Patient Safety Tip
of the Week
December 5, 2017
Massachusetts
Initiative on Cataract Surgery
Cataract surgery is generally considered to be one of the
safest surgical procedures. We have, however, identified problems related to cataract
surgery over the years (see the full list at the end of today’s column). A year
ago we discussed the findings of a report from Massachusetts’ Betsy Lehman Center for Patient Safety
regarding patient safety issues in cataract surgery (see our May 17, 2016
Patient Safety Tip of the Week “Patient
Safety Issues in Cataract Surgery”).
Now two reports have been published regarding the adverse events (AE’s) in cataract surgery from the Betsy Lehman Center study, with a focus on the anesthesia-related issues (Roberto 2017, Nanji 2017).
The first report (Roberto
2017) described the reports of 37 AE’s reported to state agencies in Massachusetts involving cataract surgery from 2011 to
2015. Wrong intraocular lens (N = 15, 41%) involved selecting a lens intended
for a different patient, and was the most frequent AE. We’ve discussed this
issue in several of our prior columns.
Next most frequent
were complications from needle-based eye blocks (N = 10, 27%), which included 5
globe perforations (serious reportable events or SRE’s) and 5 non-SRE major
incidents, such as retrobulbar hematoma. There were also 3 cases of wrong side
eye blocks and one case of wrong side surgery. Other AE’s included retained
object/tissue (2 cases) and 3 cases of suspected toxic anterior segment
syndrome. The authors discuss possible mechanisms for the permanent visual loss
related to the needle-based blocks. The authors also queried the Anesthesia
Incident Reporting System, the CRICO Comparative Benchmarking System, and the
Anesthesia Closed Claims Database and identified other adverse events. They
conclude that there is likely underreporting of adverse events in all these
data sources but that the types of injuries identified should be a signal for
investigation into ways to avoid these adverse events. In particular, they note
that reporting from ASC’s (ambulatory surgery centers) has been less robust
than from hospitals, That is a concern since there has been a massive shift in
cataract surgery from hospital-based outpatient surgery to ASC’s (Stagg
2017).
The companion paper (Nanji
2017) delved into details of the Massachusetts cases with adverse events
and a panel of experts identified 2
principal categories of contributing factors: systems failures and choice of
anesthesia technique. Systems failures included inadequate safety protocols
(48.7% of contributing factors), communication challenges (18.4%), insufficient
provider training (17.1%), and lack of standardization (15.8%). Choice of
anesthesia technique involved the increased relative risk of needle-based eye
blocks.
Among the inadequate
safety protocols they identified inadequate timeout protocols (40.5%) and
poor adherence to time-outs (37.8%) as major contributing factors. Failure to
include a second provider in the time out, incomplete time outs, and time outs
separated in time from the procedure were specific deviations noted. Improper
lens storage was cited in 13.5% of incidents and failure to use at least 2
independent sources of lens verification was also identified as a contributing
factor. One facility reported that they bring lenses for all scheduled patients
into the operating room at the start of the day.
The authors also
identified high case volumes and time pressures as significant contributing
factors. These often led to workarounds for time outs, complacency with time
outs, and distractions by concurrent activities leading to lack of active
participation in time outs. They also mention the literature notes changes in
surgical schedules may contribute.
All these are very
familiar to us. Over 20 years ago we investigated our first case of wrong lens
implantation. A high number of cases were scheduled
at an ASC for one ophthalmologist, who brought into the OR all his outpatient
records for patients scheduled that day plus all the lenses expected to be used
that day. When one patient complained he had wanted to be first case of the
day, staff changed the OR schedule and inserted that patient earlier than
originally scheduled. As a result, two
consecutive patients each received the wrong lens implants before the situation
was recognized. That was the case that led us to develop a comprehensive time
out process that served as a template for New York State’s first time out
policy and eventually Joint Commission’s Universal Protocol.
Having multiple
patient records in the room and having multiple lenses in the room simply
increased the odds of mistakes considerably. Verification of the correct lens
(using primary source verification) also needs to be a formal part of the time
out process. Because cataract surgery typically is done on an ambulatory basis,
some factors come into play. There is typically no “hospital” medical record
with details available and much of the vital information is in the physician
office notes, which have not become part of the facility medical records.
Failure to ensure that a history & physical are in the chart prior to the
start of the case also is a missed opportunity to identify discrepancies that
may lead to wrong patient or wrong eye or wrong lens events.
Nanji and colleagues
also identified communication issues as the
second major contributing factor. Many involved staff miscommunication during
lens time outs but others were miscommunications with patients (a cited example
was when the wrong patient responded when the nurse called for the next
patient). But written communication breakdowns were also an issue, often
related to poor handwriting. And, as we so often see in serious incident
investigations, failure of staff to speak up and hesitancy to voice concerns in
high-turnover rooms was involved in 28.6% of the communications challenges
identified.
The third most
common contributing factor identified was insufficient training.
Inadequate orientation and training and use of temporary staff or locum tenens
staff contributed in some cases. Inadequate training on the administration of
eye blocks was cited as a factor in the 5 cases of globe perforation in the
Massachusetts series. The authors note that less than one fourth of
anesthesiology residency programs offer ophthalmic anesthesia training.
The fourth
contributing category identified was lack of standardization across and
even within facilities. Things that have not been standardized across sites
include: lens ordering forms, site marking techniques, and even variations in
lens packaging.
Choice of anesthesia technique was a major focus of the Nanji paper. Over 40% of the adverse events in
the Massachuesetts series involved eye blocks. They note that none of the AEs
involved topical anesthesia, sub-Tenon’s block, or general anesthesia.
Importantly, the anesthesiologist with 5 reported globe perforations was a
contracted provider working his second day at the facility. His privileges had
been granted based upon information provided by a credentialing service. The
expert panel suspected that inadequate credentialing and insufficient
orientation to unfamiliar equipment and lack of knowledge/experience or
improper technique contributed as well as the inherent risks associated with
the type of anesthesia used. The Nanji paper goes into detail about the types
of anesthesia technique (including an appendix describing each in detail) and
the great variation with which each is used across facilities and providers.
The panel identified
6 key strategies to help prevent AE’s in cataract surgery:
- Perform a separate time-out immediately before administering a
block, involving active verification by at least 2 team members and the patient,
when possible
- Adopt a standardized, facility-wide policy for marking the operative
eye that involves the same unambiguous and enduring mechanism used by all
providers within the facility
- Strengthen credentialing and orientation processes for new, contracted,
and locum tenens anesthesia staff, including clear internal assessment
criteria and standardized questions to be evaluated by qualified staff;
and adequate onboarding that reviews elements such as a facility’s work
flow, site-marking policy, and time-out procedures
- Observe the initial blocks of any anesthesia provider who is new to
a facility, and require that they have adequate and documented training,
both didactic and clinical, on proper technique, management of
complications, and identification of high-risk patients
- Use the least invasive form of anesthesia that is appropriate for
the patient and case, considering the patient’s preferences and
comorbidities, the planned procedure, and potential complications
- Stay current on evidence-based practices for minimizing the risk of
harm from anesthesia, and avoid relying on personal experience to assess
the relative safety of techniques
To these we would
add our own further recommendations (these and others are described in our May
17, 2016 Patient Safety Tip of the Week “Patient
Safety Issues in Cataract Surgery”):
- Don’t allow multiple charts in the room
- Don’t allow multiple lenses in the room
- Don’t allow handwritten lens orders
- Your time outs need full participation and undivided attention of
all participants
- All primary source documents must be available in the room prior to
start of a procedure (and the H&P must be visible for all to see, not
simply “dictated”)
- Minimize last-minute schedule changes and, if a change is absolutely
necessary, make sure that all involved parties are fully aware of that
change and its implications
- Use checklists! (for case scheduling, pre-op huddle, anesthesia
block, time outs, and post-op debriefings)
The two papers resulting from Massachusetts’ Betsy Lehman Center for Patient Safety
investigation are important contributions to our understanding of factors
contributing to adverse events in cataract surgery. While cataract surgery
remains one of the safest procedures done today, the findings indicate we can
do more to make it even safer.
Some of our previous patient safety columns involving ophthalmology issues:
June 5, 2007 “Patient
Safety in Ambulatory 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”
September 2014 “Another
Blue Dye Eye Mixup”
May 17, 2016 “Patient Safety Issues in Cataract Surgery”
References:
Nanji KC, Roberto SA, Morley MG, Bayes J. Preventing Adverse Events in Cataract Surgery: Recommendations From a Massachusetts Expert Panel. Anesthesia & Analgesia 2017; Published Ahead-of-Print Post Author Corrections: October 04, 2017
Roberto SA, Bayes J, Karner PE, et al. Patient Harm in Cataract Surgery: A Series of Adverse Events in Massachusetts. Anesthesia & Analgesia 2017; Published Ahead-of-Print Post Author Corrections: October 05, 2017
Stagg BC, Talwar N, Mattox C, et al. Trends in Use of Ambulatory Surgery Centers for Cataract Surgery in the United States, 2001-2014. JAMA Ophthalmol 2017; Published online November 22, 2017
https://jamanetwork.com/journals/jamaophthalmology/article-abstract/2664081
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