What’s New in the Patient Safety World
September 2014
·
Another Blue Dye Eye Mixup
·
Update on Hourly Rounding
·
ER Visits Related to Zolpidem
and Psychiatric Medications
·
New Tubing Connections
Another Blue Dye
Eye Mixup
In our May 20, 2014
Patient Safety Tip of the Week “Ophthalmology:
Blue Dye Mixup” we discussed an unfortunate case
where methylene blue was used during cataract surgery rather than trypan blue and noted we suspected this risk could be
present at many hospitals or ambulatory surgery centers.
Well, in fact, it
has happened before. An almost identical case in North Carolina just resulted in
a $1.5 million malpractice award (Upchurch
2014). The patient was undergoing
cataract surgery and the ophthalmologist ordered VisionBlue
(trypan blue) to stain the cataract so it could be safely removed. But a nurse instead
brought methylene blue and handed it to a surgical technician, who gave it to the
ophthalmologist. Both the nurse and the technician testified they announced
that the drug was methylene blue but the ophthalmologist apparently never heard
that. The patient became permanently blind in that eye and developed glaucoma
in it as well.
Though we don’t want to minimize the importance of
communication and personal accountability in such cases, it is very clear there
is a huge system issue here. The system actually put those healthcare
workers and the patient in a vulnerable position that allowed the mistake to
happen. It is very much akin to the concentrated potassium chloride issue
of the past in which nurses accidentally administered fatal doses of
concentrated KCl to patients. There was little reason
for nurses to have access to vials of concentrated KCl
yet we placed them on nursing units and it was simply a matter of time until
someone unwittingly drew up a syringeful and
administered a fatal dose. Our eventual system fix was to remove vials of
concentrated KCl from floor stock on nursing units.
We need to do the same thing in this scenario. We need to
eliminate the opportunity for nurses or technicians and ophthalmologists to
inadvertently allow methylene blue in a patient’s eye. As we noted in our May 20, 2014 Patient Safety Tip of the Week “Ophthalmology:
Blue Dye Mixup” this is really an example
of confusion about LASA (look-alike,
sound-alike) drug pairs. So if you are an OR or
ASC that does eye surgeries, you should add this drug pair (methylene blue and trypan blue) to your LASA list and take appropriate
precautions to minimize the chance they might be mixed up. If you are a
facility that only does eye cases, you probably have no need for methylene blue
and therefore should not stock it at all.
In other facilities where you may have a legitimate need for methylene blue
(for example, it is used to help identify leaks in some surgeries or to help
identify tissue in need of debridement in others) you clearly need to store the two blue dyes separately. If
you have a dedicated “eye” room and can store all the medications and materials
for eye surgery there (or in an automated dispensing cabinet dedicated to
ophthalmology) make sure that methylene blue is not in those areas. It might
even be worth considering putting warning
labels on methylene blue stating “not for eye cases” or something to that
effect. We are unaware of any “tallman” lettering
conventions for this drug pair. A logical one might be “METHYLENE blue” and
“TRYPAN blue” but you’d have to make sure that these choices are not confused
with any other drugs or substances you stock.
This is a serious situation that could put your patients,
your staff, and your reputation at risk. It deserves your immediate attention
to ensure it doesn’t happen in your facilities.
This is also a great example of our failure to disseminate
valuable lessons learned promptly. The North Carolina case occurred in 2008,
the California case (CDPH
2014) in 2013. We don’t know if the North Carolina case had been discussed
in the ophthalmology literature before. We’re also willing to bet that these
two cases were not the only ones. With the concentrated KCl
issue it took many years for people to recognize that these cases were
happening at multiple different hospitals and ultimately implement a system
change. Let’s hope it does not take many years for hospitals and ASC’s to
implement system changes here.
Some of our previous
patient safety columns involving ophthalmology issues:
June 5, 2007 “Patient
Safety in Ambulatoy Surgery”
March 11, 2008 “Lessons
from Ophthalmology”
June 8, 2010 “Surgical
Safety Checklist for Cataract Surgery”
June 2012 “Tailored Timeouts for Ophthalmologists”
May 20, 2014 “Ophthalmology:
Blue Dye Mixup”
References:
Upchurch K. Jury awards cataract patient $1.5M in
malpractice suit. The Herald-Sun Aug. 20, 2014
CDPH (California Department of Public Health). 2014. Intake
Number CA00368387.
http://cdph.ca.gov/certlic/facilities/Documents/2567AltaBates-0HT111-Alameda-20010511.pdf
Print “September
2014 Another Blue Dye Eye Mixup”
Update on Hourly
Rounding
Though we’ve been big advocates of “hourly rounding”, also known as “purposeful rounding” and other
names, we’ve only done a couple columns about it. Our July 26, 2011 Patient
Safety Tip of the Week “Hourly
Rounding” discussed how hourly rounding, when done well, not only improves
patient satisfaction but also reduces nurse interruptions and may improve
patient safety outcomes.
We think implementing hourly rounding programs is a
no-brainer. Yet many hospitals have not implemented such programs. One of the
reasons is that it involves a major change in nurse workflow and mindset and
usually requires a significant investment of time and money in training and
education.
So researchers at St. Luke’s Episcopal Hospital in Houston,
Texas, already proponents for hourly rounding, sought to see if a “train the
trainer” program could lead to successful implementation of an hourly rounding
program without the more time- and cost- intensive structured programs
typically utilized in such implementations (Krepper
2014). They compared the two approaches on two comparable 32-bed
cardiovascular surgery nursing units. One unit received the structured
approach, which consisted of a 4-hour workshop for staff, posters in patient
rooms informing patients and families what to expect, charting of the rounding
activities both in the electronic medical record and a separate paper log kept
in the patient rooms, use of rounding “scripts”, and coaching/mentoring. The
other unit received its training via a “train the trainer” approach that had
been successfully used in the organization for several other improvement
initiatives. One staff member (the “trainer”) received in-depth training but
the rest of the staff just learned from that trainer. The rest of the staff on
that unit learned from the trainer. There were no in-room logs and no posters
or ongoing coaching/mentoring for this unit. The nurses on this unit did chart
their rounds in the electronic medical record and the nurse manager of the unit
did follow up with staff.
The researchers collected data over a 6-month implementation
period and another 6 months to determine whether the results were sustainable. There was less call light use and fewer steps
taken by the day-shift staff during the study period on the intervention unit
but no significant difference between the two units in staff perception of
“having enough time”. There were no statistically significant differences in
the number of patient falls, 30-day readmission rates, and patients’ perception
of care between the two untis.
The authors concluded that adding additional structure did
not provide any significant advantage over use of the “train the trainer”
program. The hospital did make several changes after the study was completed.
They did away with the in-room paper logs and posters but installed white
boards in patient rooms to inform the patients and families when to expect
regular “comfort care rounds”. Staff are not coached to use a specific
“script”. Each nursing unit is now allowed to decide the best time for rounding
and who will do the rounding (i.e. nurse vs. patient care assistant).
The latter issue is of interest. In our August 28, 2012
Patient Safety Tip of the Week “New
Care Model Copes with Interruptions Better” we described an
innovative program at University of Pittsburgh Medical Center (UPMC) that was
successful in improving care while handling interruptions (Kowinsky
2012). They basically
categorized two types of work: “predictable” and “unpredictable”. The predictable work occurs repetitively
and reliably and can be scheduled. This includes things like rounding, feeding,
repositioning, vital signs, etc. The unpredictable
work consists of tasks that tend to occur randomly over the course of the
day and includes things like answering call bells, blood draws, transporting
patients, handling admissions and discharges, etc. Because of the two types of
work they created two types of roles to deal with them. The “reliable rounder” addressed the
predictable work and the “variable
rounder” addressed the unpredictable work. During the simulation exercise
carried out on an unoccupied available nursing unit, they developed scenarios
and scripts and had observers watch and critique those doing role-playing.
Frontline nurses participated with leaders and quality improvement staff and
provided feedback to improve the model. They then piloted the new model on a
telemetry unit. It was budget neutral since the same number of personnel was
required as in the old model. The model was well received by hospital staff and
at both 90 days and one year there were significant improvements in call bell
response times, blood collection times, and other quality/service metrics.
So we remain advocates of the hourly rounding concept. It
appears that hospitals now have a choice as to the specific staff members who
do the rounds and the amount of resources needed to implement an hourly
rounding program.
For those of you who wish to know more about hourly rounding
we suggest that you read our July 26, 2011 Patient Safety Tip of the Week “Hourly
Rounding” which describes the concepts and elements of such programs, the
evidence for improvement in patient care and patient satisfaction, and has good
references.
References:
Krepper R, Vallejo B, Smith C, et
al. Evaluation of a Standardized Hourly Rounding Process (SHaRP).
Journal for Healthcare Quality 2014; 36(2): 62–69, March/April 2014
http://onlinelibrary.wiley.com/doi/10.1111/j.1945-1474.2012.00222.x/abstract
Kowinsky AM, Shovel J, McLaughlin M, et al.
Separating Predictable and Unpredictable Work to Manage Interruptions and
Promote Safe and Effective Work Flow. Journal of Nursing Care Quality 2012.
27(2): 109-115, April/June 2012
Print “September
2014 Update on Hourly Rounding”
ER Visits Related
to Zolpidem and Psychiatric Medications
About a year ago we
began reporting some statistics from SAMHSA (Substance Abuse and Mental
Health Services Administration) and the Drug Abuse Warning Network (DAWN), a
public health surveillance network that monitors drug-related ED visits in the
US. In our June 2013 What’s New in the
Patient Safety World column “Zolpidem
and Emergency Room Visits” we noted the DAWN report showed emergency
department visits for adverse reactions involving zolpidem
increased 220% from 2006 to 2010 (SAMHSA 2013).
SAMSHA has just
issued another DAWN report showing that the number of emergency department visits for overmedication
involving zolpidem almost doubled from 2005-2006 to 2009-2010
(SAMSHA
2014). Other drugs were combined
with the zolpidem were noted in over half (57%) of the
cases. Note that the 2013 SAMSHA report included cases of ER visits related to
any adverse reaction to zolpidem whereas all the
cases in the current SAMSHA report involve overmedication with zolpidem, with or without use of concomitant drugs. In
2005-2006 there were over 21,000 ER visits in the US related to zolpidem overmedication. This increased to over 42,000 ER
visits in 2009-2010. Almost a third of the visits were in patients in the 45-54
year old age range and females accounted for two-thirds of the cases. Compared
to the age distribution of adverse events involving zolpidem,
which were more common in older patients, cases involving overmedication were
more evenly distributed by age group. The concomitant drugs most often included
narcotic pain relievers, anti-anxiety medications or other sleep medications,
including benzodiazepines, and alchohol.
Almost half (47%) of
the ER visits resulted in hospital admission or transfer and 26% resulted in
admission to an ICU.
And last year the FDA issued warnings about the dosing of zolpidem and recommendations to avoid driving the day after
using some zolpidem products (see our June 2013 What’s New in the Patient Safety
World column “Zolpidem
and Emergency Room Visits” for details). While women seem to be more
susceptible to effects of zolpidem, leading the FDA
to require manufacturers to lower the initial recommended dose for females, a
lower initial dose in males may be wise, too.
Another recent study (Hampton
2014) estimated the numbers and
rates of adverse drug event (ADE) emergency department (ED) visits involving
psychiatric medications among US adults between 2009 and 2011. The researchers
used the National Electronic Injury Surveillance System–Cooperative Adverse
Drug Event Surveillance system and for drug prescribing during outpatient
visits used the National Ambulatory Medical Care Survey and the National
Hospital Ambulatory Medical Care Survey. Although zolpidem
caused significantly fewer ED visits per outpatient prescription visit than
lithium, quetiapine, haloperidol, or risperidone, it was
implicated in 11.5% of adult psychiatric medication ADE ED visits, significantly
more than any other drug. The elderly were particularly vulnerable to adverse
reactions from zolpidem, similar to the 2013 SAMSHA
DAWN report.
Overall, those
researchers found an estimated 89,094 psychiatric medication ADE ED visits
annually, with 19.3% resulting in hospitalization. Sedatives and anxiolytics,
antidepressants, antipsychotics, lithium salts, and stimulants were implicated
in an estimated 30,707, 25,377, 21,578, 3,620, and 2,779 respective ADE ED
visits annually. They concluded that psychiatric medications are implicated in
many ADEs treated in US ED’s and that fforts to
reduce ADEs should include adults of all ages but might prioritize medications
causing high numbers and rates of ED visits.
It’s clear that
sleep medications and psychiatric medications are responsible for many
emergency department visits. The potential benefits of such drugs must be
carefully weighed against the potential risks and particular attention needs to
be paid to dosing and use of concomitant drugs, particularly when zolpidem is prescribed. Particularly regarding sleep
medications, attention should be directed at improving sleep hygiene and use of
non-pharmacologic means to improve sleep as noted in several our our columns listed below.
Some of our previous
columns on safety issues associated with sleep meds:
August 2009 “Bold
Experiment: Hospitals Saying No to Sleep Meds”
March 23, 2010 “ISMP
Guidelines for Standard Order Sets”
May 2012 “Safety
of Hypnotic Drugs”
November 2012 “More
on Safety of Sleep Meds”
March 2013 “Sedative/Hypnotics
and Falls”
June 2013 “Zolpidem
and Emergency Room Visits”
References:
SAMHSA (Substance Abuse and Mental Health Services
Administration), Center for Behavioral Health Statistics and Quality. (May 1,
2013). Emergency Department Visits for
Adverse Reactions Involving the Insomnia Medication Zolpidem.
Rockville, MD
http://www.samhsa.gov/data/2k13/DAWN079/sr079-Zolpidem.htm
SAMSHA. Emergency Department Visits Attributed to
Overmedication That Involved the Insomnia Medication Zolpidem.
The DAWN Report August 7, 2014
http://samhsa.gov/data/2K14/DAWN150/sr150-zolpidem-2014.htm
Hampton LM, Daubresse M, Chang
H-Y, et al. Emergency Department Visits by Adults for Psychiatric Medication
Adverse Events. JAMA Psychiatry
2014; Published online July 09, 2014
http://archpsyc.jamanetwork.com/article.aspx?articleid=1885708
Print “September
2014 ER Visits Related to Zolpidem and Psychiatric
Medications”
New Tubing
Connections
Various tubing misconnections have occurred for decades,
often resulting in patient deaths. Reported cases have involved almost any
catheter you can think of (substances intended for feeding tubes being given
intravenously or via dialysis catheter, intravenous medications being given intrathecally, hypertonic intravenous contrast agents being
given intrathecally for myelography,
bladder irrigation solutions being given intravenously, intramuscular
medications like Bicillin being given intravascularly, IV fluid being injected into a
tracheostomy cuff, blood pressure cuffs being hooked up to IV lines, and many
more examples).
A variety of contributing factors and root causes for such
incidents have been identified. Obviously, the sheer number of tubes and
catheters in patients is a big problem. Such are often arranged close together
and often look very similar, prompting some to refer to “the spaghetti
syndrome”. Failure to trace the tubing back from the patient to the origin is
another issue. Particurly vulnerable times are at
handoffs or when a patient goes from one unit to another (not just unit-to-unit
transfers but especially trips to places like the radiology suite). And the
usual environmental and personnel-related factors (poor lighting, staff
fatigue, supply shortages, etc.) that are involved in many incidents also
contribute here.
But the most salient feature, of course, is that the design
of the systems allows 2 things to be connected that were never intended to be
connected. The most successful safety interventions in any industry are
constraints and forcing functions, i.e. designs that force someone to do
something or not to do something. This particular issue is one that should be
amenable to use of such forcing function solutions.
Given both the magnitude of the problem and the devastating
consequences, several groups began collaborating several years ago to come up
with new design solutions to prevent such inadvertent misconnections. The
groups included ISO (the International Organization for Standardization), AAMI
(the Association for the Advancement of Medical Instrumentations), the FDA,
manufacturers and clinicians. Important contributions in the past have also
come from ISMP, National Patient Safety Agency (UK), and the Pennsylvania
Patient Safety Authority among many others.
The result of the collaboration is that several new sets of
connector standards are forthcoming. The first ISO connector standard should be
ready in the fall of 2014, with more to follow in 2014 and 2015. Timely is a
new Joint Commission Sentinel Event Alert on managing risk during transition to
the new ISO tubing connector standards (TJC 2014). While it
contains many of the recommendations from its earlier sentinel event alert on
tubing misconnections (TJC 2006) it
focuses on the risks that might occur during the transition to the new tubing
connector standards. It cautions that, though the new standards will ultimately
improve patient safety, there could be new risks during this transition period.
The new Joint Commission sentinel event alert has many
excellent recommended actions your organization should take. We won’t repeat
them here. Go to the actual sentinel event alert
and read them. Also see our previous columns on catheter and tubing
misconnections listed below. There are links to some excellent resources in
them, particularly our April 2012
What’s New in the Patient Safety World column“Tubing
Misconnections” and August 23, 2011 Patient Safety Tip of the
Week “Catheter
Misconnections Back in the News”.
In addition to their recommendations, you should make
monitoring of these systems a priority. It would be a good process to add to
your “patient safety walk rounds” and doing periodic audits of your
organizations practices is another. As before, this topic is an excellent process
to conduct FMEA (failure mode and effects analysis) around.
Catheter/tubing misconnections are among the most
devastating patient events we have seen, since many result in patient death.
See our previous columns on this topic:
July 10, 2007 “Catheter
Connection Errors/Wrong Route Errors”
November 2007 “More
Patient Deaths from Luer Misconnections”
August 2009 “Catheter
Misconnections Continue to Occur”
March 30, 2010 “Publicly
Released RCA’s: Everyone Learns from Them”
April 2010 “RCA:
Epidural Solution Infused Intravenously”
August 2010 “ISMP
Advice on Catheter Misconnections”
August 23, 2011 “Catheter
Misconnections Back in the News”
April 2012 “Tubing
Misconnections”
References:
TJC (The Joint Commission). Sentinel Event Alert 53:
Managing risk during transition to new ISO tubing connector standards. Sentinel
Event Alert 2014: 53: 1-6, August 20, 2014
http://www.jointcommission.org/sea_issue_53/
The Joint Commission. Tubing misconnections—a persistent and
potentially deadly occurrence. Sentinel Event Alert 2006; Issue 36 April 3, 2006
http://www.jointcommission.org/assets/1/18/SEA_36.PDF
Print “September
2014 New Tubing Connections”
Print “September
2014 What's New in the Patient Safety World (full
column)”
Print “September
2014 Another Blue Dye Eye Mixup”
Print “September
2014 Update on Hourly Rounding”
Print “September
2014 ER Visits Related to Zolpidem and Psychiatric
Medications”
Print “September
2014 New Tubing Connections”
Print “September
2014 What's New in the Patient Safety World (full
column in PDF version)”
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