Medical Waste Management Regulations Registration Information Retained for at Least a Few Years

State Council Decree No. 380 Promulgation Date: 20030616

Implementation Date: 20030616 Promulgation Unit: 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" and the "Prevention and Control of Solid Waste Pollution Environment Law of the People's Republic of China*** and the State". Law on Prevention and Control of Environmental Pollution by Solid Wastes", these regulations are formulated.

Article 2 of the regulations referred to in the medical waste, refers to medical and health institutions in the medical, preventive, health care and other related activities with direct or indirect infectious, toxic and other hazardous waste. Medical waste classification catalog, by the state council administrative department of health and environmental protection **** with the development and publication.

Article 3 of these regulations shall apply to the collection, transportation, storage, disposal and supervision and management of medical waste and other activities. Medical and health institutions to treat patients with infectious diseases or suspected infectious diseases patients generated by the domestic waste, in accordance with the management and disposal of medical waste. Medical and health institutions abandoned narcotic, psychiatric, radioactive, toxic drugs and their related waste management, in accordance with relevant laws, administrative regulations and the relevant provisions of the State, the implementation of standards.

Article 4 of the state to promote the centralized harmless disposal of medical waste, 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 remote and poor areas of centralized medical waste disposal facilities 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 collection of medical waste, 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 the medical and health institutions and medical waste disposal units, should establish and improve the responsibility system for the management of medical waste, 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 due to medical waste accidents.

Article VIII of the 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 management, to prevent violations of these regulations.

Article IX of the medical and health institutions and centralized disposal of medical waste 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; if necessary, immunization of the personnel concerned, to prevent damage to their health.

Article 11 of the medical and health institutions and medical waste disposal units, should be in accordance with the "Chinese People's *** and the State Law on Prevention and Control of Environmental Pollution by Solid Wastes", the implementation of hazardous waste transfer joint management system.

Article 12 of the medical and health institutions and medical waste disposal units, should be registered on medical waste, the registration content should include the source of medical waste, type, weight or quantity, handover time, disposal, the final destination, as well as 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, should take effective measures to prevent the loss, leakage, proliferation of medical waste. Occurrence of medical waste loss, leakage, proliferation, health care institutions and centralized disposal of medical waste should be taken to reduce the hazards of emergency treatment measures 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 to transfer, trade in medical waste. It is prohibited to discard medical wastes during transportation; it is prohibited to dump or pile up medical wastes in non-storage places or mix medical wastes with other wastes and domestic garbage.

Article 15 prohibits the mailing of medical waste. Prohibit the transportation of medical waste by rail and air. There are land access, prohibit the transportation of medical waste by water; no land access must be transported by water medical waste, should be approved by the municipal people's government above the municipal level of the administrative department of environmental protection, and to take strict environmental protection measures, before being transported by water. Prohibit medical waste and passengers in the same means of transportation. It is prohibited to transport 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. Medical waste special packaging, containers, there should be obvious warning signs and warning instructions. Medical waste special packaging, containers, standards and warning signs of the provisions of the State Council administrative department of health and the administrative department of environmental protection **** with the development.

Article XVII of the medical and health institutions shall establish temporary storage facilities for medical waste, equipment, shall not be open storage of medical waste; temporary storage of medical waste shall not exceed 2 days. Medical waste temporary storage facilities, equipment, should be far from the medical area, food processing area and personnel activities and living garbage storage, and set up obvious warning signs and leakage, rodent, mosquito and fly prevention, cockroach prevention, anti-theft and prevention of child contact and other safety measures. Temporary storage facilities and equipment for medical waste should be sterilized and cleaned regularly.

Article 18 of the medical and health institutions should use leak-proof, anti-spill special delivery tools, in accordance with the unit to determine the internal delivery of medical waste time, route, will be collected, transported to the temporary storage of medical waste. Transportation tools should be used in health care institutions in the designated location in a timely manner after disinfection and cleaning.

Article 19 of the health care institutions should be based on the principle of centralized disposal of nearby, timely delivery of medical waste to the centralized disposal of medical waste disposal unit. Medical waste of pathogens in the culture medium, specimens and strains of bacteria, poisonous species preservation fluid and other high-risk wastes, should be sterilized in situ before handing over to the centralized disposal of medical waste disposal unit.

Article 20 of the medical and health institutions produce sewage, 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. Self-disposal of medical waste, should meet the following basic requirements:

(a) after 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 engaged in the centralized disposal of medical waste disposal activities, 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 technicians and the corresponding skilled workers;

(c) with the medical waste disposal effect of the institutions responsible for the testing and evaluation work and Personnel;

(D) have to ensure the safe disposal of medical waste regulations. Article 24 of the centralized disposal of medical waste storage, disposal facilities, should be far from residential (village) areas, water protection zones and traffic arteries, and factories, enterprises and other workplaces have 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 of medical waste disposal unit should be at least every 2 days to the medical and health institutions to collect and transport a 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, should 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 meet the leakage prevention, anti-spill and other environmental protection and health requirements. After the use of special vehicles for transporting medical waste, they should be disinfected and cleaned in a timely manner in the centralized disposal site for medical waste. Transportation of medical waste of special vehicles 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 a normal operating state. Article 29 of the centralized disposal of medical waste disposal unit of medical waste disposal, shall comply with state 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 administrative department of environmental protection and the administrative department of health, the medical waste disposal facilities on a regular basis, environmental pollution prevention and control and hygienic effect of testing, evaluation. Testing, evaluation results into the centralized medical waste disposal unit files, every six months to the local administrative department of environmental protection and health administrative department report. Article 31 of the centralized disposal unit of medical waste disposal of medical waste, in accordance with relevant state regulations to medical and health institutions to collect medical waste disposal costs. Medical and health institutions in accordance with the provisions of the medical waste disposal costs paid, can be included in the cost of medical care. Article 32 of the regions should use and renovation of existing solid waste disposal facilities and other facilities, 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, the municipal level above the city 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 has not been built during the centralized disposal of medical waste facilities, 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 methods and disposal units. Article 34 the local people's governments 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 unit for supervision and inspection. Article 35 the local people's governments above the county level, the competent department of health administration, shall be engaged in medical and health institutions and medical waste centralized disposal unit of medical waste collection, transportation, storage, disposal of disease prevention and control work, as well as the staff of the sanitary protection of the situation of regular supervision and inspection or unscheduled spot checks. Article 36 of the local people's government at or above the county level, the administrative department of environmental protection, shall be engaged in medical and health institutions and medical waste centralized disposal unit of medical waste collection, transportation, storage, disposal of environmental pollution prevention and control work for regular supervision and inspection or unscheduled spot checks. Article 37 The competent administrative department of health and the competent administrative department of environmental protection shall regularly exchange the results of supervision, inspection and spot check. In the supervision and inspection or random inspection found in medical and health institutions and medical waste disposal units have hidden problems, shall order the immediate elimination of hidden problems. Article 38 The competent administrative department of health, the competent administrative department of environmental protection, upon receipt of the health care institutions, medical waste disposal units and supervision and management departments and their staff in violation of these regulations of the report, complaint, denunciation and accusation, shall promptly verify, and according to law to deal with, and the results will be published. 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) to carry out on-site inspection of the relevant units, to understand the situation, on-site monitoring, investigation and collection of evidence;

(2) to inspect or copy the relevant information on the management of medical wastes, and to collect samples;

(3) to order units and individuals in violation of the provisions of the present regulations to stop violating the laws and regulations. Provisions of the units and individuals to stop illegal acts;

(4) Seizure or temporary detention of suspected violations of the provisions of these Regulations of the premises, equipment, means of transportation and goods;

(5) violation of the provisions of these Regulations to investigate and deal with the act. Article 40 occurs due to improper management of medical waste lead to the spread of infectious diseases or environmental pollution accidents, or there is evidence that the spread of infectious diseases or environmental pollution of the accident is likely to occur, the competent administrative department of health, the competent administrative department of environmental protection shall take temporary control measures, evacuate the people, control the scene, and as needed, order the suspension of the accident that leads to, or may lead to, the spread of infectious diseases or environmental pollution. 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 refuse and obstruction, shall not provide false materials. Article 42 The local people's government at or above the county level fails to organize the construction of a centralized medical waste disposal facility or to organize the development of a transitional disposal program for medical waste in accordance with the provisions of these Regulations, the people's government at a higher level shall notify and criticize, and order the completion of a centralized medical waste disposal facility or the organization of a transitional disposal program for medical waste by a specified date; and may, according to the law, impose on the main leaders of the government, and on the responsible supervisory personnel, administrative penalties. 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 their duties of supervision and inspection in accordance with the provisions of these regulations, discovering that medical and health institutions and centralized medical waste disposal units do not deal with the violations of law in a timely manner, and failing to take measures to reduce the hazards in a timely manner when the spread of infectious diseases or environmental pollution accidents occur or may occur, as well as other relevant departments. Neglect of duty, 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; caused by the spread of infectious diseases or environmental pollution accidents, the main person in charge, responsible for the competent personnel and other directly responsible personnel shall be given demotion, dismissal, expulsion of the administrative sanctions according to law; constitutes a crime, shall be investigated for criminal responsibility. Article 45 medical and health institutions, medical waste centralized disposal unit in violation of the provisions of these regulations, one of the following circumstances, 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 ordered to make corrections within a specified period of time, and shall be given a warning; failure to make corrections after the expiration of the deadline, shall be subject to a fine of more than 2,000 yuan and less than 5,000 yuan:

(a) Failure to establish, Improvement of medical waste management system, or failure to set up monitoring department or full-time (part-time) staff;

(b) failure to train the relevant personnel in relevant laws and professional skills, safety and protection, as well as emergency treatment and other knowledge;

(c) failure to engage in the collection of medical waste, transportation, storage, disposal of personnel and management personnel to take occupational health precautions;< /p>

(d) failure to register medical waste or failure to save the registration information;

(e) 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;

(f) failure to collect and transport medical waste in a timely manner;

(g) failure to regularly prevent and control of environmental pollution in the medical waste disposal facilities 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 unit 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 and ordered to make corrections within a certain period of time, and give a warning, and may also be imposed a fine of less than 5,000 yuan; overdue corrections, the penalty shall be 5,000 yuan of 30,000 yuan or more fine:

(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 the transportation of medical waste or the use of vehicles transporting medical waste to transport other items;

(d) not installed pollutants (D) does not install online monitoring devices for pollutant emissions or monitoring devices are not always in a state of normal operation. Article 47 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 of health or the administrative department of environmental protection in accordance with the responsibilities of each department shall order rectification within a specified 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 a fine of more than 10,000 yuan or more than 30,000 yuan; cause 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, be held criminally responsible:

(a) in the process of transporting medical waste, dumping, piling up of medical waste in a non-storage site, or mixing medical waste into other wastes and domestic garbage;

(b) failure to implement the transfer of hazardous waste management system;

(c) failure to carry out the transfer of hazardous wastes, the joint single 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 is not in line with the national provisions of environmental protection, health standards, norms;

(E) not in accordance with the provisions of the Regulations of the sewage, infectious disease patients or suspected infectious disease patient Excreta, for strict disinfection, or does not meet the national emission standards, discharged into the sewage treatment system;

(6) for patients with infectious diseases or suspected infectious diseases patients admitted to the living garbage, not in accordance with the management and disposal of medical waste. Article 48 medical and health institutions in violation of the provisions of these regulations, will not meet the national standards of sewage, infectious disease patients or suspected infectious disease patients of excreta discharged into the urban drainage network, by the local people's government at or above the county level, the competent department of construction administration ordered to make corrections within a certain period of time, and give a warning, and impose a fine of 5,000 yuan or more than 10,000 yuan; if overdue corrections are not made, impose a fine of more than 10,000 yuan or more than 30,000 yuan fine; if it causes the spread of infectious diseases or environmental pollution accidents, the original licensing department shall suspend or revoke the license to practice; if it constitutes a crime, it shall be investigated for criminal responsibility according to law. Article 49 If a medical and healthcare institution or a centralized medical waste disposal unit fails to take emergency treatment 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 or the competent administrative department of environmental protection of the local people's government at or above the county level to make corrections in accordance with their respective duties, be given a warning, and imposed a fine of not less than 10,000 yuan A fine of not less 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 medical and health institutions, medical waste centralized disposal units, without justifiable reasons, obstruct the competent administrative department of health or the competent administrative department of environmental protection law enforcement officers in the performance of their duties, refuse to allow law enforcement officers to enter the scene, or do not cooperate with the law enforcement authorities in the inspection, monitoring, investigation and collection of evidence, 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 duties Ordered to make corrections, and given a warning; refuses to make corrections, by the original licensing department to suspend or revoke the license to practice or business license; violation of the "Chinese People's *** and the State Administration of Public Security Punishment Regulations", constituting 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 given a warning; if the corrections are not made after the expiry of the period, a fine of more than 1,000 yuan and less than 5,000 yuan shall be imposed; if it results in 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 If a person fails to obtain a license to engage in the collection, transportation, storage and disposal of medical waste, the administrative department of 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 sender or the consignor to stop the illegal act immediately, give a warning, and confiscate the illegal proceeds; where the illegal proceeds are more than 5000 yuan, the person concerned shall be fined Income of two times or more than five times the following fine; no illegal income or illegal income of less than 5,000 yuan, and impose a fine of 5,000 yuan or more than 20,000 yuan. If a carrier knows that a shipper transports medical waste in violation of the provisions of these Regulations and still transports it, or if a carrier carries medical waste on the same vehicle as a passenger, it shall be punished in accordance with the provisions of the preceding paragraph. Article 54 medical and health institutions, medical waste centralized 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 in accordance with the law. By-laws Article 55 family planning technical services, medical research, teaching, post-mortem examination and other related activities with direct or indirect infectious, toxic and other hazardous waste management, 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 of these regulations shall come into force on the date of publication.

Legal basis:

"Regulations on the Management of Medical Waste"

Article 45 of the medical and health institutions, centralized disposal of medical waste in violation of the provisions of these regulations, one of the following circumstances, by the local people's government at or above the county level of the competent administrative department of health or the competent department of environmental protection, in accordance with their respective duties Ordered to make corrections within a certain period of time, and given a warning; if no corrections are made after the deadline, a fine of not less than 2000 yuan and not more than 5000 yuan shall be imposed:

(1) Failure to establish and improve the medical waste management system, or failure to set up a monitoring department or a full-time (part-time) staff;

(2) Failure to train the personnel concerned in the relevant laws and professional skills, safety and protection, as well as knowledge of emergency treatment;

(3) failure to provide training on the relevant laws and professional techniques, safety and emergency treatment;< /p>

(C) not engaged in the collection, transportation, storage, disposal of medical waste and other personnel and management personnel to take occupational health precautions;

(D) failure to register medical waste or failure to save the registration data;

(E) after the use of medical waste transportation tools or delivery vehicles are not in the designated location in a timely manner for disinfection and clean;

(F) failure to collect and transport medical waste in a timely manner;

(VII) failure to regularly test and evaluate the environmental pollution prevention and hygiene effects of medical waste disposal facilities, or failure to archive and report the results of testing and evaluation.