The AAOS initiated its “Sign Your Site” program in 1997 to reduce the incidence of wrong-site surgery among orthopaedic patients. In 2004, elements of this program were incorporated into The Joint Commission’s (TJC) Universal Protocol surgical standards program, which was designed to reduce preventable surgical harms including wrong site, wrong side, wrong procedure, wrong implant, wrong level, and wrong patient surgeries.

Despite the increased adoption of surgical safety programs and recognition of the importance of surgical patient safety, little evidence exists that shows any reduction in preventable surgical harms.

In 2011, Marc Chassin, MD, president of TJC, used the organization’s sentinel event database to identify the most frequent causes of preventable surgical harm. These include the following:

• Inadequate patient or surgical information
• Surgical scheduling discrepancies
• Irregularities in preoperative holding process
• Inadequate/absent surgical site marking
• Poor surgical team and patient communication
• Distractions in the operating room (OR)
• Inadequate/absent surgical “time-outs”

Based on these most frequent causes, as well as on information from current surgical safety literature, the AAOS has identified the following six critical components of surgical safety needed to minimize surgical harm—the “Critical Cs of Surgical Safety”:

1. Consent—accurate and timely informed surgical consent
2. Confirmation—timely and correct surgical patient, site, and procedure identification
3. Communication—effective, transparent communication between the patient and surgeon and among members of the surgical team
4. Consistency—regular use of standardized, validated, evidence- and/or consensus-based surgical processes such as surgical checklists
5. Concentration—focused patient, surgeon, and surgical team interactions without distractions
6. Collection—timely and systematic safety data accumulation and analysis

Results from an AAOS survey on orthopaedic surgical safety in 2011 revealed that many surgical safety processes are used in hospital ORs but are much less commonly used in ambulatory surgery centers and office procedure rooms. The survey also confirmed that preventable surgical errors occur in all orthopaedic surgical settings.

In this and subsequent articles, AAOS Now will feature each of the critical surgical safety elements.

The need for consent
Accurate, timely informed surgical consent is the first essential safety process element of any surgical procedure. Proper surgical consent meets several surgical process needs and mandates including the following:

• Legal documentation required by state laws
• Compliance with surgical regulatory processes required for surgical facility certification
• Documentation needed for proper surgical team–patient communication for confirming the appropriate site, side, level, implant, procedure, and patient
• Patient-surgeon shared decision making essential for informed patient-surgeon communication and patient satisfaction

The consent process has several important components, and deficiencies in or the absence of any component can contribute to surgical errors. It should be understood that surgical consent is not a discrete event or document; it is a critical surgical safety process. To provide the safest and best quality surgical care, the surgical consent process should contain the following elements.

Timeliness
Although surgical consent has often been obtained immediately prior to surgery, this is not optimal timing. In this setting, the patient may be unable to understand or retain information communicated from the surgeon or surgical team.

If possible, surgical consent should be obtained at least 24 hours prior to surgery, when the patient is neither stressed nor distracted by the impending procedure. This timing also allows for administrative reconciliation and correction of any inconsistencies found in surgical documentation prior to the procedure.

Comfortable location or setting
Obtaining surgical consent in settings such as a preoperative holding area or patient’s bed presents barriers to effective surgeon-patient communication, including poor lighting, the unavailability of the patient’s reading glasses or hearing aids, and inadequate support for the patient from family members or friends. Surgical consent discussions should occur in a setting that is comfortable for the patient, with adequate light, any needed patient aids, and the presence of family or friends.

Surgeon-led presentation
If surgical consent is obtained by the nursing or house staff, the patient has little opportunity to ask questions and get answers. Informed consent responsibilities should not be delegated to members of the surgical team on a routine basis.

The surgical consent process should be a surgeon-administered process and a critical component of shared decision making. Whenever possible, the surgical team should also be part of the consent process.

Clear understanding
Surgical consent forms have often contained written or spoken medical abbreviations and jargon describing the procedure. Under TJC requirements, consent forms must advise patients of the material risks, benefits, and alternatives to the planned surgery. This is best accomplished by using simple terms (written or spoken) that can be understood by the patient. Under some state laws, an interpreter may be necessary to translate for the patient and the surgeon.

The consent should include a legible, easy-to-read consent form and be performed in a setting that allows adequate time for questions. Use of surgeon-directed questions, “say-backs,” and “read-backs” to confirm understanding has been found to increase the accuracy and retention of surgical information as well as to improve patient satisfaction.

Accuracy
Historically, inaccuracies in surgical consents have been far too frequent. The surgical consent should clearly and accurately describe the intended surgical site, side, level, implant, procedure, and patient. Most surgeons use institutionally standardized consent forms but some modifications to meet individual patient needs are acceptable.

Patient-centeredness
Rather than being facility-centered and/or surgeon-centered, the surgical consent process should be patient-centered and include supporting family and friends. Placing and maintaining the patient in the center of the consent process put the patient’s safety and outcomes in clear focus and provide the best opportunity for clarity, understanding, and confirmation. As previously mentioned, the surgical consent process must include a full discussion of surgical risks, benefits, and alternatives and must be documented.

Legal documentation
The facility-based surgical consent form is a written legal document mandated by state laws. These laws generally require that the consent be signed in a timely manner prior to surgery and signed by a witness verifying the patient’s identity, surgical site, and planned procedure. If necessary, the surgeon should modify the consent form to fit both the procedure being done and the individual patient. For more information about your state’s consent laws, contact your practice’s legal counsel.

Facility regulation
Surgical consent is also a highly regulated facility-based process that is carefully evaluated by certifying organizations such as TJC. The use of surgical consent standards is specified under the Universal Protocol process and compliance is required. Hospital consent audits have demonstrated that process errors can occur in more than 10 percent of consents. If the surgical consent is absent, incomplete, or incorrect, surgical errors are more frequent.

Several complementary consent processes have demonstrated utility in orthopaedic settings. Multi-media presentations and/or classroom discussions supporting the surgeon-administered consent process have been shown to increase patient understanding, retention, and satisfaction. Interactive media requiring direct patient participation have demonstrated the most added value.

Using multiple complementary processes, however, is not additive and has not been shown to increase understanding, retention, or satisfaction. Studies have also shown that older and/or less educated orthopaedic patients recall and retain less surgical information over time.

Orthopaedic surgical consent is a complex, but critical, safety process and document. Actively engaging the patient in the consent process can improve safety and quality of care. Surgeon leadership and active involvement with the patient and surgical team throughout the process is essential to ensure reliability, prevent surgical harm, and provide the best possible surgical outcomes.

William J. Robb III, MD, chairs the AAOS Patient Safety Committee; Charles Carroll IV, MD, chairs the AAOS Ethics Committee; Calvin Kuo, MD, is the resident member of the AAOS Patient Safety Committee.

References

1. Canale ST: Wrong site surgery: A preventable complication. Clin Orthop Relat Res 2005;4533:26–29.
2. The Joint Commission: Universal Protocol. http://www.jointcommission.org/standards_information/up.aspx. Accessed December 14, 2012.
3. Stahel PF, Sabel AL, Victoroff MS, Varnell J, Lembitz A, Boyle DJ, et al: Wrong-site and wrong-patient procedures in the Universal Protocol era: Analysis of a prospective database of physician self-reported occurrences. Arch Surg 2010;145:978–984.
4. The Joint Commission: Sentinel Event Database. http://www.jointcommission.org/sentinel_event.aspx. Accessed January 4, 2013.
5. Kuo CC: Critical roles of orthopaedic surgeon leadership in healthcare systems to improve orthopaedic patient safety. Clin Orthop Relat Res, in press. Art.DOI:10.1007/s11999-012-2719-3
6. American Academy of Orthopaedic Surgeons’ Surgical Safety Survey. American Academy of Orthopaedic Surgeons, Rosemont, IL, 2011. http://www.aaos.org/research/committee/ptsafety/ptsafety.asp. Accessed January 4, 2013.