Case Study - Building A Nationwide Adverse Event Reporting and Learning System - Shin Ushiro
Case Study - Building A Nationwide Adverse Event Reporting and Learning System - Shin Ushiro
Summary
In the late 1990’s, a series of fatal accidents took place within highly regarded Japanese university
hospitals, which provoked serious concern amongst Japanese citizens. The Minister of Health and
Welfare issued a “Minister’s Urgent Appeal” to the Japanese Medical Society stating that building
trust and ensuring patient safety should be given top priority in Japan. As a result, the Japanese
government rolled out a subsidiary budget to launch a nationwide adverse event reporting and
learning system. Acting as the “Minister’s Approved Operating Body” of the healthcare system, JQ
carried out development and deployment of this system.
The Problem
After the system was launched, many medical professionals and facilities who were subject to
reporting under government ordinance were reluctant to report for fear of being blamed and/or
sued by patients, their families, and lawyers who worked as patient advocates. Influential media
was keen to report the names of the institutions and medical professionals in order to bring them
to the attention of the public and to punish them.
The Consequences
It was well known throughout Japan that media publicity of adverse events in healthcare was
rapidly growing in frequency, ultimately making medical professionals feel blamed and threatened
by influential media power. As a result, medical professionals were inclined to evade high-risk
procedures, even though it was most likely to effectively improve the condition of the patient’s
health. This behavioural pattern was called “Restrained Medicine”, which was frequently
mentioned in academic societies as a consequence of a “blame culture”, which often led to the
deterioration of the quality of clinical practice. The number of medical lawsuits were also rising
according to the statistics of the Japanese Supreme Court.
Barriers / Obstacles
In late 1990’s and early 2000’s, Japanese society and the media were not aware of the harm of a
“blame culture”. They felt that it was effective to pursue somebody and/or facility in order to
penalize them and highlight where responsibility lies. However, it does not work for the promotion
of patient safety. In addition to this, physicians struggled to articulate why an adverse event took
place so they tried to avoid reporting them.
Actions
JQ launched the nationwide adverse event reporting and learning system in which university
hospitals and other hospitals falling into the category of “Public Hospital” in Health Service Law
were subject to reporting. The system was designed to work on the internet which helped in
reducing the burden of documentation work. JQ advocated other hospitals to join on voluntary
basis to grow a group of facilities that report adverse events for patient safety.
JQ clearly proclaimed two operation principles at the inception of the system which were :
i) No-blame culture.
ii) Anonymous nature.
In order to disseminate the idea that a no-blame culture is a key principle for improving the
deteriorating status of trust in Japanese society over patient safety in healthcare, JQ held
periodical press conferences in order to issue quarterly report and annual report (i.e. five times
per year). JQ regularly publishes the above reports, monthly alerts, and also provided a database
for searching for individual events so others can learn from them. In short, JQ successfully
revealed and even enhanced the effect of “No-blame culture” in Japanese society by disclosing
data as often as it possibly could.
What Worked?
Both patient safety and trust within the healthcare industry was collapsing in late 1990’s when
medical professionals and facilities were hesitant to disclose adverse events. Through the
development and operation of the reporting and learning system, Japanese society became aware
of how patient safety could be achieved. They also learned that near-misses took place quite often
within healthcare.
The Japanese government periodically reduced the subsidiary budget for the system as the
concerns from the past began to subside.
Outcome
The reporting and learning system greatly enhanced the recognition of adverse events (such as
frequency, degree of harm, types of event) which took place in Japanese healthcare institutions.
The Japanese government later introduced an analogous system to community pharmacy for
patient safety, based on the idea that the reporting and learning system was effective. At an
institutional level, medical professionals (particularly those who were in charge of patient safety)
were frequently distributing the monthly alert released from JQ suggesting the continuity of a
“Knowledge Highway” from JQ to the frontline of medicine.
Lessons Learnt
Transparency and accountability should be given a top priority to tackle issues of nationwide scale
which ignites huge concern in our society. Japan wasted years in which medical professionals were
reluctant to be open and faithful to patients and families for fear of being blamed. The swift
building of communication channels with the media is also imperative for effectively dealing with
difficult issues like accidents in healthcare.
References / Bibliography
Shin Ushiro is an Executive Board Member, Japan Council for Quality Health Care (JQ) in which he
looks after various projects related to patient safety such as nationwide adverse event reporting
and learning system. He is also a professor of the Division of Patient Safety, Kyushu University
Hospital carrying out in-house incident reporting and learning system, staff education etc. Both
experiences of national and institutional level activities well features author’s scope of interest
and expertise.