Right patient, right site, right procedure surgery

Written by Sarah Gehrke, MSN, RN

Adverse medical events that involve patients who have undergone an operation of the wrong body part, experienced an incorrect procedure, or had a surgery intended for another patient are striking and frightening for all the parties involved.

The landmark report released in 1999 by the Institute of Medicine, To Err is Human: Building a Safer Health System, concluded that more Americans were dying annually from medical errors than motor vehicle accidents, breast cancer, and HIV. This report spurred a call to action to the healthcare community to improve patient safety.

To Err Is Human asserts that the problem is not bad people in healthcare—it is that good people are working in bad systems that need to be made safer.

Patient safety advocates designed large-scale programs to reduce harm and to provide patients with a “right-patient, right-site, and right-procedure” surgery. It soon became apparent that early efforts to prevent wrong-site/side, wrong-procedure, wrong-patient errors (WSPEs) were problematic.

Cases of WSPEs still occur despite the adoption of a Universal Protocol. These errors are devastating events that signify underlying safety issues—they are rightly termed never events—errors that should never happen.

Occurrence rates of wrong-site, wrong-patient, and wrong-procedure errors

A study supported by the Agency for Healthcare Research and Quality cautiously reviewed records from nearly 3 million surgeries over 29 years, 1985 through 2004, uncovering a rate of 1 in 112,994 cases of wrong-site surgery.

Receiving treatment in a healthcare facility is generally safe; however, wrong-site, wrong-patient, and wrong-procedure events continue to be reported to The Joint Commission. According to the 2023 Sentinel Event Data Annual Review, wrong surgery (including wrong site, wrong procedure, wrong patient, and wrong implant) remained one of the five most frequently reported sentinel event categories. The Joint Commission emphasizes that these data are based on voluntary reporting and should not be used to estimate the true incidence of these events. See Table 1.

The Joint Commission no longer reports cumulative sentinel event outcomes in this format. Instead, it emphasizes that sentinel events are patient safety events resulting in death, permanent harm, or severe temporary harm, and that voluntary reporting data should not be used to estimate national event rates.

Table 1. Leading reported sentinel event categories (2023)

*Wrong surgery includes wrong site, wrong procedure, wrong patient, and wrong implant. Reporting to The Joint Commission is voluntary and does not represent all events.

Several databases demonstrate that WSPEs occur across all specialties, with high numbers noted in orthopedic and dental surgery. Routine surgeries and procedures scheduled ahead of time, such as spinal operations and total joint replacements, have a higher rate of occurrence than emergency surgery, such as a visibly out-of-place joint or limb.

More recent annual reports from the Minnesota Department of Health continue to identify wrong-site surgery and other surgical never events as ongoing patient safety concerns, underscoring the need for strict adherence to standardized surgical safety practices.

Analyses of national patient safety data continue to demonstrate that wrong-site, wrong-patient, and wrong-procedure surgeries remain rare but preventable events. Although the exact frequency cannot be determined because reporting systems are incomplete and largely voluntary, these events continue to occur despite established safety protocols.

Dr. Kurt Jones, MD, board member of the Florida Society of Anesthesiologists, explains:

[WSPE] can happen to someone who has never had a blemish on their record. . . . There is lack of consistency [in time-outs and communication] across the board.

Although wrong-site, wrong-patient, and wrong-procedure events are rare, they continue to occur despite standardized safety protocols. The exact incidence is difficult to determine because reporting is incomplete and varies across reporting systems. The Joint Commission and the Agency for Healthcare Research and Quality recognize that these events are likely underreported. Although uncommon, they remain never events because they are considered preventable through consistent use of the Universal Protocol, preprocedure verification, site marking, and the surgical time-out.

Internal error-reporting systems may not capture all wrong-site, wrong-patient, and wrong-procedure events because reporting is often voluntary and influenced by organizational culture. Patient safety organizations continue to recognize underreporting as a significant challenge. Healthcare organizations are encouraged to promote a nonpunitive culture that supports event reporting, transparency, and continuous quality improvement to help identify system failures and reduce future errors.

Wrong-site, wrong-patient, and wrong-procedure events are considered serious preventable patient safety events and may result in significant harm to patients and healthcare organizations. These events can lead to regulatory review, malpractice claims, and financial consequences. Federal and state policies, including Centers for Medicare & Medicaid Services quality and payment initiatives, continue to encourage healthcare organizations to prevent avoidable harm through standardized safety practices.

Best practices to prevent wrong-site, wrong-patient, and wrong-procedure errors

Moving the focus from medical errors to patient safety requires a farsighted view and a collaborative effort of a multidisciplinary team. Never event prevention strategies may include:

• analysis of contributing factors (see Table 2);
• communication development;
• new and innovative technologies;
• improving the reporting of case occurrence;
• adopting a state error reporting system;
• learning from successful safety initiatives, such as in transfusion medicine; and
• reducing the shame associated with these events.

Table 2. Factors contributing to wrong-site, wrong-patient, and wrong-procedure events

Factors contributing to these events include communication failures, incomplete or inconsistent verification processes, failure to follow established safety protocols, workflow disruptions, patient identification challenges, and inadequate engagement of the patient or family when appropriate.

Additional factors that contribute to the cause of WSPEs can be found here:

• Agency for Healthcare Research and Quality
• The Joint Commission

Wrong-site, wrong-procedure, and wrong-patient errors are preventable, according to the following studies:

• A record review in facilities within five Canadian provinces demonstrates that 30%–40% of adverse events are preventable.
• A chart review of 21 Dutch hospitals shows that human factors were involved in the causation of 65% of surgical adverse events and were acknowledged as preventable through training and attention to every stage of the patient care delivery process.

In 2003, The Joint Commission developed principles and steps for preventing these errors. The Joint Commission’s Universal Protocol comprises three components:

• Preprocedure verification process
  • Purpose: To ensure that all relevant documents and studies are available before the procedure starts and that they have been reviewed and are consistent with each other, the patient’s expectations, and the team’s understanding of the intended patient, procedure, site, and, as applicable, any implants. Missing information or discrepancies must be addressed before starting the procedure.
  • Process: An ongoing process of information gathering and verification, beginning with the determination to do the procedure and continuing through all settings and interventions involved in the preoperative preparation of the patient, up to and including the “time out” just before the procedure starts.
• Marking the operative site
  • Purpose: To identify the intended site of incision or insertion unambiguously.
  • Process: For procedures involving right/left distinction, multiple structures (such as fingers and toes), or multiple levels (as in spinal procedures), the intended site must be marked so the mark will be visible after the patient has been prepped and draped.
• “Time out” immediately before starting the procedure
  • Purpose: To conduct a final verification of the correct patient, procedure, site, and, as applicable, implants.
  • Process: Active communication among all members of the surgical/procedure team, consistently initiated by a designated team member and conducted in a “fail-safe” mode—the procedure is not started until any questions or concerns are resolved.

Additional considerations:

• Include the patient in the verification process whenever possible.
• Use standardized procedure checklists to ensure items for surgery are ready and reviewed, such as a history and physical and a signed consent form for the correct procedure on the correct patient.
• When it is impractical or anatomically impossible to mark the site, such as a mucosal surface, there should be a written procedure to ensure the correct site is operated on.
• Verification, site marking, and time-out procedures should be as consistent as possible throughout the hospital or facility.
• Time-outs should be standardized and involve the individual performing the procedure, any anesthesia providers, nurse, surgical tech, or any other participants in the procedure.
• Document completion of the time-out.

The safety practice guide, Reducing the risk of wrong-site surgery, explores a data-driven process improvement known as Robust Process Improvement. By using this process in eight hospitals and surgical centers, The Joint Commission identified best practices for four main areas: scheduling, preoperative/holding, operating room, and organizational culture.

Patients are encouraged to participate in self-advocacy. In March 2002, The Joint Commission launched its Speak Up™ patient safety program to educate patients about preparing for a safe surgery.

• Speak Up™: For safe surgery
• Speak Up™ for patients
• Patient brochure: What is the correct surgery site?

Support culture change to prevent wrong-site, wrong-patient, and wrong-procedure errors

Although these events are rare, healthcare organizations can use available patient safety evidence and quality improvement strategies to reduce risk. Standardized processes, effective communication, safety culture initiatives, and continuous monitoring help identify system vulnerabilities and prevent errors.

An acknowledgment of some kind is needed given the extent of the problem and the overall quality of the health system. If directors and health educators had sufficient data on which to base resolutions, then it is likely that efficient solutions would appear.

There are many ways in which physicians, anesthesiologists, nurses, surgical techs, medical scribes, administrative staff, appointment schedulers, and other stakeholders can obtain patient safety education.

Ideas to support change:

• Search for online resources and textbooks to support learning in this area, such as universal protocols, root-cause analysis, leadership, staff engagement, procedure verifications, time-outs or procedural pauses, checklists, patient involvement, and overcoming high workload/fatigue.
• Find courses and annual meetings.
• Look for programs that offer some experiential component in which learners complete a practical project or integrate discussion.
• Establish a regular forum to discuss these events in a multidisciplinary format.
• Encourage a collaborative approach to understanding the causes of and solutions to problems by integrating staff from each department.
• Select patient cases for discussion—developing a direct and unbiased approach for choosing cases will ensure proper tracking of related obstacles. Establish a strict format for describing cases and classifying their causes, including a focus on system causes.
• Track the results of the conversation and revisit concerns periodically to determine whether steps are being taken to prevent adverse events from recurring.
• In addition to these suggestions, it is important to note that the tone used for leading round-table discussions is crucial for these topics—keep the language respectful, compassionate, and nonaccusatory. People may feel very uncomfortable with some discussion points, such as when a staff member blames themselves.

These perspectives are offered with humility and without wanting to depreciate past and ongoing endeavors. Enhancing health system quality and patient safety can be complicated. Improving patient safety requires ongoing commitment, collaboration, and continuous evaluation of systems and processes to reduce preventable harm. Thus, for patient safety, these observations and suggestions were compiled.