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Chapter 43. Prevention of Misidentifications (continued)
Subchapter 43.2. Strategies to Avoid Wrong-Site Surgery
Operating on the wrong site or body part represents a
potentially devastating event for all parties involved. Cases of "wrong-site
surgery" frequently attract considerable media attention1-4 and
foment malpractice lawsuits. Claims for wrong-site orthopedic surgeries result
in indemnity payments in 84% of cases, compared with only 30% of orthopedic
claims overall.5,6 Although orthopedics represents the largest source
of legal claims, the Physician's Insurance Association of America (PIAA) has
handled wrong-site surgery litigation from the entire range of surgical
specialties and subspecialties.6 Common factors identified in
wrong-site surgery include the involvement of multiple surgeons on a case, the
performance of multiple procedures during a single trip to the operating room,
unusual time constraints, and unusual anatomy or patient characteristics, such
as physical deformity or morbid obesity.7,8
Based upon careful review of 43 cases reported through its
Sentinel Event Policy9 over a 3-year period, the Joint Commission on
the Accreditation of Healthcare Organizations (JCAHO) issued the following
recommendations for avoiding wrong-site surgery:7,8
- Mark the operative site and involve the patient in this process.
- Require oral verification of the correct site in the operating room by
each member of the surgical team.
- Follow a verification checklist that includes all documents and medical
records referencing the intended operative procedure and site.
- Directly involve the operating surgeon in the informed consent process.
- Engage in ongoing monitoring to ensure verification procedures are
Among these recommendations, marking the operative site has
received the most attention and is the focus of this chapter.
In 1998, the American Academy of Orthopaedic Surgeons endorsed
a program of preoperative surgical site identification called "Sign your Site,"
modeled on the "Operate through your initials" campaign instituted by the
Canadian Orthopaedic Association from 1994-96.5,10 Both organizations
recommend that the operating surgeon initial the intended operative site, using
a permanent marker, during a scheduled preoperative visit. For spinal surgery,
the recommendations additionally endorse the use of intra-operative x-rays for
localization of the pathologic spinal level before proceeding with the
procedure. Many surgeons already employ their own techniques for surgical site
identification such as marking an "X" on the operative site or marking "No" on
the wrong limb.5,11,12 While these practices are commendable, they
have theoretical drawbacks including lack of standardization across operating
rooms and institutions. These alternative strategies will not be evaluated
further in this chapter.
Prevalence and Severity of the Target Safety Problem
From January 1995 to March 2001, JCAHO reviewed voluntary
reports of 1152 "sentinel events." Wrong-site surgery accounted for 114 (9.9%)
of these reports and included procedures in neurosurgery, urology, orthopedics,
and vascular surgery.13 Despite the high profile of JCAHO's Sentinel
Event Policy,9 under-reporting by healthcare organizations almost
certainly affects these statistics. Only 66% of the 1152 total events were
"self-reported" by the institutions involved. The remainder came from patient
complaints, media stories and other sources.13 In fact, using a
mandatory reporting system, the New York State Department of Health received 46
reports of wrong-site surgery from April 1, 1998 through March 31,
20004 (F. Smith, personal communication, May 2001), compared with the
114 cases JCAHO received nationally over a period 3 times longer.13
This suggests that voluntary incident reporting may underestimate the true
incidence by a factor of 20 or greater.14
The PIAA reviewed claims data from 22 malpractice carriers
representing 110,000 physicians from 1985 to 1995.5 These claims
included 331 cases of wrong-site surgery. The complete PIAA database documents
almost 1000 closed malpractice claims involving wrong-site surgery.6
However, this figure also underestimates the prevalence of wrong-site surgery,
as every case does not result in a claim. Most wrong-site surgeries involve
relatively minor procedures such as arthroscopy,10,15 rather than
limb amputations or major neurosurgical procedures. Consequently sequelae are
minimal. The State Volunteer Mutual Insurance Company (Tennessee) released a
series of 37 wrong-site surgery claims from 1977 to 1997.15
Performing the correct procedure on the wrong side constituted the most common
error (e.g., arthroscopic knee surgery on the wrong knee in 15 of the 37 cases).
Twenty-six of the patients experienced no sequelae beyond a scar, and only three
patients suffered permanent disability. Given the rarity of significant harm,
estimates of the incidence of wrong-site surgery derived from litigation data
likely underestimate the true prevalence of this problem, as do estimates based
on incident reports.
Opportunities for Impact
Some surgeons have developed their own methods for surgical
site identification,11,12 but routine preoperative evaluation and
marking of the intended surgical site by the attending surgeon has yet to become
standard practice in orthopedics or any surgical specialty. One year after its
"Sign Your Site" campaign, the American Academy of Orthopaedic Surgeons surveyed
its membership. Among the 2000 orthopedic surgeons surveyed, 77% responded that
the idea was a good one, but only 40% stated that they complied with the
recommended practice. Only one-third stated that their principal hospitals had a
"Sign Your Site" or similar program in place, although many anticipated
initiation of one in response to the campaign.16,17
The published literature includes no studies in which the
adoption of a practice related to surgical site identification is analyzed in
the setting of a controlled observational design or clinical trial. One report
described the experience of 4 orthopedic surgeons in private
practice,18 but included no comparable observations from a control
group. The experience of the Canadian Orthopaedic Association remains
unpublished, and the observed effect is based entirely on litigation
statistics10 (B. Lewis, personal communication, March 2001).
Given the egregious and distressing nature of wrong-site
surgery, the error itself represents the outcome of interest, regardless of the
clinical outcome. Unfortunately, in the absence of observational studies that
include controls, the number of malpractice claims for wrong-site surgery
represents the most widely cited outcome.
Evidence for Effectiveness of the Practice
The Canadian Medical Protective Association reported a baseline
level of litigation for wrong-site surgery at 7% of all orthopedic surgery
settlements before 1994 when the Canadian Orthopaedic Association instituted
their "Operate Through Your Initials" policy.10 Currently, there are
no known wrong-site surgery claims against orthopedic surgeons in Canada. (B.
Lewis, personal communication, March 2001) Interpreting the difference in the
rates of litigation of a rare occurrence is difficult, however, especially
without an accurate estimate of the denominator (i.e., the total number of
relevant procedures performed during the time periods involved). Moreover, the
degree to which Canadian surgeons complied with the policy is unknown. As
mentioned above, only 40% of responding American orthopedists reported adoption
of preoperative site identification in routine practice.16
In a North Dakota private practice that used preoperative site
identification with indelible ink, there was one incidence of wrong-site surgery
(pinning of the wrong phalanx in a hand) in 15,987 consecutive
cases.18 Even assuming that the sole detected case represents the
only wrong-site surgery in this sample, interpreting this low event rate is
impossible without a control group. Comparing this result with national data is
also problematic. National data on the number of orthopedics procedures
performed each year might generate an estimate of an appropriate "denominator,"
but the nationwide "numerator" is unknown. Because we do not know the extent to
which incident reporting and malpractice litigation underestimate the incidence
of wrong-site surgery, we cannot accurately estimate the baseline rate of
wrong-site surgeries for comparison with results of a case series such as the
North Dakota report cited above.18
Potential for Harm
Some surgeons may worry that marking the surgical site
increases the risk of contamination, but this concern appears
unwarranted.15,18 More concerning is the potential harm that may
arise from confusion caused by practice variability in "signing the site."
Although the original recommendations called for surgeons to initial the
intended operative site, some surgeons and hospitals mark the site with an
"X."15,16 Still others use an "X" or "No" to mark the limb or site
that should not be operated upon.11,12 In addition, there are reports
of patients crossing their legs before the ink is dry and producing an identical
mark on the contralateral knee, thus subverting the intended effect of the
intervention.10 Confusion may also ensue if operating room personnel
cover the mark with surgical drapes prior to the start of the
Costs and Implementation
The costs of marking a surgical site are negligible. Marking
procedures that require the presence of the surgeon in the preoperative area
prior to the initiation of anesthesia may require a culture shift among surgeons
and involve the costs of surgeons' time. Implementation strategies designed to
more efficiently utilize the operating surgeon's time could be designed. For
hospitalized patients, implementation might involve the operating surgeon
initialing the intended operative site at the time consent is obtained, thus
requiring that the physician be present at the time of consent. The
nurse/anesthetist, anesthesiologist or other responsible party in the preop area
would then be required to contact the operating surgeon only in cases where the
operative site has not already been initialed.
While "signing the site" represents a low-tech solution with
high face validity, no evidence supports a particular version of this practice.
Additionally, the existence of different versions of the "signing the site"
practice may cause confusion to the point of increasing the likelihood of error.
Strategies that focus only on a single aspect of the identification problem,
without considering the preoperative and operative processes as a whole may fail
to avert error. For instance, protocols that rely on review of key preoperative
x-rays in the operating room creates a new mandate to ensure that the correct
patient's x-rays are brought to the operating room.6
Practices to successfully reduce (and eventually eliminate)
wrong-site surgeries will likely combine a standard method of marking the
intended site with collaborative protocols for verification of the intended
procedure and operative site by all members of the operating room
staff.7 Straightforward as each of these processes may appear,
successful implementation may require substantial investments of time and
resources for protocol development and team training. Whatever multifaceted
practice is developed should be implemented within the setting of a planned
1. Patient's son says family was seeking the best care (family of Rajeswari
Ayyappan, who had the wrong side of his brain operated on at Memorial
Sloan-Kettering Cancer Center, discusses his health). New York Times Nov
16 1995: A16(N), B4(L).
2. Olson W. A story that doesn't have a leg to stand on (amputation of man's
left leg rather than right one may have been medically justified). Wall
Street Journal March 27 1995: A18(W), A20(E).
3. Altman LK. State fines Sloan-Kettering for an error in brain surgery (New
York State fines Memorial Sloan-Kettering Cancer Center; surgeon operates on
wrong side of patients brain). New York Times March 9 1996: 27(L).
4. Steinhauer J. So, the brain tumor's on the left, right? (Seeking ways to
reduce mix-ups in the operating room; better communication is one remedy,
medical experts say). New York Times April 1 2001: 23(N), 27(L).
5. American Academy of Orthopaedic Surgeons. Advisory statement on wrong-site
surgery. Available at: http://www.aaos.org/wordhtml/papers/advistmt/wrong.htm.
Accessed April 16, 2001.
6. Prager LO. Sign here. Surgeons put their signatures on patients' operative
sites in an effort to eliminate the change of wrong-site surgeries. Am Med
News October 12 1998:13-14.
7. The Joint Commission on Accreditation of Healthcare Organizations.
Sentinel Event Alert. Lessons Learned: Wrong Site Surgery. Available at:
http://www.jcaho.org/edu_pub/ sealert/sea6.html. Accessed March 30, 2001.
8. Lessons learned: sentinel event trends in wrong-site surgery. Jt Comm
9. Sentinel events: approaches to error reduction and prevention. Jt Comm
J Qual Improv 1998;24:175-86.
10. Position paper on wrong-sided surgery in orthopaedics. Winnepeg,
Manitoba: Canadian Orthopaedic Association Committee on Practice and Economics;
11. Lubicky JP. Wrong-site surgery. J Bone Joint Surg Am
12. Cowell HR. Wrong-site surgery. J Bone Joint Surg Am 1998;80:463.
13. Joint Commission on Accreditation of Healthcare Organizations. Sentinel
Event Statistics. Available at: http://www.jcaho.org. Accessed April 16,
14. U.S. Census Bureau. United States Census 2000: Ranking Tables for States:
Population in 2000 and Population Change from 1990 to 2000. Available at:
http://www.census.gov/population/www/cen2000/phc-t2.html. Accessed May 31,
15. American Academy of Orthopaedic Surgeons. Report of the task force on
wrong-site surgery. Available at:
http://www.aaos.org/wordhtml/meded/tasksite/htm. Accessed March 15, 2001.
16. Risk Management Foundation of the Harvard Medical Institutions. Did
Wrong-Site Surgery Remedy Work? Available at:
Accessed April 16, 2001.
17. The American Academy of Orthopedic Surgeons. Academy News. "Sign your
site" gets strong member support. Available at:
http://www.aaos.org/wordhtml/99news/os3-sign.htm. Accessed May 5,
18. Johnson PQ. Wrong site surgery in orthopaedics: analysis of 15,987 cases
at The Orthopaedic Instititute in Fargo. Paper presented at: American Academy of
Orthopaedic Surgeons 67th Annual Meeting; March 15, 2000, 2000; Los Angeles,
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