Administrative Measures for the Diagnosis and Identification of Occupational Diseases
Administrative Measures for the Diagnosis and Identification of Occupational Diseases
Administrative Measures for the Diagnosis and Identification of Occupational Diseases
Order of the National Health Commission of the People's Republic of China No. 6
January 4, 2021
The Administrative Measures for the Diagnosis and Identification of Occupational Diseases, which were adopted upon deliberation at the second commission meeting on December 4, 2020, are hereby promulgated and shall come into effect as of the date of promulgation.
Ma Xiaowei, Director
Administrative Measures for the Diagnosis and Identification of Occupational Diseases
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Law of the People's Republic of China on the Prevention and Control of Occupational Diseases (hereinafter referred to as the "Law on the Prevention and Control of Occupational Diseases) with a view to regulating the diagnosis and identification of occupational diseases and strengthening the management of the diagnosis and identification of occupational diseases.
Article 2 The diagnosis and identification of occupational diseases shall be carried out in accordance with the Law on the Prevention and Control of Occupational Diseases, the relevant provisions hereof, the Classification and Catalog of Occupational Diseases and national standards for the diagnosis of occupational diseases following the principles of scientificity, impartiality, timeliness and convenience.
Article 3 The National Health Commission (“NHC”) shall be responsible for the supervision and administration of the diagnosis and identification of occupational diseases nationwide, and each local competent health department at or above the county level shall, in light of its duties, be responsible for the supervision and administration of the diagnosis and identification of occupational diseases within its administrative region.
The competent health department of each province, autonomous region or municipality directly under the Central Government (hereinafter referred to as "provincial-level competent health department") shall, in light of the actuality of the prevention and control of occupational diseases and the planning for the medical and health service system within its administrative region, make full use of existing medical and health resources to achieve regional coverage of occupational disease diagnosis institutions.
Article 4 All localities shall strengthen the capacity building of occupational disease diagnosis institutions, provide necessary guarantee conditions and staff with relevant personnel, ensure the provision of devices and provide work funds, so as to meet the needs for the diagnosis of occupational diseases.
Article 5 All localities shall strengthen the information construction for the diagnosis and identification of occupational diseases, establish a sound information system for the whole-process exposure of employees to occupational disease hazards, occupational health examinations as well as diagnosis and identification of occupational diseases, etc., and continuously improve the accuracy, timeliness and effectiveness of information reports on the diagnosis and identification of occupational diseases.
Article 6 Each employer shall legally perform relevant obligations in the diagnosis and identification of occupational diseases as follows:
1. promptly arrange for occupational disease patients and suspected occupational disease patients to undergo diagnosis and treatment;
2. faithfully provide materials required for the diagnosis and identification of occupational diseases;
3. bear the expense for the diagnosis and identification of occupational diseases and that incurred by suspected occupational disease patients during the period of diagnosis and medical observation;
4. report occupational diseases and suspected occupational diseases; and
5. other relevant obligations as prescribed in the Law on the Prevention and Control of Occupational Diseases.
Chapter II Diagnosis Institutions
Article 7 A medical and health institution shall, within 15 working days from the date of making an occupational disease diagnosis, file a record with the provincial-level competent health department.
The provincial-level competent health department shall, within 15 working days from the date of receipt of complete record-filing materials, announce relevant information such as the list of filed medical and health institutions, addresses and diagnosis items (i.e., categories and types of occupational diseases specified in the Classification and Catalog of Occupational Diseases).
Article 8 A medical and health institution shall meet the following conditions when carrying out diagnosis of occupational diseases:
1. it holds a Medical Institution Practice License;
2. it has corresponding diagnosis and treatment subjects as well as occupational disease diagnosticians and relevant medical and health technicians commensurate with its filed diagnosis items;
3. it has premises, instruments and devices commensurate with its filed diagnosis items; and
4. it has a sound quality management system for the diagnosis of occupational diseases.
Article 9 A medical and health institution when filing a record of occupational disease diagnosis shall submit the following relevant materials to prove that it meets the conditions prescribed in Article 8 hereof:
1. original, duplicate and photocopy of its Medical Institution Practice License;
2. relevant materials including occupational disease diagnostician qualification;
3. list of relevant instruments and devices;
4. list of occupational disease information reporting personnel; and
5. relevant materials including its quality management system for the diagnosis of occupational diseases.
Article 10 Each occupational disease diagnosis institution shall be responsible for the authenticity, accuracy and legality of its record-filing information.
In the case of change to any record-filing information, the post-change information shall be submitted to the provincial-level competent health department within ten working days from the date of change therein.
Article 11 Where there is no medical and health institution carrying out the diagnosis of occupational diseases upon record-filing in a city with subordinate districts, the provincial-level competent health department shall, in light of the needs for diagnosis of occupational diseases, designate a medical and health institution that meets the conditions prescribed in Article 8 hereof to undertake the diagnosis of occupational diseases.
Article 12 The duties of an occupational disease diagnosis institution shall include:
1. carrying out the diagnosis of occupational diseases within the scope of its filed diagnosis items;
2. promptly reporting occupational diseases to the local competent health department;
3. reporting information on its diagnosis of occupational diseases as required by the competent health department; and
4. undertaking other duties as prescribed in the Law on the Prevention and Control of Occupational Diseases.
Article 13 Each occupational disease diagnosis institution shall legally and independently exercise its diagnosis competence and be responsible for the occupational disease diagnosis conclusions made by it.
Article 14 Each occupational disease diagnosis institution shall establish and improve a management system for the diagnosis of occupational diseases, strengthen training on technologies, policies and laws for relevant medical and health personnel including occupational disease diagnosticians, and take measures to improve the work conditions for the diagnosis of occupational diseases as well as elevate the service quality and level thereof.
Article 15 Each occupational disease diagnosis institution shall make public its procedures for the diagnosis of occupational diseases and scope of diagnosis items, thus facilitating the diagnosis of occupational diseases for employees.
Each occupational disease diagnosis institution along with its relevant work personnel shall respect, care for, and have concern for its employees and protect their privacy.
Article 16 A physician engaging in the diagnosis of occupational diseases shall meet the following conditions and obtain an occupational disease diagnosis qualification certificate issued by the provincial-level competent health department:
1. it has a physician practice certificate;
2. it has an intermediate or above qualification for holding health-related professional and technical posts;
3. it is familiar with laws and regulations on the prevention and control of occupational diseases and standards for the diagnosis of occupational diseases;
4. it has at least three years of working experience in the diagnosis and identification of occupational diseases; and
5. it has participated in corresponding professional training for occupational disease diagnosticians as required and passed the examination.
Each provincial-level competent health department shall, in accordance with the provisions hereof and the training outline for occupational disease diagnosticians formulated by the NHC, formulate and organize the implementation of training and examination measures for occupational disease diagnosticians within its administrative region.
Article 17 Each occupational disease diagnostician shall legally engage in the diagnosis of occupational diseases within the scope of diagnosis items filed by the relevant occupational disease diagnosis institution without going beyond the scope of its occupational disease diagnosis qualification; and it shall, in accordance with relevant provisions, participate in continuing medical education in such fields as occupational health, radiological health and occupational medicine.
Article 18 Each provincial-level competent health department shall strengthen the quality control and management of the occupational disease diagnosis institutions within its administrative region, and organize and conduct quality control assessment of occupational disease diagnosis institutions.
Occupational disease diagnosis quality control specifications and occupational disease reporting specifications for medical and health institutions shall be formulated separately.
Chapter III Diagnosis
Article 19 An employee may accept occupational disease diagnosis at an occupational disease diagnosis institution at the place where its employer is located, its household is registered, or it habitually resides.
Article 20 Diagnosis of occupational diseases shall be subject to comprehensive analysis in accordance with the Law on the Prevention and Control of Occupational Diseases, the relevant provisions hereof and the Classification and Catalog of Occupational Diseases as well as national standards for the diagnosis of occupational diseases, and in light of such information as each employee's employment history, history of exposure to occupational disease hazards, occupational disease hazard factors at the workplace as well as clinical picture and auxiliary examination result. An occupational disease diagnosis institution shall, in the case of complete materials, make a diagnosis conclusion within 30 days from the date of receipt of such complete materials.
Where there is no evidence denying the inevitable connection between occupational disease hazard factors and a patient's clinical picture, it shall be diagnosed as an occupational disease.
Article 21 Diagnosis of occupational diseases requires the following materials:
1. employee's employment history and history of exposure to occupational disease hazards (including on-duty duration, type of work, post, name of occupational disease hazard factors exposed to);
2. employee's occupational health examination result;
3. testing result of occupational disease hazard factors at the workplace; and
4. diagnosis of occupational radioactive diseases further requires individual dose monitoring files.
Article 22 Where an employee legally requires occupational disease diagnosis, no occupational disease diagnosis institution may refuse such requirement for occupational disease diagnosis, and the employee shall be informed of the procedures and materials required therefor, then fill out the Registration Form for Occupational Disease Diagnosis and provide relevant occupational disease diagnosis materials at its disposal.
Article 23 Each occupational disease diagnosis institution shall, when conducting occupational disease diagnosis, notify the employer to which the relevant employee belongs in writing to provide the occupational disease diagnosis materials as prescribed in Article 21 hereof, and the employer shall faithfully provide such materials within ten days of receipt of the notice.
Article 24 Where an employer fails to provide the required occupational disease diagnosis materials within the prescribed period of time, the relevant occupational disease diagnosis institution may legally request the competent health department to urge the employer to do so.
Article 25 Where an employee has any objection to such materials as the testing result of occupational disease hazard factors at the workplace provided by its employer, or its employer is dissolved or goes bankrupt, and no employer provides the above-mentioned materials, the relevant occupational disease diagnosis institution shall legally request the competent health department at the place where the employer is located to conduct an investigation.
The competent health department shall, within 30 days from the date of receipt of such application, make a determination of the materials subject to objection or the occupational disease hazard factors at the workplace.
The occupational disease diagnosis institution shall suspend occupational disease diagnosis before the competent health department makes an investigation conclusion or determination.
Article 26 Each occupational disease diagnosis institution may, where it is necessary to know the occupational disease hazard factors at the workplace, conduct a field investigation of the workplace or legally request the competent health department to organize a field investigation. The competent health department shall complete the field investigation within 30 days of the date of receipt of such an application.
Article 27 When determining an employee's employment history and history of exposure to occupational disease hazards, if a party concerned has any dispute over the labor relationship, type of work, post or on-duty duration, the relevant occupational disease diagnosis institution shall inform the party concerned to legally file an application for arbitration with the labor and personnel dispute arbitration commission at the place where the employer is located.
Article 28 Where, after being urged by the competent health department, an employer still fails to provide such materials as the testing result of occupational disease hazard factors at the workplace and occupational health monitoring files or provides incomplete materials, the relevant occupational disease diagnosis institution shall make an occupational disease diagnosis conclusion in light of the employee's clinical picture, auxiliary examination result, employment history, history of exposure to occupational disease hazards, and with reference to the employee's self-statements or its workmates' circumstantial evidentiary materials, as well as routine supervision and inspection information provided by relevant departments of health, etc.
......
Order of the National Health Commission of the People's Republic of China No. 6
January 4, 2021
The Administrative Measures for the Diagnosis and Identification of Occupational Diseases, which were adopted upon deliberation at the second commission meeting on December 4, 2020, are hereby promulgated and shall come into effect as of the date of promulgation.
Ma Xiaowei, Director
Administrative Measures for the Diagnosis and Identification of Occupational Diseases
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Law of the People's Republic of China on the Prevention and Control of Occupational Diseases (hereinafter referred to as the "Law on the Prevention and Control of Occupational Diseases) with a view to regulating the diagnosis and identification of occupational diseases and strengthening the management of the diagnosis and identification of occupational diseases.
Article 2 The diagnosis and identification of occupational diseases shall be carried out in accordance with the Law on the Prevention and Control of Occupational Diseases, the relevant provisions hereof, the Classification and Catalog of Occupational Diseases and national standards for the diagnosis of occupational diseases following the principles of scientificity, impartiality, timeliness and convenience.
Article 3 The National Health Commission (“NHC”) shall be responsible for the supervision and administration of the diagnosis and identification of occupational diseases nationwide, and each local competent health department at or above the county level shall, in light of its duties, be responsible for the supervision and administration of the diagnosis and identification of occupational diseases within its administrative region.
The competent health department of each province, autonomous region or municipality directly under the Central Government (hereinafter referred to as "provincial-level competent health department") shall, in light of the actuality of the prevention and control of occupational diseases and the planning for the medical and health service system within its administrative region, make full use of existing medical and health resources to achieve regional coverage of occupational disease diagnosis institutions.
Article 4 All localities shall strengthen the capacity building of occupational disease diagnosis institutions, provide necessary guarantee conditions and staff with relevant personnel, ensure the provision of devices and provide work funds, so as to meet the needs for the diagnosis of occupational diseases.
Article 5 All localities shall strengthen the information construction for the diagnosis and identification of occupational diseases, establish a sound information system for the whole-process exposure of employees to occupational disease hazards, occupational health examinations as well as diagnosis and identification of occupational diseases, etc., and continuously improve the accuracy, timeliness and effectiveness of information reports on the diagnosis and identification of occupational diseases.
Article 6 Each employer shall legally perform relevant obligations in the diagnosis and identification of occupational diseases as follows:
1. promptly arrange for occupational disease patients and suspected occupational disease patients to undergo diagnosis and treatment;
2. faithfully provide materials required for the diagnosis and identification of occupational diseases;
3. bear the expense for the diagnosis and identification of occupational diseases and that incurred by suspected occupational disease patients during the period of diagnosis and medical observation;
4. report occupational diseases and suspected occupational diseases; and
5. other relevant obligations as prescribed in the Law on the Prevention and Control of Occupational Diseases.
Chapter II Diagnosis Institutions
Article 7 A medical and health institution shall, within 15 working days from the date of making an occupational disease diagnosis, file a record with the provincial-level competent health department.
The provincial-level competent health department shall, within 15 working days from the date of receipt of complete record-filing materials, announce relevant information such as the list of filed medical and health institutions, addresses and diagnosis items (i.e., categories and types of occupational diseases specified in the Classification and Catalog of Occupational Diseases).
Article 8 A medical and health institution shall meet the following conditions when carrying out diagnosis of occupational diseases:
1. it holds a Medical Institution Practice License;
2. it has corresponding diagnosis and treatment subjects as well as occupational disease diagnosticians and relevant medical and health technicians commensurate with its filed diagnosis items;
3. it has premises, instruments and devices commensurate with its filed diagnosis items; and
4. it has a sound quality management system for the diagnosis of occupational diseases.
Article 9 A medical and health institution when filing a record of occupational disease diagnosis shall submit the following relevant materials to prove that it meets the conditions prescribed in Article 8 hereof:
1. original, duplicate and photocopy of its Medical Institution Practice License;
2. relevant materials including occupational disease diagnostician qualification;
3. list of relevant instruments and devices;
4. list of occupational disease information reporting personnel; and
5. relevant materials including its quality management system for the diagnosis of occupational diseases.
Article 10 Each occupational disease diagnosis institution shall be responsible for the authenticity, accuracy and legality of its record-filing information.
In the case of change to any record-filing information, the post-change information shall be submitted to the provincial-level competent health department within ten working days from the date of change therein.
Article 11 Where there is no medical and health institution carrying out the diagnosis of occupational diseases upon record-filing in a city with subordinate districts, the provincial-level competent health department shall, in light of the needs for diagnosis of occupational diseases, designate a medical and health institution that meets the conditions prescribed in Article 8 hereof to undertake the diagnosis of occupational diseases.
Article 12 The duties of an occupational disease diagnosis institution shall include:
1. carrying out the diagnosis of occupational diseases within the scope of its filed diagnosis items;
2. promptly reporting occupational diseases to the local competent health department;
3. reporting information on its diagnosis of occupational diseases as required by the competent health department; and
4. undertaking other duties as prescribed in the Law on the Prevention and Control of Occupational Diseases.
Article 13 Each occupational disease diagnosis institution shall legally and independently exercise its diagnosis competence and be responsible for the occupational disease diagnosis conclusions made by it.
Article 14 Each occupational disease diagnosis institution shall establish and improve a management system for the diagnosis of occupational diseases, strengthen training on technologies, policies and laws for relevant medical and health personnel including occupational disease diagnosticians, and take measures to improve the work conditions for the diagnosis of occupational diseases as well as elevate the service quality and level thereof.
Article 15 Each occupational disease diagnosis institution shall make public its procedures for the diagnosis of occupational diseases and scope of diagnosis items, thus facilitating the diagnosis of occupational diseases for employees.
Each occupational disease diagnosis institution along with its relevant work personnel shall respect, care for, and have concern for its employees and protect their privacy.
Article 16 A physician engaging in the diagnosis of occupational diseases shall meet the following conditions and obtain an occupational disease diagnosis qualification certificate issued by the provincial-level competent health department:
1. it has a physician practice certificate;
2. it has an intermediate or above qualification for holding health-related professional and technical posts;
3. it is familiar with laws and regulations on the prevention and control of occupational diseases and standards for the diagnosis of occupational diseases;
4. it has at least three years of working experience in the diagnosis and identification of occupational diseases; and
5. it has participated in corresponding professional training for occupational disease diagnosticians as required and passed the examination.
Each provincial-level competent health department shall, in accordance with the provisions hereof and the training outline for occupational disease diagnosticians formulated by the NHC, formulate and organize the implementation of training and examination measures for occupational disease diagnosticians within its administrative region.
Article 17 Each occupational disease diagnostician shall legally engage in the diagnosis of occupational diseases within the scope of diagnosis items filed by the relevant occupational disease diagnosis institution without going beyond the scope of its occupational disease diagnosis qualification; and it shall, in accordance with relevant provisions, participate in continuing medical education in such fields as occupational health, radiological health and occupational medicine.
Article 18 Each provincial-level competent health department shall strengthen the quality control and management of the occupational disease diagnosis institutions within its administrative region, and organize and conduct quality control assessment of occupational disease diagnosis institutions.
Occupational disease diagnosis quality control specifications and occupational disease reporting specifications for medical and health institutions shall be formulated separately.
Chapter III Diagnosis
Article 19 An employee may accept occupational disease diagnosis at an occupational disease diagnosis institution at the place where its employer is located, its household is registered, or it habitually resides.
Article 20 Diagnosis of occupational diseases shall be subject to comprehensive analysis in accordance with the Law on the Prevention and Control of Occupational Diseases, the relevant provisions hereof and the Classification and Catalog of Occupational Diseases as well as national standards for the diagnosis of occupational diseases, and in light of such information as each employee's employment history, history of exposure to occupational disease hazards, occupational disease hazard factors at the workplace as well as clinical picture and auxiliary examination result. An occupational disease diagnosis institution shall, in the case of complete materials, make a diagnosis conclusion within 30 days from the date of receipt of such complete materials.
Where there is no evidence denying the inevitable connection between occupational disease hazard factors and a patient's clinical picture, it shall be diagnosed as an occupational disease.
Article 21 Diagnosis of occupational diseases requires the following materials:
1. employee's employment history and history of exposure to occupational disease hazards (including on-duty duration, type of work, post, name of occupational disease hazard factors exposed to);
2. employee's occupational health examination result;
3. testing result of occupational disease hazard factors at the workplace; and
4. diagnosis of occupational radioactive diseases further requires individual dose monitoring files.
Article 22 Where an employee legally requires occupational disease diagnosis, no occupational disease diagnosis institution may refuse such requirement for occupational disease diagnosis, and the employee shall be informed of the procedures and materials required therefor, then fill out the Registration Form for Occupational Disease Diagnosis and provide relevant occupational disease diagnosis materials at its disposal.
Article 23 Each occupational disease diagnosis institution shall, when conducting occupational disease diagnosis, notify the employer to which the relevant employee belongs in writing to provide the occupational disease diagnosis materials as prescribed in Article 21 hereof, and the employer shall faithfully provide such materials within ten days of receipt of the notice.
Article 24 Where an employer fails to provide the required occupational disease diagnosis materials within the prescribed period of time, the relevant occupational disease diagnosis institution may legally request the competent health department to urge the employer to do so.
Article 25 Where an employee has any objection to such materials as the testing result of occupational disease hazard factors at the workplace provided by its employer, or its employer is dissolved or goes bankrupt, and no employer provides the above-mentioned materials, the relevant occupational disease diagnosis institution shall legally request the competent health department at the place where the employer is located to conduct an investigation.
The competent health department shall, within 30 days from the date of receipt of such application, make a determination of the materials subject to objection or the occupational disease hazard factors at the workplace.
The occupational disease diagnosis institution shall suspend occupational disease diagnosis before the competent health department makes an investigation conclusion or determination.
Article 26 Each occupational disease diagnosis institution may, where it is necessary to know the occupational disease hazard factors at the workplace, conduct a field investigation of the workplace or legally request the competent health department to organize a field investigation. The competent health department shall complete the field investigation within 30 days of the date of receipt of such an application.
Article 27 When determining an employee's employment history and history of exposure to occupational disease hazards, if a party concerned has any dispute over the labor relationship, type of work, post or on-duty duration, the relevant occupational disease diagnosis institution shall inform the party concerned to legally file an application for arbitration with the labor and personnel dispute arbitration commission at the place where the employer is located.
Article 28 Where, after being urged by the competent health department, an employer still fails to provide such materials as the testing result of occupational disease hazard factors at the workplace and occupational health monitoring files or provides incomplete materials, the relevant occupational disease diagnosis institution shall make an occupational disease diagnosis conclusion in light of the employee's clinical picture, auxiliary examination result, employment history, history of exposure to occupational disease hazards, and with reference to the employee's self-statements or its workmates' circumstantial evidentiary materials, as well as routine supervision and inspection information provided by relevant departments of health, etc.
......