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A Spine Robotic-Assisted Navigation System for Pedicle Screw Placement
Published on: May 11, 2020
Incidence, patterns, and prevention of wrong-site surgery
Mary R Kwaan1, David M Studdert, Michael J Zinner
1Department of Surgery, Brigham and Women's Hospital, Boston, MA 02115, USA.
Hypothesis:
We hypothesized that wrong-site surgery is infrequent and that a substantial proportion of such incidents are not preventable by current site-verification protocols.
Design:
Case series and survey of site-verification protocols.
Setting:
Hospitals and a malpractice liability insurer.
Patients And Other Participants:
All wrong-site surgery cases reported to a large malpractice insurer between 1985 and 2004.
Main Outcome Measures:
Incidence, characteristics, and causes of wrong-site surgery and characteristics of site-verification protocols.
Results:
Among 2,826,367 operations at insured institutions during the study period, 25 nonspine wrong-site operations were identified, producing an incidence of 1 in 112,994 operations (95% confidence interval, 1 in 76,336 to 1 in 174,825). Medical records were available for review in 13 cases. Among reviewed claims, patient injury was permanent-significant in 1, temporary-major in 2, and temporary-minor or temporary-insignificant in 10. Under optimal conditions, the Joint Commission on Accreditation of Healthcare Organizations Universal Protocol might have prevented 8 (62%) of 13 cases. Hospital protocol design varied significantly. The protocols mandated 2 to 4 personnel to perform 12 separate operative-site checks on average (range, 5-20). Five protocols required site marking in cases that involved nonmidline organs or structures; 6 required it in all cases.
Conclusions:
Wrong-site surgery is unacceptable but exceedingly rare, and major injury from wrong-site surgery is even rarer. Current site-verification protocols could have prevented only two thirds of the examined cases. Many protocols involve considerable complexity without clear added benefit.
Insights
Wrong-site surgery is rare, occurring in about 1 in 112,994 operations. Current site-verification protocols could have prevented two-thirds of these preventable surgical errors.
Area of Science:
- Patient safety in surgical procedures.
- Healthcare quality improvement initiatives.
Background:
- Wrong-site surgery (WSS) remains a concern in healthcare.
- Existing site-verification protocols aim to prevent surgical errors.
Purpose of the Study:
- To determine the incidence and preventability of wrong-site surgery.
- To evaluate the effectiveness of current site-verification protocols.
Main Methods:
- Analysis of a case series of wrong-site surgery incidents reported to a malpractice insurer (1985-2004).
- Survey of hospital site-verification protocols.
- Assessment of protocol effectiveness under optimal conditions.
Main Results:
- An incidence of 1 in 112,994 operations for non-spine wrong-site surgery was identified.
- Of 13 reviewed cases, 8 (62%) could have been prevented by the Joint Commission on Accreditation of Healthcare Organizations Universal Protocol.
- Protocol complexity varied significantly, with no clear added benefit in some cases.
Conclusions:
- Wrong-site surgery is rare, and major injury from it is even rarer.
- Current site-verification protocols have limitations in preventing all wrong-site surgeries.
- Protocol design and implementation require further optimization for enhanced patient safety.
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