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Patient Safety Tip of the Week

February 12, 2019     Special Column

From Tragedy to Travesty of Justice

 

 

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.

 

 

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

 

 

 

References:

 

 

Kelman B. Vanderbilt ex-nurse indicted on reckless homicide charge after deadly medication swap. Nashville Tennessean 2019; Published February 4, 2019

https://www.tennessean.com/story/news/health/2019/02/04/vanderbilt-nurse-reckless-homicide-charge-vecuronium-versed-drug-error/2772648002/

(Kelman 2019a)

 

 

Kelman B. Vanderbilt nurse: Safeguards were ‘overridden’ in medication error, prosecutors say. Nashville Tennessean 2019; Published February 7, 2019

https://www.tennessean.com/story/news/health/2019/02/06/vanderbilt-nurse-vecuronium-versed-patient-death-radonda-vaught/2795475002/

(Kelman 2019b)

 

 

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

https://www.ismp.org/resources/safety-enhancements-every-hospital-must-consider-wake-another-tragic-neuromuscular

 

 

CMS (Centers for Medicare and Medicaid Services). Statement of Deficiences. Complaint #TN00045852. CMS 2018; Date of survey 11/08/2018

https://bloximages.newyork1.vip.townnews.com/wsmv.com/content/tncms/assets/v3/editorial/a/7e/a7ea6b5e-f41f-11e8-af7b-570ec9f22209/5c005d6899b8d.pdf.pdf

 

 

 

 

 

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