Impact of technology-assisted versus manual sterile compounding on safety and efficiency in a Canadian community hospital.

PURPOSE: Interventions to improve the safety and efficiency of manual sterile compounding are needed. This study evaluated the impact of a technology-assisted workflow system (TAWS) on sterile compounding safety (checks, traceability, and error detection), and efficiency (task time). METHODS: Observations were conducted in an oncology pharmacy transitioning from a manual to a TAWS process for sterile compounding. Process maps were generated to compare manual and TAWS checks and traceability. The numbers and types of errors detected were collected, and task times were observed directly or via TAWS data logs. RESULTS: Analysis of safety outcomes showed that, depending on preparation type, 3 to 4 product checks occurred in the manual process, compared to 6 to 10 checks with TAWS use. TAWS checks (barcoding and gravimetric verification) produced better traceability (documentation). The rate of incorrect-drug errors decreased with technology-assisted compounding (from 0.4% [5 of 1,350 preparations] with the manual process to 0% [0 of 1,565 preparations] with TAWS use; P < 0.02). The TAWS increased detection of (1) errors in the amount of drug withdrawn from vials (manual vs TAWS, 0.4% [5/1,350] vs 1.2% [18/1565]; P < 0.02), and (2) errors in the amount of drug injected into the final container (manual vs TAWS, 0% [0/1,236] vs 0.9% [11/1,272]; P < 0.002). With regard to efficiency outcomes, TAWS use increased the mean mixing time (manual vs TAWS, 275 seconds vs 355 seconds; P < 0.001), had no significant impact on average visual checking time (manual vs TAWS, 21.4 seconds vs 21.6 seconds), and decreased average physical checking time (manual vs TAWS, 58.6 seconds vs 50.9 seconds; P < 0.001). CONCLUSION: In comparison to manual sterile compounding, use of the TAWS improved safety through more frequent and rigorous checks, improved traceability (via superior documentation), and enhanced error detection. Results related to efficiency were mixed.

Vulnerabilities for Drug Diversion in the Handling, Data Entry, and Verification Tasks of 2 Inpatient Hospital Pharmacies: Clinical Observations and Healthcare Failure Mode and Effect Analysis.

OBJECTIVES: Inpatient hospital pharmacies have a central role in managing controlled substances (CS) throughout the hospital medication use process (MUP). Our objectives were to identify vulnerabilities for diversion in the MUPs of 2 inpatient pharmacies, explore differences between the sites, and characterize the types of vulnerabilities identified. METHODS: We conducted clinical observations in 2 pharmacies to map their MUPs and performed a healthcare failure mode and effect analysis to proactively identify (1) the critical failure modes (CFMs) that make them vulnerable to diversion and (2) the controls that prevent, mitigate, or enhance the detectability of CFMs. RESULTS: We conducted 99 hours of observations between May-June and September-October 2018. We observed 36 pharmacy technicians, 4 pharmacists, and 1 clerk as they conducted tasks involving 4 processes common to both sites: procuring CS, receiving CS deliveries to the pharmacy, unit-dose packaging CS oral solids, and distributing CS to hospital units. The tasks and subtasks we mapped in the process flow diagrams led to the identification of 220 failure modes. Of these, 34 were deemed CFMs and were categorized as related to handling CS, data entry, or verification tasks. Three of the CFMs were unique to one site, given that the other site had a control for the CFM. CONCLUSIONS: Multiple vulnerabilities for diversion exist in inpatient pharmacy processes. Our results provide some much needed detail about how specific vulnerabilities in MUP tasks and subtasks lead to an increased risk of diversion.

Impact of an Electronic Decision-Support System on Nursing Triage Process: A Usability and Workflow Analysis.

PURPOSE: To qualitatively contrast emergency department triage workflow using a paper-based triage system and an electronic decision-support tool (electronic Canadian Triage and Acuity Scale (eCTAS)). METHODS: Triage nurses from a single institution were invited to perform triage assessments of mock patients using a paper-based triage system and eCTAS. These assessments were completed using simulation scenarios, some of which involved facilitators probing triage nurses' thoughts on the design of the eCTAS system. Participants were asked to "think aloud," describing their thought patterns as they completed the triage process. Similar patient scenarios with the same Canadian Emergency Department Information System (CEDIS) presenting complaint and triage score were used for comparison between paper-based triage and electronic decision-support tool (eCTAS) conditions. RESULTS: Eight participants completed at least two simulation scenarios for each condition and at least one usability scenario with eCTAS. The simulated encounters showed eCTAS provided several advantages to paper-based triage assessment process by shortlisting possible CEDIS complaints and preselecting relevant modifiers. However, usability concerns were identified with eCTAS including challenges related to data entry and eCTAS score overrides. CONCLUSIONS: Our study highlights several positive features of eCTAS and usability issues that should be addressed to enhance the intended use of eCTAS and support user adoption.

Trauma Resuscitation Using in situ Simulation Team Training (TRUST) study: latent safety threat evaluation using framework analysis and video review.

INTRODUCTION: Trauma resuscitation is a complex and time-sensitive endeavour with significant risk for error. These errors can manifest from sequential system, team and knowledge-based failures, defined as latent safety threats (LSTs). In situ simulation (ISS) provides a novel prospective approach to recreate clinical situations that may manifest LSTs. Using ISS coupled with a human factors-based video review and modified framework analysis, we sought to identify and quantify LSTs within trauma resuscitation scenarios. METHODS: At a level 1 trauma centre, we video recorded 12 monthly unannounced ISS to prospectively identify trauma-related LSTs. The on-call multidisciplinary trauma team participated in the study. Using a modified framework analysis, human factors experts transcribed and coded the videos. We identified LST events, categorised them into themes and subthemes and used a hazard matrix to prioritise subthemes requiring intervention. RESULTS: We identified 843 LST events during 12 simulations, categorised into seven themes and 38 subthemes, of which 23 are considered critical. The seven themes relate to physical workspace, mental model formation, equipment, unclear accountability, demands exceeding individuals' capacity, infection control and task-specific issues. The physical workspace theme accounted for the largest number of critical LST events (n=152). We observed differences in LST events across the four scenarios; complex scenarios had more LST events. CONCLUSIONS: We identified a diverse set of critical LSTs during trauma resuscitations using ISS coupled with video-based framework analysis. The hazard matrix scoring, in combination with detailed LST subthemes, supported identification of critical LSTs requiring intervention and enhanced efforts intended to improve patient safety. This approach may be useful to others who seek to understand the contributing factors to common LSTs and design interventions to mitigate them.

Opioid losses in terms of dosage and value, January 2012 to September 2017: a retrospective analysis of Health Canada data.

BACKGROUND: Canadian health care facilities must report losses or thefts of opioids to Health Canada. To broaden the understanding of opioid loss in Canada, we analyzed data describing these losses to estimate the amount of opioid lost, estimate the wholesale and street value, compare the distribution of loss types between facility types and compare loss trends. METHODS: We analyzed Health Canada records of losses of codeine, fentanyl, hydromorphone, morphine and oxycodone reported by Canadian facilities from January 2012 to September 2017. We conducted descriptive analyses of the opioid losses by calculating milligrams of drug lost, oral morphine equivalents, daily defined doses, approximate wholesale value and approximate street value, and compared loss trends when counted by incidents, dosage units or milligrams. RESULTS: There were 64 963 reports of loss of codeine, fentanyl, hydromorphone, morphine or oxycodone over the study period. Over 112 kg of opioids were lost, an estimated $8.7 million in wholesale cost and $136 million in street value. The dominant loss categories varied by facility type: armed robbery (30.9 kg [31.1%]) for community pharmacies, unexplained losses (6.4 kg [55.8%]) for companies and pilferage (0.8 kg [57.4%]) for hospitals. Loss trends over the study period varied by reporting metric and facility type: community pharmacy losses increased when measured by dosage units and incidents of loss, and remained stable when measured by milligrams; hospital losses increased when measured by milligrams and showed no clear trend when measured by dosage units and incidents of loss. Companies showed no clear loss trend with any reporting metric. INTERPRETATION: Large quantities of opioids were lost or stolen from community pharmacies, companies and hospitals over the study period, and these losses are valued in millions of dollars. Publishing milligrams of opioids lost annually alongside metrics such as dosage units and incidents of loss would help characterize the economic cost and the magnitude of drug losses.

Assessing the electronic Bedside Paediatric Early Warning System: A simulation study on decision-making and usability.

BACKGROUND: The Bedside Paediatric Early Warning System (BedsidePEWS) is a clinical decision support tool designed to augment clinician expertise, objectively identify children at risk for clinical deterioration, and standardize and prioritize care to improve outcomes in community settings. Although the paper-based BedsidePEWS documentation record has been shown to improve clinicians' perception of their ability to detect deterioration and follow care recommendations, research is needed to asses this impact empirically. Furthermore, as hospitals progressively move toward electronic clinical systems, knowledge regarding the impact of BedsidePEWS' novel electronic interface on clinicians' performance and user experience is required. OBJECTIVES: The primary objectives of this study were (1) to compare adherence to evidence-based care recommendations using a) electronic health record software, b) paper BedsidePEWS, and c) a novel electronic BedsidePEWS interface, and (2) to describe end-users' experiences of usability and opportunities for improvement of both paper and electronic BedsidePEWS. METHODS: Paediatric nurses participated in a repeated measures simulation study. Participants assessed simulated patients, documented patient data, and responded to a series of questions regarding follow-up care for each patient. Three patient types (i.e., stable, mild deterioration, severe deterioration) were assessed in each of three intervention conditions (i.e., electronic health record, paper BedsidePEWS, electronic BedsidePEWS). Following simulation scenarios, participants provided comments regarding the usability of the paper and electronic tools. RESULTS: Participants made 12.7% and 18.0% more appropriate care decisions with paper and electronic BedsidePEWS, respectively, than with the electronic health record intervention (p < 0.001). Accurate BedsidePEWS severity of illness score calculation was related to better adherence to evidence-based care recommendations (65%), compared to inaccurate calculation (55%), and electronic BedsidePEWS was associated with 15.7% fewer calculation errors than paper (p < 0.005). Electronic BedsidePEWS demonstrated usability benefits over its paper predecessor, including automatic score calculation and data plotting, and the potential to eliminate double charting, and participants expressed a preference for electronic BedsidePEWS in all aspects of the debrief questionnaire (p < 0.001). CONCLUSIONS: BedsidePEWS in both paper and electronic formats significantly improved participants' ability to detect deterioration and follow care recommendations compared to electronic health record software. Furthermore, results suggest that electronic BedsidePEWS would afford improved patient care in excess of the paper-based original and further contribute to the standardization, prioritization, and improvement of care in community settings.

Clinical observations and a ealthcare ailure ode and ffect nalysis to identify vulnerabilities in the security and accounting of medications in Ontario hospitals: a study protocol.

INTRODUCTION: An increasing number of opioids and other controlled substances are being stolen from healthcare facilities, diverting medications from their intended medical use to be used or sold illicitly. Many incidents of medication loss from Canadian hospitals are reported as unexplained losses. Together, this suggests not only that vulnerabilities for diversion exist within current medication-use processes (MUPs), but that hospitals lack robust mechanisms to accurately track and account for discrepancies and loss in inventory. There is a paucity of primary research investigating vulnerabilities in the security and accounting of medications across hospital processes. The purpose of this study is to map hospital MUPs, systematically identify risks for diversion or unintentional loss and proactively assess opportunities for improvements to medication accounting and security. METHODS AND ANALYSIS: We will conduct human factors-informed clinical observations and a Healthcare Failure Mode and Effect Analysis (HFMEA). We will observe hospital personnel in the intensive care unit, emergency department and inpatient pharmacy in two hospitals in Ontario, Canada. Observations will capture how participants complete tasks, as well as gather contextual information about the environment, technologies and processes. A multidisciplinary team will complete an HFMEA to map process flow diagrams for the MUPs in the observed clinical units, identify and prioritise potential methods of medication loss (failure modes) and describe mechanisms or actions to prevent, detect and trace medication loss. ETHICS AND DISSEMINATION: We received province-wide research ethics approval via Clinical Trials Ontario Streamlined Research Review System, and site-specific approvals from each participating hospital. The results from this study will be presented at conferences and meetings, as well as published in peer-reviewed journals. The findings will be shared with hospitals; professional, regulatory and accreditation organisations; patient safety and healthcare quality organisations and equipment and drug manufacturers.

Untangling Infusion Confusion: A Comparative Evaluation of Interventions in a Simulated Intensive Care Setting.

OBJECTIVES: Assess interventions' impact on preventing IV infusion identification and disconnection mix-ups. DESIGN: Experimental study with repeated measures design. SETTING: High fidelity simulated adult ICU. SUBJECTS: Forty critical care nurses. INTERVENTIONS: Participants had to correctly identify infusions and disconnect an infusion in four different conditions: baseline (current practice); line labels/organizers; smart pump; and light-linking system. MEASUREMENTS AND MAIN RESULTS: Participants identified infusions with significantly fewer errors when using line labels/organizers (0; 0%) than in the baseline (12; 7.7%) and smart pump conditions (10; 6.4%) (p < 0.01). The light-linking system did not significantly affect identification errors (5; 3.2%) compared with the other conditions. Participants were significantly faster identifying infusions when using line labels/organizers (0:31) than in the baseline (1:20), smart pump (1:29), and light-linking (1:22) conditions (p < 0.001). When disconnecting an infusion, there was no significant difference in errors between conditions, but participants were significantly slower when using the smart pump than all other conditions (p < 0.001). CONCLUSIONS: The results suggest that line labels/organizers may increase infusion identification accuracy and efficiency.

Diversion of Controlled Drugs in Hospitals: A Scoping Review of Contributors and Safeguards.

Drug losses and theft from the healthcare system are accelerating; hospitals are pressured to implement safeguards to prevent drug diversion. Thus far, no reviews summarize all known risks and potential safeguards for hospital diversion. Past incidents of hospital drug diversion have impacted patient and staff safety, increased hospital costs, and resulted in infectious disease outbreaks. We searched MEDLINE, Embase, PsycINFO, CINAHL, Scopus, and Web of Science databases and the gray literature for articles published between January 2005 and June 2018. Articles were included if they focused on hospital settings and discussed either: (1) drug security or accounting practices (any drug) or (2) medication errors, healthcare worker substance use disorder, or incident reports (only with reference to controlled drugs). We included 312 articles and extracted four categories of data: (1) article characteristics (eg, author location), (2) article focus (eg, clinical areas discussed), (3) contributors to diversion (eg, factors enabling drug theft), and (4) diversion safeguards. Literature reveals a large number of contributors to drug diversion in all stages of the medication-use process. All health professions and clinical units are at risk. This review provides insights into known methods of diversion and the safeguards hospitals must consider to prevent them. Careful configuration of healthcare technologies and processes in the hospital environment can reduce the opportunity for diversion. These system-based strategies broaden the response to diversion beyond that of individual accountability. Further evidence is urgently needed to address the vulnerabilities outlined in this review and prevent harm.

Tracking workflow during high-stakes resuscitation: the application of a novel clinician movement tracing tool during in situ trauma simulation.

Introduction: Clinician movement and workflow analysis provides an opportunity to identify inefficiencies during trauma resuscitation care. Inefficient workflows may represent latent safety threats (LSTs), defined as unrecognised system-based elements that can negatively impact patients. In situ simulation (ISS) can be used to model resuscitation workflows without direct impact on patients. We report the pilot application of a novel, tracing tool to track clinician movement during high-fidelity ISS trauma sessions. Methods: Twelve unannounced ISSs were conducted. An open source, Windows-based video overlay tracing tool was developed to generate a visual representation of participant movement during ISS. This tracing tool used a manual mouse tracking algorithm to produce point-by-point location information of a selected participant in a video. The tracing tool was applied to video recordings of clinicians performing a cricothyroidotomy during ISS trauma scenarios. A comparative workflow and movement analysis was completed, which included distance travelled and space utilisation. This data was visually represented with time-lapsed movement videos and heat maps. Results: A fourfold difference in the relative distance travelled was observed between participants who performed a cricothyroidotomy during an ISS trauma resuscitation. Variation in each participant's movement was attributable to three factors: (1) team role assignment and task allocation; (2) knowledge of clinical space: equipment location and path to equipment retrieval; and (3) equipment bundling. This tool facilitated LST identification related to cricothyroidotomy performance. Conclusion: This novel tracing tool effectively generated a visual representation of participants' workflows and quantified movement during ISS video review. An improved understanding of human movement during ISS trauma resuscitations provides a unique opportunity to augment simulation debriefing, conduct human factor analysis of system elements (eg, tools/technology, physical environment/layout) and foster change management towards efficient workflows.

Study protocol for a framework analysis using video review to identify latent safety threats: trauma resuscitation using in situ simulation team training (TRUST).

INTRODUCTION: Errors in trauma resuscitation are common and have been attributed to breakdowns in the coordination of system elements (eg, tools/technology, physical environment and layout, individual skills/knowledge, team interaction). These breakdowns are triggered by unique circumstances and may go unrecognised by trauma team members or hospital administrators; they can be described as latent safety threats (LSTs). Retrospective approaches to identifying LSTs (ie, after they occur) are likely to be incomplete and prone to bias. To date, prospective studies have not used video review as the primary mechanism to identify any and all LSTs in trauma resuscitation. METHODS AND ANALYSIS: A series of 12 unannounced in situ simulations (ISS) will be conducted to prospectively identify LSTs at a level 1 Canadian trauma centre (over 800 dedicated trauma team activations annually). 4 scenarios have already been designed as part of this protocol based on 5 recurring themes found in the hospital's mortality and morbidity process. The actual trauma team will be activated to participate in the study. Each simulation will be audio/video recorded from 4 different camera angles and transcribed to conduct a framework analysis. Video reviewers will code the videos deductively based on a priori themes of LSTs identified from the literature, and/or inductively based on the events occurring in the simulation. LSTs will be prioritised to target interventions in future work. ETHICS AND DISSEMINATION: Institutional research ethics approval has been acquired (SMH REB #15-046). Results will be published in peer-reviewed journals and presented at relevant conferences. Findings will also be presented to key institutional stakeholders to inform mitigation strategies for improved patient safety.

Ministry of Health Clinical Practice Guidelines: Prevention, Diagnosis and Management of Tuberculosis.

The Ministry of Health (MOH) has developed the clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis to provide doctors and patients in Singapore with evidence-based treatment for tuberculosis. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the MOH clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis, for the information of SMJ readers. The chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/content/moh_web/healthprofessionalsportal/doctors/guidelines/cpg_medical.html. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

Ministry of Health Clinical Practice Guidelines: Prevention, Diagnosis and Management of Tuberculosis

The Ministry of Health (MOH) has developed the clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis to provide doctors and patients in Singapore with evidence-based treatment for tuberculosis. This article reproduces the introduction and executive summary (with recommendations from the guidelines) from the MOH clinical practice guidelines on Prevention, Diagnosis and Management of Tuberculosis, for the information of SMJ readers. The chapters and page numbers mentioned in the reproduced extract refer to the full text of the guidelines, which are available from the Ministry of Health website: http://www.moh.gov.sg/content/moh_web/healthprofessionalsportal/doctors/guidelines/cpg_medical.html. The recommendations should be used with reference to the full text of the guidelines. Following this article are multiple choice questions based on the full text of the guidelines.

Multiple Intravenous Infusions Phase 2b: Laboratory Study.

BACKGROUND: Administering multiple intravenous (IV) infusions to a single patient via infusion pump occurs routinely in health care, but there has been little empirical research examining the risks associated with this practice or ways to mitigate those risks. OBJECTIVES: To identify the risks associated with multiple IV infusions and assess the impact of interventions on nurses' ability to safely administer them. DATA SOURCES AND REVIEW METHODS: Forty nurses completed infusion-related tasks in a simulated adult intensive care unit, with and without interventions (i.e., repeated-measures design). RESULTS: Errors were observed in completing common tasks associated with the administration of multiple IV infusions, including the following (all values from baseline, which was current practice): setting up and programming multiple primary continuous IV infusions (e.g., 11.7% programming errors)identifying IV infusions (e.g., 7.7% line-tracing errors)managing dead volume (e.g., 96.0% flush rate errors following IV syringe dose administration)setting up a secondary intermittent IV infusion (e.g., 11.3% secondary clamp errors)administering an IV pump bolus (e.g., 11.5% programming errors)Of 10 interventions tested, 6 (1 practice, 3 technology, and 2 educational) significantly decreased or even eliminated errors compared to baseline. LIMITATIONS: The simulation of an adult intensive care unit at 1 hospital limited the ability to generalize results. The study results were representative of nurses who received training in the interventions but had little experience using them. The longitudinal effects of the interventions were not studied. CONCLUSIONS: Administering and managing multiple IV infusions is a complex and risk-prone activity. However, when a patient requires multiple IV infusions, targeted interventions can reduce identified risks. A combination of standardized practice, technology improvements, and targeted education is required.

Multiple Intravenous Infusions Phase 2a: Ontario Survey.

BACKGROUND: Research conducted in earlier phases of this study prospectively identified a number of concerns related to the safe administration of multiple intravenous (IV) infusions in Ontario hospitals. OBJECTIVE: To investigate the potential prevalence of practices or policies that may contribute to the patient safety risks identified in Phase 1b of this study. DATA SOURCES AND REVIEW METHODS: Sixty-four survey responses were analyzed from clinical units where multiple IV infusions may occur (e.g., adult intensive care units). Survey questions were organized according to the topics identified in Phase 1b as potential contributors to patient harm (e.g., labelling practices, patient transfer practices, secondary infusion policies). RESULTS: Survey results indicated suboptimal practices and policies in some clinical units, and variability in a number of infusion practices. Key areas of concern included the following: use of primary IV tubing without back check valves when administering secondary infusions, administration of secondary infusions with/as high-alert continuous IV medications, potential confusion about how IV tubing should be labelled to reflect replacement date and time, interruptions to IV therapy due to IV pump and/or tubing changes when patients are transferred between clinical units, coadministration of continuous or intermittent infusions on central venous pressure monitoring ports, variability in respondents' awareness of the infusion pump's bolus capabilities. LIMITATIONS: Due to the limited sample size, survey responses may not be representative of infusion practices across Ontario. Answers to some questions indicated that the intent of the questions might have been misunderstood. Due to a design error, 1 question about bolus administration methods was not shown to as many respondents as appropriate. CONCLUSIONS: The Ontario survey revealed variability in IV infusion practice across the province and potential opportunities to improve safety.