This study was conducted at University Hospital A in northern Japan from fiscal year (FY) 2017 to FY 2018. The hospital contained approximately 1,160 beds and 2,650 staff members including 530 physicians (some of whom were dentists), 1,260 nurses, and 80 pharmacists. The hospital used an electronic reporting system that required all staff members to report all types of errors and near misses. As such, this study defined the scope of incident reports to include these. The reporting system operated through a local broadband network from within the hospital, with all reports reviewed by a medical safety management department (MSMD).
Randomized control trials are likely to be challenging to conduct in this area, because finding sufficient units to randomize and suitable control groups will be challenging.14 This pilot study used a time-series design with comparisons before and after the intervention. The intervention examined in this pilot study consisted of four steps, the first of which was implemented in April 2018.
Step 1: Define reporting standards beginning in April 2018
The patient safety manual used at University Hospital A requires staff to report all incidents resulting from negligence, error, or failure. However, there was no standard requiring them to submit incident reports related to sentinel events. We, therefore, collaborated with MSMD members to define reporting standards for 33 topics and identified references related to adverse events,3 used Clavien-Dindo classification for complications,15 and investigated the reporting standards of several hospitals on their homepages. As shown in Table 1, these were distributed across three categories Part 1 was related to surgery; Part 2 was related to medical events other than surgery; and Part 3 included all other events. These reporting standards were then described in the manual and announced during a patient safety meeting attended by approximately 120 risk managers, who were then required to work as departmental educators. Monthly meetings were held with these risk managers to report on their experiences in that regard.
Step 2: Improvements to create a sufficient incident reporting system since September 2018
University Hospital A was using its own electronic reporting system. However, clinical staff members asked the MSMD to improve this system because reporting forms were considered too long. A previous study suggested an appropriate reporting format in a single-page layout.11 The MSMD has an independent expert-trained department consisting of three nurses and one physician, and when there is lack of information on incident reports, they can call directly the incident reporter to obtain information. We therefore analyzed retrospective data and altered the question format from text input to select input, offered optional inputs rather than required inputs, and removed questions that were considered less important, reducing the total questions from 78 to 35. These efforts were designed to alleviate the burdens on incident reporters. These improvements reduced the time usually needed to enter one report from 20 minutes to 5–10 minutes. MSMD announced improvements and ways to use this system in the risk managers’ meeting, which was also useful for re-notifying them about ways to access and use it.
Step 3: Visualized feedback implemented by the hospital administrator since October 2018
The MSMD prepared and published monthly documents concerning the submission status of incident reports from physicians inside the hospital, while the director referred to these documents when meeting with representatives of the clinical departments consisting of physicians. The published monthly documents include the number of incident reports from physicians from each department and a description of severe cases. Severe cases are included to discuss prevention policies as part of the hospital’s risk management.
Step 4: Support and appropriate feedback as a leadership resource from the hospital administrator throughout FY 2018
The director and deputy director related to MSMD stated strongly that incident reports are crucial for hospital administration and do not entail personal liability after reporting The deputy director (also one of the risk managers) explained the importance of incident reporting for preventing similar incidents during one of the risk-manager meetings. He specifically explained that staff members who reported incidents would not receive inappropriate feedback from their bosses consequently. This was also established as a hospital rule and listed in the patient safety manual.
Data source and analysis
The MSMD collected data from April 2017 to March 2018. In this context, the administrator of individual information deleted personal identifiers such as patient names, identification numbers, and the names of hospital staff members. Data were then given to this study’s researchers. Data were varied, including reporting data (year/month/day), related personnel’s occupations, impact on the patient outcomes due to the event, and type of reports (medication errors, transfusion errors, etc.). Differences in the reporting rates before and after the intervention each month were estimated with the use of Newcombe method16 and compared with the use of chi-square tests. Additionally, we compared the number and types of reports. All analyses were performed using SAS statistical software, version 9.4 and JMP version 12.0 (SAS Institute, Cary, NC).
The MSMD collected incident reports for the hospital administration. This retrospective observational study analyzed this secondary data collected by the MSMD. The study was approved by the Ethics Committees at Iwate Medical University School of Medicine (Approval number: MH2018-073). The study involved only hospital staff members and not patients. No intervention was developed in this study. We obtained comprehensive agreements from participating hospital staff members and posted an official notice on the hospital’s website from 30 September to 31 October 2018. Moreover, participating hospital staff members could refuse to the use of data during the recruitment period. Trials Registry identification number for this study is UMIN-CTR (UMIN000041087), and the data of registration 13 July 2020 (Retrospectively registered).