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