Patient Safety Act
This act was promulgated on January 28, 2015 and implemented on July 29, 2016 for the purpose of contributing to the protection of patients and the improvement of medical quality by prescribing matters necessary for patient safety.
Main Contents of the Act
-
Patient safety
incident report -
(Prevention of recurrence
through cause analysis) -
- Reporter and contents of patient safety incident report
- Management of reporting method and procedure
- Operation of Reporting & Learning System
- Reasons for issuing patient safety alerts
- Verification of patient safety incident report
-
Criteria of
Patient Safety -
(Inducing compliance with
patient safety standards) -
- Facility and equipment management system of Medical Institutions
- Compliance with patient safety of healthcare providers
-
Patient safety
indicator -
(Patient safety level analysis
and management) -
- Compliance with patient safety of healthcare providers
- Types of data for the development of patient safety indicators and holding institution
-
Education on patient
safety activities -
(Education and management
of dedicated personnel) -
- Consignment of educational institutions
- Methods, time, contents, and others of patient safety education
- Establishment of the National Patient Safety Committee
- (Major measures for improving patient safety and medical quality)
-
- Composition and operation of the National Patient Safety Committee/Subcommittee
-
Establishment and
implementation of
patient safety plans - (Patient safety inspection and management including patient safety status survey)
-
- Content and method of the patient safety status survey
- Additional matters to be included in patient safety general plans
-
Establishment and operation of the
Patient Safety Committee -
(Planning and management of patient safety
managing activities in medical institutions) -
- Institutions established Patient Safety Committee
- Task of the Patient Safety Committee
- Composition and operation of the Patient Safety Committee
-
Deployment of dedicated patient safety
personnel -
(Planning and management of patient safety
managing activities in medical institutions) -
- Institutions deployed dedicated personnel
- Task of dedicated personnel
- Qualifications and standards for dedicated personnel
Establishment and operation of the Patient Safety Committee
Target institution
Target institution is a hospital-level medical institution with more than 200 beds, and for general hospitals, it is for medical institutions with more than 100 beds.
Composition and operation
- The committee shall be comprised of not less than five but not more than 30 members, including one chairperson, and gender shall be taken into account.
- The chairperson of the committee shall be the head of the healthcare institution, and the members of the committee shall be commissioned by the head of the healthcare institution.
- The term of office of the chairperson and members of the committee is three years.
- The committee shall be held on a regular basis at least twice a year, and it shall be held when the chairperson deems it necessary or when a majority of the members request it to convene.
- The meeting will be held with the attendance of a majority of all incumbent members, and the agenda will be decided with the consent of a majority of the members present.
- If the chairperson is unable to perform his/her duties due to unavoidable reasons, such as an accident, a member designated in advance by the chairperson shall act on behalf of the chairperson.
- Matters necessary for the operation of the committee shall be determined by the chairperson after a resolution by the committee.
Task of the committee
- Establishment and implementation of plans for the prevention of patient safety incidents and recurrence
- Appointment and deployment of dedicated patient safety personnel
- Establishment and operation of medical quality improvement activities and patient safety systems of medical institutions
- Protection of safety incident reporters and reporting contents
- Establishment and implementation of plans for patients and patient carers' participation in patient safety activities
- Matters concerning compliance with patient safety standards
- Matters concerning the operation of patient safety indicators
- Matters concerning the activation of reporting of patient safety incidents
- Matters concerning the education of patient safety activities
- Other matters specifically necessary for the improvement of patient safety activities, as determined by the Minister of Health and Welfare
Deployment of dedicated patient safety personnel
Deployment
Hospital-level medical institutions of a certain size or larger shall have dedicated patient safety personnel responsible for patient safety and improvement of medical quality.
| Hospital-level medical institutions with more than 200 beds (excluding general hospitals) | One or more dedicated personnel |
|---|---|
| General hospitals with more than 100 beds and fewer than 500 beds | One or more dedicated personnel |
| General hospitals with 500 beds or more | More than two dedicated personnel |
Qualification standard
- A person who has worked in a healthcare institution for more than five years after obtaining a license for a doctor, dentist, or oriental medical doctor
- A person qualified as a medical specialist
- A person who has worked in a healthcare institution for at least five years after obtaining a nurse's license
Task of the dedicated personnel
- Collection, analysis, management and sharing of patient safety incident information
- Education of healthcare providers to prevent patient safety incidents and recurrence
- Education of patients and carers for patient safety activities
- Report on patient safety activities
- Checking if complying with patient safety standards
- Measurement and inspection of patient safety indicators
- Other matters deemed particularly necessary by the Minister of Health and Welfare for the improvement of patient safety and medical quality.