What’s New in the Patient Safety World
December 2013
·
FDA Alert on Spinal Procedures and
Anticoagulants
·
Lessons from the SFGH Missing Patient Incident
·
Lighten Up Your
Patient’s Day!
·
Joint Commission CLABSI Toolkit
·
ECRI Institute’s 2014 Top 10 Technology Hazards
FDA Alert on
Spinal Procedures and Anticoagulants
One of the cases in
the recent round of actions by the California Department of Public Health (CDPH
#CA00332399) was that of a patient
who developed a spinal epidural hematoma and paraplegia on removal of an
epidural catheter while she was on low molecular weight heparin (LMWH). The
epidural catheter was removed by a physician’s assistant on the order of
a physician, neither of whom was privileged to insert or remove such catheters
and neither of whom was aware the patient was on LMWH.
Think this case is an extremely rare event? Think again. The
FDA has just issued a safety alert with updated recommendations to decrease
risk of spinal column bleeding and paralysis in patients on low molecular weight
heparins (FDA 2013).
The full version
of the FDA announcement has details of over 100 cases of spinal or epidural
hematoma related to neuroaxial analgesia or spinal
puncture in patients on enoxaparin over a 20 year period.
The FDA recommends that health care professionals carefully
consider the timing of spinal catheter placement and removal in patients taking
anticoagulant drugs and delay dosing of anticoagulant medications for some time
interval after catheter removal to decrease the risk of spinal column bleeding
and subsequent paralysis after spinal injections, including epidural procedures
and lumbar punctures. These new timing recommendations will be added to the
labels of anticoagulants such as low molecular weight heparins, including Lovenox and generic enoxaparin products and similar
products.
The FDA alert recommends use of a preprocedure
checklist that asks whether a patient is receiving anticoagulants and
identifies the appropriate timing of anticoagulant dosing in relation to
catheter placement or removal. Both the dose and the elimination half-life of
the anticoagulant should be considered. For example, for enoxaparin placement
or removal of a spinal catheter should be delayed for at least 12 hours after
administration of prophylactic doses such as those used for DVT prevention.
Longer delays (24 hours) are appropriate to consider for patients receiving
higher therapeutic doses of enoxaparin.
The FDA alert recommends a postprocedure
dose of enoxaparin should usually be given no sooner than 4 hours after
catheter removal.
There are several practical issues raised in the CDPH case
that are also valuable lessons. There are certain procedures that require
specific hospital privileges that we strongly recommend you mandate the
provider take a refresher course and satisfactorily complete a post-test at
least every 2 years. Examples we recommend this for are moderate sedation and
ordering PCA pumps. The same should apply to insertion and removal of epidural
catheters.
Prior to insertion of an epidural catheter you can attach a
checklist that must be completed before the epidural kit can be opened. That
checklist should include a checkbox to indicate that the provider is privileged
to insert the catheter. It should include another checkbox asking whether the
patient is on anticoagulants and not allow the kit to be opened if the
anticoagulants have not been discontinued for the specified period (we
recommend that a table of the “safe” timeframes after discontinuation be part
of the checklist, too).
The hospital in the CDPH case also began adding orange
stickers with “Anticoagulant Therapy” to be placed on all epidural dressings
after insertion.
The hospital also added a hard stop to physician ordering of
Lovenox or various heparin preparations that requires
a response to the following question “If patient has had any spinal procedures
or epidural indwelling catheters in the last 48 hours please select from the
list, otherwise select none”.
They also noted a couple features in their IT systems that
might make ordering of anticoagulants in patients with epidural catheters more
likely. One is use of a “renew all orders” button. Such could be clicked
without the provider recognizing that an epidural catheter had been placed in
the interim. Another was that physicians apparently could enter some orders via
a nurse communication screen rather than the CPOE screen. Orders entered in
this manner apparently might escape review by pharmacists or might not trigger
any alerts. You should look at your systems to see whether such features are
present.
It would also be important to include something about
anticoagulation status in your “Ticket to Ride” communication tool to alert
providers in areas such as Radiology that manipulation of the epidural catheter
may be risky (or to alert them that procedures that might be done in Radiology,
such as lumbar puncture, might be risky)
The consequences of spinal epidural hematomas are
devastating. Development of systems to avoid this preventable complication are
key.
References:
CDPH (California Department of Public Health). Complaint
#CA00332399.
FDA. Safety Announcement. FDA Drug Safety Communication:
Updated recommendations to decrease risk of spinal column bleeding and
paralysis in patients on low molecular weight heparins. November 6, 2013
http://www.fda.gov/Drugs/DrugSafety/ucm373595.htm
FDA. Safety Announcement. FDA Drug Safety Communication:
Updated recommendations to decrease risk of spinal column bleeding and
paralysis in patients on low molecular weight heparins. November 6, 2013 (full
version).
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM373735.pdf
Print “December
2013 FDA Alert on Spinal Procedures and Anticoagulants”
Lessons from the
SFGH Missing Patient Incident
Our October 15, 2013
Patient Safety Tip of the Week “Missing
Patients” had numerous recommendations about steps to be taken when a
patient goes missing. That column was an update to our July 28, 2009
Patient Safety Tip of the Week “Wandering,
Elopements, and Missing Patients”. We did the update because of the
recent events at San Francisco General Hospital where a patient was found dead
17 days after going missing. We had hoped that details of their investigation
would be shared so that other hospitals could learn from this unfortunate
incident. However, details have been slow in coming and all we’ve seen are
fragments published in the local media. Nevertheless, there are probably some
lessons learned even from those few fragments.
Like any other incident with adverse patient outcomes we
typically see a cascade of events that come together to allow that unfortunate
outcome.
A timeline of the events in this case was presented by the
Sheriff whose department oversees the security at SFGH (Yan 2013).
From descriptions in the media it does not sound like there
was ever a point in time where someone said “We have a missing patient.
Activate our missing patient protocol and procedures.” Apparently about 40
minutes went by before the hospital’s security staff was notified the patient
was missing (Van
Derbeken 2013). A nursing assistant had been
looking for her unsuccessfully during that period. One likely contributing
factor was that the patient apparently was being considered for discharge that
day. When the physician went to see the patient prior to the planned discharge,
the patient was already gone. That planned discharge and fact that she was not
subject to a psychiatric “hold” apparently led to Sheriff’s Department deputies
(the security for SFGH is provided by the Sheriff’s Department) to not really
consider handling the case as a missing patient.
The attorney for dead patient’s family said the hospital
should have known much sooner that one of its patients was missing. He pointed
out that hospital staff had deactivated the patient’s bed alarm because she
kept getting up (Palmer
2013).
Next, there was confusion over the description of the
patient. Various reports to the Sheriff’s Department described her as Asian or
African-American though she was white. (As per our previous columns, is this an
example where having a photograph of the patient might have helped?) It was
also unclear whether she was in street clothes or hospital gown.
Other communications issues include that the evening shift
deputies stationed at the hospital were not briefed by previous deputies about
the missing patient (Yan 2013).
Deputies tried to retrieve hospital surveillance-camera
footage for clues of where the patient had gone, but "hardware
problems" prevented them from doing so and it was over a week before those
videos became available.
When searches were eventually done, they were incomplete.
The perimeter of the 24-acre hospital grounds was searched and only about half
of the stairwells were checked.
The Sheriff indicated some changes have already been
implemented (Romney
2013). One is mandated daily patrols of fire stairwells. Another is
required documentation of responses to “stand alone audible alarms” (which
presumably would have occurred when the patient exited into the stairwell).
Apparently none of the stairwell door alarms were deficient, broken or
inoperable; they just weren’t all set to require manual deactivation (Sherbert
2013). Apparently now when those alarms ring, security staff will
check each one, and nurses will make sure all unit patients are accounted for,
as part of a new policy (Hoenen
2013). The video surveillance system is apparently also being
reviewed for possible upgrade.
Also, a visitor to SFGH apparently noted that she had found
herself locked in a similar stairwell at the hospital several months earlier (Rosato
2013). She had decided to skirt the elevator and walk down the
stairs. There apparently were no signs that the doors would automatically lock.
She had to bang on the doors until, finally, a nurse came and opened the door.
We’ll bet you might have similar locked stairwells in your facility. Ask your
security staff if they have ever received a cell phone call from someone locked
in such a stairwell!
Not fully clear from the media are issues related to
staffing of the security department of the hospital. Apparently the Sheriff’s
Department is responsible for providing the security at the hospital. But the
levels of training of that staff are apparently quite variable (Lamb
2013). The media reports do not detail the degree of continuity of security
staff or whether all staff have participated in drills for missing patients.
But apparently a number of changes are taking place in the deployment of staff and
training and retraining.
It is also not clear whether all hospital staff are involved
in a “missing patient” event. From the media descriptions it sounds like the
security staff were expected to do everything. In a “missing patient” event,
for which regular drills should be conducted, all hospital personnel must be
cognizant of their role. Typically, designated staff have responsibilities to
search specific sectors in a “grid” search. And there should be a “command
central” which coordinates the search and records which areas of the facility
and grounds that have been searched.
Now is a good time for all facilities to say “could that
happen here?” and do a thorough review of your policies and procedures for
missing patient incidents, including making sure you do appropriate drills for
such incidents. Take the opportunity to learn from the events at SFGH in their
unfortunate incident. We urge you to review the recommendations in our Patient
Safety Tips of the Week for July 28, 2009 “Wandering,
Elopements, and Missing Patients” and October 15, 2013 “Missing
Patients” about steps to be taken when a patient goes missing.
References:
Yan H. Body found in hospital stairwell: San Francisco
sheriff details what went wrong. CNN; November 7, 2013
http://www.cnn.com/2013/11/07/us/california-body-in-stairwell/
Van Derbeken J. Deputies missed
stairwell in search for missing woman at Calif. hospital. San Francisco
Chronicle; November 7, 2013
Palmer C. Lynne Spalding: Sheriff Tries to Explain How
Deputies Overlooked Missing Patient. SF Weekly Nov. 6 2013
http://blogs.sfweekly.com/thesnitch/2013/11/lynne_spalding_sheriff_tries_t.php
Romney L. Sheriff cites confusion, glitches in search for
missing patient. LA Times. November 6, 2013
Sherbert E. Lynne Spalding: Here's
What SFGH Is Doing to Make Hospital Safer After Missing Patient Found Dead. SF
Weekly Nov. 7 2013
http://blogs.sfweekly.com/thesnitch/2013/11/lynne_spalding_heres_what_sfgh.php
Hoenen L. Security failure blamed
for patient’s death. San Francisco hospital overhauls procedures, awaits review
results. Security Director News; November 11, 2013
http://www.securitydirectornews.com/hospitals/security-failure-blamed-patient-s-death
Rosato J. SF General Visitor Says
She Also Was Locked in Stairwell: Report. NBC Bay Area October 23, 2013
Lamb JO. Some San Francisco hospital security performed by
low-level officers.
San Francisco Chronicle November 8, 2013
Print “December
2013 Lessons from the SFGH Missing Patient Incident”
Lighten Up Your Patient’s Day!
In many of our
columns dealing with delirium we’ve noted the importance of using lighting in
the hospital that mimics normal day/night cycles to help prevent delirium. But
what about the rest of the patients in the hospital who may not be at risk for
delirium? Is their condition and hospital course impacted by the lighting in
the hospital?
Researchers from the
Cleveland Clinic say “yes”. A new study (Bernhofer
2013) used light meters and wrist actigraphy
to assess the sleep-waking patterns of hospital inpatients and correlated those
parameters with patients’ pain levels and mood. Light exposure levels were low and sleep time was poor and fragmented.
There was little sleep–wake synchronization with light. Fatigue and total mood
disturbance scores were high and inversely associated with light. Pain levels
were also high and positively associated with fatigue, but not directly with
light exposure. Low light exposure significantly predicted fatigue and total
mood disturbance. They concluded that inpatients were exposed to light levels
insufficient for circadian entrainment. Nevertheless, higher light exposure was
associated with less fatigue and lower total mood disturbance in participants
with pain.
Though the study was
small (40 total patients) this research demonstrates the need for further studies
to see if altering light exposure for inpatients would be beneficial in
affecting sleep–wake disturbances, mood and pain.
Admittedly there are lots of things other than ambient light
that impact a patient’s sleep-waking patterns. See our August 6, 2013 Patient
Safety Tip of the Week “Just
Let Me Sleep!” for details.
References:
Bernhofer EI, Higgins PA, Daly BJ,
et al. Hospital lighting and its association with sleep, mood and pain in
medical inpatients. Journal of Advanced Nursing 2013;
Article first published online : 27
OCT 2013, DOI: 10.1111/jan.12282
http://onlinelibrary.wiley.com/doi/10.1111/jan.12282/abstract
Print “December
2013 Lighten Up Your Patient’s Day!”
Joint Commission
CLABSI Toolkit
The Joint
Commission, in collaboration with Joint Commission Resources and Joint
Commission International, produced a 152-page monograph in 2012 containing
the most current information, evidence-based guidance, and resources to assist
healthcare organizations in reducing central line-associated bloodstream
infections (CLABSIs).
Now the Joint
Commission, Joint Commission Resources (JCR), and Joint Commission
International (JCI) have developed a toolkit to
supplement the monograph.
The toolkit and
monograph describe the epidemiology, mechanisms, and risk factors for
development of CLABSI’s, the economic and human impact, best practices and
successful patient safety initiatives to prevent CLABSI's, including the work
of Peter Pronovost and colleagues at Johns Hopkins
and the Michigan Keystone Project. They emphasize the factors that lead to
successful prevention programs.
The toolkit and
monograph are loaded with tools to help you have a successful CLABSI prevention
program.
References:
The Joint Commission. Preventing Central Line-Associated
Bloodstream Infections – A Global Challenge (monograph). May 16, 2012
http://www.jointcommission.org/preventing_clabsi/
The Joint Commission. CLABSI Toolkit - Preventing
Central-Line Associated Bloodstream Infections: Useful Tools, An International Perspective. November 20, 2013
http://www.jointcommission.org/Topics/Clabsi_toolkit.aspx
Print “December
2013 Joint Commission CLABSI Toolkit”
ECRI Institute’s
2014 Top 10 Technology Hazards
Each year ECRI Institute puts out its list of the top 10
health technology hazards. The ECRI Institute
2014 Top 10 Health Technology Hazards list is now out:
- Alarm hazards
- Infusion pump medication
errors
- CT radiation exposure in
pediatric patients
- Data integrity failures in
EHRs and other health IT systems
- Occupational radiation
hazards in hybrid ORs
- Inadequate reprocessing of
endoscopes and surgical instruments
- Neglecting change
management for networked devices and systems
- Risks to pediatric
patients from "adult" technologies
- Robotic surgery
complications due to insufficient training
- Retained devices and unretrieved fragments
Most of the entities on the list are repeats from prior
years and we’ve discussed most of them extensively. It’s no surprise that alarm
hazards are #1 on this year’s list. However, there are some that are new to the
list this year: #5 Occupational radiation hazards in hybrid ORs, #7 neglecting
change management for networked devices and systems, and #9 robotic surgery
complications due to insufficient training. In addition, #10 retained devices
and unretrieved fragments is a former list member
that returned this year.
Hybrid OR’s are surgical areas into which advanced imaging
capabilities are brought. Unlike radiology suites or cath
labs where personnel are very familiar with risks of ionizing radiation,
personnel in these hybrid OR’s are less likely to be fully aware of the radiation
hazards. And it is the OR staff that are especially at risk to radiation
exposure. ECRI emphasizes the importance of radiation safety programs that
include training, shielding, and monitoring.
Hazard #7 “neglecting change management for network devices
and systems” has become a real problem. This refers to changes made to one
device or system having “downstream” consequences that are unintended and
unanticipated. They cite as an example an instance where PC software upgrades
resulted in loss of remote display capability of the facility’s fetal
monitoring devices.
Hazard #9 deals with robotic surgery complications. The glow is coming off
robotic surgery. In the last few years we have seen more and more reports that
robotic surgery for certain conditions does not, as touted, result in either
better patient outcomes or fewer complications. In many cases, the widespread rapid
adoption of robotic surgery has resulted in practitioners doing procedures
before they have become sufficiently proficient with the new technology.
Recently it has also been suggested that there may be significant
underreporting of complications with robotic surgery (Cooper
2013).
One of the phenomena we’ve pointed out several times is that
described by Charles Perrow in his classic book
“Normal Accidents” (Perrow
1999) where he talks about how new technologies often simply “push
the envelope”. He cites as an example how the introduction of maritime radar
simply encouraged boats to travel faster and did little to reduce the
occurrence of maritime accidents. Many of the hazards described by the ECRI
Institute in their excellent reports on technology hazards are prime examples
of that phenomenon.
References:
ECRI Institute. ECRI Institute 2014 Top 10 Health Technology
Hazards.
https://www.ecri.org/Forms/Pages/2014_Top_10_Hazards.aspx
Cooper MA, Ibrahim A, Lyu H, Makary
MA. Underreporting of Robotic Surgery Complications. Journal for Healthcare
Quality 2013; Article first published online: 27 AUG 2013
http://onlinelibrary.wiley.com/doi/10.1111/jhq.12036/abstract
Perrow C. Normal Accidents: Living
with high-risk technologies. Princeton, New Jersey: Princeton University Press,
1999
Print “December
2013 ECRI Institute’s 2014 Top 10 Technology Hazards”
Print “December
2013 What's New in the Patient Safety World (full
column)”
Print “December
2013 FDA Alert on Spinal Procedures and Anticoagulants”
Print “December
2013 Lessons from the SFGH Missing Patient Incident”
Print “December
2013 Lighten Up Your Patient’s Day!”
Print “December
2013 Joint Commission CLABSI Toolkit”
Print “December
2013 ECRI Institute’s 2014 Top 10 Technology Hazards”
Print “December
2013 What's New in the Patient Safety World (full
column in PDF version)”
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