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 WSPEs are devastating events that signify underlying safety issues—they are rightly termed as 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 (AHRQ), 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 health-care facility is generally safe; however, WSPEs continue to be reported to The Joint Commission (TJC), with 376 occurring from 2018 through 2021 (see Table 1).

Of all the reported sentinel events from 2005 to 2021, 45.93% resulted in a loss of life, 24.25% of Unexpected additional care/Extended stay, and 11.58% suffered a severe temporary harm.

Table 1. Summary data of sentinel events reviewed by the joint commission

Note. Table 1 is a noninclusive list. The reporting of most sentinel events to The Joint Commission is voluntary and represents only a small proportion of actual 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 spinal operations and total joint replacements, have a higher rate of occurrence than an emergency surgery, such as a visible out-of-place joint or limb.

The 2016 public health report from the Minnesota Department of Health reveals that the most common types of procedures involved in wrong-site surgery/invasive procedure were spinal procedures (41%), such as injections and wrong level surgery; finger and toe procedures (6%); and eye procedures (6%).

An analysis of the National Practitioner Data Bank (NPDB) by John Hopkin’s patient safety researchers concludes the following:

• 20 times a week the wrong procedure is performed on a patient.
• 20 times a week an operation occurs on the wrong body part.

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.

Over a 13 year period, the NPDB recorded 5,940 WSPEs: 2,217 wrong-side surgical procedures and 3,723 wrong-treatment/wrong-procedure errors (see Table 2).

Table 2. NPDB occurrences of WSPE by practitioner type, 1990–2003

Source. Retrieved from NPDB.

Based on these results, Samuel C. Seiden, M.D. and Paul Barach, M.D. estimate that there are 1,300 to 2,700 WSPEs annually in the United States—they also note that:

Despite a significant number of cases, reporting of WSPEs is virtually nonexistent, with reports in the lay press far more common than reports in the medical literature. . . . Annual U.S. WSPE incidence may be at least 2-fold higher [because of underreporting of up to 50%], thus predicting a WSPE incidence of 2,600 events in the United States annually.

Internal error-reporting systems within a hospital or facility may provide a biased picture of the actual pattern of WSPEs. In 2008, the Office of Inspector General examined a nationally representative sample of 780 hospitalized Medicare beneficiaries and found that hospitals reported only 1% of events. A survey conducted about the attitude and practice of error reporting among residents and nurses suggests that interventions and training to improve error disclosure may need to be initiated (see Table3).

Table 3. The gap between nurses and residents in a community hospital’s error-reporting system

Note. Findings gathered from a self-administerd questionnaire to evaluate the use and perceptions of the hospital’s error-reporting system.

In 1999, the Institute of Medicine called for each state to implement an adverse event reporting system. The National Academy for State Health Policy (NASHP) surveyed 50 states and the District of Columbia to determine state compliance—as of January 2015, 28 confirmed that they have a system in place and 23 verified that they do not. As a result of the reporting system, 9 states describe an increase in the level of transparency and awareness of patient safety.

Review of penalties in all 50 US states for wrong-site, wrong-patient, and wrong-procedure errors

WSPEs are unacceptable, devastating, and often result in litigation—health-care organizations are under increasing pressure to eliminate them altogether. Starting February 2009, the Centers for Medicare and Medicaid Services (CMS) no longer pays for additional costs accrued by preventable errors, including WSPEs. Since then, several states and singe-pay insurers have adopted a similar policy.

The medical liability settlements found in the NPDB sheds light on the financial consequences of WSPEs (see Table 4). Payouts of over $7 million were noted.

Table 4. The cost of surgical mistakes by event type

Note. Summary of WSPEs malpractice claims between 1990 and 2010.

Click on a state in table 5 to see a summary of the state’s medical professional liability laws. Please contact us at support@PacificMedicalTraining.comEmail to reach the author and recommend other state laws we can cite.

Table 5. Medical liability law per state

Note. Statute of limitation per state.

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 multi-disciplinary team. Never event prevention strategies may include:

• analysis of contributing factors (see table 6);

• 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.

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Table 6. Factors contributing to WSPE from a case analysis

Source. Table adapted from wrong-side/wrong-site, wrong-procedure, and wrong-patient adverse events: Are they preventable? *rate of occurrence (%) retrieved from Patient Safety and Quality: An Evidence-Based Handbook for Nurses.

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

• Agency for healthcare research and quality (US)
• The joint commission

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

• A record review in facilities within 5 Canadian provinces demonstrates that 30%–40% of adverse events (AEs) are preventable.
• A chart review of 21 Dutch hospitals shows that human factors were involved in the causation of 65% of surgical AEs and were acknowledged as preventable through a means of training and an attention to every stage of the process of the delivery patient care.

In 2004, The Join Commission developed principles and steps for preventing WSPEs. TJC’s Universal Protocol is comprised of three components:

• Preoperative verification process
  • Purpose: To ensure that all of the relevant documents and studies are available prior to the start of the procedure and that they have been reviewed and are consistent with each other and with the patient’s expectations and with 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, continuing through all settings and interventions involved in the preoperative preparation of the patient, up to and including the “time out” just before the start of the procedure.
• Marking the operative site
  • Purpose: To identify unambiguously the intended site of incision or insertion.
  • 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 such that 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 member of the team, conducted in a “fail-safe” mode, i.e., 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 it 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.

Click on a state in table 7 to see a summary of the state’s surgical and invasive procedure protocol or the state’s process improvement plan. Please contact us at support@PacificMedicalTraining.comEmail to reach the author and recommend other state protocols or plans we can cite.

Table 7. Surgical and invasive procedure protocol or improvement plan per state

Note. Protocol or plan per state.

The safety practice guide, Reducing the risk of wrong-site surgery, explores a data-driven process improvement, known as Robust Process Improvement (RPI). By using RPI in eight hospitals and surgical centers, TJC identified best practices for four main areas: (1) scheduling, (2) pre-op/holding, (3) operating room, and (4) organizational culture.

Patient’s are encouraged to participate in self-advocacy. In March 2002, TJC launched its speak up™ patient safety program to educate patient’s about preparing for a safe-surgery.

Speak up™: Preparing for surgery

Speak up™ for patients

Patient brochure: What is the correct surgery site?

Support culture change to prevent WSPEs

In the lack of robust clinical data, what options do system administrators have?

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/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 WSPEs in a multidisciplinary format.
• Encourage a collaborative approach to understand the causes and solutions to problems by integrating staff from each department.
• Select patient cases for discussion—developing a direct and unbiased approach for choosing the cases will ensure proper tracking of related obstacles. Establish a strict format for describing the cases and classifying their causes, including a focus on the system causes.
• Track the results of the conversation and revisit the concerns from time to time to determine if something is being done to prevent the 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 often topics—keep the language respectful, compassionate, and non-accusatory. 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 the past and continuous endeavors. Enhancing health system quality and patient safety can be complicated. Members of the health-care team cannot disregard the lack of meaningful progress as a whole. Thus, for patient safety, these observations and suggestions were compiled.