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The
State of Florida Board of Medicine recently fined a physician $2,500 and issued
a letter of concern after he performed surgery on the wrong testicle (Neal 2021). In addition, the physician must take some
continuing medical education courses and give lecture at a medical facility on
wrong-site surgeries.
The
patient was scheduled for a varicocelectomy. Prior to the procedure, while in
conversation with the patient, the physician marked the right testicle (the
incorrect testicle) for the procedure. Following his erroneous mark, he did a
varicocelectomy on the right testicle. But, during the procedure, he realized
that the patient had consented to a left testicle varicocelectomy. He then
performed a left testicle varicocelectomy.
Since
the physician was the Board of Medicines purview, it is apparent why the focus
was on the physicians role. But what about the facilitys role? There should
have been several opportunities to prevent this wrong-site mistake. We discuss
those opportunities below.
Opportunities
to prevent wrong-site surgery occur during:
·
Booking/scheduling
·
Pre-op clinic
·
Informed consent
·
Pre-op huddle
·
Site marking
·
Surgical timeout and Surgical Safety Checklist
Lets
start with the booking of the surgical case. In our October 30, 2012 Patient Safety Tip of the
Week Surgical
Scheduling Errors we
highlighted a study by Wu et al. (Wu 2012), who did a qualitative and quantitative
analysis of errors occurring during the surgical booking/scheduling process and
identified not only patient safety issues but also analyzed the costs associated
with the delays such errors end up causing. Looking at over 17,000 surgeries
they found a booking error rate of 0.86%. Of the booking errors wrong side was
listed on 36%. Another 25% were incomplete and may not have included the
laterality. Wrong approach (eg. laparoscopic rather
than open) accounted for 17% of the errors. Other booking errors included wrong
patient information, wrong procedure, wrong site, and even wrong patient. Most
of the errors were caught in the holding area or the OR but some were caught in
the admission/registration area or assessment areas. The errors were discovered
about equally between the first case of the day, the rest of the morning, and
afternoon.
Your
surgical booking process should require specific items be filled in and
specific documents received before giving that case a final time slot. For
example, you should require a copy of the informed consent and the history and
physical before booking so that you can match the information on those against
the scheduled procedure. Note that having a copy of the history and physical
will also allow you to identify cases in which the H&P will expire before
the 30-day Joint Commission requirement. You should also include pre-op orders
where appropriate (eg. for prophylactic antibiotics).
Your
booking form should also have an area any needed special equipment or implants
can be recorded. We also recommend you have an area that indicates whether a
surgical specimen (for pathology) is anticipated.
Abbreviations
on booking logs and forms can be problematic and should not be used.
Ophthalmologists like to use OD/OS for right eye and left eye in their notes.
They should spell out right eye and left eye. Weve seen cases where OD gets
misinterpreted as AD and antibiotic drops get put in the right ear instead of
the right eye. Similarly, some of us like to indicate right or left or
bilateral by using circles around an R, L, or B respectively. That is
particularly dangerous in scheduling since it is very easy to mistake these for
the wrong side. Note that fax artifacts can further lead to misinterpretation
of some abbreviations (see our June 19, 2012 Patient Safety Tip of the Week More Problems with Faxed Orders for a discussion on types of errors related
to faxes and how to avoid them). So, you really shouldnt use abbreviations at
all on your booking forms. Similarly, you should not use acronyms on your
scheduling forms since all parties may not understand those.
Surgical
procedure codes may not match the description of the procedure being scheduled.
For those who enter a procedure code on the scheduling form we always recommend
a written description also be included so that staff can cross check to make
sure what the intended procedure is and reconcile any discrepancies.
If
more than one procedure is being scheduled on the patient, be sure that the
consent form includes all the procedures (and that the other information for
that subsequent procedure is also included if relevant).
We
also recommend that the surgical booking should include a question about
whether a surgical specimen is likely to be taken. That can be of value in
preparing staff to receive and correctly process any specimens and avoid lost
or misplaced surgical specimens (note that this should also be an item on your
Surgical Safety Checklist or equivalent).
Often
it is a non-clinical person calling in the case from the physicians office or
clinic and just as often a non-clinical person is receiving the request at the
facility and entering it into the schedule. That certainly can add
vulnerabilities to scheduling. The Minnesota Alliance for Patient Safety, which
has great resources on surgery scheduling and verification on its Safe
Surgery website, has a scheduling form template. An important facet of that form is that
there is a section that must be completed by the surgeon (or physician
performing the procedure).
And there is one logical question that very few hospitals
consider when scheduling cases: are there patients with similar names or
similar sounding names scheduled on that same day? Our many columns on patient
misidentification (see, for example, our March 26, 2019 Patient Safety Tip of
the Week Patient
Misidentification) discuss the frequency with which patients
having similar sounding names are in the hospital at any one time. One
statistic we like to point out is that, in one hospital district in Texas, 2488
patients were named Maria Garcia, and 231 of these (9.3%) also shared the same
date of birth (Lippi 2017b)! Where possible, you should attempt
to schedule cases with similar names on different days. If you cant, you
should attempt to somehow flag such cases with similar names on the paper or
electronic schedule and on the surgical schedule white board.
The
absence of primary source documents at any of these levels is a major
factor contributing to wrong-site events. In some cases, the documents are
available but staff do not take the time to review them. We suspect that may be
more of a problem when doing what some would consider minor procedures.
Primary source documents include office notes or hospital
admission notes, the booking document, the signed informed consent, and any
relevant imaging studies. One critical issue we often see relates to the
availability of the H&P at the time of surgery. Particularly since most
patients having elective surgery are admitted on the day of surgery or are
having same day surgery, the H&P must be available in advance. Weve seen
cases where the surgeon dictates the H&P on the day of admission and a
readable copy may not be available for all the OR players to read. Therefore,
it is imperative that your OR require the H&P from the surgeons office be
available prior to the day of surgery (and remember it must be appropriately
updated when it is done in advance). Having a surgical home is a good way to
ensure this, whether the surgical home is staffed by surgeons,
anesthesiologists, or preferably a multidisciplinary group. The other way, as
described in our October 30, 2012 Patient Safety Tip of the Week Surgical Scheduling Errors is
to cancel any elective cases for which a copy of both the informed consent and
the H&P are not available at least a couple days in advance of the
scheduled procedure.
A
second opportunity to verify patient, site, laterality, and procedure is in the
pre-surgical clinic or surgical home. Many of these are run by
anesthesiologists, nurse practitioners, physicians assistants, or surgeons
themselves, though we prefer the truly multidisciplinary clinic. But we wont
go into detail about such pre-surgical venues since not all patients are seen
in them.
A third important event in preventing wrong
site surgery is the informed
consent. We discussed this in
detail in our September 10, 2013 Patient Safety Tip of the Week Informed
Consent and Wrong-Site Surgery. In
that column we note that the preoperative area is not the appropriate place for
the informed consent process to take place. Proper informed consent requires
the physician or practitioner provide the patient with details of the
procedure, the potential benefits and potential harms, and the alternatives
(including what might happen with the alternative of doing nothing). That
discussion takes time and there must be adequate opportunity for the patient
(and any surrogate) to ask questions. The pressures in the preoperative area
cause considerable truncation of the informed consent process. Moreover, once a
patient has committed to coming to the hospital or ASC for a procedure, they
are very unlikely to say no. So, the more appropriate place for the informed
consent to be performed is the physicians office, clinic, or inpatient bedside
if the patient is already admitted.
We strongly recommend that you not schedule
surgery until you (the hospital or ASC) have in hand copies of the H&P, the
booking form, the consent form, and imaging studies. While you might provide a
tentative date and time for surgery you must have a drop dead date on which
you will cancel that tentatively scheduled slot if you have not received these
items. Things like the H&P may need updating to meet regulatory time frames,
but you should have available at least the H&P from the office at the time
the case was originally scheduled.
Having the consent form ahead of time will
help in the preoperative verification process. It should prompt the surgeon to
address the issues well before the day of the procedure and allow preoperative
personnel to spot discrepancies long before the day of surgery so they can be
resolved. We suggest all hospitals and ASCs do spot audits to determine how
frequently informed consents are being done on the day of the case rather than
being done in advance.
Aside from the surgical time out, site marking has
probably been one of the most important interventions aimed at reducing
wrong-surgery events. Protocols do exist for site marking for most surgical
specialties. But, in general, the site should be marked with indelible ink and
the mark should be as close to the incision site as possible (keeping in mind
how surgical draping might relate to that mark). See our May 14, 2019 Patient Safety Tip of the Week Wrong-Site Surgery and
Difficult-to-Mark Sites for a discussion on marking those sites
that are midline or otherwise difficult to mark. The site marking should be
verified by the surgeon (or clinician responsible for the procedure) and the
responsible nurse. Note that we also recommend including the anesthesiologist
if the site marking is done as part of the pre-op huddle. And the patient
must be included in verification of the site and the procedure to be performed.
That means this must be done before the patient is administered any medications
that might cloud his/her cognition. If the patient is incapable of
participating in the site verification, a patient family member or other
advocate should participate. And remember to have an interpreter for patients
who dont speak English or a signer for the hearing impaired patient present
for the site marking. Note that the Minnesota Alliance for Patient
Safety scheduling
form template, mentioned
above, includes an item regarding need for an interpreter.
The surgical
time out and use of the Surgical Safety Checklist (or equivalent)
are the last lines of defense for preventing wrong site surgery. See our many
prior columns listed below for details on time outs and use of the checklists.
But it is critical that you have full attention of all the surgical team members
during the surgical time out and use of the checklist(s). Failure to speak
up remains a problem in cases of wrong-site surgery. Unfortunately, the
persistence of hierarchies in the OR remains problematic and all too often
staff are afraid to speak up when they have questions. It is crucial that
hospital clinical and administrative leadership support, not just with words
but also with actions, a culture where all member of the team are encouraged to
speak up.
We
are often dismayed that hospitals or ambulatory surgery centers have no idea
what their time out compliance rate is. A recent article in Outpatient Surgery
(Bouchat-Friedman
2021) described how a hospital improved its time
out compliance rate from 60% to 80-90%. But there is no reason you should not
have rates of nearly 100%, especially for non-emergency procedures.
And we are not just talking about whether a surgical time
out took place. We are talking about active participation by all OR
staff during the time out. Our May 2020 What's New in the Patient Safety World
column Poor
Timeout Compliance: Ring a Bell?
discussed how frequently one or more individuals are distracted during the time
out.
How
do you audit compliance with time outs? You can have an observer in the room to
assess compliance. But the mere presence of an observer typically leads to the
OR team complying with the time out in that session (the Hawthorne effect).
Alternatively, as we have often recommended, you can use audio/video recording.
A good system uses audio/video recording not only to audit time outs, but also
to provide critiques to improve the time out process.
The Bouchat-Friedman article (Bouchat-Friedman
2021) focused on building a culture of safety.
They found that, by giving each team member a specific role in the time out
process, team members had less fear of speaking up if a potential problem is
detected, and it also emphasizes the importance of the time out process.
The Bouchat-Friedman article also emphasizes the importance of
having support from the top of the organization, as weve emphasized above.
They discuss an individual who still refused to take part in the process, so
concerns were escalated up the chain of command and the hospital's leadership
fully supported those efforts and made sure that individual was an active
participant in the time out process moving forward.
Dont
forget that the time out should be repeated any time there is a change in the
surgical team. For example, if a second surgeon enters the OR after the case
has begun, a second time out should occur.
Patient
positioning in the OR can also be a factor contributing to wrong-site
events. If a patients position is changed during the procedure, there may be
right-left confusion. Also, in our September 2021 What's New in the Patient
Safety World column Ambiguous Language in the OR we noted it is a good idea to define a
directional frame of reference at the start of a procedure, eg.
left-right from the patients perspective or the surgeons prospective, use
toward the head rather than up/down, etc. (Liu 2021). Change in position of the patient can also
obscure the site marking. Its a good practice to discuss right-left orientation
with all staff any time you change a patients position.
The
Pennsylvania Patient Safety Authority, which for many years has reported
extensively on wrong-site surgery and wrong procedures, did its most recent
extensive report last year (Yonash 2020). From the Pennsylvania Patient Safety
Reporting System (PA-PSRS) database over a five-year period from 2015 to 2019,
the authors found 368 instances of wrong-site surgery, 76% of which contributed
to or resulted in temporary harm or permanent harm to the patient. That was an
average of 1.42 wrong-site surgery events per year in Pennsylvania. Events
occurred at both acute care hospitals (79%) and ambulatory surgical facilities
(21%). There wasnt much change in event frequency for this period compared to
the previous two fiver-year periods (mean frequency 65.8, 51, and 58 during the
five-year periods of 2005-2009, 2010-2014, and 2015- 2019, respectively).
The
distribution by error type was: wrong side (52.7%), wrong site (31.5%), wrong
procedure (12.5%), wrong patient (2.7%). Almost all body sites were affected,
with spine procedures accounting for the largest portion (24%), followed by head/neck
(17%), lower extremity (14%), and upper extremity (13%). Almost every
specialty experienced wrong-site surgery events, though the type of event
varied by specialty. For example, pain management was primarily associated with
wrong side errors while interventional radiology had a relation with several
types of error (wrong side, wrong site, and wrong procedure). And within
specialties, certain procedures were more likely related to wrong-site surgical
events. For example, in urology, procedures involving stents were
over-represented.
·
Preoperative Verification and Reconciliation
·
Site Marking
·
Timeout and Intraoperative Verification
Weve discussed most of those strategies
above.
A
recent Medscape article had some sobering statistics on wrong-site surgery (Page 2021). It noted studies which found that 25% of
neurosurgeons had performed wrong-site surgeries and 25% of orthopedic surgeons
reported performing at least one wrong-site surgery during their career. And its
often more experienced surgeons who are involved in wrong-site surgery cases.
Page notes that two thirds of the surgeons who perform wrong-site surgeries are
in their 40s and 50s, compared with fewer than 25% younger than 40. Page also
notes this chilling statistic: 12.4% of doctors who were involved in sentinel
events in general had claims for more than one event.
Not all wrong side events are technically surgeries.
For many years, the most frequent wrong site events in New York State were wrong
side chest tube insertions. And wrong side thoracenteses can lead to pneumothoraxes
(see our July 2014 What's New in the
Patient Safety World column Wrong-Sided Thoracenteses). More recently, wrong side nerve
blocks have topped the list in some states. Discussion of those is beyond
the scope of todays column but we refer you to good discussions of wrong side
nerve blocks and strategies to prevent them (Vandebergh 2021, Balocco 2019). And, in our September 14, 2021
Patient Safety Tip of the Week Wrong Eye Injections, we
discussed intraocular injections into the wrong eye. So, it is incumbent upon
organizations to ensure that pre-procedure time outs and use of checklists
are used for all procedures, whether in the OR or
elsewhere. We often recommend policies and procedures that require a pre-procedure
checklist be completed before the procedure tray is dispensed and opened.
Some hospitals and ASCs are using that concept for surgeries as well as
procedures.
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 WHOs 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 2013 How
Frequent are Surgical Never Events?
January
1, 2013 Dont
Throw Away Those View Boxes Yet
August 27, 2013 Lessons
on Wrong-Site Surgery
September 10, 2013 Informed
Consent and Wrong-Site Surgery
July
2014 Wrong-Sided
Thoracenteses
March
15, 2016 Dental Patient Safety
May
17, 2016 Patient Safety Issues in Cataract Surgery
July
19, 2016 Infants and Wrong Site Surgery
September 13, 2016 Vanderbilts Electronic Procedural Timeout
May 2017
Another Success for the Safe Surgery
Checklist
May
2, 2017 Anatomy of a Wrong Procedure
June
2017 Another Way to Verify Checklist Compliance
March
26, 2019 Patient Misidentification
May
14, 2019 Wrong-Site
Surgery and Difficult-to-Mark Sites
May 2020 Poor Timeout Compliance: Ring a Bell?
September 14, 2021 Wrong
Eye Injections
See
our prior columns on huddles, briefings, and debriefings:
References:
Neal
DJ. A Tampa doctor did surgery on the wrong testicle, state board finds. Miami
Herald 2021; June 2, 2021
Wu
RL, Aufses AH. Characteristics and costs of surgical
scheduling errors. Am J Surg 2012; 204(4): 468-473, October 2012
https://www.americanjournalofsurgery.com/article/S0002-9610%2812%2900191-2/fulltext
Minnesota
Alliance for Patient Safety
https://mnpatientsafety.org/safe-surgery
Minnesota
Alliance for Patient Safety scheduling form template
https://mnpatientsafety.org/sites/default/files/uploads/attachments/scheduling-form-template.doc
Lippi
G, Chiozza L, Mattiuzzi C, Plebani
M. Patient and Sample Identification. Out of the Maze? J Med Biochem 2017; 36(2): 107-112. Published online April 22,
2017
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5471642/
Bouchat-Friedman D. Run More Effective Time Outs.
Standardized protocols, clear communication and engaged team members lead to
safer patient care. Outpatient Surgery 2021; June 28, 2021
https://www.aorn.org/outpatient-surgery/articles/outpatient-surgery-magazine/2021/july/timeout
Liu
C, McKenzie A, Sutkin G. Semantically Ambiguous
Language in the Teaching Operating Room. Journal of Surgical Education 2021;
Article in press 23 April 2021
https://www.sciencedirect.com/science/article/abs/pii/S1931720421000738?via%3Dihub
(Liu 2021)
Yonash R, Taylor M. Wrong-Site Surgery in Pennsylvania
During 20152019: A Study of Variables Associated With 368 Events From 178
Facilities. Patient Safety 2020; 2(4), 2439
https://patientsafetyj.com/index.php/patientsaf/article/view/wrong-site-surgery
Page
L. MDs Doing Wrong-Site Surgery: Why Is It Still Happening? Medscape Medical
News 2021; September 29, 2021
https://www.medscape.com/viewarticle/959938
Vandebergh V, Coll V, Keunen B.
Prevention of Wrong-Side Nerve Blocks: Part 2. Anesthesiology News 2021;
September 20, 2021
Balocco AL, Kransingh S, Lopez A,
et al. Wrong-Side Nerve Blocks And the Use of Checklists. Part 1.
Anesthesiology News 2019; October 19, 2019
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