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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, yearsince2000.TheASAClosedClaimsProjecthasrecorded


and wrong-patient adverse events (WSPEs) are devastat- 54 cases of WSPEs. Analysis of WSPE cases, including WSPE
ing, unacceptable, and often result in litigation, but their cases submitted to http://www.wrong-side.org, suggest sev-
frequency and root causes are unknown. Wrong-side/ eral common causes of WSPEs and recurrent systemic fail-
wrong-site, wrong-procedure, and wrong-patient events are ures. Based on these findings, we estimate that there are
likely more common than realized, with little evidence that 1300 to 2700 WSPEs annually in the United States. De-
current prevention practice is adequate. spite a significant number of cases, reporting of WSPEs is
virtually nonexistent, with reports in the lay press far more
Design: Analysis of several databases demonstrates that common than reports in the medical literature. Our re-
WSPEs occur across all specialties, with high numbers search suggests clear factors that contribute to the occur-
noted in orthopedic and dental surgery. Databases ana- rence of WSPEs, as well as ways to reduce them.
lyzed included: (1) the National Practitioner Data Bank
(NPDB), (2) the Florida Code 15 mandatory reporting Conclusions: Wrong-side/wrong-site, wrong-procedure,
system, (3) the American Society of Anesthesiologists and wrong-patient adverse events, although rare, are more
(ASA) Closed Claims Project database, and (4) a novel common than health care providers and patients appreci-
Web-based system for collecting WSPE cases (http://www ate. Prevention of WSPEs requires new and innovative tech-
.wrong-side.org). nologies, reporting of case occurrence, and learning from
successful safety initiatives (such as in transfusion medi-
Results: The NPDB recorded 5940 WSPEs (2217 wrong- cine and other high-risk nonmedical industries), while re-
side surgical procedures and 3723 wrong-treatment/wrong- ducing the shame associated with these events.
procedure errors) in 13 years. Florida Code 15 occurrences
of WSPEs number 494 since 1991, averaging 75 events per Arch Surg. 2006;141:931-939

P
ERFORMING A PROCEDURE ON data indicate that current practices and
the wrong side of a patients guidelines for WSPE prevention are in-
body, performing a wrong sufficient to prevent future events.
procedure, or performing the We define a WSPE as any procedure
correct procedure on the that has been performed on the opposite
wrong patient constitute some of the worst side, incorrect site, or incorrect level of the
medical errors that clinicians and pa- body; is performed on the wrong patient;
tients experience. The Institute of Medi- or is the wrong procedure. Wrong-side/
cine report To Err Is Human painted a wrong-site surgery is the most infamous,
broad picture of the magnitude of medi- but wrong-side anesthetic procedures also
cal errors in the United States and gave di- occur,2-4 and cases continue to occur out-
rections for safety improvements.1 Ques- side the operating room (OR) in virtually
tions linger about ways to prevent errors all areas of health care. Wrong-proce-
such as wrong-side surgery. Although dure and wrong-patient errors might stem
Author Affiliations: these events seem preventable, they con- from different causes but often share a root
Department of Pediatrics, The tinue to occur. We have few data on how error pathology related to ambiguous and
University of Chicago Comer often and why they occur and on why the imprecise identification. The similarity is
Childrens Hospital, Chicago, Ill
safety mechanisms in place fail to pre- often rooted in communication break-
(Dr Seiden); Departments of
Anesthesiology, Medicine, and
vent them. This report presents data dem- downs or lack of safety systems that could
Epidemiology, University of onstrating that there are many more have prevented these errors.5 However,
Miami Miller School of wrong-side/wrong-site, wrong-proce- other factors are unique to these differ-
Medicine, Miami, Fla dure, and wrong-patient adverse events ent kinds of errors of action. Studies6 have
(Dr Barach). (WSPEs) than generally appreciated. The suggested that the inability to maintain

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METHODS
Table 1. NPDB Occurrences of WSPE
by Practitioner Type, 1990-2003*
We reviewed the following 4 databases pertaining to WSPEs:
No. (%) of Cases (1) the National Practitioner Data Bank (NPDB); (2) the Florida
Code 15 mandatory reporting system; (3) the American Soci-
WrongBody Part Wrong-Procedure/ ety of Anesthesiologists (ASA) Closed Claims Project data-
Surgical Wrong-Treatment base; and (4) our novel WSPE incident reporting tool. The NPDB
Practitioner Type Procedures Errors
Public Use Data File (PUDF), which collects malpractice-
Physician 1721 (77.6) 2056 (55.2) adjudicated data throughout the United States, was searched
Intern or resident 12 (0.5) 23 (0.6) for WSPE occurrence.29 Data collected in the NPDB PUDF origi-
Dentist 402 (18.1) 1529 (41.1) nate from malpractice cases after adjudication and do not in-
Registered nurse 17 (0.8) 24 (0.6) clude adverse events that did not lead to a malpractice claim
Podiatrist 58 (2.6) 54 (1.5) or that were settled without a practitioner being named. How-
Other health professional 7 (0.3) 37 (1.0) ever, because WSPEs are so obvious, they very often lead to
Total 2217 (100) 3723 (100)
claims and result in malpractice awards in 84% to 93% of cases.26
The Florida Comprehensive Medical Malpractice Act of 1985
Abbreviations: NPDB, National Practitioner Data Bank; WSPE,
mandated the reporting of adverse events to the Florida Agency
wrong-side/wrong site, wrong-procedure, and wrong-patient adverse event.
*The data column headings are labeled with terms that are used by the for Health Care Administration. All WSPEs are required to be
NPDB. Percentages have been rounded and may not total 100. reported as the result of statute 395.0197, which states that the
report should contain a factual written statement about a par-
ticular adverse incident detailing particulars as to time, place,
right and left sidedness consistently (or confusion of right all persons directly involved (including professional titles and
and left [apraxia]) probably stems from an underlying license numbers), and the nature of the event including a de-
neurological challenge that seems to predispose hu- scription of the damage or injury. These reports must in-
clude a description of the cause of the event and the corrective
mans to confuse left and right in wrong-side errors. A
or proactive actions taken. These reports must be recorded within
procedure performed on the wrong patient or wrong side 15 days of the event (known as Code 15 reports). The ASA
is a wrong procedure, just as when procedure A is in- Closed Claims Project database includes settled malpractice
tended and procedure B is performed instead. There- claims since 1988. We queried this database for cases of WSPE.
fore, all such errors can appropriately be called WSPEs. Finally, we have been collecting WPSE cases using an anony-
The exact incidence and prevalence of WSPEs re- mous Web-based incident-reporting tool (http://www
mains unknown. We have identified many sources for .wrong-side.org).2
finding cases of WSPEs using the following 3 different
methodologies: (1) searching the medical literature, in- RESULTS
cluding lay and traditional peer-reviewed sources; (2) as-
sessing national, state, and private adverse incident da-
tabases; and (3) reporting on a sample of cases we have NATIONAL PRACTITIONER DATA BANK
collected using an anonymous Web-based reporting tool.
Accurate estimates of incidence cannot be determined The NPDB PUDF contains 2217 cases (0.94% of all re-
without mandatory reporting and true incidence of an- corded cases) of wrong-body-part surgery, and 3723 cases
nual surgical procedures. Mandatory reporting is now be- (1.58% of all recorded cases) of wrong-treatment/wrong-
coming law in Florida,7 Indiana,8 Minnesota,9 and Penn- procedure performed of 236 300 cases coded for mal-
sylvania.10 practice reported from 1990 through 2003 (Table 1).
The medical literature on WSPEs is quite limited. Sev- Wrong-patient procedures are not coded separately and
eral studies and databases document hundreds of cases. it is not possible to determine their frequency in the NPDB
Some Swedish cases were reported as early as the PUDF. The national incidence is likely higher, however,
1970s,11-14 and other case reports have appeared sporadi- because a claim does not result from each WSPE occur-
cally.15-23 From 1995 through 2005, the Joint Commis- rence, especially if minimal or no patient harm results.
sion on Accreditation of Healthcare Organizations There is also growing evidence of health care facilities sign-
(JCAHO) sentinel event statistics database ranked wrong- ing confidentiality agreements in which the plaintiffs agree
side surgery as the second most frequently reported event to remove the names of the physicians involved, and thus
with 455 instances, accounting for 12.8% of 3548 events only the hospital name appears in the sealed legal record.
reported since January 1995.24 Cowell25 reported 331 cases Annual frequencies of WSPE in the NPDB ranged from
of wrong-side surgery in a 10-year period. Meinberg and 359 to 457 cases from 1990 through 1998. The apparent
Stern26 surveyed orthopedic hand surgeons and esti- decline in occurrence in the Figure may be owing to a
mated the lifetime risk of performing a wrong-side sur- mean delay of 3.9 years from the WPSE occurrence to clos-
gery as being greater than 1 in 5. However, all are self- ing of the legal case. We predict that WSPEs reported in
reports or surveys and almost certainly underestimate the the NPDB will continue to be in the range of 400 cases
incidence, perhaps by a factor of 20 or more.27,28 In ad- per year. Physicians, according to the NPDB, performed
dition, discussions of the prevalence of WSPEs address most of the events on the wrong body part (n = 1721
almost exclusively wrong-side surgery in the OR, ignor- [77.6%]), followed by dentists (n=402 [18.1%]) (Table 1).
ing the likely more common WSPEs outside the operat- In wrong-procedure/wrong-treatment errors, the num-
ing room and hospitals, where more than 90% of health ber of dentists reports (1529 [41.1%]) were closer to those
care is delivered. of physicians (2056 [55.2%]). However, it was not pos-

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Table 2. Florida Code 15 Adverse Event Data, 1990-2003*
800 Year Reported
Year Occurred
700 No. (%) of Cases
600 Wrong Wrong Wrong
Years Site Patient Procedure Total
Cases per Year

500
2000-2003 178 (61) 34 (12) 82 (28) 294 (100)
400
1996-1999 90 (63) 22 (15) 32 (22) 144 (100)
300 1991-1995 41 (73) 7 (13) 8 (14) 56 (100)
Total 309 (63) 63 (13) 122 (25) 494 (100)
200

100 *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
0 for Health Care. A Code 15 event must be reported by the hospital within
1988 1990 1992 1994 1996 1998 2000 2002 2004 15 days, except for more serious events, which must be reported within
Year 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
Figure. National Practitioner Data Bank Public Use Data File (NPDB PUDF). which the intervention occurred and which resulted in 1 or more of a list
This long-term database of settled medicolegal cases that have been of serious preventable injuries.
reported to the NPDB demonstrates that wrong-side/wrong site, wrong Percentages have been rounded and may not total 100.
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 cation of wrong-site procedures is the OR. A large num-
in the NPDB is in fact declining. ber of wrong-site procedures occur in radiology, with an
equal number of events in unspecified locations. Cata-
sible to distinguish between wrong treatment and wrong ract procedures were the second most common wrong-
procedures in these cases. site incidents. The patients frequently had cataracts in both
When comparing mistakes of similar error pathology, eyes, and the subsequent eye was originally scheduled to
WSPEs were more common in the NPDB than were cases undergo surgery in 1 to 2 weeks. During the first surgery,
of retained foreign body after surgery, which have re- the wrong eye was selected for surgery owing to several
ceived recent attention,30 and substantially more com- factors: the wrong eye was listed on the consent form, the
mon than were cases of transfusion error.31 The NPDB preoperative nurse identified the wrong patient or the
PUDF mentions 4295 cases of retained foreign body and wrong eye for the procedure, the patient agreed to the ver-
only 52 cases of wrong blood-type transfusion. The error balized statement from the staff regarding which eye, the
processes leading to retained foreign body (known as re- anesthesiologist anesthetized the wrong eye, or the sur-
tained surgical instruments in the NPDB), along with er- geon selected the wrong eye for the procedure. Inguinal
rors in transfusion medicine, share many of the same sys- hernia was the third most common wrong-site incident
temic and cognitive failures that enabled the WSPE collected in this data set. As with cataracts, patients occa-
occurrence. However, there has been much greater suc- sionally had bilateral inguinal hernias with one side being
cess at reducing transfusion errors, as indicated by the com- more severe and requiring surgical intervention sooner than
parative incidence in the NPDB and the literature. Re- the other side.34 If the incidence of WSPEs in Florida of
search has indicated that laboratory errors in blood typing 75 cases per year is representative of the national inci-
account for only 7% of transfusion errors, with the re- dence in the United States, an extrapolation based on US
maining events attributable to human errors at the bed- census data would imply a national incidence of 1321 cases
side clerical check (the most common cause of ABO- per year.35 However, by 2 independent estimates, the Code
incompatible transfusion31), communication errors, and 15 system underreports by roughly 1 order of magni-
labeling errors32errors that are the leading root causes tude, suggesting that an estimated incidence of 1321 cases
in many WSPEs. Similarly, from 1996 through 2003, the of WSPEs per year nationally may be an underestimate,
JCAHO sentinel event statistics database report mentions since it is based on the Florida Code 15 incidence.36
13 cases of unintended retention of a foreign body (0.4%) In addition, our data and those of others suggest a
and 94 transfusion errors (2.6%) compared with the 455 higher incidence of wrong-site surgeries than that found
WSPEs (12.8%) reported.24 This relatively small number by Kwaan et al37 (who did not report on wrong-patient
of transfusion errors compared with the number of WSPEs or wrong-procedure events). Their retrospective chart re-
may result from the systems improvements that have been view reported an incidence of 1 WSPE per 112 000 pro-
introduced in blood banking and may offer lessons for suc- cedures, significantly noting that only two thirds of the
cessful WSPE prevention strategies. cases they analyzed might have been prevented by the
JCAHO universal protocol.
FLORIDA CODE 15 In Florida, with an average of 75 WSPEs per year and
MANDATORY REPORTING SYSTEM 3 858 752 combined inpatient/outpatient surgical pro-
cedures (2 452 998 outpatient discharges and 1 405 754
In Florida, there have been 494 well-documented WSPE inpatient discharges with surgical International Classifi-
reports to the state since 1991, with an average of 75 events cation of Diseases, Ninth Revision codes in 2005 [Jeff Gregg,
per year reported since 200033 (Table 2). The major lo- Bureau Chief, Agency for Healthcare Administration,

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Table 3. Classification of WSPE Reported Claims Table 4. Factors Contributing to WSPE From Case Analyses*
to the ASA Closed Claims Project Database
Human factors
Site of Error No. (%) of Cases*
High workload environment
Wrong-side procedure Fatigue
Knee 20 (37) Multiple team members
Eye 5 (9) Diffusion of authority/lack of accountability
Hip 4 (7) Team communication
Foot/ankle 3 (6) Change of personnel
Hernia 3 (6) Haste
Pain block 3 (6) Inexperience
Ear 2 (4) Incompetence
Laminectomy 1 (2) Other cognitive factors
Craniotomy 1 (2) Patient factors
Nephrectomy 1 (2) Sedation or anesthesia
Thumb 1 (2) Patient not consulted before block or anesthesia
Wrong-patient error Patient confusion of side, site, or procedure
Patients with same name 2 (4) Inability to engage patient (eg, young child or decreased
Patients looked similar 1 (2) competence)
Unknown cause 2 (4) Patient ignorance
Wrong procedure Patient has common name or same name as another patient
Wrong site near correct site 4 (7) in hospital
Other 1 (2) Procedure factors
Total 54 (100) Wrong side draped/prepped
Similar or same procedures back to back in same room
Abbreviations: ASA, American Society of Anesthesiologists; Patient position or room changed prior to initiating procedure
WSPE, wrong-side/wrong-site, wrong-procedure, and wrong-patient Attempts to prevent WSPE
adverse event. Not observing marked site/marking wrong site
*Because of rounding, percentages may not total 100. Not cross-checking for consistency in consent form, patient chart,
or OR booking form

Florida, written communication, June 26, 2006]), one Abbreviations: OR, operating room; WSPE, wrong-side/wrong-site,
would expect 1 WSPE per 51 540 surgical procedures wrong-procedure, and wrong-patient adverse event.
*These factors have been noted as occurrences in cases we have
more than twice the rate reported by Kwaan et al. The analyzed in the literature in addition to original cases submitted to http:
National Center for Health Statistics reports 43.9 mil- //www.wrong-side.org.
lion inpatient surgical procedures in 200338 and 31.5 mil-
lion outpatient surgical procedures in 1996.39 Using the
calculated incidence rate of 1 WSPE for 51 540 surgical cases submitted to http://www.wrong-side.org is rein-
procedures in Florida, one might expect 1466 events in forced by our analysis of other cases in the literature of
the United States per year. poorly resilient health care systems. These systems suf-
It is further worth noting that a recent 2003-2004 re- fer from enabling conditions that predispose WSPE oc-
view of WSPEs conducted at 17 Minnesota hospitals dem- currence. These include lack of patient involvement, lack
onstrated an incidence rate of 36.6 cases per 1 000 000 of knowledge about the procedure being performed, and
procedures, or 1 case for every 27 322 surgical proce- failure of safety mechanisms to prevent the error from
dures (Gordon Mosser, MD, written communication, May occurring (Table 4).
15, 2006). This rate would suggest an annual incidence
as high as 2760 WSPEs per year in the United States.
COMMENT
ASA CLOSED CLAIMS PROJECT DATABASE
Data from the 4 sources of WSPE reports demonstrate
The search of 5803 claims produced 54 WSPEs (0.93%) that WSPEs are more common than generally accepted
(Table 3). Wrong-side surgical adverse event errors pro- or than is reported in the literature. Although WSPEs are
vided the most detailed data and were the most com- probably relatively rare events, we believe they are sub-
mon. An anesthesiologist was present in the OR during stantially underreported and totally preventable. The in-
35 (80%) of the wrong-side errors, but most of these er- cidence of 1300 to 2700 WSPE cases per year out of more
rors were detected after induction of anesthesia. It was than 75 million surgical procedures performed annu-
determined after evaluation that better preanesthetic ally in the United States is more than 5 to 10 times greater
evaluation would have prevented only 10 of these claims than that accepted by the manufacturing industrys qual-
(Karen Posner, PhD, ASA Closed Claims Project, writ- ity-defect standard Six Sigma.40 Furthermore, although
ten communication, April 13, 2005). orthopedic surgery has received the most attention,
WPSEs continue to occur in other disciplines (eg, anes-
WSPE INCIDENT-REPORTING TOOL thesiology [Table 3]) or during ambulatory procedures
outside the OR (eg, radiology and dentistry [Table 1]).
We developed an innovative anonymous Web-based re- The increased use of conscious sedation for surgical pro-
porting site for WSPEs. Our analysis of several dozen cedures in ambulatory and free-standing surgery cen-

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Table 5. Examples of Wrong-Side/Wrong-Site, Wrong-Procedure, and Wrong-Patient Adverse Events

Wrong Side/Wrong Site Wrong Patient Wrong Procedure


Wrong-side organ (eg, lung or kidney) removal4,41 Termination of life support on wrong patient42 Wrong-embryo implantation in obstetrics43-45
Wrong-eye LASIK46 Wrong-patient radiation treatment47 Wrong-lens implantation48
Wrong-side chest tube18 Wrong-patient cardiac catheterization49,50 Wrong-organ transplantation (ABO mismatch)51
Wrong-leg amputation4 Wrong-patient tonsillectomy52 Orchiectomy instead of circumcision on patient
Wrong-side arthroscopy25 with aphasic stroke4

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

ters will likely increase these numbers. Most states have erage payment of $96 032 per claim in the NPDB, with
little oversight of freestanding procedure facilities and the largest recorded payment being $9 million.4,29
thus have little means to record WSPEs in freestanding
outpatient clinics.
WHY DO THESE ERRORS OCCUR?
WHAT IS THE NATURE AND CONSEQUENCE
OF WSPE ERRORS? The current health care system is not culturally or struc-
turally organized for preventing WSPEs. Multiple sys-
Most studies have been descriptive studies limited to or- tems and organizational factors lead to WSPE occur-
thopedic surgery and its subspecialties (eg, hand sur- rence, including similarity of site, surgery, and patient
gery). No studies have examined the types of laterality er- names; breakdowns in communication and teamwork;
rors or have included wrong-patient or wrong-procedure patient and procedure factors; and failure of existing safety
errors or wrong-side events (Table 5). Wrong-implant pro- checks (Table 3). Fail-safe patient identification sys-
cedures have occurred in obstetrics (wrong-embryo im- tems that would consistently ensure that the right pa-
plantation)43-45 and ophthalmology (wrong-lens implan- tient and right side or site are undergoing the right pro-
tation)48 and likely have occurred in other specialties. In cedure are still experimental.60 New surgical smart chips
addition, wrong-side events have been reported in correc- might offer help in reducing the impact of these medical
tive eye surgery (laser in situ keratomileusis),46 and the rapid errors.61,62 Wrong-side procedures almost certainly stem
growth of this procedure suggests that the number of such from the bilateral symmetry of the human body. There
errors will increase. Data exist on the kinds of laterality er- are unique cognitive challenges that occur partly be-
rors that are most common (eg, wrong-knee and wrong- cause of bilateral symmetry and the ease with which
finger errors).24-26,53 people can confuse left and right. Some people are prob-
Wrong-patient procedures have been reported less fre- ably genetically incapable or predisposed to consistent
quently in the medical literature.17,54-57 The lay press, how- error in distinguishing right from left in themselves and
ever, has been more active in discussing wrong-patient in others (apraxia).6
procedures, including, for example, reporting cases of ter- Clinicians grow accustomed to their right side being
mination of life support of the wrong patient,42 admin- their patients left side when facing a patient. However,
istration of radiation treatment to the wrong patient,47 the opposite is not true if the patient and the clinician
cardiac catheterizations in the wrong patient,49,50 tonsil- are facing the same direction. This can be especially chal-
lectomy in the wrong patient,52 and, of course, the widely lenging in the OR, where the patient is covered in sterile
publicized ABO-incompatible heart-lung transplant at drapes or the patients position is changed during the pro-
Duke Medical Center, Durham, NC, in 2003.51 When lat- cedure, eg, from supine to prone, or the entire table is
erality errors occur, the nature of the error and the mag- rotated 180.4 If the patient is rotated onto one side and
nitude of the consequences lead to negative and wide- the limbs are flexed then, from some viewing angles, it
spread press coverage contributing to decreased public requires significant mental effort to rotate the patients
confidence in the safety of the health care system.58,59 body so that it is spatially congruent with that of the ob-
The consequences of WSPEs range considerably from server and its laterality is made clear.63 This rotational
increased hospitalization and pain to serious iatrogenic mental effort is required to allow direct mapping of the
injury and death. In 1 case, the wrong hip was pinned clinicians perspective onto the patient. This congru-
and, during wound closure of a second operation, the pa- ence is essential to ensure correct-sided procedures. It
tient experienced cardiac arrest and died.23 Another pa- is not surprising that such a cognitively demanding pro-
tient had his healthy right lung excised instead of the can- cess could be subject to error, especially in a distraction-
cerous left lung.4 Even if there were little or no permanent rich environment like the OR. Other complexities in-
harm to a patient, the event is an embarrassing one for clude the standard practices of marking laterality on
the clinician, the hospital, and the entire health care do- radiographs, computed tomograms, and magnetic reso-
main. The public media almost always finds it difficult nance images. Each can be erroneously labeled, or the
to argue that the clinician should not be blamed for the laterality can be misinterpreted even if labeled cor-
error. Moreover, in most of these events, there is perma- rectly. Poor viewing practices and lack of adequate fa-
nent harm and resulting litigation. Consequently, WSPEs cilities for viewing at the point of care can further pre-
result in a high financial cost of malpractice, with an av- dispose to a WSPE.

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LESSONS FROM TRANSFUSION MEDICINE redundancies because the patient can be as much in er-
ror as the clinician. For instance, the Association of Peri-
The NPDB PUDF from 1990 through 2003 mentions 52 operative Registered Nurses72-74 and the subsequent
cases (0.02%) of wrongblood type transfusions, includ- JCAHO universal protocol75 suggest preoperative con-
ing 14 fatalities, and the JCAHO sentinel event statistics firmation of laterality and procedure by using docu-
database contains 94 occurrences (2.6%) of transfusion er- ments such as the patient history, physical examination
ror.24,29 Fatal transfusion errors used to be common. In findings, preoperative assessment, review of the in-
1942, acute hemolytic reactions led to 1 death for every formed consent, and applicable imaging studies. We have
935 transfusions.64 Furthermore, given the distribution of reviewed several WPSE cases in our database in which
A and B blood types in the population, the number of er- the patient was awake and alert. The patients, including
rors may be much larger than reported because a large num- one physician, failed to alert or stop the surgical team
ber of errors do not lead to adverse outcomes. The rate from performing a WPSE. One patient had his sole func-
has steadily declined over time to an estimated 1 death out tioning kidney removed after his incorrect indication of
of 1 800 000 transfusions,32 or about 12 to 13 deaths per laterality, and a patient with aphasic stroke received a bi-
year in the United Statesa nearly 2000-fold reduction lateral orchiectomy instead of the planned circumcision
in incidence.31 Although more than 222 articles on trans- because the team incorrectly understood his response to
fusion errors dating from the 1950s are referenced in indicate that he was a different patient.4 Another pa-
PubMed, we found fewer than 10 articles on WSPEs in the tient, a physician, allowed an incorrect-sided anesthesia
medical literature. Most publications pertaining to WSPEs block to be placed while observing the procedure. In ad-
are case reports or descriptive case series. dition, encouragement of patient involvement by ask-
The success of reducing transfusion errors has come ing patients to mark their own operative site preopera-
through research on common causes, near-miss and ad- tively is an important opportunity to empower patients
verse event reporting systems, safety policies, human- but has met with low compliance.76 DiGiovanni et al found
factor engineering, and the development of error-free tech- low compliance in patients marking their own opera-
nologies (eg, bar-coded patient wristbands, wireless tive site. Of the 100 patients included in the study, 59%
technologies, and computer-based patient identifica- correctly marked the procedure site, 37% did not mark
tion systems).31,65-67 Learning about transfusion errors the site, and 4% did not mark the site correctly.
through mandatory no-fault reporting, including the clas- The prevention of WSPEs is a prerequisite to safe pa-
sification, analysis, and monitoring of mistransfusions and tient care. A zero-tolerance policy is the only standard
near misses, has helped foster a more resilient and reli- that can be ethically justified by providers or accepted
able safety culture in transfusion medicine.68,69 Report- by patients and the public. Mechanisms for prevention
ing systems seem to enhance safety culture through more require specific attention to organizational and cultural
transparency, communication, and accountability.70,71 barriers that affect patient safety strategies. One of the
greatest barriers to eliminating WSPEs is that, paradoxi-
HOW CAN THESE EVENTS BE PREVENTED? cally, WPSEs occur relatively infrequently. Health care
providers usually believe that they are immune to these
Unfortunately, modern health care creates many oppor- human errors until they are involved in a WSPE. Some
tunities for WSPEs to occur. Many medical interven- have said that the rare frequency of such events is ac-
tions include procedures on organs and limbs that ap- ceptable, given that most procedures are error free. Fail-
pear externally normal and offer no cues or site salience ure to attend to the organizational and cultural barriers
to indicate the correct side for intervention (eg, arthros- to change will lead to significant physician resistance and
copy and nerve blocks). Paper checks and procedures such recurring WSPEs.
as site marking will decrease but not eliminate WSPEs. On July 1, 2004, the JCAHO implemented the uni-
The American Academy of Orthopedic Surgeons has pro- versal protocol for the prevention of WSPEs.75 The pro-
moted a site-marking policy since 1997 and has publi- tocol aims to eliminate WSPEs by using (1) preopera-
cized it extensively. However, only 70% of orthopedic tive verification of patient, site, and procedure; (2)
hand surgeons were aware of the policy and, of those, marking of the operative site; and (3) a time-out imme-
only 45% had changed their practice habits as a result of diately before starting the procedure. The policies of the
this new policy.26 JCAHO, the American Academy of Orthopedic Sur-
In addition, error prevention depends on the indi- geons, the Association of Perioperative Registered Nurses,
viduals ability and willingness to use prevention mecha- and other relevant organizations48,73-75,77-80 do not re-
nisms. For instance, Gawande et al30 found that, in 88% quire reporting or investigation of cases of WSPEs or near-
of retained surgical instrument cases, an instrument count miss WSPEs. An Association of Perioperative Regis-
had been performed in the OR and had been found to be tered Nurses position paper notes that procedures for
correct (indicating no missing instruments). Thus, the reporting and responding to wrong-site surgery or near
OR staff may have miscounted or may have reported the misses are key points of any WSPE policy and con-
correct number of instruments without actually perform- stitute an important step in reducing these events.72 With-
ing the count. Both options indicate possible opportu- out the ability and data to evaluate the reporting of WSPE
nities for failure of checklists and safety policies. errors and near misses or an accurate estimate of the fre-
Patient involvement and verification of operative site quency of such errors before implementation of the uni-
and procedure is an often recommended and appropri- versal protocol, it is impossible and premature to assess
ate protection tool. It is used in conjunction with built-in the effect of this policy on reducing WSPEs. Recent data

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published in this journal suggest that one third of wrong- been published. The shame factor associated with WSPEs
site surgery cases occurred even with careful site iden- has kept most clinicians from talking about and learn-
tification procedures similar to the JCAHO universal pro- ing from their events, thus eliminating the learning op-
tocol.37 Although comprehensive data are lacking, WSPEs portunity. The data we have presented herein indicate
have occurred after implementation of the universal pro- that WSPEs occur at a rate more common than previ-
tocol.81 In 1 health care system experience, 14 cases of ously published and without sufficient attention from re-
wrong-side and wrong-site surgery occurred from Janu- searchers, educators, or health care policy leaders. The
ary 2003 through June 2004 in the presence of an insti- lack of a national database and national reporting re-
tutional policy in concordance with the JCAHO univer- quirements prevents a realistic assessment of the fre-
sal protocol (Allison Haskins Page, MS, MHA, Fairview quency of WSPE occurrence or the efficacy of preven-
Health Systems, Minneapolis, Minn; written communi- tion efforts, such as the recent JCAHO universal protocol.
cation; April 26, 2005). This is an early indication that Our attempts to use the NPDB, the Florida Code 15 man-
the JCAHO universal protocol may be insufficient to com- datory reporting system, ASA Closed Claims Project da-
pletely prevent WSPEs, and further underscores the need tabase, and our anonymous reporting tools gave us con-
for robust research as to the protocols efficacy. venience samples that indicate a high number of cases
Careful review of the nationally promulgated poli- for which attention is warranted. It is widely believed that
cies for reducing wrong-side surgery suggests that these current reporting systems underreport occurrences of such
recommendations are supported by limited evidence. A errors by several magnitudes.
Cochrane standard-of-evidence base assessment would
barely amount to a level C, suggesting limited scientific CONCLUSIONS
validity of this protocol.82
Systems redesign will significantly diminish WSPEs
but will require a microsystem or team-based effort that Wrong-side/wrong-site, wrong-procedure, and wrong-
requires focused training on preventing WSPEs.83 Re- patient adverse events are more common than previ-
porting all errorsthose that result in harm to the pa- ously reported. Based on the several available databases
tient as well as near missesis an essential element of we have analyzed, WSPEs have been occurring steadily
developing a learning culture similar to the one that has for years without significant attention or evidence of re-
led to the dramatic safety improvements in transfusion duction in prevalence. The data support widespread un-
medicine and in other industries such as aviation and derreporting of these adverse events. At a minimum, as-
nuclear power.84-86 This will require creating conditions suming 100% of cases are reported, our extrapolation of
that help health care providers feel comfortable and safe data from Florida predict that there would be 1321 cases
to report these events without retribution.87 Every mem- in the United States annually. However, multiple stud-
ber of the health care team will view prevention of WSPEs ies1,88,89 have demonstrated that the compliance of phy-
as his or her responsibility, a position advocated by the sicians in reporting has ranged from 5% to 50% of events.
Association of Perioperative Registered Nurses.73 A pre- Assuming that this frequency of reporting is true for
procedure briefing (similar to a preflight briefing) is a WSPEs as well, the more cautious estimate of 50% un-
valuable tool that has been used in commercial aviation derreporting indicates that annual US WSPE incidence
and in the military.5 The preprocedure time-out (a final may be at least 2-fold higher, thus predicting a WSPE in-
verification of correct patient, site, and procedure) rec- cidence of 2600 events in the United States annually. Based
ommended by the JCAHO guidelines is a step in the right on the available databases, extensive review of the lit-
direction but fails to address the complexity of WSPEs.75 erature, and discussion with regulators, an estimate of
A time-out suggests something separate and external 1300 to 2700 WSPEs per year in the United States seems
rather than integral to the process, thus encouraging work- likely. Continued occurrence of WSPEs undermines the
arounds that undermine the effectiveness of these poli- goal of health care by contributing to unnecessary deaths,
cies. The time-out policy falls short in addressing health disability, suffering, malpractice, and decreased public
care challenges such as unavailable equipment, varying confidence in the health care system. The Institute of
roles, and unavailability of team members. Time-outs Medicine report1 has led to numerous efforts to im-
planned without consideration of work flow add more prove the quality and safety of patient care. Unambigu-
work and ultimately can lead to limited behavior change ous and reliable patient and procedure identification must
and pro forma acceptance. In addition, the occurrence be a priority in translating research gains into clinical prac-
of the time-out just before the surgical procedure is in- tice. Although widespread policy efforts suggest that there
effective in preventing anesthesia-related WSPEs, which might be some reduction in the incidence of WSPEs, no
can occur both inside and outside the OR. Finally, as evidence at present supports this change in outcomes.
theory and research data become available on the mecha- We believe that WSPEs are completely preventable and
nisms of WSPEs, such knowledge must be incorporated that the recommendations outlined in the following sec-
into the training of health care providers. tions will help to reduce the occurrence of WSPEs.

LIMITATIONS REPORTING

We are unable to present a definitive prevalence and in- Health care professionals must acknowledge and report
cidence of WSPEs in this report. Unfortunately, these data WSPEs and near misses and create safe ways to discuss the
are not presently available in health care and have never system- and performance-shaping factors that enable them

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to occur.5 For these lessons to become part of the culture ers, PhD, from the University of Toronto, for comments
of health care, they need to be integrated into the curricu- regarding human-factor error and analysis; Bill Ruther-
lum of all health care providers. Reporting of WSPEs will ford, MD, from the University of Western Michigan, Ju-
occur when health care providers feel safe to report them. lie Johnson, MSPH, PhD, from the Department of Medi-
Present punitive programs in a few states will likely not serve cine, University of Chicago, and Hal Kaplan, PhD, from
to enhance patient safety. Mandatory reporting of all WSPEs Columbia University and NewYork-Presbyterian Hospi-
will help raise awareness of these events. Reducing the tal, for suggestions and review of the manuscript; Wrenn
stigma and shame associated with these events, as well as Levenberg, MD, from the Department of Emergency Medi-
addressing the regulatory reform, will help. After a near miss cine, Boston University Medical Center, for assistance in
in clinical care, clinicians in Florida are at risk of paying researching the transfusion literature; Karen Posner, PhD,
significant fines and of performing community service. This from the ASA Closed Claims Project, for providing data;
practice has had a chilling effect on reporting and patient and Robert Oshel, PhD, Health Research Services Ad-
safety programs in the state (Laurie Davies, MD, Florida ministration, for assistance in searching the NPDB PUDF.
Board of Medicine, written communication, March 1, 2006).
These events happen to well-trained and respected prac-
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