Chapter 36. Wrong-Site Surgery: A Preventable 

Medical Error 

Deborah F. Mulloy, Ronda G. Hughes 

Background 

Surgery is one area of health care in which preventable medical errors and near misses can 

occur. However, until the 1999 Institute of Medicine report, To Err Is Human,

1 clinicians were 

unaware of the number of surgery-associated injuries, deaths, and near misses because there was 

no process for recognizing, reporting, and tracking these events.2 Of great concern is wrong-site 

surgery (WSS), which encompasses surgery performed on the wrong side or site of the body, 

wrong surgical procedure performed, and surgery performed on the wrong patient.3 This 

definition also includes “any invasive procedure that exposes patients to more than minimal risk, 

including procedures performed in settings other than the OR [operating room], such as a special 

procedures unit, an endoscopy unit, and an interventional radiology suite”4 (p. 11). WSS is also 

defined as a sentinel event (i.e., an unexpected occurrence involving death or serious physical or 

psychological injures, or the risk thereof) by the Joint Commission (formerly called the Joint 

Commission on Accreditation of Healthcare Organizations), which found WSSs to be the thirdhighest-ranking event.5

Causes and Consequences of Wrong-Site Surgery 

WSS can be a devastating experience for the patient and have a negative impact on the 

surgical team.6, 7 State licensure boards are imposing penalties on surgeons for WSS,8 and some 

insurers have decided to no longer pay providers for WSS or wrong-person surgery, nor for 

leaving a foreign object in a patient’s body after surgery.9 Surgery performed on the wrong site 

or wrong person has also often been held compensable under malpractice claims. Indeed, 79 

percent of wrong-site eye surgery and 84 percent of wrong-site orthopedic claims resulted in 

malpractice awards.10, 11 

WSSs are rare events, but we are learning more about their prevalence. Because reporting of 

sentinel events to the Joint Commission is voluntary, it could be that only 10 percent of actual 

WSSs are reported.12 Researchers have confirmed that the Joint Commission’s numbers are low, 

finding wide variations in the number of WSSs: 1 out of 27,686 cases,6 or 1 out of every 112,994 

surgeries,13 or 1 in 5 hand surgeons during their career,7

 or 1 out of 4 orthopedic surgeons with 

25 years’ experience.14 Regardless of the exact number of WSSs, they are seen as a preventable 

medical error if certain steps are taken and standardized procedures are implemented in the 

perioperative setting.15, 16

The incidence of reported WSS has increased in recent years. From the inception of the Joint 

Commission’s Sentinel Event program, the number of WSSs reported has increased from 15 

cases in 1998, to a total of 592 cases reported by June 30, 2007.17 Of these, WSSs most 

commonly occur in orthopedic or podiatric procedures,5

 general surgery, and urological and 

neurosurgical procedures.17 In response to the occurrence of these preventable errors, the Joint 

1 
Patient Safety and Quality: An Evidence-Based Handbook for Nurses

Commission issued two National Patient Safety Goals on January 1, 2003 to target wrong-site 

surgery: 

Goal 1—to improve the accuracy of patient identification by using two patient identifiers and 

a “time-out” procedure before invasive procedures. 

Goal 4—to eliminate wrong-site, wrong-patient, and wrong-procedure surgery using a 

preoperative verification process to confirm documents, and to implement a process to mark 

the surgical site and involve the patient/family.40

Both of these goals continue to be an ongoing priority for the Joint Commission. Yet with 

many surgical procedures traditionally performed only in acute care settings now being 

performed in freestanding surgical centers and physician offices—not necessarily all under the 

purview of the Joint Commission—surgeons, surgical teams, and patients need to be vigilant 

with all surgeries, particularly when the level of oversight and scrutiny may not be as high as in 

hospitals. 

WSS is generally caused by a lack of a formal system to verify the site of surgery or a 

breakdown of the system that verifies the correct site of surgery.18 In using root-cause analysis, a 

process that determines the underlying organizational causes or factors that contributed to an 

event, the Joint Commission found the top root causes of WSS to be communication failure (70 

percent), procedural noncompliance (64 percent), and leadership (46 percent).16 Other system 

and process causes are listed in Table 1. Risk factors associated with WSS were identified as 

emergency cases, multiple surgeons, multiple procedures, obesity, deformities, time pressures, 

unusual equipment or setup, and room changes.17 

Table 1. Causes of Wrong-Site Surgeries5, 18, 19, 20

System Factors Process Factors 

♦ Lack of institutional controls/formal system to 

verify the correct site of surgery 

♦ Lack of a checklist to make sure every check 

was performed 

♦ Exclusion of certain surgical team members 

♦ Reliance solely on the surgeon for determining 

the correct surgical site 

♦ Unusual time pressures (e.g., unplanned 

emergencies or large volume of procedures) 

♦ Pressures to reduce preoperative preparation 

time 

♦ Procedures requiring unusual equipment or 

patient positioning 

♦ Team competency and credentialing 

♦ Availability of information 

♦ Organizational culture 

♦ Orientation and training 

♦ Staffing 

♦ Environmental safety/security 

♦ Continuum of care 

♦ Patient characteristics, such as obesity or 

unusual anatomy, that require alterations in the 

usual positioning of the patient 

♦ Inadequate patient assessment 

♦ Inadequate care planning 

♦ Inadequate medical record review 

♦ Miscommunication among members of the 

surgical team and the patient 

♦ More than one surgeon involved in the 

procedure 

♦ Multiple procedures on multiple parts of a 

patient performed during a single operation 

♦ Failure to include the patient and family or 

significant others when identifying the correct 

site 

♦ Failure to mark or clearly mark the correct 

operation site 

♦ Incomplete or inaccurate communication 

among members of the surgical team 

♦ Noncompliance with procedures 

♦ Failure to recheck patient information before 

starting the operation 

2
Wrong-Site Surgery

Universal Protocol for Preventing Wrong-Site Surgery 

Early attempts to address the occurrence of WSS started with the American Academy of 

Orthopedic Surgeons (AAOS) and the North American Spine Society (NASS). After reviewing 

of 10 years of malpractice claims and polling its members,21 AAOS developed an awareness 

campaign to encourage the marking of the right surgical site, called “Sign Your Site.”22 But in 

practice, adding an additional warning such as “No” on the incorrect site and having the surgical 

team work together to verify the correct site helped the Sign Your Site program to be effective.23

The NASS further refined the Sign Your Site process by adding more detail for the appropriate 

level and site of the spine in its “Sign, Mark, and X-ray” program, calling for marking the exact 

site and side of the spine with a radiopaque indicator, and put forth a checklist for patient and 

procedure verification.24

In 2003, the Joint Commission convened a summit, including the AAOS and leaders from 23 

other organizations, to address the continued escalation of reported WSS cases (i.e., sentinel 

events reported to the Joint Commission); and the impact of WSS on patients, their families, and 

health care professionals; and associated health care costs. The summit was specifically designed 

to bring health care professionals and others together to address and develop strategies to lessen 

or eliminate WSS.14 A major outcome of the summit was creation of a protocol, The Universal 

Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery TM (see Text 

Box 1).20 This protocol was designed to be used in all areas where invasive procedures are 

performed within health care organizations, including nonoperating-room settings. The goal was 

to drastically reduce or eliminate completely the incidence of WSS by using a standardized 

routine and acceptable preoperative process of verifying the patient and the correct site, as well 

as the physician marking the site with his or her initials before the patient is sedated. 

The Universal Protocol for WSS is based on prevention theories that drive safety practice in 

high-risk industries, such as aviation and development of nuclear weapons. The operating room 

is complex with “tight coupling” of processes that happen very quickly and cannot be turned off 

once started; failed parts cannot be isolated from other parts—resulting in an unsafe process. A 

model most often used to demonstrate this is the one described by Reason25 as the Swiss cheese 

model, where error defenses breakdown or are not in place, resulting in patient harm. (See the 

chapter on human factors for more information on Reason’s model.) 

By implementing a systems change required by the WSS protocol, the possibility of a WSS 

should be prevented. The three key elements of the Universal Protocol for WSS are (1) 

preoperative verification process, (2) marking the operative site, and (3) taking a time out. The 

Universal Protocol is to be used in ambulatory care, hospitals, critical access hospitals, and 

office-based settings.20 Implementing and adhering to this protocol should eliminate WSS errors 

that can be attributable to interruptions, distractions, and too many forms or procedures. On July 

1, 2004, the Joint Commission began to include these three key Universal Protocol elements in 

its accreditation process for health care organizations and also provided further guidance on its 

implementation (see Text Box 2). 

3 
Patient Safety and Quality: An Evidence-Based Handbook for Nurses

Text Box 1. The Joint Commission Universal Protocol for Preventing Wrong Site, Wrong 

Procedure, Wrong Person SurgeryTM

Wrong site, wrong procedure, wrong person surgery can be prevented. This Universal Protocol is intended 

to achieve that goal. It is based on the consensus of experts from the relevant clinical specialties and 

professional disciplines and is endorsed by more than 40 professional medical associations and 

organizations. 

In developing this protocol, consensus was reached on the following principles: 

• Wrong site, wrong procedure, wrong person surgery can and must be prevented. 

• A robust approach—using multiple, complementary strategies—is necessary to achieve the goal of 

eliminating wrong site, wrong procedure, wrong person surgery. 

• Active involvement and effective communication among all members of the surgical team is 

important for success. 

• To the extent possible, the patient (or legally designated representative) should be involved in the 

process. 

• Consistent implementation of a standardized approach using a universal, consensus-based 

protocol will be most effective. 

• The protocol should be flexible enough to allow for implementation with appropriate adaptation 

when required to meet specific patient needs. 

• A requirement for site marking should focus on cases involving right/left distinction, multiple 

structures (fingers, toes), or levels (spine). 

• The Universal Protocol should be applicable or adaptable to all operative and other invasive 

procedures that expose patients to harm, including procedures done in settings other than the 

operating room. 

In concert with these principles, the following steps, taken together, comprise the Universal Protocol for 

eliminating wrong site, wrong procedure, wrong person surgery: 

• Preoperative verification process 

o Purpose: To ensure that all of the relevant documents and studies are available prior to the 

start of the procedure and that they have been reviewed and are consistent with each other 

and with the patient's expectations and with the team's understanding of the intended 

patient, procedure, site, and, as applicable, any implants. Missing information or 

discrepancies must be addressed before starting the procedure. 

o Process: An ongoing process of information gathering and verification, beginning with the 

determination to do the procedure, continuing through all settings and interventions involved 

in the preoperative preparation of the patient, up to and including the "time out" just before 

the start of the procedure. 

• Marking the operative site 

o Purpose: To identify unambiguously the intended site of incision or insertion. 

o Process: For procedures involving right/left distinction, multiple structures (such as fingers 

and toes), or multiple levels (as in spinal procedures), the intended site must be marked 

such that the mark will be visible after the patient has been prepped and draped. 

• "Time out" immediately before starting the procedure 

o Purpose: To conduct a final verification of the correct patient, procedure, site and, as 

applicable, implants. 

o Process: Active communication among all members of the surgical/procedure team, 

consistently initiated by a designated member of the team, conducted in a "fail-safe" mode, 

i.e., the procedure is not started until any questions or concerns are resolved. 

[Reprinted with permission from: Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. 

Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations. 2003.20] 

4
Wrong-Site Surgery

Text Box 2. Implementation Expectations for the Universal Protocol for Preventing Wrong Site, 

Wrong Procedure, and Wrong Person SurgeryTM 

These guidelines provide detailed implementation requirements, exemptions, and adaptations for special 

situations. 

Preoperative verification process

• Verification of the correct person, procedure, and site should occur (as applicable): 

o At the time the surgery/procedure is scheduled. 

o At the time of admission or entry into the facility. 

o Anytime the responsibility for care of the patient is transferred to another caregiver. 

o With the patient involved, awake, and aware, if possible. 

o Before the patient leaves the preoperative area or enters the procedure/surgical room. 

• A preoperative verification checklist may be helpful to ensure availability and review of the 

following, prior to the start of the procedure: 

o Relevant documentation (e.g., history and physical, consent). 

o Relevant images, properly labeled and displayed. 

o Any required implants and special equipment. 

Marking the operative site

• Make the mark at or near the incision site. Do NOT mark any nonoperative site(s) unless necessary 

for some other aspect of care. 

• The mark must be unambiguous (e.g., use initials or "YES" or a line representing the proposed 

incision; consider that "X" may be ambiguous). 

• The mark must be positioned to be visible after the patient is prepped and draped. 

• The mark must be made using a marker that is sufficiently permanent to remain visible after 

completion of the skin prep. Adhesive site markers should not be used as the sole means of 

marking the site. 

• The method of marking and type of mark should be consistent throughout the organization. 

• At a minimum, mark all cases involving laterality, multiple structures (fingers, toes, lesions), or 

multiple levels (spine). Note: In addition to preoperative skin marking of the general spinal region, 

special intraoperative radiographic techniques are used for marking the exact vertebral level. 

• The person performing the procedure should do the site marking. 

• Marking must take place with the patient involved, awake, and aware, if possible. 

• Final verification of the site mark must take place during the "time out." 

• A defined procedure must be in place for patients who refuse site marking. 

Exemptions

• Single organ cases (e.g., Cesarean section, cardiac surgery). 

• Interventional cases for which the catheter/instrument insertion site is not predetermined (e.g., 

cardiac catheterization). 

• Teeth–but, indicate operative tooth name(s) on documentation or mark the operative tooth (teeth) 

on the dental radiographs or dental diagram. 

• Premature infants, for whom the mark may cause a permanent tattoo. 

"Time out" immediately before starting the procedure 

Must be conducted in the location where the procedure will be done, just before starting the procedure. It 

must involve the entire operative team, use active communication, be briefly documented, such as in a 

checklist (the organization should determine the type and amount of documentation), and must, at the least, 

include: 

5 
Patient Safety and Quality: An Evidence-Based Handbook for Nurses

• Correct patient identity. 

• Correct side and site. 

• Agreement on the procedure to be done. 

• Correct patient position. 

• Availability of correct implants and any special equipment or special requirements. 

The organization should have processes and systems in place for reconciling differences in staff responses 

during the "time out." 

Procedures for non-OR settings, including bedside procedures

• Site marking must be done for any procedure that involves laterality, multiple structures, or levels 

(even if the procedure takes place outside of an OR). 

• Verification, site marking, and "time out" procedures should be as consistent as possible 

throughout the organization, including the OR and other locations where invasive procedures are 

done. 

• Exception: Cases in which the individual doing the procedure is in continuous attendance with the 

patient from the time of decision to do the procedure and consent from the patient through to the 

conduct of the procedure may be exempted from the site marking requirement. The requirement for 

a "time out" final verification still applies. 

[Reprinted with permission from: Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. 

Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations. 2003.20] 

The Association of periOperative Registered Nurses (AORN), realizing the importance of the 

Universal Protocol for WSS, worked collaboratively with the Joint Commission to develop a 

Correct Site Surgery Tool Kit. The tool kit, designed to assist health care providers to implement 

the Universal Protocol for WSS in their facilities, was endorsed by the American College of 

Surgeons, American Society of Anesthesiologists, American Society for Healthcare Risk 

Management, American Hospital Association, and the American Association of Ambulatory 

Surgery Centers. 

The AORN Correct Site Surgery Tool Kit contains a variety of resources to educate health 

care providers about the Universal Protocol for WSS and to assist them with its implementation. 

The resources include (1) an educational program on CD-ROM; (2) a pocket reference card 

outlining the steps necessary to promote patient identification, site marking, and the time out; (3) 

a template to facilitate development of a facility policy to implement the Universal Protocol for 

WSS; (4) a copy of the Universal Protocol for WSS and Guidelines for Implementing the 

Universal Protocol; (5) frequently asked questions of the Joint Commission and AORN; (6) 

letters to nurses, physicians, facility chief executive officers, and health care risk managers 

encouraging standard implementation of the Universal Protocol across all facilities; and (7) 

information for patients about the Universal Protocol for WSS and health care safety. This tool 

kit is available from AORN at http://www.aorn.org/PracticeResources/ToolKits/ 

CorrectSiteSurgeryToolKit. In addition, AORN Standards, Recommended Practices, and 

Guidelines has a position statement on Correct Site Surgery that has additional information on 

preventing wrong site surgery.39 

Several other organizations have set forth tools and policies to prevent WSS. The Veterans 

Affairs National Center for Patient Safety put forth the Ensuring Correct Surgery and Invasive 

Procedures directive, based on root-cause analysis, that adds two steps to the Joint Commission’s 

6
Wrong-Site Surgery

Universal Protocol: ensuring the consent form is administered and used properly, and having two 

members of the surgical team review patient information and radiological images prior to the 

start of the surgery.26 The OR briefing tool used at Johns Hopkins Hospital expands the time-out 

part of the Universal Protocol by prompting additional dialogue between the anesthesia care 

team, nursing, and the surgical team.27 Additionally, the British National Patient Safety Agency 

has introduced a risk management tool, setting forth a process for double-checking and 

identifying who is accountable at each stage for ensuring surgical markings on the right site to 

avoid WSS.28

Research Evidence 

There is limited research on wrong-site surgery. The majority of studies have been 

retrospective, chart reviews, case studies, and surveys of various professional organizations. The 

evidence table summarizes the most recent evidence related to WSS, specifically the three 

components of the Universal Protocol. 

In two of the retrospective studies that investigated WSS broadly, Meinberg and Stern,7 in a 

study relating to the Universal Protocol, found that nearly half of surgeons changed their 

preoperative practices in response to the Sign Your Site campaign. Since the campaign targeted 

orthopedic surgeons, they were more knowledgeable about the campaign and were more likely to 

have changed their practices. Kwaan and colleagues6 identified 62 percent of WSS cases that 

could have been prevented had providers adhered to the Universal Protocol. In this study, the 

authors concluded that the Universal Protocol would not have prevented the remaining one-third 

of WSS documented cases because of errors initiated in weeks before surgery (e.g., wrong 

documentation, inaccurate labeling of radiological reports). In an analysis of quality 

improvement efforts, similar findings also indicated implementation challenges associated with 

staff nonadherence because the issue of laterality was not addressed in the policy and the process 

was vulnerable to communication failures during handoffs.29 

Preoperative Verification 

In verifying that the right patient is to have the right surgery in the right location, one study 

found that when discrepancies occurred among clinicians, a review of the patient’s information 

could resolve the discrepancy.30 Published guidelines assert the need for a checklist to itemize 

exactly what should be checked, but do not specify what should happen if a discrepancy 

occurs.31

Marking the Site 

Three different studies and one quality improvement project assessed aspects of site marking, 

included two different approaches in who actually marks the right site. All found challenges in 

ensuring that each surgical patient had the right site marked, therefore exposing patients to 

possible WSS. One study that surveyed a small number of surgeons on their site-marking 

practices following the establishment of national guidelines, found that their practices ranged 

from no marking to marking every patient, with some relationship to the type of surgery.32 In 

approaching site marking from the point of view that it is the patient’s responsibility, instead of 

the surgeon having complete responsibility, DiGiovanni and colleagues33 sought to have patients 

7 
Patient Safety and Quality: An Evidence-Based Handbook for Nurses

mark the right site after being given a set of instructions. They found that when patients (instead 

of someone from the surgical team) were asked preoperatively to mark “no” on the wrong foot or 

ankle, 60 percent of patients marked the site correctly. 

The last study and quality improvement project assessed whether marking would cause other 

errors, because of the permanence of the ink, thereby discouraging site marking. The study found 

that marking the surgical site with a pen marker did not affect sterility or place a patient at a 

higher risk for infection.34 The quality improvement project found that staff were not marking the 

right site because the ink upset breast cancer patients and was indelible on premature infants, and 

the policy did not address laterality.29

Time Out 

Two studies found that the time out component can prevent the majority of WSS, but not 

all.6, 13, 35 Another study found that when surgeons, anesthesiologists, and nurses were trained in 

doing a standardized 2-minute briefing prior to surgery, there were specific improvements in 

communication on the surgical site and side operated on.36

Evidence-Based Practice Implications 

In response to continued WSS sentinel event reports, one of the Joint Commission’s National 

Patient Safety Goals continues to be to eliminate wrong-site, wrong-patient, and wrongprocedure surgery. Eliminating WSS errors requires a systems approach, institutionalizing robust 

systems to verify the correct site that adequately addresses potential causes of breakdowns in the 

system. Hospital and surgery center leaders and managers should evaluate their policies and 

procedures regarding WSS and marking the right site to ensure that no WSSs occur under any 

circumstances. 

Adoption of the Universal Protocol standardizes preoperative preparations, improves 

function of the health care team, and should avert any potential for WSS. All health care 

personnel must be knowledgeable about the Universal Protocol and consistently adhere to the 

three key elements—patient identification, site mark, and time out—as outlined in the Universal 

Protocol to reduce the number of WSSs occurring in the United States. 

The Universal Protocol for WSS should be adhered to on all applicable cases, as the 

operating room and procedural areas are highly coupled and complex areas that would be 

unlikely to be completely error proof. Measures should be taken that require less reliance on 

memory. For example, a surgical site mark is a measure to prevent reliance on memory. 

However, when involving patients in marking the surgical site, one needs to assess their 

physical, cognitive, and emotional ability.31 

All health care professionals have an obligation to comply with the Universal Protocol and to 

speak up if they feel patient safety is being compromised in any way.37 Nurses, specifically 

perianesthesia nurses, should function as the patient’s advocate and foster procedures that ensure 

right-site surgery.38 

Research Implications 

There is little empirical evidence regarding prevention of WSS or quantitative evaluation of 

implementation of strategies to prevent WSS. Part of the problem with research in this area has 

8
Wrong-Site Surgery

been that the medical-error data are not easy to extract, and error data are often transferred to 

medical claims data and medical liability, further preventing the sharing of such data. Mandatory 

reporting of these data has just recently been required in some States. Consequently, there are 

gaps in the current evidence on wrong-site surgery. For example, there were no randomized 

controlled studies to evaluate the effect of the Universal Protocol on WSS. Research is needed to 

determine whether the patient’s risk for WSS is associated with the organization following the 

Joint Commission’s Universal Protocol or other standardized process, or with the effectiveness 

of the surgical team in communicating with each other. It is unknown how effective surgical 

teams are in complying with the protocol on a daily basis, and it is unknown what factors or 

barriers exist to implementing the Universal Protocol for WSS in facilities across the country. 

Conclusion 

The reported number of WSS cases continues to increase as health care organizations 

become more transparent to medical error. Many health care organizations, drawing on errorprevention theories and the experience of the aviation industry, recognize that through such 

transparencies, systems can change and result in better patient outcomes. However, it is unlikely 

that WSS will fully be reported because of industrywide report cards, fear of litigation, and 

difference of opinions. Although absolute numbers of WSS may not be striking, the 

consequences to the patient on whom it occurs are dire. 

Search Strategy 

Both PUBMED® and CINAHL® databases between 1990 and March 2007 were searched, 

using wrong site surgery[keyword] OR wrong site surgery[subject heading]. This identified 239 

citations. Citations were excluded for the following reasons: non-English, dealt only with 

disclosing errors or patient preferences, opinion/editorial pieces, news articles, or 

announcements. This left 68 articles for consideration in this review, 10 of which were 

considered as evidence. 

Author Affiliations 

Deborah F. Mulloy, M.S.N., C.N.O.R., doctoral student, University of Massachusetts at 

Boston School of Nursing. E-mail: Deborah.Mulloy001@students.umb.edu. 

Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for 

Healthcare Research and Quality. E-mail: ronda.hughes@ahrq.hhs.gov. 

9 
Patient Safety and Quality: An Evidence-Based Handbook for Nurses

References 

1. Kohn LT, Corrigan JM, Donaldson MS, eds. 

To err is human: building a safer health 

system. A report of the Committee on 

Quality of Health Care in America, Institute 

of Medicine. Washington, DC: National 

Academy Press; 2000. 

2. Agency for Healthcare Research and Quality. Medical 

errors: the scope of the problem. Fact sheet. 

Publication No. AHRQ 00-P037. Available at: 

http://www.ahrq.gov/qual/errback.htm. Accessed July 

18, 2005. 

3. Carayon P, Schultz K, Hundt AS. Righting wrong site 

surgery. Jt Comm J Qual Saf 2004;30:405-10. 

4. Joint Commission. Special report! Helpful solutions 

for meeting the 2006 National Patient Safety goals. 

Joint Commission Perspectives on Patient Safety 2005 

August; 5(8):1-15. 

5. Joint Commission on Accreditation of Healthcare 

Organizations. A follow-up review of wrong site 

surgery. Sentinel Event Alert 2001;24. Available at: 

http://www.jointcommission.org/SentinelEvents/Senti

nelEventAlert/sea_24.htm Accessed December 18, 

2007. 

6. Kwaan MR, Studdert DM, Zinner MJ, et al. Incidence, 

patterns, and prevention of wrong-site surgery. Arch 

Surg 2006; 141:353-8. 

7. Meinberg EG, Stern PJ. Incidence of wrong-site 

surgery among hand surgeons. J Bone Joint Surg Am 

2003; 85:193-7. 

8. Robeznieks A. Getting it right: Florida board cracking 

down on wrong-site surgery. Mod Healthc 2005; 

35(34):18, 20. 

9. Pairolero PC. Quality, safety, and transparency: a 

rising tide floats all boats. Ann Thorac Surg 2005; 

80(2):387-95. 

10. Weber P. Large loss indemnity payments and limits of 

professional liability. Opthalmic Risk Management 

Digest 1997. Available at: 

http://www.omic.com/resources/risk_man/deskref/litig

ation/16.cfm. Accessed September 5, 2006. 

11. American Academy of Orthopaedic Surgeons. 

Advisory statement on wrong-site surgery. Available 

at: http://www.aaos.org/about/papers/advistmt/ 

1015.asp. Accessed September 5, 2006. 

12. Croteau R. Promoting correct site surgery: are you up 

to date? AORN Connections 2003; 1(12):1, 4. 

13. Seiden SC, Barach P. Wrong-side/wrong-site, wrongprocedure, and wrong-patient adverse events: are they 

preventable? Arch Surg 2006; 141:931-9. 

14. D’ambrosia R, Kilpatrick J. Medical errors and 

wrong-site surgery. Orthopedics 2002; 25(3):288. 

15. American Academy of Orthopaedic Surgeons. Report 

of the task force on wrong-site surgery. Available at 

http://www.aaos.org/wordhtml/meded/tasksite.htm. 

Accessed July 18, 2005. 

16. Joint Commission. Root causes of wrong site surgery. 

Available at http://www.jointcommission.org/NR/ 

rdonlyres/90B92D9B-9D55-4469-94B1-

DA64A8147F74/0/se_rc_wss.jpg. 

Accessed December 18, 2007. 

17. Joint Commission. Sentinel event statistics as of June 

30, 2007. Available at: 

http://www.jointcommission.org/NR/rdonlyres/D7836

542-A372-4F93-8BD7-DDD11D43E484/0/se_stats_ 

063007.pdf. Accessed December 18, 2007. 

18. Saufl NM. Universal protocol for preventing wrong 

site, wrong procedure, worng person surgery. J 

Perianesth Nurs 2004; 19: 348-51. 

19. The Association of Perioperative Registered 

Nurses.Position statement on correct surgery site. 

AORN February 2001. Available at: 

http://www.aorn.org/PracticeResources/AORNPositio

nStatements/PositionCorrectSiteSurgery/. Accessed 

August 18, 2006. 

20. Joint Commission. Universal protocol for preventing 

wrong site, wrong procedure, wrong person surgery. 

2003. Available at http://www.jointcommission.org/ 

NR/rdonlyres/E3C600EB-043B-4E86-B04ECA4A89AD5433/0/universal_protocol.pdf. Accessed 

December 18, 2007. 

21. American Academy of Orthopaedic Surgeons Council 

on Education. Report of the task force on wrong-site 

surgery. Rosemount, IL: American Academy of 

Orthopaedic Surgeons; 1998. 

22. American Academy of Orthopaedic Surgeons. Wrong 

site surgery. Available at: 

http://www5.aaos.org/wrong/viewscrp.cfm. Accessed 

August 18, 2006. 

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Wrong-Site Surgery

11 

23. Perlow DL, Perlow SM. Incidence of wrong-site 

surgery among hand surgeons. J Bone Joint Surg 

2003; 85A:1849. 

24. Wong D, Mayer T, Watters W, et al. Prevention of 

wrong site surgery: sign, mark and x-ray (SMaX). La 

Grange, IL: North American Spine Society; 2001. 

Available at: http://www.spine.org/smax.cfm. 

Accessed September 5, 2006. 

25. Reason J. Managing the risks of organizational 

accidents. Burlington, VT: Ashgate Publishing 

Company; 1997. 

26. Veterans Health Administration, Department of 

Veterans Affairs. VHA directive 2004-028: ensuring 

correct surgery and invasive procedures. Available at: 

http://www.va.gov/ncps/SafetyTopics/CorrectSurgDir.

DOC. Accessed September 5, 2006. 

27. Makary MA, Holzmueller CG, Thompson DA, et al. 

Operating room briefings: working on the same page. 

Jt Comm J Qual Saf 2006; 32:351-5. 

28. National Patient Safety Agency (NPSA), The Royal 

Collage of Surgeons of England. Patient safety alert: 

correct site surgery. Available at: 

http://www.npsa.nhs.uk/site/media/documents/885_C

SS%20PSA06%20FINAL.pdf. Accessed September 5, 

2006. 

29. Mawji Z, Stillman P, Laskowski R, et al. First do no 

harm: integrating patient safety and quality 

improvement. Jt Comm J Qual Improv 2002; 

28(7):373-86. 

30. Sexton JB, Makary MA, Tersigni AR, et al. 

Teamwork in the operating room: frontline 

perspectives among hospitals and operating room 

personnel. Anesthesiology 2006; 105:877-84. 

31. Rogers ML, Cook RI, Bower R, et al. Barriers to 

implementing wrong site surgery guidelines: A 

cognitive work analysis. IEEE Trans Syst Man 

Cybern. 2004; 34(6):757-63. 

32. Giles SJ, Rhodes P, Clements G, et al. Experience of 

wrong site surgery and surgical marking practices 

among clinicians in the UK. Qual Saf Health Care 

2006; 15:363-8. 

33. DiGiovanni CW, Kang L, Manuel J. Patient 

compliance in avoiding wrong-site surgery. J Bone 

Joint Surg Am. 2003; 85(5):815-9. 

34. Cronen G, Ringus V, Sigle G, et al. Sterility of 

surgical site marking. J Bone Joint Surg Am 2005; 

87(10):2193-5. 

35. Rothman G. Comment on Kwaan MR, Studdert DM, 

Zinner MJ, et al. Incidence, patterns and prevention of 

wrong-site surgery. Arch Surg 2006; 141: 1049-50. 

36. Makary MA, Mukherjee A, Sexton JB, et al. 

Operating room briefings and wrong-site surgery. J 

Am Coll Surg. 2007 Feb; 204(2):236-43. Epub 2006 

Dec 8. 

37. Watson D. Safety net: lessons learned from close calls 

in the OR. AORN J 2006; 84(Suppl 1):51-561. 

38. Scheidt RC. Ensuring correct site surgery. AORN J 

2002; 76:770-7. 

39. Conner R. AORN Standards, Recommended Practices, 

and Guidelines. Denver, CO: AORN, Inc.; 2007. 

40. Joint Commission on Accreditation of Healthcare 

Organizations. 2003 JCAHO National Patient Safety 

Goals. Available at: http://www.jcrinc.com/26813/ 

newsletters/3746/. Accessed December 20, 2007. 
Evidence Table. Summary of Evidence Related to Wrong-Site Surgery 

Source Safety Issue Related to Clinical Practice Design Type Study Design & Study Outcome Measure(s) Study Setting & Study Population Study Intervention Key Cronen 200534 Sterility of surgical site marking Nonrandomized control study Test the sterility of the site mark after using a surgical marking pen 20 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 g

cultu

the earms Preosurgiwith tnot a

surgiprovi

of su

DiGiovanni 200333 Surgical site marking Pretest and post-test study Evaluated 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 site 

59 pathe smarkpartiawas dthey 70% had a claim

Giles 200632 Surgical site 

marking 

Noncomparative study 

Retrospective qualitative semistructured surveys. (Level 4) 

In person or telephone interview of 38 surgeons in 14 hospitals in the U.K. 

Surg

methas difor m

12
Source Safety Issue 

Related to Clinical Practice 

Design Type Study Design & 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention Key 

JCAHO 200320 Surgical site identification 

protocol 

Published guidelines based on a consensus report 

Universal 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 intervention 

3-ste

••• 

Kwaan 20066 Wrong-site surgery Case series Incidence, 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. 

WronmajoCurreverifiprevecase

Makary 200736

Communication Pretest and 

post-test study 

Survey 306 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 brisk fpercecollaOR steam 

Mawji 200229 Surgical site identification 

protocol 

Quality improvement project 

Root-cause analysis of near misses, for project implementation using the PlanDo-Study-Act method. 

800-bed, 3-site academic hospital and network 

Implementation of surgical site policy, marking “yes” on the surgical site and “no” on the other side. 

Surgwas 

• • • 

13
14

Source Safety Issue Related to Clinical Practice Design Type Study Design & Study Outcome Measure(s) Study Setting & Study Population Study Intervention Key Meinberg 20037 Incidence of wrong-site surgery in hand surgeons Noncomparative study Survey 1,560 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 WSS Estim

1 in 221% perfoat leacaree63% even

Rogers 200431 Barriers to implementing Wrong Site Surgery Guidelines Changing practice projects/ research Observational study of surgical cases at 4 facilities: 2 outpatient surgical units 1 large metropolitan teaching university 1moderate-size Federal facility October 2001 to February 2002 Field observation and semi- structured interview questions. Total of 40 observational hours. Surg

coupincludinteraproof such but mresiliavailais upto prememassuencoinvolvprocepatiecognable 
Source Safety Issue 

Related to Clinical Practice 

Design Type Study Design & 

Study Outcome Measure(s) 

Study Setting & Study Population 

Study Intervention Key 

Sexton 200630

Teamwork climate in OR – preverification process 

Noncomparative study 

Safety Attitudes Questionnaire Survey 

2,135 OR caregivers in a 60-hospital health system, including surgeons, surgical technicians, anesthesiologists, CRNAs, and OR nurses. 

A higpercesurge(74%differanessurgianesanesWheaskeor metheir surgehierain plaairlinprefe(SextWhe“Eveeffecthe srangeagree26% this s2000

15