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 devastat-ing, unacceptable, and often result in litigation, but theirfrequency and root causes are unknown. Wrong-side/wrong-site, wrong-procedure, and wrong-patient events arelikely more common than realized, with little evidence thatcurrent prevention practice is adequate.

Design: Analysis of several databases demonstrates thatWSPEs occur across all specialties, with high numbersnoted in orthopedic and dental surgery. Databases ana-lyzed included: (1) the National Practitioner Data Bank(NPDB), (2) the Florida Code 15 mandatory reportingsystem, (3) the American Society of Anesthesiologists(ASA) Closed Claims Project database, and (4) a novelWeb-based system for collecting WSPE cases (http://www.wrong-side.org).

Results: The NPDB recorded 5940 WSPEs (2217 wrong-sidesurgicalproceduresand3723wrong-treatment/wrong-procedureerrors) in13years.FloridaCode15occurrencesof WSPEs number 494 since 1991, averaging 75 events per

yearsince2000.TheASAClosedClaimsProjecthasrecorded54casesofWSPEs.AnalysisofWSPEcases, includingWSPEcases submitted to http://www.wrong-side.org, suggest sev-eral common causes of WSPEs and recurrent systemic fail-ures. Based on these findings, we estimate that there are1300 to 2700 WSPEs annually in the United States. De-spite a significant number of cases, reporting of WSPEs isvirtually nonexistent, with reports in the lay press far morecommon than reports in the medical literature. Our re-search suggests clear factors that contribute to the occur-rence of WSPEs, as well as ways to reduce them.

Conclusions: Wrong-side/wrong-site, wrong-procedure,and wrong-patient adverse events, although rare, are morecommon than health care providers and patients appreci-ate.PreventionofWSPEsrequiresnewandinnovative tech-nologies, reporting of case occurrence, and learning fromsuccessful safety initiatives (such as in transfusion medi-cine and other high-risk nonmedical industries), while re-ducing the shame associated with these events.

Arch Surg. 2006;141:931-939

P ERFORMING A PROCEDURE ON

the wrong side of a patient’sbody, performing a wrongprocedure, or performing thecorrect procedure on the

wrong patient constitute some of the worstmedical errors that clinicians and pa-tients experience. The Institute of Medi-cine report To Err Is Human painted abroad picture of the magnitude of medi-cal errors in the United States and gave di-rections for safety improvements.1 Ques-tions linger about ways to prevent errorssuch as wrong-side surgery. Althoughthese events seem preventable, they con-tinue to occur. We have few data on howoften and why they occur and on why thesafety mechanisms in place fail to pre-vent them. This report presents data dem-onstrating that there are many morewrong-side/wrong-site, wrong-proce-dure, and wrong-patient adverse events(WSPEs) than generally appreciated. The

data indicate that current practices andguidelines for WSPE prevention are in-sufficient to prevent future events.

We define a WSPE as any procedurethat has been performed on the oppositeside, incorrect site, or incorrect level of thebody; 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 alsooccur,2-4 and cases continue to occur out-side the operating room (OR) in virtuallyall areas of health care. Wrong-proce-dure and wrong-patient errors might stemfrom different causes but often share a rooterror pathology related to ambiguous andimprecise identification. The similarity isoften rooted in communication break-downs or lack of safety systems that couldhave prevented these errors.5 However,other factors are unique to these differ-ent kinds of errors of action. Studies6 havesuggested that the inability to maintain

Author Affiliations:Department of Pediatrics, TheUniversity of Chicago ComerChildren’s Hospital, Chicago, Ill(Dr Seiden); Departments ofAnesthesiology, Medicine, andEpidemiology, University ofMiami Miller School ofMedicine, Miami, Fla(Dr Barach).

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right and left sidedness consistently (or confusion of rightand left [apraxia]) probably stems from an underlyingneurological challenge that seems to predispose hu-mans to confuse left and right in wrong-side errors. Aprocedure performed on the wrong patient or wrong sideis a wrong procedure, just as when procedure A is in-tended and procedure B is performed instead. There-fore, all such errors can appropriately be called WSPEs.

The exact incidence and prevalence of WSPEs re-mains unknown. We have identified many sources forfinding cases of WSPEs using the following 3 differentmethodologies: (1) searching the medical literature, in-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 havecollected using an anonymous Web-based reporting tool.Accurate estimates of incidence cannot be determinedwithout mandatory reporting and true incidence of an-nual surgical procedures. Mandatory reporting is now be-coming law in Florida,7 Indiana,8 Minnesota,9 and Penn-sylvania.10

The medical literature on WSPEs is quite limited. Sev-eral studies and databases document hundreds of cases.Some Swedish cases were reported as early as the1970s,11-14 and other case reports have appeared sporadi-cally.15-23 From 1995 through 2005, the Joint Commis-sion on Accreditation of Healthcare Organizations(JCAHO) sentinel event statistics database ranked wrong-side surgery as the second most frequently reported eventwith 455 instances, accounting for 12.8% of 3548 eventsreported since January 1995.24 Cowell25 reported 331 casesof wrong-side surgery in a 10-year period. Meinberg andStern26 surveyed orthopedic hand surgeons and esti-mated the lifetime risk of performing a wrong-side sur-gery as being greater than 1 in 5. However, all are self-reports or surveys and almost certainly underestimate theincidence, perhaps by a factor of 20 or more.27,28 In ad-dition, discussions of the prevalence of WSPEs addressalmost exclusively wrong-side surgery in the OR, ignor-ing the likely more common WSPEs outside the operat-ing room and hospitals, where more than 90% of healthcare is delivered.

METHODS

We reviewed the following 4 databases pertaining to WSPEs:(1) the National Practitioner Data Bank (NPDB); (2) the FloridaCode 15 mandatory reporting system; (3) the American Soci-ety of Anesthesiologists (ASA) Closed Claims Project data-base; and (4) our novel WSPE incident reporting tool. The NPDBPublic Use Data File (PUDF), which collects malpractice-adjudicated data throughout the United States, was searchedfor WSPE occurrence.29 Data collected in the NPDB PUDF origi-nate from malpractice cases after adjudication and do not in-clude adverse events that did not lead to a malpractice claimor that were settled without a practitioner being named. How-ever, because WSPEs are so obvious, they very often lead toclaims and result in malpractice awards in 84% to 93% of cases.26

The Florida Comprehensive Medical Malpractice Act of 1985mandated the reporting of adverse events to the Florida Agencyfor Health Care Administration. All WSPEs are required to bereported as the result of statute 395.0197, which states that thereport should contain a “factual written statement about a par-ticular adverse incident detailing particulars as to time, place,all persons directly involved (including professional titles andlicense numbers), and the nature of the event including a de-scription of the damage or injury.” These reports must in-clude a description of the cause of the event and the correctiveor proactive actions taken. These reports must be recorded within15 days of the event (known as Code 15 reports). The ASAClosed Claims Project database includes settled malpracticeclaims since 1988. We queried this database for cases of WSPE.Finally, we have been collecting WPSE cases using an anony-mous 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 re-corded cases) of “wrong-body-part surgery,” and 3723 cases(1.58% of all recorded cases) of “wrong-treatment/wrong-procedure performed” of 236 300 cases coded for mal-practice reported from 1990 through 2003 (Table 1).Wrong-patient procedures are not coded separately andit is not possible to determine their frequency in the NPDBPUDF. The national incidence is likely higher, however,because a claim does not result from each WSPE occur-rence, especially if minimal or no patient harm results.There is also growing evidence of health care facilities sign-ing confidentiality agreements in which the plaintiffs agreeto remove the names of the physicians involved, and thusonly the hospital name appears in the sealed legal record.Annual frequencies of WSPE in the NPDB ranged from359 to 457 cases from 1990 through 1998. The apparentdecline in occurrence in the Figure may be owing to amean delay of 3.9 years from the WPSE occurrence to clos-ing of the legal case. We predict that WSPEs reported inthe NPDB will continue to be in the range of 400 casesper year. Physicians, according to the NPDB, performedmost 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 num-ber of dentists’ reports (1529 [41.1%]) were closer to thoseof physicians (2056 [55.2%]). However, it was not pos-

Table 1. NPDB Occurrences of WSPEby Practitioner Type, 1990-2003*

Practitioner Type

No. (%) of Cases

Wrong–Body PartSurgical

Procedures

Wrong-Procedure/Wrong-Treatment

Errors

Physician 1721 (77.6) 2056 (55.2)Intern or resident 12 (0.5) 23 (0.6)Dentist 402 (18.1) 1529 (41.1)Registered nurse 17 (0.8) 24 (0.6)Podiatrist 58 (2.6) 54 (1.5)Other health professional 7 (0.3) 37 (1.0)Total 2217 (100) 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 theNPDB. Percentages have been rounded and may not total 100.



sible to distinguish between wrong treatment and wrongprocedures in these cases.

When comparing mistakes of similar error pathology,WSPEs were more common in the NPDB than were casesof retained foreign body after surgery, which have re-ceived recent attention,30 and substantially more com-mon than were cases of transfusion error.31 The NPDBPUDF mentions 4295 cases of retained foreign body andonly 52 cases of wrong blood-type transfusion. The errorprocesses leading to retained foreign body (known as re-tained surgical instruments in the NPDB), along with er-rors in transfusion medicine, share many of the same sys-temic and cognitive failures that enabled the WSPEoccurrence. However, there has been much greater suc-cess at reducing transfusion errors, as indicated by the com-parative incidence in the NPDB and the literature. Re-search has indicated that laboratory errors in blood typingaccount for only 7% of transfusion errors, with the re-maining events attributable to human errors at the bed-side clerical check (the most common cause of ABO-incompatible transfusion31), communication errors, andlabeling errors32—errors that are the leading root causesin many WSPEs. Similarly, from 1996 through 2003, theJCAHO sentinel event statistics database report mentions13 cases of unintended retention of a foreign body (0.4%)and 94 transfusion errors (2.6%) compared with the 455WSPEs (12.8%) reported.24 This relatively small numberof transfusion errors compared with the number of WSPEsmay result from the systems improvements that have beenintroduced in blood banking and may offer lessons for suc-cessful WSPE prevention strategies.

FLORIDA CODE 15MANDATORY REPORTING SYSTEM

In Florida, there have been 494 well-documented WSPEreports to the state since 1991, with an average of 75 eventsper year reported since 200033 (Table 2). The major lo-

cation of wrong-site procedures is the OR. A large num-ber of wrong-site procedures occur in radiology, with anequal number of events in unspecified locations. Cata-ract procedures were the second most common wrong-site incidents. The patients frequently had cataracts in botheyes, and the subsequent eye was originally scheduled toundergo surgery in 1 to 2 weeks. During the first surgery,the wrong eye was selected for surgery owing to severalfactors: the wrong eye was listed on the consent form, thepreoperative nurse identified the wrong patient or thewrong eye for the procedure, the patient agreed to the ver-balized statement from the staff regarding which eye, theanesthesiologist anesthetized the wrong eye, or the sur-geon selected the wrong eye for the procedure. Inguinalhernia was the third most common wrong-site incidentcollected in this data set. As with cataracts, patients occa-sionally had bilateral inguinal hernias with one side beingmore severe and requiring surgical intervention sooner thanthe other side.34 If the incidence of WSPEs in Florida of75 cases per year is representative of the national inci-dence in the United States, an extrapolation based on UScensus data would imply a national incidence of 1321 casesper year.35 However, by 2 independent estimates, the Code15 system underreports by roughly 1 order of magni-tude, suggesting that an estimated incidence of 1321 casesof 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 ahigher incidence of wrong-site surgeries than that foundby Kwaan et al37 (who did not report on wrong-patientor wrong-procedure events). Their retrospective chart re-view reported an incidence of 1 WSPE per 112 000 pro-cedures, significantly noting that only two thirds of thecases they analyzed might have been prevented by theJCAHO universal protocol.

In Florida, with an average of 75 WSPEs per year and3 858 752 combined inpatient/outpatient surgical pro-cedures (2 452 998 outpatient discharges and 1 405 754inpatient discharges with surgical International Classifi-cation of Diseases, Ninth Revision codes in 2005 [Jeff Gregg,Bureau Chief, Agency for Healthcare Administration,

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

Years

No. (%) of Cases†

WrongSite

WrongPatient

WrongProcedure Total

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

*Table reprinted from Kellier and Barach.33 Florida state law requiresincidents that are referred to as Code 15 to be reported to the Florida Agencyfor Health Care. A Code 15 event must be reported by the hospital within15 days, except for more serious events, which must be reported within24 hours. A Code 15 event is defined as “an adverse incident over whichhealthcare personnel could exercise control and the event was associatedin whole or in part with a medical intervention rather than the condition forwhich the intervention occurred and which resulted in 1 or more of a listof serious preventable injuries.”

†Percentages have been rounded and may not total 100.

800

500

700

300

100

Year ReportedYear Occurred

200

400

600

01988 1990 1992 1994 1996 20001998 2002 2004

Year

Case

s pe

r Yea

r

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



Florida, written communication, June 26, 2006]), onewould expect 1 WSPE per 51 540 surgical procedures—more than twice the rate reported by Kwaan et al. TheNational Center for Health Statistics reports 43.9 mil-lion inpatient surgical procedures in 200338 and 31.5 mil-lion outpatient surgical procedures in 1996.39 Using thecalculated incidence rate of 1 WSPE for 51 540 surgicalprocedures in Florida, one might expect 1466 events inthe United States per year.

It is further worth noting that a recent 2003-2004 re-view of WSPEs conducted at 17 Minnesota hospitals dem-onstrated an incidence rate of 36.6 cases per 1 000 000procedures, or 1 case for every 27 322 surgical proce-dures (Gordon Mosser, MD, written communication, May15, 2006). This rate would suggest an annual incidenceas high as 2760 WSPEs per year in the United States.

ASA CLOSED CLAIMS PROJECT DATABASE

The search of 5803 claims produced 54 WSPEs (0.93%)(Table 3). Wrong-side surgical adverse event errors pro-vided the most detailed data and were the most com-mon. An anesthesiologist was present in the OR during35 (80%) of the wrong-side errors, but most of these er-rors were detected after induction of anesthesia. It wasdetermined after evaluation that better preanestheticevaluation would have prevented only 10 of these claims(Karen Posner, PhD, ASA Closed Claims Project, writ-ten communication, April 13, 2005).

WSPE INCIDENT-REPORTING TOOL

We developed an innovative anonymous Web-based re-porting site for WSPEs. Our analysis of several dozen

cases submitted to http://www.wrong-side.org is rein-forced by our analysis of other cases in the literature ofpoorly resilient health care systems. These systems suf-fer from enabling conditions that predispose WSPE oc-currence. These include lack of patient involvement, lackof knowledge about the procedure being performed, andfailure of safety mechanisms to prevent the error fromoccurring (Table 4).

COMMENT

Data from the 4 sources of WSPE reports demonstratethat WSPEs are more common than generally acceptedor than is reported in the literature. Although WSPEs areprobably relatively rare events, we believe they are sub-stantially underreported and totally preventable. The in-cidence of 1300 to 2700 WSPE cases per year out of morethan 75 million surgical procedures performed annu-ally in the United States is more than 5 to 10 times greaterthan that accepted by the manufacturing industry’s qual-ity-defect standard Six Sigma.40 Furthermore, althoughorthopedic surgery has received the most attention,WPSEs continue to occur in other disciplines (eg, anes-thesiology [Table 3]) or during ambulatory proceduresoutside the OR (eg, radiology and dentistry [Table 1]).The increased use of conscious sedation for surgical pro-cedures in ambulatory and free-standing surgery cen-

Table 3. Classification of WSPE Reported Claimsto the ASA Closed Claims Project Database

Site of Error No. (%) of Cases*

Wrong-side procedureKnee 20 (37)Eye 5 (9)Hip 4 (7)Foot/ankle 3 (6)Hernia 3 (6)Pain block 3 (6)Ear 2 (4)Laminectomy 1 (2)Craniotomy 1 (2)Nephrectomy 1 (2)Thumb 1 (2)

Wrong-patient errorPatients with same name 2 (4)Patients looked similar 1 (2)Unknown cause 2 (4)

Wrong procedureWrong site near correct site 4 (7)Other 1 (2)

Total 54 (100)

Abbreviations: ASA, American Society of Anesthesiologists;WSPE, wrong-side/wrong-site, wrong-procedure, and wrong-patientadverse event.

*Because of rounding, percentages may not total 100.

Table 4. Factors Contributing to WSPE From Case Analyses*

Human factors

High workload environmentFatigueMultiple team membersDiffusion of authority/lack of accountabilityTeam communicationChange of personnelHasteInexperienceIncompetenceOther cognitive factors

Patient factorsSedation or anesthesiaPatient not consulted before block or anesthesiaPatient confusion of side, site, or procedureInability to engage patient (eg, young child or decreased

competence)Patient ignorancePatient has common name or same name as another patient

in hospitalProcedure factors

Wrong side draped/preppedSimilar or same procedures back to back in same roomPatient position or room changed prior to initiating procedureAttempts to prevent WSPENot observing marked site/marking wrong siteNot 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 haveanalyzed in the literature in addition to original cases submitted to http://www.wrong-side.org.



ters will likely increase these numbers. Most states havelittle oversight of freestanding procedure facilities andthus have little means to record WSPEs in freestandingoutpatient clinics.

WHAT IS THE NATURE AND CONSEQUENCEOF WSPE ERRORS?

Most studies have been descriptive studies limited to or-thopedic surgery and its subspecialties (eg, hand sur-gery). No studies have examined the types of laterality er-rors or have included wrong-patient or wrong-procedureerrors or wrong-side events (Table5). Wrong-implant pro-cedures have occurred in obstetrics (wrong-embryo im-plantation)43-45 and ophthalmology (wrong-lens implan-tation)48 and likely have occurred in other specialties. Inaddition, wrong-side events have been reported in correc-tive eye surgery (laser in situ keratomileusis),46 and the rapidgrowth of this procedure suggests that the number of sucherrors will increase. Data exist on the kinds of laterality er-rors that are most common (eg, wrong-knee and wrong-finger errors).24-26,53

Wrong-patient procedures have been reported less fre-quently in the medical literature.17,54-57 The lay press, how-ever, has been more active in discussing wrong-patientprocedures, including, for example, reporting cases of ter-mination of life support of the wrong patient,42 admin-istration of radiation treatment to the wrong patient,47

cardiac catheterizations in the wrong patient,49,50 tonsil-lectomy in the wrong patient,52 and, of course, the widelypublicized ABO-incompatible heart-lung transplant atDuke Medical Center, Durham, NC, in 2003.51 When lat-erality errors occur, the nature of the error and the mag-nitude of the consequences lead to negative and wide-spread press coverage contributing to decreased publicconfidence in the safety of the health care system.58,59

The consequences of WSPEs range considerably fromincreased hospitalization and pain to serious iatrogenicinjury and death. In 1 case, the wrong hip was pinnedand, during wound closure of a second operation, the pa-tient experienced cardiac arrest and died.23 Another pa-tient had his healthy right lung excised instead of the can-cerous left lung.4 Even if there were little or no permanentharm to a patient, the event is an embarrassing one forthe clinician, the hospital, and the entire health care do-main. The public media almost always finds it difficultto argue that the clinician should not be blamed for theerror. Moreover, in most of these events, there is perma-nent harm and resulting litigation. Consequently, WSPEsresult in a high financial cost of malpractice, with an av-

erage payment of $96 032 per claim in the NPDB, withthe largest recorded payment being $9 million.4,29

WHY DO THESE ERRORS OCCUR?

The current health care system is not culturally or struc-turally organized for preventing WSPEs. Multiple sys-tems and organizational factors lead to WSPE occur-rence, including similarity of site, surgery, and patientnames; breakdowns in communication and teamwork;patient and procedure factors; and failure of existing safetychecks (Table 3). Fail-safe patient identification sys-tems that would consistently ensure that the right pa-tient and right side or site are undergoing the right pro-cedure are still experimental.60 New surgical smart chipsmight offer help in reducing the impact of these medicalerrors.61,62 Wrong-side procedures almost certainly stemfrom the bilateral symmetry of the human body. Thereare unique cognitive challenges that occur partly be-cause of bilateral symmetry and the ease with whichpeople can confuse left and right. Some people are prob-ably genetically incapable or predisposed to consistenterror in distinguishing right from left in themselves andin others (apraxia).6

Clinicians grow accustomed to their right side beingtheir patient’s left side when facing a patient. However,the opposite is not true if the patient and the clinicianare facing the same direction. This can be especially chal-lenging in the OR, where the patient is covered in steriledrapes or the patient’s position is changed during the pro-cedure, eg, from supine to prone, or the entire table isrotated 180°.4 If the patient is rotated onto one side andthe limbs are flexed then, from some viewing angles, itrequires significant mental effort to rotate the patient’sbody so that it is spatially congruent with that of the ob-server and its laterality is made clear.63 This rotationalmental effort is required to allow direct mapping of theclinician’s perspective onto the patient. This congru-ence is essential to ensure correct-sided procedures. Itis not surprising that such a cognitively demanding pro-cess could be subject to error, especially in a distraction-rich environment like the OR. Other complexities in-clude the standard practices of marking laterality onradiographs, computed tomograms, and magnetic reso-nance images. Each can be erroneously labeled, or thelaterality can be misinterpreted even if labeled cor-rectly. Poor viewing practices and lack of adequate fa-cilities for viewing at the point of care can further pre-dispose to a WSPE.

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-side arthroscopy25Wrong-patient tonsillectomy52 Orchiectomy instead of circumcision on patient

with aphasic stroke4

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



LESSONS FROM TRANSFUSION MEDICINE

The NPDB PUDF from 1990 through 2003 mentions 52cases (0.02%) of wrong–blood type transfusions, includ-ing 14 fatalities, and the JCAHO sentinel event statisticsdatabase contains 94 occurrences (2.6%) of transfusion er-ror.24,29 Fatal transfusion errors used to be common. In1942, acute hemolytic reactions led to 1 death for every935 transfusions.64 Furthermore, given the distribution ofA and B blood types in the population, the number of er-rors may be much larger than reported because a large num-ber of errors do not lead to adverse outcomes. The ratehas steadily declined over time to an estimated 1 death outof 1 800 000 transfusions,32 or about 12 to 13 deaths peryear in the United States—a nearly 2000-fold reductionin incidence.31 Although more than 222 articles on trans-fusion errors dating from the 1950s are referenced inPubMed, we found fewer than 10 articles on WSPEs in themedical literature. Most publications pertaining to WSPEsare case reports or descriptive case series.

The success of reducing transfusion errors has comethrough research on common causes, near-miss and ad-verse event reporting systems, safety policies, human-factor engineering, and the development of error-free tech-nologies (eg, bar-coded patient wristbands, wirelesstechnologies, and computer-based patient identifica-tion systems).31,65-67 Learning about transfusion errorsthrough mandatory no-fault reporting, including the clas-sification, analysis, and monitoring of mistransfusions andnear misses, has helped foster a more resilient and reli-able safety culture in transfusion medicine.68,69 Report-ing systems seem to enhance safety culture through moretransparency, communication, and accountability.70,71

HOW CAN THESE EVENTS BE PREVENTED?

Unfortunately, modern health care creates many oppor-tunities for WSPEs to occur. Many medical interven-tions include procedures on organs and limbs that ap-pear externally normal and offer no cues or site salienceto indicate the correct side for intervention (eg, arthros-copy and nerve blocks). Paper checks and procedures suchas site marking will decrease but not eliminate WSPEs.The American Academy of Orthopedic Surgeons has pro-moted a site-marking policy since 1997 and has publi-cized it extensively. However, only 70% of orthopedichand surgeons were aware of the policy and, of those,only 45% had changed their practice habits as a result ofthis new policy.26

In addition, error prevention depends on the indi-vidual’s ability and willingness to use prevention mecha-nisms. For instance, Gawande et al30 found that, in 88%of retained surgical instrument cases, an instrument counthad been performed in the OR and had been found to becorrect (indicating no missing instruments). Thus, theOR staff may have miscounted or may have reported thecorrect number of instruments without actually perform-ing the count. Both options indicate possible opportu-nities for failure of checklists and safety policies.

Patient involvement and verification of operative siteand procedure is an often recommended and appropri-ate protection tool. It is used in conjunction with built-in

redundancies because the patient can be as much in er-ror as the clinician. For instance, the Association of Peri-operative Registered Nurses72-74 and the subsequentJCAHO universal protocol75 suggest preoperative con-firmation of laterality and procedure by using docu-ments such as the patient history, physical examinationfindings, preoperative assessment, review of the in-formed consent, and applicable imaging studies. We havereviewed several WPSE cases in our database in whichthe patient was awake and alert. The patients, includingone physician, failed to alert or stop the surgical teamfrom performing a WPSE. One patient had his sole func-tioning kidney removed after his incorrect indication oflaterality, and a patient with aphasic stroke received a bi-lateral orchiectomy instead of the planned circumcisionbecause the team incorrectly understood his response toindicate that he was a different patient.4 Another pa-tient, a physician, allowed an incorrect-sided anesthesiablock to be placed while observing the procedure. In ad-dition, encouragement of patient involvement by ask-ing patients to mark their own operative site preopera-tively is an important opportunity to empower patientsbut has met with low compliance.76 DiGiovanni et al foundlow compliance in patients marking their own opera-tive site. Of the 100 patients included in the study, 59%correctly marked the procedure site, 37% did not markthe site, and 4% did not mark the site correctly.

The prevention of WSPEs is a prerequisite to safe pa-tient care. A zero-tolerance policy is the only standardthat can be ethically justified by providers or acceptedby patients and the public. Mechanisms for preventionrequire specific attention to organizational and culturalbarriers that affect patient safety strategies. One of thegreatest barriers to eliminating WSPEs is that, paradoxi-cally, WPSEs occur relatively infrequently. Health careproviders usually believe that they are immune to thesehuman errors until they are involved in a WSPE. Somehave said that the rare frequency of such events is ac-ceptable, given that most procedures are error free. Fail-ure to attend to the organizational and cultural barriersto change will lead to significant physician resistance andrecurring WSPEs.

On July 1, 2004, the JCAHO implemented the uni-versal protocol for the prevention of WSPEs.75 The pro-tocol aims to eliminate WSPEs by using (1) preopera-tive verification of patient, site, and procedure; (2)marking of the operative site; and (3) a time-out imme-diately before starting the procedure. The policies of theJCAHO, the American Academy of Orthopedic Sur-geons, the Association of Perioperative Registered Nurses,and other relevant organizations48,73-75,77-80 do not re-quire reporting or investigation of cases of WSPEs or near-miss WSPEs. An Association of Perioperative Regis-tered Nurses position paper notes that “procedures forreporting and responding to wrong-site surgery or nearmisses” are “key points” of any WSPE policy and con-stitute an important step in reducing these events.72 With-out the ability and data to evaluate the reporting of WSPEerrors and near misses or an accurate estimate of the fre-quency of such errors before implementation of the uni-versal protocol, it is impossible and premature to assessthe effect of this policy on reducing WSPEs. Recent data



published in this journal suggest that one third of wrong-site surgery cases occurred even with careful site iden-tification procedures similar to the JCAHO universal pro-tocol.37 Although comprehensive data are lacking, WSPEshave occurred after implementation of the universal pro-tocol.81 In 1 health care system experience, 14 cases ofwrong-side and wrong-site surgery occurred from Janu-ary 2003 through June 2004 in the presence of an insti-tutional policy in concordance with the JCAHO univer-sal protocol (Allison Haskins Page, MS, MHA, FairviewHealth Systems, Minneapolis, Minn; written communi-cation; April 26, 2005). This is an early indication thatthe JCAHO universal protocol may be insufficient to com-pletely prevent WSPEs, and further underscores the needfor robust research as to the protocol’s efficacy.

Careful review of the nationally promulgated poli-cies for reducing wrong-side surgery suggests that theserecommendations are supported by limited evidence. ACochrane standard-of-evidence base assessment wouldbarely amount to a level C, suggesting limited scientificvalidity of this protocol.82

Systems redesign will significantly diminish WSPEsbut will require a microsystem or team-based effort thatrequires focused training on preventing WSPEs.83 Re-porting all errors—those that result in harm to the pa-tient as well as near misses—is an essential element ofdeveloping a learning culture similar to the one that hasled to the dramatic safety improvements in transfusionmedicine and in other industries such as aviation andnuclear power.84-86 This will require creating conditionsthat help health care providers feel comfortable and safeto report these events without retribution.87 Every mem-ber of the health care team will view prevention of WSPEsas his or her responsibility, a position advocated by theAssociation of Perioperative Registered Nurses.73 A pre-procedure briefing (similar to a preflight briefing) is avaluable tool that has been used in commercial aviationand in the military.5 The preprocedure time-out (a finalverification of correct patient, site, and procedure) rec-ommended by the JCAHO guidelines is a step in the rightdirection but fails to address the complexity of WSPEs.75

A time-out suggests something separate and externalrather than integral to the process, thus encouraging work-arounds that undermine the effectiveness of these poli-cies. The time-out policy falls short in addressing healthcare challenges such as unavailable equipment, varyingroles, and unavailability of team members. Time-outsplanned without consideration of work flow add morework and ultimately can lead to limited behavior changeand pro forma acceptance. In addition, the occurrenceof the time-out just before the surgical procedure is in-effective in preventing anesthesia-related WSPEs, whichcan occur both inside and outside the OR. Finally, astheory and research data become available on the mecha-nisms of WSPEs, such knowledge must be incorporatedinto the training of health care providers.

LIMITATIONS

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

been published. The shame factor associated with WSPEshas kept most clinicians from talking about and learn-ing from their events, thus eliminating the learning op-portunity. The data we have presented herein indicatethat WSPEs occur at a rate more common than previ-ously published and without sufficient attention from re-searchers, educators, or health care policy leaders. Thelack of a national database and national reporting re-quirements prevents a realistic assessment of the fre-quency of WSPE occurrence or the efficacy of preven-tion efforts, such as the recent JCAHO universal protocol.Our attempts to use the NPDB, the Florida Code 15 man-datory reporting system, ASA Closed Claims Project da-tabase, and our anonymous reporting tools gave us con-venience samples that indicate a high number of casesfor which attention is warranted. It is widely believed thatcurrent reporting systems underreport occurrences of sucherrors by several magnitudes.

CONCLUSIONS

Wrong-side/wrong-site, wrong-procedure, and wrong-patient adverse events are more common than previ-ously reported. Based on the several available databaseswe have analyzed, WSPEs have been occurring steadilyfor years without significant attention or evidence of re-duction in prevalence. The data support widespread un-derreporting of these adverse events. At a minimum, as-suming 100% of cases are reported, our extrapolation ofdata from Florida predict that there would be 1321 casesin the United States annually. However, multiple stud-ies1,88,89 have demonstrated that the compliance of phy-sicians in reporting has ranged from 5% to 50% of events.Assuming that this frequency of reporting is true forWSPEs as well, the more cautious estimate of 50% un-derreporting indicates that annual US WSPE incidencemay be at least 2-fold higher, thus predicting a WSPE in-cidence of 2600 events in the United States annually. Basedon the available databases, extensive review of the lit-erature, and discussion with regulators, an estimate of1300 to 2700 WSPEs per year in the United States seemslikely. Continued occurrence of WSPEs undermines thegoal of health care by contributing to unnecessary deaths,disability, suffering, malpractice, and decreased publicconfidence in the health care system. The Institute ofMedicine report1 has led to numerous efforts to im-prove the quality and safety of patient care. Unambigu-ous and reliable patient and procedure identification mustbe a priority in translating research gains into clinical prac-tice. Although widespread policy efforts suggest that theremight be some reduction in the incidence of WSPEs, noevidence at present supports this change in outcomes.We believe that WSPEs are completely preventable andthat the recommendations outlined in the following sec-tions will help to reduce the occurrence of WSPEs.

REPORTING

Health care professionals must acknowledge and reportWSPEs and near misses and create safe ways to discuss thesystem- and performance-shaping factors that enable them



to occur.5 For these lessons to become part of the cultureof health care, they need to be integrated into the curricu-lum of all health care providers. Reporting of WSPEs willoccur when health care providers feel safe to report them.Present punitive programs in a few states will likely not serveto enhance patient safety. Mandatory reporting of all WSPEswill help raise awareness of these events. Reducing thestigma and shame associated with these events, as well asaddressing the regulatory reform, will help. After a near missin clinical care, clinicians in Florida are at risk of payingsignificant fines and of performing community service. Thispractice has had a chilling effect on reporting and patientsafety programs in the state (Laurie Davies, MD, FloridaBoard of Medicine, written communication, March 1, 2006).These events happen to well-trained and respected prac-titioners and we should acknowledge that. We have cre-ated a voluntary anonymous Web site for reporting casesof WSPE (viewable at http://www.wrong-side.org), and weinvite health care providers to submit cases of WSPEs tothis site.

TEAM PREVENTION APPROACH

All health care professionals involved in performing in-vasive procedures—as well as the patient—must be ac-tively involved in ensuring correct surgical and inter-vention procedures. Team training—with its explicitknowledge, skills, and attitudes required of the full sur-gical team, including the clerical scheduling personnel,nurses, surgeons, and anesthesiologists—should be re-quired in health care facilities.87

HUMAN FACTORS ANALYSIS

Human factors, failure mode and effects, and root causeanalyses should be performed after all WSPEs to betterunderstand why our present systems are failing to stopthese events.75

TECHNOLOGY

Technological development of robust patient identifica-tion systems such as barcoding or radiofrequency tag-ging should be developed and their use required by medi-cal regulators.60-62

A best-practice evidence-based approach to preventWSPEs should be applied to recommendations made be-fore their dissemination and enforcement by regulatoryagencies.

Accepted for Publication: November 30, 2005.Correspondence: Paul Barach, MD, MPH, Departmentsof Anesthesiology, Medicine, and Epidemiology, Uni-versity of Miami Miller School of Medicine, 1611 NW12th Ave, Miami, FL 33136 ([email protected])or Samuel C. Seiden, MD, Department of Pediatrics, TheUniversity of Chicago Comer Children’s Hospital, 5721S Maryland Ave, Mail Code 8016, Chicago, IL 60637([email protected]).Acknowledgments: We thank Ming Wen, PhD, from theDepartment of Sociology, University of Utah, Salt LakeCity, for statistical analysis of the NPDB data; John Send-

ers, PhD, from the University of Toronto, for commentsregarding human-factor error and analysis; Bill Ruther-ford, MD, from the University of Western Michigan, Ju-lie Johnson, MSPH, PhD, from the Department of Medi-cine, University of Chicago, and Hal Kaplan, PhD, fromColumbia University and NewYork-Presbyterian Hospi-tal, for suggestions and review of the manuscript; WrennLevenberg, MD, from the Department of Emergency Medi-cine, Boston University Medical Center, for assistance inresearching the transfusion literature; Karen Posner, PhD,from the ASA Closed Claims Project, for providing data;and Robert Oshel, PhD, Health Research Services Ad-ministration, for assistance in searching the NPDB PUDF.

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