- Email: [email protected]
Patient Safety in Taiwan: A Survey on Orthopedic Surgeons
ORIGINAL ARTICLE
Patient Safety in Taiwan: A Survey on Orthopedic Surgeons Cheng-Ta Yang,1 Hsin-Hsin Chen,2 Sheng-Mou Hou3* Background/Purpose: Patient safety is an important issue in medical quality control. To our knowledge, no studies have been conducted to specifically address patient safety in surgery in Taiwan. The purposes of this study were to determine the incidence of surgical errors in Taiwan, to evaluate the effectiveness of a campaign to mark the planned operation site, and the factors that influence the frequency of this preoperative safety maneuver. Methods: In March 2004, each member of the Taiwan Orthopaedic Association was given a 12-question survey regarding wrong-site, wrong-patient, and wrong-procedure errors to provide baseline data. We then implemented a campaign to encourage orthopedic surgeons to mark the planned operation site (“Mark op site” campaign). A follow-up survey was done in October 2004, and the results of both surveys were compared. Results: On the second survey, the number of surgeons who marked the incision site had significantly increased (p < 0.05), and the incidences of reported wrong-site (0.5%) and wrong-procedure errors (2.4%) were lower than on the first survey (4.8%, p < 0.05 and 5.6%, p < 0.05). On the second survey, preoperative marking of the incision site was significantly correlated with the location of the surgeon’s practice. Conclusion: Orthopedic surgeons marked the incision sites more frequently after our campaign than before, suggesting that the campaign was effective in changing their behavior. In Taiwan, this campaign reduced the risk of wrong-site and wrong-procedure errors. [J Formos Med Assoc 2007;106(3):212–216] Key Words: orthopedics, patient safety, surgery, survey
surgeries.3 In 1997, the American Academy of Orthopaedic Surgeons (AAOS) initiated the Sign Your Site campaign.4 Since the institution of that campaign, most orthopedic surgeons in the United States now routinely take some action to prevent surgical errors. To our knowledge, no studies have been conducted to specifically address patient safety in terms of surgical errors—including wrong-site, wrong-patient, and wrong-procedure errors—in Taiwan. Moreover, the medical community in Taiwan has not had an organized effort to prevent surgical errors in the past. In 2004, we initiated
Patient safety is an important issue in managing the quality of healthcare worldwide in the 21st century. For example, in the United States, an estimated 98,000 patients die from medical errors each year, and the annual cost approaches $9 billion.1 This mortality number exceeds the number of deaths from poisonings, suicides, falls, drownings, and motor vehicle and airplane accidents.2 Among all kinds of medical errors, wrong-site surgery is preventable. In order to prevent wrong-site surgery, the Canadian Orthopaedic Association (COA) developed a successful educational program in 1994 to reduce the incidence of wrong-site
©2007 Elsevier & Formosan Medical Association .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1
Graduate of School of Medicine, National Taiwan University, 2Center for Health Policy Research and Development, National Health Research Institutes, and 3Department of Orthopedic Surgery, National Taiwan University Hospital, Taipei, Taiwan.
Received: March 13, 2006 Revised: August 22, 2006 Accepted: September 5, 2006
212
*Correspondence to: Dr Sheng-Mou Hou, Department of Orthopedic Surgery, National Taiwan University Hospital, 7 Chung Shan South Road, Taipei 100, Taiwan. E-mail: [email protected]
J Formos Med Assoc | 2007 • Vol 106 • No 3
Patient safety in surgery
a campaign—called “Mark op site”—and conducted two surveys, one before the campaign and one after it. The purpose of our study was to determine the incidence of surgical errors in Taiwan, and to evaluate the effectiveness of this campaign. We also investigated the behavior of surgeons in undertaking these preoperative safety procedures.
Methods In March 2004, a total of 1260 surgeons of the Taiwan Orthopaedic Association (TOA) were given a 12-question survey consisting of two sections (Table 1). We ensured that all the responses were kept confidential and anonymous. The first section asked about wrong-site, wrong-patient, and wrong-procedure surgeries that the surgeons or their colleagues had performed in the past year. If the respondent reported an error, we asked them when it had happened. In our analysis, we defined a variable called surgical error, which was the summed incidence of all wrong-site, wrongpatient, and wrong-procedure surgeries. The second section asked for the member’s demographic data, including sex, age, years in practice, status as a specialist and specialty, surgical load, operative assistants, and location of practice (medical center or community hospital). Regarding the location of practice, medical centers referred to hospitals with more than 500 beds, with research and teaching capabilities, whereas community hospitals referred to hospitals with 100–500 beds. After this survey was done, we implemented the “Mark op site” campaign by holding conventions for orthopedic surgeons. The content of conventions included issues on international trends in patient safety, occurrences of medical errors, preventive procedures to avoid medical errors, and experiences in promoting patient safety. We cooperated with the Taiwan Joint Commission on Hospital Accreditation to recognize the surgeons’ marking of the operation site before surgery as an important issue in patient safety. J Formos Med Assoc | 2007 • Vol 106 • No 3
Table 1. Questions designed for our first (pretest) and second (posttest) surveys: question and answer items Have you ever signed patient’s op site before surgery? Always (100%) Often (70–99%) Sometimes (30–69%) Seldom (under 29%) Never (0%) Why didn’t you sign patient’s op site before surgery? I had confidence not to do wrong surgery I think other medical assistant will remind I think that patient will identify actively No reason Other reasons No answer Last half year, have you ever had wrong-site surgery? No Yes When did that happen? Before surgery During surgery After surgery Last half year, have you ever had wrong-patient surgery? No Yes When did that happen? Before surgery During surgery After surgery Last half year, have you ever had wrong-procedure surgery? No Yes When did that happen? Before surgery During surgery After surgery
We suggested to the Department of Health that they include the rate of marking an operation site into hospital accreditation in the nearest future. Therefore, we initiated an educational program for orthopedic surgeons and hospital authorities 213
C.T. Yang, et al
Table 2. Frequency at which surgeons marked operation sites preoperatively* Marking frequency
Survey 1 (n = 375)
Survey 2 (n = 411)
Always Usually Sometimes Seldom Never
75 (20) 63 (17) 80 (21) 86 (23) 71 (19)
160 (39) 124 (30) 62 (15) 49 (12) 16 (4)
*Data are presented as n (%).
to promote patient safety. Each member of the TOA had to attend at least one course on patient safety for continuing medical education credit. In October 2004, we repeated our original survey and compared the results of the first and second surveys. A total of 1326 TOA surgeons were given the second survey. The increased number was attributed to new TOA members. All information was collected into a database (SPSS version 10.0 for Windows; SPSS Inc., Chicago, IL, USA). We used independent-sample t test and a general linear model to analyze the collected data. Findings were considered significant when the p value was < 0.05.
Results A total of 383 surgeons responded to the first survey, for a response rate of 30.4% (383 of 1260 TOA members), and 411 surgeons responded to the second survey, for a response rate of 31.0% (411 of 1326 TOA members). The frequency with which surgeons had marked the incision site before surgery is shown in Table 2. On the first survey, 75 of the respondents (20%) reported that they always marked the incision site before surgery. On the second survey, 160 surgeons (39%) reported that they did. The second survey indicated a significant improvement; that is, 69% (284/411) of surgeons always or usually marked the operation site in contrast to only 37% (138/375) in the first survey (Table 2). On the first survey, 4.8% of all surgeons reported performing wrong-site surgery at least once 214
Table 3. Reported surgical errors* Type of error
Survey 1
Survey 2
p
Wrong site Wrong patient Wrong procedure
18 (4.8) 1 (0.3) 21 (5.6)
2 (0.5) 3 (0.7) 10 (2.4)
0.000 0.361 0.013
*Data are presented as n (%).
Table 4. Frequency of marking the incision site by location of practice Surgeons (n)
Frequency of marking (%)*
Medical center† Community hospital Clinic
192 181 24
79 ± 29 69 ± 33 68 ± 39
Total
397
74 ± 32
Location
*Data are presented as mean ± standard deviation; †post hoc test. p < 0.05 vs. community hospital.
in the past year, 0.3% reported performing wrongpatient surgery at least once, and 5.6% reported performing wrong-procedure surgery at least once. On the second survey, the respective rates were 0.5%, 0.7%, and 2.4% (Table 3). The proportion of wrong-site (p < 0.05) and wrong-procedure (p < 0.05) errors was lower on the second survey than on the first. On the second survey, the frequency of marking the incision site preoperatively was significantly correlated with the location of the surgeons’ practice (Table 4). Surgeons in medical centers were significantly more likely to mark the incision site than those in community hospitals (p < 0.05). We found no significant correlation between the frequency of marking the incision site preoperatively and the surgeon’s sex, age, years in practice, status as a specialist, specialty, operative assistants, or surgical load. The frequency of marking the incision site and whether the surgeon had wrong-site, wrong-patient, or wrong-procedure errors was not significantly correlated. We found no significant correlation between surgical errors and other demographic data, including sex, age, years in practice, location of practice, specialty, surgical load, and operative assistants. J Formos Med Assoc | 2007 • Vol 106 • No 3
Patient safety in surgery
Discussion In 1999, the Institute of Medicine (IOM) published a report that alerted the public to the problem of adverse events during patient treatment.1 Newspaper headlines reported that at least 44,000 and possibly as high as 98,000 patients die each year in the United States as a result of medical errors.1 However, the IOM report was not universally accepted. Several critics debated its measurement of injurious errors, arguing that the IOM overestimated the number of deaths attributable to medical errors.5,6 The astonishing mortality rate caused by medical errors were based on only two studies: the Harvard Medical Practice Study (HMPS)7 and the Utah and Colorado Medical Practice Study.8 They also criticized the method by which the medical errors were determined. The lead author of the HMPS warned, “the reliability of identifying errors is methodologically suspected.”5 Likewise, McDonald et al6 argued that the IOM authors failed to distinguish excess mortality attributable to medical errors from deaths resulting from the patients’ underlying illnesses and the natural course of their diseases. Regardless of these arguments about the IOM report, orthopedic surgeons soon noticed that medical errors, especially wrong-site surgeries, are legitimate patient safety issues. Data about wrongsite surgeries were first documented in 1988 by the Medical Defence Union in the United Kingdom and in 1993 by the Canadian Medical Protective Association. Dr Wright proposed a program called “Operate Through Your Initials” to prevent wrong-site errors. The COA has adopted the program, which has been used throughout Canada since 1994. In the United States, the AAOS organized a task force to investigate wrong-site surgery in 1997. The purpose of the task force was to determine whether wrong-site surgery was a major problem and, if it was, to find solutions. After its investigation, the AAOS task force recommended the “Sign Your Site” plan9 as a way to reduce the number of wrong-site surgeries. The major principles of the COA and AAOS programs are similar, and thus orthopedic surgeons J Formos Med Assoc | 2007 • Vol 106 • No 3
throughout North America have been encouraged to prevent wrong-site surgery since 1997. The Sentinel Event Alert issued by the US Joint Commission on Accreditation of Healthcare Organization (JCAHO) reported 150 cases of wrong-site, wrong-patient, or wrong-procedure surgeries in December 2001.10 About 41% of these procedures were related to orthopedic or pediatric surgery. Risk factors included unusual physical characteristics of the patient, emergency cases, time pressure, multiple surgeons, and multiple procedures performed on the same patient. In our first survey done in March 2004, the average frequency of marking the incision site preoperatively was 48.4% of responding surgeons. After we started our Mark op site campaign, the second survey done in October 2004 showed that the average frequency of marking the incision site was 73.9%. More than two-thirds of all orthopedic surgeons in Taiwan now always or usually mark the operation site; this rate suggests that this campaign was effective in changing surgeons’ practice habits. However, the ideal condition should be that every surgeon marks the operation site before surgery. In our campaign, soft requests in addition to educational programs were implemented without mandatory regulation. We expect to raise the rate of marking by including this safety procedure into absolute requirements of hospital accreditation. Marking the incision site preoperatively could lower the risk of wrong-site surgery, but whether the risk of wrong-patient and wrong-procedure surgery decreases is unclear. According to our results, the proportion of surgeons who reported wrong-site and wrong-procedure surgeries was lower on the second survey than on the first, but the proportions of surgeons reporting wrongpatient surgery did not differ significantly. The low incidence of errors in patient identification may explain this finding. In Canada, the overall trend in wrong-site orthopedic procedures has been declining since 1993.11 The decrease is possibly due to the educational campaign introduced by the COA in 1994. In Taiwan, the Mark op site campaign 215
C.T. Yang, et al
also decreased the risk of wrong-site and wrongprocedure surgeries. On our second survey, the frequency of marking the incision site preoperatively was significantly correlated with the location of the surgeons’ practice (Table 3). Surgeons in medical centers were more likely to mark the incision site preoperatively than those in community hospitals. Our data agree with those from the Canadian experience. That is, surgeons in a teaching center are more likely to sign the surgical site than surgeons in nonacademic centers.11 A possible explanation may be that, in Taiwan, medical centers have more resources for education on patient safety than other hospitals. We recommend to surgeons that they mark the operation site by signing their initials on the skin themselves. This procedure is much better finished 1 day before surgery. Through the interaction, we can enhance the doctor-patient relationship and may possibly reduce medicolegal disputes. The JCAHO suggests developing processes to ensure the correct surgical site, patient, and procedure, including the following: marking the surgical site and involving the patient in the marking process; creating and using a verification checklist of appropriate documents, e.g. medical records and radiographs or other imaging studies; obtaining oral verification of the patient, surgical site, and procedure in the operating room from each member of the surgical team; and monitoring compliance with these procedures. In addition, the JCAHO recommends that surgical teams consider taking time in the operating room to verify the correct patient, procedure, and site by using active—and not passive—communication techniques.10 Through our campaign, two-thirds of surgeons almost always mark the operation site before surgery. Yet, to approach a 100% marking rate in the near future, more vigorous procedures, such as legislation, may be required.
216
Acknowledgments We appreciate the support by grants from both the Department of Health, Executive Yuan and National Health Research Institutes.
References 1. Kohn LT, Corrigan JM, Donaldson MS, et al. To Err Is Human: Building A Safer Health System. Washington, DC: Institute of Medicine, 2000. 2. Baker SP, O’Neill B, Ginsburg MJ, et al. The Injury Fact Book, 2nd edition. New York: Oxford University, 1992. 3. Canadian Orthopaedic Association Committee on Practice and Economics. Position Paper on Wrong Sided Surgery in Orthopaedics. Winnipeg, Manitoba: Canadian Orthopaedic Association, 1994. 4. Meinberg EG, Stern PJ. Incidence of wrong-site surgery among hand surgeons. J Bone Joint Surg Am 2003;85:193–7. 5. Brennan TA. The Institute of Medicine report on medical errors: could it do harm? N Engl J Med 2000;342:123–5. 6. McDonald CJ, Weiner M, Hui SL. Deaths due to medical errors are exaggerated in the Institute of Medicine report. JAMA 2000;284:93–5. 7. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370–6. 8. Thomas EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care 2000;38:261–71. 9. Canale ST, DeLee J, Edmonson A, et al. American Academy of Orthopaedic Surgeons Report of the Task Force on Wrong-Site Surgery—1998. Available at: www.aaos.org/ wordhtml/meded/tasksite.htm. 10. Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert. Issue 24. 2001. 11. Furey A, Stone C, Martin R. Preoperative signing of the incision site in orthopaedic surgery in Canada. J Bone Joint Surg Am 2002;84:1066–8. 12. Weingart SN, McL Wilson R, Gibberd RW, et al. Epidemiology of medical error. West J Med 2000;172: 390–3. 13. Windsor JA, Pong J. Laparoscopic biliary injury: more than a learning curve problem. ANZ J Surg 1998;68:186–9.
J Formos Med Assoc | 2007 • Vol 106 • No 3
Patient Safety in Taiwan: A Survey on Orthopedic Surgeons Cheng-Ta Yang,1 Hsin-Hsin Chen,2 Sheng-Mou Hou3* Background/Purpose: Patient safety is an important issue in medical quality control. To our knowledge, no studies have been conducted to specifically address patient safety in surgery in Taiwan. The purposes of this study were to determine the incidence of surgical errors in Taiwan, to evaluate the effectiveness of a campaign to mark the planned operation site, and the factors that influence the frequency of this preoperative safety maneuver. Methods: In March 2004, each member of the Taiwan Orthopaedic Association was given a 12-question survey regarding wrong-site, wrong-patient, and wrong-procedure errors to provide baseline data. We then implemented a campaign to encourage orthopedic surgeons to mark the planned operation site (“Mark op site” campaign). A follow-up survey was done in October 2004, and the results of both surveys were compared. Results: On the second survey, the number of surgeons who marked the incision site had significantly increased (p < 0.05), and the incidences of reported wrong-site (0.5%) and wrong-procedure errors (2.4%) were lower than on the first survey (4.8%, p < 0.05 and 5.6%, p < 0.05). On the second survey, preoperative marking of the incision site was significantly correlated with the location of the surgeon’s practice. Conclusion: Orthopedic surgeons marked the incision sites more frequently after our campaign than before, suggesting that the campaign was effective in changing their behavior. In Taiwan, this campaign reduced the risk of wrong-site and wrong-procedure errors. [J Formos Med Assoc 2007;106(3):212–216] Key Words: orthopedics, patient safety, surgery, survey
surgeries.3 In 1997, the American Academy of Orthopaedic Surgeons (AAOS) initiated the Sign Your Site campaign.4 Since the institution of that campaign, most orthopedic surgeons in the United States now routinely take some action to prevent surgical errors. To our knowledge, no studies have been conducted to specifically address patient safety in terms of surgical errors—including wrong-site, wrong-patient, and wrong-procedure errors—in Taiwan. Moreover, the medical community in Taiwan has not had an organized effort to prevent surgical errors in the past. In 2004, we initiated
Patient safety is an important issue in managing the quality of healthcare worldwide in the 21st century. For example, in the United States, an estimated 98,000 patients die from medical errors each year, and the annual cost approaches $9 billion.1 This mortality number exceeds the number of deaths from poisonings, suicides, falls, drownings, and motor vehicle and airplane accidents.2 Among all kinds of medical errors, wrong-site surgery is preventable. In order to prevent wrong-site surgery, the Canadian Orthopaedic Association (COA) developed a successful educational program in 1994 to reduce the incidence of wrong-site
©2007 Elsevier & Formosan Medical Association .
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
1
Graduate of School of Medicine, National Taiwan University, 2Center for Health Policy Research and Development, National Health Research Institutes, and 3Department of Orthopedic Surgery, National Taiwan University Hospital, Taipei, Taiwan.
Received: March 13, 2006 Revised: August 22, 2006 Accepted: September 5, 2006
212
*Correspondence to: Dr Sheng-Mou Hou, Department of Orthopedic Surgery, National Taiwan University Hospital, 7 Chung Shan South Road, Taipei 100, Taiwan. E-mail: [email protected]
J Formos Med Assoc | 2007 • Vol 106 • No 3
Patient safety in surgery
a campaign—called “Mark op site”—and conducted two surveys, one before the campaign and one after it. The purpose of our study was to determine the incidence of surgical errors in Taiwan, and to evaluate the effectiveness of this campaign. We also investigated the behavior of surgeons in undertaking these preoperative safety procedures.
Methods In March 2004, a total of 1260 surgeons of the Taiwan Orthopaedic Association (TOA) were given a 12-question survey consisting of two sections (Table 1). We ensured that all the responses were kept confidential and anonymous. The first section asked about wrong-site, wrong-patient, and wrong-procedure surgeries that the surgeons or their colleagues had performed in the past year. If the respondent reported an error, we asked them when it had happened. In our analysis, we defined a variable called surgical error, which was the summed incidence of all wrong-site, wrongpatient, and wrong-procedure surgeries. The second section asked for the member’s demographic data, including sex, age, years in practice, status as a specialist and specialty, surgical load, operative assistants, and location of practice (medical center or community hospital). Regarding the location of practice, medical centers referred to hospitals with more than 500 beds, with research and teaching capabilities, whereas community hospitals referred to hospitals with 100–500 beds. After this survey was done, we implemented the “Mark op site” campaign by holding conventions for orthopedic surgeons. The content of conventions included issues on international trends in patient safety, occurrences of medical errors, preventive procedures to avoid medical errors, and experiences in promoting patient safety. We cooperated with the Taiwan Joint Commission on Hospital Accreditation to recognize the surgeons’ marking of the operation site before surgery as an important issue in patient safety. J Formos Med Assoc | 2007 • Vol 106 • No 3
Table 1. Questions designed for our first (pretest) and second (posttest) surveys: question and answer items Have you ever signed patient’s op site before surgery? Always (100%) Often (70–99%) Sometimes (30–69%) Seldom (under 29%) Never (0%) Why didn’t you sign patient’s op site before surgery? I had confidence not to do wrong surgery I think other medical assistant will remind I think that patient will identify actively No reason Other reasons No answer Last half year, have you ever had wrong-site surgery? No Yes When did that happen? Before surgery During surgery After surgery Last half year, have you ever had wrong-patient surgery? No Yes When did that happen? Before surgery During surgery After surgery Last half year, have you ever had wrong-procedure surgery? No Yes When did that happen? Before surgery During surgery After surgery
We suggested to the Department of Health that they include the rate of marking an operation site into hospital accreditation in the nearest future. Therefore, we initiated an educational program for orthopedic surgeons and hospital authorities 213
C.T. Yang, et al
Table 2. Frequency at which surgeons marked operation sites preoperatively* Marking frequency
Survey 1 (n = 375)
Survey 2 (n = 411)
Always Usually Sometimes Seldom Never
75 (20) 63 (17) 80 (21) 86 (23) 71 (19)
160 (39) 124 (30) 62 (15) 49 (12) 16 (4)
*Data are presented as n (%).
to promote patient safety. Each member of the TOA had to attend at least one course on patient safety for continuing medical education credit. In October 2004, we repeated our original survey and compared the results of the first and second surveys. A total of 1326 TOA surgeons were given the second survey. The increased number was attributed to new TOA members. All information was collected into a database (SPSS version 10.0 for Windows; SPSS Inc., Chicago, IL, USA). We used independent-sample t test and a general linear model to analyze the collected data. Findings were considered significant when the p value was < 0.05.
Results A total of 383 surgeons responded to the first survey, for a response rate of 30.4% (383 of 1260 TOA members), and 411 surgeons responded to the second survey, for a response rate of 31.0% (411 of 1326 TOA members). The frequency with which surgeons had marked the incision site before surgery is shown in Table 2. On the first survey, 75 of the respondents (20%) reported that they always marked the incision site before surgery. On the second survey, 160 surgeons (39%) reported that they did. The second survey indicated a significant improvement; that is, 69% (284/411) of surgeons always or usually marked the operation site in contrast to only 37% (138/375) in the first survey (Table 2). On the first survey, 4.8% of all surgeons reported performing wrong-site surgery at least once 214
Table 3. Reported surgical errors* Type of error
Survey 1
Survey 2
p
Wrong site Wrong patient Wrong procedure
18 (4.8) 1 (0.3) 21 (5.6)
2 (0.5) 3 (0.7) 10 (2.4)
0.000 0.361 0.013
*Data are presented as n (%).
Table 4. Frequency of marking the incision site by location of practice Surgeons (n)
Frequency of marking (%)*
Medical center† Community hospital Clinic
192 181 24
79 ± 29 69 ± 33 68 ± 39
Total
397
74 ± 32
Location
*Data are presented as mean ± standard deviation; †post hoc test. p < 0.05 vs. community hospital.
in the past year, 0.3% reported performing wrongpatient surgery at least once, and 5.6% reported performing wrong-procedure surgery at least once. On the second survey, the respective rates were 0.5%, 0.7%, and 2.4% (Table 3). The proportion of wrong-site (p < 0.05) and wrong-procedure (p < 0.05) errors was lower on the second survey than on the first. On the second survey, the frequency of marking the incision site preoperatively was significantly correlated with the location of the surgeons’ practice (Table 4). Surgeons in medical centers were significantly more likely to mark the incision site than those in community hospitals (p < 0.05). We found no significant correlation between the frequency of marking the incision site preoperatively and the surgeon’s sex, age, years in practice, status as a specialist, specialty, operative assistants, or surgical load. The frequency of marking the incision site and whether the surgeon had wrong-site, wrong-patient, or wrong-procedure errors was not significantly correlated. We found no significant correlation between surgical errors and other demographic data, including sex, age, years in practice, location of practice, specialty, surgical load, and operative assistants. J Formos Med Assoc | 2007 • Vol 106 • No 3
Patient safety in surgery
Discussion In 1999, the Institute of Medicine (IOM) published a report that alerted the public to the problem of adverse events during patient treatment.1 Newspaper headlines reported that at least 44,000 and possibly as high as 98,000 patients die each year in the United States as a result of medical errors.1 However, the IOM report was not universally accepted. Several critics debated its measurement of injurious errors, arguing that the IOM overestimated the number of deaths attributable to medical errors.5,6 The astonishing mortality rate caused by medical errors were based on only two studies: the Harvard Medical Practice Study (HMPS)7 and the Utah and Colorado Medical Practice Study.8 They also criticized the method by which the medical errors were determined. The lead author of the HMPS warned, “the reliability of identifying errors is methodologically suspected.”5 Likewise, McDonald et al6 argued that the IOM authors failed to distinguish excess mortality attributable to medical errors from deaths resulting from the patients’ underlying illnesses and the natural course of their diseases. Regardless of these arguments about the IOM report, orthopedic surgeons soon noticed that medical errors, especially wrong-site surgeries, are legitimate patient safety issues. Data about wrongsite surgeries were first documented in 1988 by the Medical Defence Union in the United Kingdom and in 1993 by the Canadian Medical Protective Association. Dr Wright proposed a program called “Operate Through Your Initials” to prevent wrong-site errors. The COA has adopted the program, which has been used throughout Canada since 1994. In the United States, the AAOS organized a task force to investigate wrong-site surgery in 1997. The purpose of the task force was to determine whether wrong-site surgery was a major problem and, if it was, to find solutions. After its investigation, the AAOS task force recommended the “Sign Your Site” plan9 as a way to reduce the number of wrong-site surgeries. The major principles of the COA and AAOS programs are similar, and thus orthopedic surgeons J Formos Med Assoc | 2007 • Vol 106 • No 3
throughout North America have been encouraged to prevent wrong-site surgery since 1997. The Sentinel Event Alert issued by the US Joint Commission on Accreditation of Healthcare Organization (JCAHO) reported 150 cases of wrong-site, wrong-patient, or wrong-procedure surgeries in December 2001.10 About 41% of these procedures were related to orthopedic or pediatric surgery. Risk factors included unusual physical characteristics of the patient, emergency cases, time pressure, multiple surgeons, and multiple procedures performed on the same patient. In our first survey done in March 2004, the average frequency of marking the incision site preoperatively was 48.4% of responding surgeons. After we started our Mark op site campaign, the second survey done in October 2004 showed that the average frequency of marking the incision site was 73.9%. More than two-thirds of all orthopedic surgeons in Taiwan now always or usually mark the operation site; this rate suggests that this campaign was effective in changing surgeons’ practice habits. However, the ideal condition should be that every surgeon marks the operation site before surgery. In our campaign, soft requests in addition to educational programs were implemented without mandatory regulation. We expect to raise the rate of marking by including this safety procedure into absolute requirements of hospital accreditation. Marking the incision site preoperatively could lower the risk of wrong-site surgery, but whether the risk of wrong-patient and wrong-procedure surgery decreases is unclear. According to our results, the proportion of surgeons who reported wrong-site and wrong-procedure surgeries was lower on the second survey than on the first, but the proportions of surgeons reporting wrongpatient surgery did not differ significantly. The low incidence of errors in patient identification may explain this finding. In Canada, the overall trend in wrong-site orthopedic procedures has been declining since 1993.11 The decrease is possibly due to the educational campaign introduced by the COA in 1994. In Taiwan, the Mark op site campaign 215
C.T. Yang, et al
also decreased the risk of wrong-site and wrongprocedure surgeries. On our second survey, the frequency of marking the incision site preoperatively was significantly correlated with the location of the surgeons’ practice (Table 3). Surgeons in medical centers were more likely to mark the incision site preoperatively than those in community hospitals. Our data agree with those from the Canadian experience. That is, surgeons in a teaching center are more likely to sign the surgical site than surgeons in nonacademic centers.11 A possible explanation may be that, in Taiwan, medical centers have more resources for education on patient safety than other hospitals. We recommend to surgeons that they mark the operation site by signing their initials on the skin themselves. This procedure is much better finished 1 day before surgery. Through the interaction, we can enhance the doctor-patient relationship and may possibly reduce medicolegal disputes. The JCAHO suggests developing processes to ensure the correct surgical site, patient, and procedure, including the following: marking the surgical site and involving the patient in the marking process; creating and using a verification checklist of appropriate documents, e.g. medical records and radiographs or other imaging studies; obtaining oral verification of the patient, surgical site, and procedure in the operating room from each member of the surgical team; and monitoring compliance with these procedures. In addition, the JCAHO recommends that surgical teams consider taking time in the operating room to verify the correct patient, procedure, and site by using active—and not passive—communication techniques.10 Through our campaign, two-thirds of surgeons almost always mark the operation site before surgery. Yet, to approach a 100% marking rate in the near future, more vigorous procedures, such as legislation, may be required.
216
Acknowledgments We appreciate the support by grants from both the Department of Health, Executive Yuan and National Health Research Institutes.
References 1. Kohn LT, Corrigan JM, Donaldson MS, et al. To Err Is Human: Building A Safer Health System. Washington, DC: Institute of Medicine, 2000. 2. Baker SP, O’Neill B, Ginsburg MJ, et al. The Injury Fact Book, 2nd edition. New York: Oxford University, 1992. 3. Canadian Orthopaedic Association Committee on Practice and Economics. Position Paper on Wrong Sided Surgery in Orthopaedics. Winnipeg, Manitoba: Canadian Orthopaedic Association, 1994. 4. Meinberg EG, Stern PJ. Incidence of wrong-site surgery among hand surgeons. J Bone Joint Surg Am 2003;85:193–7. 5. Brennan TA. The Institute of Medicine report on medical errors: could it do harm? N Engl J Med 2000;342:123–5. 6. McDonald CJ, Weiner M, Hui SL. Deaths due to medical errors are exaggerated in the Institute of Medicine report. JAMA 2000;284:93–5. 7. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370–6. 8. Thomas EJ, Studdert DM, Burstin HR, et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care 2000;38:261–71. 9. Canale ST, DeLee J, Edmonson A, et al. American Academy of Orthopaedic Surgeons Report of the Task Force on Wrong-Site Surgery—1998. Available at: www.aaos.org/ wordhtml/meded/tasksite.htm. 10. Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert. Issue 24. 2001. 11. Furey A, Stone C, Martin R. Preoperative signing of the incision site in orthopaedic surgery in Canada. J Bone Joint Surg Am 2002;84:1066–8. 12. Weingart SN, McL Wilson R, Gibberd RW, et al. Epidemiology of medical error. West J Med 2000;172: 390–3. 13. Windsor JA, Pong J. Laparoscopic biliary injury: more than a learning curve problem. ANZ J Surg 1998;68:186–9.
J Formos Med Assoc | 2007 • Vol 106 • No 3