Using Improvement Science Methods to Increase Accuracy of Surgical Consents PATTI MERCURIO, MSN, RN, NE-BC; ANDREA SHAFFER ELLIS, MSN, RN, CPN; PAMELA J. SCHOETTKER, MS; RAYMOND STONE, MSCS; MARY ANNE LENK, BS; FREDERICK C. RYCKMAN, MD

ABSTRACT The surgical consent serves as a key link in preventing breakdowns in communication that could lead to wrong-patient, wrong-site, or wrong-procedure events. We conducted a quality improvement initiative at a large, urban pediatric academic medical center to reliably increase the percentage of informed consents for surgical and medical procedures with accurate safety data information at the first point of perioperative contact. Improvement activities focused on awareness, education, standardization, real-time feedback and failure identification, and transparency. A total of 54,082 consent forms from 13 surgical divisions were reviewed between May 18, 2011, and November 30, 2012. Between May 2011 and June 2012, the percentage of consents without safety errors increased from a median of 95.4% to 99.7%. Since July 2012, the median has decreased slightly but has remained stable at 99.4%. Our results suggest that effective safety checks allow discovery and prevention of errors. AORN J 100 (July 2014) 42-53. Ó AORN, Inc, 2014. http:// dx.doi.org/10.1016/j.aorn.2013.07.023 Key words: patient safety, informed consent, quality improvement, consent accuracy, surgical consent, improvement science.

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ore than a decade ago, two groundbreaking reports from the Institute of Medicine brought patient safety to the attention of both health care providers and patients, and made everyone aware that defective systems rather than calloused or careless providers were the cause of errors.1,2 Since the publication of those reports, many hospitals have implemented or revised systems to improve patient safety, such as nonpunitive error reporting, computerized order entry systems, bar coding, executive “walk rounds,” team training,

and simulation.3 However, despite these innovations, patients continue to suffer from serious and preventable safety events.3 A systematic review from 2008 suggested that adverse events affect nearly one in 10 hospitalized patients.4 Many safety improvement efforts for surgical patients have focused on wrong-site events. These include operating on the wrong patient, operating on the wrong site or the wrong side, or performing the wrong surgical procedure.5,6 Although rare, these types of events are considered unacceptable http://dx.doi.org/10.1016/j.aorn.2013.07.023

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INCREASING SURGICAL CONSENT ACCURACY because they are completely preventable. The 2007 annual report on quality and safety from The Joint Commission indicated that inadequate communication between health care providers or between providers and the patient and family members was the root cause in more than 60% of serious adverse events in accredited hospitals.7 An initial key aspect of communication for the surgical team is an accurate surgical consent.8 The consent serves as a key link in preventing breakdowns in communication that could lead to wrongpatient, wrong-site, or wrong-procedure events. The American Medical Association describes informed consent as a process of communication between the patient and his or her physician that results in the patient’s authorization or agreement to undergo a specific medical intervention.9 In the communication process, the physician providing or performing the treatment or procedure should disclose and discuss with the patient the n

patient’s diagnosis; n nature, purpose, risks, and benefits of the proposed procedure; and n nature, risks, and benefits of alternatives to the proposed procedure, including the option of not receiving any treatment.9-11 Failure of the health care provider to obtain adequate informed consent has been shown to n

compromise patient-centered care (eg, shared decision making),10-15 n increase the likelihood of a patient safety incident or medical error,16,17 10,15 n decrease patient satisfaction, and n heighten the health care provider’s exposure to liability (eg, charges of legal negligence or battery by unconsented touching).12,18-21 Although many health care professionals believe that they communicate effectively, many patients do not fully understand their health condition and the plan of care, possibly because of limited health literacy, stress, emotional distress, or personal or

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cultural beliefs.10,22-24 Many organizations use nonstandardized processes to document consent and use fill-in-the-blank forms with handwritten notes and medical jargon or generic consent-fortreatment documents that are not specific to the given procedure.15 Patients and physicians also do not always agree about which aspects of informed consent are important.25-27 In addition, the belief that the consent process is just a formality or that the consent form serves primarily to protect the physician and hospital28,29 may result in just a cursory reading by all parties.16 Analysis of results of some studies indicates that only a minority of patients carefully read the information contained in the informed consent form before they sign it.28,30 A number of studies10,13,15,22,24,31 demonstrate a renewed focus on communication interventions to improve patient comprehension in informed consent; however, there is less research related to the patient safety risks resulting from inaccurate or incomplete consent forms.22

DESCRIPTION OF THE PROBLEM At Cincinnati Children’s Hospital Medical Center, Ohio, a house-wide electronic medical record was implemented in 2008. Patient informed consents for surgical and medical procedures were not autopopulated or electronically signed in the electronic medical record. Surgeons completed paper consents, which were then sent to the health information management department to be scanned and inserted into the electronic medical record before the day of surgery for access by perioperative personnel. The standardized consent template for the hospital was used to develop procedure-specific forms in each division. It was later determined, however, that some of these procedure-specific forms did not contain all of the required elements. A hospital-wide emphasis on improving patient safety and the occasional discovery of errors on procedure-specific consent forms in the perioperative area prompted an effort to determine the scope

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KEY TAKEAWAYS FOR CLINICAL PRACTICE Using Improvement Science Methods to Increase Accuracy of Surgical Consents Why Did We Do This Project? n Failure to obtain adequate informed consent compromises patient safety, inhibits shared decision making, and compromises patient-centered care. n Preoperative nursing personnel were identifying and correcting surgical consents on the day of surgery. They considered these last-minute consent corrections to be a safety risk. What Did We Find? n The preoperative nurses’ concerns were valid: personnel assessed 1,201 consent forms from May 18 through May 31, 2011, and approximately 5% contained errors that could have affected patient safety. n We found that it was important to focus improvement efforts on n increasing awareness of the problem, n educating personnel about the problem and the importance of correct informed consents, n standardizing consent forms, n providing feedback to personnel, and n ensuring transparency of compliance with consent expectations. n Using data capture, including all informed consents and not just the consents with errors, provided some perspective of the concern. n Physicians needed confirmation and validation to trust the data. n Individual meetings with division leaders helped to build relationships and trust.

n Engaging key divisional leaders in the project helped

motivate team members to initiate change. n Timely reporting and feedback improved stakeholder

buy-in. n A diverse quality improvement team helped to ade-

quately represent all aspects of workflow. n The percentage of consents without safety errors in-

creased from a median of 95.4% to 99.7% between May 2011 and June 2012. How Can Clinicians Use These Results? n Clinicians: Nurses serve as important patient advocates to improve patient safety; therefore, nurses should share safety concerns regarding the accuracy of informed consents with their managers. Nurses also should be prepared to participate in quality improvement activities focused on identifying and rectifying deficiencies in the informed consent process. n Managers: Managers should consider using improvement science to improve perioperative safety. As part of this endeavor, managers should ensure that a written policy is available and up to date to ensure consistency in the informed consent process in all areas of the facility. After safety concerns have been individually addressed, managers may consider implementing a system-wide improvement initiative. n Educators: Educators should conduct training and provide inservice programs to educate all perioperative team members, including physicians and their office personnel, about best practices in the informed consent process.

Mercurio P et al. Using improvement science methods to increase accuracy of surgical consents. AORN J. 2014;100(1):42-53. Copyright Ó AORN, Inc, 2014.

of the problem. An examination of 1,201 completed consent forms for surgical and medical procedures was conducted between May 18 and May 31, 2011. It revealed that approximately 5% contained errors that could have affected patient safety. Although these errors were identified before the patient entered the OR, the level of risk was considered too high. Therefore, we conducted a quality improvement (QI) initiative to reliably32 improve the accuracy of informed consent completion before first perioperative contact.

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PROJECT SETTING Cincinnati Children’s Hospital Medical Center is a large, urban pediatric academic medical center. In fiscal year 2012, more than 6,000 inpatient and 27,000 outpatient surgical procedures were performed at the base hospital and at a satellite location. The medical center has a strong focus on improving quality and patient safety and, in 2005, committed to adopting the principles of high-reliability organizations.33 According to Weick et al,33 highreliability organizations

INCREASING SURGICAL CONSENT ACCURACY n

n n n

n

are preoccupied with failure (ie, regard small, seemingly inconsequential errors as a symptom that something is wrong), are reluctant to simplify (ie, encourage diversity in experience, perspective, and opinion), are sensitive to operations (ie, pay attention to what is happening on the front line), are committed to resilience (ie, develop capabilities to detect, contain, and recover from errors that do occur), and give deference to expertise (ie, ensure that decision making is in the hands of the people with the most expertise and knowledge of the situation, regardless of seniority, rank, or status).

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a signature from a nonlegal guardian or stepparent; or n a missing anesthesia type (ie, general, regional, local). Initially, we considered a missing anesthesia type to be a safety error. We addressed anesthesia type by developing a separate consent form for anesthesia. No longer considered a safety concern, undocumented anesthesia type was reclassified as an administrative error and continued to be tracked. We defined safety errors as n n n

PROJECT GOALS The specific aim of our QI project was to increase the percentage of correctly completed informed consents for surgical and medical procedures with accurate safety data information at the first point of perioperative contact. The goal was to improve from approximately 95% to 100% by June 30, 2012, for 13 surgical divisions. EVIDENCE SUPPORTING THE NEED FOR A PROCESS CHANGE An initial review of a sample of 4,762 informed consents for surgical or medical procedures occurring between May 18 and July 2, 2011, indicated that 70% of consent forms contained no errors. Among the remaining 30% of the forms, 27% contained administrative errors and 3% contained safety errors. We defined administrative errors as n n n n n n n

a missing date, time, or printed name associated with a signature; a missing witness signature; a completion date more than one year old; the wrong surgeon listed; missing or inadequate completion of foreign language consents; missing risks, benefits, or alternative treatment options; improper or incorrect completion of a consent by telephone;

n n n

incorrect or missing site or laterality, incorrectly scheduled laterality, incorrect or missing procedure, incorrectly scheduled procedure, incorrect patient name, or illegible handwriting or checkbox selection.

PROJECT METHODS The senior vice president for medical operations and vice president for perioperative services asked the clinical managers of two surgical locations (ie, an inpatient OR at the base hospital and a freestanding outpatient surgery center) to establish and co-lead an improvement team. The other team members included physicians, nurses, clinical and business managers, a health information management director, a customer service representative, an application administrator, a representative from the legal department, and a QI consultant. Improvement science methods are techniques and strategies that can be widely used in multiple settings by teams with various experience to undertake QI. We used improvement science methods, such as a key driver diagram, plan-do-study-act cycles, measurement, and statistical process control charts,34 to reliably increase the accuracy of safety data information about informed consents for surgical or medical procedures. Project Design Based on a review of the informed consents, the team reviewed the existing literature, determined AORN Journal j 45

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Figure 1. Improvement Model - Key Driver Diagram: a team at Cincinnati Children’s Hospital Medical Center, Ohio, determined that certain key drivers are necessary to ensure accurate and reliable completion of informed consents and implemented 15 interventions to improve surgical consent accuracy.

the key drivers (ie, factors)35 believed to be necessary to ensure accurate and reliable32 completion of the informed consents (Figure 1), and developed interventions to address these drivers. Improvement activities focused on improving the reliability of accurate completion of consent forms before the first perioperative contact. The team defined first perioperative contact as the point at which the patient enters the perioperative area on the day of surgery. This could be the time when the patient arrived at the preoperative or preparation area but not the time when the patient was transferred into the OR. The 15 interventions developed to address the key drivers fell into five main categories: increased awareness of the importance of accurate informed

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consents, education on properly completing the consent form, process standardization, real-time feedback and failure identification, and transparency of compliance with consent expectations. Project Population and Sampling Technique The project population consisted of all patients from the participating divisions who underwent surgical procedures from May 18, 2011, through November 30, 2012. This project fell within the guidance provided by our medical center’s institutional review board for QI projects that did not constitute human subjects research; therefore, institutional review board approval was not required.

INCREASING SURGICAL CONSENT ACCURACY Data Collection and Analysis The primary outcome measurement was the percentage of consent forms free of safety errors. Perioperative nurses at each location screened consents for accuracy and entered the data into the webbased data management application. The team coleaders pulled data from the application to create a statistical process improvement run chart.36-39 The team and division leaders used the run chart to examine the change in the percentage of consent forms with no safety errors over time. Run charts are commonly used in industry to analyze process improvement efforts and identify common-cause variation (ie, variation caused inherently by a system) and special-cause variation (ie, variation not normally part of the system that appears to be caused by specific events).36,40 Observed changes are considered special causes when any of the following criteria are true: n

there is a run (ie, eight or more consecutive points either above or below the mean and/or median center line), n there is a trend (ie, six consecutive increasing or decreasing points), or n there are alternating points (ie, at least 14 consecutive points alternating above and below the mean and/or median center line). IMPLEMENTATION Reliability is often quantified as the number of actions that achieve the intended results divided by the total number of actions taken.41-43 Level 1 reliability is achieved when there is an 80% to 90% success rate, or one to two failures per every 10 opportunities.32 Similarly, level 2 reliability is achieved when there are five or fewer failures per 100 opportunities. Level 3 reliability is achieved when there are five or fewer failures per 1,000 opportunities. We began by implementing reliability level 1 interventions that focused on increasing awareness, educating personnel, and improving standardization. We then progressed to reliability level 2 interventions focused

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on real-time feedback and failure identification, weekly reporting, and transparency. Increased Awareness In July 2011, the senior vice president for medical operations met with the chiefs of the 13 surgical divisions and sent a letter to each member of the surgical services personnel to introduce the QI project and emphasize the importance of accurate informed consents. The team co-leaders then met individually with key leaders of each participating division and community surgeons to review the safety and administrative components of the consent process and to ensure compliance with all of the required high-reliability elements (ie, preoccupation with failure, reluctance to simplify). Division leaders were asked to examine their division’s current processes for obtaining consent and checking accuracy before the day of surgery. On August 10, 2011, the senior vice president for medical operations made the first annual perioperative safety presentation to all surgical services personnel. In the presentation, he reviewed safety metrics for the previous year and emphasized key safety initiatives for the upcoming year, including this project to improve consent accuracy. Education The team co-leaders provided surgeons, business directors, and divisional leaders with education regarding the informed consent process, including key aspects of consent forms, an explanation of regulatory requirements, and tip sheets. The tip sheets described the objectives and importance of informed consent, and gave instructions on how to complete the consent form, including who can obtain consent and who can witness consent, and how to document a telephone or foreign language consent accurately. To ensure ongoing emphasis of this initiative, specific education developed by perioperative leaders on accurate completion of consent forms has been included in the orientation for all newly hired physicians (ie, deference to expertise)

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since July 2012. Because consents frequently are completed in an outpatient office, the ambulatory nursing personnel also completed a consent education module (ie, deference to expertise). Starting in August 2012, this information has been part of the annual education for ambulatory nursing personnel as well. In recognizing the link between scheduled procedure and consent, similar education was planned for the surgical schedulers (ie, deference to expertise). On August 4, 2011, the team co-leaders met with surgical schedulers from the participating divisions to discuss ways to ensure that the procedure listed on the consent form matched the scheduled procedure and how to communicate unique procedure details while emphasizing that laterality information (ie, left, right, bilateral) always should be included when appropriate. Since then, all new surgical schedulers have received this training. Standardization Initially, two divisions developed internal consent safety checks (ie, preoccupation with failure). One division reviewed consents during weekly conferences with the entire surgical team. In the other division, an administrative assistant and an RN reviewed all consents. Because these two divisions demonstrated improved accuracy of consents on the day of surgery, all divisions were asked to develop internal safety checks as well. The team revised the hospital-wide general consent template and modified it to allow for easier documentation of consents by telephone. Legal department personnel reviewed this revision and modification. Participating divisions standardized their required elements on the consent templates to create intentional redundancy and ensure clear and unambiguous communication (ie, preoccupation with failure). For example, improved clarity and legibility were attained by using a bold text font for areas that had to be completed or adding additional line space where specific information could be written or typed. Additionally, each division standardized the way that it addressed 48 j AORN Journal

MERCURIO ET AL procedure laterality on its consent forms. The project team then reviewed all division-specific consents in collaboration with division representatives. Real-Time Feedback and Failure Identification A surgical scheduler, an administrative assistant, or an RN reviewed every completed consent form in the office or preoperative area (ie, preoccupation with failure, sensitivity to operations, commitment to resilience). The perioperative team then reviewed every consent form during the preoperative portion of the surgical time out in the preoperative area. If the consent was not correct, then the patient was held in the preoperative area until the surgeon corrected the consent. Weekly Reporting An inhouse information technology specialist developed a web-based data management application to track consent errors and generate reports. Nurses in the preoperative area entered confirmed errors on consent forms into this data management application. Beginning in September 2011, the improvement team co-leaders sent weekly reports and charts showing the percentage of consent forms without errors for all divisions and for their individual division to key stakeholders, such as division chiefs, business directors, and leaders (ie, preoccupation with failure). The improvement team co-leaders shared specific consent concerns directly with key leaders to emphasize the identified error. Transparency The improvement team co-leaders posted divisionbased data in weekly reports to encourage accountability, allowing all divisions to see overall perioperative performance and compliance outside their division (ie, preoccupation with failure). This transparency created healthy competition among surgical colleagues to achieve 100% compliance. Since July 2012, consent compliance has been included in performance dashboards44-50 for all divisions.

INCREASING SURGICAL CONSENT ACCURACY

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Figure 2. Change in the percentage of consents with no safety errors at first point of perioperative contact between May 2011 and November 2012.

RESULTS We reviewed a total of 54,082 consent forms from 13 surgical divisions between May 18, 2011, and November 30, 2012. Between May 2011 and June 2012, the percentage of consents without safety errors quickly increased from a median of 95.4% to 99.7% (Figure 2). Since July 2012, the median has decreased slightly but has remained stable at 99.4%. The accuracy of the administrative components of consent forms also increased during the project, from 70% to 95%. DISCUSSION Properly completed informed consent forms can be a major help in preventing wrong-patient, wrongsite and wrong-side, and wrong-procedure events.6 Since 2004, The Joint Commission has required compliance with its Universal ProtocolTM for elimination of wrong-site surgery.51 Since then, however, the number of wrong-site surgery events reported to The Joint Commission has continued to increase.52 As with us, others have noted that errors on surgical or procedural consent forms

are common.53 Such errors on consent forms and other documents used in the preoperative reconciliation and verification compromise patient safety.5 We used improvement science methods34 to reliably increase the accuracy of safety data information on informed consents for surgical or medical procedures at the first point of perioperative contact in a busy children’s hospital. We believe that engaging key divisional leaders in the project helped them to motivate their team members to initiate change. Timely reporting and data feedback likely improved stakeholder awareness and buy-in. Some divisions were very responsive to the weekly reports and wanted to know the details of errors in their divisions. Some divisions quickly took ownership of the process by engaging someone from their team to validate consent accuracy. Two of the 13 divisions participating in the project implemented electronic informed consents. We believe that other divisions will do so in the future to further improve patient safety. Many other organizations also are making such changes,54,55

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Ambulatory Takeaways Improving Surgical Consents in the Ambulatory Setting Ambulatory surgery centers (ASCs) often can streamline and standardize processes more easily than hospitals, especially in single specialty centers where there is little deviation from procedure to procedure.1 The difficulty is in the varied settings in which surgeons practice. An ASC may have medical practitioners who practice in multiple hospitals and clinic settings, they may use different surgical consents, and the process to obtain them may differ from one facility to another. Another complication is that many ASCs continue to use paper as opposed to electronic documentation. Because the ASC is the commonality between surgeons on staff, standardization should start at the center. By taking the lead on a process improvement project for informed consent accuracy, the ASC and governing body could aid in standardizing the surgical consent process, including scheduling and verifying that the patient has made an informed decision. It is not uncommon for a patient to have limited contact with his or her surgeon preoperatively when referrals and transfers occur, and little time is spent in clinics and, subsequently, in the ASC. Informed consent begins at the time that a patient and a surgeon decide a surgical intervention is needed, and the first opportunity for error to occur is when the surgeon communicates to his office personnel what procedure is being recommended for which patient and at which facility. From there on, schedulers in the physician’s office and schedulers at the surgery center interact, along with the surgeon and patient, to schedule the procedure at an agreed upon time and place. Having a standardized surgical consent form and written documentation by the surgeon minimizes the opportunity for errorsdparticularly those that can occur with verbal orders. It is important to ensure accuracy at the point the decision is made. Patient safety is the first concern, but there are other ramifications to an incorrect or incomplete surgical consent. For example, procedures lost to cancellation often equate with lost revenue because filling an empty OR at the last minute is difficult in an ASC, and resources may be wasted as a result of cancellations that occur after the patient has arrived at the center.2 Finding external benchmarks for best practices in surgical consent accuracy against day-of-surgery cancellations for ASCs is difficult, although many organizations benchmark internally. After a baseline is established, managers can identify gaps and implement appropriate interventions. Managers and educators can work together to perform audits and provide education for compliance with the informed consent policy and accuracy in the surgical consents. Improving outcome measurements regarding consent accuracy (ie, number of same-day cancellations and on-time starts) can be a valuable project for an ASC. Terri Link, MPH, RN, CNOR, CIC, is an ambulatory education specialist at AORN, Inc, Denver, CO. Ms Link has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. 1. Merrill DG, Laur JJ. Management by outcomes: efficiency and operational success in the ambulatory surgery center. Anesthesiol Clin. 2010;28(2):329-351. 2. Haufler K, Harrington M. Using nurse-to-patient telephone calls to reduce day of surgery cancellations. AORN J. 2011;94(1):19-26.

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INCREASING SURGICAL CONSENT ACCURACY and several companies are now selling computer software designed to produce procedure-specific informed consent forms, some that can be signed digitally.56 For example, the Department of Veterans Affairs health system standardized and automated its entire informed-consent process,55 and some facilities have implemented electronic time-out procedures.57 Limitations This QI project had several limitations. The scope of this project was large. Barriers to completion included working with 13 unique divisions, each with different leadership and internal processes as well as the need to verify the accuracy of the data. Facilitators to completing this project included having team members from various parts of the process, demonstrating that the data were accurate, being responsive to the concerns of division leaders, and developing trusting relationships with key stakeholders. We have not yet reached our goal of 100% of informed consents for surgical and medical procedures with accurate safety data information at the first point of perioperative contact. We also do not have data to show the effect, if any, of increasing the accuracy of informed consents on reducing patient harm or improving patient outcomes; however, no incorrect site or laterality errors occurred during the project. We do not know whether fewer surgical procedures were delayed or cancelled because of an incorrect consent or whether patient and personnel satisfaction improved. In addition, this improvement initiative took place at a large pediatric medical center with a strong QI foundation and leadership support for QI. Future Goals Reliability in health care has been defined as the measurable capability of a process, procedure, or health service to perform its intended function in the required time under commonly occurring conditions.32,41 The failure rate is often expressed as an index based on an order of magnitude.

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Although the interventions in this QI project were designed to meet level 1, level 2, and level 3 reliability, future improvements will target only level 3 reliability. Additional interventions will focus on improving preoccupation with failure and sensitivity to operations and increasing clear and unambiguous communication. This level of reliability is achieved when there are five or fewer failures per 1,000 opportunities. CONCLUSION Nurses serve as important patient advocates to improve patient safety. We believe that improvement science can be used to promote perioperative safety. Timely reporting and feedback can improve stakeholder buy-in, and engaging key divisional leaders can help to motivate team members to initiate change. Analysis of the results of this QI project suggest that effective safety checks allow discovery and prevention of errors. Editor’s note: The Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery is a trademark of The Joint Commission, Oakbrook Terrace, IL. References 1. Institute of Medicine, Committee on Quality Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001. 2. Institute of Medicine, Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 1999. 3. Leape LL. Scope of problem and history of patient safety. Obstet Gynecol Clin North Am. 2008;35(1):1-10. 4. de Vries EN, Ramrattan MA, Smorenburg SM, Gourma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care. 2008;17(3):216-223. 5. Clarke JR, Johnston J, Finley ED. Getting surgery right. Ann Surg. 2007;246(3):395-403. 6. Clarke JR, Johnston J, Blanco M, Martindell DP. Wrongsite surgery: can we prevent it? Adv Surg. 2008;42:13-31. 7. Improving America’s Hospitals. The Joint Commission’s Annual Report on Quality and Safety 2007. The Joint Commission. November 2007. http://www.jointcommi ssion.org/assets/1/6/2007_Annual_Report.pdf. Accessed February 26, 2014. 8. Carney BL. Evolution of wrong site surgery prevention strategies. AORN J. 2006;83(5):1115-1122.

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9. Opinion 8.08 - Informed Consent. American Medical Association. http://www.ama-assn.org//ama/pub/physician -resources/medical-ethics/code-medical-ethics/opinion 808.page. Accessed April 9, 2014. 10. Quick J. Developing communication in informed consent. J Perioper Pract. 2010;20(3):108-112. 11. Committee on Bioethics, American Academy of Pediatrics. Informed consent, parental permission, and assent in pediatric practice. Pediatrics. 1995;95(2):314-317. 12. Bernat JL, Peterson LM. Patient-centered informed consent in surgical practice. Arch Surg. 2006;141(1):86-92. 13. Schenker Y, Fernandez A, Sudore R, Schillinger D. Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review. Med Decis Making. 2011;31(1): 151-173. 14. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Healthcare Decisions: the Ethical and Legal Implications of Informed Consent in the PatientPractitioner Relationship. Volume One: Report. October 1982. http://bioethics.georgetown.edu/pcbe/reports/past_ commissions/making_health_care_decisions.pdf. Accessed February 26, 2014. 15. Gottesman HE. Standardized informed consent is a key to improving patient safety. J Healthc Inf Manag. 2005; 19(4):14-16. 16. Chassin MR, Becher EC. The wrong patient. Ann Intern Med. 2002;136(11):826-833. 17. Pizzi LT, Goldfarb NI, Nash DB. Procedures for obtaining informed consent. Evidence Report/Technology Assessment No. 43; AHRQ publication 01eE058. In: Shojana K, Duncan B, McDonald K, Wachter R, eds. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Rockville, MD: Agency for Healthcare Research and Quality; 2001. http://archive.ahrq.gov/clinic/ptsafety/ chap48.htm. Accessed February 26, 2014. 18. Kuz KM. Young teenagers providing their own surgical consents: an ethical-legal dilemma for perioperative registered nurses. Can Oper Room Nurse J. 2006;24(2): 6-15. 19. Pryor F. Key concepts in informed consent for perioperative nurses. AORN J. 1997;65(6):1105-1110. 20. Brazell NE. The significance and applications of informed consent. AORN J. 1997;65(2):377-386. 21. Brick J. Informed consent and perioperative nursing. AORN J. 1996;63(1):258-261. 22. Wu HW, Nishimi RY, Page-Lopez CM, Kizer KW. Improving Patient Safety Through Informed Consent for Patients with Limited Health Literacy. Washington DC: National Quality Forum; 2005. http://www.qualityforum .org/Publications/2005/09/Improving_Patient_Safety_ Through_Informed_Consent_for_Patients_with_Limited_ Health_Literacy.aspx. Accessed February 26, 2014. 23. Agnew J, Jorgensen D. Informed consent: a study of the OR consenting process in New Zealand. AORN J. 2012; 95(6):763-770. 24. Miller MJ, Abrams MA, Earles B, Phillips K, McCleeary EM. Improving patient-provider communication for patients having surgery: patient perceptions of a revised health literacy-based consent process. J Patient Saf. 2011;7(1):30-38.

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Patti Mercurio, MSN, RN, NE-BC, is the clinical director of the same day surgery and outpatient infusion center for perioperative services at Cincinnati Children’s Hospital Medical Center, Cincinnati, OH. Ms Mercurio has no

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declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Andrea Shaffer Ellis, MSN, RN, CPN, is the clinical director of orthopaedics and sports medicine for ambulatory services at Cincinnati Children’s Hospital Medical Center, Cincinnati, OH. Ms Shaffer Ellis has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Pamela J. Schoettker, MS, is a medical writer for the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s Hospital Medical Center, Cincinnati, OH. Ms Schoettker has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Raymond Stone, MSCS, is an architect, business systems for Information Services e Application Innovation at Cincinnati Children’s Hospital Medical Center, Cincinnati, OH. Mr Stone has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Mary Anne Lenk, BS, is a senior quality improvement consultant for the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s Hospital Medical Center, Cincinnati, OH. Ms Lenk has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Frederick C. Ryckman, MD, is a professor of surgery and senior vice president of medical operations for the department of surgical services at Cincinnati Children’s Hospital Medical Center, Cincinnati, OH. Dr Ryckman has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.

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