Evidence Table

Summary of Evidence Related to Wrong-Site Surgery

SourceSafety Issue Related to Clinical PracticeDesign TypeStudy Design & Study Outcome Measure(s)Study Setting & Study PopulationStudy InterventionKey Finding(s)
Cronen 200534Sterility of surgical site markingNonrandomized control studyTest the sterility of the site mark after using a surgical marking pen20 volunteers. The right forearm was used as the experimental (marked) arm, and the left forearm as the control arm.

The experimental forearms were marked with a surgical marker as described by the protocol.
Both upper extremities were sterilized from the antecubital fossa to the phalanges with a 7.5% povidone-iodine scrub followed by the application of a 10% povidone-iodine paint.

Swabs were used to obtain samples from the experimental and control arms, as well as from the marker. Swabs were sent for microbiological culture and analysis.
No growth was seen in the cultures of the swabs used on the experimental or control arms or on the marking pens. Preoperative marking of surgical sites in accordance with the Universal Protocol did not affect the sterility of the surgical field, a finding that provides support for the safety of surgical site marking.
DiGiovanni 200333Surgical site markingPretest and post-test studyEvaluated the responses of 100 elective patients undergoing foot and ankle surgery to participating in marking the surgical site. (Level 3)Prospective study. 100 consecutive patients in a private foot-and-ankle practice followed the explicit preoperative instruction, before they underwent elective orthopedic surgery, to mark "NO" on the extremity that was not to be operated on.Patients were instructed on how to mark the site59 patients correctly marked the surgical site, 27 made no mark, 4 were considered partially marked, as the mark was different from the “NO” they were instructed to do. 70% of noncompliant patients had a worker compensation claim.
Giles 200632Surgical site markingNoncomparative studyRetrospective qualitative semi-structured surveys. (Level 4)In person or telephone interview of 38 surgeons in 14 hospitals in the U.K.Surgeon’s practices and methods of site marking varied, as did their value of the need for marking.
JCAHO 200320Surgical site identification protocolPublished guidelines based on a consensus reportUniversal Protocol is applicable to all JCAHO accredited facilities commencing on July 1, 2004.Preoperative strategy to verify the correct patient, type of procedure, and site of intervention3-step Universal Protocol:
  • Preoperative verification process.
  • Marking the operative site.
  • Time out immediately before starting the procedure
Kwaan 20066Wrong-site surgeryCase seriesIncidence, characteristics, cause of WSS.
Characteristics of site verification protocols (Level 2)
Malpractice liability insurer data from 20-year period from one-third of Massachusetts physicians and approximately 30 hospitals.
Site verification protocols in 2004 from 28 hospitals covered by 4 malpractice insurers in New England and Texas.
Retrospective medical records reviewed on 13 of 24 identified cases of WSS.
Wrong-site surgery is rare as is major injury from WSS.
Current protocols for site verification could have prevented only 2/3 of examined cases.
Makary 200736CommunicationPretest and post-test studySurvey306 operating room (OR) staff (e.g., surgeons, nurses, and anesthesiologists) at one academic medical center (85% response rate)Administered a version of the Safety Attitudes Questionnaire before and after initiation of an OR briefing program.OR briefings reduced perceived risk for WSS, improved perceived collaboration/teamwork among OR staff, and promoted using team discussions.
Mawji 200229Surgical site identification protocolQuality improvement projectRoot-cause analysis of near misses, for project implementation using the Plan-Do-Study-Act method.800-bed, 3-site academic hospital and networkImplementation of surgical site policy, marking “yes” on the surgical site and “no” on the other side.Surgical site marking policy was not being followed.
  • Handoffs were missing critical information.
  • Nature of marking was problematic.
  • Laterality of markings not included in policy.
Meinberg 20037Incidence of wrong-site surgery in hand surgeonsNoncomparative studySurvey1,560 active members of the American Society for Surgery of the Hand (ASSH) were polled by mail. Return rate of 67%.29-question survey to determine incidence of WSSEstimated number of WSS was 1 in 27,686 hand procedures. 21% hand surgeons reported performing wrong-site surgery at least once during their career; wrong finger occurred 63% of the 242 reported events.
Rogers 200431Barriers to implementing Wrong Site Surgery GuidelinesChanging practice projects/researchObservational study of surgical cases at 4 facilities: 2 outpatient surgical units 1 large metropolitan teaching university 1moderate-size Federal facilityOctober 2001 to February 2002
Field observation and semi-structured interview questions.
Total of 40 observational hours.
Surgical process is tightly coupled, complex system that includes multiple layers of interaction. Unlikely to error proof completely the process in such a dynamic environment, but measures can enhance the resiliency, such as having data available to all practitioners that is updated for everyone to see to prevent overreliance on memory. Avoid hidden assumptions, for example, that encourage patients to be involved in site-marking process as it assumes the patient is physically, cognitively, and emotionally able to correct any errors.
Sexton 200630Teamwork climate in OR – preverification processNoncomparative studySafety Attitudes Questionnaire Survey2,135 OR caregivers in a 60-hospital health system, including surgeons, surgical technicians, anesthesiologists, CRNAs, and OR nurses.A high level of teamwork was perceived by the attending surgeons (64%) and residents (74%), which was markedly different from the attending anesthesiologists (39%), surgical nurses (28%), anesthesia nurses (25%), and anesthesia residents (10%). When attending surgeons were asked about a fellow, resident, or medical student questioning their decision, 45% of attending surgeons indicated that hierarchical systems should be in place, compared to 94% of airline crew members who preferred no hierarchies (Sexton et al., 2000).

When asked the question, “Even when fatigued, I perform effectively during critical times,” the surgical team response ranged from 47% to 70% in agreement, compared with 26% of pilots who agreed with this statement (Sexton et al., 2000).

From: Chapter 36, Wrong-Site Surgery: A Preventable Medical Error

Cover of Patient Safety and Quality
Patient Safety and Quality: An Evidence-Based Handbook for Nurses.
Hughes RG, editor.

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