Occupational disease diagnosis and appraisal management measures

Occupational Disease Diagnosis and Appraisal Management Measures

Text No.: Ministry of Health Order No. 91
Promulgation Department: Ministry of Health of the People's Republic of China
Legal Effect: Department Regulations
Promulgated: February 19, 2013
Effective Date: April 10, 2013

The "Administrative Measures for the Diagnosis and Identification of Occupational Diseases" was reviewed and approved by the Ministry of Health at the ministerial meeting on January 9, 2013. It is hereby promulgated and will come into effect on April 10, 2013.

Minister: Chen Hao
February 19, 2013

Occupational Disease Diagnosis and Appraisal Management Measures

Chapter 1 General Provisions

Article 1 These measures are formulated in accordance with the Law of the People’s Republic of China on Occupational Disease Prevention and Control (hereinafter referred to as the “Prevention and Treatment of Occupational Diseases”) in order to standardize the diagnosis and identification of occupational diseases and strengthen the management of occupational disease diagnosis and appraisal.

Article 2 The diagnosis and appraisal of occupational diseases shall be conducted in accordance with the Occupational Disease Prevention Law and the relevant provisions of these Measures and the national diagnostic standards for occupational diseases, and follow the principles of science, fairness, timeliness and convenience.

Article 3 The establishment of an occupational disease diagnostic institution must be adapted to the actual needs of occupational disease prevention and control work, make full use of existing medical and health resources, and achieve regional coverage.

Article 4 Localities shall strengthen the capacity building of diagnostic institutions for occupational diseases, provide necessary guarantee conditions, and allocate relevant personnel, equipment and work funds to meet the needs of occupational disease diagnosis.

Chapter II Diagnostic Agency

Article 5 The health administration departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government (hereinafter referred to as the provincial health administrative departments) shall formulate plans for the establishment of diagnostic institutions for occupational diseases in conjunction with the prevention and treatment of occupational diseases in this administrative area and submit them to the provincial people’s government for approval.

Article 6 Occupational disease diagnostic institutions shall meet the following conditions:

(1) They hold a "Practice Permit for Medical Institutions";
(2) Relevant medical and health technicians who have the corresponding diagnosis and treatment subjects and occupational disease diagnosis doctors suitable for the diagnosis of occupational diseases;
(3) Having places and instruments and equipment compatible with the diagnosis of occupational diseases;
(D) Have a sound occupational disease diagnosis and quality management system.

Article 7 Medical institutions applying for the diagnosis of occupational diseases shall submit the following information to the provincial health administrative department:

(1) Application Form for Occupational Disease Diagnosis Agency;
(2) A photocopy of the "Medical Institution License for Practice" and a copy;
(3) The diagnosis and treatment subjects and related materials related to the occupational disease diagnosis project applied for;
(4) The occupational disease diagnosis doctors and other relevant medical and health technicians who are suitable for the application project;
(5) The list of places and equipment and equipment that are suitable for the application project;
(6) The relevant information of the occupational disease diagnosis quality management system;
(7) Other materials submitted by the provincial health administrative department.

Article 8 After the provincial health administrative department receives the application materials, it shall make a decision on whether to accept it within five working days. If the application is not accepted, it shall explain the reasons and notify the applicant in writing. If the decision is accepted, the provincial health administrative department shall promptly organize an expert group to conduct the technical review. The expert group shall complete and submit the technical review report within 60 days from the date of acceptance of the application by the health administrative department, and shall be responsible for the submitted technical review report.

Article 9 The provincial health administrative department shall make a decision on whether or not to approve within 20 working days from the date of receipt of the technical evaluation report. Approved application units shall be issued with approval certificates for occupational disease diagnostic institutions; those that do not approve shall state the reasons and notify the applicant in writing. The occupational disease diagnosis agency approval certificate is valid for five years.

Article 10 Where an occupational disease diagnosis institution needs to extend the validity period of an approval certificate for an occupational disease diagnosis institution obtained according to law, it shall apply for continuation from the original approval organ 30 days before the expiry date of the validity period of the approval certificate. If the original approval authority has passed the examination, the approval certificate shall be extended.

Article 11 A public medical and health institution that complies with the provisions of Article 6 of these Measures may apply for occupational disease diagnosis. Where a city in a district is not covered by a medical and health institution to apply for the diagnosis of occupational diseases, the provincial health administrative department shall designate a public medical and health institution to undertake the occupational disease diagnosis according to the needs of occupational disease diagnosis work, and bring it within the prescribed time limit to reach Article 6 of the present Measures. The prescribed conditions.

Article 12 The duties of an occupational disease diagnosis agency are:

(1) Carry out occupational disease diagnosis within the scope of the approved occupational disease diagnosis project;
(b) Reporting occupational diseases;
(3) Reporting occupational disease diagnosis work;
(4) To assume other duties as stipulated in the Law on the Prevention and Treatment of Occupational Diseases.

Article 13: Occupational disease diagnostic agencies shall independently exercise diagnostic rights in accordance with the law and shall be responsible for the diagnosis of occupational diseases made by them.

Article 14 The occupational disease diagnostic institution shall establish and improve the occupational disease diagnosis and management system, strengthen the technical training of the medical and health personnel and the policies and legal training for occupational disease diagnosis physicians, and take measures to improve the occupational disease diagnosis working conditions and improve the quality and level of occupational disease diagnosis services.

Article 15 The occupational disease diagnostic institution shall disclose the diagnostic procedures for occupational diseases so as to facilitate laborers to diagnose occupational diseases. Occupational disease diagnosis agencies and their related staff should respect, care for, and care for workers, and protect the privacy of workers.

Article 16 A physician engaged in the diagnosis of occupational diseases shall meet the following requirements and obtain the occupational disease diagnostic qualification certificate issued by the provincial health administrative department:

(I) Have a certificate of practicing physician;
(2) Qualifications for professional qualifications in health professional titles above intermediate level;
(C) Familiar with occupational disease prevention laws and regulations and occupational disease diagnostic standards;
(4) Engaging in the diagnosis and identification of occupational diseases for more than three years;
(5) Participate in occupational disease diagnosis doctors' corresponding professional training according to regulations and pass the assessment.

Article 17 Occupational disease diagnosis doctors shall perform occupational disease diagnosis within the scope of their qualifications and shall not engage in occupational disease diagnosis beyond their qualifications.

Article 18 The provincial health administrative department shall publish to the society the relevant information of the list of occupational disease diagnosis institutions, addresses, and diagnostic items in the administrative area.

Chapter 3 Diagnosis

Article 19 The laborer may choose to use an occupational disease diagnostic institution where the employer is located, where he is registered, or where he is often residing to conduct occupational disease diagnosis.

Article 20 Occupational disease diagnosis agencies shall, in accordance with the Occupational Disease Prevention Law and the relevant provisions of these Measures and the national occupational disease diagnostic standards, be based on the occupational history of workers, occupational hazard exposure history, occupational hazards in the workplace, clinical manifestations, and auxiliary examinations. The results, etc., were analyzed comprehensively and diagnostic conclusions were made.

Article 21 The diagnosis of occupational diseases requires the following information:

(1) Occupational history of occupational workers and exposure to occupational hazards (including names of occupational hazards at the time of occupation, type of work, post, and exposure);
(b) the results of occupational health inspections of workers;
(3) Test results of occupational hazards in the workplace;
(4) The diagnosis of occupational radiological diseases also requires personal dose monitoring files and other information;
(v) Other information related to the diagnosis.

Article 22 Where a laborer requires the diagnosis of an occupational disease in accordance with law, the occupational disease diagnostic institution shall make an appointment and inform the laborer of the occupational disease diagnosis procedures and necessary materials. The laborer shall fill out the Registration Form for the Diagnosis of Occupational Diseases and submit the occupational disease diagnostic data as stipulated in Article 21 of these Measures.

Article 23 When confirming the occupational history of workers and the exposure to occupational hazards, if the parties concerned dispute the labor relations, type of work, job position or time of occupation, the occupational disease diagnostic institution shall inform the parties concerned to arbitrate according to law to the labor personnel dispute in the place where the employing unit is located. The committee applies for arbitration.

Article 24 When an occupational disease diagnostic institution conducts an occupational disease diagnosis, it shall notify the employer of the laborer in writing to provide the occupational disease diagnostic data as stipulated in Article 21 of the present Measures and the employer shall receive it within 10 days after receiving the notification. Truthfully provided.

Article 25 If an employing unit fails to provide the information required for the diagnosis of occupational diseases within the prescribed time, the occupational disease diagnostic institution may, in accordance with law, request the production safety supervision and administration department to urge the employing unit to provide such information.

Article 26 The laborer has objections to the information on the detection results of occupational hazards in the workplace provided by the employing unit, or because the employing unit of the laborer is disbanded or bankrupted. If the employer fails to provide the above-mentioned information, the occupational disease diagnostic institution shall ask the employing person according to law. The safety production supervision and management department of the place where the unit is located investigates. The occupational disease diagnostic institution shall suspend the diagnosis of occupational diseases before the safety production supervision and management department makes investigation findings or judgments.

Article 27 When an occupational disease diagnosis institution needs to understand the occupational disease hazard factors in the workplace, it may conduct on-site investigation of the workplace, and may also ask the production safety supervision and management department to organize an on-site investigation according to law.

Article 28 The occupational disease diagnostic institution shall combine the clinical manifestations and assistance of the laborers if the employer fails to provide inspection results of occupational hazards in the workplace or occupational health monitoring files or provides incomplete information, as supervised by the production safety supervision and management department. The results of the inspection and occupational history of workers, exposure to occupational hazards, and occupational disease diagnosis conclusions were made with reference to the daily supervision and inspection information provided by the laborers' self-reporters and safety production supervision and management departments. If it is still unable to make an occupational disease diagnosis, relevant medical opinions or suggestions should be put forward.

Article 29: In the diagnosis of occupational diseases, an occupational disease diagnostic institution shall organize three or more occupational disease diagnosticians to conduct a collective diagnosis. Occupational disease diagnosis physicians shall independently analyze, judge, and submit diagnostic opinions, and no unit or individual has the right to intervene.

Article 30 When an occupational disease diagnostic institution diagnoses an occupational disease and the diagnosing physician has disagreement with the diagnosis conclusion, a diagnostic conclusion shall be formed based on the unanimous opinions of more than half of the diagnosticians. Different opinions shall be recorded truthfully. Occupational disease diagnosis physicians who participate in the diagnosis may not abstain from voting.

Article 31: Occupational disease diagnosis agencies may hire other organizations' occupational disease diagnosticians to participate in the diagnosis according to the need for diagnosis. When necessary, relevant professional experts can be invited to provide advice.

Article 32 After an occupational disease diagnostic institution makes an occupational disease diagnosis conclusion, it shall issue a certificate of occupational disease diagnosis. The occupational disease diagnosis certificate should include the following:

(1) Basic information of laborers and employers;
(b) The diagnosis. Those diagnosed with occupational diseases shall specify the name, degree (period) and treatment opinions of occupational diseases;
(c) diagnosis time. The certificate of occupational disease diagnosis shall be signed by the physicians participating in the diagnosis and shall be audited by the occupational disease diagnostic agency. The occupational disease diagnosis certificate is made in triplicate, one for the laborer and employer, and one for the diagnostic institution. The format of the occupational disease diagnosis certificate is regulated by the Ministry of Health.

Article 33 The occupational disease diagnostic institution shall establish a diagnostic file for occupational diseases and keep it permanently. The archives shall include:

(a) Occupational disease diagnosis certificate;
(B) Occupational disease diagnosis process records, including the personnel participating in the diagnosis, time, location, discussion content and diagnostic conclusions;
(3) relevant information submitted by employing units, laborers and related departments and agencies;
(d) clinical inspections and laboratory tests and other data;
(v) Other information related to the diagnosis.

Article 34 When an occupational disease diagnostic institution finds an occupational disease patient or suspected occupational disease patient, it shall promptly report it to the local administrative department of health and the production safety supervision and management department. If it is diagnosed as an occupational disease, the occupational disease diagnostic institution may, if necessary, make professional suggestions to relevant supervisory departments and employers.

Article 35 A medical and health institution that has not obtained the qualification for diagnosis of occupational disease shall inform the worker in time for diagnosis of occupational diseases at the occupational disease diagnostic institution if he suspects that the health damage of the worker may be related to the occupation he is engaged in.

Chapter 4 Identification

Article 36 If the parties object to the diagnosis of occupational diseases made by the occupational disease diagnostic institution, they may, within 30 days from the date of receipt of the occupational disease diagnosis certificate, apply for appraisal to the municipal health administrative department in which the occupational disease diagnostic institution is located. The municipal occupational disease diagnosis and appraisal committee is responsible for the first identification of occupational disease diagnostic disputes. If the parties are not satisfied with the municipal-level occupational disease appraisal conclusions, they may apply for re-appraisal to the provincial health administrative department where the original appraisal organization was located within fifteen days from the date of receiving the appraisal. The occupational disease appraisal adopts a two-level appraisal system, and the provincial occupational disease appraisal conclusion is final appraisal.

Article 37 The administrative department of public health may designate offices to specifically undertake the organization and routine work of occupational disease appraisals. The duties of an occupational disease appraisal office are:

(a) Accept the application of the parties;
(2) Organizing the parties or accepting the entrustment of the parties to extract experts for the identification of occupational diseases;
(3) Organizing an occupational disease appraisal meeting to be responsible for the receipt and dispatch of other documents related to meeting records and occupational disease appraisal and other transactional work;
(4) Establish and manage occupational disease appraisal files;
(5) Undertaking other work concerning the identification of occupational diseases entrusted by the administrative department of health. The occupational disease diagnosis institution cannot serve as an occupational disease appraisal agency.

Article 38 The local health administrative department at or above the municipal level in a district shall publicize to the society the names, working hours, locations, and appraisal procedures of the administrative organs that undertake the occupational disease appraisal according to law in the administrative area.

Article 39 The provincial health administrative department shall set up an expert database for the identification of occupational diseases (hereinafter referred to as the expert database), and adjust its members in a timely manner in accordance with actual work needs. Expert libraries can be grouped by professional category.

Article 40 Expert databases shall be made up of physicians who have acquired qualifications for diagnosis of various occupational diseases as key members, and shall be composed of experts in related disciplines such as clinical related disciplines, occupational health, and radiation hygiene. Experts should meet the following conditions:

(1) Having good professional quality and professional ethics;
(2) Qualifications for senior professional and technical positions with relevant specialties;
(C) Familiar with occupational disease prevention laws and regulations and occupational disease diagnostic standards;
(D) Physical health, capable of qualifying for occupational disease appraisal.

Article 41 Experts who have participated in occupational disease appraisal shall be determined by random selection from the expert database of the occupational disease appraisal office entrusted by the party applying for appraisal or the client. The selected experts form an expert group for occupational disease identification (hereinafter referred to as the expert group). With the consent of the parties concerned, an occupational disease appraisal office may engage relevant professional experts outside the province, autonomous region, and municipality directly under the Central Government as members of the expert group and have the right to vote.

Article 42 The number of expert groups shall be an odd number of five or more, in which the diagnosis doctors of relevant professional occupational diseases shall be more than half of the number of experts. Difficult cases should increase the number of expert groups and fully listen to opinions. The expert group has one leader and is elected by members of the expert group. The occupational disease appraisal meeting was chaired by the head of the expert group.

Article 43 If an expert who is involved in occupational disease appraisal has one of the following circumstances, he shall evade:

(1) Being a party to an occupational disease appraisal or a close relative of the party;
(2) Having participated in the diagnosis of the occupational disease or the first identification of the party;
(3) Having an interest in the identification of the parties involved in occupational diseases;
(4) Having other relationships with the parties involved in the identification of occupational diseases may affect the impartiality of the assessment.

Article 44 When applying for occupational disease appraisal, the parties shall provide the following information:

(1) Application for occupational disease appraisal;
(B) occupational disease diagnosis certificate, apply for provincial appraisal should also submit municipal occupational disease appraisal;
(3) Other relevant information requested by the health administrative department.

Article 45 The occupational disease appraisal office shall complete the examination of the data within five working days from the date of receipt of the application materials, and issue a notice of acceptance of the complete data; if the information is incomplete, it shall notify the parties in writing to supplement it. If the information is complete, it shall accept the application and organize the appraisal. After an occupational disease appraisal office receives an application for the identification of a party, it may, if necessary, read the relevant diagnostic and appraisal materials from the original occupational disease diagnostic institution or the first occupational disease appraisal office. The original occupational disease diagnostic institution or the first occupational disease appraisal administrative office shall submit the notification within 15 days from the date of receiving the notification. The occupational disease appraisal office shall organize the appraisal and form an appraisal conclusion within 60 days from the date of acceptance of the appraisal application, and issue an occupational disease appraisal statement within 15 days after the conclusion of the appraisal conclusion.

Article 46 According to the needs of occupational disease appraisal, the occupational disease appraisal office may obtain relevant information related to the diagnosis and appraisal of occupational diseases from relevant units, and relevant units shall provide truthful and timely information. The panel should listen to the parties’ statements and defenses and organize medical examinations if necessary. When it is necessary to understand the occupational hazard factors in the workplace of the appraiser, the occupational disease appraisal office may conduct on-the-spot investigation of the workplace according to the opinions of the expert group, or submit it to the production safety supervision and management department to organize on-site investigation according to law. Where it is legally requested to organize an on-site investigation by the production safety supervision and management department, the occupational disease appraisal shall be suspended before the site investigation conclusion or judgment is made. Occupational disease appraisal should follow the principle of objectiveness and impartiality. When an expert group conducts occupational disease appraisal, it may invite relevant unit personnel to attend the occupational disease appraisal meeting. All personnel involved in the identification of occupational diseases shall protect the personal privacy of the authenticated according to law.

Article 47 The expert group shall carefully review the appraisal materials, and in accordance with the relevant regulations and diagnostic criteria for occupational diseases, after thorough deliberation, conduct independent appraisal according to professional knowledge. On the basis of clear facts, conduct comprehensive analysis, make appraisal conclusions, and produce appraisal. The conclusion of the appraisal should be passed by more than two-thirds of the members of the expert group.

Article 48 The occupational disease appraisal book shall include the following contents:

(1) Basic information and identification of laborers and employers;
(2) The conclusions of the appraisal and its basis. If it is an occupational disease, it shall indicate the name and degree of the occupational disease (period);
(c) identification time. The appraisal book is stamped with the seal of the occupational disease diagnosis and appraisal committee. The first identification of occupational disease identification documents in quadruplicate, laborers, employers, the original diagnosis of a body, occupational disease appraisal offices archived; re-identification of occupational disease identification in five copies, laborers, employers, the original diagnostic agency The first occupational disease appraisal office shall be one, and the occupational disease appraisal office shall be filed again. The format of the occupational disease identification book is regulated by the Ministry of Health.

Article 49 The occupational disease appraisal shall be served on the parties concerned by the occupational disease appraisal office within 20 days from the date of conclusion of the appraisal.

Article 50 Where an appraisal conclusion is inconsistent with a diagnostic conclusion or initial appraisal conclusion, the occupational disease appraisal office shall report to the relevant health administrative department and the safety production supervision and management department in a timely manner.

Article 51 The occupational disease appraisal office shall record the occupational disease appraisal process truthfully. The content shall include:

(i) The composition of the expert group;
(b) the identification time;
(c) identifying the information used;
(4) The expert's speech and its appraisal opinion;
(v) The voting situation;
(6) The appraisal conclusion signed by the appraising expert;
(7) Other information related to the appraisal. Where there are parties who have stated and argued, they should record it truthfully. After the completion of the appraisal, the appraisal record shall be filed with the occupational disease appraisal office together with the occupational disease appraisal form and be kept forever.

Chapter 5 Supervision and Management

Article 52 Local health administrative departments at or above the county level shall formulate an annual supervision and inspection plan for the occupational disease diagnosis institution, and regularly supervise and inspect the occupational disease diagnosis institution. The inspection contents include:

(1) Implementation of laws, regulations and standards;
(B) the establishment of rules and regulations;
(3) the implementation of personnel and job responsibilities and training;
(d) Occupational disease reporting and so on. The provincial health administrative department shall organize supervision and inspection at least once a year; the municipal health administrative department of the district shall organize inspections at least once a year and conduct spot checks at random; the county-level health administrative department is responsible for daily supervision and inspection.

Article 53 Local health administrative departments at or above the municipal level in a district shall strengthen the supervision and administration of the occupational disease appraisal offices, supervise and inspect the work procedures, system implementation and occupational disease reports of the occupational diseases.

Article 54 The provincial health administrative department is responsible for conducting regular assessments of occupational disease diagnostic institutions.

Chapter 6 Legal Liability

Article 55 Where a medical and health institution engages in the diagnosis of occupational diseases without approval, the local health administrative department at or above the county level shall punish it in accordance with Article 80 of the Law on the Prevention and Treatment of Occupational Diseases.

Article 56 Where an occupational disease diagnostic institution has one of the following acts, the local health administrative department at or above the county level shall punish it in accordance with Article 81 of the Occupational Disease Prevention Law:

(1) Occupational disease diagnosis beyond the approved scope;
(2) Failure to perform the statutory duties in accordance with the provisions of the Occupational Disease Prevention Law;
(3) Issuing false certification documents.

Article 57 Where an occupational disease diagnostic institution fails to report an occupational disease or suspected occupational disease in accordance with the provisions, the local health administrative department at or above the county level shall punish it in accordance with the provisions of Article 75 of the Occupational Disease Prevention Law.

Article 58 Where an occupational disease diagnosis agency violates the provisions of the present Measures and has one of the following circumstances, the local health administrative department at or above the county level shall order it to make corrections within a time limit; if it is not corrected after the due date, it shall be given a warning and may be levied below 20,000 yuan depending on the seriousness of the circumstances. Fine:

(1) There is no establishment of occupational disease diagnostic management system;
(2) Disclosing occupational disease diagnostic procedures to workers in accordance with regulations;
(3) Leaking relevant information and materials concerning personal privacy of the laborer;
(4) Other acts in violation of these Measures.

Article 59: The occupational disease diagnosis and appraisal committee members shall be punished by the provincial health administrative department in accordance with the provisions of Article 82 of the Occupational Disease Prevention Law.

Article 60 Local health administrative departments at or above the county level and their staff members have not performed their duties in accordance with the law, and are dealt with in accordance with the provisions of the second paragraph of Article 85 of the Occupational Disease Prevention Law.

Chapter 7 Supplementary Provisions

Article 61 The expenses of the diagnosis and appraisal of occupational diseases shall be borne by the employer.

Article 62 These Measures shall be interpreted by the Ministry of Health.

Article 63 The present Measures shall come into force on April 10, 2013. The "Administrative Measures for the Diagnosis and Appraisal of Occupational Diseases" promulgated by the Ministry of Health on March 28, 2002 was repealed at the same time.