Implementation of barcode medication administration (BMCA) technology on infusion pumps in the operating rooms ============================================================================================================== * Manon Hogerwaard * Muriël Stolk * Liselotte van Dijk * Mariët Faasse * Nico Kalden * Sanne Elisabeth Hoeks * Roland Bal * Maarten ter Horst ## Abstract **Background** Medication administration errors (MAEs) are a major cause of morbidity and mortality. An updated barcode medication administration (BCMA) technology on infusion pumps is implemented in the operating rooms to automate double check at a syringe exchange. **Objective** The aim of this mixed-methods before-and-after study is to understand the medication administrating process and assess the compliance with double check before and after implementation. **Methods** Reported MAEs from 2019 to October 2021 were analysed and categorised to the three moments of medication administration: (1) bolus induction, (2) infusion pump start-up and (3) changing an empty syringe. Interviews were conducted to understand the medication administration process with functional resonance analysis method (FRAM). Double check was observed in the operating rooms before and after implementation. MAEs up to December 2022 were used for a run chart. **Results** Analysis of MAEs showed that 70.9% occurred when changing an empty syringe. 90.0% of MAEs were deemed to be preventable with the use of the new BCMA technology. The FRAM model showed the extent of variation to double check by coworker or BCMA. Observations showed that the double check for pump start-up changed from 70.2% to 78.7% postimplementation (p=0.41). The BCMA double check contribution for pump start-up increased from 15.3% to 45.8% (p=0.0013). The double check for changing an empty syringe increased from 14.3% to 85.0% (p<0.0001) postimplementation. BCMA technology was new for changing an empty syringe and was used in 63.5% of administrations. MAEs for moments 2 and 3 were significantly reduced (p=0.0075) after implementation in the operating rooms and ICU. **Conclusion** An updated BCMA technology contributes to a higher double check compliance and MAE reduction, especially when changing an empty syringe. BCMA technology has the potential to decrease MAEs if adherence is high enough. * Medication safety * Anaesthesia * Healthcare quality improvement * Patient safety * Quality improvement ### WHAT IS ALREADY KNOWN ON THIS TOPIC * Medication administration errors (MAEs) cause patient’s harm. Medication double check is introduced to reduce MAE but variation in daily practice results in low compliance. #### WHAT THIS STUDY ADDS * Barcode medication administration (BCMA) technology on infusion pumps is implemented to automate double check at pump startup and syringe exchange. BCMA technology showed potential to reduce reported MAEs. #### HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY * Rolling out of automated barcode double check on OK, ICU and the ward may increase patient safety. ## Introduction Medication administration errors (MAEs) are a major cause of morbidity and mortality among hospital patients.1 2 Approximately, 30% of medication errors occur at the administration stage and are often not intercepted.2 Especially high-risk medications dispensed with an infusion pump pose a risk to patient safety.3–5 These medications, such as narcotics, opioids and sedatives, are used in operating rooms daily. In the past years, there have been several improvements to reduce medication errors. These include pharmacists preparing medication (ie, ready to use and ready to administer), the use of printed labels and the medication double check.6 In the Netherlands, a protocol for safe injectable medication administration has been implemented in 2009, including the double check proceeding.7 However, there is variation in daily practice resulting in low compliance with the double check.8–11 Furthermore, a systematic review by Koyama *et al* did not show sufficient evidence that double check versus single check of medication administration is associated with lower rates of MAEs or reduced harm.12 The latest development to improve compliance is the use of barcode medication administration (BCMA), in which a barcode reader substitutes the double check by a coworker. Thompson *et al* found that the introduction of BCMA decreased MAEs by 43% and actual patient harm events by 54%.13 The automation can forestall human error, and therefore, prevent substitution with the wrong medication. Nonetheless, van der Veen *et al* found that workarounds to BCMA were used in nearly 63% of the administrations to cope with technical shortcomings.14 Koppel *et al* identified different causes of workarounds, including unreadable medication barcodes and malfunctioning barcode readers.15 The B. Braun Space Infusion Pumps with standardised medication library for operating rooms and ICU were introduced in the Erasmus MC in July 2017. Integration with the electronic health records (EHRs) system provided autodocumentation of administered medication. In July 2019, BCMA technology with barcode readers was introduced in the operating room for infusion pump start-up. Until implementation BCMA cannot be used when changing an empty syringe for a new one. If these shortcomings are solved with a new software, BCMA has the potential to further reduces risks and improves patient safety. However, this improvement can only be realised if there is enough compliance with BCMA.16 To ensure compliance with BCMA, better understanding is needed of how the double check is conducted in daily practice. Within the new safety management perspective Safety-II, the focus has shifted towards learning from what goes right in healthcare. This relates to the system’s ability to succeed under varying conditions.17 18 A central tenet is the understanding that systems and processes are complex, and that human performance is often satisfactory because people are resilient and adjust how they work to changing circumstances.17 19 Hollnagel states that the necessary capacities for resilient performance include the ability to monitor, respond, learn and anticipate.20 The functional resonance analysis method (FRAM) is a Safety-II tool to visualise the functions that make up a process, their interdependencies and the variability that emerges.19 21 22 FRAM helps reveal variability due to possible workarounds or adaptations from protocols that healthcare professionals undertake to ensure patient safety.23 24 Whereas other BCMA studies were about oral medication,13–16 our study is investigating double checking high-risk medications dispensed with new infusion pumps. The updated BCMA technology facilitates conducting the double check for infusion pump start-up and changing an empty syringe solely digitally.24 The double check is performed by the infusion pump software instead of the EHR system, ensuring double check in real-time instead of retrograde approval. An electronic alert is given in case of a mismatch. This before-and-after study aimed to improve the compliance with double check before and after implementation of the new BCMA technology. ## Methods ### Study design and setting The study is a single-centre before-and-after study at the Erasmus University Medical Center (Rotterdam, The Netherlands). The study has a mixed-methods design using both qualitative and quantitative methods. Interviews and observations were conducted and reported MAEs were analysed. Observations were done in November 2021 before implementation of the new technology. Implementation began in January 2022 in the operating rooms, including recovery and Post Anesthesia Care Unit (PACU). Postimplementation observations were done from the end of February until the middle of March. The implementation on the Intensive Care Unit (ICU) started at the beginning of May and was rolled out in 2 weeks. ### Medication errors MAEs reported from 2019 to October 2021 were retrieved for analysis of the current situation. MAEs from 2020 to December 2022 were used for implementation evaluation. The incidents were voluntarily reported to the quality management system iProva (Veldhoven, the Netherlands). Trained employees analyse the medication errors with a risk assessment matrix. The matrix combines an estimation of the possible consequences and an estimation of the chance of repetition. A distinction is made between low, moderate, high and very high-risk incidents. MAEs from the operating rooms, recovery, PACU and the ICU department were retrieved for analysis. Incidents with prescription, preparation or storage of medication were excluded, as were omissions and oral medication incidents. Two researchers applied the risk assessment matrix for a second assessment of the remaining MAEs. The incidents were categorised as belonging to moments 1, 2 or 3. These moments correspond with three activities in the operating room: 1. Bolus induction of medication in the peripheral intravenous line. 2. Infusion pump start-up. 3. Changing an empty syringe in the pump for a new one. A distinction was made between potentially preventable or unpreventable MAEs with the new N06 software. Disagreements were resolved by discussion and consensus. ### Qualitative research The FRAM was used to explore the process of medication administration. The ‘work-as-done’ was defined by interviews with healthcare professionals involved in the medication administration process in daily practice. A topic list based on the FRAM aspects (input, output, precondition, resources, control and time) was used for structuring the interviews.22 Interviews were conducted until the ability to obtain new information had been attained. Each interview lasted approximately 20 min. The interviews were recorded with permission and transcribed. Transcripts were analysed independently by two researchers and the outcomes were visualised in a FRAM model. Each essential function was displayed as hexagon and, if possible, relevant aspects were added: input (I), output (O), precondition (P), resources (R), control (C) and time (T). The coupling among functions can give insight into the variability of the process. Functions with variability in Output can affect the rest of the process. The FRAM model was built using FRAM Model Visualiser software.25 The FRAM outcomes were used to determine the contents of education about the new N06 software, in order to create confidence and prevent workarounds. ### Patient and public involvement A patient who experienced a medication error within the hospital was approached to report her story on video. This video was used for educating employees and raising awareness about medication safety. ### Software and barcodes High-risk medications are dispensed with B. Braun Space Infusion Pumps (B. Braun Medical; Melsungen, Germany) in the operating rooms. There is a unidirectional data flow from the pumps to the EHR system after scanning a medication barcode. Before implementation, all medications were provided with new and scannable barcodes. Barcodes were standardised for ready to use and ready to administer medication. All barcodes need to be uniform for the specific medicine and concentration instead of manufacturer specific barcodes. This will guarantee that BCMA can be used for all medicines. In January 2022 the new B. Braun software N06 (exclusively available for Erasmus MC) was implemented on the OR, facilitating BCMA at this crucial moment. ### Education In January 2022, employees were educated about the new N06 software. Clinical lessons were provided for all employees. There was a presentation about the N06 software update with short video demonstrations. The importance of double checking and use of BCMA was emphasised. The impact of medication errors was illustrated by the video of a patient who told about her experience. Furthermore, two educated employees provided physical training of the software in the operating rooms. Additional information was provided on the online platform: Ask Erasmus. ### Quantitative research Quantitative research was conducted in the operating rooms to observe adherence to the protocol. Preimplementation data were collected for 4 weeks in November 2021. Postimplementation data were collected for 4 weeks in February–March 2022, 1 month after implementation of the N06 software. The medication administration in the operating rooms was observed by the disguised method.26 Staff was not made aware of the exact aim of the observations. Each observer accompanied the anaesthesiologist assistant or anaesthesiologist who administered the medication and observed all administrations. Observers documented every administration on a data collection form. They noted whether the medication was double checked by a coworker or whether BCMA technology was used. Different types of operations and different healthcare professionals were observed at moments 1, 2 and 3. Observation at moment 3 was only possible if operations lasted longer than 1–2 hours. BCMA was preimplementation only available for moment 2. Postimplementation, it was available for moments 2 and 3. ### Data analysis The observational data from the operating rooms and MAEs were described using descriptive statistics with Microsoft Excel. Differences were tested by a Mann-Whitney test. The percentage of double check was calculated for each operation and each moment. Designing graphs and statistical analysis was performed using GraphPad Prism software V.9.3.1. A p<0.05 was considered statistically significant. ## Results ### Analysis of reported MAEs A total of 385 MAEs in the operating rooms, recovery, PACU and the ICU department were reported between 2019 and October 2021. After application of the exclusion criteria, 86 incidents were analysed (figure 1). Of the 86 MAEs, 22.1% belonged to moment 2 and 70.9% belonged to moment 3. The moment 1 incidents were excluded for further analysis, because they were not related to the infusion pump software. ![Figure 1](http://bmjopenquality.bmj.com/https://bmjopenquality.bmj.com/content/bmjqir/12/2/e002023/F1.medium.gif) [Figure 1](http://bmjopenquality.bmj.com/content/12/2/e002023/F1) Figure 1 Flow chart of MAEs selection between 2019 and 2021 in OR, PACU and recovery. OR, operating room. PACU, post anesthesia care unit Almost 4% of the moments 2 and 3 MAEs were classified as very high risk. Most of the MAEs, 65.0%, potentially posed a high risk to patient safety. 27.5% of MAEs were classified as moderate risk. Ninety per cent of the moments 2 and 3 incidents were deemed preventable by the N06 software. MAEs about wrong weight registration in the infusion pump are not preventable with BCMA, but the N06 software has an extra function that shows a pop-up to confirm the right weight after restarting the pump. ### Qualitative research We conducted 10 semistructured interviews with employees with different professions in the operating room: two anaesthesiologists, one resident, six anaesthesiology assistants and one student anaesthesiology assistant. Functions in the process of medication administration were identified. Subsequently, they were linked by the different aspects. It was an iterative process with several adjustments while constructing the model. Figure 2 shows the FRAM based on the interviews. The model represents the entire process from medication order to registration in the EHR system. Hexagons concern functions and lines concern couplings. The red functions are executed by the first employee and the blue functions are executed by a second employee. The model consists of 10 functions of which 2 foreground functions show the options for medication registration in the infusion pump: