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One
of the first patient safety incidents we investigated over thirty years ago was
a case of massive blood loss in a patient undergoing dialysis (see 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.
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.
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.
A
second consideration was the complexity of the alarm screen. 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. The most reliable patient safety interventions are forcing functions. Weve, therefore,
suggested 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.
In our April 25, 2017 Patient Safety Tip of
the Week Dialysis
and Alarm Fatigue
we discussed 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. That case had a cascade of errors that all contributed
to the fatal incident (see the prior column for details) but, once again,
failure to heed the alarm was a major one.
In both the cases described in our prior
columns, blankets had obscured
the access sites. In yet another
case of a dislodged dialysis needle (see our December 10, 2019 Patient
Safety Tip of the Week Dialysis
Line Dislodgements) a
blanket also covered the access site (Fields 2010).
So, that is a recurrent theme. Use of the blankets is a well-intentioned effort
to keep the patients comfortable. But it obviously subverts the recommendation
to maintain visualization of the access site at all times.
Weve previously recommended that, if a blanket is necessary, it should be one
that has a substantial cut-out section that allows adequate visualization of
the access site.
Recently,
a report from the Veterans Health Administration (Walton 2021) identified 281 bleeding events, including
14 deaths, during hemodialysis treatments over an 18-year period. The onset of
the bleeding was unwitnessed in 67% of the cases, leading to a delay in its
discovery and intervention. Most deaths were associated with central venous catheter
access. 33% of root cause analyses identified physical barriers to direct
observation or an equipment issue as root causes.
Of
the 14 bleeding events that resulted in death from catastrophic hemorrhage, 11
(79%) deaths were associated with hemodialysis through a central venous
catheter and 3 (21%) deaths were reported in patients receiving hemodialysis
through a vascular shunt or graft.
In
every fatal event, bleeding was discovered only after irreversible hemorrhage
had occurred. Mental status and the failure to maintain visibility of the
access site were significant contributors to fatal events. In 57% of deaths,
alteration of mental status or confusion contributed. Likewise, in 57% of
deaths the access site was not visible to the staff because of physical
environmental barriers blocking the view or the access site was covered and
concealed from view. Both alteration of mental status and a dialysis site that
was obscured from view were present in 36% of fatal cases.
An alteration
to the patients
mental or behavioral health status contributed to 19% of all bleeding
events, whereas 31% were unintentionally disconnected by a patient with normal
mental status. In 8, bleeding was the result of an intentional action by the
patient such as disconnection of the dialysis machine from the shunt/graft in a
moment of anger or frustration, and opening the
hemodialysis ports or cutting through the central dialysis catheter in an
attempted suicide.
In
their review of root causes analyses (RCAs) of these cases, Walton et al.
highlighted four areas of attention and concern:
1.
The physical location and the equipment being
used during hemodialysis.
The physical layout of the dialysis unit may obscure direct line of sight to
the patient. Staff may not be competent in the operation of the hemodialysis
equipment or no plan for managing equipment malfunctions has been established. Importantly,
they note that reliance on pressure-sensing alarms is not
recommended because this technology is known to be unreliable.
2.
Staff commitment to standardization and
attention to detail.
The
majority of bleeding
events occur unwitnessed and often associated with a failure to maintain direct
observation of the patient and/or the hemodialysis access site during the treatment.
Covering the patient with a blanket or bedding resulting in concealment of the
hemodialysis access site is a known contributing factor to unrecognized
bleeding events. Recommendations to mitigate bleeding risk during hemodialysis
include staff attention to detail when preparing the vascular access shunt or graft
site and the secure taping of the needles, ensuring bloodlines run unobstructed
from the patient to the dialysis machine and securing connecting points to
prevent separation with clips, and maintaining visibility at
all times to the vascular access site and bloodline connections. Patient
safety checklists are suggested as an important preventive intervention.
3.
The mental status of the patient.
Altered mental status is often associated with hemodialysis-related bleeding
event, including those unrecognized and those deemed self-harming acts, both
intentional and unintentional. The authors note that patients receiving chronic
hemodialysis have significantly higher rates of depression and suicidal
ideation and are known to engage in suicidal acts, commonly associated with
incision of a peripheral arteriovenous shunt or graft in the outpatient
setting. Close observation is needed in patients with alteration of mental
status. They mention that physical restraint may be considered but must be used
judiciously, as it exposes patients to additional risk and potential adverse
outcomes. Psychological support services should be a part of the
multidisciplinary team of every patient on chronic hemodialysis.
4.
The method for hemodialysis delivery.
Central venous catheters have been associated with
significant and fatal bleeding events in both the inpatient and outpatient
settings. Exsanguination from a central venous catheter if unchecked can occur
within minutes. Guidance from the Centers for Medicare & Medicaid
Services and the Kidney Disease Quality Outcome Initiative recommend that central
venous access catheters remain in place no longer than 90 days to avoid complications
including bleeding. Furthermore, the use of a central venous catheter was found
to present more than one point of failure, including dislodgment,
disconnection, and uncapping.
Many
of these recommendations were discussed in our December 10, 2019 Patient Safety
Tip of the Week Dialysis
Line Dislodgements. In that column we noted a review (Saha 2017) that
noted the following major factors leading to needle dislodgement:
·
Issues related to access care (improper taping
of access tubing to the skin, loose luer lock tubing
connection, bloodlines not being looped loosely, or access site not being
visible)
·
Patient factors (eg. a
confused patient pulling the needle out of the access)
They
describe the role of the venous alarm monitor but note that multiple factors
aside from venous pressure can affect the alarm. Plus, there are differences in
venous pressure between grafts and fistulas. As a result of wide variation in
venous pressures, staff often set the alarm thresholds at levels below that at
which a dislodgement should have triggered an alarm. They then discuss various
sensors that can detect blood leaks during venous needle dislodgement, noting
the tradeoff between safety and cost.
In
that column we also noted the work of the American Nephrology Nurses Association
(ANNA) Venous Needle Dislodgement Special Project Workgroup (Axley
2012), which reviewed recommendations of care for venous needle
dislodgement prevention and detection. They developed a set of easy-to-use tools
outlining their recommendations. These focused especially on the procedures for
taping and positioning of needles and lines. But they stressed that vascular
access and needles should be visible at all times
during hemodialysis. Checking the vascular access should be part of the
monitoring routine. And, most importantly, When the venous pressure alarm
is activated, the vascular access, needle sites, and blood line positions
should always be inspected prior to resetting the alarm and/or the alarm limits.
They also discussed the importance of patient and staff education about needle
dislodgement, including caution that alarm systems are not infallible. They
also included a risk assessment tool to help identify patients at high risk for
venous needle displacement. When such high risk
patients are identified, they suggest interventions such as stabilizing the
access limb, using one-on-one monitoring, and consideration of a blood leak
detection device.
Likewise,
The Renal Association (The
Renal Association 2018) recommends that connections and lines are
kept in full view of dialysis staff during dialysis, secured with tape if
necessary, and that any alarm should prompt visual inspection of these. It is
customary in most units to place the dialysis machine on the same side as
patient access, a practice we have recommended since our first column. They
recommend local dialysis nursing supervision guidelines should be adhered to,
though these vary from unit to unit. Some units have double-checking of line
connections by 2 nurses included in their protocols for starting dialysis.
Some
of our prior columns on dialysis, CKD, and ESRD:
March
26, 2007 Alarms
Should Point to the Problem
February 2009 Unintended
Consequences of eGFR Reporting
May 2009 Erythropoiesis-Stimulating
Agents and Mortality
September 20, 2011 When
Practice Changes the Evidence: The CKD Story
September
2013 Is Nephrologist Caseload Related to Dialysis
Mortality?
September 2014 New
Tubing Connections
June 23, 2015 Again!
Mistaking Antiseptic Solution for Radiographic Contrast
November 1, 2016 CMS
Emergency Preparedness Rule
April 25, 2017 Dialysis
and Alarm Fatigue
July 16, 2019 Avoiding
PICCs in CKD
December
10, 2019 Dialysis
Line Dislodgements
February
4, 2020 Drugs
and Chronic Kidney Disease
October
2021 Overdoing It on CKD?
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
Fields R. When Needles Dislodge, Dialysis Can
Turn Deadly ProPublica 2010; Nov. 10, 2010
https://www.propublica.org/article/when-needles-dislodge-dialysis-can-turn-deadly
Walton
E, Charles M, Morrish W, Soncrant
C, Mills P, Gunnar W. Hemodialysis Bleeding Events and Deaths: An 18-Year
Retrospective Analysis of Patient Safety and Root Cause Analysis Reports in the
Veterans Health Administration. J Patient Saf. 2021
September 24, 2021
Saha M, Allon M. Diagnosis,
Treatment, and Prevention of Hemodialysis Emergencies. Clinical Journal of the
American Society of Nephrology 2017; 12(2): 357-369
https://cjasn.asnjournals.org/content/12/2/357
Axley B, Speranza-Reid J, Williams H. Venous needle
dislodgement inpatients on hemodialysis. Nephrology Nursing Journal 2012; 39(6):
435-445
https://www.annanurse.org/download/reference/journal/vndArticle.pdf
The
Renal Association (UK). Severe blood loss in haemodialysis
patients from dialysis line disconnection and femoral catheter removal. July
23, 2018
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