We publish details about significant incidents because if an
event occurs at one facility, a similar event may well occur at another
facility no matter how unusual the circumstances surrounding the event were.
One of our earliest introductions to alarm fatigue happened in a dialysis unit.
In fact, you’ve heard us state that we often bet hospital CEO’s that we will
find a certain number of alarms disabled or otherwise tampered with when we do
a hospital visit. One of the areas we know to go to for finding such alarms is
the dialysis unit.
Though the incident occurred much earlier, we first
discussed our dialysis alarm incident in our March 26, 2007 Patient Safety Tip
of the Week “Alarms
Should Point to the Problem”. An ESRD patient was having his regularly
scheduled dialysis session. Since he would be in the dialysis center for
several hours, he was in a comfortable lounge chair that tipped back. Also,
since it was somewhat cool, he was offered a blanket to keep warm. Midway
through the dialysis session, the low-pressure alarm rang. The nurse turned off
the alarm and eyeballed the patient and saw no blood. Nothing further was done.
Soon thereafter the low pressure alarm triggered again. This time it was
recognized that the dialysis catheter had become dislodged and the patient had,
in fact, had considerable blood loss. It had not been appreciated immediately
because the blanket had been covering up the catheter site and the blood,
rather than being visible on the floor, had been pooling in the webbing of the
lounge chair.
Anyone who has ever spent time in an ICU or other high tech
medical environment knows that the usual first response to an alarm is to turn
the alarm off. Proper design of medical equipment therefore should force the
responder to focus on the source of the problem. In the case at hand, the
equipment and alarm were on the side of the patient opposite from the involved
limb so that the visual attention of the responder was not directed immediately
to the site the alarm was drawing attention to.
Unfortunately, you all have lots of equipment that have
alarms that don’t make the responder focus directly at the problem. Faulty
response to alarms is one of the “big 3” problems encountered in many root
cause analyses of sentinel events. Performing FMEA (Failure Mode and Effects
Analysis) is a good way to help anticipate events that might arise in your
critical settings.
Fast forward to the present. The California Department of
Public Health (CDPH) just published its most recent batch of statements of
deficiencies (SOD’s) and plans of correction (POC’s) regarding incidents in
California hospitals. One involved a case with striking similarities to that in
our previous column (CDPH
2017). A patient admitted with an MI suffered deterioration of his chronic
renal disease and was begun on continuous renal replacement therapy (CRRT) with
a femoral catheter for dialysis access (technically, it was continuous veno-venous hemofiltration or CVVH). For comfort, the
patient was covered with a blanket, which obscured the catheter access site. Unfortunately,
at some point the return line became loose and disconnected from the femoral
catheter which caused massive blood loss and cardiac arrest. He received CPR
and blood transfusions and was resuscitated but died several days later.
Review of the CRRT Machine Data History print-out showed
that several alarms had been triggered. First was an alarm warning that return
pressure was dropping. The print-out indicated that
the alarm was cleared 13 seconds after it was issued. The CRRT Machine
manufacturer indicated that at the time of that alarm the screen had the sign,
"WARNING: Return Pressure Dropping" on top of the screen in red
color. On the left side of the screen was written in bold, "Possible
leakage, or disconnection of return line or catheter. Patient is moving or
being moved. Action: 1. Make sure return catheter is securely connected to both
the return line and the patient. 2. To resume
treatment press CONTINUE." The Prismaflex screen
had touch screen buttons for EXAMINE ALARMS, DISCONNECT, bell icon with X
{means MUTE), CONTINUE and HELP. Roughly 3 minutes later another alarm with the
warning “Access Extremely Negative” was issued and
this alarm automatically stopped the machine.
The “complainant” told the CDPH investigator that family members
were at the bedside when the dialysis machine alarmed with a "warning message
about return pressure". The complainant stated a nurse "silenced the alarm
without checking the patient and walked out of the room for several
minutes". The family member called the nurse and when the nurse came back,
the patient looked like he was having seizure and was in cardiac arrest. The
complainant stated when the nurse pulled the blanket at the time of the cardiac
arrest there was pool of blood on the bed and the line was disconnected.
As we typically see in serious incidents with adverse
patient outcomes, there was a cascade of events that each contributed to the
unfolding crisis. The nurse had earlier temporarily stepped outside the
patient’s room to take a call from the laboratory about a critical value (high
lactate) for that patient and was looking for the physician to tell him/her
about that critical value. The patient’s nurse at the time was also a “break
nurse”, covering for the primary nurse who was on break.
We discussed salient distracting features in our January 14, 2014 Patient Safety Tip of the
Week “Diagnostic
Error: Salient Distracting Features”. Salient distractions obviously can
apply to more than just diagnosis. In the current case, the lab had just called
back a critical value on this patient status post MI. His serum lactate was
high (indicating likely inadequacy of tissue perfusion) and that merited prompt
intervention. So the nurse had to leave the room to first take the phone call
from the lab and then locate and inform the physician about that critical
value. The physician then ordered dobutamine and a
venous blood gas. And the physician came and talked to the patient’s
family about the lab results and medications. The nurse also had to respond to
those orders. It’s not clear what role those events may have played in
distracting the nurse from responding correctly to the alarm. Perhaps there was
even an element of confirmation bias in that the physician had just been in the
patient’s room and had not noticed anything unusual. It is not clear from the
CDPH document why the nurse stepped out of the room immediately after clearing
the alarm. Perhaps it was to carry out the orders related to the critical
value.
The exact timeline is a bit sketchy in one regard. The CDPH
document notes that the “break nurse” was expecting to cover for a 30-minute
break. That nurse apparently took over at about 7:00 PM. The time of the first
“Return Pressure Dropping” warning alarm was 7:54 PM. The CDPH document notes
that the primary nurse “returned early” from break because the patient was
coding. So we might wonder whether anticipation of a change in nursing coverage
played any role.
The thrust of our March 26, 2007 Patient Safety Tip of the
Week “Alarms
Should Point to the Problem” was that alarm system setups should focus
visual attention to that part of the system where the problem originates. The
current incident would seem to indicate that does not work. The readout on the
screen seems to clearly indicate where the responder should focus and even
indicates what actions should be taken.
But there are at least 2 factors important in that regard.
First is the location of the alarm screen. In the incident we described in our
prior column the alarm system was positioned on the side opposite the dialysis
access site, causing the responder to be visually focusing away from the site
of the problem. We don’t know where the alarm screen was positioned in the
current incident. But given that the low pressure alarm is probably the most
important alarm (because you can bleed out if the problem is not promptly
corrected) wouldn’t it make sense to position the alarm screen in a place that
would force the responder to visually inspect the access site?
The second consideration is the complexity of the alarm
screen. We don’t know what that screen looked like in the current incident.
While the description of the readout sounds straightforward, we don’t know that
it was the only element visible on the screen. Some of the screens of
monitoring equipment can be incredibly complicated. That complexity may lead to
responders simply taking the easy way out and clearing the alarm, particularly
if they anticipate the alarm will be re-triggered if something serious is
really going on.
But the best interventions are forcing functions. We’d suggest that these alarm systems program in
a “hard” stop for this particular
alarm that requires the responder to verify that he/she has inspected the
access site. That verification should then become part of the medical record.
Note that in the current event, there was no section in the electronic health
record for documenting the monitoring of dialysis access and blood lines.
There were several other deficiencies or lessons learned in
the CDPH case:
In the immediate aftermath of a serious event it is
important to sequester any equipment and materials that may have been involved
in the incident. That is important for two reasons: (1) to identify and
mechanical defects that may have contributed and (2) to prevent using
potentially defective equipment on other patients. Every facility should have
ready access to a checklist for responding to serious incidents. Typically,
with a serious event like the one described today, the nursing supervisor or
the administrator on-call should be immediately notified. That individual would
then access the checklist. The checklist should specify who needs to be
contacted and what action steps need to be taken, including sequestering
equipment. See our sample Serious
Event Response Checklist.
The facility’s plan of correction included the following:
One of the elements in the facility’s POC was to stop use of
blankets in patients receiving CRRT. Frankly, we don’t know how practical that
is, let alone how patient unfriendly that may be. It should not be difficult to
create blankets that would provide both warmth and privacy for patients, yet
leave critical dialysis access sites uncovered. Note that the facility’s
response technically did not ban blankets per se but just says blankets cannot
cover the dialysis access site.
We often use lessons learned from these CDPH documents
because events they describe might be replicated at other hospitals. The fact
that this current event almost duplicates one we described many years ago is
evidence that the circumstances, root causes, and contributing factors present
at one facility may well also be present at other facilities. We hope that our
readers will look at today’s cases and evaluate their own facilities to see if
their practices might render them vulnerable to similar events.
Prior Patient Safety
Tips of the Week pertaining to alarm-related issues:
References:
CDPH (California Department of Public Health). Complaint
Intake Number: CA00471877; posted 4/20/2017
http://www.cdph.ca.gov/certlic/facilities/Documents/2567_Kaiser220012544_IJAP_SanFrancisco.pdf
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