Thông tư 19/2013/TT-BYT

CIRCULAR

SPECIFYING IMPLEMENTATION GUIDELINES FOR HEALTHCARE SERVICE QUALITY MANAGEMENT IN HOSPITALS

Pursuant to the Government's Decree No. 63/2012/ND-CP dated August 31, 2012 providing for the functions, tasks, powers and organizational structure of the Ministry of Health;

The Ministry of Health hereby adopts the Circular that specifies implementation guidelines for healthcare service quality management in hospitals

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular sets out guidelines for healthcare service quality management in hospitals (hereinafter referred to as hospital quality management), including:

1. Hospital quality management contents.

2. Hospital quality management systems.

3. Hospital quality management responsibilities.

Article 2. Principles of implementation guidelines for hospital quality management

1. The patient should be put at the center of all healthcare services.

2. Quality assurance and improvement should be assumed as crucial and routine tasks, and must be conducted in a regular, continuous and steady manner.

3. Decisions in relation to hospital quality management operations should be made by taking into consideration legal and scientifically-proven bases supported by specific evidence, and should conform to practical demands for hospital quality enhancement.

4. Hospital directors shall be held accountable for hospital quality management. All of the staff members, including those who work as officials, public servants or employees (hereinafter referred to as medical staff), in hospitals must be involved in hospital quality management.

Chapter II

HOSPITAL QUALITY MANAGEMENT CONTENTS

Article 3. Drawing up the plan or schedule for hospital quality assurance and improvement

1. Quality goals and objectives must be established, adopted, published, communicated or made known to the medical staff, the patient and the public. These goals and objectives must correspond to policies or laws relating to hospital quality and resources.

2. Hospital's development and approval of the plan, and establishment of the work schedule for its quality assurance and improvement must be conducted through determination of tasks in order of priority. Contents of the quality plan must be integrated into the annual and 5-year action plan in reliance on hospital resources.

Article 4. Maintaining national technical regulations on hospitals

1. Hospitals must meet licensing requirements in accordance with the schedule referred to in the Government’s Decree No. 87/2011/ND-CP dated September 27, 2011.

2. Licensed hospitals shall be responsible for sustaining their operations in order to meet national technical regulations and other requirements adopted by the Ministry of Health.

Article 5. Establishing quality indicators, databases and measuring hospital quality

1. Provide sets of hospital quality indicators based on the Ministry of Health's guidelines and make reference to domestic or foreign endorsed sets of hospital quality indicators.

2. Identify hospital quality indicators.

3. Make necessary arrangements for collection, management, filing, depositing, exploitation and utilization of hospital quality data.

4. Integrate quality reports into general activity reports of hospitals.

5. Take advantage of information technology to establish databases, analyze and process information related to hospital quality management.

Article 6. Conduct implementation of healthcare service regulations or professional instructions

1. Make necessary arrangements for implementation of regulations or professional guidelines adopted by the Ministry of Health and respective hospitals, including instructions on diagnosis, treatment, technical procedures, patient care processes and other professional guides.

2. Conduct quality inspection activities to assess implementation of regulations or professional instructions of hospitals; provide systematic analysis of medical diagnosis, treatment and care quality, including clinical or near-clinical technical procedures for medical diagnosis, treatment and patient care.

Article 7. Taking necessary measures to ensure safety for patients and medical staff

1. Develop programs and set out specific regulations on assurance of safety for patients and medical staff with the following main contents:

a) Accurate patient identification and avoidance of any error likely to be made during the process of rendering healthcare services;

b) Safe surgery or operation;

c) Safe medication use;

d) Prevention and control of hospital-acquired infections and bacterial contaminations;

dd) Control and prevention of risks or defects arising from exchange or transmission of false information between and among medical staff;

e) Patient fall prevention;

g) Safe medical equipment use.

2. Provide safe working environment for patients, visitors and medical staff; prevent any accident, risk or exposure.

3. Establish the system for collecting and making reports on medical errors or adverse events occurring at clinical departments and within the entire hospital, including compulsory and voluntary reports.

4. Develop procedures for assessing medical errors and adverse events to identify root, systematic and medical staff's personal causes; assessing possible risks.

5. Deal with medical errors or adverse events and take necessary actions to mitigate root, systematic and personal causes to minimize medical errors, incidents or adverse events as well as prevent risks.

Article 8. Applying the set of hospital quality management standards

1. Hospitals are required to consult the set of quality management criteria and standards issued or endorsed by the Ministry of Health to designate the most appropriate set of these criteria and standards, and bring it into effect for such hospitals.

2. Procedures for effecting the set of criteria and standards for quality management shall be subject to guidelines set out by the authority issuing that set of criteria and standards or healthcare quality certification organization.

3. After obtaining healthcare quality certificates, hospitals should continue to uphold and improve their healthcare quality.

Article 9. Assessing hospital quality

1. Conduct internal assessment of hospital quality in accordance with the set of criteria and standards for healthcare quality management adopted or endorsed by the Ministry of Health.

2. Evaluate the degree of efficiency in application of criteria, standards, models and methodologies of hospital quality management to decide on appropriate ones.

3. Hospitals shall conduct a regular survey to measure satisfaction of patients, patient's families and medical staff at least once in every 3 month, which serves as a basis for improving and increasing health care service quality for patients and satisfaction for medical staff.

4. Hospitals shall establish their own quality reports and publish them at their discretion under the guidance of the Ministry of Health.

5. Regulators shall conduct assessment of hospital quality or verification of quality reports based on the set of criteria or standards for healthcare quality management adopted or endorsed by the Ministry of Health on an annual or irregular basis.

Chapter III

HOSPITAL QUALITY MANAGEMENT SYSTEM

Article 10. Organization of the hospital quality management system

1. The hospital quality management system is composed of the hospital quality management council of which the Chairperson is the hospital Director, the Vice Chairperson is the Vice Director responsible for the service area; quality management divisions/teams; full-time personnel responsible for healthcare quality management; healthcare quality management network in uniformity with the hospital scale.

2. Special-ranked hospitals and first-ranked general hospitals shall establish the healthcare quality management division; other hospitals shall take into account their respective scale, conditions and needs to decide to establish either division or team of healthcare quality management. Healthcare quality management division/team shall closely cooperate with other functional departments or divisions to perform hospital quality management duties.

3. The hospital quality management network shall be established from the level of hospital to the level of departments, divisions or affiliated units within a hospital, and its operations shall be coordinated by the healthcare quality management division/team acting as a centre of these operations.

4. Operations of the hospital quality management council:

a) The council’s Chairperson shall assign duties to council members and formulate operational rules of the council;

b) The council's Chairperson shall establish the healthcare quality management system, construct and publish hospital quality management instruments;

c) The hospital quality management council shall hold regular or irregular meetings in order to provide assistance, supervisory actions and recommendations concerning healthcare quality management.

5. Organization and tasks of the hospital quality management council, healthcare quality management division/team, tasks and powers of the Head of healthcare quality management division/team, and employees and members of the healthcare quality management network, shall be subject to instructions provided for in Article 11, 12, 13, 14 and 15 hereof.

Article 11. Organization and duties of the healthcare quality management division

1. Organization:

The hospital quality management council shall be subject to the decision on establishment, operational rules and maintenance made by the hospital Director. Its standing Secretary is the Head of the hospital quality management division/team. The number of members attending the council shall depend on the hospital scale and include representatives from relevant departments or divisions involved in hospital quality improvement and patient safety assurance activities.

2. Duties:

a) Detect quality problems, potential risks to patient safety, determine prioritized activities and make proposals for assurance and improvement of healthcare quality and patient safety to the hospital Director;

b) Assist the hospital Director in conducting implementation of the set of criteria and standards for healthcare quality management adopted or endorsed by the Ministry of Health by taking into consideration the hospital's conditions;

c) Engage in conduct of application of the set of healthcare quality criteria and standards, and internal assessment of healthcare quality in hospitals as well as verification of hospital quality reports;

d) Provide technical assistance for departments or divisions with the aim of initiating activities covered in the healthcare quality assurance and improvement scheme approved by the hospital Director.

Article 12. Organization and duties of the healthcare quality management division/team

1. Organization:

a) The quality management division shall be composed of the Head, Vice Head and employees, depending on the hospital scale and subject to the hospital Director's decision;

b) The quality management team shall be put under the hospital Director’s direct supervision or affiliated to a functional division under the management of the Head of such division.

2. Duties:

The healthcare quality management division/team shall play its role as a center that conducts and gives advice to the hospital Director and healthcare quality management on hospital quality management activities:

a) Submit the hospital quality management plan and contents to the hospital Director for his approval;

b) Perform, monitor, oversee, assess, report, cooperate and assist in making necessary arrangements for performing quality management activities and healthcare quality assurance and improvement schemes at departments or divisions;

c) Act as the central point that establishes the system for medical error or adverse event management, including consolidation, analysis, reporting, study and recommendation on error correction or mitigation solutions;

d) Act as the central point that cooperates with other departments or divisions in dealing with claims, complaints and issues arising from patient’s satisfaction;

dd) Collect, consolidate and analyze data, and manage, protect and secure information regarding hospital quality. Cooperate with statistics and information technology departments within hospitals to identify hospital quality indicators;

e) Organize or cooperate in organization of quality management training and enhancement courses;

g) Conduct internal assessment of hospital quality in accordance with the set of criteria and standards for healthcare quality management adopted or endorsed by the Ministry of Health;

h) Conduct assessment of compliance with regulations and professional guidelines adopted by the Ministry of Health;

i) Develop and make necessary arrangements for implementation of patient safety schemes.

Article 13. Duties and powers of the Head of healthcare quality management division/team

1. Duties:

a) Make necessary arrangements for fulfilling duties of the healthcare quality management division/team, and take responsibility for its operations.

b) Prepare final reports on operations of the healthcare quality management division/team, and assessment reports on results of hospital quality improvement and patient safety assurance;

c) Assist quality-related teams organized by departments or divisions to launch and implement healthcare quality assurance and improvement schemes;

d) Take part in hospital quality assessment;

dd) Act as the Secretary of the hospital quality management council.

2. Powers:

a) Check and require departments, divisions and individuals to comply with the hospital quality management plan;

b) Submit proposals to the hospital Director to grant awards to and impose disciplinary actions on individuals or collectives for their performance of healthcare quality management duties.

Article 14. Duties and powers of employees of healthcare quality management division/team

1. Duties:

a) Perform duties assigned in job descriptions of the quality management division/team and others as assigned by the Head of quality management division/team;

b) Collect, analyze, administer and secure data related to hospital quality management that falls within their remit;

c) Assist quality-related teams organized by departments or divisions to launch and implement healthcare quality assurance and improvement schemes;

d) Take part in health care training, mentorship, refresher courses and healthcare service quality assessment.

2. Powers:

a) Inspect and oversee hospital quality activities of departments and divisions;

b) Encourage individuals and affiliated units to apply remedial measures after such inspection and oversight;

c) Propose awards granted to affiliated units or individuals that excel in their quality management tasks.

Article 15. Members of the healthcare quality management network

1. Each department, division or affiliated unit (hereinafter referred to as unit) of a hospital must appoint at least one employee work as a dual-employment member for the hospital quality management network.

2. Duties of members of the healthcare quality management network:

a) Play a central role in assisting hospital leadership in conducting, performing and monitoring activities relating to hospital quality management;

b) Execute activity plans of the hospital quality management network at respective units;

c) Engage in hospital quality inspection and assessment duties as assigned by the hospital quality management council.

Chapter IV

HOSPITAL QUALITY MANAGEMENT RESPONSIBILITIES

Article 16. Responsibilities of the hospital Director

1. Direct, disseminate and raise awareness of this Circular among all hospital personnel.

2. Establish the organizational system for hospital quality management under instructions given in Article 10, 11, 12 and 15 hereof.

3. Effect or apply the set of quality management criteria and standards issued or endorsed by the Ministry of Health.

4. The hospital Director must plan budget for hospital quality management activities, including:

a) Perform relevant activities to apply the set of quality management criteria and standards issued or endorsed by the Ministry of Health;

b) Uphold and improve healthcare quality;

c) Organize and designate hospital staff members to provide healthcare quality management training, mentorship and refresher courses;

d) Grant awards to individuals or collectives excelling in their hospital quality management tasks;

dd) Enter into healthcare quality consultancy, assessment and certification contracts.

e) Perform other activities to improve hospital quality and patient safety whenever required by hospitals.

5. Ensure availability of human resources and healthcare quality management training, including:

a) Make investment in human resources for healthcare quality management duties, establish healthcare quality management division or team, and assign medical staff under full-time or dual-employment arrangements for healthcare quality management duties;

b) Organize or send medical staff to attend healthcare quality management training, mentorship or refresher courses provided by domestic and overseas entities;

c) Send medical staff members who work full-time in hospital quality management to attend courses providing in-depth hospital quality management training.

6. Ensure availability of useful equipment and working means:

a) Equip hospitals with means of analysis, processing and storage of healthcare quality management data;

b) Establish instructional instruments and documents on healthcare quality management.

7. Direct scientific researches and audit of healthcare quality management tasks.

8. Attend healthcare quality management training, mentorship or refresher courses provided by domestic and overseas entities.

Article 17. Responsibilities of the Head of a hospital’s functional divisions

1. Disseminate this Circular among all hospital personnel.

2. Set quality objectives and integrate healthcare quality management activities into the plan for activities of respective divisions and into the areas that fall within their remit.

3. Work on and cooperate with other relevant divisions or departments in application of healthcare quality management criteria and standards adopted or endorsed to respective divisions and the areas that fall within their remit.

4. Collaborate with the healthcare quality management division/team in developing the plan and performing activities to assure and improve hospital quality.

5. Attend healthcare quality management training, mentorship or refresher courses provided by domestic and overseas entities.

6. Engage in hospital quality assessment duties.

Article 18. Responsibilities of the Heads of a hospital’s departments

1. Disseminate this Circular among all department personnel.

2. Identify healthcare quality issues that must be given priority by departments to actively improve hospital quality or recommend approaches to improving hospital quality to the council.

3. Work on and cooperate with other relevant divisions, departments or affiliated units in research in or application of healthcare quality management criteria and standards adopted or endorsed to respective departments under their management.

4. Assign their employees to carry out activities to assure and improve hospital quality and evaluate results of hospital quality assurance and improvement activities.

5. Prepare review reports on outcomes of hospital quality assurance and improvement activities for submission to the hospital quality management council.

6. Collaborate with healthcare quality management division/team and relevant units in developing related hospital quality assurance and improvement schemes.

7. Attend healthcare quality management training, mentorship or refresher courses provided by domestic and overseas entities.

8. Engage in hospital quality assessment duties.

Article 19. Responsibilities of a hospital’s medical staff

1. Participate in healthcare quality improvement programs, plans or activities with reference, depending on their delegated powers and assigned duties.

2. Attend healthcare quality management training, mentorship or refresher courses provided by domestic and overseas entities.

Chapter V

IMPLEMENTARY PROVISIONS

Article 20. Roadmap for hospital quality management activities

1. First stage: 2013-2015

a) Establish the complete organizational system for healthcare quality management for Departments of Health, sectoral Health authorities and hospitals;

b) Each hospital shall organize or send medical staff to attend healthcare quality management training, mentorship or refresher courses provided by domestic and overseas entities;

c) Hospitals shall apply sets of criteria and standards for healthcare quality management adopted or endorsed by the Ministry of Health to assess, at their discretion, and improve healthcare quality;

d) Encourage hospitals to pilot application of quality models or methodologies and sets of quality management standards.

2. Second stage: 2016-2018

a) Hospitals shall evaluate efficiency in application of sets of healthcare quality criteria, standards, indicators, models and methodologies;

b) Provide training for those employees who take full-time charge of hospital quality;

c) Take initiative in applying for registration of assessment of hospital quality with quality accreditation organizations;

d) Regulators shall commence their assessment, verification and certification of hospital quality.

3. Third stage: After 2018

Hospitals shall keep on application of sets of healthcare quality criteria, standards, indicators, models and methodologies and submission of applications for registration of quality certification under the guidance of the Ministry of Health and independent quality accreditation organizations.

Article 21. Entry into force

This Circular shall enter into force from September 15, 2013.

Article 22. Implementation

1. Medical Examination and Treatment Administration shall be responsible for:

a) playing the central role in conducting, examining and assessing implementation of this Circular by its affiliated hospitals and at local levels;

b) taking charge of or cooperating with relevant units in formulation of codes, regulations, criteria, standards and indicators relating to hospital quality;

c) performing other duties concerning hospital quality management as assigned by the Minister of Health.

2. Relevant Departments or Bureaus shall, with reference to their assigned duties, get involved in directing and performing hospital quality management activities.

3. Departments of Health of centrally-affiliated cities and provinces and sectoral Health agencies shall assume the following responsibilities:

a) Assign a leader of the Department of Health/ sectoral Health agency, a leader of medical service department and an executive to take charge of managing quality of hospitals under the authority of such Department of Health/sectoral Health agency;

b) Develop the plan to improve hospital quality for the network of hospitals of provinces/sectors and submit such plant for competent authorities' approval;

c) Disseminate, direct, inspect and assess implementation of this Circular within their affiliated hospitals; submit annual and on-demand reports to the Ministry of Health.

In the process of implementation of this Circular, if there is any difficulty that may arise, concerned units should notify the Medical Examination and Treatment Administration of this to seek further instructions, explanations or possible solutions./.