Patient safety management systems and activities related to promoting voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues: A cross-sectional study.

Both voluntary in-hospital reporting and mandatory national-level reporting systems for patient safety issues need to work well to develop a patient safety learning system that is effective in preventing the recurrence of adverse events. Some of the hospital systems and activities may increase voluntary in-hospital reporting and mandatory national-level reporting. This study aimed to identify the hospital systems and activities that increase voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues. An anonymous mail survey of hospitals in Japan was conducted in 2017. The hospitals were selected by stratified random sampling according to number of beds. The survey examined the annual number of reported events in the voluntary in-hospital reporting system for patient safety and experience of reporting unexpected patient deaths possibly due to medical interventions to the mandatory national-level reporting system in the last 2 years. The relationship of the answer to the questions with the patient safety management systems and activities at each hospital was analyzed. The response rate was 18.8% (603/3,215). The number of in-hospital reports per bed was positively related to identifying events by referring complaints or questions of patients or family members, using root cause analysis for analyzing reported events, and developing manuals or case studies based on reported events, and negatively related to the unification and standardization of medical devices and equipment. The experience with mandatory national-level reporting of serious adverse events was positively related to identifying problematic cases by a person in charge of patient safety management from the in-hospital reporting system of complications and accidental symptoms. Enhanced feedback for reporters may promote voluntary in-hospital reporting of minor cases with low litigation risks. Developing an in-hospital mechanism that examines all serious complications and accidental symptoms may promote mandatory national-level reporting of serious adverse events with high litigation risks.

Prioritization of patient safety health policies: Delphi survey using patient safety experts in Japan.

Various patient safety interventions have been implemented since the late 1990s, but their evaluation has been lacking. To obtain basic information for prioritizing patient safety interventions, this study aimed to extract high-priority interventions in Japan and to identify the factors that influence the setting of priority. Six perspectives (contribution, dissemination, impact, cost, urgency, and priority) on 42 patient safety interventions classified into 3 levels (system, organizational, and clinical) were evaluated by Japanese experts using the Delphi technique. We examined the relationships of the levels and the perspectives on interventions with the transition of the consensus state in rounds 1 and 3. After extracting the high-priority interventions, a chi-squared test was used to examine the relationship of the levels and the impact/cost ratio with high priority. Regression models were used to examine the influence of each perspective on priority. There was a significant relationship between the level of interventions and the transition of the consensus state (p = 0.033). System-level interventions had a low probability of achieving consensus. "Human resources interventions," "professional education and training," "medication management/reconciliation protocols," "pay-for performance (P4P) schemes and financing for safety," "digital technology solutions to improve safety," and "hand hygiene initiatives" were extracted as high-priority interventions. The level and the impact/cost ratio of interventions had no significant relationships with high priority. In the regression model, dissemination and impact had an influence on priority (ß = -0.628 and 0.941, respectively; adjusted R-squared = 0.646). The influence of impact and dissemination on the priority of interventions suggests that it is important to examine the dissemination degree and impact of interventions in each country for prioritizing interventions.

Dermatological legal claims in Japan.

Health-care safety management has recently been highlighted for patient safety. However, specialist-based risks in clinical settings have hardly been discussed in Japan so far. A review of dermatological legal claims may delineate these risks. This study examined court precedents from the databases "Courts in Japan" and LEX/DB. Thirty-four dermatology-related civil cases were found from 1968-2006. Of the 34 cases, 32 (94%) were judged and two (6%) were retried. Of these 32 cases, 11 (34%) were appealed to higher courts. Among the 34 litigations, the defendants of eight (23%) were dermatology specialists, 20 (59%) were non-dermatologists and six (18%) of unknown specialty. The defendants' negligence was determined at either level in court in 25 of the 34 cases. The negligence in these 25 cases was categorized into five groups: (i) delayed diagnosis (none); (ii) complication during diagnosis procedure (one, 4%); (iii) inappropriate treatment (nine, 36%); (iv) complication during treatment procedure (10, 40%); and (v) insufficient informed consent (five, 20%). The present study may help to improve strategies for health-care safety management in the dermatological field in Japan.