- List the factors contributing to wrong site surgery.
- Understand the key components of the Universal Protocol for eliminating wrong site, wrong procedure, wrong person surgery.
- Appreciate the importance of communication across authority gradients.
- Understand patient preferences regarding disclosure of medical errors and the challenges and consequences for both physicians and patients.
Case & Commentary: Part 1
A 33-year-old woman with microinvasive vulvar carcinoma was admitted to a teaching hospital for a unilateral hemivulvectomy. After the patient was intubated for general anesthesia, the trainee reviewed her chart and noted that the positive biopsy was from the left side. As the trainee prepared to make an incision on the left side of the vulva, the attending surgeon stopped him and redirected him to the right side. The trainee informed the attending that he had just reviewed the chart and learned that the positive biopsy had come from the left side. The attending physician informed the trainee that he himself had performed the biopsies and recalled that they were taken from the right side. The trainee complied and performed a right hemivulvectomy.
The next day, the Chief of Pathology called the trainee to inquire about the case. The specimen he received was labeled "right hemivulvectomy" and did not reveal any evidence of cancer; whereas, the pre-operative biopsies that he had reviewed (labeled "left vulvar biopsy") had been positive. He wondered if there had been a labeling error.
Wrong site surgery is a potentially devastating event for all concerned. The full extent of this problem is unknown. Although rare in relation to the enormous number of operations performed, it is nevertheless a significant patient safety issue. From January 1995 to March 2001, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) identified 114 wrong site surgery reports from 1152 sentinel events, derived from direct reporting, patients’ complaints, and other sources. Using a mandatory reporting system, the New York State Department of Health identified 46 cases in 2 years, suggesting a much higher incidence given the smaller population (one state) and shorter time period.(1) A recent survey of hand surgeons revealed that 20% of the 1000 respondents had operated on the wrong site at least once in their career, and an additional 16% had prepared to operate on the wrong site but realized their error before making an incision.(2) The United Kingdom National Patient Safety Agency has identified a number of wrong site surgery cases in its first year of reporting and is reviewing available solutions.(3) Reporting of any kind is likely to seriously underestimate the scale of the problem, so the true rate is almost certainly much higher than the rates quoted.(4,5)
Analyses of wrong site surgery suggest that problems may occur at almost any point in the patient´s journey prior to surgery and involve a number of contributory factors.(6) Inadequate patient assessment, inadequate medical record review, poor handwriting, reliance solely on the surgeon to identify the site, and poor communication within the operative team are the most immediate problems. In addition, the chance of error is increased when multiple procedures are performed on the same patient, when a team is under time pressure, and when there is a lack of clear policies and organizational controls.(1)
Several organizations, including JCAHO and Department of Veterans Affairs (VA), have produced guidelines aimed at eliminating wrong site surgery. The guidelines systematically address each point where problems can occur.(7,8) More detailed information and guidelines are available on the web sites listed in the Table. The policies are a mixture of standardization and simplification of procedures, combined with additional checking and double-checking by the surgical team. Typically, guidelines require the marking and signing of the surgical site by the operative surgeon (who must also be involved in the consent process), involvement of the patient at the time of marking, verification of a checklist of all records in the operating room (OR), and verbal verification of the site by all members of the surgical team. JCAHO has also suggested that patients should be prepared to check and question the site if necessary. This represents a considerable cultural shift in health care both in admitting the possibility of error and actively involving patients in checking for it. Recently, JCAHO released a Universal Protocol for preventing wrong person, wrong procedure, and wrong site surgery.(7) The VA has implemented their process (8) in 10 pilot sites and received reports that the process was worthwhile, sensible, and likely to reduce error. However, the extent of adoption of this and other campaigns is unknown, and no studies have attempted to compare the various approaches or to determine whether any new risk factors may have been introduced.
In the present case, as far as one can tell, no problems occurred in the routine biopsy, labeling, and preparation prior to surgery. The site was presumably not marked, but it seems clear that there was a correctly labeled left-side biopsy and corresponding statements in the medical record. The wrong site surgery occurred because the surgeon remembered, incorrectly, that he had biopsied the right side and then chose to ignore the written record and the trainee´s doubts in favor of his own memory. A conflict between one´s own memory and documentary evidence should always raise a red flag. Studies of eyewitness testimony, for instance, have shown that it is relatively easy to introduce false material into otherwise veridical memories (for instance, confusing the clinical information of two patients) and that people express a high degree of confidence in the new memories.(9)
The new wrong site procedures, if followed, would have required the surgeon to sign the site pre-operatively, when he would have had the biopsy results in hand and the patient´s records as a further check. The guidelines also introduce another level of checking within the OR: namely, that all members of the surgical team are involved in the final verification step and the procedure is not started until all concerns are resolved. In this case, the trainee did in fact question the attending physician´s instruction, pointing out that the chart indicated that the positive biopsy was from the left side. However, he was presumably told to proceed as instructed. The trainee then went ahead with what, strictly speaking, was a mutilating operation in the face of his own doubts and documentary evidence that he was acting incorrectly. Whether he was truly reassured by the attending physician´s insistence, or simply abdicated responsibility in the face of a powerful authority figure is not clear.
Criticism might be made here of both the trainee, for not having the courage to request further checks, and of the attending, for not taking the trainee’s query seriously and at least halting the operation while the truth was established. This interaction can also be seen as reflecting the more general problem of authority gradients in clinical teams. In a survey asking whether junior members of a team should question decisions made by senior team members, pilots were almost unanimous in saying that they should.(10) The willingness of junior pilots to question decisions is not seen as a threat to authority but, as in the wrong site guidelines, as an additional defense against possible error. In contrast, in the same survey, almost a quarter of consultant surgeons stated that junior staff members should not question seniors. While strong leadership is necessary in surgery, an unwillingness to listen to junior staff is dangerous. Guidelines by themselves cannot fully address such a deep-seated cultural issue, but can provide a powerful counterweight by mandating and authorizing such questioning across an authority gradient.
Case & Commentary: Part 2
The trainee informed the pathologist that the right side had been removed, and then informed the attending surgeon about the alleged error. The attending surgeon denied that any error had been made; he insisted that the original biopsies had been mislabeled. The surgeon did not inform the patient of the error. When the patient returned for routine follow-up, the surgeon performed a vulvar colposcopy and biopsied the left side. Microinvasive cancer was noted in the biopsies. Shortly thereafter, the patient underwent a second hemivulvectomy to treat her vulvar cancer.
The first, right-sided, hemivulvectomy proved to be unnecessary. The original error was not disclosed at the time, and the patient presumably underwent the second procedure believing that cancer had been discovered on both sides. This raises a host of ethical, practical, and psychological issues. Should the error be disclosed? What principles should guide a decision to disclose? What will the impact of disclosure be on the patient and her family?
Ethically, there is little question that errors leading to harm should be disclosed, unless there are compelling arguments that disclosure is not in the patient’s best interests. It is less clear if near misses should be disclosed. In any case, the impact of disclosure must be considered, but so must the impact of not disclosing, which in this case might leave the woman believing that cancer was more widespread than it actually was. Patients who have not experienced errors report that, if a harmful error occurred in their treatment, they would desire full disclosure.(11) Patients who have actually been harmed report a need for apology, explanation, and assurance that preventative action has been taken against future incidents.(12)
Error disclosure for physicians is difficult, even heart rending. They may be anxious about the process itself, the loss of the patient’s trust, the effect on their reputation, or litigation.(13) Error disclosure for patients, however, is merely the first step in a long process of adjustment to an injury which, they now discover, could have been avoided.(14)
What impact might disclosure have in this case? To begin with, gynecological surgery is known to have a variety of effects on self image, sexual functioning, and confidence in sexual desirability over and above anxiety and distress associated with possible recurrence of cancer.(15) This woman was subjected to unnecessary surgery that both she and her partner may experience as "mutilation" and that may have considerable effects on sexual functioning, through both anatomical and psychological changes. The disclosure of the error therefore takes place within an already highly emotionally charged context. It will undoubtedly have a substantial impact of its own. Before embarking on disclosure, it is essential to consider the impact on the woman, her partner and family, and future relationships with health care professionals. Disclosing an error that has had serious consequences could be damaging if these longer-term issues are not considered. Error disclosure must be accompanied by offers of long term support, remedial treatment where possible, and a continuing relationship with the patient and family.
Wrong site surgery is a devastating, costly medical error. Prevention requires application of reliable, fail-safe check systems at multiple points along the patient’s journey to surgery and must include all team members. Disclosure of medical errors is a challenging but important feature of providing medical care and must be considered in every case.
Charles Vincent, PhD Professor of Clinical Safety Research Department of Surgical Oncology and Technology Imperial College School of Science, Technology, and Medicine St. Mary´s Hospital, London
1. Shojania KG, Duncan BW, McDonald KM, Wachter RM, eds. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Evidence Report/Technology Assessment No. 43, AHRQ Publication No. 01-E058; July 2001. Rockville, MD: Agency for Healthcare Research and Quality. [ full report available ]
2. Meinberg EG, Stern PJ. Incidence of wrong-site surgery among hand surgeons. J Bone Joint Surg Am. 2003;85-A:193-7. [ go to PubMed ]
3. National Patient Safety Agency. NPSA. [ go to related site ]
4. Stanhope N, Crowley-Murphy M, Vincent C, O´Connor AM, Taylor-Adams SE. An evaluation of adverse incident reporting. J Eval Clin Pract. 1999;5:5-12. [ go to PubMed ]
5. Leape L. A systems analysis approach to medical error. J Eval Clin Pract. 1997;3:213-22. [ go to PubMed ]
6. Vincent C, Taylor-Adams S, Chapman EJ, Hewett D, Prior S, Strange P, Tizzard A. How to investigate and analyse clinical incidents: clinical risk unit and association of litigation and risk management protocol. BMJ. 2000;320:777-81. [ go to PubMed ]
7. Joint Commission on Accreditation of Healthcare Organizations. Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. [ go to related site ]
8. Department of Veterans Affairs. Ensuring correct surgery; 2002. VHA Directive 2002-070. [ go to related site ]
9. Cohen G. Memory in the real world. Hove, UK: Psychology Press, 2003.
10. Sexton JB, Thomas EJ, Helmreich RL. Error, stress and teamwork in medicine and aviation: cross sectional surveys. BMJ. 2000;320:745-9. [ go to PubMed ]
11. Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA. 2003;289:1001-7. [ go to PubMed ]
12. Vincent C, Young M, Phillips A. Why do people sue doctors? A study of patients and relatives taking legal action. Lancet. 1994;343:1609-13. [ go to PubMed ]
13. Wu AW. Medical error: the second victim. The doctor who makes the mistake needs help too. BMJ. 2000;320:726-7. [ go to PubMed ]
14. Vincent CA. Caring for patients harmed by treatment. In Vincent CA, ed. Clinical risk management. Enhancing patient safety. London: BMJ Publications; 2001:461-79.
15. Lagana L, McGarvey EL, Classen C, Koopman C. Psychosexual dysfunction among gynecological cancer survivors. J Clin Psychol Med Settings. 2001;8:73-84.
Table. Resources and Further Information on Preventing Wrong-Site Surgery
- Joint Commission on Accreditation of Healthcare Organizations. Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. [ go to related site ]
- Department of Veterans Affairs. Ensuring correct surgery; 2002. VHA Directive 2002-070. [ go to related site ]
- American Academy of Orthopaedic Surgeons. Advisory statement on wrong site surgery. [ go to related site ]
- American Academy of Orthopaedic Surgeons. Report of the task force on wrong-site surgery. [ go to related site ]
- North American Spine Society. Prevention of wrong-site surgery: sign, mark & x-ray (SMaX). [ go to related site ]
- Association of Operating Room Nurses. AORN position statement on correct site surgery. [ go to related site ]