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The Reduction in Medical Errors on Implementing an Intensive Care Information System in a Setting Where a Hospital Electronic Medical Record System is Already in Use: Retrospective Analysis

The Reduction in Medical Errors on Implementing an Intensive Care Information System in a Setting... Background: Although the various advantages of clinical information systems in intensive care units (ICUs), such as intensive care information systems (ICISs), have been reported, their role in preventing medical errors remains unclear. Objective: This study aimed to investigate the changes in the incidence and type of errors in the ICU before and after ICIS implementation in a setting where a hospital electronic medical record system is already in use. Methods: An ICIS was introduced to the general ICU of a university hospital. After a step-by-step implementation lasting 3 months, the ICIS was used for all patients starting from April 2019. We performed a retrospective analysis of the errors in the ICU during the 6-month period before and after ICIS implementation by using data from an incident reporting system, and the number, incidence rate, type, and patient outcome level of errors were determined. Results: From April 2018 to September 2018, 755 patients were admitted to the ICU, and 719 patients were admitted from April 2019 to September 2019. The number of errors was 153 in the 2018 study period and 71 in the 2019 study period. The error incidence rates in 2018 and 2019 were 54.1 (95% CI 45.9-63.4) and 27.3 (95% CI 21.3-34.4) events per 1000 patient-days, respectively (P<.001). During both periods, there were no significant changes in the composition of the types of errors (P=.16), and the most common type of error was medication error. Conclusions: ICIS implementation was temporally associated with a 50% reduction in the number and incidence rate of errors in the ICU. Although the most common type of error was medication error in both study periods, ICIS implementation significantly reduced the number and incidence rate of medication errors. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000041471; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047345 (JMIR Perioper Med 2022;5(1):e39782) doi: 10.2196/39782 KEYWORDS clinical information system; electronic medical record; intensive care unit; medical error https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 1 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al 8.8% (14 errors in 159 prescriptions; 95% CI 4.4-13.2) before Introduction ICIS implementation to 4.6% (12 errors in 257 prescriptions; 95% CI 2.0-7.2) 6 months after ICIS implementation [12]. A Background study comparing handwritten orders with CPOE orders in a Clinical information systems in intensive care units (ICUs), cardiac ICU reported that the error rate of prescription errors such as intensive care information systems (ICISs), have been decreased from 44.8% (819 errors in 1829 prescriptions) with developed to aggregate patient information, improve operational handwritten orders to 0.8% (16 errors in 2094 prescriptions) efficiency, and obtain accurate records. A commercial ICIS with CPOE [13]. Similarly, there have been reports that CPOE consists of a critical care flowsheet; computerized physician implementation contributed to a decrease in prescription errors order entry (CPOE); and interfaces with bedside monitors, in an ICU and a decrease in parenteral nutrition medication ventilators, and other external devices. It also has the capability errors in a neonatal ICU [14,15]. to interface with other hospital systems [1]. Objectives Studies have reported that ICIS implementation is associated Although the various advantages of ICIS implementation in with both desirable and undesirable effects. The desirable effects ICUs have been reported, the role of an ICIS in preventing errors of ICISs include improved efficiency and quality of care, in an ICU remains unclear. This study aimed to investigate the improved data utilization and security, and reduced changes in the incidence and type of errors in the ICU before documentation time [2-5]. By contrast, the undesirable effects and after ICIS implementation in a setting where an EMR of ICISs include the occurrences of ICIS-related errors, reduced system is already being used and where an ICIS is not integrated speed and efficiency due to poor system usability, interruption with the EMR system. of established workflows, and the risk of system failure [5-8]. Meanwhile, the effect on the length of stay in the ICU is Methods controversial [9,10]. In particular, when both an ICIS and a hospital electronic Study Design and Setting medical record (EMR) system are used simultaneously, the This study was a retrospective analysis of the errors in the differences in performance and operability of both systems, as general ICU (18 beds, 1:2 nurse to patient ratio) of a university well as the low level of interactivity between them, can lead to hospital (1335 beds) before and after ICIS implementation by new errors. ICISs are generally interfaced with EMRs because using data from an incident reporting system. An ICIS EMR systems are used for many hospital tasks; on the other (PrimeGaia PRM-7400, Nihon Kohden Corp) was implemented hand, limitations in the level and direction of information in the ICU. After a step-by-step implementation lasting 3 coordination can prevent the sufficient integration of EMRs and months, the ICIS was used in all patients starting from April 1, ICISs. However, if ICISs are built into EMRs as modules, the integration of both systems would improve. Ethics Approval Motivation for ICIS Implementation in Our Hospital The study was approved by the Institutional Review Board of The EMR has been used throughout Tokyo Women's Medical Tokyo Women’s Medical University (approval #5224; June 20, University Hospital since 2014. Given that the EMR was not 2019), and the need for informed consent was waived due to well suited for use in the ICU, the vital sign and prescription the retrospective study design. All methods in the study were dashboards remained separate; therefore, paper-based orders performed in accordance with the relevant guidelines and and flowsheets were used concurrently. Subsequently, a critical regulations. incident occurred in the ICU, and inadequate records became Before ICIS Implementation (April 2018 to September a serious issue during the investigation of the incident. As a result, the order and charting procedures in the ICU were revised 2018) for the EMR to be used more; however, as mentioned earlier, An EMR system (HOPE EGMAIN, Fujitsu Japan Limited) was this led to an increase in staff workload. Thus, the introduction already in use in the ICU and has many components, including of a commercial ICIS was planned during the reorganization of CPOE with a clinical decision support system (CDSS), ICUs at the hospital. documentation, flowsheet, patient care instruction, and ordering and viewing functions for laboratory tests and imaging studies. ICIS Implementation and Medical Errors in the ICU However, given that the CPOE was not optimized for use in the No study has focused on the changes in error incidence in ICUs ICU, paper-based orders were used for the dosage of continuous after the implementation of a commercial ICIS adding to an injection drugs. The orders for mechanical ventilation, EMR. However, some studies have reported the effects of ICIS mechanical circulatory support, and renal replacement therapy implementation on medication errors. A comparison of a settings were also paper based. In addition, nurses had to paper-based ICU and a computerized ICU with an ICIS for manually enter the dosages of continuous injection drugs; the medication errors showed that the incidence of medical fluid balance; and the parameters derived from bedside monitors, prescription errors was 3.42% (44 errors in 1286 prescriptions) ventilators, and other monitors into the EMR flowsheet (Figure in the ICU with an ICIS compared with 27.04% (331 errors in 1). This input process was time-consuming and contributed to 1224 prescriptions) in the paper-based ICU [11]. By contrast, the heavy workload of ICU nurses. The EMR flowsheet was a study in a pediatric ICU reported that ICIS implementation did not significantly reduce the prescription error rate, from https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 2 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al not optimized as an information tool for critically ill patients and was slow to operate. Figure 1. Workflow in the study period before ICIS implementation (April 1, 2018, to September 30, 2018). CPOE: computerized physician order entry; CRRT: continuous renal replacement therapy; EMR: electronic medical record; ICIS: intensive care information system; MCS: mechanical circulatory support. the dosages of drugs and parameters because the parameters ICIS Implementation Process were automatically registered into the system. However, the A multidisciplinary implementation project team consisting of level of coordination between the EMR system and ICIS was physicians, nurses, pharmacists, clinical engineers, and hospital low (Figure 2). Most of the drugs administered in the ICU were system engineers was formed to determine the system prescribed with the ICIS, and the ordering information was sent specifications and prepare for implementation. The development to the EMR system and the logistics system of the pharmacy of the ICIS began in October 2017. The ICIS was rolled out in department. In contrast, narcotics, drugs that require approval October 2018, and training sessions for physicians and nurses or registration (broad-spectrum antibiotics, drugs for also began in October 2018. The ICIS was launched on January chemotherapy, and rarely used drugs), and blood products had 8, 2019. Considering the smooth adaptation and heterogeneity to be prescribed in both systems. Oral medications, laboratory of patients, physicians, and nurses, incremental implementation tests, and imaging tests had to be ordered using the EMR system. was chosen. The project team modified the system and The laboratory test results were displayed in the ICIS, while operational procedures during implementation. the imaging tests and their findings could be viewed only in the EMR system. The order of settings of mechanical ventilation, After ICIS Implementation (April 2019 to September mechanical circulatory support, and renal replacement therapy 2019) was maintained using a paper-based system to avoid excessive The major components of the implemented ICIS included a workflow changes for ICU physicians and nurses. Given that critical care flowsheet; CPOE without CDSS; an interface with the EMR system and ICIS were not integrated and that the ICU bedside physiologic monitors, ventilator, and other external staff needed to operate both systems simultaneously, dual devices; and an interface with an EMR system. The ICIS displays were equipped on the bedside computers to ensure replaced the CPOE, flowsheet, and patient care instruction of operational efficiency. the EMR system, and nurses no longer had to manually enter https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 3 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Figure 2. Workflow in the study period after the completion of a step-by-step implementation of ICIS (April 1, 2019, to September 30, 2019). CPOE: computerized physician order entry; CRRT: continuous renal replacement therapy; EMR: electronic medical record; ICIS: intensive care information system; MCS: mechanical circulatory support. *The patients’ basic profiles are sent from the EMR to the ICIS, except for information on their allergies and contraindications. **Blood products, narcotics, and drugs that require approval or registration (broad-spectrum antibiotics, drugs for chemotherapy, and rarely used drugs) need to be ordered in both the EMR system and ICIS. Changes in the orders are not synchronized. errors in this study. The errors were classified into 7 types on Data Collection and Outcomes the basis of the classification system of the Japan Council for Data of ICU errors in a 6-month period 1 year before the ICIS Quality Health Care (Table 1) [16]. The errors were classified implementation (April 1, 2018, to September 30, 2018) and 3 into 8 levels according to severity and influence based on the months after ICIS implementation (April 1, 2019, to September National University Hospital Council of Japan’s classification 30, 2019) were extracted from the incident reporting system to system in the incident reporting system (Table 2) [17]. The type determine the number and incidence rate of errors. The incident and level of errors were preliminarily determined by the staff reporting system in the hospital was based on voluntary filling the report and were reviewed and adjudicated by safety self-reporting. All error reports were submitted using a managers in the departments that handle errors. computer-based form and were reviewed by safety managers The primary outcomes in this study were the number and in departments that handle errors and by the Patient Safety incidence rate of errors during the 6-month study period. The Management section. Information regarding the length of stay secondary outcomes included the number and incidence rates and patients' treatment departments in the ICU was collected of errors by category and type, the patient outcome level of from the ICIS and EMR system during the study period. We errors, the number and incidence rate of ICIS-related errors, defined all events reported in the incident reporting system as and the composition of treatment departments. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 4 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Table 1. Classification of the type of errors recommended by the Japan Council for Quality Health Care. Type of errors Description Medication Errors related to medication or blood transfusion Line, tube, or drain Errors related to lines (venous routes or catheters), tubes (endotracheal tube or nasogastric tube), and drain (drainage tube from body cavities or wounds) Equipment/devices Errors related to medical equipment and devices Diagnostic testing Errors related to laboratory and imaging tests Therapeutic Errors related to treatments or procedures Nursing care Errors related to nursing care Miscellaneous None of the above Table 2. Classification of the level of severity and influence of errors recommended by the National University Hospital Council of Japan. Level Continuity of injury Severity of injury Description (NCC MERP Category) 0 None Errors or malfunctions in medicines and medical devices occurred but did not reach the N/A patient (B). 1 None N/A There was no actual harm to the patient (but there was a possibility of some influence) (C). 2 Transient Mild Treatment was not required (enhanced patient observation, mild change in vital signs, examination for confirmation of safety, etc) (D). 3a Transient Moderate A simple procedure or treatment was required (disinfection, poultice, skin suture, admin- istration of analgesics) (E). 3b Transient Severe A substantial procedure or treatment was required (significant change in vital signs, use of mechanical ventilation, surgery, prolongation of hospital stay, hospitalization, fracture, etc.) (F). 4a Permanent Mild-moderate Permanent disability or sequelae remained without significant functional impairment or cosmetic problems (G or H). 4b Permanent Moderate-severe Permanent disability or sequelae remained with significant functional impairment or cosmetic problems (G or H). 5 Death N/A Death (excluding that due to the natural course of the underlying disease) (I). Others N/A N/A Errors to which the classification was not able to be applied. NCC MERP: National Coordinating Council for Medication Error Reporting and Prevention. N/A: not applicable. Statistical Analysis Results Categorical variables are presented as frequencies and Demographics percentages, and Fisher exact test was used to analyze statistical From April 1, 2018, to September 30, 2018, 755 patients were significance. Continuous variables are presented as median and admitted to the ICU, and 719 patients were admitted from April IQR, and we used a nonparametric test (Mann-Whitney test) 1, 2019, to September 30, 2019. The total lengths of stay during for continuous variables. The incidence rate of errors was the 2018 and 2019 study periods were 2828 and 2600 calculated as the number of events per 1000 patient-days. The patient-days, respectively (Table 3). The median lengths of stay incidence rates of errors in the study periods were compared by in 2018 and 2019 were similar (1.6 days). The compositions of their 95% CIs calculated using the Poisson distribution and the treatment departments of patients were also similar between exact conditional test. Statistical significance was set at P<.05. 2018 and 2019, and cardiovascular surgery, neurosurgery, All statistical analyses were conducted using R Statistical thoracic surgery, and gastrointestinal surgery were the major Package 4.1.1 (The R Foundation for Statistical Computing). departments. The patient characteristics were comparable between 2018 and 2019. The ICU was staffed with a 1:2 nurse to patient ratio with 9 intensivists (3 to 4 during weekdays and 1 at night and on weekends). Staffing did not change between the 2 periods. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 5 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Table 3. Demographic data of the intensive care unit. Apr-Sep 2018 Apr-Sep 2019 P value Patients admitted, n 755 719 N/A Total length of stay (patient-days), n 2828 2600 N/A Length of stay (days), median (IQR) 1.6 (0.8-3.6) 1.6 (0.9-3.0) .24 Patient characteristics Age (years), median (IQR) 63 (47-74) 64 (45-72) .42 Male gender, n (%) 434 (57.5) 420 (58.4) .76 Race .93 Asian-Japanese, n (%) 747 (98.9) 711 (98.9) Asian-other, n (%) 4 (0.5) 5 (0.7) White, n (%) 2 (0.3) 2 (0.3) Other, n (%) 2 (0.3) 2 (0.3) Patients by treatment department .49 Cardiovascular surgery, n (%) 264 (35.0) 268 (37.3) Neurosurgery, n (%) 242 (32.1) 196 (27.3) Gastrointestinal surgery, n (%) 68 (9.0) 65 (9.0) Thoracic surgery, n (%) 80 (10.6) 95 (13.0) Urology and renal transplantation, n (%) 31 (4.1) 30 (4.2) Endocrine surgery, n (%) 5 (0.7) 3 (0.4) Miscellaneous surgery, n (%) 24 (3.2) 19 (2.6) Medical, n (%) 41 (5.4) 43 (5.9) N/A: not applicable. During both the periods, there were no significant changes in Evaluation Outcomes the composition of the types of errors (P=.14), and the most The number of errors was 156 in the 2018 study period and 71 common type of error was medication error (Table 5). The in the 2019 study period. The error incidence rates in 2018 and number of errors related to medication decreased from 78 in 2019 were 55.2 (95% CI 46.8-64.5) and 27.3 (95% CI 21.3-34.4) 2018 (78/156, 50.0%) to 31 in 2019 (31/71, 43.7%), and the events per 1000 patient-days, respectively (P<.001; Table 4). incidence rate of medication errors significantly decreased from Approximately 40% of errors occurred in patients treated in the 27.5 events per 1000 patient-days in 2018 (95% CI 21.8-34.4) cardiovascular surgery department in both periods, and there to 11.9 events per 1000 patient-days in 2019 (95% CI 8.1-16.9; was no significant difference in the composition of treatment Table 5). The second most common type of error was errors departments in which the errors occurred. related to line, tube, or drain. The number of errors decreased from 53 in 2018 (53/156, 34.0%) to 24 in 2019 (24/71, 33.8%), The number and incidence rate of ICIS-related errors in the but the percentage of total errors remained the same. The 2019 study period were 10 (10/71, 14%) and 3.8 (95% CI incidence rate of errors related to line, tube, or drain significantly 1.8-7.1) events per 1000 patient-days, respectively (Table 4). decreased from 18.7 events per 1000 patient-days in 2018 (95% All ICIS-related errors were associated with the CPOE CI 14.0-24.5) to 9.2 events per 1000 patient-days in 2019 (95% component of the ICIS, and the major background factors of CI 5.9-13.7; Table 5). There was no difference in the severity the errors were inadequate coordination between the ICIS and and influence level of errors in both periods (P=.59), and level EMR system (4 events due to an inability to synchronize orders 1 and 2 errors accounted for most of the errors. The incidence between both systems), unfamiliarity with ICIS operations (3 rate in level 1 errors was reduced by one-third, and the incidence events), inadequate confirmation (2 events), and specifications rate in each of the level 2 and 3a errors was reduced by one-half of the ICIS (1 event). (Table 6). https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 6 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Table 4. Errors in the periods of April 2018 to September 2018 and April 2019 to September 2019. Apr-Sep 2018 Apr-Sep 2019 P value Total errors, n 156 71 N/A Incidence rate of total errors, 55.2 27.3 <.001 events per 1000 patient-days (95% CI) (46.8-64.5) (21.3-34.4) Errors by treatment department, n (%) .18 Cardiovascular surgery 59 (37.8) 30 (42.3) Neurosurgery 25 (16.0) 11 (15.5) Gastrointestinal surgery 25 (16.0) 13 (18.3) Thoracic surgery 5 (3.2) 0 (0.0) Urology and renal transplantation 6 (3.8) 5 (7.0) Endocrine surgery 0 (0.0) 0 (0.0) Miscellaneous surgery 1 (0.6) 2 (2.8) Medical 34 (21.8) 8 (11.3) Nondepartment 1 (0.6) 2 (2.8) N/A 10 (14.1) N/A ICIS -related errors, n (%) ICIS-related errors incidence rate, N/A 3.8 (1.8-7.1) N/A events per 1000 patient-days (95% CI) N/A: not applicable. ICIS: intensive care information system. Table 5. Type of errors in periods of April 2018 to September 2018 and April 2019 to September 2019. Type of errors Apr-Sep 2018 Apr-Sep 2019 P value a a n (%) (N=156) n (%) (N=71) Incidence rate Incidence rate Medication 78 (50.0) 27.5 (21.8-34.4) 31 (43.7) 11.9 (8.1-16.9) <.001 Line, tube, or drain 53 (34.0) 18.7 (14.0-24.5) 24 (33.8) 9.2 (5.9-13.7) .004 Equipment/devices 11 (7.1) 3.9 (1.9-7.0) 4 (5.6) 1.5 (0.4-3.9) .12 Diagnostic testing 6 (3.8) 2.1 (0.8-4.6) 1 (1.4) 0.4 (0.01-2.1) .13 Therapeutic 1 (0.6) 0.4 (0.01-2.0) 3 (4.2) 1.2 (0.2-3.4) .36 Nursing care 6 (3.8) 2.1 (0.8-4.6) 5 (7.0) 1.9 (0.6-4.5) >.99 Miscellaneous 1 (0.6) 0.4 (0.01-2.0) 3 (4.2) 1.2 (0.2-3.4) .36 The incidence rate of the type of errors is presented as events per 1000 patient-days and 95% CI. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 7 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Table 6. Severity and influence level of errors in periods of April 2018 to September 2018 and April 2019 to September 2019. Level of errors Apr-Sep 2018 Apr-Sep 2019 P value a a n (%) (N=156) n (%) (N = 71) Incidence rate Incidence rate Level 0 23 (14.7) 8.1 (5.2-12.2) 7 (9.9) 2.7 (1.1-5.5) .009 Level 1 44 (28.2) 15.2 (11.3-20.9) 26 (36.6) 10.0 (6.5-14.7) .07 Level 2 47 (30.1) 16.6 (12.2-22.1) 19 (26.8) 7.3 (4.4-11.4) .002 Level 3a 33 (21.2) 11.7 (8.0-16.4) 14 (19.7) 5.4 (2.9-9.0) .01 Level 3b 7 (4.5) 2.5 (1.0-5.1) 5 (7.0) 1.9 (0.6-4.5) .78 Level 4a 0 (0.0) 0 0 (0.0) 0 N/A Level 4b 0 (0.0) 0 0 (0.0) 0 N/A Level 5 0 (0.0) 0 0 (0.0) 0 N/A Others 2 (1.3) 0.7 (0.09-2.6) 0 (0.0) 0 N/A The incidence rate of the level of errors is presented as events per 1000 patient-days and 95% CI. N/A: not applicable. Considering that the number of patients, total length of stay, Discussion and length of ICU stay were similar for both study periods, the changes in nurses’ workload and increased productivity from Principal Results the workload reduction by ICIS might have contributed to error Three important clinical observations were made in this study. reduction. First, the number and incidence rate of errors after ICIS Furthermore, the simplification and integration of drug implementation in the ICU were halved compared with those prescription and the presentation of information by ICIS might before the implementation. Second, the most common type of have contributed to an improvement in the quality of patient error was medication error before and after implementation, care by the ICU staff. Considering that the CPOE and flowsheet and the number and incidence rate of errors related to medication of the EMR system used for ICU patients before ICIS significantly decreased. Third, 14% (10/71) of the errors after implementation were not optimized for critical care settings, the implementation were relevant to the ICIS. paper-based orders were used simultaneously. A study on the The incidence of errors in the ICU differs between a study and effect of EMR implementation on medical ICUs reported that its settings. In a study on the nature and incidence of adverse the incidence rate of medication errors increased after the events and medical errors, the incidence rate of adverse events implementation despite the survival benefits [25]. The in the medical ICU and coronary care unit was 80.5 events per composition of the user interface within the ICU electronic 1000 patient-days [18]. The incidence rate of critical incidents environment has been reported to affect the task load, task in a multidisciplinary ICU was 34 events per 1000 patient-days completion time, number of cognition errors related to [19]. In the study of a voluntary card-based event reporting identification, and subsequent use of patient data [7]. In addition, system in 3 ICUs, the incidence rates of reported patient safety the use of dashboards that visualize electronic health record events were 55.5, 25.3, and 40.3 events per 1000 patient-days information has been reported to decrease the time and difficulty in the medical ICU, cardiothoracic ICU, and surgical ICU, of data gathering; reduce cognitive load, time to task completion, respectively [20]. In addition, the incidence rate of patient safety and errors; and improve situation awareness [26]. Improvements events differed by ICU intensity: 44.1 and 24.9 events per 1000 in the user interface with ICIS might have led to a reduction in patient-days in level 3 (higher intensity) and level 2 (lower both workload and errors. intensity) ICUs, respectively [21]. Considering the severity and As discussed, medication is a major cause of errors in the ICU, influence level of errors reported in this study, the error and incidence rates of errors related to medication have been incidence rates for both periods were comparable to those reported to range from 1.2 to 947 errors per 1000 patient-days reported in previous studies. [18,27-30]. The incidence rate has been reported to be higher Although the various benefits of ICIS implementation have in medical ICUs than in surgical ICUs [31]. The administration been reported, the role of an ICIS in preventing errors in an ICU of parenteral drugs, including catecholamines and vasopressors, has not been clarified. Several studies reported a decrease in analgesics and sedatives, antimicrobials, coagulation-related documentation and charting time after ICIS implementation, drugs, insulin, and electrolytes, have been found to be associated thus leaving more time for patient assessment, patient care, and with errors in the ICU [29]. Frequent dosage changes of these other nursing activities [2,4,22,23]. A study on the relationship drugs, such as after cardiac surgery, can also increase the risk between patient safety and nursing workloads showed that of medication errors. higher nursing workloads might be related to a greater number The number and incidence rate of medication errors significantly of patient safety incidents in general wards [24]; that is, the decreased after ICIS implementation in this study. The influence workload of ICU nurses can affect the incidence of errors. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 8 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al of the implementation of an integrated ICIS on the incidence Limitations of medication errors in ICUs is not well documented. A study This study has several limitations. First, this study was comparing a paper-based ICU and a computerized ICU 10 performed in a single institution with a single ICIS and with a months after ICIS implementation reported significantly lower single combination of an ICIS and EMR system. Given that the incidence and severity of medication prescription errors in an work environment and human resources in an ICU vary from ICU using an ICIS than in a paper-based ICU [11]. By contrast, hospital to hospital, the type, number, and incidence rate of several studies have addressed the effect of CPOE errors can be affected by differences in facilities. Furthermore, implementation on the incidence of medication errors. Some there are many systems in ICISs and EMRs, and their studies reported that CPOE implementation in the ICU combinations have many patterns. Therefore, the settings in significantly reduced the incidence of medication errors which the system is used also differ between an ICU and a compared to paper-based orders, whereas another study reported hospital. However, no research has examined the changes in that duplicate orders of medication increased after CPOE and medical errors before and after ICIS implementation in an ICU CDSS implementation [12,13,32-35]. The guidelines for safe where an EMR system is already in use, and we are convinced medication use in the ICU recommend CPOE implementation that this is one of the strengths of this study. Second, owing to to decrease medication errors and prevent adverse drug events the before-and-after design nature of this study, bias in both the [36]. Given that CPOE is a major component of an ICIS, the 2018 and 2019 study periods cannot be excluded. However, reduction in the number and incidence rate of medication errors given that there was no significant difference in the number of in this study could be attributed to the implementation of the patients, patient days, the length of ICU stay, or the composition ICIS. of treatment departments of patients in the ICU during the 2 periods, we believe that the situation surrounding the ICU staff In this study, the number and incidence rate of errors related to has not changed remarkably. In addition, most medical staff line, tube, or drain also significantly decreased after ICIS continued to perform the same ICU duties during both periods. implementation. Mion et al [37] reported that the incidence rate Third, the voluntary self-reporting system has limitations in that of patient-initiated device removal was 22.1 events per 1000 the reporting of errors depends on the ICU staff and on the patient days. In another study, the incidence rate of the culture and atmosphere for reporting errors in departments or accidental removal of devices was 2.3 events per 1000 organizations; thus, all errors may not be completely reported. device-days, and the most frequently removed device was a As a result, underreporting of small errors may occur, leading gastric tube (10.2 events per 1000 device-days) [38]. Unlike to some bias. However, given that the composition of the level medication errors, the ICIS did not have a function that was of errors was similar in both periods and that the ICU staff were directly related to the reduction of errors related to line, tube, regularly educated about medical safety, their attitudes toward or drain. However, the changes in nurses’ workload by the ICIS error reporting and the culture and atmosphere of the ICU might have contributed to the error reduction. toward errors did not change significantly. In this study, 14% (10/71) of the errors after ICIS Conclusions implementation were relevant to the ICIS. Although the incidence of errors related to an integrated ICIS with several We performed a retrospective analysis of the errors in the ICU components is not well documented, the results of studies on before and after ICIS implementation in a setting where an EMR CPOE may be applied since it contributed to ICIS-related errors system is already in use. ICIS implementation was temporally in this study. In a study on duplicate medication order errors, associated with a 50% reduction in the number and incidence 13% of incidents in medical ICUs and 6% in surgical ICUs were rate of errors in the ICU. Although the most common type of reported to be CPOE related, and the incidence rate of duplicate error was medication error in both study periods, the number orders of medication increased from 11.6 errors per 1000 and incidence rate of medication errors significantly decreased patient-days to 41.6 errors per 1000 patient-days after CPOE after ICIS implementation. The ICIS-related errors accounted implementation [35,39]. These percentages and incidence rates for 14% (10/71) of the errors after the implementation. Our of errors are comparable to the results of our study. analysis suggests that ICIS could play a pivotal role in preventing errors even in a setting where an EMR system is already in use. Acknowledgments The authors would like to thank all the nurses, pharmacists, and doctors in the intensive care unit of Tokyo Women’s Medical University Hospital for undertaking the challenging implementation of the intensive care information systems against a heavy workload and for providing assistance in the continuous improvement process. The authors specifically thank Toru Sorimachi (Hospital Information Technology Department); Hirofumi Yoshioka and Hitoshi Terasaki (Department of Patient Safety Management); and Yujiro Narita, Yasuhito Mori, Kumiko Hayashi, and Shinichi Saeki (Nihon Kohden Corp). The authors would also like to thank Dr Yasuto Sato (Clinical and Academic Research Promotion Center, Tokyo Women’s Medical University; Graduate School of Public Health, Shizuoka Graduate University of Public Health) for assisting with the statistical analysis as well as Honyaku Center Inc. for English-language editing. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 9 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Data Availability The data sets generated during or analyzed during this study are available from the corresponding author on reasonable request. Authors' Contributions YS managed the ICIS implementation project, designed the study, collected and analyzed the data, and wrote the manuscript. NS and MI helped manage the ICIS implementation and prepared the manuscript. TN helped design the study and reviewed the manuscript. All authors approved the final version of the manuscript. 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[doi: 10.1016/j.jcrc.2006.11.002] [Medline: 17869966] Abbreviations CDSS: clinical decision support system CPOE: computerized physician order entry EMR: electronic medical record ICIS: intensive care information system ICU: intensive care unit Edited by T Leung; submitted 23.05.22; peer-reviewed by KM Kuo, H Musawir, I Mircheva; comments to author 10.07.22; revised version received 01.08.22; accepted 14.08.22; published 31.08.22 Please cite as: Seino Y, Sato N, Idei M, Nomura T The Reduction in Medical Errors on Implementing an Intensive Care Information System in a Setting Where a Hospital Electronic Medical Record System is Already in Use: Retrospective Analysis JMIR Perioper Med 2022;5(1):e39782 URL: https://periop.jmir.org/2022/1/e39782 doi: 10.2196/39782 PMID: 35964333 ©Yusuke Seino, Nobuo Sato, Masafumi Idei, Takeshi Nomura. Originally published in JMIR Perioperative Medicine (http://periop.jmir.org), 31.08.2022. 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The Reduction in Medical Errors on Implementing an Intensive Care Information System in a Setting Where a Hospital Electronic Medical Record System is Already in Use: Retrospective Analysis

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Abstract

Background: Although the various advantages of clinical information systems in intensive care units (ICUs), such as intensive care information systems (ICISs), have been reported, their role in preventing medical errors remains unclear. Objective: This study aimed to investigate the changes in the incidence and type of errors in the ICU before and after ICIS implementation in a setting where a hospital electronic medical record system is already in use. Methods: An ICIS was introduced to the general ICU of a university hospital. After a step-by-step implementation lasting 3 months, the ICIS was used for all patients starting from April 2019. We performed a retrospective analysis of the errors in the ICU during the 6-month period before and after ICIS implementation by using data from an incident reporting system, and the number, incidence rate, type, and patient outcome level of errors were determined. Results: From April 2018 to September 2018, 755 patients were admitted to the ICU, and 719 patients were admitted from April 2019 to September 2019. The number of errors was 153 in the 2018 study period and 71 in the 2019 study period. The error incidence rates in 2018 and 2019 were 54.1 (95% CI 45.9-63.4) and 27.3 (95% CI 21.3-34.4) events per 1000 patient-days, respectively (P<.001). During both periods, there were no significant changes in the composition of the types of errors (P=.16), and the most common type of error was medication error. Conclusions: ICIS implementation was temporally associated with a 50% reduction in the number and incidence rate of errors in the ICU. Although the most common type of error was medication error in both study periods, ICIS implementation significantly reduced the number and incidence rate of medication errors. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000041471; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047345 (JMIR Perioper Med 2022;5(1):e39782) doi: 10.2196/39782 KEYWORDS clinical information system; electronic medical record; intensive care unit; medical error https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 1 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al 8.8% (14 errors in 159 prescriptions; 95% CI 4.4-13.2) before Introduction ICIS implementation to 4.6% (12 errors in 257 prescriptions; 95% CI 2.0-7.2) 6 months after ICIS implementation [12]. A Background study comparing handwritten orders with CPOE orders in a Clinical information systems in intensive care units (ICUs), cardiac ICU reported that the error rate of prescription errors such as intensive care information systems (ICISs), have been decreased from 44.8% (819 errors in 1829 prescriptions) with developed to aggregate patient information, improve operational handwritten orders to 0.8% (16 errors in 2094 prescriptions) efficiency, and obtain accurate records. A commercial ICIS with CPOE [13]. Similarly, there have been reports that CPOE consists of a critical care flowsheet; computerized physician implementation contributed to a decrease in prescription errors order entry (CPOE); and interfaces with bedside monitors, in an ICU and a decrease in parenteral nutrition medication ventilators, and other external devices. It also has the capability errors in a neonatal ICU [14,15]. to interface with other hospital systems [1]. Objectives Studies have reported that ICIS implementation is associated Although the various advantages of ICIS implementation in with both desirable and undesirable effects. The desirable effects ICUs have been reported, the role of an ICIS in preventing errors of ICISs include improved efficiency and quality of care, in an ICU remains unclear. This study aimed to investigate the improved data utilization and security, and reduced changes in the incidence and type of errors in the ICU before documentation time [2-5]. By contrast, the undesirable effects and after ICIS implementation in a setting where an EMR of ICISs include the occurrences of ICIS-related errors, reduced system is already being used and where an ICIS is not integrated speed and efficiency due to poor system usability, interruption with the EMR system. of established workflows, and the risk of system failure [5-8]. Meanwhile, the effect on the length of stay in the ICU is Methods controversial [9,10]. In particular, when both an ICIS and a hospital electronic Study Design and Setting medical record (EMR) system are used simultaneously, the This study was a retrospective analysis of the errors in the differences in performance and operability of both systems, as general ICU (18 beds, 1:2 nurse to patient ratio) of a university well as the low level of interactivity between them, can lead to hospital (1335 beds) before and after ICIS implementation by new errors. ICISs are generally interfaced with EMRs because using data from an incident reporting system. An ICIS EMR systems are used for many hospital tasks; on the other (PrimeGaia PRM-7400, Nihon Kohden Corp) was implemented hand, limitations in the level and direction of information in the ICU. After a step-by-step implementation lasting 3 coordination can prevent the sufficient integration of EMRs and months, the ICIS was used in all patients starting from April 1, ICISs. However, if ICISs are built into EMRs as modules, the integration of both systems would improve. Ethics Approval Motivation for ICIS Implementation in Our Hospital The study was approved by the Institutional Review Board of The EMR has been used throughout Tokyo Women's Medical Tokyo Women’s Medical University (approval #5224; June 20, University Hospital since 2014. Given that the EMR was not 2019), and the need for informed consent was waived due to well suited for use in the ICU, the vital sign and prescription the retrospective study design. All methods in the study were dashboards remained separate; therefore, paper-based orders performed in accordance with the relevant guidelines and and flowsheets were used concurrently. Subsequently, a critical regulations. incident occurred in the ICU, and inadequate records became Before ICIS Implementation (April 2018 to September a serious issue during the investigation of the incident. As a result, the order and charting procedures in the ICU were revised 2018) for the EMR to be used more; however, as mentioned earlier, An EMR system (HOPE EGMAIN, Fujitsu Japan Limited) was this led to an increase in staff workload. Thus, the introduction already in use in the ICU and has many components, including of a commercial ICIS was planned during the reorganization of CPOE with a clinical decision support system (CDSS), ICUs at the hospital. documentation, flowsheet, patient care instruction, and ordering and viewing functions for laboratory tests and imaging studies. ICIS Implementation and Medical Errors in the ICU However, given that the CPOE was not optimized for use in the No study has focused on the changes in error incidence in ICUs ICU, paper-based orders were used for the dosage of continuous after the implementation of a commercial ICIS adding to an injection drugs. The orders for mechanical ventilation, EMR. However, some studies have reported the effects of ICIS mechanical circulatory support, and renal replacement therapy implementation on medication errors. A comparison of a settings were also paper based. In addition, nurses had to paper-based ICU and a computerized ICU with an ICIS for manually enter the dosages of continuous injection drugs; the medication errors showed that the incidence of medical fluid balance; and the parameters derived from bedside monitors, prescription errors was 3.42% (44 errors in 1286 prescriptions) ventilators, and other monitors into the EMR flowsheet (Figure in the ICU with an ICIS compared with 27.04% (331 errors in 1). This input process was time-consuming and contributed to 1224 prescriptions) in the paper-based ICU [11]. By contrast, the heavy workload of ICU nurses. The EMR flowsheet was a study in a pediatric ICU reported that ICIS implementation did not significantly reduce the prescription error rate, from https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 2 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al not optimized as an information tool for critically ill patients and was slow to operate. Figure 1. Workflow in the study period before ICIS implementation (April 1, 2018, to September 30, 2018). CPOE: computerized physician order entry; CRRT: continuous renal replacement therapy; EMR: electronic medical record; ICIS: intensive care information system; MCS: mechanical circulatory support. the dosages of drugs and parameters because the parameters ICIS Implementation Process were automatically registered into the system. However, the A multidisciplinary implementation project team consisting of level of coordination between the EMR system and ICIS was physicians, nurses, pharmacists, clinical engineers, and hospital low (Figure 2). Most of the drugs administered in the ICU were system engineers was formed to determine the system prescribed with the ICIS, and the ordering information was sent specifications and prepare for implementation. The development to the EMR system and the logistics system of the pharmacy of the ICIS began in October 2017. The ICIS was rolled out in department. In contrast, narcotics, drugs that require approval October 2018, and training sessions for physicians and nurses or registration (broad-spectrum antibiotics, drugs for also began in October 2018. The ICIS was launched on January chemotherapy, and rarely used drugs), and blood products had 8, 2019. Considering the smooth adaptation and heterogeneity to be prescribed in both systems. Oral medications, laboratory of patients, physicians, and nurses, incremental implementation tests, and imaging tests had to be ordered using the EMR system. was chosen. The project team modified the system and The laboratory test results were displayed in the ICIS, while operational procedures during implementation. the imaging tests and their findings could be viewed only in the EMR system. The order of settings of mechanical ventilation, After ICIS Implementation (April 2019 to September mechanical circulatory support, and renal replacement therapy 2019) was maintained using a paper-based system to avoid excessive The major components of the implemented ICIS included a workflow changes for ICU physicians and nurses. Given that critical care flowsheet; CPOE without CDSS; an interface with the EMR system and ICIS were not integrated and that the ICU bedside physiologic monitors, ventilator, and other external staff needed to operate both systems simultaneously, dual devices; and an interface with an EMR system. The ICIS displays were equipped on the bedside computers to ensure replaced the CPOE, flowsheet, and patient care instruction of operational efficiency. the EMR system, and nurses no longer had to manually enter https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 3 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Figure 2. Workflow in the study period after the completion of a step-by-step implementation of ICIS (April 1, 2019, to September 30, 2019). CPOE: computerized physician order entry; CRRT: continuous renal replacement therapy; EMR: electronic medical record; ICIS: intensive care information system; MCS: mechanical circulatory support. *The patients’ basic profiles are sent from the EMR to the ICIS, except for information on their allergies and contraindications. **Blood products, narcotics, and drugs that require approval or registration (broad-spectrum antibiotics, drugs for chemotherapy, and rarely used drugs) need to be ordered in both the EMR system and ICIS. Changes in the orders are not synchronized. errors in this study. The errors were classified into 7 types on Data Collection and Outcomes the basis of the classification system of the Japan Council for Data of ICU errors in a 6-month period 1 year before the ICIS Quality Health Care (Table 1) [16]. The errors were classified implementation (April 1, 2018, to September 30, 2018) and 3 into 8 levels according to severity and influence based on the months after ICIS implementation (April 1, 2019, to September National University Hospital Council of Japan’s classification 30, 2019) were extracted from the incident reporting system to system in the incident reporting system (Table 2) [17]. The type determine the number and incidence rate of errors. The incident and level of errors were preliminarily determined by the staff reporting system in the hospital was based on voluntary filling the report and were reviewed and adjudicated by safety self-reporting. All error reports were submitted using a managers in the departments that handle errors. computer-based form and were reviewed by safety managers The primary outcomes in this study were the number and in departments that handle errors and by the Patient Safety incidence rate of errors during the 6-month study period. The Management section. Information regarding the length of stay secondary outcomes included the number and incidence rates and patients' treatment departments in the ICU was collected of errors by category and type, the patient outcome level of from the ICIS and EMR system during the study period. We errors, the number and incidence rate of ICIS-related errors, defined all events reported in the incident reporting system as and the composition of treatment departments. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 4 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Table 1. Classification of the type of errors recommended by the Japan Council for Quality Health Care. Type of errors Description Medication Errors related to medication or blood transfusion Line, tube, or drain Errors related to lines (venous routes or catheters), tubes (endotracheal tube or nasogastric tube), and drain (drainage tube from body cavities or wounds) Equipment/devices Errors related to medical equipment and devices Diagnostic testing Errors related to laboratory and imaging tests Therapeutic Errors related to treatments or procedures Nursing care Errors related to nursing care Miscellaneous None of the above Table 2. Classification of the level of severity and influence of errors recommended by the National University Hospital Council of Japan. Level Continuity of injury Severity of injury Description (NCC MERP Category) 0 None Errors or malfunctions in medicines and medical devices occurred but did not reach the N/A patient (B). 1 None N/A There was no actual harm to the patient (but there was a possibility of some influence) (C). 2 Transient Mild Treatment was not required (enhanced patient observation, mild change in vital signs, examination for confirmation of safety, etc) (D). 3a Transient Moderate A simple procedure or treatment was required (disinfection, poultice, skin suture, admin- istration of analgesics) (E). 3b Transient Severe A substantial procedure or treatment was required (significant change in vital signs, use of mechanical ventilation, surgery, prolongation of hospital stay, hospitalization, fracture, etc.) (F). 4a Permanent Mild-moderate Permanent disability or sequelae remained without significant functional impairment or cosmetic problems (G or H). 4b Permanent Moderate-severe Permanent disability or sequelae remained with significant functional impairment or cosmetic problems (G or H). 5 Death N/A Death (excluding that due to the natural course of the underlying disease) (I). Others N/A N/A Errors to which the classification was not able to be applied. NCC MERP: National Coordinating Council for Medication Error Reporting and Prevention. N/A: not applicable. Statistical Analysis Results Categorical variables are presented as frequencies and Demographics percentages, and Fisher exact test was used to analyze statistical From April 1, 2018, to September 30, 2018, 755 patients were significance. Continuous variables are presented as median and admitted to the ICU, and 719 patients were admitted from April IQR, and we used a nonparametric test (Mann-Whitney test) 1, 2019, to September 30, 2019. The total lengths of stay during for continuous variables. The incidence rate of errors was the 2018 and 2019 study periods were 2828 and 2600 calculated as the number of events per 1000 patient-days. The patient-days, respectively (Table 3). The median lengths of stay incidence rates of errors in the study periods were compared by in 2018 and 2019 were similar (1.6 days). The compositions of their 95% CIs calculated using the Poisson distribution and the treatment departments of patients were also similar between exact conditional test. Statistical significance was set at P<.05. 2018 and 2019, and cardiovascular surgery, neurosurgery, All statistical analyses were conducted using R Statistical thoracic surgery, and gastrointestinal surgery were the major Package 4.1.1 (The R Foundation for Statistical Computing). departments. The patient characteristics were comparable between 2018 and 2019. The ICU was staffed with a 1:2 nurse to patient ratio with 9 intensivists (3 to 4 during weekdays and 1 at night and on weekends). Staffing did not change between the 2 periods. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 5 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Table 3. Demographic data of the intensive care unit. Apr-Sep 2018 Apr-Sep 2019 P value Patients admitted, n 755 719 N/A Total length of stay (patient-days), n 2828 2600 N/A Length of stay (days), median (IQR) 1.6 (0.8-3.6) 1.6 (0.9-3.0) .24 Patient characteristics Age (years), median (IQR) 63 (47-74) 64 (45-72) .42 Male gender, n (%) 434 (57.5) 420 (58.4) .76 Race .93 Asian-Japanese, n (%) 747 (98.9) 711 (98.9) Asian-other, n (%) 4 (0.5) 5 (0.7) White, n (%) 2 (0.3) 2 (0.3) Other, n (%) 2 (0.3) 2 (0.3) Patients by treatment department .49 Cardiovascular surgery, n (%) 264 (35.0) 268 (37.3) Neurosurgery, n (%) 242 (32.1) 196 (27.3) Gastrointestinal surgery, n (%) 68 (9.0) 65 (9.0) Thoracic surgery, n (%) 80 (10.6) 95 (13.0) Urology and renal transplantation, n (%) 31 (4.1) 30 (4.2) Endocrine surgery, n (%) 5 (0.7) 3 (0.4) Miscellaneous surgery, n (%) 24 (3.2) 19 (2.6) Medical, n (%) 41 (5.4) 43 (5.9) N/A: not applicable. During both the periods, there were no significant changes in Evaluation Outcomes the composition of the types of errors (P=.14), and the most The number of errors was 156 in the 2018 study period and 71 common type of error was medication error (Table 5). The in the 2019 study period. The error incidence rates in 2018 and number of errors related to medication decreased from 78 in 2019 were 55.2 (95% CI 46.8-64.5) and 27.3 (95% CI 21.3-34.4) 2018 (78/156, 50.0%) to 31 in 2019 (31/71, 43.7%), and the events per 1000 patient-days, respectively (P<.001; Table 4). incidence rate of medication errors significantly decreased from Approximately 40% of errors occurred in patients treated in the 27.5 events per 1000 patient-days in 2018 (95% CI 21.8-34.4) cardiovascular surgery department in both periods, and there to 11.9 events per 1000 patient-days in 2019 (95% CI 8.1-16.9; was no significant difference in the composition of treatment Table 5). The second most common type of error was errors departments in which the errors occurred. related to line, tube, or drain. The number of errors decreased from 53 in 2018 (53/156, 34.0%) to 24 in 2019 (24/71, 33.8%), The number and incidence rate of ICIS-related errors in the but the percentage of total errors remained the same. The 2019 study period were 10 (10/71, 14%) and 3.8 (95% CI incidence rate of errors related to line, tube, or drain significantly 1.8-7.1) events per 1000 patient-days, respectively (Table 4). decreased from 18.7 events per 1000 patient-days in 2018 (95% All ICIS-related errors were associated with the CPOE CI 14.0-24.5) to 9.2 events per 1000 patient-days in 2019 (95% component of the ICIS, and the major background factors of CI 5.9-13.7; Table 5). There was no difference in the severity the errors were inadequate coordination between the ICIS and and influence level of errors in both periods (P=.59), and level EMR system (4 events due to an inability to synchronize orders 1 and 2 errors accounted for most of the errors. The incidence between both systems), unfamiliarity with ICIS operations (3 rate in level 1 errors was reduced by one-third, and the incidence events), inadequate confirmation (2 events), and specifications rate in each of the level 2 and 3a errors was reduced by one-half of the ICIS (1 event). (Table 6). https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 6 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Table 4. Errors in the periods of April 2018 to September 2018 and April 2019 to September 2019. Apr-Sep 2018 Apr-Sep 2019 P value Total errors, n 156 71 N/A Incidence rate of total errors, 55.2 27.3 <.001 events per 1000 patient-days (95% CI) (46.8-64.5) (21.3-34.4) Errors by treatment department, n (%) .18 Cardiovascular surgery 59 (37.8) 30 (42.3) Neurosurgery 25 (16.0) 11 (15.5) Gastrointestinal surgery 25 (16.0) 13 (18.3) Thoracic surgery 5 (3.2) 0 (0.0) Urology and renal transplantation 6 (3.8) 5 (7.0) Endocrine surgery 0 (0.0) 0 (0.0) Miscellaneous surgery 1 (0.6) 2 (2.8) Medical 34 (21.8) 8 (11.3) Nondepartment 1 (0.6) 2 (2.8) N/A 10 (14.1) N/A ICIS -related errors, n (%) ICIS-related errors incidence rate, N/A 3.8 (1.8-7.1) N/A events per 1000 patient-days (95% CI) N/A: not applicable. ICIS: intensive care information system. Table 5. Type of errors in periods of April 2018 to September 2018 and April 2019 to September 2019. Type of errors Apr-Sep 2018 Apr-Sep 2019 P value a a n (%) (N=156) n (%) (N=71) Incidence rate Incidence rate Medication 78 (50.0) 27.5 (21.8-34.4) 31 (43.7) 11.9 (8.1-16.9) <.001 Line, tube, or drain 53 (34.0) 18.7 (14.0-24.5) 24 (33.8) 9.2 (5.9-13.7) .004 Equipment/devices 11 (7.1) 3.9 (1.9-7.0) 4 (5.6) 1.5 (0.4-3.9) .12 Diagnostic testing 6 (3.8) 2.1 (0.8-4.6) 1 (1.4) 0.4 (0.01-2.1) .13 Therapeutic 1 (0.6) 0.4 (0.01-2.0) 3 (4.2) 1.2 (0.2-3.4) .36 Nursing care 6 (3.8) 2.1 (0.8-4.6) 5 (7.0) 1.9 (0.6-4.5) >.99 Miscellaneous 1 (0.6) 0.4 (0.01-2.0) 3 (4.2) 1.2 (0.2-3.4) .36 The incidence rate of the type of errors is presented as events per 1000 patient-days and 95% CI. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 7 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Table 6. Severity and influence level of errors in periods of April 2018 to September 2018 and April 2019 to September 2019. Level of errors Apr-Sep 2018 Apr-Sep 2019 P value a a n (%) (N=156) n (%) (N = 71) Incidence rate Incidence rate Level 0 23 (14.7) 8.1 (5.2-12.2) 7 (9.9) 2.7 (1.1-5.5) .009 Level 1 44 (28.2) 15.2 (11.3-20.9) 26 (36.6) 10.0 (6.5-14.7) .07 Level 2 47 (30.1) 16.6 (12.2-22.1) 19 (26.8) 7.3 (4.4-11.4) .002 Level 3a 33 (21.2) 11.7 (8.0-16.4) 14 (19.7) 5.4 (2.9-9.0) .01 Level 3b 7 (4.5) 2.5 (1.0-5.1) 5 (7.0) 1.9 (0.6-4.5) .78 Level 4a 0 (0.0) 0 0 (0.0) 0 N/A Level 4b 0 (0.0) 0 0 (0.0) 0 N/A Level 5 0 (0.0) 0 0 (0.0) 0 N/A Others 2 (1.3) 0.7 (0.09-2.6) 0 (0.0) 0 N/A The incidence rate of the level of errors is presented as events per 1000 patient-days and 95% CI. N/A: not applicable. Considering that the number of patients, total length of stay, Discussion and length of ICU stay were similar for both study periods, the changes in nurses’ workload and increased productivity from Principal Results the workload reduction by ICIS might have contributed to error Three important clinical observations were made in this study. reduction. First, the number and incidence rate of errors after ICIS Furthermore, the simplification and integration of drug implementation in the ICU were halved compared with those prescription and the presentation of information by ICIS might before the implementation. Second, the most common type of have contributed to an improvement in the quality of patient error was medication error before and after implementation, care by the ICU staff. Considering that the CPOE and flowsheet and the number and incidence rate of errors related to medication of the EMR system used for ICU patients before ICIS significantly decreased. Third, 14% (10/71) of the errors after implementation were not optimized for critical care settings, the implementation were relevant to the ICIS. paper-based orders were used simultaneously. A study on the The incidence of errors in the ICU differs between a study and effect of EMR implementation on medical ICUs reported that its settings. In a study on the nature and incidence of adverse the incidence rate of medication errors increased after the events and medical errors, the incidence rate of adverse events implementation despite the survival benefits [25]. The in the medical ICU and coronary care unit was 80.5 events per composition of the user interface within the ICU electronic 1000 patient-days [18]. The incidence rate of critical incidents environment has been reported to affect the task load, task in a multidisciplinary ICU was 34 events per 1000 patient-days completion time, number of cognition errors related to [19]. In the study of a voluntary card-based event reporting identification, and subsequent use of patient data [7]. In addition, system in 3 ICUs, the incidence rates of reported patient safety the use of dashboards that visualize electronic health record events were 55.5, 25.3, and 40.3 events per 1000 patient-days information has been reported to decrease the time and difficulty in the medical ICU, cardiothoracic ICU, and surgical ICU, of data gathering; reduce cognitive load, time to task completion, respectively [20]. In addition, the incidence rate of patient safety and errors; and improve situation awareness [26]. Improvements events differed by ICU intensity: 44.1 and 24.9 events per 1000 in the user interface with ICIS might have led to a reduction in patient-days in level 3 (higher intensity) and level 2 (lower both workload and errors. intensity) ICUs, respectively [21]. Considering the severity and As discussed, medication is a major cause of errors in the ICU, influence level of errors reported in this study, the error and incidence rates of errors related to medication have been incidence rates for both periods were comparable to those reported to range from 1.2 to 947 errors per 1000 patient-days reported in previous studies. [18,27-30]. The incidence rate has been reported to be higher Although the various benefits of ICIS implementation have in medical ICUs than in surgical ICUs [31]. The administration been reported, the role of an ICIS in preventing errors in an ICU of parenteral drugs, including catecholamines and vasopressors, has not been clarified. Several studies reported a decrease in analgesics and sedatives, antimicrobials, coagulation-related documentation and charting time after ICIS implementation, drugs, insulin, and electrolytes, have been found to be associated thus leaving more time for patient assessment, patient care, and with errors in the ICU [29]. Frequent dosage changes of these other nursing activities [2,4,22,23]. A study on the relationship drugs, such as after cardiac surgery, can also increase the risk between patient safety and nursing workloads showed that of medication errors. higher nursing workloads might be related to a greater number The number and incidence rate of medication errors significantly of patient safety incidents in general wards [24]; that is, the decreased after ICIS implementation in this study. The influence workload of ICU nurses can affect the incidence of errors. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 8 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al of the implementation of an integrated ICIS on the incidence Limitations of medication errors in ICUs is not well documented. A study This study has several limitations. First, this study was comparing a paper-based ICU and a computerized ICU 10 performed in a single institution with a single ICIS and with a months after ICIS implementation reported significantly lower single combination of an ICIS and EMR system. Given that the incidence and severity of medication prescription errors in an work environment and human resources in an ICU vary from ICU using an ICIS than in a paper-based ICU [11]. By contrast, hospital to hospital, the type, number, and incidence rate of several studies have addressed the effect of CPOE errors can be affected by differences in facilities. Furthermore, implementation on the incidence of medication errors. Some there are many systems in ICISs and EMRs, and their studies reported that CPOE implementation in the ICU combinations have many patterns. Therefore, the settings in significantly reduced the incidence of medication errors which the system is used also differ between an ICU and a compared to paper-based orders, whereas another study reported hospital. However, no research has examined the changes in that duplicate orders of medication increased after CPOE and medical errors before and after ICIS implementation in an ICU CDSS implementation [12,13,32-35]. The guidelines for safe where an EMR system is already in use, and we are convinced medication use in the ICU recommend CPOE implementation that this is one of the strengths of this study. Second, owing to to decrease medication errors and prevent adverse drug events the before-and-after design nature of this study, bias in both the [36]. Given that CPOE is a major component of an ICIS, the 2018 and 2019 study periods cannot be excluded. However, reduction in the number and incidence rate of medication errors given that there was no significant difference in the number of in this study could be attributed to the implementation of the patients, patient days, the length of ICU stay, or the composition ICIS. of treatment departments of patients in the ICU during the 2 periods, we believe that the situation surrounding the ICU staff In this study, the number and incidence rate of errors related to has not changed remarkably. In addition, most medical staff line, tube, or drain also significantly decreased after ICIS continued to perform the same ICU duties during both periods. implementation. Mion et al [37] reported that the incidence rate Third, the voluntary self-reporting system has limitations in that of patient-initiated device removal was 22.1 events per 1000 the reporting of errors depends on the ICU staff and on the patient days. In another study, the incidence rate of the culture and atmosphere for reporting errors in departments or accidental removal of devices was 2.3 events per 1000 organizations; thus, all errors may not be completely reported. device-days, and the most frequently removed device was a As a result, underreporting of small errors may occur, leading gastric tube (10.2 events per 1000 device-days) [38]. Unlike to some bias. However, given that the composition of the level medication errors, the ICIS did not have a function that was of errors was similar in both periods and that the ICU staff were directly related to the reduction of errors related to line, tube, regularly educated about medical safety, their attitudes toward or drain. However, the changes in nurses’ workload by the ICIS error reporting and the culture and atmosphere of the ICU might have contributed to the error reduction. toward errors did not change significantly. In this study, 14% (10/71) of the errors after ICIS Conclusions implementation were relevant to the ICIS. Although the incidence of errors related to an integrated ICIS with several We performed a retrospective analysis of the errors in the ICU components is not well documented, the results of studies on before and after ICIS implementation in a setting where an EMR CPOE may be applied since it contributed to ICIS-related errors system is already in use. ICIS implementation was temporally in this study. In a study on duplicate medication order errors, associated with a 50% reduction in the number and incidence 13% of incidents in medical ICUs and 6% in surgical ICUs were rate of errors in the ICU. Although the most common type of reported to be CPOE related, and the incidence rate of duplicate error was medication error in both study periods, the number orders of medication increased from 11.6 errors per 1000 and incidence rate of medication errors significantly decreased patient-days to 41.6 errors per 1000 patient-days after CPOE after ICIS implementation. The ICIS-related errors accounted implementation [35,39]. These percentages and incidence rates for 14% (10/71) of the errors after the implementation. Our of errors are comparable to the results of our study. analysis suggests that ICIS could play a pivotal role in preventing errors even in a setting where an EMR system is already in use. Acknowledgments The authors would like to thank all the nurses, pharmacists, and doctors in the intensive care unit of Tokyo Women’s Medical University Hospital for undertaking the challenging implementation of the intensive care information systems against a heavy workload and for providing assistance in the continuous improvement process. The authors specifically thank Toru Sorimachi (Hospital Information Technology Department); Hirofumi Yoshioka and Hitoshi Terasaki (Department of Patient Safety Management); and Yujiro Narita, Yasuhito Mori, Kumiko Hayashi, and Shinichi Saeki (Nihon Kohden Corp). The authors would also like to thank Dr Yasuto Sato (Clinical and Academic Research Promotion Center, Tokyo Women’s Medical University; Graduate School of Public Health, Shizuoka Graduate University of Public Health) for assisting with the statistical analysis as well as Honyaku Center Inc. for English-language editing. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 9 (page number not for citation purposes) XSL FO RenderX JMIR PERIOPERATIVE MEDICINE Seino et al Data Availability The data sets generated during or analyzed during this study are available from the corresponding author on reasonable request. Authors' Contributions YS managed the ICIS implementation project, designed the study, collected and analyzed the data, and wrote the manuscript. NS and MI helped manage the ICIS implementation and prepared the manuscript. TN helped design the study and reviewed the manuscript. All authors approved the final version of the manuscript. 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[doi: 10.1016/j.jcrc.2006.11.002] [Medline: 17869966] Abbreviations CDSS: clinical decision support system CPOE: computerized physician order entry EMR: electronic medical record ICIS: intensive care information system ICU: intensive care unit Edited by T Leung; submitted 23.05.22; peer-reviewed by KM Kuo, H Musawir, I Mircheva; comments to author 10.07.22; revised version received 01.08.22; accepted 14.08.22; published 31.08.22 Please cite as: Seino Y, Sato N, Idei M, Nomura T The Reduction in Medical Errors on Implementing an Intensive Care Information System in a Setting Where a Hospital Electronic Medical Record System is Already in Use: Retrospective Analysis JMIR Perioper Med 2022;5(1):e39782 URL: https://periop.jmir.org/2022/1/e39782 doi: 10.2196/39782 PMID: 35964333 ©Yusuke Seino, Nobuo Sato, Masafumi Idei, Takeshi Nomura. Originally published in JMIR Perioperative Medicine (http://periop.jmir.org), 31.08.2022. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Perioperative Medicine, is properly cited. The complete bibliographic information, a link to the original publication on http://periop.jmir.org, as well as this copyright and license information must be included. https://periop.jmir.org/2022/1/e39782 JMIR Perioper Med 2022 | vol. 5 | iss. 1 | e39782 | p. 12 (page number not for citation purposes) XSL FO RenderX

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JMIR Perioperative Medicine – JMIR Publications

Published: Aug 31, 2022

Keywords: clinical information system; electronic medical record; intensive care unit; medical error

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