Nursing and patient safety
in Japan
1. Patient safety in Japan

Japanese Nursing Association

1. Patient safety in Japan
2. Nursing and patient safety(to be issued soon)
3. Japanese Nursing Associationin action (to be issued soon)

日本看護協会2

Terminology• Medical Safety: The term “Medical Safety” is used in Japan in the textof the Medical Care Act as well as in various guidelines of the Ministryof Health, Labour and Welfare (MHLW).
However, a clear definition of “Medical Safety” has not been
published.
In 2002, the Medical Safety Management Council of the MHLW
published a report titled, “Comprehensive Management for Medical
Safety Promotion– for the Prevention of Medical Accidents,” in which
the view is expressed that embracing patients’ safety as the highest
priority will nurture a “Safety Culture” as the background for the safe
provision of healthcare. This view has been maintained in a 2005
MHLW report titled, “On Future Medical Safety Management.”
At the same time the term, “Patient Safety,” which is often used
overseas, is also used in Japan.
• Patient Safety: The WHO defines Patient Safety as, “… reducing therisk of unnecessary harm associated with healthcare to an acceptable
minimum…”(WHO International Classification for Patient Safety, World Health Organization 2009, Geneva;
http://www.who.int/patientsafety/taxonomy/icps_full_report.pdf (Accessed on July 8, 2015))• Medical Accidents: This term refers to all accidents that occur
anywhere and involve healthcare, and that result in physical injury or
death, including cases in which healthcare professionals are the victim,
as well as falls in corridors. (“Comprehensive Management for
Medical Safety Promotion,” a report by the Medical Safety
Management Council, MHLW, 2002)

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History and Overview

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Ensuring Safety in Healthcare
Healthcare interventions, by nature, exert some form ofimpact on a patient’s body. Providing safe healthcare is
the highest priority. Across the world, efforts are made toassure patient safety.
In Japan, ensuring safety in healthcare practice wasconsidered the responsibility of individual healthcare
professionals, such as physicians.
In 1999, a spate of serious medical accidents occurred
within a short period, alerting society to the issue of
ensuring safety in healthcare. The response led toacceptance of the concept that, instead of relying on
individual efforts, organization–wide efforts are necessary
to address this issue. Various measures have been put into
place to ensure safety at various levels, and to establish amechanism to ensure safety across an entire system at
the human level (healthcare professionals), the material
level, the organizational level, the software level, and soforth.

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Events Concerning Safety in Healthcare
1999

A spate of medical accidents, the issue became social problem

2001

The year of Patient Safety Action (PSA)
MHLW established a Medical Safety Promotion Office

2002“Comprehensive Management for Medical Safety Promotion”
published by MHLW Medical Safety Management Review Committee
Partial amendment of the Ordinance for Enforcement of the Medical
Care Act: Hospitals and clinics with beds were mandated to establish
a medical safety management system

2003

Partial amendment to the Ordinance for Enforcement of the Medical
Care Act: Stronger safety management system in advanced
treatment hospitals and clinical training hospitals

2005“On Future Medical Safety Management” published by a working
group on the review of medical safety management

2007

The 5th amendment of the Medical Care Act came into force, andmandated all healthcare institutions, including clinics without beds
and dental clinics, to have a medical safety management system; andstipulating the role of medical care safety support centers(prefectural level)

Enforcement of the amendment to the Medical Practitioners Act andthe amendment to the Dental Practitioners Act, mandating
reeducation and training of medical or dental practitioners who were
subject to administrative punishment
2008

Amendment to the Act on Public Health Nurses, Midwives, andNurses enabled the Minister of Health, Labour and Welfare to ordera nurse, etc., who was subject to administrative punishment, toundergo a reeducation course

2009

Creation of the Obstetric Compensation System

2015

Medical Accident Investigation System (To come into force on
October 1)
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Medical Safety Measures

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Medical Safety Promotion Week

Medical Safety Promotion Week 2014 poster
Source: MHLW website
http://www.mhlw.go.jp/topics/bukyoku/isei/i-anzen/torikumi/iryouanzen14.html(Accessed on June 23, 2015)

The week around November 25 is annually marked as the “Medical
Safety Promotion Week.”
The Medical Safety Promotion Week started in 2001 with the message
advocating, “Patient Safety Actions (PSA): the collaborative actions byhealthcare professionals to protect the safety of patients.”
The Minister of Health, Labour and Welfare called for setting the week.
The aim of the week is to facilitate better awareness of healthcare
workers, promotion for organizational efforts at healthcare institutions,promotion for efforts at healthcare related organizations and raisingawareness among the citizens.
The week is hosted by the MHLW, with support from professionalorganizations like the JNA and many other healthcare relatedorganizations. During the week, many events such as symposiums andtraining courses take place.
Reference: MHLW website http://www.mhlw.go.jp/topics/bukyoku/isei/i-anzen/torikumi/iryouanzen14.html
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Ten Key Points for Providing Safe
Healthcare
An Overview of Medical Safety
Philosophy(1) Safety culture

Patient
Relationship withpatients(2) Dialog and patientparticipation
Individual staff(6) Anticipating risks andrational checking(7) Managing own healthOrganizational efforts(3) Problem solving approach(4) Rules and protocols

職員
staff

Other
institutions

Working relationship among staff(5) Staff communication
Human relationship with environment and materials(8) Utilization of technologies and innovation;(9) Medication administration; and (10) Improving environment
Source: MHLW; “Ten Key Points in Providing Safe Medical Care” chart (partially edited)
http://www.mhlw.go.jp/topics/2001/0110/tp1030-1f.html (Accessed on July 13, 2015)

MHLW published the “Ten Key Points for Providing Safe Healthcare” in 2001. To provide
safe care, healthcare institutions have to establish an organizational framework for
medical safety and raise staff awareness. The Ten Key Points were developed to cover
every staff at any healthcare institution. Concise expressions are used to present theten particularly important key points ((1) Safety culture; (2) Dialog and patientparticipation; (3) Problem solving approach; (4) Rules and protocols; (5) Staff
communication; (6) Anticipating risks and rational checking; (7) Management of one’s
own health; (8) Utilizing technologies and innovation; (9) Medication administration;and (10) Improving environment) in the framework of the six important areas of
medical safety management.

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Ten Key Points in Providing Safe
Healthcare
1.

Let us establish a culture of safety and a system to apply our efforts(Safety culture)

2.

Patient participation for heightened safety; dialog to deepen mutual
understanding (Dialog and patient participation)3.

Let us share our experiences; let us apply the lessons we learnt(Problem-solving approach)

4.

Rules and protocols: Set, Adhere and Revise (Rules and protocols)5.

Let us break the inter-division barriers and create a workplace where
everyone can share views (Staff communication)

6.

Anticipate the risks ahead; keep the key points and check properly(Anticipating the risks and rational checking)7.

Manage one’s own health: the first step as a healthcare personnel(Managing one’s own health)8.

Prevent an accident using technology and innovation (Utilizing
technologies and innovation)

9.

Double-check the patient and the medicine, take care of the routeand dose (Medication administration)

10. Improve the care environment; create a work environment(Improving the environment)
Source: MHLW “Ten Key Points in Providing Safe Medical Care”
http://www.mhlw.go.jp/topics/2001/0110/tp1030-1f.html (Accessed on July 13, 2015)

The Ten Key Points for Providing Safe Healthcare are as listed
above.
The respective healthcare institutions use the Ten Key Points toraise staff awarenessJapanese Nursing Association

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Initiative to Collect Medical Near-Miss/Adverse Event Information
Healthcare institution
Reporting of medical near-miss cases andadverse event information
Registered analysis organization
Citizens, healthcare institutions, related organizations, academic societies,
government organizations, and other similar parties
Dissemination of information, development of preventative andimprovement measures, their implementation, etc.
MHLW started the initiative to compile information about near-miss cases in 2001.
Following a partial amendment to the Ordinance for Enforcement of the Medical
Care Act in 2004, collection of adverse event data started, and National Center for
Advanced and Specialized Medical Care, hospitals run by National Hospital
Organizations (Incorporated Administrative Agencies), university hospitals, andadvanced treatment hospitals, etc. were mandated to provide such data within
two weeks after a medical accident occurs. Other types of hospitals are also
asked to participate on a voluntary basis.
“Registered analysis organizations,” on the register of the Minister of Health,Labour and Welfare collect the information, perform comprehensive analyses andprovide the results widely to such parties as healthcare institutions. Facilities
utilize the provided information for the development and implementation of
preventative measures and/or improvement measures. The information is alsoutilized for pharmaceuticals- and medical device-related improvement, such asname changes of medicine with similar names.
* An advanced treatment hospital is a hospital that is capable of: providing advanced medical care; carrying out thedevelopment and evaluation of advanced medical care techniques, and providing training on advanced medical care, andwhere the staffing and facilities are adequate for such a hospital, and have been approved by the Minister of Health, Labourand Welfare.
Reference: Initiative to Collect Medical Near-Miss/Adverse Event Information, Japan Council for Quality Health Care, Public
Interest Incorporated Foundation http://www.med-safe.jp/ (Accessed on July 14, 2015)
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Safety Management Tasks for
Pharmaceuticals and Medical Devices
Flow of Safety Management Tasks
MHLW• Side effects information• Safety-related information• New pharmaceuticals
information

Manufacturers• Package insert information• Emergency safety information• New pharmaceuticals
information• Recall information

Pharmaceuticals
and Medical
Devices Agency

Healthcare institutions,
pharmacies etc.
Healthcare workers
Providinginformation

Consumers

The Pharmaceuticals and Medical Devices Agency (PMDA), Incorporated
Administrative Agency takes the three roles; assessment and approval ofpharmaceuticals and medical devices, safety management and relief services foradverse health effect.
As safety management tasks related to medical safety, PMDA centralizes thecollection and analysis of such safety information including information about
adverse events, malfunctions, infections, etc. concerning pharmaceuticals or
medical devices after their market release, as well as information about adverse
events in the development stage; and considers necessary safety management.
PMDA also provides information to healthcare workers and consumers so thatpharmaceuticals and medical devices can be used safely and with a sense of
security.
PMDA provides consultation services for the corporations concerning better
safety for individual pharmaceuticals or medical devices, and also addresses
citizens’ inquiries about the safety of pharmaceuticals and medical devices.
Source: Pharmaceuticals and Medical Devices Agency, Incorporated Administrative Agency (PMDA)
https://www.pmda.go.jp/index.html (Accessed on July 17, 2015)
Incorporated Administrative Agency System is aimed to separate some administrative activities and tasks from the policy
implementation division of the Cabinet or ministry to a responsible organization that has the status of an independent legal person,
to improve the quality of work, and to vitalize and improve efficiency to facilitate autonomous operation and better transparency.
Source: Ministry of Internal Affairs and Communications
http://www.soumu.go.jp/main_sosiki/gyoukan/kanri/satei2_01_01.html (Accessed on July 16, 2015)
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Obstetric Compensation System
Purpose:• To provide compensation covering the economic burden on thefamily of a child who suffers severe cerebral palsy associatedwith a birth-related cause• To analyze data to determine the cause and provide helpful
information to prevent recurrence• To strive for the prevention of disputes, for early resolution ofcases and to improve the quality of obstetric careAmount of compensation payment:• ¥30 million (including a lump sum payment of ¥6 million andanother ¥24 million paid in installments over 20 years)¥1million US$ 8,022.00(as of August 11,2015)

Japan Obstetric Compensation System for Cerebral Palsy is a frameworkthat utilizes a private insurance scheme to pay compensation to persons
who suffer cerebral palsy despite having undergone a normal pregnancy
and childbirth process. By having childbirth facilities join a casualty
insurance scheme in which operator of this scheme is a contractor,
compensation payment is made to children who are subject tocompensation. Childbirth facilities pay premiums per birth case.
The compensation system was reviewed to improve the environment sothat families can receive obstetric care with a sense of security. Thissystem was established in 2009.
Source: MHLW
http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/iryou/i-anzen/sanka-iryou/index.html(Accessed on July 17, 2015)
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Medical Accident Investigation
SystemSystem overview• When a medical accident occurs at a healthcare institution,
it is mandatory to report to a medical accident
investigation support center and to perform medical
accident investigation to identify the cause of the accident.
• An internal investigation of a medical accident isperformed, and the investigation outcome report is thencollected by a private third party institution (Medical
Accident Investigation Support Center) to analyze it withthe aim of preventing recurrence and improving the safety
and quality of healthcare.

Amendment of the Medical Care Act in 2014 established the Medical
Accident Investigation System, which will start on October 1, 2015
The medical accidents in this system refers to the provision in the
Article 6-10 of the Medical Care Act, “... a death or stillbirth caused byor considered caused by healthcare provided by a healthcare workers
who works in the said hospital, but without anticipation of the said
death or stillbirth by the manager, as stipulated by the Ordinance ofthe Ministry of Health, Labour and Welfare”

Reference: MHLW website
http://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000061201.html (Accessed on June 23, 2015)
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Medical Care Safety Support
CenterMain tasks of the Medical Care Safety Support Center• To handle complaints and inquiries from patients and their families,
and to offer advice to them as well as the managers at theirhealthcare institutions• To provide the information on ensuring medical safety to thehealthcare institutions, their patients and their families, and/or the
citizens within the center’s precinct• To implement training at the healthcare institutions within thecenter’s precinct• To provide the support necessary to ensure the safety of healthcare
within the center’s precinct
Source: Article 6-11, Medical Care Act

Establishment of medical care safety support centers started in 2003.
Their position was recognized by the Medical Care Act of 2007. Over
300 centers across the country have been established including thosebelonging to prefectures and cities and special words with public healthcenters.

Source: Medical Care Safety Support Center Website
http://www.anzen-shien.jp/aboutus/index.html (Accessed on July 1, 2015)

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Medical Care Safety Support
Center(Cases)Number of inquiries received at prefectural Medical Care
Safety Support Centers

30,00025,00020,00015,00010,000
5,000
0

2003

2004

2005

2006 2007 2008 2009
Complaints
Inquiries

2010

2011

2012

2013
(Year)* When the data were collected in 2003, one prefecture was yet to establish a center. The
data from Shimane and Mie are also not classified into complaints and other inquiries,
therefore they are not reflected in the data presented in the above chart.
Source: Medical Care Safety Support Center Website http://www.anzen-shien.jp/aboutus/index.html(Accessed on July 1, 2015)

The chart above shows the number of complaints and inquiries handled by
prefectural Medical Care Safety Support Centers. In addition to theprefectural centers, the Medical Care Safety Support Centers at cities andspecial wards with public health centers and the secondary healthcare
service areas also handle complaints and inquiries.
In terms of complaint handling classification, the two most often received
complaint categories are “Medical act and content of healthcare” followedby “Attitude of healthcare workers at the institution,” which make up morethan half of all complaints. In terms of other inquiries, the top category was“Matters concerning health or disease”.
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Medical Safety
Management System in
Organization

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Organization–wide Safety Management
Organization–wide Safety Management

Guideline concerning
medical safety

Hospital

Advanced
Treatment
Hospital

ClinicMaternity home

⃝

⃝

⃝

⃝
⃝
(Not applicable
if there is not a
facility to admit
inpatients)

Committee concerning
medical safety⃝⃝⃝(Not applicable
to clinics without
beds)

Staff training

⃝

⃝

⃝

⃝

Measures for improvement

⃝

⃝

⃝

⃝

Full-time medical safety
manager⃝

Safety management division⃝

Inquiry/consultation systemfor patient⃝

The partial amendment to the Medical Care Act in 2002 mandated hospitals and clinics
with beds to establish a medical safety management system including establishing
their guideline concerning medical safety, holding of committee meetings on medical
safety, running of staff training for medical safety and improvement measures toensure medical safety such as internal accident reporting within the healthcare
institution.
Since 2003, advanced treatment hospitals have been mandated to assign a full timesafety manager, to establish a safety management division and to ensure the provisionof a patient inquiry/consultation service, as means to further enhance the safety
management system.
Since 2007 all healthcare institutions including clinics without bed and maternity
homes have been mandated to have a medical safety management system. In addition,such matters as prevention of healthcare-associated infections, pharmaceutical safety
management and medical device safety management, were stipulated.
* Full-time: a staff member who mainly performs the tasks, though can perform another range of tasks“On Trial of a Part of Ministerial Ordinance for the Partial Amendment of the Ordinance for Enforcement of the Medical Care Act” A notice of thedirector of the Health Policy Bureau, Ministry of Health, Labour and Welfare (HPB Notice No. 0830001 of August 30, 2002)
http://www.wam.go.jp/wamappl/bb13GS40.nsf/0/49256fe9001ac4c749256c29000b3836/$FILE/siryou1.PDF (Accessed on June 25, 2015)“On Enforcement of a Part of the Ministerial Ordinance for the Partial Amendment of the Ordinance for Enforcement of the Medical Care Act” Anotice of the director of the Health Policy Bureau, Ministry of Health, Labour and Welfare (HPB Notice No. 1007003 of October 7, 2002)
http://www.mhlw.go.jp/topics/bukyoku/isei/i-anzen/hourei/dl/021007-1.pdf (Accessed on June 25, 2015)

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Safety Management in Organization
Medical Safety Management Framework
Example of a large-scale healthcare institution
Director of
hospital

Medical accident
response
committee

Office of Medical Safety Management

Medical accident
investigationcommittee

The person responsible for medical safety management
Full-time staff dedicated to
medical safety
Medical safety manager
Nurses, pharmacists,
administrative staff,
In-house medical
mediators etc.

members
Responsible
person forpharmaceuticalsafetymanagement

Responsible
person for
medical device
safetymanagement

Patient
inquiry/consultationdesk
In-house medical
mediators

Members: nurses, pharmacists,
administrative staff, in-house
medical mediators etc.

Working group

Medical safety committee
ClinicalDivision

Nursing
Division

Administrative
Division

Pharmacist

patient
consultation
office…

Fall
prevention

Heads ofdivision

Medication
error
prevention

SurgicalsafetyMedical safety promotion meeting
Clinical
Departments

Hospitalunits

Pharmacist

Administrative
Division…
Member of medical safety
promotion committee ineach department

Staff
Japanese Nursing Association: Standard Text for Promoting Medical Safety 2013

The chart above shows an example of a medical safety management
framework in a large-scale healthcare institution.
* Though there is not an established definition of a large-scale healthcare
institution, a reference to the medical treatment fee category classification suggests
it to be either an advanced treatment hospital or a general hospital with at least
500 beds.
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Safety Management in Organization
Medical Safety Management Framework
Example of a medium- to small-scale healthcare institution
Director of
hospital

Top management
meeting

Medical accident
response
committee

Medical accident
investigationcommittee

Medical safety
promotioncommittee

Risk managers
liaison committee

Incident
deliberative
councilJapanese Nursing Association: Standard Text for Promoting Medical Safety 2013

The chart above shows an example of medical safety management
framework in a medium- to small-scale healthcare institution.
* Though there is not an established definition of a medium- to small-scale
healthcare institution, a reference to the medical treatment fee categorysuggests it to a hospital with fewer than 200 beds.

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Safety Management in Organization
Medical Safety Manager
Tasks of a medical safety manager• To establish the safety management system
Participation in steering team of a multidisciplinary safety
management committee, safety management division, etc., anddevelopment of a safety management guideline, etc.

• To implement staff education and training on medical
safety• To collect and analyze data for the prevention of medical
accidents, to devise measures, to provide feedback and toevaluate it• To handle medical accidents• To nurture a safety culture
The medical safety manager shall perform the tasks ordered by theadministrator of the healthcare institutions with 1) delegation of theauthority necessary for safety management, and 2) provision of theresources necessary for safety management (such as human resources,
budget and infrastructure). 1)
Previously, the guideline of tasks for the manager and training
concerning medical safety had been the responsibility of the respective
healthcare institutions. However, in 2007, MHLW published work
guidelines for the medical safety managers and a guideline forformulating training programs.

1) Source and reference: MHLW Medical Safety Management Review Council“Guideline for tasks of the medical safety management officer and guideline for training program development – for
improvement of the quality of medical safety management officers,” Working group for review of improvement of quality of
medical safety management officers. March 2007
http://www.mhlw.go.jp/topics/bukyoku/isei/i-anzen/houkoku/dl/070330-2.pdf(Accessed on June 25, 2015)

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Safety Measures andMedical Treatment Fee
2002

Start of the provision to reduce the amount of medical treatment fee if a
medical safety management system has not been established.

2006

Establishment of a medical safety management system, a safety
management system guideline, holding of committee meetings,
measures for improvement and staff training were included in thefacility-related schedule for the basic admission fee calculation.
A medical safety premium was added to the medical treatment fee if ahealthcare professional with a certain level of education was appointed
as a medical safety manager.

2010

Two requirements were set for a medical safety manager to receive themedical safety management premium; raising the value of the medical
treatment fee if the manager engages the work of safety management
exclusively.

Medical treatment fee schedule sets the price of insurance-covered
healthcare services in Japan. There are also provisions concerning safetymeasures in the medical treatment fee.
A provision was introduced in 2002 to reduce the value of medical treatment
fee if a medical safety management system was not established. However,this measure was abolished in 2006.
In 2006, establishment of a medical safety management system became arequirement for the basic admission fees, including the fees for provision ofbasic medical care, nursing service and a care environment on admission. In
other words, the facilities that failed to take medical safety management
became unable to claim the basic admission fees. In addition, it was allowed
to add a medical safety premium to the value of the medical treatment fee if
a person with a certain level of education was appointed as a medical safety
manager.
Reference: Japanese Nursing Association: Standard Text for Promoting Medical Safety 2013
Public notice of the Ministry of Health, Labour and Welfare No.93 of March 6, 2006
Public notice of the Ministry of Health, Labour and Welfare No.72 of March 5, 2010

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Legal Liabilities Arising
From a Medical Accident

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Medical Accidents and Legal
Liabilities• Criminal liabilities (Penal Code)• Civil liabilities (Civil Code)• Administrative liabilities (Act on Public Health Nurses,
Midwives and Nurses, National Public Service Act andother similar legislations)
The liabilities of a nurse in case of a medical accident may be Criminal
liabilities, Civil liabilities and/or Administrative liabilities.
In Japan, the Act on Public Health Nurses, Midwives and Nurses
stipulates administrative punishment when one faces administrative
liabilities. Article 9 of the Act stipulates the Grounds for
Disqualification. Article 14 stipulates three types of administrative
punishments: Admonition; Suspension of practice for up to three
years; and Revocation of License.
The Act stipulates that the opinions of the Medical Ethics Council
shall be sought before handing down an administrative punishment.
The Medical Ethics Council shall take the following four viewpoints
into particular consideration when deliberating: i.) Respect for life; ii.)
Assurance of physical and mental inviolability; iii.) Nurse’s
responsibilities about the proper use of their knowledge and skills
and to inform patients; and iv.) Morals and dignity as a professional.
In 2008, it became mandatory for a nurse who was given admonitionor suspension of practice, or who had his/her license revoked, toundergo a re-education program under the order of the Minister of
Health, Labour and Welfare.
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