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Based on video surveillance review, interview, and document review, the hospital failed to keep three of three patients (Pt 3, Pt 6, and Pt 8) free from all forms of abuse or harassment when:

1. Pt 3 was admitted to the Emergency Department as a 5150 (Welfare and Institutions Code, which allows an adult who is experiencing a mental health crisis to be involuntarily detained for a 72 hour hospitalization) /danger to others for aggressive behavior and nursing staff witnessedan Emergency Medical Technician (EMT) (not a hospital employee) physically restrain Pt 3 and policies and procedures were not followed to protect Pt 3's right to be free from physical abuse. (Refer to A 0145, #1)

2. Pt 6 was admitted for 9/2/24 to the psychiatric (Psych) unit (area where patients who have mental health issues are kept for safe care) of the hospital for suicidal ideation (thoughts of wanting to end one's life) and aggressive behavior and on 9/3/24 the hospital security personnel used a taser on Pt 6 against their policy for taser use and against the recommendations of The Centers for Medicare and Medicaid Services (CMS). (Refer to A 0145, #2)

3. Pt 7 was admitted on 9/23/24 to the Psych unit of Hospital A for psychosis (a group of symptoms that involve a loss of touch with reality) and history of aggression and hearing voices. A plan of care was created for Pt 7's Psychosis and aggression, but the interventions were not effective and resulted in the facilities inability to prevent Pt 7 from physically attacking Pt 8. (Refer to A 0145, #3)

These failures resulted in physical and psychosocial (e.g. harm to one's mental health) harm to Pt 3, Pt 6, and Pt 8.


Findings:


1. During a review of Pt 3's "Patient Care Report (PCR a document that records the care given to a patient by Emergency Medical Service (EMS) while transporting them to a medical facility)," dated 9/30/24, the "PCR" indicated, EMS was called for a patient with chief complaint of violent behavior. Upon arrival, [City Name] Police Department advised EMS that Pt 3 spit on law enforcement faces ... Pt 3 was found in police car with handcuffs behind her back. Pt 3 was assisted to EMS gurney and placed in wrist restraints for aggressive behavior. Pt 3 continued to be aggressive so restraints were applied to ankles as well. According to the PCR, on the way to Hospital A, Pt 3 was cooperative and apologetic. Pt 3 was brought to the hospital and handed off to ED staff.

During a review of Pt 3's "History and Physical (H&P a formal assessment of a patient's condition by a Medical Doctor)," dated 10/1/24, the "H&P" indicated, Pt 3 presented to the ED under 5150 (Welfare and Institutions Code, which allows an adult who is experiencing a mental health crisis to be involuntarily detained for a 72 hour hospitalization) for danger to others. Pt 3 was initially aggressive and uncooperative requiring medications but became cooperative after medications were given. Patient 3 was medically cleared (medical professional evaluated Pt 3 and determined there are no underlying medical illness) and was evaluated by the psychiatric liaison (mental health professional who specializes in the connection between mind and body and how it affects physical and mental health) and Pt 3 was cleared to discharge to police custody.

During an interview on 11/5/24 at 8:45 a.m. with Registered Nurse (RN) 23, RN 23 stated he witnessed an EMS worker walking by Pt 3's gurney while in the ED hallway and Pt 3 spit on the EMS worker. RN 23 stated he witnessed the EMS worker lunge at Pt 3 after being spit on. RN 23 stated he witnessed the EMS worker leaning against the hospital gurney with one foot hanging over the rail which was in the up position on the gurney. RN 23 stated it appeared the EMS worker had his arm pressing down on Pt 3's head and shoulder area and away from EMS workers face. RN 23 stated the EMS worker was pulled off Pt 3 by law enforcement. Pt 3 was handcuffed by law enforcement to gurney along with having hospital restraints on her wrists. RN 23 stated he did not inform the ED Medical Doctor (MD) about the incident and did not write a note about the incident. RN 23 stated he should have informed the MD and written a note in the electronic health record.

During an interview on 11/5/24 at 2:25 p.m. with Security Officer (SO) 1, SO 1 stated he witnessed Pt 3 spit on the EMS worker and then the EMS worker "aggressively threw himself" at Pt 3. SO 1 stated the EMS worker was using his elbow and forearm to the patient's head area to hold Pt 3 down. SO 1 stated the EMS worker used his elbow to push down and away from Pt 3's jaw. SO 1 stated the EMS worker was almost laying on Pt 3 with his body and was "dangling off the gurney". SO 1 stated this lasted about 3 seconds and then a law enforcement officer pulled the EMS worker "over the rails" to get him off Pt 3. SO 1 stated he did not see the EMS worker again and an EMS Supervisor arrived about an hour later and talked with law enforcement.

During an interview on 11/6/24 at 7:30 a.m. with SO 2, SO 2 stated security was made aware of a 5150 patient who was on the way to Hospital A on 9/30/24 around 10:30 p.m. SO 2 stated he witnessed law enforcement and hospital security assisting Pt 3 into hospital restraints which included both wrists and ankles along with handcuffs to each wrist in hospital gurney in the hallway. SO 2 stated he asked law enforcement to remove handcuffs to better position the patient and restrict movement, but law enforcement refused to remove handcuffs due to Pt 3's aggressive nature. SO 2 stated he witnessed an EMS worker walk by Pt 3's gurney and Pt 3 spit on the EMS worker. The EMS worker then lunged at Pt 3 where both his feet left the ground, and he was on his toes with side rails up laying on Pt 3. SO 2 stated it appeared the EMS worker had his forearm in Pt 3's neck and shoulder area, and it looked like his forearm was pressing down into Pt 3. SO 2 stated law enforcement then pulled the EMS worker off Pt 3.

3. SO 2 stated at this point, law enforcement agreed to reposition Pt 3. SO 2 stated Pt 3 was positioned on her back with right arm upward to right side of head in a wrist restraint as well as handcuff. The left arm was down by her left hip in a wrist restraint and handcuffed as well. SO 2 stated both ankles were in restraints also at this time. SO 2 stated this was when a spit hood (cloth/mesh device placed of the head of a patient designed to stop them from spitting/biting) was reapplied because Pt 3 could no longer take it off due to being repositioned. SO 2 stated Pt 3 was calm after this repositioning and reapplying of the spit hood. SO 2 stated report was filed and followed chain of command (to an authoritative structure established to resolve administrative, clinical, or other patient safety issues by allowing healthcare clinicians to present an issue of concern through the lines of authority until a resolution is reached) when he reported to security and medical personnel.

During an interview on 11/4/24 at 10:30 a.m. with Medical Doctor Resident (MDR) 2, MDR 2 stated he was assigned to care for Pt 3 and was not made aware that Pt 3 was assaulted by EMS worker. MDR 3 stated if he had been made aware of any assault, he would have done a physical and mental evaluation of Pt 3 and reported the incident.

During an interview on 11/4/24 at 11:15 a.m. with the Director of Emergency Department (DED), the DED stated he was aware of the incident that occurred with Pt 3 and stated the expectation is for all nurses to inform Medical Doctors when there is an assault in the facility. The DED stated this is not negotiable. The DED stated the expectation is for all patients to be free from any form of abuse.

During an interview on 11/7/24 at 2:20 p.m. with Risk Manager (RM) 1, RM 1 stated that after the incident involving an EMS worker and Pt 3, there was no Root Cause Analysis (RCA Used for events with serious harm or death where the goal is to identify the root causes of an issue and develop a plan to prevent it from happening again) review or an Apparent Cause Analysis (ACA Used for near misses or events with minimal to no harm with where the goal to identify an action plan to address the immediate situation and prevent recurrence) review. RM 1 stated there was a regular investigation. RM 1 stated this incident was found to be unavoidable. RM 1 stated the investigation did not discover that Pt 3 had about 12 inch wiggle room which allowed her to take the spit hood off while in handcuffs. RM 1 stated there needs to be an update with law enforcement to better determine who has authority for patients in handcuffs. RM 1 stated at this time there is no plan to prohibit the involved EMS worker to return to the hospital and there is no plan to ensure similar incidents do not occur.

During a review of the facility's policy and procedure (P&P) titled, "Patient's Rights and Responsibilities," dated 2/10/2022, the P&P indicated, "I. PURPOSE. To define the rights and responsibilities of patients who receive services at (Hospital A Name) ... IV. PATIENT RIGHTS ... 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, free from verbal or physical abuse or harassment ... 25. To be free from neglect; exploitation; and verbal, mental, physical, sexual abuse, and corporal punishment ..."

Attempts were made to contact Pt 3 and the EMS provider between 11/4/24-11/7/24 but neither have responded.

2. During a review of Pt 6's face sheet (FS document that has the patient's demographic information to include name, date of birth, contact information, insurance, chief complaint etc..), dated 9/18/24, the FS indicated Pt 6 was admitted on 9/2/24 at 3:42 p.m. for Suicidal Ideation (SI thinking about or planning suicide) and psychosis (a group of symptoms that involve a loss of touch with reality) not specified (NOS) and was a transfer from Hospital A to the off campus psychiatric unit and was discharged on 9/4/24 at 11:32 a.m. disposition written as homeless or homeless shelter.

During a review of Pt 6's "ED Pt Care timeline," dated 11/1/24, the ED (emergency department) timeline indicated Pt 6 had a Mental Status Exam (MS) on 9/2/24 at 10:47 a.m. with a chief complaint of Psychiatric Suicidal. The MS indicated, " ... Patient presented Alert and oriented times 3 (patient is alert to person, place, and time) patient respond to name. Patient confirmed name and date of birth. GCS 15 (Glasgow Coma Scale clinical scale used to reliably measure a person's level of consciousness; scoring 3 15; 15 best score). Patient is observed ambulating in the unit without difficulties. Patient appears anxious. Rapid speech inconsistent and demanding. Patient hesitate in engaging in assessment process. Writer. Inquired regarding event leading to ED encounter. Patient states just let me out of here right now. "I was drinking I do not have to tell you anything." Writer advises patient of 1799 hold (medical hold allows licensed healthcare providers to detain a patient for up to 24 hours) in ED and patient endorses suicidal ideation with plan (approves the plan to keep him safe). Patient noted increased agitation and refused to listen and demanded to leave. Patient report relocating to [name of city] recently, patient again demanded. I just want my car so I can drive off right now. Patient refused to acknowledge Suicidal ideation and plan. Patient refused to disclose where he lives, mental health history, substance use, psychotropic (affects a patient's mental state) medications, and history treatment. Patient appears guarded and insists on discharge. Patient refused to give collateral. Patient reports he is receiving mental health services via telehealth. Patient denies any VH (visual hallucinations - seeing things that are not there), AH (auditory hallucinations- hearing things that are not real), HI (homicidal ideations- thoughts about killing someone). Patient offered and encouraged to follow up with Fresno County Behavioral Health. Patient declined resources. Patient present poor insight and judgment on mental health and current status. Patient presents symptomatic (showing signs of disease or injury) and unstable. Psychiatrically for discharge at this time, patient presents highly impulsive and at risk for further decompensation (decline in mental stability) due to poor insight, judgment, and thoughts of harm to self behaviors... Refuses or feels unable to agree to safety plan... Recommendation/ plan of care. Recommendation is to place patient on a 5150 hold (a legal term for a 72 hour psychiatric hospitalization for someone experiencing a mental health crisis) for danger to self and refer a patient to inpatient psychiatric treatment. Continue to endorse suicidal ideation. Patient continues to be symptomatic for psychiatric illness and recommendation is to refer to inpatient psychiatric hospital for stabilization ..."

During a review of Pt 6's History and Physical (H&P) dated 9/3/24, at 7:50 a.m., the H&P indicated, "History of Present Illness: 42 year old male patient with past medical history of type 2 diabetes (body doesn't produce enough insulin (a hormone that lowers the level of glucose (a type of sugar) in the blood) or your cells don't respond properly to insulin), hyperlipidemia (abnormally high levels of lipids or fats in the blood), seizures (a sudden change in behavior, movement, or consciousness caused by abnormal electrical activity in the brain), migraines (a severe headache that causes throbbing, pulsing head pain on one side of your head), substance abuse (excessive use of alcohol, pain medication, or illegal drugs), bipolar disorder (a mental illness that causes unusual shifts in a person's mood, energy, activity levels, and concentration) admitted on 5150 due to danger to self. It is reported the patient presented to ED with symptoms of worsening depression with suicidal thoughts with plan to jump off into a freeway. Patient reported that he was not feeling right. Patient reported that his medications were not helping him ... Upon admission patient was agitated and aggressive towards staff he received Zyprexa (antipsychotic (treat symptoms of psychosis) medication can treat several mental health conditions) 10 mg (milligram unit of measurement) IM (inter muscular) emergency medication. Patient refused vitals yesterday. Today, patient refused to participate in H&P exam versus being sleepy ... Past Medical History: ... PTSD (post traumatic stress disorder a mental health condition that can develop after someone experiences or witnesses a traumatic event) ... TBI (traumatic brain injury a brain injury that is caused by an outside force) ... Plan ... Therapy per Psychiatry ..."

During a review of Pt 6's document titled, "Significant Event Note," dated 9/3/24, at 12:07 p.m., indicated, at "11:25 (a.m.) Pt (patient Pt 6) asking to speak to social worker with reason, "I don't want to be here". Reassured patient that SW will talk to him today but is not available right now. Patient went back to room. At 11:49, Pt barricaded himself in room blocking the doors with his body. Explained to pt that he is able to stay in his room with the door closed but cannot barricade door due to safety concerns. Pt refusing to move. Security was called to room for assistance. After continued refusal, pt opened door, raised fist, was screaming profanities, and threatened to hit staff. Code grey (a call overhead requesting assistance for a combative patient) called overhead. Medication orders placed Zyprexa 10 milligrams IM injection given to pt's arm per pt preference. Pt provided with 2 cups of water and snacks per request. Explained to patient that he needs to stay in his room until he remains calm, Pt refused to stay in his room stating, "I will go wherever I want, if I want water I will get water." Due to this response, ptmoved to Quiet Room (QR- safe room with no objects to hurt themselves or others) for safety reasons. In route to QR, patient attacked security officer. Pt safely brought down to ground by security and staff, pt tased in the LLE (left lower extremity) and abdomen, brought into QR and placed on violent locked restraints (physical restraints that fully immobilize a patient- all four limps restrained (4-point restraint) -used as an emergency measure to keep a patient or others safe when there is a risk of physical harm). Redness noted to abdomen. LLQ (Left lower quadrant- location left lower abdomen), oozing blood to L upper lip. Sitter at bedside, will continue to monitor. 12:40 (p.m.) Pt continues to shout profanities and demand release. MD updated; new orders placed for additional medication. Linen and gown change due to urination. Thorazine (medication used to treat mental health conditions) 100 milligrams IM medicated, will continue to monitor."

During an interview on 10/30/24, at 1:25 p.m., with Charge Nurse (CN 1), CN 1 stated she worked on 9/3/24 and was assigned to the unit 4 where Pt 6 resided. CN 1 stated she had just come back from break when she noticed security was down the hallway and she was updated that Pt 6 had barricaded himself in his room. CN 1 stated she pushed the code button when she heard commotion and the staff had gotten Pt 6's door open, she informed his nurse (Registered Nurse (RN 1)) to contact the doctor and get orders for medication. CN 1 stated the Code team arrived and attempted to deescalate the situation by talking with Pt 6, but Pt 6 was very agitated, unpredictable, and unstable, "we tried to offer him juice and therapy, then [RN 1] brought the medication, all [Pt 6] stated was that he wanted to leave". CN 1 stated Pt 6 accepted the medication and was asked to stay in his room until the medication started to help, he had promised to stay in his room but no more than 5 10 minutes later he was yelling and screaming wanting to leave his room, so security was called to help escort him to the quiet room. CN 1 stated she walked in front, and they had 3 4 security officers on the sides and behind Pt 6 while they walked him to the quiet room. CN 1 stated Pt 6 has a history of a TBI, and he lunged at and attacked the security officer to his right side, he started to swing and hit with his fists. CN 1 stated the security and staff tried to contain him and Pt 6 was resistant and would not stop fighting, he was told multiple times to stop, and he would not. CN 1 stated Security told him that they would tase him if he didn't calm down and he didn't so security tased him in his right lower abdomen. CN 1 stated he was still yelling and fighting after he was tased and then Pt 6 froze and was calm enough to move him to the quiet room. CN 1 stated she attempted to talk with Pt 6 once he was put in the 4 point violent restraints, but Pt 6 was erratic, and "we were waiting for his medication to take effect". CN 1 stated even in restraints he was verbally abusive and threatening staff by saying he would cut her head off and statements that he wanted a gun to shoot himself.

During an interview on 10/30/24, at 1:53 p.m., with Mental Health Worker (MHW 1), MHW 1 stated she worked on 9/3/24 and was doing room checks and noticed Pt 6 was getting agitated and barricaded himself in his room, at that time she informed the nurse of what Pt 6 was doing. MHW 1 stated the nurse went to try and deescalate the patient and security helped to try to get the patient to open his door. MHW 1 stated she did not see Pt 6 get tased; she was busy watching the other patients in this unit.

During an interview on 10/30/24, at 2:05 p.m., with MHW 2, MHW 2 stated part of her job was to round on patients every 15 minutes and when she attempted to open Pt 6's door to do her visual check of the patient he had barricaded himself in there and would not let her in. MHW 2 stated she told the nurse and the nurse attempted to talk to Pt 6 to get him to open the door and security joined him in his attempts. MHW 2 stated "I don't know if he [Pt 6] tried to hit [nurses name]" but security had to intervene. MHW 2 stated the therapist, and the house supervisor were also there attempting to deescalate the patient. MHW 2 stated Pt 6 was agitated, and she thinks he attacked the security guard and "they took him down" and a couple of minutes later they tased him. MHW 2 stated once Pt 2 was calm enough they took him to the quiet room, and he was placed in 4 point restraints.

During an interview on 10/30/24, at 2:15 p.m., with the Security Team Lead (STL), the STL stated he was working downtown at Hospital A when he heard on the radio that there was an agitated patient pacing back and forth and his staff were not able to deescalate him. STL stated he left Hospital A and headed to the off campus psychiatric unit, once their Pt 6 was in his room and "we heard banging on his wall", and Pt 6 had shut the door hard. STL stated, "medical staff came, and we opened the door, and I observed Pt 6 punching the wall" at this medical staff had gotten orders for restraints, so "we needed to move him to the quiet room." STL stated Pt 6 initially refused to go to the quiet room saying he "was going to kill us but after several attempts we convinced him to exit the room and walk with us to the quiet room". STL stated out of nowhere while in the hallway "Pt 6 attacked one of our officers by pushing her which caused her to hit her head on the wall and we went hands on with Pt 6. Once on the floor, one of our officers was pinned underneath Pt 6." STL stated, "we were having a hard time getting ahold of Pt 6's arms and legs, we could not get him [his officer] out from under Pt 6 because Pt 6 was punching and kicking". STL stated, "I undid my taser, removed the cartridge to give him a dry stun to gain control of him, it kind of worked. As soon as the cycle was over, he [Pt 6] started again. I then gave him a couple of more stuns with the taser, after the fourth one we got control, placed him in the taco (hard plastic device used to lift patients off the floor) and moved him to the room where we restrained him even during that he was cussing and spitting at us." STL stated he has done the initial taser training upon hire and does continued education on taser use annually.

During a review of the video footage of the incident on 9/3/24, Pt 6 was observed having multiple staff attempt to talk with him while he barricaded himself in his room. Pt 6 emerged from his room at 12:14 p.m., a total of four security guards were standing around him, one in front, one to each side and one behind him, nursing staff and mental health workers were also walking with the patient to the quiet room when Pt 6 pushed the female officer to his right hard and she hits the wall behind her, at that point a second officer jumps in and takes Pt 6 to the ground, the two other officers are attempting to restrain Pt 6 but Pt 6 was hitting and kicking out his legs. The security officer who initially took Pt 6 down to the floor was under the patient and one of the security officers, the team lead was seen pulling out his taser and tasing Pt 6, multiple staff surround Pt 6, so it is difficult to see the patient and where he got tased, nursing staff bring medication and give it in the patient's arm. Pt 6 was seen still fighting then goes still and security was able to restrain him and put him in the taco face down. At 12:20 p.m. Pt 6 was seen transported into the quiet room in the taco and being moved onto the bed where four point restraints were being placed on him,
Pt 6 was still fighting but was secured and nursing staff was now doing an assessment.

During a review of the hospital's policy titled, "Taser Usage," dated 2/17/21, indicated, "I. PURPOSE the purpose of this policy is to establish guidelines for the deployment and use of the taser by Security Services Staff. II. POLICY This policy is established to control the deployment and use of the taser to maximize the safety of the facility and staff while limiting potential injuries and corporate liability. A taser may only be possessed and deployed by an authorized, designated, certified, and properly trained security officer or supervisor of this department. III DEFINITIONS ... c. Taser the taser is a less than deadly device used to incapacitate subject (s) by discharging an electronic current into the subject via two wired probes. The taser may also be use in a touch stun capacity with a discharged cartridge in the device or when the taser is not equipped with a cartridge ... VII. A. the following procedure shall be adhered to while deploying a taser in an authorized manner and circumstances. 1. The taser shall not be deployed or displayed at any time unless the officer has specific information that reasonably indicates the use of a taser is warranted. The circumstances of each incident shall dictate the reasonableness for the deployment of the taser. The officer must reasonably believe that a credible threat to the safety of the officer or others exists. 2. The taser should not be used to simply overcome resistance when adequate assistance is available. 3. The taser shall not be used as an intimidation tool to gain compliance where the reasonable deployment is not justified. The taser shall not be deployed against passive demonstrators ... X. MULTIPLE APPLICATIONS If after the first application of the taser, an office is unable to gain compliance and circumstances allow, the officer should consider whether or not the taser device is operating properly and if other options or tactics may be more appropriate. However, multiple, and reasonable applications on the subject may be warranted and are not precluded. XI. AFTER DISCHARGE RESPONISBILITIES ... B. The taser officer shall prepare a detailed incident report which thoroughly covers the circumstances and justification for deployment. The identification of the utilized taser shall be identified in the documentation. Each officer involved in the taser incident shall complete a supplemental report detailing their actions and observations. All documentation shall be done promptly without delay ... XIII. TASER USE REVIEW BOARD After each taser deployment, the shift supervisor and manager shall review all documentation to evaluate the appropriateness for the deployment. All taser deployment reviews shall be completed by the Use of Force Review Board as defined by the Use of Force policy."

During a review of the hospital's policy titled, "Use of Force," dated 8/22/23, indicated, "I. PURPOSE the purpose of this policy is to provide security officers with guidelines for the legal and proper use of physical force where required to protect the safety of patient's staff, visitors, others, and property. II. POLICY It is the policy of [name of hospital] Security Department that security officers are permitted to use reasonable force when: A. the security officer reasonably believes that he/she is in imminent danger of suffering bodily injury or being touched unlawfully ("self defense"), someone is in imminent danger of suffering bodily injury ("defense of another"), or to protect [name of hospital] property from immediate harm ("defense of property"). B. The security officer reasonably believes that the use of reasonable force is necessary to defend against that danger. The security officer shall use the minimum amount of force necessary to accomplish lawful objectives and immediately cease once an individual is under control. The security officer shall use no more force than is reasonably necessary to defend against the danger ... IV. USE OF FORCE CONTINUUM The use of force continuum is a system used by this department to determine the reasonable force is a given situation ... The possible security officer response levels are as follows: A. Level 1: Officer presence (examples: physical appearance, professional bearing) B. Level 2: Verbal commands (example: clear and deliberate) C. Level 3: Soft techniques (examples: physical control tactics/wrist locks (grabbing the opponent's hand and twisting and/or bending it in a non-natural direction) D. Level 4: Hard techniques (examples: Taser/strike points/impact weapons/ OC Spray). All levels identified above in the use of force continuum shall be documented and investigated pursuant to this department's policy.

During a review of the facility's policy and procedure (P&P) titled, "Patient's Rights and Responsibilities," dated 2/10/2022, the P&P indicated, "I. PURPOSE. To define the rights and responsibilities of patients who receive services at (Hospital A Name) ... IV. PATIENT RIGHTS ... 2. To receive considerate and respectful care, be made comfortable and maintain dignity in a safe setting, free from verbal or physical abuse or harassment ... 25. To be free from neglect; exploitation; and verbal, mental, physical, sexual abuse, and corporal punishment ..."

During a review of the State Operations Manual (SOM) Appendix A Survey Protocol, Regulations and Interpretive Guidelines for Hospitals,dated 4/19/2024, the SOM indicated, " ... CMS does not consider the use of weapons in the application of restraint or seclusion as a safe, appropriate health care intervention. For the purposes of this regulation, the term "weapon" includes, but is not limited to, pepper spray, mace,nightsticks, tasers, cattle prods, stun guns, and pistols. Security staff may carry weapons as allowed by hospital policy, and State and Federal law. However, the use of weapons by security staff is considered a law enforcement action, not a health care intervention. CMS does not support the use of weapons by any hospital staff as a means of subduing a patient in order to place that patient in restraint or seclusion. If a weapon is used by security or law enforcement personnel on a person in a hospital (patient, staff, or visitor) to protect people or hospital property from harm, we would expect the situation to be handled as a criminal activity and the perpetrator be placed in the custody of local law enforcement ..."

3. During a review of Pt 7's face sheet (FS) dated 10/10/24, the FS indicated Pt 7 was a 30 year old male admitted on 9/23/24 at 10:22 p.m. for Psychosis (a collection of symptoms that affect the mind, where there has been some loss of contact with reality) and was a transfer from Hospital A to the off campus psychiatric unit and was discharged on 10/7/24 at 2 p.m.

During a review of Pt 7's History and Physical (H&P) date 9/22/24 at 9:12 a.m., the H&P indicated, " ... chief complaint Patient presents with Psych Bizarre Behavior. EMS went on scene, pt refusing to answer questions. Refusing treatment. Making odd comments about being 13 year old ... History of Present Illness: [name of Pt 7] is a 30 y.o. male patient with reported history of schizophrenia (a chronic mental disorder that affects a person's ability to think, perceive reality, and interact socially), marijuana abuse who was brought in by ambulance to ED on 1799 for SI (suicidal ideation thoughts of killing himself) ... On asking about SI, he nods yes but says "I don't remember why". Denies ETOH (ethanol- type of alcohol) abuse. Smokes marijuana off and on. Reports hearing voices in his head but does not remember what the voices state ..."

During a review of Pt 7's document titled, "Plan of Care," dated 10/3/24 at 12:12 p.m., the plan of care indicated, "Problem: Risk for violence/aggression towards others Goal: Refrain from acts of violence/aggression during length of stay, and demonstrate improved impulse controls at the time of discharge LTG [long term goal] Outcome: Not Progressing Goal: Verbalize thoughts and feelings associated with harming others STG [short term goal] Outcome: Progressing Goal: Refrain from harming others STG Outcome: Not Progressing Goal: Refrain from destructive acts on the environment or property STG Outcome: Progressing Goal: Control angry outbursts STG Outcome: Not progressing ... Goal: Identify appropriate positive anger management techniques LTG Outcome: Not Progressing ... Problem: Cognitive Perceptual Pattern Impaired Goal: Able to refrain from responding to false sensory perceptions (hallucinations, are the experience of perceiving objects or events through the senses when they are not present) STG Outcome: Not Progressing Goal: Refrain from acting on delusional thinking (a fixed false belief that a person holds onto, even when there is evidence that it is not real)/internal stimuli (changes, experiences, or feelings that occur within someone) STG Outcome: Not Progressing Goal: Demonstration of accurate environmental perceptions LTG Outcome: Not Progressing ... Problem: Coping Ineffective Goal: Able to identify one positive

Based on observation, review of hospital policies and procedures (P&P) and interview with staff, it was determined that the hospital failed to maintain drug storage areas in accordance with acceptable standards of practice when:

1a. Six different types of IV (intravenous, into the vein) solution bags were identified stored in one plastic bin labeled for normal saline (NS, 0.9% sodium chloride solution, a mixture of salt and water) 1 L (liter, unit of measurement) IV bags in one of three inspected Emergency Department (ED) medication rooms (ED Yellow); and

1b. Nine NS 500 ml (milliliter, unit of measurement) IV solution bags were identified stored in a bin labeled for NS 500 ml irrigation solution (used for cleansing, washing, or rinsing) bags one of three inspected ED medication rooms (ED Red).

2. Three different types of IV solution bags were identified stored in one of one ED Trauma Equipment Rooms that was not monitored for temperature or humidity.

3. Four IV medications and an anesthesia medication tray (tray containing multiple medications used during surgery) were identified inside a supply cart in one of two inspected Operating Rooms (Trauma OR).

These failures had the potential to result in administration of incorrect or unusable medications to patients in the hospital.

Findings:

1a. During a tour of the hospital's ED Yellow Medication Room on 10/30/24 at 11:10 a.m. with the Pharmacy Manager (PM), the following IV bags were identified in a bin labeled for NS 0.9% IV 1 L IV bags:

- One dextrose 5% (D5W, a mixture of sugar and water) / 0.45% sodium chloride (1/2 NS, half-normal saline solution, a mixture of salt and water) with 20 mEq (milliequivalent, unit of measurement) potassium chloride (to treat low potassium) 1 L IV bag;

- Two dextrose 10% (D10W, a mixture of sugar and water) 1 L IV bags;

- One NS 500 ml IV bag;

- One D5W 1 L IV bag; and

- One 1/2 NS 1 L IV bag.

During an interview on 10/30/24 at 11:15 a.m. with the PM, the PM acknowledged the IV bags listed above were not stored in the correct bin. The PM stated IV bags were stocked by Materials Management staff and Pharmacists checked medication rooms during monthly unit inspections.

1b. During a tour of the hospital's ED Red Medication Room on 10/30/24 at 11:19 a.m. with the PM, nine NS 500 ml IV bags were identified stored in a bin labeled for NS 500 ml irrigation solution bags.

During an interview on 10/30/24 at 11:21 a.m. with the PM, the PM acknowledged the NS 500 ml IV bags were not stored in the correct bin.

During a follow-up interview on 10/31/24 at 9:16 a.m. with the PM, the PM stated the expectation was for the bins to be filled with what was labeled on the bin. The PM added, if the wrong product had been given to a patient, it could have led to negative patient safety.

During an interview on 11/1/24 at 11:05 a.m. with the Director of Pharmacy (DOP), the DOP stated the IV bags inside the bin should have matched the label on the bin to prevent errors.

During a review of the hospital's policy and procedure (P&P) titled, "Patient Labeling/Storage/Rotation of Inventory," dated 11/2/22, the P&P indicated, "After verification of labeling requirements, identify bin location to shelve inventory...Verify Lawson number, manufacture product number, and location of each item prior to shelving inventory."

2. During a tour of the hospital's ED Trauma Equipment Room on 10/30/24 at 11:29 a.m. with the PM, a shelf with three large plastic bins were observed. Each plastic bin contained the following IV bags:

- NS 1 L;

- NS 500 ml; and

- Lactated Ringer (LR, a mixture of water, sodium chloride, sodium lactate, potassium chloride, and calcium chloride) 1 L.

The ED Trauma Equipment Room was not observed to have been monitored for temperature and humidity.

During an interview on 10/30/24 at 11:34 a.m. with the PM, the PM said he would need to check if temperature and humidity was monitored in the ED Trauma Equipment Room.

During a follow-up interview on 10/31/24 at 9:12 a.m. with the PM, the PM stated that the ED Trauma Equipment Room was not monitored for temperature or humidity. The PM stated IV bags were considered medications and needed to be stored according to manufacturer's specifications. The PM added, if not stored according to manufacturer's specifications, the efficacy of the IV bags could have been compromised.

During a concurrent interview and record review on 11/1/24 at 2:49 p.m. with the Manager of Plant Operations and Maintenance (MPOM), the hospital's ED Trauma Rooms' temperature, humidity, and pressure logs dated May, June, July, September, and October 2024 were reviewed. The ED Trauma Rooms' temperature, humidity, and pressure logs indicated Trauma Rooms 1 through 3 were monitored but did not indicate that the ED Trauma Equipment Room was monitored. The MPOM stated staff had not monitored temperature, humidity, or pressure inside the ED Trauma Equipment Room.

During an interview on 11/1/24 at 3 p.m. with the DOP, the DOP stated IV bags are considered medications and the expectation was for the IV bags to have been stored according to manufacturer instructions to ensure potency was maintained. The DOP acknowledged the temperature and humidity of the ED Trauma Equipment Room was not monitored.

Review of the manufacturer instructions on the NS 1 L, NS 500 ml, and LR 1 L IV bags' outer packaging indicated, "Store unit in moisture barrier overwrap at room temperature (25 [degrees Celsius]/77 [degrees Fahrenheit])..."

During a review of the hospital's P&P titled, "Medications - Orders, Administration, Storage, Documentation," dated 12/19/23, the P&P indicated, "Medications will be securely stored at all times and at the appropriate temperature."

3. During a tour of the hospital's Trauma Operating Room (OR) 2 on 10/30/24 at 2:50 p.m. with the PM, the following medications were observed stored inside an anesthesia supply cart:

- One anesthesia medication tray (contained multiple medications for surgery);

- One phenylephrine (to treat very low blood pressure or heart problems during surgery) 1000 micrograms (mcg, unit of measurement)/10 ml in NS, 10 ml injection syringe;

- Two Cefazolin (an antibiotic used for infection) 1 gram (g, unit of measurement) powder for injection vials;

- One Rocuronium (a powerful muscle relaxer for use during surgery) 50 milligram (mg, unit of measurement)/5 ml, 5 ml injection vial; and

- One hydralazine (to treat high blood pressure) 20mg/1 ml, 1 ml injection vial.

During an interview on 10/30/24 at 3 p.m. with the PM, the PM stated medications should not have been stored inside the anesthesia supply cart.

During a follow-up interview on 10/31/24 at 9:21 a.m. with the PM, the PM stated, the expectation was for medications to be stored secured in the proper location according to the hospital's P&P.

Further review of the hospital's P&P titled, "Medications - Orders, Administration, Storage, Documentation," dated 12/19/23, indicated, "All medications removed from a medication storage area (e.g., floor stock, Pyxis) must only be removed for one patient at a time. If medication dispensed is not administered or used, the medication should be returned to the original storage area as soon as possible, but no later than the end of the shift."

Based on observation, interview, and document review, the hospital failed to ensure:

1a. Controlled Substance (CS, those with high potential for abuse and addiction) medications were stored according to hospital policy and procedures (P&P) for one of four randomly sampled patients (Patient 47); and

1b. Patient's medication brought from home was reconciled and accounted for one of four randomly sampled patients (Patient 48).

These failures had the potential for CS medication diversion (illegal use of prescription medication or use for purposes not intended by the prescriber) and unauthorized access to medications.

Findings:

1a. During a tour of the hospital's Pharmacy on 10/30/24 at 2:03 p.m. with the Pharmacy Manager (PM) and the Director of Pharmacy (DOP), an inspection of pharmacy cabinets designated for storage of patient's home medications was conducted. Patient 47's ten medications brought from home were identified inside the pharmacy cabinets, including the following CS medications:

- Morphine (a potent controlled medication for pain) 15 milligrams (mg, unit of measure) tablets; and

-Norco (hydrocodone-acetaminophen, a potent controlled medication for pain) 5/325 mg tablets.

During an interview on 10/30/24 at 2:09 p.m. with Pharmacy Technician Supervisor (PTS) 1, in the presence of the PM and DOP, the PTS 1 stated any licensed pharmacy staff could have accessed the pharmacy cabinets designated for storage of patient's home medications.

During an interview on 10/30/24 at 2:15 p.m. with PM, in the presence of the DOP, the PM described process for use of patient's CS medication brought from home during admission to the hospital as follows:

- If the hospital did not stock the CS medication, the patient's CS medication brought from home would have been used when the patient was admitted to the hospital;

- When received from the nurse, a pharmacist would count the CS medication tablets and secure the CS medication inside the CII Safe (automated system that stores, tracks and monitors controlled substances inventory); and

- When needed by the patient, the nurse would have signed out each dose from the pharmacy.

During the same interview, the PM stated Patient 47's CS medications brought from home were not used because the pharmacy stocked both morphine and Norco. The PM stated Patient 47's morphine and Norco brought from home were handled as belongings, stored in the pharmacy cabinet designated for storage of patient's home medications, and not counted by a pharmacist.

1b. During an interview on 11/1/24 at 9:36 a.m. with the PTS 2, in the presence of the PM and DOP, the PTS 2 stated every month a pharmacy technician reviewed documentation of all patient medication brought from home in EPIC (the hospital's electronic health records system) and reconciled with the medications brought from home stored in the pharmacy cabinet.

During a concurrent interview and record review on 11/1/24 at 9:51 a.m. with the PTS 2, in the presence of the PM and DOP, Patient 48's electronic medical record was reviewed. Patient 48's medical record titled, "Patient Home Meds [medication]," dated 8/13/24, indicated medication brought by Patient 48 was an "unlabeled medication bottle" stored in the pharmacy cabinet. When PTS 2 searched for Patient 48's medication inside the pharmacy cabinet, PTS 2 was unable to locate it. Furthermore, PTS 2 was unable to provide documentation in the medical record that indicated the medication was returned to Patient 48. PTS 2 was unable to account for Patient 48's medication brought from home.

During an interview on 11/1/24 at 11 a.m. with the DOP, the DOP stated the expectation was for all medications (CS or non-CS) to be stored and accounted for in a traceable manner to avoid diversion, and for medication brought from home to have been returned to the patient. When asked if the patient home medication monthly reconciliation process was being done adequately, the DOP said, "No."

During a review of the hospital's policy and procedure (P&P) titled, "Medication From Home," dated 2/10/22, the P&P indicated, "Storage of patient's home medication...non-Emergency Department...pharmacy staff receive the patient's Medicine Inventory bag (for medication safe keeping)..."

During a review of the hospital's P&P titled, "Controlled Substances - Storage," dated 1/8/24, the P&P indicated, "All Controlled substances are stored in the pharmacy and in the CII safe that are not being used for patient specific purposes."

Based on observation, interview, and document review, the hospital failed:

1a. To ensure unusable IV (intravenous, into the vein) medications were not available for use when two opened and used medication vials, intended for single use, were not discarded according to manufacturer's instructions in one of two inspected Operating Rooms (Trauma OR); and

1b. To ensure IV bags removed from the manufacturer's protective overwrap were labeled with an expiration date in one of two inspected Operating Rooms (Trauma OR).

These failures had the potential for patients in the hospital to receive expired medications.


Findings:

During a tour of the hospital's Trauma Operating Room (OR) 2 on 10/30/24 at 2:50 p.m. with the PM, the following was observed:

1a. Two opened and used IV medication vials, intended for single use, were identified stored inside an anesthesia supply cart as follows:

- One IV propofol (used for sedation during surgery) 200 milligrams (mg, unit of measurement)/20 milliliters (ml, unit of measurement), 20 ml single use vial; and

- One IV protamine (used to reverse the effects a blood thinner, heparin) 50 mg/5 ml, 5 ml single use vial.

1b. Two unwrapped and undated normal saline (NS, 0.9% sodium chloride solution, a mixture of salt and water) 1 liter (L, unit of measurement) IV bags were identified inside the same anesthesia supply cart as mentioned above; and one unwrapped and undated NS 1 L IV bag was identified on top of surgery equipment.

During an interview on 10/30/24 at 3 p.m. with the PM, the PM stated medications should not have been stored inside the anesthesia supply cart. The PM further added, IV bags should have been kept in the manufacturer wrapper or dated when the wrapper was removed.

During a follow-up interview on 10/31/24 at 9:21 a.m. with the PM, the PM stated the expectation was for opened single use IV medication vials to have been discarded.

During an interview on 11/1/24 at 11:08 a.m. with the Director of Pharmacy (DOP), the DOP stated the expectation was for medications to have been secured to prevent diversion (illegal use of prescription medication or use for purposes not intended by the prescriber). The DOP stated medications that were opened and unusable should not have been available due to the potential for contamination and patient harm if used.

During a review of the hospital's policy and procedures (P&P) titled, "Medications - Orders, Administration, Storage, Documentation," dated 12/19/23, the P&P indicated, "All medications...that are not immediately administered are to be labeled...Immediately discard any medication or solution that is found unlabeled..."

A review of propofol IV manufacturer instructions, retrieved from DailyMed (a public website operated by the U.S. National Library of Medicine), dated September 2023, indicated, "Propofol ...must be prepared for single patient use only. Any unused propofol...must be discarded at the end of the anesthetic [surgery] procedure..."

Review of protamine IV manufacturer instructions, retrieved from DailyMed, dated November 2022, indicated, "Preservative free. Discard unused portion."

Review of the manufacturer instructions on the NS 1 L IV bag's outer packaging, indicated, "Store unit in moisture barrier overwrap at room temperature (25 [degrees Celsius]/77 [degrees Fahrenheit]) until ready to use."

Based on interview and record review, the hospital failed to implement interventions meant to support the effectiveness of their policy and procedure (P&) titled "Universal Protocol - Procedural Areas." On 9/23/24, the facility self-reported to the California Department of Public Health (CDPH), a wrong site biopsy (a procedure to remove a piece of tissue or a sample of cells from your body so that it can be tested in a laboratory) procedure was performed on Patient (Pt) 1 on 9/19/24. The hospital reported a Root Cause Analysis (RCA- a tool used to help healthcare organizations retrospectively study events where patient harm or undesired outcomes occurred to identify and address the root causes) was conducted. The RCA indicated hospital staff did not identify the wrong side had been sampled until after the procedure had been completed.

This failure resulted in a biopsy to the incorrect side for Pt 1, and had the potential for future patients to unnecessarily suffer from the effects of wrong site surgery/procedures such as pain, injury, and additional surgery/procedures.

Findings:

During a review of Pt 1's "Short Form History & Physical (H&P)" dated 9/19/24, the H&P indicated Pt 1 "...76-year-old... Reason for visit: Image-guided biopsy (a biopsy test performed using a CT (CT-Computed Tomography: images used to check the position of a biopsy needle) needed...Past Medical History (PMD): Dementia (a progressive state of decline in mental abilities), Diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing), hypertension (HTN-high blood pressure), liver abscess (a pus-filled mass that develops in the liver)...Diagnosis: right lung mass (an abnormal growth in the lungs)..."

During a review of Pt 1's physician order "CT Biopsy Lung Left (Order Number) dated 9/18/23, the order indicated "...Reason for Exam newly diagnosed bronchogenic adeno ca[rcinoma] (a type of cancer that starts in mucus-producing (glandular) cells), heme[otologist] (a doctor or scientist who specializes in diagnosing and treating diseases of the blood, bone marrow, and lymphatic system)/onc[ologist] (A doctor who has special training in diagnosing and treating cancer) rec[ommends] IR (IR-Interventional Radiology- IR is a therapeutic and diagnostic specialty that uses imaging techniques like X-rays, CT scans, ultrasounds, and MRIs to guide doctors as they perform procedures) consult to biopsy (a procedure that removes cells or tissue from your body) the 6 mm (mm-is the abbreviation for millimeter, a unit of length in the metric system that is equal to one thousandth of a meter) nodule (a growth or lump that may be malignant (cancer) or benign (not cancer) in Left lower lobe (LLL) [of the lung]..."

During a review of Pt 1's "Discharge Summary" dated 9/25/24, the summary indicated "...Admit date: 9/11/24... Discharge Date: 9/25/24...Chief Complaint:... Headache... Admission Diagnosis: Lung mass...

During a review of Pt 1's "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics and Rendering of Other Medical Services (Consent)" dated 9/19/24 signed by Pt 1's [medical decision maker] via telephone and witnessed by hospital staff, the Consent indicated "...Operation or procedure...Computed Tomography (CT) Guided Left Lung Mass Biopsy (a procedure that uses a CT scan to guide a needle to remove a tissue sample from an abnormal area in the body) with Possible Chest Tube Placement (a hollow, flexible tube placed into the chest) with Procedural Sedation (a medical technique. It's used to calm a person before a procedure)..."

During a review of Pt 1's "Post Procedural Note: CT Biopsy (Procedural Note)" dated 9/19/24, the Procedural Note indicated "...Preoperative Diagnosis: right lung cancer, LLL 6 mm nodule...Post-operative Diagnosis: Same as preoperative diagnosis...Findings: Biopsy performed of 6 mm LLL lung nodule biopsy... Specimen: Core biopsy specimen(s) were collected..."

During a concurrent interview and record review on 11/7/24 at 3:13 p.m., with the Interim Director of Imaging (IDIS), the Clinical Nurse Supervisor (CS) 1 and Registered Nurse (RN) 11, RN 11 stated he is new to the role of nurse in the Interventional Radiology department, has worked in IR for about a year. RN 11 stated before that he was an Emergency Department (ED) RN for 6 years. RN 11 stated he prepares for the time out (a pause to confirm the correct patient, procedure, and site before a medical procedure begins. It's a safety measure to prevent errors like performing the wrong procedure on the wrong patient or body part) by reviewing the patient's (Pt's) Electronic Health Record (EHR) for provider order, laboratory results, Pt allergies, etc. then he reads the consent, word-for-word, including Pt Name and Medical Record Number (MRN) to be ready when the doctor [performing the procedure] enters the procedure room. RN 11 stated once the doctor enters the room, he waits until everyone is at attention, not doing other tasks and says "are we ready for a timeout?" He then calls out the Pt name, MRN verified with data on screen [monitor staged in procedure room with Pt information displayed for the team], also calling out medication(s) to be given to Pt for sedation (administration of a drug to produce a state of calm or sleep), any additions or questions are discussed at this time. RN 11 stated the CT Technician (Tech) will verbalize the specimen to be collected during the procedure if indicated. RN 11 stated he ends with verbalizing "do we all agree?" If yes, then the time-out is complete. During a review of Pt 1's consent with RN 11, RN 11 confirmed Pt 1's consent indicated the biopsy was to be performed on Pt 1's left [lung] side. RN 11 stated he "can't speak to why the doctor did the wrong side," the procedure is image guided and site marking is not indicated. CS 1 stated even experienced IR RN's (such as himself) do the time out "exactly the same way" [as RN 11 described]. CS 1 stated they (IR RNs) are focused on their task(s) in monitoring the patient and ensuring the patient is safe under moderate sedation that they do not watch as other team members do their tasks. RN 11 stated he was focused on his role, due to his being new to it and did not observe the IRMD prepare the patient for the insertion of the biopsy needle. RN 11 explained patients in IR are frequently positioned for a procedure for insertion with the imaging guided technology used by the IRMD to guide their progress from insertion through and to the destination for sampling. RN 11 stated because of the nature of the procedure, he would not have been able to determine if the IRMD was accessing the [correct] site ordered for sampling. IDIS and CS 1 confirmed they do not believe there is anything more that hospital staff could have done in this situation. IDIS and CNS 1 stated a RCA was done by the Risk Management department. The IDIS and CNS 1 stated the opportunities identified during the RCA were: implementation of a trial using and avatar (an individual's avatar is the virtual equivalent of a single real person) on which the MD marks the site to identify the correct side when there is a laterality (specifying which side of the body a medical condition affects) indicated. IDIS stated they started a 3-month trial of this "avatar" process on in Computed Tomography (CT) procedural area on 10/5/24. IDIS and CNS 1 stated they also identified the need to "jog the provider's thought process." The IDIS and CNS 1 stated they have implemented a requirement for the doctor to "verbalize the procedure to be done by the proceduralist so the team has the opportunity to speak up." IDIS stated the doctor [in this case] "self-reported this incident" with leadership making report of the event to Risk Management "immediately."

During an interview on 11/7/24 at 4:09 p.m., via telephone with the IRMD and Director of Risk Management Regulatory Patient Safety (RMD), the IRMD stated in "looking back, in reviewing, he saw this [wrong side biopsy] that day [9/19/24] in his review [after the procedure had been completed]. The IRMD stated as part of his regular practice, he reviewed [Pt 1's] past imaging showing Pt 1 had a transbronchial biopsy [under] fluoroscopy done first, then a CT biopsy was ordered of the left lung. The IRMD stated the order was "clear on the order, [he] confused the patients, in dictating report." IRMD stated he saw that Pt 1 was "still prone (positioned face down) and on the table, [he] did the right side." IRMD stated he "made assumptions, it was a stressful day in the department." IRMD stated he has been performing biopsies for 35 years and was "shocked about it and self-reported." The IRMD stated he was not involved in the RCA review, he was out of town, but he is aware of interventions made to prevent this from happening again. The IRMD stated the avatar process "doesn't seem to help. It is a trial, why not try it?; it could be helpful." IRMD stated that with "most of what we (as providers) do, "you do not see the abnormality. IRMD stated the doctor is preparing a clean site on insertion, everything we [doctor] do is to a visible lesion (An area of abnormal or damaged tissue caused by injury, infection, or disease) and where you enter isn't always where you need to end up. The IRMD stated that marking the site for this kind of procedure "that kind of marking doesn't help." The IRMD stated he "mixed up the patients" and this led to Pt 1's having a biopsy to the wrong side [right when left was ordered]. IRMD stated what could have been done differently is "if the MD changes an order, because they do change orders, the original indicated Pt 1's right [lung] and he changed [the order] to left, after speaking with the ordering doctor. , the initial order was blank side, we are doing this site if this were included in the time-out. The IRMD stated that using the order for readback during the time-out process and not the consent would be most helpful. The IRMD stated if the team read off the order instead of consent that would have helped prevent this event. The IRMD stated his recommendations had not been shared with others on the leadership team.

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

Based on observation, interview, and record review the hospital failed to secure two of seven anesthesia carts, when the anesthesia carts in operating room (OR) 4 and OR 2 were not locked and the medication inside was accessible to anyone.

This failure had the potential to result in drug diversion (this happens when healthcare providers obtain or use prescription medicines illegally) or unauthorized access and use of prescription medications.

Findings:

During the initial tour of the Endoscopic (Endo) OR areas on 10/30/24 at 10:40 a.m., with the Director of Endo, there were seven procedure rooms, Patient (Pt) 28 was seen leaving procedure room 4 with the Anesthesiologist (ANS) 1 pushing his gurney; Doctor (MD) 2 was seen sitting inside the room charting with his back to the anesthesia cart which was across the room. The Endo Tech in the room was seen cleaning the environment for the next patient to come in, she stopped and took the dirty scope which was in a red closed biohazard bag and a hard outside container to the dirty endoscope room. The ANS medication cart was blue and was located in the right-hand corner of room 4. The ANS cart had plastic trash on top of it. When the top drawer of the ANS cart was pulled it opened. The ANS cart had a lock on the outside, but it was not set. Inside the cart top drawer were the following medications: Phenylephrine (used to treat low blood pressure) 100 mcg/mL (units of measurement- micrograms/milliter) in a 10 mL syringe; Propofol (anesthetic causes relaxation and sleepiness before and during surgery) 1 % (percent) 20 mL; ephedrine (medication to treat low blood pressure during surgery) 50 mg/mL 1 mL; Ondansetron (medication used to prevent vomiting) 2 mg/mL 1 mL; Dexamethasone (medication used to prevent nausea and vomiting after surgery) 10 mg/mL 1 mL; Succinylcholine (Paralytic- can relax the muscles during surgery) 200 mg/10 mL; Epinephrine (used to improve the quality and duration of anesthesia, and to reduce bleeding) 1 mg/ml; Rocuronium (Paralytic- can relax muscles during surgery) 10 mg/mL 5 mL vial; Glycopyrrolate (used prior to surgery to reduce/stop salivary gland and respiratory secretions) 2 mL. The Director stated this anesthesia cart should be locked when left unattended.

During an interview on 10/31/24 at 10:55 a.m., with ANS 1, ANS 1 stated he takes his anesthesia medications out of the locked pyxis (Automated dispensing machines provide secure medication storage on patient care units, along with electronic tracking of the use of narcotics and other controlled medications) in the morning and puts them in his anesthesia cart, and keeps the cart unlocked all day until his last procedure then he returns any leftover medication back to the pyxis. ANS 1 explained that he wants to be able to have access to those medications as soon as possible for his patients. ANS 1 stated he understood the anesthesia cart should be locked when he leaves the room, but this was not his practice.

During a concurrent observation and interview on 10/31/24, at 11 a.m., with the DOE, while in Endo operating room 2 after the Anesthesia provider (ANS 2) and patient had left, the DOE reached over and pulled the top drawer of the blue anesthesia cart. The top drawer partially opened and on the second pull, the drawer completely opened, and the anesthesia cart was unlocked. The DOE stated the drawer was caught on the medication box and inside this anesthesia cart were the same medications as the anesthesia cart in room 4. A couple of minutes later the Anesthesia provider (ANS 2) came into the room and stated he thought he had locked the anesthesia cart. ANS 2 stated his normal practice is to lock the anesthesia cart when he leaves the room.

During an interview on 10/31/24, at 11:05 am with the DOE, the DOE stated the anesthesia carts should be locked before the anesthesia provider leaves the room.

During a review of the hospital's policy titled, "Medications for Anesthesia in Surgery and Endoscopy," dated 10/28/23, indicated, "I. PURPOSE To provide guidelines for the provision and safeguarding of narcotic and non-narcotic anesthesia medications in the Operating Room (OR) and Endoscopy areas, so that they are readily available for administration to the patient by an anesthesia provider. II. DEFINITION ... B. Anesthesia medication tray: a compartmentalized tray containing non-narcotic medications routinely used by the anesthesia provider for a procedure requiring anesthesia care. The compartments are labeled with the medication name, strength, and the inventory Periodic Automatic Replacement (PAR) level of each compartment in the tray. No controlled substances are to be part of the inventory of this tray. II. POLICY ... a. Anesthesia medication trays, may be stocked by persons holding the following job titles, within their scope of practice: i. Registered Nurse (RN) ii. Licensed Vocational Nurse (LVN) iii. Pharmacy Technician (Tech) iv. Pharmacist v. Anesthesia Provider vi. Anesthesia Technician ... 3. Anesthesia cart medication drawers and ADSs are to be locked when unattended by licensed personnel ..."

During a review of the hospital's document titled, "Anesthesiology Delineation of Privileges," dated 7/14/22, indicated, " ... Acknowledgement of Applicant ... A. In exercising any clinical privileges granted. I am constrained by Hospital and Medical Staff policies and rules applicable generally and any applicable to the particular situation ..."

During a review of a professional reference titled, "Healthcare-Associated Infections (HAI) Drug Diversion Planning and Response Toolkit for State and Local Health Departments," date June 2019 was written by Council of State and Territorial Epidemiologist (CSTE), it indicated, " ... Toolkit Introduction Drug diversion is defined as "any criminal act or deviation that removes a prescription drug from its intended path from the manufacturer to the patient," including everything from outright theft of the drug to doctor shopping, prescription forging, manufacture or sales of counterfeit drugs and international smuggling. While any medication may be involved in a diversion event, some drugs are more commonly targeted than others: Anti-anxiety medications and sedatives ... Prescription pain medications ... sleep aids ... Anesthetics, such as Propofol These high-value medications are often sought for their particular psychoactive effects, and many are habit-forming ... Alarming in 2007, the U.S. Substance Abuse and Mental Health Services Administration estimated that an average of 103,000 doctors, nurses, medical technicians, and healthcare aids a year were abusing or dependent on illicit drugs. HCP (healthcare personnel) may divert drugs via several mechanisms: False documentation (e.g., the medication is not administered to the patient, as indicated, or is falsely listed as "wasted") Scavenging wasted medication ... Theft by tampering (e.g., substituting medication in a container or syringe with a similar-looking substance, which may then be administered to patients in place of the intended drug) and this diversion can harm patients in at least four ways: reduced quality of care given by impaired HCP Failure to receive essential medications, possibly resulting in pain and suffering Exposure to infectious agents Falsification of patient records which could lead to additional medication administered to the patient to make up for medication unknowingly not received ..."