Just as a push to perform cataract surgery in the office
setting has appeared, a study from Massachusetts has revealed preventable
patient safety errors continue to occur in cataract surgery. Don’t get us wrong
– cataract surgery is one of the safest procedures of all and the rates of
adverse events are very small indeed. But the Massachusetts experience would
certainly would suggest the need to have the same degree of oversight and
reporting of adverse events in office practice that we have in hospitals and
ambulatory surgery centers (ASC’s).
The Betsy Lehman Center for Patient Safety and Medical Error
Reduction just published its analysis of adverse events occurring during
cataract surgery in Massachusetts between 2011 and 2015 (Betsy
Lehman Center 2016). The study was done in conjunction with the
Massachusetts Department of Public Health, the Massachusetts Society of Eye
Physicians and Surgeons, the Massachusetts Society of Anesthesiologists, and
the Massachusetts Board of Registration in Medicine. Representatives from
various hospital and patient safety organizations also served either on the
steering committee or as reviewers.
While the numbers of adverse events were small (28 serious
events over the 5 year period), the continued occurrence of wrong lens, wrong
patient, and wrong eye procedures is bothersome. In addition, loss of vision
from nerve blocks was also noted.
Implantation of the
Wrong Intraocular Lens (IOL)
Implantation of the
wrong intraocular lens (IOL) represented over half the cases in the Betsy
Lehman Center report and occurred 15 times in the 5 year period. That is a
problem near and dear to our heart. Twenty years ago we reviewed a scenario
where two consecutive patients received implantation of incorrect intraocular
lenses after another patient had been inserted into the surgical schedule
because he complained he had been told he’d be the first case of the day. After
our review of the cases and identification of numerous factors that contributed
we commented “I can’t believe this has never occurred before”, only to be
confronted with sheepish grins indicating this had not been the first time such
had occurred. Shortly thereafter we were at a meeting of the clinical committee
advising the New York State Department of Health on its incident reporting
system. During the lunch break, we asked if any of the other hospitals
represented had experienced similar incidents. The hands of at least a third of
the hospital representatives went up! As a result of those cases, we developed
one of the very first comprehensive “timeout” polices in the US, one that later
served as a model for similar policies across New York and the country (see our
Patient Safety Tip of the Week “Weighing
in on Double-Booked Surgery”).
John Simon and his colleagues at Albany Medical College subsequently
published an analysis of New York state cases as part of their retrospective
review of 106 cases of surgical “confusions” in several venues (Simon
2007a, Simon
2007b, Simon
2007c). These include 42 cases from the Ophthalmic Mutual Insurance Co. and
64 cases from the New York Patient Occurrence and Reporting Tracking System
(NYPORTS). 67 cases involved wrong lens implants, 15 cases wrong-eye
operations, 14 cases wrong-eye block, 8 wrong patient or procedure, and 2 wrong
corneal transplant. Based on these findings, they estimated an incidence of 6.9
such errors per 100,000 ophthalmologic surgeries.
Implantation of the wrong intraocular lens was the most
common occurrence in both databases. Errors in both the preoperative period and
operative period were found to lead to the incorrect implantation. In the
preoperative period, contributory causes identified included faulty calibration
of the A-scan equipment, transposition of records from the ophthalmologist’s
office, transcription errors, switched patient identification stickers, and
transposition of IOL power calculations while faxing records on two patients at
the same time.
Intraoperative errors in almost all cases involved failure
to identify the lens specifications properly before implantation. Multiple
contributory factors were identified, including changes in the OR schedule,
changed staff assignments, staff changes during the procedure, poor lighting,
multitasking and other distractions, and misreading the label on the implant
box. In one case the surgeon had dropped multiple patient charts and they were
out of order when reassembled.
Fortunately, analysis of the cases of implantation of the
wrong IOL by Simon’s group and other studies (Kelly 2011)
(Rongé
2006) have helped identify many of the factors contributing to these
events so that preventive measures are now recognized.
The Betsy Lehman Center report cites that many of the
reported events stemmed from:
They also identified the following key factors contributing
to incorrect IOL implantation:
We like to emphasize the problem created by late changes in the surgical schedule. In our
original case 20 years ago a patient complained that his surgeon had told him
he was going to be the first case of the morning. So staff rearranged the
schedule, inserting his case before several others on the schedule. The surgeon
had several patient charts and multiple IOL’s arranged in order in the OR at
the time, further complicating the situation. That led to our original
“timeout” policy which set forth not only patient verification procedures but
also banned the presence in the OR of
either charts or IOL’s or imaging studies on more than one patient at a time.
Almost every analysis of implantation of incorrect IOL’s also mentions change
in the surgical schedule as a contributing factor in some cases. It’s a good
practice now to let all parties know when a case is taken out of order (either
an add-on case, a cancellation, or other change in the order of the scheduled
surgical list). While Universal Protocol should always lead to verification of
correct patient, procedure, laterality, etc. the “mental image” of the surgical
schedule may still lead to parties mistaking patients or items even after a
properly done timeout.
And they make the following key recommendations to prevent
wrong lens, wrong eye, wrong patient errors:
The report stresses that the method for lens orders should be standardized. They note that handwritten orders for lenses are
vulnerable to errors and instead recommend offices submit either typed requests for lenses or fill out formal forms, preferably electronic forms. Note that
a study on wrong IOL implantations in the UK (Kelly 2011)
also identified abbreviations as contributing to the problem. They warned that
the dangerous abbreviations ‘D’ for
diopter and ‘+’ for plus and ‘-’ for minus may result in confusion. The UK
study also gave examples of handwritten transcription errors such as mixing up ‘11’
and ‘17’, ‘14’ and ‘19’, ‘10.5’ and ‘19.5’, ‘20’ and ‘2D’, etc. The Betsy
Lehman Center study provided an example of a handwritten IOL order in which ‘+17.50’
and ‘+12.50” were confused. Bottom line:
don’t accept handwritten IOL orders!
Biometry errors were
also noted in the UK study (Kelly 2011).
These included use of incorrect biometry formulas, misfiling biometry reports
in the wrong patient record, mixing IOL powers for right and left eyes, and
failure to remove contact lenses when doing biometric measurements. The UK authors
recommend:
Another problem may arise when patients have the same or similar last names (Rongé
2006). While we would hope all facilities are religiously practicing
2-factor verification for all patients, we still recommend that the surgeon,
anesthesiologist, and the OR staff review the surgical schedule for the day and
identify in advance any instances where patients have the same or similar last
names so that special precautions may be taken
Furthermore, the Betsy Lehman Center study suggests that
lenses should be stored in a
separate space outside the operating room. Only
the lens or lenses for the current patient should be present in the OR. In
cases we had seen in the past, an anachronistic practice in which ophthalmologists
would get their IOL’s from vendors on consignment and literally bring a whole
bag of IOL’s into the OR was a major factor in these adverse events. They also
recommend designating a limited number of individuals who may retrieve the IOL’s from storage and place them with the
patient chart. In addition, verification
of the IOL should be done by several individuals (e.g., lens room staff, the nurse
who retrieves the lens, and the surgeon) independently and as a team check to
make sure that the lens is correct at multiple points such as when the lens is
pulled from the storage closet, when the operating room is prepared for the
patient, and immediately before lens enters the sterile field. It is important
that several source documents be used during the verification process. These
would include the patient chart, the original calculation sheet, the surgeon’s
IOL order form, and the surgical print-out. From these sources the eye size,
the lens model and lens power should be verified against the lens packaging.
Like any other timeout or verification process, this is not a passive event.
Rather each person should verbally verify the required information and anyone
should be able to stop the case if there is any doubt or discrepancy
identified. The process should also require documentation of the verification.
We’d also like to again stress the importance of having all source documents available before you
start a case. In our June 5, 2007 Patient Safety Tip
of the Week “Patient
Safety in Ambulatoy Surgery” we lamented that the quality of the medical
records is often not as good in ambulatory settings. The “facility” medical
record is often scant and the physician often brings in his/her office notes
that are “unofficial” as far as the facility is concerned. Often critical
information is in the physician office record and never appears in the facility
medical record. It is therefore incumbent upon the facility and entire team to
ensure the adequacy of the medical record and all documentation prior to the
procedure.
Ironically, one contributing factor identified in the UK
study (Kelly
2011) was the use of white boards in the OR to list the power of the IOL.
Sometimes IOL on the white board was not erased and updated when a new patient
entered the OR. This was particularly a problem when the order of patients was
changed.
And, of course, all the procedures, protocols, and
checklists in the world will fail if all staff do not adhere to them. Failure
to devote full attention of all staff during timeouts or other verifications,
failure to use active rather than passive responses during such verifications,
and cultures that do not allow any member of the OR team to stop a procedure
are all problems we see over and over again in review of adverse events.
Time pressures
are also a concern. Surgeons doing cataract surgery may have many cases
scheduled in a single morning. Liz Kowaczyk, the
Boston Globe’s excellent health correspondent writing on the Betsy Lehman
report (Kowalczyk
2016), interviewed an anonymous nurse who described the surgeon
coming in and saying “I have to be out of here by noon so let’s get going.” Bet
none of your surgeons ever say that! Right!
Organizations should utilize some of the resources available
for patient safety in both hospitals and the ambulatory surgery setting. The
American Academy of Ophthalmology has issued good guidance statements on avoiding
wrong-site surgery and avoiding incorrect intraocular lens placement (AAO
2011) with good examples of how checklists might be utilized, including The
Wrong-Site Wrong-IOL Checklist in its Appendix 3. Also, in our June 8, 2010 Patient
Safety Tip of the Week “Surgical
Safety Checklist for Cataract Surgery” we discussed the UK National Patient
Safety Agency (NPSA) Surgical
Safety Checklist: for Cataract Surgery ONLY, based upon the WHO Surgical
Safety Checklist.
The proliferation of so many new IOL options, such as
multifocal and aspheric optics, has perhaps increased the odds of making
mistakes (Rongé
2006). One of the discussants in that article, Dr. David Chang, called
on lens manufacturers to help surgeons and ASC personnel avoid confusion by
using different colors on their IOL boxes. The Betsy Lehman Center report also
mentioned design of lens packaging (eg. similar labels and product codes, small print) as being
problematic.
We refer you to that article from EyeNet
(Rongé
2006) for descriptions of how several ambulatory centers have
developed protocols for matching patients with the correct IOL’s.
And what do you do if you make a mistake like implantation
of an incorrect IOL? We refer you to our columns on disclosure and apology listed below. Sometimes a patient would have
required use of corrective lenses anyway after cataract surgery and they will
simply require a different corrective prescription than they would have otherwise.
But they still need to be told of the error(s) made, with an appropriate and
sincere apology. Multiple studies have now validated the “disclosure and
apology” approach as being not only the right thing to do but also reducing
liability costs in the long run.
Wrong-Eye Anesthesia
or Surgery
Surgery or anesthesia on the wrong eye was the second most
common event in the Betsy Lehman Center report. Most events were anesthetizing
the wrong eye, highlighting the importance
of performing a separate timeout prior to nerve blocks. Key contributing
factors apply to both anesthesia and surgery:
The importance of involving
the patient in verification of the correct eye should be stressed. Again,
an active rather than passive response from the patient should be sought (have
the patient tell you which eye is to be operated on rather than asking “It’s
this eye, isn’t it?”). But we’ll add our own caveat: given the demographics of
the patient population undergoing cataract surgery there will be a substantial
prevalence of cognitive dysfunction. We’ve all seen cases of wrong-site surgery
where the patient indicated the wrong side. So it is critical that all source documents be consulted as
part of the verification process either for the anesthesia or the surgery.
Surgical site marking
is important and must be standardized across your facilities. Key features of
such marking include that the mark should be unambiguous and should be “sufficiently
permanent” to last through the procedure and be placed in an area that will
still be visible after the patient is prepped and draped. There are examples
where, for example, a “sticky colored dot” affixed to the skin over the eye
intended for surgery becomes dislodged during the prep and draping.
Nerve Blocks Leading
to Loss of Vision
The Betsy Lehman Center report included five cases of
serious harm to patients, several of whom suffered permanent loss of vision, which
occurred in a single day as a result of eye blocks administered by a contracted
anesthesiologist during his second day at the facility and noted several reports
elsewhere of other complications related to retrobulbar
and peribulbar blocks.
The report recommends that:
Wrong Patient Surgery
Though there was only one reported case of wrong patient
surgery in the Betsy Lehman Center report, the report has a discussion on ways
to prevent wrong patient surgery. We refer you to our numerous columns on
wrong-site, wrong-patient surgery listed at the end of today’s column.
The report goes on to detail recommendations for healthcare
organizations and their leadership, ophthalmologists, surgeons,
anesthesiologists, nurses and patients. It also emphasizes the important role
that non-clinicians (eg. office staff) have in
ensuring patient safety. The report is very well referenced and you’ll find it
very valuable.
There are several other adverse events not included in the
Betsy Lehman Center Report:
Methylene Blue
Accidents
Another adverse event seen in cataract surgery is the inadvertent injection of methylene blue (dye)
instead of trypan blue which results in catastrophic loss of vision (see
our prior columns of May 20, 2014 “Ophthalmology:
Blue Dye Mixup” and September 2014 “Another
Blue Dye Eye Mixup”). That is a problem calling
for a system fix as described in those columns.
Intraoperative Floppy
Iris Syndrome (IFIS)
In our June 8, 2010 Patient Safety Tip of the Week “Surgical
Safety Checklist for Cataract Surgery” we noted that the UK National
Patient Safety Agency (NPSA) Surgical
Safety Checklist: for Cataract Surgery ONLY, included a question about
whether the patient was on tamsulosin or other alpha
blocker. That is because of the risk of the “intraoperative floppy iris
syndrome (IFIS)” and other complications (Bell et al 2009).
Moving Cataract
Surgery to the Office?
In today’s introductory paragraph we noted the likely trend
of moving cataract surgery away from hospitals and ambulatory surgery centers
to the office setting. Such a trend is likely to follow after a recent study
demonstrated the relative safety and effectiveness of such procedures done in
the office setting (Ianchulev
2016). We expect that payors will also
push for that trend since the overall costs will likely be lower. But few
states have robust systems in place for reporting adverse events in the office
setting. Given the findings in the Betsy Lehman Center report we would be very
leery of such a move unless appropriate regulatory oversight and reporting is
put in place for the office setting.
Cataract surgery in general is one of the safest surgeries
undertaken today. Yet the Betsy Lehman Center report emphasizes that errors and
adverse events still occur and that system interventions need to be implemented
to minimize the risks even in this relatively safe surgery.
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”
September 2014 “Another
Blue Dye Eye Mixup”
Some of our prior columns
related to wrong-site surgery:
September 23, 2008 “Checklists
and Wrong Site Surgery”
June 5, 2007 “Patient
Safety in Ambulatory Surgery”
July 2007 “Pennsylvania
PSA: Preventing Wrong-Site Surgery”
March 11, 2008 “Lessons
from Ophthalmology”
July 1, 2008 “WHO’s
New Surgical Safety Checklist”
January 20, 2009 “The
WHO Surgical Safety Checklist Delivers the Outcomes”
September 14, 2010 “Wrong-Site
Craniotomy: Lessons Learned”
November 25, 2008 “Wrong-Site
Neurosurgery”
January 19, 2010 “Timeouts
and Safe Surgery”
June 8, 2010 “Surgical
Safety Checklist for Cataract Surgery”
December 6, 2010 “More
Tips to Prevent Wrong-Site Surgery”
June 6, 2011 “Timeouts
Outside the OR”
August 2011 “New
Wrong-Site Surgery Resources”
December 2011 “Novel
Technique to Prevent Wrong Level Spine Surgery”
October 30, 2012 “Surgical
Scheduling Errors”
January 1, 2013 “Don’t
Throw Away Those View Boxes Yet”
January 2013 “How
Frequent are Surgical Never Events?”
August 27, 2013 “Lessons
on Wrong-Site Surgery”
September 10, 2013 “Informed
Consent and Wrong-Site Surgery”
July 2014 “Wrong-Sided
Thoracenteses”
Some of our prior
columns on Disclosure & Apology:
July 24, 2007 “Serious
Incident Response Checklist”
June 16, 2009 “Disclosing Errors That Affect Multiple
Patients”
June 22, 2010 “Disclosure
and Apology: How to Do It”
September 2010 “Followup
to Our Disclosure and Apology Tip of the Week”
November 2010 “IHI:
Respectful Management of Serious Clinical Adverse Events”
April 2012 “Error
Disclosure by Surgeons”
June 2012 “Oregon
Adverse Event Disclosure Guide”
December 17, 2013 “The
Second Victim”
Other very valuable
resources on disclosure and apology:
References:
The Betsy Lehman Center for Patient Safety and Medical Error
Reduction. Advancing Patient Safety in Cataract Surgery: A Betsy Lehman Center
Expert Panel Report. May 2016
http://www.betsylehmancenterma.gov/pdf/BLC_Cataract_Report_digital.pdf
Simon JW. Preventing Surgical Confusions in Ophthalmology
(presentation at NYSDOH Patient Safety Conference, Albany, NY, May 2007)
Simon JW. Preventing Surgical Confusions In
Ophthalmology (An American Ophthalmolgical Society
Thesis). Trans Am Ophthalmol Soc
2007; 105: 513-529
http://www.aosonline.org/xactions/2007/1545-6110_v105_p513.pdf
Simon JW, Ng Y, Khan S, Strogatz
D. Surgical Confusions in Ophthalmology. Archives of Ophthalmology 2007;
125(11): 1515-1522
http://archopht.ama-assn.org/cgi/content/abstract/125/11/1515
Kelly SP, Jalil A. Wrong
intraocular lens implant; learning from reported patient safety incidents. Eye
(Lond) 2011; 25: 730-734
http://www.nature.com/eye/journal/v25/n6/full/eye201122a.html
Rongé LJ. Human Error During Cataract Surgery: Right Patient, Wrong Lens. EyeNet Magazine May 2006
http://www.aao.org/eyenet/article/human-error-during-cataract-surgery-right-patient-
Kowalczyk L. Report faults
cataract surgery errors. Boston Globe 2016; May 12, 2016
American Academy of Ophthalmology Cataract and Anterior
Segment Panel. Preferred Practice Plan Guidelines. Cataract in the Adult Eye.
San Francisco, CA: American Academy of Ophthalmology; 2011
http://www.aao.org/preferred-practice-pattern/cataract-in-adult-eye-ppp--october-2011
NHS NPSA. Surgical Safety Checklist: for Cataract Surgery
ONLY (adapted from the WHO Surgical Safety Checklist)
Bell CM, Hatch WV, Fischer HD et al. Association Between Tamsulosin and Serious Ophthalmic Adverse Events in Older
Men Following Cataract Surgery. JAMA 2009; 301(19): 1991-1996
http://jama.ama-assn.org/cgi/content/full/301/19/1991
Ianchulev T, Litoff
D, Ellinger D, et al. Office-Based Cataract Surgery.
Population Health Outcomes Study of More than 21 000 Cases in the United
States. Ophthalmology 2016; 123(4): 723-728 April 2016
http://www.aaojournal.org/article/S0161-6420%2815%2901489-X/abstract
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