You are on page 1of 7

ORIGINAL ARTICLE

Incorrect Surgical Procedures Within and Outside of the Operating Room
Julia Neily, RN, MS, MPH; Peter D. Mills, PhD, MS; Noel Eldridge, MS; Edward J. Dunn, MD, MPH; Carol Samples, BGS; James R. Turner, BS; Audrey Revere; Ralph G. DePalma, MD; James P. Bagian, MD, PE
Objective: To describe incorrect surgical procedures reResults : We reviewed 342 reported events (212 adverse events and 130 close calls). Of these, 108 adverse events (50.9%) occurred in an OR, and 104 (49.1%) occurred elsewhere. When examining adverse events only, ophthalmology and invasive radiology were the specialties associated with the most reports (45 [21.2%] each), whereas orthopedics was second to ophthalmology for number of reported adverse events occurring in the OR. Pulmonary medicine cases (such as wrong-side thoracentesis) and wrong-site cases (such as wrong spinal level) were associated with the most harm. The most common root cause of events was communication (21.0%). Conclusions: Incorrect ophthalmic and orthopedic surgical procedures appear to be overrepresented among adverse events occurring in ORs. Outside the OR, adverse events by invasive radiology were most frequently reported. Incorrect surgical procedures are not only an OR challenge but also a challenge for events occurring outside of the OR. We support earlier communication based on crew resource management to prevent surgical adverse events.

ported from Veterans Health Administration (VHA) Medical Centers from 2001 to mid-2006 and provide proposed solutions for preventing such events.
Design: Descriptive study. Setting: Veterans Health Administration Medical Centers. Participants: Veterans of the US Armed Forces. Interventions: The VHA instituted an initial directive, “Ensuring Correct Surgery and Invasive Procedures,” in January 2003. The directive was updated in 2004 to include non–operating room (OR) invasive procedures and incorporated requirements of The Joint Commission Universal Protocol for preventing wrong-site operations. Main Outcome Measures: The categories included 5 incorrect event types (wrong patient, side, site, procedure, or implant), major or minor surgical procedures, location in or out of the OR, therapeutic or diagnostic events, adverse event or close call, inpatient or ambulatory events, specialty department, body segment, and severity and probability of harm.

Arch Surg. 2009;144(11):1028-1034 or more wrong-patient, wrong-site, and wrong–invasive procedure events reported per year in that state for 20032005.4 Wrong-site surgical procedure was the sentinel event most frequently reported to The Joint Commission.5 The literature indicates that the true incidence of incorrect surgical procedures is not known with confidence. Despite efforts to eliminate incorrect surgical procedures, these events continue to occur.3,5-7

Author Affiliations: Department of Veterans Affairs, Veterans Health Administration (Mss Neily, Samples, and Revere; Drs Mills, Dunn, DePalma, and Bagian; and Messrs Eldridge and Turner); Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire (Dr Mills); Department of Surgery, Uniformed Services University of the Health Sciences (Dr DePalma), and Department of Military and Emergency Medicine, F . Edward He ´ bert School of Medicine (Dr Bagian), Bethesda, Maryland; and Department of Preventive Medicine and Community Health, University of Texas Medical Branch, Galveston (Dr Bagian).

can be devastating. Some examples include wrong-site, 1 wrong-side, wrong-procedure, or wrong-patient events.2 Based on the database analysis of Seiden and Barach,2 we estimated that 5 to 10 of these events occur daily in the United States. A report from Pennsylvania stated that some aspect of an actual or close-call wrong-site surgical procedure occurs every other day in that state.3 Kwaan et al1 examined a malpractice insurance database for wrong-site surgical procedures and estimated an incidence of 1 in 112 994 nonspine, wrong-site surgical procedures. That study did not include wrongpatient or wrong-procedure events and excluded non–operating room (OR) cases, so it is understandable that this rate appears lower than that reported by Seiden and Barach. The New York Patient Occurrence and Reporting Tracking System database, for which reporting is mandatory, indicated 100

I

NCORRECT SURGICAL PROCEDURES

See Invited Critique at end of article
The Veterans Health Administration (VHA) developed and implemented a pilot program to reduce the risk of incorrect surgical events in April 2002, which resulted in the dissemination of a national directive in January 2003. Subsequently, The Joint Commission issued a Universal Pro-

(REPRINTED) ARCH SURG/ VOL 144 (NO. 11), NOV 2009 1028

WWW.ARCHSURG.COM

©2009 American Medical Association. All rights reserved. Downloaded From: http://archsurg.jamanetwork.com/ by oceana mega on 05/10/2013

tocol for Preventing Wrong Site.15 Operating room reported events could have occurred at any of the 130 VHA facilities providing surgical services.jamanetwork. we analyzed surgical adverse events and close calls from VHA RCAs and incident reports (termed safety reports in the VHA system). effective July 1.0%) provide surgical services. An additional search was conducted using a natural language processing search method that uses data and text mining (PolyAnalyst). Events were not limited to the OR and included incidents in procedure rooms or radiology suites and at the bedside. In the VHA for catastrophic events. 130 (85.12 In addition. if a step was skipped. This included any incision or puncture to the patient. Inpatient procedures were defined as those performed on an inpatient hospitalized for at least 1 night before or after the procedure. CODING PROCESS Two independent teams of a surgeon and at least 1 nonclinical researcher coded each report.11 The Joint Commission also requires an RCA for sentinel events. All rights reserved. root cause analysis (RCA) teams examine what happened and why it occurred. such as site marking. The teams reconciled differences to arrive at a consensus for a final categorization of each case. 11).D. After categorization was completed. Rou- (REPRINTED) ARCH SURG/ VOL 144 (NO. We also describe reporting before and after dissemination of policies to ensure correct surgical procedures.) coded the root causes of events into major categories Other Categories Service or specialty was coded as the surgical or medical service or specialty department that performed the procedure. Adverse Event vs Close Call An adverse event was defined as an incident in which the patient had undergone a surgical procedure of any type unnecessarily. the wrong procedure was written on the consent form.14 In this study. spinal. Results were filtered to include only events pertaining to incorrect surgical procedures or incorrect invasive procedures.13 The VHA staff submits RCAs and incident reports to a central database. A close call was defined as an incident in which a recognizable step toward a surgical adverse event occurred without the patient being subjected to a surgical or invasive procedure as previously defined in our definition of adverse event. but minor surgical procedures may or may not take place in the OR. These data were limited to RCAs and safety reports submitted to the National Center for Patient Safety and were not abstracted from medical records. MAIN OUTCOME MEASURES Major and Minor Surgical Procedures Major surgical procedures were defined as “procedures performed under general. a procedure room in a clinic or emergency department.79 for the last 10 cases.6% and ␬ of 0.18 Non-OR environments may be any setting where an invasive procedure is performed. Cases in which the patient needed admission solely because of the adverse event or close call were counted as ambulatory. and all carotid endarterectomies and inguinal herniorrhaphies. this was considered a deviation from the directive but not a close call.N. and the Committee for the Protection of Human Subjects. OR vs Non-OR An OR was defined as part of a suite in a hospital or in an outpatient ambulatory surgical center with dedicated staff. eg. regardless of anesthesia type. Some examples included the wrong patient was given a consent form. the wrong surgical site was marked. equipment.10. DESIGN We analyzed reported surgical adverse events in the VHA and described categories of events. reaching consensus when the root causes did not clearly fit into any one category. approved this project. 2004.9 to be fully consistent with the Universal Protocol and to address implementation questions. Dartmouth College.8 The VHA issued an updated version of its directive on Ensuring Correct Surgery and Invasive Procedures on June 24. including injections and administration of regional or general anesthetic not needed for the planned procedure.COM ©2009 American Medical Association. Major or minor surgical procedures are performed on outpatients or inpatients. but the correct procedure was performed. White River Junction. Wrong Procedure and Wrong Person Surgery. considered this project exempt. Topical applications to the skin or via eyedrops were considered close calls. an interventional procedure room in a radiology department. and P.16 which produced the final data set for this study. or at the bedside. two of us ( J. DATA SOURCES We searched the VHA National Center for Patient Safety database for surgical adverse events occurring between January 1. Event Location.”17(p493) Minor surgical procedures were defined as any other invasive procedure. and then recommend actions to prevent reoccurrence. whereas non-OR events could have occurred at any of the 153 VHA facilities. such as a procedure performed on the wrong patient or wrong site. and epidural anesthesia. METHODS such as education or communication. NOV 2009 1029 WWW.ARCHSURG. Ambulatory procedures were those for which the preoperative plan called for sameday admission and discharge. For example. 2004. All major surgical procedures occur in the OR. 2001. We then independently coded remaining cases. Therapeutic procedures were defined as procedures to treat medical conditions. We coded 10 cases by consensus to develop draft categories of root causes and then independently coded 40 cases in groups of 10 and refined the codebook until we reached an agreement of 80. The purpose of this analysis is to provide information and proposed solutions regarding incorrect surgical events and to provide a unique perspective by summarizing reports from a large health care system over 51⁄2 years.M. Veterans Affairs Medical Center. VHA staff members are required to use RCA for potentially catastrophic closecall events. and June 30. and the wrong site or wrong patient was prepped. The Research and Development Committee. and diagnostic procedures were defined as procedures to establish a diagnosis.com/ by oceana mega on 05/10/2013 . 2006. Solely omitting a required step in the VHA directive9 or Universal Protocol19 did not constitute a close call. and space guidelines consistent with Joint Commission standards. Vermont. SETTING AND PARTICIPANTS Of 153 major facilities in the VHA. Downloaded From: http://archsurg.

to June 30.20 This directive was updated and reissued in mid-2004 to include invasive procedures not conducted in the OR.ARCHSURG.19 Wrong patient Yes Did the patient get a procedure intended for someone else (even if almost identical to what he or she really needed)? No Wrong side Yes Did the patient get a procedure intended for his or her left side rather than his right side. mouth. prostate biopsy instead of cystoscopy (biopsy planned for other patient in waiting area) Wrong eye receives implant. Before January 2003. One hundred eight reported adverse events (50. The VHA held nationwide briefings with Patient Safety and Quality Management staff about the directive and sent educational resources to all VHA medical centers. 3. ophthalmology and invasive radiology had the most reports. Ensuring Correct Surgery flowchart. Event type included wrong patient. 2006. to September 30. and leg/foot. arm/hand. 2000. and 104 reported adverse events (49. Wrong Procedure. or after the VHA directive9 was rewritten to include procedures performed outside the OR and the Joint Commission Universal Protocol for Preventing Wrong Site. or before the VHA directive “Ensuring Correct Surgery” was issued.9%) occurred in the OR.1%) occurred elsewhere.jamanetwork. eye. but it was the wrong procedure? No Wrong finger. such as those that required the injection of dye or catheterization. wrong procedure. Reported adverse events were for 51⁄2 years ( January 1. only invasive radiological procedures. 2001. From January 1.9 concurrent with the requirement to implement the Joint Commission’s Universal Protocol for Preventing Wrong Site. to June 30. to June 30.75 to account for this time difference. Table 2 displays reported adverse events by specialty and event type. or a mistaken lab value or similar problem. In cases where multiple sites were identified. and the independent variable was time period.3%) of which were not discernible by our coders. or when the VHA directive was in effect but there was no Joint Commission requirement and the directive was for OR cases only. wrong side. Table 1 displays cases by category. 76 (11. 2006). 2006) and the number of surgical cases was for 6 years (October 1. Each event was categorized as only 1 type of event.There is something incorrect about this surgical or invasive procedure that is not related to the technical skill of the provider. tine radiographs or magnetic resonance images did not meet the definition of invasive procedure and were not considered in this study. 11). so we multiplied the first and last year of fiscal year data on surgical cases by 0. lack of imaging data causes surgeon to decide not to conduct operation or to abort procedure after start Wrong implant Yes Was the wrong implant used. Examples: Mr Johnson not Mr Johnston. 2003. For reported adverse events only. abdomen. Wrong Person Surgery. The analysis of root causes revealed 672 total root causes. We used 3 time periods for analysis: 1. were included. INTERVENTIONS The VHA required implementation of its initial directive. “Ensuring Correct Surgery and Invasive Procedures.14: We received and analyzed 342 reports of surgical events: 212 actual adverse events (62. Events coded as an actual SAC 3 were analyzed with an RCA.0%). SAFETY ASSESSMENT CODE Adverse events reported within the VHA are rated by the patient safety manager for actual and potential harm using 2 criteria: harm (catastrophic to minor) and probability (frequent to remote). 2. Events coded as SAC 1 or 2 may receive an RCA if the facility chooses to do so but do require submission as a safety report. 2004. the body segment coded was the incision location. The dependent variable was SAC score. information is provided for 596 WWW. 45 each (21. Wrong Procedure. Harm and probability are combined for a score from 1 to 3 called the Safety Assessment Code (SAC). wrong mole removed ANALYSIS We described characteristics of the events and used ␹2 analysis to identify relationships between SAC scores. Figure 2 displays major root cause categories. 2004. or vice versa? No Wrong site Yes Did the patient get the correct procedure but on the wrong part of the body (not left/right)? No Did the procedure take place on the correct part of the body. to correctly assign a category (Figure 1). From July 1. such as specialty and type of adverse events. or was the correct implant unavailable? No Other Yes Was the procedure wrong in some other way? No Consider removing report from set under review Figure 1.com/ by oceana mega on 05/10/2013 . RESULTS Wrong procedure Yes Cystoscopy instead of prostate biopsy or carpal tunnel procedure instead of release of Dupuytren contracture (without evidence of wrong patient) Implant for other eye used (but correct eye operated on). We used analysis of variance to analyze mean differences in SAC scores over time.2%). Consequently. developed by the VHA to help staff prioritize adverse events and close calls11. pelvis.COM (REPRINTED) ARCH SURG/ VOL 144 (NO. were categorized as having medium or high harm or not. and other variables. wrong intervertebral space. NOV 2009 1030 ©2009 American Medical Association.0%) and 130 close calls (38. The parts of the body were developed based on this data set: head/neck. The algorithm used to categorize events must be followed in order. which were categorized as occurring or not occurring. All rights reserved. wrong knee scoped 1 represents the lowest priority and 3 the highest priority. which. spine. We placed the number of reported adverse events over the number of surgical cases for that specialty and multiplied this by 10 000 for a rate of reported adverse events per 10 000 cases. and wrong implant. Wrong Person Surgery was effective. thorax.” in January 2003. late discovery that correctsized orthopedic implant is not available Equipment not available. for analysis. Anatomic body segment was coded as the site at which the surgical procedure occurred. wrong site.19 We calculated a reported adverse event rate for the top 7 categories of OR reported adverse events. Downloaded From: http://archsurg.

such as handoffs between staff members in which information was missing. NOV 2009 1031 ©2009 American Medical Association. All rights reserved.6%) included issues such as the patient was not properly identified during the time-out. gastrointestinal tract medicine.8 reported adverse events for every 10 000 cases.Table 1.jamanetwork. 2006. Table 2.75. Root causes related to time-out problems (17. whereas orthopedics had 1. operating room. Ophthalmology had 1. to September 30. 11).0%) and included examples such as informed consent issues and problematic communication of critical information between team members. 2000. a The date range for reported adverse events and close calls is January 1. of OR Inpatient (n = 614 581) b Therapeutic Diagnostic Outpatient (n = 1 413 653) b Therapeutic Diagnostic Total No. None of the other top 7 specialties of OR adverse events had at least 1 adverse event per 10 000 cases. and internal medicine.com/ by oceana mega on 05/10/2013 . Data on the percentage of surgical cases were retrieved WWW. and OR vs non-OR procedure. of Reports Non-OR procedures Inpatient Therapeutic Diagnostic Outpatient Therapeutic Diagnostic Grand Total procedures b Major Surgical Procedure 1 119 459 31 0 16 1 48 Minor Surgical Procedure 908 774 3 0 54 2 59 Subtotal 2 028 233 34 0 70 3 107 No. Data on reported adverse events came from the study database. b These data are for procedures that were entered into the surgery package of the Department of Veterans Affairs electronic medical record system (fiscal years 2001-2006: October 1.COM (REPRINTED) ARCH SURG/ VOL 144 (NO. Number of Reported Adverse Events by Specialty Adverse Event Specialty Ophthalmology Invasive radiology Orthopedics Urology Dentistry General surgery Pulmonary medicine Cardiology Neurosurgery Vascular surgery Cardiothoracic Podiatry Dermatology Gastrointestinal medicine Internal medicine Plastic surgery Otolaryngology Obstetrics-gynecology Total Wrong Patient 5 31 1 6 0 2 1 4 1 1 1 0 1 1 1 0 0 0 56 Wrong Side 16 5 8 12 2 4 7 1 1 3 2 2 0 0 1 0 1 0 65 Wrong Site 0 1 3 1 13 4 1 0 3 0 1 1 2 0 0 1 0 0 31 Wrong Procedure 2 3 2 3 0 3 0 0 0 0 0 0 0 2 0 0 0 1 16 Wrong Implant 22 5 12 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 41 Other 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 Total 45 45 26 23 15 13 9 6 5 5 4 3 3 3 2 1 1 1 210 root causes (88. c Data were missing for 28 cases. so the total sample size for this table was 314 rather than 342. dermatology. Reported Surgical Cases by Category a No.5 y by multiplying fiscal year 2001 and fiscal year 2006 data by 0. The number of cases in 5 dichotomous categories: reported adverse event vs close call. inpatient vs outpatient. of Reported Adverse Events Procedure Total No. major vs minor surgery.ARCHSURG. 2001.2 reported adverse events per every 10 000 cases. to June 30. therapeutic vs diagnostic procedure. 2006) and adjusted for 5. dentistry (OR oral surgery is included). The top root cause was communication problems (21. Downloaded From: http://archsurg. of Reported Close Calls Major Surgical Procedure 1 119 459 33 0 17 0 50 Minor Surgical Procedure 908 774 3 0 37 1 41 Subtotal 2 028 233 36 0 54 1 91 Grand Total 2 028 233 70 0 124 4 198 0 0 0 0 48 27 16 30 29 161 27 16 30 29 209 0 0 0 0 50 1 3 1 9 55 1 3 1 9 105 28 19 31 38 314 c Abbreviation: OR. and events were categorized into specialties by the research team. These data are for OR procedures and do not include specialties such as invasive radiology.7%).

Figure 5 displays the rate of reports per month for adverse events and close calls for the 3 time periods by location. Other Human Factor Problems Or Schedule Problems Training and Education Other Root Causes Problems With Policy Documentation Staffing Problems Time Pressure 0 5 10 15 20 25 Wrong Patient Wrong Side Wrong Site Wrong Procedure Wrong Implant Other 0 5 10 15 20 OR Non-OR 25 % of Root Causes % of Reported Adverse Events Figure 2.45. This is consistent with the findings of Clarke et al. others found that wrong-lens implants constituted the highest percentage of “surgical confusions” in ophthalmologic cases. at times. patient. Figure 4 displays reported adverse event types and location. Percentage of type of reported adverse events by location.9.5 0.4%]). 45 each (21. waiting until moments before “takeoff” (such as during the final time-out19) may. could help with this problem.2%. be too late to correct the problem.5 1.01) 2 . All rights reserved.81.” and not from the research team.COM (REPRINTED) ARCH SURG/ VOL 144 (NO. Each reported adverse event was assigned to only 1 category.7 At moments before incision. and other factors (poWWW.0 1.21 Preoperative briefings. ordered according to flowchart (Figure 1) categories (n = 212).2%). 11).Communication Problems Time-out Problems Nonstandardization.0 % of Reported Adverse Events Reported OR Adverse Events Reported OR Close Calls Reported Non-OR Reported Non-OR Adverse Events Close Calls Figure 3. This study reviewed 342 surgical events involving the wrong side. The reported adverse events were almost evenly split between those occurring inside and outside the OR (108 and 104. Analysis of variance of the mean actual SAC score for reported events across the 3 time points revealed significant change over time (F.1 Pulmonary medicine cases 2 (such as wrong-side thoracentesis) (␹1 .com/ by oceana mega on 05/10/2013 . and wrong-site cases (such as wrong spinal level) (␹1 4. ophthalmology and invasive radiology had the most reports.ARCHSURG.1%]) and wrong patient (56 [26. or procedure.0 0. For reported adverse events by specialty. Downloaded From: http://archsurg. the team may have already fixed in their mind the surgical procedure to be performed.22 We need to work proactively to prevent incorrect surgical procedures. so events in categories other than “wrong patient” were performed on the correct patient. Reports per Month Abdomen Spine Head/Neck 0 5 10 15 20 25 OR Non-OR Before any directive (before January 2003) VA directive for OR cases only (January to June 2004) VA directive updated to include non-OR cases and Joint Commission Universal Protocol (After June 2004) 2. Most events (65%) were actual SAC 1. OR indicates operating room. When examining solely OR reported adverse events. Wrong implant was the category with the most reported adverse events for ophthalmology and orthopedics (48. implant. OR indicates operating room. P Ͻ. respectively). Figure 3 displays reported adverse events by body segment and location. ophthalmology exhibited the highest percentage of reports followed by orthopedics. P Յ. In a recent study. NOV 2009 1032 ©2009 American Medical Association. including those specifying implant and assuring availability. but the aspect varied.01). and 12% were actual SAC 3. OR indicates operating room. even though these 2 specialties did not have the highest percentage of OR cases. respectively).174.5 2. Briefings are part of the VHA Medical Team Training program. the event was often the unpleasant surprise that the desired-size implant was not available in the OR or elsewhere in the hospital.03) were associated with the most harm. and after the updated directive that included non-OR events and Joint Commission Universal Protocol by location (n = 331). from the VHA Computerized Patient Record System “surgery package. after the Veterans Affairs (VA) directive for events in the operating room (OR). Eye Arm/Hand Leg/Foot Pelvis Thorax Mouth Figure 4. mean SAC scores initially decreased then increased again after the updated directive. This system does not account for events that could have been included in more than 1 category.9% and 46. Rates of reports of actual events and close calls reported per month before any directive. COMMENT Figure 5. General categories of root causes of surgical events (N = 596). 23% were SAC 2. P =. Percentage of reported adverse events by body segment and location (n = 208).jamanetwork. Ophthalmology events typically included a lens mixup. 12. site. such as operating on the wrong side of the wrong patient. for orthopedics. The 2 most commonly reported adverse events were wrong side (66 [31.

REFERENCES 1. However.sitioning. Samples.com/ by oceana mega on 05/10/2013 . Studdert DM. 2. 2006. Turner. We will continue to promote early and effective communication to prevent surgical and invasive adverse events. we examined event types and specialties facing the biggest challenges. patients with poor pulmonary reserve had wrong-sided thorocentesis. Disclaimer: The views expressed in this article do not necessarily represent the views of the Department of Veterans Affairs or of the US government. orthopedics. Dunn. 11). Therefore. MPH.ARCHSURG. and the patient safety manager to report them to the VHA National Center for Patient Safety. and Turner. Wrong-side/wrong-site. Arch Surg.7 We advocate earlier improved communication based on crew resource management principles. Eldridge. In 2 cases. it is difficult to predict when and where these events will occur. Time-out procedures alone have not been enough to prevent incorrect surgical and invasive procedures. Mills. It is important to recognize that surgical adverse events were reported for numerous specialties and in non-OR settings. Kwaan MR. we know that not all incidents are reported.jamanetwork. and Turner. In the VHA. Third. It is also difficult to predict these events because our knowledge of surgical adverse events depends on reporting. Vermont. Dunn. This indicates that events reported in non-OR settings may have been underappreciated in previous studies. Doing the “right” things to correct wrong- (REPRINTED) ARCH SURG/ VOL 144 (NO. Ophthalmology. Downloaded From: http://archsurg. wrong-procedures. Washington.COM ©2009 American Medical Association. Drafting of the manuscript: Neily. Turner. and material support: Neily. patterns. and many facilities incorporate the patient into the preoperative briefing. Most reported events caused minor or no injury. It is clear that incorrect surgical events can occur in virtually any specialty where invasive procedures are performed and that all parts of the anatomy are vulnerable to adverse events. Dunn. pulmonary medicine. and Bagian. others lacked the depth necessary for a detailed analysis. which has not been achieved. and DePalma.5. Turner.7 that the patient and the nurse provide an effective defense against surgical adverse events. CONCLUSIONS Adverse events and close calls related to surgical procedures continue to occur. VT 05009 (julia. White River Junction. Revere. DePalma.22 Through this initial analysis. we were limited by the information contained in the RCAs and safety reports. Financial Disclosure: None reported. Dunn. Eldridge. results are descriptive.141(9):931939. Acquisition of data: Eldridge. based on reported data. Zinner MJ. DePalma. and the Veterans Affairs Medical Center. Eldridge. 3. This is also consistent with the findings of Clarke et al. White River Junction.neily@va. Veterans Health Administration. and Bagian had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Author Contributions: Ms Neily and Drs Mills. reports of adverse events from OR and non-OR settings have been roughly equal. Study concept and design: Neily. we could not describe patient demographic characteristics. Seiden SC. Funding/Support: This material is the result of work supported with resources and the use of facilities at the Department of Veterans Affairs National Center for Patient Safety at Ann Arbor. resulting in acute cardiopulmonary deterioration. Samples. MS. pulmonary medicine cases and wrong-site cases were more likely to be related to harm. Samples. These reports are deliberately deidentified to protect patient and reporter confidentiality. It is also possible that non-OR events were even more likely to be underreported because they may have been less obvious. Critical revision of the manuscript for important intellectual content: Neily. Although there have been more than 400 000 reports of all types of adverse events and close calls to the VHA National Center for Patient Safety. which may not represent the true rate.141(4):353-358. and the Department of Veterans Affairs Central Office.gov). Although some reports were detailed. Gawande AA. Therefore. Administrative. Incidence. The cases described in this study were limited to those reported. 215 N Main St. technical. and DePalma. Michigan. Despite these limitations we believe this analysis of a large. Revere. Dunn. OR schedule) may contribute to health care providers believing they are about to correctly perform the procedure. Analysis and interpretation of data : Neily. Correspondence: Julia Neily. and DePalma. and prevention of wrong-site surgery. and invasive radiology cases (with particular attention to issues involving correct implant and patient verification) represent areas of highest utility for corrective actions. consent. Revere. Pennsylvania Patient Safety Authority. it is difficult to determine whether the differences seen in adverse events by specialty or over time are owing to variability in the degree of reporting by specialty or during different time periods. Dunn. Accepted for Publication: October 15. NOV 2009 1033 WWW. Our data regarding the number of adverse surgical events required those working in the surgical setting to report incidents to the hospital patient safety manager. but we cannot be certain. 2008. 2006. Eldridge. and wrongpatient adverse events: are they preventable? Arch Surg. Mills. DC. We believe that reports that describe the most harmful events more closely approximate the true incidence than those describing less harmful events. and Bagian. The VHA Medical Team Training program22 also promotes this kind of communication. It is also important to note that this study includes reports up to mid2006. Eldridge. therefore. Second. All rights reserved. Statistical analysis: Mills.23 We propose communicating more clearly and earlier when preparing for surgical and invasive procedures. RN. Study supervision: Neily and Bagian. we plan to conduct a follow-up report with recent data that will reflect additional interventions and changes to our system. detailed data set of reports is a reasonable description of the current situation and can provide insights for those inside and outside the VHA who seek to prevent incorrect surgical adverse events. Barach P. We know our data did not encompass all incorrect surgical adverse events in the VHA because that would require 100% reporting of adverse events and close calls.

Accessed January 28. Bagian JP. As the surgical critical care team is wondering the next morn- T ing about the causes of this patient’s abrupt hemodynamic deterioration. et al. Megaputer Intelligence new release. 2008. Simon JW. All rights reserved. individual practitioners. Culture change: prevention. Sentinel event policies and procedures. the infusion pump’s malfunction during midnight transport for computed tomography may never be reported by the nurse and intern who transported the intensive care unit patient.ARCHSURG. 2005. New York Patient Occurrence Reporting and Tracking System report: appendix C. Department of Veterans Affairs National Center for Patient Safety.5: criteria and standards for performance of ambulatory (same day) surgery performed in ambulatory or dedicated surgical suites. 2008. http://vaww1.pdf%20and%2013.gov /surgery/. The Joint Commission.pa.COM ©2009 American Medical Association. (REPRINTED) ARCH SURG/ VOL 144 (NO. although this is merely a hypothesis and not a data-driven conclusion.html. 6. 2008. Neily J. Johnston J. whereas almost no plastic surgery events were reported. et al. Gosbee J. The science of reporting adverse events in the era of legal liability. Downloaded From: http://archsurg. 2001. 10. Finley ED. http://www. diagnostic and treatment centers.us/nysdoh/hospital/nyports/annual_report/2002-2004 /docs/2002-2004_nyports_annual_report. 18. National VA Surgical Quality Improvement Program. Accessed January 27. Clarke JR. PhD. Accessed October 12. 21. not punishment. Mills PD. Office of Health Systems Management. and peer-controlled program for the measurement and enhancement of the quality of surgical care. Division of Primary and Acute Care Services.psa. and Internet-driven public pressure is imperfect. Wrong Person Surgery. 2008. Accessed January 27. 8.gov/vhapublications /ViewPublication. Capturing. MA 02114 (gvelmahos@partners. New York State surgical and invasive procedure protocol for hospitals. the most harmful adverse events (wrong-side thoracentesis by pulmonary medicine and wrong-site operations by different specialists). MSEd Correspondence: Dr Velmahos. George C. outcome-based. Accessed January 27. rely in great part on honesty and personal values for the candid reporting of many adverse events. Wrong Person Surgery.pdf. The Department of Veterans Affairs’ NSQIP: the first national.com. State of New York. Ngo Y. Medical team training: applying crew resource management in the Veterans Health Administration. recording. Department of Health.va. 2008. Arch Ophthalmol.org/SentinelEvents/PolicyandProcedures/se_pp. 2008. http://www. Ensuring correct surgery and invasive procedures. 13.patientsafety. Financial Disclosure: None reported.33(6):317-325.state. http://www. Division of Primary and Acute Care Services. http://www. Accessed January 27. and the most common root cause of the problem (communication). Boston. In this study.DDD11D43E484/0/se_stats_063007.patientsafety.state. INVITED CRITIQUE Patient Safety Systems: A Long Way to Go he initiatives taken by the VHA Medical Centers toward patient safety are many and laudable. Wrong Procedure. Bagian JP. VHA National Patient Safety Improvement Handbook.health.us/psa/lib/psa/advisories/v4n2_june_2007 /jun_2007_v4_n2_article_wrong-site_surgery. www. 11.asp?pub_ID=414.gov/vision. It is possible that honesty is exposed and penalized. Daley J. site surgery. 12. Bagian JP. pay for performance. Crittenden MD. 14. 9.va.pdf. Developing and deploying a patient safety program in a large health care delivery system: you can’t fix what you don’t know about. Surgical confusions in ophthalmology. 2008. ambulatory surgery centers.jointcommission . http://www. no link can be drawn to the issues that complicated his or her transport the night before. we will be relying on human nature to resolve the problem. Ste 810. Qual Saf Health Care.ny. And whether we examine human nature from a theological or teleological point of view. Accessed January 27.html#ECS.org/NR/rdonlyres/D7836542-A372-4F93-8BD7 . 22. We. and analyzing these complications obeys a few rules and standards. 2008. VHA Handbook 1102. 7.htm.org/PatientSafety/UniversalProtocol/up_facts.125(11):1515-1522. 19. Department of Veterans Affairs. Universal Protocol for Preventing Wrong Site. a distinguished group of authors reports on the adverse events and close calls recorded from 2001 to 2006 in the VHA database.27(10):522-532. the most frequently encountered adverse events (wrong eye implant and unavailable orthopedic implant). http://vaww1. 20. Reason J.jamanetwork.gov/Pubs /NCPShb. http://www . 2008. 228(4):491-507. Henderson W. 2007.jointcommission. http://www.4. an attitude of convenient forgetfulness is not. 17. 11). part 2: human error and organisational failure. 2009. Dunn EJ.htm. Khan S. Strogatz D. Department of Veterans Affairs National Center for Patient Safety. 23. Wrong Procedure. Ensuring correct surgery and invasive procedures. Accessed October 12. Facts about the Universal Protocol for Preventing Wrong Site.6. http://www. Until we create standardized systems that will reliably capture all adverse events. For example.org). 22(1):3-16. Accessed January 27. Accessed January 27. NOV 2009 1034 WWW. Jt Comm J Qual Patient Saf. Department of Surgery. The Joint Commission. Sentinal event statistics: as of December 31.patientsafety. 1998.gov/vhapublications/ViewPublication . The authors conclude that earlier communication will prevent surgical adverse events.com/ by oceana mega on 05/10/2013 . http://www1. even more so as it pertains to willingly exposing its own deficiencies. It is hard to imagine that errors never occur in some specialties and routinely happen in others.14(1):56-60. Jt Comm J Qual Improv. validated. PolyAnalyst 4. 15. Massachusetts General Hospital.246(3): 395-405. Ann Surg.ny. The Joint Commission. Carmack AL.asp?pub_ID=1106. Department of Veterans Affairs National Center for Patient Safety.state.jointcommission. US Department of Veterans Affairs Intranet.us /professionals/protocols_and_guidelines/surgical_and_invasive_procedure/docs /protocol. 2008. Surgery.org/NR/rdonlyres /E3C600EB-043B-4E86-B04E-CA4A89AD5433/0/universal_protocol. Office of Health Systems Management. Velmahos. Getting surgery right.megaputer. a quality assurance–attentive chief of ophthalmology may be the main reason for reporting all ophthalmologic complications. The results uncover the most frequently involved departments (ophthalmology and orthopedics). Lee C. therefore.pdf.health. risk-adjusted. Safety in the operating theatre.gov/SafetyTopics .jointcommission. Although there is little doubt that amputating the wrong limb is easily discoverable. http: //www. 16. http: //www. Department of Health. 2007.pdf. we would all agree that it is rather imperfect. The Joint Commission. pages 63-64. 2008. 2008. 2006. Accessed October 12. MD. Patient safety: what is really at issue? Front Health Serv Manage. 2007. Accessed April 29. Department of Veterans Affairs National Center for Patient Safety. Khuri SF. Ann Surg. 2007. 5. 2005. Accessed November 6.doc. 165 Cambridge St. State of New York.va. Accessed January 27.