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Feature Story

The Culture of Criminalization Part 1

Ginny K. Renkiewicz, PhD, MHS, EMT-P, FAEMS

On December 26, 2017, Vanderbilt University Medical Center (VUMC) nurse RaDonda Vaught was asked by a patient’s primary nurse in the neurosurgical critical care unit (NCU) to retrieve and administer a milligram of Versed to a patient in radiology scheduled for a PET scan.

The patient, Charlene Murphey, had been admitted the day prior for an intraparenchymal hematoma. She was alert and oriented but anxious about the procedure due to claustrophobia.

Vaught had a trainee with her that day and went to the automatic dispensing cabinet (ADC) to withdraw the medication. However, the order had not yet made it to the ADC, so Vaught initiated an override, which began with her typing in the letters VE to pull up Versed.

Vaught selected the first drug on the list, had to go through the remaining screens, collected her supplies, and made her way to radiology. Once there, she checked the patient’s wristband, reconstituted the medication, and administered it. She was unable to document the medication administration because there were no barcode scanners in radiology.

Vaught left the patient in the care of radiology staff and headed to the emergency department (ED) to conduct a swallow study. Prior to arriving in the ED, an overhead page signaled a rapid response in radiology.

Since she had just been there, Vaught returned to radiology with her trainee just in time to see Murphey intubated with a return of spontaneous circulation (ROSC) following administration of CPR. She’d received the paralytic vecuronium, not the sedative Versed. Murphey was returned to the NCU and placed on life support, which was terminated a day later.

Once her error was discovered, Vaught self-reported to anyone who would listen. She was terminated from Vanderbilt on January 3, 2018, for failure to follow the "5 rights" of medication administration.

This tragic story has widespread implications across health care, including EMS. Part 1 of this 2-part series chronicles the timeline of events and the error-inducing environment. Part 2 will examine the legal ramifications and analyze lessons learned.

Individual vs. System Errors

We’ve all heard the RaDonda Vaught story, and tragic as it is, she did commit a medication error. However, was it simple human error that led to the death of Charlene Murphey, or was it something more? This article describes how system error, rather than a clinician’s negligent behavior, contributed to this tragedy.

In his book Risk Management in the Oil and Gas Industry, safety expert Gerardo Portela da Ponte Jr. defines human error as that which is “influenced by the natural vulnerabilities (unpredictable), human limitations (unavoidable), and the error-inducing environment (designed for).”1

Human limitations are unavoidable—we all make mistakes, and we cannot always plan for unpredictability, so we must focus on creating systems that reduce the potential for errors to occur. The airline industry uses psychologist James Reason’s “Swiss cheese model of accident causation” to increase system redundancy in safety checks, thus reducing the occurrence of human error.

This model theorizes that each person or system component is a slice of Swiss cheese, and each slice has holes that errors can slip through. But when proper safety checks and systems that account for human error (holes) are created, those people-slices come together in a big block of cheese that no error can penetrate. In these systems, rarely is one person blamed for an error that occurs—it is the faulty system that allowed the error to happen.

Just culture is another such model. Just culture empowers employees to report errors, accounts for mistakes, and uses errors as learning tools with which to improve the system. Employees are only disciplined for reckless behavior or malevolent acts, not simple errors. In all cases, the system is also evaluated to determine institutional culpability.

The crucial requirement of conducting system and institutional analyses was ignored in Vaught’s case. It does not excuse her behavior, but systems analysis through a just culture model would help to fully explain not only why the error occurred and the full culpability of each party involved, but more importantly, what we can do in the future to prevent these errors.

The Error-Inducing Environment

According to a spokesperson for VUMC, the error occurred because an employee circumvented multiple safety mechanisms.2 Yet a Centers for Medicare and Medicaid Services (CMS) investigation concluded that “The hospital…[precipitated] a serious and immediate threat to the health and safety of all patients and placed them in immediate jeopardy and risk of serious injuries and/or death.” Let’s take a closer look at the VUMC system.

Medication Overrides

There were multiple system errors that contributed to Murphey’s death. Namely, there was a standard of normalized deviance regarding the ADCs. The computerized medication system was new, and at the time of the error, the electronic health record (EHR), ADC software, and pharmacy notification system were not communicating. This led to substantial delays and technical problems in order verification.

Additionally, because of these delays, VUMC issued a directive that instructed nurses to override the system as needed until it could be fixed. Vaught testified at her hearing with the Tennessee Board of Nursing (TBON) that “Overriding was something we did as part of our practice every day. You couldn’t get a bag of fluids for a patient without using the override function.”3 In fact, over the course of three days of treatment, the ADC log showed 20 separate overrides performed for Murphey alone.

The VUMC policy required all medication orders be reviewed by a pharmacist unless a delay would harm the patient, including sudden changes in clinical status. Having an override feature in the first place and including a medication as dangerous as vecuronium on the override list was a system vulnerability that clearly led to disastrous consequences.

The Institute for Safe Medication Practices (ISMP) advises that the override feature is one of the biggest problems with ADCs because of the challenges in preventing non-urgent overrides and reducing errors by having orders first reviewed by pharmacists.4 When the settings of the ADCs are such that routine medications (such as bags of fluids) can’t be removed, it results in consistent overriding of the ADC, which increases the likelihood for error.

Safety Labeling

The TBON investigation (which occurred prior to Vaught’s trial) examined the safety features of the ADC. These features included shrink-wrapping the medication and multiple warnings regarding the request for a paralytic.

VUMC told CMS that Vaught ignored ADC screen warnings and bin stickers that said Warning: Paralyzing Agent Causes Respiratory Arrest.5 However, the TBON investigation failed to ascertain when these stickers and warnings were added, which was after the event occurred.3

Vaught could not have overlooked sticker warnings because they were not available in the ADC system at the time of the incident. Further, questions posed to witnesses reflected current safety conditions at VUMC and not those at the time of the event. Vaught admitted to not looking at the front of the medication vial, an obvious error.

Using the just culture model, that behavior would be considered a negligent error caused by the system and result in employee counseling and system reform. It is possible, in the absence of audible alarms or other safety features, that a distracted clinician simply picked up the incorrect medication. We have all done that. We were just lucky we caught ourselves in time or our patient didn’t die. But outcome bias due to Murphey’s death does not place more blame on Vaught or any less on the system.

The Role of the ‘Help-All’ Nurse

At the time of the incident, Vaught was functioning as a “help-all” nurse, a role she said she was comfortable performing, despite the hospital not having any sort of position description. In fact, Vanderbilt’s regulatory officer told CMS investigators they had never heard the term help-all nurse and didn’t think it a hospital-wide term.5

Despite the lack of a position description and belief in its existence by hospital leadership, the role of the help-all nurse was defined as being generally responsible for rapid response, stat calls, transports, floating, procedures, admissions and discharges, transfers, and patient flow. Help-all nurses did not take their own patients; instead, they took direction from the clinical staff leader. With this ambiguity, VUMC was setting conditions for a lack of accountability and individual failure simply through not defining the roles and responsibilities of the help-all nurse with a clearly defined position description.

Even with help-all nurses, the nurse-to-patient ratio at VUMC was often 1:3 instead of the 1:1 (or at most 1:2) recommended ratio.6,7 Vaught said she was distracted and tired, which is not surprising given that nurses are generally overworked and often have baseline fatigue.8 If an ICU nurse has three patients and is passing off assignments to a help-all nurse, then that nurse is reliant upon information given by word of mouth, which may not be accurate when clinicians are distracted or busy. It’s like playing the telephone game—except with people’s lives.

The Radiology Department

A radiology nurse called the NCU and spoke with the patient’s primary nurse, asking that someone come down and administer Versed to the anxious Murphey. When questioned as to why, the radiology nurse indicated radiology staff were uncomfortable administering Versed.

During certain scans, some patients are under general anesthesia, and many people receive various anxiolytics prior to diagnostic or interventional radiology procedures. A radiology nurse should be comfortable administering a drug that is likely often given in that area. Had radiology nurses administered the Versed, Vaught would have never been put in this situation, and Murphey might still be alive.

Vaught said she administered the drug and radiology staff “took the patient back.” The anonymous CMS complaint indicated the patient was not discovered unresponsive until after a 20-minute PET scan. If the patient was in the care of radiology staff, how was it not noticed that she was unresponsive prior to being placed in the scanner?

Additionally, Murphey was an ICU patient, many of whom are monitored for decompensation during scans and other procedures. It's possible the same reason Vaught did not monitor Murphey is the same reason the radiology staff didn’t monitor her: there was no hospital policy on monitoring patients who received medications.

The Lack of Monitoring

Why didn’t Vaught monitor the patient after administering the medication? According to her testimony, Murphey was left with radiology staff who took her to the back. Radiology staff later testified they told Vaught they could not monitor the patient; however, they advised CMS investigators they had been monitoring the patient on video.

The patient had also recently received an intravenous radioactive tracer for the scan. Radiology staff saw her eyes closed and never physically checked on her despite the hospital policy requiring patients be checked every five minutes when in the radiology observation unit.

Hospital policy did not require monitoring after Versed administration because it was neither listed in the sedation policy nor defined as a high-alert medication. As such, Vaught may have thought she did not have to monitor the patient, particularly since Murphey was moved to a radiology observation room. VUMC also had an independent double-check policy for paralytic medications in place at the time of the event but was not enforcing it.5

Documentation and Notification

Much was made of the lack of documentation of vecuronium in Murphey’s chart. There was no barcode scanner in radiology. Radiology was scheduled to receive this hardware as part of a new system rollout but hadn’t yet received the equipment. Vaught could have documented the vecuronium by accessing the patient’s chart in the ED before or after the swallow study, but she never made it there because of the rapid response page.

Vaught told CMS investigators that she asked about documenting the medication upon her arrival back to the NCU and was told by the nurse manager that the new system would log the medication to the patient’s record, and it would show up in a different area in a special color.

Once the medication error was discovered, Vaught went immediately to the patient’s room and told the physician, advance practice nurse (APRN), and several residents. After that conversation, one of the physicians wrote a progress note in the patient’s chart that stated:

“Received patient to NCU after cardiac arrest in PET scan. Per report, ROSC was achieved after approximately 2 rounds of ACLS. Patient was intubated during event. Current medications… vecuronium.”5

Vecuronium was documented in the chart after all, but it was made to look as if it were part of the resuscitative effort. No dose or route was documented.

It is not surprising there was confusion surrounding this event because VUMC had three different and contradictory notification policies in the case of medical error. Its “deaths requiring medical examiner” reporting policy required the medical examiner be notified first; the “unanticipated outcomes” policy advised that the patient or their family should be notified first; and the “patient and visitor” policy indicated that the Office of Risk and Insurance Management and administrative coordinator should be notified immediately.

Further complicating notification, the word “immediately” was not defined in terms of policy priority. Despite the prompt reporting of the event, it took eight days to send out a patient safety serious event notification to operational leaders and the hospital’s chief nursing officer.

Report to the Medical Examiner

Physicians are required by Tennessee law to report deaths to the medical examiner (ME). If the death is natural, then the treating physician completes the death certificate. If not, then the death falls under the ME’s jurisdiction.

When the ME was called for Murphey, they were told the patient was admitted with an intraparenchymal hematoma (MRI results confirmed this diagnosis and were reviewed by the ME). The physician mentioned an unsubstantiated rumor of a medication error but did not mention the name of the drug to the ME. Given that Murphey’s death appeared natural, the ME denied jurisdiction and let the treating physician complete the death certificate, which said Murphey died of natural causes due to the intraparenchymal hematoma.

Because of this, no autopsy was conducted, which means we will never know how much vecuronium Murphey received. Given the medication half-life in bile of 42 hours, an autopsy could possibly have quantified the vecuronium and potentially determined its relationship to cause of death, were Murphey’s death immediately investigated or reported to the ME.

The investigation into the medical error did not begin until the patient had died, some 10 hours after the medication was administered and nine hours after the error was discovered. At least one of the physicians interviewed by CMS stated that “the patient got such a small dose, and they were anxious about the test, so we can’t say it contributed to her demise.”5

According to a study conducted by forensic chemist Shawn Vorce, et al., “Delays in testing for vecuronium in postmortem samples may cause a decline in reportable concentrations from the time of death, especially if the samples are not stored at the proper temperature and pH. The resulting concentrations would be difficult to interpret and could not be correlated to any pharmacological effect.”9

Part 2 of this series will examine the legal ramifications of this case and analyze lessons learned that could apply to EMS.

References

1. Portela da Ponte, Jr., G. Chapter 2 - Fundamentals of risk management. Editor(s): Gerardo Portela da Ponte, Jr. Risk Management in the Oil and Gas Industry. Gulf Professional Publishing. 2021. Pps: 5-54

2. Dickson V. CMS threatens to revoke Vanderbilt’s Medicare participation after patient death. Modern Healthcare. November 28, 2021. Accessed June 7, 2022: https://www.modernhealthcare.com/article/20181128/NEWS/181129938/cms-threatens-to-revoke-vanderbilt-s-medicare-participation-after-patient-death

3. Institute for Safe Medication Practices. TN Board of Nursing’s Unjust Decision to Revoke Nurse’s License: Travesty on Top of Tragedy! August 12, 2021. Accessed April 4, 2022: https://www.ismp.org/resources/tn-board-nursings-unjust-decision-revoke-nurses-license-travesty-top-tragedy

4. Department of Health and Human Services Centers for Medicare & Medicaid Services. Statement of Deficiencies and Plan of Correction. November 8, 2018. Accessed April 1, 2022: https://hospitalwatchdog.org/wp-content/uploads/VANDERBILT-CMS-PDF.pdf

5. Kelman B. Ex-Vanderbilt nurse Radonda Vaught loses nursing license for fatal drug error. The Tennessean. Published July 23, 2021. Accessed on May 31, 2022: https://www.tennessean.com/story/news/health/2021/07/23/ex-vanderbilt-nurse-Radonda-vaught-loses-license-fatal-error/8069185002/

6. Vanderbilt University Medical Center. ICU Job Description. Accessed June 14, 2022: https://vanderbilt.taleo.net/careersection/.vu_cs/jobdetail.ftl?job=2114596&src=JB-10700

7. Tevington, P. (2011). Mandatory nurse-patient ratios. Medsurg Nursing, 20(5), 265-8. Retrieved from http://ez-proxy.methodist.edu:2048/login?url=https://www.proquest.com/scholarly-journals/mandatory-nurse-patient-ratios/docview/897483346/se-2?accountid=12408

8. Waddill-Goad SM. Stress, Fatigue, and Burnout in Nursing. Journal of Radiology Nursing. Volume 38, Issue 1. 2019; 44-46. doi: 10.1016/j.jradnu.2018.10.005.

9. Vorce SP, Mallak CT, Jacobs A. Quantitative Analysis of the Aminosteroidal Non-Depolarizing Neuromuscular Blocking Agent Vecuronium by LC-ESI-MS: A Postmortem Investigation. Journal of Analytical Toxicology. 2008. Vol. 32; pgs. 422-27

Ginny K. Renkiewicz, PhD, MHS, EMT-P, FAEMS, is chair and assistant professor of health care administration at Methodist University, Fayetteville, N.C. She is vice chair of the North Carolina Association of EMS Educators.

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