Our May 2017 What's
New in the Patient Safety World column “Another
Success for the Safe Surgery Checklist” discusses the utility of the Safe Surgery Checklist (also known as the
Surgical Safety Checklist) in improving patient outcomes. It stresses the
importance of not just the checklist but also active engagement of and buy-in
by staff in roll out and adoption of the checklist.
Today’s column
illustrates how having such a checklist without an appropriate culture of
safety can lead to adverse patient outcomes.
In its most recent batch of statements of deficiencies
(SOD’s) and plans of correction (POC’s) regarding incidents in California
hospitals the California Department of Public Health (CDPH) included a case in
which a patient’s ovaries were incorrectly removed during a surgical procedure
(CDPH
2017). A patient with symptomatic uterine leiomyomata was intended to have
a total laparoscopic hysterectomy with
bilateral salpingectomy and incidental appendectomy. Intent was to preserve her
ovaries. However, the ovaries mistakenly removed during surgery.
The surgical booking
form listed as the procedure “TCH (total complete hysterectomy), BSO (bilateral
salpingo oophorectomy), appy
(appendectomy) ... " and the roster of surgical
cases scheduled for that day indicated for this patient "Procedure:
laparoscopic hysterectomy, BSO (bilateral salpingo
oophorectomy, appendectomy".
But the consent
indicated the (handwritten) procedure: "Laparoscopic hysterectomy-removal
of both fallopian tubes –appendectomy" and the preop
H&P signed by the surgeon indicated under "Plan” “A total laparoscopic
hysterectomy with bilateral salpingectomy is planned. We will save the ovaries
and incidental appendectomy will be performed.”
The surgeon led the
surgical timeout and no one noted the disparity between the booking form and surgical
case roster vs. the H&P and consent. The surgery was performed and both
ovaries were mistakenly removed. The following day the patient apparently
informed the surgeon that she was not supposed to remove her ovaries. The
surgeon admitted she had made a mistake and removed the ovaries.
Root cause analysis
revealed numerous contributing factors/root causes. One contributing factor for
wrong patient/site/side/procedure incidents is surgical scheduling or
booking. In our October 30, 2012 Patient Safety Tip of the Week “Surgical
Scheduling Errors” we discussed how errors made during booking or
scheduling are commonly made. But we noted that the vast majority of such
errors never reach the patient because they are intercepted during several
opportunities before the surgery actually takes place. In this case those
several opportunities failed to intercept the error. In addition to the faulty
immediate surgical (verification) timeout in the OR, there were opportunities
to identify the error when the patient was admitted and when the patient was
transferred to the preprocedure area. Also missing
from the CDPH documents is any mention of a presurgical
huddle/briefing. The presurgical huddle is an
excellent opportunity for the surgeon, anesthesiologist, and OR nurse to get
together and not only confirm what is to be done but also discuss any special
needs for the procedure and plan for possible contingencies (see the list of
our prior columns on briefings and debriefings below). For example, we feel
that one topic to be discussed during the preop
briefing is what surgical specimens are expected to be sent to the pathology
lab. Had that been discussed here it probably would have been recognized that
the ovaries were not to be removed.
The facility
apparently did utilize the WHO
Surgical Safety Checklist but, as we noted above, there were several
features in the local culture that rendered that checklist inadequate. One
nurse stated "My signature was for the patient identification only, the
doctor MD led the time out..". Another nurse stated:
"My signature only means I was part of identifying the correct patient and
date of birth, not the right procedure". Neither nurse saw the consent or
the H&P or other portions of the medical record. Hospital policy required
the timeout to be led by the circulating nurse, not the physician. Yet both
nurses and the Director of Quality Services indicated this physician leads her
own timeout. The physician said “…she is not perfect and she forgot the correct
procedure ... " yet did not seem to acknowledge
that use of a checklist is to help avoid forgetting such items. And it is not
clear from the CDPH document whether the facility was auditing compliance with
the timeout/verification process and the checklist before this event took
place. Even regarding the surgical scheduling, the response was "That was
just a request for a time slot from the doctor's office ...
" rather than acknowledging the importance of scheduling in
avoiding wrong patient/site/laterality/procedure. The old saw “culture
trumps policy every time” was clearly in effect here.
This case reaffirms
the problems associated with surgical scheduling/booking. For details about all
aspects of surgical scheduling that impact patient safety see our October 30,
2012 Patient Safety Tip of the Week “Surgical
Scheduling Errors”. Another point not elaborated upon in the CDPH document
is use of the abbreviation “BSO” for bilateral salpingo-oopherectomy.
We’ve cautioned that in scheduling forms and documents you should avoid both
abbreviations and acronyms. The full name of the procedure should be written
out and abbreviations avoided. In particular, use of “R” or “L” or “B” for
laterality should be avoided. Sometimes an “R” gets misinterpreted as a “B” or
vice versa when indicating laterality of the procedure. We would also wonder
here whether the person calling from the physician office simply called in “BSO”
out of habit when only a bilateral salpingectomy was intended (without the oophorectomy).
Often it is a non-clinical person calling in the case from the office or clinic
and just as often (as appears to have happened in this particular case) a
non-clinical person is receiving the request at the facility and entering it
into the schedule.
The case also
clearly illustrates the importance of having primary source documents
available in the OR. During the verification process all parties need to make
sure that the procedure and laterality are corroborated in the H&P and
consent.
One critical issue
is 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. We’ve 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 surgeon’s 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.
It is extremely
common in academic settings and even in community or rural hospitals for
surgeons to obtain the informed consent in the preoperative area. Our June 5,
2007 Patient Safety Tip of the Week “Patient
Safety in Ambulatory Surgery”
noted that ambulatory surgery is particularly vulnerable to missing documents
because those documents are usually in the surgeon’s office rather than at the
hospital. That is why you need to be firm in your requirement for such
documents before cases are scheduled. And, yes, we still continue to encounter
some surgeons who look at the document as some sort of regulatory requirement
foisted upon them! We hope you’ll also
go back to our September 10, 2013 Patient Safety Tip of the Week “Informed
Consent and Wrong-Site Surgery” to see problems associated with informed
consent.
And don’t forget
about imaging studies. We have recommended that copies of relevant imaging reports
also be available. While copies of actual images are often present in the OR,
many of the personnel who need to participate in site/side verification may not
be familiar with interpretation of such images. Therefore, they should look at
the imaging reports to verify site/side.
There was also
deviation in this case from the facility policy that the circulating nurse lead the timeout. We also like the “Minnesota Timeout”
concept in which someone other than the surgeon leads the time out process.
That helps prevent team members from simply agreeing with the surgeon. The
timeout is supposed to be an active rather than passive process and there
should not be undue deference to the surgeon. Every member of the team needs to
speak up and not be afraid to challenge any aspect.
There are several
topics we hope the facility addressed in its own RCA that are not mentioned in
the CDPH document. An obvious one is whether there were any time pressures that
may have contributed to shortcuts taken. Did this surgeon/team have multiple
cases scheduled that day, particularly cases that may have been similar and
actually included removal of ovaries.
One issue we usually
ask early in an RCA of an adverse event is whether indications for surgery were
appropriate. For example, in this case we’d ask not only whether the
hysterectomy was clinically indicated but also whether the incidental
appendectomy was indicated. “Incidental” appendectomy has been a controversial
topic for many years. There are some guidelines, albeit based on lower grades
of evidence, regarding incidental appendectomy in gynecologic procedures (ACOG
2016, Tam
2013).
Though a site
marking may not be indicated in patients having bilateral procedures, don’t
forget that involving the patient in the sort of preop
setting where a site marking would ordinarily be performed is also another
opportunity to verify with the patient the procedure to be performed. So there
should be a “site marking ceremony” even when no site marking is indicated.
The POC (plan of
correction) from the facility reeducated all relevant staff regarding use of
the signed consent form and H&P to correctly verify the patient, surgical
procedure, and site/side/level. It acknowledged the fallibility of using
scheduling documents for the purposes of verification of patient/procedure/site/laterality
and indicated the schedule should not be used for verification. We’re not so
sure we’d dismiss the schedule outright. Having a clinical person do the
scheduling and review the required documentation (consent, H&P) provides
one more opportunity to flag a possible mistake.
The facility’s POC
also reiterated that their policy precludes the timeout being led by the
surgeon.
The attending
surgeon and the facility’s Risk and Patient Safety Manager met with affected patient
promptly following surgical event and agreements were reached with the patient regarding
appropriate clinical monitoring and provision of appropriate medication therapy.
As part of the POC a
checklist/tracer tool was developed, implemented and revised to audit correct
use of the checklist and verification process. We’ll also add our commentary
here that simply auditing a checklist is not enough. We’ve seen too many times
all items checked on such checklists even if they have not been done.
Therefore, we recommend any audit for compliance include some form of random
observation of the timeouts (by either direct observation or review of video
monitoring of procedures). You will be surprised at how many hospitals have
implemented the Safe Surgery Checklist (or equivalent) and assumed it was being
used properly, only to find out compliance was poor when they have an adverse
event.
Yes, errors during surgery booking/scheduling contributed to
the incorrect procedure in this case but the real root causes were likely more
related to issues related to culture and imperfect adoption of the surgical
safety checklist. This is a good reminder that faulty adoption of a safe
surgical checklist without ensuring an appropriate culture of safety is in
place may lead to a false sense of security.
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 2013 “How
Frequent are Surgical Never Events?”
January 1, 2013 “Don’t
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”
May 17, 2016 “Patient
Safety Issues in Cataract Surgery”
July 19, 2016 “Infants
and Wrong Site Surgery”
September 13, 2016 “Vanderbilt’s
Electronic Procedural Timeout”
May 2017 “Another
Success for the Safe Surgery Checklist”
See our prior columns on huddles, briefings,
and debriefings:
References:
CDPH (California Department of Public Health). Complaint
Intake Number: CA00477434
http://www.cdph.ca.gov/certlic/facilities/Documents/2567_SequoiaHospital_IJAP_SanMateo.pdf
WHO Surgical Safety Checklist
http://www.who.int/entity/patientsafety/safesurgery/tools_resources/SSSL_Checklist_finalJun08.pdf
ACOG (American
College of Obstetricians and Gynecologists). Committee Opinion Number 323. Elective
Coincidental Appendectomy. November 2005 (reaffirmed in 2016).
Tam T, Harkins G. Elective
laparoscopic appendectomy in gynecologic surgery: When, why, and how. OBG Manag
2013;25(3): 42-49
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