保健医療科学

2024

Vol.73 No.1 p.42 − 54

Topics: Recent topics in public health in Japan 2024

＜ Review ＞
Patient safety in long-term care in JapanTANEDA Kenichiro
Department of Health and Welfare Services, National Institute of Public Health
Abstract
As Japan progresses toward a “super-aging society,” long-term care facilities will become increasingly important, as they will be needed to provide effective long-term healthcare services to elderly people in need. In
promoting patient safety initiatives, “reporting first” is essential to address accidents in a timely manner. In
Japan, a national accident reporting system, the Project to Collect Medical Near-Miss/Adverse Event Information, was launched in 2004, and the Medical Accident Investigation System was launched in 2015. Meanwhile,the information on accidents that local governments gather from long-term care facilities is not necessarily
utilized for safety among the affected population. For this reason, efforts are being made to standardize reporting forms and strengthen the safety management system at these facilities, with a view to establishing a system to utilize this information at the national level in the future. Further, from interview data on the status ofefforts at long-term care facilities, it is clear that more initiatives are needed at both the facility and municipal
levels to develop a coordinated system to prevent accidents (reporting, analysis, planning of countermeasures,
implementation, evaluation, etc.). There is a need for training multiple professionals, including users and theirfamilies, for collaboration in long-term care patient safety. This paper offers an overview of the current state ofpatient safety undertakings in long-term care settings in Japan today.
keywords: long-term care, patient safety, reporting system, lawsuits, training(accepted for publication, January 29, 2024)

I. Introduction

As Japan becomes a “super-aging society,” long-term care
(LTC) facilities to provide safe long-term healthcare services to elderly people in need have become increasingly
important. In promoting patient safety initiatives, “reporting
first,” that is, voluntary incident reporting, is necessary to
identify accidents that have occurred. The Project to Collect
Medical Near-Miss/Adverse Event Information by the Japan
Council for Quality Health Care (JQ) was launched in 2004
as a national accident reporting system for patient safety[1],[2]. Additionally, in 2015, the Japan Medical Safety Research
Organization launched the Medical Accidents Investigation
System, which focuses on fatal accidents[3]. Each reporting
system has helped improve patient safety through learningfrom many accidents that have occurred in the medical field
and by proposing systems to prevent recurrence.

The collection of information on accidents in long-termcare facilities is the responsibility of local governments, but
the data collected are not always utilized for further safety
improvement in such facilities. For this reason, efforts arebeing made to standardize reporting forms and strengthen
the patient safety management system at long-term carefacilities, with a view to establishing a system to utilize thisinformation at the national level in the future. This paper
will introduce past and current patient safety efforts related
to long-term care in Japan.

II. Changes in the system for promoting patient safety in long-term care
In 1999, Article 31 of the “Standards for Facilities andOperation of Special Nursing Home for the Elderly,” aCorresponding author: TANEDA Kenichiro
2-3-6 Minami, Wako, Saitama 351-0197, Japan.
Tel: 048-458-6150
Fax: 048-469-2768
E-mail: taneda.k.aa@niph.go.jp

42

J. Natl. Inst. Public Health, 73 (1) : 2024

Patient safety in long-term care in Japan
Ministry of Health and Welfare [currently the Ministry of
Health, Labour and Welfare (MHLW)] ordinance, stipulated
the following items regarding prevention of and response toaccidents [4]:- Guidelines shall be established for responding to accidents and preventing accidents from occurring.
- When an accident occurs or a situation arises that
could lead to an accident, a system shall be establishedto ensure that the relevant facts are reported and that
staff members are informed of remedial measures tobe taken through fact-based analysis.
- Committee meetings to prevent the occurrence ofaccidents and training for staff members shall be held
regularly.
- A person shall be appointed to supervise and ensure
the appropriate implementation of the measures listed
in the preceding item.
(*If a nursing home does not meet the facility standards for the above four items, it is subject to exclusionfrom long-term care insurance from 2021 onward.)- If an accident occurs during the treatment of a resident, the special nursing home must promptly notify
the municipality, the residentʼs family, etc., and takenecessary measures.
- A special nursing home for the elderly shall record thecircumstances of the accident set forth in the preceding
paragraph and the measures taken after the accident.
- In the event that an accident occurs that should becompensated for because of the treatment of residents,
the special nursing home for the elderly shall promptly
compensate for the damages.
Long-term care welfare facilities for the elderly (special
nursing homes for the elderly) [5] accept residents who
require long-term care and provide daily living support services such as assistance with bathing and eating, functional
therapy/exercises, and medical care, to enable as many residents as possible to return to their homes after care.
In 2001‒2002, the “Study Group on Risk Managementin Welfare Services” discussed approaches to risk management in welfare services. The use of welfare services has
shifted from being implemented in accordance with public
policy measures to a private contract-based system. Traditionally, welfare services were provided as administrative
measures, and the administrative organs determined whether a service was necessary or not, the service contents, andthe service providers. Under the contract-based system,
mutual rights and obligations are clarified and services
must be provided appropriately. It was pointed out that withwelfare services, ensuring the safety and security of users
is fundamental, and that there is an urgent need to establish
a risk management system in welfare services that is cen-

tered on accident prevention measures. The “Guidelines for
Risk Management in Welfare Services: Seeking the Smiles
and Satisfaction of Users” were then compiled. [6]Overview of guidelines(1) General overview◦Basic perspectives on risk management in social services- Many accidents can be prevented by providing higher-quality services (quality improvement).
- As each facility has highly individualized needs, adequate considerations and adaptations are required ateach facility.
◦Roles and responsibilities of management- Importance of managementʼs leadership and determination(2) Development of a system to promote risk management◦Points to consider when developing a risk management
system and promoting initiatives- Improvement of organizational culture- Organization-wide efforts- Continuous efforts(3) Guidelines for accident prevention measures◦Perspectives and specific measures based on the characteristics of welfare services- Importance of communication- Measures to resolve complaints- Importance of reviewing operations and taking initiatives from a risk management perspective(4) Guideline for handling accidents when they occur◦Basic consideration of the preferences of users and theirfamilies, and thinking from the other partyʼs perspective- Importance of daily efforts from the basic perspectiveof improving the quality of services- Organizational response, based on facts, and a single
point of contact are the best general practice- Grasping the facts and fully explaining the situation to
the family, etc., considering and implementing remedial
measures, and responding with sincerity- Necessity of preparedness and awareness for prompt
response immediately after an accident
In 2006, as a part of the revision of the LTC compensation system, it became mandatory to prevent LTC accidents
by improving the system in facilities in the course of efforts
to improve the quality of services, and some revisions weremade to the above standards as follows:
Prevention of Accidents and Response to the Occurrence of Accidents (Article 31 of the Standards)(1) Guidelines for the prevention of accidents
The “guidelines for the prevention of accidents” to be
maintained by special nursing homes for the elderly shall

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43

TANEDA Kenichiro
include the following items.
Basic policy regarding the prevention of LTC
accidents at facilities
1) Matters related to committees and other organizations
within the facility for the prevention of LTC accidents
2) Basic policy on staff training for the prevention of LTC
accidents
3) Basic policy on measures for improvement aimed atensuring safety in LTC, including reporting methods
for LTC accidents that have occurred at a given facility
and near-miss cases that did not lead to LTC accidents
but are likely to lead to an LTC accident if left unchecked (hereafter referred to as “LTC accidents, etc.”)
4) Basic policy on measures to be taken in the event of an
LTC accident, etc.
5) Basic policy regarding residentsʼ access to these guidelines
6) Other basic policies necessary to advance LTC accident prevention measures(2) Informing staff of remedial measures to be implemented
through fact reporting/analysis
It should be noted that the purpose of a special nursing home to establish and disseminate reporting andimprovement measures is to share information about
LTC accidents, etc. throughout the facility and prevent
future recurrence; it is never for the purpose of punishing staff.
The following concrete steps are envisioned.
1) Forms for reporting LTC accidents, etc., shall be prepared.
2) LTC staff and other staff shall record the circumstances, background, etc. of each LTC accident, etc., andreport on LTC accidents, etc., according to the form in
1).
3) The committee for the prevention of accidents mentioned in item 3) below shall compile and analyze thecases reported in item 2) above.
4) In analyzing the cases, the situation at the time of the
LTC accident, etc. shall be analyzed, the causes andresults of the LTC accident, etc. shall be summarized,
and preventive measures shall be discussed.
5) The reported cases and the results of the analysis shallbe made known to the staff.
6) Evaluate the effectiveness of preventive measures after implementation.
(3) Accident prevention committee
The “Accident Prevention Committee” at special nursing
homes for the elderly is a committee that evaluates measures to prevent the occurrence of LTC accidents as wellas their recurrence, and is composed of a wide range of
personnel (e.g., facility director (manager), office manag-

44

er, doctors, nurses, LTC staff, and lifestyle consultation
staff). It is necessary to clarify the responsibilities anddivision of roles among the members of the committee,
as well as determine a dedicated supervisor to oversee
safety measures.
The Accident Prevention Review Committee shouldbe established and operated independently from othercommittees such as the Steering Committee. However,the Infection Control Committee may be established andoperated together with the Accident Prevention Review
Committee, since it is recognized that the positions involved and matters handled are closely related. The person in charge of the Accident Prevention Review Committee should preferably be the individual responsible foroverall care. It is also desirable to utilize safety experts
outside the facility as members of the Accident Prevention Review Committee.
(4) Staff training for purposes of accident prevention
The content of training for the prevention of accidents for
LTC and other staff shall include the dissemination andcultivation of suitable knowledge regarding fundamental
aspects of accident prevention, etc., as well as thoroughsafety management capacities based on the guidelines at
the relevant special nursing home for the elderly.
To ensure thorough staff education in an organizedmanner, the relevant special nursing care facility should
prepare a training program based on the guidelines, holdregular education sessions (at least twice a year), andalways conduct training in the prevention of accidents
when newly hired.
It is also necessary to record the details of the training
conducted, which may be conducted on-site at the staffʼs
own facility.
(5) Compensation for damages
If a special nursing home is required to compensate auser for damages, it must do so promptly. Therefore, it isdesirable to have indemnity insurance or the capacity tocompensate for damages.
The 17th Long-term Care Remuneration Revision Verification and Research Committee meeting was held in March
2019. In the “Survey and Research Project on the Safety
and Sanitation Management System in LTC Geriatric Welfare Facilities,” a project to verify the revision of LTC remuneration in FY 2008[7] , the types of accidents reported
to the municipalities were “falls due to physiological weakness” (91.2%), “falls due to environmental hazards” (84.6%),“accidental medication” (72.5%), “aspiration” (72.1%), and“pica” (68.9%). In addition, 46.7% of the municipalities “donot compile or analyze” the reported LTC accident information, and 30.7% “do not utilize” this information. The

J. Natl. Inst. Public Health, 73 (1) : 2024

Patient safety in long-term care in Japan
results suggest that there are limitations in the ability ofmunicipalities to analyze and utilize accident information.
The survey also revealed variations in the standard of thereports regarding the scope of accidents that municipalities
require of establishments, and the need to establish rules,
including the scope of reportable content regarding accidents that occurred at LTC facilities.
In the report summarizing the deliberations on the revision of LTC fees for FY2021 held in February 2020, it
was stated that “in light of the fact that accident reporting
standards vary from municipality to municipality, the national government will prepare and disseminate a reporting
format from the perspective of contributing to information
accumulation and effective utilization of such information
through the standardization of accident reporting in the
future.” Because of the need for the standardization of accident reporting, in March 2021, the MHLW issued the Reporting Forms for Accidents at Long-term Care Insured Facilities, etc.,” which presented standardized reporting forms
for the utilization of LTC accident information reported to
local governments,. In principle, all accidents that should bereported should fall under the following two categories: (1)
accidents that resulted in death, and (2) accidents that werediagnosed by a physician and required some form of medical
treatment or medication
The reporting of other accidents should be handled byeach municipality. In addition, as a reporting procedure,the “submission of accident reports to the municipality bye-mail is preferred,” which also promotes efficient operation.

III. Current state of the long-term care safety management framework
A survey of LTC facilities and municipalities was conducted from October to November 2022 as part of a research
project on risk management for LTC-insured facilities (Table1). The purpose of the survey was to gain an understandingof the actual situation regarding the utilization of the newaccident reporting form and the content of reported accident information, as well as to obtain basic data that would
contribute to the analysis of reported accident informationand the study of how the data should be utilized.
Long-term care welfare facilities for the elderly (special
nursing homes for the elderly) accept residents who requirelong-term care and provide daily living support services
such as assistance with bathing and eating, functional therapy/exercises, and medical care, with the aim of enabling as
many residents as possible to return to their homes.
Long-term care health facilities for the elderly/Rehabilitation facilities for the elderly[8] accept residents who will
eventually return home, and provide rehabilitation, necessary medical care, LTC, and other services to enable themto live as independently as possible.
Integrated Facilities for Medical and Long-term Care /Nursing Care Medical Clinics[9] are facilities that combine
medical functions such as “routine medical management”
and “end-of-life care and terminal care” with “assisted livingʼ
functions, geared toward the elderly who have both longterm medical and LTC needs.
III-1. Summary of results of a survey of LTC facilities(1) Percentage of full-time employees who had attended
training courses
Of full-time employees, 56.7% responded that “80% ormore” had attended training courses during FY2021,
and 18.8% responded that “60-80%” had attended training courses during the same period.
(2) Percentage of full-time employees who received training
Of full-time employees, 56.7% responded that “80% ormore” had attended training courses during FY2021,
and 18.8% responded that “60-80%” had attended training courses during the same period.
(3) Challenges regarding training implementation
An overall 60.5% of the respondents said that “it is difficult to find time for training and to adjust to the date

Table 1 Target facilities and collection status
Target facility/organization

Total numNumber of surveys Survey collection Valid survey collecNumber of surveys issued
bertion rate
collected
rateLong-term care welfare facilities
for the elderly

8,340

3,800 (Random selection)

1,600

42.10%

42.10%

Long-term care health facilities
for the elderly/Rehabilitation facilities for the elderly

4,226

1,550 (Random selection)

540

34.80%

34.80%

Integrated Facilities for medical
and long-term care/Nursing Care
Medical Clinic

671

653

253

38.70%

38.70%

Municipalities

1,718

1,630

801

49.10%

49.10%

Prefectures

47

47

47

100%

100%

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45

TANEDA Kenichiro
and time” and 52.3% said that “the level of understanding training by staff members varies.”(4) Forms for reporting LTC accident information
Overall, 78.7% of the respondents answered that information on LTC accidents occurring in their facilities
was recorded in the facilityʼs own accident report form,and 61.0% said that it was recorded in the accident report form prescribed by the municipality.
(5) Methods of analyzing information on LTC accidents andnear-misses
Regarding the method of analyzing information on LTC
accidents and near-misses, 89.4% of the respondents
answered that they report the “Total the number of
LTC accidents and near-misses” and 69.9% answeredthat they “Organize the number of LTC accidents andnear-misses by type of accident (falls, aspiration, etc.)
to identify trends.”(6) Effective measures and initiatives to prevent LTC accidents
According to respondents, the most effective measures
to prevent LTC accidents were “Investigation of thecauses of LTC accidents and consideration of measures
to prevent recurrence” (72.6%), “Investigation of thecauses of near-misses and consideration of measures
to prevent recurrence” (52.1%), and “Implementationof facility-wide training on LTC accidents” (40.7%).
(7) Accident prevention challenges for facilities
An overall 39.6% of the respondents answered “Difficulty in ensuring user safety due to lack of manpower”
and 38.7% answered “Inability to find time to study
organizational measures due to busy work schedule” aschallenges for facilities in preventing LTC accidents.
(8) Format of accident reports to the local municipal government
Overall, 72.6% of the facilities selected “Yes” for the
standard accident report form provided by the MHLW
for submitting accident reports to the municipality.
(9) Method of accident report submission to the local municipal government
In all, 43.2% of the facilities submitted accident reports
to the municipality by hand delivery, 35.2% by mail,and 32.1% by e-mail.
(10) Support obtained from the local municipal government
Regarding support from municipalities for the prevention of LTC accidents and their recurrence, 59.0% of
the respondents answered that they “do not receive
any support from municipalities.” The support received
from the municipality was “Advice on how to respondto LTC accidents occurring at the facility (e.g., handling of family members)” at 14.6%.
(11) Potentially beneficial support from the local municipal46

government
A total of 56.2% of respondents answered “Provisionof information on case studies and efforts to prevent
recurrence of LTC accidents at other facilities” and34.6% answered “Information on external training programs appropriate to the situation of LTC accidents attheir facilities” as the most useful support they could
receive from their municipalities in terms of LTC accident prevention and recurrence prevention.
III-2. Summary of survey results targeting municipalities(1) Establishment of reporting formats and forms from facilities to the local municipal government
Of the respondents, 64.5% answered that they use the“Standard Accident Report Form (Ministry of Health,Labour and Welfare),” and 20.2% answered that they
use a form separately prescribed by the municipality.
(2) Utilization of “4. Summary of Accident” entries
Regarding the status of utilization of responses to “4.
Summary of Accident” in the Standard Form for Accident Reports (Ministry of Health, Labour and Welfare),45.8% of the municipalities responded that they “tabulate and analyze” the responses.
(3) Status of utilization of responses to “5. Response to Accident Occurrence” entries
Regarding the status of utilization of responses to “5.
Response to Accident Occurrence” entries in the Standard Form for Accident Reports (Ministry of Health,Labour and Welfare), 36.2% of municipalities responded that they “tabulate and analyze” such information.
(4) Utilization of “6. Situation at the time of accident” entries
Regarding the status of utilization of responses to “6.
Situation at the time of the accident” in the Standard
Form for Accident Reports (Ministry of Health, Labourand Welfare), 36.8% of the municipalities answered thatthey “do not utilize” the form, while 24.0% answeredthat they “tabulate and analyze” such information.
(5) Status of utilization of “7. Factor Analysis of Accidents”
entries
Regarding the status of utilization of responses to “7.
Factor Analysis of Accidents” in the Standard Form for
Accident Reports (Ministry of Health, Labour and Welfare), 34.4% of the municipalities answered that they
“do not utilize” such information, and 24.0% answeredthat they “tabulate/analyze” such information.
(6) Status of utilization of “8. Preventive measures againstrecurrence” entries
Regarding the utilization status of “8. Preventive measures against recurrence” responses in the Standard

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Patient safety in long-term care in Japan
Form for Reporting Accidents (Ministry of Health,Labour and Welfare), 36.0% of municipalities answeredthat they do not utilize them, and 23.4% answered thatthey utilize individual information on LTC accidents
that occurred at each facility to provide support to theaffected facility.
(7) Scope of reportable accidents
Of the municipalities that responded “Yes,” 95.9% stated “accidents resulting in death” and 96.6% stated “accidents requiring some kind of treatment such as medication or treatment after being diagnosed by a doctor(including doctors working at the facility and doctors
assigned to the facility)” as the scope of LTC accidents
to be reported.
(8) Specification of reporting method
Regarding the reporting method of LTC accidents fromfacilities to municipalities, 42.8% of first reports weremade by “e-mail” and 40.7% by “telephone.” In the second report, 43.4% of the respondents chose “hand delivery at the relevant office,” and 43.1% chose “e-mail.”In the final report, 51.7% of respondents chose “handdelivery at the counter,” and 47.9% chose “postal mail.”(9) Whether reported LTC accidents are tabulated/analyzed
Regarding the tabulation/analysis conducted, 59.3% of
respondents simply tabulated the number of LTC accidents, and 32.2% identified trends by organizing thenumber of LTC accidents that occurred by type (falls,
aspiration, etc.).
(10) Status of utilization of LTC accident information
Regarding the utilization of LTC accident information,
49.6% of the respondents indicated that this information was “used to provide guidance and support to thefacility that submitted the LTC accident report” and28.6% selected “used to provide on-site guidance andadvice to facilities other than those that submitted LTC
accident reports (e.g., case studies). An overall 5.2%of respondents selected “to be used in regular training
sessions for facilities in the municipality.”(11) Challenges in tabulating, analyzing, and utilizing LTC
accident information
Regarding issues in the compilation, analysis, and utilization of LTC accident information, 57.6% of respondents answered that they “do not have the manpower
to perform the tabulation and analysis” and 47.9%
answered that they “do not have the know-how to perform the tabulation and analysis.”(12) Requests to the municipality regarding risk management at local LTC facilities
Regarding requests to the municipal government regarding risk management of local LTC facilities, 40.9%of the respondents requested “distribution of a format/

tool for tabulating LTC accident information” and37.7% requested “preparation of a manual on how totabulate and analyze LTC accident information.”
III-3. Summary of prefectural-level survey results(1) Status of accident information collection
Regarding the collection of information on accidents
occurring at facilities throughout prefectures, 48.9% of
respondents answered that they “require municipalities to report” and 44.7% answered that they “require
the LTC facilities to report.”(2) Reporting forms and formats from LTC facilities to prefectures
Regarding the reporting format/forms used by offices
to prefectural authorities, 57.1% of the respondents
said that they use the “Standard Accident Report Form
(Ministry of Health, Labour and Welfare)” and 33.3%
said that they use the form prescribed by prefectures.
(3) Items requiring reporting
Regarding items not included in the forms separately
prescribed by prefectural governments, 71.4% of the
respondents answered “No items not included” and28.6% answered “Root cause analysis of the accident.”(4) Whether information on reported LTC accidents is tabulated and analyzed
Regarding whether the reported LTC accident information is tabulated and analyzed, 57.5% of respondents
answered that they “organize the number of LTC accidents by type (falls, aspiration, etc.) to identify trends,”
and 52.5% answered that they “organize the number of
LTC accidents by facility type to identify trends.”(5) Status of utilization of LTC accident information
Regarding the utilization of LTC accident information,
70.0% of respondents answered that they “use the information to provide guidance and support to the facility that submitted the LTC accident reports,” and 47.5%
answered that they “use the information to provide onsite guidance and advice to facilities other than thosethat submitted a given LTC accident report” (e.g., tooffer case studies).
(6) Challenges in tabulating, analyzing, and utilizing LTC
accident information
With regard to challenges in tabulating, analyzing, andutilizing LTC accident information, 65.0% of respondents indicated they “do not have the manpower to tabulate and analyze” and 40.0% responded that “municipal
employees do not have the opportunity to learn how tocompile and analyze LTC accidents.”(7) Support for municipalities
Regarding support for municipalities in preventing
LTC accidents and their recurrence, 46.8% of respon-

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TANEDA Kenichiro
dents answered that they “do not provide support tomunicipalities” and 40.4% answered that they “provide
advice on how to receive LTC accident reports fromfacilities.”(8) Requests to the prefectural government regarding risk
management at local LTC facilities
Regarding requests concerning risk management measures in nursing homes, 59.6% of respondents wanted“dissemination of best practices in the use of nursing
home accident information” and 51.1% wanted “distribution of a format/tool for compiling nursing home
accident information.”
At the 26th meeting of the Verification and ResearchCommittee for Revision of LTC Compensation, LTC Benefit Cost Subcommittee of the Social Security Council, it was
decided that the number of accident reports from LTC-insured facilities should first be disclosed after careful discussion and organization of the following issues, which should
be clarified prior to disclosure:- The appropriateness of the term “LTC accident” andits definition- Comparison of the occurrence of LTC accidents in
non-facility settings and in the facility- Consideration of an appropriate denominator to enableverification of the incidence rate
- Methods to disclose the number of incidents, analysis
of causes, and integrated preventative measures- Methods of publication that contribute to the promotion of risk management at the facility, such as figuresthat can be compared with LTC facilitiesʼ own figures- The significance of widely publicizing the number ofreported cases

IV. Review of legal precedent relevant to longterm care and other facilities and categorization of response modalities
Litigation has a significant impact on safety efforts inlong-term care facilities. A review of legal precedent related
to LTC shows that there are many cases involving falls, aspiration, and choking. However, accidents involving medication, such as accidental ingestion or dropping of medicationon the floor or somewhere, occur frequently in the LTC
setting, but few cases have resulted in litigation.
This
is thought to be because the accidents are addressed andresolved before they become life-threatening events. The
following is a survey of the number of cases involving falls(caused by frailty or environmental hazards), aspiration, andchoking, which are the most frequently litigated types of
LTC accidents, as well as the most current case law.
(1) Cases involving falls

48[Period and number of cases]
Date of last judgment: December 26, 1988, to November 1, 2022
⃝Legal precedents for falls (Number of cases: 54)- 1988 to 2000: 9 cases- 2001 to 2010: 17 cases- 2011 to 2022: 28 cases[Place of occurrence]
During commuting (outpatient): 21 cases; hospitalization (inpatient): 37 cases; other (home, recreation center): 5 cases[Recent judicial rulings]⃝A case in which the court found that it was “sufficiently foreseeable” that an 87-year-old man withdementia was likely to leave the bathroom on his
own and suffer a fall if he was unattended, and ordered financial compensation to be paid
(Kobe District Court, November 1, 2022, decision)⃝A case in which an LTC employee briefly left aresident with dementia seated on a toilet seat unattended and the resident suffered a fall and diedfrom related injuries 72 days later, and the court
found that there was a causal relationship between
the LTC employeeʼs negligence and the incident(Tsu District Court, March 14, 2019, decision)(2) Court precedents involving aspiration and choking[Period and number of cases]
Date of last judgment: December 23, 2000, to December 21, 2020
⃝Judicial rulings related to aspiration cases (Numberof cases: 30)- 2000 to 2010: 12 cases- 2011 to 2020: 18 cases[Place of occurrence]
During commuting: 8 cases; During admission (hospitalization): 20 cases; Home-visit nursing care: 2 cases[Recent judicial rulings]⃝A case in which the defendant facility was acquitted on the grounds that the defendant did not havea duty of care to serve the victim a small meal
in a suitable manner after confirming its modeof preparation before being served to the victim-plaintiff.
(Tokyo High Court (Appeals Court), July 28, 2020,
decision)(3) Accidents other than falls, aspiration, and choking
From the review of precedents, there were 31 casesof accidents other than falls and aspiration/choking.
The breakdown is as follows: 2 cases during bathing, 8cases of decubitus ulcers, 6 cases of wandering, and 15
other cases.

J. Natl. Inst. Public Health, 73 (1) : 2024

Patient safety in long-term care in Japan(4) Categorization of responses
Based on precedents and overseas efforts, the following seven perspectives were considered as typologies
of responses to adverse events that should be considered. Fall cases are used as an example. Ultimately, it
is not the fall itself that should be prevented but thedisability (adverse event) caused by the fall:
1) Identification of and response to fall susceptibility (patientʼs condition and environment):(Example ruling in a case involving a fall incident)
A case in which the operator was found liable for damages for failing to install a bed release sensor in an
accident in which a patient fell while trying to go to thebathroom late at night and developed an acute subdural
hematoma, on the grounds that the operator violated
their duty of care for safety.
(Example ruling in a case involving a fall incident)
In a case in which a resident fell from a window in her
room and suffered multiple fractures and later died, thestopper of the window was found to be defective because it could be removed by pulling hard on it by handeven when it was locked.
- In the examples of countermeasures taken in theUK, there are references to “identification of elderly
people at high risk for falling,” “multifactorial fall risk
assessment of elderly people at high risk for falling,”and “strength and balance training for high-risk individuals.”
2) Early detection of behavior that could lead to a fall:(Example ruling in a case involving a fall incident)
A case in which an LTC worker left a resident with dementia seated on a toilet seat and the resident fell, suffering an acute subdural hematoma injury, and death,and the LTC worker was found to be negligent andcausally related.
- If it is not possible to prevent behaviors that could
lead to falls, adverse events can be prevented bypromptly discovering that the behavior has occurredand responding in a timely manner.
3) Prevention of injuries when falls do occur:
LTC facilities should also take steps to prevent injuries
and other adverse events from occurring even if a fall
does occur. Examples include the use of hip protectors/
cushion pants and protective caps to absorb the impactof a fall on the femur and reduce the risk for fractures,and the use of flooring materials (shock-absorbingmats) to reduce the impact of a fall on the floor.
4) Early detection of adverse events (injury/disability after a fall event)(Example ruling in a case involving a fall incident)
A hospitalized patient with multiple cerebral infarctions

fell and died in the hospital room. The hospital was
found liable for damages on the grounds that the nurse
was negligent in failing to escort the patient.
- Even if a patient falls, early detection of the fall increases the possibility of minimizing the damage tothe patient.
- In an example of a countermeasure taken in the UK,
there is a reference to “confirming fractures and other injuries caused by falls.”- A statement by a working group of the Japan Geriatrics Society and the National Association of GeriatricHealth Care Facilities, “To make people aware offalls in LTC facilities - a message to the public” (July2021)[10], includes a description of “example procedures for responding to falls”
5) Early treatment of adverse events (injury/disability
after a fall event)(Example ruling in a case involving a fall incident)
An elderly person contracted with a day-care facility
to receive LTC services. When the elderly individualleft his seat to exit the facilityʼs shuttle, they fell. The
operator of the LTC facility was found to have not violated their duty of care to ensure safety but was foundto have violated the duty to have the patient promptly
examined by a physician.
- Not only the early detection of a fall but also thesubsequent diagnosis of the presence or absence ofadverse events and timely treatment is required.
- In the example of the UKʼs efforts, there are references to “safety manuals for falls/response after afall” and “examination after a fall incident.”6) Cooperation between LTC facilities and medical institutions:- Cooperation is especially necessary in cases such as 4)
and 5) above.
7) Efforts to prevent legal action:- Even though various measures have been taken,some adverse events due to falls have occurred that
could not be avoided. Sharing safety-related risks
with users and their families and cooperative efforts
is required.
- The statement by a working group of the Japan Geriatrics Society and the National Association of Geriatric Health Care Facilities, “To make people awareof falls in LTC facilities ‒ a message to the public”(July 2021) indicates that “the existence of falls thatcannot be prevented” is considered a contributing
factor in this regard. “Appendix 1. Information thatshould be shared between facility staff and residents
and their families in relation to falls, etc.” included inthis document is also a useful reference[10].

J. Natl. Inst. Public Health, 73 (1) : 2024

49

TANEDA Kenichiro- In the example of the UK initiative, there is a reference to “risk assessment and intervention in thehome,” reminding all that falls can occur in the home
as well.

V. Hearing on the status of measures taken
by LTC facilities(1) Efforts and issues
Interviews were conducted with LTC safety personnel
from about 20 corporations and organizations involved in
LTC from 2019 to 2021, and the following items were raised
regarding LTC safety initiatives and issues, etc.:
Reference measures- (Facilities affiliated with hospitals)
Facility directors participate in the safety management
committee of the affiliated hospitals and work together
to position elder care facilities, group homes, and visiting nurse stations as a department within the hospital- (An elder care facility attached to a psychiatric hospital)
The safety management committee of the elder carefacility collaborates with the hospital on cases that are
difficult to handle or cases that should be shared withthe hospital- Once a week, a case study meeting is held: committee
members go to the site of the case study meeting andconduct a detailed study, such as considering the bed
direction
Issues related to fall risk
- Even if there is a high risk for falling due to wandering,the care managerʼs permission is required for the useof sensors- Residentsʼ physical functions (vision and hearing) aredeteriorating, but they are unable to receive medical examinations because of restraints posed by the
COVID-19 pandemic. As such, the status of these residentsʼ remaining capacities remains unclear, and they
are at high risk for falling- LTC staff membersʼ ages are relatively advanced. Thismay be why LTC staff are sometimes unable to noticechanges in these residents- Measures to prevent falls are being taken in the formof physical restraints- Inability to confirm with residents with dementia thecause(s) of fall incidents
Issues related to medication- Many residents drop their medicine on the floor or
somewhere- There are many incidents of dropped medication, but
it is often difficult to identify who is supposed to takethat medication found on the floor

50- After giving medication, the resident spits it out- There is a set procedure for giving medication, but theextent to which its proper execution is confirmed is
not clear
Challenges of working together as a team
- LTC staff maintain records only for the leader- Difficulty in collaboration between nurses and LTC
staff- Difficulty in giving attention to each other- Can not do without reservation- No time to attend training due to lack of staff- Unclear who will lead conferences- Little opportunity for discussion- The need for collaboration with multiple professions is
recognized, but there are no opportunities to learn how
to work together systematically, and there are many
accidents due to poor communication- LTC staff may find it difficult to understand the contents of reports from medical care staff and the proposed countermeasures, and may feel alienated from
them
Reporting system issues- Reporting culture has not taken root
- Examples of reports: falls, accidental medication, skinpeeling, aspiration, different foods, trauma inside andoutside the facility, and complaints- Reporting varies considerably from facility to facility- Kiken Yochi (Risk Prediction) Training (KYT) is conducted, but a systematic root cause analysis is not- Incident reports are difficult to share- Differences in the way near-misses and incidents areperceived- No review of near-misses and incidents- Results of the “why-why” analysis are used as a meansof seeking individual responsibility- Nurses and LTC staff differ in how they receive cases- Even if there is a report, it does not lead to effective
prevention of recurrence because there is no system toanalyze the reported incidents- Mandatory reports are made to the local government,
but there is no actionable feedback
Challenges related to learning opportunities- Lack of education on LTC safety- There are few opportunities to learn about safety in asystematic manner. As a result, there is resistance toreporting accidents and fear of punishment, and few
incidents are reported.
- There is little content on safety measures, as the focus
is on “understanding the elderly” and responding topatients in a more personal manner- Few people have received training in patient safety

J. Natl. Inst. Public Health, 73 (1) : 2024

Patient safety in long-term care in Japantation in LTC facilities, and said, “Yes, situations likethis occur.”〇Significance of TeamTEPPS® training in LTC facilities
TeamTEPPS® training could be used in LTC facilities and offices with diverse functions to learn about
teamwork for enjoyable and successful outcomes.
The fact that all participants mentioned the tools theylearned as safety measures and said, “Iʼm going to try
this,” was considered an effect of the training. A factor
contributing to incidents in LTC facilities is the teamcollaboration problem, just as in hospitals. The participants expressed a desire to continue actively incorporating TeamTEPPS® training into safety and infection
control training.
(3) Need for systematic efforts
Based on the interviews regarding the status of initiatives at LTC facilities, we inferred that there are avariety of issues that need to be addressed in orderto report incidents, consider countermeasures, andput them into practice. Specifically, there are few opportunities to learn about safety in a systematic andcontinuous manner. As a result, the significance ofreporting is not well understood, and reports tend tobe sporadic. Moreover, even when there are reports,
there is no mechanism to systematically analyze accidents and effectively prevent recurrence, not only in
LTC facilities but also in local governments. Anotherfactor contributing to many accidents is poor communication. In examining these issues, the “Ten Essentials
for Providing Safe Medical Care” and the “Overall
Structure of Patient Safety” prepared on September
11, 2001, by the Human Error Subcommittee of theMedical Care Safety Measures Study Council, Medical
Policy Bureau, Ministry of Health, Labour and Welfare,- There is a strong awareness of abuse prevention andcomplaint handling, with guidance on abuse being themain focus- There is a strong perception that “accidents will not
happen if individuals just stay vigilant”
Issues related to infection- Every year, various infectious diseases tend to spreadin specialized dementia wards (norovirus, scabies,
COVID-19/influenza, etc.)(2) Training: Example of the approach taken at a certain social welfare corporation (team training)〇Background of training implementation and outline oftraining content
When incidents and COVID-19 cases occurred, on-site
interviews revealed many communication problems.
Therefore, they conducted a participatory training (2hours) using materials from TeamSTEPPS®[11], anevidence-based team training.
〇Participants: 14 LTC workers, nurses, rehabilitation
professionals, and others who wished to participate.
- Over 80% with more than 10 years of occupational
experience- Offices where they work: Residential/in-facility
services (LTC elder care facilities, special nursing
homes, etc.), commuting LTC (day-care service centers, etc.), and others (home-visit rehabilitation, etc.)〇Findings from the post-training questionnaire- 90% responded that they enjoyed learning and foundit useful for their work.
- From watching the video materials and exchanging
opinions, staff realized the importance of mutual
support, communication, leadership, and situation
monitoring of people, objects, etc. Staff felt particularly strongly about the video materials on rehabili-

A

User
FamilyB
E

Phylosophy ❶ Safety culture

Relationship with users

C

Organizational measures❸ Problem-solving approach❷ Dialogue and patient engagement ❹ Policies and procedures

Individual staff

Staff❻ Anticipation and reasonable
identification of hazards

D

Relationship among staff
members

Other
institutions
Other
institutions

Staff❼ Personal health management

G⓫ Coordination withother institutions❺ Communication among staff members

F

Relationship between people
and the environment/objects❽ Use and application of technology ❾ Medication❿ Environmental improvements

Figure 1 Overall Structure of Patient Safety in Long-term CareJ. Natl. Inst. Public Health, 73 (1) : 2024

51

TANEDA Kenichiro
can be consulted[12]. Taking this into consideration,
the overall structure of patient safety in LTC (Figure1), which shows the overall picture of various issues
at LTC sites, and a system to learn systematically as ateam (team training such as TeamSTEPPS®) and work
better together with colleagues, users, and their families is necessary to prevent accidents.
In the overall structure of patient safety LTC (Figure1), first, it is essential to foster a “① Safety Culture”
at each facility as “A. Philosophy” An organizational
culture that prioritizes the safety of users rather thanbusiness operations is necessary. In “B. Relationshipwith users,” “② Dialogue and patient engagement”
is required, and this will also help avoid unnecessary
lawsuits, etc. in the event of unavoidable accidents. “C.
Organizational measures” require a “③ Problem-solving approach” and “④ Policies and procedures.” Regarding “D. Relationships among staff members,” “⑤Communication among staff” is essential in providing
safe care. Conversely, “⑥ Anticipation and reasonable
identification of hazards” and “⑦ Personal health management” are required for “E. Individual staff.” In “F.
Relationships between people and the environment/
objects,” “⑧ Use and application of technology,” “⑨Medication,” and “⑩ Environmental improvements”
are also useful perspectives. In “G. Other institutions,”
based on many cases, it is considered essential to “⑪
Cooperate with other institutions” such as medical
institutions outside the facility in a timely manner to
respond to events that are difficult to resolve throughmeasures taken by the affected facility alone.

VI. Economic incentives to promote safety
Starting in 2021, LTC insurance will establish an additional reimbursement for safety measures, which will
increase the income of LTC facilities if the following items
are met- Development of guidelines for accident prevention- Establishment of a system to ensure that all staff members are aware of the details of accidents and measures
to prevent recurrence, including posting of information
regarding the accident- Organization of committees and training on accident
prevention- Assignment of a manager who has attended external
training
If these systems are not implemented, a deduction will
be applied in the reimbursement, resulting in a decrease inrevenue for the LTC facility. The content of the above items
to be included in external training is left to each facility or-

52

ganization and has not been standardized. In the area of patient safety, the MHLW has provided information describing
the content of patient safety training that managers should
undergo[13].

VII. Conclusion
Safe LTC practices are required at LTC facilities. The
first step necessary for safe LTC is the identification of accidents and other incidents through voluntary reporting fromthe field and analysis to prevent their recurrence. However,many LTC facilities and municipalities that receive reports
lack the reporting and learning mechanisms to make thishappen. Based on the extracted precedents and domestic
and international efforts, the following seven perspectives
were considered as a classification (systematic approach) of
measures to prevent adverse events (e.g., injuries due tofalls, aspiration, etc.) and recurrence of adverse events:(1) Understanding the likelihood of adverse eventsand the mode of response- The elderly are at high risk for falls, aspiration, andchoking as they age, and it is necessary to understandthe likelihood of adverse events for each individual
and respond accordingly (depending on the size andfunction of the facility), considering various individual
factors. Sharing with users and their families the risks
to users and the limitations of the facilityʼs response tothese risks will help avoid unnecessary lawsuits, etc.,
in relation to item (7) Measures to prevent cases
involving unavoidable incidents from developing
into lawsuits below.
(2) Early detection of behaviors leading to adverse events(3) Prevention of injury less likely to occur even in thepresence of behaviors leading to adverse events(4) Early detection of adverse events(5) Early treatment of adverse events(6) Cooperation between LTC facilities and medical institutions- Collaboration is especially necessary for items (4)Early detection of adverse events) and (5) (Early
treatment of adverse events above- For smooth determination of the degree of injury andresponse, consider establishing a cooperative system
during normal operation and a system that can be consulted even during emergencies(7) Measures to prevent cases involving unavoidable
incidents from developing into lawsuits- While it is necessary to share safety-related risks, etc.,with users and their families and to work in collaboration with them, in relation to item (1) Understanding
the likelihood of adverse events and the modeof response above, the likelihood of adverse events

J. Natl. Inst. Public Health, 73 (1) : 2024

Patient safety in long-term care in Japan
identified for each individual user and how to respondto them (including limitations due to the size and function of the facility) should be shared with users andtheir families by preparing case descriptions and otherinformation for each facility. At this point, seek understanding and cooperation from users and their families
that excessive preventive measures can limit their autonomy, quality of life, and functional recovery, and alsocollaborate with them.
On the basis of these results, further efforts are expected at both the facility and municipal levels to develop andpromote a system for systematically addressing accident
prevention (reporting, analysis, planning countermeasures,
implementation, evaluation, etc.) and training for collaboration among multiple professions, including users and theirfamilies, using the overall structure of LTC safety(Figure 1)
as a reference.

Reference[1] 日本医療機能評価機構．医療事故情報収集等事業
Japan Council for Quality Health Care. [Project to Collect
Medical Near-Miss/Adverse Event Information]
https://www.med-safe.jp/contents/english/index.html (inJapanese) (accessed 2024-01-23)[2] Taneda K. Patient safety: History and recent updates inJapan. J Natl Inst Public Health. 2019;68(1):55-60.
[3] Japan Medical Safety Research Organization．Medical
Accidents Investigation System.
https://www.medsafe.or.jp/modules/en/index.php?content_id=1 (accessed 2024-01-23)[4] 平成十一年厚生省令第四十六号 特別養護老人ホー
ムの設備及び運営に関する基準[Heisei 11 nen Koseishorei dai 46 go Standards for Facilities and Operation of Special Nursing Home for the
Elderly]
https://elaws.e-gov.go.jp/document?lawid=411M50000
100046 (in Japanese) (accessed 2024-01-23)[5] 厚生労働省．介護老人福祉施設（特別養護老人ホーム）
Ministry of Health, Labour and Welfare. [Long-term carewelfare facilities for the elderly (special nursing homes
for the elderly)]
https://www.kaigokensaku.mhlw.go.jp/publish/group14.
html (in Japanese) (accessed 2024-01-23)[6] 厚生労働省．福祉サービスにおける危機管理（リスクマネジメント）に関する取り組み指針
Ministry of Health, Labour and Welfare. [Fukushi service
ni okeru kiki kanri (risk management) ni kansuru torikumi shishin)]https://www.mhlw.go.jp/houdou/2002/04/h0422-2.html (inJapanese) (accessed 2024-01-23)[7] 平成 30 年度介護報酬改定検証事業「介護老人福祉施設における安全・衛生管理体制等の在り方についての調査研究事業」（結果概要）（案）
Heisei 30 nendo Kaigo Hoshu Kaitei Kensho Jigyo. [Survey and Research Project on the Safety and Sanitation
Management System in LTC Geriatric Welfare Facilities
kekka gaiyoan]
https://www.mhlw.go.jp/content/12601000/000488392.pdf(in Japanese) (accessed 2024-01-23)[8] 厚生労働省．どんなサービスがあるの？ 介護老人保健施設（老健）
Ministry of Health, Labour and Welfare. [Long-term carehealth facilities for the elderly/Rehabilitation facilities forthe elderly (roken)]https://www.kaigokensaku.mhlw.go.jp/publish/group15.
html (in Japanese) (accessed 2024-01-23)[9] 厚生労働省．介護医療院とは？
Ministry of Health, Labour and Welfare. [Integrated Facility for Medical and Long-term Care towa?]
https://www.mhlw.go.jp/kaigoiryouin/about/ (in Japanese)(accessed 2024-01-23)[10] 日本老年医学会，全国老人保健施設協会．介護施設
内での転倒を知っていただくために〜国民の皆様へのメッセージ〜
The Japan Geriatrics Society, Japan Association of Geriatrics Health Services Facilities. [To make people aware offalls in LTC facilities: a message to the public]
https://www.jpn-geriat-soc.or.jp/info/important_info/
pdf/20210803_01_02.pdf (in Japanese) (accessed 202401-23)[11] TeamSTEPPS®
https://www.ahrq.gov/teamstepps-program/index.html[12] 厚生労働省．医療安全の全体構成．
（安全な医療を提供するための 10 の要点）
Ministry of Health, Labour and Welfare. [Overall structure of patient safety (Anzen na iryo o teikyosuru tameno
10 no yoten)]https://www.mhlw.go.jp/topics/2001/0110/tp1030-1f.html(in Japanese) (accessed 2024-01-23)[13] 厚生労働省医政局総務課医療安全推進室．医療安全管理者の業務指針および養成のための研修プログラ
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53

TANEDA Kenichiro＜総説＞
我が国における介護現場の安全の取り組み
種田憲一郎
国立保健医療科学院医療・福祉サービス研究部

抄録
超高齢社会を迎えて，介護施設の果たす役割は益々大きくなり，介護施設において，安全な介護の実施が求められている．医療安全の取組みの推進において，まず起きている事故を把握することの必要性から，「Reporting first」と言われる．本邦においては，国レベルの事故報告システムとして，
2004 年から医療事故情報収集等事業，2015 年から医療事故調査制度が開始されている．一方で介護における事故情報収集に関しては，地方公共団体にまかされているが，必ずしも介護の安全に活かされていない．このため介護現場の事故情報収集においても，将来，国レベルでの活用の仕組みの構築を視野にいれた，報告様式の標準化，介護現場の安全管理体制の強化などが取り組まれつつある．さらに介護現場の取組み状況についてのヒアリングなどからは，介護安全の全体構成（案）を参考に，事故予防に体系的に取組むための仕組み（報告，分析，対策立案，実施，評価など）と利用者・家族も含めて多職種で協働する訓練を整備・推進する取組みが，各施設レベルでも各自治体レベルでもさらに期待される．この論文では，本邦における介護現場における安全の取組みの現状について紹介する．
キーワード：介護，医療安全，報告制度，訴訟，研修

54

J. Natl. Inst. Public Health, 73 (1) : 2024