Chapter 43. Prevention of Misidentifications (continued)

 Subchapter 43.2. Strategies to Avoid Wrong-Site Surgery

Background

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 attention^1-4 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 followed.

Among these recommendations, marking the operative site has received the most attention and is the focus of this chapter.

Practice Description

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

Study Designs

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).

Study Outcomes

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 surgery.¹⁰

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.

Comment

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 observational study.

References

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 Perspect 2000;20:14.

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; 1994.

11. Lubicky JP. Wrong-site surgery. J Bone Joint Surg Am 1998;80:1398.

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, 2001.

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, 2001.

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: http://www.rmf.harvard.edu/publications/resource/feb1999news/article2/ 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, 2001.

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, CA.

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