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Based on observation, interview and record review, the Condition of Participation (COP) Compliance with Federal, State, and Local laws and regulations related to the health and safety of patients was determined to be NOT MET when:

1. The hospital did not report a wrong side procedure within five days of detection (Refer to A-0022, item 1)

2a. The nurse-to-patient staffing ratios (refers to the number of patients a single nurse is responsible for at a given time) were 1:3 in the Intensive Care Unit (ICU- a hospital unit that provides specialized care for patients who are critically ill) on 12/30/24, 12/31/24, 1/1/25, and 1/13/25 (Refer to A-0022, item 2a)

2b. The nurse-to-patient ratio assignments for the Stepdown unit (SD- a unit providing patient care between intensive care and acute care levels) were 1:4 on 11/1/24, 12/11/24, 1/4/25, 1/11/25, 1/13/25, and 1/24/25 (Refer to A-0022, item 2b)

2c. The nurse-to-patient ratio assignments for the Cardiac Progressive Care Units (CPCU- (CPCU- a hospital unit that provides care for patients with cardiac issues on telemetry monitor [ medical device that continuously monitors and records patients heart rate, blood pressure, respiratory rate, and oxygen level]) patients were 1:5 on 11/1/24, 12/11/24, 1/4/25, 1/11/25, 1/13/25, 1/18/25, 1/24/25, and 1/29/25 (Refer to A-0022, item 2c)

2d. The nurse-to-patient ratio assignments for the Emergency Department (ED- hospital area for patients requiring immediate medical attention)) were 1:5 and 1:6 on 2/3/25 (Refer to A-0022, item 2d)

The cumulative effect of this systemic failure resulted in the facility's substantial noncompliance with federal, state and local laws (Refer A022).


49884

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

Findings:

1.The hospital failed to have a QAPI program that implemented changes to lead to improvement when the Plan of Correction submitted to CDPH for a survey exited 12/10/24 was not implemented. The QAPI program did not implement effective improvement activities to address the use of the Emergency Department (ED- an outpatient area in the hospital that provides immediate medical care to patients with urgent or life-threatening conditions) as a holding area for patients admitted as inpatients (patients who stays in the hospital overnight). (Refer to A0283)

2. The hospital failed to have a QAPI program that tracked and monitored adverse events (AE- a harmful and negative outcome that happens to a patient provided medical care) and implement preventive measures when Patient (Pt) 6 experienced a wrong side surgical procedure for a left sided interscalene block (an injection of medication that numbs the bundle of nerves that extend to the upper arms, hands and shoulders), and a left sided peripheral nerve block (a needle injects numbing medication near specific nerves in shoulder region, blocking pain signals) and a right shoulder nerve block was performed. The QAPI did not conduct a root cause analysis to determine the cause and implement measures to ensure future incidences would not occur. (Refer to A0286)

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

Based on observation, interview, and record review the hospital failed to provide surgical services in accordance with acceptable standards of practice when:

The hospital failed to ensure prevention of surgical errors for Patient (Pt) 6, when Pt 6 was consented for a left reverse total shoulder arthroplasty (shoulder joints replaced with artificial parts, reversing the normal ball and socket structure) surgery and Anesthesia Medical Doctor (AMD) 1 ordered a left shoulder nerve block (a procedure that numbs the nerves in the shoulder area, providing pain relief) and did not verify correct surgical site in accordance with the hospital's policy and procedure (P&P) titled "Universal Protocol - Procedural Areas" before performing a right shoulder nerve block. Medical Doctor (MD) 2 informed the family of the error of the nerve block to the wrong side and obtained consent to perform the left shoulder arthroplasty with local anesthesia to the left shoulder and Pt 6 under general anesthesia.

These failures led to Pt 6 receiving the wrong-side nerve block to the right shoulder and avoidable pain and suffering and non-use of the right shoulder. This failure resulted in Pt 6 being under general anesthesia longer than expected, potentially causing inadequate post-operative pain relief, the need to administer opiates (strong pain medication) for pain, possibly unnecessarily; and the error required an unplanned overnight hospital stay.

The cumulative effect of these systemic issues resulted in the hospital not ensuring quality patient care in a safe setting.

Based on interview and record review, the hospital failed to be in compliance with state laws regarding self-reporting of adverse events and nurse staffing levels when:

1. The hospital did not self-report a wrong side nerve block performed on Patient 6 in accordance with Health and Safety Code 1279.1

2. The hospital did not meet the required staffing levels for various units within the hospital in accordance with California Code of Regulations Title 22, Chapter 1 General Acute Care Hospitals, sections 70217 (a)(1)(8)(9)(10).

These failures resulted in the potential harm of not ensuring the safety of patients and possibly negatively affecting quality of care.

Findings:

1. During a concurrent interview and record review on 1/29/25 at 2:23 p.m. with Nurse Manager (NM) 7, Patient (Pt) 6's "History & Physical [H&P- an assessment from physician including medical history and exam]," dated 12/2/25 was reviewed. The "H&P" indicated; Pt 6 was 71 years old and presented to the hospital on 12/2/24 for surgery. The "H&P," indicated Pt 6, " ... is indicated for reverse total shoulder arthroplasty [a surgical procedure that replaces the shoulder joint with artificial parts, reversing the normal ball-and-socket structure]. She was explained the risks, benefits, and alternatives ... The patient is consented [gave permission] for left reverse total shoulder arthroplasty ...". NM 7 stated the operating physician speaks with the patient in the pre-operative unit (are in the hospital where patients are prepared for surgery) to answer any questions, ensure all consents have been signed, and mark the surgical site with a skin marker.

During a review of Pt 6's "Anesthesia Preprocedure Evaluation [APE]," dated 12/2/24 at 8:16 a.m., the "APE" indicated, Anesthesia Medical Doctor (AMD) 1 completed a physical exam of Pt 6 on 12/2/24 at 8:16 a.m. The "APE" indicated Pt 1's anesthesia plan was general anesthesia (medication causing loss of feeling and awareness like a deep sleep), a left sided interscalene block (an injection of medication that numbs the bundle of nerves that extend to the upper arms, hands and shoulders), and a left sided peripheral nerve block (a needle injects numbing medication near specific nerves in shoulder region, blocking pain signals). The "APE" indicated, " ... Informed Consent [Physician educates a Pt about risks, benefits, and alternatives of procedure] [AMD 1] have discussed the planned anesthesia care with the patient and/or legal representative, including the following: the nature and purpose of the planned anesthesia; the risks, benefits and side effects of the planned anesthesia; alternatives for the planned anesthesia and their associated risks, benefits, and side effects ... The patient and/or legal representative demonstrated understanding of the information provided. After careful consideration, the patient and/or legal representative agreed to proceed with the planned anesthesia care ...".

During an interview on 1/31/25 at 10:07 a.m. with the Director of Risk Management (DRM), the DRM stated the Risk Management department received an IRIS (Incident Response Improvement System) report and investigated the incident. The DRM stated the hospital legal department reviewed the incident to decide if it needed to be reported to CDPH. The DRM stated, based on the review, the hospital determined the incident did not meet the CDPH reporting criteria for an adverse event. The DRM stated nerve block was not considered a surgery, however agreed the nerve block was given in the Operating Room (OR-dedicated space in the hospital where surgical procedures are performed) as part of the surgery process. The DRM stated a time-out (a brief pause in the surgical procedure to verify critical information and ensure patient safety) was completed to verify information and ensure patient safety. The DRM stated the nerve block was not a stand-alone procedure and did not carry some risk to Pt 6. The DRM stated the hospital did not conduct a root cause analysis (RCA- the process of discovering underlying causes of a problem to prevent recurrence) but completed actions items and held safety meetings about the incident. The DRM stated in retrospect, the anesthesia procedure was part of the surgical process.

During an interview on 1/31/25 at 3:46 p.m. with the Director of Surgery (DS), the DS stated, he was informed of the wrong side block on 12/2/25 by NM7. The DS stated the investigation started on 12/2/25. The DS stated an incident report was filed by Registered Nurse (RN) 10, who was Pt 6's nurse during surgery, after Pt 6 was moved from the OR. The DS stated the incident report was sent to the Risk Management department.

During an interview on 2/3/25 at 12:04 p.m. with NM 7, NM 7 stated, she was the Manager on shift on 12/2/25, the day of Pt 6's surgery. NM 7 stated she contacted the DS to inform him of the incident. NM 7 stated, RN 10 reported the wrong side nerve block from the OR over the phone. NM 7 stated she waited for Pt 6's surgery to finish, then met with RN 10 to help with the incident report and talk to the staff about the incident.

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

2a. During a concurrent interview and record review on 1/31/25 at 1:38 p.m. with Manager (NM) 3, the "ICU Staffing Assignment Sheets (ISA)", dated 12/31/24 and 1/13/25, were reviewed. NM 3 stated the maximum nurse-to-patient ratio for ICU patients was 1:2 [one nurse assigned with 2 patients]. NM 3 stated on 12/31/24 three Registered Nurses (RN) each had a nurse-to-patient ratio of 1:3 on day shift and one RN had a 1:3 nurse-to-patient ratio on the night shift. The "ISA" dated 12/31/24 indicated, " ... No Break RN [nurse to care for a patient assignment while their RN is on break] ...". NM 3 stated when there is no Break RN was available, the Clinical Supervisor (CS), Clinical Educator (CE) or Clinical Nurse Specialist (CNS) will cover for a break, but only the CS is available on the night shift. NM 3 stated with a CS relieving 10 RNs with patient assignments, for their thirty- minute break, it would take over five hours to give all the nurses their meal breaks. The "ISA", dated 1/13/25, and indicated, " ... 4 teams tripled @ 0700 [7:00 a.m.] ... stopped triple @ 0930 [9:30 a.m.] ... [RN name] - tripled @ 1609 [4:19 p.m.] ..." and NM 3 stated this meant the four nurses were assigned to three patients each from 7:00 a.m. to 9:30 a.m. and another nurse had three patients from 4:09 p.m. to 7:00 p.m.

During a review of the "ISA", dated 12/30/24, the "ISA" indicated a Registered Nurse (RN) on day shift was assigned to care for three patients. The "ISA" indicated, " ... Ø [no] break RN coverage - day shift ... [RN's first name] with 3 pt [patient] assignment from 1300 -1700 [1:00 p.m. to 5:00 p.m.] ...".

During a review of the "ISA", dated 1/1/25, the "ISA" indicated two RNs on day shift had a 1:3 nurse-to-patient ratio.

2b. During a review of "Stepdown Assignment Sheets (SDA)", dated 11/1/24, the "SDA" indicated three nurses were caring for stepdown acuity patients with a nurse-to-patient ratio of 1:4 on the night shift.

During a review of "SDA", dated 12/11/24, the "SDA" indicated two nurses were caring for stepdown acuity patients with a nurse-to-patient ratio of 1:4 on the day shift.

During a review of "SDA", dated 1/4/25, the "SDA" indicated one nurse was caring for four stepdown acuity patients with a nurse-to-patient ratio of 1:4 on the day shift.

During a review of "SDA", dated 1/11/25, the "SDA" indicated one nurse was caring for a stepdown acuity patient with a nurse-to-patient ratio of 1:4 on the day shift and one nurse was caring for a stepdown acuity patient with a nurse-to-patient ratio of 1:4 on the night shift.

During a review of "SDA", dated 1/13/25, the "SDA" indicated one nurse was caring for a stepdown acuity patient with a nurse-to-patient ratio of 1:4 on the day shift and one nurse was caring for three stepdown acuity patients with a nurse-to-patient ratio of 1:4 on the night shift.

During a concurrent interview and record review on 2/3/25 at 2:03 p.m. with Nurse Manager (NM) 2, the "SDA", dated 1/24/25 was reviewed. NM 2 stated two nurses caring for stepdown acuity patients had a nurse-to-patient ratio of 1:4. NM 2 stated the maximum nurse-to-patient ratio for stepdown patients was 1:3.

2c. During an interview on 1/29/25 at 3:15 p.m. with RN 1 on CPCU Tower 2, RN 1 stated the maximum nurse-to-patient ratio for the CPCU was 1:4, but assignments were often 1:5. RN 1 stated he was caring for five patients today. RN 1 stated for the past six months, usually two nurses each shift had 1:5 nurse to patient ratio. RN 1 stated the CPCU has a break nurse approximately 70% of the time. RN 1 stated for the last two months the Clinical Supervisor (CS) covers for breaks if there is no break nurse. RN 1 stated before, nurses would cover for each other during breaks, caring for their own patients as well as the other nurse's patients, which made the nurse-to-patient ratio 1:8 during breaks.

During an interview on 1/29/25 at 3:20 p.m. with RN 2 on CPCU Tower 2, RN 2 stated, " ... I have five patients every two - three weeks myself ...". RN 2 stated after the new year (2025) it became more common to have a 1:5 nurse-to-patient ratio. RN 2 stated she had five patients today. RN 2 stated when nurses cover breaks for each other, the covering nurse carried two phones and cares for 8-10 patients during the other nurse's break.

During an interview on 1/29/25 at 3:25 p.m. with RN 3 on CPCU Tower 2, RN 3 stated he had five patients today and last week she had five patients on four of six days. RN 3 stated last week all nurses in the CPCU had a 1:5 nurse-to-patient ratio.

During an interview on 1/30/25 at 10:59 a.m. with Complainant (CO) 2, CO 2 stated 3 North CPCU had a 1:5 nurse-to-patient ratio for at least two nurses on each day shift for over a month.

During an interview on 1/31/25 at 9:50 a.m. with CO 1, CO 1 stated CPCU staffing was unsafe, there was frequently no break nurse and if he went on break, he was told to give report and his assignment to another nurse with a full patient assignment.

During a review of "North Tower 3 Assignment Sheets (NTA)", dated 11/1/24, The "NTA" indicated one nurse on 1 North was assigned 5 CPCU patients on the day shift and on 3 North Surgical CPCU two nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the night shift.

During a review of "NTA", dated 12/11/24, the "NTA" indicated two nurses on 3 North Surgical CPCU were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the day shift.

During a review of "NTA", dated 1/4/25, The "NTA" indicated two nurses on 1 North were each assigned 5 CPCU patients on the day shift.

During a review of "Tower 2 CPCUs Assignment Sheets (T2A)", dated 1/4/25, the "T2A" indicated 4 nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the day shift.

During a review of "NTA", dated 1/11/25, the "NTA" indicated three nurses on 3 North Surgical CPCU were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the night shift.

During a review of "T2A", dated 1/11/25, the "T2A" indicated four nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the night shift.

During a review of "NTA", dated 1/13/25, the "NTA" indicated three nurses on 3 North Surgical CPCU were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the day shift.

During a review of "T2A", dated 1/13/25, the "T2A" indicated eight nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the day shift and two nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the night shift.

During a review of "NTA", dated 1/18/25, the "NTA" indicated two nurses on 3 North Surgical CPCU were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the day shift and two nurse were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the night shift.

During a review of "T2A", dated 1/18/25, the "T2A" indicated four nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the day shift and two nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the night shift.

During a review of "NTA", dated 1/24/25, The "NTA" indicated one nurse on 1 North was assigned CPCU patients with a 1:5 nurse-to-patient ratio and two nurses on 3 North Surgical CPCU were assigned CPCU patients with a 1:5 nurse-to-patient ratio on day shift.

During a review of "T2A", dated 1/24/25, the "T2A" indicated four nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the day shift.

During a review of "NTA", dated 1/29/25, The "NTA" indicated three nurses on 1 North were assigned 5 CPCU patients at a 1:5 nurse-to-patient ratio and two nurses on 3 North Surgical CPCU were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the day shift. The "NTA" indicated two nurses on 3 North Surgical CPCU were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the night shift.

During a review of "T2A", dated 1/29/25, the "T2A" indicated four nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the day shift. The "T2A" indicated four nurses were assigned CPCU patients with a 1:5 nurse-to-patient ratio on the night shift.

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

2d. During an interview on 2/3/25 at 10:08 a.m. with Emergency Department Manager (EDM) 2, EDM 2 stated an area in the ED called EDIN (ED inpatient) was a designated location where nurses care for patients who are admitted while they wait for an inpatient bed.

During a review of the "ED Tracking Board for the EDIN (TB, an electronic screen, listing patient's location, patient's complaint, type of inpatient bed requested, and nurse assigned to care for the patient)", dated 2/3/25 at 10:41 a.m., the "TB" indicated Registered Nurse (RN) 17, RN 18, RN 19, and RN 20 each were assigned care for six patients.

During a review of the "TB", dated 2/3/24 at 11:08 a.m., the "TB" indicated RN 14, RN 15, and RN 16 were each were assigned care for five patients.

During a review of the "TB", dated 2/3/25 at 10:41 a.m., the "TB" indicated RN 19 was assigned four patients requiring beds in the telemetry and two patients requiring beds in the medical/surgical (M/S) unit. The "TB" indicated RN 20 was assigned three patients requiring telemetry beds and three patients requiring M/S beds. The "TB" indicated RN 17 was assigned two patients requiring telemetry beds, three patients requiring M/S beds, and one patient requiring a stepdown bed.

During an interview on 2/3/25 at 5 p.m. with EDM 2, EDM 2 stated The EDM 2 stated the EDIN was staffed according to bed type requested and not according to the acuity (the severity or complexity of a patient's medical condition).

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


49884

Based on interview, review of video surveillance and document review, the hospital failed to ensure patients' right to be free from physical abuse and free from restraints for one of one patient, Patient (Pt) 43, when on 2/2/25 the Security Watch Commander (SWC) deployed the use of a taser (a handheld, battery-powered device that delivers an electric shock to temporarily disable a person) to restrain Pt 43 against the hospital's policy and procedure on use of tasers and against CMS guidance on use of tasers. Registered Nurses (RN)s failed to document the use of a taser in Pt 43's medical record, failed to assess Pt 43 after a change of condition, and failed to have a physician assess Pt 43 after a taser strike.

This failure resulted in the inappropriate use of tasers to restrain Pt 43, led to cuts and bleeding on Pt 43's skin, had the potential for further injuring Pt 43's fractured (broken bone) left hand, and for mental harm to Pt 43. The use of the taser directly led to harming another staff member, Security Officer (SO) 1.

Findings:

During a review of Pt 43's "Emergency Department Provider Notes [EDPN- assessment from physician including medical history and exam]" dated 2/1/25, the "EDPN" indicated Pt 43 was admitted on 2/1/25 at 10:16 p.m. for Psychiatric 5150 Danger to Self [a state law that allows law enforcement and mental health professionals to detain someone for 72 hours for a mental health evaluation and treatment] (found by police walking barefoot through traffic with bleeding on face and hands and holding onto rose with thorns). Pt 43 had abrasions (scrapes) to the face, both hands and both feet. Pt 43 had a flat affect (absent display of emotions), and poor eye contact. Pt 43's visit diagnosis was bizarre (very strange or unusual) behavior and closed displaced fracture (bone break not through the skin) of fifth metacarpal (connects the pinkie finger to the palm) bone of left hand.

During a review of Pt 43's "ED Care Timeline [EDCT]," dated 2/1/25 to 2/2/25, the "EDCT" indicated, Pt 43 was moved to the SCU [Special Care Unit- is a locked unit within the Emergency Department (ED) where patients who are in a psychiatric or behavioral emergency and do not require complex medical treatments are placed] on 2/1/25 at 10:16 p.m. The "EDCT" indicated, on 2/1/25 at 10:41 p.m. a head-to-toe assessment was completed by LNs indicating Pt 43 had cuts and redness to both hands, his face, his left knee, and left foot. The "EDCT" indicated, at 11:30 p.m. " ... ED Notes: Writer and secondary RN entered SCU and attempted to clean pt's open wounds. Pt refused care, pt states "I like the wounds how they are, I like to walk around barefoot, I dont want them cleaned. I have a right to say no ..." The "EDCT" indicated, on 2/1/25 at 11:33 p.m. Pt 43 was a flight risk (attempt to leave unit) and during Pt 43's psychiatric assessment he was withdrawn (avoiding interaction), preoccupied (distracted), and guarded (cautious). The "EDCT" indicated, Pt 43's general attitude was suspicious, and he was a low risk for violence on the violence assessment tool (tool used to assess risk for violence). The "EDCT" indicated, on 2/1/25 from 11:45 p.m. to 2/2/25 at 1:30 a.m. documented under "Continuous Observation" Pt 43 was awake, lying down, and quiet or awake lying down talking to staff. The "EDCT" indicated, on 2/2/25 at 1:19 a.m. an ED Note by RN 13: " ... Writer attempted to initiate splint [medical device used to support and immobilize an injured body part] application process. Pt refused splint application. Writer explained benefits and risk of ignoring medical treatment and application of medical equipment. Pt states that he is going to hell regardless so there is no point "it is what it is" ... MD notified. Awaiting orders and further plan of care ..." The "EDCT" indicated, on 2/2/25 1:45 a.m. Pt 43 was "... Awake; Abusive to staff; Agitated (uneasiness, nervous); Evidence of harmful behavior (verbal or actions) (Patient assaulted officer. Pt being placed in four-point [both wrists and ankle] restraints [preventing movement of body and limbs]) ...". The "EDCT" indicated, on 2/2/25 at 1:48 a.m. orders were placed for violent restraints, and 5 milligram (mg- a unit of measurement) haloperidol (medication used to treat agitation, and irritability) injection (a shot with a needle to give medication), 50 mg diphenhydramine (medication causes sedation) injection and 2 mg lorazepam (medication to treat anxiety and nervousness) injection were ordered. The "EDCT" indicated, 2/2/25 at 2:46 a.m. an ED note addendum documented by Registered Nurse (RN) 13 " ...Writer witnessed pt [Pt 43] approached SCU door, security officer opened the door and spoke to pt. Pt assaulted [make a physical attack on] security officer at this time and officer was able to close the door at this time. Pt hitting body against door and barricaded [blocked] himself against the door. Code assessment was called overhead at this time, MD was also notified. Pt began to escalate [increase rapidly] in behaviors, became increasingly agitated. Security stepped in to carry out 4 point restraint orders. Pt restrained to gurney, bed wheels unlocked. Restraints applied on wrist. Prior left-hand injury at admission, restraint applied to lower wrist, hand in neutral position resting on the gurney. Medication orders were also carried out. Pt still agitated at this time ...". The "EDCT" indicated, 2/2/25 at 4:15 a.m. Pt 43's vital signs were taken by a Certified Nursing Assistant (CNA). The "EDCT" indicated, the next complete patient assessment was documented on 2/2/25 at 8:00 a.m. by a RN . The "EDCT" did not contain any reference to the use of a taser on Pt 43 and did not contain a head-to-toe assessment of Pt 43 by RN 13 after the taser strike.

During a review of Pt 43's "EDPN Continued", dated 2/2/25 no time on documentation, the "EDPN Continued" indicated, " ... The following face to face evaluation was performed within 1 hour of the patient being placed in restraints. Unable to obtain review of systems due to patient condition. The behavioral assessment indicates danger to self, danger to others, violent. I reviewed and assessed patient's history, drugs and labs if available and determined that there are no immediately reversible conditions. The patient's medical and behavioral condition and reaction to the intervention continued attempts or displays of harmful behaviors. I have determined the need to continue the restraint or seclusion ..." Pt 43's medical record did not contain any reference of taser use and did not contain any "EDPN" with an assessment by a physician after the taser strike.

During a concurrent interview and security footage video review on 2/4/25 at 2:37 p.m. with the Security Operations Manager (SOM), the security video from the SCU from 2/2/25 beginning at 1:45 a.m. was reviewed. The video footage angle was shot from the south facing north. Large glass observation windows, and a glass door were on the left (West) wall of the room. A solid wall was on the North side of the room with a glass door at a 90-degree angle to the door on the West side of the room. The only entry points to the room were the two glass doors. The right (East) side of the room had three gurneys against the wall in a row in view of the camera. Pt 43 was observed in the middle gurney, with an empty gurney on either side. At 1:45 a.m. Pt 43 was observed sitting in an upright position on the middle gurney with both metal siderails up rocking from front to back. At 1:46 a.m. Pt 43 got out of the gurney and went to the door on the West side of the room. Pt 43 was observed standing by the door for approximately 30-45 seconds. The door opened a small crack (door opens inward). Pt 43 quickly struck out his arm, palm first through the opening in the door. Pt 43 withdrew his arm. The SOM stated, Security Officer (SO) 1 was hit in the face when Pt 43 thrust his palm through the door. At 1:47 a.m. the door was closed, and Pt 43 was observed bracing himself against the door with his left shoulder. At 1:48 a.m. staff could be seen in the observation windows, and through the glass door on West side and in the door on the North side. The SOM stated two officers were at each entry point. At 1:49 a.m. Pt 43 moved away from the door and into a sitting position on the floor between the two doors. Pt 43 was sitting with legs folded to his side and hands up on both sides of his face. The SOM stated the officers were actively communicating with the patient for him to move away from the door. At 1:50 a.m. four officers entered the room at the same time, two from each door, surrounded Pt 43 and began attempting to restrain limbs. At 1:51 a.m. a flash of light could be seen on the lower left of the screen near the patient and between two officers. The SOM stated the flash of light was the taser being deployed (fired). The SOM stated, Pt 43 was hit with one prong and SO1 was hit with the other prong. Immediately after the taser flash another officer came into the room for a total of five. At 1:57 a.m. a restrained Pt 43 was lifted by five officers onto the gurney, and limbs restrained to gurney. At 2:01 a.m. all hospital staff exited the SCU. The SOM stated, there was another patient in the SCU out of the video frame that never moved from his gurney.

During a telephone interview with Registered Nurse (RN) 13 on 2/4/25 at 3 p.m. RN 13 stated, she was Pt 43's primary nurse on the night of 2/1/25 and morning of 2/2/25. RN 13 stated, she remembered the incident when Pt 43 was tased. RN 13 stated, she saw Pt 43 was attempting to get up out of the gurney, but his side rails were up. RN 13 stated, she turned her back to set something down and Pt 43 was at the door by the time she turned back around. RN 13 stated, SO1 pushed open the door a crack to ask what the patient wanted, and Pt 43 pulled the door inward by the inner door frame. RN 13 stated, Pt 43 then struck out his right hand and made direct contact with SO1's face. RN 13 stated, SO1 pushed the door closed and once it was shut Pt 43 used his left shoulder to brace the door shut. RN 13 stated, SO1 contacted additional security officers. RN 13 stated, she messaged the physician and got an order for 4-point restraints and chemical restraint medications. RN 13 stated, she called a "code assessment [ an overhead page for assistance when a patient had escalating behaviors]" when Pt 43 hit SO1. RN 13 stated, she would call a "code assessment" when a patient started to escalate, and the physician was supposed to come to bedside to assess the situation. RN 13 stated, no one responded to her page for "code assessment". RN 13 stated, officers told Pt 43 to sit down, and he complied. RN 13 stated, four officers went into the room and surrounded the patient. RN 13 stated, one officer had their taser drawn before they entered the room, as soon as the officer lowered the taser, Pt 43 grabbed his legs and RN 13 saw the taser fire. RN 13 stated, she looked at Pt 43's skin after the incident and he had dried blood, but there were no taser prongs stuck in his skin. RN 13 stated Pt 43 "may or may not have been tased". RN 13 stated, she saw the taser deployed, but did not see where the prongs struck Pt 43, or see any prong removed from Pt 43. RN 13 stated, she did not document the taser use, and the officers did not tell her where Pt 43 was struck with the prongs. RN 13 stated, she administered the ordered medications after Pt 43 was restrained on the gurney. RN 13 stated, Pt 43's physician did not come and assess the patient after the taser strike. RN 13 stated, she did not complete a head-to-toe assessment on Pt 43 after the incident, but his respirations remained equal and unlabored (breathing normally).

During an interview on 2/4/25 at 3:40 p.m. with Emergency Department Manager (EDM) 1, EDM 1 stated, her expectation was for RNs to contact security staff when a patient was going to hurt themselves or someone else. EDM 1 stated, when patient's behaviors began escalating, RNs were supposed to call for a code assessment. EDM 1 stated, the Physician, the Charge Nurse and Clinical Supervisor should respond to the page for a code assessment. EDM 1 stated, medical staff were supposed to collaborate with security prior to application of restraints. EDM 1 stated, there was no documentation in Pt 43's medical record indicating Pt 43 was tased. EDM 1 did not say why RN 13 did not document the taser strike to Pt 43.

During a concurrent observation and interview on 2/5/25 at 7:39 a.m. with SO1, SO1 had no bruising around her left eye. SO1 had a bandage to the back of her left hand. SO1 stated, her left eye was still tender to the touch. SO1 stated, her left hand still had two small puncture wounds. SO1 stated, she worked the overnight shift on 2/1/25 to 2/2/25 and recalled the incident with Pt 43. SO1 stated, she saw Pt 43 approach the door and he knocked SO1 stated, Pt 43 was mumbling, so she opened the door a crack. SO1 stated, the SCU did not have an intercom system, the only way to communicate with patients inside the unit was to open the door or speak loudly through the glass. SO1 stated, she was struck hard by Pt 43's right palm near her left eye. SO1 stated, she pushed the door closed and called the SWC to report the incident and get additional officers to the area. SO1 stated, RN 13 called the physician for violent-restraint and medication orders. SO1 stated, the plan was for all four responding officers to enter the room together and surround Pt 43 then apply restraints. SO1 the SWC told the officers if Pt 43 attacked anyone, "I'm going to pop him (clarified this meant he would tase Pt 43)". SO1 stated, the SWC removed his taser from the holster, turned the taser camera on, and pointed the taser at Pt 43. SO1 stated, Pt 43 was sitting on the floor, and two officers entered the room from each door. SO1 stated the officers surrounded Pt 43 and began trying to apply restraints but Pt 43 reached out and grabbed the SWC's legs. SO1 stated, the SWC fired the taser at Pt 43. SO1 stated, one of the taser prongs hit her left hand and she informed the SWC she had been hit. SO1 stated, she did not know if the other prong hit Pt 43. SO1 stated, she removed the wire and prong from her hand and continued restraining Pt 43. SO1 stated the officers restrained Pt 43 and moved him to the gurney, then left the SCU. SO1 stated she was then seen as a patient in the ED where the physician bandaged her hand and sent her for a Computed Tomography (CT - medical imaging procedure using X-Rays and a computer to create detailed pictures inside the body).

During an interview on 2/5/25 at 8:06 a.m. with SO2, SO2 stated, he recalled the events from the overnight shift on 2/1/25 p.m. to 2/2/25 a.m. with Pt 43. SO2 stated, the plan was to enter the room two officers per door. SO2 arrived to the SCU area and Pt 43 was sitting on the floor, with his arms up and hands balled into fists next to his head. SO2 stated, the SWC "said something about a taser" but SO2 could not hear him because of the background noise around the unit. SO2 stated, SO1 and the SWC entered the door on the North and the SWC had his taser drawn. SO2 stated, him and SO3 entered through the West door. SO2 stated, after all officers entered the room and began surrounding Pt 43, Pt 43 grabbed for the SWC's leg and the SWC fired the taser at Pt 43. SO2 stated, he assumed the taser hit Pt 43. SO2 stated, he heard SO1 announce twice she was hit by a taser prong. SO2 stated, SO1 removed the prong from her hand. SO2 stated, the officers continued applying restraints to Pt 43's arms and legs. SO2 stated he was aware Pt 43 had a fracture in his hand, and he was trying not to manipulate (move around) his hand too much. SO2 stated he was applying the restraints to Pt 43's arms and Pt 43's hand was bleeding. SO2 stated, he could not see clearly where Pt 43 was hit by the taser prong.

During an interview on 2/5/25 at 8:24 a.m. with SO3, SO3 stated, he responded to the SCU when he heard the call for officer response over the radio. SO3 stated, Pt 43 was bouncing on the balls of his feet (padded areas under the toes) "clearly agitated". SO3 stated the SWC told him to go get restraints. SO3 stated the officers were given directives to open both doors at the same time and approach the patient. SO3 stated, the SWC advised their dispatch a taser application was likely because of Pt 43's behavior. SO3 stated, the four security officers entered the SCU and the SWC had his taser drawn. SO3 stated Pt 43 had gone silent. SO3 stated Pt 43 reached for the SWC's leg with his right arm, and his left arm came around, throwing his body weight toward the SWC. SO3 stated the SWC fired his taser hitting Pt 43 with one prong in his midsection and the other prong hit SO1 in her left hand. SO3 stated, he did not recall who removed the taser prong from Pt 43's midsection.

During an Interview on 2/5/25 at 8:51 a.m. with SOM, the SOM stated, the taser should not have been removed from the holster before Pt 43 grabbed the SWC's leg. The SOM stated, the SWC did not follow hospital Policy and Procedure in many ways during the incident. The SOM stated, the SWC did not announce "taser" before deploying the weapon. The SOM stated, after discharging the taser the SWC should have called law enforcement to take custody of Pt 43. The SOM stated, the SWC should have requested assault charges be filed against Pt 43. The SOM stated, when a taser was discharged a clinical assessment of Pt 43 should have been done. The SOM stated the SWC did not notify RN 13 the taser hit Pt 43, which led to RN 13 not completing a clinical assessment and not notifying the physician. The SOM stated the SWC did not take photographs the site where Pt 43 was hit by the taser as policy dictated.

During an interview on 2/5/25 at 9:45 a.m. with the Chief Nursing officer (CNO) the CNO stated the ED Charge Nurse, leadership, and the physician should have responded to the overhead page by RN 13 for Pt 43's code assessment. The CNO stated her expectation was for clinical supervisors to be a part of the code assessment. The CNO stated the code assessment team should have a discussion to help come up with a plan for the patient to de-escalate or medicate and restrain.

During a review of the hospital's Policy and Procedure (P&P) titled, "Taser Usage," dated 1/8/25, the P&P indicated, " ... The use of a TASER by security staff is considered a law enforcement action, not a health care intervention The purpose of this policy is to establish guidelines for the deployment and use of the a TASER by Security Services Staff ... [Name of hospital] does not support the use of a TASER by any hospital staff as a means of achieving a clinical objective, including but not limited to, subduing a patient in order to place that patient in restraints or seclusion. If a TASER is used by a security officer or law enforcement personnel on a person on [Name of hospital] property (patient, staff, or visitor) to protect people or hospital property from harm, local law enforcement will be notified and [Name of hospital] will request that the person is taken into law enforcement custody ... Deploy/Deployment - The removal of a device from its carrying holster for display or use. The actual application or discharge of a tool or device, such as the TASER, is not required to be considered deployment ... Application - The firing of projectile probes regardless if contact with an individual is made or the application of a drive stun to an individual ... 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. Weapon- Pursuant to CMS' State Operation Manual, Appendix A, A "weapon" includes, but is not limited to ... pepper spray, mace, nightsticks, TASERS, cattle prods, stun guns and pistols ... Criteria for Use ... The use of a TASER by [Name of hospital] Security staff may only be used in response to imminent danger of bodily harm, unlawful touching or threat of harm to [Name of Hospital] property. Security officers who use a TASER to stop harm must affect a citizen's arrest. Local law enforcement must be contacted and [Name of Hospital] must request that the individual is placed in law enforcement custody ... The following procedure shall be adhered to while deploying a TASER in an authorized manner and circumstances ... The TASER shall not be deployed or displayed at any time unless the officer has specific information that reasonably indicates the imminent use of a TASER is warranted ... The officer must reasonably believe that a credible threat to the safety of the officer or others exists ... The TASER should not be used to simply overcome resistance when adequate assistance is available ... The TASER shall not be used as an intimidation tool to gain compliance where the reasonable deployment is not justified ... A TASER shall never be used as a means of achieving a clinical objective, including but not limited to, subduing a patient in order to place that patient in restraints or seclusion ... Tactical Deployment ... Prior to discharging the TASER, the officer shall loudly announce "TASER" when the circumstances allow, to notify everyone that the TASER is being fired ... AFTER DISCHARGE RESPONSIBILITIES ... [Name of hospital] will contact local law enforcement and request that the person is taken into law enforcement custody ... The identification of the utilized TASER shall be identified in the documentation. ... After the subject has been taken into custody/control, security staff shall: ... Ensure the person's injuries are promptly examined by clinical staff and any embedded probes are Removed ... Appropriate photographs should be taken to document the incident and any injuries that may have been sustained from the use of a TASER ... 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 P&P titled, "Reporting and Investigation Requirements Concerning Qualifying Level 3 and All Level 4 Use of Force Incidents," dated 1/8/25, the P&P indicated, " ... It is the policy of [Name of Hospital] to conduct confidential investigations concerning ... all Level 4 use of force incidents as set forth below ... All level 4 incidents, including hard techniques such as tasers, strike points, impact weapons [ a tool used to gain control] and OC spray [a chemical irritant that's also known as pepper spray] ... A security officer shall notify their supervisor or shift coordinator as soon as practical following the application of physical force and a referral to Risk Management shall be made through IRIS [hospital incident reporting system] for ... all Level 4 use of force incidents ...The use of defensive equipment (aka. "Weapons," including but not limited to, pepper spray, mace, nightsticks, tasers, cattle prods, stun guns, and pistols) by security staff or law enforcement personnel on a person on [Name of Hospital] property is considered a law enforcement action, not a health care intervention. The supervisor, shift coordinator or designee is responsible for notifying local law enforcement anytime there is a use or application of defensive equipment and a request to have that person taken into custody must be made ...".

During a review of the hospital's P&P titled, "Use of Force," dated 1/8/25, the P&P indicated, " ...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 ... It is the policy of [name of hospital] Security Department that security officers are permitted to use reasonable force when ... The security officer reasonably believes that he/she is in imminent danger of suffering bodily injury or being touched unlawfully ("self-defense"), someone else is in imminent danger of suffering bodily injury ("defense of another") ... 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 ... The use of force continuum is a system used by this department to determine the reasonable force in a given situation. If the subject continues to rise in hostility, it may be necessary for the security officer to raise the level of force to counter the actions of the subject for self-defense and/or defense of another and/or defense of property. The possible security officer response levels are as follows ... Level 1: Officer presence (examples: physical appearance, professional bearing) ... Level 2: Verbal Commands (examples: clear and deliberate) ... Level 3: Soft techniques (examples: physical control tactics/wrist locks) ... Level 4: Hard techniques (examples: Tasers/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 ... The following factors and circumstances should be taken into consideration when using physical force on a patient: ... if clinical restraints are ordered by a properly licensed clinician, and a patient resists the application of restraints, the minimum amount of force reasonably necessary to control the situation may be used in order to apply restraints ...".

During a review of the hospital's 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 hospital's P&P titled, "Documentation in the Health Record," dated 6/14/2018, the P&P indicated, " ... PURPOSE ... To provide a complete record of patient care and patient progress ... To facilitate communication among care providers and enhance continuity of care ... To provide a legal record of patient care ... All care providers caring for the patient are to document within their scope of practice/job description ... All patient care and activities are to be documented at the time care is provided ...".

During a review of the hospital's P&P titled, "Standard of Practice Emergency Department," dated 9/23/24, the P&P indicated " ... STANDARD OF PRACTICE: Safety, Medication, IV Therapy, Infection Control. The patient will be provided a safe, therapeutic environment for the delivery of health care. The Licensed Nurse will: ... Adhere to all established [Name of Hospital] policies/procedures ... Intervene appropriately to correct unsafe situations ... Patient Rights & Nursing Process. The patient will have a systematic and continuous assessment of their health status performed by a Licensed Nurse, utilizing the nursing process. The RN will: 1. Collect, document, and communicate data to the interdisciplinary team. The frequency of data collection will vary according to the gravity of patient's problems/needs as well as individual standardized procedure and physician order ... Documentation on the Emergency Department Electronic Health Record (EHR) will reflect assessment of the patient's status and needs ... system specific assessment at the onset of patient treatment with ongoing assessment dependent upon patient condition and response to treatment ... Advise the physician of any alterations in the patient's psychological and/or physiological condition ..."

During a review of a professional reference titled, "Health professionals' routine practice documentation and its associated factors in a resource-limited setting: a cross-sectional study," dated 2/16/23, the professional article indicated, " ... Documentation is a standard way of keeping ongoing patient care information. It is the relevant facts of routine health information and patient care plans, such as professionals' evaluation and judgement about the patients, evaluation charts, tests, reports, subjective notes or professionals' reflections ... Documenting routine practices is essential for the continuity of patient care, ... communication among healthcare professionals and better patient diagnoses and treatments ... it should be patient-focused, accurate, relevant, clear, permanent, confidential and timely ... Poor documentation practice affects patient management, continuity of patient care and medicolegal [medical and legal] issues, which arise from incomplete and inadequate documentation, lack of accuracy and poor quality. It leads to adverse patient outcomes, medication errors and patient deaths. Distorted health information may influence health professionals' decision-making capabilities due to inappropriate and misleading documentation practices ...".

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 ..."

Based on interview and record review, the hospital failed to have a Quality Assurance and Performance Improvement (QAPI-is a systematic approach to improving the quality of care and services delivered to patients) program that tracked and monitored adverse events (AE- a harmful and negative outcome that happens to a patient provided medical care) and implement preventive measures when Patient (Pt) 6 experienced a wrong side surgical procedure for a left sided interscalene block (an injection of medication that numbs the bundle of nerves that extend to the upper arms, hands and shoulders), and a left sided peripheral nerve block (a needle injects numbing medication near specific nerves in shoulder region, blocking pain signals) and instead a right shoulder nerve block was performed. The QAPI program did not conduct a root cause analysis (is a method used to identify the main cause of an issue) to determine the cause and implement measures to ensure future incidences would not occur.

This failure resulted in the potential harm of patients not benefiting from effective measure and reoccurrence of adverse events and negative patient outcomes.

Findings:

During a review of Pt 6's "Anesthesia Preprocedure Evaluation [APE]," dated 12/2/24 at 8:16 a.m., the "APE" indicated, Anesthesia Medical Doctor (AMD) 1 completed a physical exam of Pt 6 on 12/2/24 at 8:16 a.m. The "APE" indicated Pt 1's anesthesia plan was general anesthesia (medication causing loss of feeling and awareness like a deep sleep), a left sided interscalene block (an injection of medication that numbs the bundle of nerves that extend to the upper arms, hands and shoulders), and a left sided peripheral nerve block (a needle injects numbing medication near specific nerves in shoulder region, blocking pain signals). The "APE" indicated, " ... Informed Consent [Physician educates a Pt about risks, benefits, and alternatives of procedure] [AMD 1] have discussed the planned anesthesia care with the patient and/or legal representative, including the following: the nature and purpose of the planned anesthesia; the risks, benefits and side effects of the planned anesthesia; alternatives for the planned anesthesia and their associated risks, benefits, and side effects ... The patient and/or legal representative demonstrated understanding of the information provided. After careful consideration, the patient and/or legal representative agreed to proceed with the planned anesthesia care ...".

During an interview on 1/30/25 at 12:04 with Anesthesia Medical Doctor (AMD) 1, AMD 1 stated, she recalled Pt 6's wrong sided nerve block on 12/2/25. AMD 1 stated, she (AMD 1) was the anesthesia provider for Pt 6's surgery on 12/2/25. AMD 1 stated the planned anesthesia for Pt 6's surgery was general anesthetic combined with a nerve block. AMD 1 stated, before starting the nerve block, RN 10 conducted a time-out procedure, during which the surgical site was confirmed aloud. AMD 1 stated, she could not see the surgeon's skin marking for the surgical site because it was below the shoulder, where she had inserted the needle. AMD 1 stated she administered a nerve block on Pt 6' right shoulder [non-operative side] AMD 1 stated, she should have double checked the surgeon's skin marking before administering the nerve block to Pt 6's right shoulder.

During a telephone interview on 1/30/25 at 3 p.m. with Medical Doctor (MD) 2, MD 2 stated he recalled performing Pt 6's surgery on 12/2/24. MD 2 stated, he was Pt 6's Orthopedic Surgeon (Specialist physician for treating bones, joints, muscles, tendons, and ligaments) for her shoulder surgery. MD 2 stated, Pt 6's surgery was planned for the left shoulder, and the Anesthesia Provider administered a nerve block on the right shoulder. MD 2 stated no one from the Risk Management Department had talk to him about the incident and he was not aware of any root case analysis conducted.

During an interview on 1/31/25 at 10:07 a.m. with the Director of Risk Management (DRM), the DRM stated the Risk Management department received an IRIS (Incident Response Improvement System) report and investigated the incident. The DRM stated the hospital legal department reviewed the incident to decide if it needed to be reported to California Department of Public Health (CDPH-a state agency that works to promote the health of California residents) The DRM stated, based on the review, the hospital determined the incident did not meet the CDPH reporting criteria for an adverse event. The DRM stated a root cause analysis was not conducted. The DRM stated nerve block was not considered a surgery, however agreed the nerve block was given in the Operating Room (OR-dedicated space in the hospital where surgical procedures are performed) as part of the surgery process. The DRM stated a time-out (a brief pause in the surgical procedure to verify critical information and ensure patient safety) was completed to verify information and ensure patient safety. The DRM stated the nerve block was not a stand-alone procedure and did not carry some risk to Pt 6. The DRM stated the hospital did not conduct a root cause analysis (RCA- the process of discovering underlying causes of a problem to prevent recurrence) but completed actions items and held safety meetings about the incident. The DRM stated in retrospect, the anesthesia procedure was part of the surgical process.

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

Based on interview and record review, the hospital failed to ensure the physician ordered Order Set titled, "Insulin Orders for Non-Pregnant Adult" (pre-written physician orders instructing the nurse as to what medication to give and what to do if the patient's blood glucose is too low) provided safe directives for nursing staff when two registered nurses (RN 5 and RN 6) followed physician orders which resulted in one of 44 patients (Pt 1) having fluctuating blood glucose levels, resulting in a Code Blue (cardiac arrest.)

This failure resulted in Patient (Pt) 1 experiencing very low blood sugar and may have contributed to Pt 1's death.

Findings:

During a review of the hospital's Facility Reported Incident (FRI) submitted to the California Department of Public Health on 12/2/24, the FRI indicated, " ...On 11/19/24, a 79-year-old male patient ... was admitted to the cardiac progressive care unit (CPCU) unit. On 11/21/24, patient underwent a right hip [surgery], tolerated procedure well, and was transferred back to CPCU at 1813 PM (6:13 p.m.) At 2028 PM (8:28 p.m.) [insulin glargine - a long-acting insulin] 10 units subcutaneously (a shot) was administered per physician order. At 2231PM (10:31 p.m.), patient's blood sugar was checked, resulted at 47 and he was given Dextrose 50% (D50) 50 mL IV (IV - into the vein) per order. At 2241 PM (10:41 p.m.), patient's blood sugar was rechecked and resulted at 138 ...At 0324 AM (3:24 a.m.), Monitor Tech notified RN that SpO2 (oxygen and heart rate monitor) was reading "no pulse." RN immediately responded ...Code Blue was called, and CPR (chest compressions and other life-saving measures) was initiated ... On 11/25/24, patient had a sudden change in mentation (mental activity) and stopped following commands with GCS 10 (Glasgow Coma Scale - measures the level of consciousness) decreasing to 7.

During a review of hospital document titled, "History & Physical (H&P)" dated 11/19/24, the H&P indicated Pt 1 was sent to the hospital on 11/19/24 by his orthopedic (bone) doctor because he had a hip fracture (broken hip) and needed surgery. The H&P indicated Pt 1 was a " ...79 y.o. (year old) male patient with a history of diabetes mellitus 2 (disease that causes blood sugar to rise too high and drop too low) with nephropathy (kidney disease,) retinopathy(eye disease,) hypertension,(high blood pressure) dyslipidemia, (high cholesterol,) coronary artery (heart vessel) disease ... End Stage Renal Disease (kidneys were failing, and blood sugar is difficult to control) ... anemia (body doesn't have enough healthy blood cells.)"

During an interview on 1/30/25 at 11:00 a.m. with RN 6, RN 6 stated she was the nurse for Pt 1 on 11/21/24 on the day shift (7 a.m. to 7:30 p.m.) RN 6 stated that during the handoff report from RN 23 at 7:00 a.m. on 11/21/24 (the process of giving information about the patients' care and needs to the nurse who will be taking over care) RN 23 told her that Pt 1 was NPO (not eating or drinking anything) because he was going to surgery that day to have his hip repaired. RN 6 stated Pt 1 had an Order Set titled "Subcutaneous (given into the skin - a shot) Insulin Orders for Non-Pregnant Adult" was for managing the patient's blood sugar level, and if the blood sugar level dropped below 70 mg/dl (milligrams per deciliter, a measurement - Normal range of blood sugar is 70-99 mg/dl.) RN 6 stated she was also informed by RN 23 that Pt 1 was a dialysis patient (meaning the patient undergoes a process of filtering the blood because the kidneys do not function normally) and his last dialysis treatment was yesterday morning (11/20/24.) Pt 1's blood sugar was 53 on 11/21/24 at 5:00 a.m. and RN 23 gave the first dose of 10 ml (milliliters, a liquid measurement) of D50 (D50 - 50% dextrose solution - a concentrated sugar solution given into the vein to quickly raise the sugar level in the blood) and at 5:35 a.m. and when RN 23 rechecked, it was 156, so no further action was needed according to the Order Set. RN 6 stated when she checked on Pt 1 that morning, on 11/21/24 around 7:00 a.m., he was alert and talking to her. RN 6 stated she checked Pt 1's blood sugar at around 11:00 a.m., and it was 66 mg/dl, mg/dl, so she gave the second dose of D50 because that is what the Order Set instructed her to do. RN 6 stated on 11/21/24 at 11:38 a.m. MD (Medical Doctor) 5 was notified that Pt 1's blood sugar was 66 mg/dl. D50 was given per the Order Set and when rechecked the blood sugar was 212 mg/dl. RN 6 stated she told the doctor Pt 1 had a low blood sugar at 5:00 a.m. and again at 11:00 a.m. and that D50 was given each time. RN 6 stated the Order Set did not instruct her to call the doctor, but she believed the doctor would want to know that the patient's blood sugar was fluctuating. Pt 1's surgery was scheduled for 4:00 p.m. and before the patient was placed on a gurney to be transported to surgery RN 6 stated that she checked the blood sugar again, and it was again below 70 mg/dl, so she gave another 10 ml of D50 per the Order Set instructions, the 3rd dose of the day, and told the nurse from surgery to recheck Pt 1's blood sugar in 10 minutes. RN 6 stated the nurse in surgery did recheck and Pt 1's blood sugar and it was above 100 ml/dl, so no further action was needed according to the Order Set. RN 6 stated that Pt 1 returned from surgery at about 6:30 p.m., right before shift change. RN 6 stated she told the oncoming night nurse (RN 5) about the incidents of low blood sugar and that Pt 1 had received three doses of 10 mls (milliliters, a liquid unit of measure) of D50 and that he just drank 4 ounces of apple juice between the time that he returned from surgery at 6:30 p.m. and when report started at about 7:00 p.m. RN 6 stated Pt 1 had not had anything to eat during her shift from 7:00 a.m. to 7:30 p.m. except the apple juice right after surgery., and pt had been NPO since yesterday (11/19/24 at 4:23 p.m., more than 24 hours before surgery.)

During an interview on 1/30/25 at 8:39 a.m. with RN 5, RN 5 stated she was the nurse assigned to Pt 1 on 11/21/24 on the night shift. RN 5 stated Pt 1 had surgery during the day shift and was back in his room before her shift started at 7:00 p.m. RN 5 stated she received a hand-off report from RN 6 that Pt 1 had surgery during the day and his blood sugar levels had been up and down, and he had received 3 doses of D50, one at around 5:00 a.m. one at around 11:00 a.m., and another around 4:00 p.m. right before the patient went in for surgery. RN 5 stated she explained to Pt 1 what each of his medications were for before giving them, including the insulin glargine (long-acting insulin) and gave the 10 units insulin glargine shot at 8:28 p.m. RN 5 stated the Order Set indicated specifically not to hold the insulin glargine even if blood sugar is low or if the patient is NPO. RN 5 stated Pt 1 was scheduled to have his blood sugar checked at 11 p.m., so she did a fingerstick at 10:30 p.m. and it showed a blood sugar level of 47 mg/dl, a very low level. RN 5 stated she gave D50 according to the physician's Order Set. RN 5 stated Pt 1's blood sugar came up to 138 mg/dl within 10 minutes after receiving the D50. RN 5 stated she did not call the doctor because the Order Set did not instruct her to call as long as the blood sugar comes back up after receiving D50. RN 5 stated Pt 1 rested comfortably the rest of the evening, and that she "looked in on him" several times. RN 5 stated Pt 1 had a routine blood draw by a phlebotomist (person who draws blood) at 3:03 a.m. and the phlebotomist did not report any concerns about Pt 1 to her. RN 5 stated she received a call from the Monitor Tech (the person who was watching Pt 1's heart and respiration monitor outside his room) stating Pt 1's monitor was reading, "no pulse." RN 5 stated she went to the room and found Pt 1 unresponsive and without a pulse, and she called a Code Blue (process to call a team of medical professionals to try to revive a patient.) RN 5 stated Pt 1's blood sugar was less than 10 mg/dl, and he was given more D50 during the Code Blue, and his heart started to beat again, then he was transferred to Intensive Care Unit.

During an interview and record review on 1/29/25 at 10:59 a.m. with Nurse Manager (NM) 1 and the Director of Inpatient Services (DIS), NM 1 stated they did a Root Cause Analysis (RCA- a process of investigating the reasons why errors happen to try to keep them from happening again) on this case and determined there were some things that needed to change. NM 1 stated the Order Set for Subcutaneous (given into the skin - a shot) Insulin Orders for Non-Pregnant Adult wasn't clear, and changes were made to the Order Set because of the incident with Pt 1. NM 1 stated there was a lack of critical thinking skills from nursing, and the doctor should have been called during the day to discuss what could be done about Pt 1's blood sugar that kept dropping a few hours after he received the D50. NM 1 stated, "We were chasing the Blood Sugar. Giving repetitive doses of D50 should have raised a flag." The DIS stated that this incident required urgent education to all nurses and doctors, and changes to the Order Set. The DIS stated there have been changes to the Order Set in this facility as well as other facilities managed by this organization.

During an interview on 1/30/25 at 11:30 a.m. with a Pharmacist (Pharm 1,) Pharm 1 stated he was familiar with the situation of Pt 1's blood sugar dropping after receiving multiple doses of D50. Pharm 1 stated the insulin glargine, also called basal insulin, was given "per protocol" as was the D50 that was given when Pt 1's blood sugar was below 70 ml/dl. Pharm 1 stated when an order for medication is received in the pharmacy, the pharmacist reviews the individual orders, including reviewing relevant laboratory results, the patient's height, weight, and age, and other medications the patient is on to make sure the medications don't interfere with each other.

During an interview with the Director of Pharmacy (DP), the DP stated the hospital has an Order Set Committee, and committee decides how often each Order Set should be reviewed. DP stated the Order Set for Insulin Orders for Non-Pregnant Adult was reviewed in 2023. The DP stated all Order Sets are reviewed by the Pharmacy and Therapeutics Committee, which she attends. The DP stated the Pharmacy Department did not monitor the use of D50 in the past, but now they are monitoring its usage to serve as another safety check, a change that has been put into place since and because of the incident with Pt 1.

During an interview on 1/31/25 at 11:00 a.m. with MD 1, MD 1 stated he has worked at this hospital for about 2 years and has been a hospitalist (doctor who sees patients who are admitted to a hospital) for over 20 years. MD 1 stated he admitted Pt 1 and ordered the insulin glargine as part of the Order Set. MD 1 stated he has the ability to customize the Order Set. MD 1 stated for Pt 1, he came in for elective surgery (not an emergency surgery.) MD 1 stated when he first admitted Pt 1, his blood sugar was "almost 400." Pt 1 wasn't scheduled for the surgery for a day or two, and so he ordered meals for the patient and expected him to be eating. MD 1 stated he takes into account the patient's age, weight, and he knew that Pt 1 had end-stage renal disease. MD 1 stated it was his "clinical judgement call" to use the Order Set and to select the insulin glargine dose. MD 1 stated he ordered a diet for Pt 1 on 11/20/24 and was not notified that Pt 1 was not eating the day prior to the surgery or that the patient had been having drops in his blood sugar levels requiring repeated doses of D50 on 11/21/24.

During a review of Order Set ... titled "insulin glargine (brand name) injection 10 units nightly" the order indicated it was started on 11/19/24 at 4:22 p.m. by MD 1. The order indicated, "Admin instructions: Basal insulin should not be held based on pre-dose blood glucose level or meal status." The document indicated the order was reviewed by Pharmacist 2 (RPH 2). The document indicated, "Diet NPO - DIET EFFECTIVE NOW, Starting on Tuesday, 11/19/24 at 1623 (4:23 p.m.) until specified."

During a review of hospital document titled, "flowsheets," the flowsheet indicated on 11/20/2024 at 12:12 p.m. Pt 1 drank 240 ml (about 8 ounces) of liquid and ate 50% of his meal. The flowsheet did not indicate what foods or beverages Pt 1 ate or drank. The flowsheet indicated on 11/20/24 at 4:22 p.m. Pt 1 drank 180 ml (about 6 ounces) and at 50% of his meal. There is no documentation of any more food or beverages during the evening of 11/20/24 or in the morning. The flowsheet indicated on 11/21/24 at 8:00 a.m. patient was NPO.

During a review of nursing note by RN 5, the note dated 11/22/2024 3:53 a.m. indicated, "0318: Received call from cardiac monitoring about patient's oxygen sensor not reading. Writer went in to check on patient. Found patient unresponsive, cool to touch. No pulse. 0319: Writer started compressions and emergency activated. 0320: Activated code blue. Code blue team at bedside. 0342: Code blue ended. Patient transferred to higher level of care in ICU 0351: Called son [name] to update on patient. No answer. Left voicemail."

During a review of hospital document titled, "Progress Notes" dated 11/22/24 at 2:33 p.m. by Nurse Practitioner (NP) 1, NP 1's note indicated, "Assessment: Acute Hypoxic Respiratory Failure" Occurred due to PEA (PEA - Pulseless Electrical Activity, which is a cardiac arrest rhythm that occurs when a person's heart stops but there is still electrical activity.) Intubated (breathing tube inserted down his throat and connected to machine to breathe for patient) .... Suspect PEA due to hypoglycemia."

During a review of physician note dated 12/2/2024 by MD 4, the note indicated, "Death note: Patient expired peacefully on comfort care with family at bedside at 0603 a.m. ..."

During a review of a professional reference from the Cleveland Clinic Journal of Medicine, "Managing diabetes in hemodialysis patients: Observations and recommendations" retrieved from www.ccjm.org on February 10, 2025, the article indicated, "ESRD significantly alters glycemic control, the results of hemoglobin A1c testing, and the excretion of antidiabetic medications. The various and opposing effects of ESRD and dialysis can make blood glucose levels fluctuate widely, placing patients at risk of hypoglycemia-and presenting a challenge for nephrologists and internists."

During a review of the professional reference from Academic Life in the Emergency Department, Dec 31, 2014, retrieved from https://www.aliem.com/d50-vs-d10-severe-hypoglycemia-emergency-department/ titled, "D50 vs D10 for Severe Hypoglycemia in the Emergency Department - Drawbacks of D50, the article indicated, "1. Rebound hypoglycemia: After administration of D50 there is an excess amount of glucose available, leading to increased uptake and utilization by the tissues, which suppresses both gluconeogenesis and glycogenolysis. Without continued administration of dextrose-containing fluids, this may result in rebound hypoglycemia.


49884

Based on observations, interviews and record review, the hospital failed to maintain a clean and sanitary environment in accordance with hospital policy and procedures, CDC and clinical standards of practice for infection control when:

1. The Nursery Unit (an area in the hospital where newborn babies are cared for) soiled utility room (a room designated to store waste products, soiled items, and used medical equipment) cabinet stored an open package of unused disposable diapers and an unused package of baby wipes. The Inpatient Surgical Unit (an area in the hospital where patients who require surgery are cared for) soiled utility room cabinet stored two unused white specimen buckets (a container used to store and transport patient specimens removed from surgery for laboratory testing). The Outpatient Endoscopy Unit (an outpatient center that serves patient needing endoscopic procedure- allows doctor to see inside the body without a performing major surgery) soiled utility room cabinet stored four unopened containers of a spill control product (a material designed to contain and absorb liquid spills). The Peri-Operative Unit (is a hospital unit that provides care to patients before, during, and after surgery) soiled utility room cabinet stored a plastic bag containing new unopened cleaning supplies including, two bottles of a rust remover product, one bottle of a liquid cleanser, and several scrubbing pads.

2. The Outpatient Surgical Unit clean supply room two packages of tissue traps (disposable collection devices used in surgery, tissue and fluids are vacuumed into container for disposal), and a package of sterile gloves inside a blue container were found on the floor between the wire racks which stored clean and sterile operating room supplies.

These failures resulted to significantly increasing the potential risk for cross contamination (the transfer of harmful bacteria from one place, object, or person to another with harmful effect) which could harm patients.

3. RN 12 failed to perform hand hygiene during Pt 26's surgery prior to entering the Operating Room (OR), upon donning and doffing gloves, and touching both Patient 26 and OR equipment/areas.

This failure was a serious breach of aseptic technique (germ free condition) and significantly increases the risk for Pt 26 for an infection due to the potential contamination transfer from RN 12's hands to Pt 26 and the sterile environment (free of germs).

4. Intravenous lines (IV) infusing medications were not labeled with a date to be changed for four of 46 patients (Pt - patients 30, 32, 45, and 46).

This failure had the potential to put Pt 30, Pt 32, Pt 45, and Pt 46 at risk of infection from contaminated IV lines.

Findings:

1. During a concurrent observation and interview on 1/28/25 at 11 a.m. with Nurse Manager (NM) 6 in the Nursery Unit soiled utility room, the cabinet stored an open package of unused disposable diapers and unused baby wipes. Nurse Manager (NM) 6 stated the diaper and wipes should not have been stored in the soiled utility room and were not suitable for patient use any longer due to the risk of infection by cross contamination (the spread of harmful bacteria or viruses form one place or thing to another) that could spread infection.

During a concurrent observation and interview on 1/28/25 at 2:25 p.m. with NM 7 in the Inpatient Surgical Department soiled utility room, the cabinet stored two white specimen buckets. NM 7 stated the specimen buckets was unused and should not be stored in the soiled utility room. NM 7 stated, anything stored in the soiled utility room was considered dirty.

During a concurrent observation and interview on 1/28/25 at 2:50 p.m. with NM 10 in the Outpatient Endoscopy Department soiled utility room, the cabinet stored four unopened containers of a foam spill control product. NM 10 stated, anything in the soiled utility room was considered dirty. NM 10 stated, using products from the soiled utility room for patients had a potential risk for cross contamination and could result to an infection.

During a concurrent observation and interview on 1/28/25 at 3:30 p.m. with Clinical Supervisor (CS) 3 in the Peri-Operative Department soiled utility room, the cabinet stored a plastic bag with new unopened cleaning supplies including, two bottles of a rust remover product, one bottle of a liquid cleanser, and several scrubbing pads. CS 3 stated, the items should not be stored in the soiled utility room cabinets. CS 3 stated the items were now considered contaminated and should not be used. CS 3 stated, using the products had the potential for cross contamination.

During an interview on 2/4/25 at 1:04 p.m. with the Director of Infection Prevention (DIP), the DIP stated, supplies intended for patient use should not be stored in a soiled utility room because the soiled utility room was a dirty area, and the hospital needed to ensure items used for patients were clean.

During an interview on 2/5/25 at 9:43 a.m. with the Chief Nursing Officer (CNO), the CNO stated once patient care items are in the soiled utility room, the items were considered dirty and not suitable for patient use due to the risk for infection.

During the review of professional reference titled, "What is the difference between a clean and dirty utility room? (WID)", dated 9/4/18, the "WID" indicated, " ... 'Dirty' doesn't refer to visible mess. It simply means a patient has come into contact with the item, so it either needs to be made sanitary for the next use or disposed of completely. When items from the clean utility room are sent to a patient, the dirty utility room (or sluice room) is where the used items end up, in order to be cleaned or disposed of. Generally, these will be containers which have been used to collect and hold human waste. If waste items aren't managed correctly, adhering to thorough infection control guidelines, they can become a serious HCAI [Healthcare-associated infection, infection resulting from a healthcare intervention] risk. So, this is where the reference to 'dirty' comes into play - potentially, these utensils can harbor microbes which are extremely dangerous if allowed to spread ...".

2. During a concurrent observation and interview on 1/28/25 at 2:33 p.m. with the Director of Operations (DO) and The Director of Supply Chain (DSC), in the Outpatient Surgery Department supply room, two packages of tissue traps, and a packaged of sterile gloves inside a blue container, were found on the floor between the wire racks which stored packaged clean and sterile operating room supplies. The DO stated, the supplies should not be on the floor. The DSC stated, supplies should not be used in the operating room for patient surgeries after being on the floor. The DSC stated the reason not to use surgical supplies from the floor was to prevent the spread of infection.

During an interview on 2/4/25 at 1:06 p.m. with Infection Prevention Manager (IPM), the IPM stated, the OR supplies found on the floor should not be used in the OR for patients and should be discarded. The IPM stated, the OR supplies found on the floor could carry microorganisms into the patient's OR environment and had the potential to cause an infection.

During an interview on 2/5/25 at 9:40 a.m. with the CNO, the CNO stated, her expectations was for clean supplies should be stored in a way that protects from contamination and should not be on floor. The CNO stated, clean supplies found on the floor should not be use on patients and should be discarded.

During a review of the professional reference titled, "The role of the surface environment in healthcare-associated infections", dated August 2013, the professional reference indicated, " ...Hospital surfaces are frequently contaminated with important healthcare-associated pathogens (bacteria). Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider's hands or gloves that may result in patient-to-patient transmission of nosocomial (originating from the hospital) pathogens ..."

During a review of the professional reference titled, "Good Storage and Distribution Practices for Medical Products", (retrieved from https://www.who.int/publications/m/item/trs-1025-annex-7) dated 6/17/20, the professional reference indicated, " ...Storage and distribution are important activities in the supply chain management of medical products ... Storage areas should be of sufficient capacity to allow orderly storage of the various categories of medical products ... Storage areas should be appropriately designed, constructed, maintained or adapted. They should be kept clean and there should be sufficient space and lighting ... Materials and medical products should be stored off the floor, away from walls and ceilings, protected from direct sunlight and suitably spaced, to permit ventilation, cleaning and inspection ... Materials and medical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination ..."

During a review of the professional reference titled, "Keeping it Sterile: Fundamentals of Sterile Storage," (retrieved from https://www.ormanager.com/keeping-it-sterile-fundamentals-of-sterile-storage/) dated 7/20/23, the professional reference indicated, " ... Using sterile items in surgery is a fundamental practice, not a rudimentary one that can or should be taken for granted. Put simply, using unsterile items can result in a patient infection. If sterile storage conditions are not appropriate, the items can become contaminated. Such contamination may go undetected, rendering items unsafe and unusable. Therefore, healthcare facilities must take action to create an environment that properly protects sterile packages. This includes securing a proper sterile storage environment and developing policies and procedures to help ensure sterile packages are safely stored and handled ... Sterile packages should be handled with care and positioned so they are not crushed, bent, compressed, or punctured. Sterile items should never be stored on floors ..."

3. During an observation on 1/31/25 at 4:47 p.m. in OR 1, RN 12 was assigned as the Circulating RN (manages the overall flow of a surgical procedure and ensure patient safety) for Pt 26's surgery. RN 12 entered the OR and did not perform hand hygiene prior to donning (put on) gloves and was observed collecting and preparing surgical supplies for Pt 26 surgical procedure. RN 12 with gloved hands touch Pt 26's legs and positioned on to the stirrups (devices that position a patient's legs), RN 12 moved a small portable table which hold surgical instruments and surgical supplies closer to Pt 26. RN 12 placed the packaged of antiseptic skin prep (a cleaning solution used to decrease surgical site infection) on the surgical stand and open the package. RN 12 moved the trash container closer to the surgical area and the trash lid was used as a tabletop. RN 12 doffed (removed) her gloves and did not perform hand hygiene and proceeded to open the plastic package of a sterile gloves and donned sterile gloves. RN 12 cleaned and disinfect Pt 26's surgical site with betadine (an antiseptic used to prevent infection), and after disinfecting the surgical site RN 12 doffed her sterile gloves and did not perform hand hygiene. RN 12 reached to her pocket for her phone, pushed the buttons, and returned the phone to her pocket. RN 12 was typing on the computer with ungloved hands, and after proceeded to donned sterile gloves without performing hand hygiene. RN 12 plugged a tube with irrigation fluids for Pt 26' surgery, and after went back to typing on the computer with gloves, then touched the light control switch on the wall. After Pt 26's surgery was completed, RN 12 doffed her gloves and donned new gloves without performing hand hygiene, and transported Pt 26 to the Post Operative Unit.

During review of Pt 26's "History & Physical (H&P- an assessment from physician including medical history and exam)," dated 1/27/25, the "H&P" indicated, Pt 26 was a female presenting to the physician's office with a chief complaint of preoperative exam for a scheduled surgery on 1/31/25. Pt 26's scheduled surgery was an operative dilation and curettage (D&C-small instruments are used to open the lower narrow part of the womb, hysteroscopy (an exam of the inside of the womb, with a narrow telescope with a light and camera).

During an interview on 1/31/25 at 5:25 p.m. with RN 12, RN 12 stated, RN 12 stated "I forget sometimes" to do hand hygiene between glove changes. RN 12 stated it was important to remember to clean hands by performing hand hygiene to not give the patient an infection.

During an interview on 1/31/25 at 5:28 p.m. with the Director of Surgery (DS), the DS stated, applying hand sanitizing gel before and after gloving was important, to prevent infection.

During an interview on 2/4/25 at 1:15 p.m. with the IPM, the IPM stated, the expectation for OR staff to perform hand hygiene, before touching a patient, after touching a patient, before putting on gloves and after taking off gloves. The IPM stated, hands could potentially be contaminated at any time. The IPM stated, performing hand hygiene prevents introducing microorganisms to the patients.

During a review of the hospital's Policy and Procedure titled, "Hand Hygiene," dated 4/14/22, the P&P indicated, " ...The purpose of this policy is to promote effective hand hygiene practices and reduce the transmission of microorganisms amongst patients, personnel and visitors ... Hand hygiene - A general term referring to any action of hand cleansing ... Hand hygiene is the single most important means of preventing the spread of infection and is to be performed in any interaction where transmission of microorganisms is possible ... At [Name of Hospital] the expectation is that all healthcare personnel will perform hand hygiene following World Health Organization (WHO) guidelines ... Indications for hand hygiene:1. Before and after touching the patient 2. Before handling an invasive device for patient care, regardless of whether or not gloves are used 3. Before donning sterile or non-sterile gloves 4. After contact with body fluids or excretions, mucous membranes, non-intact skin, or wound dressings 5. If moving from contaminated body site to another body site during care of the same patient 6. After contact with inanimate surfaces and objects (including medical equipment) in the immediate vicinity of the patient 7. After removing sterile or non-sterile gloves ... Hand hygiene can be accomplished by hand washing with soap and water or using an alcohol-based hand rub ... Use of gloves ... The use of gloves does not replace the need for hand hygiene by either hand rubbing or handwashing. ... When wearing gloves, change or remove gloves during patient care if moving from a contaminated body site to either another body site (including non-intact skin, mucous membrane or medical device) within the same patient or the environment ...".

During a review of professional reference from the CDC titled, "Clinical Safety: Hand Hygiene for Healthcare Workers, dated 2/27/24, the professional reference indicated, " ... Hand hygiene protects both healthcare personnel and patients. Hand hygiene means cleaning your hands with Handwashing with water and soap (e.g., plain soap or with an antiseptic). Antiseptic hand rub (alcohol-based foam or gel hand sanitizer) ... Cleaning your hands reduces: The potential spread of deadly germs to patients. The spread of germs, including those resistant to antibiotics ... Know when to clean your hands ... Immediately before touching a patient ... Before performing an aseptic task such as placing an indwelling device or handling invasive medical devices ... Before moving from work on a soiled body site to a clean body site on the same patient ... After touching a patient or patient's surroundings ... After contact with blood, body fluids, or contaminated surfaces ... Immediately after glove removal ..."

4. During a concurrent observation and interview on 1/28/25 at 10:45 a.m. with the Inpatient Cardiovascular Services Director (ICSD) and RN 22 in Intensive Care Unit (ICU), observed RN 22 caring for Pt 32 at bedside. Observed intravenous (IV) tubing infusing an antibiotic. The tubing had a sticker attached that indicated tubing was to be changed "Saturday" but not a date. There was a line on the sticker that indicated, "date" but no date was filled in. I asked RN 22 how she knew if it needed to be changed this coming Saturday, or if it should have been changed last Saturday. RN 22 stated this information is shared nurse-to-nurse during shift change. The ICSD stated they have been discussing whether the labels should have a date or not and stated this is "going to Professional Practice Council for discussion."

During a concurrent observation and interview on 1/28/25 at 10:49 a.m. with the ICDS and RN 21 in the Intensive Care Unit (ICU), observed RN 21 caring for Pt 30 at bedside. RN 21 was in the room changing the IV line for propofol (a powerful anesthetic and sedative.) Observed CRRT was also in process (Continuous Renal Replacement Therapy is a type of dialysis - dialysis does the work of the kidneys when a patient has a serious kidney disease or injury) and fentanyl (a powerful pain reliever) was infusing. All the IV tubing lines were labeled with stickers indicating the day of the week the line was to be changed, but not a date. RN 21 said, "that's how we do it. Different days have different colored labels, so it makes it easy to see what lines you need to change on your shift." She said some lines have to be changed every day, and others can go longer.

During a concurrent observation and interview on 2/3/25 at 10:55 a.m. with the Clinical Supervisor (CS) 2 in the Intensive Care Unit (ICU), we entered the room of Pt 45. Observed one bag of IV fluid labeled Lactated Ringers (replaces fluids and electrolytes). There was a sticker on the IV tubing that indicated, "change Saturday" with no date to indicate if it should have been changed last Saturday or if it needs to be changed next Saturday. Observed one bag of piperacillin/ tazobactam (an antibiotic) with a sticker on the IV tubing that indicated, "Change Sunday" with no date to indicate if it should have been changed last Saturday or if it needs to be changed next Sunday. Observed one bag labeled vancomycin (an antibiotic) with a sticker on the IV tubing that indicated, "change Thursday" with no date to indicate if it should have been changed last Thursday or if it needs to be changed next Thursday. CS2 stated labeling with just the day and not the date is the current practice.

During a concurrent observation and interview on 2/3/25 at 10:59 a.m., entered the room of Pt 46 with CS 2. Observed one bag of fentanyl with sticker on the IV tubing that indicated, "Change Wednesday" with no date to indicate if it should have been changed last Wednesday or if it needs to be changed next Wednesday. Observed one bag labeled dexmedetomidine which CS 2 stated was a sedative. There was a sticker on the IV tubing that indicated, "change Wednesday" with no date to indicate if it should have been changed last Wednesday or if it needs to be changed next Wednesday.

During an interview on 2/3/25 at 11:05 a.m. with the ICU Manager (NM3), NM3 stated the lines are to be labeled with a sticker indicating the day the tubing is to be changed, not the date. NM3 stated this is their practice, and he believed this was consistent with their policy.

During an interview on 2/4/25 at 1:03 pm with the Director of Inpatient Safety and Infection Prevention (DIP) the DIP stated it is important for IV lines to be changed because it could put the patient at risk of an infection. The DIP stated some IV lines need to be changed more often for some medications, so an actual date on the label is important to make it clear when the line is due to be changed.

During an interview on 2/5/25 at 9:38 a.m. with the CNO, the CNO stated she was aware that there are different practices for labeling IV tubing in the hospital. The CNO stated, "IV tubing labels should have a date on them. I expect nurses to follow the policy."

During a review of hospital policy titled, "Intravenous Tubing Changes, Intermittent Infusion Devices & IV Sites," dated 06/14/2024, the policy indicated, " ... V. PROCEDURE ... C. Label new IV tubing with date to be changed."

Based on interview and record review, the hospital failed to ensure prevention of surgical errors for one of three patients, Patient (Pt) 6, when Pt 6 was consented for a left reverse total shoulder arthroplasty (shoulder joints replaced with artificial parts, reversing the normal ball and socket structure) surgery and Anesthesia Medical Doctor (AMD) 1 ordered a left shoulder nerve block (a procedure that numbs the nerves in the shoulder area, providing pain relief) and did not verify correct surgical site in accordance with the hospital's policy and procedure (P&P) titled "Universal Protocol - Procedural Areas" before performing a right shoulder nerve block. Medical Doctor (MD) 2 informed the family of the error of the nerve block to the wrong side and obtained consent to perform the left shoulder arthroplasty with local anesthesia to the left shoulder and Pt 6 under general anesthesia.

These failures led to Pt 6 receiving the wrong-side nerve block to the right shoulder and avoidable pain and suffering and non-use of the right shoulder. This failure resulted in Pt 6 being under general anesthesia longer than expected, potentially causing inadequate post-operative pain relief, the need to administer opiates (strong pain medication) for pain, possibly unnecessarily; and the error required an unplanned overnight hospital stay.

Findings:

During a concurrent interview and record review on 1/29/25 at 2:23 p.m. with Nurse Manager (NM) 7, Patient 6's "History & Physical (H&P- an assessment from a physician including medical history and exam)," dated 12/2/25 was reviewed. The "H&P" indicated, Pt 6 was 71 years old and presented to the hospital on 12/2/24 for surgery. The "H&P" indicated, Pt 6's medical condition requiring surgery was, primary osteoarthritis (degenerative joint disease that affects the cartilage that cushions the ends of bones) of left shoulder, and left glenohumeral (ball and socket joint that connects the upper end of arm bone to the socket of shoulder blade) arthritis (inflammation of joints).The "H&P," indicated Pt 6, " ... is indicated for reverse total shoulder arthroplasty [a surgical procedure that replaces the shoulder joint with artificial parts, reversing the normal ball-and-socket structure]. [Pt 6] was explained the risks, benefits, and alternatives ... The patient is consented [gave permission] for left reverse total shoulder arthroplasty ...". NM 7 stated the operating physician spoke with the patient in the pre-operative unit (are in the hospital where patients are prepared for surgery) to answer any questions, ensure all consents have been signed, and mark the surgical site with a skin marker.

During a review of Pt 6's "Anesthesia Preprocedure Evaluation [APE- assess a patient's medical history and current condition to determine if they can tolerate anesthesia (a medical intervention that prevents pain during procedures) for surgery]," dated 12/2/24 at 8:16 a.m., the "APE" indicated, Anesthesia Medical Doctor (AMD) 1 completed a physical exam of Pt 6 on 12/2/24 at 8:16 a.m. The "APE" indicated Pt 1's anesthesia plan was general anesthesia (medication causing loss of feeling and awareness like a deep sleep), a left sided interscalene block (an injection of medication that numbs the bundle of nerves that extend to the upper arms, hands and shoulders), and a left sided peripheral nerve block (a needle injects numbing medication near specific nerves in shoulder region, blocking pain signals). The "APE" indicated, " ... Informed Consent [AMD 1] have discussed the planned anesthesia care with the patient and/or legal representative, including the following: the nature and purpose of the planned anesthesia; the risks, benefits and side effects of the planned anesthesia; alternatives for the planned anesthesia and their associated risks, benefits, and side effects ... The patient and/or legal representative demonstrated understanding of the information provided. After careful consideration, the patient and/or legal representative agreed to proceed with the planned anesthesia care ...".

During a review of "Orders," dated 11/25/25, the "Orders" indicated, " ... Anesthesia Services per Assessment and Plan ... Ordering Provider: [Medical Doctor (MD) 2] ... Written ... 12/2/24 0755 [7:55 a.m.] ...".

During a review of "Anesthesia Orders [AO]," dated 12/2/25, the "AO" indicated, " ... Peripheral Nerve Block ... Ordering Provider: AMD 1 ... 12/2/24 0820 [8:20 a.m.] ... Indications ... at surgeon's request and post-op pain management ...".

During a review of Pt 6's "Progress Note [PN]," dated 12/2/25 at 2:06 p.m., the "PN" documented by MD 2 indicated, " ... Upon entering the OR [Operating Room], after the nerve block had been performed, I was notified that the block had inadvertently [accidentally] been completed on the contralateral [opposite] side. After thorough discussion with the attending anesthesiologist, it was decided that a nerve block would not be performed on the ipsilateral [same side of body as surgery] shoulder due to risk of phrenic nerve palsy [when the nerve that controls the diaphragm (controls breathing) is incapable of movement] and need for continued ventilation [machine assisted breathing] after the completion of the surgery. I discussed the issue with the patient's son prior to prepping [cleaning the surgical site to remove germs] and draping [putting a sterile barrier around surgical site] the patient and he expressed understanding of the error that was made. I discussed that we would still proceed with the planned procedure on the left shoulder and keep the patient overnight as both of her upper extremities (arms) would have limited use and she would need increased help with personal hygiene, feeding herself, and completing ADLs (activities of daily living, dressing, bathing, eating). He expressed understanding of the plan and I re-entered the OR around 1130 am to continue prepping and draping for the procedure on the left shoulder. The procedure on the left shoulder commenced at 1157 am ..."

During a review of Pt 6's "Anesthesia Progress Note [APN]," dated 12/2/25 at 2:50 p.m., the "APN" indicated, " ... Spoke with patient's son to explain that interscalene peripheral nerve block was placed on right side instead of left. Explained that patient will have limited use of right arm during period of block, and the duration is typically 12-24 hours ...".

During a concurrent interview and record review on 1/29/25 at 2:30 p.m. with NM 7 Pt 6's "Timeout Universal Protocol [TUP],", dated 12/2/25, was reviewed. The "TUP" indicated, Pt 6's anesthesia time out (a brief pause in an operation to confirm the patient, procedure, and site) was on 12/2/25 at 11:16 a.m. The "TUP" indicated the timeout type was an anesthesia block, and the procedure was a left arthroplasty reverse total shoulder with MD 2. The "TUP" indicated, the timeout questions were, correct patient, correct site, correct side, correct position, correct procedure, and site marked. The "TUP" indicated, a "Yes" response to all time out questions. The "TUP" indicated, the OR staff present for the anesthesia block time out were, AMD 1, RN 10, Surgical Technician (ST) 2, and a Medical Doctor Resident. NM 7 stated during the time-out, all OR staff were expected to stop all activities and focus on the time-out process. NM 7 stated the time-out questions are asked verbally and directed to everyone in the room. NM 7 stated each staff member should provide a verbal confirmation before the procedure or surgery begins, to ensure everyone pauses and listens to the time-out to prevent wrong site procedures.

During an interview on 1/30/25 at 12:04 with Anesthesia Medical Doctor (AMD) 1, AMD 1 stated, she recalled Pt 6's wrong sided nerve block on 12/2/25. AMD 1 stated, she (AMD 1) was the anesthesia provider for Pt 6's surgery on 12/2/25. AMD 1 stated the planned anesthesia for Pt 6's surgery was general anesthetic combined with a nerve block. AMD 1 stated, before starting the nerve block, RN 10 conducted a time-out procedure, during which the surgical site was confirmed aloud. AMD 1 stated, she could not see the surgeon's skin marking for the surgical site because it was below the shoulder, where she had inserted the needle. AMD 1 stated an ultrasound (US-machine that uses sound waves to create real-time pictures of internal organs and tissues and displays them on a screen) machine was used during the nerve block procedure. AMD 1 stated a less preferred (Per AMD 1's the screen is more difficult to read) US machine was initially set up in the OR on Pt 6's right side (non-operative side). AMD 1 stated, during the process of starting the general anesthesia, the technician brought in the preferred US machine and placed at the foot of the bed on Pt 6's left side (operative side). The less-preferred US was then removed from the operating room. AMD 1 stated, she asked RN 10 to move the US machine closer because she could not see the screen. AMD 1 stated RN 10 then moved the US machine to Pt 6's left shoulder. AMD 1 stated, RN 10 prepped Pt 6's right shoulder and she (AMD 1) performed a nerve block. AMD 1 stated, later MD 2 entered the OR and noticed no needle mark on Pt 6's left shoulder, AMD 1 stated she realized the wrong shoulder had been blocked. AMD 1 stated, administering a nerve block to Pt 6's left shoulder after having administered one to the right shoulder was not possible due to the risk of phrenic nerve damage (occurs when the nerve that controls the respiratory muscle are damage, making it difficult to breath). AMD 1 stated Pt 6's family decided to proceed with the surgery, and MD 2 used a local anesthesia (temporarily blocks pain to an area) to Pt 6's left the shoulder for the surgery. AMD 1 stated, Pt 6 was already asleep for the nerve block, and she did not think it added much time to the general anesthesia. AMD 1 stated, she should have double checked the surgeon's skin marking before administering the nerve block to Pt 6's right shoulder.

During a telephone interview on 1/30/25 at 3 p.m. with MD 2, MD 2 stated he recalled performing Pt 6's surgery on 12/2/24. MD 2 stated, he was Pt 6's Orthopedic Surgeon (Specialist physician for treating bones, joints, muscles, tendons, and ligaments) for her shoulder surgery. MD 2 stated, Pt 6's surgery was planned for the left shoulder, and he marked Pt 6's left arm. MD 2 stated the mark was large enough to be visible. MD 2 stated, he entered the OR and observed Pt 6 was intubated and under general anesthesia, however, the left shoulder was not prepped for surgery. MD 2 stated, he inquired with the OR team about the nerve block, when he noticed there was no mark on the operative shoulder [left shoulder] from the injection. MD 2 stated, typically, there should be a visible mark such as redness or a small drop of blood, where the needle entered. MD 2 stated, he looked at Pt 6's left shoulder and commented to AMD 1 she "didn't even leave a mark" when she did the nerve block. MD 2 stated, AMD 1's face lost all color, she looked at RN 10 and said she blocked the wrong shoulder. MD 2 stated AMD 1 pulled down Pt 6's gown from the right arm and saw no MD skin pen mark and looked at the left arm and saw the MD site marking. MD 2 stated, administering a nerve block to Pt 6's left shoulder after AMD 1 administered one to the right shoulder was not possible due to the risk of phrenic nerve damage. MD 2 stated this condition could lead to post operative respiratory depression (loss of the ability to breathe). MD 2 stated the alternative plan to continue with the left shoulder surgery was to administer a local anesthesia and for Pt 6 to be admitted for observation. MD 2 stated, he contacted Pt 6's family, who agreed to proceed with the surgery using local anesthesia and for Pt 6 to remain in the hospital overnight for observation. MD 2 stated, he preferred and requested a nerve block for Pt 6's type of surgery because it gave superior post operative pain relief and reduces opiate consumption in the first 24 hours after surgery. MD 2 stated, due to the lack of a nerve block, Pt 6 potentially could have a higher opiate (strong pain medication) consumption.

During an interview on 1/30/25 at 3:27 p.m. with Registered Nurse (RN) 10, RN 10 stated, he recalled the surgical case involving Pt 6. RN 10 stated, he was Pt 6's circulating nurse (nurse who works in OR to manage patient care and safety) during her surgery. RN 10 stated, when a nerve block was performed, the surgical staff had to position the room and move all equipment to the patient's non-operative side. RN 10 stated, the anesthesiologist used an US machine to guide the needle for the nerve block procedure. RN 10 stated, the US machine was initially set up on the patient's non-operative side, when the room was prepared for Pt 6 surgical case. RN 10 stated, AMD 1 requested a different US machine, and the exchange occurred before he (RN 10) entered the operating room with Pt 6. RN 10 stated Pt 6 was moved into the OR on a gurney. RN 10 stated the new US machine was set up on Pt 6 operative side and he did not realize the US machine was positioned in the incorrect place and should have been on the non-operative side. RN 10 stated, AMD 1 administered general anesthesia and intubated Pt 6 on the gurney. RN 10 stated during the procedure, he was standing at the bottom of the gurney, and Pt 6's extremities were covered with blankets. RN 10 stated from where he was standing prevented him from seeing the surgical site marking on Pt 6 left shoulder. RN 10 stated he performed a time-out from his position, confirming the surgery was a total left shoulder procedure and the anesthesia was a left shoulder block. RN 10 stated after the nerve block was performed, Pt 6 was moved onto the OR table and positioned for surgery. RN 10 stated, before Pt 6 was prepped for surgery MD 2 entered the OR and observed Pt 6's left shoulder and inquired about the nerve block due to the absence of needle marks from the nerve block. RN 10 stated, he noticed AMD 1's face turned white, and AMD 1 told MD 2 she blocked the wrong shoulder. RN 10 stated he reported the incident to his manager in real-time and filed an incident report. RN 10 stated, he should have pulled the blanket down lower to reveal the surgical site marking and could have prevented the error. RN 10 stated, he did not see the Intravenous (IV) lines (a thin flexible tube attached to a pump inserted into a vein to deliver fluids) or Blood Pressure (BP) lines coming off the right arm. RN 10 stated, the IV and BP cuff would not be placed on Pt 6 operative side. RN 10 stated, seeing the lines on Pt 6 right shoulder side should have been an indicator Pt 6 should not have been blocked on the right shoulder.

During an interview on 1/31/25 at 3:46 p.m. with the Director of Surgery (DS), the DS stated, his expectation for OR staff was to conduct the time-outs according to the policy. The DS stated, OR staff are expected to ensure the surgical consent was signed and accurate. The DS stated, OR staff should double-check the type of surgery and the operative site, especially if there was a site marking. The DS stated he expected OR staff to pause all activities in the OR, verify site markings, and listen to the time-out information. The DS stated if any information was incorrect, they should speak up. The DS stated a time-out should occur before anesthesia and before the surgical incision begins.

During an interview on 2/5/25 at 9:38 a.m. with the Chief Nursing Officer (CNO), the CNO stated, OR staff were expected to follow the hospital's Universal Protocol P&P when a timeout was being announced. The CNO stated OR staff should visualize the skin marking when the side and site are announced during the time-out.

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, " ... PURPOSE ... To provide guidance to peri-procedural [time before, during, or after a medical procedure] personnel for verifying the correct patient, procedure, and site during operative or other invasive procedures ... To provide guidance for improving team communication through a culture of safety in order to reduce the incidence of medical errors ... The Universal Protocol must be followed on all procedures that require an informed consent. This includes all invasive/operative procedures, and all procedures done under Procedural Sedation whether invasive or noninvasive ... The Universal Protocol is composed of the following elements:1. Pre-Procedure verification. 2. Marking the site, when applicable 3. Procedural Briefing 4. Time Out. 5. Debriefing ... Site Marking ... The site is to be marked at or adjacent to the incision site at a location that will be visible after the patient is prepped and draped, when anatomically and technically possible ... Time Out ...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 ... The Time Out involves the immediate members of the procedure team, including the individual performing the procedure and other active participants who will be participating in the procedure from the beginning ... Conduct the Time Out immediately before the procedure begins with the patient properly positioned, prepped and draped ... All activities are to be suspended for the duration of the Time Out, ... so that all members of the team are focused on elements of the Time Out. ...Time Out addresses and verbally confirms among all team members the following elements ... Correct patient ...Confirmed with two identifiers (per Patient Identification policy) ... Correct procedure and laterality (when applicable) as consented ... Site marked (when applicable) ...".

During a review of professional reference titled, "When Left Is Right and Right Is Wrong: A Case Report of Two Near-Miss Wrong-Sided Peripheral Nerve Blocks," (retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC9217577/) dated 6/15/22, the professional reference indicated, " ... Wrong-sided peripheral nerve blocks occur with a surprisingly high frequency despite being described as a "never event." Timeout procedures are performed and documented, yet timeout omission is rarely cited as a contributing factor for wrong-sided blocks ... Author Recommendations ...Reduce time pressure to perform regional blocks by stressing the importance of quality over on-time starts when nerve blocks are involved ... Be aware of environmental cues by making mental notes of patients with bilateral injuries ...Visualize the procedure mark immediately prior to performing nerve block. Occasionally, a separate block mark may be needed if surgical mark is far from the nerve block site ...Place separate procedure marks when multiple blocks (i.e., front/back blocks) are performed on the same patient. Visualize both marks during the initial timeout ...After repositioning, institute a pause point to confirm that the second procedural mark is visible before performing the second block ...".

During a review of professional reference titled, "Lasting effects of general anesthetics on the brain ..." (retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC6443620/) dated 3/11/19, the professional reference indicated, " ...General anesthetics are commonly used in major surgery. To achieve the depth of anesthesia for surgery, patients are being subjected to a variety of general anesthetics, alone or in combination. It has been long held an illusory concept that the general anesthesia is entirely reversible, and that the central nervous system is returned to its pristine state once the anesthetic agent is eliminated from the active site. However, studies indicate that perturbation (departing from established course) of the normal functioning of these targets may result in long-lasting ... undesirable effects. The ... aging brain may be vulnerable to anesthesia. An important mechanism for anesthesia-induced developmental neurotoxicity (damage to the brain, spinal cord or nerves from brain and spinal cord) ... Exposure to anesthesia to the aged brain can be a risk of the long-lasting impairments of cognitive (the mental process of gaining knowledge) function ...".