans to meet the goal by making their current process more efficient.

During a review of a document titled, "18-Month Plan to Reduce ED Boarding to Under Eight Hours" provided by the IVPO on 6/12/25, the document indicated, "Goal: Reduce average ED boarding time from 25.4 hours to under 8 hours by December 2026, with a primary focus on throughput optimization, clinical workflow redesign, and real-time operational accountability."

During a review of a document titled, "Percent of Patients Boarded in [hospital name] ED for less than 8 hours" provided on 6/12/25, the document indicated for the month of May 2025, 18% of patients were boarding for less than 8 hours (82% of boarding patients exceeding 8 hours) in the ED. The document indicated, "January 1, 2025 - May 31, 2025: ED Discharges: 1,217." This document indicated it was prepared by the Interim Vice President of Operations.

Based on observations, interviews, and record reviews, the hospital failed to develop and maintain individualized care plans (CP-a document that outlines a patient's health conditions, treatments and other information to guide their care and ensure continuity) for patient six and patient 15 that accurately reflect their specific needs as required by hospital policy when:

1. Pt 6's CP did not include important details about her pain location, effective medications, or other pain management interventions.

This failure could potentially result in poor pain control and delayed treatment.

2. Pt 15's CP did not identify her as non-English speaker or address her communication needs to ensure she fully understands her care.

This failure could potentially lead to miscommunication, misunderstanding about treatment, medications errors and reduced patient safety.

Findings:

1. During a concurrent interview and record review on 6/6/25 at 10:17 a.m. with the Emergency Room Director (ERD), Pt 6's Electronic Medical Record (EMR) was reviewed. The document titled "History and Physical (H&P)," dated 6/1/25 at 5:31 p.m. indicated Pt 6 was a 78-year-old female who came to the hospital on 6/1/25 at 2:30 p.m. with an injury and swelling to her right leg after a fall on 5/27/25. Pt 6 had been seen previously for her leg injury and had been prescribed antibiotics. Pt 6 also had other health issues, including venous insufficiency (not enough blood flowing to her legs) diabetes (a disease where the body has trouble regulating blood sugar levels), and kidney problems (any condition where the kidneys are damaged or not functioning properly).

The ERD stated Pt 6 had a physician order on 6/1/25 at 5:19 for inpatient care. The ERD reviewed Pt 6's document titled "Pain monitoring". The pain monitoring dated 6/1/25 at 10:54 p.m. indicated Pt 6 reported a pain level of 10 (on a scale of 1-10, with 10 being the worst pain) on her lower legs. Pt 6 was given a tablet of hydromorphone and acetaminophen (a powerful pain medication) and her pain level dropped to a one. On 6/2/25 at 5:22 a.m. Pt 6 reported a pain level of 9, this time in her lower back. Pt 6 was given hydromorphone and acetaminophen, and her pain reassessment was noted as "better" but no number was recorded indicating how sever the pain was. On 6/2/25 at 8:42 a.m. Pt 6 reported her pain level was 8 and no treatments were documented. At 12:40 p.m. Pt 6 reported a pain level of 8, now on her hip. Pt 6 was given hydromorphone and acetaminophen, and at 1:20 p.m. her pain level was 5, with no further interventions.

The ERD reviewed Pt 6's pain management CP titled, "Control of Acute Pain" and "Reduced Pain Sensation" started on 6/2/25 at 6:11 a.m., the care plan did not indicate where the pain was located, what medications help, or if any other treatments were used. The ERD stated there should have been more detailed information for Pt 6's pain, especially since she reported pain in different areas. The ERD stated the CP should be individualized and focused on Pt 6's specific needs.

During an interview on 6/12/24 at 9:25 a.m. with Pt 6, Pt 6 stated she was in a lot of pain while she was in the hospital, mainly in her leg, but her back also hurt. Pt 6 stated she was given pain medication, which helped with the pain.

2. During a concurrent interview and record review on 6/6/25 at 10:32 a.m. with Emergency Department Manager (EDM) 1, Pt 15's EMR was reviewed. The EMR indicated Pt 15 spoke Spanish and needed an interpreter. EDM 1 stated Spanish was considered a communication barrier for Pt 15. Pt 15's CP dated 6/2/25 to 6/3/25, was reviewed. EDM 1 stated Pt 15's CP did not indicate any communication barrier.

During a concurrent observation and interview on 6/6/25 at 1:16 p.m. in Pt 15's room, Pt 15 was alert and sitting up in bed. Pt 15 was asked in Spanish if she speaks and understands English. Pt 15 shook her head "no".

During an interview on 6/12/25 at 9:30 a.m. with the Chief Nursing Officer (CNO), the CNO stated it was important to identify and address communication barriers so staff could properly explained care to patients.

During a review the hospital policy & procedure (P&P) titled, "Interpreters/Translation: Non-English/limited English Proficient & Deaf/Hearing Impaired", dated 6/14/24, the P&P indicated, " ... Providing care/service to the patient requiring interpreter services ... Incorporate the communication barrier on the patient's plan of care ...".

During a review of a professional reference titled, "Safety first: The importance of interpreters & translated documents in preventing patient harm", the reference indicated, " ... When used effectively, interpreters and translated documents not only enable providers to communicate with their LEP [limited English proficiency] and NEP [non-English proficiency] patients, but also help promote patient safety by preventing medical errors and patient harm, which will minimize health disparities within this population ... open communication channels with their provider allows these patients to truly be in the center of their care ...".

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 ...".

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

1. The nursing staff failed to do a head-to-toe assessment (HTTA-thoroughly examine the body) for one of 10 patients (Pt 3) when Pt 3 was brought to the emergency department (ED- provides immediate medical care to patients with urgent or life-threatening conditions) by ambulance after a motorcycle accident and the nurse did not remove his clothing to check for injuries and did not listen to his heart, lungs, and abdominal (stomach area) sounds (an assessment using a stethoscope [a device used to listen to sounds inside the body] helps the nurse listen to the heart, lungs, and stomach to check if the body is working normally).

This failure had the potential to result in Pt 3 not receiving prompt care for his broken wrists, broken clavicle (collar bone) and scrapes on his body from contact with the pavement and had the potential to delay treatment of major injuries that could be hidden under his clothing.

2. Three of three patients (Patient (Pt) 2, Pt 21 and Pt 22) did not have their skin assessed and documented each shift by ED nursing staff, and Pt 21 did not have a dual nurse skin assessment when transferred to another patient care area per hospital P&P titled, "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", "Admission & Ongoing Assessment - Nursing (Acute Care)", and "Documentation in the Health Record".

These failures placed Pt 2, Pt 21, and Pt 22's skin at risk for further breakdown, and was the potential cause for Pt 2's hospital acquired (developed during hospital stay) stage 3 (full thickness) pressure injury (PI -damage to the skin and underlying tissue caused by prolonged pressure) to the coccyx (tailbone).

3. One of 10 patients (Pt 22) admitted as an inpatient and held in the ED, did not have a head-to-toe assessment completed by ED nursing staff after being admitted as an inpatient, according to hospital P&P titled, "Admission & Ongoing Assessment - Nursing (Acute Care)".

This failure placed Pt 22 at risk for nursing staff to miss a change of condition by not having a baseline assessment.

4. Two out of 10 sampled patients (Pt 2 and Pt 21) admitted as inpatients to the hospital and held in the Emergency Department (ED) were not provided hygiene care while in the ED according to hospital Policy and Procedure (P&P) titled "Oral Care", and the "Patient Care Tech 1 Job Description".

These failures had the potential to increase Pt 2 and Pt 21's risk of infection, and risk for skin breakdown. Theses failure also had the potential to decrease Pt 2 and Pt 21's self-esteem, and sense of dignity (self-worth).

5. One out of 10 sampled patients (Pt 2) did not receive a meal or snacks while admitted and held in the ED on 3/27/25 according to physician order.
This failure had the potential to cause weakness, weight loss, and compromise his immune system leading to an increased risk of infections.

6. For two of twelve patients (Pt 2 and Pt 21) a nutritional risk screening was not completed or was not completed accurately by nursing staff within 24 hours of admission according to the hospital's P&P titled, "Nutritional Care and Documentation in the EHR [Electronic Health Record]."

These failures had the potential to delay a Registered Dietitian (RD) for medical nutrition therapy for Pt 2 and Pt 21. This delay could lead to a range of serious consequences, including delayed illness recovery, poor wound healing and weight loss.

7. The hospital failed to ensure an enteral feeding (a method of providing nutrition directly into the gastrointestinal tract through a tube) was labeled with the date and time of change for one of two patients (Patient 65) in accordance with hospital P&P.

This failure had the potential to result in the use of expired or contaminated formula, increasing the risk for infection or compromised nutritional support.

Findings:

1. During an interview on 6/2/25 at 8:45 a.m. with the mother of Pt 3 (M3), M3 stated she was called to the scene of the motorcycle accident on 5/9/25 and arrived in the ED soon after the ambulance that brought Pt 3 to the ED. M3 stated she is a registered nurse at a different hospital, and she was in the ED with Pt 3 while he was waiting for treatment. M3 stated at no time did any nurse listen to Pt 3's heart, lungs, or abdomen, nor did anyone ask him to remove his clothing so his body could be examined.

During an interview on 6/4/25 at 2:38 p.m. with Emergency Department Manager (EDM) 1, EDM 1 opened the Electronic Medical Record (EMR- is a digital version of a patient's paper chart, containing medical history, diagnosis, and medication) for Pt 3. EDM 1 stated the chart indicated Pt 3 arrived in the ED on 5/9/25 at 5:17 p.m. with multiple fractures (many broken bones), ESI level of 2 (Emergency Severity Index (ESI) is a tool used in emergency departments to determine how sick or injured a patient is, with level one (1) being the most critical and level 5 being not very sick or injured at all.) EDM 1 stated the EMR indicated Pt 3 had been in a motorcycle accident. EDM 1 was unable to find documentation of a physical assessment, including no documentation that a nurse listens to Pt 3's heart, lungs, or abdomen, or removed his clothing to look for other injuries. EDM 1 stated, "it looks like we didn't do a physical assessment. "We didn't strip him and flip him." EDM 1 explained this as the standard process of removing all clothing from a patient's body and checking the entire body for injuries, which she would expect for a patient who had been in a motorcycle accident.

During an interview on 6/5/25 at 8:05 a.m. with RN 16, RN 16 stated she was the first nurse assigned to Pt 3 after triage (a system for quickly assessing a patient upon arrival to determine the severity of their condition and priority of their care). RN 16 stated her shift on 5/9/25 started at 7 a.m. and would end after she gave report to the oncoming nurse between 7 p.m. and 7:30 p.m. RN 16 stated she was assigned to care for Pt 3 "towards the end of her shift." RN 16 stated Pt 3 was alert and walking around, "if I had tried to put him in a gown, I think he would have refused." RN 16 stated she did not recall asking Pt 3 to remove his clothing to allow her to do a more thorough examination. RN 16 stated Pt 3 had an intravenous line (is a small tube put into a vein to give medicine or fluids directly into the body), which was placed by the ambulance staff prior to arrival in the ED. RN 16 stated Pt 3's mother was with him in the ED and asked to speak with the doctor. RN 16 stated she contacted Medical Doctor (MD) 1, who was assigned to Pt 3. MD 1 ordered pain medication for Pt 3 but did not come to see Pt 3 immediately.

During a concurrent interview and record review on 6/10/25 at 7:30 a.m. with Registered Nurse (RN) 15, RN 15 accessed and reviewed her own notes in the EMR. RN 15 stated she was assigned to care for Pt 3 when her shift started on 5/9/25 at 7 p.m. RN 15 stated she was assigned in the "Red Zone" which she described as the area where critically ill patients are placed. RN 15 stated this was an appropriate location within the ED for Pt 3 because he had been in a motorcycle accident, and he had an ESI of 2. RN 15 could not find documentation to indicate she had done a physical assessment to check for other injuries to Pt 3. RN 15 stated she did not listen to Pt 3's heart, lungs, or abdomen, and did not remove Pt 3's clothing to examine him. RN 15 stated her documentation showed she first saw Pt 3 on 5/9/25 at 7:35 p.m.

During an interview on 6/10/25 at 11:30 with MD 1, MD 1 stated he had recently reviewed the EMR for Pt 3 and remembered the patient. MD 1 stated he started the medical screening exam right after the ambulance brought Pt 3 at the hospital. MD 1 stated he remembered Pt 3 was alert, oriented, and able to speak clearly and described his accident. MD 1 stated Pt 3 was not having any difficulty breathing, his abdomen felt soft, and his head and neck could move normally, so he wasn't concerned of getting an immediate image of Pt 3's head and neck. MD 1 stated he remembered Pt 3 had tenderness to his wrists, so he ordered an x-ray of the wrists. MD 1 stated he received a call from the RN caring for Pt 3 asking him to come and talk with Pt 3's mother, but at the same time, the ED had a "code white" (a baby wasn't breathing) with another patient. MD 1 stated he ordered pain medication for Pt 3 and told the nurse he would come to check on Pt 3 as soon as possible.

During a review of hospital document titled "Physician Emergency - ED Provider Note," signed by MD 1 dated 5/9/25 at 5:43 p.m., the note indicated, "35 y.o. (year old) male brought in by ambulance for complaints of multiple abrasions (scrapes), bilateral (both sides) wrist pain, R (right) clavicle (collar bone) pain with deformity (misshaped due to break), and mid back pain s/p (after) solo motorcycle accident this evening. States he was the solo rider driving approximately 10 MPH when he lost control of the motorcycle. He was lay the bike onto the road. Denies loss of consciousness (didn't pass out). He was wearing a helmet. No shortness of breath, nausea, or vomiting.

During a review of hospital policy titled, "Standard of Practice for Emergency Department," dated 0/23/24, the policy indicated, " ... B. STANDARD OF PRACTICE: Patient Rights & Nursing Process. The patient will have a systematic and continuous assessment of their health status performed by a Licensed Nurse, utilizing the nursing process. The RN will: 1. Collect, document, and communicate data to the interdisciplinary team. The frequency of data collection will vary according to the gravity of patient's problems/needs as well as individual standardized procedure and physician order, a. Documentation on the Emergency Department Electronic Health Record (EHR) will reflect assessment of the patient's status and needs.

During a review of hospital policy titled "Triage," dated 9/20/24, the document indicated, " ...PURPOSE: A. To promptly identify patients with an emergency medical condition at [name of hospital]. B. To determine the appropriate area for treatment. C. To facilitate patient flow through the Emergency Department (ED). D. To provide initial assessment of arriving patients. E. To decrease door to provider times. F. To facilitate the treatment of patients within the ED.

During a review of hospital policy titled, "Emergency Severity Index Policy" dated 9/10/24, the document indicated, "PURPOSE: To provide guidelines for all patients presenting to the Emergency Department. All patients presenting to the Emergency Department will undergo an Emergency Severity Index Assessment by the triage nurse to initiate a Medical Screening Examination and determine the timing, urgency and appropriate location in the ED for completion of the Medical Screening examination and disposition of the patient. DEFINITION: Emergency Severity Index (ESI): The ESI is a 5-level Emergency Department Triage algorithm that sorts patients into 5 groups from 1 (Immediate) to 5 (non-urgent) based on predicted acuity and resource needs. POLICY: Patients will have the Emergency Severity Index (ESI) assessment at the Triage area of the Emergency Department or within the treatment area of the Emergency Department. PROCEDURE: The triage nurse will categorize the patient into one of the following five (5) ESI Levels. The levels will be determined by using the following: Index Level Definitions, Data Base, and ESI algorithm. Index Level Definitions: ESI Level 1 - Immediate; ESI Level 2 - Emergent ..."

The California Code of Regulations, Title 22, Section 70215 states "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), defines 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.



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2. During a concurrent interview and record review on 6/5/25 at 11:15 a.m. with Nurse Manager (NM) 3, NM 3 opened Pt 2's EMR and stated, Pt 2 arrived in the ED on 3/27/25 at 5:53 a.m., with a complaint of being unable to urinate (pee). Pt 2's hospital document titled, "History and Physical (H&P-an assessment from physician including medical history and exam)," dated 3/27/25, was reviewed. The "H&P" indicated Pt 2 had a complaint of scrotal (the sack of skin and muscle that holds the testicles outside the body) swelling the size of a grapefruit and urinary retention (unable to urinate). NM 3 stated Pt 2 had a past medical history (PMH) of benign prostatic hyperplasia (BPH-the prostate gland [walnut-sized gland located in the male reproductive system, just below the bladder] enlarges). NM 3 stated Pt 2 was admitted to the hospital as an inpatient for a perianal fistula (an abnormal tunnel-like connection between the anal canal and the skin surrounding the anus) and urinary tract infection (UTI- a bacterial infection that occurs when bacteria enter the urinary tract and multiply). NM 3 reviewed Pt 2's hospital document titled, "Admit Discharge Transfer Log (ADT)", which showed where Pt 2 was moved throughout his hospital stay. NM 3 stated Pt 2 was moved to the inpatient Medical Surgical (MS) Unit (patients with a variety of medical and surgical conditions receive care) on 3/28/25 at 2:55 p.m. The "ADT" indicated, Pt 2 had physician inpatient admit orders but stayed in the ED for 27 hours and 31 minutes before transferred to the MS unit. NM 3 reviewed Pt 2's hospital document titled "Skin Integrity Accordion [SIA]," dated 3/27/25 to 4/3/25. The "SIA" indicated, Pt 2 did not receive a complete skin assessment, including, "skin integrity [healthy and intact state of skin]", "activity", "Braden Scale [an assessment tool used in healthcare to determine risk of developing PI [pressure injury] scored from 6-23 lower number indicates higher risk]", and "Hygiene", until Pt 2 was moved to the inpatient MS unit on 3/28/25. The "SIA" indicated, ED RNs did not perform an admission skin assessment on 3/27/25. NM 3 stated the night shift ED RNs on 3/27/25, and the day shift ED RNs on 3/28/25 did not perform a complete skin assessment. NM 3 stated the ED RNs should have performed a complete skin assessment during admission assessment and every shift. NM 3 stated on 3/28/25 at 3:30 p.m. the MS nurses documented Pt 2 had a discoloration to coccyx and swelling to the scrotum. NM 3 stated no photos were taken of the coccyx discoloration because nurses usually do not take photos of discoloration. NM 3 stated on 4/2/25 at 9 p.m. the MS nurses discovered a stage 3 PI on Pt 2's coccyx. The "SIA" indicated "intact" skin and scrotum swelling from 3/29/25 to 3/31/25. NM 3 stated, MS nurses documented an incision to the scrotum and penis on 3/31/25. NM 3 stated Pt 2 had a darker pigmented skin tone, which may have made it harder to spot early signs of deep tissue injury (DTI - a type of PI where damage occurs to underlying tissues, but the skin may appear intact or only slightly discolored and can progress into a full thickness wound if not addressed promptly) on Pt 2's coccyx. NM 3 stated the DTI may have developed to a stage 3 PI. NM 3 stated Pt 2 was able to walk and shift positions but was reluctant to do so because of pain and swelling to the scrotum. NM 3 stated nursing notes indicated staff often found Pt 2 in the same position during rounds (when medical staff check on patients). NM 3 stated Pt 2's stage 3 PI was preventable and a full skin assessment in the ED could have started early prevention interventions which was not done. NM 3 stated MS nurses knew Pt 2 was not walking much or shifting his weight in bed but did not adjust care plan interventions to prevent the PI from progressing or catch signs of the PI getting worse. NM 3 stated Pt 2 should have been placed on a specialty bed designed to prevent bed sores or PI but was not. NM 3 stated on 4/3/25 Pt 2 was provided a specialty bed.

During a concurrent interview and record review on 6/9/25 at 9:30 a.m. with Emergency Department Manager (EDM) 2, Pt 2's hospital document titled "Emergency Department Timeline [EDT]". The "EDT" indicated, on 3/27/25 at 7:45 p.m. a HTTA was completed but no comprehensive skin assessment was documented. EDM 2 stated Pt 2 had a Braden Scale Score (Scores are from 6 to 23, lower number indicates higher risk) completed without a documented skin assessment. EDM 2 stated he was unable to find a documented skin assessment for Pt 2 while in the ED. EDM 2 stated there should been a skin assessment documented in Pt 2's Medical Record at the time of admission on 3/27/25, and one for the night on 3/27/25 and the morning shift of 3/28/25. EDM 2 stated a comprehensive skin assessment in the ED was important to have a baseline and identify any wounds or skin issues early, to initiate appropriate wound care interventions. EDM 2 stated skin assessment should have been done every shift in the ED but was not.

During a concurrent interview and record review on 6/5/25 at 2:56 p.m. with NM 2, Pt 21's EMR was reviewed. NM 2 stated, Pt 21 arrived in the ED by ambulance from a Skilled Nursing Facility (SNF-a type of healthcare facility that provides 24-hour skilled nursing care and rehabilitation services to individuals who require medical care and support after a hospital stay, but do not need the intensive level of care provided in a hospital) on 5/24/25 at 3:50 p.m. NM 2 reviewed Pt 21's hospital document titled, "H&P", dated, 5/25/25, NM 2 stated Pt 21 was a 74-year-old admitted with altered mental status (AMS- confusion or changes in thinking or behavior) and Failure to Thrive (FTT -a serious decline in physical and mental function with weight loss, poor appetite, and reduced activity levels), chronic hypoxic respiratory failure (a condition where the lungs don't properly oxygenate the blood) on home oxygen, diabetes mellitus (disorder characterized by difficulty in blood sugar control and poor wound healing), and was bedbound (confined to bed) with weakness of lower legs. NM 2 stated Pt 21 had physician's inpatient admit orders on 5/25/25 at 12:55 a.m. and was transferred to the Stepdown Unit (a unit bridging the gap between the intensive care unit (ICU) and the general MS floor) on 5/26/25 at 4:30 p.m. NM 2 reviewed Pt 21's "SIA", and stated, ED RNs did not document a nightshift skin assessment on 5/25/25. NM 2 stated, the Stepdown RNs did not document a two-person skin assessment on 5/26/25, as required by the hospital policy. NM 2 stated RN 2 admitted Pt 21 to the Stepdown Unit on 5/26/25 at 4:41 p.m. but did not document a skin assessment. NM 2 stated RN 2 should have completed a two-person skin assessment with another nurse upon admission to the unit. NM 2 stated a two-person skin assessment allowed nurses to have a second set of eyes to look for skin breakdown on patients. NM 2 stated the first documented skin assessment in the Stepdown unit was completed later that night on 5/26/25 at 8 p.m. and showed redness on Pt 21's right heel, not documented in the ED. NM 2 stated Pt 21 had had a Braden Score of 12 indicating a high risk of PI and needed pressure reduction interventions put in place for skin protection.

During a concurrent observation and interview on 6/ 6/25 at 9:45 a.m., Pt 21 was seen lying in her hospital bed on her back with the head of the bed raised to a 30° angle. Pt 21 had a nasal oxygen tube, a pressure relief boot on her left foot, and a pillow under her right heel to keep it elevated. Pt 21 was watching TV and agreed to be interviewed. Pt 21 stated she had been in the hospital for a few weeks and the nurses were treating wounds on her heels and bottom. Patient 21 stated she was feeling better compared to when she first arrived.

During an interview on 6/6/25 at 9:48 a.m. with RN 4, RN 4 stated she was Pt 21's primary nurse for the day. RN 4 stated Pt 21 had a DTI on her left heel and was wearing a protective boot to help prevent PI. RN 4 stated she has received patients from the ED before who had wounds that were not documented. RN 4 stated when patients were admitted to the unit, a full head to toe assessment and a two-nurse skin checked are required. RN 4 stated she usually does the skin check and assessment when she takes the first set of vital signs. RN 4 stated skin assessment should be done every shift.

During a concurrent interview and record review on 6/9/25 at 9:41 a.m. with EDM 2, Pt 21's "ADT," dated, 5/24/25 to 5/26/25, and "SIA," dated 5/24/25 to 5/28/25, were reviewed. EDM 2 verified in Pt 21's "SIA" there was no skin assessment documented on 5/25/25 during the night shift. EDM 2 stated Pt 21 should have a skin assessment completed every shift.

During a concurrent interview and record review on 6/12/25 at 8:35 a.m. with RN 2, Pt 21's "SIA", "Skin Photos" and "HTTA" dated 5/26/25 were reviewed. RN 2 stated he was Pt 21's primary nurse on 5/26/25 when she was transferred from the ED to the Stepdown Unit. RN 2 stated he worked day shift on 5/26/25 from 7 a.m. to 7:30 p.m. RN 2 stated he remembered Pt 21 and confirmed he completed the HTTA assessment on 5/26/25 at 4:42 p.m. RN 2 stated dual nurse skin checks was required by hospital policy. RN 2 stated he took four photos of Pt 21's skin issues, including a wound on the coccyx, redness on the right heel, abrasion under breast, and a red mark to the leg, but admitted he forgot to document. RN 2 stated he should have documented Pt 21's skin assessment to have a baseline for the care team to monitor.

During a concurrent interview and record review on 6/9/25 at 9:54 a.m. with EDM 2, EDM 2 reviewed Pt 22's EMR. EDM 2 stated Pt 22 arrived at the ED by ambulance on 5/9/25 at 2:47 p.m. for altered mental status. EDM 2 reviewed Pt 22's H&P dated 5/9/25, the H&P indicated Pt 22 was 94 years old with a history of high blood pressure (a condition where the force of blood against the artery walls is consistently too high) and breast cancer (a disease when cells in the breast grow out of control, potentially forming tumors) The H&P also indicated redness and a possible open wound on the lower right leg, especially near the ankle, which was warm and tender to touch. EDM 2 stated Pt 22 22 was admitted as an inpatient later that night at 10:08 PM with a diagnosis of "likely metabolic encephalopathy [a brain dysfunction causing confusion] due to underlying sepsis [a life-threatening blood infection], [with] acute kidney injury [A sudden and often reversible decline in kidney function]." EDM 2 reviewed Pt 22's hospital document titled, "EDT", the EDT indicated Pt 22 stayed in the ED for 31 hours and 37 minutes before being moved to the inpatient Cardiac Progressive Care (care for patients with heart conditions) Unit on 5/11/25 at 5:45 p.m. EDM 2 reviewed Pt 22's hospital document titled, "SIA" dated, 5/9/25 to 6/3/25, EDM 2 stated, there was no skin assessment documented skin assessment for the night shift on 5/10/25. The "SIA" indicated Pt 22 had wounds to her arm and ankle when transferred to the CPCU from the ED. EDM 2 stated full skin assessments should be completed upon admission to the unit, and every shift.

During an interview on 5/12/25 at 9:41 a.m. with the Chief Nursing Officer (CNO), the CNO stated, her expectation was that skin assessments were completed and documented per policy, in any unit of the hospital. The CNO stated skin assessments should be ongoing and continuous. The CNO sated nursing should adjust the patient's care plan interventions as the patient's conditions changes based on assessments.

During a review of the hospital's P&P titled, "Pressure Injury Risk Assessment, Prevention, Staging and Treatment", dated 5/19/25, indicated, " ...All patients shall be assessed upon admission, then every shift, and with condition changes using the Braden Scale for Predicting Pressure Sore Risk [tool used by healthcare workers]. ...The initial skin assessment upon admission and/or transfer from another unit will be conducted by an RN and a secondary licensed staff member. ...Refine the assessment by including these additional risk factors: a. Fragile skin b. Existing pressure injury of any stage, including those injuries that have healed or are closed c. Impairments in blood flow to extremities from vascular [arteries and veins] disease, diabetes [high blood sugar] or tobacco use 4. Develop a plan of care based on the areas of risks, rather than on the total risk assessment score. For example, if the risk stems from immobility, address turning, positioning, and the support surface. If the risk is from malnutrition, address this problem, etc. B. Prevention (All patients regardless of score) 1. Skin Care a. Inspect all of the skin following admission and document the assessment in the medical record within 24 hours of admission. b. Re-assess the skin routinely per the Standards of Practice Documentation Grid. c. Assess pressure points, including under equipment contact sites, and also over boney prominences [areas where bones are close to skin], such as the sacrum [area above tailbone on back], coccyx, buttocks, heels, ischium [hip bones], trochanters [upper part of thigh bone], elbows, and under medical devices. d. When inspecting darkly pigmented skin, look for changes in skin tone, skin temperature and tissue consistency compared to adjacent skin. Moistening the skin assists in identifying changes in color ... Document initial skin assessment and Braden Scale score in the EHR [electronic health record] ...".

During a review of the hospital's P&P titled, "Admission & Ongoing Assessment - Nursing (Acute Care)", dated 5/19/25, indicated, " ...Patients being admitted to the acute care facility through the Emergency Department (ED) will have the admission and assessment process initiated in the ED. The information gathered will be verified and completed as necessary by the RN in the inpatient receiving area ... A comprehensive nursing admission assessment using the nursing process will be initiated by the RN within two hours of the patient's admission.
Integumentary [skin] status. ...3. The comprehensive initial nursing admission assessment is to be documented by the RN and/or admission team completing the admission. Ongoing nursing assessment will be initiated by the RN or LVN at the beginning of every shift in accordance with their scope of practice ...".

During a review of the hospital's 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. B. All patient care and activities are to be documented at the time care is provided. ... 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. 2. Documentation of care planning, completion of bedside educational modules, and result reviewing and graphing may be recorded outside the patient's room ...".

During a professional reference review titled, "Nursing interventions in preventing pressure injuries in acute inpatient care: a cross-sectional national study", dated 6/12/23, the professional reference indicated, " ...Several nursing interventions for pressure injury prevention have been identified, including risk and skin status assessment. ... Preventing pressure injuries (PIs) is an important part of nurses' work in hospitals and in communities. Pressure injuries arise from a failure of skin integrity due to unrelieved pressure and other forces, such as a bony area contacting external surfaces or a medical device causing pressure. ...Most importantly, PIs reduce the quality of life of patients, along with the quality of care. ...An earlier study identified that every tenth patient arriving at the hospital already had PIs or developed them within 36 h of admission. Thus, nurses and other health care personnel play a significant role in PI prevention. According to the International Guideline, pressure injuries stage I are a prognostic factor for higher stage PIs. Each patient should go through a comprehensive skin and tissue assessment after admission, or after being transferred to healthcare services as a part of the risk assessment. A skin assessment should also be implemented prior to being discharged from healthcare services. ...PI risk and skin status assessments are of high importance for HAPI prevention ..."

3. During a concurrent interview and record review on 6/6/25 at 10:34 p.m. with NM 1 and Assistant Nurse Manager (ANM) 1, NM 1 reviewed Pt 22's EMR and stated Pt 22 arrived at the ED on 5/9/25 at 2:48 p.m., physician inpatient order was placed on 5/9/25 at 10:08 p.m. and Pt 22 was transferred on an inpatient bed in CPCU on 5/11/25 at 5:45 p.m. Pt 22 stayed in the ED for 43 hours and 37 minutes. NM 1 reviewed Pt 22's document titled "HTTA", from 5/9/25 to 5/13/25. NM 1 compared the HTTA both the ED and the CPCU, and stated the level of care should be the same in both areas. ANM 1 stated the ED nurses did not performed the NIH (National Institute of Health Stroke Scale) stroke scale (a widely used tool to assess the severity of stroke in patients. It's a 11-item scale that evaluates neurological function and deficits, with scores ranging from 0 to 42, where higher scores indicate greater severity), HENT (a physical examination focusing on the Head, Eyes, Ears, Nose, and Throat), Respiratory assessment (a systematic evaluation of the breathing process and lung function to identify any potential problems or abnormalities), Edema assessment (the process of evaluating swelling, or edema, in the body), Neurovascular assessment (a clinical evaluation of a patient's circulation and nerve function in a limb, typically an extremity, to detect any signs of impaired blood flow or nerve damage) Abdominal and Bowel sounds assessment ( is a physical exam of the abdomen to assess the condition of the digestive, GU assessment (genitourinary- a systemic evaluation of the urinary system, Mobility assessment (a process to evaluate a person's ability to move), Psychosocial assessment (a comprehensive evaluation of an individual's mental health, social well-being, and ability to function within their environment, and Fall risk assessment (a process used to identify individuals who are at increased risk of falling).

During a concurrent interview and record review on 6/9/25 at 10:05 a.m. with EDM 2, EDM 2 reviewed Pt 22's EMR and stated Pt 22 arrived at the ED on 5/9/25 at 2:48 p.m., physician inpatient order was placed on 5/9/25 at 10:08 p.m. EDM 2 reviewed Pt 22's HTTA and stated the ED nurses did not document a HTTA at the time of admission or once per shift as required. EDM 2 stated it was important to complete a HTTA to establish a baseline for Pt 22' condition and identify changes in patient 22's condition to provide appropriate care.

During a review of the hospital's P&P titled, "Admission & Ongoing Assessment - Nursing (Acute Care)", dated 5/19/25, indicated, " ...Patients being admitted to the acute care facility through the Emergency Department (ED) will have the admission and assessment process initiated in the ED. The information gathered will be verified and completed as necessary by the RN in the inpatient receiving area. ... A comprehensive nursing admission assessment using the nursing process will be initiated by the RN within two hours of the patient's admission... While aspects of data collection may be delegated by the RN to other care providers within their scope of practice, job description, and in accordance with the policy, the RN is responsible for coordinating the patient's plan of care and patient/family education (refer to Role-Based Patient Care by Scope of Practice policy). 2. A compreh

Based on observation, interview, and record review, the hospital failed to administer medications in accordance with physician orders, hospital policies, and acceptable standards of practice for three of 72 sampled patients (Patient 1, Patient 12, and Patient 16) when:

1. Nursing staff did not administer intravenous (IV, into the vein) magnesium at the ordered time and rate and did not administer PRN (as needed) intravenous blood pressure medication according to physician's orders for Patient 12;

2. The hospital did not administer IV vancomycin (an antibiotic to treat infection) at the scheduled time for Patient 16; and

3. An intramuscular (IM, into the muscle) medication administered to Patient 1 was prepared by one LN (ANM 4, Assistant Nursing Manager 4) and administered by another LN (Registered Nurse 1) and the LNs did not follow acceptable standards of safe medication administration.

These failures resulted in the hospital not ensuring safe and accurate administration of medications, preventable medication errors, delays in treatment, and potential for subtherapeutic and/or adverse clinical outcomes.

Findings:

1a. A review of Patient 12's History & Physical (H&P - comprehensive patient assessment) indicated he presented to the Emergency Department (ED) on 6/2/25 with a complaint of shortness of breath. The Assessment & Plan indicated, "Atrial fibrillation with RVR (rapid ventricular response, a condition where the heart is beating irregularly and faster than normal, potentially causing symptoms like palpitations, dizziness, or shortness of breath) ... keep K (potassium > [greater than] 4, Mg (magnesium) > [greater than] 2 ..."

A review of Patient 12's medical record indicated the following physician's orders:
- Magnesium sulfate 1 gram/100 milliliter (g/mL, a unit of measurement) infusion (administered through the vein): 1 g IV every hour administered over one hour, scheduled start and end 6/2/25 at 6:21 a.m. after two doses were administered.

During a concurrent interview and record review on 6/11/25 at 2:16 p.m. with Nurse Manager 2 (NM 2), Patient 12's physician's orders and Medication Administration Record (MAR) for the magnesium infusion were reviewed. NM 2 confirmed the order for magnesium was for two doses to be administered every hour, and each to be infused over one hour. NM 2 reviewed the MAR and confirmed the first dose was administered on 6/2/25 at 4:50 a.m. and the second dose was administered at 5:21 a.m., only 31 minutes apart. NM 2 reviewed Patient 12's record and confirmed Patient 12 only had one IV (intravenous, into the vein) line when the magnesium was administered.

During a review of the hospital's P&P titled, "Medications- Orders, Administration, Storage, Documentation," dated 12/19/23, the P&P indicated, "III. Policy ... B. Medication Administration ... 11. Timing of Medication Administration a. The timing of medication administration is based on the nature of the medication and its clinical application to ensure safe and timely administration ... 17. It is the responsibility of the person administering the medication to verify the following ... d. The right time ... V. PROCEDURE ... K. Review administration instructions on MAR ..."

1b. A review of Patient 12's History & Physical indicated he presented to the Emergency Department (ED) on 6/2/25 with a complaint of shortness of breath. The Assessment & Plan indicated, "Atrial fibrillation with RVR."

A review of Patient 12's medical record indicated the following physician's orders:
- Metoprolol (medication to slow heart rate) injection 5 milligrams (mg, a unit of measurement): 5 mg IV every 6 hours PRN (as needed) for HR (heart rate) > 110 bpm (beats per minutes), scheduled start date 6/2/25 at 12:13 a.m.

During a concurrent interview and record review on 6/12/25 at 11:19 a.m. with NM 2, Patient 12's vitals dated 6/3/25 were reviewed. NM 2 confirmed Patient 12's heart rate was documented at 117 bpm on 6/3/25 at 7:59 a.m. She confirmed metoprolol was not administered to Patient 12 and stated if the heart rate was greater than 110 bpm, the nurse should have administered it per the doctor's orders.

During a review of the hospital's P&P titled, "Medications- Orders, Administration, Storage, Documentation," dated 12/19/23, the P&P indicated, "III. Policy ... B. Medication Administration ... 11. Timing of Medication Administration a. The timing of medication administration is based on the nature of the medication and its clinical application to ensure safe and timely administration ... 17. It is the responsibility of the person administering the medication to verify the following ... d. The right dose e. The right time F. The right route ... V. PROCEDURE ... K. Review administration instructions on MAR ..."

2. A review of Patient 16's H&P indicated he presented to the ED on 6/2/25 with complaints of swelling, redness and pain in his lower right extremity. The Assessment and Plan indicated, "Sepsis (an infection in the blood) ... Start Zosyn (an antibiotic to treat infection) and vancomycin empirically ... Cellulitis (a skin infection) and abscess (a pus-filled pocket that forms in the body due to an infection) of lower extremity ... Start Zosyn and vancomycin empirically ..."
A review of Patient 16's medical record indicated physician's orders for the following antibiotics (medication to treat infection):
- Vancomycin (an antibiotic to treat infection) 1.5 g/500 milliliters (g/mL, a unit of measurement): 1,500 mg IV 3 times per day, administered over 120 minutes, scheduled start date 6/2/25 at 1 p.m.
- Zosyn (antibiotic to treat infection) 3.375 g/mL: 3.375 g IV 3 times per day, scheduled start date 6/2/25 at 8:23 a.m.

During a concurrent interview and record review on 6/11/25 at 3:07 p.m. with Director of Pharmacy (DOP), Patient 16's MAR was reviewed. The DOP confirmed the MAR indicated vancomycin scheduled for 6/2/25 at 1 p.m. was not administered to Patient 16 until 5:02 p.m. that day, approximately 4 hours later than scheduled.

During an interview on 6/12/25 at 8:33 a.m. with DOP, DOP stated Patient 16 was administered the vancomycin later than scheduled because the patient only had one IV line at the time.

During an interview on 6/12/25 at 9:10 a.m. with NM 2, Patient 16's medical record was reviewed. NM 2 confirmed Patient 16 only had one IV line at the time vancomycin was scheduled to be administered. NM 2 reviewed Patient 16's record and confirmed there was no documentation of a second IV line. NM 2 stated if a patient had multiple medications schedule to be administered at or around the same time, nursing staff were expected to contact pharmacy and work with the pharmacist to plan how to administer them. She stated she was not sure contacted the pharmacy and stated sometimes it was documented and other times it was not.

During a review of the hospital's P&P titled, "Medications- Orders, Administration, Storage, Documentation," dated 12/19/23, the P&P indicated, "III. Policy ... B. Medication Administration ... 11. Timing of Medication Administration a. The timing of medication administration is based on the nature of the medication and its clinical application to ensure safe and timely administration. These medications are classified as either not eligible for scheduled dosing times or eligible for scheduled dosing times ... ii. Medications eligible for scheduled dosing times are prescribed on a repeated cycle of frequency ... Medications eligible for scheduled dosing times may be classified as time critical or non-time critical scheduled medications; I. Time critical A. Maintain total one-hour administration window where administration may occur up to 30 minutes before or after scheduled time. Examples of time critical scheduled medications include but may not be limited to: 1. Antibiotics ... 17. It is the responsibility of the person administering the medication to verify the following ... d. The right dose e. The right time F. The right route ... V. PROCEDURE ... K. Review administration instructions on MAR ... M. Each person administering medications or treatment is required to check the medication against the MAR or original written order ... prior to medication administration."

3. During an interview and video surveillance review on 6/9/24 at 11:10 a.m., with Security Operations Manager (SOM) 1, and Vice President (VP) of Regulatory, Risk, and Medical Affairs (VPR), RN 1 was observed at Pt 1's bedside in the Special Care Unit (SCU- locked and monitored area where mental behavioral health patients are placed) in the Emergency Department (ED) when Assistant Nurse Manager (ANM) 4 was observed to hand an unlabeled syringe to RN 1. RN 1 administered the medication to Pt 1 while she was being physically restrained by Security Offices (SOs) who were in the process of applying four-point locking restraints (the physical restraint of a patient's limbs using restraints on all four limbs simultaneously) to Pt 1's wrists and ankles.

During a review of Pt 1's "Face Sheet (FS)" dated 5/9/25, the FS indicated, "... [Pt 1] arrived at the ED on 5/9/25 at 17:27 (5:27 p.m.) ... Discharge Date/Time: 5/11/25 at 21:40 (9:40 p.m.) ..."

During a review of Pt 1's "ED Provider Notes (ED Note)" dated 5/9/25, the ED Note indicated, "[Pt 1] ...54-year-old ...presents to the ED for evaluation s/p (status/post- after) alleged assault today. Patient has complaints of headache and nausea... Patient states while she was at the rental property she was allegedly assaulted by her tenants... patient alleges "police came and hit the backside of my car. ...denies SI (Suicidal Ideation- thoughts of harming self), HI (Homicidal Ideation- thoughts of harming others), visual hallucinations, or auditory hallucinations. ...Discussion...a past medical history of generalized anxiety disorder (worrying constantly and can't control it) ...Patient reporting abdominal pain and recent diagnosis of pregnancy. Patient appears to have delusions... Patient was placed on a 1799 hold (a short-term, 24-hour psychiatric detention used in California hospitals for gravely disabled (a condition in which a person: as a result of a mental health disorder, impairment by chronic alcoholism, severe substance use disorder, or a co-occurring mental health disorder and severe substance use disorder, is unable to provide for their basic personal needs for food, clothing, shelter, personal safety, or necessary medical care)... Patient attempted to elope from the SCU area and would not respond to verbal redirection requiring 4-point restraints, diphenhydramine/haloperidol/lorazepam (antianxiety medication). Patient was seen by psychiatric liaison who recommended lifting 1799 hold... The patient currently appears clinically sober, without evidence of ingestion or withdrawal. At this time, is medically clear. Awaiting psych recs (recommendations)..."

During a review of Pt 1's Medication Administration Record (MAR) dated 6/10/25 for dates 5/8/25 through 5/11/25, the MAR indicated "...Lorazepam (brand name) injection 2 mg (milligrams- unit of measure) Dose: 2 mg Freq. ONCE Route: IM Start 5/9/25 18:36 (6:36 p.m.) ...5/9/25...18:32 (6:32 p.m.) (2mg)-$Given..."

During an interview and video surveillance review on 6/11/25 at 9:09 a.m., with Assistant Nurse Manager (ANM) 4, ANM 4 stated she responded to assist with an agitated patient in the SCU. ANM 4 stated lorazepam was already ordered with haloperidol and diphenhydramine ordered later. ANM 4 stated she obtained the lorazepam vial, drew up the medication into a syringe, applied the needle and handed it to RN 1 to administer the medication. ANM 4 stated the bar code scanning step in the medication administration process was bypassed due to the situation. ANM 4 stated she entered the SCU and handed the pre-filled syringe to the RN 1. ANM 4 stated she verbally communicated to RN 1 that the syringe contained lorazepam. ANM 4 stated the syringe was not labeled. ANM stated she usually asks if she can help by giving the medication but did not this time. ANM 4 stated she scanned the vials [into Pt 1's medical record] following the incident with Pt 1. ANM stated ideally, bar code scanning happens at bedside to ensure the patient's 5 rights are upheld (for example: inform the patient, confirm the right route and then document).

During an interview and video surveillance review on 6/11/25 at 1:15 p.m., with RN 1 and ED Manager (EDM) 1, RN 1 stated while attempting to prevent Pt 1 from leaving the SCU and then being placed in locking restraints to both wrists and ankles, ANM 4 responded to the event and offered to get the lorazepam ordered to help return Pt 1 to "an acceptable level of behavior." RN 1 stated ANM 4 returned and handed the prepared syringe to her for administration. RN 1 stated ANM 4 verbalized that the syringe contained lorazepam. RN 1 stated she administered the medication through paper scrubs and into Pt 1's right leg. RN 1 stated she did not witness ANM 4 draw up the lorazepam from its original container but administered it because she felt the situation was emergent. EDM 1 stated it is a nursing professional standard that if you prepare the medication, you administer the medication.

During an interview on 6/12/25 at 9:53 a.m., with Chief Nursing Officer (CNO), CNO stated the medication administration policy indicated nursing staff could draw up medications in an "emergency" without labeling the syringe and hand it to another nurse to inject. Stated the policy was uploaded (provided) and the area had been highlighted.

During a review of the hospital P&P titled "Medications - Orders, Administration, Storage, Documentation" dated 12/19/23, the P&P indicated " ... I. PURPOSE: To provide guidelines for the safe and accurate .... administration ... of medications ... II. DEFINITIONS ... D. Five Rights of Medication Administration 1. The right drug 2. The right patient 3. The right dose 4. The right time 5. The right route...III. POLICY: ...B. Medication Administration ... 8. Medications shall be administered using Bar Code Medication Administration (BCMA) in all areas that BCMA is implemented. Exceptions to this process are emergencies, scanner equipment not available at time of administration, and system not working, and when using approved EHR Narrators (e.g., sedation narrator).17. It is the responsibility of the person administering the medication to verify the following ... a. Drug allergies, b. The right drug, c. The right patient, d. The right dose, e. The right time, f. The right route ... V. PROCEDURE: ... F. Before administering any medications, verify that no contraindications to the medication exist and check drug allergies ...G. ... verify the medication label matches the Medication Administration Record (MAR) or prescriber's order ... J. ... 3 ... a. ... I. Containers used to transfer medication and solutions from the original packaging include such things as syringes ... ii. An immediately administered medication is one that an authorized staff member prepares or obtains, and administers directly to the patient without any break in the process, such as laying the syringe or container down for later use ... EXCEPTION: A medication that has been transferred from the original container and is immediately administered does not have to be labeled. NOTE: Pre-labeled empty syringes or containers are not acceptable ... b. The new label on the transfer container or syringe contains the following information: i. Name of solution or medication ... ii. Strength and amount ... iii. Volume ... vi. Date prepared ... c. If the person preparing the medication or solution is not the person administering it, verify the information on the new label, both verbally and visually, between two individuals qualified to participate in the procedure. Verify information on the label against the original medication or solution container ... L. On patient care areas using the point of care BCMA scanning system to administer medications:... f. When the patient's condition necessitates quick actions and/or the scanning of medications/IVs would impede the ability of staff to deliver medications in an emergent situation, staff must complete the five rights of medication administration check before administration. The documentation of the administration of the medications/IVs is completed in the EHR when the patient is stabilized..."

According to the National Institutes of Health (NIH)'s National Library of Medicine, "Nursing Rights of Medication Administration" by Hanson A, Haddad LM. Nursing Rights of Medication Administration. [Updated 2023 Sep 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Electronically retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK560654/ on 11/13/24 the article indicated " ...Nurses have a unique role and responsibility in medication administration, in that they are frequently the final person to check to see that the medication is correctly prescribed and dispensed before administration ...

According to the Joint Commission's "National Patient Safety Goals® Effective January 2024 for the Hospital Program" dated 10/4/24, the article indicated "...Goal 3. Improve the safety of using medications. NPSG.03.04.01 Label all medications, medication containers, and other solutions on and off the sterile field in perioperative and other procedural settings. Note: Medication containers include syringes, medicine cups, and basins...Rationale for NPSG.03.04.01 Medications or other solutions in unlabeled containers are unidentifiable. Errors, sometimes tragic, have resulted from medications and other solutions removed from their original containers and placed into unlabeled containers. This unsafe practice neglects basic principles of safe medication management, yet it is routine in many organizations. The labeling of all medications, medication containers', and other solutions is a risk-reduction activity consistent with safe medication management. This practice addresses a recognized risk point in the administration of medications in perioperative and other procedural settings..."

According to the National Institutes of Health (NIH)'s National Library of Medicine, "Medication Routes of Administration" by Kim J, De Jesus O. Medication Routes of Administration. [Updated 2023 Aug 23]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Electronically retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK568677/on 11/14/24 the article indicated "Five (5) Rights of Medication Use (the "five rights" are emphasized for the preparation of medication administration: right patient, right drug, right dose, right site, and right timing. It is essential to explain to patients how the medication will be administered, obtain consent for procedures when indicated (e.g., central venous catheter), and help prepare patients before they receive their medication. The site of application of the drug should be chosen based on its adequacy and indications. The label on the medication should be checked for its name, dose, and approved usage route."

According to the National Institutes of Health (NIH)'s National Library of Medicine "Medication Administration Safety and Quality: An Evidence-Based Handbook for Nurses" Hughes RG, Blegen MA. Medication Administration Safety. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 37. Electronically retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK2656/ on 11/15/24 the article indicated "Medication errors occur in all settings5 and may or may not cause an adverse drug event (ADE). Medications with complex dosing regimens and those given in specialty areas (e.g., intensive care units, emergency departments, and diagnostic and interventional areas) are associated with increased risk of ADEs.6 Phillips and colleagues7 found that deaths (the most severe ADE) associated with medication errors involved central nervous system agents, antineoplastics, and cardiovascular drugs. Most of the common types of errors resulting in patient death involved the wrong dose (40.9 percent), the wrong drug (16 percent), and the wrong route of administration (9.5 percent). The causes of these deaths were categorized as oral and written miscommunication, name confusion (e.g., names that look or sound alike), similar or misleading container labeling, performance or knowledge deficits, and inappropriate packaging or device design."

Based on observation, interview, and record review, the hospital failed to demonstrate current and accurate records were kept for the receipt and disposition for all scheduled drugs, including patient's own medications (POM, personal belongings) categorized as controlled substances (drugs regulated by the government due to potential for abuse, misuse, or health risks) for one of one patient, Patient (Pt 71) in accordance with professional standards when staff stored Pt 71's POM and were not able to determine whether the POM contained controlled substances. The pharmacy did not have a system in place to accurately record receipt and disposition of POM stored in the pharmacy.

These failures had the potential for inadequate oversight for controlled substances accountability for 325 patients, preventable loss of patient's property, inadequate hospital measures to prevent drug diversion (illegal distribution of controlled substances not intended by the prescriber), and impaired (under the influence) staff providing patient care.

Findings:

During an interview on 6/3/25 at 11:28 a.m. with Director of Pharmacy (DOP), DOP stated the hospital followed ASHP (American Society of Health System - a professional organization) standards of practice for hospital pharmacy services.

During a concurrent observation and interview on 6/3/25 at 2:03 p.m. with the Pharmacy Manager/Pharmacist-in-Charge (PM/PIC), an inspection of the locked cabinet designated for POM without active medication orders to be dispensed in the hospital was conducted. Inside the cabinet was a red plastic bin labeled, "PATIENTS' OWN MEDICATIONS. CONTROLLED. TO BE DESTROYED." Two sealed plastic bags labeled "8952046" and "8952047" were observed stapled together inside the red bin. The bags were prelabeled with "Patient's Medicine Inventory" with spaces for staff to fill out which included the patient's name and inventory of what medications were placed in the bag. Outside of the bag labeled "8952046" was a pink sticker labeled "DISCHARGED DATE: 3/26/25 DESTRUCTION DATE: 4/26/25." Inside of the bags were Patient 71's medications along with papers and a pill box that contained various pills. PM/PIC stated staff visually inspected the medications placed in the bag to know if any of them were controlled substances. She stated that in this case it was difficult to know what was in the bag since it was not filled out appropriately and it was difficult to visually inspect with unlabeled pills in the pill box and papers stuffed in the bag. PM/PIC stated since they could not verify what was in the bag, they were treating the contents as though they were controlled substances.

During an interview on 6/6/25 at 10:15 a.m. with PM/PIC, PM/PIC stated to verify the contents of the bags containing Patient 71's medications, it would have had to be opened and inspected but they did not do that because it would have compromised the security seal. PM/PIC confirmed the bags came from the Emergency Department (ED) and stated they do not open the bag unless they receive authorization or give it back to nursing staff to take to the patient to open it. The PM/PIC stated the hospital has received controlled substances of POM in the past to store in the Pharmacy Department and the hospital has potential in the future to receive controlled substances of POM to store in the Pharmacy Department.

During a concurrent interview and record review on 6/6/25 at 1:33 p.m. with DOP, PM/PIC and Pharmacy Manager/Quality & Education (PM/QE), hospital policies on patient's home medications and controlled substances were reviewed. PM/QE stated the hospital's policy on POM would address storage of POM CS. Review of the policies titled, "Medication from Home," dated 3/14/25, and "Controlled Substance- Surveillance System," dated 6/27/24 did not contain policies or procedures regarding narcotic accountability for POM categorized as controlled substances.

During a review of "ASHP [American Society of Health System - a professional organization] Guidelines on Preventing Diversion of Controlled Substances," dated 2022, the section titled "Purpose" indicated, "Controlled Substances (CS) diversion in health systems can lead to serious patient safety issues, harm to the diverter, and significant liability risk to the organization. Diversion puts patients at risk of harm, directly or indirectly." The section titled "Patient's Own Medications, Medical Cannabis [plant], Marijuana [substance with mind-altering effects], and Illicit [not permitted] Substances," indicated "Healthcare organization should develop procedures for the disposition of patients CS ...brought into a facility." The section titled "CS Brought into the Hospital by Patients," indicated "Procedures are established that address special circumstances to ensure controls are in place to secure CS and prevent diversion of CS brought into the organization by patients. Patients should be encouraged to return their own medications to home via a household member or authorized agent when possible. Alternatively, patients or their authorized agent may be provided with an envelope to mail prescriptions to their home or directed to a collection receptacle for disposal ...CS should only be allowed when they are to be administered to the patient pursuant to a medication order, on behalf of the patient, and with their consent. These medications should be inventoried and stored in a secure location. When a patient is not able to maintain security of their own medications due to loss of competence or death, or when medications are abandoned, documentation of the patient's home medications, quantity [physical count] inventoried, and signature of two verifying HCWs [licensed health care workers] should be recorded in the medical record upon receipt of the medications, and arrangements made as soon as possible for appropriate disposition."

During a review of "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals," dated 2013, the section titled "Purpose" indicated, "The following minimum standard guidelines are intended to serve as a basic guide for the provision of pharmacy services in hospitals." The section titled "Controlled Substances" indicated, "There shall be policies and procedures to ensure control of the distribution and use of controlled substances and other medications with a potential for abuse. These policies and procedures shall be consistent with applicable laws and regulations and shall include methods for preventing and detecting diversion." The section titled "Patient's Own Medications" indicated, "Drug products and related devices brought into the hospital by patients shall be identified by the pharmacy and documented in the patient's medical record if the medications are to be used during hospitalization. They shall be administered only pursuant to a prescriber's order and according to hospital policies and procedures, which should ensure the pharmacist's identification and validation of medication integrity as well as the secure and appropriate storage and management of such medications."

During a review of the hospital's policy and procedure titled, "Medication from Home," dated 3/14/25, the P&P indicated, "IV. Procedure A Storage of a Patient's Home Medication ... 2. Emergency Department a. If no one is available to take the patient's medication home, the Licensed Nurse obtains a 'Patient's Medicine Inventory' bag from the unit supply shelf or from the Stockroom. b. Licensed Nurse completed the Inventory section on the bag by listing the patient's medication and places the medication in the bag. c. Licensed Nurse places the patient's label on the front of the bag in the section asking for the patient information and on the tear-off receipt at the top of the bag. d. Licensed Nurse seals the bag. e. Licensed Nurse to record patient's home medication in the EHR under Patient Stored Medications section ..."

During a review of the hospital's policy and procedure titled, "Patient Valuables and Personal Property," dated 5/3/23, the P&P indicated, " IV. PROCEDURE ...B. Medications from Home ... 2. If no one is available to take the medications home, the medications are listed on the patient's medicine inventory bag and placed in this plastic bag in the presence of the patient if possible, and sent to Pharmacy for storage."

During a review of the hospital's policy and procedure titled, "Controlled Substances - Surveillance System," dated 6/27/24, the P&P indicated, "Purpose. To ensure compliance with California and Federal laws pertaining to accountability of controlled substances ...Policy ... The Pharmacy Managers and/or PICs must have risk mitigation strategies employed to reduce the risk of controlled substance theft or significant loss."

During a review of the hospital's policy and procedure titled, "Controlled Substances - Storage," dated 12/6/24, the P&P indicated, "Purpose. To ensure that all Drug Enforcement Administration (DEA - federal law enforcement agency) defined controlled substances are managed in compliance with State and Federal laws pertaining to proper storage of controlled substances within the hospital ... Policy ... It is the responsibility of the Pharmacy Manager/designee to abide by the State and Federal Laws pertaining to proper storage of controlled substances."

Based on interview and record review, the hospital failed to provide patient safety for medication use for three of 72 sampled patients (Patient 6, Patient 9, and Patient 16) when:

1. Patient 16's vancomycin (an antibiotic to treat infection) trough (a blood level to measure the amount of antibiotic in the body) levels were not obtained in accordance with professional standards to guide dosing and monitor safety, despite Patient 16 receiving multiple doses of the antibiotic;

2. Multiple incomplete and unclear PRN (as needed) pain medication orders were not clarified for indication for use (e.g. mild, moderate, or severe pain) prior to administration (Patients 6 and 9); and

3. A pain assessment was not completed before an opioid pain medication (a class of medication identified as high-risk/high-alert medications - drugs that bear a heightened risk of causing significant patient harm when used in error) was administered to Patient 9.

These failures had the potential to result in inappropriate medication administration, preventable medication errors, unmonitored antibiotic use, suboptimal therapeutic outcomes, increased risk of adverse drug events including vancomycin-related toxicity (kidney and ear damage) and oversedation, and patient harm or death.

Findings:

1. A review of Patient 16's History & Physical (H&P, comprehensive patient assessment) indicated he presented to the ED on 6/2/25 with complaint of swelling, redness and pain in his lower right extremity. The Assessment and Plan indicated, "Sepsis (an infection in the blood) ... Start Zosyn (an antibiotic to treat infection) and vancomycin empirically ... Cellulitis (a skin infection) and abscess (a pus-filled pocket that forms in the body due to an infection) of lower extremity ... Start Zosyn and vancomycin empirically ..."

A review of Patient 16's medical record indicated a loading dose (an initial higher dose of a drug that may be given at the beginning of a course of treatment before dropping down to a lower maintenance dose) of vancomycin 2 grams/500 ml (g/ml, a unit of measurement) ordered on 6/2/25 and administered at 7:54 a.m. Following the loading dose, Patient 16 was ordered vancomycin 1.5 g/500 ml, administered 3 times per day, dated 6/2/25 and administered on the following dates and times: 6/2/25 at 5:02 p.m., 6/2/25 at 10:02 p.m., 6/3/25 at 4:29 a.m., 6/3/25 at 1:35 p.m., 6/4/25 at 12:26 a.m., and 6/4/25 at 8:26 a.m. This was a total of seven vancomycin doses over the span of three days.

A review of Patient 16's pharmacy progress notes titled, "Clinical Pharmacy- Vancomycin Consult Initiation," dated 6/2/25 at 8:42 a.m., the note indicated, "3. Pharmacy will order trough level as clinically appropriate ... 5. Pharmacy will continue to monitor patient and adjust vancomycin therapy as clinically indicated ..."

A review of Patient 16's Initial Dose Comment documented by the pharmacist for vancomycin, dated 6/3/25, the document indicated, " ...Vancomycin may take some time to accumulate. Will check trough tomorrow."

During an interview on 6/3/25 at 11:28 a.m., with Director of Pharmacy (DOP), DOP stated the hospital followed ASHP (American Society of Health-System Pharmacists - a professional pharmacy organization) standards of practice for hospital pharmacy services.

A review of Patient 16's Nursing Reminder task indicated an order dated 6/4/25 at 12:30 p.m. for the first vancomycin trough after the seventh administered dose (instead of around third or fourth vancomycin dose).

During a concurrent interview and record review on 6/11/25 at 3:07 p.m. with MSC 1, Patient 16's labs were reviewed. MSC 1 confirmed there were no vancomycin trough levels drawn for Patient 16.

During a concurrent interview and record review on 6/12/25 at 8:33 a.m. with DOP, Patient 16's labs were reviewed. DOP confirmed vancomycin trough levels had not been completed for Patient 16. DOP stated the order for trough levels to be drawn was on 6/4/25 but the medication had been discontinued before it was due. DOP stated the reason trough levels were not ordered to be drawn sooner was because Patient 16 was obese.

According to Micromedex (a comprehensive, evidence-based online database that provides drug, disease, and toxicology information for healthcare professionals), the half life of vancomycin in an adult with normal kidney function is four to six hours. This range indicates vancomycin trough levels should be completed between 12 and 30 hours after initiating therapy. Review of the section titled "Medication Safety" indicated, "Perform early and frequent therapeutic monitoring of AUC [area under the serum curve, method for monitoring vancomycin therapy] exposure in obese patients for dose adjustments; obtain peak and trough concentrations if possible."

A review of "Therapeutic Monitoring of Vancomycin in Adult Patients: A Consensus Review of the American Society of Health-System Pharmacists [ASHP], the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists," dated 2009, indicated, "Vancomycin has long been considered a nephrotoxic (toxic to the kidneys) and ototoxic (toxic to the ears) agent. Excessive serum (blood) drug concentrations have been implicated, and it was assumed that monitoring of serum concentrations would allow interventions that decrease toxicity... All patients receiving prolonged courses of vancomycin should have at least one steady-state trough concentration obtained (just before the fourth dose)."

During a review of the facility's procedure titled, "Adult Vancomycin and Aminoglycoside Dosing Guidelines," dated 11/23/21, the procedure indicated, "I. Purpose: To establish adult pharmacokinetic (PK) dosing guidelines for parenterally (through the vein) administered aminoglycosides and vancomycin to be used by [the hospital system's] clinical pharmacists ... III. Policy: These guidelines will be used to dose and monitor the use of aminoglycosides or vancomycin therapy by [the hospital system's] clinical pharmacists in patients 18 years of age or greater ... C. Vancomycin Dosing Guidelines ... 7. Monitoring ... b. Trough levels are obtained after the patient has reached steady-state if vancomycin therapy is expected to continue for greater than 3 days (a minimum of 3 to 5 half lives [the time it takes for the amount of a drug's active substance in your body to reduce by half] ... around the 3rd or 4th maintenance dose) ..."

2a. A review of Patient 9's History & Physical (H&P) indicated he was admitted to the emergency department (ED) on 6/1/25 with suspected diagnoses which included sepsis (a life-threatening condition that arises when the body's response to an infection spirals out of control, causing widespread inflammation and potentially damaging organs) and a history of chronic back pain.

A review of Patient 9's medical record indicated physician's orders for the following:
- Hydrocodone/APAP (an opioid pain medication) 10/325 milligrams (mg, a unit of measurement for dose): 1 tablet every 6 hours PRN for pain (for unspecified pain level, where is 0/10 is no pain and 10/10 is severe pain), scheduled start date 6/1/25 at 11:50 p.m. and "End Date/Time" on 6/3/25 at 1:24 p.m.
- Acetaminophen (medication to treat pain and fever) 650 mg: 1 tablet every 6 hours PRN for mild pain (for numeric score 1-3/10), fever, for temperature greater than 39 degrees Celsius, scheduled start date 6/1/25 at 10:41 p.m. and "End Date/Time" on 6/4/25 at 12:03 a.m.

During a concurrent interview and record review on 6/12/25 at 9:06 a.m. with Director of Pharmacy (DOP), Patient 9's orders for pain medication were reviewed. DOP stated there was a role for pharmacy to clarify overlapping orders indicated for pain, such as Resident 9's orders for Hydrocodone/APAP and acetaminophen, to clarify with the prescriber when each medication was indicated. DOP reviewed Patient 9's medical record and confirmed pharmacy did not seek clarification for the above-mentioned orders.

During a concurrent interview and record review on 6/12/25 at 9:35 a.m. with Nurse Manager 2 (NM 2), Patient 9's orders for pain medication were reviewed. NM 2 stated it was the expectation of nursing staff to obtain clarification if a patient had multiple as-needed pain medication orders.

2b. A review of Patient 6's H&P indicated she was admitted to the ED on 6/1/25 with suspected diagnoses which included cellulitis (an infection caused by bacteria spreading through a break in the skin) of the right leg and swelling of both legs.

A review of Patient 6's medical record indicated physician's orders for the following:
- Hydrocodone/APAP 5/325 mg: 1 tablet every 4 hours PRN for pain (for unspecified pain level), scheduled start date 6/1/25 at 2:47 p.m. and "End Date/Time" of 6/1/25 at 5:19 p.m.
- Hydrocodone/APAP 5/325 mg: 1 tablet every 6 hours PRN for pain (for unspecified pain level), modified time of 6/1/25 at 5:19 p.m., and "End Date/Time" of 6/5/25 at 9:30 p.m.
- Acetaminophen 650 mg: 1 tablet every 6 hours PRN for mild pain (for numeric score 1-3/10), fever, for temperature greater than 39 degrees Celsius, scheduled start date 6/1/25 at 5:19 p.m. and "End Date/Time" for 6/5/25 at 9:30 p.m.

During a concurrent interview and record review on 6/12/25 at 9:08 a.m. with DOP, Patient 6's orders for pain medication were reviewed. DOP confirmed it was expected for pharmacy to get clarification of duplicate orders and acknowledged that it was not done.

During a review of the hospital's policy and procedure (P&P) titled, "Medication Orders- Pharmacist Order Review Process," dated 12/3/24, the P&P indicated, "II. Policy: The Pharmacist will review all medication orders to assure that appropriate medication prescribing (dose, route, drug) is performed for the purposes of accuracy and patient safety ... If there are questions and/or concerns, the prescriber will be contacted to discuss these concerns ..."

During a review of the hospital's P&P titled, "Medications- Orders, Administration, Storage, Documentation," dated 12/19/23, the P&P indicated, "III. Policy A. Medication Orders ... 4. Any orders for medications that are illegible, incomplete, and/or unclear will require clarification ... b. If an illegible, incomplete, and/or unclear order is received in the Pharmacy, the Pharmacist will contact the ordering prescriber and will clarify using the telephone/verbal order process ... Pharmacy will communicate the changes to the patient's RN (registered nurse) ..."

During a review of the hospital's P&P titled, "Pain Assessment & Management- Patients 14 and Older," dated 1/15/25, the P&P indicated, "IV. Procedure ...B. Data Collection and Assessment ...6. Pain management scales utilizing the 0-10 descriptors, will be assessed as a pain rating of 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain. Patients denial of pain will be interpreted as 0 ... D. Implementation 1. Medications will be administered based on the patient's pain scale level identified and as ordered by the provider."

3. A review of Patient 9's H&P indicated he was admitted to the ED on 6/1/25 with suspected diagnoses which included severe sepsis and acute kidney failure.

A review of Patient 9's medical record indicated a physician's order for fentanyl (an opioid medication to treat severe pain) injection 25 micrograms (mcg, a unit of measurement), every hour PRN for moderate pain, severe pain, scheduled start date 6/3/25 at 1:10 p.m.

Fentanyl belongs to a class of drugs called opioids. IV opioids work in the brain to produce a variety of effects including pain relief. IV opioids are potent and potentially dangerous medications due to their potential to cause adverse events, such as over sedation, respiratory depression, and death in some cases.

During a concurrent interview and record review on 6/11/25 at 1 p.m. with NM2, Patient 9's Pain Monitoring dated 6/3/25 and Medication Administration Record (MAR) for fentanyl were reviewed. NM 2 confirmed Patient 9's MAR indicated he was administered fentanyl 25 mcg on 6/4/25 at 3:51 a.m. NM 2 reviewed the Pain Monitoring on 6/4/25 and confirmed she did not see a pain assessment completed prior to the administration. She stated she did not see any documentation between 2:21 a.m. and 4:21 p.m. regarding pain. NM 2 stated it was expected for nursing staff to do an assessment using a scale prior to pain medication administration, then look at the medications in a patient's chart to see which one would be deemed appropriate for the pain.

American Society of Health-System Pharmacists (ASHP), the largest professional association of pharmacists in the United States, has identified minimum standard guidelines intended to serve as a basic guide for the provision of pharmacy services in hospitals. The "ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals," dated 4/13/12, indicated, "Medication therapy monitoring includes a proactive assessment of patient problems and an assessment of the following: a. The therapeutic appropriateness of the patient's medication regimen ... c. The appropriateness of the dose of the medication, as well as the route, method, and frequency of administration of the medication ... e. Medication-medication, medication-food, medication-dietary supplement, medication-laboratory test, and medication-disease interactions. f. Adverse drug reactions and other undesired effects ... h. Clinical and pharmacokinetic laboratory data to evaluate the efficacy and safety of medication therapy and to anticipate toxicity and adverse effects."

During a review of the hospital's P&P titled, "Pain Assessment & Management- Patients 14 and Older," dated 1/15/25, the P&P indicated, "IV. Procedure ... E. Monitor- Assessment/Reassessment of Pain Management and Adverse Effects 1. Assessment for pain so to be completed using the appropriate pain assessment tools during routine unit assessment times, prior to pain medication administration and as needed."

Based on staff interviews and review of hospital documents, the hospital failed to ensure food and nutrition services were organized effectively when the structure of the hospital policy and procedure regarding nutrition screening and assessment was not following current standards of practice according to the Academy of Nutrition and Dietetics.

This failure has the potential to result in the delay of nutritional care and interventions for patients, which can worsen patient health outcomes. (Cross Reference A-0398)

Findings:

During the course of the full validation survey from 6/3/25 until 6/5/25, nine clinical records were reviewed for clinical nutrition care. Two clinical records (Patient 46 and 21) had inaccurate nursing admission nutrition risk assessments. Patient 46 was not appropriately assessed for nutrition risk and there was no referral to the Registered Dietitian when Patient 46's admission history and physical (H&P) were performed by the physician, dated 5/31/25, indicated that Patient 46's chief complaint was failure to thrive (a decline caused by chronic diseases and functional impairments which can cause weight loss, decreased appetite, poor nutrition, and inactivity). The physician's "H&P" also indicated Patient 46 had no appetite and had lost weight 1 week prior to the hospital admission. After the H&P was completed, the nurse did the Malnutrition Screening Tool (MST) to determine the patient's nutrition risk by asking two questions: "have you lost weight recently without trying? No, have you been eating poorly because of a decreased appetite? No." Within two hours of admission the nurse did a comprehensive nursing assessment and determined Patient 46 had nausea. Despite this Patient 46 received a score of 0 on the MST tool and a nutrition consult was not triggered.

During a review of Patient 21's history and physical completed by the physician, dated 5/25/25, indicated the patient was admitted to the hospital with a chief complaint of altered mental status (change in a person's cognitive function, including alertness, attention, orientation, and memory) and failure to thrive per staff at the skilled nursing facility with decreased appetite and intake for two to three days. The nursing nutrition screen for the MST was scored as a 0 and answered No to the questions "have you lost weight recently without trying? And have you been eating poorly because of a decreased appetite?" (Cross Reference A-0398)

During an interview with the Registered Dietitian (RD 1) on 6/04/2025 at 11:42 a.m. with a concurrent clinical nutrition chart review, RD 1 explained the process for seeing inpatients. RD 1 indicated patients are seen within 24 hours from a MD consult, within 36 hours of a nutrition support consult and within 48 hours from a nursing or education consult. The RD also indicated patients who are on clear liquids (CL) would be seen within 3 days and patients who are nothing by mouth (NPO). The remaining patients would be seen within 5 days of admission. RD 1 confirmed nursing does the nutrition admission screen within 24 hours. RD 1 stated an MST score of 2 or greater for poor nutrition, weight loss, wounds, enteral (EN) or parenteral nutrition (PN) (feeding by tube through the gut or vein), or burns.

During a review of the hospital policy and procedures titled, "Nutritional Care and Documentation in the EHR", dated 2/10/25, indicated Nursing is responsible for the initial screening during the admission process and all patients will be screened for nutrition risk within 24 hours of admission. The following indicators would generate a referral to the Registered Dietitian (RD). For Adult patients, a malnutrition score of greater than or equal to two on the Malnutrition Screening Tool, nutrition support (enteral or parental nutrition - feeding by the gut or vein), pressure injury stage II or greater or a major burn greater than 20% total body surface area. The policy indicated "The RD will perform a nutrition assessment for all patients a. within 24 hours of receiving an Inpatient Consult for all reasons except education. b. within 36 hours of initial nutrition support orders (unless patient's nutrition support needs were already assessed and documented by RD). c. within 48 hours of receiving a Nursing Referral generated from the Nutrition Screening conducted on admission .... 3. Within 24 hours of consult for Calorie Count, the RD will initiate the Calorie Count ... 4. Within 48 hours of consult or referral for education, the RD will provide nutrition education within the parameters of the diet order or as specified within the Consult. 5. Unless previously consulted, the RD will perform a nutrition assessment for all adult patients ... b. within 5 days of admission at CCMC excluding perinatal patients. These patients are assessed within 7 days of admission .... 7. Unless previously consulted, the RD will perform a nutrition assessment for all patients a. with a diet order of NPO for 3 days. b. with diet orders of NPO and Clear Liquid for 5 days. c. with a diet order of Clear Liquid for 5 days."

During an interview with the Clinical Nutrition Manager (CNM) on 6/5/25 starting at 1:50 p.m., the CNM was asked to describe how they identify high risk nutrition patients, after admission, who have specialized diets s such as renal (kidnet health) diet or consistent carbohydrate diet orders. CNM stated the RDs use clinical judgement for malnutrition. The CNM also stated the RDs review the hospital census each morning and review diets such as NPO/CL and patients receiving EN/PN. The RD summarized a system, that unless a consult was ordered, all patients with therapeutic diets would be assessed within 5 days. The remaining patients would be assessed on the sixth day of admission. The CNM stated their policy, and procedure is based on the Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM). The CNM stated the RDs also get a list of patients on anticoagulant medications so they can educate them for food-drug interactions. CNM reviewed the AND NCM in conjunction with surveyors and acknowledged that the policy does not capture all the items listed in the AND NCM.

During a review of the Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2025, the NCM indicated to have Screening for nutrition problems other than malnutrition that included obesity, patients with history of heart failure, presence of edema on admission, and need for sodium-restricted diet. It also indicated, "In adults undergoing dialysis, assessments are best obtained after treatment when body fluid compartment levels are more likely to be balanced." The NCM referenced "KDOQI Clinical Practice Guideline for Nutrition in CKD (CPG)", dated 2020, the CPG indicated, ". . .percent change in usual body weight (dry weight in maintenance dialysis patients) may be a more reliable measure."

Additionally the NCM indicated "the Academy of Nutrition and Dietetics Evidence Analysis Library (EAL) Type 1 and Type 2 Diabetes Evidence-Based Nutrition Practice Guidelines for Adults make the following recommendations regarding carbohydrate intake (Academy EAL, 2008) In persons on medical nutrition therapy alone, glucose-lowering medications, or fixed insulin doses, meal and snack carbohydrate intake should be kept consistent on a day-to-day basis ..... The amount of carbohydrate is determined by the RDN (Registered Dietitian Nutritionist) in consultation with the individual with diabetes." It indicated the following amounts are often used as a starting point, for women it is three to four carbohydrate servings per meal and one if desired for a snack and for men it is four to five per meal and one if desired for snack. It further indicated the amounts can then be adjusted based on the individual's determination of what is reasonable for him or her to follow long-term and on blood glucose monitoring results. The hospital policy and procedure did not reflect the current standard of practice.

During a review of the hospital "Diet Manual", dated revised 11/24, indicated the hospital had diets called diabetic diet and consistent carbohydrate diet. Both diets indicated they provided a consistent amount of carbohydrates during mealtimes and up to four (4) carbohydrates are provided at each meal and that an evening snack consisting of one (1) carbohydrate and 1 protein exchange would be provided upon physician's order. It is unclear whether patients with Diabetes Mellitus (DM - a disorder characterized by difficulty in blood sugar control and poor wound healing) would get the appropriate amount of carbohydrate, based on their individualized nutritional needs, if the RD does not assess the patient in a timely manner while hospitalized.

Based on staff interviews, review of clinical records and hospital documents, the hospital failed to ensure therapeutic diet orders were followed when the hospitals diet manual and the department's policy and procedure for nutrition supplementation did not provide clear parameters when the Registered Dietitian initiated nutrition supplements.

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

Findings:

During a review of clinical record for Patient 21 in the presence of the Registered Dietitian (RD 1) and Clinical Nutrition Manager (CNM), Patient 21 was admitted to the hospital with a chief complaint of altered mental status (change in a person's cognitive function, including alertness, attention, orientation, and memory) and failure to thrive (a decline caused by chronic diseases and functional impairments which can cause weight loss, decreased appetite, poor nutrition, and inactivity) per staff at the skilled nursing facility with decreased appetite and intake for two to three days. Review of physician orders dated 5/26/25, indicated a ground/minced diabetic diet. Review of diet orders, written by a Registered Dietitian, dated 5/29/25 at 10:51 a.m., initiated a nutrition supplement (Ensure Max protein) two times a day.

During a concurrent interview with the clinical record review of Patient 21 with RD 1 on 6/4/25 at 12:10 p.m., RD 1 stated the hospital has a system for every diet order there is a mechanism for the physician to check a box as a "yes" to allow the RD to provide oral nutrition supplements. RD 1 acknowledged for Patient 21 that was not checked or marked as a "yes" in the current diet order. During an interview with RD 1 on 6/4/25 at 3:01 p.m., RD 1 stated if the diet order did not give the RD the ability initiate a nutrition supplement, then the RD needed to call the physician and get a telephone order.

During a review of the diet order entry system in the electronic medical record, indicated "RD may individualize the dietary treatment plan within the parameters of the prescribed diet order as outlined in the diet manual? (Examples: may provide snacks, accommodate preferences, adjust portion sizes and provide oral nutrition supplements)."

During a review of the hospital policy and procedure titled "Enteral Nutrition, Oral Nutrition Supplements, and Parenteral Nutrition" dated 1/5/23, indicated " ...A. . B. A physician order is required for the provision of any food/beverage support for therapeutic diets, ONS, EN support and PN support. Orders are placed in the Electronic Health Record (EHR) .....D. A RD may individualize the patient's nutritional or dietary treatment, when necessary, by modifying the distribution, type, or quantity of food and nutrients within the parameters of the diet order unless otherwise stated in the diet order by a patient's provider. This includes the planning and provision of ONS and specified EN formulas which may be added, changed, or discontinued. Refer to the respective facility diet manual for approved nutritional interventions based on the prescribed diet."

During a review of the hospital's Diet Manual and Enteral Nutrition Formulary 2025, dated revised November 2024, noted the section titled "approved nutritional interventions" was consistent with the hospital's enteral, parenteral and oral nutritional supplement policy. that "all diet orders include the option of an Oral Nutrition Supplement (ONS). The diet manual also included a crosswalk that showed the different diets and what oral nutrition supplements were allowed. However, this portion of the diet manual die not include under what circumstances or parameters oral nutrition supplements could be added by the RD.

During an interview with the CNM on 6/5/25 at 1:50 p.m., CNM acknowledged the policy and diet manual did not specify under which circumstances an ONS would be initiated and additionally lacked specific parameters such as frequency, duration and monitoring for effectiveness of the intervention.

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. In two of two sampled rooms (The Inpatient and Outpatient Sterile Processing Decontamination [SPD] rooms), SPD staff did not clean and maintain the floors and six of six washer conveyors (a sterile processing room conveyor system is a specialized material handling solution designed for healthcare environments like hospitals and surgical centers. Its main purpose is to automate the transportation of medical instruments and supplies throughout the sterile processing workflow, from decontamination to sterilization and storage.) in accordance with manufacturer's instructions. A white substance was found on the floor in the Inpatient Decontamination room. In six of six conveyor systems, white residue and black debris was observed.

2. Staff failed to ensure a biohazardous waste container (a special container to dispose of items that might have germs, blood, needles, glass, medication, and sharp objects) was closed in an ultrasound (a test using soundwaves to make pictures of the body) treatment room (Ultrasound Room 2) that was not in use, and in accordance with the hospital's policy and national guidelines.

3. Staff failed to ensure the hospitals policy for transporting contaminated (dirty or with germs that could make people sick) instruments was followed and there were no biohazardous labels or containers for contaminated vaginal ultrasound probe transportation.

4. Soiled adhesive from tape was left on the walls in in two of two sampled obstetric (OB - a branch of medicine that deals with pregnancy, childbirth) operating area rooms (C-Section 2 and Clean Supply Room) and should have been removed and cleaned in accordance with infection control standards.

5. Staff did not document the monitoring for cooling of potentially hazardous foods that were located in the hospital walk-in refrigerator in accordance with hospital policies and procedures and standards of practice.

6. Food items stored in a reach-in refrigerator in the hospital kitchen were greater than 41 degrees Fahrenheit (F) and not in accordance with standards of practice.

7. Areas of the kitchen and adjacent areas were not maintained in a sanitary manner in accordance with standards of practice. The cooks' tool cabinet was disorganized and had food crumbs., The catering/doctors' lounge cooking line had a build up of black grime and the cafeteria cooking line had a build-up of food on the floor under the equipment and under the counter refrigerators had food crumbs on the shelves.

8. In the NICU (neonatal intensive care unit), bottles were being washed in a handwashing sink and a sanitizer that is not food safe was being used to sanitize the bottle preparation counter and staff did not follow standards of practice for these items.

9. The hospital failed to ensure a single-use only syringe used to administer medications was discarded after use in accordance with hospital policy and procedure.
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:

During an interview on 6/11/25 at 9:50 a.m., in the Imaging Department, with the Infection Prevention Director (IPD), the IPD stated the hospital followed nationally recognized guidelines:
a. APIC - Association for Professionals in Infection Control

b. AORN - Association of Perioperative Registered Nurses

c. AAMI - Association for the Advancement of Medical Instrumentation

d. ASHRAE - American Society of Heating, Refrigerating, and Air-Conditioning Engineers

e. CDC - Center for Disease Control and Prevention

f. OSHA - Occupational Safety and Health Administration

1. During a concurrent observation and interview, on 6/5/25, at 10:50 a.m., with the Sterile Processing Department (SPD) Manager (SPM), Director of Surgical Services (SSD), Surgical Services Nurse Educator (NE 1), SPD Supervisor (SPS), and Infection Preventionist (IP 1), on the first floor, in the Inpatient Sterile Processing decontamination room, between the cart washer and the conveyor system, the floor was observed with four inches of white substance or residue in the corner next to the floor sink. SPM stated, it appears to be salts left from hard water and the machine the cleaning staff use for the floor missed the corner. SPM stated, the staff should have manually cleaned the corner and made sure the floors were clean. SPM stated, it is expected the floors are terminally cleaned (thorough disinfection and cleaning) every day.

During a concurrent observation and interview, on 6/5/25, at 10:55 a.m., with the SPM, SSD, NE 1, SPS and IP 1, on the first floor, in the Inpatient Sterile Processing decontamination room, the conveyor system was observed with white spots and white residue before four of four entrances to the washer/disinfectors. SPM stated, the white spots are water deposits and appear after the staff clean the conveyor system. SPM stated, a separate vendor has been used to clean the conveyors. SPM stated, the conveyor should be cleaned without any visible spots or debris.

During a concurrent observation and interview, on 6/5/25, at 11:20 a.m., with the SPM, SSD, NE 1, IP 1 and Infection Preventionist Director (IPD), on the first floor, in the Outpatient Sterile Processing decontamination room, the conveyor system was observed with white spots and black residue before two of two entrances to the washer/disinfectors. The washers/disinfectors had not been used for the day. SPM stated, the conveyor should be cleaned daily so that no white spots or debris is in the conveyor system.

During an interview, on 6/11/25, at 9:15 a.m., with the IP 1 and Infection Preventionist Director (IPD), IP 1 stated, the SPS decontamination rooms should be cleaned daily and there should be no water spots or debris on the floor. IP 1 stated, there should be no water spots on the equipment or conveyor system for any of the washers in SPS. IPD stated, he agrees with IP 1 and SPS should ensure that the equipment and floors are clean.

During an interview, on 6/11/25, at 9:15 a.m., with the Chief Nursing Officer (CNO), the CNO stated, she expected the SPS decontamination rooms should be cleaned daily and her team would be looking into cleaning the equipment more often if needed. CNO stated, the SPS staff should follow the policies about cleaning and ensure the hard water spots are cleaned on the floor and equipment.

During a review of the conveyor system manufacturers operator manual titled, "[BRAND NAME] Conveyor System", dated 8/7/23, the manual indicated, " ... 5.3 Routine Maintenance ... Maintenance procedures described in this section must be performed as required at the suggested frequency. The indicated frequencies are minimums and can be changed if use warrants ... Clean conveyor drip pan ... 1x [once]/day ... Clean motorized and/or non-motorized rollers ... 1x [once]/day ... Clean plastic side and corner guides ... 1x[once]/day ..."

During a review of the facility policy and Procedure (P&P) titled, "Environmental Cleaning and Disinfection Policy", dated 10/31/23, the record indicated, " ... To reduce the risk of healthcare-associated infections (HAIs) by defining the general requirements for cleaning and disinfection performed by the environmental services department. ... Tasks sheets have been developed that detail the cleaning and disinfection requirements for designated areas. Tasks sheets also include general reminders about cleaning and disinfection, as wells as, a room checklist ... Department leadership will perform regular service quality checks ... "

According to the Centers for Disease Control (CDC), undated, retrieved 8/2/24 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html, " Microorganisms have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface.)"

During a review of the document titled, "CDC's Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings" retrieved from, 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 .. Reprocessing of reusable medical equipment between each patient or when soiled..."

2. During a concurrent observation and interview on 6/11/25 at 9:50 a.m., in Ultrasound Department Room 2 with the Manager of Imaging Department (MID), the Ultrasound Sonographer (US - person trained to use a machine to take pictures of the body using sound waves) 1, and the IPD, a red biohazardous sharps container was observed open while the room was not in use. The US validated the open container and stated the lid should be closed. The MID stated the container should be closed so others were not poked accidentally when handling the container, and it was a hospital policy that the container lid be closed when the room was not in use. The IPD stated an open biohazardous sharps container was an "infection control concern" and a potential for cross contamination (unintentional transfer of harmful germs from one person, object, or surface to another).

During an interview on 6/12/25 at 9:30 a.m., with the Chief Nursing Officer (CNO), the CNO stated it was her expectation that staff follow all corporate policies.

During a review of the hospital's policy and procedure (P&P) titled, "Medical Waste Management", dated 4/27/27, the P&P indicated "I. PURPOSE A. To prevent the contamination of patients, staff, equipment, and environment with medical waste ...V. PROCEDURE A. Waste Segregation ...3. Deposit Sharps into leak resistant, puncture resistant, rigid container which are taped or have tight lids ..."

During a review of the hospital's P&P titled, "Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated "III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ...".

A review of OSHA's regulatory requirement indicated the following, "...29 CFR 1910.1030(d)(4)(iii)(B)(1)(i), dated 08/09/2007 (August 9, 2007), requires
that...Regulated waste shall be placed in containers which are...Closable...".

3. During a concurrent observation and interview on 6/11/25 at 10:01 a.m., in Ultrasound Department Room 2, with the Director of Imaging (DID), MID, US 1, and the IPD, the US described how she transported a contaminated vaginal ultrasound probe from outside of the department for high level disinfection (the process used for the destruction of all germs except for low levels of bacterial spores). US 1 stated she transported a contaminated ultrasound probe by hand with plastic bag over the probe head, and the connection cord was uncovered. US 1 stated contaminated probes were not transported in a closed container with a biohazardous label. US 1 stated there were no designated containers for transporting contaminated ultrasound probes. The DID and MID validated the department did not have instrument containers and biohazardous labels for transport of contaminated instruments. The DID, MID, and US 1 were not aware of the hospital's instrument transport policy for contaminated instruments. The IPD stated "ultrasound probes should be in a well-marked container for transport" so anyone in the hospital was aware there was a "potentially biohazardous instrument being transported".

During an interview on 6/12/25 at 9:30 a.m., with the CNO, the CNO stated it was her expectation that staff follow all corporate policies.

During an interview on 6/12/25 at 10:50 a.m., with the IPD, the IPD stated there was a corporate policy for instrument transport and acknowledged the policy for instrument transport was not followed. The IPD stated contaminated instruments must be transported in a closed container and "clearly marked" as biohazardous to keep people safe.

During a review of the hospital's P&P titled, "Instrument Transport" dated 9/22, the P&P indicated "I. PURPOSE: To provide guidelines for cleaning, transporting instruments and medical devices to Sterile Processing other designated location for sterilization or disinfection to maintain infection prevention principles, safety, and facilitate optimal patient outcomes ...III. Policy ...C. Contaminated instruments must be contained during transport ...IV. Procedure H. Transport instruments to decontamination(to remove dangerous germs from objects so they are safe to handle or reuse) area ...in enclosed box that is: 1. Puncture resistant; ...a. Labeled with an indicator that indicates the contents are

During a review of the hospital's P&P titled, "Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated "III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens 3. Limiting the transmission of infections associated with procedures 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ..."

During the review of ANSI/AAMI ST79::2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, the guidelines indicated the following standard for hand transport of contaminated equipment "6 Handling, collection, and transport of contaminated items ...Procedures must be developed, with support from the infection prevention and control and hazardous materials personnel, to protect personnel, patients, and the environment from contamination and to comply with OSHA regulations ...6.5.4 Prior to transportation, items contaminated with blood and other potentially infectious materials should be placed in a container that is puncture=resistant, leak-proof on the bottoms and sides, labeled as biohazardous, and sealed. ..."

4. During a concurrent observation and interview on 6/11/25 at 10:18 a.m., in the OB operating room (OR) area with the Nurse Manager of OB (NM 5), and the IPD, in C-Section 2 room, and the clean supply room between C-Section 2 and C-Section 3, there was sticky brown and black residue on the walls. NM 5 stated the sticky substance on the walls was tape residue. NM 5 stated the nurses continue to use tape even after they have been trained not to. NM 5 stated tape residue created an infection control issue. The IPD stated sticky residue is harder to clean and tape residue can harbor infections in the OR. The IPD stated "tape is an IP no no".

During an interview on 6/11/25 at 10:32 a.m., with an environmental service staff member (EVSS)1, EVSS 1 stated she cleaned the C-section OR's and supply area. EVSS 1 stated she received special training to work in the OR she was trained specifically to remove tape residue by using a special tool to scratch tape residue off and use adhesive remover. EVSS 1 was not aware there was tape residue in C-Section 2 and the clean supply room.

During an interview on 6/12/25 at 9:30 a.m., with the CNO, the CNO stated it was her expectation that staff follow all corporate policies and sticker residue should have been removed.

During a concurrent interview and document review on 6/12/25 at 10:25 a.m., with the IPD, the IDP shared a flyer titled "Did You Know", dated June 2025. The document stated "Recent surveys and departmental audits have identified the need for increased attention to peeling or deteriorating stickers and labels across our facilities. Sticky residue from labels and tape can interfere with the effective cleaning and sterilization. These items must be fully removed, including all adhesive residue." The IPD stated sticky tape residue was an infection control issue because sticky residue was "harder to clean and harbors infection". The IPD stated the surface beneath the sticky residue cannot be effectively cleaned.

During a review of the hospital's P&P titled, "Procedural Area Terminal Cleaning", dated 01/2024, the P&P indicated " ...V. PROCEDURE ...D. Examine walls for visible soil and disinfect as needed ..."

During a review of the hospital's P&P titled, "Infection Prevention Plan - [Name of Hospital System], dated 2/27/27, the P&P indicated "III GOAL A. The goal of [Name of Hospital System] Infection Prevention Program is to minimize the risk of acquiring and transmitting healthcare associated infections (HAI)/infectious diseases to patients, employees, medical staff, residents, volunteers, contractors, students, and visitors. The overall goals of [Name of Hospital System] Infection Prevention program include ...2. Limited unprotected exposures to pathogens. 3. Limiting the transmission of infections associated with procedures. 4. Limiting the transmission of infections associated with the use of medical equipment, devices, and supplies. 5. Improving compliance with hand hygiene guidelines ...VIII. Responsibility A. Final responsibility for quality patient care resides with the Board of Trustees. Responsibility for infection prevention is delegated through the Medical Staff Office to the Infection Prevention Committee. The Infection Preventionist operate under direction of the Infection Prevention Committee and the Quality Management Department ..."

A review of AORN "Guidelines for Environmental Cleaning", dated January 2020 indicated " ...terminal cleaning and disinfection of operating or procedure rooms be performed daily when these areas are in use. This process involves thorough cleaning of all surfaces and equipment to reduce the risk of infection ..."

A review of OSHA requirements for bloodborne pathogens dated 8/9/2007, indicated the following: "... 29 CFR 1910.1030(d)(4)(ii): All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials.

29 CFR 1910.1030(d)(4)(ii)(A): Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning".

5. Potentially hazardous foods (PHF) are those foods capable of supporting bacterial growth associated with foodborne illness. PHF includes foods like milk, meat, poultry, fish, eggs, and certain cooked foods like rice and pasta and require time and temperature control for food safety (Food and Drug Administration, FDA, Food Code, 2022).

During the initial tour of the hospital kitchen on 6/3/25 starting at 10:59 a.m., in the hospital kitchen one of the walk-in refrigerators, there were multiple previously cooked foods that were located inside. There was a container of white-bean soup dated 6/1/25 and a hotel pan of white rice dated 6/1/25 use by 6/5/25.

During an interview with the Executive Chef (EC) on 6/04/2025 at 10:41 a.m., EC stated the expectation is for foods that are cooled to go in the blast chiller and document on the cooling log. EC stated he was currently looking for cooling logs for 6/1 to see where the white bean soup and white rice were documented.

During an interview with the Director of Food Services (DFS) on 6/05/2025 at 1:35 p.m., DFS stated they don't have the cooling log for the white rice and the white bean soup. DFS stated it either got misplaced or not done. DFS stated she expects all items that are cooled to be on the cooling logs.

During a review of the hospital policy and procedure titled "Food Cooling", dated 12/8/24, indicated cooked PHF shall be cooled from 140 to 70 degrees F within 2 hours and to 41 degrees F within a total of six hours. It indicated under food cooling documentation, the cook will document the date, name of food item, temperature of food item and the time the cooling process started on the food cooling log. It indicated at 2 hours the cook will record the temperature of the food item on the food cooling log, at or before 6 hours, the cook will record the temperature of the food item on the food cooling log. It indicated once the cooling process is complete, the cook will cover, label and date the item and store appropriately.

6. During the initial tour of the hospital kitchen on 6/3/25 at 11:20 a.m.., in the hospital kitchen, an under-counter reach-in refrigerator located across from the cook line, there were multiple food items. There was previously cooked pasta that was dated 6/3/25 that was 43.2 degrees F, tuna salad dated 5/31/25 that was 42.4 degrees F. In the other under counter reach-in refrigerator located across from the cook line, there was a container of previously cooked pasta dated 6/3/25 that was 44.4 degrees F, ham dated 5/30 that was 42.6 degrees F, previously cooked beef dated 6/3 was 46.2 degrees, another container of previously cooked pasta dated 6/3 was 42.6 degrees F. During a concurrent interview with the EC on 6/3/25 at 11:30 a.m., EC took temperatures of the food items and acknowledged the temperatures were too high and stated that the reach-in refrigerators needed to be lowered.

During a review of the hospital policy and procedures titled "Storage", dated 11/13/24, indicated under refrigerated storage the prevailing air temperature of refrigeration units containing potentially hazardous foods must be cold enough to maintain them temperature of food stored therein at 41 degrees F or below.

7. During an observation and concurrent interview with the Food Service Director (FSD) on June 3, 2025, at 10:50 am, the chef's tool cabinet, was disorganized and the drawers had food crumbs. A thermometer probe was sticky. Inside one of the cabinets there was a unknown black powder spill on the equipment inside, and on the shelf and on the door. The FSD stated the cabinet should be maintained clean and organized.

During an observation in the kitchen on June 3, 2025, at 11:18 am, the catering and doctors' lounge cooking line that included a flat top grill, a grill, larger flat top grill and a fryer, there was black grime build-up on the equipment, the storage drawers under the equipment had food crumbs and grease build-up.

During an observation in the dish room and concurrent interview with Executive Chef (EC) on June 3, 2025 at 2:07 pm, staff are washing dishes using the high temperature dish machine (dishwashers that reach extremely high temperatures during their rinse cycles in order to sanitize dishes). EC put a temperature measuring disc into the machine at the rack level to determine the highest temperature reached. The temperature measuring device read 145 degrees Fahrenheit. EC stated the temperature should be 160 degrees Fahrenheit. EC put another temperature measuring device in the machine to get a second reading. This time the temperature was 141 degrees Fahrenheit.

During an observation in the cafeteria kitchen on June 3, 2025, at 2:43 pm, the under the counter refrigerators had food and crumbs inside on the shelves. The floor under the equipment had a build-up of food and trash.

During an interview with the Food Service Director (FSD), on June 5, 2025, at 1:35 pm, FSD stated there were some items that were not on the cleaning logs or that needed to be updated with more detail. FSD stated her expectation is that the catering and doctors lounge cooking line and the cafeteria cooking line should be maintained clean. She stated the cleaning log for the cook's tool cabinet also needs to be updated to be cleaned more frequently. The FSD stated in regard to the dish machine, the temperature at the rack level should be 160 degrees.

During a review of the nutrition and dining services facility policy titled, "Infection Prevention", dated 04/16/2025, indicated "Cleaning: The objective is to maintain the greatest degree of sanitation possible in all food areas and to prevent growth of bacteria in all areas. These duties are divided among Nutrition and Dining employees and outsourced as necessary."

During a review of the nutrition and dining services facility policy titled, "Infection Prevention", dated 04/16/2025, indicated, "Dishwashing: 3. High temperature dish machine sanitizing occurs by use of the matrix of time and temperature. Dish machine temperatures maintained are: a. Wash: 150-165°F, b. Final Rinse: 180°F or above, c. Rack Level: 160°F or above."

8. During an observation in the NICU (neonatal intensive care unit) (specialized area within a hospital that provides advanced care for newborns who need intensive medical attention) and concurrent record review on June 4, 2025, at 1:56 pm, Registered Nurse (RN 14) cleaned the counter top where she was going to prepare a baby bottle with [Company Name] germicidal disposable wipes (disinfecting wipes that use Quaternary ammonium (type of chemical that is used to kill bacteria, viruses, and mold) and isopropyl alcohol (is a clear, colorless, bitter liquid commonly found in "rubbing alcohol, Intoxication may occur through ingestion or inhalation of vapors, especially in infants) to kill microorganisms (germs). The label on the wipes indicated "this product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contact intact mucous membranes (such as the nose, mouth, lungs, and stomach) but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.)

During an interview with the Clinical Nutrition Manager (CNM) on June 5, 2025, at 11:41am, CNM stated the germicidal disposable wipes do not indicate that they are food safe.

During an interview with the Infection Preventionist Director (IPD), on June 5, 2025, at 3:20 pm, IPD stated the instructions for use did not indicate that the product is food safe or not.

During a review of the standard of practice by the Academy of Nutrition and Dietetics, titled "Infant and Pediatric Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities", Third Edition, dated 2019, indicated, "All work surfaces must be cleaned with an antimicrobial sanitizing solution that is appropriate for food contact surfaces."

During an observation in the NICU on June 4th, 2025, at 11:33 am, Registered Nurse 14 fed the baby a bottle of breast milk. After completing the feeding she took the bottle to the sink in a room next door and washed the bottle in the sink with [brand name] dish soup.

During an interview with the Nurse Manager 6 (NM6) of the NICU, on June 4, 2025, at 2:15pm, the sink in the room where Registered Nurse 14 washed the bottle was in the isolation supply room and the sink was for nursing staff handwashing.

During an interview with the Clinical Nutrition Manager (CNM), on June 5, 2025, at 11:41am, CNM stated there should be a separate sink for bottle washing. They should not be washing bottles in a handwashing sink.

During a review of the FDA Federal Food Code, dated 2022, 2-301.15 indicated, "food employees shall clean their hands in a handwashing sink or approved automatic handwashing facility and may not clean their hands in a sink used for food preparation or warewashing, or in a service sink or a curbed cleaning facility used for the disposal of mop water and similar liquid waste." In addition, "Effective handwashing is essential for minimizing the likelihood of the hands becoming a vehicle of cross contamination. It is important that handwashing be done only at a properly equipped handwashing facility in order to help ensure that food employees effectively clean their hands. Handwashing sinks are to be conveniently located, always accessible for handwashing, maintained so they provide proper water temperatures and pressure, and equipped with suitable hand cleansers, nail brushes, and disposable towels and waste containers, or hand dryers. It is inappropriate to wash hands in a food preparation sink since this may result in avoidable contamination of the sink and the food prepared therein. Service sinks may not be used for food employee handwashing since this practice may introduce additional hand contaminants because these sinks may be used for the disposal of mop water, toxic chemicals, and a variety of other liquid wastes. Such wastes may contain pathogens from cleaning the floors of food preparation areas and toilet rooms and discharges from ill persons."

9. During a concurrent medication pass observation and interview on 6/4/25 at 8:59 a.m. with Registered Nurse 17 (RN 17), RN 17 was observed preparing and administering medications to Patient 64. RN 17 administered medications to Patient 64 through a [manufacturer] 60 milliliter (ml, a unit of measurement) sterile syringe attached to a G-tube (gastrostomy tube, a feeding tube inserted through the abdominal wall into the stomach when a person is unable to eat or drink adequately). After the medications were administered to Patient 64, RN 17 went to sink and washed the syringe with water then dried it with a paper towel. RN 17 then placed the syringe onto Patient 64's bedside table. When asked if the syringe was multiple use, RN 17 looked at the package labeling and stated it was single-use and discarded the syringe into the trash bin.

During a concurrent observation and interview on 6/4/25 at 10:23 a.m. with RN 18 and RN 19 in Patient 65's room, an unwrapped 60 mL syringe covered with an orange-colored crusty substance was observed laying on top of a small, folded towel next to the sink. Next to the syringe on top of the same towel were two bottles of water, a stack of medication cups and a stack of plastic drinking cups. RN 19 stated RN 18 had used the syringe to administer medications to Patient 65 earlier that morning. RN 18 stated the syringe was no longer sterile after use but saved it to check with RN 19 on what to do after its use.

During a concurrent observation and interview on 6/6/25 at 11:57 a.m. with Infection Prevention Director (IPD), the product labeling of the 60 ml syringe used to administer medications to Patient 64 and 65 was reviewed. The [manufacturer's] product labeling indicated "STERILE, SINGLE USE ONLY." IPD confirmed the manufacturer's product labeling indicated the syringe was single use only. He stated it should have been discarded after use and staff were e