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Wrong-Site Surgery, Retained Surgical Items,
and Surgical Fires
A Systematic Review of Surgical Never Events
Susanne Hempel, PhD; Melinda Maggard-Gibbons, MD; David K. Nguyen, MD; Aaron J. Dawes, MD;
Isomi Miake-Lye, BA; Jessica M. Beroes, BS; Marika J. Booth, MS; Jeremy N. V. Miles, PhD;
Roberta Shanman, MLS; Paul G. Shekelle, MD, PhD
IMPORTANCE Serious, preventable surgical events, termed never events, continue to occur
despite considerable patient safety efforts.
OBJECTIVE To examine the incidence and root causes of and interventions to prevent
wrong-site surgery, retained surgical items, and surgical fires in the era after the
implementation of the Universal Protocol in 2004.
DATA SOURCES We searched 9 electronic databases for entries from 2004 through June 30,
2014, screened references, and consulted experts.
STUDY SELECTION Two independent reviewers identified relevant publications in June 2014.
DATA EXTRACTION AND SYNTHESIS One reviewer used a standardized form to extract data
and a second reviewer checked the data. Strength of evidence was established by the review
team. Data extraction was completed in January 2015.
MAIN OUTCOMES AND MEASURES Incidence of wrong-site surgery, retained surgical items,
and surgical fires.
RESULTS We found 138 empirical studies that met our inclusion criteria. Incidence estimates
for wrong-site surgery in US settings varied by data source and procedure (median estimate,
0.09 events per 10 000 surgical procedures). The median estimate for retained surgical
items was 1.32 events per 10 000 procedures, but estimates varied by item and procedure.
The per-procedure surgical fire incidence is unknown. A frequently reported root cause was
inadequate communication. Methodologic challenges associated with investigating changes
in rare events limit the conclusions of 78 intervention evaluations. Limited evidence
supported the Universal Protocol (5 studies), education (4 studies), and team training
(4 studies) interventions to prevent wrong-site surgery. Limited evidence exists to prevent
retained surgical items by using data-matrix–coded sponge-counting systems (5 pertinent
studies). Evidence for preventing surgical fires was insufficient, and intervention effects were
not estimable.
CONCLUSIONS AND RELEVANCE Current estimates for wrong-site surgery and retained
surgical items are 1 event per 100 000 and 1 event per 10 000 procedures, respectively, but
the precision is uncertain, and the per-procedure prevalence of surgical fires is not known.
Root-cause analyses suggest the need for improved communication. Despite promising
approaches and global Universal Protocol evaluations, empirical evidence for interventions
is limited.
JAMA Surg. doi:10.1001/jamasurg.2015.0301
Published online June 10, 2015.
Supplemental content at
jamasurgery.com
Author Affiliations: Author
affiliations are listed at the end of this
article.
Corresponding Author: Susanne
Hempel, PhD, Southern California
Evidence-Based Practice Center,
RAND Corporation, 1776 Main St,
Santa Monica, CA 90401
(susanne_hempel@rand.org).
Clinical Review & Education
Review
(Reprinted) E1
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Wrong-site surgery, retained surgical items, and surgi-
cal fires continue to occur despite sizeable preven-
tion efforts by patient safety agencies, national ac-
creditation bodies, professional societies, and hospitals and their
medical staff.Wrong-site surgery refers to surgery on the wrong site
or the wrong side, the wrong procedure, the wrong implant, or the
wrong patient. Retained surgical items are items unintentionally left
in a patient after surgery; some events are clinically asymptomatic
and discovered only long after the procedure. Surgical fires are fires
in the operating room, including on and in the patient (eg, airway
fires). Fire triangle elements are routinely present during surgery—
ignition sources such as lasers, fuels such as drapes, and oxidizers
such as supplemental oxygen—making the operating room an en-
vironment where fires develop more quickly, burn hotter, and are
more difficult to extinguish.
1
The events have potentially devastat-
ing consequences for the patient, and health care practitioners and
facilities may also experience severe repercussions. All three are con-
sidered preventable (termed never events) and not acceptable risks
of surgery.
2
Surgical safety has been a prominent issue during the past de-
cade. The Universal Protocol (http://www.jointcommission.org
/standards_information/up.aspx), a concerted effort to improve sur-
gical safety after a thorough review of the root causes of wrong-
site surgery, was implemented in 2004 for hospitals accredited by
the Joint Commission. The protocol includes the following compo-
nents: (1) preoperative verification of the patient, (2) marking of the
surgical site, and (3) performing a time-out before the procedure be-
gins. A 2003 landmark study on the risks for retained surgical items
3
resulted in mainstream attention. In the same year, the Joint Com-
mission issued a sentinel event alert regarding the prevention of sur-
gical fires.
4
Despite these developments, a 2010 systematic review
5
found no literature to substantiate the effectiveness of the Univer-
sal Protocol in decreasing the rate of wrong-site or wrong-levelsur-
gery,and a 2012 Cochrane review on the topic
6
included only 1 study;
to our knowledge, interventions to prevent retained surgical items
and surgical fires have not been reviewed systematically. Ten years
after the implementation of the Universal Protocol and conse-
quent discussions of surgical safety,we undertook a systematic re-
view to estimate the incidence and root causes of wrong-site sur-
gery, retained surgical items, and surgical fires and the effects of
interventions aimed at preventing them.
Methods
Literature Search
The review questions and process were guided by a technical ex-
pert panel. We searched PubMed, CINAHL, CENTRAL, and Web of
Science to identify individual studies and reviews and SCOPUS and
IEEE XPlore to identify technological advances. We scanned the ref-
erences of the included studies and reviews, searched the Coch-
rane Effective Practice and Organisation of Care Group specialized
register,National Guideline Clearinghouse, and PubMed Health and
consulted subject matter experts for pertinent literature. (Review
is registered at crd.york.ac.uk/PROSPERO: CRD42013004524.)
Searches were undertaken in June 2014 to identify studies pub-
lished since 2004, the year the Universal Protocol was introduced.
The review provides incidence estimates after implementation of
the Universal Protocol, root-cause analyses of incidents that occur
despite the widely implemented Universal Protocol, and effects of
interventions building on the Universal Protocol.
7
Searches were re-
stricted to English-language publications and combined broad search
terms (eg, never events) and specific events of interest (eg, surgi-
cal confusion, gossypiboma, operating room fire) as documented in
eAppendix 1 of the Supplement.
Study Selection
A first (S.H.) and a second (D.K.N., A.J.D., and I.M.-L.) review inde-
pendently assessed publications for inclusion; discrepancies were
resolved through discussion by the review team. We included US in-
cidence studies reporting on wrong-site surgery, retained surgical
items, and surgical fires during surgical procedures that included in-
cisions and US-applicable
7
root-cause and risk factor analyses re-
porting on events during surgical procedures that included inci-
sions. We included international controlled and uncontrolled
evaluations of interventions aimed at preventing wrong-site sur-
gery, retained surgical items, and surgical fires during surgical and
other invasive procedures that reported on events or near misses.
Studies with concurrent (eg, randomized clinical trials) and historic
(eg, before-and-after intervention studies) controls and uncon-
trolled studies (after-intervention studies) were eligible.
Data Abstraction and Quality Assessment
A surgeon trained in systematic review methods (D.K.N. and A.J.D)
used a pilot-tested and standardized form to extract the data, and
an experienced systematic reviewer (S.H.) checked the data; dis-
crepancies were resolved through discussion. For incidence stud-
ies, we computed events per 10 000 performed surgical proce-
dures. For root-cause analyses, we abstracted events, assessment
details, causes, and risk factors. For intervention evaluations we
documented the setting, procedure, study design, numbers of pa-
tients, practitioners, and/or procedures, adverse events (including
costs associated with the intervention), and event, near-miss, and/or
composite outcome. Data extraction was completed in January 2015.
We computed odds ratios (ORs) and 95% CIs to estimate interven-
tion effects. Publications were too heterogeneous to assess the qual-
ity formally, but we differentiated studies as follows: incidence stud-
ies reported per-procedure estimates or other data; root-cause
analyses were rank ordered by the number of investigated events
and the use of multivariate analysis methods; and intervention stud-
ies were stratified by comparator (concurrent, historic, or none)
and outcome (reporting per-procedure event rates vs other effect
estimates).
Data Synthesis and Strength of Evidence
Incidence, root-cause analyses, and intervention studies were
grouped by event (ie, wrong-sitesurgery, retained surgical items, and
surgical fires). Strength of evidence (SOE) ratings were established
by drawing on GRADE (Grading of Recommendations Assessment,
Development and Evaluation) and context-sensitive criteria devel-
oped for patient safety practices.
8
Criteria included the number of
identified studies per intervention, study design and inherent limi-
tations, consistency of per-procedure results, strength of effect, pre-
cision of results, theoretical or empirical basis of intervention, and
sufficient intervention description. The SOE distinguished the fol-
lowing 5 levels: high (further research is very unlikely to change our
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confidence in the estimate of effect), moderate (further research is
likely to have an important effect on our confidence in the estimate
and may change the estimate), low (further research is very likely
to have an important effect on our confidence in the estimate and
is likely to change the estimate), very uncertain (the estimate is very
uncertain or the evidence is insufficient to estimate per-procedure
effects), or not estimable (the evidence is insufficient to estimate
an effect of the intervention) (eAppendix 2 in the Supplement).
Results
We identified 5399 publications. The literature flow is docu-
mented in the eFigure in the Supplement. We obtained 1146 publi-
cations in full-text form. In total, we included 138 empirical studies
in the review. Some studies reported on more than 1 event (eg,
wrong-site surgery and retained surgical items) or more than 1 re-
view question (eg, incidence and root causes).
Incidence
Wrong-Site Surgery
We identified 27 US estimates of wrong-site surgery incidence.
Definitions of events, analyzed procedures, denominators, and
reported estimates varied, as documented in eTable 1 in the
Supplement. Per-procedure data are shown in the Figure.
9-36
The
median incidence estimate for wrong-site surgery across 7 US
studies reporting general per-procedure estimates was 0.09
events per 10 000 surgical procedures; however, estimates varied
widely. Estimates from surgical specialties also varied, across and
within specialties, ranging from 0.5 events according to ophthal-
mological claims data and state reporting records
19
to 4 events per
10 000 procedures based on an analysis of a survey of strabismus
surgeons (response rate, 47%).
16
Three recent surveys with low
response rates (7%-54%)
17,37,38
showed that more than 50% of
respondents had performed 1 or more wrong-level spinal surgical
procedure (lifetime prevalence). For more details, see eTable 1 in
the Supplement.
Figure. Incidence of Wrong-Site Surgery and Retained Surgical Items
Source
Neily et al,10 2011
Wu and Aufses,9 2012
Mulloy,12 2008
Neily et al,11 2009
Kwaan et al,13 2006
Cima et al,15 2010
Knight and Wedge,14 2010
Shen et al,16 2013 (strabismus)
James et al,18 2012 (orthopedic)
Mody et al,17 2008 (spinal)
Simon,19 2007 (ophthalmologic)
Marquez-Lara et al,21 2014 (lumbar spinal)
Vachhani and Klopfenstein,20 2013 (neurosurgical)
Jin et al,23 2007 (cataract)
Marquez-Lara et al,22 2014 (cervical spinal)
0 3 92 4 5 6 7 8
Rate per 10
000 Procedures (95% CI)
1
0.000 (0.000-2.095)
0.404 (0.329-0.491)
1.030 (0.895-1.180)
0.360 (0.343-0.374)
0.089 (0.057-0.131)
0.089 (0.002-0.495)
0.000 (0.000-0.668)
3.990 (3.418-4.631)
3.215 (2.915-3.539)
0.620 (0.491-0.771)
0.500 (0.240-0.919)
1.941 (0.400-5.671)
2.614 (2.202-3.081)
1.035 (0.676-1.516)
1.125 (0.232-3.287)
Rate per 10 000
Procedures (95% CI)
Studies Concerning Wrong-Site Surgery
A
Source
Stawicki et al,24 2013
McIntyre et al,26 2010
Rupp et al,25 2012
Judson et al,27 2013
Egorova et al,29 2008
Hunter and Gimber,28 2010
Cima et al,30 2011
Chen et al,32 2011
Cima et al,31 2008
Camp et al,33 2010
Vannucci et al,34 2013 (CVC placement)
Marquez-Lara et al,21 2014 (lumbar spinal)
Teixeira et al,35 2007 (cavitary trauma)
Marquez-Lara et al,22 2014 (cervical spinal)
0 3 92 4 5 6 7 8
Rate per 10
000 Procedures (95% CI)
1
1.430 (0.900-2.173)
0.200 (0.027-0.803)
0.710 (0.147-2.087)
0.835 (0.101-3.016)
1.760 (0.213-6.350)
1.430 (0.535-3.173)
0.000 (0.000-0.422)
1.780 (1.232-2.485)
1.200 (1.063-1.348)
1.800 (1.614-1.996)
0.994 (0.747-1.297)
3.039 (0.828-7.779)
0.318 (0.137-0.627)
2.984 (0.615-8.719)
1.311 (0.357-3.358)
Rate per 10 000
Procedures (95% CI)
Studies Concerning Retained Surgical Items
B
Lutgendorf et al,36 2011 (vaginal delivery)
Wrong-site surgery includes wrong
site, wrong side, wrong patient,
wrong implant, and wrong
procedure. Error bars indicate
95% CI. Data in parentheses
specify type of procedure where
indicated. CVC indicates central
venous catheter.
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Retained Surgical Items
Surgical sponges were the most commonly reported retained items
in 21 identified incidence studies (eTable 2 in the Supplement). The
median incidence estimate for retained surgical items was 1.32events
per 10 000 surgical procedures based on studies reporting per-
procedure data (Figure). Incidence estimates varied widely and
ranged from no retained sponges
30
to 3.04 retained guidewires
34
per 10 000 procedures. Studies varied by how theydef ined events
and near misses, specifically how items identified in routine radio-
graphic studies after initial wound closure were classified (eTable 2
in the Supplement). About half of the included studies reported that
a counting protocol was in place at the time of the incident, and 4
studies
24,26,31,32
stated that events were discovered evenwhen sur-
gical counts were recorded as correct and/or routine radiographic
imaging was performed.
Surgical Fires
We identified 3 studies of surgical fires (eTable 3 in the Supple-
ment), but none reported a per-procedure estimate of the inci-
dence of surgical fires. A 2011 survey of otolaryngologists and head
and neck surgeons (response rate, 29%)
39
showed that 23% had
experienced at least 1 operating room fire.
Root Causes
Sixty-one identified studies document a large number of individual
root causes and risk factors for surgical never events. Fulldetails are
presented in eTables 4 through 6 in the Supplement.
Wrong-Site Surgery
A frequently reported cause of wrong-site surgery across 28 identi-
fied analyses
10,11,13,14,16,40-53
(eTable 4 in the Supplement) was com-
munication problems, including miscommunications among staff,
missing information that should have been available to the operat-
ing room staff,surgical team members not speaking up when they no-
ticed that a procedure targeted the wrong side, and a surgeon ignor-
ing surgical team members who questioned laterality. An analysis of
672 root causes of incorrect surgical procedures within and outside
the operating room
11
showed that communication problems were the
most frequent cause, accounting for 21% of the total. A review of the
Pennsylvania Patient Safety Reporting System
46
concluded that
events resulted from misinformation (eg, false information obtained
from other departments) or from misperception (eg, right-left con-
fusions). Laterality was a major concern with surgical procedures in-
volving symmetrical structures.
41
Nineteen reports
10,11,13,14,16,40,42-53
identified policy issues as the cause or the contributing factor. These
issues included not following safety procedures (eg, lack of a time-
out), technically following safety procedures that were inadequate in
practice (eg, the site mark was not visible after draping), lack of poli-
cies, or lack of standardization of procedures. A detailed institutional
review of wrong-site surgery cases
44
concluded that the forms did not
ask for sufficient detail (eg, laterality of the procedure) or were not
completed, that workflow standardization was lacking (eg, the staff
did not realize the need for document reconciliation), or that respon-
sibilities were not clearly identified.
Retained Surgical Items
The 19 analyses of retained surgical items
10,24,26,31-33,40,54-60
(eTable
5 in the Supplement) identified a variety of root causes and risk fac-
tors, including case (patient and procedural characteristics), staff
(communication and policies), and equipment variables. Case vari-
ables were, for example, suggested by a pediatric surgical patient
data set that showed an increased risk during gynecologic
procedures
33
; a review of 254 gossypibomas reported that risk fac-
tors were generally case specific (eg, emergency procedures)
54
; and
a multivariate analysis
24
reported an independent association with
unexpected intraoperative events and with procedure duration.Pa-
tient body mass index was a significant predictor in multivariate
analyses,
24
contributed to published cases,
54
and was identified in
an institutional root-cause analysis.
26
Regarding staff variables, 2 se-
ries of root-cause analyses
31,55
determined that poor communica-
tion (eg, failure to communicate suspicions) was a core factor. Fur-
thermore, 7 studies
24,54,56-60
reported incomplete or undocumented
counts as a contributing factor.These included 2 multivariate analy-
ses showing incorrect counts,
40
and any safety variance (including
incorrect counts and lack of documentation)
10
increased the risk for
retained items.
24,60
Several institutional root-causeanalyses pointed
to problems with policies (eg, although technology was available to
staff, no guidance specified when to obtain postoperative radio-
graphs, the count policy was not standardized, or items were re-
tained that were not routinely counted). Equipment variables were
suggested in a large Veterans Health Administration data set
32
that
found an association between device malfunctions in 30% of cases
of foreign bodies left during a surgical procedure.
Surgical Fires
We identified 16 analyses of surgical fires
39,61-65
(eTable 6 in the
Supplement). Based on an analysis of closed claims of 103 fires,
61
electrocautery was the ignition source in 93 claims (90%). Survey
data of 100 reported fires
39
showed that common fuels were en-
dotracheal tubes and drapes or towels, and supplemental oxygen
was in use in most of the cases. Fire risk increased with procedures
involving the face and neck.
39,62-64
An institutional root-cause
analysis
65
demonstrated lack of staff awareness of—and failure to
communicate—risks.
Interventions
We identified 78 evaluations of diverse approaches aimed at
preventing wrong-site surgery, retained surgical items, and surgi-
cal fires. Full details are discussed in eTables 7 through 12 in the
Supplement.
Wrong-Site Surgery
Five studies
12,18-20,66
analyzed the effect of the Universal Protocol
as a patient safety intervention (Table1; for more details, see eTable
7 in the Supplement). A before-and-after intervention study
20
re-
ported a statistically significant reduction in events during a 7-year
follow-up in a neurosurgical practice (odds ratio [OR], 9.01 [95% CI,
3.06-26.82]; ORs >1.00 indicate fewer incident events with the in-
tervention). A time series using events reported to the American
Board of Orthopedic Surgery database
18
found a reduced inci-
dence of wrong-site local or regional anesthesia, wrong-site skin in-
cision, wrong-site surgical exposure, incomplete operation, wrong
procedure, wrong side, wrong digit, or wrong level of spine events
6 years after the mandate (OR, 1.16[95% CI, 0.72-1.86]), but the trend
was not statistically significant, even when spinal cases were ex-
cluded. A trend of reduced surgical confusion (wrong implant, trans-
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plant, eye, eye block, patient, or procedure)
19
was shown 14 months
after the mandate using cases reported to a state reporting system
(OR, 1.42[95% CI, 0.78-2.58]), but the trend wasnot statistically sig-
nificant. One study,
12
based on responses to a survey sent to hos-
pital representatives of the American Hospital Association, showed
an increase in reported events (OR, 0.80[95% CI, 0.75-0.85]),with
a peak in 2004 just before and after the introduction of the Univer-
sal Protocol. An after-intervention study
66
reported no events in
7983 patients with skin cancer,attributed to the adoption of the pro-
tocol, but the baseline rate was not reported. Across identified stud-
ies, the SOE was judged to be low (documented in detail in eTable
13 in the Supplement).
We identified 25 studies evaluating various ways of operation-
alizing components of (eg, verification process, site marking, time-
out), alternatives for (eg, the World Health Organization Safe Sur-
gery Checklist, the Veteran Affairs Correct Surgery Directive), or
additions to (eg, surgical briefings) the Universal Protocol. The ap-
proaches are described in detail in eTable 8 in the Supplement;
Table2 summarizes studies that reported per-procedure event data
before and after the intervention.
10,15,68-74
None of the studies re-
ported a statistically significant effect on wrong-site surgery events,
despite 8 of 9 studies reporting no incident events after implemen-
tation of the intervention. The SOE across studies was insufficient
(eTable 14 in the Supplement), and the intervention effect was
not estimable.
We identified 15 studies focusing on team training, education, or
safety culture. Each study described a unique intervention, includ-
ing educational programs, process redesign approaches, crew re-
source management components, clandestine operating room au-
dits, surgical procedure simulations, and new safety policies (eTable
9 in the Supplement). Table2 summarizes studies that reported per-
procedure data.
10,72,73
Limited evidence supported educational in-
terventions (4 studies with SOE very uncertain). One of the relevant
studies
72
reported statistically significant improved per-procedure
data; an educational intervention in Taiwancombining the introduc-
tion of a clinical guideline to reduce the incidence of wrong-site tooth
extraction with a training program presenting cases of erroneous ex-
tractions resulted in significant improvements during a period of 6
years (OR, 7.39 [95% CI, 1.85-29.56]). Limited evidence supports medi-
cal team training approaches (4 studies with SOE very uncertain). One
of the relevant studies, a medical team training program to improve
communication and patient safety in the operating room combined
with the Veteran Affairs Directive for Ensuring Correct Surgery,
10
showed a decrease in the monthly rate of reported adverse events
(from 3.2 to 2.4events; P= .02)and an increase in repor ted close calls
(from 1.97 to 3.24; P= .001) within and outside the operating room.
The SOE for all other interventions was insufficient, and the interven-
tion effect was not estimable.
Nine identified studies evaluated the effects of technical equip-
ment, such as intraoperative imaging techniques (eTable 10 in the
Table 1. Evaluation of Wrong-Site Surgery After UP
Source
Setting/Surgery
Type
Study Design
(Length of
Follow-up) Intervention and Compliance
Effect on Near Misses, Events,
or Composite Outcomes
OR
(95% CI)
a
Vachhani
et al,
20
2013
Academic
neurosurgical
practice/
neurosurgery
Before-and-after,
22 743
procedures
(7 y)
UP; compliance: NA
(noncompliance contributed to
1 of 3 cases)
Before UP: 12 incidents (0.07%, all wrong-level
spinal surgery) in 5 y, 2 not identified before end of
procedure; After UP: 3 incidents (0.02%, wrong-level
spinal surgery, wrong-side cranial surgery) in 7 y
after implementation, 1 not identified before end of
procedure (P< .001)
9.01
(3.06-26.82)
James
et al,
18
2012
ABOS
database/
orthopedic
surgery
Time series,
1 291 396 cases
(6 y)
UP; compliance: NA Incidence rate (wrong-site local or regional anesthesia,
wrong-site skin incision, wrong-site surgical exposure,
incomplete operation on the wrong site, wrong
procedure, wrong side, wrong digit, wrong level of
spine) 1999-2005: 0.0072%; 2006-2010 (after
mandate): 0.0062% (P= .55); Nonspinal incidents,
1999-2005: 0.0042%; 2006-2010: 0.0028% (P= .30)
1.161
(0.72-1.86)
Simon,
19
2007;
Simon
et al,
67
2007
NYPORTS
database/
ophthalmology
Before and after
(14 mo)
UP; compliance: NA Before UP: 52 surgical confusions (wrong patient,
wrong eye, wrong eye block, wrong implant, wrong
transplant) in 49 mo (7.4 incidents per 100 000
procedures); After UP: 10 incidents in 14 mo (5 of
100 000 procedures) (P= .26)
1.42
(0.78-2.58)
Mulloy,
12
2008
AHA hospitals
performing
surgical
procedures/
operating room
data
Time series,
325 survey
respondents
(3 y)
UP, AORN CSSTK including
educational program, pocket
card, template for policy
development, copy of protocol,
and material and guidelines for
implementation; compliance:
all 3 UP elements had been
performed in 29%-42% of
wrong-site surgery cases
Event rates per 100 000 surgeries: 1.93 in 2001,
3.30 in 2002, 2.91 in 2003, 3.77 in first half of 2004,
4.27 in second half of 2004, 3.67 in 2005, 3.14 in
2006; Near miss: 7585 in second half of 2004,
11 607 in 2005; 7320 in 2006
0.80
(0.75-0.85)
Starling and
Coldiron,
66
2011
Academic
dermatologic
surgical
practice/skin
cancer
After-
intervention only,
7983 procedures
(6 y)
JC protocol; before-procedure
patient identification
verification (wristband), site
identification by surgeon and
patient, photograph of site,
preoperative time-out;
compliance: NA (100% implied)
0 wrong-site surgery events in records of 7983 cases
after UP
NA
Abbreviations: ABOS, American Board of Orthopedic Surgery; AHA, American
Hospital Association; AORN, Association of Perioperative Registered Nurses;
CSSTK, Correct Site Surgery Toolkit; JC, Joint Commission; NA, not available;
NYPORTS, New York PatientOccurrence and Tracking System; OR, odds ratio;
UP, Universal Protocol.
a
An OR of greater than 1.00 favors the post-UP result.
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Table 2. Evaluation of Wrong-Site Surgery by Type of Intervention
Source Country/Setting
Design
(Length of Follow-up)
Intervention
Focus Intervention Components and Compliance Effect on Near Misses Effect on Event Incidents
Garnerin
et al,
68
2008
Switzerland/
academic medical
center, anesthesia
practice
Before-and-after,
252 855 procedures
(1 y)
Verification
protocol
Checking patient ID and site of surgery developed by interdisciplinary team;
anesthetist to perform checks, patient asked to participate if able using
open-ended questions (no prompting), corroborated with medical record,
wristband, and scheduling information, site compared with medical record,
surgeon check, and schedule; protocol distributed to all anesthesia staff
as pocket-sized document; audit and some feedback; Compliance: improved
for all but 1 item; ranged from 59% (protocol, patient ID check) to
99% (wristband)
Before: 4 of 181 710
wrong-site anesthesia
procedures
After: 0 of 71 145
(P= .58)
After: 0 of 71 145 during and after
intervention; Before: 0 events in
181 710 procedures; OR, NC
Lee
et al,
69
2007
United States/oral
and facial surgery
center
Before-and-after,
10 595 tooth
extractions (before)
(10 mo)
Time-out
protocol,
guidelines for
wrong-tooth/
wrong-site
surgery
Clinical guidelines developed and circulated to educate; time-out protocol
implemented; Compliance: NA
NA After: 0 wrong-tooth or wrong-site
surgery in 10 mo; Before: 5 events
in 2 y (10 595 extractions; event
rate 0.047% of extracted teeth,
0.09% of patients); OR (95% CI),
4.13 (0.60-28.45)
Ablinger
et al,
70
2010
Switzerland/urban
medical center
Before-and-after,
15 461 cases
(18 mo)
Surgical checklist
based on WHO
Safe Surgery
Checklist
Implementation of 13-item surgical safety checklist “4-step-protocol” for every
patient undergoing surgical procedure in operating room; Compliance: NA
NA After: 0 of 10 560 cases during
18 mo; Before: 1 event in 4901
cases during 52 mo; OR (95% CI),
23.45 (0.35-158.7)
DeFontes
and
Surbida,
71
2004
United States/
Kaiser Permanente
medical center
Before-and-after,
6795 procedures/y
(1 y)
Preoperative
briefing
Preoperative safety briefing; similar to preflight checklist; surgeon, anesthetist,
circulator, and scrub nurse discuss background of case, assess risks, and offer
relevant information and expectations; Compliance: NA
Before: 0 reported n
ear misses
After: 5
After: 0 events in year
since implementation;
Before: 3 events in year before
intervention; OR (95% CI),
7.39 (0.77-71.07)
Chang
et al,
72
2004
Taiwan/academic
medical center, oral
surgery practice
Before-and-after,
24 406 and 19 904
extractions/y,
respectively
(3 y)
Education and
clinical guideline
Clinical guideline to prevent erroneous tooth extractions; description in written
order, inform patient about tooth position and reason for removal; operator
should verify order with patient; communicate with referring dentist if unclear;
check tooth position before and after forceps application; staff training program
for residents and interns; training sessions included cases with erroneous
extractions; Compliance: NA
NA After: 0 events in3y(P< .01);
Before: 8 wrong-site extractions
in 3 y (annual rates, 0.026%,
0.025%, and 0.046%); OR (95% CI),
7.39 (1.85-29.56)
Neily
et al,
10
2011
United
States/VAMC
Time series
(3 y)
Medical team
training
Training requires 2-mo planning with core change team; 1-d face-to-face learning
session, mandatory attendance; 12-mo follow-up and coaching; emphasis on
preoperative briefing and postoperative debriefing; in addition to VA directive for
ensuring correct surgery; Compliance: NA, training presumably 100%
Rate of close calls increased
from 1.97/mo to 3.24/mo
(P< .001)
Event rate per month decreased
from 3.2 to 2.4 (P= .02); highest
harm category dropped 14%
(RR [95% CI], 0.86 [0.75-0.97];
P= .02) each year (drop of 0.17
events per 100 000 procedures/y);
OR, NC
Yoon
et al,
73
2013
United States/
tertiary care
orthopedic surgery
Before-and-after,
6126 cases before
and 6089 after
(5 mo)
Audit and
feedback of near
misses, education
All members of team encouraged to report near misses (eg, incorrectly booked
surgery, improperly performed time-out); web-based event reporting system;
reminders part of briefing and debriefing; education; culture of safety; near
misses audited; mandatory education for offending physicians and staff (20-min
educational course); monthly patient safety review; root-cause analysis as
needed; Compliance: NA
Booking error rate decreased
from 0.75% to 0.41%
(P= .01)
Improperly performed
time-out decreased from
18.7% to 5.9% (P< .001)
After and before: 0 never events;
OR, NC
Cima
et al,
15
2010
United
States/academic
medical center
Before-and-after,
5299 procedures
before and 4354 after
(1 y)
Computerized
listing system
Changes to computerized surgical listing system based on error analysis;
mandatory entries for laterality; Compliance: NA
Reduction in listing errors
from 1.5% to 0.54%
(P< .05), gynecologic
surgery; from 2.06% to
0.49% (P< .05), colorectal
surgery
After: no adverse outcomes from
errors; Before: 0 wrong-patient
procedures; OR, NC
Ku
et al,
74
2011
Taiwan/medical
center
Before-and-after,
22 000 patients
(1 y)
RFID Patient Advancement Monitoring System, surgical, RFID to control patient flow
process through perioperative processes, quality and efficiency of care;
Compliance: 100%
NA After and before: 0 wrong-patient
or surgical procedure events;
OR, NC
Abbreviations: ID, identification; NA, not available; NC, not computable; NHS, National Health Service; OR, odds ratio; RFID,radiofrequency identification; RR , rateratio; VAMC, Veterans Affairs medical center; WHO, WorldHealth Organization.
Clinical Review & Education Review Wrong-Site Surgery,Retained Surgical Items, and Surgical Fires
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Supplement). The largest studies,
15,74
which reported data before
and after the intervention for more than 100 procedures, are shown
in Table 2. None of the studies reported statistically significant re-
ductions in wrong-site surgery events. The SOE was insufficient, and
the intervention effect was not estimable.
Retained Surgical Items
We identified 17 publications evaluating 18 interventions to preventre-
tention of surgical items, including counting or imaging protocols,
equipment-based improvements, and team training approaches
(eTable11 in the Supplement). Studies reporting per-procedure event
data are shown in Table 3.
25,26,30,36,75-77
The SOE was insufficient
(eTable14 in the Supplement), and the effect of interventions was not
estimable, except for interventions using technology such as sponge-
coding systems (5 studies with SOE very uncertain). One before-and-
after intervention study reported a statistically significant reduction
using a data-matrix–coded sponge-counting system that eliminated
retained sponges,
30
but effects in other studies were not estimable.
Abar-codingrandomizedclinical trial
77
foundnoretaineditemsineither
treatment arm across 300 surgical procedures; a radiofrequency de-
tection system
25
resulted in no retained items after a short follow-up
(2285 patients; prior event rate, 1 per 54 000); and denominator data
were lacking in other studies.
Surgical Fires
Eight empirical evaluations of interventions to prevent surgical fire—
through education, equipment, safety culture, or fire risk scoring—
were identified (eTable12 in the Supplement). One study that evalu-
ated the effect of superimposed high-frequency jet ventilation on
more than 200 endoscopic laryngotracheal surgical procedures
78
reported no airway fires in 1515 procedures, but no preintervention
event rate was reported for comparison. The SOE was insufficient,
and the intervention effect was not estimable (eTable 15 in the
Supplement).
Discussion
Our systematic review has 3 important conclusions. First, incidence
estimates for wrong-site surgery and retained surgical items vary, and
no per-procedure estimate of surgical fires exists. Second, the root-
cause analyses identified a range of causes and contributing factors and
suggest the need for better communication. Third, few evaluations of
interventions to reduce the specific outcome of wrong-site surgery,
retained surgical items, and surgical fires have been conclusive.
Whether the event occurrence can be reduced to zero to achieve
a true never-event rate is unclear, but with approximately 50 million
US surgical procedures performed annually,
79
our median estimate
of 1 wrong-site surgery per 100 000 procedures and 1 retained sur-
gical item per 10 000 procedures translates to an estimated 500
wrong-site surgeries and 5000 retained surgical items annually, which
constitute too many events. By comparison, the risk for death among
US airline passengers in 2012 was 1 in 45 million flights, and because
annual national statistics are collected, we know that this risk has been
steadily improving. Flying was only half as risky in 2012 as it was in
2000.
80
Assessing whether the risks for wrong-site surgery, re-
tained surgical items, or surgical fires are changing over time is im-
peded by the lack of a standardized reporting system, such as the one
that exists for aviation disasters. Several US states have now intro-
duced reporting mandates, and a comprehensive analysis should im-
prove estimates of incidence. However, a national reporting system
is necessary to provide national estimates.
Inadequate communication was a recurring theme across root-
cause analyses; however a large number of unique causes and con-
tributing factors have been suggested, in particular for retained
surgical items. As more data are collected, a large number of root-
cause analyses for Joint Commission–accredited hospitals will be
available and may help to identify the relative importance of com-
peting causes and risk factors.
81
Our finding of limited evidence of the interventions to reduce the
incidence of wrong-site surgery, retained surgical items, and/or surgi-
cal fires should not be interpreted to mean the evidence is limited for
all surgical safety interventions. Most surgical safety interventions are
designed to address several surgical safety targets and are evaluated
using composite outcomes, or they are designed to address more com-
mon adverse events, such as surgical site infections and even opera-
tivemortality.
82
Severalevaluationsof surgical safety interventions have
reported improvementsinpertinentoutcomes,andonthisbasis,safety
and regulatory authorities have advocated their widespread adoption.
However,w hether these interventions specif ically reduce the never-
events investigated in this review remains unproven.
An assessment of the effectiveness of interventions for rare out-
comes faces substantial methodologic challenges. Using standard
inferential statistics, we can calculate that if an event occurs once
in 20 000 occurrences, we would require a sample of 5 million ob-
servations to have sufficient power to detect a reduction to once in
30 000occurrence s. Such numbers are beyondthe capacity of most
single institutions and indicate the need for multisite evaluations.
Our review identifies studies in which researchers observed a 20%
to 35% reduction in events, but this difference was not statistically
significant. Lack of statistical power could be 1 explanation for these
findings. For evaluations of rare events,the use of alternative meth-
ods of assessing associations, such as run charts or statistical pro-
cess control, may prove to be more useful tools than standard in-
ferential statistics to inform the effect of quality improvement
interventions. These studies could be complemented by assessing
the more common near misses and adherence to process mea-
sures identified as key processes in root-cause analyses.
Our review has a number of limitations. First, we restricted our
search to English-language literature because our focus was on sur-
gical safety in high-income countries, in particular the United States.
Second, many of the studies we identified had methodologic prob-
lems, including insufficient or no comparator data, insufficient sample
sizes and/or follow-up, or even lack of reporting on the events of in-
terest with a denominator. These methodologic limitations re-
strain us from drawing further conclusions.
Conclusions
Current estimates for wrong-site surgery and retained surgical
items are 1 event per 100 000 and 1 event per 10 000 proce-
dures, respectively, but the estimates are imprecise and vary
across sources and specialties. The per-procedure incidence of
surgical fires is not known. Root-cause analyses suggest the need
for improved communication. Despite promising individual
Wrong-Site Surgery, Retained Surgical Items, and Surgical Fires Review Clinical Review & Education
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Table 3. Evaluation of Retained Surgical Items by Type of Intervention
Source
Design
(Length of
Follow-up) Intervention Focus Intervention Components and Compliance Cost and/or AE
Effect on
Near Misses Effect on Event Incidents
Counting/Imaging Protocol
Lutgendorf
et al,
36
2011
Before-and-after,
10 500 deliveries
(after)
(2 y)
Count and radiography
protocol to reduce
occurrence of retained
sponges after vaginal
delivery vs vaginal sweep
Developed by multidisciplinary team; sponge count before and after all vaginal
deliveries; practitioner to initiate counts, nurses verify and document counts; if
count incorrect, and vaginal sweep ineffective, thorough examination and
radiography; use of larger,radiopaque sponges; sponges laid out side-by-side on
delivery carts to facilitate counting; avoidance of sponges in vagina if possible;
tail left in view at all times; staff training; Compliance: regular audits, data NA
$2.50/Delivery; counts took
approximately 1 min
NA After: event rate 0 per 10 500
deliveries in2yafternewprotocol
implemented; Before: 1 of 5000
deliveries with event (sponges)
in 5 y with vaginal sweep;
OR (95% CI), 4.06 (0.58-28.23)
McIntyre
et al,
26
2010
Before-and-after,
12 000 surgical
procedures/y
(18 mo)
Count and radiography
policy
Radiography after any procedure in which body cavity is opened or wound is
large enough to retain instrument or sponge, performed regardless of whether
final closure has occurred, packing left, or additional surgery planned;
radiographic study must cover entire surgical field, interpreted by senior resident
or attending physician; relief counts must occur before change of personnel;
baseline sponge counts mandatory, communication of packing or removal of
packing; if abdominal cavity is explored landmarks from diaphragm to symphysis
must be visualized; staff tutorial; Compliance: NA
$63 825 For 990
radiographic studies
NA After: 0 cases in 18 mo since
implementation; Before: 3 cases
in 2 y before all policy changes
implemented; OR (95% CI),
5.76 (0.59-56.64)
Rupp
et al,
25
2012
Before-and-after
(NA)
Count protocol Sponge ACCOUNTing System
75
; several structural elements, medical personnel
training, equipment (eg, sponge holder racks) to facilitate accurate accounting
of soft goods/sponges; Compliance: NA
Inexpensive NA After: event rate 1 of 54 000;
Before: 1 retained item per 36 000
operations before implementation;
OR (95% CI), 1.52 (0.09-25.68)
Team Training
Cima
et al,
76
2009
Before-and-after,
50 000 operations/y
(2 y)
Conscientious count
campaign
Phase I: defect analysis; tools collaboratively designed; Phase II: awareness and
communication, mandatory meeting for all operating room personnel; team
communication and education, videos and printed materials, team training
simulation, audits with feedback, standardized counting process; “Red Rules”
(inviolable operating room rules, Universal Protocol, Correct Count Process
followed); Phase III: monitoring and control, rapid response event team formed
to deal with events within 24-36 h to provide real-time feedback, nonpunitive
approach to errors; Compliance: 99.4% in third quarter in daily random audits
of baseline count, tucked item documentation, and final counts
NA Before: RFO or
near miss once
every 16 d
After: 1 event every 69 d,
sustained for 2 y; Before: RFO or
near miss every 16 d; OR, NC
Equipment
Cima
et al,
30
2011
Before-and-after,
87 404 operations
(after)
(18 mo)
Data-matrix–coded
sponge-counting system
System includes a wide variety of labeled cotton surgical sponge products;
each item has a unique data-matrix tag; bulk scanning in, and each sponge must
be scanned out at end of procedure; Compliance: NA
Additional $11.63/ case,
11.4- vs 4.0-s count time
(decreased with practice);
59% rate process as very
efficient, 82% feel
comfortable with process
3 Incorrect
manual counts
caught
After: 0 of 87 404 retained
sponges during 18-mo study;
Before: retained sponge every 64 d
in 6 y prior; significant change in
event frequency (P< .001);
OR (95% CI), 3.49 (1.51-8.09)
Greenberg
et al,
77
2008
RCT
148 control and
150 intervention
operations
(60 d)
Bar coding surgical
sponges vs traditional
counting protocol
Control: standard perioperative registered nurses protocol for counting
instruments and sponges, simultaneous manual count by ST and circulator, and
written record; when removed from sterile field, sponges were counted and
placed in sterile bags with 10 sponges per bag, count manually performed by
both ST and registered nurse; Intervention: same as control with addition of
bar-coded sponges; sponges scanned when placed on sterile field and counted;
when removed from sterile field scanned again and counted before being placed
into bags by registered nurse; concurrent counts with ST in bar code arm were
not required; Compliance: NA
Mean time spent on counts:
8.6 min (control) vs 12 min
(intervention), P< .001),
mean time spent on sponge
counts (2.4 min (control) vs
5.3 min (intervention),
P< .001)
3 Retained
sponges found
before patient
left operating
room in bar code
group
0 Retained sponges in both groups
at 60 d of follow-up; OR, NC
Rupp
et al,
25
2012
Before-and-after,
2285 patients (after)
10-mo study period
(mean, 20 mo)
RFDS RF Surgical Systems Inc incorporated adjunct to standard sponge-counting
algorithm including Sponge ACCOUNTing System; RFDS tagged sponges;
RF wand; staff training, flow diagrams of protocols, educational materials,
assessment, and feedback; Compliance: NA
35 Miscounts (1.53%);
increased cost by
$13.54/case
1 Near miss
detected with
RFDS (in drapes;
routine protocol
did not detect it)
After: 0 retained items in 2285
patients; Before: rate 1 of 54 000
operations; OR (95% CI),
2.84 (0-5800)
Abbreviations: AE, adverse effect associated with intervention; NA, not applicable; NC, not computable; OR, odds ratio; RF, radiofrequency;RFDS, RF detection system; RFO, retained foreign object; ST, surgical technologist.
Clinical Review & Education Review Wrong-Site Surgery,Retained Surgical Items, and Surgical Fires
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approaches (ie, education, team training, a data-matrix–coded
sponge-counting system), apart from global Universal Protocol
evaluations, empirical evidence to support any particular interven-
tion is limited. Distinct methodologic challenges impede the analy-
sis of these rare but potentially devastating events and may neces-
sitate different evaluation methods.
ARTICLE INFORMATION
Accepted for Publication: February 2, 2015.
Published Online: June 10, 2015.
doi:10.1001/jamasurg.2015.0301.
Author Affiliations: Southern California Evidence-
Based Practice Center, RAND Corporation, Santa
Monica (Hempel, Booth, Shanman); Department of
Surgery, Veterans Affairs Greater Los Angeles
Healthcare System, Los Angeles, California
(Maggard-Gibbons, Dawes); Department of
Surgery, DavidGeffen School of Medicine,
University of California, Los Angeles (Maggard-
Gibbons, Nguyen); Robert Wood Johnson Clinical
Scholars Program, University of California,
Los Angeles (Dawes); Evidence-Based Synthesis
Program (ESP) Center, WestLos Angeles Veterans
Affairs Medical Center, LosAngeles, California
(Miake-Lye, Beroes, Shekelle);RAND Health, RAND
Corporation, Santa Monica, California (Miles).
Author Contributions: Drs Hempel and Shekelle
had full access to all of the data in the study and
take responsibility for the integrity of the data and
the accuracy of the data analysis.
Study concept and design: Hempel,
Maggard-Gibbons, Miles, Shekelle.
Acquisition, analysis, or interpretation of data:
Hempel, Maggard-Gibbons, Nguyen, Dawes,
Miake-Lye, Beroes, Booth, Miles, Shanman.
Drafting of the manuscript: Hempel, Dawes,
Miake-Lye, Beroes, Shanman.
Critical revision of the manuscript for important
intellectual content: Hempel, Maggard-Gibbons,
Nguyen, Dawes, Booth, Miles, Shekelle.
Statistical analysis: Hempel, Booth, Miles.
Obtained funding: Shekelle.
Administrative, technical, or material support:
Hempel, Nguyen, Dawes, Miake-Lye, Beroes,
Shanman.
Study supervision: Maggard-Gibbons
Conflict of Interest Disclosures: None reported.
Funding/Support: The study is based on a
systematic review conducted by the Evidence-
Based Synthesis Program (ESP) funded by the
Department of Veterans Affairs (VA).
Role of the Funder/Sponsor:Thi s study was
funded as a systematic review.The funding source
had no role in the conduct of the study; collection,
management, analysis, and interpretation of the
data; preparation, review,or approval of the
manuscript; and decision to submit the manuscript
for publication.
Disclaimer: The findings and conclusions in this
publication are those of the authors who are
responsible for its contents; the findings and
conclusions do not necessarily represent the views
of the VA. The ESP was established to provide
timely and accurate syntheses of targeted health
care topics and the reports comply with high
methodologic standards and synthesis methods.
Additional Contributions: Douglas Paull, MD,
Robin Hemphill, MD, VernaGibbs, MD, Mark
Wilson, MD, PhD, EdwardDunn, MD, William
Gunnar, MD,Kenneth Lipshy, MD, and Thomas
Scott, MD, Veterans AffairsGreater Los Angeles
Healthcare System, provided technical expertise.
They were not compensated for this role. Sydne
Newberry, PhD,edited the manuscript, and Aneesa
Motala, BA, assisted with article retrieval. Both are
employees of RAND Corporation and received no
financial compensation outside of usual salary.
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