Professor Shin Ushiro is Executive Board Member – Japan Council for Quality Health Care (JQ) and Deputy Director and Professor of Patient Safety – Kyushu University Hospital.
In 2002, Japan launched a comprehensive national policy on patient safety (find out more about this in my first blog post). It revealed the roles of four key stakeholders – healthcare providers, the government, manufacturers, and citizens/patients. The launch of institutional and national reporting and learning systems was highlighted as one of the new roles of healthcare providers and the government. It is notable that the Institute of Medicine (USA) released a report “To Err is Human” in 1999 in which it assigned a chapter to reporting and learning systems. Relevant revisions were subsequently made to law and ministerial ordinance to commence the systems at institutional and national levels.
Launch of national reporting and learning system
The Japan Council for Quality Health Care (JQ) is a foundation, namely, a private organisation, on quality and safety that was established in 1995 to launch hospital accreditation in my country. The JQ launched the national reporting and learning system in 2004.
I was appointed to work on the system as a divisional director. I initially wondered if medical professionals and medical institutions reported adverse events/near-misses to the JQ because “no-blame culture” was not as robust as it currently is. Contrary to my negativity, the reporting and learning system worked well, with an incrementally large number of cases reported by medical institutions.
I am happy to share my observations and thoughts on why the system was welcomed in medical institutions and in our society:
- Strict adherence by the JQ to “no-blame” reporting and “anonymity” ensured reporting from medical institutions.
- Repeated call for registration through a series of lectures across the country (20-30 lectures annually during the introductory years).
- Feedback to medical professionals with helpful products e.g. monthly alert, reports, adverse event/near-miss database.
- Pressure on medical institutions for registration by media and patients/families/lawyers.
- Guidance and instruction by the local government through annual/regular inspection.
- Transparency ensured by disclosing and providing data and products e.g. reports, alerts, and database for practical and research use to the healthcare frontline, research institutions, manufacturers, and other stakeholders.
Products of the national reporting and learning system as helpful feedback to healthcare frontline
The JQ national reporting and learning system has produced a variety of feedback products, such as periodical reports including numerical and thematic analysis, monthly alerts, and a database of adverse events and near-misses. I would like to stress that feedback which people on healthcare frontlines see as helpful is important to the sustainability of the system.
This is also highlighted in a report – ‘Patient Safety 2030’ published by Imperial College London. The report states that frontline workers report incidents because they value the feedback received and vice versa. An example of how these products are embedded on the healthcare frontline in Japan can be seen at Kyushu University Hospital (KUH). Here, JQ’s monthly alert is included on monthly meeting agendas and the committee on patient safety. The alert is delivered to each clinical division/department and staff put signatures to it to confirm they have seen it.
The reach of the products is assessed on such occasions as JQ’s hospital accreditation, peer-review program of university hospitals, and governmental inspection. In addition, I would like to highlight that practicality is also vital for staff. They work in different local contexts. Therefore, recommendations do not impose impractically high hurdles. This is a perspective that the JQ have valued in running the national reporting and learning system and producing feedback.
Value of transparency
I believe that JQ’s database of adverse events and near-misses is unique. The JQ initiated the database with close communication with registered facilities, saying that the database is developed for patient safety and therefore names of institution and frontline workers are not disclosed. The database is used not only by frontline workers and researchers, but by manufacturers, as their products may be involved in adverse event and near-miss.
For instance, adverse events caused by “sound-alike drug” is frequently reported in the JQ’s system. As multiple manufacturers are involved in the case, they need to work jointly when action is taken. Before the database was launched, it was unlikely for different companies to jointly work on issues like “sound-alike drug” incidents because they are independent and even competitive in the market. However, after the JQ initiated disclosure through the database, manufacturers have begun to work jointly to respond to events in such a way that they issue an alerting document with both company’s names quoting adverse event/near-miss disclosed in the database to enlighten frontline workers on the “sound-alike drug” event and deliver proposals on corrective action.
Furthermore, the JQ in collaboration with researchers on AI successfully developed an AI model which produces large structured-datasets of “named-entity recognitions (NERs)”. The research team initially produced a small number of annotated adverse events related to medication errors that was obtained from the database and finetuned AI with it. This achievement implies that the AI model would work with electronic health records and detect medication errors with decent accuracy to report to the relevant division or body at institutional and national level, without reporting by medical professionals. Why was the AI model developed and this future perspective is proposed here? I proudly say that transparency through disclosure described above made all the positive change happen.
Expansion of the national reporting and learning system
Following positive achievements with the original reporting and learning system, the JQ and the MHLW jointly launched equivalent systems targeting different healthcare institutions such as community pharmacy (2009) and dental clinic (2023).
The MHLW launched a policy called ‘Pharmacy Vision for Patient’ in 2015 in which movement was emphasized on shifting the pharmacist’s role in community pharmacy from work for product to work for patient such as detection of prescription error, early detection of side effects and education to patients on medication therapy.
Currently, the pharmaceutical near-miss reporting and learning system receives a large number of cases in which wrong prescription was corrected by pharmacist who clarified the doctor’s intention through a phone call. This accounts for nearly 80% of all near-misses. The MHLW has facilitated community pharmacy to enrol in the system by providing financial incentives in the public healthcare insurance system. We, therefore, have so far observed approximately 75% of community pharmacies in my country enrolled in the system.
Another system covering dental near-misses commenced in 2023 based on the experience of the preceding two systems. What is unique about dental near-miss is that it involves a wide variety of medical devices with which dentists and assistants work in delivering dental care such as turbine, engine, ultrasonic scaler, and dental vacuum. Near-miss related to dental technology is also an event not seen in other systems.
Safety in dental care has been less highlighted in our society and we have not yet learned from errors at a national level. The system, therefore, will provide an opportunity for dentists and staff to improve patient safety in their facilities and for our society to be informed with enhanced transparency of what is happening and how we address challenges on patient safety in dental care.
