Wrong-Site, Wrong-Procedure, and Wrong-Patient Surgery
Background
Few medical errors are as vivid and terrifying as those that involve patients who have undergone surgery on the wrong body part, undergone the incorrect procedure, or had a procedure intended for another patient. These "wrong-site, wrong-procedure, wrong-patient errors" (WSPEs) are rightly termed never events—errors that should never occur and indicate serious underlying safety problems.
Wrong-site surgery may involve operating on the wrong side, as in the case of a patient who had the right side of her vulva removed when the cancerous lesion was on the left, or the incorrect body site. One example of surgery on the incorrect site is operating on the wrong level of the spine, a surprisingly common issue for neurosurgeons. A classic case of wrong-patient surgery involved a patient who underwent a cardiac procedure intended for another patient with a similar last name.
While much publicity has been given to these high-profile cases of WSPEs, these errors are in fact relatively rare. A seminal study estimated that such errors occur in approximately 1 of 112,000 surgical procedures, infrequent enough that an individual hospital would only experience one such error every 5-10 years. However, this estimate only included procedures performed in the operating room; if procedures performed in other settings (for example, ambulatory surgery or interventional radiology) are included, the rate of such errors may be significantly higher. One study using Veterans Affairs data found that fully half of WSPEs occurred during procedures outside of the operating room.
Preventing Wrong-Site, Wrong-Procedure, and Wrong-Patient Surgery
Early efforts to prevent WSPEs focused on developing redundant mechanisms for identifying the correct site, procedure, and patient, such as "sign your site" initiatives, that instructed surgeons to mark the operative site in an unambiguous fashion. However, it soon became clear that even this seemingly simple intervention was problematic. An analysis of the United Kingdom's efforts to prevent WSPEs found that, although dissemination of a site-marking protocol did increase use of preoperative site marking, implementation and adherence to the protocol differed significantly across surgical specialties and hospitals, and many clinicians voiced concerns about unintended consequences of the protocol. In some cases, there was even confusion over whether the marked site indicates the area to be operated on, or the area to be avoided. Site marking remains a core component of The Joint Commission's Universal Protocol to prevent WSPEs.
Root cause analyses of WSPEs consistently reveal communication issues as a prominent underlying factor. The concept of the surgical timeout—a planned pause before beginning the procedure in order to review important aspects of the procedure with all involved personnel—was developed to improve communication in the operating room and prevent WSPEs. The Universal Protocol also specifies use of a timeout prior to all procedures. Although initially designed for operating room procedures, timeouts are now required before any invasive procedure. Comprehensive efforts to improve surgical safety have incorporated timeout principles into surgical safetychecklists; while these checklists have been proven to improve surgical and postoperative safety, the low baseline incidence of WSPEs makes it difficult to establish that a single intervention can reduce or eliminate WSPEs.
It is worth noting, however, that many cases of WSPEs would still occur despite full adherence to the Universal Protocol. Errors may happen well before the patient reaches the operating room, a timeout may be rushed or otherwise ineffective, and production pressures may contribute to errors during the procedure itself. Ultimately, preventing WSPEs depends on the combination of system solutions, strong teamwork and safety culture, and individual vigilance.
Current Context
Wrong-patient, wrong-site, and wrong-procedure errors are all considered never events by the National Quality Forum, and are considered sentinel events by The Joint Commission. In February 2009, the Centers for Medicare and Medicaid Services (CMS) announced that hospitals will not be reimbursed for any costs associated with WSPEs. (CMS has not reimbursed hospitals for additional costs associated with many preventable errors since 2007.)
Few medical errors are as vivid and terrifying as those that involve patients who have undergone surgery on the wrong body part, undergone the incorrect procedure, or had a procedure intended for another patient. These "wrong-site, wrong-procedure, wrong-patient errors" (WSPEs) are rightly termed never events—errors that should never occur and indicate serious underlying safety problems.
Wrong-site surgery may involve operating on the wrong side, as in the case of a patient who had the right side of her vulva removed when the cancerous lesion was on the left, or the incorrect body site. One example of surgery on the incorrect site is operating on the wrong level of the spine, a surprisingly common issue for neurosurgeons. A classic case of wrong-patient surgery involved a patient who underwent a cardiac procedure intended for another patient with a similar last name.
While much publicity has been given to these high-profile cases of WSPEs, these errors are in fact relatively rare. A seminal study estimated that such errors occur in approximately 1 of 112,000 surgical procedures, infrequent enough that an individual hospital would only experience one such error every 5-10 years. However, this estimate only included procedures performed in the operating room; if procedures performed in other settings (for example, ambulatory surgery or interventional radiology) are included, the rate of such errors may be significantly higher. One study using Veterans Affairs data found that fully half of WSPEs occurred during procedures outside of the operating room.
Preventing Wrong-Site, Wrong-Procedure, and Wrong-Patient Surgery
Early efforts to prevent WSPEs focused on developing redundant mechanisms for identifying the correct site, procedure, and patient, such as "sign your site" initiatives, that instructed surgeons to mark the operative site in an unambiguous fashion. However, it soon became clear that even this seemingly simple intervention was problematic. An analysis of the United Kingdom's efforts to prevent WSPEs found that, although dissemination of a site-marking protocol did increase use of preoperative site marking, implementation and adherence to the protocol differed significantly across surgical specialties and hospitals, and many clinicians voiced concerns about unintended consequences of the protocol. In some cases, there was even confusion over whether the marked site indicates the area to be operated on, or the area to be avoided. Site marking remains a core component of The Joint Commission's Universal Protocol to prevent WSPEs.
Root cause analyses of WSPEs consistently reveal communication issues as a prominent underlying factor. The concept of the surgical timeout—a planned pause before beginning the procedure in order to review important aspects of the procedure with all involved personnel—was developed to improve communication in the operating room and prevent WSPEs. The Universal Protocol also specifies use of a timeout prior to all procedures. Although initially designed for operating room procedures, timeouts are now required before any invasive procedure. Comprehensive efforts to improve surgical safety have incorporated timeout principles into surgical safetychecklists; while these checklists have been proven to improve surgical and postoperative safety, the low baseline incidence of WSPEs makes it difficult to establish that a single intervention can reduce or eliminate WSPEs.
It is worth noting, however, that many cases of WSPEs would still occur despite full adherence to the Universal Protocol. Errors may happen well before the patient reaches the operating room, a timeout may be rushed or otherwise ineffective, and production pressures may contribute to errors during the procedure itself. Ultimately, preventing WSPEs depends on the combination of system solutions, strong teamwork and safety culture, and individual vigilance.
Current Context
Wrong-patient, wrong-site, and wrong-procedure errors are all considered never events by the National Quality Forum, and are considered sentinel events by The Joint Commission. In February 2009, the Centers for Medicare and Medicaid Services (CMS) announced that hospitals will not be reimbursed for any costs associated with WSPEs. (CMS has not reimbursed hospitals for additional costs associated with many preventable errors since 2007.)
What's New in Wrong-Site, Wrong-Procedure, and Wrong-Patient Surgery on AHRQ PSNet
REVIEW
Applying fault tree analysis to the prevention of wrong-site surgery.
Abecassis ZA, McElroy LM, Patel RM, Khorzad R, Carroll C IV, Mehrotra S. J Surg Res. 2015;193:88-94.
STUDY
Intercepting wrong-patient orders in a computerized provider order entry system.
Green RA, Hripcsak G, Salmasian H, et al. Ann Emerg Med. 2014 Dec 17; [Epub ahead of print].
Applying fault tree analysis to the prevention of wrong-site surgery.
Abecassis ZA, McElroy LM, Patel RM, Khorzad R, Carroll C IV, Mehrotra S. J Surg Res. 2015;193:88-94.
Intercepting wrong-patient orders in a computerized provider order entry system.
Green RA, Hripcsak G, Salmasian H, et al. Ann Emerg Med. 2014 Dec 17; [Epub ahead of print].
Turn the Other Cheek.
John Starling III, MD. AHRQ WebM&M [serial online]. March 2012
The Inside of a Time Out.
David L. Feldman, MD, MBA. AHRQ WebM&M [serial online]. May 2008
Mark My Tooth.
Richard A. Smith, DDS. AHRQ WebM&M [serial online]. July/August 2007
Right? Left? Neither!
Elizabeth A. Howell, MD, MPP; Mark R. Chassin, MD, MPP, MPH. AHRQ WebM&M [serial online]. May 2006
X-ray Flip.
Marc J. Shapiro, MD. AHRQ WebM&M [serial online]. Febuary 2004
The Other Side.
Charles Vincent, PhD. AHRQ WebM&M [serial online]. October 2003
John Starling III, MD. AHRQ WebM&M [serial online]. March 2012
David L. Feldman, MD, MBA. AHRQ WebM&M [serial online]. May 2008
Richard A. Smith, DDS. AHRQ WebM&M [serial online]. July/August 2007
Elizabeth A. Howell, MD, MPP; Mark R. Chassin, MD, MPP, MPH. AHRQ WebM&M [serial online]. May 2006
Marc J. Shapiro, MD. AHRQ WebM&M [serial online]. Febuary 2004
Charles Vincent, PhD. AHRQ WebM&M [serial online]. October 2003
Neily J, Mills PD, Eldridge N, et al. Arch Surg. 2011;146 1235-1239.
Stahel PF, Sabel AL, Victoroff MS, et al. Arch Surg. 2010;145:978-984.
Incorrect surgical procedures within and outside of the operating room.Neily J, Mills PD, Eldridge N, et al. Arch Surg. 2009;144:1028-1034.
A surgical safety checklist to reduce morbidity and mortality in a global population.Haynes AB, Weiser TG, Berry WR, et al; for the Safe Surgery Saves Lives Study Group. N Engl J Med. 2009;360:491-499.
Operating room briefings and wrong-site surgery.Makary MA, Mukherjee A, Sexton BJ, et al. J Am Coll Surg. 2007;204:236-243.
Incidence, patterns, and prevention of wrong-site surgery.Kwaan MR, Studdert DM, Zinner MJ, Gawande AA. Arch Surg. 2006;141:353-358.
The wrong patient.Chassin MR, Becher EC. Ann Intern Med. 2002;136:826-833.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; December 2008. Report No. OEI-06-07-00471.
The Joint Commission.
Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery.The Joint Commission.
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