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Based on medical record review, review of facility documentation, and interview, the facility failed to ensure the governing body provided effective oversight of the hospital's contracted anesthesia services and failed to hold the contracted Certified Registered Nurse Anesthetist (CRNA) #1 accountable for a medication error which resulted in serious harm for 1 patient (#13) of 3 patients reviewed for obstetric surgical services.

The findings include:

Patient #13 was admitted to the facility A on 11/30/2023, for an elective cesarean section (c-section) under spinal anesthesia for a large gestational age fetus.

On 11/30/2023 at 7:53 AM, Patient #13 was administered the wrong medication via the incorrect route, during an elective cesarean section (c-section). CRNA #1 made a life threatening medication error by administering 375 micrograms (mcg) of digoxin (a medication used to treat various heart conditions, which is to be administrated orally or directly into the vein,) intrathecally (a route of administration for drugs via an injection into the spinal canal) instead of the ordered Marcaine (a medication used to decrease feeling in a specific area it is injected into the spinal canal's epidural space, the space outside of the spinal membrane). CRNA #1 did not follow basic medication administration standards and practices by failing to identify and verify the correct medication, Marcaine, which was to be administered and continued to incorrectly administer the digoxin intrathecally. CRNA #1 chose to wait until after the C. Section had been completed (more than 1 hour) before notifying the operating physician of the serious medication error.
As a result of the medication error, Patient #13 required mechanical ventilation (helps you breathe or breathes for you when you can't breathe on your own), was diagnosed with Acute Metabolic Encephalopathy (a condition in which brain function is disturbed either temporarily or permanently due to different diseases or toxins in the body) and Respiratory Failure. Patient #13 was transferred to Facility B for a higher-level of acute care on 11/30/2023.

On 12/20/2023 Patient #13 was transferred to Facility C which is a brain and spinal cord injury rehabilitation facility where she receives inpatient therapy. Patient #13 suffered serious harm, serious injury, and serious impairment as a direct result of the medication error.

During an interview on 2/12/2024 at 10:00 AM, the hospital Administrator, Chief Nursing Officer (CNO), and Risk Manager, revealed that CRNA#1 was still employed with the contracted anesthesia service practicing in the same capacity as he did on 11/30/2023. Further interview with the hospital Administrator, CNO, and Risk Manager revealed there was no evidence the Governing Body provided oversight or interventions such as in-service training, review of pharmaceutical services, or corrective actions for CRNA#1 or any other contracted anesthesia providers to address and prevent reoccurrence of the serious medication error which had occurred on 11/30/2023. Continued interview with the hospital Administrator, when asked, regarding any actions taken on behalf of the Governing Body regarding CRNA#1, the Administrator refused to answer stating "it was handled." When surveyor asked to elaborate the Administrator replied the same "it was handled.'

Refer to A049.

Based on review of facility policy, medical record review, facility documentation, and interviews, the facility's governing body failed to ensure that the medical staff including contracted Certified Registered Nurse Anesthetist (CRNA) #1 was held accountable to the governing body for the quality of care provided to patient (Patient #13) of 3 obstetric surgical patients reviewed.

The findings include:

Review of Facility A's policy titled, "Medication Administration and General Guidelines," revised 2019, showed "...Each licensed certified personnel is responsible for knowing and practicing The Five Rights of medication administration...Right medication...Right route...A medication error is any preventable event that may cause or lead to...patient harm...If a medication error occurs...immediately notify the Physician...Notify charge nurse, Nurse Manager, and/or Nursing Supervisor as well as the patient..."

Review of Facility A's policy titled, "Adverse Events, Including Sentinel and Unusual Events," revised 1/2023, showed "...Unusual Events are unexpected occurrences or accidents resulting in...life-threatening injury, or potential serious injury to a patient...Medication errors resulting in serious harm, serious disability, near death..."

Review of the Acute Care ISMP Medication Safety Alert newsletter, Volume 28, Issue 17, dated August 24, 2023, showed "...BUPIVACAINE SPINAL [Marcaine]...for intrathecal use and digoxin are both available in 2 mL (milliliter) ampules...Since medications are not often provided in ampules, this can heighten the risk of mix-ups between the two drugs...We previously received reports about cases in which digoxin had been accidentally administered via a neuraxial route (e.g., epidural, intrathecal) instead of the intended BUPivacaine...Among the 33 events reported, digoxin was the medication most commonly administered in error and was associated with paraplegia and encephalopathy in eight patients..."

Medical record review showed Patient #13 was admitted to Facility A on 11/30/2023, for an elective cesarean section (c-section) under spinal anesthesia for large gestational age fetus. Continued review showed complication of administration of anesthesia or sedation in labor and delivery resulted in acute metabolic encephalopathy (alteration in consciousness) and respiratory failure with hypoxia (low oxygen).

Review of the Medication Administration Record dated 11/30/2023, showed CRNA #1 administered 375 micrograms (mcg) Digoxin (a medication used to treat various heart conditions to be administered orally or directly into the vein); the Digoxin had been administered intrathecally (a route of administration for drugs via an injection into the spinal canal) at 7:53 AM. Continued review showed 1.6 milliliters (mL) Marcaine (a medication used to decrease feeling in a specific area and is injected into the spinal canal's epidural space) had been administered intrathecally at 8:13 AM.

Review of the Anesthesia Record dated 11/30/2023 at 8:22 AM, showed the C-Section started at 8:22 AM, the baby was delivered at 8:33 AM, the surgery was completed at 9:18 AM, and Patient #13 was moved to an obstetrics room at 9:24 AM. Review showed Patient #13 was transferred to the Intensive Care Unit (ICU) at 9:52 AM. Patient #13 was alert, oriented, and vital signs stable.

Review of the ICU Progress Notes dated 11/30/2023 at 9:52 AM, showed Patient #13 transferred to ICU via bed, and was alert and oriented upon arrival, followed commands with upper extremities, and had no movement at this time with lower extremities. At 11:00 AM, Patient #13 was lethargic, and responded minimally to sternal rub only. The Physician was at Resident #13's bedside, and permission was obtained from patient #13's mother for intubation (a procedure that places a tube down the throat and into your windpipe to help you breathe). At 11:10 AM, patient intubated without difficulty.

Review of Consultation Notes dated 11/30/2023 at 12:13 PM, showed Patient #13 "...decompensated with change in neurological status and was intubated for airway protection. She had received intrathecal digoxin. Plan for emergent transfer to [Facility B] for...acute hypoxic respiratory failure...intubated 11/30/2023 secondary to inability to protect airway and intrathecal digoxin..."

Review of Obstetric (OB) Physician Consultation Notes dated 11/30/2023 at 12:57 PM, showed "...[Patient #13] underwent cesarean section under spinal anesthesia. The initial attempted subarachnoid block [intrathecal/spinal] was ineffective and it was discovered that approximately 375 mcg of digoxin had been injected intrathecally as opposed to Marcaine. A repeat subarachnoid block with Marcaine was effective. The patient was transferred after surgery to the intensive care unit steroid infusion was begun digoxin antibody [medication reversal agent] was administered due to the patient's obtundation [reduced alertness and reaction to stimuli] and inability to protect airway the patient was electively intubated...placed on mechanical ventilation [helps you breathe or breathes for you when you can't breathe on your own]...recommends transfer for neurology..."

Review of a Computed Tomography (CT scan) dated 11/30/2023 at 1:17 PM, showed the indication for the CT scan was altered mental status. "...No acute intracranial abnormalities are identified although CT cannot reliably exclude acute infarct [reduced blood supply to the brain]..."

Review of a discharge summary dated 11/30/2023 at 2:45 PM, showed Patient #13 was discharged from Facility A and transferred to Facility B via EMS (Emergency Medical Services) to the neurology intensive care unit.

Review of Facility B's History and Physical dated 11/30/2023, showed "...11/30/2023, patient [Patient #13] underwent elective cesarean section under spinal anesthesia. Anesthesia records in EMR [Electronic Medical Record] indicate the patient had received intrathecal digoxin instead of bupivacaine [Marcaine] for the initial attempt at anesthetic block...Patient was transferred to the ICU [Intensive Care Unit], and intubated...On arrival to [Facility B] ICU...initial exam did not show any ocular, pupillary, or limb movements...unresponsive and comatose...This is a highly irregular and complex medical case..."

During a telephone interview on 2/6/2024 at 7:37 PM, CRNA #1 stated he had been advised not to discuss these matters with anyone and to refer to his legal representation [Attorney Name Provided].

During an interview on 2/7/2024 at 12:56 PM, in the conference room, the Intensivist/Anesthesiologist stated he treated Patient #13 after a decrease in level of consciousness while in the ICU. The patient was intubated for airway protection. The physician stated that he consulted with telehealth ICU who recommended transfer to Facility B for higher level of care.

During an interview on 2/7/2024 at 2:25 PM, in the conference room, Registered Nurse (RN) ICU stated she had cared for patient #13. The RN stated the patient had been transferred to the ICU immediately after the C-Section and had become unresponsive and intubated approximately 30 minutes to 1 hour after coming to the ICU. The RN stated the patient received intravenous (IV) steroids and was transferred to Facility B.

During an interview on 2 /8/2024 at 2:25 PM, in the conference room, the OB Physician stated he had delivered the baby of patient #13 on 11/30/2023. The physician stated he had been made aware of the medication error after the cesarean section had been completed by CRNA #1. The physician stated if he had been notified immediately after the medication error occurred, he would have consulted with high risk to get recommendations as to whether to deliver the baby or wait.

During an interview on 2/13/2024 at 10:35 AM, in the conference room, the Operating Room (OR) Circulating Nurse stated she was present in the OR the day of the event 11/30/2023. The RN stated during the transport back to the patient's room, the CRNA told her (OR Circulating Nurse) he (CRNA) needed to find the delivering physician, because there was an issue. The CRNA then disclosed to the OR nurse he had administered Digoxin instead of Marcaine. The error was disclosed to the delivering physician (unsure of exact time) after the c-section ended. The patient was transported to ICU for further care and monitoring. The OR Circulating Nurse stated she alerted the Director of Surgical Services and the Senior Risk Manager.

During an interview on 2/13/2024 at 11:54 AM, in the conference room, the Director of Surgical Services stated she had been notified by the OR Circulating Nurse on 11/30/2023 of the incident. The Director stated she notified the Chief Nursing Officer (CNO) and the Supervising Anesthesiologist of the incident, and an investigation began.

During an interview on 2/13/2024 at 12:06 PM, in the conference room, the Senior Risk Manager stated she was notified approximately 30-40 minutes after the incident occurred by the OR Circulating Nurse and a Root Cause Analysis (RCA), and an investigation had been initiated but any findings of the Root Cause Analysis was considered protected under peer review and was not shared with the survey team. The incident was sent to quality for review on 12/4/2023, digoxin had not been removed from OB automated medication dispensing cabinets until 12/5/2023, and quality submitted the incident for peer review on 12/8/2023 but the findings were not shared with the survey team when requested to see. The Senior Risk Manager stated the ISMP Medication Safety Alert had been received by pharmacy prior to the incident and the CNO and Senior Risk Manager had not been included in the safety alerts. The Senior Risk Manager confirmed the 5 rights of medication had not been followed by the CRNA.

During an interview on 2/13/2024 at 1:46 PM, in the conference room, the Corporate Director of Risk and Regulatory confirmed the facility was aware of an ISMP alert regarding the administration of Digoxin instead of Marcaine via intrathecal route resulting in the death of a patient. The Corporate Director of Risk and Regulatory also confirmed the facility did not act or adapt policies related to the alert or ISMP recommendations until December 2023 after the incident with patient #13.

During an interview on 2/13/2024 at 2:49 PM, in the OB surgery suite, the Pharmacy Director stated that the CRNAs working out of the Omnicell anesthesia workstation will scan the medication using a scanner housed in a holder located next to a computer monitor on top of the workstation. When the CRNA scans the medication to be administered, the name of the medication shows up on the monitor in large letters and documents the time the medication was scanned and administered. The antidote medication to digoxin toxicity is Digibind which is maintained in the pharmacy refrigerator and was available 24 hours a day. There was no literature on how to treat a patient receiving digoxin intrathecally but the sooner the Digibind can be administered the better for the patient.

A video was taken during part of the Pharmacy Director's interview. She demonstrated the Omnicell used by the CRNA on 11/30/2023. The bupivacaine [Marcaine] was in the 1st drawer of the 9 drawer Omnicell workstation and the digoxin was in the 5th drawer. She explained that only one of the Omnicell drawers can be opened at any one time.

During an interview on 2/14/2024 at 9:14 AM, in the conference room, the Legal Counsel stated all documents related to the investigation of CRNA #1 are considered protected under the Peer Review clause at this time.

During a telephone interview on 2/15/2024 at 2:49 PM, the Previous Pharmacist (last day employed 1/26/2024) ISMP came to her. The Previous Pharmacist stated she would set them aside and the ISMP alerts were reviewed quarterly by the Hospital Quality Assurance Team. The Pharmacist stated she was unsure if she notified anyone of the alert, she received ISMP Safety Alert regarding the Digoxin and Marcaine dated 8/24/2023.

Based on review of The Institute for Safe Medication Practices (ISMP) Safety Alert; Digoxin Injection Prescribing Information-Package Insert; Lippincott Manual of Nursing Practice, 11th Edition; Case Report- Inadvertent Intrathecal Administration of Digoxin, with Review of the Literature; Clinical Update- Potential for Patient Harm from Intrathecal Administration of Preserved Solutions; and Review of the Code of Ethics for the Certified Registered Nurse Anesthetist, review of policies and procedures and interview, the hospital failed to ensure patients' rights were protected and promoted to receive care in a safe setting for 1 (Patient #13) of 3 patients who received a Cesarean Section (a surgical procedure which babies are delivered through an incision in the mother's abdomen) and received the wrong medication via an incorrect route. The Certified Registered Nurse Anesthetist (CRNA) #1 made a life threatening medication error by administering 375 micrograms (mcg) of digoxin (a medication used to treat various heart conditions) intrathecally (the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord) instead of BUPivacaine (Marcaine-a medication used to decrease feeling in a specific area and is injected into the spinal canal's epidural space). Patient #13 was transferred to the Intensive Care Unit and intubated (a breathing tube inserted into the airway, connected to a machine that delivers Oxygen to the lungs). The patient's clinical status further deteriorated and subsequently had to be transferred to a higher level of care at (Facility B) for Acute Metabolic Encephalopathy (a condition in which brain function is disturbed either temporarily or permanently due to different diseases or toxins in the body) and Respiratory Failure.

Facility A did not ensure the safety and well-being of Patient #13 when CRNA #1 failed to follow basic medication administration standards and practices and failed to identify and verify the medication prior to administration. In addition, CRNA #1 did not immediately notify the supervising physician of the medication error as required in Facility A's Medication Administration policy.

This error placed Patient #13 and all Obstetric (OB) surgical patients in a serious and immediate threat and placed them in immediate jeopardy and risk of serious injuries and/or death.

Refer to A0144

Based on review of The Institute for Safe Medication Practices (ISMP) Safety Alert; Digoxin Injection Prescribing Information-Package Insert; Lippincott Manual of Nursing Practice, 11th Edition; Case Report- Inadvertent Intrathecal Administration of Digoxin, with Review of the Literature; Clinical Update- Potential for Patient Harm from Intrathecal Administration of Preserved Solutions; and Review of the Code of Ethics for the Certified Registered Nurse Anesthetist, review of policies and procedures and interview, the hospital failed to ensure patients' rights were protected and promoted to receive care in a safe setting for 1 (Patient #13) of 3 patients who received a Cesarean Section (a surgical procedure which babies are delivered through an incision in the mother's abdomen) and received the wrong medication via an incorrect route. The Certified Registered Nurse Anesthetist (CRNA) #1 made a life threatening medication error by administering 375 micrograms (mcg) of digoxin (a medication used to treat various heart conditions) intrathecally (the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord) instead of BUPivacaine (Marcaine-a medication used to decrease feeling in a specific area and is injected into the spinal canal's epidural space). Patient #13 was transferred to the Intensive Care Unit and intubated (a breathing tube inserted into the airway, connected to a machine that delivers Oxygen to the lungs). The patient's clinical status further deteriorated and subsequently had to be transferred to a higher level of care at (Facility B) for Acute Metabolic Encephalopathy (a condition in which brain function is disturbed either temporarily or permanently due to different diseases or toxins in the body) and Respiratory Failure.

The failure of Facility A to ensure the safety and well-being of Obstetric (OB) patients receiving a C-section placed Patient #13 and all OB patients in a serious and immediate threat and placed them in immediate jeopardy and risk of serious injuries and/or death.

The findings included:

Review of the ISMP Medication Safety Alert titled, "Obstetrical Patient Receives Ampule of Digoxin Instead of BUPivacaine [Marcaine] for Spinal Anesthesia" dated 08/24/2023 revealed, "Problem: A pregnant patient with no significant past medical history was undergoing a scheduled cesarean delivery in an operating room (OR) and was to receive spinal anesthesia...The anesthetist inadvertently removed an ampule of digoxin rather than BUPivacaine, prepared the dose, and administered it intrathecally. The anesthetist did not scan the barcode or read the label aloud to another staff member prior to administration. Anesthesia staff then recognized that the patient was not getting the anticipated BUPivacaine effects and thought that it had been injected into the wrong space...a second dose was administered. The cesarean team delivered a healthy baby. However, shortly after the birth, the patient complained of dizziness, blurred vision, and a severe headache with left facial drooping and left-sided weakness. She began losing her ability to communicate and then experienced apnea and complete paralysis. She was intubated and transferred to the intensive care unit...Inadvertent digoxin administration into the intrathecal space was suspected...The team determined that the patient was brain dead, and she died shortly thereafter...We [ISMP] have previously received reports about cases in which digoxin had been accidentally administered via a neuraxial route (e.g., epidural, intrathecal) instead of the intended BUPivacaine...One review (Patel S. Cardiovascular drug administration errors during neuraxial anesthesia...J Cardiothoracic Vasc Anesth.[Journal of Cardiothoracic and Vascular Anesthesia] 2023,37[2]:291-8) analyzed inadvertent neuraxial cardiovascular medication administration errors reported between 1972 and 2022. Among the 33 events reported, digoxin was the medication most commonly administered in error and was associated with paraplegia and encephalopathy in eight [8] patients...Safe Practice Recommendations: Given the repeated number of serious mix-ups between digoxin ampules and local anesthetics...organizations should consider the following recommendations: Review which medications (with special attention to ampules are available in each unit-specific ADC [Automatic Dispensing Cabinet] location, anesthesia tray, and medication kit. Remove those that are not needed (considering typical diagnoses). Evaluate whether digoxin needs to be stocked in your OR and labor and delivery unit or if it can be requested from the pharmacy, as needed. Employ individual locked pockets or segregated storage, especially for high-alert medications like digoxin, or medications given via the spinal route, such as preservative-free BUPivacaine...Avoid stocking medications in ampules when possible or store them far apart, and never store more than one medication in an ampule in an open matrix drawer. In the OR, order BUPivacaine for patients and scan the barcode prior to administration. Read labels aloud, as would typically occur at handoffs between the circulating and surgical nurse...Educate staff (e.g., anesthesia personnel, nurses, pharmacists, pharmacy technicians) and conduct regular competency assessments about the safe use of ADCs during orientation and annually. Share this event with staff and discuss lessons learned. In addition, conduct regular reviews and discussions of medication events and close calls reported in your organization and by outside organizations such as ISMP..."

Review of the Digoxin Injection Prescribing Information from the package insert, undated, revealed "...Dosage form: injection. Drug classes: Group V(5) antiarrhythmics [medications to prevent and treat abnormal heartbeats], Inotropic [drugs that tell your heart muscles to beat or contract with more or less power] agents...DIGOXIN Injection, for intravenous or intramuscular use Initial U.S. [United Stated] Approval: 1954...Digoxin dose is based on patient-specific factors (age, lean body weight, renal function, etc.)...Avoid bolus administration...Ampuls containing 500 mcg [micrograms] (0.5 mg) in 2 mL [milliliters]...Warnings and Precautions...Digoxin toxicity: Indicated by nausea, vomiting, visual disturbances, and cardiac arrhythmias...Pediatric patients: Newborn infants display variability in tolerance to digoxin...Distribution...Digoxin crosses both the blood-brain barrier and the placenta...FOR SLOW INTRAVENOUS OR DEEP INTRAMUSCULAR USE...Each mL [milliliter] contains digoxin 250 mcg...propylene glycol (a preservative) 0.4 mL..."

Review of Lippincott's Manual of Nursing Practice, 11th Edition, revealed, "...NURSING ALERT Medication errors are often a result of calculation errors, drug preparation errors, human errors...Ultimately, the nurse is accountable for the medication or solutions administered...Alternative Infusion Devices...Intraspinal access devices...Access devices placed in the epidural, intrathecal...spaces...Administer only preservative-free medications or solutions..."

Review of a CLINICAL UPDATE titled "Potential for patient harm from intrathecal administration of preserved solutions" revealed, "...It is generally accepted in anaesthetic practice that products containing preservatives should not be administered epidurally because of the documented risks of anaphylaxis and the potential risk of neurotoxicity from the preservative agents. Similarly, it is standard practice that any agent given intrathecally should be preservative free...Steps should be taken to ensure that preservative-free products are used. Staff involved with the preparation and administration of intrathecal preparations need to be educated about the risks associated with preservatives in this setting...Vials of agents containing preservative which could mistakenly be prepared for intrathecal administration should be labelled "Not for intrathecal administration."

Review of the "Code of Ethics for the Certified Registered Nurse Anesthetist" undated, revealed "...Responsibility to the Patient. The CRNA respects the patient's moral and legal rights, and supports the patient's safety...and well-being...Participates in honest and transparent disclosure of an adverse or unanticipated event to the patient and others with the patient's consent...is honest in all professional interactions to avoid any form of deception...Reports critical incidents, adverse events, medical errors, and near misses in accordance with law, accreditation standards, and institutional policy to promote a culture of safety, maintain the integrity of the profession..."

Review of the facility's policy titled, "Medication Administration and General Guidelines" revised 8/2019, revealed "...Safety...Each licensed certified personnel is responsible for knowing and practicing the Five Right's of medication administration: Right patient...Right medication, Right dose, Right route and Right time...Any department in the hospital, which administers medications, by whatever route, is accountable for medication errors...If a medication error occurs...Immediately notify the Physician and initiate and orders..."

The CRNA did not follow the facility's Medication Administration policy. The Obstetrician/Supervising Physician was not notified of this error immediately when the CRNA realized the patient was given the wrong medication via the wrong route.

Medical record review revealed Patient #13 was admitted to Facility A on 11/30/2023 for an elective c-section for a large for gestational age (LGA) fetus. Patient #13 received an incorrect medication intrathecally which resulted in Acute Metabolic Encephalopathy (reduced oxygen to the brain) and respiratory failure with hypoxia (not enough oxygen in the blood).

Review of the History and Physical Report dated 11/30/2023, revealed, "...patient underwent elective cesarean section under spinal anesthesia. Anesthesia records in EMR [electronic medical record] indicate the patient had received intrathecal digoxin instead of bupivacaine for the initial attempt at anesthetic block. Symptoms of amblyopia [poor vision that happens in 1 eye] and dizziness were initially noticed by patient's mother post-cesarean. Patient developed dyspnea and was transferred to the ICU [Intensive Care Unit], and intubated [a tube in the windpipe to deliver Oxygen to the lungs]...Patient placed on mechanical ventilation [a machine called a ventilator to provide air in and out of the lungs]...Tele ICU [enables off-site clinicians to interact with bedside staff to consult on patient care.] recommended emergent transfer to [Facility B] steroids and stat [immediately] brain CT [Computerized Tomography - a series of very fast X-Rays]..." Patient #13 underwent multiple tests. The LP (Lumbar Puncture) showed an elevated opening pressure (increased pressure in the brain). Continued review revealed, "...initial exam did not show any ocular, pupillary, or limb movements. Pt [Patient] unresponsive and comatose...This is a highly irregular and complex medical case...There were -7 reports in the literature of accidental digoxin administered intrathecally. Our team reviewed this overnight..."

Review of the Medication Administration Record dated 11/30/2023 revealed Patient #13 received 375 mcg of digoxin on 11/30/2024 at 7:53 AM and Patient #13 received 1.6 mL of BUPivacaine on 11/30/2024 at 8:13 AM.

Review of the Anesthesia Record dated 11/30/2023 revealed the surgery began at 8:22 AM.

Review of a Gynecology-Obstetrics Report dated 11/30/2023 revealed the baby was born at 8:33 AM.

Review of the Anesthesia Record dated 11/30/2023 revealed the surgery stopped at 9:18 AM. Patient was out of the OR room at 9:29 AM. Patient was transported to ICU at 9:52 AM.
It was unable to be determined how long the CRNA knew about the error and when the CRNA reported the error to the OB Physician/Supervising Physician. It was sometime after the birth at 8:33 AM and the transfer to ICU at 9:53 AM. The CRNA knew of the error at approximately 7:55 AM and the transfer to ICU occurred at 9:53 AM for a time span of approximately 1hr and 58 minutes.

The Obstetrician/supervising physician was not notified of this error immediately when CRNA #1 realized the patient was given the wrong medication via the wrong route.

Patient #13 was immediately placed in an unsafe clinical situation when she received the incorrect medication via an incorrect route, and CRNA #1 did not immediately notify the physician for approximately 2 hours.

Review of a Progress Note dated 11/30/2023 9:52 AM, revealed "...Received to ICU...Alert and oriented upon arrival follows commands with upper extremities. No movement at this time with lower extremities..."
Patient #13 began displaying the same neurological symptoms in her lower extremities as 7 other surgical patients that had received Digoxin intrathecally.

Review of a Case Reports in Neurological Medicine: Case Report: Inadvertent Intrathecal Administration of Digoxin, with Review of the Literature, published October 20, 2023, revealed 7 surgical case outcomes with intrathecal digoxin to include neurological findings. Case 1, 2, and 3 were absent lower limb reflexes. Case 4 had symmetrical, bilateral lower extremity weakness with subsequent paraplegia. Case 5 and 6 had paraplegia of the limbs, and Case 7 had quadriplegia.

Review of a Progress Note dated 11/30/2023 11:00 AM, revealed, "Lethargic and responds minimally to sternal [the bone located in the middle of the chest] rub only...received permission from pt's mother for intubation..."

Review of Consultation Notes dated 11/30/2023 12:13 PM, revealed "...Tele-ICU Initial Assessment...Patient...presented for elective cesarean section for large for gestational age fetus. C-section went uneventfully no complications. She however decompensated with change in neurological status and was intubated for airway protection. She had received intrathecal digoxin...Plan for emergent transfer to [Named Hospital #2] ...My assessment of the patient is: 1. Acute hypoxic respiratory failure intubated November 30th secondary to inability to protect airway 2. Intrathecal digoxin...I placed the following orders in the EMR: Plan for urgent transfer to [Facility B] Receive steroids...stat CT head prior to transfer..."

Review of Consultation Notes dated 11/30/2023 12:57 PM, revealed "...Patient underwent cesarean section under spinal anesthesia. The initial attempted...block was ineffective and it was discovered that approximately 375mcg [micrograms] of digoxin had been injected intrathecally as opposed to Marcaine...The patient was transferred after surgery to the intensive care unit steroid infusion was begun digoxin antibody FAB [an antidote for overdose of digoxin] was administered due to the patient's obtundation [diminished responsiveness to stimuli, often due to a state of reduced consciousness] and inability to protect airway the patient was electively intubated placed on mechanical ventilation. She is currently on assist-control [a setting on the ventilator that sets a fixed amount of air that is delivered at set intervals or when the patient initiates a breath] volume sedated with propofol..."

Review of an Other Procedures report dated 11/30/2023, revealed "...Critical Care Procedure Note...12:58 [PM]...PROCEDURE: Endotracheal intubation...INDICATION: Impending respiratory failure...PREOPERATIVE DIAGNOSIS(ES) Inadvertent intrathecal injection of digoxin, acute metabolic encephalopathy...POSTOPERATIVE DIAGNOSIS(ES) Same..."

Review of Facility A's investigation dated 11/30/2023, a note handwritten by CRNA #1 on stated pulled a 2 mL glass ampule with green labeling that he thought to be Bupivacaine. CRNA #1 wrote that he scanned the ampule to register the medication. CRNA #1 drew up the intended dose through the filter and administered the medication. The patient did not achieve the level of numbness intended. He suspected a failed spinal. He examined the ampule for an expiration date. He then realized it was Digoxin. He wrote he felt the delivery should take place with precedence. The case continued and he tended to the patient. He performed a second spinal anesthetic with success and the case continued as normal. He wrote that he reviewed case studies about incidental administration of intrathecal digoxin. He determined that observing the patient for neurological symptoms while preparing for post-surgical intervention was prudent. He notified the surgical team when he finished the technical parts of the case. He concluded that they had a condition that required immediate attention. Pharmacy was notified and a plan was developed based on the case studies. The plan was put in motion. He notified the family and what was being done to mitigate the sequela.


During an interview on 2/14/2024 at 3:30 PM, the OB physician shared the details of the incident regarding the intrathecal administration of Digoxin the patient. He stated the CRNA started the spinal as he was drying his hands. The OB Physician stated the patient said, "...I can still feel everything..." The OB Physician stated he thought the CRNA did the wrong thing, and it was a normal C-section. The OB Physician stated the CRNA came to him before he left the OR and said to him "...I need to talk to you...". The OB Physician stated he went to check on the baby and congratulated the father, then he went to the dictation room for at least 30 minutes. The OB Physician stated the CRNA came to the dictation room and stated, "We have a situation, I inadvertently administered Digoxin intrathecally, it's very serious and needs to transfer her to ICU". The OB Physician stated he went with the CRNA to the family and the family was aware of some situation, we would transfer her to ICU. The OB Physician stated, "I called the Intensivist. The OB Physician was asked if he would expect the CRNA to notify him immediately of the medication error. The OB Physician stated, "The expectation was different because the patient was awake and listening and that would have been terrifying, I think [Named CRNA] made the right decision." The OB Physician was asked if he had been notified immediately would that have changed how he handled the case. The OB Physician stated, "Nobody knew what to do, the intern called a specialist, and he called Poison Control. He called a specialist in Houston and New York. There was no data. [Named Medical Director] was calling around to experts as well." The OB Physician was asked if he was aware of the plans and interventions that were put in place and did, he felt they were effective. The OB Physician stated, "Yes, I believe the plans in place are good, the hospital immediately made plans to ensure this would not happen again." The OB Physician was asked if he had privilege at any other hospital. The OB Physician stated this was the only hospital he is in, and he is in private practice as an OB/GYN. (Obstetrician/Gynecologist).

During an interview on 2/14/2024 at 3:59 PM, the OB Technician was asked if she remembered the incident on 11/30/2023 regarding the medication error. The OB Technician stated she did remember. The OB Technician stated the patient came in with the circulator (RN) and the CRNA still in her bed. The patient was transferred to the OR bed. The first attempt at the spinal was done. When they were doing the vaginal prep, the patient was feeling it. The patient sat up and a second spinal was successful, and the case proceeded. She was asked if she heard anyone say out loud the patient received the wrong drug, she stated she never heard it and heard about it when the patient was taken back to her room. The OB Technician stated the Circulating Nurse came and told her that (CRNA #1) gave the wrong medication. The OB Technician stated she did not know what digoxin was. The OB Technician stated after the procedure, (CRNA #1) said, "...we need to get the patient to her room quickly..." The OB Technician stated she found that to be a strange remark from the CRNA because he never said things like that.

During an interview on 2/16/2024 at 8:50 AM, The ICU RN was asked about (Named Patient #13). The ICU RN stated she was aware of (Named Patient #13) and she was a post-partum patient that accidently received digoxin in an epidural. The ICU RN stated the patient was awake and alert at 9:52 AM but was numb from the waist down. ICU RN stated the patient progressed to being lethargic and unarousable about 11:00 AM. The Medical Director was at bedside because the patient needed to be intubated and put on a ventilator. The ICU RN stated, "...The family was very vocal about what happened..."

Based on review of facility policy, medical record review, facility documentation, and interviews, the facility's Quality Assurance Performance Improvement (QAPI) failed to ensure an ongoing, hospital-wide quality assessment and performance improvement program related to pharmaceutical and anesthesia services for 1 obstetric surgical patient (Patient #13) of 3 obstetric surgical patients reviewed.

The findings include:

Patient #13 was administered the wrong medication via the incorrect route, on 11/30/2023 during an election cesarean section (the surgical delivery of a baby through a cut (incision) made in the mother's abdomen and uterus). The Certified Registered Nurse Anesthetist (CRNA) administered 375 micrograms (mcg) Digoxin (to be administrated orally or directly into the vein, a medication used to treat various heart conditions) was administered intrathecally (a route of administration for drugs via an injection into the spinal canal) instead of Marcaine (medication used to numb the body to relieve pain during procedures/surgery). The facility failed to immediately take steps to identify and prevent this error.

Review of the Acute Care Institute for Safe Medication Practices (ISMP) Medication Safety Alert, Volume 28, Issue 17, dated August 24, 2023, showed "...BUPIVACAINE SPINAL [Marcaine]...for intrathecal use and digoxin are both available in 2 mL (milliliter) ampules...Since medications are not often provided in ampules, this can heighten the risk of mix-ups between the two drugs...We previously received reports about cases in which digoxin had been accidentally administered via a neuraxial route (e.g., epidural, intrathecal) instead of the intended BUPivacaine...Among the 33 events reported, digoxin was the medication most commonly administered in error and was associated with paraplegia and encephalopathy in eight patients..."

During a telephone interview on 2/15/2024 at 2:49 PM, the Previous Pharmacist (last day employed 1/26/2024) stated the ISMP came to her via email. The Previous Pharmacist stated she would set them aside and the ISMP alerts were reviewed quarterly by the Hospital Quality Assurance Team. The Pharmacist stated she was unsure if she notified anyone of the alert, she confirmed she received the ISMP Safety Alert regarding the Digoxin and Marcaine dated 8/24/2023.

During an interview on 2/13/2024 at 12:06 PM, in the conference room, the Senior Risk Manager stated she was notified approximately 30-40 minutes after the incident occurred by the OR Circulating Nurse and a Root Cause Analysis (RCA), and an investigation had been initiated. The incident was sent to quality for review on 12/4/2023, digoxin had not been removed from OB automated medication dispensing workstation cabinets until 12/5/2023, and quality submitted the incident for peer review on 12/8/2023. The Senior Risk Manager stated the ISMP Medication Safety Alert had been received by pharmacy prior to the incident and the CNO and Senior Risk Manager had not been included in the safety alerts. The Senior Risk Manager confirmed the 5 rights of medication had not been followed by the CRNA on 11/30/2023.

During an interview on 2/13/2024 at 1:46 PM, in the conference room, the Corporate Director of Risk and Regulatory confirmed the facility was aware of an 8/24/2023, ISMP alert regarding the administration of Digoxin instead of Marcaine via intrathecal route resulting in the death of a patient. The Corporate Director of Risk and Regulatory also confirmed the facility did not act or adapt policies related to the 8/24/2023, alert or ISMP recommendations until December 2023 after the incident with Patient #13.

Review of Facility A's QAPI meeting minutes for August 2023, September 2023, October 2023 and November 2023 revealed no evidence the QAPI committee had been receiving or reviewing the ISMP alerts in order assist with mitigating medical errors within their facility.

Failure of the QAPI committee to actively review and act upon the 8/24/2023 National Medication Safety Alert, resulted in serious harm, serious injury and serious impairment, when Patient #13 suffered from acute metabolic encephalopathy (brain dysfunction), which required mechanical ventilation (a type of therapy that helps you breathe or breathes for you when you are unable to breathe on your own). Patient #13 was transferred to Facility B for a higher-level acute care on 11/30/2023, on 12/20/2023 she was transferred to Facility C which is a brain and spinal cord injury rehabilitation facility where she is currently receiving inpatient therapy.

Refer to A-286

Based on review of medical record review, facility documentation, and interviews, the facility's Quality Assurance Performance Improvement (QAPI) failed to ensure an ongoing, hospital-wide quality assessment and performance improvement program to reduce medication errors for 1 obstetric surgical patient (Patient #13) of 3 obstetric surgical patients reviewed.

The findings include:

Patient #13 was administered the wrong medication via the incorrect route, on 11/30/2023 during an election cesarean section (the surgical delivery of a baby through a cut (incision) made in the mother's abdomen and uterus). Certified Registered Nurse Anesthetist (CRNA) #1 administered 375 micrograms (mcg) Digoxin (to be administered orally or directly into the vein, a medication used to treat various heart conditions) was administered intrathecally (a route of administration via an injection into the spinal canal) instead of Marcaine (medication used to numb the body to relieve pain during procedures/surgery). The facility failed to immediately take steps to identify and prevent this error.

Review of the Acute Care Institute for Safe Medication Practices (ISMP) Medication Safety Alert, Volume 28, Issue 17, dated August 24, 2023, showed "...BUPIVACAINE SPINAL [Marcaine]...for intrathecal use and digoxin are both available in 2 mL (milliliter) ampules...Since medications are not often provided in ampules, this can heighten the risk of mix-ups between the two drugs...We previously received reports about cases in which digoxin had been accidentally administered via a neuraxial route (e.g., epidural, intrathecal) instead of the intended BUPivacaine...Among the 33 events reported, digoxin was the medication most commonly administered in error and was associated with paraplegia and encephalopathy in eight patients..."

Review of QAPI Meeting Minutes from August 2023, September 2023, October 2023, and November 2023 showed no documentation the QAPI Committee had reviewed the ISMP alert dated 8/24/2023.

During an interview on 2/13/2024 at 12:06 PM, in the conference room, the Senior Risk Manager stated the 8/24/2023 ISMP Medication Safety Alert had been received by pharmacy prior to the incident on 11/30/2023.

During an interview on 2/13/2024 at 1:46 PM, in the conference room, the Corporate Director of Risk and Regulatory confirmed the facility was aware of an ISMP alert regarding the administration of Digoxin instead of Marcaine via intrathecal route resulting in the death of a patient dated 8/24/2023. The Corporate Director of Risk and Regulatory also confirmed the facility did not act or adapt policies related to the alert or ISMP recommendations until December 27, 2023, after the incident with Patient #13.

During an interview on 2/15/2024 at 2:10 PM, the Legal Counsel (Hospital Attorney) stated the ISMP medication alerts in the newsletters would go to the Director of Pharmacy. The Legal Counsel confirmed the hospital did receive the ISMP medication alert on August 24, 2023, and no meeting had been held in August to discuss any alerts that came in. The next action meeting was held on 11/9/2023, and they reviewed 2 action plans from ISMP. Neither action plan was for the August 24th, 2023, alert regarding a death of a patient who mistakenly received digoxin instead of Bupivacaine during a routine c-section. The Legal Counsel confirmed only the Director of Pharmacy received the ISMP medication alert.

During an interview on 2/15/2024 at 2:26 PM, the Legal Counsel stated, "...no one in leadership remembers any action taken on the bi-weekly newsletters. We would wait on the Quarter Action Plans..."

During a telephone interview on 2/15/2024 at 2:49 PM, the previous Director of Pharmacy (last day employed 1/26/2024) was asked if she was aware of the medication error that occurred on 11/30/2023 with the OB patient. She confirmed she was aware. The previous Director of Pharmacy confirmed she received the ISMP bi-weekly (every other week) newsletters (Medication Alerts). She was asked if she made any immediate changes when she received the alert about a patient receiving Digoxin by mistake during a routine c-section and the Director of Pharmacy stated, "...we would make changes during the quarterly review based on the quarterly reports [from ISMP]..."

Based on review of The Institute for Safe Medication Practices (ISMP) Safety Alert, current standards of practice, review of policies and procedures, observation and interview, the hospital failed to ensure Pharmaceutical services implemented procedures to minimize the risk of medication errors for 1 of 3 (Patient #13) patients who received an Obstetric Cesarean Section (C-section) (a surgical procedure which babies are delivered through an incision in the mother's abdomen). Resident #13 received an incorrect medication of Digoxin (a medication used to treat various heart conditions to be administered orally or directly into the vein) stored in an ampule (a sealed glass capsule containing a liquid) and was administered to the wrong route by the Certified Registered Nurse Anesthetist (CRNA).

The failure of the hospital to ensure the pharmaceutical services practiced in accordance with accepted professional principles resulted in a medication error for Patient #13 who received an incorrect medication in the wrong route: intrathecally (the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord). Patient #13 was transferred to the Intensive Care Unit and intubated (a breathing tube inserted into the airway, connected to a machine that delivers Oxygen to the lungs). This error placed all Obstetric (OB) patients in a serious and immediate threat and placed them in immediate jeopardy and risk of serious injuries and/or death.

The findings included:

The hospital failed to ensure the pharmaceutical services acted upon the ISMP Medication Alert received on 8/24/2023. The hospital did not put interventions in place at the time of the alert that could have prevented Patient #13 from suffering harm from the incorrect medication administration.

Refer to A491

Based on review of The Institute for Safe Medication Practices (ISMP) Safety Alert, Digoxin Injection Prescribing Information-Package Insert, ISMP List of High-Alert Medications in Acute Care Settings, Bupivacaine Hydrochloride Package Insert, American Association of Nurse Anesthesiology (AANA) Code of Ethics, and Practice Guidelines for Analgesia and Anesthesia for the Obstetric Patient, review of policies and procedures, observation and interview, the hospital failed to ensure Pharmaceutical services implemented procedures to minimize the risk of medication errors for 1 (Patient #13) of 3 patients reviewed who received an Obstetric Cesarean Section (c-section-a surgical procedure which babies are delivered through an incision in the mother's abdomen). The hospital failed to ensure the Certified Registered Nurse Anesthetist (CRNA) administered the correct medication through the correct route when Patient #13 was in the operating room to receive a C-section to deliver a baby. Patient #13 received an incorrect medication Digoxin (a medication used to treat various heart conditions to be administered orally or directly into the vein) stored in an ampule (a sealed glass capsule containing a liquid) and it was administered to via the wrong route by the CRNA. Patient #13 should have received BUPivacaine (Marcaine-a medication used to decrease feeling in a specific area and is injected into the spinal canal's epidural space) intrathecally.

The failure of the hospital to ensure the pharmaceutical services practiced in accordance with accepted professional principles resulted in a medication error for Patient #13 who received an incorrect medication in via the wrong route, intrathecally (the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord). Patient #13 was transferred to the Intensive Care Unit and intubated (a breathing tube inserted into the airway, connected to a machine that delivers Oxygen to the lungs). This error placed all Obstetric (OB) patients in a serious and immediate threat and placed them in immediate jeopardy and risk of serious injuries and/or death.

The findings included:

Review of the ISMP Medication Alert titled, "Obstetrical Patient Receives Ampule of Digoxin Instead of BUPivacaine [Marcaine] for Spinal Anesthesia" dated 08/24/2023 revealed, "Problem: A pregnant patient with no significant past medical history was undergoing a scheduled cesarean delivery in an operating room (OR) and was to receive spinal anesthesia...The anesthetist inadvertently removed an ampule of digoxin rather than BUPivacaine, prepared the dose, and administered it intrathecally. The anesthetist did not scan the barcode or read the label aloud to another staff member prior to administration. Anesthesia staff then recognized that the patient was not getting the anticipated BUPivacaine effects and thought that it had been injected into the wrong space...a second dose was administered. The cesarean team delivered a healthy baby. However, shortly after the birth, the patient complained of dizziness, blurred vision, and a severe headache with left facial drooping and left-sided weakness. She began losing her ability to communicate and then experienced apnea and complete paralysis. She was intubated and transferred to the intensive care unit...Inadvertent digoxin administration into the intrathecal space was suspected...The team determined that the patient was brain dead, and she died shortly thereafter...We [ISMP] have previously received reports about cases in which digoxin had been accidentally administered via a neuraxial route (e.g., epidural, intrathecal) instead of the intended BUPivacaine...One review (Patel S. Cardiovascular drug administration errors during neuraxial anesthesia...J Cardiothorac Vasc Anesth.[Journal of Cardiothoracic and Vascular Anesthesia] 2023,37[2]:291-8) analyzed inadvertent neuraxial cardiovascular medication administration errors reported between 1972 and 2022. Among the 33 events reported, digoxin was the medication most commonly administered in error and was associated with paraplegia and encephalopathy in eight [8] patients...Safe Practice Recommendations: Given the repeated number of serious mix-ups between digoxin ampules and local anesthetics...organizations should consider the following recommendations: Review which medications (with special attention to ampules are available in each unit-specific ADC [Automatic Dispensing Cabinet] location, anesthesia tray, and medication kit. Remove those that are not needed (considering typical diagnoses). Evaluate whether digoxin needs to be stocked in your OR and labor and delivery unit or if it can be requested from the pharmacy, as needed. Employ individual locked pockets or segregated storage, especially for high-alert medications like digoxin, or medications given via the spinal route, such as preservative-free BUPivacaine...Avoid stocking medications in ampules when possible or store them far apart, and never store more than one medication in an ampule in an open matrix drawer. In the OR, order BUPivacaine for patients and scan the barcode prior to administration. Read labels aloud, as would typically occur at handoffs between the circulating and surgical nurse...Educate staff (e.g., anesthesia personnel, nurses, pharmacists, pharmacy technicians) and conduct regular competency assessments about the safe use of ADCs during orientation and annually. Share this event with staff and discuss lessons learned. In addition, conduct regular reviews and discussions of medication events and close calls reported in your organization and by outside organizations such as ISMP..."

The ISMP Medication Alert dated August 24, 2023, identified Digoxin as a "high-alert" medication.

Review of the ISMP List of High-Alert Medications in Acute Care Settings dated 2018 revealed, "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error...classes/Categories of Medications...antiarrhythmics...epidural and intrathecal medications, inotropic medications..."

Review of the Digoxin Injection Prescribing Information from the package insert, undated reveale "...Dosage form: injection. Drug classes: Group V(5) antiarrhythmics [medications to prevent and treat abnormal heartbeats], Inotropic [drugs that tell your heart muscles to beat or contract with more or less power] agents...DIGOXIN Injection, for intravenous or intramuscular use Initial U.S. [United Stated] Approval: 1954...Digoxin dose is based on patient-specific factors (age, lean body weight, renal function, etc.)...Avoid bolus administration...Ampuls containing 500 mcg [micrograms] (0.5 mg) in 2 mL [milliliters]...Warnings and Precautions...Digoxin toxicity: Indicated by nausea, vomiting, visual disturbances, and cardiac arrhythmias...Pediatric patients: Newborn infants display variability in tolerance to digoxin...Distribution...Digoxin crosses both the blood-brain barrier and the placenta..."

Digoxin is classified as an antiarrhythmic and an inotropic medication. BUPivacaine is classified as an intrathecal medication. Both medication classes are listed on the ISMP List of High-Alert Medications.

Review of the practice guidelines titled "AANA Analgesia and Anesthesia for the Obstetric Patient" undated, revealed "...Response and Review of Emergencies. Establishing an obstetric rapid response team is recommended and can improve management of maternal and fetal complications and emergencies, which may lead to improved maternal, fetal, and neonatal outcomes. An obstetric rapid response team is composed of healthcare professionals who train together to respond to early signs of maternal and fetal emergencies. A rapid response team may include an in-house obstetric professional, anesthesia professional, labor and delivery registered nurse, operating room registered nurse, neonatal professional(s), respiratory therapist, and other clinical specialists as indicated...A review of emergency incidents is part of a continuous quality improvement program to provide an opportunity for the interprofessional team to assess performance and outcomes and to make recommendations for team education and process improvement. The primary responsibility of the anesthesia professional is to the maternal patient. Another healthcare professional should be available whose sole responsibility is to care for the neonate..."

Review of the "Code of Ethics for the Certified Registered Nurse Anesthetist" undated, revealed "...Responsibility to the Patient. The CRNA respects the patient's moral and legal rights, and supports the patient's safety...and well-being...Participates in honest and transparent disclosure of an adverse or unanticipated event to the patient and others with the patient's consent...is honest in all professional interactions to avoid any form of deception...Reports critical incidents, adverse events, medical errors, and near misses in accordance with law, accreditation standards, and institutional policy to promote a culture of safety, maintain the integrity of the profession..."

Review of the facility's policy titled, "Medication Administration and General Guidelines" revised 8/2019, revealed "...Safety...Each licensed certified personnel is responsible for knowing and practicing the Five Right's of medication administration: Right patient...Right medication, Right dose, Right route and Right time...Any department in the hospital, which administers medications, by whatever route, is accountable for medication errors...If a medication error occurs...Immediately notify the Physician and initiate and orders..."

The CRNA did not follow the facility's Medication Administration policy. The Obstetrician/Supervising Physician was not notified of this error immediately when the CRNA realized the patient was given the wrong medication via the wrong route.

Medical record review revealed Patient #13 was admitted to Facility A on 11/30/2023 for an elective c-section for a large for gestational age (LGA) fetus. Patient #13 received an incorrect medication intrathecally which resulted in Acute Metabolic Encephalopathy (reduced oxygen to the brain) and respiratory failure with hypoxia (not enough oxygen in the blood).

Review of the History and Physical Report dated 11/30/2023, revealed, "...patient underwent elective cesarean section under spinal anesthesia. Anesthesia records in EMR [electronic medical record] indicate the patient had received intrathecal digoxin instead of bupivacaine for the initial attempt at anesthetic block. Symptoms of amblyopia [poor vision that happens in 1 eye] and dizziness were initially noticed by patient's mother post-cesarean. Patient developed dyspnea and was transferred to the ICU [Intensive Care Unit], and intubated [a tube in the windpipe to deliver Oxygen to the lungs]...Patient placed on mechanical ventilation [a machine called a ventilator to provide air in and out of the lungs]...Tele ICU [enables off-site clinicians to interact with bedside staff to consult on patient care.] recommended emergent transfer to [Facility B] steroids and stat [immediately] brain CT [Computerized Tomography - a series of very fast X-Rays]..." Patient #13 underwent multiple tests. The LP (Lumbar Puncture) showed an elevated opening pressure (increased pressure in the brain). Continued review revealed, "...initial exam did not show any ocular, pupillary, or limb movements. Pt [Patient] unresponsive and comatose...This is a highly irregular and complex medical case...There were -7 reports in the literature of accidental digoxin administered intrathecally. Our team reviewed this overnight..."

Review of the Medication Administration Record dated 11/30/2023 revealed Patient #13 received 375 mcg of digoxin on 11/30/2024 at 7:53 AM and Patient #13 received 1.6 mL of BUPivacaine on 11/30/2024 at 8:13 AM.

Review of the Anesthesia Record dated 11/30/2023 revealed the surgery began at 8:22 AM.

Review of a Gynecology-Obstetrics Report dated 11/30/2023 revealed the baby was born at 8:33 AM.

Review of the Anesthesia Record dated 11/30/2023 revealed the surgery stopped at 9:18 AM. Patient was out of the OR room at 9:29 AM. Patient was transported to ICU at 9:52 AM.
It was unable to be determined how long the CRNA knew about the error and when the CRNA reported the error to the OB Physician/Supervising Physician. It was sometime after the birth at 8:33 AM and the transfer to ICU at 9:53 AM. The CRNA knew of the error at approximately 7:55 AM and the transfer to ICU occurred at 9:53 AM for a time span of approximately 1hr and 58 minutes.

The Obstetrician/supervising physician was not notified of this error immediately when the CRNA realized the patient was given the wrong medication via the wrong route.

Review of a Progress Note dated 11/30/2023 9:52 AM, revealed "...Received to ICU...Alert and oriented upon arrival follows commands with upper extremities. No movement at this time with lower extremities..."

Review of a Progress Note dated 11/30/2023 11:00 AM, revealed, "Lethargic and responds minimally to sternal [the bone located in the middle of the chest] rub only...received permission from pt's mother for intubation..."

Review of Consultation Notes dated 11/30/2023 12:13 PM, revealed "...Tele-ICU Initial Assessment...Patient...presented for elective cesarean section for large for gestational age fetus. C-section went uneventfully no complications. She however decompensated with change in neurological status and was intubated for airway protection. She had received intrathecal digoxin...Plan for emergent transfer to [Named Hospital #2]...My assessment of the patient is: 1. Acute hypoxic respiratory failure intubated November 30th secondary to inability to protect airway 2. Intrathecal digoxin...I placed the following orders in the EMR: Plan for urgent transfer to [Facility B] Receive steroids...stat CT head prior to transfer..."

Review of Consultation Notes dated 11/30/2023 12:57 PM, revealed "...Patient underwent cesarean section under spinal anesthesia. The initial attempted...block was ineffective and it was discovered that approximately 375mcg [micrograms] of digoxin had been injected intrathecally as opposed to Marcaine...The patient was transferred after surgery to the intensive care unit steroid infusion was begun digoxin antibody FAB [an antidote for overdose of digoxin] was administered due to the patient's obtundation [diminished responsiveness to stimuli, often due to a state of reduced consciousness] and inability to protect airway the patient was electively intubated placed on mechanical ventilation. She is currently on assist-control [a setting on the ventilator that sets a fixed amount of air that is delivered at set intervals or when the patient initiates a breath] volume sedated with propofol..."

Review of an Other Procedures report dated 11/30/2023, revealed "...Critical Care Procedure Note...12:58 [PM]...PROCEDURE: Endotracheal intubation...INDICATION: Impending respiratory failure...PREOPERATIVE DIAGNOSIS(ES) Inadvertent intrathecal injection of digoxin, acute metabolic encephalopathy...POSTOPERATIVE DIAGNOSIS(ES) Same..."

Review of Facility A's investigation dated 11/30/2023, a note handwritten by CRNA #1 on stated pulled a 2 mL glass ampule with green labeling that he thought to be Bupivacaine. The CRNA wrote that he scanned the ampule to register the medication. The CRNA drew up the intended dose through the filter and administered the medication. The patient did not achieve the level of numbness intended. He suspected a failed spinal. He examined the ampule for an expiration date. He then realized it was Digoxin. He wrote he felt the delivery should take place with precedence. The case continued and he tended to the patient. He performed a second spinal anesthetic with success and the case continued as normal. He wrote that he reviewed case studies about incidental administration of intrathecal digoxin. He determined that observing the patient for neurological symptoms while preparing for post-surgical intervention was prudent. He notified the surgical team when he finished the technical parts of the case. He concluded that they had a condition that required immediate attention. Pharmacy was notified and a plan was developed based on the case studies. The plan was put in motion. He notified the family and what was being done to mitigate the sequela.

During an interview on 2/14/2024 at 2:55 PM, the Labor and Delivery Registered Nurse (L&D RN) was asked to describe the incident that occurred 11/30/2023 with the medication error in the OR regarding Patient #13. The L&D RN stated she remembered the incident. (Patient #13) was her patient prior to the C-section. She stated she took the baby from the OR to the nursery. The L&D RN stated when she returned, (Patient #13) was sleepy, but she talked to us, she was awake and conscious just really sleepy. The L&D RN stated they transferred her to ICU pretty quickly. The L&D RN was asked if she knew of any drugs Patient #13 was given prior to the transfer to ICU. The L&D RN stated there was a bag of medication that was hung by the CRNA as they were leaving to transport to ICU, it was SoluMedrol IV. (intravenous). The L&D RN stated (Patient #13) was still conscious when she was taken to ICU for monitoring. The L&D RN was asked if there was any change in level of consciousness. The L&D RN stated, "No, I went to the ICU once to do a fundal check (A massage to help encourage the uterus to continue to contract and prevent postpartum hemorrhage) and Patient # 13 was intubated at that time The L&D RN was asked if she was in the delivery room at the time of the incision. The L&D RN stated she was in the room at the time, but she did not see the lumbar puncture. The L&D RN stated the (Named CRNA) came out to the nurse's station and told me what happened. He asked me to call the pharmacist then handed him the phone. The CRNA told the L&D RN to go to the bedside to check vital signs. The L&D RN stated (Named CRNA) told the family what happened and (Named OB Physician) did speak to the family at some point. The L&D RN stated she stayed with (Patient #13) until they transferred her to ICU.

During an interview on 2/14/2024 at 3:30 PM, the OB physician shared the details of the incident regarding the intrathecal administration of Digoxin the patient. He stated the CRNA started the spinal as he was drying his hands. The OB Physician stated the patient said, "...I can still feel everything..." The OB Physician stated he thought the CRNA did the wrong thing, and it was a normal C-section. The OB Physician stated the CRNA came to him before he left the OR and said to him "...I need to talk to you...". The OB Physician stated he went to check on the baby and congratulated the father, then he went to the dictation room for at least 30 minutes. The OB Physician stated the CRNA came to the dictation room and stated, "We have a situation, I inadvertently administered Digoxin intrathecally, it's very serious and needs to transfer her to ICU". The OB Physician stated he went with the CRNA to the family and the family was aware of some situation, we would transfer her to ICU. The OB Physician stated, "I called the Intensivist. The OB Physician was asked if he would expect the CRNA to notify him immediately of the medication error. The OB Physician stated, "The expectation was different because the patient was awake and listening and that would have been terrifying, I think [Named CRNA] made the right decision." The OB Physician was asked if he had been notified immediately would that have changed how he handled the case. The OB Physician stated, "Nobody knew what to do, the intern called a specialist, and he called Poison Control. He called a specialist in Houston and New York. There was no data. [Named Medical Director] was calling around to experts as well." The OB Physician was asked if he was aware of the plans and interventions that were put in place and did, he feel they were effective. The OB Physician stated, "Yes, I believe the plans in place are good, the hospital immediately made plans to ensure this would not happen again." The OB Physician was asked if he had privilege at any other hospital. The OB Physician stated this was the only hospital he is in, and he is in private practice as an OB/GYN. (Obstetrician/Gynecologist).

During an interview on 2/14/2024 at 3:59 PM, the OB Technician was asked if she remembered the incident on 11/30/2023 regarding the medication error. The OB Technician stated she did remember. The OB Technician stated the patient came in with the circulator (RN) and the CRNA still in her bed. The patient was transferred to the OR bed. The first attempt at the spinal was done. When they were doing the vaginal prep, the patient was feeling it. The patient sat up and a second spinal was successful, and the case proceeded. She was asked if she heard anyone say out loud the patient received the wrong drug, she stated she never heard it and heard about it when the patient was taken back to her room. The OB Technician stated the Circulating Nurse came and told her that (CRNA #1) gave the wrong medication. The OB Technician stated she did not know what digoxin was. The OB Technician stated after the procedure, (CRNA #1) said, "...we need to get the patient to her room quickly..." The OB Technician stated she found that to be a strange remark from the CRNA because he never said things like that.

During an interview on 2/15/2024 at 2:10 PM, the Legal Counsel (Hospital Attorney) stated the ISMP medication alerts in the newsletters would go to the Director of Pharmacy. The Hospital Attorney confirmed the hospital did receive the ISMP medication alert on August 24, 2023.
The Hospital Attorney confirmed there was no meeting in August to discuss any alerts that came in. The next action meeting was on November 9th, 2023, and they reviewed 2 action plans from ISMP. Neither action plan was for the August 24th, 2023, Alert regarding a death of a healthy patient who mistakenly received digoxin instead of Bupivacaine during a routine c-section. The Hospital Attorney confirmed only the Director of Pharmacy received the ISMP medication alert.

During an interview on 2/15/2024 at 2:26 PM, the Hospital Attorney stated, "...no one in leadership remembers any action taken on the bi-weekly newsletters. We would wait on the Quarter Action Plans..."

During a telephone interview on 2/15/2024 at 2:49 PM, the previous Director of Pharmacy was asked if she was aware of the medication error that occurred on 11/30/2023 with the OB patient. She confirmed she was aware. The previous Director of pharmacy confirmed she received the ISMP bi-weekly (every other week) newsletters (Medication Alerts). She was asked if she made any immediate changes when she received the alert about a patient receiving Digoxin by mistake during a routine C-section. The previous Director of Pharmacy stated, "We would make changes during the review based on the quarterly reports [from ISMP]." The previous Director of Pharmacy was asked if this error should have been reviewed when the alert was received in August of 2023. The previous Director of Pharmacy stated, "The first I knew of the alert was during the review. I recall the action agenda and put it to the committee."

During an interview on 2/16/2024 at 8:50 AM, The ICU RN was asked about (Named Patient #13). The ICU RN stated she was aware of (Named Patient #13) and she was a post-partum patient that accidently received digoxin in an epidural. The ICU RN stated the patient was awake and alert at 9:52 AM but was numb from the waist down. ICU RN stated the patient progressed to being lethargic and unarousable about 11:00 AM. The Medical Director was at bedside because the patient needed to be intubated and put on a ventilator. The ICU RN stated, "...The family was very vocal about what happened..."

Based on review of facility policy, medical record review, review of facility documentation, and interview, the facility failed to ensure anesthesia services were provided in a safe setting for 1 patient (#13) of 3 patients reviewed for obstetric surgical services.

The findings include:

Patient #13 was administered the wrong medication via the incorrect route, on 11/30/2023 during an elected cesarean section (c-section). Certified Registered Nurse Anesthetist (CRNA) #1 administered 375 micrograms (mcg) digoxin (to be administrated orally or directly into the vein, a medication used to treat various heart conditions) was administered intrathecally (a route of administration for drugs via an injection into the spinal canal). The correct medication should have been Marcaine (a medication used to decrease feeling in a specific area it is injected into the spinal canal's epidural space). CRNA #1 failed to verify the correct medication Marcaine and administered digoxin intrathecally. CRNA #1 did not notify the operating physician immediately of the medication error and waited until after the C-Section was completed before he notified the physician of the medication error (in excess of 1 hour). As a result of the medication error, Patient #13 required mechanical ventilation (helps you breathe or breathes for you when you can't breathe on your own), was diagnosed with acute metabolic encephalopathy and respiratory failure. Patient #13 was transferred to Facility B for higher-level acute care on 11/30/2023. On 12/20/2023 Patient #13 was transferred to Facility C which is a brain and spinal cord injury rehabilitation facility where she is currently receiving inpatient therapy. Patient #13 suffered serious harm, serious injury, serious impairment because of the medication error.

Refer to A1002.

Based on facility policy review, Acute Care Institute for Safe Medication Practices (ISMP) Medication Safety Alert newsletter, medical record review, and interviews the facility failed to provide Anesthesia services in a safe manner for 1 patient (Patient #13) of 3 patients reviewed for obstetric spinal procedures.

The findings include:

Review of Facility A's policy titled, "Medication Administration and General Guidelines" revised 2019, showed "...Each licensed certified personnel is responsible for knowing and practicing The Five Right's of medication administration...Right medication...Right route...A medication error is any preventable event that may cause or lead to...patient harm...If a medication error occurs...immediately notify the Physician...Notify charge nurse, Nurse Manager, and/or Nursing Supervisor as well as the patient..."

Review of Facility A's policy titled, "Adverse Events, Including Sentinel and Unusual Events" revised 1/2023, showed "...Unusual Events are unexpected occurrences or accidents resulting in...life-threatening injury, or potential serious injury to a patient...Medication errors resulting in serious harm, serious disability, near death..."

Review of the Acute Care ISMP Medication Safety Alert newsletter, Volume 28, Issue 17, dated August 24, 2023, showed "...BUPIVACAINE SPINAL [Marcaine]...for intrathecal use and digoxin are both available in 2 mL (milliliter) ampules...Since medications are not often provided in ampules, this can heighten the risk of mix-ups between the two drugs...We previously received reports about cases in which digoxin had been accidentally administered via a neuraxial route (e.g., epidural, intrathecal) instead of the intended BUPivacaine...Among the 33 events reported, digoxin was the medication most commonly administered in error and was associated with paraplegia and encephalopathy in eight patients..."

Medical record review showed Patient #13 was admitted to Facility A on 11/30/2023, for an elective cesarean section (c-section) under spinal anesthesia for large gestational age fetus. Continued review showed complication of administration of anesthesia or sedation in labor and delivery resulted in acute metabolic encephalopathy (alteration in consciousness) and respiratory failure with hypoxia (low oxygen).

Review of Hospital A's investigation dated 11/30/2023, a handwritten note dated and signed by CRNA #1 on revealed the CRNA pulled a 2mL glass ampule with green labeling that he thought to be Bupivacaine. The CRNA wrote that he scanned the ampule to register the medication. The CRNA drew up the intended dose through the filter and administered the medication. The patient did not achieve the level of numbness intended. He suspected a failed spinal. He examined the ampule for an expiration date. He then realized it was Digoxin. He wrote he felt the delivery should take place with precedence. The case continued and he tended to the patient. He performed a second spinal anesthetic with success and the case continued as normal. He wrote that he reviewed case studies about incidental administration of intrathecal digoxin. He determined that observing the patient for neurological symptoms while preparing for post-surgical intervention was prudent. He notified the surgical team when he finished the technical parts of the case. He concluded that they had a condition that required immediate attention. Pharmacy was notified and a plan was developed based on the case studies. The plan was put in motion - He notified the family and what was being done to mitigate the sequela.

Review of the Medication Administration Record dated 11/30/2023, showed Certified Registered Nurse Anesthetist (CRNA) #1 administered 375 micrograms (mcg) Digoxin (a medication used to treat various heart conditions to be administered orally or directly into the vein); the Digoxin had been administered intrathecally (a route of administration for drugs via an injection into the spinal canal) at 7:53 AM. Continued review showed 1.6 milliliters (mL) Marcaine (a medication used to decrease feeling in a specific area and is injected into the spinal canal's epidural space) had been administered intrathecally at 8:13 AM.

Review of the Anesthesia Record dated 11/30/2023 at 8:22 AM, showed C-Section started at 8:22 AM, baby delivered at 8:33 AM, surgery completed at 9:18 AM, and Patient #13 was moved to an obstetrics room at 9:24 AM. Review showed Patient #13 was transferred to the Intensive Care Unit (ICU) at 9:52 AM. Patient #13 was alert, oriented, and vital signs stable.

Review of the ICU Progress Notes dated 11/30/2023 at 9:52 AM, showed Patient #13 transferred to ICU via bed, and was alert and oriented upon arrival, followed commands with upper extremities, and had no movement at this time with lower extremities. At 11:00 AM, Patient #13 was lethargic, and responded minimally to sternal rub only. The Physician was at Resident #13's bedside, and permission was obtained from Patient #13's mother for intubation (a procedure that places a tube down the throat and into your windpipe to help you breathe). At 11:10 AM, patient intubated without difficulty.

Review of Consultation Notes dated 11/30/2023 at 12:13 PM, showed Patient #13 "...decompensated with change in neurological status and was intubated for airway protection. She had received intrathecal digoxin. Plan for emergent transfer to [Facility B] for...acute hypoxic respiratory failure...intubated 11/30/2023 secondary to inability to protect airway and intrathecal digoxin..."

Review of Obstetric (OB) Physician Consultation Notes dated 11/30/2023 at 12:57 PM, showed "...[Patient #13] underwent cesarean section under spinal anesthesia. The initial attempted subarachnoid block [intrathecal/spinal] was ineffective and it was discovered that approximately 375 mcg of digoxin had been injected intrathecally as opposed to Marcaine. A repeat subarachnoid block with Marcaine was effective. The patient was transferred after surgery to the intensive care unit steroid infusion was begun digoxin antibody [medication reversal agent] was administered due to the patient's obtundation [reduced alertness and reaction to stimuli] and inability to protect airway the patient was electively intubated...placed on mechanical ventilation [helps you breathe or breathes for you when you can't breathe on your own]...recommends transfer for neurology..."

Review of a Computed Tomography (CT Scan) dated 11/30/2023 at 1:17 PM, showed the indication for the CT Scan was altered mental status. "...No acute intracranial abnormalities are identified although CT cannot reliably exclude acute infarct [reduced blood supply to the brain]..."

Review of a discharge summary dated 11/30/2023 at 2:45 PM, showed Patient #13 was discharged from Facility A and transferred to Facility B via EMS (Emergency Medical Services) to the neurology intensive care unit.

Review of Facility B's History and Physical dated 11/30/2023, showed "...11/30/2023, patient [Patient #13] underwent elective cesarean section under spinal anesthesia. Anesthesia records in EMR [Electronic Medical Record] indicate the patient had received intrathecal digoxin instead of bupivacaine [Marcaine] for the initial attempt at anesthetic block...Patient was transferred to the ICU [Intensive Care Unit], and intubated...On arrival to [Facility B] ICU...initial exam did not show any ocular, pupillary, or limb movements...unresponsive and comatose...This is a highly irregular and complex medical case..."

During a telephone interview on 2/6/2024 at 7:37 PM, CRNA #1 stated he had been advised not to discuss these matters with anyone and to refer to his legal representation [Attorney Name Provided].

During an interview on 2/7/2024 at 12:56 PM, in the conference room, the Intensivist/Anesthesiologist stated he treated Patient #13 after a decrease in level of consciousness while in the ICU. The patient was intubated for airway protection. The physician stated that he consulted with telehealth ICU who recommended transfer to Facility B for higher level of care.

During an interview on 2/7/2024 at 2:25 PM, in the conference room, Registered Nurse (RN) ICU stated she had cared for Patient #13. The RN stated the patient had been transferred to the ICU immediately after the C-Section and had become unresponsive and intubated approximately 30 minutes to 1 hour after coming to the ICU. The RN stated the patient received intravenous (IV) steroids and was transferred to Facility B.

During an interview on 2 /8/2024 at 2:25 PM, in the conference room, the OB Physician stated he had delivered the baby of Patient #13 on 11/30/2023. The physician stated he had been made aware of the medication error after the cesarean section had been completed by CRNA #1. The physician stated if he had been notified immediately after the medication error occurred, he would have consulted with high risk to get recommendations as to whether to deliver the baby or wait.

During an interview on 2/13/2024 at 10:35 AM, in the conference room, the Operating Room (OR) Circulating Nurse stated she was present in the OR the day of the event 11/30/2023. The RN stated during the transport back to the patient's room, the CRNA told her (OR Circulating Nurse) he (CRNA) needed to find the delivering physician, because there was an issue. The CRNA then disclosed to the OR nurse he had administered Digoxin instead of Marcaine. The error was disclosed to the delivering physician (unsure of exact time) after the c-section ended. The patient was transported to ICU for further care and monitoring. The OR Circulating Nurse stated she alerted the Director of Surgical Services and the Senior Risk Manager.

During an interview on 2/13/2024 at 11:54 AM, in the conference room, the Director of Surgical Services stated she had been notified by the OR Circulating Nurse on 11/30/2023 of the incident. The Director stated she notified the Chief Nursing Officer (CNO) and the Supervising Anesthesiologist of the incident, and an investigation began.

During an interview on 2/13/2024 at 12:06 PM, in the conference room, the Senior Risk Manager stated she was notified approximately 30-40 minutes after the incident occurred by the OR Circulating Nurse and a Root Cause Analysis (RCA), and an investigation had been initiated. The incident was sent to quality for review on 12/4/2023, digoxin had not been removed from OB automated medication dispensing cabinets until 12/5/2023, and quality submitted the incident for peer review on 12/8/2023. The Senior Risk Manager stated the ISMP Medication Safety Alert had been received by pharmacy prior to the incident and the CNO and Senior Risk Manager had not been included in the safety alerts. The Senior Risk Manager confirmed the 5 rights of medication had not been followed by the CRNA.

During an interview on 2/13/2024 at 1:46 PM, in the conference room, the Corporate Director of Risk and Regulatory confirmed the facility was aware of an ISMP alert regarding the administration of Digoxin instead of Marcaine via intrathecal route resulting in the death of a patient. The Corporate Director of Risk and Regulatory also confirmed the facility did not act or adapt policies related to the alert or ISMP recommendations until December 2023 after the incident with Patient #13.

During an interview on 2/14/2024 at 9:14 AM, in the conference room, the Legal Counsel stated all documents related to the investigation of CRNA #1 are considered protected under the Peer Review clause at this time.

During an interview on 2/14/2024 at 2:55 PM, the Labor and Delivery Registered Nurse (L&D RN) was asked to describe the incident that occurred 11/30/2023 with the medication error in the OR. The L&D RN stated she remembered the incident. (Patient #13) was her patient prior to the C-section. She stated she took the baby from the OR to the nursery. The L&D RN stated when she returned, (Patient #13) was sleepy, but she talked to us, she was awake and conscious just really sleepy. The L&D RN stated they transferred her to ICU pretty quickly. The L&D RN was asked if she knew of any drugs Patient #13 was given prior to the transfer to ICU. The L&D RN stated there was a bag of medication that was hung by the CRNA as we were leaving to transport to ICU, it was SoluMedrol IV. (intravenous). The L&D RN stated (Patient #13) was still conscious when she was taken to ICU for monitoring. The L&D RN was asked if there was any change in level of consciousness. The L&D RN stated, "No, I went to the ICU once to do a fundal check (A massage to help encourage the uterus to continue to contract and prevent postpartum hemorrhage) and Patient # 13 was intubated at that time The L&D RN was asked if she was in the delivery room at the time of the incision. The L&D RN stated she was in the room at the time, but she did not see the lumbar puncture. The L&D RN stated the (CRNA #1) came out to the nurse's station and told me what happened. He asked me to call the pharmacist then handed him the phone. The CRNA told the L&D RN to go to the bedside to check vital signs. The L&D RN stated (CRNA #1) told the family what happened and (Named OB Physician) did speak to the family at some point. The L&D RN stated she stayed with (Patient #13) until they transferred her to ICU.

During an interview on 2/14/2024 at 3:30 PM, the OB Physician was asked to share the details of the incident regarding the intrathecal administration of Digoxin to Patient #13. He stated the CRNA started the spinal as he was drying his hands. The OB Physician stated the patient said, "...I can still feel everything..." The OB Physician stated he thought that the CRNA did the wrong thing by not informing him of his medication error before the surgery began. The OB Physician was asked if he closed (stitched or stapled the incision) the patient. He stated he usually does the closure. The OB Physician stated the CRNA came to him before he left the OR and said to him "I need to talk to you". The OB Physician stated he went to check on the baby and congratulated the father, then he went to the dictation room for at least 30 minutes. The OB Physician stated the CRNA came to the dictation room and stated, "We have a situation, I inadvertently administered Digoxin intrathecally, it's very serious and needs to transfer her to ICU". The OB Physician stated he went with the CRNA to the family and the family was aware of some situation, we would transfer her to ICU. The OB Physician stated, "...I called the Intensivist. The OB Physician was asked if he would expect the CRNA to notify him immediately of the medication error...the expectation was different because the patient was awake and listening and that would have been terrifying, I think [CRNA #1] made the right decision..." The OB Physician was asked if he had been notified immediately would that have changed how he handled the case "...nobody knew what to do, the intern called a specialist, and he called Poison Control. He called a specialist in Houston and New York. There was no data. [Named Medical Director] was calling around to experts as well..." The OB Physician was asked if he was aware of the plans and interventions that were put in place and did he feel they were effective. The OB Physician stated, "...yes, I believe the plans in place are good, the hospital immediately made plans to ensure this would not happen again." The OB Physician was asked if he had privilege at any other hospital. The OB Physician stated this was the only hospital he is in, and he is in private practice as an OB/GYN. (Obstetrician/Gynecologist).

During an interview on 2/15/2024 at 2:10 PM, the Legal Counsel (Hospital Attorney) stated the ISMP medication alerts in the newsletters would go to the Director of Pharmacy. The Hospital Attorney confirmed the hospital did receive the ISMP medication alert on August 24, 2023.The Hospital Attorney confirmed there was no meeting in August to discuss any alerts that came in. The next action meeting was on November 9th, 2023, and they reviewed 2 action plans from ISMP. Neither action plan was for the August 24th, 2023, Alert regarding a death of a healthy patient who mistakenly received digoxin instead of Bupivacaine during a routine C-section. The Hospital Attorney confirmed only the Director of Pharmacy received the ISMP medication alert.

During an interview on 2/15/2024 at 2:26 PM, the Legal Counsel stated, "...no one in leadership remembers any action taken on the bi-weekly newsletters. We would wait on the Quarter Action Plans."

During a telephone interview on 2/15/2024 at 2:49 PM, the previous Director of Pharmacy was asked if she was aware of the medication error that occurred on 11/30/2023 with the OB patient. She confirmed she was aware. The previous Director of pharmacy confirmed she received the ISMP bi-weekly (every other week) newsletters (Medication Alerts). She was asked if she made any immediate changes when she received the alert about a patient receiving Digoxin by mistake during a routine C-section. The previous Director of Pharmacy stated, "We would make changes during the review based on the quarterly reports [from ISMP]." The previous Director of Pharmacy was asked if this error should have been reviewed when the alert was received in August of 2023. The previous Director of Pharmacy stated, "The first I knew of the alert was during the review. I recall the action agenda and put it to the committee."

During an interview on 2/16/2024 at 8:50 AM, The ICU RN was asked about (Named Patient #13). The ICU RN stated she was aware of (Named Patient #13) and she was a post-partum patient that accidently received digoxin in an epidural. The ICU RN stated the patient was awake and alert at 9:52 AM but was numb from the waist down. ICU RN stated the patient progressed to being lethargic and unarousable about 11:00 AM. The Medical Director was at bedside because the patient needed to be intubated and put on a ventilator. The ICU RN stated, "...The family was very vocal about what happened..."

During a telephone interview on 2/15/2024 at 2:49 PM, the Previous Pharmacist (last day employed 1/26/2024) ISMP came to her. The Previous Pharmacist stated she would set them aside and the ISMP alerts were reviewed quarterly by the Hospital Quality Assurance Team. The Pharmacist stated she was unsure if she notified anyone of the alert, she received ISMP Safety Alert regarding the Digoxin and Marcaine dated 8/24/2023.