Medication errors, critical incidents, adverse drug events, and more: a review examining patient safety-related terminology in anaesthesia.

Literature focused on quantifying or reducing patient harm in anaesthesia uses a variety of labels and definitions to represent patient safety-related events, such as 'medication errors', 'adverse events', and 'critical incidents'. This review extracts and compares definitions of patient safety-related terminology in anaesthesia to examine the scope of this variability and inconsistencies. A structured review was performed in which 36 of the 769 articles reviewed met the inclusion criteria. Similar terms were grouped into six categories by similarities in keyword choice (Adverse Event, Critical Incident, Medication Error, Error, Near Miss, and Harm) and their definitions were broken down into three base components to allow for comparison. Our analysis found that the Medication Error category, which encompasses the greatest number of terms, had widely variant definitions which represent fundamentally different concepts. Definitions of terms within the other categories consistently represented relatively similar concepts, though key variations in wording remain. This inconsistency in terminology can lead to problems with synthesising, interpreting, and overall sensemaking in relation to anaesthesia medication safety. Guidance towards how 'medication errors' should be defined is provided, yet a definition will have little impact on the future of patient safety without organisations and journals taking the lead to promote, publish, and standardise definitions.

Using flow disruptions to understand healthcare system safety: A systematic review of observational studies.

This systematic review provides information on the methodologies, measurements and classification systems used in observational studies of flow disruptions in clinical environments. The PRISMA methodology was applied and authors searched two databases (PubMed and Web of Science) for studies meeting the following inclusion criteria: (a) were conducted in a healthcare setting, (b) explored systems-factors leading to deviations in care processes, (c) were prospective and observational, (d) classified observations, and (e) were original research studies published in peer-reviewed journals. Thirty studies were analyzed and a variety of methods were identified for observer training, data collection and observation classification. Although primarily applied in surgery, comparable research has been successfully conducted in other venues such as trauma care, and delivery rooms. The findings of this review were synthesized into a framework of considerations for conducting rigorous methodological studies aimed at understanding clinical systems.

Research and Exploratory Analysis Driven-Time-data Visualization (read-tv) software.

MOTIVATION: Research & Exploratory Analysis Driven Time-data Visualization (read-tv) is an open source R Shiny application for visualizing irregularly and regularly spaced longitudinal data. read-tv provides unique filtering and changepoint analysis (CPA) features. The need for these analyses was motivated by research of surgical work-flow disruptions in operating room settings. Specifically, for the analysis of the causes and characteristics of periods of high disruption-rates, which are associated with adverse surgical outcomes. MATERIALS AND METHODS: read-tv is a graphical application, and the main component of a package of the same name. read-tv generates and evaluates code to filter and visualize data. Users can view the visualization code from within the application, which facilitates reproducibility. The data input requirements are simple, a table with a time column with no missing values. The input can either be in the form of a file, or an in-memory dataframe- which is effective for rapid visualization during curation. RESULTS: We used read-tv to automatically detect surgical disruption cascades. We found that the most common disruption type during a cascade was training, followed by equipment. DISCUSSION: read-tv fills a need for visualization software of surgical disruptions and other longitudinal data. Every visualization is reproducible, the exact source code that read-tv executes to create a visualization is available from within the application. read-tv is generalizable, it can plot any tabular dataset given the simple requirements that there is a numeric, datetime, or datetime string column with no missing values. Finally, the tab-based architecture of read-tv is easily extensible, it is relatively simple to add new functionality by implementing a tab in the source code. CONCLUSION: read-tv enables quick identification of patterns through customizable longitudinal plots; faceting; CPA; and user-specified filters. The package is available on GitHub under an MIT license.

Diagnosing barriers to safety and efficiency in robotic surgery.

Recent studies exploring the effects of surgical robots on teamwork are revealing challenges not reflected in clinical studies. This study is a sub analysis of observational data collected from 89 procedures utilising the da Vinci systems. Previous analyses had demonstrated interactions between flow disruptions and contextual factors. This study sought a more granular analysis to provide better insight for improvement. Raters sub-classified disruptions, based upon the original notes, grouped according to four operative phases (pre-robot; docking; surgeon on console; undocking; and finish). The need for repeated utterances; additional supplies retrieval; fogging or matter on the endoscope and procedure-specific training were particularly disruptive. Variations across phases reflect differing demands across the operative course. Combined qualitative and quantitative observational methodologies can identify otherwise undocumented sources of process variation and potential failure. Future observational frameworks should attempt to merge human reliability analysis, a priori modelling, and post hoc analyses of observational data. Practioner Summary: Robotic surgery introduces new challenges into the operating room. Direct observation was used to classify and identify flow disruptions in order to diagnose problems in need of improvement. This technique complements other error prediction and system diagnostic methods which may not account for the complexity and transparency of health care.

Preventing Retained Central Venous Catheter Guidewires: A Randomized Controlled Simulation Study Using a Human Factors Approach.

BACKGROUND: Retained central venous catheter guidewires are never events. Currently, preventative techniques rely on clinicians remembering to remove the guidewire. However, solutions solely relying upon humans to prevent error inevitably fail. A novel locked procedure pack was designed to contain the equipment required for completing the procedure after the guidewire should have been removed: suture, suture holder, and antimicrobial dressings. The guidewire is used as a key to unlock the pack and to access the contents; thereby, the clinician must remove the guidewire from the patient to complete the procedure. METHODS: A randomized controlled forced-error simulation study replicated catheter insertion. We created a retained guidewire event and then determined whether clinicians would discover it, comparing standard practice against the locked pack. RESULTS: Guidewires were retrieved from 2/10 (20%) standard versus 10/10 (100%) locked pack, n = 20, P < 0.001. In the locked pack group, participants attempted to complete the procedure; however, when unable to access the contents, this prompted a search for the key (guidewire). Participants discovered the guidewire within the catheter lumen, recovered it, utilized it to unlock the pack, and finish the procedure. A structured questionnaire reported that the locked pack also improved subjective safety of central venous catheter insertion and allowed easy disposal of the sharps and guidewire (10/10). CONCLUSIONS: The locked pack is an engineered solution designed to prevent retained guidewires. Utilizing forced-error simulation testing, we have determined that the locked pack is an effective preventative device and is acceptable to clinicians for improving patient safety.

Reducing Operating Room Turnover Time for Robotic Surgery Using a Motor Racing Pit Stop Model.

BACKGROUND: Operating room (OR) turnover time, time taken between one patient leaving the OR and the next entering, is an important determinant of OR utilization, a key value metric for hospital administrators. Surgical robots have increased the complexity and number of tasks required during an OR turnover, resulting in highly variable OR turnover times. We sought to streamline the turnover process and decrease robotic OR turnover times and increase efficiency. METHODS: Direct observation of 45 pre-intervention robotic OR turnovers was performed. Following a previously successful model for handoffs, we employed concepts from motor racing pit stops, including briefings, leadership, role definition, task allocation and task sequencing. Turnover task cards for staff were developed, and card assignments were distributed for each turnover. Forty-one cases were observed post-intervention. RESULTS: Average total OR turnover time was 99.2 min (95% CI 88.0-110.3) pre-intervention and 53.2 min (95% CI 48.0-58.5) at 3 months post-intervention. Average room ready time from when the patient exited the OR until the surgical technician was ready to receive the next patient was 42.2 min (95% CI 36.7-47.7) before the intervention, which reduced to 27.2 min at 3 months (95% CI 24.7-29.7) post-intervention (p < 0.0001). CONCLUSIONS: Role definition, task allocation and sequencing, combined with a visual cue for ease-of-use, create efficient, and sustainable approaches to decreasing robotic OR turnover times. Broader system changes are needed to capitalize on that result. Pit stop and other high-risk industry models may inform approaches to the management of tasks and teams.

Increased Age Predicts Failure to Rescue.

Failure to rescue (FTR), defined as any death after the development of in-hospital complications, is an important quality measure, but the relationship with age after a traumatic injury, has not been well defined. We sought to examine whether older trauma patients are at higher risk for FTR. The National Trauma Databank (NTDB) research datasets 2007 to 2011 were queried for patients ≥16 years who had any reported complication. Those who survived (non-FTR) were compared with those who did not (FTR) using a forward logistic regression model. Overall, 218,986 subjects met inclusion criteria of those, 201,358 (91.2%) survived their complication (non-FTR) and 17,628 (8.8%) died (FTR). A forward logistic regression identified age 65 to 89 years as the strongest predictor of FTR [adjusted odds ratio (AOR) 95% confidence interval (CI): 6.58 (6.11, 7.08), P < 0.001]. Using age group 16 to 45 years as the reference group, the adjusted risk for FTR increased with increasing age in a stepwise fashion [AOR (95 % CI): 1.94 (1.80, 2.09) for age 46 to 65 years, 6.78 (6.19, 7.42) for age 66 to 89 years and 27.58 [21.81, 34.87] for age ≥90 years]. The adjusted risk of FTR also increased in a stepwise fashion with increasing number of complications, reaching AOR (95 per cent CI) of 2.25 (2.07, 2.45), P < 0.001 for ≥4 complications. The risk of failure to rescue increases with age and number of complications. Strategies which track this quality measure to encourage early recognition and treatment of complications in the elderly are necessary.

Flow disruptions during trauma care.

BACKGROUND: Flow disruptions (FDs) are deviations from the progression of care that compromise safety or efficiency. The frequency and specific causes of FDs remain poorly documented in trauma care. We undertook this study to identify and quantify the rate of FDs during various phases of trauma care. METHODS: Seven trained observers studied a Level I trauma center over 2 months. Observers recorded details on FDs using a validated Tablet-PC data collection tool during various phases of care-trauma bay, imaging, operating room (OR)-and recorded work-system variables including breakdowns in communication and coordination, environmental distractions, equipment issues, and patient factors. RESULTS: Researchers observed 86 trauma cases including 72 low-level and 14 high-level activations. Altogether, 1,759 FDs were recorded (20.4/case). High-level trauma comprised a significantly higher number (p = 0.0003) and rate of FDs (p = 0.0158) than low-level trauma. Across the three phases of trauma care, there was a significant effect on FD number (p < 0.0001) and FD rate (p = 0.0005), with the highest in the OR, followed by computed tomography. The highest rates of FD per case and per hour were related to breakdowns in coordination. CONCLUSIONS: This study is the largest direct observational study of the trauma process conducted to date. Complexities associated with the critical patient who arrives in the trauma bay lead to a high prevalence of disruptions related to breakdowns in coordination, communication, equipment issues, and environmental factors. Prospective observation allows individual hospitals to identify and analyze these systemic deficiencies. Appropriate interventions can then be evaluated to streamline the care provided to trauma patients.

Barriers to trauma patient care associated with CT scanning.

BACKGROUND: Trauma care is often delivered to unstable patients with incomplete medical histories, under time pressure, and with a need for multidisciplinary collaboration. Trauma patient flow through radiology is particularly prone to deviations from optimal care. A better understanding of this process could reduce errors and improve quality, flow, and patient outcomes. STUDY DESIGN: Disruptions to the flow of trauma care during trauma activations were observed over a 10-week period at a level I trauma center. Using a validated data collection tool, the type, nature, and impact of disruptions to the care process were recorded. Two physicians unaffiliated with the study conducted a post hoc, blinded review of the flow disruptions and assigned a clinical impact score to each. RESULTS: There were 581 flow disruptions observed during the radiologic care of 76 trauma patients. An average of 30.5 minutes (95% CI, 27-34; median, 29; interquartile range, 20-38) was spent in the CT scanner, with a mean of 14.5 flow disruptions per hour (95% CI, 11.8-17.2). Coordination problems (34%), communication failures (19%), interruptions (13%), patient-related factors (12%), and equipment issues (8%) were the most frequent disruption types. Flow disruptions with the highest clinical impact were generally related to patient movements while in the scanner, problems with ordering systems, equipment unavailability, and ineffective teamwork. CONCLUSIONS: Although flow disruptions cannot be eliminated completely, specific targeted interventions are available to address the issues identified.

Flow disruptions in trauma care handoffs.

BACKGROUND: Effective handoffs of care are critical for maintaining patient safety and avoiding communication problems. Using the flow disruption observation technique, we examined transitions of care along the trauma pathway. We hypothesized that more transitions would lead to more disruptions, and that different pathways would have different numbers of disruptions. METHODS: We trained observers to identify flow disruptions, and then followed 181 patients from arrival in the emergency department (ED) to the completion of care using a specially formatted PC tablet. We mapped each patient's journey and recorded and classified flow disruptions during transition periods into seven categories. RESULTS: Mapping the transitions of care shows that approximately four of five patients were assessed in the ED, transferred to imaging for further diagnostics, and then returned to the ED. There was a mean of 2.2 ± 0.09 transitions per patient, a mean of 0.66 ± 0.15 flow disruptions per patient, and 0.31 ± 0.07 flow disruptions per transition. Most of these (53%) were related to coordination problems. Although disruptions did not rise with more transitions, patients who went directly to the operating room or needed direct admission to intensive care unit were significantly more likely (P=0.0028) to experience flow disruptions than those who took other, less expedited pathways. CONCLUSIONS: Transitions in trauma care are vulnerable to systems problems and human errors. Coordination problems predominate as the cause. Sicker, time-pressured, and more at-risk patients are more likely to experience problems. Safety practices used in motor racing and other industries might be applied to address these problems.

A multicenter trial of aviation-style training for surgical teams.

AIMS: This study measured the effect of aviation-style team training on 3 surgical teams from different specialties. It focused on team working and communication, particularly briefing, time-out, and debriefing, and sought to understand how improvements in team skills could be implemented in a broad range of naturalistic surgical environments to improve safety, quality, and efficiency. METHOD: Surgical teams performing maxillofacial, vascular, and neurosurgery were studied during 112 operations: 51 before and 61 after intervention. Human factors experts delivered the training of up to 2 days in the classroom followed by 6 days of coaching in theater for each team. Trained observers measured teamwork using the Oxford NOTECHS and the frequency of preoperative briefings, pre-incision time-outs, and postoperative debriefings. The Safety Attitudes Questionnaire and ethnographic observations were used to provide contextual details. RESULTS: There were significantly more time-outs (chi = 18.17, P < 0.001), briefings (chi = 8.62, P = 0.004), and debriefings (chi = 8.58, P = 0.004) after the intervention. The NOTECHS scores showed an interaction between site and intervention (F2,106 = 7.57, P = 0.001). The Safety Attitudes Questionnaire and ethnographic observations helped understand these differences. CONCLUSIONS: Aviation-style teamwork training can increase compliance and team performance, but this was influenced by the attitude and collaboration of key individuals, and the effect was reduced by significant latent failures. This study demonstrates the need to improve organizational and personal management factors in the National Health Service if training in patient safety is to be effective and sustained. It also shows the influence of working conditions on clinical studies of quality improvement.

Quality and safety on an acute surgical ward: an exploratory cohort study of process and outcome.

OBJECTIVE: To evaluate patient safety in an emergency surgical unit using process and outcome measures in parallel. BACKGROUND: Patient harm from errors in care is common in modern surgical practice. Measurement of the problem is essential to any solution, but current methods of evaluating patient harm are either impractical or inadequate. We have therefore analyzed compliance with safety-relevant care processes, with the aim of developing a process-based system for evaluating ward safety. METHODS: Adverse events (AE), potential adverse events (PAE), and 7 safety-relevant processes were measured on a 38-bed surgical emergency unit over a 16-week period. AE, PAE, and process measures were studied by prospective direct observation in large convenience samples, using objective measures. Possible influences on AE and PAE risk were analyzed. RESULTS: Compliance with the 7 processes studied ranged from 23% to 89%. The AE and PAE rates were 11.9% and 13.8% in a 63% sample of admissions (n = 607). Length of stay was significantly associated with both AE (P < 0.001) and PAE (P < 0.001). Having an operation was also associated with AE (P = 0.001) but not with PAE. No other factors appeared to influence AE/PAE rates. Delays were the commonest causes of both AE and PAE. CONCLUSIONS: Compliance with individual care processes on a ward with average levels of patient harm is poor. Length of hospital stay increases the risk of both AE and PAE, suggesting a system defect. A bundle of care processes may be useful for monitoring safety improvement.

Improving patient safety by identifying latent failures in successful operations.

BACKGROUND: The risk of technical failure during operations is recognized, but there is evidence that further improvements in safety depend on systems factors, in particular, effective team skills. The hypotheses that small problems can escalate to more serious situations and that effective teamwork can prevent the development of serious situations, were examined to develop a method to assess these skills and to provide evidence for improvements in training and systems. METHOD(S): Observations were made during 24 pediatric cardiac and 18 orthopedic operations. Operations were classified by accepted indicators of risk and the observations used to generate indicators of performance. Negative events were recorded and organized into 3 levels of clinical importance (minor problems, those negative events that were seemingly innocuous; intraoperative performance, the proportion of key operating tasks that were disrupted; and major problems, events that compromised directly the safety of the patient or the quality of the treatment). The ability of the team to work together safely was classified using a validated scale adapted from research in aviation. Operative duration was also recorded. RESULT(S): Both escalation and teamwork hypotheses were supported. Multiple linear regression suggests that for every 3 minor problems above the 9.9 expected per operation (P <.001), intraoperative performance reduces by 1% (P = .005), and operative duration increases by 10 minutes (P = .032). Effective teams have fewer minor problems per operation (P = .035) and consequently higher intraoperative performance and shorter operating times. Operative risk affected intraoperative performance (P = .004) and duration (P <.001), with the type of operation affecting only duration (P <.001). Eight major problems were observed; these showed a strong association with risk, intraoperative performance, teamwork, and the number of minor problems. CONCLUSION(S): Structured observation of effective teamwork in the operating room can identify substantive deficiencies in the system, even in otherwise successful operations. Decreasing the number of minor problems can lead to a smoother, safer, and shorter operation. Effective teamwork can help decrease the number of small problems and prevent them from escalating to more serious situations. The most effective and sustainable route to improved safety is in capturing these minor problems and identifying related system improvements, combined with training in safe team working. This method is a validated and practical way to improve performance during otherwise successful operations.

Patient handover from surgery to intensive care: using Formula 1 pit-stop and aviation models to improve safety and quality.

BACKGROUND: We aimed to improve the quality and safety of handover of patients from surgery to intensive care using the analogy of a Formula 1 pit stop and expertise from aviation. METHODS: A prospective intervention study measured the change in performance before and after the implementation of a new handover protocol that was developed through detailed discussions with a Formula 1 racing team and aviation training captains. Fifty (23 before and 27 after) postsurgery patient handovers were observed. Technical errors and information omissions were measured using checklists, and teamwork was scored using a Likert scale. Duration of the handover was also measured. RESULTS: The mean number of technical errors was reduced from 5.42 (95% CI +/-1.24) to 3.15 (95% CI +/-0.71), the mean number of information handover omissions was reduced from 2.09 (95% CI +/-1.14) to 1.07 (95% CI +/-0.55), and duration of handover was reduced from 10.8 min (95% CI +/-1.6) to 9.4 min (95% CI +/-1.29). Nine out of twenty-three (39%) precondition patients had more than one error in both technical and information handover prior to the new protocol, compared with three out of twnety-seven (11.5%) with the new handover. Regression analysis showed that the number of technical errors were significantly reduced with the new handover (t = -3.63, P < 0.001), and an interaction suggested that teamwork (t = 3.04, P = 0.004) had a different effect with the new handover protocol. CONCLUSIONS: The introduction of the new handover protocol lead to improvements in all aspects of the handover. Expertise from other industries can be extrapolated to improve patient safety, and in particular, areas of medicine involving the handover of patients or information.

Localizable auditory warning pulses.

Three important forms of information available to the listener may be identified in any auditory warning: what (semantic), where (location) and when (perceived urgency). Each form is addressed in the present design study of auditory warning pulses. Recordings were made via a dummy head, and were presented dichotically to listeners in a left/right localization task. The first experiment identified a suitable notched noise component for providing location information in the pulse stimulus. The second experiment required participants to simultaneously identify a distinct tonal signature and the location of the sound when they were presented with one of three tonal types, or one of three compound (tone plus noise) stimuli. Response accuracy and response latency for this identification and localization task were significantly better with the compound than with tone alone stimuli. Perceived urgency of compound complex tone plus noise stimuli was investigated in the third experiment. While there may be a trade-off between localization acuity and perceived urgency, the addition of noise components to the auditory warning pulse was shown to enhance the location information available to the listener. It is suggested that some auditory warning designs will benefit from the simultaneous provision of what and where forms of information in the sounds.