Revealing complex interdependencies in surgical instrument reprocessing using SEIPS 101 tools.

Sterile Processing Departments (SPDs) must clean, maintain, store, and organize surgical instruments which are then delivered to Operating Rooms (ORs) using a Courier Network, with regular coordination occurring across departmental boundaries. To represent these relationships, we utilized the Systems Engineering Initiative for Patient Safety (SEIPS) 101 Toolkit, which helps model how health-related outcomes are affected by healthcare work systems. Through observations and interviews which built on prior work system analyses, we developed a SEIPS 101 journey map, PETT scan, and tasks matrices to represent the instrument reprocessing work system, revealing complex interdependencies between the people, tools, and tasks occurring within it. The SPD, OR and Courier teams are found to have overlapping responsibilities and a clear co-dependence, with critical implications for the successful functioning of the whole hospital system.

The impact of resident training on robotic operative times: is there a July Effect?

It is unknown whether the July Effect (a theory that medical errors and organizational inefficiencies increase during the influx of new surgical residents) exists in urologic robotic-assisted surgery. The aim of this study was to investigate the impact of urology resident training on robotic operative times at the beginning of the academic year. A retrospective chart review was conducted for urologic robotic surgeries performed at a single institution between 2008 and 2019. Univariate and multivariate mix model analyses were performed to determine the association between operative time and patient age, estimated blood loss, case complexity, robotic surgical system (Si or Xi), and time of the academic year. Differences in surgery time and non-surgery time were assessed with/without resident presence. Operative time intervals were included in the analysis. Resident presence correlated with increased surgery time (38.6 min (p < 0.001)) and decreased non-surgery time (4.6 min (p < 0.001)). Surgery time involving residents decreased by 8.7 min after 4 months into the academic year (July-October), and by an additional 5.1 min after the next 4 months (p = 0.027, < 0.001). When compared across case types stratified by complexity, surgery time for cases with residents significantly varied. Cases without residents did not demonstrate such variability. Resident presence was associated with prolonged surgery time, with the largest effect occurring in the first 4 months and shortening later in the year. However, resident presence was associated with significantly reduced non-surgery time. These results help to understand how new trainees impact operating room times.

Healthcare team resilience during COVID-19: a qualitative study.

BACKGROUND: Resilience, in the field of Resilience Engineering, has been identified as the ability to maintain the safety and the performance of healthcare systems and is aligned with the resilience potentials of anticipation, monitoring, adaptation, and learning. In early 2020, the COVID-19 pandemic challenged the resilience of US healthcare systems due to the lack of equipment, supply interruptions, and a shortage of personnel. The purpose of this qualitative research was to describe resilience in the healthcare team during the COVID-19 pandemic with the healthcare team situated as a cognizant, singular source of knowledge and defined by its collective identity, purpose, competence, and actions, versus the resilience of an individual or an organization. METHODS: We developed a descriptive model which considered the healthcare team as a unified cognizant entity within a system designed for safe patient care. This model combined elements from the Patient Systems Engineering Initiative for Patient Safety (SEIPS) and the Advanced Team Decision Making (ADTM) models. Using a qualitative descriptive design and guided by our adapted model, we conducted individual interviews with healthcare team members across the United States. Data were analyzed using thematic analysis and extracted codes were organized within the adapted model framework. RESULTS: Five themes were identified from the interviews with acute care professionals across the US (N = 22): teamwork in a pressure cooker, consistent with working in a high stress environment; healthcare team cohesion, applying past lessons to present challenges, congruent with transferring past skills to current situations; knowledge gaps, and altruistic behaviors, aligned with sense of duty and personal responsibility to the team. Participants' described how their ability to adapt to their environment was negatively impacted by uncertainty, inconsistent communication of information, and emotions of anxiety, fear, frustration, and stress. Cohesion with co-workers, transferability of skills, and altruistic behavior enhanced healthcare team performance. CONCLUSION: Working within the extreme unprecedented circumstances of COVID-19 affected the ability of the healthcare team to anticipate and adapt to the rapidly changing environment. Both team cohesion and altruistic behavior promoted resilience. Our research contributes to a growing understanding of the importance of resilience in the healthcare team. And provides a bridge between individual and organizational resilience.

The movement of syringes and medication during anesthesiology delivery: An observational study in laparoscopic surgeries.

The movements of syringes and medications during an anesthetic case have yet to be systematically documented. We examine how syringes and medication move through the anesthesia work area during a case. We conducted a video-based observational study of 14 laparoscopic surgeries. We defined 'syringe events' as when syringe was picked up and moved. Medications were administered to the patient in only 48 (23.6%) of the 203 medication or syringe events. On average, 14.5 syringe movements occurred in each case. We estimate approximately 4.2 syringe movements for each medication administration. When a medication was administered to the patient (either through the IV pump or the patient port), it was picked up from one of 8 locations in the work area. Our study suggests that the syringe storage locations vary and include irregular locations (e.g., patient bed or provider's pockets). Our study contributes to understanding the complexity in the anesthesia work practices.

The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.

The next generation of surgical robotics is poised to disrupt healthcare systems worldwide, requiring new frameworks for evaluation. However, evaluation during a surgical robot's development is challenging due to their complex evolving nature, potential for wider system disruption and integration with complementary technologies like artificial intelligence. Comparative clinical studies require attention to intervention context, learning curves and standardized outcomes. Long-term monitoring needs to transition toward collaborative, transparent and inclusive consortiums for real-world data collection. Here, the Idea, Development, Exploration, Assessment and Long-term monitoring (IDEAL) Robotics Colloquium proposes recommendations for evaluation during development, comparative study and clinical monitoring of surgical robots-providing practical recommendations for developers, clinicians, patients and healthcare systems. Multiple perspectives are considered, including economics, surgical training, human factors, ethics, patient perspectives and sustainability. Further work is needed on standardized metrics, health economic assessment models and global applicability of recommendations.

Anesthesia Workspaces for Safe Medication Practices: Design Guidelines.

BACKGROUND: Studies show that workspace for the anesthesia providers is prone to interruptions and distractions. Anesthesia providers experience difficulties while performing critical medication tasks such as medication preparation and administration due to poor ergonomics and configurations of workspace, equipment clutter, and limited space which ultimately may impact patient safety, length of surgery, and cost of care delivery. Therefore, improving design of anesthesia workspace for supporting safe and efficient medication practices is paramount. OBJECTIVES: The objective of this study was to develop a set of evidence-based design guidelines focusing on design of anesthesia workspace to support safer anesthesia medication tasks in operating rooms (ORs). METHODS: Data collection was based on literature review, observation, and coding of more than 30 prerecorded videos of outpatient surgical procedures to identify challenges experienced by anesthesia providers while performing medication tasks. Guidelines were then reviewed and validated using short survey. RESULTS: Findings are summarized into seven evidence-based design guidelines, including (1) locate critical tasks within a primary field of vision, (2) eliminate travel into and through the anesthesia zone (for other staff), (3) identify and demarcate a distinct anesthesia zone with adequate space for the anesthesia provider, (4) optimize the ability to reposition/reconfigure the anesthesia workspace, (5) minimize clutter from equipment, (6) provide adequate and appropriately positioned surfaces for medication preparation and administration, and (7) optimize task and surface lighting. CONCLUSION: This study finds many areas for improving design of ORs. Improvements of anesthesia work area will call for contribution and cooperation of entire surgical team.

Speech Communication Interference in the Operating Room.

INTRODUCTION: Operating room communication is frequently disrupted, raising safety concerns. We used a Speech Interference Instrument to measure the frequency, impact, and causes of speech communication interference (SCI) events. METHODS: In this prospective study, we observed 40 surgeries, primarily general surgery, to measure the frequency of SCI, defined as "group discourse disrupted according to the participants, the goals, or the physical and situational context of the exchange." We performed supplemental observations, focused on conducting postsurgery interviews with SCI event participants to identify contextual factors. We thematically analyzed notes and interviews. RESULTS: The observed 103 SCI events in 40 surgeries (mean 2.58) mostly involved the attending (50.5%), circulating nurse (44.6%), resident (44.6%), or scrub tech (42.7%). The majority (82.1%) of SCI events occurred during another patient-related task. 17.5% occurred at a critical moment. 27.2% of SCI events were not acknowledged or repeated and the message was lost. Including the supplemental observations, 97.0% of SCI events caused a delay (mean 5 s). Inter-rater reliability, calculated by Gwet's AC1 was 0.87-0.98. Postsurgery interviews confirmed miscommunication and distractions. Attention was most commonly diverted by loud noises (e.g., suction), conversations, or multitasking (e.g., using the electronic health record). Successful strategies included repetition or deferment of the request until competing tasks were complete. CONCLUSIONS: Communication interference may have patient safety implications that arise from conflicts with other case-related tasks, machine noises, and other conversations. Reorganization of workflow, tasks, and communication behaviors could reduce miscommunication and improve surgical safety and efficiency.

Associations of flow disruptions with patient, staff, and process outcomes: a prospective observational study of robotic-assisted radical prostatectomies.

BACKGROUND: Technological advancements in the operating room (OR) have sparked new challenges for surgical workflow, OR professionals, and patient safety. Disruptive events are frequent across all surgical specialties, but little is known about their effects on patient outcomes and the influence of systemic factors. The aim was to explore the associations of intraoperative flow disruptions (FDs) with patient outcomes, staff workload, and surgery duration. METHODS: Prospective, single-center, and multi-source study comprising direct and standardized OR observations of urologic surgical procedures, clinical patient outcomes, and staff- and patient-reported outcome data (PROMs; 3-month follow-up). All data were recorded between 01/2020 and 10/2021. FDs were assessed using standardized procedure observations. Linear and logistic regression analyses including multiple system factors were used to explore the effects of FDs on surgical outcomes. RESULTS: 61 robotic-assisted radical prostatectomy procedures were captured (with 61 patients and 243 staff reports). High rates of FDs were observed; however, our analyses did not show significant relationships with patient complication rates. Equipment- and patient-related FDs were associated with increased staff workload. No association was found between higher rates of FDs and procedure duration. CONCLUSIONS: FDs were not related to inferior patient outcomes. Our findings may inform future OR investigations that scrutinize the complex interplay of human, team, process, and technological components that mitigate the effects of FDs during surgery.

Demands of surgical teams in robotic-assisted surgery: An assessment of intraoperative workload within different surgical specialties.

BACKGROUND: Current approaches to assessing workload in robotic-assisted surgery (RAS) focus on surgeons and lack real-world data. Understanding how workload varies by role and specialty aids in identifying effective ways to optimize workload. METHODS: SURG-TLX surveys with six domains of workload were administered to surgical staff at three sites. Staff reported workload perceptions for each domain on a 20-point Likert scale, and aggregate scores were determined per participant. RESULTS: 188 questionnaires were obtained across 90 RAS procedures. Significantly higher aggregate scores were reported for gynecology (Mdn â€‹= â€‹30.00) (p â€‹= â€‹0.034) and urology (Mdn â€‹= â€‹36.50) (p â€‹= â€‹0.006) than for general (Mdn â€‹= â€‹25.00). Surgeons reported significantly higher scores for task complexity (Mdn â€‹= â€‹8.00) than both technicians (Mdn â€‹= â€‹5.00) (p â€‹= â€‹0.007), and nurses (Mdn â€‹= â€‹5.00). CONCLUSIONS: Staff reported significantly higher workload during urology and gynecology procedures, and experienced significant differences in domain workload by role and specialty, elucidating the need for tailored workload interventions.

Identifying Workflow Disruptions in Robotic-Assisted Bariatric Surgery: Elucidating Challenges Experienced by Surgical Teams.

PURPOSE: Bariatric surgery is an effective and durable treatment for weight loss for patients with extreme obesity. Although traditionally approached laparoscopically, robotic bariatric surgery (RBS) has unique benefits for both surgeons and patients. Nonetheless, the technological complexity of robotic surgery presents new challenges for OR teams and the wider clinical system. Further assessment of the role of RBS in delivering quality care for patients with obesity is necessary and can be done through a human factors approach. This observational study sought to investigate the impact of RBS on the surgical work system via the study of flow disruptions (FDs), or deviations from the natural workflow progression. MATERIALS AND METHODS: RBS procedures were observed between October 2019 and March 2022. FDs were recorded in real time and subsequently classified into one of nine work system categories. Coordination FDs were further classified into additional sub-categories. RESULTS: Twenty-nine RBS procedures were observed at three sites. An average FD rate of 25.05 (CI = ± 2.77) was observed overall. FDs were highest between insufflation and robot docking (M = 29.37, CI = ± 4.01) and between patient closing and wheels out (M = 30.00, CI = ± 6.03). FD rates due to coordination issues were highest overall, occurring once every 4 min during docking (M = 14.28, CI = ± 3.11). CONCLUSION: FDs occur roughly once every 2.4 min and happen most frequently during the final patient transfer and robot docking phases of RBS. Coordination challenges associated with waiting for staff/instruments not readily available and readjusting equipment contributed most to these disruptions.

Anticipating adaptation: tracking the impact of planned and unplanned adaptations during the implementation of a complex population-based genomic screening program.

In 2021, the Medical University of South Carolina (MUSC) launched In Our DNA SC. This large-scale initiative will screen 100,000 individuals in South Carolina for three preventable hereditary conditions that impact approximately two million people in the USA but often go undetected. In anticipation of inevitable changes to the delivery of this complex initiative, we developed an approach to track and assess the impact of evaluate adaptations made during the pilot phase of program implementation. We used a modified version of the Framework for Reporting Adaptations and Modification-Enhanced (FRAME) and Adaptations to code adaptations made during the 3-month pilot phase of In Our DNA SC. Adaptations were documented in real-time using a REDCap database. We used segmented linear regression models to independently test three hypotheses about the impact of adaptations on program reach (rate of enrollment in the program, rate of messages viewed) and implementation (rate of samples collected) 7 days pre- and post-adaptation. Effectiveness was assessed using qualitative observations. Ten adaptations occurred during the pilot phase of program implementation. Most adaptations (60%) were designed to increase the number and type of patient contacted (reach). Adaptations were primarily made based on knowledge and experience (40%) or from quality improvement data (30%). Of the three adaptations designed to increase reach, shortening the recruitment message potential patients received significantly increased the average rate of invitations viewed by 7.3% (p = 0.0106). There was no effect of adaptations on implementation (number of DNA samples collected). Qualitative findings support improvement in effectiveness of the intervention after shortening the consent form and short-term positive impact on uptake of the intervention as measured by team member's participation. Our approach to tracking adaptations of In Our DNA SC allowed our team to quantify the utility of modifications, make decisions about pursuing the adaptation, and understand consequences of the change. Streamlining tools for tracking and responding to adaptations can help monitor the incremental impact of interventions to support continued learning and problem solving for complex interventions being delivered in health systems based on real-time data.

We tracked adaptations to a large-scale population genetic screening program at the Medical University of South Carolina (MUSC) using the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME). We found adaptations during program roll-out that impacted implementation outcomes. Our approach to tracking adaptations for the program allowed us to quantify the utility of modifications, make decision about pursuing changes, and understand consequences of adaptations.

A better way: training for direct observations in healthcare.

Direct observation is valuable for identifying latent threats and elucidating system complexity in clinical environments. This approach facilitates prospective risk assessment and reveals workarounds, near-misses and recurrent safety problems difficult to diagnose retrospectively or via outcome data alone. As observers are an instrument of data collection, developing effective and comprehensive observer training is critical to ensuring the reliability of the data collection and reproducibility of the research. However, methodological rigour for ensuring these data collection properties remains a key challenge in direct observation research in healthcare. Although prior literature has offered key considerations for observational research in healthcare, operationalising these recommendations may pose a challenge and unless guidance is also provided on observer training. In this article, we offer guidelines for training non-clinical observers to conduct direct observations including conducting a training needs analysis, incorporating practice observations and evaluating observers and inter-rater reliability. The operationalisation of these guidelines is described in the context of a 5-year multisite observational study investigating technology integration in the operating room. We also discuss novel tools developed during the course our project to support data collection and examine inter-rater reliability among observers in direct observation studies.

A Novel Approach for Engagement in Team Training in High-Technology Surgery: The Robotic-Assisted Surgery Olympics.

INTRODUCTION: There is ongoing interest in the development of technical and nontechnical skills in healthcare to improve safety and efficiency; however, barriers to developing and delivering related training programs make them difficult to implement. Unique approaches to training such as "serious games" may offer ways to motivate teams, reinforce skill acquisition, and promote teamwork. Given increased challenges to teamwork in robotic-assisted surgery (RAS), researchers aimed to develop the "RAS Olympics," a game-based educational competition to improve skills needed to successfully perform RAS. METHODS: This pilot study was conducted at an academic medical center in Southern California. Robotic-assisted surgery staff were invited to participate in the "RAS Olympics" to develop their skills and identify opportunities to improve processes. Impact of the activity was assessed using surveys and debriefs. RESULTS: Sixteen operating room team members participated and reacted favorably toward the RAS-Olympics (average score, 4.5/5). They enjoyed the activity, would recommend all staff participate, felt that it was relevant to their work, and believed that they practiced and learned new techniques that would improve their practice. Confidence in skills remained unchanged. Participants preferred the RAS Olympics to traditional training because it provided an interactive learning environment. CONCLUSIONS: The successful implementation of the RAS Olympics provided insight into new opportunities to engage surgical staff members while also training technical and nontechnical skills. Furthermore, this shared experience allowed surgical staff members to gain a greater appreciation for their teammates and an understanding of the current challenges and methods to improve teamwork and communication while promoting safety and efficiency in RAS.

Improving safety in the operating room: Medication icon labels increase visibility and discrimination.

Misreading labels, syringes, and ampoules is reported to make up a 54.4% of medication administration errors. The addition of icons to medication labels in an operating room setting could add additional visual cues to the label, allowing for improved discrimination, visibility, and easily processed information that might reduce medication administration errors. A multi-disciplinary team proposed a method of enhancing visual cues and visibility of medication labels applied to vasoactive medication infusions by adding icons to the labels. Participants were 1.12 times more likely to correctly identify medications from farther away (p < 0.001, AOR = 1.12, 95% CI: 1.02, 1.22) with icons. When icons were present, participants were 2.16 times more likely to be more confident in their identifications (p < 0.001, AOR = 2.16, 95%CI: 1.80, 2.57). Carefully designed icons may offer an additional method for identifying medications, and thus reducing medication administration errors.

Understanding "Work as Done": Using a Structured Video-Based Observational Method to Understand and Model the Role of the Physical Environment in Complex Clinical Work Systems.

OBJECTIVE: To describe the planning, development, and implementation of a structured video-based observational method that can be used to systematically examine and model the role of the physical environment within healthcare systems. BACKGROUND: Direct observation methods are often used in healthcare to study complex healthcare systems. However, these observations often occur in real time, which predisposes the collected data to shortcomings such as time lags in recording of activities, overlooking events, or limiting the scope of information than can be collected. Video observation approaches eliminate many of these challenges and provide opportunities for researchers to understand and model the role of the physical environment. METHODS: An approach to developing and implementing a structured video-based observational method to study and model complex health systems is presented. RESULTS: A structured observational approach can be highly effective for collecting multiple layers of data necessary for understanding interactions between the physical environment and other systems components in healthcare settings. The proposed video-based observation method is effective in settings that have clearly defined environmental boundaries, limited number of people, are complex and fast-paced such as the OR, ED trauma rooms, and ICU rooms. CONCLUSIONS: Video-based observation is an effective complement to the traditional observational method for in-depth study of the built environment in health systems, enabling researchers to employ quantitative approaches to data collection and analysis, in addition to qualitative interpretations.

Human Factors Integration in Robotic Surgery.

OBJECTIVE: Using the example of robotic-assisted surgery (RAS), we explore the methodological and practical challenges of technology integration in surgery, provide examples of evidence-based improvements, and discuss the importance of systems engineering and clinical human factors research and practice. BACKGROUND: New operating room technologies offer potential benefits for patients and staff, yet also present challenges for physical, procedural, team, and organizational integration. Historically, RAS implementation has focused on establishing the technical skills of the surgeon on the console, and has not systematically addressed the new skills required for other team members, the use of the workspace, or the organizational changes. RESULTS: Human factors studies of robotic surgery have demonstrated not just the effects of these hidden complexities on people, teams, processes, and proximal outcomes, but also have been able to analyze and explain in detail why they happen and offer methods to address them. We review studies on workload, communication, workflow, workspace, and coordination in robotic surgery, and then discuss the potential for improvement that these studies suggest within the wider healthcare system. CONCLUSION: There is a growing need to understand and develop approaches to safety and quality improvement through human-systems integration at the frontline of care.Precis: The introduction of robotic surgery has exposed under-acknowledged complexities of introducing complex technology into operating rooms. We explore the methodological and practical challenges, provide examples of evidence-based improvements, and discuss the implications for systems engineering and clinical human factors research and practice.