Purpose: To improve the quality of informed consent by conducting an audit specific to informed consent documents. Methods: A two-tiered audit with 21 audit items was conducted annually, beginning in FY 2016, on the informed consent documents of all departments. The auditor for the first stage was an administrative staff member who was considered to be closest to the patient’s perspective in the hospital. Based on the results of the audit, recommendations for improvement were made annually. Results: Most of the audit items were adequately described in at least 80% of the informed consent documents. However, the explanation of the other options for medical practice and the absence of questions from the patient was inadequate. Recommendations for improvement were made, and improvements were made over time. The content of the explanatory documents was generally rated as easy to understand. There was general agreement between the auditors. Conclusion: By conducting an audit focusing on written infromed consent, the administrative staff, who are close to the patient’s point of view, were able to understand the current state of informed consent in the hospital, identify issues, and make improvements.

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Pharmacists involved in cancer chemotherapy are required to administer anti-cancer drugs appropriately and ensure that safety protocols are followed. However, the examinations required for cancer chemotherapy, and the appropriate management of patient records and laboratory data, are often influenced by the pharmacists’ knowledge and experience. Therefore, in order to verify chemotherapy regimens, we have developed a novel regimen check system, as a part of the existing medical record system. Using this system, we investigated the number of inquiries that were made, prior to the confirmation of cancer chemotherapy. We observed that the pharmacists made an inquiry of 46 cases (48.4%) related to medical examinations, and 12 (12.6%) related to supportive care. It was observed that a pharmacists prior experience did not influence the number of inquiries that he made by using this system (p = 0.933, Fisher’s exact test). Using this system, we consider that the checks in cancer chemotherapy regimens can be equalized. In addition, we consider that this system can enable to safely administer cancer chemotherapy.

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A case of patient death after liver transplantation due to a mistake in the replacement of a blood purification device in 2011 was used as a case study. In this case, a plasma separator was mistaken for a hemofilter in the replacement of the continuous hemodiafiltration channel, and dialysis was continued without noticing the mistake, resulting in death. When the accident was announced, related academic societies discussed the risks and requested that manufacturing and sales companies change the product standards so that they are foolproof. The medical institution conducted an internal medical accident investigation and submitted a report to the Japan Society for Blood Purification in Critical Care, which analyzes human errors. Their report concluded there were two ways to prevent recurrence of this accident: aspects that should be addressed within the medical institution, and introduction of nationwide measures against risks that may occur at any medical institution. The latter cannot be achieved without the cooperation of manufacturing and sales companies. Manufacturers have worked to improve the visibility of medical device packaging and change connectors to prevent misconnections. The Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency held a review meeting to support the movement to change medical device standards and approved a new standard. After the accident in 2011, through activities in various fields, changes to the shape of the connection port of the membrane plasma separator were completed using the ISO80369-7 misconnection prevention connector standard. Although it took 8 years, the risk of similar accidents will be eliminated by the introduction of foolproof measures. Reporting and sharing of accident information is one important way to make healthcare safer.

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In 2005, Tokyo Medical University Hospital introduced an annual “Memorial Day” event for conversations with families of patients who had suffered in-hospital medical accidents. Post-accident, the hospital and families would have discussions since both parties accepted and shared the Independent Medical Accident Investigation Committee's incident report. Through these post-event discussions, Memorial Day, an annually recurring opportunity for listening to lectures and remembering and preventing similar accidents in the future, was created. Over time, the hospital staff’s attitude toward Memorial Day shifted from a day of reflection to pledging their commitment to improve medical safety. This shift convinced some patients’ family members that the hospital was losing interest in Memorial Day as an occasion for recalling past events. However, family members whose interests were similar to the hospital, continued treating Memorial Day as an opportunity for renewing our medical safety pledge and for maintaining accident-related memories. Memorial Day emerged through discussions with family members through a collaborative process. Rather than specific outcomes, it was noted that sharing and interactions between the patient’s family and the hospital staff result in positive outcomes, whether it is tangible or intangible, and fosters safety culture in the hospital.

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Five years have passed since the medical accident investigation system was launched in Japan. This system has the characteristics of open disclosure and accountability to a bereaved family. The process of open disclosure has five stages: informing the bereaved family of the patient’s death; explaining the situation to the family before reporting to the Medical Accident Investigation and Support Center; interviewing the family if needed; explaining the investigation results to the family; and finally continuing communication with the family, if necessary. However, some healthcare professionals fear that this self-report system for patient safety will be unintentionally used for litigation. To assess the impact of this open disclosure, we interviewed both bereaved families and medical staff involved in medical accidents about their experience. Many of the bereaved families said that they had a great deal of distrust of medical institutions immediately after the accident, but they were able to accept the hospital’s response through the accident investigation and dialogue with the medical staff involved. The medical staff involved said that open disclosure would help the bereaved family recover, which would in turn help them recover. At one medical institution that conducted 15 medical accident investigations over 5 years, most of the bereaved families and medical staff involved expressed positive opinions of the investigation, although one case was brought to civil court. The medical accident investigation, which involves communication between bereaved families and medical staff under the law, may lead to the recovery of both parties.

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The appointment of a medical equipment safety manager (MESM) was required for all medical facilities in Japan by the revision of the medical law in 2007.We believe that this has improved the safety of medical equipment in medical facilities. However, in the current status, there are problems such as differences the knowledge and skills of MESMs between each medical facility. Furthermore, there is a problem that the personnel required for maintenance cannot be secured. In a questionnaire survey on MESMs, clinical engineers (CEs) were in charge of MESM in 70% of medical facilities to which CEs were assigned. At these medical facilities, CEs carried out accurate maintenance and efficient management of many medical equipment, and regular training for the safe use of medical equipment. But the burden on MESMs were increasing. In small and medium-sized hospitals that do not have CEs, there are situations where the safety management of medical equipment was not sufficient. If CEs are not assigned, the minimum safety management of medical equipment is required for all hospitals. Many new engineering medical technologies and medical equipment will continue to be introduced in the medical field. Therefore, it is very important to enhance the role of MESM and the medical equipment safety management system in order to ensure the quality and safety of healthcare in the future. In addition, it is important for hospital managers to fully understand the importance of safety management of medical equipment and to support the construction of a safety management system.

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