State Council Decree No. 380
Date of Issue: 20030616 Date of Implementation: 20030616 Promulgating Authority: State Council General Provisions
Article 1 In order to strengthen the safe management of medical waste, to prevent the spread of disease, to protect the environment, and to safeguard human health, these regulations are formulated in accordance with the "Prevention and Control of Infectious Diseases Law of the People's Republic of China*** and the State Law on Prevention and Control of Environmental Pollution by Solid Waste of the People's Republic of China*** and the State. and the State Law on Prevention and Control of Environmental Pollution by Solid Wastes", the formulation of these regulations.
Second Article The medical waste referred to in these regulations refers to the medical and health institutions in the medical treatment, prevention, health care and other related activities generated by the direct or indirect infectious, toxic and other hazardous waste.
Medical waste classification catalog, by the State Council administrative department of health and the administrative department of environmental protection **** with the development and publication.
Article 3 These regulations shall apply to the collection, transportation, storage, disposal and supervision and management of medical waste.
Life wastes generated by patients with infectious diseases or suspected infectious diseases admitted to medical and health institutions shall be managed and disposed of in accordance with medical wastes.
Management of narcotic, psychotropic, radioactive and toxic drugs and their related wastes discarded by medical and health institutions shall be carried out in accordance with the relevant laws, administrative regulations and relevant national regulations and standards.
Article IV of the State to promote the centralized harmless disposal of medical waste, and encourage research and development of safe disposal of medical waste related technology.
Local people's governments at or above the county level is responsible for organizing the construction of centralized medical waste disposal facilities.
The state on the construction of centralized medical waste disposal facilities in remote and poor areas to give appropriate support.
Article 5 of the people's governments at or above the county level, the competent administrative department of health, medical waste collection, transportation, storage, disposal activities in the implementation of unified supervision and management of disease prevention and control; the competent administrative department of environmental protection, the medical waste collection, transportation, storage, disposal activities in the prevention and control of environmental pollution in the implementation of unified supervision and management.
People's governments at or above the county level, other relevant departments in their respective areas of responsibility for the supervision and management of medical waste disposal.
Article VI of any unit or individual has the right to medical and health institutions, medical waste disposal units and supervision and management departments and their staff for violations of the law to report, complaints, whistleblowing and accusations. Article VII of medical and health institutions and medical waste disposal units, should establish and improve the responsibility system for medical waste management, its legal representative is the first person responsible for the effective fulfillment of their duties to prevent the spread of infectious diseases and environmental pollution caused by medical waste.
Article VIII of medical and health institutions and centralized medical waste disposal unit, shall formulate rules and regulations related to the safe disposal of medical waste and emergency response plan in the event of an accident; set up monitoring department or full-time (part-time) staff responsible for checking, supervising and implementing the management of the unit's medical waste, and to prevent violations of these regulations.
Article IX of the medical and health institutions and medical waste disposal units, should be engaged in the unit of medical waste collection, transportation, storage, disposal and other work of personnel and management personnel, relevant laws and professional skills, safety and protection, as well as emergency treatment and other knowledge training.
Article 10 of the medical and health institutions and medical waste disposal units, shall take effective occupational health protection measures, engaged in the collection of medical waste, transportation, storage, disposal and other work of personnel and management personnel, equipped with the necessary protective equipment, regular health checks; when necessary, immunization of the personnel concerned, to prevent damage to their health.
Article XI of the medical and health institutions and medical waste centralized disposal unit, shall, in accordance with the provisions of the "Chinese people's *** and the State Solid Waste Pollution Prevention and Control Law", the implementation of hazardous waste transfer joint bill management system.
Article XII of the medical and health institutions and medical waste centralized disposal unit, should be registered for medical waste, the registration content should include the source of medical waste, type, weight or quantity, handover time, disposal method, the final destination and the signature of the person in charge of such items. Registration information to be kept for at least three years.
Article XIII of the medical and health institutions and medical waste disposal units, shall take effective measures to prevent the loss, leakage, spread of medical waste.
The occurrence of medical waste loss, leakage, proliferation, medical and health institutions and centralized medical waste disposal unit shall take emergency measures to reduce the harm, to provide medical care and on-site rescue of patients; at the same time, to the local people's government at the county level, the competent administrative department of health, the competent administrative department of environmental protection report, and may be jeopardized by the unit and the residents of the notification.
Article 14 prohibits any unit or individual from transferring, buying or selling medical waste.
It is prohibited to discard medical wastes during transportation; it is prohibited to dump or pile up medical wastes in non-storage locations or to mix medical wastes with other wastes and domestic garbage.
Article 15 prohibits the mailing of medical waste.
It is prohibited to transport medical waste by rail or air.
Where there is a land route, it is prohibited to transport medical waste by water; where there is no land route and medical waste must be transported by water, it shall be approved by the competent administrative department for environmental protection of the people's government at or above the municipal level of the district and strict environmental protection measures shall be taken before it is transported by water.
It is prohibited to carry medical waste and passengers on the same means of transportation.
Prohibit the transportation of medical waste on the water bodies in the drinking water source protection zone. Article XVI of the medical and health institutions should be timely collection of medical waste generated by the unit, and in accordance with the categories placed in leak-proof, anti-sharp penetration of special packaging or closed containers.
Special packaging for medical waste, containers, there should be obvious warning signs and warning instructions.
Specialized packaging for medical waste, containers, standards and warning signs of the provisions of the State Council, the competent administrative department of health and the competent administrative department of environmental protection **** with the development.
Article XVII of the medical and health institutions shall establish temporary storage facilities and equipment for medical waste, shall not be open storage of medical waste; temporary storage of medical waste shall not exceed 2 days.
Temporary storage facilities for medical waste, equipment, should be far away from the medical area, food processing areas and personnel activities, as well as living garbage storage places, and set up obvious warning signs and leakage, rodent, mosquito and fly prevention, cockroach, anti-theft, and prevention of children in contact with other safety measures.
The temporary storage facilities and equipment for medical waste should be sterilized and cleaned regularly.
Article 18 of the medical and health institutions shall use anti-leakage, anti-spill special delivery tools, in accordance with the unit to determine the internal delivery of medical waste time, route, medical waste will be collected, transported to the temporary storage site.
Transportation tools should be used in health care institutions after the designated location in a timely manner to disinfect and clean.
Article 19 of the medical and health institutions should be based on the principle of centralized disposal of medical waste in a timely manner to the centralized disposal of medical waste disposal unit.
Medical waste of pathogens in the culture medium, specimens and strains of bacteria, viruses, preservation of high-risk wastes, such as liquid, should be sterilized in situ before handing over the centralized disposal of medical waste disposal unit.
Article 20 of the sewage generated by medical and health institutions, patients with infectious diseases or suspected infectious disease patient excreta, shall be strictly disinfected in accordance with national regulations; to meet the national emission standards before being discharged into the sewage treatment system.
Article 21 does not have the conditions of centralized disposal of medical waste in rural areas, medical and health institutions shall, in accordance with the requirements of the competent administrative department of health of the people's government at the county level, the competent administrative department of environmental protection, their own local disposal of medical waste. Disposal of medical waste, should meet the following basic requirements:
(a) the use of disposable medical instruments and easily damaged medical waste, should be disinfected and disfigured;
(b) can be incinerated, it should be incinerated in a timely manner;
(c) can not be incinerated, disinfected and centralized landfill. Article 22 The unit engaged in the centralized disposal of medical waste, shall apply to the people's governments at or above the county level of the administrative department of environmental protection to obtain a business license; without obtaining a business license shall not be engaged in activities related to the centralized disposal of medical waste.
Article 23 of the centralized disposal of medical waste unit, shall meet the following conditions:
(a) with environmental protection and health requirements of medical waste storage, disposal facilities or equipment;
(b) with trained technical personnel and the corresponding skilled workers;
(c) with the medical waste disposal effect of the detection, evaluation Institutions and personnel responsible for testing and evaluating the effectiveness of medical waste disposal;
(d) have rules and regulations to ensure the safe disposal of medical waste.
Article 24 The storage and disposal facilities of the centralized medical waste disposal unit shall be far away from residential (village) areas, water protection zones and traffic arteries, and factories, enterprises and other workplaces with appropriate safety protection distance, and in line with the provisions of the State Council administrative department of environmental protection.
Article 25 of the centralized disposal unit of medical waste should be at least every two days to medical and health institutions to collect and transport medical waste, and is responsible for the storage and disposal of medical waste.
Article 26 of the centralized disposal of medical waste disposal unit to transport medical waste, shall comply with national regulations on the management of transportation of dangerous goods, the use of special vehicles with obvious medical waste identification. Special vehicles for medical waste should be leak-proof, anti-spill and other environmental protection and health requirements.
Special vehicles for the transport of medical waste should be used after the centralized disposal of medical waste should be disinfected and cleaned in a timely manner.
Special vehicles for the transportation of medical waste shall not transport other items.
Article 27 of the centralized disposal of medical waste disposal unit in the delivery of medical waste should ensure safety, shall not be discarded, scattered medical waste.
Article 28 of the centralized disposal of medical waste units should be installed online monitoring devices for pollutant emissions, and to ensure that the monitoring device is often in normal operation.
Article 29 of the centralized disposal of medical waste disposal unit of medical waste, shall comply with national regulations on environmental protection, health standards, norms.
Article 30 of the centralized disposal of medical waste disposal unit shall, in accordance with the provisions of the competent administrative department of environmental protection and the competent administrative department of health, the medical waste disposal facilities on a regular basis for the prevention of environmental pollution and hygienic effect of testing, evaluation. Testing, evaluation results are deposited in the centralized disposal of medical waste unit files, every six months to the local administrative department of environmental protection and the competent administrative department of health report.
Article 31 of the centralized disposal of medical waste disposal units dispose of medical waste, in accordance with the relevant provisions of the state medical waste disposal fees charged to health care institutions.
Medical and health institutions in accordance with the provisions of the medical waste disposal fees, can be included in medical costs.
Article 32 Each region shall utilize and renovate the existing solid waste disposal facilities and other facilities for the centralized disposal of medical waste, and meet the basic environmental protection and health requirements.
Article 33 does not yet have a centralized disposal facilities or disposal capacity is insufficient in the city, from the date of implementation of these regulations, cities above the municipal level of the district shall be built within one year of the centralized disposal of medical waste facilities; county-level cities shall be built within two years of the centralized disposal of medical waste facilities. County (flag) the construction of centralized medical waste disposal facilities, by the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
In the period has not yet built a centralized disposal facility for medical waste, the relevant local people's government shall organize the development of environmental protection and health requirements in line with the transitional disposal of medical waste program, to determine the collection of medical waste, transportation, disposal and disposal of medical waste disposal unit. Article 34 the local people's government at or above the county level, the competent administrative department of health, the competent administrative department of environmental protection, shall, in accordance with the provisions of these regulations, in accordance with the division of responsibilities, the medical and health institutions and centralized disposal of medical waste units for supervision and inspection.
Article 35 The competent department of health administration of the local people's government at or above the county level, shall carry out regular supervision and inspection or unscheduled random inspection of medical and health institutions and medical waste disposal units engaged in the collection, transportation, storage, disposal of medical waste in the prevention and control of disease, as well as the staff's sanitary protection and other circumstances.
Article 36 of the local people's governments at or above the county level, the competent administrative department of environmental protection, shall be engaged in the collection of medical and health institutions and medical waste disposal units in the collection of medical waste, transportation, storage, disposal of environmental pollution prevention and control of regular supervision and inspection or unscheduled spot checks.
Article 37 The competent administrative department of health, the competent administrative department of environmental protection shall regularly exchange the results of supervision and inspection and spot checks. In the supervision and inspection or random inspection of medical and health institutions and medical waste disposal units found to exist hidden dangers, shall order the immediate elimination of hidden dangers.
Article 38 The competent administrative department of health, the competent administrative department of environmental protection, received the medical and health institutions, medical waste disposal units and supervision and management departments and their staff in violation of these regulations of the report, complaints, whistleblowing and accusations, shall be verified in a timely manner, and according to the law to deal with, and will be the results of the publicity.
Article 39 The competent administrative department of health and the competent administrative department of environmental protection, in performing their duties of supervision and inspection, shall have the right to take the following measures:
(1) conducting on-site inspections of the units concerned to learn about the situation, on-site monitoring, and investigating and obtaining evidence;
(2) inspecting or copying relevant information on medical waste management, and collecting samples;
(3) Order units and individuals in violation of the provisions of these Regulations to stop illegal acts;
(iv) Seizure or temporary detention of suspected violation of the provisions of these Regulations of the premises, equipment, means of transportation and goods;
(v) investigation of violations of the provisions of these Regulations.
Article 40 In the event of the spread of infectious diseases or environmental pollution due to improper management of medical wastes, or when there is evidence that the spread of infectious diseases or environmental pollution is likely to occur, the competent administrative department of health, the competent administrative department of environmental protection shall take temporary control measures, evacuate the personnel, control the scene, and order the suspension of the operations that lead to, or may lead to, the spread of infectious diseases or environmental pollution according to the needs. environmental pollution accident operations.
Article 41 Medical and health institutions and medical waste centralized disposal units, the relevant departments of the inspection, monitoring, investigation and evidence collection, shall cooperate, shall not be refused and obstructed, shall not provide false materials. Article 42 The local people's government at or above the county level fails to organize the construction of centralized medical waste disposal facilities in accordance with the provisions of these regulations, or to organize the development of transitional disposal of medical waste program, the people's government at a higher level to notify the criticism, and ordered to complete the centralized disposal of medical waste facilities within a limited period of time, or to organize the development of transitional disposal of medical waste program; and may be the government's main leaders, the responsible persons in charge, according to the law to be given Administrative sanctions.
Article 43 The competent administrative department of health, the competent administrative department of environmental protection or other relevant departments of the people's governments at or above the county level, failing to perform the duties of supervision and inspection in accordance with the provisions of these regulations, discovering that medical and health care institutions and centralized disposal of medical wastes do not deal with the violations of the law in a timely manner, the occurrence of or the possibility of the spread of infectious diseases or environmental pollution accidents do not take timely measures to reduce the hazards, and other negligence of duty. Measures, as well as other negligence, dereliction of duty, malfeasance, by the people's government at this level or the people's government at a higher level of the relevant departments ordered to make corrections, and notification of criticism; cause the spread of infectious diseases or environmental pollution accidents, the main person in charge, the supervisory personnel responsible for the other directly responsible personnel shall be given demotion, dismissal, dismissal of administrative sanctions; constitutes a crime, shall be investigated for criminal responsibility. Give administrative sanctions.
Article 45 Where a medical and healthcare institution or a centralized medical waste disposal unit violates the provisions of these Regulations and is involved in any of the following cases, it shall be ordered by the competent administrative department of health or the competent administrative department of environmental protection of the local people's government at or above the county level to make corrections within a certain period of time in accordance with their respective duties and shall be given a warning; and if it fails to make corrections after the expiration of this period, it shall be subject to a fine of not less than 2,000 yuan but not exceeding 5,000 yuan:
( (A) did not establish and improve the medical waste management system, or did not set up a monitoring department or full-time (part-time) staff;
(B) not to the relevant personnel for the relevant laws and professional skills, safety and protection, as well as emergency treatment and other knowledge training;
(C) not engaged in the collection of medical waste, transportation, storage, disposal of personnel and management personnel to take occupational
(4) failure to register medical waste or failure to save the registration information;
(5) after the use of medical waste delivery tools or delivery vehicles are not in the designated location in a timely manner for disinfection and cleaning;
(6) failure to collect and transport medical waste in a timely manner;
(7) not regularly on the disposal of medical waste Facilities for environmental pollution prevention and control and hygienic effect of testing, evaluation, or failure to test, evaluation of the effect of archiving, reporting.
Article 46 Medical and health institutions, centralized medical waste disposal units in violation of the provisions of these Regulations, one of the following circumstances, then by the local people's government at or above the county level, the competent administrative department of health or the competent administrative department of environmental protection, in accordance with their respective responsibilities, shall order rectification within a certain period of time, and give a warning, and may also be imposed on a fine of not more than 5,000 yuan; overdue rectification, shall be punished by a fine of 5,000 yuan or more than 30,000 yuan. Fines of less than:
(A) storage facilities or equipment does not meet the environmental protection, health requirements;
(B) medical waste according to the category is not placed in special packaging or containers;
(C) does not meet the standards of the use of special vehicles for transporting medical waste or the use of vehicles for transporting medical waste to transport other items;
(D) failure to install online monitoring device for pollutant emissions;
(D) failure to install online monitoring device for pollutant emissions. ) Failure to install online monitoring devices for pollutant emissions or monitoring devices are not always in a state of normal operation.
Article 47 The medical and health institutions, medical waste centralized disposal unit in one of the following circumstances by the local people's government at or above the county level, the administrative department in charge of health or the administrative department in charge of environmental protection in accordance with the responsibilities of the respective departments shall order rectification within a certain period of time, give a warning, and impose a fine of 5,000 yuan or more than 10,000 yuan; overdue rectification, shall be imposed on 10,000 yuan or more than 30,000 yuan fine; cause the spread of infectious diseases or environmental pollution accidents. The spread of infectious diseases or environmental pollution accidents, by the original licensing department to suspend or revoke the license to practice or business license; constitutes a crime, shall be held criminally responsible:
(a) in the delivery process to discard medical waste, dumping, piling up of medical waste in a non-storage site, or mixing of medical waste into other wastes and domestic garbage;
(b) failure to implement the Hazardous waste transfer joint management system;
(C) the medical waste to the unit or individual who has not obtained a business license to collect, transport, storage, disposal;
(D) the disposal of medical waste does not comply with the national provisions of the environmental protection, health standards, norms;
(E) not in accordance with the provisions of these regulations on sewage, infectious disease patients or suspected infectious disease patient excreta, strict disinfection, or does not meet the national emission standards, discharged into the sewage treatment system;
(F) the admission of infectious disease patients or suspected infectious disease patients generated by the living garbage, not in accordance with the management and disposal of medical waste.
Article 48 Where a medical and health institution violates the provisions of these Regulations by discharging into the urban drainage network sewage that has not reached the national standard, or excreta from patients with infectious diseases or patients suspected of having infectious diseases, the competent department of construction administration of the local people's government at or above the county level shall order correction within a specified period of time, give a warning and impose a fine of 5,000 yuan or more than 10,000 yuan; if no correction is made within that period of time, it shall impose a fine of 10,000 yuan or more than 30,000 yuan; and the result shall be a fine of more than 30,000 yuan. Above 30,000 yuan fine; cause the spread of infectious diseases or environmental pollution accidents, by the original licensing department to suspend or revoke the license to practice; constitutes a crime, shall be investigated for criminal responsibility.
Article 49 If a medical and health institution or a centralized medical waste disposal unit fails to take emergency measures in the event of loss, leakage or proliferation of medical waste, or fails to report to the competent administrative department of health and the competent administrative department of environmental protection in a timely manner, it shall be ordered by the competent administrative department of health of the local people's government at or above the county level or by the competent administrative department of environmental protection in accordance with their respective responsibilities to rectify the situation, and shall be given a warning. warning, and impose a fine of not less than 10,000 yuan and not more than 30,000 yuan; if it causes the spread of infectious diseases or environmental pollution accidents, the original licensing department shall suspend or revoke the license to practice or business license; if it constitutes a crime, it shall be investigated for criminal responsibility according to law.
Article 50 Where a medical and health institution or a centralized medical waste disposal unit, without justifiable reasons, obstructs law enforcement officers of the competent administrative department of health or the competent administrative department of environmental protection in the performance of their duties, refuses to allow law enforcement officers to enter the site, or fails to cooperate with law enforcement officers in their inspections, monitoring, investigations and evidence collection, the competent administrative department of health or the competent administrative department of environmental protection of the local people's government at or above the county level shall In accordance with their respective responsibilities and order correction, and give a warning; refuses to make corrections, the original licensing department to suspend or revoke the license to practice or business license; violation of the "Chinese People's Republic of China *** and the State Administration of Public Security Punishments Ordinance", constitutes a violation of public security management, the public security organs shall be punished according to law; constitutes a crime, shall be investigated for criminal responsibility.
Article 51 does not have the conditions of centralized disposal of medical waste in rural areas, medical and health institutions do not dispose of medical waste in accordance with the requirements of these Regulations, by the people's government at the county level, the competent administrative department of health or the competent administrative department of environmental protection in accordance with their respective responsibilities ordered to make corrections within a certain period of time, and shall be given a warning; if it fails to make corrections after the expiration of the period of time, shall be sentenced to a fine of more than 1,000 yuan and less than 5,000 yuan; causing the spread of infectious disease The spread of infectious diseases or environmental pollution accidents, by the original licensing department to suspend or revoke the license to practice; constitutes a crime, shall be investigated for criminal responsibility.
Article 52 Where a person fails to obtain a license to engage in the collection, transportation, storage and disposal of medical waste, the competent administrative department for environmental protection of the local people's government at or above the county level shall order the immediate cessation of the illegal act, confiscate the illegal income, and may impose a fine of not more than one times of the illegal income.
Article 53 Where a person transfers or buys or sells medical wastes, mails or transports medical wastes by rail or by air, or transports medical wastes by waterway in violation of the provisions of these Regulations, the competent administrative department for environmental protection of the local people's government at or above the county level shall order the transferring or buying or selling party, the maker or shipper to stop the illegal act immediately, give a warning, and confiscate the illegal proceeds; where the illegal proceeds exceeds 5,000 yuan, a fine of two times the illegal proceeds shall be imposed. or more, and impose a fine of not less than two times but not more than five times the illegal income; if there is no illegal income or the illegal income is less than 5,000 yuan, and impose a fine of not less than 5,000 yuan but not more than 20,000 yuan.
A carrier who transports medical waste knowing that the shipper has violated the provisions of these Regulations, or a carrier who carries medical waste on the same vehicle as a passenger, shall be punished in accordance with the provisions of the preceding paragraph.
Article 54 medical and health institutions, centralized medical waste disposal units in violation of the provisions of these regulations, resulting in the spread of infectious diseases or environmental pollution accidents, causing damage to others, shall bear civil liability. Appendix
Article 55 The management of directly or indirectly infectious, toxic and other hazardous wastes generated in family planning technical services, medical research, teaching, post-mortem examination and other related activities shall be carried out in accordance with these Regulations.
Article 56 The management of medical waste in military medical and health institutions shall be formulated by the competent health department of the Chinese People's Liberation Army with reference to these Regulations.
Article 57 These regulations shall come into force on the date of publication.