Statement and Persistence of the Problem

Wrong site, wrong procedure and wrong person surgeries are sentinel events (an unexpected occurrence involving death or serious physical or psychological injury) that The Joint Commission tracks through its voluntarily reported Sentinel Event Database. Launching the Joint Commission’s Universal Protocol in July 2004 was followed by a sustained increase (not decrease) in the number of reported cases of wrong site surgery in the United States. The occurrence of these particular events – as reported to The Joint Commission - persists as a problem at the current rate of 8-10 new cases per month and remains the most frequently reported sentinel event in the database. Similarly, persistence of this patient safety problem is well recognized in those individual states with mandatory reporting systems for medical errors that include wrong site surgery.

This trend could be construed simply as a reflection of expanded reporting, but the fact remains that the apparent incidence and frequency of this problem is not decreasing. These infrequent, though not rare, occurrences provide an important opportunity for better understanding the complexities involved in achieving organizational and professional cultural change that may also be relevant to resolution of other patient safety issues beyond those focused on performance of correct surgery.

Recognizing the significance of this persistent problem, The Joint Commission convened a second Wrong Site Surgery Summit where over 50 organizations participated in February 2007. This follow-up Summit sought to objectively review experience to date with the Universal Protocol, to examine the barriers to achieving consistent compliance with the Universal Protocol, and to explore other potential strategies for eliminating wrong site surgery.

Examples of salient discussion points and consensus at the 2007 Universal Protocol Summit:

• The three primary components for the Universal Protocol (procedure verification, site marking, time-out) are effective if properly implemented and consistently followed.
• Further refinements to and elaboration of the Universal Protocol to make it more directive (i.e., prescriptive) would be beneficial for improving success of the protocol.
• Re-emphasis is still needed that the Universal Protocol applies to all types of procedures in all types of procedure areas.
• A general misperception exists that time pressures are a hindrance to compliance with the Universal Protocol but there are no data to support the assertion.
• Effective organization management of this issue requires local ownership of changes in relevant policies and procedures, along with active engagement by the CEO and the Board.
• A "stop-the-line" mentality should be encouraged given the complexity of multiple systems and processes active in operative/procedural environments.
• Autonomous performance should be discouraged, and inter-disciplinary team performance with mutual accountability should be encouraged.
• Confirmation bias and behavioral automaticity in the use of checklists are barriers to improvement processes and should be recognized as such.
• Effective methods of direct observation and measurability of success are still required that are effective across settings and institutions.
• Cultural transformation occurs over years and/or decades (generations).

Revisions to the Universal Protocol were developed, vetted and approved utilizing the same processes as for the National Patient Safety Goals program. The revised Universal Protocol was released to the field in June 2008. Feedback since this release provided information for the following clarifications, which provided in the format of Frequently Asked Questions (FAQs).