human factors

Is human error a crime?

A fatal mistake

On first hearing about this case involving a medication error, I envisaged writing a short article on the criminalisation of human error. However, the more that I researched, the more interesting the case became.

I read several court documents and obtained investigation reports by the Department of Health and Human Services. I watched several hours of a Tennessee Board of Nursing Hearing, including nurse RaDonda Vaught walking through the events in her own words. This article is the result of that research – I hope that you find the case as thought-provoking as I did.

What happened?

The simple story reported in the media is that on 25 March 2022, nurse RaDonda Vaught was found guilty of criminally negligent homicide and abuse of an impaired adult, following a medication error that led to the death of a patient in 2017.

But the full story, as you might expect, is a little more complicated than that.

Let’s unpack the timeline and explore the various twists and turns in this case.

24 Dec 2017: A 75-year old patient is admitted to Vanderbilt University Medical Center with headaches and loss of vision. An MRI scan found a subdural hematoma (bleeding on the brain).

26 Dec 2017: The patient was improving, but required a full body PET scan. She was anxious about this procedure due to being claustrophobic, and was prescribed a sedative (Versed, 2mgs intravenously). Prior to being given the sedative, the patient was injected with a radioactive tracer by a radiology technician, which requires an hour’s wait for this to circulate throughout the body prior to the PET scan. During this waiting time, nurse RaDonda Vaught injected the patient with vecuronium (instead of Versed) – a drug that induces paralysis. Neuromuscular blockers such as vecuronium can lead to progressive paralysis until respiration ceases.

PET scan - humanfactors101.com
The patient was prescribed a sedative to reduce anxiety prior to a full body PET scan. She was injected with paralysing medication instead, which stopped her breathing.

Approximately 30 minutes later, the patient was found to be pulseless and unresponsive. She was resuscitated, but never regained consciousness and was placed on life support.

On hearing the emergency call, and returning to the PET scan area, RaDonda Vaught was shown the medication that she had administered to the patient and realised her mistake. But the medication-induced paralysis left the patient brain-dead before the error was discovered.

Nurse Vaught completes a report of the event in Veritas, the hospital’s reporting system.

27 Dec 2017: The patient’s care (mechanical ventilation) is withdrawn and she passes away with family present. The hospital states that they were very open with the family, informing them that there was a medication error, that likely impacted the patient’s breathing.

27 Dec 2017: The death is reported to the County Medical Examiner, the cause of death attributed to the subdural hematoma. I have seen this report, which states “natural causes of complications of the intra-cerebral hemorrhage”. The medication error is not mentioned, nor is the role of vecuronium referred to. Given the information provided by the hospital, the death is not independently investigated by the Medical Examiner. Vanderbilt University Medical Center did not report the medication error to the State or Federal authorities.

3 Jan 2018: RaDonda Vaught’s employment is terminated by Vanderbilt University Medical Center.

[early 2018, date unknown]: Vanderbilt University Medical Center negotiated an out-of-court settlement with the patient’s family, which is thought to require non-disclosure of the death or medication error (i.e. a confidentiality agreement).

3 Oct 2018: Nine months after the incident, health officials are alerted to the medication error by an anonymous complaint (obtained via Freedom of Information requests).

RaDonda Vaught - Anonymous complaint - 3 October 2018
The anonymous complaint to The Department of Health which led to investigations by both the Department and law enforcement (obtained via Freedom of Information)

23 Oct 2018: The Tennessee Department of Health (which investigated the anonymous complaint) writes to Vanderbilt University Medical Center with the outcomes of the investigation. The letter, signed by Director Office of Investigations, states that “the acts of the practitioner did not constitute a violation of the statutes and/or rules governing the profession. Therefore, the complaint has been closed, but the record will remain on file in this Office”.

23 Oct 2018: The Tennessee Department of Health, responsible for medical discipline proceedings, also takes no action against RaDonda Vaught. The letter to Vaught, signed by Director Office of Investigations, states that “a decision was made that this matter did not merit further action”, and that “The purpose of this letter is to inform you of the outcome. This is not a disciplinary action, and no record of it will appear in your licensure file”. To be clear, the Department of Health does not pursue disciplinary action against the nurse.

31 Oct to 8 Nov 2018: The Centers for Medicare and Medicaid Services conducts an unannounced onsite survey of Vanderbilt University Medical Center in relation to the anonymous complaint. Almost a year after the event, this investigation found many deficiencies. The report of this inspection (in total 105 pages) states “Based on policy review, medical record review, and interview, the hospital failed to ensure patients’ rights were protected to receive care in a safe setting and implemented measures to mitigate risks of potential fatal medication errors to the patients receiving care in the hospital. The failure of the hospital to mitigate risks associated with medication errors and ensure all patients’ received care in a safe setting to protect their physical and emotional health and safety placed all patients in a SERIOUS and IMMEDIATE THREAT and placed them in IMMEDIATE JEOPARDY and risk of serious injuries and/or death” (p.1). The Centers for Medicare and Medicaid Services announced that the Medicare reimbursement for Vanderbilt might be revoked unless it can demonstrate measures to improve. This would have a significant financial impact on the hospital.

16 Nov 2018: The Vanderbilt University Medical Center provides a ‘Plan of Correction’ to the Centers for Medicare and Medicaid Services, outlining the corrective measures that it has taken to address the deficiencies cited by the onsite survey. The hospital states that “Preparation and/or execution of this Plan of Correction does not constitute admission or agreement by the Hospital of the truth of the facts alleged or conclusions set forth in this statement of deficiencies”. The measures include review of (or changes to) policies and procedures, provision of training, and monitoring to ensure the continued effectiveness of these measures. This Plan prevents the proposed action to revoke Medicare reimbursement.

5 Dec 2018: Vaught is interviewed by the Tennessee Bureau of Investigation.

4 Feb 2019: Vaught is arrested and charged for her role in the death of the patient. She is charged with criminal reckless homicide and impaired adult abuse. Disciplinary action is then filed in order to revoke her license.

5 Feb 2019: Tennessee Board of Licensing Health Care Facilities meets to consider the case. No disciplinary action is taken against the hospital.

20 Feb 2019: Vaught enters a plea of not-guilty at the arraignment hearing. Vaught’s defense attorney refers to systemic problems related to the dispensing of medication at the hospital. The trial was then delayed due to COVID-19.

27 March 2019: The State investigators allege that Vaught made ten separate errors and overlooked warning signs.

20 August 2019: The Medical Examiner reviews the case. The cause of death is revised to “acute vecuronium intoxication” and now recorded as “accidental”.

27 Sept 2019: The earlier decision by the Tennessee Department of Health (Board of Nursing) is reversed, and Vaught is charged with unprofessional conduct, neglecting a patient that required care and failing to maintain an accurate patient record. The Board calls for the revocation of Vaught’s nursing license, fines of $3000 and Vaught to pay the costs of this action.

RaDonda Vaught is now facing both a criminal trial and a professional discipline hearing. There is some legal debate as to which should proceed first.

22-23 July 2021: The Tennessee Board of Nursing holds a medical disciplinary hearing (also delayed due to COVID-19). Vaught provided testimony, including accepting responsibility for the error, but also stating that her error was made possible due to flawed procedures and processes. As a result of the hearing, the Board revokes Vaught’s nursing license on 23 July 2021.

21 March 2022: The criminal trial begins. Note that this trial took place after the Tennessee Board of Nursing hearing when RaDonda Vaught’s license was revoked.

25 March 2022: Vaught is found guilty of criminally negligent homicide and abuse of an impaired adult.

The criminal trial

Medical error is a frequent occurrence. Unfortunately, patients sometimes die as a result of their treatment – although the actual number is a controversial subject. A 2016 study by the John Hopkins University suggests that medical errors are the third leading cause of death in the U.S., but this study has drawn some criticism. Regardless, we know that many preventable adverse events occur every year. Staff might be disciplined, sacked, or lose their license; and hospitals often pay compensation to families.

But in this case, a medical error led to the nurse going on trial in a criminal court. Importantly, RaDonda Vaught is not on trial for intending to cause harm to the patient, nor is she on trial for being impaired by drugs or alcohol. She is, however, on trial for a medical error. This is highly unusual – such medical errors are usually handled by licensing Boards and civil courts. Criminal prosecutions by their nature focus on the individual healthcare provider, even though it is generally acknowledged that many medical errors result from system failures.

It is unusual for a nurse to be charged criminally, when there is no intent to harm a patient. The trial of nurse RaDonda Vaught could set a precedent for future medical errors to be treated as criminal cases.

In response to the trial, the American Nurses Association (ANA) raised concerns that the criminalisation of medical errors could have a chilling effect on reporting and process improvement. The Association stated:

“Health care is highly complex and ever-changing, resulting in a high risk and error-prone system. Organizational processes and structures must support a ‘just culture’, which recognizes that health care professionals can make mistakes and systems may fail. All nurses and other health care professionals must be treated fairly when errors occur. ANA supports a full and confidential peer review process in which errors can be examined and system improvements and corrective action plans can be established. Swift and appropriate action should and must always be taken as the situation warrants”

The American Nurses Association (ANA), News Release, 23 March 2022

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Understanding the medication error

If we explore the actions of the nurse from a human factors perspective, we might consider the relevant Performance Influencing Factors. The prosecution argued that Vaught ignored several warning signs when obtaining and preparing the medication. This is why they claim that her actions amounted to gross neglect. There is some debate in the profession as to how culpable Vaught might be.

All nurses and other healthcare professionals make mistakes at some point in their career – most of them cause no harm to patients, but some might. However, would most nurses make the same mistakes that Vaught did in this event?

“This was not a ‘singular’ or ‘momentary’ mistake”.

District Attorney

Central to this case is the use of an automated system that dispenses drugs. The prosecution’s case includes that Vaught had to override warnings on this electronic medication cabinet.

As in many hospitals, nurses retrieve medications from several mobile units that are stocked by the hospital pharmacy, known as an Automated Dispensing Machine (ADM). The nurse enters the first two letters of the drug and a drawer containing that medication will open. The nurse can search through a list of medications prescribed for a patient, or can search from a wider list of all medications.

Vaught and her defense attorney claimed that there were issues with the hospital’s computer system that led to delays in the pharmacy system linking prescribed medications to the patient’s profile on the automated machines. They claim that the hospital gave staff permission to temporarily override the system in order to obtain medications.

RaDonda Vaught initially attempted to withdraw the drug Versed from the Automated Dispensing Machine by entering the first two letters “VE”. However, the cabinet did not recognise that drug name when she searched for it on the console. This is because the cabinet defaulted to generic drug name searches – the drug was listed under its generic name, midazolam – rather than under the brand name Versed.

When the search for Versed did not produce any results, Vaught then checked another computer system and found that there was an order for Versed under the patient’s name. Vaught returned to the Automated Dispensing Machine. She triggered an override that unlocked other medications and again searched for “VE”. She selected the first item on the list of drugs, which was vecuronium and this was dispensed from the machine.

It’s not unusual for staff to perform an override on the medication cabinet. It appears that this is ‘normal’ and a daily occurrence in hospitals. In her testimony at the Tennessee Board of Nursing Hearing, Vaught stated that the hospital was instructing nurses to use such overrides in order to overcome ongoing problems following a change to the electronic patient record system. For this particular patient, Vaught stated that at least 20 medication cabinet overrides were undertaken by various nurses in the three days of her treatment.

“Overriding was something we did as part of our practice every day”.

Nurse RaDonda Vaught, testimony at Tennessee Nursing Board, July 2021

RaDonda Vaught was working as a ‘help-all’ or a ‘floater’ nurse, and was not this patient’s primary carer. She agreed to administer the sedative to the patient on her way to attending to another patient. Whilst obtaining the drug from the medication cabinet, we know that RaDonda Vaught was training another nurse and reported that she was distracted when retrieving the medication. They were discussing a ‘swallow study’ that they were about to perform on a patient.

Vaught is alleged to have consciously disregarded the front of the drug label. She states that she was surprised that the medication was a powder and immediately looked at the reconstitution directions on the rear of the label. Versed, however, is a liquid medication, ready to administer.

The nurse did not scan the medication prior to administering it; however, a scanner was not available in the area of this patient at the time of the event.

Vaught missed several warnings, but we know that this may happen for a variety of reasons. In this case, the full reasons for her behaviour do not appear to have been examined – or they are not publicly available.

“Make no mistake – this type of error has happened in other hospitals”.

Institute for Safe Medication Practices (ISMP), Volume 27, Issue 7, April 7, 2022

The Institute for Safe Medication Practices (ISMP) states that the same system vulnerabilities are found in other hospitals, and through its National Medication Errors Reporting Program, confirms that the same error has occurred in other hospitals.

There were so many human factors issues that may have been relevant but do not seem to have been considered, such as confirmation bias, normalisation of behaviours, alert fatigue, inattentional blindness and why people do what makes sense to them at the time.

Monitoring the patient

The Board of Nursing Hearing and prosecution alleges that Vaught did not monitor the patient after injecting her with the medication. Had Vaught done so, the effects of the error may have been apparent. However, Vaught reports that she questioned the need to monitor the patient with their primary carer. She was told that monitoring was not required. (Vaught was acting as a “help-all” nurse, supporting other staff, and did not have any patients assigned to her). The investigation by The Centers for Medicare and Medicaid Services found that there was no procedure or guidance regarding the manner and frequency of monitoring of patients during and after medications were administered (p.50).

Unanswered questions:

  • Was it common practice for nurses to talk to others when withdrawing drugs from the Automated Dispensing Machine? The investigation did not examine whether this was normal, accepted practice in the hospital.
  • Did Vaught recognise that talking to a trainee (about another medical procedure) whilst retrieving medication could influence her performance?
  • Were patients normally monitored after receiving Versed for mild sedation prior to radiology scans?
  • Was there a full investigation to understand the medication error and the influence of system failures?
  • Were all of the ‘warnings’ that Vaught is alleged to have missed present at the time of the event, or were they implemented afterwards as corrective actions?
  • Were all instances of healthcare staff obtaining non-urgent medication from an override investigated?

Set up to fail?

Was Vaught set up to fail by the system? Were there organisational failures by Vanderbilt University Medical Center that contributed to this tragedy? I have mentioned above the failures of the hospital computer system, the process of obtaining medication and the need to routinely override the automated system.

“the hospital failed to provide adequate patient safeguards, encouraged workarounds of existing safety systems, and even engaged in a cover-up of the incident”

Statement on the conviction of RaDonda Vaught, Washington State Nurses Association

The investigation by the Centers for Medicare and Medicaid Services clearly pointed to failures by the hospital. It stated that failures of the hospital to mitigate risks associated with medication errors placed patients at risk of serious injuries and/or death.

However, the Tennessee Board of Nursing is reported to ignore the significant contribution of system failures. The Board Chair said “The only thing we are charged with is the mistake that was made by the respondent in front of us today”. At this hearing, the Prosecutor acknowledges that there were system failures at the hospital that contributed to the medication error. However, the Prosecutor stressed that the Board is “not here to look at the system”. He considered that the Board was looking only at “individual conduct”.

But how can Vaught’s behaviour be viewed in isolation of the complex system in which she was working? We know that human behaviour is influenced by many factors – and not considering these factors in an assessment of Vaught’s behaviour does not make sense. In my review of publicly available information, I did not find reference to, or any evidence of, an investigation that considered Vaught’s actions in relation to the system failures that contributed to this event.

“This was a systemic problem at Vanderbilt, not a RaDonda Vaught problem”

Opening remarks at trial – Peter Strianse, RaDonda Vaught’s defense attorney

In order to make a proper assessment of Vaught’s behaviour, I would expect the case to be informed by a thorough and timely investigation into the medication error. However, the medical discipline Hearing was held three and a half years after the event – which does not appear to have been thoroughly investigated at the time. The Board appears to rely on an assessment of policies, procedures and systems at the date of the Hearing, rather than the conditions that existed at the time of the event.

The hospital made several improvements following the investigation by the Centers for Medicare and Medicaid Services – and it appears from the Hearing that the Board assessed Vaught’s behaviours in the light of these corrective actions, rather than with reference to the conditions in December 2017. For example, were all of the ‘red flags’ that Vaught is reported to have overlooked actually present at the time of the event? Had Vaught been set up to fail not once, but twice?

The Tennessee Board of Nursing has not filed disciplinary action against all nurses who have not read a medication label, failed to monitor a sedated patient, obtained non-urgent medication from an override or failed to document a medication in the patient’s record.

“We are engaged in a pretty high-stakes game of musical chairs and blame-shifting. And when the music stopped abruptly, there was no chair for RaDonda Vaught. Vanderbilt University Medical Center? They found a seat.”

Peter Strianse, Defense Attorney opening statement, 21 March 2022

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The criminal conviction

On 25 March 2022, RaDonda Vaught was found guilty of criminally negligent homicide and abuse of an impaired adult. She is currently awaiting sentencing in May 2022.

In response to the conviction, the American Nurses Association (ANA) and the Tennessee Nurses Association (TNA) issued a joint statement. It is worth repeating this statement here in its entirety:

“We are deeply distressed by this verdict and the harmful ramifications of criminalizing the honest reporting of mistakes.

Health care delivery is highly complex. It is inevitable that mistakes will happen, and systems will fail. It is completely unrealistic to think otherwise. The criminalization of medical errors is unnerving, and this verdict sets into motion a dangerous precedent. There are more effective and just mechanisms to examine errors, establish system improvements and take corrective action. The non-intentional acts of individual nurses like RaDonda Vaught should not be criminalized to ensure patient safety.

The nursing profession is already extremely short-staffed, strained and facing immense pressure – an unfortunate multi-year trend that was further exacerbated by the effects of the pandemic. This ruling will have a long-lasting negative impact on the profession.

Like many nurses who have been monitoring this case closely, we were hopeful for a different outcome. It is a sad day for all of those who are involved, and the families impacted by this tragedy.”

The American Nurses Association (ANA) and the Tennessee Nurses Association (TNA), 25 March 2022

Staffing pressures have meant that in many hospitals nurses are looking after more patients, working longer shifts, and working more shifts. Under these circumstances, we might expect medication errors (and other adverse events) to increase.

The question that many in the healthcare sector will be asking themselves is: “Could I be next?”. The healthcare system is already under strain, but now has criminalisation of mistakes to add to the profession. Medical staff – already exhausted and demoralised – (and it could be argued are already more prone to error because of these issues), now have another concern: errors may result in a lengthy prison sentence.

Second victims

Medication error - humanfactors101.com
Physicians have higher rates of burnout, depressive symptoms, and suicide risk than the general population.

Although patients are the obvious victims of medical errors, healthcare professionals are sometimes described as the second victims. The phrase “second victim” was coined by Dr. Albert Wu, a professor at the Johns Hopkins Bloomberg School of Public Health. It refers to the person who has to live with the aftermath of making a serious medical error, which may lead to anxiety, sleeping disorders, a loss of confidence and immense feelings of guilt.

Following a medical error, they may get little support. Healthcare professionals may turn to alcohol and other drugs in response to the emotional impact. And the suicide rate among physicians is higher than the general population – more than double for female physicians.

In September 2010, Kimberly Hiatt accidently gave an infant an overdose of calcium chloride, which may have contributed to the death of the child five days later (who was critically ill at the time). Hiatt had worked at Seattle Children’s hospital for 25 years and was a critical care nurse. Following an investigation, she was dismissed by the hospital and was devastated by the event. The following April, she took her own life. Organisations have a duty to consider how they respond to those who harm patients in their care.

And the organisation?

The investigation by the Department of Health found that the hospital failed to report this incident to the Tennessee Department of Health as mandated. It also found that:

“the hospital failed to ensure that the Quality Assurance and Performance Improvement (QAPI) program thoroughly analyzed a critical adverse event and all the causes, and implement preventive actions that included adding additional safety parameters associated with overriding paralytics and other High Alert medications from an automated dispensing cabinet (ADC) to ensure that a similar critical adverse event could not reoccur” (page 26).

The hospital had a High Alert Medications policy and Vecuronium was listed as a high alert medication. However, this policy did not detail any procedure or guidance regarding the manner and frequency of monitoring patients during and after medications were administered.

The hospital failed to notify the Davidson County Medical Examiner that the death occurred during, or as a result of, a medical error:

“Based on document review, review of hospital policies and procedures, medical record review, and interview the hospital failed to ensure all physicians followed policies, and rules and regulations for reporting unusual and unexpected deaths [including during or as a result of a medication error] to the County Medical Examiner” (page 38).

As noted earlier, Vanderbilt University Medical Center reached a financial settlement with the family of the deceased patient prior to the anonymous complaint to the Health Department. And yet, it is reported that this information was not disclosed to the jury in Vaught’s trial. It also appears that the jury was not informed of previous similar situations that occurred at this Medical Center.

The Vanderbilt University Medical Center was not on trial here. A single individual, a nurse employed at the Center, was the only person on trial. But as Vaught has herself stated, she did not go to work in a vacuum, but worked within a system.

Vaught admits to over-riding the automated medication cabinet. However, even with an override, should it have been possible for a nurse to access a paralysing medication so easily? The past president of the American Association of Nurse Attorneys, Lorie Brown, stated that “This is a medication that you should never, ever, be able to override to. It’s probably the most dangerous medication out there”.

Healthcare under a criminal malpractice regime

There are concerns that this case may have a negative impact on patient care. The criminalisation of medication errors has the potential to drive human errors underground. If cases such as this reduce reporting of medical errors, patient safety will suffer. Less reporting means less potential to learn. How can organisations learn from that which they do not know?

But there are many other potential adverse consequences:

  • Physicians may become more reluctant to take on difficult cases
  • They may apply the most conventional and uncontroversial methods
  • Physicians may shy away from applying high-risk or experimental treatments
  • There will be an increase in unnecessary tests (defensive medicine)
  • People may be hesitant to choose healthcare as a career.

Final thoughts

This case is tragic. From a human factors perspective, it is recognised that healthcare is a complex system. Human errors are to be expected in this environment. Even highly trained and experienced professionals make mistakes – in all industries, not just healthcare. Given this, we would expect staff to be able to report errors without fear of criminalisation so that they can be investigated. This would enable the conditions that influence such errors to be examined and improvements made to the system. This case has a focus on the active failures of an individual, rather than the latent failures that enabled the error to occur.

If staff are afraid to report errors and adverse events, then these will remain hidden and the opportunity to learn will be lost. The difficulties staff experienced in their “work as done” that contributed to this event are now less likely to be reported to hospital management. I’ve written elsewhere about how a culture of blaming healthcare leaders when they “fail” to deliver may be preventing others from wanting to take on these challenges (see “Leadership: Delivering the impossible”). Unfortunately, a culture of blaming nurses for medication errors may also dissuade others from joining the profession.

This case will no doubt have led to many conversations in the healthcare sector, particularly amongst nurses. It’s not clear why this particular medication error led to charges of reckless homicide (later reduced to criminally negligent homicide). This criminalisation of medical errors will have long-reaching effects on the nursing profession, potentially reversing the gains made in patient safety over the past 20 years. And could errors be criminalised in other industries?

On her GoFundMe page, which raised funds for her legal defence, Vaught stated that:

“Many feel very strongly that setting the precedent that nurses should be indicted and incarcerated for inadvertent medical errors is dangerous. The many details of this incident deserve to be properly reviewed and addressed so that we all have an opportunity to learn from my mistake and create changes that will ensure the safety of all future patients as well as maintaining the future honesty, integrity and safe practices of all nurses”.

In 1999, the pivotal report “To Err is Human” by the Institute of Medicine led to sweeping changes in healthcare. This report outlined how blaming individuals does not change the underlying factors that contribute to medical errors. It also stated that blaming an individual does little to make the system safer – or prevent someone else from similar errors.

However, this case may ensure that for every step that has been taken forward in patient safety, we have now taken two steps backwards.

The mantra may have been To Err is Human. Sadly, it may now have become To Err is a Crime.

References

Tennessee Board of Nursing disciplinary hearing 22 July 2021

Tennessee Board of Nursing disciplinary hearing 23 July 2021

Centers for Medicare and Medicaid Services report and Corrective Plan.