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Patient Safety Tip
of the Week
September
7, 2021
The
Vanderbilt Tragedy Gets Uglier
We
have done several columns on the tragic incident at Vanderbilt in which a
patient died after being inadvertently administered a neuromuscular blocking
agent (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” and February 12, 2019 “From Tragedy to Travesty of Justice”).
The nurse involved in that incident was charged
with criminal homicide. That trial has not yet taken place. The Tennessee Board
of Nursing recently revoked her nursing license, fined her, and ordered her to
pay an inordinate amount to cover prosecution costs (Warick 2021). Perhaps the word “persecution” would be
more appropriate than “prosecution”.
While
we do not defend the errors and deviations from practice that she made (and she
did make multiple ones), when we review a serious incident we always ask “Could another nurse/physician/pharmacist make
similar errors, given the set of circumstances this individual acted in?”
Our answer to that question in those prior columns was “yes”. Once again, a
healthcare worker has been placed at the “sharp end” of a cascade of errors,
left with the “smoking gun” and bearing the brunt of blame for a catastrophic
event that had multiple root causes and contributing factors.
It's
worth reiterating here the findings in our February 12, 2019 Patient Safety Tip of the Week “From Tragedy to Travesty of Justice” and
our other previous columns on this incident:
_____________________________________________________________________
In our December 11, 2018 Patient Safety Tip
of the Week “Another
NMBA Accident” we
discussed a tragic case where a patient was administered a fatal dose of the
NMBA (neuromuscular blocking agent) vecuronium instead of the ordered Versed.
We discussed a whole cascade of errors, root causes, and contributing factors
that were important in leading to the unfortunate outcome.
At the end of that column
we noted that the nurse who administered the fatal dose had been terminated
from the hospital. While acknowledging that the nurse made several egregious
errors, we noted that there were multiple system issues that put her in
position to be at the “sharp end” of the error cascade. Now that nurse has been
charged with reckless homicide and impaired adult abuse in Tennessee (Kelman
2019).
Clearly,
the nurse who was charged 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).
Though
the prosecutors apparently were barred from publicly discussing the merits of
the case, a spokesman for the District Attorney’s Office said in a brief
statement that overriding the safeguards of the ADC (automated dispensing
cabinet) was central to the charge of reckless homicide (Kelman
2019b).
The
nurse did override the 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. 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”.
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 patient’s 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.”
The
CMS inspection report (CMS
2018) also 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”).
We refer you back to our December 11, 2018
Patient Safety Tip of the Week “Another
NMBA Accident” for
discussion of all the system issues we identified as root causes or
contributing factors. But, to summarize, we can identify at least 19
points where interventions or different decisions could have prevented this
tragic death:
1.
Ordering the PET scan
We’ don’t know details about the patient’s condition but we’d 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 patient’s 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”.
10.
Double checks were not required for ADC
overrides
Even though we’ve noted double checks are not without their own problems, an
independent double check might well have identified that the wrong drug had
been pulled. Note that, ideally, there would have been two double checks (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 don’t 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 don’t you stop on the way and give this sedation to
the patient in the PET suite?”. We’d certainly wonder how the communication actually took place and what details were included in this
“handoff”.
15.
Barcoding was not implemented in the
radiology/PET suite
If there had been the opportunity to barcode scan both the patient’s ID
bracelet and the medication vial/label, it’s 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 patient’s 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.
In our December 11, 2018 Patient Safety Tip
of the Week “Another
NMBA Accident” 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 recommended terminating the nurse. And we
think that charging this individual with reckless homicide is an outrageous
travesty of justice. This nurse will undoubtedly live with the memory of this
terrible accident the rest of her life. But to put her through the rigors of a
homicide trial, even if she is ultimately acquitted, is simply wrong.
______________________________________________________________________
And
the current revocation of here nursing license, especially in view of the
upcoming criminal trial, is particularly bothersome.
ISMP
(Institute for Safe Medication Practices) recently expressed a stance similar
to ours (ISMP 2021). They also stressed a few important
considerations. First, they note there was undoubtedly significant outcome
bias in the Board’s decision, noting that “the Board has not filed
disciplinary action against all TN nurses who have not read a medication label
carefully, obtained a nonurgent medication from an ADC via override, drawn an
incorrect conclusion, failed to monitor a sedated patient, or failed to
document a medication error in the patient’s record.” In this case, the patient
died, so the decision was likely biased because of that outcome.
ISMP
further argues that the Board relied on an incomplete investigation of the
event, particularly related to the question, “What normally happens in similar
circumstances?” ISMP would have wanted to know what happens “normally” for patients
who were anxious about radiology scans due to claustrophobia. It would have
asked whether they were given oral anxiolytics or IV sedatives, and whether they
were monitored and by whom and for how long? ISMP also notes the Board failed
to consider all the system deficiencies that they have outlined, most of which
we have discussed in our prior columns.
ISMP
also notes this nurse was contrite and honest in admitting errors she made and
was devastated about the tragic patient outcome.
Every
day in every hospital, healthcare workers make some of the mistakes or
deviations noted in this incident. Fortunately, in most cases, harm does not
come to patients. But when systems fail, adding contributing factors and
lacking safety defenses, bad outcomes ensue. Did the Tennessee Board of
Nursing, the hospital, and the prosecutors in the upcoming trial really
consider that fundamental question “Could another nurse/physician/pharmacist
make similar errors, given the set of circumstances this individual acted in?”
We think anyone considering the totality of circumstances in this case would
agree with both our view and ISMP’s view that the actions against this nurse
(now by multiple parties) have been unjust.
Some of our prior columns on neuromuscular
blocking agents (NMBA’s):
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 NMBA’s”
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 NMBA’s”
References:
Warick S. Former nurse accused of giving fatal dose of
wrong medicine to patient loses nursing license. News 4 Nashville 2021; Jul 26,
2021
Kelman B. Vanderbilt ex-nurse indicted on reckless homicide
charge after deadly medication swap. Nashville Tennessean 2019; Published February
4, 2019
Kelman B. Vanderbilt nurse: Safeguards were ‘overridden’ in
medication error, prosecutors say. Nashville Tennessean 2019; Published February
7, 2019
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
CMS
(Centers for Medicare and Medicaid Services). Statement of Deficiences.
Complaint #TN00045852. CMS 2018; Date of survey 11/08/2018
ISMP
(Institute for Safe Medication Practices). TN Board of Nursing’s Unjust
Decision to Revoke Nurse’s License: Travesty on Top of Tragedy! ISMP Medication
Safety Alert! Acute Care Edition 2021; 26(16): August 12, 2021
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