Notice of the Hainan Provincial Health Commission

on Revising the Hainan Administrative Measures for the Medical Quality Control Center (Trial)

The health commissions of all cities, counties, and autonomous counties in Hainan; the Health and Medical Products Administration for Hainan Boao Lecheng International Medical Tourism Pilot Zone; all affiliated hospitals of the Hainan Medical University; hospitals under the Commission; the Medical Management Service Guidance Center of the Commission (Provincial Medical Quality Control Office); all provincial quality control centers; and related affiliated hospitals:

In order to standardize the establishment and management of the Medical Quality Control Center (MQCC) in Hainan, establish and improve the medical quality control system, and further improve the safety level of medical quality, according to the "Notice of the General Office of the National Health Commission on Issuing the Administrative Rules for Medical Quality Control Centers" (No. 1 [2023] of the General Office of the National Health Commission), our commission has organized the revision of the "Hainan Administrative Measures for the Medical Quality Control Center (Trial)" on the basis of the actual situation of Hainan. This is now issued to you for compliance and implementation.

Contact person: Zhao Shuai; Contact number: 65818176.

Hainan Provincial Health Commission

May 9, 2023

(This document is proactively disclosed)

Hainan Administrative Measures for the Medical Quality Control Center (Trial)

(Revised on April 23, 2023)

Chapter I General Provisions

Article 1: To strengthen the management of medical quality safety, improve the system of medical quality management and control, and standardize the construction and management of the Medical Quality Control Center (hereinafter referred to as the Quality Control Center), these measures are formulated in accordance with the Basic Medical and Health Promotion Law of the People's Republic of China, the Regulations on the Management of Medical Institutions, the Measures for Medical Quality Management, and other laws, regulations, and provisions.

Article 2: The Quality Control Center referred to in these Measures refers to the medical quality control organization that is established, commissioned, or designated by the health administrative departments at or above the county level to improve medical quality safety and service level, promote the homogenization of medical quality safety, and achieve continuous improvement of medical quality safety in accordance with the needs of management work.

Article 3: According to the level of the health administrative department that establishes, commissions, or designates the Quality Control Center, the Quality Control Center is divided into provincial, municipal, and county (district) level Quality Control Centers (groups).

According to the professional field and work direction of the Quality Control Center, the Quality Control Center is divided into clinical, medical technology, and management type Quality Control Centers, etc.

Article 4: The Provincial Health Commission is responsible for the planning, establishment, management, and assessment of the Provincial Quality Control Center. Health administrative departments below the provincial level are responsible for the planning and relevant management work of the Quality Control Center at this level.

The Provincial Health Commission establishes the Hainan Provincial Medical Quality Control Office (hereinafter referred to as the Provincial Quality Control Office) in the Medical Management Service Guidance Center of the Commission and entrusts the Provincial Quality Control Office to be responsible for the daily management of the provincial Quality Control Center.

Article 5: The establishment of the Quality Control Center should be based on the actual needs of medical quality safety management work. In principle, only one Quality Control Center at this level is set up in the same professional field and work direction.

Article 6: Health administrative departments below the provincial level should refer to the establishment of the provincial Quality Control Center, establish corresponding municipal, county (district) level Quality Control Centers, or designate existing municipal, county (district) level Quality Control Centers for docking work.

Article 7: Health administrative departments below the provincial level should register the establishment and adjustment of the Quality Control Center at this level with the superior health administrative department annually, and make them public to the society.

Chapter II Duties and Formation Mechanism

Article 8: The provincial Quality Control Center carries out the following tasks under the leadership of the Provincial Health Commission:

(1) Analyzing the current situation of medical quality and safety in the domestic and international fields, and formulating plans, proposals, and specific measures for medical quality and safety management and control in our province.

(2) Drafting quality control indicators, standards, and quality safety management requirements for the specialty, proposing quality safety improvement targets and comprehensive strategies, and organizing quality control training in the specialty field.

(3) Collecting and analyzing medical quality and safety data, regularly publishing quality control information, and compiling annual reports on medical services and quality safety in the specialty.

(4) Strengthening the construction of the quality and safety management talent team in the field of the specialty, and implementing the requirements for medical quality and safety management and control work.

(5) Establishing a province-wide professional quality control network, guiding the quality control centers and medical institutions at and below the provincial level to carry out medical quality and safety management and control work.

(6) Undertaking other tasks assigned by the Provincial Health Commission.

Article 9: The Quality Control Center at or below the provincial level refines and organizes the implementation of medical quality and safety management requirements and measures under the leadership of the health administrative department at the same level, referring to the duties of the provincial Quality Control Center, and undertakes other work assigned by the health administrative department.

Article 10: The establishment of the provincial Quality Control Center involves the following steps:

(1) The Provincial Health Commission proposes a setup plan according to work needs, clarifies professional fields and work directions, and proposes conditions required by units intending to undertake the work of the professional Quality Control Center.

(2) Units intending to undertake the work of the professional Quality Control Center should first submit an application to the health administrative department at the municipal, county (district) level to which they belong, and submit the application to the Provincial Health Commission level by level. The Provincial Health Commission conducts a preliminary selection of the applicants. Medical institutions directly under or managed by the Provincial Health Commission can directly apply to the Provincial Health Commission.

(3) The Provincial Health Commission conducts a preliminary selection based on the application status of various units, confirms no more than three units to enter the election defense, and publicizes them according to the corresponding publicity system.

(4) The Provincial Health Commission organizes the election defense and determines the unit undertaking the work of the Quality Control Center (hereinafter referred to as the unit to which the Quality Control Center is affiliated) and the person in charge of the Quality Control Center based on the situation of the election defense.

(5) The provincial Quality Control Center that is newly established or changes its affiliated unit has a preparation period of one year. After the preparation period is completed and accepted, it is officially confirmed. The establishment process of the Quality Control Center below the provincial level is determined by the health administrative department at the same level.

Article 11: The unit to which the provincial Quality Control Center is affiliated should meet the following basic conditions:

(1) It should have the office space, equipment, facilities, and full-time personnel needed for quality control work, and ensure the funds needed for quality control work.

(2) In principle, those applying for clinical professional Quality Control Centers should be Grade III Level A hospitals, with a sound medical quality and safety management and control system and good quality management results.

(3) The overall strength of the applied specialty is strong, demonstrating obvious advantages and influence in the province, and the academic leader has a high academic status and reputation.

(4) No serious violations and major medical quality and safety incidents have occurred within three years.

(5) It can undertake the quality control tasks assigned by the Provincial Health Commission. The conditions for the unit to which the Quality Control Center below the provincial level is affiliated are determined by the health administrative department at the same level.

Article 12: Institutions or organizations applying to be affiliated with the Quality Control Center should submit the following materials to the relevant health administrative department:

(1) Basic information about the unit.

(2) The work and achievements of the unit in the field of medical quality and safety management.

(3) Personnel structure, technical ability, academic status, and equipment and facilities conditions in the field of the proposed specialty.

(4) Qualification conditions for the person recommended as the person in charge of the Quality Control Center, and the number of full-time (part-time) staff, office space, equipment, facilities, and funding conditions prepared for the Quality Control Center.

(5) Thoughts and plans on quality control work in the proposed specialty field.

Article 13: The defense review expert group is composed of professionals in clinical, management, and other fields who are familiar with the national medical quality and safety management system and working conditions. These experts exhibit good professional ethics, professional knowledge, and business capabilities. The participation of experts in the defense review expert group adheres to a recusal system and a responsibility accountability system.

Chapter III Operation and Supervision Management

Article 14: Health administrative departments at all levels should provide the necessary support for the Quality Control Center at their respective levels to carry out their work. Medical institutions should actively cooperate with Quality Control Centers at all levels to carry out quality control work within their jurisdiction according to laws and regulations.

Article 15: The institution affiliated with the Quality Control Center should provide support for the operation of the Quality Control Center, including necessary office space, equipment, facilities, personnel, and funds.

Article 16: The Quality Control Center should establish and implement management systems such as work meetings, expert management, fund management, information security, and evaluation based on actual conditions.

Article 17: Each Quality Control Center should have one person in charge, responsible for the overall work of the Quality Control Center. The provincial Quality Control Center should designate at least one full-time secretary responsible for daily work.

Article 18: The person in charge of the Quality Control Center is recommended by the affiliated unit and is determined after approval by the health administrative department at the same level; in principle, the person in charge should be a formal employee of the affiliated unit and meet the following conditions:

(1) Have good professional ethics and a sense of responsibility, be upright and fair in conduct, and be willing to dedicate.

(2) Have strong professional capabilities, be enthusiastic about medical quality and safety management work, and be familiar with and master related laws, regulations, rules, and professional knowledge of medical quality and safety management.

(3) Have strong organizational and coordination skills, and hold high academic status and prestige in the area of quality control and the field of the specialty.

(4) Have a good physical condition and sufficient working time, and be able to perform the duties of the person in charge of the Quality Control Center.

(5) Meet other conditions stipulated by the health administrative department.

Article 19: If the person in charge of the Quality Control Center cannot continue to perform their duties during their tenure, the affiliated unit should recommend a new candidate within one month, and it is determined after the approval of the health administrative department at the same level.

Article 20: The provincial Quality Control Center should establish an expert committee, and the city (prefecture) and county (district) Quality Control Centers can establish expert groups to provide technical support for their quality control work and implement specific tasks.

Article 21: The setup of expert committees (groups) at each Quality Control Center should meet the actual work needs and the following requirements:

(1) Only one expert committee is set up for each Quality Control Center. The number of members of the expert committee of the provincial Quality Control Center does not exceed 25, and the number of members from the affiliated unit of the Center does not exceed 4.

(2) The expert committee has one chairman, who is the person in charge of the Quality Control Center; up to two deputy chairmen can be set, and at least one of them should be an expert from a non-affiliated unit of the Center. In principle, honorary positions such as honorary chairman and consultant are not set.

(3) The list of members of the expert committee of the provincial Quality Control Center is recommended by the affiliated unit of the Quality Control Center and is determined after the approval of the Provincial Health Commission.

The specific setting method of the expert committee (group) of the Quality Control Center below the provincial level is determined by the health administrative department at the same level.

Article 22: The tenure of the expert committee of the provincial Quality Control Center spans a duration of 4 years. If a member cannot continue to perform their duties during their term, they will not be supplemented.

Article 23: The provincial Quality Control Center can establish sub-specialty quality control expert groups according to work needs, and the number of members of the expert group does not exceed 15. The setting of the sub-specialty quality control expert group should be determined after the approval of the Provincial Health Commission.

The sub-specialty quality control expert group has one group leader and can set up one deputy group leader. The group leader should also be a member of the expert committee. The list of expert group members is determined by the affiliated unit of the Quality Control Center and is put on record by the Provincial Health Commission.

Article 24: Quality Control Centers at all levels should regularly hold meetings of their own expert committees (groups) and sub-specialty quality control expert groups, discuss plans, technical schemes, and important matters of quality control work in their own specialty, and implement the tasks of the Quality Control Center; regularly convene meetings of the persons in charge of the Quality Control Centers at the next lower level in their own specialty, arrange quality control work, and exchange quality control work experiences.

Article 25: Quality Control Centers at all levels should formulate and implement their own specialty quality control work planning and annual work plans, and submit annual work plans and work summaries to the health administrative department at the same level and the superior Quality Control Center in the same specialty as required in a timely manner. The work plan should be formulated in line with the principles of operability and quantifiability, and the specific tasks should clearly define the time limit for completion.

The Quality Control Center should report important activities and arrangements outside the annual work plan to the health administrative department in advance.

Article 26: The budget for the operation of the Quality Control Center should be managed according to the budget plan and should be specifically allocated for specific purposes. The budget for the Quality Control Center should be integrated into the financial management of the affiliated unit and should strictly follow the financial management requirements of the affiliated unit. The Quality Control Center must comply with relevant financial regulations to ensure the regular management and use of funds.

Article 27: The Quality Control Center should actively use information technology to strengthen quality control work. It should use information systems that comply with national network and data security regulations to collect, store, and analyze data, develop and implement related network and data security management systems in accordance with national regulations, and ensure network and data security.

Article 28: The Quality Control Center should use data resources within the prescribed scope. When articles, works, and other results using medical quality and safety data resources are to be published, the source of the data should be indicated, and the Quality Control Center should be used as the first unit.

Article 29: For provincial Quality Control Centers printing documents in the name of the Quality Control Center, the relevant regulations of the Provincial Health Commission should be followed. For Quality Control Centers below the provincial level printing documents in the name of the Quality Control Center, the relevant regulations of the health administrative department at this level should be followed.

Article 30: The Quality Control Center should strictly carry out its work according to the following regulations to strengthen self-management:

(1) Without the consent of the health administrative department at the same level, activities unrelated to quality control work should not be carried out in the name of the Quality Control Center.

(2) Other units or individuals should not be entrusted or indirectly entrusted in violation of regulations to carry out quality control activities in the name of the Quality Control Center.

(3) Funds sponsored by enterprises should not be used to carry out work in violation of regulations in the name of the Quality Control Center.

(4) Any profit-making activities that charge units or individuals should not be sponsored or participated in violation of regulations in the name of the Quality Control Center.

(5) Seals should not be illegally carved, and official documents should not be printed illegally in the name of the Quality Control Center.

(6) All types of certificates or expert appointments should not be issued in violation of regulations in the name of the Quality Control Center.

(7) Medical quality and safety data resources should not be used illegally for research unrelated to quality control work, or for profit-making activities or activities that violate laws and regulations.

Article 31: Members of the expert committee (group), sub-specialty expert group, and related staff of the Quality Control Center should strictly comply with laws, regulations, and relevant regulations on quality control work. They should not organize and participate in profit-making activities in violation of regulations in the name of the expert committee and the Quality Control Center staff, and should not use quality control work to seek personal gains in violation of regulations.

Article 32: Quality Control Centers at all levels should strengthen the daily management and assessment of the expert committee members and staff of the center. If any violations are found, they should be corrected immediately and dealt with according to relevant regulations within the scope of their responsibilities.

Article 33: Health administrative departments at all levels should establish a supervision and management and dynamic adjustment mechanism for the Quality Control Centers at their level, and implement dynamic management and adjustment of the Quality Control Centers.

Article 34: The Provincial Health Commission should establish an annual assessment system for the provincial Quality Control Center; the assessment results are divided into four levels: excellent, good, qualified, and unqualified.

The assessment of Quality Control Centers below the provincial level is managed by the health administrative department at the same level.

Article 35: According to the annual assessment results, the Provincial Health Commission implements dynamic management of the affiliated units of the provincial Quality Control Center in a 4-year management cycle:

(1) For a Quality Control Center that meets any of the following conditions, no adjustments will be made to the affiliated unit:

All four annual assessment results within the management cycle are good or above;

Two annual assessment results within the management cycle are excellent, and there are no unqualified results.

(2) If there are two unqualified annual assessments within the management cycle, the affiliation relationship is immediately dissolved, and a new affiliated unit for the Quality Control Center is re-selected; the original affiliated unit does not participate in this round of selection.

(3) For Quality Control Centers that re-select affiliated units according to this regulation after the affiliation term expires, the original affiliated unit can participate in the selection.

Article 36: If a Quality Control Center is involved in any serious situation stipulated in Article 30 of these regulations, the affiliation relationship is immediately dissolved, and a new affiliated unit for the Quality Control Center is re-selected; the current affiliated unit is excluded from participating in this selection process and is ineligible to apply as the affiliated unit for a newly established Quality Control Center of another specialty for a period of four years.

Article 37: The adjustment cycle for the expert committee (group) and sub-specialty expert group is 4 years. After the affiliation of the Quality Control Center is dissolved, the expert committee (group) and the sub-specialty expert group are dissolved at the same time.

Article 38: If an expert of the expert committee (group) or sub-specialty expert group is involved in any serious situation stipulated in Article 31, or if they do not undertake the work tasks arranged by the Quality Control Center for a long time, they should be removed from the expert committee (group) or sub-specialty expert group in time.

If a staff member of the Quality Control Center is involved in any serious situation stipulated in Article 31, the affiliated unit should handle it according to the law and regulations.

Article 39: The relevant materials for quality control work should be properly preserved by the Quality Control Center, and paper materials should be converted to electronic versions for preservation. When the affiliated unit of the Quality Control Center changes, the original affiliated unit should seal the relevant paper materials and electronic materials of the quality control work. Furthermore, in accordance with the time limit stipulated by the health administrative department, the original affiliated unit must hand over the electronic copy of the materials, quality control management network, information platform, management authority, and quality control data to the new affiliated unit, to ensure the seamless and orderly transition of quality control work in this specialty.

Chapter 4: Supplementary Provisions

Article 40: Health administrative departments at the provincial level and below can formulate management methods for Quality Control Centers within their jurisdiction based on this method and the needs of quality control work in their jurisdiction.

Article 41: This method has been in effect since November 3, 2022. As of the date of implementation of this method, the "Hainan Province Medical Quality Control Management Regulations (Trial)" (Qiongwei Medical [2014] No. 42) is hereby abolished. If the original regulations are inconsistent with this method, this method shall prevail.

Article 42: The Provincial Health Commission assumes the responsibility for interpreting this method.