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Data suggests that nearly half of all adverse events in hospitalised patients are related to surgical care, and significantly, at least half of these may be preventable.1 Implementation of a simple, widely applicable and measureable system that may prevent these critical events has been the focus of a widely publicised campaign by the World Health Organization (WHO).The WHO "Safe Surgery Saves Lives" campaign in 2008 led to the introduction of the WHO Surgical Safety Checklist to operating theatres around the world.2Implementation of this tool has been shown to reduce the mortality and inpatient complications from a baseline of 1.5% and 11%, to 0.8% and 7% respectively.3 In a prospective analysis of elective surgical procedures, the use of a surgical checklist has been shown to detect significant errors or prevent critical events from occurring in 7.7% of all operations.4 Figure 1. Time Out Procedure checklist In New Zealand, District Health Boards reported that, for the 2009/10 year, 374 people treated in their hospitals were involved in a serious or sentinel adverse clinical event that was actually or potentially preventable.5 Adverse medical events are not only devastating for the patients, their families and the health professionals involved but place a significant burden on health expenditure, accounting for 20% (NZ$600 Million) of health spending in New Zealand.5 Recent media reports have highlighted some of the issues around the implementation of the WHO surgical safety checklist in New Zealand, with less than half of New Zealand District Health Boards utilising the WHO Surgical safety checklist.6 Comparatively, in the United Kingdom, the WHO surgical safety checklist has been made mandatory in all National Health Service hospitals despite the various disadvantages and issues related to its successful implementation in the literature. In the WHO pilot study over 90% of clinicians said they would want the checklist to be used if they needed surgery.7 In 2006, Pronovost et al8 successfully implemented a simple checklist for central venous catheter insertion in the intensive care unit, with the aim to ensure evidence-based guidelines were followed to minimise central venous line infections. A preoperative surgical safety checklist, similar in design to Pronovost's checklist, with a specific focus on the preoperative safety was implemented into the three major elective surgery hospitals in Christchurch in 2004. It was called the "Time Out Procedure" (TOP) and was carried out immediately after induction of anaesthesia and prior to preparation and draping of the surgical site (Figure 1). The aim of this study was to prospectively analyse the results of such a checklist by comparing the initial results of implementation of the TOP to the results 4 years later. We wished to compare the discrepancies in the checklist to see whether the accuracy of the documentation, initiation and acceptance of the TOP had improved and to determine whether surgical practice had changed as a result. Methods The TOP was implemented into the three major hospitals performing elective operations in Christchurch (New Zealand) in 2004 and was performed in all surgical specialties. The TOP involved a circulating nurse calling "Time Out", ensuring that all members of the surgical team, including surgeons and their assistants, anaesthetists, anaesthetic technicians and all nursing staff were in attention. Once the attention of all members of the surgical team was ensured, the pertinent patient identification information was then read from the completed surgical consent form, followed by the proposed surgical procedure and site/side of operation. This information was then crosschecked by other members of the surgical team against the patient's identification label, as well as patient clinical documentation, and appropriate surgical site marking was confirmed prior to proceeding with surgical site preparation and draping. The completed TOP sheets were collected by the respective theatre managers, and then collated and analysed on a monthly basis. Any discrepancy from the TOP form was categorised as: System or Process Discrepancy which included non participation of the surgical team or incorrect timing of the TOP. Consent and Limb Marking Discrepancy including incorrect consent, wrong limb/site marked or no marking. Incorrect Patient Details. Critical or Near Miss Events. These discrepancies were collated and analysed. The initial prospective analysis was completed shortly after the implementation of the TOP, from September 2004 until April 2005 (Phase 1). A further prospective study was performed 4 years later from October 2008 until September 2009 (Phase 2). A questionnaire was then designed to examine the consultant surgeons' attitudes towards the TOP. One statement that we felt most likely to be relevant was modified from the Safety Attitudes Questionnaire, which is a validated instrument used to measure attitudes in various safety-related domains in healthcare.9,10 This statement was ‘The Time Out Procedure is a valuable tool in preventing wrong site surgery.' Four more statements were developed to address the utility of the time out procedure, as well as the role of the surgeon and the surgical team in preventing wrong site operation. To maximise response rates, objective questions were answered first, and statements regarding the surgeons' own behaviours were answered last. All responses were marked as ‘agree', ‘not sure', and ‘disagree'. A pilot study was performed on three consultant surgeons, using a convenience sample, from which we did not identify any problems. A total of 53 questionnaires were hand delivered to the respective departmental secretaries of the all surgical specialties in Christchurch Public Hospital. All questionnaires were accompanied by sealable return envelopes to maintain anonymity. We did not record any identifying data. The responses were then collated and analysed. Intervention: During the 4 years, the continuation of the TOP was ensured by the respective operating theatre managers, and all operating theatre nurses, including newly employed staff, received continual training on its implementation. Primary outcome: Changes in the rate of discrepancies between the two study phases, plus surgeons attitudes toward the TOP and its roles after 4 years of experience. Statistical analysis was performed with OpenEpi (v2.3.1) software.11 The level of significance (two-tailed) was set at p<0.05. The Mantel-Haenszel Chi-squared test was utilised to compare Phase 1 to Phase 2. Data collection in both study phases was performed at the same hospitals, and therefore it was assumed that the two data sets came from distributions with similar discrepancies. This study was approved by the Upper South A Regional Ethics Committee of the Ministry of Health. Results There were no wrong site operations during the 8 months (Phase 1) and 12 months (Phase 2) of data collection. The comparison of the total number of operative procedures and completed TOP forms between Phase 1 and Phase 2 is shown in Table 1. Table 1. Comparison of total operations and Time Out Procedures (TOP) between Phase 1 and Phase 2 Time Out Procedure Phase 1 Sept 2004 to April 2005 Phase 2 Oct 2008 to Sept 2009 Total operations 10330 25086 Incomplete TOP 1321 (12.8%) 434 (1.7%) Completed TOP 9009 (87.2%) 24652 (98.2%) Total incidents 695 (7.7%) 2281 (9.3%) There was a significant improvement in completing the TOP forms with 98.2% completed in Phase 2 compared to the earlier Phase 1 (87.2%, p<0.001) but there was a higher rate of total incidents in Phase 2 (9.3% compared to 7.7%, p<0.001). The TOP was not performed in 24 out of 434 Incomplete TOPs in Phase 2. The discrepancies are summarised in Table 2. System and process discrepancy was the major contributor, with Phase 2 having 73.6% errors compared to Phase 1 (29.7%, p<0.001). The great majority of these were due to absence of the surgeon and/or the assistant at the TOP. Consent and limb marking discrepancies had improved in Phase 2 (25% compared to 38%; p<0.001) with some improvement in the accuracy of the consent, however there remained a high incidence of no site marking (7.1%). There was a significant increase in no site/side documentation on the surgical consent or operation list in Phase 2 (4% compared to 1.4%; p<0.001). While site/side variation between the consent form, operating list or patient notes had improved to 3.9% in Phase 2 compared to 11.7% in Phase 1. Accuracy of patient information had improved by Phase 2 (1.4% compared to 4.2%, p<0.001)) however there were still 31 procedures performed where the patient details were incorrect to the point that the patient would not have been able to have a blood transfusion on the preoperative cross-match or group and hold. There were three ‘near misses' in Phase 1 which were captured by the TOP. Two of these involved changes in the order of the list, and subsequently, the wrong patient was present in the operating room. One case involved a surgeon having a different understanding as to what surgical procedure was going to be performed compared to that written on the consent form. There were no ‘near misses' in Phase 2. It was noted that 4 surgeons refused to be involved in the TOP in Phase 1 as they felt they had already checked the site or side, or thought that the TOP was too time consuming. Table 2. Comparison of Time Out Procedure discrepancies between Phase 1 and Phase 2 Time Out Procedure discrepancies Phase 1 Sept 2004 to April 2005 Phase 2 Oct 2008 to Sept 2009 System/Process Discrepancy Surgeon/Assistant Not Present* TOP Post Preparation & Draping 206 (29.7%) 129 (18.6 %) 35 (5%) 1679 (73.6%) 1665 (73%) 14 (0.6%) Consent/Limb Marking Discrepancy Operation Side/Site Not Marked No Site/Side Documentation * Site/Side Variation * Alterations/Additional Procedures* 265 (38%) 75 (10.8%) 10 (1.4%) 81 (11.7%) 44 (6.3%) 571 (25%) 162 (7.1%) 91 (4%) 89 (3.9%) 229 (10%) Incorrect Patient Details* 29 (4.2%) 31 (1.4%) Critical/Near Miss Events* 3 (0.4%) 0 *Indicates where significant difference was found between Phase 1 and Phase 2. Fifty-three questionnaires examining the attitudes of consultant surgeons towards the Time Out Procedure were distributed and 50 completed questionnaires were received with a 94% response rate (Table 3). The majority of the consultant surgeons agreed that wrong site operation was a devastating but preventable complication with only one disagreeing. Most (88%) of the surgeons agreed that the time out procedure is a valuable tool in preventing wrong site operation, while five were ‘not sure' and one disagreed. There was general agreement that all members of the surgical team have a collective responsibility in ‘getting it right', and that surgeon participation in the time out procedure was vital to its success and should be mandatory. Table 3. Time Out Procedures consultant questionnaire results Time Out Procedure questionnaire Agree Not sure Disagree Wrong site operation is a devastating but preventable complication. 98% (49) 0 2% (1) The Time Out Procedure is a valuable tool in preventing wrong site operation. 88% (44) 10% (5) 2% (1) All members of the surgical team have a collective responsibility in ‘getting it right'. 94% (47) 2% (1) 4% (2) Surgeon participation in the Time Out Procedure is vital to its success and should be mandatory. 92% (46) 6% (3) 2% (1) I believe that the Time out procedure is a valuable and integral part of the surgical procedure. 86% (43) 10% (5) \r\n

Summary

Abstract

Aim

A preoperative surgical safety checklist was implemented into three major hospitals performing elective operations in Christchurch (New Zealand) in 2004. A prospective analysis of the results of this cTime Out Procedured (TOP) was performed upon its implementation and 4 years later.

Method

All members of the surgical team who participated in the TOP were recorded, as were the details of any discrepancies encountered during the TOP. The results of the initial prospective analysis from September 2004 until April 2005 (Phase 1, 10330 procedures) were compared to a further prospective study 4 years later from October 2008 until September 2009 (Phase 2, 25086 procedures). Surgeons attitudes towards the TOP were analysed with a questionnaire.

Results

There were no wrong site operations in either phases of the study. Completion of the TOP improved in Phase 2 (98% compared to 87%, p

Conclusion

This study suggests that surgical checklists such as the TOP are a useful tool in identification and prevention of wrong site surgery. Our practice with consent and limb marking has improved over the two study periods. However, there continues to be surgeon resistance to these checklists, and further research will help to identify the reasons and possible solutions to this phenomenon.

Author Information

Alex J-J Lee, House Officer, Department of Orthopaedic Surgery, Christchurch Hospital, Christchurch; Sumit Raniga, Orthopaedic Trainee, Department of Orthopaedic Surgery, Christchurch Hospital, Christchurch; Gary J Hooper, Senior Lecturer, Orthopaedic Surgeon, Department of Orthopaedic Surgery and Musculoskeletal Medicine, University of Otago, Christchurch; Ali Perry, Operating Theatre Manager, St Georges Hospital, Christchurch; Robyn Bisset, Day Surgery Unit Manager, St Georges Hospital, Christchurch; Diane Darley, Nurse Manager, Operating Suite, Burwood Hospital, Christchurch; Carmel Hurley-Watts, Theatre Services Manager, Southern Cross Hospital, Christchurch

Acknowledgements

Correspondence

Dr Alex J-J Lee, Department of Orthopaedic Surgery, Christchurch Hospital, Riccarton Avenue, Private Bag 4710, Christchurch 8011, New Zealand. Fax: +64 (0)3 3640909

Correspondence Email

jaejinl.lee@cdhb.govt.nz

Competing Interests

None known.

The second global patient safety challenge, Safe Surgery Saves Lives WHO 2008. http://www.safesurg.org/materials.htmlImplementation Manual, WHO surgical safety checklist 2009. Available fromhttp://www.who.int/patientsafety/safesurgery/tools_resources/en/index.htmlHaynes A, Weiser T, Berry W, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360(5):491-9Hooper G, Darley D, Patton D, et al. Time out - Avoiding wrong site surgery - an audit of six months experience. J Bone Joint Surgery Br, 2006; 88-b( SUPP II):31.Health Quality & Safety Commission New Zealand, Making our Hospitals Safer: Serious and Sentinel Events 2009/2010www.hqsc.govt.nzLaugesen R. Just checking. The New Zealand Listener 2010 Mar;3643:16-21.Wilson I, Walker I. The WHO Surgical Safety Checklist: the evidence. J Perioper Pract. 2009 Oct;19(10):362-4.Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease cathter-related bloodstream infections in the ICU. N Engl J Med 2006;355(26):27252732.Sexton JB, Helmreich RL, Neilands TB, et al. The Safety Attitudes Questionnaire: psychometric properties, benchmarking data, and emerging research. BMC Health Serv Res 2006;6:44.Makary MA, Sexton JB, Freischlag JA, et al. Operating room teamwork among physicians and nurses: teamwork in the eye of the beholder. J Am Coll Surg 2006;202:746-752.Dean AG, Sullivan KM, Soe MM. OpenEpi: Open Source Epidemiologic Statistics for Public Health, Version 2.3.1.www.OpenEpi.com, updated 2010/19/09.Johnston G, Ekert L, Pally E. Surgical Site Signing and Time Out: Issues of Compliance or Complacence. J Bone Joint Surg (Am) 2009;91:2577-80.de Vries EN, Prins HA, Crolla RM, et al. Effect of a comprehensive surgical safety system on patient outcomes. N Engl J Med 2010;363:1928-1937.Haynes AB, Weiser TG, Berry WR, et al. Changes in safety attitude and relationship to decreased postoperative morbidity and mortality following implementation of a checklist-based surgical safety intervention. BMJ Qual Saf 2011;20:102-107.Khoshbin A, Lingard L, Wright JG. Evaluation of preoperative and perioperative operating room briefings at the Hospital for Sick Children. Can J Surg 2009;52(4):309-315.Lingard L, Regehr G, Orser B, et al. Evaluation of a preoperative checklist and team briefing among surgeons, nurses, and anaesthesiologists to reduce failures in communication. Arch Surg 2008;143(1):1217.Amalberti R, Auroy Y, Berwick D, et al. Five system barriers to achieving ultrasafe health care. Ann Intern Med 2005;142(9):756-764.DeFontes J, Surbida S. Preoperative safety briefing project. (accessed 26 May 2012);The Permanente Journal 2004;8:21-27.http://www.thepermanentejournal.org/files/PDF/Spring2004.pdf#page=23Awad SS, Fagan SP, Bellows C, et al. Bridging the communication gap in the operating room with medical team training. Am J Surg 2005;190(5):770-774.

For the PDF of this article,
contact nzmj@nzma.org.nz

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Data suggests that nearly half of all adverse events in hospitalised patients are related to surgical care, and significantly, at least half of these may be preventable.1 Implementation of a simple, widely applicable and measureable system that may prevent these critical events has been the focus of a widely publicised campaign by the World Health Organization (WHO).The WHO "Safe Surgery Saves Lives" campaign in 2008 led to the introduction of the WHO Surgical Safety Checklist to operating theatres around the world.2Implementation of this tool has been shown to reduce the mortality and inpatient complications from a baseline of 1.5% and 11%, to 0.8% and 7% respectively.3 In a prospective analysis of elective surgical procedures, the use of a surgical checklist has been shown to detect significant errors or prevent critical events from occurring in 7.7% of all operations.4 Figure 1. Time Out Procedure checklist In New Zealand, District Health Boards reported that, for the 2009/10 year, 374 people treated in their hospitals were involved in a serious or sentinel adverse clinical event that was actually or potentially preventable.5 Adverse medical events are not only devastating for the patients, their families and the health professionals involved but place a significant burden on health expenditure, accounting for 20% (NZ$600 Million) of health spending in New Zealand.5 Recent media reports have highlighted some of the issues around the implementation of the WHO surgical safety checklist in New Zealand, with less than half of New Zealand District Health Boards utilising the WHO Surgical safety checklist.6 Comparatively, in the United Kingdom, the WHO surgical safety checklist has been made mandatory in all National Health Service hospitals despite the various disadvantages and issues related to its successful implementation in the literature. In the WHO pilot study over 90% of clinicians said they would want the checklist to be used if they needed surgery.7 In 2006, Pronovost et al8 successfully implemented a simple checklist for central venous catheter insertion in the intensive care unit, with the aim to ensure evidence-based guidelines were followed to minimise central venous line infections. A preoperative surgical safety checklist, similar in design to Pronovost's checklist, with a specific focus on the preoperative safety was implemented into the three major elective surgery hospitals in Christchurch in 2004. It was called the "Time Out Procedure" (TOP) and was carried out immediately after induction of anaesthesia and prior to preparation and draping of the surgical site (Figure 1). The aim of this study was to prospectively analyse the results of such a checklist by comparing the initial results of implementation of the TOP to the results 4 years later. We wished to compare the discrepancies in the checklist to see whether the accuracy of the documentation, initiation and acceptance of the TOP had improved and to determine whether surgical practice had changed as a result. Methods The TOP was implemented into the three major hospitals performing elective operations in Christchurch (New Zealand) in 2004 and was performed in all surgical specialties. The TOP involved a circulating nurse calling "Time Out", ensuring that all members of the surgical team, including surgeons and their assistants, anaesthetists, anaesthetic technicians and all nursing staff were in attention. Once the attention of all members of the surgical team was ensured, the pertinent patient identification information was then read from the completed surgical consent form, followed by the proposed surgical procedure and site/side of operation. This information was then crosschecked by other members of the surgical team against the patient's identification label, as well as patient clinical documentation, and appropriate surgical site marking was confirmed prior to proceeding with surgical site preparation and draping. The completed TOP sheets were collected by the respective theatre managers, and then collated and analysed on a monthly basis. Any discrepancy from the TOP form was categorised as: System or Process Discrepancy which included non participation of the surgical team or incorrect timing of the TOP. Consent and Limb Marking Discrepancy including incorrect consent, wrong limb/site marked or no marking. Incorrect Patient Details. Critical or Near Miss Events. These discrepancies were collated and analysed. The initial prospective analysis was completed shortly after the implementation of the TOP, from September 2004 until April 2005 (Phase 1). A further prospective study was performed 4 years later from October 2008 until September 2009 (Phase 2). A questionnaire was then designed to examine the consultant surgeons' attitudes towards the TOP. One statement that we felt most likely to be relevant was modified from the Safety Attitudes Questionnaire, which is a validated instrument used to measure attitudes in various safety-related domains in healthcare.9,10 This statement was ‘The Time Out Procedure is a valuable tool in preventing wrong site surgery.' Four more statements were developed to address the utility of the time out procedure, as well as the role of the surgeon and the surgical team in preventing wrong site operation. To maximise response rates, objective questions were answered first, and statements regarding the surgeons' own behaviours were answered last. All responses were marked as ‘agree', ‘not sure', and ‘disagree'. A pilot study was performed on three consultant surgeons, using a convenience sample, from which we did not identify any problems. A total of 53 questionnaires were hand delivered to the respective departmental secretaries of the all surgical specialties in Christchurch Public Hospital. All questionnaires were accompanied by sealable return envelopes to maintain anonymity. We did not record any identifying data. The responses were then collated and analysed. Intervention: During the 4 years, the continuation of the TOP was ensured by the respective operating theatre managers, and all operating theatre nurses, including newly employed staff, received continual training on its implementation. Primary outcome: Changes in the rate of discrepancies between the two study phases, plus surgeons attitudes toward the TOP and its roles after 4 years of experience. Statistical analysis was performed with OpenEpi (v2.3.1) software.11 The level of significance (two-tailed) was set at p<0.05. The Mantel-Haenszel Chi-squared test was utilised to compare Phase 1 to Phase 2. Data collection in both study phases was performed at the same hospitals, and therefore it was assumed that the two data sets came from distributions with similar discrepancies. This study was approved by the Upper South A Regional Ethics Committee of the Ministry of Health. Results There were no wrong site operations during the 8 months (Phase 1) and 12 months (Phase 2) of data collection. The comparison of the total number of operative procedures and completed TOP forms between Phase 1 and Phase 2 is shown in Table 1. Table 1. Comparison of total operations and Time Out Procedures (TOP) between Phase 1 and Phase 2 Time Out Procedure Phase 1 Sept 2004 to April 2005 Phase 2 Oct 2008 to Sept 2009 Total operations 10330 25086 Incomplete TOP 1321 (12.8%) 434 (1.7%) Completed TOP 9009 (87.2%) 24652 (98.2%) Total incidents 695 (7.7%) 2281 (9.3%) There was a significant improvement in completing the TOP forms with 98.2% completed in Phase 2 compared to the earlier Phase 1 (87.2%, p<0.001) but there was a higher rate of total incidents in Phase 2 (9.3% compared to 7.7%, p<0.001). The TOP was not performed in 24 out of 434 Incomplete TOPs in Phase 2. The discrepancies are summarised in Table 2. System and process discrepancy was the major contributor, with Phase 2 having 73.6% errors compared to Phase 1 (29.7%, p<0.001). The great majority of these were due to absence of the surgeon and/or the assistant at the TOP. Consent and limb marking discrepancies had improved in Phase 2 (25% compared to 38%; p<0.001) with some improvement in the accuracy of the consent, however there remained a high incidence of no site marking (7.1%). There was a significant increase in no site/side documentation on the surgical consent or operation list in Phase 2 (4% compared to 1.4%; p<0.001). While site/side variation between the consent form, operating list or patient notes had improved to 3.9% in Phase 2 compared to 11.7% in Phase 1. Accuracy of patient information had improved by Phase 2 (1.4% compared to 4.2%, p<0.001)) however there were still 31 procedures performed where the patient details were incorrect to the point that the patient would not have been able to have a blood transfusion on the preoperative cross-match or group and hold. There were three ‘near misses' in Phase 1 which were captured by the TOP. Two of these involved changes in the order of the list, and subsequently, the wrong patient was present in the operating room. One case involved a surgeon having a different understanding as to what surgical procedure was going to be performed compared to that written on the consent form. There were no ‘near misses' in Phase 2. It was noted that 4 surgeons refused to be involved in the TOP in Phase 1 as they felt they had already checked the site or side, or thought that the TOP was too time consuming. Table 2. Comparison of Time Out Procedure discrepancies between Phase 1 and Phase 2 Time Out Procedure discrepancies Phase 1 Sept 2004 to April 2005 Phase 2 Oct 2008 to Sept 2009 System/Process Discrepancy Surgeon/Assistant Not Present* TOP Post Preparation & Draping 206 (29.7%) 129 (18.6 %) 35 (5%) 1679 (73.6%) 1665 (73%) 14 (0.6%) Consent/Limb Marking Discrepancy Operation Side/Site Not Marked No Site/Side Documentation * Site/Side Variation * Alterations/Additional Procedures* 265 (38%) 75 (10.8%) 10 (1.4%) 81 (11.7%) 44 (6.3%) 571 (25%) 162 (7.1%) 91 (4%) 89 (3.9%) 229 (10%) Incorrect Patient Details* 29 (4.2%) 31 (1.4%) Critical/Near Miss Events* 3 (0.4%) 0 *Indicates where significant difference was found between Phase 1 and Phase 2. Fifty-three questionnaires examining the attitudes of consultant surgeons towards the Time Out Procedure were distributed and 50 completed questionnaires were received with a 94% response rate (Table 3). The majority of the consultant surgeons agreed that wrong site operation was a devastating but preventable complication with only one disagreeing. Most (88%) of the surgeons agreed that the time out procedure is a valuable tool in preventing wrong site operation, while five were ‘not sure' and one disagreed. There was general agreement that all members of the surgical team have a collective responsibility in ‘getting it right', and that surgeon participation in the time out procedure was vital to its success and should be mandatory. Table 3. Time Out Procedures consultant questionnaire results Time Out Procedure questionnaire Agree Not sure Disagree Wrong site operation is a devastating but preventable complication. 98% (49) 0 2% (1) The Time Out Procedure is a valuable tool in preventing wrong site operation. 88% (44) 10% (5) 2% (1) All members of the surgical team have a collective responsibility in ‘getting it right'. 94% (47) 2% (1) 4% (2) Surgeon participation in the Time Out Procedure is vital to its success and should be mandatory. 92% (46) 6% (3) 2% (1) I believe that the Time out procedure is a valuable and integral part of the surgical procedure. 86% (43) 10% (5) \r\n

Summary

Abstract

Aim

A preoperative surgical safety checklist was implemented into three major hospitals performing elective operations in Christchurch (New Zealand) in 2004. A prospective analysis of the results of this cTime Out Procedured (TOP) was performed upon its implementation and 4 years later.

Method

All members of the surgical team who participated in the TOP were recorded, as were the details of any discrepancies encountered during the TOP. The results of the initial prospective analysis from September 2004 until April 2005 (Phase 1, 10330 procedures) were compared to a further prospective study 4 years later from October 2008 until September 2009 (Phase 2, 25086 procedures). Surgeons attitudes towards the TOP were analysed with a questionnaire.

Results

There were no wrong site operations in either phases of the study. Completion of the TOP improved in Phase 2 (98% compared to 87%, p

Conclusion

This study suggests that surgical checklists such as the TOP are a useful tool in identification and prevention of wrong site surgery. Our practice with consent and limb marking has improved over the two study periods. However, there continues to be surgeon resistance to these checklists, and further research will help to identify the reasons and possible solutions to this phenomenon.

Author Information

Alex J-J Lee, House Officer, Department of Orthopaedic Surgery, Christchurch Hospital, Christchurch; Sumit Raniga, Orthopaedic Trainee, Department of Orthopaedic Surgery, Christchurch Hospital, Christchurch; Gary J Hooper, Senior Lecturer, Orthopaedic Surgeon, Department of Orthopaedic Surgery and Musculoskeletal Medicine, University of Otago, Christchurch; Ali Perry, Operating Theatre Manager, St Georges Hospital, Christchurch; Robyn Bisset, Day Surgery Unit Manager, St Georges Hospital, Christchurch; Diane Darley, Nurse Manager, Operating Suite, Burwood Hospital, Christchurch; Carmel Hurley-Watts, Theatre Services Manager, Southern Cross Hospital, Christchurch

Acknowledgements

Correspondence

Dr Alex J-J Lee, Department of Orthopaedic Surgery, Christchurch Hospital, Riccarton Avenue, Private Bag 4710, Christchurch 8011, New Zealand. Fax: +64 (0)3 3640909

Correspondence Email

jaejinl.lee@cdhb.govt.nz

Competing Interests

None known.

The second global patient safety challenge, Safe Surgery Saves Lives WHO 2008. http://www.safesurg.org/materials.htmlImplementation Manual, WHO surgical safety checklist 2009. Available fromhttp://www.who.int/patientsafety/safesurgery/tools_resources/en/index.htmlHaynes A, Weiser T, Berry W, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360(5):491-9Hooper G, Darley D, Patton D, et al. Time out - Avoiding wrong site surgery - an audit of six months experience. J Bone Joint Surgery Br, 2006; 88-b( SUPP II):31.Health Quality & Safety Commission New Zealand, Making our Hospitals Safer: Serious and Sentinel Events 2009/2010www.hqsc.govt.nzLaugesen R. Just checking. The New Zealand Listener 2010 Mar;3643:16-21.Wilson I, Walker I. The WHO Surgical Safety Checklist: the evidence. J Perioper Pract. 2009 Oct;19(10):362-4.Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease cathter-related bloodstream infections in the ICU. N Engl J Med 2006;355(26):27252732.Sexton JB, Helmreich RL, Neilands TB, et al. The Safety Attitudes Questionnaire: psychometric properties, benchmarking data, and emerging research. BMC Health Serv Res 2006;6:44.Makary MA, Sexton JB, Freischlag JA, et al. Operating room teamwork among physicians and nurses: teamwork in the eye of the beholder. J Am Coll Surg 2006;202:746-752.Dean AG, Sullivan KM, Soe MM. OpenEpi: Open Source Epidemiologic Statistics for Public Health, Version 2.3.1.www.OpenEpi.com, updated 2010/19/09.Johnston G, Ekert L, Pally E. Surgical Site Signing and Time Out: Issues of Compliance or Complacence. J Bone Joint Surg (Am) 2009;91:2577-80.de Vries EN, Prins HA, Crolla RM, et al. Effect of a comprehensive surgical safety system on patient outcomes. N Engl J Med 2010;363:1928-1937.Haynes AB, Weiser TG, Berry WR, et al. Changes in safety attitude and relationship to decreased postoperative morbidity and mortality following implementation of a checklist-based surgical safety intervention. BMJ Qual Saf 2011;20:102-107.Khoshbin A, Lingard L, Wright JG. Evaluation of preoperative and perioperative operating room briefings at the Hospital for Sick Children. Can J Surg 2009;52(4):309-315.Lingard L, Regehr G, Orser B, et al. Evaluation of a preoperative checklist and team briefing among surgeons, nurses, and anaesthesiologists to reduce failures in communication. Arch Surg 2008;143(1):1217.Amalberti R, Auroy Y, Berwick D, et al. Five system barriers to achieving ultrasafe health care. Ann Intern Med 2005;142(9):756-764.DeFontes J, Surbida S. Preoperative safety briefing project. (accessed 26 May 2012);The Permanente Journal 2004;8:21-27.http://www.thepermanentejournal.org/files/PDF/Spring2004.pdf#page=23Awad SS, Fagan SP, Bellows C, et al. Bridging the communication gap in the operating room with medical team training. Am J Surg 2005;190(5):770-774.

For the PDF of this article,
contact nzmj@nzma.org.nz

View Article PDF

Data suggests that nearly half of all adverse events in hospitalised patients are related to surgical care, and significantly, at least half of these may be preventable.1 Implementation of a simple, widely applicable and measureable system that may prevent these critical events has been the focus of a widely publicised campaign by the World Health Organization (WHO).The WHO "Safe Surgery Saves Lives" campaign in 2008 led to the introduction of the WHO Surgical Safety Checklist to operating theatres around the world.2Implementation of this tool has been shown to reduce the mortality and inpatient complications from a baseline of 1.5% and 11%, to 0.8% and 7% respectively.3 In a prospective analysis of elective surgical procedures, the use of a surgical checklist has been shown to detect significant errors or prevent critical events from occurring in 7.7% of all operations.4 Figure 1. Time Out Procedure checklist In New Zealand, District Health Boards reported that, for the 2009/10 year, 374 people treated in their hospitals were involved in a serious or sentinel adverse clinical event that was actually or potentially preventable.5 Adverse medical events are not only devastating for the patients, their families and the health professionals involved but place a significant burden on health expenditure, accounting for 20% (NZ$600 Million) of health spending in New Zealand.5 Recent media reports have highlighted some of the issues around the implementation of the WHO surgical safety checklist in New Zealand, with less than half of New Zealand District Health Boards utilising the WHO Surgical safety checklist.6 Comparatively, in the United Kingdom, the WHO surgical safety checklist has been made mandatory in all National Health Service hospitals despite the various disadvantages and issues related to its successful implementation in the literature. In the WHO pilot study over 90% of clinicians said they would want the checklist to be used if they needed surgery.7 In 2006, Pronovost et al8 successfully implemented a simple checklist for central venous catheter insertion in the intensive care unit, with the aim to ensure evidence-based guidelines were followed to minimise central venous line infections. A preoperative surgical safety checklist, similar in design to Pronovost's checklist, with a specific focus on the preoperative safety was implemented into the three major elective surgery hospitals in Christchurch in 2004. It was called the "Time Out Procedure" (TOP) and was carried out immediately after induction of anaesthesia and prior to preparation and draping of the surgical site (Figure 1). The aim of this study was to prospectively analyse the results of such a checklist by comparing the initial results of implementation of the TOP to the results 4 years later. We wished to compare the discrepancies in the checklist to see whether the accuracy of the documentation, initiation and acceptance of the TOP had improved and to determine whether surgical practice had changed as a result. Methods The TOP was implemented into the three major hospitals performing elective operations in Christchurch (New Zealand) in 2004 and was performed in all surgical specialties. The TOP involved a circulating nurse calling "Time Out", ensuring that all members of the surgical team, including surgeons and their assistants, anaesthetists, anaesthetic technicians and all nursing staff were in attention. Once the attention of all members of the surgical team was ensured, the pertinent patient identification information was then read from the completed surgical consent form, followed by the proposed surgical procedure and site/side of operation. This information was then crosschecked by other members of the surgical team against the patient's identification label, as well as patient clinical documentation, and appropriate surgical site marking was confirmed prior to proceeding with surgical site preparation and draping. The completed TOP sheets were collected by the respective theatre managers, and then collated and analysed on a monthly basis. Any discrepancy from the TOP form was categorised as: System or Process Discrepancy which included non participation of the surgical team or incorrect timing of the TOP. Consent and Limb Marking Discrepancy including incorrect consent, wrong limb/site marked or no marking. Incorrect Patient Details. Critical or Near Miss Events. These discrepancies were collated and analysed. The initial prospective analysis was completed shortly after the implementation of the TOP, from September 2004 until April 2005 (Phase 1). A further prospective study was performed 4 years later from October 2008 until September 2009 (Phase 2). A questionnaire was then designed to examine the consultant surgeons' attitudes towards the TOP. One statement that we felt most likely to be relevant was modified from the Safety Attitudes Questionnaire, which is a validated instrument used to measure attitudes in various safety-related domains in healthcare.9,10 This statement was ‘The Time Out Procedure is a valuable tool in preventing wrong site surgery.' Four more statements were developed to address the utility of the time out procedure, as well as the role of the surgeon and the surgical team in preventing wrong site operation. To maximise response rates, objective questions were answered first, and statements regarding the surgeons' own behaviours were answered last. All responses were marked as ‘agree', ‘not sure', and ‘disagree'. A pilot study was performed on three consultant surgeons, using a convenience sample, from which we did not identify any problems. A total of 53 questionnaires were hand delivered to the respective departmental secretaries of the all surgical specialties in Christchurch Public Hospital. All questionnaires were accompanied by sealable return envelopes to maintain anonymity. We did not record any identifying data. The responses were then collated and analysed. Intervention: During the 4 years, the continuation of the TOP was ensured by the respective operating theatre managers, and all operating theatre nurses, including newly employed staff, received continual training on its implementation. Primary outcome: Changes in the rate of discrepancies between the two study phases, plus surgeons attitudes toward the TOP and its roles after 4 years of experience. Statistical analysis was performed with OpenEpi (v2.3.1) software.11 The level of significance (two-tailed) was set at p<0.05. The Mantel-Haenszel Chi-squared test was utilised to compare Phase 1 to Phase 2. Data collection in both study phases was performed at the same hospitals, and therefore it was assumed that the two data sets came from distributions with similar discrepancies. This study was approved by the Upper South A Regional Ethics Committee of the Ministry of Health. Results There were no wrong site operations during the 8 months (Phase 1) and 12 months (Phase 2) of data collection. The comparison of the total number of operative procedures and completed TOP forms between Phase 1 and Phase 2 is shown in Table 1. Table 1. Comparison of total operations and Time Out Procedures (TOP) between Phase 1 and Phase 2 Time Out Procedure Phase 1 Sept 2004 to April 2005 Phase 2 Oct 2008 to Sept 2009 Total operations 10330 25086 Incomplete TOP 1321 (12.8%) 434 (1.7%) Completed TOP 9009 (87.2%) 24652 (98.2%) Total incidents 695 (7.7%) 2281 (9.3%) There was a significant improvement in completing the TOP forms with 98.2% completed in Phase 2 compared to the earlier Phase 1 (87.2%, p<0.001) but there was a higher rate of total incidents in Phase 2 (9.3% compared to 7.7%, p<0.001). The TOP was not performed in 24 out of 434 Incomplete TOPs in Phase 2. The discrepancies are summarised in Table 2. System and process discrepancy was the major contributor, with Phase 2 having 73.6% errors compared to Phase 1 (29.7%, p<0.001). The great majority of these were due to absence of the surgeon and/or the assistant at the TOP. Consent and limb marking discrepancies had improved in Phase 2 (25% compared to 38%; p<0.001) with some improvement in the accuracy of the consent, however there remained a high incidence of no site marking (7.1%). There was a significant increase in no site/side documentation on the surgical consent or operation list in Phase 2 (4% compared to 1.4%; p<0.001). While site/side variation between the consent form, operating list or patient notes had improved to 3.9% in Phase 2 compared to 11.7% in Phase 1. Accuracy of patient information had improved by Phase 2 (1.4% compared to 4.2%, p<0.001)) however there were still 31 procedures performed where the patient details were incorrect to the point that the patient would not have been able to have a blood transfusion on the preoperative cross-match or group and hold. There were three ‘near misses' in Phase 1 which were captured by the TOP. Two of these involved changes in the order of the list, and subsequently, the wrong patient was present in the operating room. One case involved a surgeon having a different understanding as to what surgical procedure was going to be performed compared to that written on the consent form. There were no ‘near misses' in Phase 2. It was noted that 4 surgeons refused to be involved in the TOP in Phase 1 as they felt they had already checked the site or side, or thought that the TOP was too time consuming. Table 2. Comparison of Time Out Procedure discrepancies between Phase 1 and Phase 2 Time Out Procedure discrepancies Phase 1 Sept 2004 to April 2005 Phase 2 Oct 2008 to Sept 2009 System/Process Discrepancy Surgeon/Assistant Not Present* TOP Post Preparation & Draping 206 (29.7%) 129 (18.6 %) 35 (5%) 1679 (73.6%) 1665 (73%) 14 (0.6%) Consent/Limb Marking Discrepancy Operation Side/Site Not Marked No Site/Side Documentation * Site/Side Variation * Alterations/Additional Procedures* 265 (38%) 75 (10.8%) 10 (1.4%) 81 (11.7%) 44 (6.3%) 571 (25%) 162 (7.1%) 91 (4%) 89 (3.9%) 229 (10%) Incorrect Patient Details* 29 (4.2%) 31 (1.4%) Critical/Near Miss Events* 3 (0.4%) 0 *Indicates where significant difference was found between Phase 1 and Phase 2. Fifty-three questionnaires examining the attitudes of consultant surgeons towards the Time Out Procedure were distributed and 50 completed questionnaires were received with a 94% response rate (Table 3). The majority of the consultant surgeons agreed that wrong site operation was a devastating but preventable complication with only one disagreeing. Most (88%) of the surgeons agreed that the time out procedure is a valuable tool in preventing wrong site operation, while five were ‘not sure' and one disagreed. There was general agreement that all members of the surgical team have a collective responsibility in ‘getting it right', and that surgeon participation in the time out procedure was vital to its success and should be mandatory. Table 3. Time Out Procedures consultant questionnaire results Time Out Procedure questionnaire Agree Not sure Disagree Wrong site operation is a devastating but preventable complication. 98% (49) 0 2% (1) The Time Out Procedure is a valuable tool in preventing wrong site operation. 88% (44) 10% (5) 2% (1) All members of the surgical team have a collective responsibility in ‘getting it right'. 94% (47) 2% (1) 4% (2) Surgeon participation in the Time Out Procedure is vital to its success and should be mandatory. 92% (46) 6% (3) 2% (1) I believe that the Time out procedure is a valuable and integral part of the surgical procedure. 86% (43) 10% (5) \r\n

Summary

Abstract

Aim

A preoperative surgical safety checklist was implemented into three major hospitals performing elective operations in Christchurch (New Zealand) in 2004. A prospective analysis of the results of this cTime Out Procedured (TOP) was performed upon its implementation and 4 years later.

Method

All members of the surgical team who participated in the TOP were recorded, as were the details of any discrepancies encountered during the TOP. The results of the initial prospective analysis from September 2004 until April 2005 (Phase 1, 10330 procedures) were compared to a further prospective study 4 years later from October 2008 until September 2009 (Phase 2, 25086 procedures). Surgeons attitudes towards the TOP were analysed with a questionnaire.

Results

There were no wrong site operations in either phases of the study. Completion of the TOP improved in Phase 2 (98% compared to 87%, p

Conclusion

This study suggests that surgical checklists such as the TOP are a useful tool in identification and prevention of wrong site surgery. Our practice with consent and limb marking has improved over the two study periods. However, there continues to be surgeon resistance to these checklists, and further research will help to identify the reasons and possible solutions to this phenomenon.

Author Information

Alex J-J Lee, House Officer, Department of Orthopaedic Surgery, Christchurch Hospital, Christchurch; Sumit Raniga, Orthopaedic Trainee, Department of Orthopaedic Surgery, Christchurch Hospital, Christchurch; Gary J Hooper, Senior Lecturer, Orthopaedic Surgeon, Department of Orthopaedic Surgery and Musculoskeletal Medicine, University of Otago, Christchurch; Ali Perry, Operating Theatre Manager, St Georges Hospital, Christchurch; Robyn Bisset, Day Surgery Unit Manager, St Georges Hospital, Christchurch; Diane Darley, Nurse Manager, Operating Suite, Burwood Hospital, Christchurch; Carmel Hurley-Watts, Theatre Services Manager, Southern Cross Hospital, Christchurch

Acknowledgements

Correspondence

Dr Alex J-J Lee, Department of Orthopaedic Surgery, Christchurch Hospital, Riccarton Avenue, Private Bag 4710, Christchurch 8011, New Zealand. Fax: +64 (0)3 3640909

Correspondence Email

jaejinl.lee@cdhb.govt.nz

Competing Interests

None known.

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