Sharing the county experience : Japan

Shin Ushiro M.D., PhD. 1-4

1. Japan Council for Quality Health Care（JQ）

2. International Society for Quality Health Care (ISQua)

3. Kyushu University Hospital

4. Ministry of Health, Labour and Welfare, Japan

Sharing the county experience : Japan

WHO Global Patient Safety Network (GPSN) Webinar Series

公益財団法人日本医療機能評価機構

Japan Council for Quality Health Care

◼ Jan 1999: Yokohama City University HospitalTwo patients were mixed-up during surgery and the wrong organs (Heart of

patient X and Lung of patient Y) were operated.

◼ Feb 1999: Tokyo Metropolitan Hiroo HospitalA patient after surgery was mistakenly injected with disinfectant instead of an

anticoagulant. The patient died.

◼ Feb 2000: Kyoto University HospitalThe hospital staff mistakenly poured ethanol into a humidifying unit of a ventilator

instead of distilled water. The patient died.

◼ Apr 2000: Tokai University HospitalAn oral drug was mistakenly given through intravenous route. The pediatric

patient died.

Devastating Medical Malpractice Cases that triggered

public concern



People

Health

-care

Providers

Govern-ments

Manu

-facturers

Patient

participation/empowerment

• Enhanced informed consent

• Engaged in healthcare

improvement process

• Fail safe design

• Improvement of drugs,

medical devices for user-

friendly purpose, etc.

Schematic image of the “Holistic Policy on PS”(Released in 2002

from MHLW* Expert Panel)

Citizens

Govern

-ments

• In-hospital reporting system

• Safety management system

• Guidelines for safety measures

• Education & Training

• National incident reporting

system

• Educational workshops

• Instructions/Directives to

medical institutions /

manufacturers

• Research funding, etc.

* MHLW; Ministry of Health, Labour and Welfare

Development of reporting and learning systems in Japan

２００１

２００４

２００８

JQ MoHLW

Subsidiary budget for R/L system of

Pharmaceutical Near-Miss

• R/L system of Near-Miss

• Operator : Pharmaceuticals and

Medical Devices Agency (PMDA)

i) R/L system of Near-Miss

ii) R/L system of Adverse Event

R/L system of Near-Miss/Adverse Event

Revision of the government ordinance for

R/L system of Near-Miss/Adverse Event

R/L system of Pharmaceutical Near-Miss

MoHLW; Ministry of Health, Labour and Welfare

Revision of “Health Care Act” to

mandate internal R/L system to all

medical institutions (Hospitals, Clinics)２００６

Subsidiary budget for R/L system of

Near-Miss/Adverse Event



Reporting & Learning System institutionalized in healthcare

system in Japan

Medical institution

(Hospital, Clinic)

Internal reporting

system mandated by

Health care act

External reporting system

participated by mandatory*

and voluntary hospitals

* Hospitals mandated to report

under the government

ordinance• University hospitals

• National Hospital Group, etc.

On-site survey

Accreditation

Reporting of AEs,

Near-miss

(a part of institutions)

Central, Local

governments

Regular

inspection*

* Inspection under “Health Care Act”; Hospital-annually, Clinic-every 2-3 years



AE reporting/learning

system (medical institution)

Investigation system of

accidental death

2015 -

2004 -

2008 -

AE reporting/learning

system (Pharmacy)

2021

Nationwide reporting/investigation/learning system with

public or quasi public nature

Cerebral palsy compensation

investigation/prevention system

2009 -



Year 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020Mandatory 1,114 1,296 1,266 1,440 1,895 2,182 2,483 2,535 2,708 2,911 3,374 3,428 3,598 4,030 4,049 4,345Voluntary 151 155 179 123 169 521 316 347 341 283 280 454 497 535 483 533.7

0

1,000

2,000

3,000

4,000

5,000

6,000

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Mandatory Voluntary

Trajectory of the AE reporting to JQ

4,512 accidents, 28,607 near-miss / 2019

Adverse

event

Japan National University Hospital Alliance on

Patient Safety (JANUHA-PS) Annual Congress, 2019

Chair; Tokyo Medical-Dental University

Hospital

Vice-Chair; Kagoshima University

Hospital



Probable reason for “the steady rise” in external reporting• Strict adherence to “No-blame” and “Anonymity” in operation by JQ

• Repeated call for registration through series of lectures across

Japan (20-30 lectures annually)

• Feedback to medical professionals with helpful products i.g. Monthly

alert, Reports, Database

• Pressure on medical institutions for registration by media and

patient/family/lawyer

• Guidance, instruction by the local government through

annual/regular inspection

• Enhanced transparency by providing data for practical and research

use to the healthcare fronts and research institution, etc.



Production flow on thematic analysis (initial & recurrent event)

and Monthly Alert

Monthly alert

Thematic analysis

Thematic analysis of recurrent event

Reporting of AE/Near-miss to JQ

Other themes

Monthly Alert (2012, 2018)Thematic analysis

Failure to Confirm CT, MRI Imaging Report

Jun 09, 2018 YOMIURI SHIMBUN (Newspaper)

• The physician in charge

ignored cancer in organs that

he/she did not specialize in.

• CT imaging reports mentioned

to “Cancer”.

• Nine similar cases including

two fatal cases were verified

through internal investigation .

• Preventive measures should

be in place in expedited

manner.

Prevention by newly equipped

vigilance module in EHR



“Patient Safety Information” (Monthly alert)

Preventive/improvement

measuresIllustration to facilitate better

and instant understanding of

the key statement

Logo

Key statement

Case presentationsTitle



FAX

Website

Distribution of monthly alert

Notice by

Central,

Local

authorities

Medical institutions

& professionals

including 5,956*

institutions receiving

it through FAX, i.e.

approximately 70% of

Japanese hospitals）

* Registration figure as of Sep, 2020

Collaboration with “Global Patient Safety Alerts”, initiative by

Canadian Patient Safety Institute

YouTube; https://www.youtube.com/watch?v=2-9iS9CaN3Y



Type key word for search : “Dialysis”

706 AEs are matched.

• Choose “Adverse event” and/or

“Near-miss”

• Choose “Type of events”

“Browse” button

“Download” button by

digital file format

Database of AE / Near-miss on homepage



◼ Project Investigator (研究代表者)

◼ Dr Zoie SY WONG

◼ ウォンスイー

◼ Associate Professor

◼ Graduate School of Public

Health

◼ St. Luke’s International

University

◼ 聖路加国際大学

◼ 公衆衛生大学院准教授

◼ Email: [email protected]

Project Investigator ; Dr Zoie SY WONG

Associate Professor, Graduate School of Public Health

St. Luke’s International University

From Reports to Knowledge for Patient

Safety Improvement through Advancements

in Artificial Intelligence

Japan Society for the Promotion of Science (JSPS)

Grant-Aid for Scientific Research B (2018-2021)



Research through collective analysis of AEs related to

laparoscopic surgery



Release of alert by manufactures on sound-alike drugs:

“SENIRAN” vs “CERCINE” (2019)

• We have submitted a

request that “SENIRAN”,

a trade name, is

removed from the market

to be replaced with

generic name

“Bromazepam” for radical

measure for prevention.

• Events of drug mix-up due

to phonetic similarity have

been reported in JQ’s

national RLS.

“SENIRAN”Anti-anxiety agent

“CERCINE”Minor tranquilizer



Facebook

Distribution of data/knowledge through SNS（Facebook）(2014~)

• Quarterly/Annual report,

• Thematic analysis

• Thematic analysis of

recurrent event

• Patient safety alert, etc.



Disclosure and publicity

• Quarterly report No. 1-62

• Annual report 2005-2019

• Reports are Released at press conference

NHK News (TV News), August 29, 2016 MediFax (Daily Healthcare News),July 3, 2020



Takeaways

i. Japan underwent desperate medical accident in late 1990 which

highlighted installing of reporting and learning system on institutional and

national levels.

ii. JQ launched the national system in 2004 and has successfully operated

it with production of reports, alerts DB ant so on. The products of the

system have been widely utilized for practical and research use.

iii. Equivalent systems were built step-by-step such as systems for

community pharmacy and perinatal medicine. No-fault

compensation/investigation/prevention system for cerebral palsy is so

unique that deserves distribution on global basis.

iv. Key elements of the success are “no-blame culture”, “anonymity

principle”, “pressure by media”, ”transparency”, accountability“,

“awareness of global trend” and so on.

Date post:	04-Feb-2022
Category:	Documents
Upload:	others
View:	1 times
Download:	0 times

Sharing the county experience : Japan

Documents