HospitalInspections.org

Based on video surveillance review, interview, and document review the hospital failed toprotect and promote four of four patient's (Pt 3, Pt 6, Pt 8, and Pt 4) rights when:

1. Pt 3 was admitted to the Emergency Department (ED) 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 witnessed an 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)

4. Pt 4 was marked as "eloped (when a patient leaves a hospital without authorization or supervision, and it could pose a threat to the patient's safety or health)" while still in ED and did not get results of physician ordered computed tomography (CT medical imaging procedure that uses X rays to create detailed cross sectional images of the body) or medications to alleviate pain. (Refer to A 0144).

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 ensure an organized nursing service that provides 24 hour nursing when:

1. The hospital failed to ensure Licensed Nurses (LNs) developed and/or updated individualized care plans ( CP-a written document that outlines the care a patient will receive, based on their specific needs and goals) related to infection, sepsis (a severe infection in the blood) and chest pain for four of 73 sampled patients (Patients (Pt) 2, 14, 16, and 17). (Refer to A0396).

2. The hospital failed to ensure LNs assessed and reassessed pain levels for three of 73 patients (Pt 15, Pt 18, and Pt 73) in accordance with hospital policies and procedures (P&P) and acceptable standards of practice (Refer to A0398).

3. The hospital failed to ensure Licensed Nurses (LNs) administered medications in accordance with the hospital's policy and procedure (P&P) titled "Medications Orders, Administration, Storage, Documentation" and acceptable standards of practice for medication administration safety, when one of one sampled patients (Pt) 74 was administered Fentanyl and Versed from incompletely labeled syringes (without required " 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 ...,") intravenously (IV into the vein) bolused (single dose of a drug or other substance given over a short period of time) medication(s) by Registered Nurse (RN) 9 which had been prepared by another LN (RN 10). (Refer to A0405).

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

Based on observation, interview, and record review the hospital failed to ensure that safe pharmaceutical services had been provided and meet the needs of each patient as evidenced by:

The hospital failed to maintain drug storage areas in accordance with acceptable standards of practice. in one of three inspected Emergency Department (ED) medication rooms; in one of one ED Trauma Equipment Rooms, and cart in one of two inspected Operating Rooms (OR).
Refer to A 491

The hospital failed to ensure an effective system to accurately reconcile controlled drugs (medications with high probability of addiction and are controlled by the federal government) losses for two of five sampled patients (Patients 54, 57). Refer to A 494

The hospital failed to develop and implement a policy and procedure that addressed the use of auto verified medication orders (orders entered by providers and medications dispensed bypassing verification of a pharmacist) and did not have a system for monitoring the appropriate use of the auto verification process to ensure that medications dispensed by the use of auto verification process were distributed in accordance with applicable standards of practice. The hospital auto verified approximately 60,000 medication orders from 10/1/24 to 10/31/24. Refer to A 500

The hospital failed to ensure all sterile (germ free) compounding (a process of making sterile medications administered into the vein) and the administration of chemotherapy (toxic cancer treatment that uses drug to kill or stop the growth of cancer cells) drugs was performed
consistent with national standards of practice. Refer to A 501

The hospital failed to ensure Controlled Substance (CS, those with high potential for abuse and addiction) medications were stored according to facility policy and procedures (P&P) for one of four randomly sampled patients (Patient 47); and Patient's medication brought from home was reconciled and accounted for one of four randomly sampled patients (Patient 48). Refer to A 503

The hospital failed to ensure unusable 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 (OR); and IV (intravenous, into the vein) bags removed from the manufacturer's protective overwrap were labeled with an expiration date in one of two inspected ORs. Refer to A 505

The cumulative effect of this systemic problem resulted in the facility's inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.

Based on observation, interview, and record review, the hospital failed to ensure one of four sampled patients (Pt) 4 received complete and ordered treatment in the Emergency Department (ED) when Pt 4 was marked as "eloped (when a patient leaves a hospital without authorization or supervision, and it could pose a threat to the patient's safety or health)" while still in ED and did not get results of physician ordered computed tomography (CT-medical imaging procedure that uses X-rays to create detailed cross-sectional images of the body) or medications to alleviate pain.

This failure resulted in Pt 4 having pain that was not treated and had the potential to delay treatment for possible injuries that may have been found on the CT scan.

Findings:

During a concurrent observation and interview on 10/31/24 at 11:30 a.m., with Manager of Emergency Department (MED) 3 in the Provider at Triage (PAT -waiting area for patients) 2 area, three staff members called out patient names for continued care. Staff members did not walk the entire lobby calling patient names. Staff stood outside the door to the lobby and called patients' names. Staff called a patient's name two times and then went back into the PAT 3 (where provider assess patients and confidential information is discussed) area. During this observation one patient approached MED 3 and asked if his name was called and stated he "couldn't hear because it was loud." MED 3 stated staff will attempt to call patient three separate times and if no response, they are marked as eloped and taken out of the Emergency Tracking Board (ETB - a computerized log used to monitor the progress and location of a person while being treated during their stay in the ED.) MED 3 stated the patient must re-register and start the process again from the beginning if they are marked as "eloped" , as if they were a new patient. MED 3 stated hospital policy and procedure (P&P) was to enter a note in the patient's EMR (Electronic Medical Record) after a third and final attempt at calling for patient is made to indicate the patient did not respond after being called three times and is considered to be eloped. MED 3 stated staff do not chart every time they have called the patient.

During an interview on 11/6/24 at 9:45 a.m., with Pt 4, Pt 4 stated he arrived at the hospital on 10/11/24 around 5:30 p.m., by ambulance, due to a Motor Vehicle Accident (MVA). Pt 4 stated he was sent to the PAT 1 area and then met with a provider (doctor or other medical professional) who ordered pain medication for his back pain and a CT. Pt 4 stated he then went to the PAT 2B (area where medications are administered) area to receive his pain medicine and was told to return to the PAT 1 area to wait for his CT results, which he was told would take approximately one hour. Pt 4 stated he returned from CT to PAT 1 and waited for approximately 2 hours for his name to be called for CT results. Pt 4 stated he did not leave the PAT 1 or use the restroom while waiting for his name to be called. Pt 4 stated he saw a provider walk by and inquired about CT results and continued pain. Pt 4 stated the provider stated they would prescribe more pain meds and inquire about CT results which take roughly 2 hours to return. Pt 4 stated he waited about one more hour and inquired about results from PAT 2 area staff who informed him that he had been taken out of the system as eloped. Pt 4 informed staff that he was present the entire time and had not heard his name at any time and no staff walked over to where he was sitting calling out patient names. Staff informed Pt 4 that he had to re-register and start the process over from the beginning. Pt 4 stated he left because he could no longer sit in pain. Pt 4 stated he went to urgent care about 5 days later, due to continued pain where he was diagnosed with "severe whiplash."

During an interview on 11/6/24 at 11:10 a.m., with Director of Emergency Department (DED), the DED stated there is no policy if a patient elopes to be checked back into system at the same point in the ED process . The patient must begin the entire process over from the beginning. The DED stated that is the expectation. The DED stated that if there is a situation where a patient was intentionally or accidently discharged as eloped, then it should be elevated to a supervisor to discuss.

During an interview on 11/6/24 at 2:30 p.m., with Certified Nursing Assistant (CNA) 1, CNA 1 stated she waits about 15 minutes
between calling the same patients and after the third call, she notifies the nurse and provider to let them know that the patient did not answer three calls. CNA 1 stated she believed overhead call/paging system is only used after third attempt at calling the patient. CNA 1 stated that she puts the number of attempted calls on the ETB. Once the patient is taken out the system, all notes are automatically deleted from the ETB and cannot be retrieved. CNA 1 stated she should be charting the third attempt to call a patient in the patient chart, not just the ETB.

During an interview on 11/6/24 at 2:45 p.m., with MED 2, MED 2 stated that the expectation is that all staff document all attempts to call patients in the patient's chart so all staff can see if attempts were made. MED 2 stated education to staff began approximately June, 2024 . MED 2 stated the problem with the ETB is that it deletes all notes once a patient is taken out of the system and staff cannot see what notes were put in.

During an interview on 11/7/24 at 9:45 a.m., with Registered Nurse (RN) 25, RN 25 stated the ETB is where notes and updates are documented to communicate what needs to be done for a patient, especially if they go from one area to another. RN 25 stated the notes on the ETB do not transfer to the patient's chart and notes should be documented in the patient's chart. RN 25 stated staff should be documenting on a nurses note or flow sheet in the patient's chart when a patient does not answer three times. RN 25 stated the overhead call/paging system is used every time staff call a patient. RN 25 stated if a patient is taken out of the system already, it is up to the provider to put them back into the system if it is an emergent situation. If it is not an emergent situation then the process starts from the beginning.

During an interview on 11/7/24 at 1:45 p.m., with Licensed Vocation Nurse (LVN) 3, LVN 3 stated staff sometimes use overhead call/paging system, and he doesn't know specifics on criteria as to when they should be using overhead call/paging system. LVN 3 stated staff should be calling out patient names in all PAT areas. LVN 3 stated staff should be writing a nurse's note in the patient's chart to let all staff know that an attempt was made to call the patient when there was no response. LVN 3 stated he thinks staff use the ETB to track the first and second attempt just because it is easier and faster. LVN 3 stated if patient has been taken out of the system, such as an elopement, and the patient wants to continue care, then it just depends on how long they have been gone. LVN 3 stated if it has been 30-40 minutes then patient can resume care and the elopement can be undone and care can continue from when they left. LVN 3 stated if it is longer than 40 minutes the patient needs to re-register and start the process all over again.

During a record review of Pt 3's "Emergency Department Timeline (EDTL)," dated 10/11/24, the EDTL indicated, " ... 2209 [10:09 p.m.], After MSE (Medical Screening Exam)-No Response, After Medical Screen Call-No Response: 1st Call, (CNA 1 Name) ... 2306 [11:06], ED Notes, Pt is NAx3 (No Answer three times), will remove from [name brand computerized application] ... 2307 [11:07 p.m.], AMA/Eloped (Against Medical Advice) Disposition (the final destination for a patient after receiving care, or the decision made about a patient's care in an ED) Selected, ED Disposition set to Eloped ..."

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 c

Based on observation, interview, and record review, the hospital failed to ensure nursing staff updated and developed individualized care plans (required documents to help guide care for patients) related to infection (Pt (patient) 2 and Pt 14), sepsis (a severe infection in the blood) (Pt 14 ) and chest pain (Pt 17) for four of 73 sampled patients (Pts 2, 14, 16, and 17) when:

1. Nurses did not develop an individualized care plan for Pt 2's infection when his admitting diagnosis (the reason he was admitted to the hospital) was for a disease caused by the human immunodeficiency virus (HIV) that severely damages the body's immune system and makes it difficult for the body to fight off infections.

2. Nurses did not develop an individualized care plan for Pt 14's potential for infection when he had a broken femur (thigh bone) from a motorcycle accident and the bone tore through the skin (an open fracture) and was sticking out, causing a risk for infection.

3. Nurses did not develop an individualized care plan for Pt 16's sepsis (a severe and often deadly infection) when his admitting diagnosis was cholangitis (condition that is usually caused by a bacterial infection or blockage in the bile duct near the gallbladder) and was diagnosed with sepsis after admission.

4. Nurses did not develop an individualized care plan for Pt 17's chest pain when the primary reason he was transferred to Hospital B was for a NSTEMI (non-ST elevated myocardial infarction - a type of heart attack that occurs when the heart doesn't get enough oxygen.)


These failures had the potential to cause inconsistent delivery of care, which can result in the decline or lack of improvement for Pts 2, 14, 16, and 17's health conditions.

Findings:

1. During a concurrent observation and interview on 11/1/24 at 1:10 p.m. with the Director of Inpatient Cardiovascular Services (DICS) and Registered Nurse (RN) 24, observed Pt 2 in his bed in room Pt 2's hospital room. RN 24 stated Pt 2 was in isolation (in a private room to) because he has an infection, and we were required to wear an isolation gown (a disposable gown worn over clothing while in the patient's room and discarded when leaving the room to prevent the spread of infection) to enter the room.

During a concurrent interview and record review 11/1/24 at 2:38 p.m. with the Director of Intensive Care Services (DICS) and the Manager of the Intensive Care Unit (MICU), the MICU opened the Electronic Medical Record (EMR) for Pt 2. The document titled, "Consults," dated 10/9/24 by MDF (Medical Doctor Fellow (a doctor who is continuing their education) 3 indicated Pt 2 was a man with a history of an immune deficiency disease which makes it difficult for the body to fight off infections, illnesses, and certain cancers. He was admitted to the hospital on 9/21/24. The consult indicated Pt 2 had a previous admission from 8/5/24 - 9/5/24 for meningitis (an infection in the brain or spinal fluid) and an immune deficiency disease.

During a review of document titled "Progress Notes" dated 10/31/24 by MD (Medical Doctor) 5, the document indicated a chest x-ray on 10/19/24 showed, "worsening consolidation (when the air in the small airways of the lungs is replaced with a fluid, solid, or other material such as pus, blood, water, stomach contents) in the right mid and upper lung with cavitation (a gas-filled area in the lung) near complete opacity (areas in the normally dark-appearing lung that appear denser, hazy, or cloudy) of the right lower and middle lobes (sections of the lung.)"

During a review of the hospital document titled, "Plan of Care" the MICU and DICU searched for a care plan related to infection and were unable to find one. The MICU stated Pt 2 has infections currently and is at high risk of infection because of his diagnosis of immune deficiency which makes it harder for his body to fight infection. When asked if a care plan for infection management and prevention should have been included in the Care Plan, the DICU stated, "I would have liked there to be one."

2. During a concurrent interview and record review on 11/4/24 at 1:00 p.m. with the Director of Pediatrics (DPED) and the Clinical Educator for Pediatrics (CE1,) CE 1 opened the EMR for Pt 14. The document titled, "H&P (History and Physical) dated 10/29/24 at 4:52 p.m. indicated Pt 14 was a male who was riding a motorcycle on 10/29/24 when he was hit by a car. The note indicated Pt 14 was "found to have a left femur fracture (broken thigh bone) and left pulmonary contusion (a bruise on the lung from a chest injury) ... Assessment & Plan ...A. left open femur fracture (the long bone in the thigh was broken and immune deficiency) ... placed in traction with orthopedics. Given Ancef in the ED (Emergency Department)." The hospital document titled "Orthopedic Surgery Progress Note," dated 11/1/24 at 9:43 a.m. indicated Pt 14 went to surgery on 10/30/24 for a " ...midshaft femur fx (fracture) 2/2 MCC (a fracture that is considered to have a major complication (MCC) due to its severity, typically indicating a displaced or complex fracture that might require extensive surgical intervention and could lead to significant complications like infection, blood loss, or impaired function.)

During a review of the hospital document titled "Plan of Care" DPED and CE 1 searched the document for a care plan related to infection and they were unable to find one. DPED stated, "I don't see a care plan for infection, and all surgical patients are at risk of infection." CE 1 stated nurses should have created a care plan for infection prevention, especially since Pt 14 had an open fracture.

3. During a concurrent interview and record review on 10/31/24 at 2:45 p.m. with the DICS, the opened the EMR for Pt 16. The document titled, "Progress Notes," dated 10/31/24 at 12:01 p.m. indicated, " ...[Pt 16] is a ... male with a medical history significant for recurrent cholangitis (condition that is usually caused by a bacterial infection or blockage in the bile duct near the gallbladder) metastatic cholangiocarcinoma (a rare and aggressive cancer that occurs when bile duct cancer cells spread beyond the bile ducts to other parts of the body, GERD (gastroesophageal reflux disease - A digestive disease in which stomach acid or bile irritates the food pipe lining ...Assessment & Plan ... A: Sepsis ... with most probably intraabdominal (inside the abdomen) source ..."
The DICS then opened the document titled, "Plan of Care" and searched for a care plan related to sepsis or active infection and was unable to find one. The DICS stated nurses should have created a care plan for sepsis.

4. During a concurrent observation and interview on 10/30/24 at 3:25 p.m. with RN 26, we entered a hospital room at Hospital B and observed Pt 17 lying on his back in a hospital bed. Pt 17 appeared to be uncomfortable, and stated he had a "heart problem" and was probably going in for heart surgery.

During a concurrent interview and record review on 10/31/24 at 2:45 p.m. with the DICS, the DICS opened the EMR for Pt 17. The document titled, "Progress Notes," dated 10/31/24 at 7:27 a.m. indicated Pt 17 was a man who went to a nearby hospital with chest pain which started 4-5 days before he went to the hospital. He was transferred to Hospital B for a higher level of cardiac (heart) care. Progress note indicated, "Daily plan: CAD (coronary (heart) artery disease - planned for CABG (Coronary artery bypass grafting (CABG) is a surgical procedure that improves blood flow to the heart by bypassing blocked or narrowed coronary arteries) on 10/31/24 ... Assessment & Plan: NSTEMI (non-ST elevated myocardial infarction - a type of heart attack that occurs when the heart doesn't get enough oxygen.) The DICS then opened the document titled, "Plan of Care" and searched for a care plan related to cardiac care and was unable to find one. The DICS stated nurses should have developed a care plan for cardiac care because that is the main reason Pt 17 came to the hospital and the reason he was having surgery.

During a review of the hospital's policy and procedure (P&P) titled "Interdisciplinary (involves nursing and other health providers) Plan of Care" dated 10/12/23, the P&P indicated, "... initiate the Plan of Care based on the patient's comprehensive assessment and medical care of the provider responsible for the patient ... Document the Interdisciplinary/Nursing Interventions when identified ... Activate interventions for the problems identified based on patient assessment ... For outcomes not met, develop and document an action plan such as notification of provider, change in interventions, or new orders."

All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer).

Based on interview, clinical record review, and hospital policy review, the hospital failed to ensure three out of 73 Patients (Pt) had their pain levels assessed and reassessed in accordance with hospital policy and procedure when:

1. Pt 15 was administered intravenous (IV in the vein) opioid(a class of pain relieving drugs used for moderate to severe pain) for severe pain and did not receive a post intervention pain assessment within 30 minutes.

2. Pt 18 was administered oral (by mouth) medication for moderate pain and did not receive a post intervention pain assessment within 60 minutes.

3. Pt 73 was administered IV medication for severe pain and did not receive a post intervention pain assessment within 30 minutes.

These failures had the potential to delay care and treatment decisions to achieve an acceptable pain level to facilitate timely discharge for Pts 15, 18, and 73.

Findings:

1. During a record review on 10/31/24 2:38pm in the Directors office of Hospital B with the Director of In Patient Cardiovascular Service (DICS), the DICS opened the Electronic Medical Record (EMR) for Pt 15. The document titled, "History and Physical (H&P a formal assessment of a Pt's medical history and current condition)," dated 10/28/24 at 8:07 p.m., the "H&P" indicated, Pt with a "diagnosis of subcutaneous abscess (a pus filled cavity within the skin caused by a local bacterial infection). Pt 15 had two surgical procedures on 9/6/24 to explore and clean the abscess and on 10/29/24 an incision and drainage ("I&D" a cut made to reach the abscess and release pus from the body). Pt 15's "Pain Monitoring Summary" indicated on 10/29/24 at 4:24 p.m., Pt 15 complained of severe pain 10/10 (Pain scale 0 10 descriptors, 0 no pain, 1 3 mild pain, 4 6 moderate pain, and 7 10 severe pain) with pain goal (an acceptable level of pain intensity) of 4/10. Pt 15 was administered IV hydromorphone (an opioid pain medicine to relieve severe pain given in the vein). The "Pain Monitoring Summary" record indicated a post intervention pain reassessment was not documented after receiving an IV opioid.

During an interview on 11/6/24 at 9:20 a.m. at Hospital B with the Manager of Emergency Department (MED1), the MED1 stated he expects Licensed Nurses (LN) to reassess Pt's pain for intervention effectiveness once pain is identified and after medications are administered.

During an interview on 11/6/24 at 11:00 a.m., in the Directors office of Hospital A with the Manager of 1E (M1E), the M1E stated the pain reassessment was expected to occur within 30 minutes after giving an IV pain medication or one hour after giving an oral pain medication to ensure pain has resolved or to implement another intervention if the pain has not been relieved.

2. During a record review of Pt 18's "Hospitalist Daily Progress Note", dated 10/31/24, the progress note indicated, this was previously admitted to Hospital A on 9/15/24 and discharged 9/19/24 subsequently re admitted to Hospital A on 10/28/24. Pt 18 had swelling on the lower right leg, a chronic wound over the right lower leg, right mid and lower femoral deep vein thrombosis ("DVT" a blood clot formed in a deep vein, usually in the legs) and thrombophlebitis (an inflammatory process that causes a blood clot to form and block one or more veins, usually in the legs).

During a record review and concurrent interview on 11/5/24 2:10 p.m., in the Director's office at Hospital B with Director of In Patient Cardiovascular Service (DICS), the DICS opened the EMR for Pt 18. The document titled; "Pain Monitoring Summary" dated 10/30/24 at 5:22 p.m. indicated Pt 18 complained of inner ankle pain 6/10 (moderate pain) with a pain goal of 5/10. Pt 18 was administered an oral (by mouth) dose of 650 milligrams (a unit of measurement of weight ) acetaminophen. (pain reliver or feverreducer) The "Pain Monitoring Summary" record indicated a pain reassessment was not documented after receiving oral pain medication. The DICS stated there was no post intervention pain reassessment done after Pt 18 was administered medication at 5:22 p.m.

During an interview on 11/6/24 at 9:20 a.m., at Hospital B with the Manager of Emergency Department (MED1), MED1 stated, he expects LNs to reassess Pt's pain for intervention effectiveness once pain is identified and after medications are administered.

During an interview on 11/6/24 at 11:00 a.m., in the Directors office of Hospital A with the Manager of 1E (M1E), M1E stated, pain reassessment was expected to occur within 30 minutes after giving an IV pain medication or 1 hour after giving oral pain medication to ensure pain has resolved or to implement another intervention if the pain has not been relieved.

3. During a concurrent interview and record on 11/7/24 with the Director of Emergency Department (DED) the DED opened the Electronic Medical Record (EMR) for Pt 73. The document titled, "History and Physical" (H&P a formal assessment of a Pt's medical history and current condition by a medical provider) dated 10/30/24, indicated Pt 73 arrived at Hospital A on 10/30/24 at 9:16 a.m. with chief complaint low back pain. The "H&P" indicated, " ... who presents to the Emergency Department (ED) with headache and lower back pain ... notes she has peed herself due to having to walk slow from her back pain and did not make it to the toilet ..."

During a concurrent interview and record review on 11/7/24 at 2:45 p.m., with the DED, Pt 73's "Emergency Department Timeline (EDTL)", dated 10/30/24 was reviewed. The "EDTL" indicated, " ... 10:01 [a.m.] Medication Given: acetaminophen (Tylenol) table 1,000 mg [milligram, a unit of measure] Dose 1,000 mg; Route: Oral ...". The "EDTL" indicated no other pain assessment was conducted until 12:37 p.m. on 10/30/24. The "EDTL" indicated, " ...12:38 [p.m.] Medication Given: Ketorolac (pain medication) injection15 mg Dose 15 mg; Route:
Intravenous (administered into a vein) ..." The "EDTL" indicated no other pain assessment was conducted until 14:00 (2:00 p.m.). The DED stated oral pain medications should be reassessed in 45 minutes to an hour and IV (intravenous) medications should be reassessed in 15 minutes to 30 minutes. The DED stated if pain is not reassessed, then there is no way of knowing if the medication was effective. The DED stated reassessments were not completed on Pt 73 and should have been.

During a review of facility's policy and procedure titled, "Pain Assessment & Management Patients 14 and Older" Policy and Procedure dated 9/13/24, indicated, "...E. Evaluation/Reassessment of Pain Management ...2. Reassessment: pain intensity, level of sedation, respiratory rate, and pattern, if receiving opioids, and presence of adverse effects (an unwanted undesirable effect that is possibly related to a drug) will be reassessed after each unscheduled pharmacological (using medication to treat a patient's condition) pain management intervention (the act of interfering to prevent harm or improve function) once a sufficient time has lapsed for the treatment to reach peak effect. A. Generally, IV medication is effective within 30 minutes and PO (by mouth) medication is effective within 60 minutes. This re assessment will be documented in the EHR (electronic health record) using the appropriate pain and sedation scale ...4. Compare post intervention pain level to acceptable pain level to determine intervention effectiveness and/or additional interventions for Pts able to provide a self report ..."

Based on observation , interview, and record review, the hospital failed to ensure Licensed Nurses (LNs) administered medications in accordance with the hospital's policy and procedure (P&P) titled "Medications Orders, Administration, Storage, Documentation" and acceptable standards of practice for medication administration safety, when one of one sampled patients, (Pt) 74 was administered fentanyl and versed from incompletely labeled syringes (without required " 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 ...,") intravenously (IV into the vein) bolused (single dose of a drug or other substance given over a short period of time) medication(s) by Registered Nurse (RN) 9 which had been prepared by another LN (RN 10).

This failure resulted in a medication administration error for Patient (Pt) 74. Pt 74 received IV medication without administering LN verification of the "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 (a thin, flexible tube that's inserted into a vein). 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...)" prior to use, which had the potential to result in Pt 74's harm, up to and including death.

Findings:

During an observation of Pt 74's procedure on 11/6/24 at 8:48 a.m. in the Interventional Radiology (IR-a medical specialty that uses minimally invasive image-guided procedures to diagnose and treat conditions in the body) department, room one (1), RN 9 was observed at the bedside speaking with Pt 74. RN 10 was observed to be drawing up medication from two vials into separate syringes at the medication cart located in room 1. RN 10 recapped the syringes and placed the empty vials onto the left, lower area on the surface of the medication cart. RN 10 handed the 2 pre filled syringes to RN 9. RN 9 administered the ordered IV medication during the procedure.

During a review of Pt 74's "Short Form History and Physical (H&P)" dated 11/6/24, the H&P indicated, "..History of Present Illness: Renal (kidney) failure, ascites (a buildup of fluid in your abdomen (belly) often due to liver disease), poor function to perm cath (a flexible tube that's inserted into a blood vessel in the neck or upper chest to provide long term access to the bloodstream) ... Past Medical History ...Congestive Heart Failure (CHF when your heart can't pump blood well enough to give your body a normal supply), Chronic kidney disease, (CKD- is a long-term condition that occurs when the kidneys are damaged and can't filter blood properly) dialysis (a treatment that replicates the kidney's function and cleans the waste from blood for individuals with kidney disease or kidney failure) patient ..."

During a review of Pt 74's "Authorization for and Verification of Consent to Surgery, Administration of Anesthetics [a drug or other substance that causes a loss of feeling or awareness] and Rendering of Other Medical Services (Consent)" dated 11/6/24, the Consent indicated Pt 74 was to have a " ...Tunneled dialysis (a flexible catheter (thin tube) that goes into a vein in your chest) catheter exchange with procedural sedation (the techniques of managing a patient's pain and anxiety to facilitate appropriate medical care) and paracentesis (a procedure in
which a thin needle or tube is put into the abdomen to remove fluid from the peritoneal cavity (the space within the abdomen that contains the intestines, the stomach, and the liver)."

During an interview on 11/6/24 at 9:25 a.m. with RN 9 and RN 10 immediately after Pt 74's procedure in the IR procedure room, RN 10 stated he obtained and drew up the sedation medications (Fentanyl and Midazolam) ordered by the IRMD and transferred them into the syringes for use during the procedure. RN 9 stated she had and pre-labeled the syringes with medication name labels. RN 9 stated this practice allows for the RN to know which medication should be transferred into them. RN 9 and RN 10 explained they have worked as a team for some time and have developed a workflow in which like the situation with Pt 74, one nurse drew up the medication and the other administered it. RN 9 stated she did not watch RN 10 transfer medications from vials to the pre-labeled syringe(s). RN 9 referred to the syringes used in Pt 74's procedure and each syringe was observed to have a only a medication name label on the each syringe. RN 10 stated he did not prepare the medication in the presence of RN 9, she was "with the patient, trying to calm him down." RN 10 stated he was not aware of a policy against this practice. RN 9 stated she was not able to ensure the right medication had been drawn up in the right syringe(s) because she did not witness RN 10 prepare the medications. RN 9 stated the potential harm to the patient, as a result of this practice is that the patient could receive the wrong medication.

During an interview on 11/6/24 at 9:38 a.m. with the Clinical Supervisor (CS) 1 and the Interim Director of Imaging Services (IDIS), they stated their expectation was for LNs to follow the hospital's P&P on medication administration.

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 ... III. POLICY: ... B. Medication Administration ... 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 ... 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 ... d. Immediately discard any medication or solution that is found unlabeled ..."

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, electronically obtained from https://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2024/npsg_chapter_hap_jan2024.pdf on 11/15/24, 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 (the time around a surgical operation, typically from when a patient enters the hospital or doctor's office until they return home) and other procedural settings (a room in a hospital where procedures are performed that may require sterile (free from germs) instruments or supplies, but don't require an aseptic (medically clean or without infection). 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 ndicated (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 settings 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 colleagues 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, 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."

Current and accurate records must be kept of the receipt and distribution of all scheduled drugs.

Based on interview and record review, the hospital failed to ensure an effective system to monitor high usages of controlled drug (medications with high probability of addiction and are controlled by the federal government) by providers and accurately reconcile controlled drugs losses for two of five sampled patients (Patients 54, 57).

This failure increased the potential to result in unaccounted controlled drug loss and for hospital staff to divert controlled drugs, which could put Patients 54 and 57 at risk for potential adverse outcomes including inadequate pain relief, as well as the potential for hospital staff to abuse controlled drugs.

Findings:

During an interview on 10/31/24 at 11:28 a.m., with Pharmacy Manager (PM), when asked about reconciliation of controlled drug losses, PM stated the Control Substance Coordinator (CSC) was responsible for reconciling control drug discrepancies (records of drugs taken out of an automated dispensing cabinet [ADC machine containing controlled drugs] by nurses or providers but are not accounted for by administration or waste records) in the hospital. PM stated CSC reviewed reports and patient records on weekdays and worked closely with the hospital's drug diversion committee.

During a concurrent interview and record review on 11/1/24 at 1:17 p.m., with CSC and Pharmacy Manager Education and Clinical (PMEC), a report titled, "Providers Reconciled Discrepancy Report (PRDR)," dated 10/1/24 to 10/31/24, were reviewed. The PRDR indicated the following:

On 10/8/24, an anesthesiologist (doctor who administers drugs to cause a loss of feeling or awareness [anesthesia] in a patient), withdrew Ketamine (medication that doctors use as an anesthetic to induce loss of consciousness) 100 mg (milligrams unit of measurement) from an
ADC and administered 40 mg to Patient (PT) 54. The PRDR indicated Ketamine 60 mg was unaccounted for, when asked, CSC was unable to locate documentation of Ketamine 60 mg administration or waste for PT 54 on 10/8/24. A review of PT 54's Anesthesia Record, dated 10/8/24, indicated the same anesthesiologist that administered Ketamine 60 mg to PT 54 on 10/8/24 had documented the administration 13 days later, on 10/21/24.

On 10/15/24, an anesthesiologist withdrew Fentanyl (medication used for pain management) 100 mcg (microgram unit of measurement) from an ADC for PT 57. The PRDR indicated Fentanyl 100 mcg was unaccounted for, CSC was unable to locate documentation of Fentanyl
100 mcg administration or waste for PT 57 on 10/15/24. A review of PT 57's Anesthesia Record dated 10/15/24, indicated the same anesthesiologist that administered Fentanyl 100 mcg to PT 57 on 10/15/24 had documented the administration 6 days later, on 10/21/24.

During a continued concurrent interview and record review on 11/1/24 at 1:17 p.m. with CSC and PMEC, CSC acknowledged the anesthesiologists' common practice was to resolve the control drug discrepancies by documenting late administration entries for the unaccounted controlled drug administrations on patients' anesthesia records. PMEC stated providers could make corrections on patients' medication administration record and document the administration was given on a specific day. When asked if there was a surveillance report to track and trend how many providers were documenting late administration entries for control drug administrations, PMEC stated no. When asked how pharmacy was able to determine
whether the late entries were accurate or potential diversions, PMEC was unable to provide an answer.

During an interview on 11/1/24 at 2:21 p.m., with CSC and Director of Pharmacy (DOP), CSC stated unresolved discrepancy reports and high user (providers and staff with high number of control drug dispense) reports were emailed to nursing management. CSC acknowledged
providers including anesthesiologists and CRNAs (Certified Registered Nurse Anesthetist a nurse who administers anesthesia and other medications, and provide care before, during, and after medical procedures) also accessed control drugs out of the ADC . When asked if high
user reports for providers were shared with the anesthesiologists, CSC stated no. The CSC said high user reports were given to nursing management to share with the anesthesiologists. DOP acknowledged nursing management did not have oversight over the anesthesiologists
and did not monitor anesthesia practice.

During an interview on 11/4/24 at 1:13 p.m., with PM and DOP, PM stated the purpose of the high user trend report was for pharmacy to collaborate with nursing and anesthesia to identify trends and intervene if it could potentially lead to diversion. DOP stated there were
opportunities for additional oversight for anesthesia providers and control substance handling practices. DOP acknowledged pharmacy was expected to have oversight of controlled drug handling.

During an interview on 11/4/24 at 3 p.m., with Chief Nursing Officer (CNO) and DOP, CNO stated the CNO was part of the controlled substances diversion prevention committee. CNO acknowledged the committee would not be able identify potential controlled drug diversion
(illegal use of prescription medication or use for purposes not intended by the prescriber) with the current practice used by anesthesiologists to resolve control drug discrepancies. DOP acknowledged the expectation was for anesthesia providers to have documented their review of the high user report. DOP was unable to provide documentation that the high user report for providers was being reviewed.

During a review of the hospital's Policy and Procedure (P&P) titled, "Controlled Substance Surveillance System", dated 6/27/24, the P&P indicated, "Monthly Review of Anomalous Usage Report. Pharmacy generates an ADC report that identifies ADC end users with high activity of controlled substance withdrawals in comparison to a similar cohort. This report is reviewed by the pharmacy leadership and unit nursing and anesthesia leadership to ensure appropriate use of controlled substances. Nursing and anesthesia leadership attests compliance on a monthly basis."

During a review of the hospital's P&P titled, "Controlled Substances Diversion Prevention Steering Committee Charter", dated 3/12/4, the P&P indicated, "Reviews and analyzes organizational data from controlled substances surveillance reports on a regular basis to identify trends and opportunities for improvement."

§482.25(b) Standard: Delivery of Services

In order to provide patient safety, drugs and biologicals must be controlled and
distributed in accordance with applicable standards of practice, consistent with
Federal and State law.

Based on interview and record review, the hospital failed to develop and implement a policy and procedure that addressed the use of auto verified medication orders (orders entered by providers and medications dispensed bypassing verification of a pharmacist) and did not
have a system for monitoring the appropriate use of the auto verification process to ensure that medications dispensed by the use of auto verification process was distributed in accordance with applicable standards of practice. The hospital auto verified approximately
60,000 medication orders from 10/1/24 to 10/31/24.

This failure had the potential for the dispensing and administration of inappropriate medications auto-verified for all patients in the Emergency Department (ED), resulting in patent harm.

Findings:

During an interview on 10/30/24 at 9:57 a.m., with Director of Pharmacy (DOP) and Pharmacy Manager (PM), DOP and PM were asked about the medication order verification process. DOP stated ED providers were able to enter certain medication orders without verification by a pharmacist. DOP stated the auto verified orders entered by the ED providers were made available to licensed nursing staff to administer to patients from the automated dispensing machine (medication distribution system that provides computer controlled storage, dispensing, and tracking of drugs at the point of care in patient care units).

During an interview on 10/30/24 at 1:48 p.m., with PM, when asked about the hospital's Auto verification Policy and Procedures (P&P), PM stated the hospital did not have an auto verification P&P. PM stated management had decided to turnoff auto verification process in the ED.

During an interview on 11/1/24 at 11:11 a.m., with Medication Safety Coordinator (MSC) and DOP, MSC stated he was unsure when auto verification process was initiated or who initiated it. DOP stated it was initiated in 2011 due to concerns for potential delay and turn around time for medications in the ED. DOP stated the medication order had to be placed by an ED physician for an ED patient for a medication that was available in the automated dispensing machine and not on the hospital's "Never Auto verify" list.

During an interview on 11/1/24 at 11:16 a.m., with MSC and DOP, when asked about the importance of having a hospital P&P for auto verification, MSC stated an auto verification P&P would have provided additional guideline and transparency. DOP stated an auto verification P&P would have had periodic review and evaluation of the process. DOP stated medications were periodically added to the "Never Auto verify" list. DOP acknowledged she was a member of the Pharmacy & Therapeutics (P&T) committee, and stated its role was to
have oversight in pharmaceutical service (processes involved in the preparation, distribution, and administration of drugs) to ensure medications were available and used appropriately. The DOP added, it would have been useful to have a standardized policy. MSC stated
having auto verified medications that have undergone medication safety review would add another layer of oversight to have ensured appropriate use of auto verified medications.

During an interview on 11/1/24 at 11:23 a.m., with DOP, DOP stated the decision to have auto verification happened before her leadership. DOP acknowledged since she had been in the position of DOP, no guidelines were established for the use of auto verification in the hospital.
DOP stated it was important to establish clear criteria for selection of medications that can or cannot be auto verified for associated risk, as well as have periodic review of process and patient outcome. When asked about retrospective review (looking back at auto verified
medication orders that have been processed for appropriateness and outcomes to improve process) of auto verified medication orders, DOP stated no retrospective review of auto verified medication orders had been conducted since the auto verification process was initiated in 2011. DOP acknowledged that by bypassing a pharmacist's first review, a patient could potentially have been administered an inappropriate dose of a medication. DOP acknowledged auto verified medication orders were not restricted to one time orders, and could have been ongoing orders in ED, where a patient could have received multiple doses of an auto verified medication.

During a review of the hospital's "Never Auto verify" list, undated, the following medications were not observed to be on the list: fentanyl (controlled substance drug with a high potential for abuse and addiction, used to treat pain) IV (intravenous into the vein), propofol IV
(powerful drug used to help patients relax or sleep), and Vancomycin IV (drug used to treat infections). DOP acknowledged the medications were not listed on the hospital's "Never Auto verify" list and stated fentanyl IV could have been ordered by a provider as an ongoing order
without review by a pharmacist, which could have potentially put a patient at risk for adverse effects such as respiratory depression or sedation if inappropriate doses were administered. DOP stated propofol IV and vancomycin IV could have also been ordered by a provider as
ongoing orders without review by a pharmacist, which could have also potentially put a patient at risk for adverse effects.

During a record review on 11/4/24 at 11:18 a.m., with DOP and PM, the hospital's "Auto verified Medication Order List", dated 10/1/24 to 10/30/24 was reviewed. The hospital's "Auto verified Medication Order List" indicated orders for Patients (PT) 52 and 53.

During a review of PT 52's "Medication Administration Record (MAR)," dated 10/5/24, the MAR indicated fentanyl (medication for pain) 75 mcg (micrograms unit of measurement) IV every 2 hours as needed for severe pain, ordered 10/5/24 at 7:54 p.m., and discontinued on
10/6/24 at 5:18 p.m.; lidocaine patch (medication for pain), apply 1 patch to right lower back, and 1 patch to left lower back every 24 hours, administered over 12 hours, ordered 10/5/24 at 9:18 a.m., and discontinued on 10/6/24 at 5:18 p.m.

During a concurrent interview and record review with DOP on 11/4/24 at 11:29 a.m., PT 52's MAR was reviewed. DOP acknowledged PT 52's fentanyl and lidocaine patch orders were continuous orders and not one time orders and were processed via auto verification. DOP
acknowledged lidocaine patch was not considered an emergency medication and stated the rules were for ED providers to write medication orders that were on not on the "Never Auto verify" list, however some of the medications auto verified included routine medications and
non emergency medications.

During a review of PT 53's MAR, dated 10/5/24, the MAR indicated hydromorphone (pain medication) 0.5 mg (milligrams) IV every 2 hours as needed for severe pain, ordered 10/5/24 at 9:06 a.m., and discontinued on 10/7/24 at 12:40 a.m.

During a concurrent interview and record review with DOP on 11/4/24 at 11:38 a.m., PT 53's MAR was reviewed. DOP acknowledged PT 53's hydromorphone order was not a one time order.

During an interview on 11/4/24 at 2:41 p.m., with Chief Nursing Officer (CNO), and Director of Nursing Operations (DNO), when asked about auto verification, CNO stated it was established to keep up with patient flow during emergencies, to prevent delay in patient care. CNO acknowledged the hospital did not have an auto verification policy and procedure, and stated the importance of a policy and procedure was to enable review by all disciplines, including physicians and nursing staff to make sure everyone agreed, conduct risk assessment, and ensure the practice was safe. CNO acknowledged PT 52's lidocaine patch order was not an emergency order and stated non emergency medication orders were included for auto verification. CNO acknowledged if a medication was not ordered as one time but as needed, then the medication order was be considered a maintenance order. CNO stated it was important for pharmacist, professionals who were specialized with medications, to assist physicians and nursing to check the effect of an ordered medication on the patient's diseases, allergies, kidney function, or anything that would change the effect of a medication. DNO acknowledged the hospital did not conduct a retrospective review of auto verification medication orders and stated, it should be happening. CNO stated it was important to look for safety concerns around anytime of dosing. When asked how many medication orders were being auto verified, DNO stated approximately 2,000 orders per day.

During a review of the hospital's P&P titled, "Pharmacy and Therapeutics Committee Charter," dated 2/9/23, the P&P indicated, "To review and recommend to the MEC [Medical Executive Committee committee of medical staff who is responsible for making decisions related to patient care, clinical policies, and physician performance] relevant policy, procedures, and protocols that may be necessary for the operation of medication usage and nutrition care."

During a review of American Journal Health System Pharmacy article titled, "ASHP [American Society of Health System Pharmacists] Guidelines: Minimum Standard for Pharmacies in Hospitals," dated 2013, the article stated, "All medication orders shall be prospectively
reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in which the treatment of the patient would be significantly
compromised by the delay that would result from pharmacist review of the order. There shall be a procedure for retrospective review of these orders."

During a review of American Journal Health System Pharmacy article titled, "ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System," dated 5/15/21, the article stated, "The formulary system should review and approve all policies related to the medication use process; all medication use policies, regardless of their origination, should flow through the P&T committee."


During a review of ASHP article titled, "Autoverification Toolkit," dated 2024, the article stated, "3. Define scope for autoverification ... 5. Draft policy changes to support autoverification within the organization. a. Medication use policies b. Downtime policies .... 6. Seek appropriate committee approval for policy changes. a. Pharmacy and Therapeutics b. Relevant clinical leadership/medical staff committees ... 8. Develop process for continued assessment and optimization/new requests for autoverification. Monitoring may include but is not limited to: a. Patient safety events b. Technical event c. Retrospective analysis of auto verified orders d. Autoverification utilization ... 9. Develop education plan for all appropriate stakeholders. a. Initial roll out education b. Ongoing educational needs ..."

§482.25(b)(1) All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws.

Based on interview and record review, the hospital failed to ensure all sterile (germ free) compounding (a process of making sterile medications administered into the vein) and the administration of chemotherapy (toxic cancer treatment that uses drug to kill or stop the
growth of cancer cells) drugs was performed consistent with national standards of practice when:

1. For one out of one sampled patient, Patient (PT) 51, chemotherapy medication Gemcitabine was dispensed from pharmacy and administered without the use of a closed system transfer device (CSTD drug transfer device that prevents the transfer of contamination from
environment into the drug containing system and the escape of hazardous drug or vapor concentrations outside the drug containing system).

2.One of one Environmental Services Staff (EVS) (EVS 1), cleaned the sterile compounding area without completion of the pharmacy competency assessment.

These failures increased the potential for patients to be administered contaminated medications leading to severe infections and exposure of hazardous drugs to patients and staff leading to adverse effects, including skin irritation, and severe effects, pregnancy complications, and
cancer.

]Findings:

1. During an interview on 10/30/24 at 10:20 a.m. with the Sterile Compounding Coordinator (SCC) in the pharmacy sterile compounding room, SCC stated all compounded chemotherapy drugs were sent with CSTD, unless the provider who ordering the medication requested not to have one. SCC stated in most instances chemotherapy medication prepared in a syringe was dispensed with a CSTD and chemotherapy medication dispensed in an IV (intravenous into the vein) bag was dispensed with tubing (connects IV bag to patient's access site) containing normal saline (solution of salt and water),in most instances.

During an interview on 10/31/24 at 2:02 p.m., with Registered Nurse Educator for Surgery (RNES), when asked about chemotherapy medication administration into a patient's bladder, RNES stated pharmacy delivered the chemotherapy medication in a syringe to the operating
suite (section of hospital that includes multiple operating rooms, as well as other rooms and spaces). During surgery, a licensed nurse would hand the syringe containing chemotherapy medication to the surgeon, and the surgeon would administer the chemotherapy. When asked how the surgeon administered the chemotherapy medication into the patient's bladder, RNES stated the surgeon would attach a bigger syringe to the patient's foley catheter (flexible tube that drain urine from the bladder) then removed the cap off the smaller syringe with chemotherapy medication, administered chemotherapy medication into larger syringe, and used gravity for instillation (medical procedure to slowly introduce a liquid medication into the body) into bladder through the foley catheter.

During an interview on 10/31/24 at 2:11 p.m., with Nursing Manager for the operating room (NM) 11, NM 11 stated that administering administration of chemotherapy medication from smaller syringe into larger syringe using gravity was not a closed system if the smaller
syringe containing the chemotherapy medication did not attach directly to the foley catheter. NM 11 stated when by not using a CSTD was not used, the chemotherapy medication was exposed to the air, potentially exposing staff, and patient to chemotherapy medication.

During an interview on 10/31/24 at 2:14 p.m., with Pharmacy Manager (PM), PM stated that Gemcitabine (chemotherapy medication that can be used to treat bladder cancer) had a CSTD, what pharmacy was missing was the CSTD connector that attached to the foley. PM stated
pharmacy would make sure to send the CSTD connector with any hazardous drug which had to be administered using an intra catheter (tube inserted into the bladder to deliver drugs directly into the bladder).

During a concurrent interview and record review on 10/31/24 at 2:25 p.m., with PM, PT 51's "Medication Administration Record (MAR)," dated 7/18/24, was reviewed. The MAR indicated Gemcitabine 2000 mg (milligrams unit of measurement) in Normal Saline (solution of salt and water) 0.9% (concentration) ml (milliliter unit of measurement) intravesical (within the bladder) syringe, with administration instructions, "must be administered by MD [physician]. NOT FOR IV USE. Chemotherapy drug, use double ASTM [develops standard for chemotherapy gloves] gloves, chemo gown, eye/face protection (if liquid that could splash), and CSTD for administration. Dispose of properly,", was ordered on 7/18/24 at 11:18 a.m. and administered on 7/18/24 at 2:56 p.m. The PM acknowledged Gemcitabine was dispensed from pharmacy in a CSTD.

During a telephone interview on 11/4/24 at 12:38 p.m., with Medical Doctor (MD) 1, MD 1 stated he was one of two urologists (doctor who specializes in conditions that affect the urinary tract and reproductive system in people) who performed bladder instillation with
chemotherapy medications at the hospital. MD 1 stated that during a bladder instillation surgery, immediately following the procedure after a foley catheter with a catheter syringe was placed in the patient's bladder, he would inject the chemotherapy medication from the smaller
syringe into the catheter syringe and allowed it to drain by gravity. MD 1 stated he was aware of using a CSTD and used one at the infusion center. MD 1 stated using an CSTD in the operating room will required pressure, which would not have been safe for a patient who had just undergone surgery, so it was considered safer to have been administered by using gravity. MD 1 acknowledged he did not use a CSTD. MD 1 acknowledged by injecting the chemotherapy medication from the smaller syringe into the catheter syringe, the medication was no longer sterile and stated it was done at the end, after the sterile part of the procedure.

During an interview on 11/4/24 at 4:26 p.m., with Director of Pharmacy (DOP) and Vice President of Regulatory, Risk, Medical Affairs (VPR), when asked about compounding and dispensing Gemcitabine with CSTD, DOP stated pharmacy was able to compound Gemcitabine in IV solution bags with primed tubing or syringes with CSTD, based on provider preference. VPR stated providers had tried it with a bag once and it leaked into the surgical field. When asked, VPR was unable to provide literature regarding the inability to use CSTD during administration of the chemotherapy medication in an operating room due to positive pressure not safe for patients who had just undergone surgery.

During a review of the "CSTD Manufacturer Information Leaflet (MIL)" provided by the hospital, the MIL indicated, "[brand] closed male luer [type of connector attached to syringe to make it leak free connections between two parts] for use with [brand] needle free valve and
open female luer connectors only ... Achieving a Closed System. Proper use of [brand] closed male luer and [brand] needle free valve will ensure a closed system. A closed system may also be achieved with an open female luer connector if handled as follows: do not disconnect the
system once it is connected. Discard the entire system as one after use."

During a review of an article provided by the hospital, titled, "Intravesical Administration of Therapeutic Medication for the Treatment of Bladder Cancer,", dated 6/2020, the article indicated, "Reconstitute 1000 mg/50 ml normal saline or 2000 mg/50 100 ml normal saline, or use premixed Gemcitabine with closed system administration set ... Procedure: Insert a catheter tip syringe containing the treatment with an adaptor at the tip of the syringe to prevent spillage or splash during insertion. Or, insert the primed tubing attached to medication vial into the catheter. Instill ... Gemcitabine per gravity flow or by gentle push instillation."

During a review of United States Pharmacopeia (USP a nationally recognized reference for hazardous drug) publication titled, "USP 800 Hazardous Drugs Handling in Healthcare Settings" printed 10/9/23, the publication indicated, "A CSTD must be used when administering antineoplastic HDs [hazardous drugs] when the dosage form allows."

During a review of Pharmacy Times (a nationally recognized reference) article, titled "Closed System Transfer Devices Reduce Exposure to Contaminants,", dated 3/2023, the article indicated, "Closed system transfer devices (CSTDs) are used during the preparation of hazardous drugs (HDs) as a mechanism to reduce the transfer of drugs or vapors into the environment ... Antineoplastic [cancer treating] drugs are generally nonselective in their mechanism of action [how they work], affecting both cancerous and noncancerous cells; this leads to adverse effects, including skin irritation, and severe effects, such as pregnancy complications and some forms of congenital [condition present at birth] disabilities. Exposure is even linked to some forms of cancer.1 Therefore, nurses, pharmacists, and pharmacy technicians handling these medicines face exposure to aerosols, droplets, and vapors of dangerous chemotherapy drugs, which can easily escape standard syringes and
contaminate the workplace. Furthermore, because of the adhesive properties of chemotherapy drugs, these contaminants can leave the designated workspace.4 Traces of chemotherapy drugs have been found on unlikely places, such as doorknobs, keyboards, and other surfaces,
placing other hospital staff members, patients, and their families at risk."

2. During a concurrent interview and record review on 11/1/24 at 3:40 p.m., with Sterile Compounding Coordinator (SCC), the "EVS Cleaning Log (CL),", dated September 2024 was reviewed. The CL indicated EVS 1 independently entered and cleaned the hazardous and
non hazardous IV sterile compounding areas on 9/7/24 and 9/8/24. SCC acknowledged EVS 1 independently entered and cleaned the hazardous and non hazardous IV sterile compounding areas but was unable to provide documentation for EVS 1's completion and passing of
the EVS competency administered by pharmacy. SCC stated EVS is expected to notify pharmacy of any new EVS staff so they can complete the cleaning competency. SCC stated EVS 1 should not have cleaned the IV sterile compounding areas by herself if she was not signed off for competency because it could potentially lead to microbial (organisms that are too small to see with the naked eye and can cause disease) growth in the IV sterile compounding rooms.

During an interview on 11/1/24 at 3:51 p.m. with EVS Supervisor (EVSS), EVSS stated EVS staff was expected to pass the EVS competency administered by pharmacy before EVS staff was allowed to clean the IV sterile compounding areas. EVSS stated she placed EVS 1 on the schedule to clean the IV sterile compounding area even though EVS 1 had not completed or pass the competency required by the pharmacy department because she did not have any other staff and did not communicate with pharmacy. EVSS stated having an EVS staff who was not properly trained to clean the IV sterile compounding areas could potentially lead to contamination of the pharmacy and medications.

During an interview on 11/1/24 at 3:55 p.m. with DOP, DOP acknowledged potential for contamination of the IV sterile compounding areas and sterile medications, and stated the expectation was for EVS to notify pharmacy and pharmacy would have a trained pharmacy staff clean the IV sterile compounding areas.

During a review of the hospital's "EVS Cleaning/Disinfecting/Decontaminating Observational Competency (EVS Competency)" undated, the EVS Competency indicated, "Minimum acceptable score: 100% compliance with procedures and techniques. Personnel must attend [hospital] new product education. Personnel will be provided MDSD MSDS [Material Safety Data Sheet provides information on how to safely handle chemical products] for current cleaning and disinfecting products for their review. Personnel will be provided information on decontamination of surfaces soiled with hazardous drugs. Personnel will understand and demonstrate the following procedures listed below for cleaning/disinfecting/decontaminating secondary engineering controls (SEC [germ free area with increased air supply, filtration, and pressure where equipment for making sterile medications are housed]) in order to successfully pass competency."

During a review of the hospital's Policy and Procedure (P&P) titled, "Intravenous Admixtures,", dated 5/23/24, the P&P indicated, "All cleaning and disinfecting activities will be performed by trained and appropriately garbed [clothed] personnel using facility approved agents and procedures."

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 observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when:

1. Clean utility rooms, medication rooms and nursing stations had peeling stickers leaving adhesive residue on the surface, and

2. IV tubing labels did not have a discard date in place.

These failures placed staff and patients at risk of cross contamination and infection in Hospital A and Hospital B (Antepartum, Labor & Delivery, Neonatal Intensive Care Unit, Obstetric Triage, Pediatric, Cardiovascular Unit, Medical/Surgical/Telemetry, Post Anesthesia Care Unit).

Findings:

1. During an observation and concurrent interview on 10/30/24 at 4:23pm at Hospital B with the Manager of Med/Surg/Telemetry (FMMS) and Manager of PACU (FMP), the 3rd Floor clean utility room and 2nd Floor Phase 2 clean utility room cabinet and shelves had paper labels that were lifting, peeling, and leaving adhesive residue on the surface. The FMMS stated the peeling labels were a potential source of infection because staff cannot clean the surface completely. The FMP stated the peeling and lifting labels harbor bacteria and staff are unable to clean which creates the potential to transmit bacteria from staff hands to the sticker and to a patient.

During an observation and concurrent interview on 10/31/24 at 9:17am Hospital A with the Director of Pediatrics (DPED) and the Manager of 4NICU (M4NICU), the 4NICU's clean utility room, medication room, Respiratory Therapy storage room, and soiled utility room cabinets, drawers, supply storage containers and biohazard containers had paper labels lifting and/or peeling leaving adhesive residue on the surface. At 9:35am, the M4NICU stated the area where the paper labels were peeling or lifting cannot be cleaned properly which may lead to an infection prevention concern.

During an observation and concurrent interview on 10/31/24 at 9:42am Hospital A with DPED and M4NICU, the 4NICU patient care area Room 467 had tape used to secure laminated printed signage on cabinets. The DPED stated they previously did not use tape to secure signs. The DPED stated tape can be a source that harbors bacteria and may create an infection risk.

During an observation on 10/31/24 at 10:43am at Hospital A with the Director of Pediatrics (DPED), the Labor & Delivery Med Room (H3150) had paper labels on the cabinet shelves and in OB Triage on cabinets 6, 7, 8.

During an interview on 10/31/24 at 1:21pm Hospital A Director's office with VPSC, SCM, and SCD, the SCD stated they reviewed the photos of the peeling labels with adhesive exposed or residue left on the surface at Hospital A and Hospital B. SCD stated they are in the process of a 6-month conversion optimization re-labeling project. SCD stated they will create a day-to-day process to audit the condition of the labels to ensure staff escalate to leadership when labels need to be replaced and utilize QAPI to audit for compliance.

2. During an observation and concurrent interview on 10/30/24 at 3:50p.m., in Hospital B with the Manager of Medical/Surgical/Telemetry (FMMS) and CPCU Clinical Supervisor (FCCS), Room 305 had an intravenous line (within a vein, a tube or needle is placed inside a vein for giving medication or fluids into the bloodstream) sticker without the date to be changed. FCCS stated the IV tubing stickers have different colors for days of the week the tubing change is due and the IV tubing maybe changed from every 3 days to every 7 days.

During an observation on 10/31/24 at 9:42am Hospital A with the Director of Pediatrics (DPED) and Manager of NICU (M4NICU), in 4W NICU Room 467C the IV-line sticker did not identify the discard date.

During an interview on 11/7/24 1:04pm at Hospital A Directors Office with the Director of Pediatrics (DPED), the DPED stated the IV tubing is changed every 72 hours and labeled using a color-coded label identifying the day of the week it should be changed, example Saturday, Sunday, Monday etc. The DPED stated the IV tubing label should be dated/timed per the policy to ensure the tubing is changed timely to avoid tubing being changed on the second or third Saturday. The DPED stated the risk of not changing an IV tubing timely could increase the risk to develop a blood stream infection.

During a conference call interview and hospital policy review on 11/7/24 2:30pm in Hospital A Directors Office with the Director of Inpatient Cardiovascular Service (DICS) and the Clinical Supervisor (RN13), RN 13 stated the iv tubing labels are color coded and should state the day the label must be changed. RN 13 stated IV tubing labels should be changed every 7 days. RN 13 stated they do not need to write a date on the label because staff may change the IV tubing before 7 days. RN 13 reviewed the hospital policy and procedure titled, "Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites" dated 6/14/24. RN13 stated "if you take it word for word, you should write the date the IV tubing should be changed on the IV tubing label". RN 13 stated the patient would have an increased risk of infection iv the IV tubing is not changed timely because the tubing may collect bacteria as some medications may corrode and cause cracking in the tubing.

During a review of the hospital's policy and procedure titled, "Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites", dated 6/14/2024, section "V. PROCEDURE" indicated, "C. Label new IV tubing with date to be changed."
According to the American Journal of Infection Control, dated 9/2021, retrieved 11/14/24 from https://www.ajicjournal.org/article/S0196-6553(21)00139-5/fulltext, " ...Tape cannot be cleaned or disinfected ...Study identified microorganisms grew on the adhesive and non-adhesive side of tape ...The authors concluded that adhesive tape may transmit pathogenic bacteria that may contribute to infection ..."

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 ..."