COMPLETION REPORTA Study on Medical Accident Reporting System in Japan for Implementing Improvement Strategies in Malaysia
Dr. Puteri Nemie Jahn Kassim
Professor
Ahmad Ibrahim Kulliyyah of Laws International Islamic University Malaysia
Title of Research Project:
A Study on Medical Accident Reporting System in Japan for Implementing Improvement Strategies inMalaysia
Principal Researcher:
Professor Dr. Puteri Nemie Jahn Kassim
Ahmad Ibrahim Kulliyyah of Laws
International Islamic University Malaysia
Malaysia
Result of the Research:
Adverse events or “injuries due to medical care” due to practice, products, procedures and systems may emerge at
all stages in the process of care-giving. The occurrence of medical error induces adverse events, which may becaused by a combination of human factors and system factors. However, majority of medical errors are considered
preventable, particularly, those involving human errors. Therefore, patient safety management requires various
institutional initiatives to be taken in order to encourage open disclosure of medical errors, to prevent their reoccurrence and ultimately, to learn from them. Amongst the various patient safety initiatives that have been takenin Japan is implementing a wider use of internal reporting systems for hospitals and building a system to provide
and collect information. The Japan Council for Quality Health Care (JCQHC), a third party hospital accreditation
organisation, has been tasked to collect ‘medical near-miss/adverse event’ information for the promotion of patient
safety and medical adverse event prevention. In the light of increasing number of adverse events reported toJCQHC in 2014, the amendment to the Japan Medical Care Act was made to establish the Medical Accident
Investigation System which is also known as iryojiko chosa seido. The new system came into operation onOctober 1, 2015 and made it mandatory for all medical institutions in Japan to report any ‘unexpected deaths’ inrelation to medical care to a medical accident investigation support centre and perform medical accident
investigation to identify the cause of the accident. The number of mandatory reporting medical institutions as of
31st December 2014 is 275 hospitals and the number of reported accidents collected from January 1st toDecember 2014 is 2911 cases, which include 225 cases resulting in death. According to Articles 6 – 10 of theMedical Care Act, administrators of hospitals, clinics or birthing center shall undertake measures for (i) theestablishment of policies to ensure safety in medical care; (ii) the implementation of training for employees; (iii)measures to ensure safety in medical care in other relevant hospitals, clinics or birthing centers. Further, accordingto Articles 1 - 11(i) of the Act, administrators of the hospitals shall ensure medical safety based on regulations

described in Articles 6 - 10 in (i) preparing guidelines for medical safety control; (ii) holding committee meetings
on medical safety control; (iii) training staff in medical safety control; and (iv) taking improvement measures
aimed at ensuring medical safety, such as, reporting of medical accidents that occur within medical institutions.
Medical accidents subjected to this system are “death or stillbirth which are caused or suspected to have beencaused by care provided by employees of the medical institutions, and which are unforeseen by the administrator”.
Subsequently, the outcome of the investigation will be collected by a private third party institution known as the‘Medical Accident Investigation Support Centre’. This Centre is tasked to analyse the result of the accident withthe objective of preventing its recurrence as well as improving the safety and quality of healthcare. They must also
explain the results of their investigations to relatives of the deceased and submit a report on each case to the Japan
Medical Safety Research Organisation so that they are able to analyse the information and propose steps to avoid
similar mistakes. This step is considered very beneficial in making the healthcare institution more transparent andaccountable. Overall, the initiative taken by Japan is very much applauded and can provide valuable lessons formany countries, including Malaysia, in ensuring that adverse events in medical institutions are reported, discussed
and prevented. In particular, the following strategies implemented in Japan can be further developed in Malaysia tostrengthen and improve Malaysia’s incident and investigative system namely; (i) To create an incident reportingand investigative system, under a clear legislative framework to provide clear rules and guidance for medical
institutions to know clearly their duties on reporting and implications of not reporting on adverse events
particularly, those leading to death; (ii) To develop specialized and separate bodies to handle the ‘reporting’ and‘collection’ of adverse events cases, the ‘investigation’ and ‘analysis’ of the cases and finally, the ‘plan of action’for preventing future recurrence; (iii) To inculcate a culture of transparency in making it mandatory to explain to
the affected persons such as the bereaved families on the events leading to the mishap and providing them with thenecessary documents as substantial evidence. Implementing these strategies will ultimately, ensure thepreservation of public confidence in medical institutions in Malaysia as well as systemic improvements in patient
safety and professional discipline.

Publication of the Results of Research Project:
Verbal Presentation (Date, Venue, Name of Conference, Title of Presentation, Presenter, etc.)
1. Name of Presenter: Prof Dr Puteri Nemie Jahn Kassim
Title of Presented Paper: “Integrating Patient Safety and Risk Management: The Role of Law andHealthcare Organisations”
Name of Conference : International Conference on Global Business, Social Science, Entrepreneurship2016 (ICoGBSE 2016)
Theme of Conference: Law &Society
Organiser: Global Business & Social Entrepreneurship
Date and Venue:
27th to 28th December 2016 at Kinabalu Pines Resort, Kundasang, Sabah, Malaysia
Thesis (Name of Journal and its Date, Title and Author of Thesis, etc.)
1. Name of Author: Prof Dr Puteri Nemie Jahn Kassim
Title of Paper: “Mandatory Incident Reporting through Legislative Framework: Towards Enhancing
Patient Safety Culture in Healthcare Settings”
Name of Journal : International Journal on Humanities, Language, Business and Culture (HLCB)
Status: Published in 2017, Volume 1, Number 2, pp. 181-189 at http://www.icohlcb.com ; eISSN: 01268147
2. Name of Authors:
Prof Dr Puteri Nemie Jahn Kassim & Prof Dr Shin Ushiro
Title of Paper : “The Reporting of Adverse Events in Healthcare Setting: A Study on the Japanese andMalaysian Incident Reporting System”
Status: In press…to be submitted for publication in selected journal after final editing of the article by theauthors.
Book (Publisher and Date of the Book, Title and Author of the Book, etc.)
None