The Case

A 56-year-old man underwent two skin biopsies to evaluate clinically concerning lesions. The first biopsy was diagnostic for squamous cell carcinoma (SCC) and documented as "left cheek" in the health record. The second biopsy was consistent with an atrophic solar keratosis (a benign finding) and the site was documented as "left inferior orbit."

The patient was then referred to a dermatologic surgeon to have his SCC excised. The accompanying referral documentation included a diagram of a face with the SCC biopsy site marked by an "X" on the left cheek. The pathology report included a description of the anatomic location that was also noted as "left cheek." On the day of surgery, standard preprocedure verification was completed. The surgery site was marked after the patient confirmed the biopsy site with use of a mirror, two physicians identified a biopsy scar within a clinical lesion on the left cheek, the diagram from the referring physician was reviewed, and the anatomic description of the site from the pathology report was confirmed. The surgeon then excised a lesion on the left cheek.

The patient returned to his referring physician, who immediately realized that the wrong lesion (the benign solar keratosis) had been excised. The patient returned to the surgeon to report the mistake. On closer review, he realized that the actual site of the SCC was, while nominally on the left cheek, more specifically near the preauricular skin. The lesion excised was the one referred to as "left inferior orbit" rather than "left cheek"—an error that resulted from ambiguity in the description and the patient's self-identification of the wrong lesion. The patient required a second surgical excision to remove the SCC lesion.

The Commentary

To err is human. Increased attention to human error (1-3) continues to promote a growing number of patient safety initiatives and quality improvement strategies, all focused on reducing patient harm. This case highlights a patient who experienced wrong-site office-based surgery during treatment for his skin cancer.

The Joint Commission defines wrong-site surgery as any surgery performed on the wrong site or the wrong patient, or performance of the wrong procedure.(4) It is one of the most commonly reported sentinel events, unexpected occurrences involving death or serious physical or psychological injury, or the risk thereof.(5) The American Academy of Dermatology Association Ad Hoc Task Force on Patient Safety and Quality (6) has also identified wrong-site surgery as a major patient safety issue, adding needed awareness of this problem to the office-based surgical setting.

The true incidence of wrong-site office-based procedures is difficult to determine, given a paucity of literature in this setting. It is clear that dermatology is not immune to the risks for wrong-site surgery, as dermatologic surgeons performed an estimated 3.1 million procedures for skin cancer treatment alone in 2010, primarily in the office setting.(7) Our best estimates of wrong-site surgeries come from prospectively collected adverse event reporting data in Florida and Alabama. The most recent analysis described 46 deaths and 263 procedure-related complications occurring from office-based surgeries performed in Florida over the past 10 years.(8) Of those, dermatologists reported only four total complications (1.3% of all complications) and no deaths; one of the complications involved a wrong-site surgery during a Mohs procedure performed with local anesthesia. In 6 years of Alabama data, there were 3 deaths and 49 procedure-related complications and hospital transfers. Of those, dermatologists reported one complication (1.9% of all complications) and no deaths. These data suggest that office-based surgery does not represent a substantial hazard to patients, and that dermatologic procedures performed in this setting have an exceedingly low complication rate.(8)

Although the risk is low, even one case can have devastating results. Most published reports of dermatology-specific wrong-site surgery originate from Mohs surgery data. The Mohs surgeon is specially trained as a cancer surgeon, pathologist, and reconstructive surgeon. The Mohs procedure involves surgically removing skin cancer layer by layer and examining the tissue under a microscope until healthy, cancer-free tissue around the tumor is reached (called "clear margins"). Mohs surgery is unique because 100% of the surgical margins are evaluated, and it has the highest success rate of all treatments for skin cancer—up to 99%. A recent survey of 300 Mohs surgeons revealed that 14% of their malpractice lawsuits were a result of wrong-site surgery.(9) As illustrated in this case, errors in identifying the correct biopsy site during surgical treatment of skin cancer are often the culprit.

There are myriad causes for confusion in surgical site identification, which include pathology office or laboratory errors, inadequate documentation by the referring physician, and imprecise diagrams. Severe actinic damage or scars from previous procedures can also obscure the exact location of biopsy sites. The patient in this case self-identified the wrong surgical site. It's an unfortunate reminder that the reliability of patient reports to pinpoint biopsy site locations is often problematic. In fact, patients presenting for dermatologic surgery have been shown to be incorrect 16.6% to 31.4% of the time when attempting to identify their surgical site.(10,11) The dermatologic surgeon in this case appropriately reviewed both a diagram from the referring physician and the anatomic description of the site from the pathology report before performing surgery. Unfortunately, a recent study suggested that Mohs surgeons incorrectly identify biopsy sites 5.9% of the time when using anatomic descriptions on pathology reports, biopsy site diagrams, and palpation. In contrast, all biopsy sites were correctly identified when using prebiopsy photographs of skin lesions.(9)

Quality improvement strategies to prevent these events from occurring should focus on the role of photography and standardized protocols for office-based surgeries. Although photography has been strongly recommended to document biopsy sites (9,12), a recent survey of members of the American College of Mohs Surgery (ACMS) found that only 47% of physicians used photography to confirm biopsy sites.(13) This suggests that use of preoperative biopsy site photography, while integral in an ideal correct surgery site protocol, has yet to become the standard of care for dermatologic surgeons everywhere. My own anecdotal experience suggests that use of an electronic health record (EHR) is an excellent means of integrating biopsy site photography use into daily practice. Real-time access to preoperative biopsy site photographs in an EHR is incredibly useful for preventing wrong-site surgeries in our offices, and is superior to paper-based diagrams, written descriptions, and paper pathology reports. However, most patients referred from outside providers arrive with only a paper pathology report to guide biopsy site identification.

Independent of photography solutions, a useful correct surgery site protocol can be applied to the ambulatory setting to confirm original biopsy sites.(14) In a study adopting such a protocol over a 6-year period, there were 0 cases of wrong-site surgery in 7983 Mohs micrographic surgeries performed; surgery was occasionally deferred because the correct biopsy site could not be identified. The protocol involved both physician and patient (+/- family) participation in biopsy site identification at consultation. If the biopsy site was not identifiable, then further consultation was undertaken with the patient's referring provider and/or family. Frozen biopsies were employed if necessary to identify tumor sites on the day the patient presented for surgery. If the biopsy site still could not be identified, then frozen biopsy specimens were sent for formalin pathology interpretation and the patient was observed at 3-month intervals. This protocol was easily integrated into daily dermatologic surgery practice and proved effective in guarding against cases of wrong-site surgery.

While wrong-site office-based surgery is a rare event in dermatology practices, it can occur if necessary safeguards are not present. This case is a humbling reminder that even the safest of procedures can benefit from improved systems to mitigate risk and enhance patient safety.

Take-Home Points

• Wrong-site surgery in office-based settings is a rare event but it poses a significant patient safety threat in the absence of proper risk reduction strategies.
• Dermatologic surgery is generally safe, but the risk for wrong-site procedures—particularly during Mohs surgery—stems largely from incorrect identification of a surgical biopsy site.
• Preoperative biopsy site photography and correct site protocols are two solutions that appear to be effective, but these have yet to become the standard of care for office-based surgeons.

John Starling, III, MD Private Practice Mohs Micrographic Surgery, Cutaneous Oncology, and Dermatologic Surgery Dermatology Associates of Wisconsin, S.C., Oshkosh, Wisconsin

References

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2. O'Donnell J. States lax in regulating cosmetic surgery. USA Today. December 27, 2011. [Available at]

3. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: Committee on Quality of Health Care in America, Institute of Medicine. National Academies Press; 2000. ISBN: 9780309068376.

4. The Joint Commission. A follow-up review of wrong site surgery. Sentinel Event Alert. December 5, 2001. [Available at]

5. The Joint Commission. Sentinel Event Alert. [Available at]

6. Elston DM, Taylor JS, Coldiron B, et al. Patient safety: Part I. Patient safety and the dermatologist. J Am Acad Dermatol. 2009;61:179-190. [go to PubMed]

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12. Ke M, Moul D, Camouse M, et al. Where is it? The utility of biopsy-site photography. Dermatol Surg. 2010;36:198-202. [go to PubMed]

13. Campbell RM, Perlis CS, Malik MK, Dufresne RG Jr. Characteristics of Mohs practices in the United States: a recall survey of ACMS surgeons. Dermatol Surg. 2007;33:1413-1418. [go to PubMed]

14. Starling J 3rd, Coldiron BM. Outcome of 6 years of protocol use for preventing wrong site office surgery. J Am Acad Dermatol. 2011;65:807-810. [go to PubMed]