Standard of healthcare Korea Institute for Healthcare Accreditation. Fair Accreditation,Trusted KOIHA

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1 Standard of healthcare Korea Institute for Healthcare Accreditation Fair Accreditation,Trusted KOIHA

2 Ansimi, the guardian angel, gives the accreditation marks to the reliable hospitals, you can choose with confidence, and ensures safety! With the accreditation wand held in one hand at all times, Ansimi is striving to create safe and trustworthy hospitals. With Ansimi, the KOIHA will be your partner in achieving a healthy and happy life.

3 The KOIHA gaining the trust of people The KOIHA going worldwide The KOIHA contributes to maintaining and increasing people s health by raising the level of patient safety and medical quality.

4 for patient safety for best healthcare Introduction of the KOIHA 04 Overview of the accreditation program 06 for healthcare organizations Accreditation procedure and survey 08 Support for preparation of accreditation 13 Evaluation of mental health institutions 16 Patient safety 17

5 The KOIHA will open the door to the advanced medical culture! This accreditation is not limited to certain healthcare organizations, but is a mandatory requirement for protecting health of all citizens. Professionalism Fairness Autonomy

6 Korea Institute for Healthcare Accreditation Introduction of the KOIHA 04 we are The KOIHA provides direction for healthcare organizations Background of the establishment Since the advancement of the healthcare organization evaluation system was adopted as one of the national agendas in January 2008, the healthcare organization accreditation system was introduced as an action plan, and the establishment of the specialized accreditation institute has been carried forward. Article 58 in the Medical Service Act, specifying the voluntary application and accreditation of healthcare organizations, was revised in July 2010, and the KOIHA was launched in October 2010 as the specialized accreditation institute for the operation of healthcare organization accreditation system. Purpose of the establishment The KOIHA was founded to contribute to the maintenance and promotion of national health by raising the level of medical quality and patient safety through the integration of an accreditation system for healthcare organizations and the completion of various evaluation tasks conducted to target healthcare organizations. Main tasks Operation of the accreditation process for healthcare organizations, such as reception of applications, conducting site surveys, analyzing evaluation results, and determination of the accreditation ratings. Providing support services for operation of the accreditation system such as providing consultation services to healthcare organizations. Supporting research, studies and policy development related to the accreditation system for healthcare organizations. Implementing by integrating the evaluation tasks of the healthcare organizations done according to other laws. Patient safety-related tasks such as development and operation of the Patient Safety Reporting and Learning System. Basis of the establishment The KOIHA, founded based on Article 58 of the Medical Service Act, is a specialized accreditation institute that carries out the consigned tasks that are determined by the Minister of Health and Welfare to be required for accreditation.

7 Standard of healthcare 05 mission & vision customer service Mission and vision Mission Realization of a new medical culture to enhance patient safety and quality of medical care Vision Becoming the world s best professional accreditation institute taking the lead in continuous quality improvement Professionalism Enhancing professionalism in accreditation and patient safety Core values Fairness Ensuring fairness in execution of the tasks Autonomy Empowering healthcare organizations to autonomously maintain their quality Customer service charter The KOIHA will practice as follows in order to become an institution trusted by the citizens through executing the healthcare organization accreditation system and evaluation tasks with fairness and creating a new medical culture to improve patient safety and quality of medical care. Patients and guardians Healthcare organizations Government and related agencies To promote the accreditation system Increasing the number of healthcare organizations participate in the accreditation system Providing education & training to the healthcare organizations Providing customized consulting services Strategic goals To establish a trustworthy accreditation system Acquiring and maintaining ISQua accreditation Reinforcing competencies of the surveyors Establishing an effective surveyor management system To lead the culture of patient safety 12 strategic tasks Supplementing the accreditation standards on a continuous basis Promoting research projects Establishing a patient safety system To strengthen the management system for sustainable development Strengthening the organizational competencies Fulfilling customer satisfaction Managing the information system in a systematic manner Citizens K- standard Open mind Interaction Healthcare Accuracy Surveyors We will strive for patient safety and medical quality improvements with principles and standards. We will consider and act from a customer's standpoint with an open mind. We will develop a mutual trust via identification of customer s needs. We will create a safe medical environment by providing objective information. We will improve customer value by performing tasks accurately and fairly.

8 Korea Institute for Healthcare Accreditation Overview of the accreditation program for healthcare organizations 06 about Setting a standard of trust for healthcare organizations The healthcare organization accreditation system, as a system that the government investigates healthcare organizations to verify the level of patient safety and medical quality, surveys fairly whether the level of healthcare organization is appropriate based on the 500 measurable elements developed by the Ministry of Health and Welfare and the KOIHA, which is the specialized institute for accreditation, and grants a Accreditation Mark for Healthcare Organizations. Goal _Improvement of patient safety and medical quality The healthcare organization accreditation system is a system that investigates whether all employees are faithfully carrying out the policies and regulations that the healthcare organization has autonomously developed. This system has been executed since 2010 in order to lay the groundwork for healthcare organizations to make voluntary and continuous efforts for patient safety and quality improvement in medical care and to provide high-quality medical services to citizens. Target _All healthcare organizations that are above the hospital level The program is executed through voluntary participation of healthcare organizations that are above the hospital level. It has been mandatory since 2013 for long term care hospitals and mental health institutions to have accreditation to protect patient rights. Effect The healthcare organization accreditation system is a scheme that has brought the innovation of the medical culture by paving the way to change the supplier-oriented medical culture into a consumer-oriented culture. The effect has been gained to induce a culture of autonomous quality control by healthcare organizations through annual interim self-surveys and on-site surveys in addition to evaluating performance level on the policies and regulations made autonomously by healthcare organizations. Furthermore, this system is utilized as an opportunity to align the overall systems of healthcare organizations, such as providing an education opportunity to all employees regarding patient safety and quality improvement of medical care.

9 Standard of healthcare 07 qualification standard Accreditation standards The accreditation standards developed to be applicable to all healthcare organizations are focused on the patient safety and medical quality, which are the core areas of healthcare organizations, and are emphasizing on medical care processes more than the facilities or structures of the healthcare organizations, so that they can contribute to continuous improvement activities. Accreditation mark The accredited healthcare organizations are eligible to use the accreditation mark for four years. Furthermore, the accreditation results are published on the KOIHA website in accordance with Article 58-7 of the Medical Service Act (declaration and utilization of accreditation), thereby related information on the accredited healthcare organizations can be found. Basic value system Safety assurance activities Continuous quality improvement Patient care system Care delivery system and evaluation Patient care Surgery and anesthesia / sedation care Medication management Respect and protection of patient rights Administrative management system Management and organizational operation Management of human resources Management of safe facilities and environment Infection management Management of medical information / records Performance management system Clinical quality indicators The accreditation mark is framed with a shield that symbolizes safety and protection, carrying the meaning that the foremost priority is in patient safety. The shape of the bird s wing, which symbolizes hope, illustrates the vision of healthcare organizations that receive the KOIHA accreditation.

10 Korea Institute for Healthcare Accreditation Accreditation procedure and survey 08 How to Going through a fair and systematic accreditation process Accreditation process Since the survey for the healthcare organization accreditation starts with a voluntary application, healthcare organizations may undertake the accreditation process at the time of their desire once they understand the accreditation standards and their preparation for accreditation is complete. Prior to accreditation Submission of the application Accreditation survey Notification of receipt On-site and document survey Notification of the survey schedule (within one month from the notification of receipt) Accreditation rating granted by the Accreditation Deliberating Committee After accreditation Notification and declaration of the accreditation rating Objection to the rating and confirmation of the accreditation rating Notification of accreditation rating (within six month after the accreditation survey) Notification of accreditation grade Medical Institution Interim self-survey / on-site survey Application for re-accreditation Application for re-accreditation (within four years)

11 Standard of healthcare 09 trust Application for accreditation Healthcare organizations may fill the application out via online at the KOIHA web site ( Hospital-level healthcare organizations may voluntarily apply for the accreditation survey at their convenience. Note that the application should be submitted at least two months before the accreditation survey starts. The KOIHA gives the final notification to the healthcare organization within one month of the application submitted after adjusting the survey schedule with the applicant organization by considering the applicant s preferred survey dates and the order of application submitted. The costs required for the accreditation survey are paid by the healthcare organization. Exception applies to the long term care hospitals and mental health institutions that the costs of accreditation are supported once within the accreditation period. General hospitals seeking to become designated as a tertiary general hospital should receive the accreditation survey. [Article 3(4) of the Medical Service Act, Article 2 of the Regulations on the Designation and Appraisal, etc. of Tertiary General Hospitals] Hospital-level medical institutions seeking to be designated as a specialized hospital should receive this accreditation. [Article 3(5) of the Medical Service Act, Article 2 of the Regulations on the Designation and Appraisal, etc. of Specialized Hospitals] Hospital-level medical institutions seeking to become a training hospital should receive this accreditation. [Article 13 of the Law of Improvement on Training Environment and Status for Medical Residents, Article 4 in the Enforcement Ordinance section of the same act] Hospital-level medical institutions seeking to become a research-oriented hospital should receive this accreditation. [Article 15 of the Health and Medical Service Technology Promotion Act, Article 12 of the Enforcement Regulation section of the same act] Hospital-level medical institutions seeking to be designated as a medical institution recruiting foreign patients should receive this accreditation. [Article 14 of the Act on Medical Overseas Entry and Foreign Patient Attraction Support, Notification No of the Ministry of Health and Welfare] Since 2013, the Medical Service Act has specified that it is mandatory for long term care hospitals and mental health institutions to apply for accreditation considering the characteristics of medical services and patient right protection. [Section 2 in Article 58 of the Medical Service Act]

12 Korea Institute for Healthcare Accreditation 10 Accreditation survey The professional surveyors investigate through on-site survey, by respecting the hospital s own policies and regulations, to find out whether the accreditation standards are met, and depending on whether regulations have been put in place and the level of performance and improvement, the hospital is evaluated as being high, medium, and low. The survey introduces and implements the tracer methodology which investigates the hospital from patient s perspective following the flow of medical care provided to the patient, and the survey incorporates medical record review, interviews with patients or staff, observation, group discussion, and so on. Process of tracer survey Selecting priority target patients for the survey Reviewing the patient s records and verifying information Interviewing the staff in charge of the care, treatment, and services Evaluating the environment of the patient Interviewing the patient and family Tracer methodology Tracing survey methodology: Individual patient tracing survey + System tracing survey It is a survey method that evaluates how patients experience the main functions of healthcare organizations (medical procedures, delivery systems, and safety structures, etc.) along the flow of the medical services provided to the patients. System tracing survey The system tracing survey is a survey method that investigates the entire system of a healthcare organization, and it consists of 6 areas including continuous quality improvement, medication management, management of human resources, infection control, management of safe facilities and environment, and management of medical information/records. Continuous quality improvement Medication management From hospital visit and admission to discharge from the hospital. Management of safe facilities and environment Management of Human resources Infection Control Management of medical information / records

13 Standard of healthcare 11 Survey types Regular surveys Main survey This survey is a regular on-site survey that investigates the entire standards in order for the healthcare organization to receive accreditation. Interim self-survey This survey is a regular survey annually conducted by the healthcare organization itself during the accreditation period to constantly maintain and manage patient safety and quality improvements. The accredited organizations must submit the results of self-survey, the results of management on planned agendas, and improvement outcomes of the priority management standards to the KOIHA in order to maintain Accreditation status. Interim on-site survey This survey is a regular survey conducted on-site of the healthcare organization during the accreditation period for the healthcare organization to continuously maintain and manage patient safety and quality improvement. The interim on-site survey is conducted by the KOIHA surveyor team within 24~36 months after being accredited. Non-regular surveys Additional survey This survey is a supplementary survey conducted to determine accreditation rating, and it may be done through written documents or on-site. The additional survey is conducted at the behest of the healthcare organization if there is a medium evaluation result among the mandatory measurable elements despite the fact that the main survey result grants accreditation or conditional accreditation. It is conducted when the additional survey is deemed necessary by the Accreditation Deliberating Committee operated according to Article 22 in the Constitution of the KOIHA. Occasional survey This survey may be conducted when specific requirements arise during the accreditation period for the accredited healthcare organization, and the entire area or the areas with service changes will be investigated. General wards Intensive care unit Outpatient Emergency room Operating room Various testing room & laboratories Other departments

14 Korea Institute for Healthcare Accreditation 12 Accreditation Results There are 3 ratings based on the surveys and evaluation results of the healthcare organizations: accreditation granted, accreditation granted under condition, and accreditation denied. Accreditation This indicates that the corresponding healthcare organization has achieved an appropriate level of quality and patient safety in all of the medical service procedures provided. (Accreditation period: 4 years) Conditional accreditation This means that the corresponding healthcare organization made efforts to improve its quality, but still has some underachieving areas that will be accredited in the future with further effort. (Valid period: 1 year) Accreditation is valid for four years and must be renewed after that time. Conditional accreditation is valid for one year. In addition to accreditation, an annual interim self-survey shall be conducted during the valid accreditation period for healthcare organization to continuously maintain patient safety and quality improvement, and the results shall be submitted to the KOIHA. The interim on-site survey is also conducted after 24 to 36 months from the accreditation date. Surveyors The surveyors are composed of specialists in various professions such as doctors, nurses, and other healthcare professionals who have experiences working at the hospital-level healthcare organizations. The KOIHA provides online education, basic education, written exam, on-site education, and observation education for the applicants after they have been selected from document screening and interviews, and continuous education and evaluation are provided after they have been selected as surveyors in order to enhance their expertise and objectivity.

15 Standard of healthcare 13 Support for preparation of accreditation education The KOIHA operates various educational and consulting programs to induce voluntary participation of healthcare organizations and support them to effectively prepare for accreditation. Education Basic education for accreditation preparation In order to help Healthcare organizations efficiently prepare for the accreditation process and promote an accurate understanding of the accreditation program, the KOIHA provides basic education about the standards and methodology of accreditation survey. Education and support for accreditation preparation - the cornerstone of voluntary accreditation Education to maintain and manage accreditation The KOIHA supports the accredited healthcare organizations in their efforts to continuously improve patient safety and medical quality and maintain their accreditation. Training to cultivate staff in charge of the preparation for accreditation This education is provided to those staff in the healthcare organizations who are designated to assist healthcare organizations prepare for accreditation so that they can autonomously prepare for accreditation survey and make improvements on patient safety and medical quality.

16 Korea Institute for Healthcare Accreditation 14 consulting Efficient custom-tailored guide for accreditation preparation

17 Standard of healthcare 15 Consulting Submission of the application Application for consulting (within seven days of application submission) Confirmation and notification of consulting schedule Consulting provided (within two weeks after providing consultation) Sending the report of consulting result Notification of receipt Confirmation schedule (within a week after receipt notification) and fee payment instruction (one month prior to consulting) Sending the report of consulting result (\within two weeks from the date when consulting completed) Applied healthcare organization Consulting for accreditation preparation This is a consulting program that supports efficient accreditation preparation by providing an overall direction setup and practical guidelines for the early stage of accreditation preparation. The consulting program may prevent excessive spending due to over-investment on the facility and staffing arrangement of the healthcare organization and may improve the overall systems of the healthcare organization through reviewing the policies related to the accreditation standards. Target : Healthcare organizations at the early stage of accreditation preparation Content : On-site inspection on facilities and environments of the healthcare organization Providing a schematic road map for accreditation preparation Coaching of TF configuration for accreditation preparation and reviewing the policies related to the accreditation standards Setting up operational direction for major committees, leadership interview for accreditation preparation Inspection per major system (ST) and presentation of action plans Mock survey consulting This is a consulting program that provides a mock survey that is similar to that of the accreditation survey to a healthcare organization prior to conducting the accreditation survey. Healthcare organization can experience the accreditation survey process to verify whether the requirements in the accreditation standards are being satisfied and identify deficiencies, thereby allowing them to perform improvement activities to prepare for their final accreditation. Target : Healthcare organizations at the final inspection stage of accreditation preparation. Content : Overall frame is the same as that of the on-site survey Reviewing the policies related to the accreditation standards On-site inspection on facilities and environments of the healthcare organization Presentation of action plans to tackle weak points and deficiencies for each standard Verifying the staff in charge, responsible departments, and priorities Custom-tailored consulting and quality management This is an effective program to improve the overall level of the healthcare organization by providing custom-tailored consulting services on the specific subjects and formats required by the healthcare organization, such as policies, patient safety and quality improvements, infection control, and medication management.

18 Korea Institute for Healthcare Accreditation Evaluation of mental health institutions 16 evaluation Professional evaluation without overlooking details In consideration of the characteristics of mental diseases, a 3-year cycle evaluation of mental health institutions must be conducted pursuant to Article 31 of the Act on Mental Health Improvements and Support of Welfare for Patient with Mental Illness (Evaluation on the facilities of mental health promotion) to establish a management system for patient safety and quality of medical services in mental health institutions. 1. Filling out the application Notification of the receipt sent to the medical institution 2. Sending out the evaluation schedule 3. On-site evaluation Duration: one to two days Surveyors: 3 people 4. Deliberation on the evaluation result 5. Notification of the survey result Submission of objections regarding the survey result (within 30 days after notification date) 6. Re-evaluated every three years Contents of the evaluation Elements concerning facilities and equipment Elements concerning employees and qualifications Elements concerning operational status and performances of treatment, care, and rehabilitation Elements that are deemed necessary by the Minister of the Health and Welfare

19 Standard of healthcare 17 Patient safety for patient The Patient Safety Act, which has been effective as of July 29, 2016, specifies certain items required for patient safety to improve medical quality and protect patients. This act is focused on the prevention of the recurrence of accidents, finding the causes of accidents, and taking corrective actions through the participation of patients and guardians together rather than denouncing accidents that have already occurred. The KOIHA performs tasks, such as reception and verification of patient safety incidence reports and management of patient safety personnel, through operating the Patient Safety Reporting and Learning System which was consigned by the Minister of Health and Welfare. Notification No of the Ministry of Health and Welfare The consignment of tasks required to survey and study data collected in accordance with Article 15 of the Patient Safety Act and information about the autonomous report of patient safety incidents for patient safety according to Section 1 of Article 16 in the Patient Safety Act, including practices and tasks related to the management of changes in patient safety personnel, warning and alarm issuance, reception, collection, verification, and analysis of data to develop the patient safety indicators and autonomous report data. The Patient Safety Reporting and Learning System is a new patient safety platform whose learning system has been provided and shared after collecting nationwide information about patient safety incidents and implementing the patient safety system voluntarily by healthcare organizations. The data on reported patient safety incidents is systematically analyzed and utilized as precious resources to prevent another accident.

20 Korea Institute for Healthcare Accreditation 18 patient safety act The main content of the Patient Safety Act Hospital-level Healthcare organizations whose number of beds is more than 200 and general hospitals whose number of beds is more than 100 shall establish and execute a plan to prevent the recurrence of patient safety incidents and install and operate a Patient Safety Committee for the education of patient safety activities and compliance to the patient safety standards. They must also have a specialized patient safety personnel who is in charge of the tasks related to patient safety and quality improvement. Autonomous report of patient safety incidents [Law 14, 16, 17] (Prevention of recurrence through analysis on causes) Patient safety standards [Law 9] (Induction of compliance to the patient safety standards) Installation of national patient safety committee [Law 8] (Main policies for the improvement of patient safety and medical quality) The installation and operation of the patient safety committee [Law 11] (Planning and management of patient safety management activities at the healthcare organizational level) Reporter, content, method, and procedure of autonomous report Implementation and operation of the reporting and learning system Reasons for warning and alarm issuance Verification of the autonomous report content Patient safety index [Law 10, 15] (Analysis and management on patient safety level) Management system for facilities and equipment in healthcare organizations Compliance details for healthcare practitioners ensuring patient safety Patient safety education [Law 13] (Education and management of specialized patient safety personnel) Configuration and operation of the national patient safety committee / sub-committee Establishment and enforcement of comprehensive patient safety planning [Law 7] (Inspection and management of patient safety management, such as surveys on patient safety status) Organizations that install a patient safety committee Tasks of the patient safety committee Configuration and operation of the patient safety committee Assignment of specialized patient safety personnel [Law 12] (Planning and management of patient safety management activities at the healthcare organization level) The matters required for development and dissemination of patient safety indicators Types and retention period of the data for developing patient safety indicators Consignment of education institutions Method, time, and content of patient safety education Content and methodology concerning how patient safety status should be surveyed Additionally included items for comprehensive patient safety planning Organizations that assign specialized patient safety personnel Tasks of specialized patient safety personnel Qualification and assignment criteria of specialized patient safety personnel

21 Standard of healthcare 19 Realization of the voluntary patient safety system How to report patient safety incidents Patient safety incidents refer to the occurrence of damage or side effects to lives, physical bodies, and mental status when medical services are provided to patients by medical practitioners as well as accidents that are likely to occur. The medical practitioners, heads of healthcare organization, specialized patient safety personnel, patients, and guardians who are responsible for or aware of patient safety incidents can report these accidents through the Patient Safety Reporting and Learning System autonomously. In addition, the patient safety report form may be downloaded and submitted via , fax, or mail to the KOIHA, which is the operation institute for the report and learning system. Patient Safety Reporting and Learning System : address: patientsafety@koiha.or.kr Fax: Mail: To the staff in charge of patient safety, KOIHA, 8th floor of 10 K.B.C. Bldg., Gukhoe-daero 76-gil, Yeongdeungpo-gu, Seoul, Korea Information about reporters and Healthcare organizations is strictly protected, and private information that can identify individuals will all be deleted after verification of the content of patient safety incidents. Duty of reporting specialized patient safety personnel The head of healthcare organization shall report on the status of specialized patient safety personnel according to the related form if specialized patient safety personnel is appointed, dismissed, or changed.

22 Standard of healthcare Korea Institute for Healthcare Accreditation

23 The KOIHA aims for the improvement of patient safety, medical service quality and the value of rights! The KOIHA will be the guide, leading the new medical culture, as a specialized accreditation body trusted by the citizens and stretching out to the world.

24 10th Floor 10 Gukhoe-daero 76-gil, Yeongdeungpo-gu, Seoul Tel Fax

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