HospitalInspections.org

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.12 GOVERNING BODY was out of compliance.

A-0084 CONTRACTED SERVICES The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. Based on observations, interviews, and document review, the facility's governing body failed to ensure contracted services were provided in a safe and effective manner. Specifically, the governing body failed to ensure anesthesia services provided by contract followed standard practices in order to provide safe patient care. Additionally, the governing body failed to ensure the QAPI and Infection Control program sufficiently identified concerns with anesthesia services and implemented preventative measures.

Based on observations, interviews, and document review, the facility's governing body failed to ensure contracted services were provided in a safe and effective manner. Specifically, the governing body failed to ensure anesthesia services provided by contract followed standard practices in order to provide safe patient care. Additionally, the governing body failed to ensure the QAPI and Infection Control program sufficiently identified concerns with anesthesia services and implemented preventative measures. (Cross-reference A-286, A-940 and A-747).

Findings include:

Facility By-laws:

The Governing Body By-laws read, the system board through the region board delegates to the Board or the corporation the following powers: Oversee patient safety, quality of care, and the patient experience; oversee credentialing and privileging for facility or program medical staff and clinical staff or other privileged health care providers or professional personnel including reviewing and approving or disapproving appointments, terminating appointments, delineating or curtailing clinical privileges, and administering other discipline, including formal corrective actions; oversee the medical staff including approving medical staff bylaws, rules, regulations, and policies promptly acting upon recommended medical staff matters, and receiving medical staff reports regarding activities to improve medical practice and patient care; oversee quality of care by implementing and monitoring quality assurance guidelines, quality improvement, safety initiatives and patient grievances; and ensure all contracted and shared or centralized services comply with applicable conditions of participation, meet the contractual and other applicable standards for services and are provided in a safe and effective manner.

The Medical Staff By-laws read, the medical staff's purpose and responsibilities are to report to and be accountable to the governing body for matters within its responsibilities. Additionally, to provide oversight of quality and safety of care, treatment and services provided by practitioners.

Contracts:

The contracted agreement between the facility and the contracted anesthesia providers who provided care at the facility read, the contractor will provide the services in accordance with the following: recognized medical standards, including the professional standards of conduct and practice as may from time to time be required or recommended by the state medical association, American Medical Association or American Osteopathic Association as applicable, and the professional bodies which the facility is or may become a member. The services will also be provided in accordance with the bylaws, rules, regulations, policies, guidelines, protocols, procedures, and directives of the facility and the medical staff now in force as may hereafter be adopted by the facility or the medical staff.

Monitoring and Evaluation: The contractor and contractor's representatives shall be subject to periodic and ongoing facility monitoring and evaluations to determine if such contracted services are provided safely and effectively. In the event that the facility reasonably determines that the contractor and contractor's representative have failed to provide services in a safe and effective manner consistent with performance expectations or facility policies and procedures, the facility shall provide written notice to the contractor specifying in sufficient and reasonable detail such non-compliance. The contractor and contractor's representatives shall be subject to corrective action plans developed by the facility or developed by the contractor and approved by the facility to improve the services that do not meet the facility's reasonable expectations or may be deemed to be in breach of this agreement as provided below.

Quality Performance Metrics: the contractor will support and participate in improved quality performance metrics work prioritized by the facility's annual strategic plan. On a quarterly basis, the contractor and facility shall review the quality metrics, to reasonably detail Contractor's progress in meeting the quality metrics.

References:

The American Society of Anesthesiologists (ASA) Statement on Labeling of Pharmaceuticals for Use in Anesthesiology, provided by the facility read, the primary consideration for the design and use of labels for syringes, drug infusion bags, and medication containers should be the reduction of medication errors and thus safer patient care. Syringes: The drug's generic name and concentration (in units per milliliter (ml)) should be the most prominent items displayed on the label of each syringe. The date and time of preparation, and the preparer's initials or name, should also be included. The patient's name and route of administration may also be printed on the label. Labeling medications is an essential step in decreasing the risk of medication errors, and influences selection of the correct medication, determining and then administering the correct dose, and ensuring that the medication chosen has not passed its expiration time or date. This is especially true for the practice of anesthesiology, which involves administration of a wide variety of potent medications. Medications with widely differing actions, for example, sedative/hypnotics, opiates, neuromuscular blockers, vasopressors, and vasodilators, are often used in the course of a single anesthetic, at times simultaneously. These medications are often given in high-acuity situations, in environments with high workload, poor visibility, and multiple distractions. It is recognized that perioperative medication errors are a significant source of morbidity and, rarely, mortality. Labels may be applied in various circumstances. They are most commonly applied to syringes drawn up by anesthesia providers at the point of care. Identification of a medication is verified by reading the label. Therefore, although multiple factors contribute to medication errors, consistency and clarity of pharmaceutical and syringe labeling, in accordance with human factors principles, remain important elements of error prevention.

First, all medications and solutions that are not immediately administered must be labeled. A medication that is immediately administered is defined as one that is prepared or obtained, taken directly to a patient, and administered to that patient, without any break in the process. Second, each medication must be labeled as soon as it is prepared, which is when it is taken from its original packaging and transferred to another container. Third, the label must include the following information: medication or solution name, strength, amount of the medication or the solution containing the medication (if not apparent from the container), diluent name and volume (if not apparent from the container), and either expiration time (when expiration occurs in less than 24 hours) or date (when not used within 24 hours). However, the date and time are not necessary for short procedures, as defined by the organization.

The American Society of Anesthesiologists (ASA) Statement on Standard Practice for Avoidance of Medication Errors in Neuraxial Anesthesia, provided by the facility, read, medication(s) drawn up into a syringe that are to be added from outside the sterile field during the procedure must be labeled in accordance with accepted standards. When these medications are added the person performing the procedure must confirm the drug, concentration, and dose with the assistant.

Findings include:

1. The facility's Governing Body failed to ensure contracted anesthesiologists followed facility policies and national standards for care provided to surgical patients.

A. On 11/15/23 at 9:22 a.m., an observation was conducted with perioperative medical director (Director) #13 of video footage recorded from operating room (OR) #9 of a case performed on 10/31/23.

i. Video review showed Anesthesiologist #7 prepared medications for Patient #2 while a surgery case for a prior patient was ongoing. Video review showed at 10:09 a.m., Anesthesiologist #7 pulled a vial of propofol (an anesthesia medication used to sedate patients prior to a procedure) from drawer #1 in the Omnicell anesthesia medication cart, drew up the propofol into one 50 milliliter (ml) syringe and one 10 ml syringe. Anesthesiologist #7 did not label either syringe and she placed both syringes into the locked Omnicell anesthesia general medication storage drawer (used to store medications not used immediately).

During this portion of the video review, Director #13 stated medication drawn up in advance and stored for later use should have been labeled before it was placed in the medication storage drawer.

ii. At 10:11 a.m., Anesthesiologist #7 pulled a vial of mepivicaine (an anesthesia medication used to numb an area of the body prior to a procedure), which was a 20 ml vial with a navy blue cap, from the anesthesia Omnicell drawer #2 and a vial of tranexamic acid (TXA, a medication used to treat or prevent excessive blood loss), which was a 10 ml vial with a yellow cap from drawer #3, and placed both vials into the Omnicell anesthesia general medication storage drawer with the propofol syringes that were drawn up earlier.

iii. At 10:12 a.m., Anesthesiologist #7 pulled a vial of lidocaine (a medication with multiple uses, including pain relief, numbing of an area of the body, or treating abnormal heart rhythms), which was a five ml vial with a light blue cap, drew it up into a syringe, labeled it, and placed it in the Omnicell anesthesia general medication storage drawer with the propofol syringes, mepivacaine vial, and TXA vial.

iv. At 11:42 a.m., Anesthesiologist #7 opened the Omnicell anesthesia general medication storage drawer, removed both syringes of propofol and the syringe of lidocaine, and placed them on the anesthesia monitor cart. At 11:46 a.m., Patient #2 was brought into OR #9.

v. At 11:47 a.m., Anesthesiologist #7 took a spinal anesthesia kit (which contained bupivacaine) and a three ml syringe from the Omnicell anesthesia cart, then pulled the vial of TXA from the general medication storage drawer and carried the kit, syringe, and TXA vial to the patient's bedside.

At 11:49 a.m., after the spinal procedure was performed (outside the view of the video camera), Anesthesiologist #7 placed both the vial of TXA with the yellow cap now removed, and the three ml syringe at the bottom right corner of the cart's medication preparation area.

During this portion of the video review, Director #13 stated Anesthesiologist #7 had taken the vial of TXA and the three ml syringe to the patient's bedside at the time of the spinal procedure and not the mepivacaine or lidocaine, which were the medications that were supposed to be administered at that time. Director #13 stated TXA should not have been administered at that time in the procedure.

vi. At 11:55 a.m., Anesthesiologist #7 took the 50 ml syringe of propofol from the anesthesia monitor cart to the patient's bedside. At 11:56 a.m., Anesthesiologist #7 took the 10 ml syringe of propofol and the syringe of lidocaine off of the anesthesia monitor cart and injected them into Patient #2's IV tubing.

During this portion of the video review, Director #13 stated no other syringes of lidocaine had been drawn up or administered to the patient before or after the syringe of lidocaine was injected into the patient's IV tubing with the propofol at 10:56 a.m.

This was in contrast to the medical record review of Patient #2 (see below) where Anesthesiologist #7 documented she had accidentally administered lidocaine for the initial spinal procedure rather than mepivacaine.

vii. At 11:57 a.m., Anesthesiologist #7 sat down in front of the Omnicell anesthesia cart, picked up the vial of TXA, looked at it several times, then opened the Omnicell anesthesia general medication storage drawer, took out the vial of mepivacaine with the cap still in place and placed it onto of the cart next to the vial of TXA. At 11:57 a.m., Anesthesiologist #7 walked away from the Omnicell anesthesia medication cart then walked back to the cart once again picked up the vial of TXA and looked at it before she placed it back on top of the cart.

During this portion of the video review, Director #13 stated this was the same vial of TXA that had been brought the the patient's bedside at the time the spinal anesthesia procedure was performed (see above). Director #13 confirmed that mepivicaine and lidocaine had not been drawn up for use at the time of the initial spinal anesthesia procedure and neither had been brought to the patient's bedside at the time the first spinal anesthesia procedure was performed.

viii. At 11:58 a.m., Anesthesiologist #7 opened a second spinal anesthesia kit, picked up a three ml syringe, opened the vial of mepivacaine, and placed them on the anesthesia monitor cart. Anesthesiologist #7 then performed a second spinal anesthesia procedure. Anesthesiologist #7 did not draw up or pull additional TXA from the Omnicell and did not administer TXA intravascularly immediately before the time of incision, which was when the TXA was intended to be administered.

During this portion of the video review, Director #13 stated after the TXA was taken from the cart at the time of the initial spinal anesthesia procedure, it was not used again. Director #13 stated additionally, TXA was not drawn up and given to Patient #2 through her IV line as per protocol.

This was in contrast to the medical record review of Patient #2 (see below) where Anesthesiologist #7 documented TXA IV protocol was followed and TXA was administered intravenously (within a vein or veins) at 12:06 p.m.

Overall, a review of the video footage conducted with Director #13 indicated TXA had been administered at the time of the initial spinal anesthesia procedure. Specifically, the review revealed a vial of TXA was brought to the patient's bedside at the time of the initial spinal anesthesia procedure (the vial was not in view during the procedure). The same vial of TXA was then returned to the anesthesia cart with the cap removed. Mepivacaine, which was to be administered during the initial spinal anesthesia procedure, was never removed from the anesthesia storage drawer until the second spinal anesthesia procedure. Lidocaine was only drawn up once when it was administered through the IV after the initial spinal anesthesia procedure had been performed.

B. Medical record review for Patient #2

i. A review of Patient #2's medical record revealed the patient was admitted on 10/31/23 at 9:48 a.m. for a total knee arthroplasty (a surgical procedure to resurface a knee damaged by arthritis). During the procedure, a second block was performed due to the first spinal block's lack of effectiveness. Patient #2 was taken to the Post Anesthesia Care Unit (PACU) at 1:35 p.m., once the surgical procedure was completed. At 1:37 p.m. Anesthesiologist #7 documented Patient #2 developed spinal myoclonus (sudden, brief involuntary twitching or jerking of a muscle or group of muscles) and pain in her hips and back, tachycardia (a heart rate faster than normal), and hypertension (high blood pressure) while in the PACU. A provider note written by medical doctor (Physician) #9 on 10/31/23 at 3:51 p.m. revealed there was a concern Patient #2 received intrathecal (the space between the spinal cord and the membranes that support it) TXA (a drug that acts by inhibiting the process that dissolves clots, thereby reducing bleeding) during surgery and the patient exhibited clinical symptoms that matched accidental intrathecal TXA administration which included gluteal and lower extremity myoclonus. A death pronouncement note written by registered nurse (RN) #11 revealed Patient #2 was pronounced dead on 11/1/23 at 9:54 a.m.

C. A review of the Investigation and Actions document provided by the facility revealed the investigation and actions implemented since the adverse patient event occurred on 10/31/23. Review of the investigation revealed the following:

i. On 11/1/23, the senior leadership and quality teams met to discuss the event. When requested from regulatory and caregiver safety manager (Manager) #1, no further documentation that indicated what was discussed or outcomes determined by the discussion was provided.

ii. On 11/2/23, the senior director of clinical safety and risk (Director) #3 and the system leader risk director (Director) #4 reviewed the pharmacy surveillance video of Anesthesiologist #7 providing care to Patient #2 during the spinal block. When requested, information that detailed conclusions drawn from the video review was not made available as the review was considered inconclusive. It was later identified by the regulatory and caregiver safety manager (Manager) #1 that the correct people had not reviewed the video and the review should have included an anesthesiology provider who had first-hand experience with the medications and situation in question. In addition, a staff debrief was held to provide emotional support.

iii. On 11/3/23, the facility began a cause mapping, and a perioperative area morning huddle was held. According to the huddle information sheet, staff were notified of the event and were asked to provide support to their colleagues.

iv. On 11/7/23 interviews were conducted with staff. Upon review of the specific staff members interviewed, Anesthesiologist #7, the provider identified by the facility as making a medication error, was not interviewed.

v. On 11/8/23 risk and pharmacy department staff met to discuss switching TXA vials to piggyback bags, and this was added to the plan of action items to discuss at the Friday meeting on 11/17/23.

vi. On 11/9/23 the event was sent to peer review.

vii. On 11/13/23 leadership discussed immediate change from vials to piggyback (medication administered via secondary IV tubing connected to the primary tubing) for TXA medication with OR staff.

viii. On 11/14/23, 14 days after the sentinel event occurred, TXA vials were removed from the OR anesthesia carts and replaced with TXA piggyback bags, which were stored in the OR core. Education with staff regarding the change to TXA storage was provided.

D. Additional surgical video surveillance reviews revealed infection control practices were not followed per facility policy and national standards.

a. In four of four video reviews conducted of randomly selected anesthesia procedures, lapses in infection control practices were identified. The lapses included not scrubbing the tops of vials with alcohol before medication administration, drawing up medications for one patient while another patient's surgical case was occurring, lapses in hand hygiene, breaking sterile technique during the preparation of a sterile procedure, and anesthesia providers placing a Mistral-Air hose (a device intended to raise and maintain a patient's temperature by means of surface warming) down their pants then using later on patients without being cleaned before use. (Cross-reference A-747)

E. Interviews

a. On 11/14/23 at 11:41 a.m., an interview with Director #13 was conducted. Director #13 stated there was no standard procedure for how anesthesia providers labeled medications used in anesthesia procedures and each anesthesia provider had their own established procedure for doing so. Director #13 stated it was not standard practice at the facility to label medications added to the sterile field or to label medications prepared before a patient procedure which were stored for later use. Director #13 stated there was a risk to patient safety if standardized procedures were not used by all anesthesia providers.

This was in contrast to the governing body bylaws which read, contracted services must meet applicable standards for services and were provided in a safe and effective manner. This was also in contrast to the ASA standards which read, all medications and solutions that were not immediately administered must be labeled.

b. On 11/20/23 at 9:44 a.m., an interview was conducted with infection prevention manager (manager) #15. Manager #15 stated her role was to oversee the infection prevention program, work on infection prevention policies, and perform infection prevention risk assessments. Manager #15 stated she completed audits and observations in the operating rooms on a quarterly basis and assessed for compliance with infection prevention standards. Manager #15 stated issues related to breaks in the sterile process for spinal anesthesia were not identified during these audits. Manager #15 stated spinal anesthesia kits and medications should not have been prepared during cases for patients for whom the spinal kits and medications were not intended. Manager #15 stated preparing spinal anesthesia kits and medications before the patient they were intended for in the OR was a breach of the facility's expected standard of practice. Manager #15 stated the preparation of spinal anesthesia kits was a sterile procedure and once hand hygiene was performed and sterile gloves were donned, nothing should have been touched outside of the kit. Manager #15 stated the risk of not utilizing sterile technique when spinal anesthesia kits were prepared included cervical spinal infection, meningitis (inflammation of the tissues surrounding the brain and spinal cord), and death.

c. On 11/20/23 at 9:02 a.m., an interview was conducted with chief executive officer (CEO) #18.
CEO #18 explained all providers were credentialed and there were quality performance metrics that were reviewed by the leadership assigned for oversight over their area of practice. CEO #18 stated if there was a concern with a specific service or provider, she expected those concerns would be brought to her attention. CEO #18 stated the governing board met monthly and she would report on the facility's quality improvement, patient engagement, and specific quality metrics.

CEO #18 stated the role of the governing body was to ensure the regulations were met and competent services were provided to ensure patient safety. CEO #18 explained the governing board was important as they were responsible for oversight and to ensure safe patient care. Additionally, CEO #18 stated the governing board had the power to approve recommendations and had ultimate oversight of the facility. CEO #18 stated oversight of contracted providers was the same as providers who were employed by the facility. CEO #18 stated oversight of provider practice was completed through ongoing professional practice evaluation (OPPE). CEO #18 stated providers in their first year of employment or contract had OPPEs completed at the six-month and one-year marks by the leadership who oversaw their area of practice. CEO #18 stated after one year, provider OPPEs were completed annually. CEO #18 stated if concerns with providers arose which required immediate action, a peer review process was initiated and concerns were addressed before the annual OPPE review.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PROGRAM was out of compliance.

(A-0286) PATIENT SAFETY (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ...(3) That clear expectations for safety are established. Based on document review and interviews, the facility failed to ensure all causes of a critical adverse event were analyzed and that preventative actions were implemented to prevent recurrence in one of one patients reviewed who experienced a critical event after a surgical procedure.

Based on document review and interviews, the facility failed to ensure all causes of a critical adverse event were analyzed and that preventative actions were implemented to prevent recurrence in one of one patients reviewed who experienced a critical event after a surgical procedure. (Patient #2) (Cross-reference A-940)

Findings include:

Facility document:

The 2023 Quality Assurance and Performance Improvement (QAPI) plan read, leadership has identified acceptable safety behavior for error prevention. Identification of actual and potential risk and safety events and responding to mitigate those risks are fundamental to our quality and safety program. The risk management department facilitates the Root Cause Analysis (RCA) and coordinates with others to implement approved risk reduction strategies and actions. Each care site conducts timely, thorough, and credible RCA when sentinel events are identified. RCA findings are used to identify opportunities for process and system improvements to reduce the risk of recurrence. Contracted services that impact Patients or the Environment of care: The governing body delegates actions to the hospital's QAPI program to: Assess those services under contract that affect the patient or environment of care; identify quality and performance problems and implement appropriate corrective or improvement activities; and to ensure the monitoring and sustainability of those corrective or improvement activities. A summary of contracted services and their performance results will be communicated to the Board of Directors via their Quality Committee. The summary will also be presented to the medical staff for input (not approval). The designated service leader or contract owner for each contract service is expected to monitor the performance. Quality or performance problems identified by the identified service leader or contract owner will be referred to the local PEC/MEC or other designated committee or group of individuals. The Quality Director will ensure the Board of Directors is aware of performance issues and will provide performance improvement support as needed to support improvement initiatives and sustainability.

Facility policies:

The Patient Safety Event Reporting policy read, the purpose is to guide in the identification and intensive assessment of sentinel events in order to improve patient care, treatment, and services to reduce their probability of recurrence; to have a positive impact in improving patient care, treatment, and services and in preventing unintended harm; and to increase the general knowledge about patient safety events, their contributing factors and strategies for prevention. A sentinel event is a patient safety event that reaches a patient and results in death, severe harm, or permanent harm. The procedure for a sentinel event is for identification, immediate response, and reporting to occur. Upon identification of a patient safety event, the patient care provider will immediately perform necessary healthcare interventions to protect and support the patient's clinical condition. As appropriate, perform necessary healthcare interventions to contain the risk to others.

The Adverse Drug Events policy read, an adverse drug event is defined as unexpected symptoms or incidents caused by medical treatment that is an inherent risk when medication therapy is used. The adverse drug event (ADE) is created through either leaving out or by the administration of a medicine or medicines during which a patient may be harmed, with effects ranging from mild discomfort to death.

1. The facility failed to investigate all causative factors and implement actions after a sentinel event occurred.

A. A review of Patient #2's medical record revealed an adverse event occurred while receiving anesthesia care at the facility.

i. Patient #2 was admitted to the facility on 10/31/23 at 9:48 a.m. for a total knee arthroplasty (a surgical procedure to resurface a knee damaged by arthritis). An anesthesia procedure note written by Anesthesiologist #7 on 10/31/23 at 12:08 p.m. revealed two spinal blocks were performed on Patient #2. Anesthesiologist #7 documented the first spinal block was performed using lidocaine 1% as a local skin anesthetic and mepivacaine 50 milligrams (mg) for spinal analgesia. Anesthesiologist #7 further documented the first spinal block she performed was identified as inadequate when the patient complained of knee pain with no noticeable block during surgical preparation. Anesthesiologist #7 documented she realized she had swapped the vial of lidocaine and mepivacaine and inadvertently administered lidocaine for the first spinal block. A second anesthesia procedure note written by Anesthesiologist #7 on 10/31/23 at 12:18 p.m. revealed a second spinal block was performed with no immediate complications after a failed and inadequate block was performed with the incorrect medication ten minutes prior. Anesthesiologist #7 documented TXA IV (a drug that acts by inhibiting the process that dissolves clots, thereby reducing bleeding) protocol was followed and TXA was administered intravenously (within a vein or veins) at 12:06 p.m.

Record review showed Patient #2 was taken to the post anesthesia care unit (PACU) at 1:35 p.m., once the surgical procedure was completed. At 1:37 p.m., Anesthesiologist #7 documented Patient #2 developed spinal myoclonus (sudden, brief involuntary twitching or jerking of a muscle or group of muscles), pain in her hips and back, tachycardia (a heart rate faster than normal), and hypertension (high blood pressure) while in the PACU. An anesthesiology note written by Anesthesiologist #8 revealed he assisted with Patient #2's care while in PACU and called a stroke alert (a medical emergency notification for staff to respond immediately when patients experience stroke symptoms) due to her symptoms. Anesthesiologist #8 revealed he remained with Patient #2 when she was transported for a computed tomography (CT) scan and subsequently to the ICU. CT results showed no evidence of stroke. At 2:45 Patient #2 was transferred and admitted to the Intensive Care Unit (ICU).

A provider note written by medical doctor (Physician) #9 on 10/31/23 at 3:51 p.m. revealed there was a concern Patient #2 received intrathecal (through the spine) TXA during surgery and the patient exhibited clinical symptoms that matched accidental intrathecal TXA administration, which included gluteal and lower extremity myoclonus. Similar concerns with accidental intrathecal TXA administration were documented by Physician #10 and Physician #12. A provider note written by Physician #10 on 11/1/23 at 8:34 a.m. revealed Patient #2 had developed severe hypotension (low blood pressure), multiple end-stage organ failure, status epilepticus (a seizure lasting longer than five minutes), shock (a critical condition brought on by the sudden drop in blood flow through the body), and generalized myoclonus despite aggressive medical management. A death pronouncement note written by registered nurse (RN) #11 revealed Patient #2 was pronounced dead on 11/1/23 at 9:54 a.m.

B. A review of the Investigation and Actions document provided by the facility revealed the investigation and actions implemented since the adverse patient event occurred on 10/31/23. Review of the investigation revealed the following:

i. On 11/1/23, the senior leadership and quality teams met to discuss the event. When requested from regulatory and caregiver safety manager (Manager) #1, no further documentation that indicated what was discussed or outcomes determined by the discussion was provided.

ii. On 11/2/23, the senior director of clinical safety and risk (Director) #3 and the system leader risk director (Director) #4 reviewed the pharmacy surveillance video of Anesthesiologist #7 providing care to Patient #2 during the spinal block. When requested, information that detailed conclusions drawn from the video review was not made available as the review was considered inconclusive. It was later identified by the regulatory and caregiver safety manager (Manager) #1 that the correct people had not reviewed the video and the review should have included an anesthesiology provider who had first-hand experience with the medications and situation in question. In addition, a staff debrief was held to provide emotional support.

iii. On 11/3/23, the facility began a cause mapping and a perioperative area morning huddle was held. According to the huddle information sheet, staff were notified of the event and were asked to provide support to their colleagues.

iv. On 11/7/23 interviews were conducted with staff. Upon review of the specific staff members interviewed, Anesthesiologist #7, the provider identified by the facility as making a medication error, was not interviewed.

v. On 11/8/23 risk and pharmacy department staff met to discuss switching TXA vials to piggyback bags, and this was added to the plan of action items to discuss at the Friday meeting on 11/17/23.

vi. On 11/9/23 the event was sent to peer review.

vii. On 11/13/23 leadership discussed immediate change from vials to piggyback (medication administered via secondary IV tubing connected to the primary tubing) for TXA medication with OR staff.

viii. On 11/14/23, 14 days after the sentinel event occurred, TXA vials were removed from the OR anesthesia carts and replaced with TXA piggyback bags, which were stored in the OR core. Education with staff regarding the change to TXA storage was provided.

C. Interviews with leadership further revealed factors that led to the incident were not identified and preventative measures were not implemented until after the survey start date of 11/13/23.

i. On 11/13/23 at 4:24 p.m., an interview was conducted with the regulatory and caregiver safety manager (Manager) #1 and the director of quality (Director) #2. Director #2 stated an investigation had begun for the medication adverse event that occurred to Patient #2. She stated the facility was still trying to determine what error had occurred. Director #2 stated a multidisciplinary meeting with senior leadership was held on 11/2/23. She explained additionally that day, another debrief was conducted with the physicians and staff who had been a part of the adverse patient event. Director #2 stated an RCA was started and at the time of the interview, staff were still being interviewed related to the event. Director #2 explained a meeting was to be held on 11/17/23 (17 days after the adverse event) to discuss the investigation and identify and implement interventions.

ii. On 11/14/23 at 10:21 a.m., an interview was conducted with the facility's corporate senior director of clinical safety and risk (Director) #3. Director #3 stated her role was to assist with the devastating error. She stated the facility and corporate leadership did not want to be too reactive too soon to prevent additional potential issues. Director #3 stated during the initial investigation of the adverse patient event with Patient #2, it was determined that the vials of TXA should have been removed and replaced with an IV bag. Director #3 stated the action plan for the sentinel event was expected to be implemented on 11/17/23. Further, Director #3 explained the facility would have identified causes and actions to implement on 11/17/23, 17 days after the event occurred.

iii. On 11/14/23 at 10:39 a.m., an interview was conducted with system leader risk director (Director) #4. Director #4 stated she provided supportive care to the staff who were involved in the event. Director #4 then stated as part of the investigation she examined the anesthesia work station. Director #4 stated a recommendation by the pharmacy was to reorganize the drawers in the anesthesia cart and that the TXA vials should have been changed to the IV piggyback bags. Director #4 stated it was determined TXA should have been changed from vials to IV piggyback due to the known risk of accidental TXA administration via the wrong route and that it was considered best practice. Director #4 then stated the standardized process was for doctors to verify their own medications and label medications.

Director #4 stated according to Patient #2's medical record, the TXA had been scanned as given intravenously (IV). Director #4 stated the video was reviewed of the anesthesia medication preparation and administration during the case. Director #4 revealed during the incident with Patient #2, the medications were immediately drawn up and not labeled by Anesthesiologist #7. Director #4 concluded the video was inconclusive with no concerns identified, however, staff had been notified of the event during huddles.

D. Review of video footage from Patient #2's case revealed additional lapses in standard practice and potential causative factors that were not identified by the facility.

i. On 11/15/23 at 9:22 a.m., an observation was conducted with periOperative medical director (Director) #13 of video footage recorded from operating room (OR) #9 of a case performed on 10/31/23 involving Patient #2.

a. Video review showed Anesthesiologist #7 prepared medications for Patient #2 while a surgery case for a prior patient was ongoing. Video review showed at 10:09 a.m., Anesthesiologist #7 pulled a vial of propofol (an anesthesia medication used to sedate patients prior to a procedure) from drawer #1 in the Omnicell anesthesia medication cart, drew up the propofol into one 50 milliliter (ml) syringe and one 10 ml syringe. Anesthesiologist #7 did not label either syringe and she placed both syringes into the locked Omnicell anesthesia general medication storage drawer (used to store medications not used immediately).

During this portion of the video review, Director #13 stated medication drawn up in advance and stored for later use should have been labeled before it was placed in the medication storage drawer.

b. At 10:11 a.m., Anesthesiologist #7 pulled a vial of mepivacaine (an anesthesia medication used to numb an area of the body prior to a procedure), which was a 20 ml vial with a navy blue cap, from the anesthesia Omnicell drawer #2 and a vial of tranexamic acid (TXA, a medication used to treat or prevent excessive blood loss), which was a 10 ml vial with a yellow cap from drawer #3, and placed both vials into the Omnicell anesthesia general medication storage drawer with the propofol syringes that were drawn up earlier.

c. At 10:12 a.m., Anesthesiologist #7 pulled a vial of lidocaine (a medication with multiple uses, including pain relief, numbing of an area of the body, or treating abnormal heart rhythms), which was a five ml vial with a light blue cap, drew it up into a syringe, labeled it, and placed it in the Omnicell anesthesia general medication storage drawer with the propofol syringes, mepivacaine vial, and TXA vial.

d. At 11:42 a.m., Anesthesiologist #7 opened the Omnicell anesthesia general medication storage drawer, removed both syringes of propofol and the syringe of lidocaine, and placed them on the anesthesia monitor cart. At 11:46 a.m., Patient #2 was brought into OR #9.

e. At 11:47 a.m., Anesthesiologist #7 took a spinal anesthesia kit (which contained bupivacaine) and a three ml syringe from the Omnicell anesthesia cart, then pulled the vial of TXA from the general medication storage drawer and carried the kit, syringe, and TXA vial to the patient's bedside.

At 11:49 a.m., after the spinal procedure was performed (outside the view of the video camera), Anesthesiologist #7 placed both the vial of TXA with the yellow cap now removed, and the three ml syringe at the bottom right corner of the cart's medication preparation area.

During this portion of the video review, Director #13 stated Anesthesiologist #7 had taken the vial of TXA and the three ml syringe to the patient's bedside at the time of the spinal procedure and not the mepivacaine or lidocaine, which were the medications that were supposed to be administered at that time. Director #13 stated TXA should not have been administered at that time in the procedure.

f. At 11:55 a.m., Anesthesiologist #7 took the 50 ml syringe of propofol from the anesthesia monitor cart to the patient's bedside. At 11:56 a.m., Anesthesiologist #7 took the 10 ml syringe of propofol and the syringe of lidocaine off of the anesthesia monitor cart and injected them into Patient #2's IV tubing.

During this portion of the video review, Director #13 stated no other syringes of lidocaine had been drawn up or administered to the patient before or after the syringe of lidocaine was injected into the patient's IV tubing with the propofol at 10:56 a.m.

This was in contrast to the medical record review of Patient #2 (see below) where Anesthesiologist #7 documented she had accidentally administered lidocaine for the initial spinal procedure rather than mepivacaine.

g. At 11:57 a.m., Anesthesiologist #7 sat down in front of the Omnicell anesthesia cart, picked up the vial of TXA, looked at it several times, then opened the Omnicell anesthesia general medication storage drawer, took out the vial of mepivacaine with the cap still in place and placed it onto of the cart next to the vial of TXA. At 11:57 a.m., Anesthesiologist #7 walked away from the Omnicell anesthesia medication cart then walked back to the cart once again, picked up the vial of TXA, and looked at it before she placed it back on top of the cart.

During this portion of the video review, Director #13 stated this was the same vial of TXA that had been brought the the patient's bedside at the time the spinal anesthesia procedure was performed (see above). Director #13 confirmed that mepivicaine and lidocaine had not been drawn up for use at the time of the spinal anesthesia procedure and neither had been brought to the patient's bedside at the time the first spinal anesthesia procedure was performed.

h. At 11:58 a.m., Anesthesiologist #7 opened a second spinal anesthesia kit, picked up a three ml syringe, opened the vial of mepivacaine, and placed them on the anesthesia monitor cart. Anesthesiologist #7 then performed a second spinal anesthesia procedure. Anesthesiologist #7 did not draw up or pull additional TXA from the Omnicell and did not administer TXA intravascularly immediately before the time of incision, which was when the TXA was intended to be administered.

During this portion of the video review, Director #13 stated after the TXA was taken from the cart at the time of the initial spinal anesthesia procedure, it was not used again. Director #13 stated additionally, TXA was not drawn up and given to Patient #2 through her IV line as intended per protocol.

This was in contrast to the medical record review of Patient #2 (see below) where Anesthesiologist #7 documented TXA IV protocol was followed and TXA was administered intravenously (within a vein or veins) at 12:06 p.m.

Overall, a review of the video footage conducted with Director #13 indicated TXA had been administered at the time of the initial spinal anesthesia procedure. Specifically, the review revealed a vial of TXA was brought to the patient's bedside at the time of the initial spinal anesthesia procedure (the vial was not in view during the procedure). The same vial of TXA was then returned to the anesthesia cart with the cap removed. Mepivacaine, which was to be administered during the initial spinal anesthesia procedure, was never removed from the anesthesia storage drawer until the second spinal anesthesia procedure. Lidocaine was only drawn up once when it was administered through the IV after the initial spinal anesthesia procedure had been performed.
The video review was in contrast to the interview with Director #4 who stated no breaches were identified in practice from her review of the video. The anesthesiologist failed to label the medications, failed to verify medications, and did not identify the non-standard practice of administering two spinal blocks to a patient. In addition, the anesthesiologist prepared medications for one patient during another patient's surgical case.

E. Interviews with staff revealed there had been no process changes implemented or education provided to prevent the recurrence of the adverse event.

i. On 11/14/23 at 3:49 p.m., an interview was conducted with surgical technician (Tech) #5. Tech #5 stated she had found out about the adverse event that occurred to Patient #2 from her manager. Tech #5 stated that as of the interview, she was not aware of any changes that had been implemented and did not receive follow-up education after the event.

ii. On 11/14/23 at 4:17 p.m., the circulating registered nurse (RN) #6 who cared for Patient #2 was interviewed. RN #6 stated after the event with Patient #2, a debrief occurred regarding the event with Patient #2 and emotional support resources were made available to staff. RN #6 explained she was unaware of any process changes and had not received any education since the event occurred.

iii. On 11/16/23 at 1:33 p.m., an interview was conducted with Anesthesiologist #7. Anesthesiologist #7 stated when she identified she may have made a medication error, she filed an incident report. She stated at the time of this interview, she had not heard any follow-up regarding the safety event report she had filed and had not been a part of the adverse event investigation. Additionally, Anesthesiologist #7 stated she had not discussed Patient #2's adverse event with facility leadership and was not interviewed as part of the investigation. Anesthesiologist #7 further stated she had not received any education until after the start of the survey and an immediate jeopardy was called on 11/15/23 at 11:53 a.m.

iv. On 11/16/23 at 4:16 p.m., an interview was conducted with Anesthesiologist #8. Anesthesiologist #8 stated he had assisted in the post-anesthesia care unit (PACU) after Patient #2's event. Anesthesiologist #8 stated when a potential medication error had occurred, the error should have been reported to the rest of the team in the OR. He additionally stated if an inappropriate medication was administered, the surgical case may need to be stopped in order to ensure the patient was okay and to reassess what may have happened and provide care to the patient.

Anesthesiologist #8 stated he had not received any education regarding the sentinel until the night before this interview, after an immediate jeopardy was called.

Patient #2's anesthesia care was further discussed with Anesthesiologist #8. Anesthesiologist #8 stated if an initial spinal block did not work, the process was to place the patient under general anesthesia. Anesthesiologist #8 stated if another block was placed, there was a concern for a patient to experience a high spinal (a life-threatening complication associated with a spinal block) which could have resulted in bradycardia (slow heart rate), hypotension (low blood pressure), and apnea (temporary cessation of breathing).

The interview was in contrast to the facility's investigative review of the event which did not identify the inappropriate practice of doing a second spinal.

v. On 11/20/23 at 8:09 a.m., a second interview was conducted with Director #2. Director #2 stated the process for investigating incidents started with a daily review of all patient events that were submitted from the previous 24 hours. Director #2 explained when the initial review occurred, the team determined which patient events had concerns that needed to be escalated. Director #2 further explained serious events would be escalated to a higher tier review. She stated a huddle was then conducted with the manager of the team where the event occurred. Director #2 stated if an immediate solution was not determined then there was a meeting to debrief on the event.

In regards to Patient #2, Director #2 stated the event was escalated to the senior leadership team at the hospital and hospital corporate system. The meeting with the senior leadership teams occurred on 11/1/23 at 8:00 a.m.

At 3:13 p.m., a final interview was conducted with Director #2. Director #2 stated the importance of the QAPI program was to learn from mistakes made and adverse events. Director #2 stated when adverse events occurred, it was important to implement actions in order to keep patients safe and prevent recurrence.

vi. On 11/14/23 at 11:41 a.m., an interview was conducted with Director #13. Director #13 stated he had not been asked to review the video of Patient #2's surgical case and had not done so before the survey started on 11/13/23. Director #13 stated no anesthesiology provider had reviewed the video as part of the facility's investigation into the concerns with Patient #2's surgical case. Director #13 stated when he reviewed the video, he identified several concerns, and parts of the video had been difficult to watch due to the level of the concerns. Director #13 stated an anesthesiologist should have been part of the review as they had direct knowledge of anesthesia practice and the areas of concern identified during the survey. Director #13 stated he identified the medication that was pulled by Anesthesiologist #7 and brought to the spinal anesthesia kit at the time the initial spinal anesthesia was administered was TXA and not mepivacaine or lidocaine. Director #13 stated he identified Anesthesiologist #7 had failed to label medications and had prepared medications for one patient during another patient's surgical case.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 INFECTION PREVENTION AND CONTROL AND ANTIBIOTIC STEWARDSHIP PROGRAMS was out of compliance.

A-0747 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program.

Based on observations, interviews, and document review, the facility failed to ensure an active hospital-wide program for surveillance, prevention, and control of hospital-acquired infections (HAIs) demonstrated adherence to nationally recognized infection prevention standards for six of seven patients reviewed who received spinal and general anesthesia. (Patients #2, #4, #5, #6, #7, and #9) Specifically, the facility failed to ensure hand hygiene practices, sterile technique, and use of operating room equipment were performed in accordance with policy and national guidelines.

Findings include:

Facility policy:

The Hand Hygiene policy read, hand hygiene (hand washing or sanitizing) is the single most critical and effective procedure for preventing healthcare-associated infections, protecting our patients, healthcare workers (HCWs), and customers by reducing the presence of microbes on hands. This policy applies to all persons working for or on behalf of the facility. Hand sanitizing means applying hospital-approved waterless antiseptic hand rub product to all areas of
the hands; rub together until dry. This reduces the number of microorganisms present on the hands. Hand Washing means vigorous, brief rubbing together of all surfaces of lathered hands, followed by rinsing under a stream of water. Hand Washing with plain soap suspends microorganisms and allows them to be rinsed off (mechanical removal); while washing with antimicrobial-containing products kills or inhibits the growth of microorganisms (chemical removal). Perform hand hygiene at every opportunity including prior to any direct patient contact even if gloves are to be worn, prior to entrance and following exit of patient room or care areas, regardless of interaction with the patient environment, before and after any direct patient contact or contact with the patient's environment, after removing gloves worn for any reason, and after touching any inanimate sources that are likely to be contaminated with microorganisms.

References:

The Association of periOperatice Registered Nurses (AORN) guidelines for Medication Safety (3/16/23), provided by the facility, read, medications must be administered in accordance with local, state, or federal regulations, medication orders, accepted standards of practice, and healthcare organization policies and procedures. Transfer medications and solutions to the sterile field as close to the time of use as possible while using sterile technique. Transfer only one medication at a time to the sterile field and apply a label immediately before another medication or solution is transferred. Do not interrupt or distract personnel who are retrieving or preparing medications. Retrieve medications for only one patient at a time, as close to the time of the procedure as possible. Prepare medications in a designated area that is clean and separated from potential sources of contamination. Disinfect medication vial stoppers with alcohol and allow the stopper to dry before each entry, including the initial entry after removal of the cap or cover.

The Association of periOperatice Registered Nurses (AORN) guidelines for Sterile Technique (11/1/18), provided by the facility, read, and perform hand hygiene before opening sterile supplies. Perform surgical hand antisepsis and don a sterile gown and gloves before preparing or using a sterile field. Prepare the sterile field as close as possible to the time of use. Only sterile items should come into contact with the sterile field. Open, dispense, and transfer sterile items to the sterile field by methods that maintain the sterility and integrity of the item and the sterile field. When transferring medications and sterile solutions to the sterile field, verify and label the medication or solution immediately after transfer. Continually maintain the sterile field. Participate in quality assurance and performance improvement activities that are consistent with the health care organization's plan to improve understanding of and compliance with the principles and processes of sterile technique. Document significant or major breaks in sterile technique that is not immediately corrected or report these per organizational policy.

The Association of periOperatice Registered Nurses (AORN) guidelines for Transmission-Based Precautions (12/1/23, provided by the facility, read, clean reusable medical equipment (e.g., blood glucose meters, blood pressure cuffs, pulse oximeter probes, surgical instruments, endoscopes) that have been used for one patient and disinfect or sterilize equipment in accordance with the manufacturer's written instructions for use (IFU) before use for another patient and when soiled. Cleaning and disinfection or sterilization of soiled reusable medical equipment decreases the risk for cross-contamination and disease transmission to the patient.

The Mistral-Air Instructions for Use (IFU), provided by the facility, read, The Mistral-Air Warming System is a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming. There is no replacement for care providers being attentive to their patient's needs and equipment operation. Read and understand all warnings and precautions before using or prescribing the Mistral-Air Plus warming unit. The Mistral-Air Plus warming unit is fitted with an air filter; however airborne contamination shall be taken into consideration when using the warming system. A physician order is required for setting temperature and for continued use. No free hosing- caution, hose nozzle must be connected to a compatible forced air blanket or thermal injury may occur.

1. The facility failed to ensure anesthesiology providers performed hand hygiene, prepared medication per policy and national standards, and did not prepare medication and spinal anesthesia kits during surgical procedures for other patients.

A. Video Review

i. On 11/16/23 at 7:35 a.m., an observation was made of video footage recorded of operating OR #8. On 10/27/23 at 12:01 p.m., Anesthesiologist #14 prepared for Patient #7's total knee replacement surgical case while the prior case was in the room and surgery was in progress. At 12:01 p.m., Anesthesiologist #14 pulled vials of Fentanyl (a strong medication used to treat pain), Versed (a sedative used to cause drowsiness before a procedure), and propofol (an anesthesia medication used to sedate patients before a procedure) from the Omnicell anesthesia medication cart. Anesthesiologist #14 drew up propofol into a syringe with tubing attached, did not scrub the hub of the vial or perform hand hygiene before drawing up the medication, then placed the syringe along with the Fentanyl and Versed vials into the Omnicell anesthesia general medication storage drawer.

At 12:42 p.m., Anesthesiologist #14 opened a spinal anesthesia kit and donned sterile gloves. With the spinal anesthesia kit open, he then pulled a vial of mepivacaine (an anesthesia medication used to numb an area of the body before a procedure) and a syringe from the Omnicell anesthesia medication cart with his sterile gloves still on, drew up the mepivacaine into the syringe without scrubbing the hub, and placed the syringe into the sterile spinal anesthesia kit. Anesthesiologist #14 continued to use gloves that had touched the non-sterile medication cart and the medication vial while he worked with items in the spinal anesthesia kit.

At 12:46 p.m., Anesthesiologist #14 pulled vials of bupivacaine (an anesthetic medication used to numb a part of the body) and lidocaine (a medication with multiple uses, including pain relief, numbing of an area of the body, or treating abnormal heart rhythms) out of the spinal anesthesia kit and drew them into separate syringes, did not label or verify either syringe and then placed them back into the spinal kit.

At 12:46 p.m., Anesthesiologist #14 closed the spinal anesthesia kit and taped it shut for use in a later case. Throughout the preparation of medication and the spinal anesthesia kit, Anesthesiologist #14 touched his personal cell phone and did not perform hand hygiene before handling medication or patient care equipment. In addition, Anesthesiologist #14 placed his cell phone on the medication preparation area several times and did not clean the area before he prepared the medication.

Similar findings of medications prepared in advance during surgical cases for other patients, lack of hand hygiene prior to medication preparation and administration, and lack of hand hygiene after personal equipment was used were observed from video footage reviewed of surgical cases for Patients #2, #4, #5, #6, #7, and #9.

A similar finding of a breach in the sterile process during the preparation of sterile spinal anesthesia kits was observed in the surgical case of Patient #5.

a. This was in contrast to the Hand Hygiene policy which read, hand hygiene (hand washing or sanitizing) was the single most critical and effective procedure for preventing healthcare-associated infections, protecting patients, healthcare workers, and customers by reducing the presence of microbes on hands. Hand hygiene should have been performed at every opportunity including prior to any direct patient contact even if gloves were worn, prior to entrance and following exit of patient room or care areas, regardless of interaction with the patient environment, before and after any direct patient contact or contact with the patient's environment, after gloves were worn or removed for any reason, and after touching any inanimate sources that were likely to be contaminated with microorganisms.

b. This was also in contrast to the AORN guidelines for Sterile Technique which instructed to perform hand hygiene before opening sterile supplies. The sterile field should have been prepared as close as possible to the time of use. Only sterile items should have come into contact with the sterile field. The guidelines also instructed to open, dispense, and transfer sterile items to the sterile field by methods that maintained the sterility and integrity of the item and the sterile field and to retrieve medications for only one patient at a time, as close to the time of the procedure as possible. Medications should have been prepared in a designated area that was clean and separated from potential sources of contamination. Medication vial stoppers should have been disinfected with alcohol and the stopper should have been allowed to dry before each entry, including the initial entry after the cap or cover was removed.

ii. On 11/16/23 at 8:26 a.m., an observation was made of video footage recorded in operating OR #9 of a case performed on 10/19/23 during the surgical case of Patient #9. Video footage showed at 11:48 a.m., Anesthesiologist #16 took the end of the Mistral-Air hose and stuck it down inside the front of her pants. Anesthesiologist #16 kept the Mistral-Air hose down her pants for twenty minutes while she provided patient care. Anesthesiologist #16 removed the Mistral-Air hose from her pants, did not clean it, and placed it back on top of the Mistral-Air machine.

A similar finding of an anesthesia provider who had placed the Mistral-Air hose into their clothing was observed in the surgical cases of Patient #5.

a. This was in contrast to the AORN guidelines for Transmission-Based Precautions, which read, clean reusable medical equipment that was used for one patient and disinfect or sterilize equipment in accordance with the manufacturer's written instructions for use (IFU) before use for another patient and when soiled.
Cleaning and disinfection or sterilization of soiled reusable medical equipment decreased the risk for cross-contamination and disease transmission to the patient.

b. This was also in contrast to the Mistral-Air IFUs which read, The Mistral-Air Plus warming unit was fitted with an air filter; however airborne contamination shall be taken into consideration when using the warming system. A physician order was required for setting temperature and for continued use. No free hosing- caution, hose nozzle must be connected to a compatible forced air blanket or thermal injury may occur.

B. Interviews

i. On 11/16/23 at 8:45 a.m., an interview was conducted with the pharmacy systems tech and Omnicell administrator (Tech) #19. Tech #19 stated part of his role was to watch video footage of the anesthesiologist in the operating room (OR) when drug diversion was suspected. Tech #19 stated he often observed anesthesiology providers place the tube of the Mistral-Air machine into their clothing during surgical procedures when he did video reviews for the pharmacy.

ii. On 11/20/23 at 9:44 a.m., an interview was conducted with infection prevention manager (Manager) #15. Manager #15 stated her role was to oversee the infection prevention program, work on infection prevention policies, and perform infection prevention risk assessments. Manager #15 stated she completed audits and observations in the operating rooms on a quarterly basis and assessed for compliance with infection prevention standards. Manager #15 stated issues related to breaks in the sterile process for spinal anesthesia were not identified prior to the survey. Manager #15 stated spinal anesthesia kits and medications should not have been prepared during cases for patients whom the spinal kits and medications were not intended for. Manager #15 stated preparing spinal anesthesia kits and medications prior to the patient they were intended for being in the OR was a breach of the facility's expected standard of practice. Manager #15 stated the preparation of spinal anesthesia kits was a sterile procedure and once hand hygiene was performed and sterile gloves were donned, nothing should have been touched outside of the kit. Manager #15 stated the risk of not utilizing sterile technique when spinal anesthesia kits were prepared included spinal infection, meningitis, and death.

iii. On 11/20/23 at 2:51 p.m., a second interview was conducted with Manager #15. Manager #15 stated performing hand hygiene prior to drawing up and administering medications was facility practice and the expected procedure from all staff in the OR. Manager #15 stated hand hygiene should have been performed before handling medications, before sterile or non-sterile gloves were donned, and after staff touched personal equipment such as cell phones. Manager #15 stated hand hygiene was important because it prevented the spread of organisms, reduced the risk of contamination, and reduced the risk of spreading germs.. Manager #15 stated when medication was drawn up from a vial, the hub of the vial should have been scrubbed for 10-15 seconds after the cap of the vial was removed. Manager #15 stated the cap of the vial was to prevent the accumulation of dust and did not provide sterility or cleanliness. Manager #15 stated staff placing the Mistral-Air machine hose into any article of their own clothing was an absolute infection control issue and an unacceptable use of patient care equipment. Manager #15 stated staff who placed the Mistral-Air machine down their pants and up their shirts risked germs being spread from those areas into the OR circulating air. Manager #15 stated the risks of a Mistral-Air machine used on a patient after it was placed into a staff member's clothing included an increased risk of a surgical site infection. Manager #15 stated personal items such as cell phones should have never been placed on a medication preparation area due to the risk of contamination. Manager #15 stated the risk of contaminating a medication preparation area with personal items included the risk for a bloodstream infection and local site infection.

iv. On 11/16/23 at 4:16 p.m., an interview was conducted with Anesthesiologist #8. Anesthesiologist #8 explained the process of sterile technique in the OR. Anesthesiologist #8 stated when sterile gloves were utilized, nothing else could be touched except for other sterile items. Anesthesiologist #8 stated if sterile technique was broken during a spinal block procedure, there was a risk of spreading an infection to the patient's spine such as meningitis or spinal abscess.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.51 SURGICAL SERVICES was out of compliance.

A-0940 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered.

Based on observations, interviews, and document review, the facility failed to implement preventative measures to ensure safe patient care. Specifically, after a sentinel event (a medication error that led to significant patient harm) preventative measures were not implemented to prevent reoccurrence for one of three patients reviewed who received spinal anesthesia. (Patient #2). In addition, medications used for anesthesia prepared in advance were not labeled in accordance with facility policy for five of seven patients reviewed who received spinal and general anesthesia. (Patients #2, #5, #6, #7, and #9)

Findings include:

Facility policies:

The Medication Labeling On and Off the Sterile Field policy read, all medications, medication containers, and/or solutions are appropriately labeled on and off the sterile field. To maintain a safe environment for the patient, it is vital that medications, containers that hold medications, and solutions of medications are labeled appropriately. Label all medication containers
whenever medications are prepared but not immediately administered using the five
rights of medication administration. Label when any medication or solution is transferred from the original packaging to another container. Be sure to include the medication name, strength,
quantity, diluent, and volume, expiration date when not used within 24 hours, and expiration time when expiration occurs in less than 24 hours.

The Adverse Drug Events policy read, a medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing, order communication, product labeling, packaging, nomenclature, compounding; dispensing, distribution, administration, education; monitoring, and use. Required action steps following an adverse drug event include reporting all medication error events and adverse drug reaction events that reach the patient to the appropriate physician and initiate appropriate changes in care as directed. Document all administered medications, including those administered in error in the medical record.

The Perianesthesia Patient Care Guideline Policy read, the administration of medication requires the patient barcode and medication barcode must be scanned prior to administration per hospital policy. All medications will be labeled with patient information and medication concentration.

References:

The American Society of Anesthesiologists (ASA) Statement on Labeling of Pharmaceuticals for Use in Anesthesiology (12/13/20), provided by the facility read, the primary consideration for the design and use of labels for syringes, drug infusion bags, and medication containers should be the reduction of medication errors and thus safer patient care. Syringes: The drug's generic name and concentration (in units per mL) should be the most prominent items displayed on the label of each syringe. The date and time of preparation, and the preparer's initials or name, should also be included. The patient's name and route of administration may also be printed on the label. Labeling of medications is an essential step in decreasing the risk of medication errors, and influences selection of the correct medication, determining and then administering the correct dose, and ensuring that the medication chosen has not passed its expiration time or date. This is especially true for the practice of anesthesiology, which involves administration of a wide variety of potent medications. Medications with widely differing actions, for example, sedative/hypnotics, opiates, neuromuscular blockers, vasopressors, and vasodilators, are often used in the course of a single anesthetic, at times simultaneously. These medications are often given in high-acuity situations, in environments with high workload, poor visibility, and multiple distractions. It is recognized that perioperative medication errors are a significant source of morbidity and, rarely, mortality. Labels may be applied in various circumstances. They are most commonly applied to syringes drawn up by anesthesia providers at the point of care. Identification of a medication is verified by reading the label. Therefore, although multiple factors contribute to medication errors, consistency and clarity of pharmaceutical and syringe labeling, in accordance with human factors principles, remain important elements of error prevention.

First, all medications and solutions that are not immediately administered must be labeled. A medication that is immediately administered is defined as one that is prepared or obtained, taken directly to a patient, and administered to that patient, without any break in the process. Second, each medication must be labeled as soon as it is prepared, which is when it is taken from its original packaging and transferred to another container. Third, the label must include the following information: medication or solution name, strength, amount of the medication or the solution containing the medication (if not apparent from the container), diluent name and volume (if not apparent from the container), and either expiration time (when expiration occurs in less than 24 hours) or date (when not used within 24 hours). However, the date and time are not necessary for short procedures, as defined by the organization.

The American Society of Anesthesiologists (ASA) Statement on Standard Practice for Avoidance of Medication Errors in Neuraxial Anesthesia (12/13/20), provided by the facility, read, medication(s) drawn up into a syringe that are to be added from outside the sterile field during the procedure must be labeled in accordance with accepted standards. When these medications are added the person performing the procedure must confirm the drug, concentration, and dose with the assistant.

The Association of periOperative Registered Nurses (AORN) guidelines for Medication Safety (3/16/23), provided by the facility, read, medications must be administered in accordance with local, state, or federal regulations, medication orders, accepted standards of practice, and healthcare organization policies and procedures. Administer medications in accordance with the manufacturer ' s IFU. Before administering a medication, verify the right patient, using two health care organization-approved identifiers, right medication, right dose, right route and right time. Before administering a medication, verify the concentration of the medication medication administration rate. Carefully read the labels on all medication containers before removing the contents for preparation or administration. Immediately label all medications, solutions, compounds, or liquids transferred from the original container.

The Association of periOperative Registered Nurses (AORN) guidelines for Medication Safety (3/16/23), provided by the facility, read, medications must be administered in accordance with local, state, or federal regulations, medication orders, accepted standards of practice, and healthcare organization policies and procedures. Transfer medications and solutions to the sterile field as close to the time of use as possible while using sterile technique. Transfer only one medication at a time to the sterile field and apply a label immediately before another medication or solution is transferred. Do not interrupt or distract personnel who are retrieving or preparing medications. Retrieve medications for only one patient at a time, as close to the time of the procedure as possible. Prepare medications in a designated area that is clean and separated from potential sources of contamination. Disinfect medication vial stoppers with alcohol and allow the stopper to dry before each entry, including the initial entry after removal of the cap or cover.

The Tranexamic Acid (TXA) Instructions for Use (IFUs) provided by the facility, read, TXA injection is an antifibrinolytic (a drug that acts by inhibiting the process that dissolves clots, thereby reducing bleeding) indicated in patients with hemophilia (a bleeding disorder in which the blood does not clot properly) for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Inadvertent injection into the neuraxial system (spinal area) may result in seizures. The recommended dose of TXA is 10 mg/kg of actual body weight intravenously administered as a single dose. TXA injection is not approved and not recommended for neuraxial administration.

1. The facility failed to ensure policies, procedures, and national guidelines for the administration of anesthesia medications were followed.

A. On 11/15/23 at 9:22 a.m., an observation was conducted with perioperative medical director (Director) #13 of video footage recorded from operating room (OR) #9 of a case performed on 10/31/23.

i. Video review showed Anesthesiologist #7 prepared medications for Patient #2 while a surgery case for a prior patient was ongoing. Video review showed at 10:09 a.m., Anesthesiologist #7 pulled a vial of propofol (an anesthesia medication used to sedate patients prior to a procedure) from drawer #1 in the Omnicell anesthesia medication cart, drew up the propofol into one 50 milliliter (ml) syringe and one 10 ml syringe. Anesthesiologist #7 did not label either syringe and she placed both syringes into the locked Omnicell anesthesia general medication storage drawer (used to store medications not used immediately).

During this portion of the video review, Director #13 stated medication drawn up in advance and stored for later use should have been labeled before it was placed in the medication storage drawer.

ii. At 10:11 a.m., Anesthesiologist #7 pulled a vial of mepivicaine (an anesthesia medication used to numb an area of the body prior to a procedure), which was a 20 ml vial with a navy blue cap, from the anesthesia Omnicell drawer #2 and a vial of tranexamic acid (TXA, a medication used to treat or prevent excessive blood loss), which was a 10 ml vial with a yellow cap from drawer #3, and placed both vials into the Omnicell anesthesia general medication storage drawer with the propofol syringes that were drawn up earlier.

iii. At 10:12 a.m., Anesthesiologist #7 pulled a vial of lidocaine (a medication with multiple uses, including pain relief, numbing of an area of the body, or treating abnormal heart rhythms), which was a five ml vial with a light blue cap, drew it up into a syringe, labeled it, and placed it in the Omnicell anesthesia general medication storage drawer with the propofol syringes, mepivacaine vial, and TXA vial.

iv. At 11:42 a.m., Anesthesiologist #7 opened the Omnicell anesthesia general medication storage drawer, removed both syringes of propofol and the syringe of lidocaine, and placed them on the anesthesia monitor cart. At 11:46 a.m., Patient #2 was brought into OR #9.

v. At 11:47 a.m., Anesthesiologist #7 took a spinal anesthesia kit (which contained bupivacaine) and a three ml syringe from the Omnicell anesthesia cart, then pulled the vial of TXA from the general medication storage drawer and carried the kit, syringe, and TXA vial to the patient's bedside.

At 11:49 a.m., after the spinal procedure was performed (outside the view of the video camera), Anesthesiologist #7 placed both the vial of TXA with the yellow cap now removed, and the three ml syringe at the bottom right corner of the cart's medication preparation area.

During this portion of the video review, Director #13 stated Anesthesiologist #7 had taken the vial of TXA and the three ml syringe to the patient's bedside at the time of the spinal procedure and not the mepivacaine or lidocaine, which were the medications that were supposed to be administered at that time. Director #13 stated TXA should not have been administered at that time in the procedure.

vi. At 11:55 a.m., Anesthesiologist #7 took the 50 ml syringe of propofol from the anesthesia monitor cart to the patient's bedside. At 11:56 a.m., Anesthesiologist #7 took the 10 ml syringe of propofol and the syringe of lidocaine off of the anesthesia monitor cart and injected them into Patient #2's IV tubing.

During this portion of the video review, Director #13 stated no other syringes of lidocaine had been drawn up or administered to the patient before or after the syringe of lidocaine was injected into the patient's IV tubing with the propofol at 10:56 a.m.

This was in contrast to the medical record review of Patient #2 provided below where Anesthesiologist #7 documented she had accidentally administered lidocaine for the initial spinal procedure rather than mepivacaine.

vii. At 11:57 a.m., Anesthesiologist #7 sat down in front of the Omnicell anesthesia cart, picked up the vial of TXA, looked at it several times, then opened the Omnicell anesthesia general medication storage drawer, took out the vial of mepivacaine with the cap still in place and placed it onto of the cart next to the vial of TXA. At 11:57 a.m., Anesthesiologist #7 walked away from the Omnicell anesthesia medication cart then walked back to the cart once again picked up the vial of TXA and looked at it before she placed it back on top of the cart.

During this portion of the video review, Director #13 stated this was the same vial of TXA that had been brought the the patient's bedside at the time the spinal anesthesia procedure was performed (see above). Director #13 confirmed that mepivicaine and lidocaine had not been drawn up for use at the time of the spinal anesthesia procedure and neither had been brought to the patient's bedside at the time the first spinal anesthesia procedure was performed.

viii. At 11:58 a.m., Anesthesiologist #7 opened a second spinal anesthesia kit, picked up a three ml syringe, opened the vial of mepivacaine, and placed them on the anesthesia monitor cart. Anesthesiologist #7 then performed a second spinal anesthesia procedure. Anesthesiologist #7 did not draw up or pull additional TXA from the Omnicell and did not administer TXA intravascularly immediately before the time of incision, which was when the TXA was intended to be administered.

During this portion of the video review, Director #13 stated after the TXA was taken from the cart at the time of the spinal anesthesia procedure, it was not used again. Director #13 stated additionally, TXA was not drawn up and given to Patient #2 through her IV line.

This was in contrast to the medical record review of Patient #2 provided below where Anesthesiologist #7 documented TXA IV protocol was followed and TXA was administered intravenously (within a vein or veins) at 12:06 p.m.

Overall, a review of the video footage conducted with Director #13 indicated TXA had been administered at the time of the initial spinal anesthesia procedure. Specifically, the review revealed a vial of TXA was brought to the patient's bedside at the time of the initial spinal anesthesia procedure (the vial was not in view during the procedure). The same vial of TXA was then returned to the anesthesia cart with the cap removed. Mepivacaine, which was to be administered during the initial spinal anesthesia procedure, was never removed from the anesthesia storage drawer until the second spinal anesthesia procedure. Lidocaine was only drawn up once when it was administered through the IV after the initial spinal anesthesia procedure had been performed.

B. Medical Record Review

i. Medical record review revealed Patient #2 was admitted to the facility on 10/31/23 at 9:48 a.m. for a total knee arthroplasty (a surgical procedure to resurface a knee damaged by arthritis). An anesthesia procedure note written by Anesthesiologist #7 on 10/31/23 at 12:08 p.m. revealed two spinal blocks were performed on Patient #2. Anesthesiologist #7 documented the first spinal block was performed using lidocaine 1% as a local skin anesthetic and mepivacaine 50 mg for spinal analgesia. Anesthesiologist #7 further documented the first spinal block she performed was identified as inadequate when the patient complained of knee pain with no noticeable block during the surgical preparation. Anesthesiologist #7 documented she had swapped the vial of lidocaine and mepivacaine and inadvertently administered lidocaine for the first spinal block.

This was in contrast with the video footage which showed Anesthesiologist #7 brought a vial of TXA, not a vial of lidocaine, to the patient's bedside during the first spinal block.

According to the medical record, a second anesthesia procedure note written by Anesthesiologist #7 on 10/31/23 at 12:18 p.m. revealed a second spinal block was performed with no immediate complications after a failed and inadequate block was performed with the incorrect medication ten minutes prior. Anesthesiologist #7 documented the second spinal block procedure was effective and provided an adequate spinal block.

Anesthesiologist #7 documented TXA IV protocol was followed and TXA was administered intravenously at 12:06 p.m. This was in contrast with the observation of the video surveillance that showed TXA was not administered intravenously at any time during the procedure.

Record review showed Patient #2 was taken to the post anesthesia care unit (PACU) at 1:35 p.m., once the surgical procedure was completed. At 1:37 p.m., Anesthesiologist #7 documented Patient #2 developed spinal myoclonus (sudden, brief involuntary twitching or jerking of a muscle or group of muscles), pain in her hips and back, tachycardia (a heart rate faster than normal), and hypertension (high blood pressure) while in the PACU. An anesthesiology note written by Anesthesiologist #8 revealed he assisted with Patient #2's care while in the PACU and called a stroke alert (a medical emergency notification for staff to respond immediately when patients experience stroke symptoms) due to her symptoms. Anesthesiologist #8 revealed he remained with Patient #2 when she was transported for a computed tomography (CT) scan and subsequently to the intensive care unit (ICU). The CT results showed no evidence of stroke. At 2:45 p.m., Patient #2 was transferred and admitted to the ICU.

A provider note written by medical doctor (Physician) #9 on 10/31/23 at 3:51 p.m. revealed there was a concern Patient #2 received intrathecal (the space between the spinal cord and the membranes that support it) TXA during surgery and the patient exhibited clinical symptoms that matched accidental intrathecal TXA administration which included gluteal and lower extremity myoclonus. Similar concerns with accidental intrathecal TXA administration were documented by Physician #10 and Physician #12. A provider note written by Physician #10 on 11/1/23 at 8:34 a.m. revealed Patient #2 had developed severe hypotension (low blood pressure), multiple end-stage organ failure, status epilepticus (a seizure that lasts longer than five minutes), shock (a critical condition brought on by the sudden drop in blood flow through the body), and generalized myoclonus despite aggressive medical management. Physician #10 further documented he explained to Patient #2's family there was no chance of meaningful neurologic recovery as the patient had sustained a severe anoxic brain injury (injury caused by a lack of oxygen to the brain) due to the progression of her symptoms. Physician #10 documented Patient #2's family decided to discontinue life-sustaining care due to the prognosis provided. A death pronouncement note written by registered nurse (RN) #11 revealed Patient #2 was pronounced dead on 11/1/23 at 9:54 a.m. RN #11 documented Patient #2 was unresponsive, her pupils were not reactive to light, there were no heart or breath sounds for one minute, and there was no spontaneous breathing.

C. Further review of video footage of four video reviews conducted of randomly selected anesthesia procedures, lapses in infection control and medication administration practices were identified.

i. On 11/16/23 at 7:35 a.m., an observation was made of video footage recorded of operating OR #8. On 10/27/23 at 12:01 p.m., Anesthesiologist #14 prepared for Patient #7's surgical case and pulled Fentanyl (a strong medication used to treat pain), Versed (a sedative used to cause drowsiness prior to a procedure), and propofol vials from the Omnicell anesthesia medication cart. Anesthesiologist #14 drew up propofol into a syringe with tubing attached, did not label the syringe, and placed the syringe, along with the vials of Fentanyl and versed, into the Omnicell anesthesia general medication storage drawer.

At 12:10 p.m., Anesthesiologist #14 took a vial of bupivacaine (an anesthetic medication used to numb a part of the body) from an opened and used spinal anesthesia kit and placed it on top of the Omnicell anesthesia medication cart where a designated area for medication preparation was located.

At 12:42 p.m., Anesthesiologist #14 opened a new spinal anesthesia kit and pulled a vial of mepivacaine from the Omnicell anesthesia medication cart.

At 12:45 p.m., Anesthesiologist #14 drew up mepivacaine into a syringe, did not label or verify it, and placed the syringe into the spinal anesthesia kit.

At 12:46 p.m., Anesthesiologist #14 pulled bupivacaine and lidocaine out of the spinal anesthesia kit and drew them up into separate syringes, did not label them, and then placed the syringes back into the spinal kit. At 12:46 p.m., Anesthesiologist #14 closed the spinal anesthesia kit and taped it shut for use in a later case.

ii. Similar findings of medications prepared in advance and not labeled were found in observations of surgical cases for Patients #2, #5, #6, and #9. The observations were in contrast to the following policies and guidelines:

a. The Medication Labeling On and Off the Sterile Field policy which read, all medications, medication containers, and/or solutions should have been appropriately labeled on and off the sterile field. To maintain a safe environment for the patient, it was vital that medications, containers that hold medications, and solutions of medications were labeled appropriately. Medication containers should have been labeled whenever medications were prepared but not immediately administered using the five rights of medication administration. Any medication or solution that was transferred from the original packaging to another container should have been labeled. The medication label should have included the name, strength, quantity, diluent, volume, expiration date when not used within 24 hours, and expiration time when expiration occurred in less than 24 hours.

b. The American Society of Anesthesiologists (ASA) Statement on Labeling of Pharmaceuticals for Use in Anesthesiology which read, labeling of medications was an essential step in decreasing the risk of medication errors. All medications and solutions that were not immediately administered must be labeled. A medication that was immediately administered was defined as one that was prepared or obtained, taken directly to a patient, and administered to that patient, without any break in the process. Each medication must be labeled as soon as it was prepared, which was when it was taken from its original packaging and transferred to another container. The medication label should have included the medication or solution name, strength, amount of the medication or the solution containing the medication, diluent name, and volume), and either expiration time (when expiration occurred in less than 24 hours) or date (when not used within 24 hours).

c. The American Society of Anesthesiologists (ASA) Statement on Standard Practice for Avoidance of Medication Errors in Neuraxial Anesthesia which read, medication(s) drawn up into a syringe that were added from outside the sterile field during the procedure must be labeled in accordance with accepted standards. When these medications were added, the person who performed the procedure was required to have confirmed the drug, concentration, and dose with the assistant.

d. The Association of periOperative Registered Nurses (AORN) guidelines for Medication Safety, which read, medications must be administered in accordance with local, state, or federal regulations, medication orders, accepted standards of practice, and healthcare organization policies and procedures. Before medication administration, the right patient, dose, route, and concentration of the medication administration rate and time should have been verified. All labels on medication containers should have been carefully read for preparation and administration. All medications, solutions, compounds, or liquids should have been labeled immediately when transferred from the original container.

D. Interviews

i. On 11/14/23 at 3:49 p.m., an interview was conducted with surgical technician (Tech) #5. Tech #5 stated the standard process for medication administration in the OR was for the RN and the Tech to verify the medication label and expiration date together prior to administration. Tech #5 stated any medication added to the sterile field was verified by her and the RN, and then labeled with the name, concentration, and expiration date. Tech #5 stated this process was done to ensure the correct medications were given to patients. Tech #5 stated the risk of not labeling medication included giving a patient the incorrect medication which could lead to death.

ii. On 11/14/23 at 4:17 p.m., the circulating registered nurse (RN) #6, who cared for Patient #2, was interviewed. RN #6 stated when she prepared medications in the OR, she first reviewed patient allergies and the surgical preference card to ensure she had the correct medications. RN #6 stated any medications added to the sterile field were verified with the OR technician for the correct medication, concentration, and expiration date. RN #6 stated it was important medications were labeled to ensure the correct medication was given. RN #6 stated the risk of not labeling medications included giving the wrong medication which could lead to poor patient outcomes.

RN #6 stated after Anesthesiologist #7 completed the first spinal anesthesia procedure and Patient #2 was placed into position for surgery, Patient #2 continued to complain of knee pain, could feel them prepping her knee for incision, and had no numbing sensation. RN #6 stated Anesthesiologist #7 then announced she had used the incorrect medication during the first spinal anesthesia procedure and needed to perform a second spinal anesthesia procedure before the surgical case proceeded.

iii. On 11/16/23 at 1:33 p.m., an interview was conducted with Anesthesiologist #7. Anesthesiologist #7 stated when she identified she may have made a medication error, she filed an incident report. She stated at the time of this interview, she had not heard any follow-up regarding the safety event report she had filed. Anesthesiologist #7 stated she had not received any education until after the start of the survey and an immediate jeopardy was called. Additionally, Anesthesiologist #7 stated she had not discussed Patient #2's adverse event with facility leadership and was not interviewed as part of the investigation.

iv. On 11/16/23 at 4:16 p.m., an interview was conducted with Anesthesiologist #8. Anesthesiologist #8 stated he had assisted in the PACU after Patient #2's event. Anesthesiologist #8 stated when a potential medication error occurred, the error should have been reported to the rest of the team in the operating room (OR). He additionally stated if an inappropriate medication was administered, the surgical case may have needed to be stopped in order to ensure the patient was okay and to reassess what may have happened and provide care to the patient. Anesthesiologist #8 stated after he evaluated the possible causes of Patient #2's clinical presentation, he identified the symptoms associated with accidental intrathecal administration of TXA matched the patient's symptoms closely and other differential diagnoses were less likely. Anesthesiologist #8 stated a cerebrospinal fluid (CSF) lavage (a process that dilutes and removes the drug from cerebrospinal fluid, limiting damage) would have been an effective intervention to reduce patient harm from intrathecal administration of TXA if the medication error had been identified immediately and the lavage performed immediately. Anesthesiologist #8 stated he discussed the CSF lavage with the ICU provider and neurologist, however, due to the duration of time since the TXA had been administered, it was determined it would no longer have been an effective intervention. Anesthesiologist #8 stated it was standard for TXA to be administered about 20 minutes after spinal anesthesia was performed and a 10 ml syringe was used to push TXA over five to ten minutes through the IV line.

Anesthesiologist #8 explained there was no need for TXA at the time of the spinal procedure and therefore, he would not pull TXA from the Omnicell until it was needed in order to reduce the chances of a medication error. Anesthesiologist #8 stated he always labeled and verified the medications he prepared for anesthesia because there was no margin of error and mistakes could have had life-threatening results.

Patient #2's anesthesia care was further discussed with Anesthesiologist #8. Anesthesiologist #8 stated if an initial spinal block did not work, the process was to place the patient under general anesthesia (a method of medically inducing loss of consciousness that rendered a patient unarousable even with painful stimuli). Anesthesiologist #8 stated if another spinal block was placed, there was a concern for a patient to experience a high spinal (a life-threatening complication associated with a spinal block) which resulted in bradycardia (slow heart rate), hypotension (low blood pressure), and apnea (temporary cessation of breathing).

v. On 11/14/23 at 11:41 a.m., an interview was conducted with Director #13. Director #13 stated the spinal anesthesia kits contained lidocaine, which was used to numb the skin before the spinal block procedure, and bupivacaine, which was not used by most anesthesia providers due to its long-lasting effects. Director #13 stated instead of using the bupivacaine from the spinal kit, anesthesia providers added mepivacaine from a vial pulled from the Omnicell to the spinal anesthesia kit using sterile technique. Director #13 stated there was no standard procedure used by anesthesia providers at the facility when mepivacaine or other medications were added to spinal anesthesia kits. In addition, Director #13 stated there was no standard procedure for how anesthesia providers labeled medications used in anesthesia procedures and that each anesthesia provider had their own established procedure for doing so. Director #13 stated it was not standard practice at the facility to label medications added to the sterile field or to label medications prepared before a patient procedure which were stored for later use. Director #13 stated there was a risk to patient safety if standardized procedures were not used by all anesthesia providers.