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Patient Safety Tip
of the Week
April
12, 2022
A
Healthcare Workers Worst Fear
As healthcare workers, our worst fear is that we might make
a mistake that causes harm or death to one of our patients. Some also fear that
such a mistake will lead to loss of respect from colleagues or a malpractice
suit. But few would fear that such a mistake could lead to criminal charges and
time in prison.
But
all that changed recently. In multiple columns we discussed the tragic incident
at Vanderbilt in which a patient died after accidentally being given the
neuromuscular blocking agent (NMBA) vecuronium instead of the sedating agent
Versed. See our Patient Safety Tips of the Week for December 11, 2018 Another NMBA Accident, January
1, 2019 More on Automated Dispensing Cabinet (ADC)
Safety, February
12, 2019 From Tragedy to Travesty of Justice,
and September 7, 2021 The
Vanderbilt Tragedy Gets Uglier for details. In late March 2022 a jury
convicted RaDonda Vaught, the nurse involved in that
incident, of gross neglect of an impaired adult and negligent homicide (Kelman 2022). She was acquitted of reckless homicide, a
more serious charge than negligent homicide.
Vaught
did make multiple serious mistakes in the incident. But there were multiple
system problems that contributed to the devastating outcome. In fact, in our
prior columns we identified at least 19 points where interventions or different
decisions could have prevented this tragic death.
Any time we review an incident in which human error
occurred, we always ask Could another nurse/physician/pharmacist have made
similar errors under these same circumstances?. In the Vanderbilt NMBA
incident, we concluded that it was quite conceivable that another nurse might
have made similar errors given the same set of circumstances and contributing
factors. That is, the many system issues actually put that nurse in a position where human error
would leave her at the sharp end of the error cascade. As such, we would not
have even recommended terminating the nurse. Yet she ultimately had her nursing
license revoked by the Tennessee Board of Nursing and now has been convicted of
these criminal offenses.
Vaught
readily admitted the error(s) immediately after the incident and showed remorse
at every stage. Vaught did not testify in the trial. But, according to Kaiser
Health News (Kelman 2022), she previously admitted to the drug error in
an interview with law enforcement officials in which she and said she
"probably just killed a patient." And, during proceedings before the
Tennessee Board of Nursing she testified that she allowed herself to become
"complacent" and "distracted" while using the medication
cabinet and did not double-check which drug she had
withdrawn despite multiple opportunities. She told the nursing board "I
know the reason this patient is no longer here is because of me" and, as
she broke down crying, "There won't ever be a day that goes by that I
don't think about what I did."
It is
worthwhile reiterating details of the incident, its contributing factors, and
lessons learned. We pieced together details of the case from the CMS inspection
report (CMS
2018) and media reports at the time (NewChannel5
2018), (Kelman
2018a), (Kelman
2018b), (Ellison
2018).
The
patient was a 75 y.o. woman with an intracranial hemorrhage,
admitted to the hospitals Neuro ICU. Two days later she was alert and oriented
and stable and was now in the Neuro Stepdown Unit and waiting for a bed on the
regular floor. On that day she was sent to the radiology department for a total
body PET scan. The patient told staff about claustrophobia and a physician
ordered Versed 2 mg intravenously for sedation for the procedure. PET scan
staff requested a nurse from the Neuro ICU administer the Versed because their
own nurses would not be able to perform monitoring of the patient.
That
nurse from the Neuro ICU was already going to the ER to administer a swallowing
study. The nurse looked in the patients profile on the ADC (Automated
Dispensing Cabinet) for the Versed but could not find it. (The ADC was in the
Neuro Intensive Care Unit, not in radiology.) Therefore, the nurse used the
override function on the ADC to search for it. The nurse recalled talking to an
orientee about the swallowing study while entering the first two letters VE
into the ADC. The first medication on the list was chosen. The nurse did not
recognize that the medication chosen was vecuronium, not Versed. The nurse
looked at the back of the vial to see how to reconstitute the medication but
did not recheck the name of the medication on the vial. The nurse grabbed a
sticker from the patients medication file, a handful of flushes, alcohol
swabs, and a blunt-tip needle. The nurse put the medication vial in a baggie
and wrote on the baggie PET scan, Versed 1-2 mg and
went to Radiology to administer the medication. The nurse found the patient
waiting in the PET scan area, reconstituted the medication, and administered
the medication intravenously to the patient, then left the PET scan area. In
the CMS interview the nurse could not remember the exact dose administered but
thought it was 1 milliliter. The nurse put the leftover medication in the
baggie and gave it to another nurse. The nurse did not monitor the patient
after administering the medication.
The
order for Versed had been entered at 2:47 PM. It was verified by a pharmacist
at 2:49 PM. It was never dispensed from the ADC. Vecuronium, however, was
dispensed from the ADC at 2:59 PM, via the override function. There was never
an order for vecuronium and no verification from a pharmacist.
The
nurse did not document the administration of the medication. Apparently
the nurse had been told that the new system would capture it in the MAR.
Nurses
in the Neuro ICU heard the code call to Radiology and wondered whether it might
be for their patient who was having a PET scan.
It was their patient, and she was brought back to the Neuro ICU after
the resuscitation. There a second nurse showed the baggie to the first nurse
and asked Is this the med you gave the patient?.
When the nurse answered yes, the second nurse said This isnt Versed. Its
vecuronium.
The
patient was subsequently put on comfort care after discussion with family about
the neurological sequelae and died the following day.
Clearly,
Vaught made the following errors:
- After entering only the first two letters VE for Versed she chose
the first drug shown and she overrode a warning in a red box stating that
it should be for STAT orders
- She removed the vial from the
ADC and did not look at the label which was for
vecuronium, not Versed.
- She did not question why she
had to reconstitute this preparation (which would not ordinarily have been
required if the drug was Versed).
- After administering the
medication to the patient in the PET suite, she left to perform another
task in the ER, and did not monitor the patient to whom she had
administered the medication. (Note that the CMS report does not detail how
long she actually observed the patient before
leaving the PET suite).
- She failed to document
anywhere the details of the drug administration (again, note that there
were some system issues that contributed to failure to document).
We refer you back to our December 11, 2018
Patient Safety Tips of the Week Another
NMBA Accident and
February 12, 2019 From Tragedy to Travesty of Justice for
discussion of all the system issues we identified as root causes or
contributing factors. But, to summarize, we identified at least 19
points where interventions or different decisions could have prevented this
tragic death:
1.
Ordering the PET scan
We dont know details about the indication for the PET scan. We suspected that
it might have been looking to see if this was a hemorrhagic metastasis.
Testimony in the trial suggests that was the reason. But, even then, wed question
whether the PET scan would have been more appropriately ordered as an
outpatient, in which case she probably would have been given an oral sedating
agent and there would have been no phone call to the Neuro ICU for a nurse to
administer an IV sedating agent.
2.
A good pre-PET scan checklist could have flagged
claustrophobia and the possible need for sedation before the patient was sent
to the PET suite. Then, a more informed decision about the need for monitoring
might have been made.
3.
Was a PET sedation protocol available?
Recognizing that a substantial number of patients require sedation for PET
scans, and that certain sedating agents are contraindicated during PET, there
should be formal protocols for PET that take into account
how long the sedation is required. Those protocols should include specific
drugs and routes of administration as well as guidelines about who needs to be
monitored and what monitoring equipment is needed.
4.
Choice of route of administration for a sedating
agent
We wondered why an intravenous agent was chosen rather than an oral agent,
particularly since fairly long duration action was
desired here. But when we looked at practices of some PET scan units, we found
it fairly common that intravenous agents like
midazolam were used.
5.
A Ticket to Ride checklist for intrahospital
transport might, likewise, have raised the need for patient monitoring during
the procedure.
6.
Decision that patient did not need monitoring
The decision that the patient did not need monitoring was actually
made by a different nurse. The PET scan technicians had thought the
patient needed monitoring but the patients nurse from the Neuro ICU told them
she did not need monitoring.
7.
Decision to send a nurse who may not have been
familiar with patient
The nurse who was sent to administer the drug was a help nurse who did not
have primary responsibility for the patient. It is not clear how much, if
anything, she actually knew about that patient. We
wonder what sort of handoff was actually done
between the primary nurse and the nurse sent to the PET suite.
8.
Generic vs. brand name issue
The CMS investigative report indicates the physician order was for Versed
(brand name) but the ADC search function defaults to generic names, hence
Versed did not appear on the ADC search. There should be better consistency
between how brand names and generic names are handled in all IT systems.
Culture also plays a role here. We do see that, in most settings, healthcare
professionals will still call it Versed rather than midazolam.
9.
ADC did not have an adequate warning
As discussed above, the ADC warning for vecuronium should have been something
like Verify that the patient is
intubated and mechanically ventilated or that this drug is being used for an
intubation procedure. See our comments later regarding the warning.
10.
Double checks were not required for ADC overrides
Even though weve noted double checks are not without their own problems, an
independent double check might well have identified that the wrong drug had
been pulled. A double check is probably not needed for all drugs in an ADC, but
clearly should be required when someone is attempting to remove an NMBA. (Note
that, ideally, there would have been two double checks here - one to override
the ADC warning, and one to identify the drug that was removed from the ADC).
11.
Drug vial did not have salient enough warning
The vial in the current case did have a red top and message WARNING:
PARALYZING AGENT. Yet that was not conspicuous enough to get the attention of
the nurse. It seems to us you need to put it in some unique sort of container,
perhaps a cardboard or plastic cage or something that makes it more difficult
to remove as a means of attracting attention to the high-risk nature of the
medication.
12.
Nurse failed to look at drug name on the vial
No excuse here. This clearly would have prevented the accident.
13.
Nurse failed to ask herself why she needed to
reconstitute the medication
Simply thinking I dont recall ever having to reconstitute Versed before
should have been a clue that this was the wrong drug.
14.
Nurse sent to do 2 separate tasks (ER swallow
test, PET scan sedation)
It almost sounds like the second task was an afterthought Since you are going
down to the ER anyway, why dont you stop on the way and give this sedation to
the patient in the PET suite?. Wed certainly wonder how the communication actually took place and what details were included in this
handoff. In addition, the double task may have contributed to the distraction
in which the nurse was describing the swallowing test to the orientee at the
same time she was withdrawing the medication from the ADC.
15.
Barcoding was not implemented in the
radiology/PET suite
If there had been the opportunity to barcode scan both the patients ID
bracelet and the medication vial/label, its likely that vecuronium would have
been recognized as the wrong medication.
16.
Inadequate post-dose observation
The CMS investigative report does not mention how long the nurse stayed with
the patient following the administration of what she thought was Versed.
Sedation following Versed administration might take a while. Paralysis after
injection of vecuronium should be apparent within a few minutes at most. So
even observing the patient for a few minutes might have identified the
accident. What is not clear is what the patients condition was when she was
moved from the injection room to the patient room where she was to stay
while the radiotracer was distributed. Did no one notice paralysis?
17.
No physiologic monitoring done
All thought that the medication to be administered was Versed. Injection of
Versed or other sedating agent in a patient with an acute neurological
condition should have merited monitoring with at least EKG and pulse oximetry. Capnographic monitoring would probably have been difficult
in the PET suite. But even though an early rise in pCO2 would have been missed,
the patient ultimately would have developed hypoxia and heart rate changes that
should have led to alarms and resuscitation.
18.
EMAR or way to document medication
administration in the radiology/PET suite was not available.
Perhaps, if required to do formal documentation of the medication
administration at the time of administration, the nurse might have recognized
the mistake at a time when rescue of the patient was still possible.
19.
Time pressures?
The previous day was a holiday and the PET unit was
very busy, likely catching up on scans that might have been done a day earlier.
If it were less pressured, perhaps the threat to send the patient back without
a scan (if she could not be sedated immediately) might not have taken place.
It is
conceivable that a different action or decision at any one of the above 19
points might have prevented this tragic accident. Yes, several of these relate
directly and solely to the nurse. But the majority are enabling factors that
can allow a human error to break through multiple defense systems and lead to
patient harm.
ADC
overrides are a central issue in this case. Vaught did override a warning
on the ADC screen. But we identified two system issues regarding ADC overrides.
First, hospital policy and ADC settings apparently
did not require an independent double check for the override.
Second,
even more importantly, the warning on
the ADC screen was inadequate. The nurse may well have considered this a
STAT order since she was told to go down to the PET suite now or they will
send the patient back here without doing the scan. The hospital had been having
some technical problems with medication cabinets in 2017 but they were
apparently resolved prior to Vaught pulling the wrong medication from the ADC
The hospitals medication safety program director testified during the trial
that, at the time of the incident, there was labeling on the pockets for
paralyzing agents that gave a warning to nurses when they remove it from the
drug case. "There's a pop-up message and another layer or warning that
you're accessing a paralyzing agent." (Sutton 2022).
Our
recommendation is that the warning for removal of an NMBA should include a
hard stop, i.e. it should require a specific action
prior to removal. A proper warning would have said something like Verify that the patient is intubated and
mechanically ventilated or that this drug is being used for an intubation
procedure and require that verification on screen.
Note
that ISMP (ISMP
2019), in its own review of the issue following
this case, agrees with us and recommends Display an interactive warning (e.g.,
Patient must be intubated to receive this medication) on ADC screens
that interrupts all attempts to remove a neuromuscular blocker via a patients
profile or on override. The warning should require the user to enter or select the
purpose of the medication removal (other should not be a choice) and verify
that the patient is (or will be) manually or mechanically ventilated. This type
of warning provides an opportunity to specify why the user is being interrupted
and requires the user to document a response.
We
also dont know what the units culture was regarding overrides. The CMS
inspection report (CMS
2018) does not mention whether overriding an ADC
alert was an issue unique to this nurse or whether ADC overrides had become a
routine part of the culture of the unit (i.e. normalization of deviance). How
often do nurses in that unit (or elsewhere in the hospital) override warnings
when removing drugs from an ADC? Hospitals need to keep logs of ADC overrides
and include review of these in their quality improvement and patient safety
activities.
Another
issue raised by this case has to do with the number of letters needed to be
entered on the ADC screen to identify a drug. In this case, entering just VE
led to vecuronium being chosen rather than Versed. In 2019 ISMP, in its Guidelines for the Safe Use of Automated
Dispensing Cabinets, recommended the entry of a minimum of
five characters of a drug name during searches in ADCs. (Note that ISMPs
Guidelines for Safe Electronic Communication
of Medication Information also include that requirement for medication
searches on other forms of electronic communication.) That is an improvement
but, even then, there are challenges. ISMP saw reports where even entry of 5
letters was associated with errors (ISMP 2021) and summarized the circumstances in which
these errors were occurring. Despite these limitations and challenges, ISMP
still recommends using at least five characters when conducting drug name
searches. In that 2021 article ISMP has recommendations for dealing with drug
names with the same beginning characters beyond five letters and some other
problematic issues.
The
verdicts in this case go well beyond the travesty of justice done to RaDonda Vaught. They have implications that will be on the
minds of healthcare workers everywhere. The American Nurses Association issued
the following statement (ANA 2022) after the verdict in this case was reached:
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.
And
the American Organization of Nursing Leadership (AONL 2022) issued the following statement:
The
verdict in this tragic case will have a chilling effect on the culture of
safety in health care. The Institute of Medicines landmark report To Err Is
Human concluded that we cannot punish our way to safer medical practices.
We must instead encourage nurses and physicians to report errors so we can
identify strategies to make sure they dont happen again. Criminal
prosecutions for unintentional acts are the wrong approach. They
discourage health caregivers from coming forward with their mistakes,
and will complicate efforts to retain and recruit more people in to
nursing and other health care professions that are already understaffed and
strained by years of caring for patients during the pandemic.
We,
too, are concerned. We hope that this does not lead to failure to report
medical errors because of fear of criminal action. There obviously was no
criminal intent by RaDonda Vaught. She was
straightforward in owning up to the mistakes she made
and she lives with this every day. We hope that reporting and analysis of this
tragic case have led to multiple improvements and lessons learned that every healthcare
organization should be aware of.
We
hope that RaDonda Vaught will appeal the convictions.
Absent that, we hope that the judge will show leniency in sentencing. It has
been a tragedy for the family of the patient who died unnecessarily. But it is
also a tragedy for RaDonda Vaught and nurses and
healthcare professionals everywhere.
Some of our prior columns on neuromuscular
blocking agents (NMBAs):
June
19, 2007 Unintended Consequences of Technological
Solutions
July
31, 2007 Dangers of Neuromuscular Blocking Agents
November
2007 FMEA Related to Neuromuscular Blocking Agents
May
20, 2008 CPOE Unintended Consequences - Are Wrong
Patient Errors More Common?
January
31, 2012 Medication
Safety in the OR
February 7, 2012 Another
Neuromuscular Blocking Agent Incident
October 22, 2013 How
Safe Is Your Radiology Suite?
December 9, 2014 More
Trouble with NMBAs
December 11, 2018 Another NMBA Accident
January 1, 2019 More on Automated Dispensing Cabinet (ADC)
Safety
February 12, 2019 From Tragedy to Travesty of Justice
April 2019 ISMP on Designing Effective Warnings
February
2021 ISMP: 2 Alerts on NMBAs
September
7, 2021 The
Vanderbilt Tragedy Gets Uglier
References:
Kelman B. Nurse Convicted of Neglect and Negligent Homicide
for Fatal Drug Error. Kaiser Health News 2022; March 25, 2022
https://khn.org/news/article/radonda-vaught-nurse-drug-error-vanderbilt-guilty-verdict/
CMS
(Centers for Medicare and Medicaid Services). Statement of Deficiences.
Complaint #TN00045852. CMS 2018; Date of survey 11/08/2018
NewChannel5.
Vandy patient dies after nurse gives lethal dose of
wrong drug; threatened Medicare reimbursements.
NewsChannel5 (Nashville, TN) 2018; November 29, 2019
Kelman B, Vanderbilt didnt tell medical examiner about
deadly medication error, feds say. Nashville Tennessean 2018; Published Nov.
29, 2018 | Updated Nov. 30, 2018
Kelman B, At Vanderbilt, a nurse's error killed a patient
and threw Medicare into jeopardy. Nashville Tennessean 2018; Published Nov. 29,
2018
Ellison
A. CMS threatens to terminate Vanderbilt's Medicare contract after fatal
medication error. Beckers Hospital CFO Report 2018; November 29, 2018
Sutton
C, West E, Davis C. Second day of testimony concludes in trial for RaDonda Vaught, former Vanderbilt Medical Center nurse.
NewsChannel5 Nashville 2022; March 24, 2022
ISMP
(Institute for Safe Medication Practices). Safety Enhancements Every Hospital
Must Consider in Wake of Another Tragic Neuromuscular Blocker Event. ISMP
Medication Safety Alert! Acute Care Edition 2019; January 17, 2019
ISMP
(Institute for Safe Medication Practices). Guidelines for the Safe Use of
Automated Dispensing Cabinets. ISMP 2019; February 7, 2019
https://www.ismp.org/resources/guidelines-safe-use-automated-dispensing-cabinets
ISMP
(Institute for Safe Medication Practices). Guidelines for Safe Electronic
Communication of Medication Information. ISMP 2019; January 16, 2019
https://www.ismp.org/resources/guidelines-safe-electronic-communication-medication-information
ISMP
(Institute for Safe Medication Practices). Challenges with Requiring Five
Characters During ADC Drug Searches Via Override. ISMP Medication Safety Alert!
Acute Care Edition 2021; October 21, 2021
American
Nurses Association. Statement in Response to the Conviction of Nurse RaDonda Vaught. ANA March 25, 2022
American
Organization for Nursing Leadership (AONL). Statement in Response to the
Conviction of Nurse RaDonda Vaught, ANOL 2022; March
28, 2022
https://www.aonl.org/press-releases/Statement-in-Response-to-the-Conviction-of-Nurse-RaDonda-Vaught
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