The effect of a simple checklist on frequent pre-induction deficiencies

Transcription

1 Acta Anaesthesiol Scand 2010; 54: Printed in Singapore. All rights reserved r 2010 The Authors Journal compilation r 2010 The Acta Anaesthesiologica Scandinavica Foundation ACTA ANAESTHESIOLOGICA SCANDINAVICA doi: /j x The effect of a simple checklist on frequent pre-induction deficiencies Ø. THOMASSEN 1,2,G.BRATTEBØ 1,3,E.SØFTELAND 1,H.M.LOSSIUS 2,4 and J-K. HELTNE 1,5 1 Department of Anaesthesia and Intensive Care, Haukeland University Hospital, Bergen, Norway, 2 Department of Research, Norwegian Air Ambulance Foundation, Drøbak, Norway, 3 Betanien University College, Bergen, Norway, Departments of 4 Surgical Sciences and 5 Medical Sciences, University of Bergen, Bergen, Norway Background: A substantial proportion of anaesthesiarelated adverse events are preventable by identification and correction of errors in planning, communication, fatigue, stress, and equipment. The aim of this study was to develop and implement a pre-induction checklist in order to identify and solve problems before induction of anaesthesia. Methods: The checklist was developed in a stepwise manner using a modified Delphi technique, literature search, expert s opinion, and a pilot version, and then implemented in a clinical environment during a 13-week study period. Each list was registeredandanalysedusing statistical process control. The checklist was mandatory, but emergency cases were excluded. Results: The checklist, containing 26 items, was used in 502 (61%) of a total of 829 inductions. Eighty-five checklists (17%) identified one or more missing items. The number of missing items decreased significantly throughout the study period. The most important missing items were lack of a second laryngoscope available, introducer not having been fitted to the endotracheal tube, the endotracheal tube cuff not having been tested, and no separate ventilation bag being available. It took a median of 88.5 s (range ) to perform the checklist when no items were missing. The pre-induction time was the same before and after the checklist was introduced (25.1 vs min, P ). Conclusions: It is possible to develop, introduce, and use a pre-induction checklist even in a hectic and stressful clinical environment. The checklist identified and reduced a surprisingly large number of missing items required in a standard induction protocol. Accepted for publication 9 August 2010 r 2010 The Authors Journal compilation r 2010 The Acta Anaesthesiologica Scandinavica Foundation Background ANAESTHESIOLOGY is considered to be a leading discipline in the field of patient safety; nevertheless, serious complications still occur. 1 Events related to the airway are an important cause of lifethreatening anaesthesia-related complications. 2 The true incidence of anaesthesia-related problems are unknown, as most adverse events and near accidents are not reported. 3 5 Failure to check equipment and inattention are factors associated with adverse events. 6,7 A checklist is an organized tool that outlines criteria for a particular process. Checklists simplify conceptualization and recall of information. 8 Aviation and other so-called high-reliability organizations (HRO) use checklists to help decrease human error. 9 Checklists have been demonstrated to be effective in selected medical fields, but are rarely used on a daily basis A recent study found that the majority of the members of the operating team believe that a pre-operative checklist increases patient safety. 14 It is argued that the use of checklists is far more difficult in medicine than aviation, given the variability in the patient population and the unpredictability of human physiology. 9 Despite complexity and diversity among patients, a substantial proportion of anaesthesia-related adverse events are preventable by identification and correction of errors or omissions in planning, communication, fatigue, stress, and equipment. 15,16 Themaingoalwhenusing checklists is to make such potential hazards visible by proactively searching and probing the system. Problem Several adverse events have been reported from the operating theatres at our hospital. Some of the 1179

2 Ø. Thomassen et al. causes have been identified as a malfunction of anaesthesia machines, lack of certain airway management equipment, and wrong use of or missing medications. Today, the anaesthesia machine is tested routinely by a nurse anaesthetist (NA) performing an extensive morning check and then a shorter check before each new patient, in adherence to the manufacturer s manual. It is the anaesthesiologist s own responsibility, based on his/her memory and experience, to decide whether any other checks should be performed before induction. There are no department protocols describing general mandatory safety measures before induction of anaesthesia. New junior doctors are introduced to the field of anaesthesia through the learning by doing approach. It is likely that at least some adverse events could have been prevented with a standardized pre-induction checklist. Aim The aim of this study was to develop and implement a pre-induction checklist in order to identify and solve problems before induction of anaesthesia. The outcome measures included personnel compliance, identification of missing items, and the time spent to complete the checklist. We also wanted to measure the variation in compliance and findings. Methods Setting The study was performed in the anaesthesia and intensive care department of an 1100-bed tertiary teaching hospital. The personnel involved were 26 NA, four consulting anaesthesiologists, and four junior doctors who served seven operating theatres (neuro-, plastic, burn, and ENT surgery). Interventions The checklist was developed in a stepwise manner (Fig. 1). First, adverse event reports from our department identifying missing equipment or planning as contributing causes were reviewed. Second, PubMed was searched using the keywords checklist and anaesthesia. Further items were developed after a discussion during the annual meeting in The Danish Society for Patient Safety. We also obtained input based on extensive checklist experiences at London HEMS. Based on this process, we 1180 Adverse event reports Literature search PubMed Checklist First Version Checklist Second Version Checklist Final Version Fig. 1. Development process of checklist. Experts Modified Delphi Method (Department consultants) Pilot testing designed the first version of the checklist. It was further developed using a modified Delphi technique. 17 The department s consultants were asked to add or remove items through a two-step revision procedure on , resulting in the second version. All the consultants participated in the Delphi process. This pilot version was then tested in 20 elective inductions and evaluated by the study group. After this three-step process, the graphical layout of a final checklist was made by a professional designer, printed on paper, foliated, and attached to each anaesthetic machine. All patients planned for general anaesthesia (GA), regional anaesthesia (RA), or local anaesthesia (LA) were included, and the checklist was introduced as mandatory. After a thorough discussion, patients who required emergency surgery were excluded to avoid potentially delaying induction when time was critical. The checklist was not to be used as a memory list while preparing for anaesthesia, but to control preparedness just before induction. Measures Every Monday morning at 8:00 hours during the 13-week study period, we collected the checklists from the previous week and counted operations performed during the same period. Each collected list was numbered and scanned for remarks, and registered in an SPSS data base. We also measured the time spent in the operating theatre before induction and, in the last phase of the project, the specific time used to perform each checklist. Statistical methods Data were analysed using statistical process control This is a statistical method used to evaluate a process during its run in order to

3 Pre-induction checklist constantly check whether it is deviating from the expected pattern. The method is useful for identifying time-related changes. We used a p-chart with three-sigma control limits to analyse process variation [Run Charter (version 3.5, PQ Systems Inc., Dayton, OH, USA), upper control limit (UCL), and lower control limit (LCL) 3 SD from the mean] and an independent two-sample t-test to analyse time spent performing the checklist. Results We received 15 feedbacks on the first version of the checklist during the testing period, and the final checklist contained 26 items (Fig. 2). During a period of 13 weeks, the checklist was used in 502 CHECKLIST - BEFORE INTUBATION Hode Hals seksjonen, KSK, HUS VENTILATOR Missing Controlled Vaporizer filled Simple leakage test Extra ventilation bag (Laerdal) Remote-control for operation table INTUBATION Laryngoscope blade length Additional laryngoscope Magill`s forceps Suction working Suction catheter connected Tube sizes Cuffl leakage Tube introducer preformed Bougie available Xylocain gel (nasal intubation) Guedel air ways PATIENT IV running BP, HR, SpO2 recorded MEDICATION Type, volume and dose agreed Double checked and labeled TIVA: correct syringe in pump Suxamethonium available Anti anaphylactic drug available IF UNEXPECTED DIFFICULT INTUBATION Algorithm agreed upon Neccessary equipment available Available senior if airway problems Comments on the back side Fig. 2. Final version of the pre-induction checklist. (61%) of a total of 829 inductions (Fig. 3). Eightyfive checklists (17%) identified one or more missing items (Fig. 4). The range of checklists with missing items was 4 46% on a weekly basis. The most important missing items were lack of a second laryngoscope available, introducer not having been fitted to the endotracheal tube, the endotracheal tube cuff not having been tested, and no separate ventilation bag being available (Table 1). It took a median of 88.5 s (range ) to perform the checklist when no items were missing (n 5 32). The mean time spent in the operating theatre before induction was the same before and after the checklist was introduced (25.1 min, n vs min, n 5 502, t-test 1.15, P ). Causes of variation by week The number of missing items decreased significantly throughout the study period and in the last seven weeks, the percentages of missing items were one run under the mean. In the second, third, and fifth week, there were special causes of variation on the frequency of missing items. During the third study week, the percentages of missing items and the use of the checklist were above UCL and under LCL, respectively. In the second and the fifth week, the use of the checklist was above UCL. In the last 7 weeks of the study period, the percentages of missing items were one run under the mean, showing a significant decrease in the frequency of missing items throughout the study period. Discussion Induction of anaesthesia is a complex and potentially hazardous procedure. If unexpected situations occur, time is essential to a successful outcome. Delay caused by missing or nonfunctional equipment may be critical. In the present study, the use of a pre-induction checklist uncovered and reduced a surprisingly large number of omitted or missing items. In specific situations, the missing items would have been essential in handling an unforeseen situation. An additional laryngoscope and separate manual ventilation bag are both essential backup equipment if the bulb or the battery in the laryngoscope or the mechanical ventilator malfunctions, respectively. Better prepared We observed a decrease in the frequency of missing items throughout the study period. This may be 1181

4 Ø. Thomassen et al. Use of the checklist p chart Temporary: UCL = 78.92; Mean =60.55; LCL = Inspected Mean = 63.77; Counts Mean = % use Week Fig. 3. Control p-chart showing the proportion (%) of patients in whom the checklist was used for each week. UCL, upper control limit; LCL, lower control limit. 50 Missing items p chart Temporary: UCL = 35.04; Mean = 16.93; LCL = none Inspected Mean = 38.62; Counts Mean = % Missing items Week Fig. 4. Control p-chart showing the proportion (%) of identified missing items for each week. UCL, upper control limit; LCL, lower control limit. due to learning effects from the checklist itself resulting in improvements of pre-induction preparation. Checklist fatigue is a well-known phenomenon. 8 The frequency of list use did not decline throughout, and therefore, it is less likely that such 1182 fatigue in fact occurred or was a cause of the decrease in missing items. Involuntary automaticity is a cognitive mechanism that may cause individuals to miss cues even though they are right in front of them. 21 This phenomenon is difficult to

5 Pre-induction checklist Table 1 Most frequently identified deficiencies. Identified deficiency Number Additional laryngoscope 18 Preformed tube introducer available 17 Cuff leakage checked 16 Ventilation bag available 11 Additional tube ( one size) available 10 BP, HR, SpO 2 recorded 9 IV running 8 measure, but we believe our study period was too short to develop such automaticity. Cultural differences in checklist use Use of checklists is highly regulated in HROs. 9 Preoccupation with failure, reluctance to simplify interpretations, and sensitivity to operations are characteristics responsible for the mindfulness that keeps HROs working well when facing unexpected situations. Health care is far behind these organizations in checklist implementation. 22 Our checklist was used in 61% of all anaesthesias during the testing period despite instructions that completing the checklist from memory or not using it at all was a protocol violation. A few persons in leading positions, both formal and informal, discouraging checklist use may have contributed to this low compliance. In other cultures, such behaviour would have been regarded as unacceptable and a pilot wouldbegroundedifheorsheusedthe before take-off checklist in only two-thirds of the flights. Eastern holiday as a cause of special variation The eastern holiday occurred during the third week of the project. We knew that most of the regular doctors and nurses would be off on the holiday and prepared the remaining staff on the importance of information to unfamiliar personnel on the study. During this holiday period, checklist use declined to 30%, and at the same time, detection of error increased to 46%. Time is life and money Often, there is limited time to perform preparations before a GA. Surgeons are pushing to start the procedure and every minute is money for the administration in a cost-effective focused health care system. During the pilot study, there were critical comments on the time issue. The checklist contained 26 items, but was completed in 88.5 s and did not cause any significant difference in preinduction time (25.1 vs min). Success factors for checklist implementation An effective, standardized methodology to develop and design specific medical checklists has not been previously presented and validated. 8 We believe that the comprehensive and thorough method used here was essential to generate a checklist useful in daily work. Probably the most important factor for success when introducing a checklist is to focus on avoiding checklist fatigue during the planning stages and to makethelistsimpletocarryout. 21 After the study was completed, use of the checklist became standard as an essential part of the pre-operative protocol. We also felt that such a process must be supervised by a participating senior clinician. In order to prove credibility to the nurses and senior doctors, the researchers themselves must be present during such a study. During the study period, two new junior doctors were introduced to the department. Retrospectively, we were not adequately prepared for providing continuous supply of information and encouragement during the study period. Only during the second and the fifth week of the study did the chief consultant send an with instructions to keep spirits high. The use of the checklist was above 90% during these 2 weeks. Limitations We decided to also include patients receiving RA or LA in order to be prepared when having to convert to GA due to limitations of, or a poor functioning of, LA or RA. There is always a need to be prepared for such conversions and also for complications related to the anaesthesia (RA or LA) itself. We believe that this wide inclusion criteria might be an important factor in explaining the underuse of the checklist. With a response rate of only 61%, it is likely that the real number of missing items was higher than our findings indicate (17%). Before the study, all nurses and doctors had received thorough information through s, personal letters, several lessons at morning meetings, and training during the development of the list. The group was sensitized to the aim of the project before it started. It is likely that a majority tried to prepare the induction better than they would under normal circumstances. This bias could yield a falsely low number of missing items. Underestimating when reporting adverse events is well known. 5 Adverse events statistics rely on self-reporting at our hospital. We believe that a 1183

6 Ø. Thomassen et al. majority of our adverse events are not reported at all. In order to show a decrease in morbidity or mortality after introducing a checklist, an adverse event reporting system with high sensitivity is required at the outset. It would have been of considerable value in this study to include frequencies of adverse events as a study endpoint, but at this stage, it is not possible due chiefly to our culture of underreporting. We do not know whether the missing items revealed by the checklist would have caused any adverse events or increased morbidity or mortality. It is, however, fair to assume that the decrease in pre-induction omissions resulted in fewer potentially dangerous situations for the patients. Conclusions A pre-induction checklist is a useful tool to detect missing or malfunctioning equipment. It is possible to develop, introduce, and use such a list even in a hectic and stressful clinical environment. The checklist identified and reduced a surprisingly large number of missing items required in a standard induction protocol. The low compliance raises new questions and the need of further studies on feasibility and cultural aspects in health care systems. Acknowledgements We thank professor Torben Wisborg for valuable inputs during the study period and for comments on the manuscript, Per Bredmose, MD, London HEMS, and Norwegian Air Ambulance Foundation for financial support to Ø.T.during the study period. Ethical approval: Not required. Conflict of interest: None. References 1. Gaba DM. Anaesthesiology as a model for patient safety in health care. Br Med J 2000; 320: Cheney FW. The American society of anesthesiologists closed claims project: what have we learned, how has it affected practice, and how will it affect practice in the future? Anesthesiology 1999; 91: Alberti KG. Medical errors: a common problem. Br Med J 2001; 322: Haller G, Myles PS. Learning from incidents and nearmisses reports. Anesthesiology 2005; 102: Karson AS, Bates DW. Screening for adverse events. J Eval Clin Pract 1999; 5: Marcus R. Human factors in pediatric anesthesia incidents. Paediatr Anaesth 2006; 16: Cooper JB, Newbower RS, Long CD, McPeek B. Preventable anesthesia mishaps: a study of human factors Qual Saf Health Care 2002; 11: Hales B, Terblanche M, Fowler R, Sibbald W. Development of medical checklists for improved quality of patient care. Int J Qual Health Care 2008; 20: Hales BM, Pronovost PJ. The checklist a tool for error management and performance improvement. J Crit Care 2006; 21: Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009; 360: DuBose JJ, Inaba K, Shiflett A, Trankiem C, Teixeira PG, Salim A, Rhee P, Demetriades D, Belzberg H. Measurable outcomes of quality improvement in the trauma intensive care unit: the impact of a daily quality rounding checklist. J Trauma 2008; 64: Verdaasdonk EG, Stassen LP, Hoffmann WF, van der Elst M, Dankelman J. Can a structured checklist prevent problems with laparoscopic equipment? Surg Endosc 2008; 22: Hart EM, Owen H. Errors and omissions in anesthesia: a pilot study using a pilot s checklist. Anesth Analg 2005; 101: Nilsson L, Lindberget O, Gupta A, Vegfors M. Implementing a pre-operative checklist to increase patient safety: a 1- year follow-up of personnel attitudes. Acta Anaesthesiol Scand 2010; 54: Bell D. Avoiding adverse outcomes when faced with difficulty with ventilation. Anaesthesia 2003; 58: Davies JM. Team communication in the operating room. Acta Anaesthesiol Scand 2005; 49: Bowles N. The Delphi technique. Nurs Stand 1999; 13: Noyez L. Control charts, cusum techniques and funnel plots. A review of methods for monitoring performance in healthcare. Interact Cardiovasc Thorac Surg 2009; 9: Carey R, Lloyd R. Measuring quality improvement in healthcare: a guide to statistical process control applications. Milwaukee, WI: Quality Press, Fasting S, Gisvold SE. Statistical process control methods allow the analysis and improvement of anesthesia care. Can J Anaesth 2003; 50: Wilson IH, Walker IA. Theatre checklists and patient safety. Anaesthesia 2008; 63: Karl RC. Aviation. J Gastrointest Surg 2009; 13: 6 8. Address: Øyvind Thomassen Department of Anaesthesia and Intensive Care Haukeland University Hospital PO box 1, 5021 Bergen Norway oyvt@helse-bergen.no 1184