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Information Statement

WRONG-SITE SURGERY

This Information Statement was developed as an educational tool based on the opinion of the authors. It is not a product of a systematic review. Readers are encouraged to consider the information presented and reach their own conclusions.

Wrong-site surgery is a devastating problem that affects both the patient and surgeon and results from poor preoperative planning, lack of institutional controls, failure of the surgeon to exercise due care, or a simple mistake in communication between the patient and the surgeon.

Wrong-site surgery is not just an orthopaedic surgery problem that occurs because the surgeon operates on the wrong limb. This is a system problem that affects other surgical specialties as well. While the number of reported orthopaedic surgery cases is not high relative to the total number of orthopaedic professional liability insurance claims, a retrospective study of a sample of insurers across the country provides evidence that 84 percent of the cases involving wrong-site orthopaedic surgery claims resulted in indemnity payments over a 10-year period, compared to all other types of orthopaedic surgery claims where indemnity payments were made in 30 percent of orthopaedic surgery claims during this same time period.

Recommendations for Eliminating Wrong-Site Surgery

Although the problem of wrong-site surgery has been addressed and use of the Universal Protocol is strongly promoted by Joint Commission, the American Academy of Orthopaedic Surgeons' (AAOS) and other professional organizations, efforts to eliminate wrong-site surgery have been unsuccessful. Wrong-site surgeries continue to occur despite national campaigns. There is overall consensus that the Universal Protocol is effective if properly implemented and followed. The Canadian Orthopaedic Association mounted a significant educational program from 1994-1996 to eliminate this problem and has reported that the number of known wrong-site orthopaedic surgery claims in Canada has subsequently dropped dramatically.

The American Academy of Orthopaedic Surgeons (AAOS) believes that a unified effort among surgeons, hospitals and other health care providers to initiate preoperative and other institutional regulations can effectively eliminate wrong-site surgery in the United States.

Consequently, the AAOS urges other surgical and health care provider groups to join the effort in implementing effective controls to eliminate this system problem for both inpatient and outpatient procedures.

Effective Methods of Eliminating Wrong-Site Surgery

Wrong-site surgery is preventable by having the surgeon, in consultation with the patient when possible, place his or her initials on the operative site using a permanent marking pen prior to the patient being moved to the location of the procedure and then operating through or adjacent to his or her initials. Spinal surgery done at the wrong level can be prevented with an intraoperative X-ray that marks the exact vertebral level (site) of surgery. Similarly, institutional protocols should include these recommendations and involve operating room nurses and technicians, hospital room committees, anesthesiologists, residents and other preoperative allied health personnel. Verification of the correct patient, procedure, and surgical site should be confirmed before the patient leaves the pre-procedure area and enters the procedure room.

Consequently, eliminating wrong-site surgery means the surgeon, in consultation with the patient when possible, places his or her initials on the operative site in a way that cannot be overlooked and in a manner that will be clearly incorrect if transferred onto another body area prior to surgery. The intended site should be marked such that the mark will be visible after the patient has been prepped and draped. The patient's records also should be available in the operating facility. Checklists may be employed prior to the procedure to ensure that consent forms were accurately completed and signed, relevant documentation (i.e.; history and physical) is accurate, the diagnostic and radiology test results are correct, and any reasonably anticipated blood products, tissues, devices and/or special equipment for the procedure is available and correctly matched to the patient.

Once the patient has been moved into the operating room, the surgical team should pause to take a "time-out" to communicate about the specific patient and procedure. A time-out should include confirmation of the patient's identity, correct procedure, site, equipment and implants/devices, as applicable, and administering of antibiotics. The time-out should also include a double-check of the patient's medical record and x-rays. Missing information or discrepancies must be addressed before starting the procedure. All members of the team (including the orthopaedic surgeon, anesthesiologist, circulating nurse, and scrub nurse) should participate in the time-out to communicate with other members of the team and to raise any questions or concerns which should be resolved before proceeding.

As outlined in its Information Statement “Communicating Adverse Outcomes”, the AAOS believes that in any communication with the patient or patient's family regarding care rendered, particularly in relation to an untoward event such as wrong- site surgery, orthopaedic surgeons must be truthful in all circumstances.

As indicated in the attached recommendations, particular circumstances of individual cases require specific and different actions on the part of the surgeon in the event that wrong-site surgery is discovered, but in all cases the patient's choice and the best interest of the patient should be the determining factors in decision-making.

Appendix 1 - Recommendations for Management Following the Discovery of Wrong-Site Surgery

A. General
If, during the course of a surgical procedure, or after surgery has been completed, it is determined that the surgery is being or has been performed at the wrong site, the surgeon should always:

    1. Act in accord with the patient's best interests and to promote the patient's well-being
    2. Record the events in appropriate medical records

B. General Anesthesia
If the procedure is being performed under general anesthesia, when it is determined that the surgery is being performed at the wrong site, the surgeon should:

    1. Take appropriate steps to return the patient, as nearly as possible, to the patient's preoperative condition;
    2. Perform the desired procedure at the correct site, unless there are medical reasons not to proceed, e.g., if proceeding with the surgery at the correct site would materially increase the risk associated with extended length of the surgical procedure or if correct-site surgery would likely result in an additional and unacceptable disability;
    3. Advise the patient, and the patient's family, if appropriate, as soon as reasonably possible, of what occurred and the likely consequences, if any, of the wrong-site surgery.

C. Local Anesthesia
If the procedure is being performed under a local anesthesia and the patient is clearly able to comprehend what has occurred and competent to exercise judgment, the surgeon should:

    1. Take appropriate steps to return the patient, as nearly as possible, to the patient's preoperative condition;
    2. Advise the patient of what has occurred, recommend to the patient what, in the surgeon's best judgment, is the appropriate course for the patient to follow under the circumstances; and
    3. Truthfully answer any relevant question posed by the patient and then proceed as directed by the patient.

D. Discovery after Surgery
If, after the surgical procedure has been completed, it is determined that the surgery was performed at the wrong site, the surgeon should: as soon as reasonably possible, discuss the mistake with the patient and, if appropriate, with the patient's family and recommend an immediate plan to rectify the mistake unless there is a medical reason not to proceed.

References:

Joint Commission. Universal Protocol. Accessed September 8, 2008 http://www.jointcommission.org/PatientSafety/UniversalProtocol/

Copyright American Academy of Orthopaedic Surgeons September 1997.
Revised December 2008.

This material may not be modified without the express written permission of the American Academy of Orthopaedic Surgeons.

Information Statement 1015

For additional information, contact the Public Relations Department at 847-384-4036.

Open/save the checklist in PDF format.

SIGN-YOUR-SITE
A Checklist for Safety

_____ Surgeon involves the patient in confirming the operative site during the marking of the operative site by the surgeon. Copies of the operative permit/informed consent form should state the site and side of surgery.

_____ Surgeon signs initials to the operative site in permanent marking pen.

_____ Immediate members of the operative team verify the correct site.

_____ Surgeon verifies that X-rays and medical records are for the correct patient, as well as confirming the identity of the patient.

_____ Immediate members of the operative team double-checks each of the following items against the marked site:

_____ Medical records
_____ X-rays and other imaging studies
_____ Informed consent
_____ Operating room/anesthesia record
_____ Correct equipment/implant/device available

_____ In spine surgery or when the bone or level is not identifiable visually, surgeon takes an intraoperative X-ray using markers that do not move to confirm the site.

Complete all the items on this page. Relying on a single preventive effort only can result in errors!

Patient Name: _______________
Physician: __________________
Procedure(s): _______________
Date: ___________

Signature of Person Completing the Checklist:

________________________________________

Checklist materials derived from and modified with the permission of the North American Spine Society.

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