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

1. The hospital failed to develop and implement policies and procedures (P&P) to minimize medication errors as in accordance with accepted professional standards when it did not have:

a. Global P&P addressing medication administration rights (right patient, right drug, right dose, right route, and right time) for physicians and other licensed professionals allowed by law to administer medications besides those for nursing staff; and

b. Policy and procedures to establish and implement standardized hand-off or communication process during the transfer of patient information, including medications, to help minimize communication breakdowns and reduce the risk of errors.

The lack of P&Ps contributed to a medication error for one of 31 sampled patients (Patient 2). Patient 2 was intended to receive sodium bicarbonate (injectable medication to lower the amount of acid in the blood) but received bupivacaine solution (a local anesthetic; works by blocking the nerves from transmitting pain signals, numbing the targeted area) by mistake. (Refer to A-491)

2. A medication was not stored in accordance with the hospital P&P in one of three Pyxis Medstations (an automatic dispensing cabinet or ADC; computer-based system for the storage and dispensing of medications and supplies). The failure had the potential for the medication to be selected by error during a high-stress situation such as during a medical emergency. (Refer to A-491)

3. The hospital failed to ensure a medication was safely controlled and administered in accordance with accepted standards of practice to meet the needs of one our of 31 sampled patients (Patient 2). An Operating Room (OR) nursing staff (Registered Nurse A), a perfusionist (specialized healthcare professional who operates the heart-lung machine during major surgical procedures), and an anesthesiologist (Physician A, doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures) failed to check the medication label during medication hand-off (the hand-over of the medication from one person to another) or before medication administration for Patient 2. Patient 2 was to receive sodium bicarbonate but received intravenous (IV, directly into a vein) bupivacaine solution by mistake during a surgical procedure. Consequently, Patient 2 required the administration of a reversal agent, intralipid (lipid emulsion, for treating local anesthetic systemic toxicity) solution, to reverse the effects of bupivacaine. The medication error contributed to Patient 2's death which occurred during the procedure, shortly after the medication error. (Refer to A-500)

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

Based on observation, interviews, and record review, the hospital failed to develop and implement policies and procedures (P&P) to minimize medication errors as in accordance with accepted professional standards; and failed to store a medication in accordance with its P&P, when:

1. The hospital did not have a "global" P&P addressing medication administration rights (right patient, right drug, right dose, right route, and right time) for physicians and other licensed professionals allowed by law to administer medications besides those for nursing staff; and did not have P&P to establish and implement a standardized hand-off or communication process during the transfer of patient information, including medications, to help minimize communication breakdowns and reduce the risk of errors.

The lack of P&Ps contributed to a medication error for one of 31 sampled patients (Patient 2). Patient 2 was intended to receive sodium bicarbonate (injectable medication to lower the amount of acid in the blood) but received bupivacaine (a local anesthetic; works by blocking the nerves from transmitting pain signals, numbing the targeted area) by mistake. The medication error contributed to Patient 2's death during a surgical procedure (Refer to A-0500 for additional information).

2. A medication was not stored in accordance with the hospital P&P in one of three Pyxis Medstations (an automatic dispensing cabinet or ADC; computer-based system for the storage and dispensing of medications and supplies). The failure had the potential for the medication to be selected by error during a high-stress situation such as during a medical emergency.

Findings:

1. On 6/17/25 starting at 10:25 a.m., a concurrent interview and review of Patient 2's clinical record with multiple hospital staff including the Director of Regulatory Compliance (DRC), Director of Quality (DOQ), and the Director of Pharmacy (DOP) indicated Patient 2 was a 76-year old patient admitted to the hospital with diagnoses including a heart attack (also known as myocardial infarction, a serious condition that occurs when a blood clot blocks blood flow to the heart) and history of hypertension (high blood pressure) and hyperlipidemia (high lipids in the blood). The interview and record review reflected the following:

- On 5/12/25 at 5:24 p.m., Patient 2 arrived in the Emergency Department after two weeks of intermittent worsening midback pain.

- On the same day, on 5/12/25, she was diagnosed with NSTEMI (non-ST segment elevation myocardial infarction, which is a type of heart attack), unstable angina (a heart problem that causes sudden chest pain, often while resting), and coronary artery disease (condition where build-up of plaque in the heart's arteries that could lead to heart attack or ischemic stroke), and was admitted to the Critical Care Unit (CCU, specialized hospital department that gives care to people who are critically ill).

- During the hospital stay, on 5/14/25, Patient 2 underwent a heart bypass surgery called coronary artery bypass grafting (CABG; where a healthy blood vessel, typically taken from the chest, arm, or leg, is grafted onto the coronary artery, creating a new path for blood to flow to the heart muscle) with 3 grafts.

- A day later, on 5/15/25, she was brought back to the Operating Room (OR) for an emergent procedure called redo sternotomy (surgical procedure that involves cutting through the sternum to access the heart and surrounding structures), sternal washout (procedure that involves washing or cleaning out debris, contaminants, or excess fluid of the surgical area) because of the worsening lactate (or lactic acid, is a natural byproduct of cellular metabolism often caused by impaired tissue oxygenation) elevation as well as uncorrectable acidosis (excessive buildup of acid in the body fluids, causing the blood pH to drop below the normal range).

On 6/17/25 at 11:40 a.m., a review of Patient 2's Anesthesia Record (the main document of medications administered for the relief of pain and sensation during the procedure), dated 5/15/25, with the DRC, the DOQ, and the DOP indicated Patient 2 was in the OR Room 5 (OR5) for an emergent "redo sternotomy, sternal washout" on 5/15/25 at 1:42 p.m. A review of the hand-written narrative in this Anesthesia Record, written by the anesthesiologist (Physician A, doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures), indicated, "After 7 amps [ampules] of bicarb [sodium bicarbonate], depleting the in-room supply additional bicarb was acquired from central Pyxis. Inadvertently administering bupivacaine... following the bupivacaine, BP [down arrow] [blood pressure dropped], Epi [epinephrine, medication to increase BP] and cardiac [heart] massage started, Intralipid [lipid emulsion administration for treating local anaesthetic systemic toxicity] was administered, patient defibrillated [controlled electric shock to restore the normal rhythm] to ROSC [return of spontaneous circulation], 3 total arrests were successfully defibrillated before fulminant [severe and sudden in onset] right heart failure. Time of death 1605 [4:05 p.m.]."

During a concurrent interview and record review with multiple hospital staff including the DRC and the DOP on 6/17/25 at 11:45 a.m., the DRC explained that during Patient 2's washout surgery on 5/15/25, Physician A requested for more sodium bicarb to be brought in. Registered Nurse (RN) A, who was the nurse on duty, went to the Pyxis in the surgery area (SURPX) to remove 4 vials of sodium bicarb but she grabbed 4 vials of bupivacaine by mistake. The DOP showed a picture of the two medication vials: the sodium bicarb came in as 8.4%,1 milliEquivalent (unit of measurement) per milliliter (mL) injection solution; and the bupivacaine came in 0.25%, 125 milligrams (mg, unit of measurement) per 50 mL, injection solution. Each was in a 50-mL glass vial containing clear, water-like solution. The DOP stated both medications were stored in the Pyxis tower (a vertical unit of the Pyxis, designed for storing multiple large-volume medications; where the user can have access to multiple medications when the tower door is opened).

During an interview with the Patient Safety Director (PSD) on 6/17/25 at 12:05 p.m., in the presence of the DRC, the DOQ, and the DOP, the PSD stated she got notified right away after the medication error occurred. She immediately went to the OR while the team was still there. She explained the bupivacaine was inadvertently administered instead of sodium bicarbonate. She further explained, during the surgery, Physician A requested for more sodium bicarb to be brought into the OR, the nurse ran to the Pyxis outside of OR5, "accidentally grabbed the bupivacaine, handed it to the perfusionist, who handed to [Physician A] who administered it." The DOP stated the medication error was reported internally on 5/16/25 as a "Sentinel Event" (a patient safety event [not primarily related to the natural course of a patient's illness or underlying condition] that reaches a patient and results in death, severe harm, or permanent harm).

During an interview with the Vice President of Surgical Services (VPSS) in the presence of the DRC on 6/17/25 at 3:03 p.m., the VPSS stated she was part of the investigation after the medication error happened. She explained RN A removed the bupivacaine vials instead of the intended sodium bicarb vials, and did not check the label on the vials to make sure it was the correct medication. She handed it to the perfusionist who handed it to Physician A, who administered the whole vial of bupivacaine (125 mg). The VPSS stated each person was supposed to check for the correct medication before handing off to another person, and before medication administration. She added, "The expectation is for them to call out what they are doing, what they are giving, to treat it like a code [medical emergency in which a team of medical personnel work to revive an individual]." She stated this was an unusual situation where the medication was brought in during a case, so the medication was not in the sterile field (area established with sterile surgical drapes around a patient's surgical site and on the table/tray that will hold the instruments and necessary surgical items).

During the survey, on 6/18/25 at 9:07 a.m., the DRC and DOQ were asked to provide a "global policy" addressing the medication administration by physicians and other licensed disciplines allowed by law to administer medications, the DRC stated she checked the hospital policies and medical staff bylaws but she could not find any other policy than the one already provided to the surveyors titled "Administration of Medications by Nursing."

A review of the hospital's P&P titled "Administration of Medications by Nursing," reviewed 8/2023, indicated, "Administration of Medications in eMAR [electronic Medication Administration Record] 1. The licensed nurse checks the patient's allergies... 2. At the time of administration of a medication, the licensed individual verifies the right patient is receiving the right drug, dose, via the right route at the right time."

A review of the hospital P&P titled "Intraoperative [during the course of a surgical operation] Medications", dated 8/2024, indicated, "All medications on the sterile field will be verified including medication strength, dosage, and expiration date."

In an interview with the Chief Medical Officer (CMO, who is also an anesthesiologist) in the presence of the DRC on 6/18/25 at 10:05 a.m., when asked if there was a hospital policy governing the medication administration by physicians, the CMO stated he was not aware of any besides that addressed to nursing. He added, "It falls upon the physician to give the right medication as intended." When asked to explain "sterile field," the CMO stated it is within the "surgical drape around the patient." He stated the anesthesiologist and the perfusionist are not in the sterile field.

During an interview with RN A on 6/18/25 at 11:02 a.m., she stated, on the day of the event, the perfusionist asked if she could get some sodium bicarb from the Pyxis. She stated she went and got 3 vials from the SURPX, went into OR5, put them on the perfusionist's table, and told him the medication was there. When asked if she looked at the vials to ensure she got the right medication, RN A stated, "I didn't look when I retrieved the medication." She also stated, "I'm not sure why I didn't look at it before giving it to them. I should look."

During an interview with the perfusionist on 6/18/25 at 2:03 p.m., in the presence of the DRC and the DOQ, he stated Patient 2 "was super ill and very acidotic." He stated Physician A needed more sodium bicarb, RN A went to retrieve it, "came back, and handed it to me, and I handed it to [Physician A]. It was the wrong medication that was given, that's what I know." He added, "Four vials were handed to me. I gave them to [Physician A] who gave the medication." He stated he did not look at the vials before handing them to Physician A. When asked whether he should have looked, the perfusionist stated, "Yes, but there's a lot of things going on" as it was a "very hectic and chaotic environment."

An interview was conducted with Physician A on 6/18/25 starting at 2:30 p.m. in the presence of the DRC and DOQ. He explained, during Patient 2's washout procedure, he had used up 7 vials from the OR5 Pyxis and from the perfusionist's medication tray. He knew that he needed more as Patient 2 continued to be in an acidotic state. After the perfusionist handed the vials (those that were brought in by RN A) to him, Physician A stated he put them on the back table. He said he was not sure about the duration from the time they were given to him to the time of administration as there were a lot of things going on. He continued, "The vial I picked up turned out to be bupivacaine." When asked whether he checked the vial for correct medication before administration, he stated, "No, it didn't happen." He stated Patient 2's BP started to drop and she went into arrhythmia (irregular heart rhythms). He stated the team began treating the patient, massaged the heart, gave epinephrine, and "shocked the patient out of arrhythmia." He continued, "At that point I looked back at the table and saw the four vials said bupivacaine... Immediately following that, we identified the error, announced to the surgeon, and called for intralipid." He stated the patient had three episodes of V-tach [ventricular tachycardia; a rapid heartbeat originating in the heart's lower chambers (ventricles), typically with a rate of 100 or more beats per minute], and the team was able to bring the heart back to the level prior to the event by IV intralipid, heart massage, epinephrine administration, and other supportive measures. He further explained, "We brought her back to stable position. She was on her third bag of lipid at this time. The patient's acidotic status never normalized.... Her lactate continued to increase... When lactate is rising, the patient is dying; their body organs are not getting up the oxygen... After the fourth V-tach, she didn't recover from it. She developed fulminant heart failure."

During the same interview with Physician A as above, on 6/18/25 at 2:55 p.m., Physician A confirmed he administered the whole vial of bupivacaine (125 mg) to Patient 2 via IV route. When asked about the potential adverse effects from IV bupivacaine administration, Physician A stated hypotension (low BP) and arrhythmia "were potential causes of local anesthetics."

During the continued interview with Physician A on 6/18/25 at 3:03 p.m., when asked whether the medication error caused or contributed to Patient 2's death, Physician A stated, "The severity of illness was what led to her death." He added the medication error was discovered within a minute of administration, that "intralipid was given as soon as discovered, and we were able to get her back to the same level as before." He explained that her acidotic condition led to multi-organ damage including liver failure and bowel ischemia (condition where the blood supply to the intestines is reduced, potentially leading to tissue damage or death).

During a telephone interview with the Medical Director of Surgical Services (Physician B) in the presence of the DOQ on 6/23/25 starting at 3:15 p.m., Physician B stated he was informed of the medication error; and as a result, communicated with other anesthesiologists including reminding them to review the medication label and confirm out loud what they are receiving during a procedure. He stated, "In this case, they didn't look at the label." He stated they are to review the medication label and call out the medication, such as "confirm bicarbonate" when they receive it. He stated everyone is expected to ensure they are receiving or administering the right medication. When asked if there was a specific policy for physicians administering medications, Physician B stated, "There's no specific one for physicians. We try to abide by the one for nursing. It applies to everyone who gives medication. In reality, it applies to everyone. Not because you are a physician you don't have to do that." When asked for his professional opinion whether the medication error caused or contributed to Patient 2's death, Physician B stated, "It happened within 3 seconds. In my professional opinion, a lot of things had gone wrong with the patient. She was acidotic which spelled disaster already... The medication error did not help the scenario. It wasn't the cause of death. Prognosis was already poor for this patient. That doesn't take away the gravity of this error." When asked what national standards of practice the hospital followed for anesthesia services, Physician B stated they followed the American Society of Anesthesiologists (ASA) for best practices; and for policies, the hospital followed the Association of periOperative Registered Nurses (AORN, a national organization that provides nursing education, standards, and services that enable optimal outcomes for patients undergoing operative and other invasive procedures).

A review of the manufacturer's Product Information (PI, detailed description of a drug's uses, dosage range, side effects, drug-drug interactions, and contraindications) for bupivacaine injection, revised 11/2018, reflected it is a local anesthetic indicated to produce local or regional anesthesia (or pain relief) for surgery and other procedures. It works by blocking the nerves from transmitting pain signals, numbing the targeted area. The dosage varies depending on anesthetic procedure, the area to be anesthetized, the depth and duration of anesthesia, etc. The PI indicated the multi-dose bupivacaine 0.25% injection solution can be used for infiltration (injected directly into the tissue at a surgical site to provide pain relief) or nerve blocking (injected near the nerve endings to numb a specific area). Under Adverse Reactions, the PI indicated, "The most commonly encountered acute adverse experiences which demand immediate counter-measures are related to the CNS [central nervous system] and the cardiovascular [relating to the heart and blood vessels] system." Related to cardiovascular system reactions, the PI indicated, "High doses or unintentional intravascular [inside blood vessels] injection may lead to... hypotention... ventricular arrhythmias, including ventricular tachycardia... and cardiac arrest."

A review of the AORN's "Guideline for Medication Safety" (MS Guideline), approved March 16, 2023, indicated, "This document provides guidance to perioperative personnel for safe medication management practices. These recommendations, which are based on a systematic review of the available literature, are intended to support perioperative registered nurses (RNs) and other clinicians implementing evidence-based practices in all phases of medication management in the perioperative setting and to decrease the risk of medication errors." The MS Guideline indicated; "1.3. In collaboration with physicians, pharmacists, nurses, risk and quality personnel, and other identified key stakeholders, develop and maintain policies and procedures that address authority, accountability, responsibility, and patient and personnel safety in all phases of the medication use processes in perioperative care." Under Communication, the MS Guideline indicated, "5.3. Visually and verbally confirm the medication information when a medication is passed to the licensed independent practitioner for subsequent administration..." Guideline 7.3 of the MS Guideline indicated," Before administering a medication, verify: right patient, using two health care organization-approved identifiers; right medication; right dose; right route; and right time."

In an email communication with the DRC on 6/26/25 at 12:31 p.m., she was requested to provide a P&P that addressed the standardized handing off process, or method of communication, from one licensed staff to another such as during surgery. In an email response on 6/26/25 at 1:14 p.m., the DRC replied, "I do not have anything that specific, only one regarding medications in the sterile field, which this was not the case."

A review of the AORN's "Guidelines for Team Communication," approved January 1, 2024, indicated the "Operating room (OR) is a high-risk sociotechnical [involving social and technical elements] environment with various professionals working in close proximity, and effective team communication in the perioperative and procedural environment is the foundation of optimal patient outcomes." Guideline 2.1 indicated, "Establish and implement a standardized hand-off process for the transfer of patient information between individuals... The Joint Commission's [a healthcare accrediting organization] sentinel event database includes reports of inadequate hand-off communication contributing to adverse events, including wrong-site surgery, delay in treatment, falls, and medication errors." Guideline 2.2 indicated, "Establish an interdisciplinary team at the facility level to develop a standardized hand-off process. A standardized hand-off process helps to identify risks during the perioperative phases so the team can take action to minimize threats to patient safety."

2. During a visit to OR5 with the DRC and the DOP on 6/17/25 at 2:45 p.m., a Pyxis Medstation (an ADC) was identified inside OR5. The DOP was asked to open a medication drawer for inspection. A review of a matrix drawer (allows access to multiple medications housed within the same drawer when it's opened) identified three 5-mL ampules of lidocaine 1.5% with epinephrine (a combination of medications used as local anesthetic for use in certain surgical procedures) injection solutions inside Pocket 30. Two of the ampules had the expiration date of 11/2024. The DOP reviewed the Pyxis' inventory and stated these ampules were not supposed to be in the Pyxis.

During a follow-up interview with the DOP on 6/18/25 at 12:15 p.m., the DOP stated he could not find any reason why the lidocaine/epinephrine ampules were in OR5 Pyxis. He stated, "I think that anesthesia [personnel] dropped them in there. They should be put in the return bin or to give to pharmacy" if not used.

During another interview with the DOP on 6/23/25 at 10:03 a.m., the DOP stated the pharmacy did not stock ampules in Pyxis Medstations. He stated anesthesia staff must have used it from a medication kit (a kit containing medications for a specific medical emergency or procedure) and put them in the Pyxis. He additionally stated the OR Pyxis Medstations do not have a return bin, so the medications not used during a procedure should be wasted or returned to the pharmacy.

A review of the hospital P&P titled "Patient Care Areas Medication Storage and Security," reviewed 1/2025, indicated, "The hospital safely stores medications including... Implements policy addressing the control of medication...including safe storage, handling, security, disposition, and return to storage" and "Removes expired... medications and stores them separately from medications available for administration..."

Based on interview and record review, the hospital failed to ensure a medication was safely controlled and administered in accordance with accepted standards of practice for one out of 31 sampled patients (Patient 2). An Operating Room (OR) nursing staff (Registered Nurse A), a perfusionist (specialized healthcare professional who operates the heart-lung machine during major surgical procedures), and an anesthesiologist (Physician A, doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures) failed to check the medication label during medication hand-off (the hand-over of the medication from one person to another) or before medication administration for Patient 2. Patient 2 was to receive sodium bicarbonate (injectable medication to lower the amount of acid in the blood when blood acid level is high) but received intravenous (IV, directly into a vein) bupivacaine solution (a local anesthetic; works by blocking the nerves from transmitting pain signals, numbing the targeted area) by mistake during a surgical procedure. Consequently, Patient 2 required the administration of a reversal agent, intralipid (lipid emulsion, for treating local anesthetic systemic toxicity) solution, to reverse the effects of bupivacaine. The medication error contributed to Patient 2's death which occurred during the procedure, shortly after the medication error.

Findings:

On 6/17/25 starting at 10:25 a.m., a concurrent interview and review of Patient 2's clinical record with multiple hospital staff including the Director of Regulatory Compliance (DRC), Director of Quality (DOQ), and the Director of Pharmacy (DOP) indicated Patient 2 was a 76-year old patient admitted to the hospital with diagnoses including a heart attack (also known as myocardial infarction, a serious condition that occurs when a blood clot blocks blood flow to the heart). The interview and record review indicated the following events and timelines:

- On 5/12/25 at 5:24 p.m., Patient 2 arrived in the Emergency Department [ED] after two weeks of intermittent worsening midback pain. A review of the ED's History of Present Illness, dated 5/12/25, indicated Patient 2 also had hypertension (high blood pressure), hyperlipidemia (high lipids in the blood), active tobacco use, and "reports that she had a history of a prior cerebral aneurysm [a weakness in a blood vessel in the brain that balloons and fills with blood]... She has had multiple siblings that have had ruptured cerebral aneurysm."

- On the same day, 5/12/25, she was diagnosed with NSTEMI (non-ST segment elevation myocardial infarction, which is a type of heart attack), unstable angina (a heart problem that causes sudden chest pain, often while resting), and coronary artery disease (buildup of plaque in the heart's arteries that could lead to heart attack or ischemic stroke). Patient 2 was admitted to the Critical Care Unit (CCU, specialized hospital department that gives care to people who are critically ill) 5/12/25 at 10:40 p.m.

- On 5/13/25, Patient 2 continued to have intermittent pain. A review of the Critical Care Progress Notes, dated 5/13/25, indicated Patient 2 had a left heart catheterization (medical procedure that involves inserting a catheter into the left side of the heart to assess its function and diagnose or treat certain heart conditions) which showed right coronary artery 50% stenosis (abnormal narrowing) with ejection fraction (EF, measurement of how much blood leaves the left ventricle with each heartbeat) of 35% (normal EF is between 55% and 70%).

- On 5/14/25 at 2:49 p.m., Patient 2 underwent a heart bypass surgery called coronary artery bypass grafting (CABG; where a healthy blood vessel, typically taken from the chest, arm, or leg, is grafted onto the coronary artery, creating a new path for blood to flow to the heart muscle) with 3 grafts. A review of the Cardiothoracic (related to the heart and chest cavity) Progress Notes, dated 5/15/25, indicated Patient 2 "was found to have multivessel coronary disease including a left main coronary artery stenosis which is greater than 75%. Based on her symptoms and presentation an intra-aortic balloon pump [a device that controls blood flow from the heart. It deflates when the heart pumps blood out and inflates when the heart rests between beats] was placed in the cardiac catheterization lab. Improved her symptoms. She continued to have chest tightness. Based on this she was taken for emergent coronary artery bypass graft."

- On 5/15/25, a review of the Clinical Report, dated 5/15/25 at 0000 (midnight), indicated the arterial blood gas (ABG) test (measures the oxygen and carbon dioxide levels in your blood as well as blood's pH balance) was indicative of metabolic acidosis (excessive buildup of acid in the body fluids) with elevated lactate (or lactic acid, is a natural byproduct of cellular metabolism often caused by impaired tissue oxygenation) level.

- On 5/15/25 at 1:42 p.m., Patient 2 was brought back to the OR for an emergent procedure called "Redo sternotomy [surgical procedure that involves cutting through the sternum to access the heart and surrounding structures], sternal washout [procedure that involves washing or cleaning out debris, contaminants, or excess fluid of the surgical area]." A review of the 5/15/25 Operative Report indicated Patient 2 was brought to the OR "because of the worsening lactate elevation as well as uncorrectable acidosis with a picture of hematoma [clotted blood that forms in an organ, tissue, or body space]... there was the hopes that by cleaning her out that this would help resolve the acidosis." The report further indicated, "Sodium bicarbonate was being administered to try and correct her severe persistent acidosis however she inadvertently received bupivacaine intravenously. From this point on the patient became worse hemodynamically [associated with the dynamics of blood flow] and had persistent unprovoked recurrent episodes of ventricular tachycardia [V-tach; a rapid heartbeat originating in the heart's lower chambers (ventricles), typically with a rate of 100 or more beats per minute] resistant to internal defibrillation [electrical current to restore a normal heart rhythm in cases of potentially fatal arrhythmias or irregular heart rhythms]." The Operative Report continued to describe that, despite the administration of intralipid, heart massage, and multiple defibrillations, the "[r]ight ventricle absolutely continued to dilate [widen/enlarge] and became akinetic [no movement]."

- On 5/15/25 at 4:05 p.m., Patient 2 was pronounced dead.

On 6/17/25 at 11:40 a.m., a review of Patient 2's Anesthesia Record (the main document of medications administered for the relief of pain and sensation during the procedure), dated 5/15/25, with the DRC and the DOP indicated Patient 2 was brought into OR Room 5 (OR5) for an emergent "Redo Sternotomy, sternal washout" on 5/15/25 starting at 1:42 p.m. A review of the hand-written narrative in the Anesthesia Record, written by Physician A, indicated, "After 7 amps [ampules] of bicarb [sodium bicarbonate], depleting the in-room supply additional bicarb was acquired from central Pyxis. Inadvertently administering bupivacaine... following the bupivacaine, BP [down arrow] [blood pressure dropped], Epi [epinephrine, medication to increase BP] and cardiac [heart] massage started, Intralipid was administered, patient defibrillated to ROSC [return of spontaneous circulation], 3 total arrests were successfully defibrillated before fulminant [severe and sudden in onset] right heart failure. Time of death 1605 [4:05 p.m.]."

During a concurrent interview and record review with multiple hospital staff including the DRC and the DOP on 6/17/25 at 11:45 a.m., the DRC explained that during Patient 2's washout surgery on 5/15/25, Physician A had used up the sodium bicarb supply in the OR, he requested for more to be brought in. RN A, who was the nurse on duty, went to the Pyxis (an automatic dispensing cabinet [ADC] for the storage and dispensing of medications) in the surgery area (SURPX) to remove 4 vials of sodium bicarb but she grabbed 4 vials of bupivacaine instead. The DOP showed a picture of the two medication vials: the sodium bicarb came in as 8.4%,1 milliEquivalent (unit of measurement) per milliliter (mL) injection solution; and the bupivacaine came in 0.25%, 125 milligrams (mg, unit of measurement) per 50 mL, injection solution. Each was in a 50-mL glass vial containing clear, water-like solution. The DOP stated both medications were stored in the Pyxis tower (a vertical unit of the Pyxis, designed for storing multiple large-volume medications, where the user can have access to multiple medications when the tower door is opened). The sodium bicarb vials were in Bin 1, located on the top rack; and the bupivacaine vials were in Bin 11, directly below Bin 1.

On 6/17/25 at 11:50 a.m., a review of the Pyxis Report for the SURPX with the DOP and the DRC indicated RN A removed 4 vials of "sodium bicarbonate" on 5/15/25 at 2:23 p.m. from the SURPX; and another nurse, RN B, accessed the sodium bicarbonate in the SURPX on 5/15/25 at 3:06 p.m. The DRC stated RN A got the bicarb order "but pulled the wrong drug" at 2:23 p.m., and RN B went in the Pyxis at 3:06 p.m. to validate who had pulled the medication, and to see if the bupivacaine vials were placed in the bin for sodium bicarb. She stated there was no misplacing of medications. The DRC stated the medication error was caught sometime between 2:23 p.m. and 3:06 p.m., a period of 43 minutes, on that day.

During an interview with the Patient Safety Director (PSD) on 6/17/25 at 12:05 p.m., in the presence of the DRC, the DOQ, and the DOP, the PSD stated she got notified right away after the medication error occurred. She immediately went to the OR while the team was still there. She explained the bupivacaine was inadvertently administered instead of sodium bicarbonate. She further explained, during the surgery, Physician A requested for more sodium bicarb to be brought into the OR, the nurse ran to the Pyxis outside of OR5, "accidentally grabbed the bupivacaine, handed it to the perfusionist, who handed to [Physician A] who administered it." The DOP stated the medication error was reported internally on 5/16/25 as a "Sentinel Event" (a patient safety event [not primarily related to the natural course of a patient's illness or underlying condition] that reaches a patient and results in death, severe harm, or permanent harm).

In an interview with the DOP on 6/17/25 at 12:34 p.m., he stated he inventoried the bupivacaine vials in the SURPX: there were 28 counts before the incident, and 24 counts after the incident on 5/15/25.

During an interview with the Vice President of Surgical Services (VPSS) in the presence of the DRC on 6/17/25 at 3:03 p.m., the VPSS stated she was part of the investigation after the medication error happened. She explained RN A removed the bupivacaine vials instead of the intended sodium bicarb vials, and did not check the label on the vials. She handed it to the perfusionist who handed it to Physician A, who administered the whole vial of bupivacaine. The VPSS stated each person was supposed to check for the correct medication before handing off to another person, and before medication administration. She added, "The expectation is for them to call out what they are doing, what they are giving, to treat it like a code [a medical emergency in which a team of medical personnel work to revive an individual]."

During the survey, on 6/18/25 at 9:07 a.m., the DRC and DOQ were asked to provide a "global policy" addressing the medication administration by physicians and other licensed disciplines allowed by law to administer medications, the DRC stated she checked the hospital policies and medical staff bylaws but she could not find any other than the one already provided to the surveyors titled "Administration of Medications by Nursing."

A review of the hospital's P&P titled "Administration of Medications by Nursing," reviewed 8/2023, indicated, "Administration of Medications in eMAR [electronic Medication Administration Record] 1. The licensed nurse checks the patient's allergies... 2. At the time of administration of a medication, the licensed individual verifies the right patient is receiving the right drug, dose, via the right route at the right time."

In an interview with the Chief Medical Officer (CMO, who is also an anesthesiologist) in the presence of the DRC on 6/18/25 at 10:05 a.m., when asked whether the medication error contributed to or caused Patient 2's death, the CMO stated Patient 2 was "extremely acidotic, which put her in a very grave condition." He continued, "Would she have died if the medication error didn't happen? Most likely. Would it excuse the med error? Absolutely not!" He added, "It falls upon the physician to give the right medication as intended." When asked whether bupivacaine was needed in Patient 2's surgery, the CMO stated, "No." When asked about the risks of giving bupivacaine intravenously, the CMO responded, "Full blown cardiac arrest [sudden and unexpected cessation of heart function] is the risk."

During an interview with RN A on 6/18/25 at 11:02 a.m., she stated, on the day of the event, one of the nurses in OR5 asked for help to get medications in. She went to the pharmacy to get the "medication tray for the heart" to give to the perfusionist. When she was about to leave, the perfusionist asked if she could get some sodium bicarb from the Pyxis. She stated she went and got 3 vials from the SURPX, went back into OR5, put them on the perfusionist's table, and told him the medication was there. When asked if she looked at the vials to ensure she got the right medication, RN A stated, "I didn't look when I retrieved the medication." She also stated, "I'm not sure why I didn't look at it before giving it to them. I should look."

During an interview with the perfusionist on 6/18/25 at 2:03 p.m., in the presence of the DRC and the DOQ, he stated Patient 2 "was super ill and very acidotic." He stated Physician A needed more sodium bicarb, RN A went to retrieve it, "came back, and handed it to me, and I handed it to [Physician A]. It was the wrong medication that was given, that's what I know." He added, "Four vials were handed to me. I gave them to [Physician A] who gave the medication." He stated he did not look at the vials before handing them to Physician A. When asked whether he should have looked, the perfusionist stated, "Yes, but there's a lot of things going on" as it was a "very hectic and chaotic environment."

An interview was conducted with Physician A on 6/18/25 starting at 2:30 p.m. He explained Patient 2 had undergone the CABG surgery the day prior, and she was brought back to the OR as she was extremely acidotic; the thought was that it may be caused by bleeding or a clot. During the washout procedure, he had used up 7 vials of sodium bicarb from the Pyxis that was in the room and from the perfusionist's medication tray. He stated he knew that he needed more as Patient 2 continued to be in acidotic state. After the perfusionist handed the vials (those that were brought in by RN A) to him, Physician A stated he put them on the back table. He said he was not sure about the duration from the time they were given to him to the time of administration as there were a lot of things going on. He continued, "The vial I picked up turned out to be bupivacaine." When asked whether he checked the vial for correct medication, he stated, "No, it didn't happen." He stated Patient 2's BP started to drop and she went into arrhythmia. He stated the team began treating the patient, massaged the heart, gave epinephrine, and "shocked the patient out of arrhythmia." He continued, "At that point I looked back at the table and saw the four vials said bupivacaine... Immediately following that, we identified the error, announced to the surgeon, and called for intralipid." He stated the patient had 3 episodes of V-tach, and the team was able to bring the heart back to the level prior to the event by IV intralipid, heart massage, epinephrine administration, and other supportive measures. He further explained, "We brought her back to stable position. She was on her third bag of lipid at this time. The patient's acidotic status never normalized... Her lactate continued to increase... When lactate is rising, the patient is dying; their body organs are not getting up the oxygen... After the fourth V-tach, she didn't recover from it. She developed fulminant heart failure."

During the same interview with Physician A as above, on 6/18/25 at 2:55 p.m., he further explained that Patient 2 "likely had a heart attack 2 weeks prior to admission. She's been living with this heart attack. She was on the bypass [the heart-lung machine that temporarily takes over the function of the heart and lungs by maintaining the circulation of blood and oxygen throughout the body] and they were trying to wean her off the bypass. She was given the balloon pump..." When asked about the typical use of bupivacaine, Physician A stated it is a local anesthetic, which could be injected into the targeted area to numb it during surgery or procedure, and sometimes a whole vial could be used for a large area. Physician A confirmed he administered the whole vial of bupivacaine to Patient 2 via IV route. When asked about the effects of IV bupivacaine administration, Physician A stated hypotension (low BP) and arrhythmia "were potential causes of local anesthetics."

During the continued interview with Physician A on 6/18/25 at 3:03 p.m., when asked whether the medication error caused or contributed to Patient 2's death, Physician A stated, "The severity of illness was what led to her death." He added the medication error was discovered within a minute of administration, that "intralipid was given as soon as discovered, and we were able to get her back to the same level as before." He explained that her acidotic condition led to multi-organ damage including liver failure and bowel ischemia (condition where the blood supply to the intestines is reduced, potentially leading to tissue damage or death).

During a telephone interview with the Medical Director of Surgical Services (Physician B) in the presence of the DOQ on 6/23/25 starting at 3:15 p.m., Physician B stated he was informed of the medication error; and as a result, communicated with other anesthesiologists including reminding them to review the medication label and confirm out loud what they are receiving during a procedure. He stated, "In this case, they didn't look at the label." He stated they are to review the medication label and call out the medication, such as "confirm bicarbonate" when they receive it. He stated everyone is expected to ensure they are receiving or administering the right medication. He explained, "It applies to everyone. Not because you are a physician you don't have to do that." When asked for his professional opinion whether the medication error caused or contributed to Patient 2's death, Physician B stated, "It happened within 3 seconds. In my professional opinion, a lot of things had gone wrong with the patient. She was acidotic which spelled disaster already... The medication error did not help the scenario. It wasn't the cause of death. Prognosis was already poor for this patient. That doesn't take away the gravity of this error." When asked what national standards of practice the hospital followed for anesthesia services, Physician B stated they followed the American Society of Anesthesiologists (ASA) for best practices; and for policies, the hospital followed the Association of periOperative Registered Nurses (AORN, a national organization that provides nursing education, standards, and services that enable optimal outcomes for patients undergoing operative and other invasive procedures).

A review of the manufacturer's Product Information (PI, detailed description of a drug's uses, dosage range, side effects, drug-drug interactions, and contraindications) for bupivacaine injection, revised 11/2018, reflected it is a local anesthetic indicated to produce local or regional anesthesia (or pain relief) for various surgical and diagnostic procedures. It works by blocking the nerves from transmitting pain signals, numbing the targeted area. The dosage varies depending on anesthetic procedure, the area to be anesthetized, the depth and duration of anesthesia, etc. The PI indicated the multi-dose bupivacaine 0.25% injection solution can be used for infiltration (injected directly into the tissue at a surgical site to provide pain relief) or for nerve blocking (injected near the nerve endings to numb a specific area). Under Adverse Reactions, the PI indicated, "The most commonly encountered acute adverse experiences which demand immediate counter-measures are related to the CNS [central nervous system] and the cardiovascular [relating to the heart and blood vessels] system." Related to cardiovascular system reactions, the PI indicated, "High doses or unintentional intravascular [inside blood vessels] injection may lead to... hypotention... ventricular arrhythmias, including ventricular tachycardia... and cardiac arrest."

A review of the AORN's "Guideline for Medication Safety" (MS Guideline), approved March 16, 2023, indicated, "This document provides guidance to perioperative personnel for safe medication management practices. These recommendations, which are based on a systematic review of the available literature, are intended to support perioperative registered nurses (RNs) and other clinicians implementing evidence-based practices in all phases of medication management in the perioperative setting and to decrease the risk of medication errors." The MS Guideline indicated; "1.3. In collaboration with physicians, pharmacists, nurses, risk and quality personnel, and other identified key stakeholders, develop and maintain policies and procedures that address authority, accountability, responsibility, and patient and personnel safety in all phases of the medication use processes in perioperative care." Under Communication, the MS Guideline indicated, "5.3. Visually and verbally confirm the medication information when a medication is passed to the licensed independent practitioner for subsequent administration..." Guideline 7.3 of the MS Guideline indicated, "Before administering a medication, verify: right patient, using two health care organization-approved identifiers; right medication; right dose; right route; and right time."

During an email communication with the DRC on 6/26/25 at 12:31 p.m., a request was made to provide a policy that addressed the handing off medication, or a standardized method of communication, from one licensed staff to another such as during surgery. In an email response on 6/26/25 at 1:14 p.m., the DRC replied that she did not have anything specific to this process.

A review of the AORN's "Guidelines for Team Communication," approved January 1, 2024, indicated the "Operating room (OR) is a high-risk sociotechnical [involving social and technical elements] environment with various professionals working in close proximity, and effective team communication in the perioperative and procedural environment is the foundation of optimal patient outcomes." Guideline 2.1 indicated, "Establish and implement a standardized hand-off process for the transfer of patient information between individuals... The Joint Commission's [a healthcare accrediting organization] sentinel event database includes reports of inadequate hand-off communication contributing to adverse events, including wrong-site surgery, delay in treatment, falls, and medication errors." Guideline 2.2 indicated, "Establish an interdisciplinary team at the facility level to develop a standardized hand-off process. A standardized hand-off process helps to identify risks during the perioperative phases so the team can take action to minimize threats to patient safety."

A review of the ISMP (the Institute for Safe Medication Practices, a nonprofit patient safety organization with recognized national expertise in medication error prevention) Guidelines for the Safe Use of Automated Dispensing Cabinets 2019, it indicated, "Core Safety Process # 8 Develop Procedures for Accurate ADC Withdrawal and Transfer to the Bedside for Administration Processes must be developed to reduce the risk or mitigate the harm associated with accessing a medication without an order, or the selection and administration of the wrong medication, dose, route, or frequency due to medication retrieval errors from the ADC." The Core Safety Process 8.3 of the Guidelines indicated, "To limit the risk of wrong drug/dose/formulation selections from ADCs... Confirm accurate selection by visually comparing the drug label to the order... This manual check should include: 1. Drug identification (generic name and/or brand name if available) 2. Validation of drug concentration, dose, and dosage form."