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.
An uncomfortable amount of errors exist within the health-care system. The researchers, reporting in the journal Surgery, calculate that 80,000 never events occurred in United States facilities over a 20 year period—and they believe their estimate is likely on the low end.
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 1,281 occurring from 2005 through 2016. Interestingly, the number of cases increased by 39% between 2014 and 2015 and slightly decreased the following year (see Table 1).
Of all the reported sentinel events from 2005 to 2016, 53.6% resulted in a loss of life, 25.5% of patients needed unforeseen supplemental care, and 8.9% suffered a permanent loss of function.
Table 1. Summary Data of Sentinel Events Reviewed by The Joint Commission
|Type of Event||2014||2015||2016||2005 to 2016|
|Wrong-Site, Wrong-Patient, Wrong-Procedure||73||120||104||1281|
|Unintended Retention of Foreign Object||116||123||120||1231|
|Delay in Treatment||79||83||54||1068|
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:
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
|Practitioner Type||Wrong-Body Part Surgical Procedures - No. (%) of Cases||Wrong-Procedure/Wrong-Treatment Errors - No. (%) of Cases|
|Physician||1,721 (77.6)||2,056 (55.2)|
|Intern or Resident||12 (0.5)||23 (0.6)|
|Dentist||402 (18.1)||1,529 (41.1)|
|Registered Nurse||17 (0.8)||24 (0.6)|
|Podiatrist||58 (2.6)||54 (1.5)|
|Other Health professionals||7 (0.3)||37 (1.0)|
Source. Retrieved from NPDB.
Based on these results, https://www.nm.org/doctors/1659568558/samuel-c-seiden-md 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
|Practice and Attitude of Error Reporting||Residents||Nurses|
|Aware of reporting system||54%||97%|
|Used reporting system||13%||72%|
|Uncomfortable admitting mistakes||29%||64%|
|Rate facility as non-supportive to reporting errors||38%||0%|
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.
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
|Event Type||Cases||Average Payout|
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 email@example.com to reach the author and recommend other state laws we can cite.
Table 5. Medical Liability Law Per State
|Arizona||Kansas||New Hamshire||South Dakota|
Note. Statute of limitation per state.
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);
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 6. Factors Contributing to WSPE From a Case Analysis
|Human Factors||Procedure Factors||Patient Factors|
|*Team communication (70%)||*Procedural non-compliance (64%) — includes factors below||Patient has common name or same name as another patient in hospital|
|*Diffusion of authority (46%)||Not cross-checking for consistency in consent from, patient chart, or OR booking form||Inability to engage patient (young child or decreased competence)|
|Inconsistency||Not observing marked site/marking||Sedation or anesthesia|
|High workload/Staffing||Wrong side dropped/prepped||Patient not consulted before block or anesthesia|
|Fatigue||Similar or same procedure back to back in same room||Patient confusion of side, site, or procedure|
|Multiple team members or change in personnel||Patient position or room changed prior to initiating procedure||Patient ignorance|
|Lack of accountability/leadership|
|Environment (noise, heat, etc.)|
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:
Wrong-site, wrong-Procedure, wrong-patient errors are preventable, according to the following studies:
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.
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.
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 firstname.lastname@example.org 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
|Arizona||Kansas||New Hamshire||South Dakota|
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.
Patient Brochure: What is the Correct Surgery Site?
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:
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.