Skip to main content

Advertisement

ADVERTISEMENT

Feature Story

The Culture of Criminalization Part 2

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

Part 2 of a 2-part series.

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 chronicled the timeline of events and the error-inducing environment. Part 2 will examine the legal ramifications and analyze lessons learned.

Legal Issues of the Case

Chain of custody. Chain of custody is defined as the single most important process of evidence documentation that shows the court that evidence is original and has been maintained by someone qualified to preserve such evidence.1 A verified chain of custody also shows the evidence was never left unaccounted for; that is, the whereabouts were always known, which prohibits tampering, other discontinuity error, or damage.

Theoretically, there should be custody documentation of the evidence from the crime scene to the lab for examination and then to the court for procedural admission into evidence.

When the vecuronium was initially retrieved, it was placed in a Ziploc-type plastic bag with a syringe and other materials. After administration of the medication, Vaught gave the bag to the patient’s primary nurse.

The bag did not surface again until the CMS investigation on November 2, 2018—310 days later—when the director for clinical risk management presented the bag to CMS investigators and said: “My understanding is that this is the actual [bag].”

The formal investigation was not started by VUMC until a day after the error. CMS interviewed a pharmacist and asked whether they knew where the vial was. The pharmacist said it was their “understanding that the vial was not quarantined in time. We cannot tell how much she got, that’s my understanding.”

The bag didn’t make another appearance for 35 days, when a Tennessee Bureau of Investigation request for forensic examination dated December 7, 2018 was completed, more than a month after the CMS investigation and nearly a year after Murphey’s death.

Clearly, there is uncertainty as to whether the bag in evidence was the one used by Vaught. In addition, the CMS report states, “There was no way to tell what was vecuronium and what was normal saline and no way to determine how much of the drug the patient was actually administered.”2 Given the 310-day delay between evidence receipt and collection, there was ample opportunity for that evidence to have been damaged, tampered with, or otherwise compromised.

Corporate, civil, and criminal liability. VUMC settled with Murphey’s family in early 2018 to avoid a civil suit. But why didn’t the district attorney’s office pursue a criminal case against the hospital? The Tennessee statute on corporate liability would have allowed for such a prosecution. However, given that VUMC is one of the largest employers in the area, it might not have been in the public’s best interests to bring charges against the hospital. If found guilty, VUMC could lose its federal funding, which would potentially shut down a major academic medical center and be a big hit to the local economy.

Regulatory Action

The CEO of the hospital appeared before the Tennessee Board for Licensing Health Care Facilities. The board decided not to pursue action against VUMC.

During Vaught’s disciplinary hearing at the TBON, the vice chair admitted there were “many mistakes and failures” but that the board had oversight of only Vaught’s actions. What Vaught did or did not do can neither be analyzed in a vacuum, nor can her actions be separated from the system in which those actions were performed.

After-action Steps

There is no evidence this event was discussed by either the Executive Committee or Medication Executive Committee from January 2018 to November 2018.2 VUMC did modify several policies after the CMS investigation, including its medication administration and medical examiner policies.

A patient monitoring policy was created and approved by November 27, 2018. All nurses and paramedics who worked with paralytics had to complete an online training module outlining policy changes. Those hired with less than six months of experience were also required to attend a workshop on safe medication administration. Failure to complete the required training(s) would result in ineligibility to work. VUMC reviewed its sedation policies and determined no changes were needed.

Most paralytics were removed from ADCs, and shrink-wrapping and colored bin stickers were implemented for those remaining. However, VUMC kept rocuronium in the ADCs accessible by override because leadership felt the benefits of access outweighed potential patient risk. Rocuronium remained accessible via override throughout 2018 despite not a single employee being trained.

A new procedure required CNOs to randomly pull five charts from each unit per week to assess for compliance with medication safety. In the event noncompliance was observed, the CNO would follow up with the unit managers to ensure compliance with targeted training. Monthly override reports for paralytic agents were to be compiled and reviewed by the Medication Safety Committee.

Weekly meetings of the Event Review Committee would evaluate whether occurrences reported to risk management needed to be reported to the TDOH. VUMC leadership told CMS investigators it was working with the TDOH to determine what the reporting requirements were for sentinel events. Policies for clinicians and staff cannot be clear if hospital leadership is unsure what should be reported.

These solutions are still reactionary and non-preventative. They also concentrate the onus of responsibility on the clinician instead of the system, lining up with safety scientist Sidney Dekker’s “bad apple” theory.3 Using leadership for case review can create dissension in the ranks and separates leadership from clinicians, creating an “us versus them” mentality. Finally, these measures are designed to instill fear to produce compliance—the antithesis of Just Culture.

Just Solutions

Appropriate solutions might include additional clinician training for new policies but should also take a system-wide approach to evaluating the error. The first thing would be to overhaul the reporting system, focusing on a just culture and removing hierarchy from compliance initiatives or error reporting.

Empowering clinicians and staff to report errors happens by listening, encouraging open and honest communication, and assuming the system is at fault first, not the individual. Systems management is a lot like benchmarking in strategic management; egos are put aside to look at the system for the best way…even if that way isn’t current practice. We know humans are fallible creatures, yet we are expected to maintain perfection the second we step into our workplace. Why not embrace that fallibility to create the safest possible environment we can for patients and employees?

With respect to the ADCs, why have an override available at all? Emergent medications or banal items, like fluids, could be moved out of the ADCs and into crash carts or separate areas. For medication look-up, it would be easy to add a third letter. Vaught entering VER would have never brought up vecuronium. Or perhaps implementing an audible alarm that sounds when high-risk medications are requested might interrupt what may have become a mindless task. Proper training of all clinicians on the new system prior to rollout would also have been beneficial. Any one of these system solutions may have prevented this entire incident.

Regarding incident reporting, clearer investigatory practices are needed, including those that immediately involve leadership, clinician, and patient or family resources for sentinel events. Contradictory policies must be streamlined and clarified. The physicians talked to the family, but they failed to follow the hospital policies regarding grief resources and counseling.

The physicians should not solely be responsible for this. No resources or support were provided to Vaught or any other clinicians. Perhaps there could be an on-call advocate who comes in to support clinicians, ensures patients and their families receive needed resources, and collects any needed information or evidence at the time of the event.

All clinicians should be trained to their scope of practice, and having backup methods available might be appropriate when rolling out new procedures, particularly when departments are on scheduled changeover and do not have the necessary hardware. 

Conclusions

Given all the system faults present in this event, what Vaught did rises only to the level of negligent behavior in a Just Culture model. At this level most of the culpability rests on the system that allowed the error to occur and not on the person who got caught in that system. Management should evaluate the weak points in their systems and correct them, particularly in health care, when lives are at stake. Why should it be safer to fly in a plane than be treated at a hospital?

There was no thought given to the devastating mental and emotional effect causing a patient’s death had on Vaught. Among EMS professionals, the rate of causing death or harm to a patient is nearly five times higher in those who had trauma- or stress-related disorders compared to those who did not, and nine times higher in those with suicidality.4 Vaught committed the medication error and took responsibility for it, but she was also a victim of the system within which she worked.

Because of the inadequate preservation and continuity of evidence, the only way we know the patient received vecuronium was by Vaught’s admission, a self-report that was used to criminally prosecute her. Given that her self-report was one the main pieces of evidence, such criminal prosecution may deter current and future clinicians from the field and severely hamper error reporting, endangering patients’ lives and slowing the progress of medicine.

We must ask ourselves whether it serves society to convict an individual for an obvious system failure. And if we do, how will the system respond?  

References

  1. Badiye A, Kapoor N, Menezes RG. Chain of Custody. [Updated 2022 Feb 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK551677/
  2. 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/
  3. Dekker S. Punishing People or Learning from Failure? The Choice is Ours. Center for Human Factors Aviation. Linköping Institute of Technology. Accessed June 7, 2022: https://www.faasafety.gov/files/gslac/library/documents/2019/Feb/177523/Punishing%20People%20or%20Learning%20from%20Failure.pdf
  4. Renkiewicz GK & Hubble MW. Secondary Traumatic Stress in Emergency Services Systems (STRESS) Project: Quantifying Personal Trauma Profiles for Secondary Stress Syndromes in Emergency Medical Services Personnel with prior Military Service. Journal of Special Operations Medicine. Spring 2021; 21(1):55-64. 2021.

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.

Comments

Submitted by jbassett on Sun, 03/19/2023 - 12:37

Totally unfair to blame just one person. I see this as big pharma and political. All comes down to who has the most money and once again, the little guy, underdog pays the price. Yes, new protective policies, training and proceedures need to be placed with several checkpoints for checks and double checks. Im finding some people, doctors, nurses etc are becoming very complacent, careless , comfortable and no one wants to take responsibility, just the paycheck. Sad world we live in. 

—Ellen Higginbotham

Submitted by jbassett on Sun, 03/19/2023 - 12:39

Great article, however I believe every provider needs to visually read and inspect every vial before administering a medication. The system did not fail Vaught. Vaught failed to read the vial. I have been a been a paramedic for quite a while, and I have never, ever, made such an egregious mistake. We constantly change medication concentrations, sometimes even the color cap changes on the top! I have never administered a medication and not known exactly what I was giving. Providers need to take ownership of the tools they have available to them.

—Nick White

Submitted by jbassett on Mon, 03/20/2023 - 13:09

I feel the fact that, Vaught took responsibility shows her character.
sometimes that's all the evidence you need. 

—Rachel Brundage

Advertisement

Advertisement

Advertisement