Wrong Site Surgery

Wrong-site surgery (WSS) is the quintessential medical error. It is preventable, it bears the risk of serious adverse outcome and it is almost always the result of systems failure. WSS involves the wrong patient, side, implant, organ, limb or site on the spine.

The Joint Commission reported the following statistics at the New York State Patient Safety Conference 2007

From 1995 through 2006, WSS accounted for approximately 13% of all sentinel events (i.e. an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof; access The Joint Commission's definition of sentinel events, and more about their sentinel event policy.)

• 2006 WSS report: wrong surgical site (75%), wrong patient (17%), wrong procedure (8%).
• The same report reported incidence by top 5 surgical specialties:
  • 20% Orthopedics
  • 20% General surgery
  • 16% Anesthesia
  • 10% Cardiovascular-thoracic
  • 8% Dental/Oral Maxillofacial
• 2006 WSS by setting:
  • 53% Hospital-based Ambulatory Surgery
  • 29% Inpatient OR (Operating Room)
  • 13% ICU/ER/SPU
  • 5% Free-standing Ambulatory Surgery
• 2006 Top 5 Root Cause Analysis of 76 WSS in descending order:
  • Procedural compliance
  • Communication
  • Leadership
  • Availability of Information
  • Competency
• 2006 Risk Factors for WSS:
  • 19% Emergency case
  • 13% Multiple Surgeons
  • 10% Multiple Procedures
  • 16% Morbid obesity/physical deformity
  • 13% Unusual time pressure
  • 13% Unusual equipment or set-up
  • 12% Room Change

The lack of an effective national response to adverse events has prompted individual states to take action to reduce the risk to citizens. A number of states are spearheading WSS reduction. The info below is a sampling of state activity. There are certainly other states working toward WSS reduction.

Pennsylvania:

The Pennsylvania Patient Safety Authority created a “Self-Assessment Checklist for Program Elements Associated with Preventing Wrong-Site Surgery.” Analysis of data returned by healthcare facilities that used the checklist, suggests the following:

• The exact description of the procedure must be the same on the surgical schedule and the surgical consent; both should include side and site.
• Every individual who handles preoperative documentation must reconcile that documentation by: schedule, procedure, patient, consent, Labs/Studies, etc.. Discrepancies must be corrected prior to the patient entering the OR.
• The attending surgeon verifies the presence of all necessary preoperative documents and corrects any discrepancies prior to the patient entering the OR.
• An alert patient or surrogate should participate in patient identification, document verification and site marking.
• The site markings should be visible when the patient is prepped and draped, and referred to during the time-out.('time-out' refers to period of time where all clinical activity is halted; usually called for until policy and procedures are carried out. )
• Anesthesia providers should also do a time-out before regional blocks.
• Surgeons should explicitly empower any OR team member to speak up if their understanding is different from that stated during the time-out.

Florida:

Florida has required mandatory reporting of selected adverse incidents since 1985

The following outline may help familiarize non-OR personnel with some of the processes used by surgical teams to reduce wrong-site surgery. This outline is not comprehensive and does not include any diagnosis or procedure-specific considerations. The order of verification will vary by institution, procedure and patient status:

• Admitting RN:
• Patient identification confirmed consistent with policy and procedure (P&P); 2 forms of ID standard.
• Color coded, facility-specific patient ID secured to patient: ID, Allergies, Risks, etc .
• Pre-op monitoring initiated per P&P: Pulse oximetry, BP, etc; corrective action if abnormal.
• Patient or legal representative description of: procedure, surgical site and side is compared to Surgery schedule; deviations documented and OR team notified.
• Consent, lab/study results on chart consistent with orders and scheduled surgical procedure.
• Surgeon(s):
  • Patient identification verified per P&P; deviations documented, corrective actions taken.
  • History&Physical and all necessary test/study results available; deviations documented, corrective actions taken.
  • Surgical consent describing procedure, site and side are signed & dated by patient, surgeon and duly witnessed.
  • Operative site is marked with hypoallergenic permanent marker, using an unambiguous and recognizable convention that will be visible when patient is prepped and draped. When possible, marking will be done in presence of another team member and prior to patient sedation.
• Anesthesia:
  • Pre-op testing results, consistent with planned procedure, are on chart; deviations documented, corrective actions taken.
• Valid surgical consent consistent with scheduled procedure on chart; deviations documented, corrective actions taken.
• Patient identification verified per P&P, deviations documented, corrective actions taken.
• Patient or legal representative understands and is able to describe the procedure/treatment, purpose, site, side and expected procedure outcome.
• Anesthetic plan with risks and benefits described to patient, including post-op pain control options.
• Consent for Anesthesia signed by patient, anesthetist and witnessed per P&P.
• Pre-Op antibiotics as ordered administered 1 hour before anticipated incision time.
• Anesthesia safety checklist completed.
• Circulating RN:
  • History&Physical, Orders, Labs/Studies reviewed; deviations documented, corrective actions taken.
  • Patient identification verified per P&P; deviations documented, corrective actions taken.
  • Valid surgical consent describing site and side consistent with scheduled procedure; deviations documented, corrective actions taken.
  • Patient interview: allergies, previous surgeries, anesthetic difficulties, implants, skin defect, positioning considerations, etc. documented; team notified of corrective action. Patient participation and questions solicited.
  • Patient or legal representative understands and is able to describe the treatment, purpose, site, side and expected. outcome; deviations documented, corrective actions taken.
  • Patient or legal representative identifies correct site and surgeon's mark.
  • Patient or legal representative verifies surgical consent and signatures.
  • Patient appropriate education regarding positioning, induction and post-op environment. Patient questions and expectations solicited and discussed.
• Team assessment:
  • All team members ready and available.
  • OR prepared for scheduled procedure, implants ready or available (correct anesthesia supplies; correct positioning. equipment; correct side, size, type etc. of implant).
  • Team member(s) escort correctly identified patient to the OR.
  • The team members introduce themselves to patient by name and role.
  • "Time out" (all clinical activity halted) - initiated by consistent team member (e.g., anesthesia, surgeon, RN circulator per P&P).
  • Designated "time out" initiator conducts final verification of correct patient, procedure, site, side, implants etc.
  • Each member affirms readiness to proceed.

Wrong-site surgery occurs because:

• Organizational leadership is lacking,
• Procedural steps are skipped,
• Team members are exchanged,
• Schedules are altered,
• Etc.

Each team member must sustain a culture of safety even under emergency conditions. The false economy of short-cuts must be repudiated. Patient safety first and last!

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