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Patient Safety Tip
of the Week
November 10, 2020
More
on Infusion Pump Errors
The tragic death of a prominent cancer researcher serves as
a stark reminder of things that can go wrong with infusion pumps (Evans
2020). The 61-year-old man was admitted to the
hospital with a stroke. Over the next two days his condition stabilized
and he began speech, physical and occupational therapies. His diet
was advanced to solid foods. But, as plans were being made for his move to a
rehab facility, his condition took a turn for the worse and he failed a
swallowing test. His breathing became labored and a feeding tube
was inserted due to his difficulty swallowing. During the procedure, he
apparently aspirated a large piece of food from his stomach. It lodged
in his airway and he suffered acute respiratory arrest and was placed
on a ventilator.
To
sedate him while he was on the ventilator, he was given four small doses
of fentanyl, ranging from 25 to 75 micrograms. At that time he was responsive and able to follow simple commands. It
was anticipated he would come off the ventilator soon.
A
little after 11 PM, a nurse covering for his primary nurse responded to an
alarm going off on a medication pump next to his bed. An IV bag of Lactated
Ringer's solution needed to be replaced. The nurse obtained a new bag of
the solution and hung it on the pole along with other medications also
attached to the pump. One of those bags contained the fentanyl, which had been
discontinued 12 hours earlier. The nurse scanned the bag of Lactated Ringer's solution
and a barcode that came up on the pump before restarting it at 11:24 p.m. She
had attached the Lactated Ringer's solution to one channel on the pump, but
mistakenly pushed the start button for another channel — the one attached
to a bag of fentanyl. As soon as she pushed the start button on the module that
was actually going to give the fentanyl, the alarm went
off. But, instead of checking the alarm and reading the alarm code, the
nurse just hit a silence button. A few minutes later, another nurse who checked
the pump also missed the error.
We, of
course, do not know details about the hospital’s own root cause analysis (RCA)
or incident investigation but it should have focused on at least the following
issues:
- Time of day (?change
of shift)
- Handoff(s)
- Alarm fatigue
- Fentanyl bag left hanging after no
longer needed
- No independent double check
- Failure to rescue
- Channel selection/line attachment
- Multiple lines (were the lines
appropriately labeled?)
- Overreliance on technology (belief that barcoding
was enough)
- Several of these items also suggest a problem
with the culture of safety
- Transparency/Disclosure and Apology
Our March
2020 What's New in the Patient Safety World column “ISMP Smart Infusion Pump Guidelines” discussed ISMP’s “Guidelines for Optimizing
Safe Implementation and Use of Smart Infusion Pumps” (ISMP 2020). The
hospital violated two of the most important recommendations in that guideline.
One
point that was emphasized in those guidelines was performance of double
checks at certain points. When starting selected facility-defined
high-alert medication infusions and at additional facility-defined steps (e.g.,
change of shift/handoffs, change in the rate/dose of infusion, change in bag/bottle/syringe)
hospitals should require that a double check be performed and documented to verify
the following before starting the infusion:
1.
Patient
2.
Patient weight used for weight-based medications
3.
Drug/solution
4.
Drug concentration
5.
dose-rate of continuous infusions, dose and rate of intermittent infusions
6.
Channel selection
7.
Line attachment
ISMP noted that technology (eg. barcoding) is the preferred method for double checking most of
these items but use of a second practitioner is necessary to perform and
document an independent double check for line attachment. (Keep in mind
that we also always recommend that, when multiple lines are connected to
multiple different sources, it is critical that good labeling be placed not
only on the sources but also on the lines themselves).
While
those 2 issues provide, arguably, the most important lessons learned from this
tragic incident, keep in mind that the cascade of errors in this case is
typical of most adverse events where there is a bad patient outcome. Almost each
of the issues above represented an opportunity to intervene and stop the cascade
before an unfortunate outcome occurred.
In our
March 5, 2019 Patient Safety Tip of the
Week “Infusion Pump Problems” we
did an extensive review of safety issues related to infusion pumps. We hope you’ll go back to that column to review our many recommendations.
There was also another recent review of human-based
errors involving smart infusion pumps (Kirkendal 2020). The authors classified five main
categories: undocumented orders, drug library errors, programming errors,
administration errors, and ancillary equipment errors. Within these five main
categories of errors, the investigative team identified specific types and even
more granular subtypes.
While
they discussed issues like programming errors and drug library errors, they also
stressed several other important issues: misunderstanding or misinterpreting
pump alerts, forgetting to close tube clamps, and bag misalignment with
multiple infusions. And they acknowledged that some errors may be the result of
workarounds performed by clinicians to intentionally bypass safety features.
Lastly, we are strong believers in transparency and
disclosure and apology Not only is that
the right thing to do, but one can only wonder if prompt disclosure and apology
might have prevented the details of this tragic case from being splashed in the
headlines. Our many columns and resources on disclosure and apology and
communication and resolution programs are also listed below.
Our
prior columns related to infusion pump issues:
·
May 2010
“FDA's
Infusion Pump Safety Initiative”
·
April
27, 2010 “Infusion
Pump Safety”
·
August 2016 “Home Infusion Therapy Pitfalls”
- March
5, 2019 “Infusion Pump Problems”
·
March 2020 “ISMP Smart Infusion Pump Guidelines”
·
August 4, 2020 “Intravenous
Issues”
Some of our prior columns on Disclosure
& Apology:
July 24, 2007 “Serious
Incident Response Checklist”
June 16, 2009 “Disclosing
Errors That Affect Multiple Patients”
June
22, 2010 “Disclosure and Apology: How to Do It”
September 2010 “Followup to Our
Disclosure and Apology Tip of the Week”
November
2010 “IHI: Respectful Management of Serious
Clinical Adverse Events”
April 2012
“Error
Disclosure by Surgeons”
June 2012 “Oregon
Adverse Event Disclosure Guide”
December 17, 2013 “The
Second Victim”
July 14, 2015
“NPSF’s
RCA2 Guidelines”
June 2016 “Disclosure and Apology: The CANDOR Toolkit”
August 9, 2016 “More
on the Second Victim”
January 3, 2017 “What’s Happening to “I’m Sorry”?”
October 2017 “More Support for Disclosure and Apology”
April 2018 “More Support for Communication and Resolution
Programs”
August
13, 2019 “Betsy
Lehman Center Report on Medical Error”
September
2019 “Leapfrog’s Never Events Policy”
Other very valuable
resources on disclosure and apology:
- IHI’s “Respectful Management of Serious
Clinical Adverse Events” (Conway 2010)
- The Canadian Disclosure Guidelines (Canadian Patient Safety Institute 2008)
- The Harvard Disclosure Guidelines (Massachusetts Coalition for the
Prevention of Medical Errors 2006)
- The ACPE Toolkit (American College of Physician Executives)
- Oregon Patient Safety Commission Oregon Adverse Event Disclosure Guide.
References:
Evans T. Drug error at Eskenazi Hospital killed prominent cancer researcher. Here's
how it happened. Indianapolis Star 2020; October 30, 2020
ISMP (Institute for Safe Medication Practices).
Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps.
ISMP 2020; February 10, 2020
https://www.ismp.org/guidelines/safe-implementation-and-use-smart-pumps
Kirkendal, ES.,
Timmons K., Huth H, et al. Human-Based Errors Involving
Smart Infusion Pumps: A Catalog of Error Types and Prevention Strategies. Drug Saf 2020;
https://link.springer.com/article/10.1007/s40264-020-00986-5#citeas
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