保健医療科学

2019Vol.68 No.1 p.55−60

Topics: Recent topics in public health in Japan 2019

＜ Review ＞
Patient safety: History and recent updates in Japan
Kenichiro Taneda
Department of International Health and Collaboration/Department of Health and Welfare Services,
National Institute of Public Health

Abstract
Japan Ministry of Health, Labour and Welfare (MOHLW) hosted the Third Patient Safety Ministerial
Global Summit in April, 2018, in Tokyo, Japan. Healthcare quality including patient safety is one of criticalaspects to achieve Universal Health Coverage (UHC) under Sustainable Development Goals (SDGs). Japan
has been striving for patient safety improvement around the last 20 years. This article describes some of
the recent activities including the new reporting system of death cases due to medical accidents, the reformof patient safety management at advanced treatment hospitals. These our experiences in Japan would be
useful for other countries.
keywords: patient safety, reporting and learning system, global summit(accepted for publication, 7th February 2019)

I．Introduction of patient safety measures inJapandescribed similar patient safety issues in 1999 and 2001 reFigure 1 “TO ERR IS HUMAN”
spectively1, of2).Medicine) Report in 1999
US IOM(Figure(InstituteJapan achieved universal health insurance coverage of thenation in 1961. Then Japanese health system was ranked
top in overall goal achievement according to WHO World
Health Report 2000[1]. However, the quality of healthcare
services was not necessary as good as we thought. In 1999
and early 2000, Japan experienced the series of serious
patient safety accidents (Table 1). Interestingly, The US
and UK also published the reports on patient safety which+HDOWKFDUHLQWKH8QLWHG6WDWHVLVQRW
DVVDIHDVLWVKRXOGEHDQGFDQEH$W
OHDVWSHRSOHDQGSHUKDSVDVPDQ\DVSHRSOHGLHLQKRVSLWDOVHDFK\HDUDVDUHVXOWRIPHGLFDOHUURUVWKDWFRXOGKDYHEHHQSUHYHQWHGDFFRUGLQJWRHVWLPDWHVIURPWZRPDMRUVWXGLHV(YHQXVLQJWKHORZHUHVWLPDWH
SUHYHQWDEOHPHGLFDOHUURUVLQKRVSLWDOVH[FHHGDWWULEXWDEOHGHDWKVWRVXFKIHDUHGWKUHDWVDVPRWRUYHKLFOHZUHFNVEUHDVWFDQFHUDQG$,'6Table
Table11 Patient
Patientsafety
safetyaccidents
accidents which
which triggered
triggerednationalpatientpatient
safetysafetymeasuresin Japannationalmeasures
in JapanFigure“TOERR IS HUMAN”
IOM
Figure2 1“Anorganization
with aUSmemory”(InstituteofMedicine)
Report1999
UK DOH (Department of Health) Report inin2001

 January, 1999: Yokohama City University Hospital
Patients for heart surgery and lung surgery were mixed up, and operations were
performed for different parts of the bodies.

“Yet the best researchEDVHGHVWLPDWHVZHKDYHUHYHDOHQRXJKWRVXJJHVWWKDWLQ
1+6KRVSLWDOVDORQHDGYHUVHHYHQWVLQZKLFKKDUPLVFDXVHGWRSDWLHQWV February, 1999: Tokyo Metropolitan Hiroo Hospital
After a surgeｒy, ｄisinfectant, instead of anticoagulants, was administeredintravenously by mistake, which resulted in the patient’s death.
 February, 2000: Kyoto University Hospital
Ethanol was put into a humidifier of a respirator/ventilator by mistake, instead of
distilled water, and then the patient died of its toxicity.
 April, 2000: Tokai University Hospital
Oral medication was administered intravenously, due to confusion withenteral nutrition route, , which resulted in the pediatric patient’s death.

Corresponding author: Kenichiro Taneda
2-3-6 Minami, Wako-shi, Saitama 351-0197 Japan.

•

RFFXULQDURXQGRIDGPLVVLRQV– RU
DWDUDWHLQH[FHVVRID\HDU•

cost the service an estimated £2 billion
D\HDULQDGGLWLRQDOKRVSLWDOVWD\VDORQHZLWKRXWWDNLQJDQ\DFFRXQWRI
human or wider economic costs.”

Figure 2 “An organization with a memory” UK DOH(Department of Health) Report in 2001

E-mail: taneda.k.aa@niph.go.jp

J. Natl. Inst. Public Health, 68 (1) : 201955

Kenichiro Taneda

II．Brief history of patient safety measuresin 2000s[1]
In response to these accidents, Japanese government
established the office of patient safety promotion within
MOHLW in 2001, and then patient safety measure review
meeting “National Council for Patient Safety” was held withexperts (Table 2).
In 2002, the council coordinated the “patient safety
promotion comprehensive measures” report. The report
described the followings: the patient safety measures atmedical facilities, safety improvements on medication andmedical equipment, education and training on patient safety, system improvements to promote patient safety suchas development of patient consultation services, providing information on patient safety, and scientific researchon patient safety. Various patient safety measures wereenforced based on this report. In October 2002, the ministerial ordinance mandated medical facilities with inpatient
facilities to establish a patient safety management system.
In April 2003, advanced treatment hospitals were requredto arrange medical safety management personnel, a patient
safety management department, and patient consultation
services. In 2004, they were also enforced to report patient
safety incidents to the national adverse event reporting andlearning system operated by the Japan Council for Quality
Health Care (JQ)[2] (Figure 3).
Patient safety has been stipulated through revisions ofministerial ordinances. In the amendment of the Medical
Service Act in 2006, patient safety was included in the Act
and the all medical facilities were mandated to establish apatient safety management system. All prefectures werealso obliged to establish a Patient Safety Support Center toconduct consultations for patients and residents and to support patient safety activities at healthcare facilities.
In 2009, the Japan Obstetric Compensation System for
Cerebral Palsy (JOCS-CP) was launched as a novel system
of no-fault compensation and investigation/prevention. JQ
was appointed to manage JOCS-CP and its financial source
is mainly from public health insurance system. Guardians ofa patient with cerebral palsy have been provided monetarycompensation as well as its investigational report.

Table
Patient Safety
Safety measures
measuresinin2000s
2000s
Table 22 Overview
Overview ofof Patient
2001 - Office of Patient Safety at Ministry of Health, Labor and Welfare (MHLW)- National Council for Patient Safety

2002 - The "Patient Safety Promotion Comprehensive Measures" report- Ministerial ordinance: Mandate of Patient Safety management at advanced treatment
hospitals, teaching hospitals, general hospitals, and clinics with inpatient facilities

2003 - Ministerial ordinance: Mandate to have patient safety manager, patient safety division, andoffice of patient complaint at advanced hospitals, etc.
- “Urgent appeal of Patient safety accident measures“: Patient safety as one of the mostimportant issues of medical policy by the Minister of MHLW

2004 - National Adverse Event Reporting and Learning System- Ministerial ordinance: Mandate of patient safety reporting system at advanced hospitals, etc.

2006 Amendment in Medical Service Act for patient safety: Mandate of patient safety system atall healthcare facilities including clinics without inpatient facilities and midwifery centers, toestablish patient safety support centers in each prefecture

2009 The Japan Obstetric Compensation System for Cerebral Palsy (JOCS-CP))LJ 7KH1XPEHURI$GYHUVH(YHQWVUHSRUWHGWR-4SUHVHQWHGE\'U
8VKLUR LQWKH3DWLHQW6DIHW\6XPPLWKWWSZZZFRQJUHFRMSSVJPVSGI'D\B(YHQLQJB6HVVLRQ(6B6KLQB8VKLURSGI

Figure 3 The Number of Adverse Events reported to JQ presented byDr. Ushiro in the Patient Safety Summit

56

J. Natl. Inst. Public Health, 68 (1) : 2019

Patient safety: History and recent updates in Japan

III．Recent Updates

in a designated patient safety seminar every year. Ahospital director should have experiences on patientsafety activities before.
- To have personnel, such as a vice hospital director,
who is responsible for the whole patient safety management. The personnel is required to participate ina designated patient safety seminar every year.
- To have personnel who is responsible for medication
safety management. The personnel is required toparticipate in a designated patient safety seminar every year.
- To have personnel who is responsible for medical
equipment safety management. The personnel isrequired to participate in a designated patient safetyseminar every year.
- To have a doctor as a full-time patient safety officer- A ll death cases should be reviewed to determine
whether there is a case which should be reported tothe Medical Accident Investigation and Support Center.
- To conduct peer-review including a site visit on patient safety among advanced hospitals- To have external reviews on patient safety by external experts including a patient representative twice ayear- To have some indicators to monitor patient safety

1. Investigation System of death cases due to MedicalAccident[3]In 2015, the Medical Accident Investigation and Support
Center (ISC) was established and then operated by the Japan Medical Safety Research Organization (Medsafe Japan)(Figure 4). This new system aims to prevent recurrencesof serious events resulting in unforeseen death of patientsat all healthcare facilities including small clinics. The ultimate decision of “Medical Accident” is made by a directorof a concerned healthcare facility under the concept of“Professional Autonomy and Self-Regulation”. The reports“In-Hospital Investigation” submitted to ISC is more than
900 cases in total as of February 5th, 2019. Based on thereports, ISC has published booklets to facilitate preventionsof medical accidents, including “Central Venous Catheterization”, “Acute Pulmonary Thromboembolism” and “Anaphylaxis caused by injections”.
)LJ

,QYHVWLJDWLRQ6\VWHPRI'HDWK&DVHVGXHWR0HGLFDO$FFLGHQWVKWWSVZZZPHGVDIHRUMSPRGXOHVHQLQGH[SKS"FRQWHQWBLG Figure 4 Investigation System of Death Cases due toMedical Accidents

2. Local networking on patient safety
In 2018, the MHLW initiated the new financial incentive
to facilitate mutual learning and support among local hospitals. The hospitals can receiver better re-imbursement
if they could establish local networking to improve patientsafety. The hospitals are required to organize meetings andsite visits on regular basis to learn patient safety activities
from each other.

4. Patient Safety Culture in Japan
In 2001, the committee on human error under MHLW
identified particularly important issues for patient safety
and then mentioned “safety culture” in the first place. It isessential to foster a culture of safety in healthcare facilities
to provide safe care. Therefore, the author translated andadministered the validated patient safety culture survey
tool developed originally by the Agency for Healthcare Research and Quality (AHRQ) in US[4,5]. The figure 5 shows)LJXUH3DWLHQW6DIHW\&XOWXUHLQ-DSDQDQGWKH8QLWHG6WDWHVLQ
D )UHTXHQF\RIHYHQWVUHSRUWHG



3. Reform of patient safety management at advancedtreatment hospitals
Because of several serious accidents at university hospitals, the MHLW organized the task force committee toimprove patient safety management at advanced treatmenthospitals such as university hospitals in 2015. Since 2016,
the drastic reform of patient safety management proposedby the committee has been implemented at advanced treatment hospitals.
The reform includes the followings:- A hospital director/president is required to participate

H 7HDPZRUNZLWKLQXQLWV




E 2YHUDOOSHUFHSWLRQVRISDWLHQWVDIHW\





G 2UJDQL]DWLRQDO OHDUQLQJ&RQWLQXRXVLPSURYHPHQW

K 1RQSXQLWLYH UHVSRQVHWRHUURU

O +DQGRIIVDQGWUDQVLWLRQV

N 7HDPZRUNDFURVVXQLWVF 6XSHUYLVRUPDQDJHUH[SHFWDWLRQV J )HHGEDFNDQG
DQGDFWLRQVSURPRWLQJSDWLHQWVDIHW\ FRPPXQLFDWLRQDERXWHUURUM 0DQDJHPHQWVXSSRUWI &RPPXQLFDWLRQRSHQQHVV IRUSDWLHQWVDIHW\L 6WDIILQJ• &RPSRVLWH/HYHO$YHUDJH3HUFHQW3RVLWLYH5HVSRQVH□-DSDQ )DFLOLWLHV ■ WKH86 8VHU&RPSDUDWLYH'DWDEDVH5HSRUWFigure 5 Patient Safety Culture in Japan and the UnitedStates in 2018

J. Natl. Inst. Public Health, 68 (1) : 201957

Kenichiro Taneda
the recent survey result of patient safety culture in Japan
in 2018 (Average response rate: 89%) compared with theone in US in 2018 (Average response rate: 54%). Japanneeds to improve patient safety culture in particularly in thefollowing aspects: staffing, communication openness, andmanagement support for patient safety. As one of strategies
to improve patient safety culture, we have implemented
TeamSTEPPS® in collaboration with US[6].

all patients and people during their interaction with healthcare systems, whoever they are, wherever they live, by2030”
We hope that our experiences in Japan can contribute toother countries, global patient safety movement, and then
Universal Health Coverage ultimately.

References
5. Third Global Ministerial Summit on Patient Safety
Tokyo, in April 2018[7]In 2016 and 2017, the UK and German governments
hosted the first two Summits respectively. In 2018, the Japanese Government organized the third Summit in Tokyo,
as the first host country in Asia (Figure 6). There wereapproximately 500 participants including delegations from44 countries with18 Ministers/Vice-ministers, delegatesfrom international organizations, patient safety experts andother stakeholders. We expected that, through the Summit, the global patient safety movement would spread to
all the countries of the world regardless of their region or
income level to achieve UHC because UHC requires qualityof healthcare services[8]. In the summit, Mr. Katsunobu
Kato, Minister of Health, Labour and Welfare, Japan, clearlystated “I stressed sincere hope that UHC and patient safety
will be promoted hand-in-hand in a holistic manner, leading
to coherent and effective policy measures, tailored to thecircumstances of each country.”
At the end of the summit, the “Tokyo Declaration” wasendorsed by the majority of participating countries. The
declaration will facilitate patient safety as an integral element towards the achievement of UHC, and then promoteand support “Global action on patient safety” among allcountries, including low- and middle- income countries.
Quote from Tokyo Declaration on Patient Safety:“We reaffirm our commitment to improving patient safety
in order to reduce all avoidable harm and the risk of harm to[1] WHO. The world health report 2000 - Health systems: improving performance. https://www.who.int/
whr/2000/en/whr00_en.pdf?ua=1 (accessed 2019-0207)[2] Patient Safety Activities at Ministry of Health, Labourand Welfare (MOHLW). https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/i-anzen/index.
html (accessed 2019-02-07)[3] The Japan Council for Quality Health Care (JQ). http://www.med-safe.jp/contents/english/index.html (accessed 2019-02-07)[4] Medical Accident Investigation System. https://www.
medsafe.or.jp/ (accessed 2019-02-07)[5] US AHRQ Surveys on Patient Safety Culture. https://www.ahrq.gov/sops/index.html (accessed 2019-02-07)[6] 種田憲一郎，奥村泰之，相澤裕紀，長谷川敏彦．安
全文化を測る―患者安全文化尺度日本語版の作成．
医療の質・安全学会誌．2009;4(1):10-24.
Taneda K, Okumura Y, Aizawa Y, Hasegawa T. [Reliability and validity of the Japanese version of the hospitalsurvey on patient safety culture.] The Japanese Journalof Quality and Safety in Healthcare. 2009;4(1):10-24. (inJapanese)[7] The official website of the Military Health System.
Patient Safety in Action: Collaboration with Japan
Leads to Diffusion of TeamSTEPPS Overseas. https://health.mil/News/Articles/2017/11/01/Patient-Safe-)LJXUH3DWLHQW6DIHW\*OREDO0LQLVWHULDO6XPPLWLQ7RN\R

http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000204000.html

Figure 658

Patient Safety Global Ministerial Summit 2018 in Tokyo

J. Natl. Inst. Public Health, 68 (1) : 2019

Patient safety: History and recent updates in Japanty-in-Action-Collaboration-with-Japan-Leads-to-Diffusion-of-TeamSTEPPS-Overseas (accessed 2019-02-07)[8] Patient Safety Global Summit 2018. http://www.congre.
co.jp/psgms2018/index.html (accessed 2019-02-07)[9] 種 田 憲 一 郎．SDGsの 要 で あ るUHCの 必 須 要 素：
サービスの質・安全とこれに資する包括的人々中心のサービス．保健医療科学．2017;66(4):380-386.
Taneda K. [Integrated people-centred health services
for healthcare quality and patient safety to contributeto UHC under SDGs.] J. Natl. Inst. Public Health.
2017;66(4):380-386. (in Japanese)

J. Natl. Inst. Public Health, 68 (1) : 201959

Kenichiro Taneda

患者安全−日本における歴史（概要）と近年の取組み−
種田憲一郎
国立保健医療科学院国際協力研究部／医療福祉サービス研究部

抄録
2018年 4 月に，厚生労働省は第三回の患者安全閣僚級グローバルサミットを東京にて実施した．患者 安 全 を 含 む 医 療 の 質 は，SDG（Sustainable Development Goals） で 提 案 さ れ るUHC（UniversalHealth Coverage）を達成するために重要な要素の一つである．日本は，過去約20年間にわたって患者安全の改善に努めてきた．今回の特集記事では，死亡事故を対象とした医療事故調査制度，特定機能病院における医療安全管理体制の見直しなど，近年の日本における患者安全の活動について紹介する．これらの経験は諸外国においても参考となる取組みと思われる．
キーワード：患者安全，閣僚級患者安全サミット，UHC

60

J. Natl. Inst. Public Health, 68 (1) : 2019