Wrong Site Wrong Procedure.pdf

ORIGINAL ARTICLE

Wrong-Side/Wrong-Site, Wrong-Procedure,
and Wrong-Patient Adverse Events
Are They Preventable?
Samuel C. Seiden, MD; Paul Barach, MD, MPH

Hypothesis: Wrong-side/wrong-site, wrong-procedure,
and wrong-patient adverse events (WSPEs) are devastating, unacceptable, and often result in litigation, but their
frequency and root causes are unknown. Wrong-side/
wrong-site, wrong-procedure, and wrong-patient events are
likely more common than realized, with little evidence that
current prevention practice is adequate.
Design: Analysis of several databases demonstrates that
WSPEs occur across all specialties, with high numbers
noted in orthopedic and dental surgery. Databases analyzed included: (1) the National Practitioner Data Bank
(NPDB), (2) the Florida Code 15 mandatory reporting
system, (3) the American Society of Anesthesiologists
(ASA) Closed Claims Project database, and (4) a novel
Web-based system for collecting WSPE cases (http://www
.wrong-side.org).
Results: The NPDB recorded 5940 WSPEs (2217 wrongside surgical procedures and 3723 wrong-treatment/wrongprocedure errors) in 13 years. Florida Code 15 occurrences
of WSPEs number 494 since 1991, averaging 75 events per

P

Author Affiliations:
Department of Pediatrics, The
University of Chicago Comer
Children’s Hospital, Chicago, Ill
(Dr Seiden); Departments of
Anesthesiology, Medicine, and
Epidemiology, University of
Miami Miller School of
Medicine, Miami, Fla
(Dr Barach).

yearsince2000.TheASAClosedClaimsProjecthasrecorded
54 cases of WSPEs. Analysis of WSPE cases, including WSPE
cases submitted to http://www.wrong-side.org, suggest several common causes of WSPEs and recurrent systemic failures. Based on these findings, we estimate that there are
1300 to 2700 WSPEs annually in the United States. Despite a significant number of cases, reporting of WSPEs is
virtually nonexistent, with reports in the lay press far more
common than reports in the medical literature. Our research suggests clear factors that contribute to the occurrence of WSPEs, as well as ways to reduce them.
Conclusions: Wrong-side/wrong-site, wrong-procedure,
and wrong-patient adverse events, although rare, are more
common than health care providers and patients appreciate. Prevention of WSPEs requires new and innovative technologies, reporting of case occurrence, and learning from
successful safety initiatives (such as in transfusion medicine and other high-risk nonmedical industries), while reducing the shame associated with these events.

Arch Surg. 2006;141:931-939

ERFORMING A PROCEDURE ON

the wrong side of a patient’s
body, performing a wrong
procedure, or performing the
correct procedure on the
wrong patient constitute some of the worst
medical errors that clinicians and patients experience. The Institute of Medicine report To Err Is Human painted a
broad picture of the magnitude of medical errors in the United States and gave directions for safety improvements.1 Questions linger about ways to prevent errors
such as wrong-side surgery. Although
these events seem preventable, they continue to occur. We have few data on how
often and why they occur and on why the
safety mechanisms in place fail to prevent them. This report presents data demonstrating that there are many more
wrong-side/wrong-site, wrong-procedure, and wrong-patient adverse events
(WSPEs) than generally appreciated. The

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data indicate that current practices and
guidelines for WSPE prevention are insufficient to prevent future events.
We define a WSPE as any procedure
that has been performed on the opposite
side, incorrect site, or incorrect level of the
body; is performed on the wrong patient;
or is the wrong procedure. Wrong-side/
wrong-site surgery is the most infamous,
but wrong-side anesthetic procedures also
occur,2-4 and cases continue to occur outside the operating room (OR) in virtually
all areas of health care. Wrong-procedure and wrong-patient errors might stem
from different causes but often share a root
error pathology related to ambiguous and
imprecise identification. The similarity is
often rooted in communication breakdowns or lack of safety systems that could
have prevented these errors.5 However,
other factors are unique to these different kinds of errors of action. Studies6 have
suggested that the inability to maintain

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METHODS

Table 1. NPDB Occurrences of WSPE
by Practitioner Type, 1990-2003*
No. (%) of Cases

Practitioner Type
Physician
Intern or resident
Dentist
Registered nurse
Podiatrist
Other health professional
Total

Wrong–Body Part
Surgical
Procedures

Wrong-Procedure/
Wrong-Treatment
Errors

1721 (77.6)
12 (0.5)
402 (18.1)
17 (0.8)
58 (2.6)
7 (0.3)
2217 (100)

2056 (55.2)
23 (0.6)
1529 (41.1)
24 (0.6)
54 (1.5)
37 (1.0)
3723 (100)

Abbreviations: NPDB, National Practitioner Data Bank; WSPE,
wrong-side/wrong site, wrong-procedure, and wrong-patient adverse event.
*The data column headings are labeled with terms that are used by the
NPDB. Percentages have been rounded and may not total 100.

right and left sidedness consistently (or confusion of right
and left [apraxia]) probably stems from an underlying
neurological challenge that seems to predispose humans to confuse left and right in wrong-side errors. A
procedure performed on the wrong patient or wrong side
is a wrong procedure, just as when procedure A is intended and procedure B is performed instead. Therefore, all such errors can appropriately be called WSPEs.
The exact incidence and prevalence of WSPEs remains unknown. We have identified many sources for
finding cases of WSPEs using the following 3 different
methodologies: (1) searching the medical literature, including lay and traditional peer-reviewed sources; (2) assessing national, state, and private adverse incident databases; and (3) reporting on a sample of cases we have
collected using an anonymous Web-based reporting tool.
Accurate estimates of incidence cannot be determined
without mandatory reporting and true incidence of annual surgical procedures. Mandatory reporting is now becoming law in Florida,7 Indiana,8 Minnesota,9 and Pennsylvania.10
The medical literature on WSPEs is quite limited. Several studies and databases document hundreds of cases.
Some Swedish cases were reported as early as the
1970s,11-14 and other case reports have appeared sporadically.15-23 From 1995 through 2005, the Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) sentinel event statistics database ranked wrongside surgery as the second most frequently reported event
with 455 instances, accounting for 12.8% of 3548 events
reported since January 1995.24 Cowell25 reported 331 cases
of wrong-side surgery in a 10-year period. Meinberg and
Stern26 surveyed orthopedic hand surgeons and estimated the lifetime risk of performing a wrong-side surgery as being greater than 1 in 5. However, all are selfreports or surveys and almost certainly underestimate the
incidence, perhaps by a factor of 20 or more.27,28 In addition, discussions of the prevalence of WSPEs address
almost exclusively wrong-side surgery in the OR, ignoring the likely more common WSPEs outside the operating room and hospitals, where more than 90% of health
care is delivered.
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We reviewed the following 4 databases pertaining to WSPEs:
(1) the National Practitioner Data Bank (NPDB); (2) the Florida
Code 15 mandatory reporting system; (3) the American Society of Anesthesiologists (ASA) Closed Claims Project database; and (4) our novel WSPE incident reporting tool. The NPDB
Public Use Data File (PUDF), which collects malpracticeadjudicated data throughout the United States, was searched
for WSPE occurrence.29 Data collected in the NPDB PUDF originate from malpractice cases after adjudication and do not include adverse events that did not lead to a malpractice claim
or that were settled without a practitioner being named. However, because WSPEs are so obvious, they very often lead to
claims and result in malpractice awards in 84% to 93% of cases.26
The Florida Comprehensive Medical Malpractice Act of 1985
mandated the reporting of adverse events to the Florida Agency
for Health Care Administration. All WSPEs are required to be
reported as the result of statute 395.0197, which states that the
report should contain a “factual written statement about a particular adverse incident detailing particulars as to time, place,
all persons directly involved (including professional titles and
license numbers), and the nature of the event including a description of the damage or injury.” These reports must include a description of the cause of the event and the corrective
or proactive actions taken. These reports must be recorded within
15 days of the event (known as Code 15 reports). The ASA
Closed Claims Project database includes settled malpractice
claims since 1988. We queried this database for cases of WSPE.
Finally, we have been collecting WPSE cases using an anonymous Web-based incident-reporting tool (http://www
.wrong-side.org).2
RESULTS

NATIONAL PRACTITIONER DATA BANK
The NPDB PUDF contains 2217 cases (0.94% of all recorded cases) of “wrong-body-part surgery,” and 3723 cases
(1.58% of all recorded cases) of “wrong-treatment/wrongprocedure performed” of 236 300 cases coded for malpractice reported from 1990 through 2003 (Table 1).
Wrong-patient procedures are not coded separately and
it is not possible to determine their frequency in the NPDB
PUDF. The national incidence is likely higher, however,
because a claim does not result from each WSPE occurrence, especially if minimal or no patient harm results.
There is also growing evidence of health care facilities signing confidentiality agreements in which the plaintiffs agree
to remove the names of the physicians involved, and thus
only the hospital name appears in the sealed legal record.
Annual frequencies of WSPE in the NPDB ranged from
359 to 457 cases from 1990 through 1998. The apparent
decline in occurrence in the Figure may be owing to a
mean delay of 3.9 years from the WPSE occurrence to closing of the legal case. We predict that WSPEs reported in
the NPDB will continue to be in the range of 400 cases
per year. Physicians, according to the NPDB, performed
most of the events on the wrong body part (n = 1721
[77.6%]), followed by dentists (n=402 [18.1%]) (Table 1).
In wrong-procedure/wrong-treatment errors, the number of dentists’ reports (1529 [41.1%]) were closer to those
of physicians (2056 [55.2%]). However, it was not posWWW.ARCHSURG.COM

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Table 2. Florida Code 15 Adverse Event Data, 1990-2003*

800

Year Reported
Year Occurred

700

No. (%) of Cases†

Cases per Year

600

Years

500

2000-2003
1996-1999
1991-1995
Total

400
300

Wrong
Site

Wrong
Patient

Wrong
Procedure

Total

178 (61)
90 (63)
41 (73)
309 (63)

34 (12)
22 (15)
7 (13)
63 (13)

82 (28)
32 (22)
8 (14)
122 (25)

294 (100)
144 (100)
56 (100)
494 (100)

200
100
0
1988

1990

1992

1994

1996

1998

2000

2002

2004

Year

Figure. National Practitioner Data Bank Public Use Data File (NPDB PUDF).
This long-term database of settled medicolegal cases that have been
reported to the NPDB demonstrates that wrong-side/wrong site, wrong
procedure, and wrong-patient adverse events (WSPEs) have been occurring
at a fairly steady rate. The graph underscores the usual lag time between
WSPE occurrence and reporting to the NPDB. The approximate 3- to 5-year
lag time is presumed to be caused by the lengthy adjudication process via
the legal system and is not believed to be an indication that WSPE incidence
in the NPDB is in fact declining.

sible to distinguish between wrong treatment and wrong
procedures in these cases.
When comparing mistakes of similar error pathology,
WSPEs were more common in the NPDB than were cases
of retained foreign body after surgery, which have received recent attention,30 and substantially more common than were cases of transfusion error.31 The NPDB
PUDF mentions 4295 cases of retained foreign body and
only 52 cases of wrong blood-type transfusion. The error
processes leading to retained foreign body (known as retained surgical instruments in the NPDB), along with errors in transfusion medicine, share many of the same systemic and cognitive failures that enabled the WSPE
occurrence. However, there has been much greater success at reducing transfusion errors, as indicated by the comparative incidence in the NPDB and the literature. Research has indicated that laboratory errors in blood typing
account for only 7% of transfusion errors, with the remaining events attributable to human errors at the bedside clerical check (the most common cause of ABOincompatible transfusion31), communication errors, and
labeling errors32—errors that are the leading root causes
in many WSPEs. Similarly, from 1996 through 2003, the
JCAHO sentinel event statistics database report mentions
13 cases of unintended retention of a foreign body (0.4%)
and 94 transfusion errors (2.6%) compared with the 455
WSPEs (12.8%) reported.24 This relatively small number
of transfusion errors compared with the number of WSPEs
may result from the systems improvements that have been
introduced in blood banking and may offer lessons for successful WSPE prevention strategies.
FLORIDA CODE 15
MANDATORY REPORTING SYSTEM
In Florida, there have been 494 well-documented WSPE
reports to the state since 1991, with an average of 75 events
per year reported since 200033 (Table 2). The major lo(REPRINTED) ARCH SURG/ VOL 141, SEP 2006
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*Table reprinted from Kellier and Barach.33 Florida state law requires
incidents that are referred to as Code 15 to be reported to the Florida Agency
for Health Care. A Code 15 event must be reported by the hospital within
15 days, except for more serious events, which must be reported within
24 hours. A Code 15 event is defined as “an adverse incident over which
healthcare personnel could exercise control and the event was associated
in whole or in part with a medical intervention rather than the condition for
which the intervention occurred and which resulted in 1 or more of a list
of serious preventable injuries.”
†Percentages have been rounded and may not total 100.

cation of wrong-site procedures is the OR. A large number of wrong-site procedures occur in radiology, with an
equal number of events in unspecified locations. Cataract procedures were the second most common wrongsite incidents. The patients frequently had cataracts in both
eyes, and the subsequent eye was originally scheduled to
undergo surgery in 1 to 2 weeks. During the first surgery,
the wrong eye was selected for surgery owing to several
factors: the wrong eye was listed on the consent form, the
preoperative nurse identified the wrong patient or the
wrong eye for the procedure, the patient agreed to the verbalized statement from the staff regarding which eye, the
anesthesiologist anesthetized the wrong eye, or the surgeon selected the wrong eye for the procedure. Inguinal
hernia was the third most common wrong-site incident
collected in this data set. As with cataracts, patients occasionally had bilateral inguinal hernias with one side being
more severe and requiring surgical intervention sooner than
the other side.34 If the incidence of WSPEs in Florida of
75 cases per year is representative of the national incidence in the United States, an extrapolation based on US
census data would imply a national incidence of 1321 cases
per year.35 However, by 2 independent estimates, the Code
15 system underreports by roughly 1 order of magnitude, suggesting that an estimated incidence of 1321 cases
of WSPEs per year nationally may be an underestimate,
since it is based on the Florida Code 15 incidence.36
In addition, our data and those of others suggest a
higher incidence of wrong-site surgeries than that found
by Kwaan et al37 (who did not report on wrong-patient
or wrong-procedure events). Their retrospective chart review reported an incidence of 1 WSPE per 112 000 procedures, significantly noting that only two thirds of the
cases they analyzed might have been prevented by the
JCAHO universal protocol.
In Florida, with an average of 75 WSPEs per year and
3 858 752 combined inpatient/outpatient surgical procedures (2 452 998 outpatient discharges and 1 405 754
inpatient discharges with surgical International Classification of Diseases, Ninth Revision codes in 2005 [Jeff Gregg,
Bureau Chief, Agency for Healthcare Administration,
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Table 3. Classification of WSPE Reported Claims
to the ASA Closed Claims Project Database

Table 4. Factors Contributing to WSPE From Case Analyses*
Human factors

Site of Error

No. (%) of Cases*

Wrong-side procedure
Knee
Eye
Hip
Foot/ankle
Hernia
Pain block
Ear
Laminectomy
Craniotomy
Nephrectomy
Thumb
Wrong-patient error
Patients with same name
Patients looked similar
Unknown cause
Wrong procedure
Wrong site near correct site
Other
Total

20 (37)
5 (9)
4 (7)
3 (6)
3 (6)
3 (6)
2 (4)
1 (2)
1 (2)
1 (2)
1 (2)
2 (4)
1 (2)
2 (4)
4 (7)
1 (2)
54 (100)

Abbreviations: ASA, American Society of Anesthesiologists;
WSPE, wrong-side/wrong-site, wrong-procedure, and wrong-patient
adverse event.
*Because of rounding, percentages may not total 100.

Florida, written communication, June 26, 2006]), one
would expect 1 WSPE per 51 540 surgical procedures—
more than twice the rate reported by Kwaan et al. The
National Center for Health Statistics reports 43.9 million inpatient surgical procedures in 200338 and 31.5 million outpatient surgical procedures in 1996.39 Using the
calculated incidence rate of 1 WSPE for 51 540 surgical
procedures in Florida, one might expect 1466 events in
the United States per year.
It is further worth noting that a recent 2003-2004 review of WSPEs conducted at 17 Minnesota hospitals demonstrated an incidence rate of 36.6 cases per 1 000 000
procedures, or 1 case for every 27 322 surgical procedures (Gordon Mosser, MD, written communication, May
15, 2006). This rate would suggest an annual incidence
as high as 2760 WSPEs per year in the United States.

High workload environment
Fatigue
Multiple team members
Diffusion of authority/lack of accountability
Team communication
Change of personnel
Haste
Inexperience
Incompetence
Other cognitive factors
Patient factors
Sedation or anesthesia
Patient not consulted before block or anesthesia
Patient confusion of side, site, or procedure
Inability to engage patient (eg, young child or decreased
competence)
Patient ignorance
Patient has common name or same name as another patient
in hospital
Procedure factors
Wrong side draped/prepped
Similar or same procedures back to back in same room
Patient position or room changed prior to initiating procedure
Attempts to prevent WSPE
Not observing marked site/marking wrong site
Not cross-checking for consistency in consent form, patient chart,
or OR booking form
Abbreviations: OR, operating room; WSPE, wrong-side/wrong-site,
wrong-procedure, and wrong-patient adverse event.
*These factors have been noted as occurrences in cases we have
analyzed in the literature in addition to original cases submitted to http:
//www.wrong-side.org.

cases submitted to http://www.wrong-side.org is reinforced by our analysis of other cases in the literature of
poorly resilient health care systems. These systems suffer from enabling conditions that predispose WSPE occurrence. These include lack of patient involvement, lack
of knowledge about the procedure being performed, and
failure of safety mechanisms to prevent the error from
occurring (Table 4).
COMMENT

ASA CLOSED CLAIMS PROJECT DATABASE
The search of 5803 claims produced 54 WSPEs (0.93%)
(Table 3). Wrong-side surgical adverse event errors provided the most detailed data and were the most common. An anesthesiologist was present in the OR during
35 (80%) of the wrong-side errors, but most of these errors were detected after induction of anesthesia. It was
determined after evaluation that better preanesthetic
evaluation would have prevented only 10 of these claims
(Karen Posner, PhD, ASA Closed Claims Project, written communication, April 13, 2005).
WSPE INCIDENT-REPORTING TOOL
We developed an innovative anonymous Web-based reporting site for WSPEs. Our analysis of several dozen
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Data from the 4 sources of WSPE reports demonstrate
that WSPEs are more common than generally accepted
or than is reported in the literature. Although WSPEs are
probably relatively rare events, we believe they are substantially underreported and totally preventable. The incidence of 1300 to 2700 WSPE cases per year out of more
than 75 million surgical procedures performed annually in the United States is more than 5 to 10 times greater
than that accepted by the manufacturing industry’s quality-defect standard Six Sigma.40 Furthermore, although
orthopedic surgery has received the most attention,
WPSEs continue to occur in other disciplines (eg, anesthesiology [Table 3]) or during ambulatory procedures
outside the OR (eg, radiology and dentistry [Table 1]).
The increased use of conscious sedation for surgical procedures in ambulatory and free-standing surgery cenWWW.ARCHSURG.COM

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Table 5. Examples of Wrong-Side/Wrong-Site, Wrong-Procedure, and Wrong-Patient Adverse Events
Wrong Side/Wrong Site
Wrong-side organ (eg, lung or kidney) removal4,41
Wrong-eye LASIK46
Wrong-side chest tube18
Wrong-leg amputation4
Wrong-side arthroscopy25

Wrong Patient

Wrong Procedure

Termination of life support on wrong patient42
Wrong-patient radiation treatment47
Wrong-patient cardiac catheterization49,50
Wrong-patient tonsillectomy52

Wrong-embryo implantation in obstetrics43-45
Wrong-lens implantation48
Wrong-organ transplantation (ABO mismatch)51
Orchiectomy instead of circumcision on patient
with aphasic stroke4

Abbreviations: LASIK, laser in situ keratomileusis; OR, operating room.

ters will likely increase these numbers. Most states have
little oversight of freestanding procedure facilities and
thus have little means to record WSPEs in freestanding
outpatient clinics.
WHAT IS THE NATURE AND CONSEQUENCE
OF WSPE ERRORS?
Most studies have been descriptive studies limited to orthopedic surgery and its subspecialties (eg, hand surgery). No studies have examined the types of laterality errors or have included wrong-patient or wrong-procedure
errors or wrong-side events (Table 5). Wrong-implant procedures have occurred in obstetrics (wrong-embryo implantation)43-45 and ophthalmology (wrong-lens implantation)48 and likely have occurred in other specialties. In
addition, wrong-side events have been reported in corrective eye surgery (laser in situ keratomileusis),46 and the rapid
growth of this procedure suggests that the number of such
errors will increase. Data exist on the kinds of laterality errors that are most common (eg, wrong-knee and wrongfinger errors).24-26,53
Wrong-patient procedures have been reported less frequently in the medical literature.17,54-57 The lay press, however, has been more active in discussing wrong-patient
procedures, including, for example, reporting cases of termination of life support of the wrong patient,42 administration of radiation treatment to the wrong patient,47
cardiac catheterizations in the wrong patient,49,50 tonsillectomy in the wrong patient,52 and, of course, the widely
publicized ABO-incompatible heart-lung transplant at
Duke Medical Center, Durham, NC, in 2003.51 When laterality errors occur, the nature of the error and the magnitude of the consequences lead to negative and widespread press coverage contributing to decreased public
confidence in the safety of the health care system.58,59
The consequences of WSPEs range considerably from
increased hospitalization and pain to serious iatrogenic
injury and death. In 1 case, the wrong hip was pinned
and, during wound closure of a second operation, the patient experienced cardiac arrest and died.23 Another patient had his healthy right lung excised instead of the cancerous left lung.4 Even if there were little or no permanent
harm to a patient, the event is an embarrassing one for
the clinician, the hospital, and the entire health care domain. The public media almost always finds it difficult
to argue that the clinician should not be blamed for the
error. Moreover, in most of these events, there is permanent harm and resulting litigation. Consequently, WSPEs
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erage payment of $96 032 per claim in the NPDB, with
the largest recorded payment being $9 million.4,29
WHY DO THESE ERRORS OCCUR?
The current health care system is not culturally or structurally organized for preventing WSPEs. Multiple systems and organizational factors lead to WSPE occurrence, including similarity of site, surgery, and patient
names; breakdowns in communication and teamwork;
patient and procedure factors; and failure of existing safety
checks (Table 3). Fail-safe patient identification systems that would consistently ensure that the right patient and right side or site are undergoing the right procedure are still experimental.60 New surgical smart chips
might offer help in reducing the impact of these medical
errors.61,62 Wrong-side procedures almost certainly stem
from the bilateral symmetry of the human body. There
are unique cognitive challenges that occur partly because of bilateral symmetry and the ease with which
people can confuse left and right. Some people are probably genetically incapable or predisposed to consistent
error in distinguishing right from left in themselves and
in others (apraxia).6
Clinicians grow accustomed to their right side being
their patient’s left side when facing a patient. However,
the opposite is not true if the patient and the clinician
are facing the same direction. This can be especially challenging in the OR, where the patient is covered in sterile
drapes or the patient’s position is changed during the procedure, eg, from supine to prone, or the entire table is
rotated 180°.4 If the patient is rotated onto one side and
the limbs are flexed then, from some viewing angles, it
requires significant mental effort to rotate the patient’s
body so that it is spatially congruent with that of the observer and its laterality is made clear.63 This rotational
mental effort is required to allow direct mapping of the
clinician’s perspective onto the patient. This congruence is essential to ensure correct-sided procedures. It
is not surprising that such a cognitively demanding process could be subject to error, especially in a distractionrich environment like the OR. Other complexities include the standard practices of marking laterality on
radiographs, computed tomograms, and magnetic resonance images. Each can be erroneously labeled, or the
laterality can be misinterpreted even if labeled correctly. Poor viewing practices and lack of adequate facilities for viewing at the point of care can further predispose to a WSPE.
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LESSONS FROM TRANSFUSION MEDICINE
The NPDB PUDF from 1990 through 2003 mentions 52
cases (0.02%) of wrong–blood type transfusions, including 14 fatalities, and the JCAHO sentinel event statistics
database contains 94 occurrences (2.6%) of transfusion error.24,29 Fatal transfusion errors used to be common. In
1942, acute hemolytic reactions led to 1 death for every
935 transfusions.64 Furthermore, given the distribution of
A and B blood types in the population, the number of errors may be much larger than reported because a large number of errors do not lead to adverse outcomes. The rate
has steadily declined over time to an estimated 1 death out
of 1 800 000 transfusions,32 or about 12 to 13 deaths per
year in the United States—a nearly 2000-fold reduction
in incidence.31 Although more than 222 articles on transfusion errors dating from the 1950s are referenced in
PubMed, we found fewer than 10 articles on WSPEs in the
medical literature. Most publications pertaining to WSPEs
are case reports or descriptive case series.
The success of reducing transfusion errors has come
through research on common causes, near-miss and adverse event reporting systems, safety policies, humanfactor engineering, and the development of error-free technologies (eg, bar-coded patient wristbands, wireless
technologies, and computer-based patient identification systems).31,65-67 Learning about transfusion errors
through mandatory no-fault reporting, including the classification, analysis, and monitoring of mistransfusions and
near misses, has helped foster a more resilient and reliable safety culture in transfusion medicine.68,69 Reporting systems seem to enhance safety culture through more
transparency, communication, and accountability.70,71
HOW CAN THESE EVENTS BE PREVENTED?
Unfortunately, modern health care creates many opportunities for WSPEs to occur. Many medical interventions include procedures on organs and limbs that appear externally normal and offer no cues or site salience
to indicate the correct side for intervention (eg, arthroscopy and nerve blocks). Paper checks and procedures such
as site marking will decrease but not eliminate WSPEs.
The American Academy of Orthopedic Surgeons has promoted a site-marking policy since 1997 and has publicized it extensively. However, only 70% of orthopedic
hand surgeons were aware of the policy and, of those,
only 45% had changed their practice habits as a result of
this new policy.26
In addition, error prevention depends on the individual’s ability and willingness to use prevention mechanisms. For instance, Gawande et al30 found that, in 88%
of retained surgical instrument cases, an instrument count
had been performed in the OR and had been found to be
correct (indicating no missing instruments). Thus, the
OR staff may have miscounted or may have reported the
correct number of instruments without actually performing the count. Both options indicate possible opportunities for failure of checklists and safety policies.
Patient involvement and verification of operative site
and procedure is an often recommended and appropriate protection tool. It is used in conjunction with built-in
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redundancies because the patient can be as much in error as the clinician. For instance, the Association of Perioperative Registered Nurses72-74 and the subsequent
JCAHO universal protocol75 suggest preoperative confirmation of laterality and procedure by using documents such as the patient history, physical examination
findings, preoperative assessment, review of the informed consent, and applicable imaging studies. We have
reviewed several WPSE cases in our database in which
the patient was awake and alert. The patients, including
one physician, failed to alert or stop the surgical team
from performing a WPSE. One patient had his sole functioning kidney removed after his incorrect indication of
laterality, and a patient with aphasic stroke received a bilateral orchiectomy instead of the planned circumcision
because the team incorrectly understood his response to
indicate that he was a different patient.4 Another patient, a physician, allowed an incorrect-sided anesthesia
block to be placed while observing the procedure. In addition, encouragement of patient involvement by asking patients to mark their own operative site preoperatively is an important opportunity to empower patients
but has met with low compliance.76 DiGiovanni et al found
low compliance in patients marking their own operative site. Of the 100 patients included in the study, 59%
correctly marked the procedure site, 37% did not mark
the site, and 4% did not mark the site correctly.
The prevention of WSPEs is a prerequisite to safe patient care. A zero-tolerance policy is the only standard
that can be ethically justified by providers or accepted
by patients and the public. Mechanisms for prevention
require specific attention to organizational and cultural
barriers that affect patient safety strategies. One of the
greatest barriers to eliminating WSPEs is that, paradoxically, WPSEs occur relatively infrequently. Health care
providers usually believe that they are immune to these
human errors until they are involved in a WSPE. Some
have said that the rare frequency of such events is acceptable, given that most procedures are error free. Failure to attend to the organizational and cultural barriers
to change will lead to significant physician resistance and
recurring WSPEs.
On July 1, 2004, the JCAHO implemented the universal protocol for the prevention of WSPEs.75 The protocol aims to eliminate WSPEs by using (1) preoperative verification of patient, site, and procedure; (2)
marking of the operative site; and (3) a time-out immediately before starting the procedure. The policies of the
JCAHO, the American Academy of Orthopedic Surgeons, the Association of Perioperative Registered Nurses,
and other relevant organizations48,73-75,77-80 do not require reporting or investigation of cases of WSPEs or nearmiss WSPEs. An Association of Perioperative Registered Nurses position paper notes that “procedures for
reporting and responding to wrong-site surgery or near
misses” are “key points” of any WSPE policy and constitute an important step in reducing these events.72 Without the ability and data to evaluate the reporting of WSPE
errors and near misses or an accurate estimate of the frequency of such errors before implementation of the universal protocol, it is impossible and premature to assess
the effect of this policy on reducing WSPEs. Recent data
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been published. The shame factor associated with WSPEs
has kept most clinicians from talking about and learning from their events, thus eliminating the learning opportunity. The data we have presented herein indicate
that WSPEs occur at a rate more common than previously published and without sufficient attention from researchers, educators, or health care policy leaders. The
lack of a national database and national reporting requirements prevents a realistic assessment of the frequency of WSPE occurrence or the efficacy of prevention efforts, such as the recent JCAHO universal protocol.
Our attempts to use the NPDB, the Florida Code 15 mandatory reporting system, ASA Closed Claims Project database, and our anonymous reporting tools gave us convenience samples that indicate a high number of cases
for which attention is warranted. It is widely believed that
current reporting systems underreport occurrences of such
errors by several magnitudes.

published in this journal suggest that one third of wrongsite surgery cases occurred even with careful site identification procedures similar to the JCAHO universal protocol.37 Although comprehensive data are lacking, WSPEs
have occurred after implementation of the universal protocol.81 In 1 health care system experience, 14 cases of
wrong-side and wrong-site surgery occurred from January 2003 through June 2004 in the presence of an institutional policy in concordance with the JCAHO universal protocol (Allison Haskins Page, MS, MHA, Fairview
Health Systems, Minneapolis, Minn; written communication; April 26, 2005). This is an early indication that
the JCAHO universal protocol may be insufficient to completely prevent WSPEs, and further underscores the need
for robust research as to the protocol’s efficacy.
Careful review of the nationally promulgated policies for reducing wrong-side surgery suggests that these
recommendations are supported by limited evidence. A
Cochrane standard-of-evidence base assessment would
barely amount to a level C, suggesting limited scientific
validity of this protocol.82
Systems redesign will significantly diminish WSPEs
but will require a microsystem or team-based effort that
requires focused training on preventing WSPEs.83 Reporting all errors—those that result in harm to the patient as well as near misses—is an essential element of
developing a learning culture similar to the one that has
led to the dramatic safety improvements in transfusion
medicine and in other industries such as aviation and
nuclear power.84-86 This will require creating conditions
that help health care providers feel comfortable and safe
to report these events without retribution.87 Every member of the health care team will view prevention of WSPEs
as his or her responsibility, a position advocated by the
Association of Perioperative Registered Nurses.73 A preprocedure briefing (similar to a preflight briefing) is a
valuable tool that has been used in commercial aviation
and in the military.5 The preprocedure time-out (a final
verification of correct patient, site, and procedure) recommended by the JCAHO guidelines is a step in the right
direction but fails to address the complexity of WSPEs.75
A time-out suggests something separate and external
rather than integral to the process, thus encouraging workarounds that undermine the effectiveness of these policies. The time-out policy falls short in addressing health
care challenges such as unavailable equipment, varying
roles, and unavailability of team members. Time-outs
planned without consideration of work flow add more
work and ultimately can lead to limited behavior change
and pro forma acceptance. In addition, the occurrence
of the time-out just before the surgical procedure is ineffective in preventing anesthesia-related WSPEs, which
can occur both inside and outside the OR. Finally, as
theory and research data become available on the mechanisms of WSPEs, such knowledge must be incorporated
into the training of health care providers.

Wrong-side/wrong-site, wrong-procedure, and wrongpatient adverse events are more common than previously reported. Based on the several available databases
we have analyzed, WSPEs have been occurring steadily
for years without significant attention or evidence of reduction in prevalence. The data support widespread underreporting of these adverse events. At a minimum, assuming 100% of cases are reported, our extrapolation of
data from Florida predict that there would be 1321 cases
in the United States annually. However, multiple studies1,88,89 have demonstrated that the compliance of physicians in reporting has ranged from 5% to 50% of events.
Assuming that this frequency of reporting is true for
WSPEs as well, the more cautious estimate of 50% underreporting indicates that annual US WSPE incidence
may be at least 2-fold higher, thus predicting a WSPE incidence of 2600 events in the United States annually. Based
on the available databases, extensive review of the literature, and discussion with regulators, an estimate of
1300 to 2700 WSPEs per year in the United States seems
likely. Continued occurrence of WSPEs undermines the
goal of health care by contributing to unnecessary deaths,
disability, suffering, malpractice, and decreased public
confidence in the health care system. The Institute of
Medicine report1 has led to numerous efforts to improve the quality and safety of patient care. Unambiguous and reliable patient and procedure identification must
be a priority in translating research gains into clinical practice. Although widespread policy efforts suggest that there
might be some reduction in the incidence of WSPEs, no
evidence at present supports this change in outcomes.
We believe that WSPEs are completely preventable and
that the recommendations outlined in the following sections will help to reduce the occurrence of WSPEs.

LIMITATIONS

REPORTING

We are unable to present a definitive prevalence and incidence of WSPEs in this report. Unfortunately, these data
are not presently available in health care and have never

Health care professionals must acknowledge and report
WSPEs and near misses and create safe ways to discuss the
system- and performance-shaping factors that enable them

(REPRINTED) ARCH SURG/ VOL 141, SEP 2006
937

CONCLUSIONS

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to occur.5 For these lessons to become part of the culture
of health care, they need to be integrated into the curriculum of all health care providers. Reporting of WSPEs will
occur when health care providers feel safe to report them.
Present punitive programs in a few states will likely not serve
to enhance patient safety. Mandatory reporting of all WSPEs
will help raise awareness of these events. Reducing the
stigma and shame associated with these events, as well as
addressing the regulatory reform, will help. After a near miss
in clinical care, clinicians in Florida are at risk of paying
significant fines and of performing community service. This
practice has had a chilling effect on reporting and patient
safety programs in the state (Laurie Davies, MD, Florida
Board of Medicine, written communication, March 1, 2006).
These events happen to well-trained and respected practitioners and we should acknowledge that. We have created a voluntary anonymous Web site for reporting cases
of WSPE (viewable at http://www.wrong-side.org), and we
invite health care providers to submit cases of WSPEs to
this site.
TEAM PREVENTION APPROACH
All health care professionals involved in performing invasive procedures—as well as the patient—must be actively involved in ensuring correct surgical and intervention procedures. Team training—with its explicit
knowledge, skills, and attitudes required of the full surgical team, including the clerical scheduling personnel,
nurses, surgeons, and anesthesiologists—should be required in health care facilities.87
HUMAN FACTORS ANALYSIS
Human factors, failure mode and effects, and root cause
analyses should be performed after all WSPEs to better
understand why our present systems are failing to stop
these events.75
TECHNOLOGY
Technological development of robust patient identification systems such as barcoding or radiofrequency tagging should be developed and their use required by medical regulators.60-62
A best-practice evidence-based approach to prevent
WSPEs should be applied to recommendations made before their dissemination and enforcement by regulatory
agencies.
Accepted for Publication: November 30, 2005.
Correspondence: Paul Barach, MD, MPH, Departments
of Anesthesiology, Medicine, and Epidemiology, University of Miami Miller School of Medicine, 1611 NW
12th Ave, Miami, FL 33136 ([email protected])
or Samuel C. Seiden, MD, Department of Pediatrics, The
University of Chicago Comer Children’s Hospital, 5721
S Maryland Ave, Mail Code 8016, Chicago, IL 60637
([email protected]).
Acknowledgments: We thank Ming Wen, PhD, from the
Department of Sociology, University of Utah, Salt Lake
City, for statistical analysis of the NPDB data; John Send(REPRINTED) ARCH SURG/ VOL 141, SEP 2006
938

ers, PhD, from the University of Toronto, for comments
regarding human-factor error and analysis; Bill Rutherford, MD, from the University of Western Michigan, Julie Johnson, MSPH, PhD, from the Department of Medicine, University of Chicago, and Hal Kaplan, PhD, from
Columbia University and NewYork-Presbyterian Hospital, for suggestions and review of the manuscript; Wrenn
Levenberg, MD, from the Department of Emergency Medicine, Boston University Medical Center, for assistance in
researching the transfusion literature; Karen Posner, PhD,
from the ASA Closed Claims Project, for providing data;
and Robert Oshel, PhD, Health Research Services Administration, for assistance in searching the NPDB PUDF.
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