Composition and Risk Assessment of Perioperative Patient Safety Incidents Reported by Anesthesiologists from 2009 to 2019, a single-center retrospective cohort study

Composition and Risk Assessment of Perioperative Patient Safety Incidents Reported by Anesthesiologists from 2009 to 2019, a single-center retrospective cohort study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research article Composition and Risk Assessment of Perioperative Patient Safety Incidents Reported by Anesthesiologists from 2009 to 2019, a single-center retrospective cohort study Xue Zhang, Shuang Ma, Xueqin Sun, Yuelun Zhang, Weiyun Chen, Qing Chang, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-86731/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 07 Jan, 2021 Read the published version in BMC Anesthesiology → Version 1 posted 13 You are reading this latest preprint version Abstract Background : Patient safety incident reporting has been an important means of improving patient safety and enhancing organizational quality control. Reports of anesthesia-related incidents are of great value for analysis to improve perioperative patient safety. However, the utilization of incident data is far from sufficient, especially in developing countries such as China. Methods : All patient safety incidents reported by anesthesiologists in a Chinese academic hospital between September 2009 and August 2019 were collected from the incident reporting system. We reviewed the freeform text reports, supplemented them with information from the patient medical record system. Composition analysis and risk assessment were performed. Results : In total, 847 patient safety incidents were voluntarily reported by anesthesiologists during the study period among 452,974 anesthetic procedures, with a reported incidence of 0.17%, much less than the incidence reported by some developed countries. Patients with worse ASA physical status were more vulnerable to suffering from PSIs. The most common type of incident was related to the airway (N=208, 27%), followed by cardio-cerebrovascular (N=99, 13%) and pharmacological incidents (N=79, 10%). Those preventable incidents with extreme or high risk were found out through risk assessment, to provide reference for the department to implement more standard operation procedures. Conclusions : This study describes characteristics of 847 patient safety incidents voluntarily reported by anesthesiologists within eleven years in a Chinese academic hospital. Airway incidents constitute the majority of incidents reported by anesthesiologists. Under-reporting is severe in China, and the importance of summarizing and utilizing anesthesia incident data should be scrutinized. Anesthesiology & Pain Medicine Anesthesia Incident reporting system Patient safety Risk assessment Figures Figure 1 Background According to the World Health Organization (WHO) international classification for patient safety, a patient safety incident (PSI) is an event or circumstance that could have resulted, or did result, in unnecessary harm to a patient [ 1 ]. PSI reporting has been an important means of improving patient safety and enhancing organizational quality control. Many developed countries, such as the United States of America, Australia, the United Kingdom and Germany, already have national PSI reporting systems for prospective collection of PSI data even since 1993 [ 2 – 6 ]. These systems similarly encourage the blame-free submission of incident reports, with the aim of finding such defects before causing harm [ 3 ]. By understanding the theory more thoroughly and thanks to the development of new technologies, anesthesia has become safer in recent decades. However, the quality of anesthesiologists' work could be challenged by the increasing number of old and sick patients, more complicated surgical procedures, new drugs and new equipment, increasing pressure and professional burnout. The Declaration of Helsinki as amended in June 2010 emphasized that all institutions providing anesthesia care to patients must contribute to the recognized national or other major audits of safe practice and to critical incident reporting systems [ 7 ]. In a 2019 European survey, 78.7% of responders stated that their hospital used a critical incident reporting system [ 8 ]. In the United Kingdom, a specialty-specific incident reporting system for anesthesia was introduced in 2010 [ 9 ]. However, few studies have characterized incidents from anesthesia practice, and none of these have been from developing countries. As far as we know, nation-wide incident reporting systems are not well established and managed in most developing countries, including China. It has become a huge waste of clinical information because timely identification of errors makes pre-emptive efforts for clinical change and improvement possible. As the top hospital in China, Peking Union Medical College (PUMC) Hospital established a PSI reporting system in 2009. Hereby, we analysed all patient safety incidents reported by anesthesiologists in PUMC Hospital in an eleven-year period to share information with other anesthesiologists to better improve patient safety in perioperative care. Methods Data Collection An incident reporting system was established in 2009 in PUMC Hospital. All healthcare workers are authorized to log in the system and report patient safety incidents either anonymously or not. The incidents were described in freeform text to provide information on patient circumstances, details of the incident, perceived contributing factors, hidden danger, and suggestions for prevention. The database was examined for all incidents reported by anesthesiologists from September 2009 to August 2019 with the approval of the Peking Union Medical College Hospital Institutional Review Board (S-K1107, 25 March 2020). Data were also collected from the patients’ records, including anesthesia records, to supplement the information in the incident reports. Data Cleaning The incidents were reviewed by professional reviewers for reclassification. We have eight reviewers from the department of anesthesiology to clean the data into Excel table form. All members of the research group signed confidentiality agreements before receiving the data. To ensure validity and reliability throughout the study, two independent reviewers reviewed the same part of the data separately, and all the members received uniform training about the data extraction. The two reviewers met to discuss discrepancies until they reach an agreement. When discrepancies could not be resolved by discussion between the two reviewers, the problem was discussed at a weekly meeting of the whole research group under the direction of the senior investigators. The process of data cleaning included two parts. The first part was incident classification and detail collection. We collected patient sex, date, time and place of incident occurrence, type of surgery, and phase of anesthesia when the incident occurred for further group analysis. Incidents were classified into seven types: airway incidents, cardio-cerebrovascular incidents, pharmacological incidents, equipment incidents, spinal or regional anesthesia incidents, incidents related to surgery and other incidents. For each type of incident, more detailed information was collected. The second part of data cleaning was risk assessment. Risk assessment was performed based on the estimated risk of recurrence and estimated consequences for the patient. Then, the incident is automatically classified into four risk categories: extremely high, high, medium and low risk (Table 1 ) [ 11 ]. The reviewers also classified subjectively whether the incidents were preventable, unpreventable or undecided. Table 1 Risk assessment matrix. Consequences/ risk of recurrence Almost inevitable Probable Possible Small Very small Catastrophe Extremely high Extremely high Extremely high Extremely high Extremely high Very serious High High High High High Serious High High High Medium Medium Marginally serious High High Medium Medium Low None Medium Medium Medium Low Low Statistical Analysis Data were stored in a relational structure using Microsoft Office Excel 2016 (Microsoft Corp. 2016). SPSS (IBM SPSS statistics Version 26) was used for statistical analysis of the dataset. We described the demographic and basic clinical characteristics of the patients involved in the safety incidents. The “percentage of patients with incidents” for different ASA categories was calculated by the number of patients with reported incidents divided by the total number of patients with the same ASA grade, and the risk ratio with the 95% confidence interval (CI) was estimated using the ASA I as the reference group. A two-sided P value less than 0.05 was regarded as statistically significant. Results Of the 847 patient safety incidents voluntarily reported by anesthesiologists from September 2009 to August 2019, 74 cases were excluded because they were reported repetitively or not related with anesthesia. In total, 773 cases were enrolled among 452,974 anesthesia care episodes, with an overall PSI reporting incidence of 0.17%. Case number of different types of incidents are shown in Fig. 1 . The average age of the 773 patients involved in the incidents was 51.79 ± 31.91 (mean ± SD), and the median age was 54. Regarding ASA physical status, patients with worse physical status were more vulnerable to suffering from PSIs (Table 2 ). Other details related to patients and the reported incidents are shown in table 3. Table 2 ASA physical status of patients with reported incidents. ASA No. of patients with incidents No. of patients without incidents % of patient with incidents Risk ratio (95% CI) I 78 105467 0.074 1.00 II 253 118620 0.213 2.88 (2.24 to 3.72)* III 89 14332 0.617 8.40 (6.19 to 11.39)* IV 37 981 3.635 51.00 (34.31 to 75.80)* V 5 78 6.024 86.68 (34.16 to 219.91)* *p < 0.05. CI: confidence interval. ASA: American Society of Anesthesiologists. Since the ASA data of patients without incidents were available only after 2013 due to technological issues (the electronic anesthesia record system in PUMC Hospital was established in 2013, so the ASA status of patients without incidents reported could only be collected after 2013), only data from 2013 to 2019 were used for analysis related to ASA status related analysis. Table 2 Demographic variables and other details on the reported incidents. Item (N = 773) Detail Number of incidents (%) Patient sex Male 315 (40.8) Female 357 (46.2) NA 101 (13.1) Date of occurrence Weekday 692 (89.5) Weekend 22 (2.8) NA 59 (7.6) Time of occurrence Working hours (8:00am-4:00 pm) 445 (57.6) Nonworking hours (4:01 pm-7:59am) 312 (40.3) NA 16 (2.1) Place of occurrence In the OR (including PACU) 649 (84.0) Out of the OR 93 (12.0) NA 31 (4.0) Type of surgery Elective surgery 620 (80.2) Emergency surgery 110 (14.2) Labor analgesia 4 (0.5) NA 39 (5.0) Phase of anesthesia Pre-induction 62 (8.0) when incident Induction 77 (10.0) occurred Maintenance 247 (32.0) Emergence 73 (9.4) Recovery in PACU 31 (4.0) Post-operative period 77 (10.0) During spinal or regional anesthesia procedure 45 (5.8) NA 161 (20.8) OR: operating room. PACU: post-anesthesia care unit. The total number of incidents with available information in each part is not equal to 773 because some of the data was incomplete or missing. Airway Incidents Twenty-seven percent (208 of 773) of PSIs were airway-related incidents. Sixty-five (31.3%) occurred during intubation, 41 (19.7%) occurred during anesthesia maintenance, 73 (35.1%) occurred during extubation, and 28 (13.5%) incidents were reported after the patient returned to the ward. There was also one patient (0.5%) who had airway obstruction in the OR before anesthesia induction. The most common airway incident categories were bronchospasm or laryngospasm (N = 32), post-intubation hoarseness (N = 28), dental injury (N = 20), intubation failure (N = 17), intubation delay caused by difficult airway (N = 15), airway obstruction (N = 14), and aspiration (N = 10). Ninety-six (46.15%) of the patients suffered from airway-related hypoxemia, comprising 34 mild cases (with minimal SpO 2 ≥ 85% for less than 5 min) and 62 severe cases (with minimal SpO 2 < 85% or hypoxemia for more than 5 min). Nine patients had bradycardia, and 3 patients even had cardiac arrest caused by hypoxemia. We also noticed that 61 patients received unplanned secondary intubation for different reasons. Some of those reasons were related to anesthesia procedures, such as airway obstruction or spasm (N = 18), hypoxemia after extubation (N = 13), residual paralysis of muscle relaxation (N = 6), unplanned change of airway maintaining devices (N = 3), endotracheal tube prolapse or dislocation (N = 2), and other reasons related to anesthesia (N = 3). Others were related to the patients or surgery related (N = 16). Cardio-cerebrovascular Incidents In total, 72 cardiovascular events and 27 cerebrovascular events were reported as PSIs. However, cardio-cerebrovascular events could also be found in other types of incidents. For example, surgical haemorrhage is always accompanied by hypotension. As a result, we combined cardio-cerebrovascular-related incidents for analysis in this part. The most common types of cardiovascular incidents were hypotension and cardiac arrhythmia, with 205 and 158 incidents for each type, respectively. Intraoperative blood loss was the most common cause of hypotension (N = 112, 54.6%), followed by anaphylactic shock (N = 47, 22.9%). As for cardiac arrhythmia, sinus tachycardia and bradycardia were most frequently reported, consisting of 49 and 32 incidents, respectively. CPR occurred in 67 patients, with a rate of 1.48 per 10000 anesthesia episodes. Twenty-four (35.8%) of the CPR cases were cardiogenic, and 43 (64.2%) cases were caused by other reasons, such as surgical haemorrhage and severe hypoxemia due to airway problems. Pharmacological And Transfusion Incidents Fifty-five pharmacological incidents and 24 transfusion-related incidents were collected from the system. The majority of incidents falling in the pharmacological category were anaphylactic reactions, among which 20 and 13 were related to antibiotics and blood products, respectively. Other incidents occurred during drug supply (N = 1), drug storage (N = 1), drug preparation (N = 4), blood product preparation (N = 2), and drug administration (N = 4). Six severe adverse drug reactions and 2 cell-saver related incidents were also reported. Other Incidents Incidents occurring more than 5 times among 198 other types of incidents are listed as follows. A total of 143 incidents revealed problems in multidisciplinary corporation and communication. Twelve incidents were related to anesthesia records. Six reported occupational exposure. Risk Assessment Risk assessment data are shown in Table 4 . We paid special attention to preventable incidents with extreme or high risk. For airway incidents, 7 were accompanied by secondary intubation, 5 were related to aspiration, and 4 incidents occurred due to unexpected difficult airway intubation failure. For cardio-cerebrovascular incidents, 10 and 9 were accompanied by hypotension and arrhythmia, respectively. Five patients received CPR. Three patients suffered from peri-operative cerebral infarction, and 2 patients were diagnosed with myocardial infarction. For pharmacological incidents, 4 of those incidents were related to the blood distribution procedure. Two incidents occurred during drug preparation and caused incorrect drug administration and resulted in patient harm. Table 4 Risk and preventability assessment for patient safety incidents. Risk/preventability Preventable (N) Unpreventable (N) Undecided (N) Airway incidents Extremely high 2 0 0 High 23 55 6 Medium 47 68 6 Low 1 0 0 Cardio-cerebrovascular incidents Extremely high 5 4 4 High 8 19 15 Medium 14 26 0 Low 2 2 0 Pharmacological incidents Extremely high 1 0 0 High 8 51 3 Medium 7 2 3 Low 2 1 1 Discussion To err is human, and error is unavoidable. Patient safety incident reporting can help physicians learn from error and improve patient safety. PUMC Hospital is one of the first hospitals establishing a patient incident reporting system in China, and its department of anesthesiology has been in the top three departments according to the number of incidents reported for many years. However, the incident reporting incidence of our department during the last 11 years was only 0.17%, much less than those reported from developed countries [ 10 , 12 , 13 ]. In developing countries such as China, there are numerous reasons contributing to under-reporting, including inconvenient reporting systems, inconstant reporting standards, poor safety culture among institutions, fear of punishing action, and inadequate systematic analysis of the reports and feedback [ 9 , 14 , 15 ]. Moreover, Chinese doctors are suffering from increasing burnout and decreasing job satisfaction [ 16 ], which reduces the amount of attention paid to things other than daily clinical work. Only a few people work on quality control and patient safety improvement in China, especially in underdeveloped regions. Most physicians have little knowledge on how the reported incidents will be analysed and how the results are going to generate changes to improve patient safety eventually. Consequently, the phenomenon of under-reporting is very severe in China. Implementation of a better and more convenient PSI reporting system, unification of reporting standards, encouragement for blame-free reporting, periodic summarizing and timely feedback of PSI data to the public may help increase the PSI reporting rate. Airway incidents were the most common type of incidents reported and were the top concern for anesthesiologists. This is in consistent with other anesthesia-related incident research [ 10 ], but different from incident composition reported by other departments, such as the ICU [ 17 ]. ICU incident analysis has found that airway incidents caused more harm for patients than other types of incidents [ 18 ], so anesthesiologists should pay more attention to airway incidents. Pharmacological incidents are always associated with harm for patients [ 19 ]. Runciman and colleagues reported that 36% of anesthesia-related incidents were associated with adverse drug events [ 20 ]. Webster and colleague found that one drug administration error was reported for every 133 anesthetics [ 21 ]. However, only 79 pharmacological incidents (including transfusion-related incidents) were reported in our PSI system, much less than the PSI reporting rate in other researches. There are mainly two reasons for this result. Firstly, many events were not reported simply because the doctor didn’t notice that PSI had occurred, or due to the misconception that such events do not cause severe patient harm so that reporting is not necessary. Secondly, lots of precautions were taken to prevent them from happening. We have been using international color-code standard for anesthetic labels to avoid drug confusion [ 22 ]. Double check by at least two anesthesia doctors or nurses must be done before using drugs, and ampoules were not allowed to be thrown away before the patient went out of the operating room. These measures help us to minimize the incidence of pharmacological PSIs in our department. Risk assessment is useful for helping physicians determine the types of incidents that are harmful for patients but preventable, so intervention could be performed from the department perspective. Take airway incidents for example. We found from our analysis that among those preventable incidents with extreme or high risk, 7 were accompanied by secondary intubation. Therefore, we reported all second intubation cases during the daily morning shift in detail so that every physician could learn from these cases and pay more attention to them in their clinical work. We also noticed that many cases were related to unexpected difficult airway intubation failure. Therefore, we conducted difficult airway management training for physicians to improve their mastering skills. We can also identify some common types of incidents that are worth analysing from our results. For example, we had 28 post-intubation hoarseness incidents reported, among which 25 were caused by arytenoid dislocation (AD). AD is a rare but severe complication after general anesthesia with endotracheal intubation. This complication frequently appeared in our incident reporting system and had already attracted our attention. We conducted a case-control study and identified that AD was associated with prolonged operation time and that an intubation stylet appeared to protect against AD [ 23 ]. Consequently, our department encouraged anesthesiologists to use an intubation stylet, especially for patients who underwent long-term surgery. On the other hand, standard operation procedures (SOPs) could be implemented to provide physicians with guidance for dealing with clinical situations that may cause PSIs. For instance, most of the pharmacological incidents reported in our research were anaphylaxis reactions, which often have quick onset and can cause serious threats to life if not treated rapidly and correctly. Therefore, our department has implemented a SOP for intra-operative anaphylaxis, which not only reminds anesthesiologists to pay attention to drug allergy prevention but also guides them for treatment and resuscitation when anaphylaxis occurs. We had already implemented lots of SOPs (such as difficult airway management, bronchospasm and laryngospasm, post-intubation hoarseness, anesthesia-related dental injury, aspiration, etc) based on the result of PSI analysis. More SOPs would be introduced in the future, and the effectiveness of SOPs should be further evaluated. This study also has some limitations. First, the freeform text incident data were subjective and incomplete. This was a common problem that all PSIs had, so misunderstanding and imperfection were unavoidable to a large extent. To make up for the deficiency as much as possible, we supplemented incident information through reading patients’ records and tried our best to ensure the validity and reliability during data cleaning as described above. Second, our study was a single-centre study, and the phenomenon of under-reporting was severe. What’s more, nonroutine events without patient injury or even with mild patient physiologic disturbances might not be reported, although these events were also important for guiding organizational patient safety improvement interventions [ 24 ]. Consequently, the result might not reflect the whole picture. Under-reporting is unavoidable, but our hospital has taken many measures to increase the reporting rate. For example, our hospital has specially assigned administration staff to manage those reported incidents and feedback to the related department and individual. The hospital also provides financial incentives to encourage incident reporting. Our department also had quality control group, and has periodically analysed PSI information and shared summary reports with the whole department to give feedback. Therefore, our reporting rate is relatively high in China. More complete incident reporting systems should be established, and better incident reporting cultures should be cultivated in developing countries. Large, multi-centre trials may be needed, and more attention should be paid to better summarize the incident and to make the data more valuable in the future. Conclusions We analysed 847 patient safety incidents voluntarily reported by anesthesiologists within eleven years in a Chinese teaching hospital. The reporting rate was only 0.17%, reflecting that under-reporting is still severe in China. Airway incidents constitute the majority of incidents which is in consistent with other developed countries. The importance of summarizing and utilizing anesthesia incident data should be scrutinized. Measures should be done from department or higher organizational perspective based on PSI analysing results, such as PSI events summary and feedback, and SOP implementation. List of Abbreviations WHO : World Health Organization PSI: patient safety incident PUMC: Peking Union Medical College AD: arytenoid dislocation SOP: standard operation procedures Declarations Ethics approval and consent to participate This investigation was a retrospective hospital-based study approved by Peking Union Medical College Hospital Institutianal Review Board (S-K1107, 25 March 2020). No written informed consent was obtained from participants since that it is a retrospective study without any individual person’s data. All the data were collected from the patient safety incident reporting system in our hospital. Availability of data and materials The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests. Funding This study was supported by the Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences (2019XK320018). Author’s contributions XZ (Xue Zhang) collected data, did data cleaning and was the major contributor in writing the manuscript. SM collected data and work on data analysis. YZ directed the study design and participated in the statistical analysis. WC directed the design and modified the article. XS, QC, HP and XZ (Xiuhua Zhang) helped on data collection and gave methodology supervision. LS and YH were project administration, directed the design of the study and gave supervision to the study. Acknowledgements The authors would like to thank all of the clinical staff who have collected and submitted patient safety incidents for the PSI reporting system. The authors also would like to acknowledge Dr. Ling Lan, Lingeer Wu, Huizhen Huang, Yuchen Yuan, Jiawen Yu, Jie Wu, Pei Xu, for their contribution on data interpretation and cleaning. The authors would also like to show great respect to the administrative staff in PUMC Hospital, for they have always been supporting the analysis of PSI and the implementation of analysing results into clinical use. Authors’ information ZX: Secretary of Chinese National Center for Quality Assurance of Anesthesia, Working Secretary of Anesthesia Quality Assurance Group of Chinese Society of Anesthesiology (CSA) SM: Permanent Secretary of Chinese National Center for Quality Assurance of Anesthesia, Academic Secretary of Anesthesia Quality Assurance Group of CSA LS: Committee Member of Experts Committee, Chinese National Center for Quality Assurance of Anesthesia, Committee Member and Vice General Secretary of CSA, Deputy Head of Anesthesia Quality Assurance Group of CSA YH: Chairman of CSA, Chief of Chinese National Center for Quality Assurance of Anesthesia References [1] World Health Organization. ‘More than Words’— Conceptual Framework for the International Classification for Patient Safety . Geneva: World Health Organization, 2009. [2] Pham JC, Girard T, Pronovost PJ. What to do with healthcare incident reporting systems. J Public Health Res 2013; 2 : e27. [3] Catchpole K, Bell MDD, Johnson S. Safety in anaesthesia: a study of 12 606 reported incidents from the UK National Reporting and Learning System. Anaesthesia 2008; 63 : 340-6. [4] Welker AS, St. Pierre M, Heinrichs W, Ghezel-Ahmadi V, Schleppers A. The German critical incident reporting system for anesthesiology. J Patient Saf 2015; 11 : 204-9. [5] Reed S, Arnal D, Frank O, Gomez-Arnau JI, Hansen J, Lester O, Mikkelsen KL, Rhaiem T, Rosenberg PH, St Pierre M, Schleppers A, Staender S, Smith AF . National critical incident reporting systems relevant to anaesthesia: a European survey. Br J Anaesth 2014; 112 : 546-55. [6] Russell WJ, Webb RK, Vanderwalt JH, Runciman WB. Problems with ventilation: an analysis of 2000 incident reports. Anaesth Intens Care 1993; 21 : 617-20. [7] Mellin-Olsen J, Staender S, Whitaker DK, Smith AF. The Helsinki declaration on patient safety in anaesthesiology. Eur J Anaesthesiol 2010; 27 : 592-7. [8] Wu HHL, Lewis SR, Čikkelová M, Wacker J, Smith AF. Patient safety and the role of the Helsinki declaration on patient safety in anaesthesiology. Eur J Anaesthesiol 2019; 36 : 946-54. [9] Mahajan RP. Critical incident reporting and learning. Br J Anaesth 2010; 105 : 69-75. [10] Saito T, Wong ZW, Thinn KK, Poon KH, Liu E. Review of critical incidents in a university department of anaesthesia. Anaesth Intensive Care 2015; 43 : 238-43. [11] Heideveld-Chevalking AJ, Calsbeek H, Damen J, Gooszen H, Wolff AP. The impact of a standardized incident reporting system in the perioperative setting: a single center experience on 2,563 ‘near-misses’ and adverse events. Patient Saf Surg 2014; 8 : 46. [12] Maaløe R, la Cour M, Hansen A , et al. Scrutinizing incident reporting in anaesthesia: why is an incident perceived as critical? Acta Anaesthesiol Scand 2006; 50 : 1005-13. [13] Kumar V, Barcellos WA, Mehta MP, Carter JG. An analysis of critical incidents in a teaching department for quality assurance a survey of mishaps during anaesthesia. Anaesthesia 1988; 43 : 879-83. [14] Carson-Stevens A, Hibbert P, Avery A , et al. A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice. BMJ Open 2015; 5 : e009079. [15] Thomas AN, McGrath BA. Patient safety incidents associated with airway devices in critical care: a review of reports to the UK National Patient Safety Agency. Anaesthesia 2009; 64 : 358-65. [16] Li H, Zuo M, Gelb AW , et al. Chinese anesthesiologists have high burnout and low job satisfaction. Anesth Analg 2018; 126 : 1004-12. [17] Thomas AN, MacDonald JJ. A review of patient safety incidents reported as ‘severe’ or ‘death’ from critical care units in England and Wales between 2004 and 2014. Anaesthesia 2016; 71 : 1013-23. [18] Thomas AN, Taylor RJ. Review of patient safety incidents reported from critical care units in North-West England in 2009 and 2010. Anaesthesia 2012; 67 : 706-13. [19] Thomas AN, Taylor RJ. An analysis of patient safety incidents associated with medications reported from critical care units in the North West of England between 2009 and 2012. Anaesthesia 2014; 69 : 735-45. [20] Runciman WB, Roughead EE, Semple SJ, Adams RJ. Adverse drug events and medication errors in Australia. Int J Qual Health Care 2003; Suppl 1 : i49-59. [21] Webster CS, Merry AF, Larsson L, McGrath KA, Weller J. The frequency and nature of drug administration error during anaesthesia. Anaesth Intensive Care 2001; 29 : 494-500. [22] Webster CS. Estimating and reporting error rates, and detecting improvements. Eur J Anaesthesiol 2018; 35 : 60-1. [23] Wu L, Shen L, Zhang Y, Zhang X, Huang Y. Association between the use of a stylet in endotracheal intubation and postoperative arytenoid dislocation: a case-control study. BMC Anesthesiol 2018; 18 : 59. [24] Liberman JS, Slagle JM, Whitney G, Shotwell MS, Lorinc A, Porterfield E, Weinger MB. Incidence and classification of nonroutine events during anesthesia care. Anesthesiology 2020; 133 : 41-52. Cite Share Download PDF Status: Published Journal Publication published 07 Jan, 2021 Read the published version in BMC Anesthesiology → Version 1 posted Editorial decision: Major revision 09 Nov, 2020 Review # 3 received at journal 07 Nov, 2020 Reviewer # 4 agreed at journal 03 Nov, 2020 Reviewer # 3 agreed at journal 03 Nov, 2020 Review # 2 received at journal 17 Oct, 2020 Review # 1 received at journal 16 Oct, 2020 Reviewer # 2 agreed at journal 13 Oct, 2020 Reviewer # 1 agreed at journal 12 Oct, 2020 Reviewers invited by journal 07 Oct, 2020 Editor assigned by journal 29 Sep, 2020 Submission checks completed at journal 28 Sep, 2020 Editor invited by journal 28 Sep, 2020 First submitted to journal 27 Sep, 2020 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Ma","email":"","orcid":"","institution":"Chinese Academy of Medical Sciences and Peking Union Medical College Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Shuang","middleName":"","lastName":"Ma","suffix":""},{"id":3025984,"identity":"74f62dc3-5a7d-4313-af76-9819b8eb2afe","order_by":2,"name":"Xueqin Sun","email":"","orcid":"","institution":"Chinese Academy of Medical Sciences and Peking Union Medical College Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Xueqin","middleName":"","lastName":"Sun","suffix":""},{"id":3025985,"identity":"c4557095-91cb-401c-b8b9-90953a627714","order_by":3,"name":"Yuelun Zhang","email":"","orcid":"","institution":"Chinese Academy of Medical Sciences and Peking Union Medical College Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Yuelun","middleName":"","lastName":"Zhang","suffix":""},{"id":3025986,"identity":"879a28b4-3fe7-44c5-9b7e-e1c036bdd667","order_by":4,"name":"Weiyun Chen","email":"","orcid":"","institution":"Chinese Academy of Medical Sciences and Peking Union Medical College Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Weiyun","middleName":"","lastName":"Chen","suffix":""},{"id":3025987,"identity":"dff73bc7-6933-4320-99f0-9e9dec99be60","order_by":5,"name":"Qing Chang","email":"","orcid":"","institution":"Chinese Academy of Medical Sciences and Peking Union Medical College Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Qing","middleName":"","lastName":"Chang","suffix":""},{"id":3025988,"identity":"5174bdd0-db4d-43e6-bb5a-25900667b934","order_by":6,"name":"Hui Pan","email":"","orcid":"","institution":"Chinese Academy of Medical Sciences and Peking Union Medical College Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Hui","middleName":"","lastName":"Pan","suffix":""},{"id":3025989,"identity":"2d202849-cd51-49a9-b242-121d2d349700","order_by":7,"name":"Xiuhua Zhang","email":"","orcid":"","institution":"Chinese Academy of Medical Sciences and Peking Union Medical College Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Xiuhua","middleName":"","lastName":"Zhang","suffix":""},{"id":3025990,"identity":"e2975a84-0912-4fa5-9f9a-9b69442192e7","order_by":8,"name":"Le Shen","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0klEQVRIiWNgGAWjYJACZgaGAwwM7AyMDxIqakjRwszAbPDgzDHStLBJPmxhJqzcXCI78XPBnzty5szMxyoSG9gY+Nu7E/BqsZyRu1l6ZtszY8tmtrQbiTtkGCTOnN2AV4vBjdxtzLwNhxM3HOYxu5F4ho3BQCKXCC08fw7XbzjM/60gsY2ZWC1shxMMDvOwMRClxbLn7WZp3rbDhhsOsxlLJJw5xkPQL+bsuRs/Ax0mb3C8+eHHHxU1cvztvQQchi7Ag1c5Vi2jYBSMglEwCjAAAEgnSktavl5PAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-2563-0012","institution":"Chinese Academy of Medical Sciences and Peking Union Medical College Hospital","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Le","middleName":"","lastName":"Shen","suffix":""},{"id":3025991,"identity":"50f8217b-e727-4da1-90da-d3c484ea932b","order_by":9,"name":"Yuguang Huang","email":"","orcid":"","institution":"Chinese Academy of Medical Sciences and Peking Union Medical College Hospital","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Yuguang","middleName":"","lastName":"Huang","suffix":""}],"badges":[],"createdAt":"2020-10-02 00:02:11","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-86731/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-86731/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12871-020-01226-0","type":"published","date":"2021-01-07T15:00:36+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":2868863,"identity":"2ed17543-6dda-4b0b-8f0e-1790d3f16bed","added_by":"auto","created_at":"2020-10-08 19:57:11","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":45132,"visible":true,"origin":"","legend":"Case enrollment and classification.\nThe figure shows number of cases reported by anesthesiologists during the 11-year study period and the classification of the final case cohort for analysis.","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-86731/v1/e1a11aceee35ca3d77c954b1.jpg"},{"id":13600801,"identity":"cade3a06-d5f4-4d25-bd9f-44a7675e43ba","added_by":"auto","created_at":"2021-09-17 05:45:19","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":428780,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-86731/v1/cb0913fd-78c0-45bd-801d-d500f16f432d.pdf"}],"financialInterests":"","formattedTitle":"Composition and Risk Assessment of Perioperative Patient Safety Incidents Reported by Anesthesiologists from 2009 to 2019, a single-center retrospective cohort study","fulltext":[{"header":"Background","content":"\u003cp\u003eAccording to the World Health Organization (WHO) international classification for patient safety, a patient safety incident (PSI) is an event or circumstance that could have resulted, or did result, in unnecessary harm to a patient [\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e]. PSI reporting has been an important means of improving patient safety and enhancing organizational quality control. Many developed countries, such as the United States of America, Australia, the United Kingdom and Germany, already have national PSI reporting systems for prospective collection of PSI data even since 1993 [\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e]. These systems similarly encourage the blame-free submission of incident reports, with the aim of finding such defects before causing harm [\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eBy understanding the theory more thoroughly and thanks to the development of new technologies, anesthesia has become safer in recent decades. However, the quality of anesthesiologists' work could be challenged by the increasing number of old and sick patients, more complicated surgical procedures, new drugs and new equipment, increasing pressure and professional burnout. The Declaration of Helsinki as amended in June 2010 emphasized that all institutions providing anesthesia care to patients must contribute to the recognized national or other major audits of safe practice and to critical incident reporting systems [\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e]. In a 2019 European survey, 78.7% of responders stated that their hospital used a critical incident reporting system [\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e]. In the United Kingdom, a specialty-specific incident reporting system for anesthesia was introduced in 2010 [\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e]. However, few studies have characterized incidents from anesthesia practice, and none of these have been from developing countries.\u003c/p\u003e\n\u003cp\u003eAs far as we know, nation-wide incident reporting systems are not well established and managed in most developing countries, including China. It has become a huge waste of clinical information because timely identification of errors makes pre-emptive efforts for clinical change and improvement possible. As the top hospital in China, Peking Union Medical College (PUMC) Hospital established a PSI reporting system in 2009. Hereby, we analysed all patient safety incidents reported by anesthesiologists in PUMC Hospital in an eleven-year period to share information with other anesthesiologists to better improve patient safety in perioperative care.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAn incident reporting system was established in 2009 in PUMC Hospital. All healthcare workers are authorized to log in the system and report patient safety incidents either anonymously or not. The incidents were described in freeform text to provide information on patient circumstances, details of the incident, perceived contributing factors, hidden danger, and suggestions for prevention. The database was examined for all incidents reported by anesthesiologists from September 2009 to August 2019 with the approval of the Peking Union Medical College Hospital Institutional Review Board (S-K1107, 25 March 2020). Data were also collected from the patients\u0026rsquo; records, including anesthesia records, to supplement the information in the incident reports.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\n\u003cp\u003e\u003cstrong\u003eData Cleaning\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe incidents were reviewed by professional reviewers for reclassification. We have eight reviewers from the department of anesthesiology to clean the data into Excel table form. All members of the research group signed confidentiality agreements before receiving the data. To ensure validity and reliability throughout the study, two independent reviewers reviewed the same part of the data separately, and all the members received uniform training about the data extraction. The two reviewers met to discuss discrepancies until they reach an agreement. When discrepancies could not be resolved by discussion between the two reviewers, the problem was discussed at a weekly meeting of the whole research group under the direction of the senior investigators.\u003c/p\u003e\n\u003cp\u003eThe process of data cleaning included two parts. The first part was incident classification and detail collection. We collected patient sex, date, time and place of incident occurrence, type of surgery, and phase of anesthesia when the incident occurred for further group analysis. Incidents were classified into seven types: airway incidents, cardio-cerebrovascular incidents, pharmacological incidents, equipment incidents, spinal or regional anesthesia incidents, incidents related to surgery and other incidents. For each type of incident, more detailed information was collected.\u003c/p\u003e\n\u003cp\u003eThe second part of data cleaning was risk assessment. Risk assessment was performed based on the estimated risk of recurrence and estimated consequences for the patient. Then, the incident is automatically classified into four risk categories: extremely high, high, medium and low risk (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e) [\u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e]. The reviewers also classified subjectively whether the incidents were preventable, unpreventable or undecided.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eRisk assessment matrix.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eConsequences/ risk of recurrence\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eAlmost inevitable\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eProbable\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003ePossible\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eSmall\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eVery small\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCatastrophe\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eExtremely high\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eExtremely high\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eExtremely high\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eExtremely high\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eExtremely high\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eVery serious\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSerious\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMarginally serious\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLow\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLow\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLow\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\n\u003ch2\u003e\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData were stored in a relational structure using Microsoft Office Excel 2016 (Microsoft Corp. 2016). SPSS (IBM SPSS statistics Version 26) was used for statistical analysis of the dataset. We described the demographic and basic clinical characteristics of the patients involved in the safety incidents. The \u0026ldquo;percentage of patients with incidents\u0026rdquo; for different ASA categories was calculated by the number of patients with reported incidents divided by the total number of patients with the same ASA grade, and the risk ratio with the 95% confidence interval (CI) was estimated using the ASA I as the reference group. A two-sided P value less than 0.05 was regarded as statistically significant.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eOf the 847 patient safety incidents voluntarily reported by anesthesiologists from September 2009 to August 2019, 74 cases were excluded because they were reported repetitively or not related with anesthesia. In total, 773 cases were enrolled among 452,974 anesthesia care episodes, with an overall PSI reporting incidence of 0.17%. Case number of different types of incidents are shown in Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n\u003cp\u003eThe average age of the 773 patients involved in the incidents was 51.79\u0026thinsp;\u0026plusmn;\u0026thinsp;31.91 (mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD), and the median age was 54. Regarding ASA physical status, patients with worse physical status were more vulnerable to suffering from PSIs (Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). Other details related to patients and the reported incidents are shown in table 3.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eASA physical status of patients with reported incidents.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eASA\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eNo. of patients with incidents\u003c/p\u003e\n\u003c/th\u003e\n\u003cth colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003eNo. of patients without incidents\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e% of patient with incidents\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eRisk ratio (95% CI)\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eI\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e78\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e105467\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.074\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1.00\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eII\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e253\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e118620\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.213\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2.88 (2.24 to 3.72)*\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIII\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e89\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e14332\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.617\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8.40 (6.19 to 11.39)*\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIV\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e37\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e981\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3.635\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e51.00 (34.31 to 75.80)*\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eV\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e78\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6.024\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e86.68 (34.16 to 219.91)*\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003ctfoot\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"6\"\u003e*p\u0026thinsp;\u0026lt;\u0026thinsp;0.05. CI: confidence interval. ASA: American Society of Anesthesiologists.\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tfoot\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSince the ASA data of patients without incidents were available only after 2013 due to technological issues (the electronic anesthesia record system in PUMC Hospital was established in 2013, so the ASA status of patients without incidents reported could only be collected after 2013), only data from 2013 to 2019 were used for analysis related to ASA status related analysis.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab3\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eDemographic variables and other details on the reported incidents.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eItem\u003c/p\u003e\n\u003cp\u003e(N\u0026thinsp;=\u0026thinsp;773)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eDetail\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eNumber of incidents (%)\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"2\" align=\"left\"\u003e\n\u003cp\u003ePatient sex\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e315 (40.8)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFemale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e357 (46.2)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNA\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e101 (13.1)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDate of occurrence\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eWeekday\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e692 (89.5)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eWeekend\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22 (2.8)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNA\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e59 (7.6)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTime of occurrence\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eWorking hours (8:00am-4:00\u0026nbsp;pm)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e445 (57.6)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNonworking hours (4:01\u0026nbsp;pm-7:59am)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e312 (40.3)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNA\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e16 (2.1)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePlace of occurrence\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIn the OR (including PACU)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e649 (84.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOut of the OR\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e93 (12.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNA\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e31 (4.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eType of surgery\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eElective surgery\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e620 (80.2)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEmergency surgery\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e110 (14.2)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLabor analgesia\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4 (0.5)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNA\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e39 (5.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePhase of anesthesia\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePre-induction\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e62 (8.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ewhen incident\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eInduction\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e77 (10.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eoccurred\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMaintenance\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e247 (32.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEmergence\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e73 (9.4)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eRecovery in PACU\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e31 (4.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePost-operative period\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e77 (10.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDuring spinal or regional anesthesia procedure\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e45 (5.8)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNA\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e161 (20.8)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003ctfoot\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\"\u003eOR: operating room. PACU: post-anesthesia care unit.\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tfoot\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eThe total number of incidents with available information in each part is not equal to 773 because some of the data was incomplete or missing.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eAirway Incidents\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eTwenty-seven percent (208 of 773) of PSIs were airway-related incidents. Sixty-five (31.3%) occurred during intubation, 41 (19.7%) occurred during anesthesia maintenance, 73 (35.1%) occurred during extubation, and 28 (13.5%) incidents were reported after the patient returned to the ward. There was also one patient (0.5%) who had airway obstruction in the OR before anesthesia induction. The most common airway incident categories were bronchospasm or laryngospasm (N\u0026thinsp;=\u0026thinsp;32), post-intubation hoarseness (N\u0026thinsp;=\u0026thinsp;28), dental injury (N\u0026thinsp;=\u0026thinsp;20), intubation failure (N\u0026thinsp;=\u0026thinsp;17), intubation delay caused by difficult airway (N\u0026thinsp;=\u0026thinsp;15), airway obstruction (N\u0026thinsp;=\u0026thinsp;14), and aspiration (N\u0026thinsp;=\u0026thinsp;10). Ninety-six (46.15%) of the patients suffered from airway-related hypoxemia, comprising 34 mild cases (with minimal SpO\u003csub\u003e2\u003c/sub\u003e\u0026thinsp;\u0026ge;\u0026thinsp;85% for less than 5\u0026nbsp;min) and 62 severe cases (with minimal SpO\u003csub\u003e2\u003c/sub\u003e\u0026thinsp;\u0026lt;\u0026thinsp;85% or hypoxemia for more than 5\u0026nbsp;min). Nine patients had bradycardia, and 3 patients even had cardiac arrest caused by hypoxemia. We also noticed that 61 patients received unplanned secondary intubation for different reasons. Some of those reasons were related to anesthesia procedures, such as airway obstruction or spasm (N\u0026thinsp;=\u0026thinsp;18), hypoxemia after extubation (N\u0026thinsp;=\u0026thinsp;13), residual paralysis of muscle relaxation (N\u0026thinsp;=\u0026thinsp;6), unplanned change of airway maintaining devices (N\u0026thinsp;=\u0026thinsp;3), endotracheal tube prolapse or dislocation (N\u0026thinsp;=\u0026thinsp;2), and other reasons related to anesthesia (N\u0026thinsp;=\u0026thinsp;3). Others were related to the patients or surgery related (N\u0026thinsp;=\u0026thinsp;16).\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eCardio-cerebrovascular Incidents\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eIn total, 72 cardiovascular events and 27 cerebrovascular events were reported as PSIs. However, cardio-cerebrovascular events could also be found in other types of incidents. For example, surgical haemorrhage is always accompanied by hypotension. As a result, we combined cardio-cerebrovascular-related incidents for analysis in this part. The most common types of cardiovascular incidents were hypotension and cardiac arrhythmia, with 205 and 158 incidents for each type, respectively. Intraoperative blood loss was the most common cause of hypotension (N\u0026thinsp;=\u0026thinsp;112, 54.6%), followed by anaphylactic shock (N\u0026thinsp;=\u0026thinsp;47, 22.9%). As for cardiac arrhythmia, sinus tachycardia and bradycardia were most frequently reported, consisting of 49 and 32 incidents, respectively. CPR occurred in 67 patients, with a rate of 1.48 per 10000 anesthesia episodes. Twenty-four (35.8%) of the CPR cases were cardiogenic, and 43 (64.2%) cases were caused by other reasons, such as surgical haemorrhage and severe hypoxemia due to airway problems.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003ePharmacological And Transfusion Incidents\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eFifty-five pharmacological incidents and 24 transfusion-related incidents were collected from the system. The majority of incidents falling in the pharmacological category were anaphylactic reactions, among which 20 and 13 were related to antibiotics and blood products, respectively. Other incidents occurred during drug supply (N\u0026thinsp;=\u0026thinsp;1), drug storage (N\u0026thinsp;=\u0026thinsp;1), drug preparation (N\u0026thinsp;=\u0026thinsp;4), blood product preparation (N\u0026thinsp;=\u0026thinsp;2), and drug administration (N\u0026thinsp;=\u0026thinsp;4). Six severe adverse drug reactions and 2 cell-saver related incidents were also reported.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eOther Incidents\u003c/strong\u003e\u003c/p\u003e \u003cp\u003eIncidents occurring more than 5 times among 198 other types of incidents are listed as follows. A total of 143 incidents revealed problems in multidisciplinary corporation and communication. Twelve incidents were related to anesthesia records. Six reported occupational exposure.\u003c/p\u003e \u003cp\u003e\u003cstrong\u003eRisk Assessment\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eRisk assessment data are shown in Table \u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e. We paid special attention to preventable incidents with extreme or high risk. For airway incidents, 7 were accompanied by secondary intubation, 5 were related to aspiration, and 4 incidents occurred due to unexpected difficult airway intubation failure. For cardio-cerebrovascular incidents, 10 and 9 were accompanied by hypotension and arrhythmia, respectively. Five patients received CPR. Three patients suffered from peri-operative cerebral infarction, and 2 patients were diagnosed with myocardial infarction. For pharmacological incidents, 4 of those incidents were related to the blood distribution procedure. Two incidents occurred during drug preparation and caused incorrect drug administration and resulted in patient harm.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab4\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eRisk and preventability assessment for patient safety incidents.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eRisk/preventability\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003ePreventable (N)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eUnpreventable (N)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eUndecided (N)\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" align=\"left\"\u003e\n\u003cp\u003eAirway incidents\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eExtremely high\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e23\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e55\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e47\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e68\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLow\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" align=\"left\"\u003e\n\u003cp\u003eCardio-cerebrovascular incidents\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eExtremely high\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e19\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e14\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e26\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLow\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" align=\"left\"\u003e\n\u003cp\u003ePharmacological incidents\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eExtremely high\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e51\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLow\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eTo err is human, and error is unavoidable. Patient safety incident reporting can help physicians learn from error and improve patient safety. PUMC Hospital is one of the first hospitals establishing a patient incident reporting system in China, and its department of anesthesiology has been in the top three departments according to the number of incidents reported for many years. However, the incident reporting incidence of our department during the last 11\u0026nbsp;years was only 0.17%, much less than those reported from developed countries [\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e]. In developing countries such as China, there are numerous reasons contributing to under-reporting, including inconvenient reporting systems, inconstant reporting standards, poor safety culture among institutions, fear of punishing action, and inadequate systematic analysis of the reports and feedback [\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e]. Moreover, Chinese doctors are suffering from increasing burnout and decreasing job satisfaction [\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e], which reduces the amount of attention paid to things other than daily clinical work. Only a few people work on quality control and patient safety improvement in China, especially in underdeveloped regions. Most physicians have little knowledge on how the reported incidents will be analysed and how the results are going to generate changes to improve patient safety eventually. Consequently, the phenomenon of under-reporting is very severe in China. Implementation of a better and more convenient PSI reporting system, unification of reporting standards, encouragement for blame-free reporting, periodic summarizing and timely feedback of PSI data to the public may help increase the PSI reporting rate.\u003c/p\u003e\n\u003cp\u003eAirway incidents were the most common type of incidents reported and were the top concern for anesthesiologists. This is in consistent with other anesthesia-related incident research [\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e], but different from incident composition reported by other departments, such as the ICU [\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e]. ICU incident analysis has found that airway incidents caused more harm for patients than other types of incidents [\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e], so anesthesiologists should pay more attention to airway incidents.\u003c/p\u003e\n\u003cp\u003ePharmacological incidents are always associated with harm for patients [\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e]. Runciman and colleagues reported that 36% of anesthesia-related incidents were associated with adverse drug events [\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e]. Webster and colleague found that one drug administration error was reported for every 133 anesthetics [\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e]. However, only 79 pharmacological incidents (including transfusion-related incidents) were reported in our PSI system, much less than the PSI reporting rate in other researches. There are mainly two reasons for this result. Firstly, many events were not reported simply because the doctor didn\u0026rsquo;t notice that PSI had occurred, or due to the misconception that such events do not cause severe patient harm so that reporting is not necessary. Secondly, lots of precautions were taken to prevent them from happening. We have been using international color-code standard for anesthetic labels to avoid drug confusion [\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e]. Double check by at least two anesthesia doctors or nurses must be done before using drugs, and ampoules were not allowed to be thrown away before the patient went out of the operating room. These measures help us to minimize the incidence of pharmacological PSIs in our department.\u003c/p\u003e\n\u003cp\u003eRisk assessment is useful for helping physicians determine the types of incidents that are harmful for patients but preventable, so intervention could be performed from the department perspective. Take airway incidents for example. We found from our analysis that among those preventable incidents with extreme or high risk, 7 were accompanied by secondary intubation. Therefore, we reported all second intubation cases during the daily morning shift in detail so that every physician could learn from these cases and pay more attention to them in their clinical work. We also noticed that many cases were related to unexpected difficult airway intubation failure. Therefore, we conducted difficult airway management training for physicians to improve their mastering skills.\u003c/p\u003e\n\u003cp\u003eWe can also identify some common types of incidents that are worth analysing from our results. For example, we had 28 post-intubation hoarseness incidents reported, among which 25 were caused by arytenoid dislocation (AD). AD is a rare but severe complication after general anesthesia with endotracheal intubation. This complication frequently appeared in our incident reporting system and had already attracted our attention. We conducted a case-control study and identified that AD was associated with prolonged operation time and that an intubation stylet appeared to protect against AD [\u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e]. Consequently, our department encouraged anesthesiologists to use an intubation stylet, especially for patients who underwent long-term surgery.\u003c/p\u003e\n\u003cp\u003eOn the other hand, standard operation procedures (SOPs) could be implemented to provide physicians with guidance for dealing with clinical situations that may cause PSIs. For instance, most of the pharmacological incidents reported in our research were anaphylaxis reactions, which often have quick onset and can cause serious threats to life if not treated rapidly and correctly. Therefore, our department has implemented a SOP for intra-operative anaphylaxis, which not only reminds anesthesiologists to pay attention to drug allergy prevention but also guides them for treatment and resuscitation when anaphylaxis occurs. We had already implemented lots of SOPs (such as difficult airway management, bronchospasm and laryngospasm, post-intubation hoarseness, anesthesia-related dental injury, aspiration, etc) based on the result of PSI analysis. More SOPs would be introduced in the future, and the effectiveness of SOPs should be further evaluated.\u003c/p\u003e\n\u003cp\u003eThis study also has some limitations. First, the freeform text incident data were subjective and incomplete. This was a common problem that all PSIs had, so misunderstanding and imperfection were unavoidable to a large extent. To make up for the deficiency as much as possible, we supplemented incident information through reading patients\u0026rsquo; records and tried our best to ensure the validity and reliability during data cleaning as described above. Second, our study was a single-centre study, and the phenomenon of under-reporting was severe. What\u0026rsquo;s more, nonroutine events without patient injury or even with mild patient physiologic disturbances might not be reported, although these events were also important for guiding organizational patient safety improvement interventions [\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e]. Consequently, the result might not reflect the whole picture. Under-reporting is unavoidable, but our hospital has taken many measures to increase the reporting rate. For example, our hospital has specially assigned administration staff to manage those reported incidents and feedback to the related department and individual. The hospital also provides financial incentives to encourage incident reporting. Our department also had quality control group, and has periodically analysed PSI information and shared summary reports with the whole department to give feedback. Therefore, our reporting rate is relatively high in China. More complete incident reporting systems should be established, and better incident reporting cultures should be cultivated in developing countries. Large, multi-centre trials may be needed, and more attention should be paid to better summarize the incident and to make the data more valuable in the future.\u003c/p\u003e"},{"header":"Conclusions","content":" \u003cp\u003eWe analysed 847 patient safety incidents voluntarily reported by anesthesiologists within eleven years in a Chinese teaching hospital. The reporting rate was only 0.17%, reflecting that under-reporting is still severe in China. Airway incidents constitute the majority of incidents which is in consistent with other developed countries. The importance of summarizing and utilizing anesthesia incident data should be scrutinized. Measures should be done from department or higher organizational perspective based on PSI analysing results, such as PSI events summary and feedback, and SOP implementation.\u003c/p\u003e "},{"header":"List of Abbreviations","content":"\u003cp\u003eWHO : World Health Organization\u003c/p\u003e\n\u003cp\u003ePSI: patient safety incident\u003c/p\u003e\n\u003cp\u003ePUMC: Peking Union Medical College\u003c/p\u003e\n\u003cp\u003eAD: arytenoid dislocation\u003c/p\u003e\n\u003cp\u003eSOP: standard operation procedures\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e Ethics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis investigation was a retrospective hospital-based study approved by Peking Union Medical College Hospital Institutianal Review Board (S-K1107, 25 March 2020). No written informed consent was obtained from participants since that it is a retrospective study without any individual person\u0026rsquo;s data. All the data were collected from the patient safety incident reporting system in our hospital.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e Availability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e Competing interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e Funding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was supported by the Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences (2019XK320018).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e Author\u0026rsquo;s contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eXZ (Xue Zhang) collected data, did data cleaning and was the major contributor in writing the manuscript. SM collected data and work on data analysis. YZ directed the study design and participated in the statistical analysis. WC directed the design and modified the article. XS, QC, HP and XZ (Xiuhua Zhang) helped on data collection and gave methodology supervision. LS and YH were project administration, directed the design of the study and gave supervision to the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e Acknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank all of the clinical staff who have collected and submitted patient safety incidents for the PSI reporting system. The authors also would like to acknowledge Dr. Ling Lan, Lingeer Wu, Huizhen Huang, Yuchen Yuan, Jiawen Yu, Jie Wu, Pei Xu, for their contribution on data interpretation and cleaning. The authors would also like to show great respect to the administrative staff in PUMC Hospital, for they have always been supporting the analysis of PSI and the implementation of analysing results into clinical use.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e Authors\u0026rsquo; information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eZX: Secretary of Chinese National Center for Quality Assurance of Anesthesia, Working Secretary of Anesthesia Quality Assurance Group of Chinese Society of Anesthesiology (CSA)\u003c/p\u003e\n\u003cp\u003eSM: Permanent Secretary of Chinese National Center for Quality Assurance of Anesthesia, Academic Secretary of Anesthesia Quality Assurance Group of CSA\u003c/p\u003e\n\u003cp\u003eLS: Committee Member of Experts Committee, Chinese National Center for Quality Assurance of Anesthesia, Committee Member and Vice General Secretary of CSA, Deputy Head of Anesthesia Quality Assurance Group of CSA\u003c/p\u003e\n\u003cp\u003eYH: Chairman of CSA, Chief of Chinese National Center for Quality Assurance of Anesthesia\u003c/p\u003e"},{"header":"References","content":"\u003cp\u003e[1]\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; World Health Organization. \u003cem\u003e\u0026lsquo;More than Words\u0026rsquo;\u0026mdash; Conceptual Framework for the International Classification for Patient Safety\u003c/em\u003e. Geneva: World Health Organization, 2009.\u003c/p\u003e\n\u003cp\u003e[2]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Pham JC, Girard T, Pronovost PJ. What to do with healthcare incident reporting systems. \u003cem\u003eJ Public Health Res\u003c/em\u003e 2013; \u003cstrong\u003e2\u003c/strong\u003e: e27.\u003c/p\u003e\n\u003cp\u003e[3]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Catchpole K, Bell MDD, Johnson S. Safety in anaesthesia: a study of 12\u0026nbsp;606 reported incidents from the UK National Reporting and Learning System. \u003cem\u003eAnaesthesia\u003c/em\u003e 2008; \u003cstrong\u003e63\u003c/strong\u003e: 340-6.\u003c/p\u003e\n\u003cp\u003e[4]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Welker AS, St. Pierre M, Heinrichs W, Ghezel-Ahmadi V, Schleppers A. The German critical incident reporting system for anesthesiology. \u003cem\u003eJ Patient Saf\u003c/em\u003e 2015; \u003cstrong\u003e11\u003c/strong\u003e: 204-9.\u003c/p\u003e\n\u003cp\u003e[5]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Reed S, Arnal D, Frank O, Gomez-Arnau JI, Hansen J, Lester O, Mikkelsen KL, Rhaiem T, Rosenberg PH, St Pierre M, Schleppers A, Staender S, Smith AF\u003cem\u003e.\u003c/em\u003e National critical incident reporting systems relevant to anaesthesia: a European survey. \u003cem\u003eBr J Anaesth\u003c/em\u003e 2014; \u003cstrong\u003e112\u003c/strong\u003e: 546-55.\u003c/p\u003e\n\u003cp\u003e[6]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Russell WJ, Webb RK, Vanderwalt JH, Runciman WB. Problems with ventilation: an analysis of 2000 incident reports. \u003cem\u003eAnaesth Intens Care \u003c/em\u003e1993; \u003cstrong\u003e21\u003c/strong\u003e: 617-20.\u003c/p\u003e\n\u003cp\u003e[7]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Mellin-Olsen J, Staender S, Whitaker DK, Smith AF. The Helsinki declaration on patient safety in anaesthesiology. \u003cem\u003eEur J Anaesthesiol\u003c/em\u003e 2010; \u003cstrong\u003e27\u003c/strong\u003e: 592-7.\u003c/p\u003e\n\u003cp\u003e[8]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Wu HHL, Lewis SR, Čikkelov\u0026aacute; M, Wacker J, Smith AF. Patient safety and the role of the Helsinki declaration on patient safety in anaesthesiology. \u003cem\u003eEur J Anaesthesiol\u003c/em\u003e 2019; \u003cstrong\u003e36\u003c/strong\u003e: 946-54.\u003c/p\u003e\n\u003cp\u003e[9]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Mahajan RP. Critical incident reporting and learning. \u003cem\u003eBr J Anaesth\u003c/em\u003e 2010; \u003cstrong\u003e105\u003c/strong\u003e: 69-75.\u003c/p\u003e\n\u003cp\u003e[10]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Saito T, Wong ZW, Thinn KK, Poon KH, Liu E. Review of critical incidents in a university department of anaesthesia. \u003cem\u003eAnaesth Intensive Care\u003c/em\u003e 2015; \u003cstrong\u003e43\u003c/strong\u003e: 238-43.\u003c/p\u003e\n\u003cp\u003e[11]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Heideveld-Chevalking AJ, Calsbeek H, Damen J, Gooszen H, Wolff AP. The impact of a standardized incident reporting system in the perioperative setting: a single center experience on 2,563 \u0026lsquo;near-misses\u0026rsquo; and adverse events. \u003cem\u003ePatient Saf Surg\u003c/em\u003e 2014; \u003cstrong\u003e8\u003c/strong\u003e: 46.\u003c/p\u003e\n\u003cp\u003e[12]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Maal\u0026oslash;e R, la Cour M, Hansen A\u003cem\u003e, et al.\u003c/em\u003e Scrutinizing incident reporting in anaesthesia: why is an incident perceived as critical? \u003cem\u003eActa Anaesthesiol Scand\u003c/em\u003e 2006; \u003cstrong\u003e50\u003c/strong\u003e: 1005-13.\u003c/p\u003e\n\u003cp\u003e[13]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Kumar V, Barcellos WA, Mehta MP, Carter JG. An analysis of critical incidents in a teaching department for quality assurance a survey of mishaps during anaesthesia. \u003cem\u003eAnaesthesia\u003c/em\u003e 1988; \u003cstrong\u003e43\u003c/strong\u003e: 879-83.\u003c/p\u003e\n\u003cp\u003e[14]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Carson-Stevens A, Hibbert P, Avery A\u003cem\u003e, et al.\u003c/em\u003e A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice. \u003cem\u003eBMJ Open\u003c/em\u003e 2015; \u003cstrong\u003e5\u003c/strong\u003e: e009079.\u003c/p\u003e\n\u003cp\u003e[15]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Thomas AN, McGrath BA. Patient safety incidents associated with airway devices in critical care: a review of reports to the UK National Patient Safety Agency. \u003cem\u003eAnaesthesia\u003c/em\u003e 2009; \u003cstrong\u003e64\u003c/strong\u003e: 358-65.\u003c/p\u003e\n\u003cp\u003e[16]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Li H, Zuo M, Gelb AW\u003cem\u003e, et al.\u003c/em\u003e Chinese anesthesiologists have high burnout and low job satisfaction. \u003cem\u003eAnesth Analg\u003c/em\u003e 2018; \u003cstrong\u003e126\u003c/strong\u003e: 1004-12.\u003c/p\u003e\n\u003cp\u003e[17]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Thomas AN, MacDonald JJ. A review of patient safety incidents reported as \u0026lsquo;severe\u0026rsquo; or \u0026lsquo;death\u0026rsquo; from critical care units in England and Wales between 2004 and 2014. \u003cem\u003eAnaesthesia\u003c/em\u003e 2016; \u003cstrong\u003e71\u003c/strong\u003e: 1013-23.\u003c/p\u003e\n\u003cp\u003e[18]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Thomas AN, Taylor RJ. Review of patient safety incidents reported from critical care units in North-West England in 2009 and 2010. \u003cem\u003eAnaesthesia\u003c/em\u003e 2012; \u003cstrong\u003e67\u003c/strong\u003e: 706-13.\u003c/p\u003e\n\u003cp\u003e[19]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Thomas AN, Taylor RJ. An analysis of patient safety incidents associated with medications reported from critical care units in the North West of England between 2009 and 2012. \u003cem\u003eAnaesthesia\u003c/em\u003e 2014; \u003cstrong\u003e69\u003c/strong\u003e: 735-45.\u003c/p\u003e\n\u003cp\u003e[20]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Runciman WB, Roughead EE, Semple SJ, Adams RJ. Adverse drug events and medication errors in Australia. \u003cem\u003eInt J Qual Health Care \u003c/em\u003e2003; \u003cstrong\u003eSuppl 1\u003c/strong\u003e: i49-59.\u003c/p\u003e\n\u003cp\u003e[21]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Webster CS, Merry AF, Larsson L, McGrath KA, Weller J. The frequency and nature of drug administration error during anaesthesia. \u003cem\u003eAnaesth Intensive Care\u003c/em\u003e 2001; \u003cstrong\u003e29\u003c/strong\u003e: 494-500.\u003c/p\u003e\n\u003cp\u003e[22]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Webster CS. Estimating and reporting error rates, and detecting improvements. \u003cem\u003eEur J Anaesthesiol \u003c/em\u003e2018; \u003cstrong\u003e35\u003c/strong\u003e: 60-1.\u003c/p\u003e\n\u003cp\u003e[23]\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp;\u0026nbsp; Wu L, Shen L, Zhang Y, Zhang X, Huang Y. Association between the use of a stylet in endotracheal intubation and postoperative arytenoid dislocation: a case-control study. \u003cem\u003eBMC Anesthesiol\u003c/em\u003e 2018; \u003cstrong\u003e18\u003c/strong\u003e: 59.\u003c/p\u003e\n\u003cp\u003e[24] \u0026nbsp;\u0026nbsp;\u0026nbsp; Liberman JS, Slagle JM, Whitney G, Shotwell MS, Lorinc A, Porterfield E, Weinger MB. Incidence and classification of nonroutine events during anesthesia care. \u003cem\u003eAnesthesiology\u003c/em\u003e 2020; \u003cstrong\u003e133\u003c/strong\u003e: 41-52.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-anesthesiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bane","sideBox":"Learn more about [BMC Anesthesiology](http://bmcanesthesiol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bane","title":"BMC Anesthesiology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Anesthesia, Incident reporting system, Patient safety, Risk assessment","lastPublishedDoi":"10.21203/rs.3.rs-86731/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-86731/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Patient safety incident reporting has been an important means of improving patient safety and enhancing organizational quality control. Reports of anesthesia-related incidents are of great value for analysis to improve perioperative patient safety. However, the utilization of incident data is far from sufficient, especially in developing countries such as China.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: All patient safety incidents reported by anesthesiologists in a Chinese academic hospital between September 2009 and August 2019 were collected from the incident reporting system. We reviewed the freeform text reports, supplemented them with information from the patient medical record system. Composition analysis and risk assessment were performed.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: In total, 847 patient safety incidents were voluntarily reported by anesthesiologists during the study period among 452,974 anesthetic procedures, with a reported incidence of 0.17%, much less than the incidence reported by some developed countries. Patients with worse ASA physical status were more vulnerable to suffering from PSIs. The most common type of incident was related to the airway (N=208, 27%), followed by cardio-cerebrovascular (N=99, 13%) and pharmacological incidents (N=79, 10%). Those preventable incidents with extreme or high risk were found out through risk assessment, to provide reference for the department to implement more standard operation procedures.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: This study describes characteristics of 847 patient safety incidents voluntarily reported by anesthesiologists within eleven years in a Chinese academic hospital. Airway incidents constitute the majority of incidents reported by anesthesiologists. Under-reporting is severe in China, and the importance of summarizing and utilizing anesthesia incident data should be scrutinized.\u003c/p\u003e","manuscriptTitle":"Composition and Risk Assessment of Perioperative Patient Safety Incidents Reported by Anesthesiologists from 2009 to 2019, a single-center retrospective cohort study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2020-10-08 19:57:08","doi":"10.21203/rs.3.rs-86731/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2020-11-10T00:00:00+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2020-11-08T00:00:00+00:00","index":3,"fulltext":"Recommendation: Major revisions required\nForm responses:\n---\n\nComments to Author:\n---\nThe authors present a 10-year retrospective analysis of patient safety anesthesia incident report under the justification of \"trial and error\" to identify and avoid problems in the future based on prior experiences. The results are somewhat predictable based on what is current reported by the ASA and the APSF, where airway is the most common one.\nThis manuscript does add to the body of literature since the authors when through many miniscule details in the incident reports, pretty much what sells this paper is table 2. That being said the English grammar still needs some work. No idea what \"other incidents\" are, poor reporting of \"cardio-cerebrovascular events\", since this term is not universally known in the literature.\nAnd very importantly, no especial segment for obvious human errors? APSF clearly state that human errors (mishaps, near misses, wrong medication, wrong side/site) is one of the most common causes. This must be mentioned in this manuscript.\n\nMajor Concerns:\n- Background: any examples regarding PSI reporting systems?\n- I believe you should include/incorporate the importance of implementation and transition of electronic medical records, since this has highly impacted the reporting of perioperative events (or not?), please comment on that.\n- \"Thanks to the development of new techs\", which ones? References?\n- Such a strong country like China does not have a nationwide PSI system? Well, hard to comment on that since I am not Chinese, but the APSF does have a dedicated segment for China, and there are publications about it:\nhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371930/\nSo, I would recommend to remove the phrase that China does not have a PSI reporting system.\n- Methods: What are \"professional reviewers\", are these people part of the investigational team of this manuscript? Third parties?\n- \"8 reviewers from the department of anesthesiology\", are these people listed as authors, or you have some sort of consortium or research group? Please specify.\n- Who are the \"two independent reviewers\"? (Identify with initials)\n- Who are the \"senior investigators\"? (Identify with initials)\n- You really need to define \"cardio-cerebrovascular incidents\", this nomenclature is weird and not widely known. I recommend to use \"MACE: Major Adverse Cardiac Events\", and then explain in the method section what does that include, just a suggestion.\n- Who come up with this classification in 7 types, is this published somewhere? Or this is pretty much what you found as you searched? This is confusing. I\n- Table 1 literally comes from the study cited in reference 11, please make sure copyrights are good for this.\n- I still do not understand what \"other incidents\" are or imply?\n- Does low job satisfaction lead to errors? Hard to say, this looks like a very personal note from the authors, I'd recommend to remove.\n- You keep insisting in the discussion section regarding the lack of reporting, please see my prior point.\n- I don't see in your limitations the lack of electronic medical records, and lack of electronic reporting system.\n\nMinor concerns:\n- Place of manufacturing of excel.\n- \"The mean age of the…. Was 51.79 (SD +- 31.91)\"* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. Your name, email address, title of the reviewed manuscript, name of the journal, and date of your review submission (the “Review Data”) will then be transmitted to Publons upon publication of the manuscript. If you have already registered at Publons, they will notify you of the receipt of this review and update your profile as per your settings and their policy. If you are not registered with Publons, you will receive an email from them asking you to register in order for them to be able to recognize your review on your new profile page. Publons may use the Review Data to generate derivative metadata for the benefit of Publons and you as a reviewer, carefully considering the sensitivity of such information. For example, Publons may verify your record as a reviewer by updating your profile published on its webservice if you have registered for such service or help editors to identify candidate reviewers. Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **Yes**\n* Declaration of competing interests: **I declare that I have no competing interests**\n* Reviewer Publication Consent. I agree for my report to be made available under an Open Access Creative Commons CC-BY License (http://creativecommons.org/licenses/by/4.0) if this manuscript is accepted for publication. Any comments that I do not wish to be included in the published report have been included as confidential comments to the editor, which will not be published.: **I agree to the terms of the CC-BY 4.0 license; please do not publish my name with my report. (default)**\n* Is the study design appropriate to answer the research question (including the use of appropriate controls), and are the conclusions supported by the evidence presented?: **Yes**\n* Are the methods sufficiently described to allow the study to be repeated?: **Yes**\n* Is the use of statistics and treatment of uncertainties appropriate?: **Yes**\n* Is the presentation of the work clear?: **Yes**\n* Are the images in this manuscript (including electrophoretic gels and blots) free from apparent manipulation?: **Yes**\n"},{"type":"reviewerAgreed","content":"","date":"2020-11-04T01:00:00+00:00","index":4,"fulltext":""},{"type":"reviewerAgreed","content":"","date":"2020-11-04T00:00:00+00:00","index":3,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2020-10-17T12:00:00+00:00","index":2,"fulltext":"Recommendation: Accept after minor essential revisions\nForm responses:\n---\n\nComments to Author:\n---\nPlease include all comments for the authors in this box rather than uploading your report as an attachment. Please only upload as attachments annotated versions of manuscripts, graphs, supporting materials or other aspects of your report which cannot be included in a text format.\nPlease overwrite this text when adding your comments to the authors.\n\nThis paper investigated 847 patient safety incidents voluntarily reported (PSR) by anesthesiologists of one Chinese academic hospital in an 11 year period. This effort deserves praise, revealing the hospital's dedication for improvement. This is a retrospective analysis. The study provides some valuable results. However, after reviewing the manuscript, there are some issues that need to be addressed prior to its publication.\n\n1) Based on the description in the methodology section, the data collection process appears to have selection bias and potential subjective preferences. Is it a better alternative to process the data?\n2) In the demographic data table, the authors did not list age or BMI characteristics. Does age or BMI have any impact on airway or cardio, cerebral-vascular, and pharmacological incidents?\n3) The ASA physical status table and Demographic variable table are both labeled as Table 2, which may need to be edited.\n4) In Table 4, can authors describe the definition preventable versus unpreventable incidents? The judgment is based on what criteria ?\n5) It is recommended that authors ask a native English speaker to edit the manuscript and improve the paper's quality and readability. For example, under the report, \"severe\" can be changed to \"not uncommon\" or \"evident\". \"Clean\" the data into an Excel \"table form\" can be changed to \"consolidate\" the data into Excel \"format\". Data \"cleaning\" can be changed to data \"processing\". Multidisciplinary \"corporation\" can be changed to multidisciplinary \"team\" etc.\n* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. Your name, email address, title of the reviewed manuscript, name of the journal, and date of your review submission (the “Review Data”) will then be transmitted to Publons upon publication of the manuscript. If you have already registered at Publons, they will notify you of the receipt of this review and update your profile as per your settings and their policy. If you are not registered with Publons, you will receive an email from them asking you to register in order for them to be able to recognize your review on your new profile page. Publons may use the Review Data to generate derivative metadata for the benefit of Publons and you as a reviewer, carefully considering the sensitivity of such information. For example, Publons may verify your record as a reviewer by updating your profile published on its webservice if you have registered for such service or help editors to identify candidate reviewers. Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **No**\n* Declaration of competing interests: **I declare that I have no competing interests**\n* Reviewer Publication Consent. I agree for my report to be made available under an Open Access Creative Commons CC-BY License (http://creativecommons.org/licenses/by/4.0) if this manuscript is accepted for publication. Any comments that I do not wish to be included in the published report have been included as confidential comments to the editor, which will not be published.: **I agree to the terms of the CC-BY 4.0 license; please do not publish my name with my report. (default)**\n* Is the study design appropriate to answer the research question (including the use of appropriate controls), and are the conclusions supported by the evidence presented?: **Yes**\n* Are the methods sufficiently described to allow the study to be repeated?: **Yes**\n* Is the use of statistics and treatment of uncertainties appropriate?: **Yes**\n* Is the presentation of the work clear?: **Yes**\n* Are the images in this manuscript (including electrophoretic gels and blots) free from apparent manipulation?: **Yes**\n"},{"type":"editorInvitedReview","content":"","date":"2020-10-17T00:00:00+00:00","index":1,"fulltext":"Recommendation: Reject\nForm responses:\n---\n\nComments to Author:\n---\nThank you for your paper.\nIt is an interesting review of a single center reporting.\nPlease reshape table 1 because is not well intellegibile.\nThe other concern is about the reporting amount which is very low, with these numbers any inference on anesthesia complication would be not the picture of real world.\nUnfortunately the application and value of the percentage of reporting you have mention cannot be used for a conclusive discussion* Publons Reviewer Recognition. Springer Nature can send verification of this review directly to Publons (a subsidiary of Clarivate Analytics). If you would like to take advantage of this service, please click on the “Yes” option below. Your name, email address, title of the reviewed manuscript, name of the journal, and date of your review submission (the “Review Data”) will then be transmitted to Publons upon publication of the manuscript. If you have already registered at Publons, they will notify you of the receipt of this review and update your profile as per your settings and their policy. If you are not registered with Publons, you will receive an email from them asking you to register in order for them to be able to recognize your review on your new profile page. Publons may use the Review Data to generate derivative metadata for the benefit of Publons and you as a reviewer, carefully considering the sensitivity of such information. For example, Publons may verify your record as a reviewer by updating your profile published on its webservice if you have registered for such service or help editors to identify candidate reviewers. Please find the details of processing in Publons’ privacy policy https://publons.com/about/terms: **Yes**\n* Declaration of competing interests: **I declare that I have no competing interests**\n* Reviewer Publication Consent. I agree for my report to be made available under an Open Access Creative Commons CC-BY License (http://creativecommons.org/licenses/by/4.0) if this manuscript is accepted for publication. Any comments that I do not wish to be included in the published report have been included as confidential comments to the editor, which will not be published.: **I agree to the terms of the CC-BY 4.0 license; please do not publish my name with my report. (default)**\n* Is the study design appropriate to answer the research question (including the use of appropriate controls), and are the conclusions supported by the evidence presented?: **Yes**\n* Are the methods sufficiently described to allow the study to be repeated?: **Yes**\n* Is the use of statistics and treatment of uncertainties appropriate?: **Yes**\n* Is the presentation of the work clear?: **Yes**\n* Are the images in this manuscript (including electrophoretic gels and blots) free from apparent manipulation?: **Yes**\n"},{"type":"reviewerAgreed","content":"","date":"2020-10-13T12:00:00+00:00","index":2,"fulltext":""},{"type":"reviewerAgreed","content":"","date":"2020-10-12T12:00:00+00:00","index":1,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2020-10-07T12:00:00+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2020-09-29T12:00:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2020-09-28T12:00:00+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2020-09-28T12:00:00+00:00","index":"","fulltext":""},{"type":"submitted","content":"","date":"2020-09-27T12:00:00+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-anesthesiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bane","sideBox":"Learn more about [BMC Anesthesiology](http://bmcanesthesiol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bane","title":"BMC Anesthesiology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"acc25fd9-1866-4824-b883-be701de66bf8","owner":[],"postedDate":"October 8th, 2020","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":690174,"name":"Anesthesiology \u0026 Pain Medicine"}],"tags":[],"updatedAt":"2021-01-10T15:05:19+00:00","versionOfRecord":{"articleIdentity":"rs-86731","link":"https://doi.org/10.1186/s12871-020-01226-0","journal":{"identity":"bmc-anesthesiology","isVorOnly":false,"title":"BMC Anesthesiology"},"publishedOn":"2021-01-07 15:00:36","publishedOnDateReadable":"January 7th, 2021"},"versionCreatedAt":"2020-10-08 19:57:08","video":"","vorDoi":"10.1186/s12871-020-01226-0","vorDoiUrl":"https://doi.org/10.1186/s12871-020-01226-0","workflowStages":[]},"version":"v1","identity":"rs-86731","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-86731","identity":"rs-86731","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}