Laboratory safety and biosafety management measures

Laboratory safety and biosafety management measures (Draft)

Chapter I General principles

Article 1 in order to strengthen the safety and biosafety management of the laboratories of Beijing brain science and brain like Research Center (hereinafter referred to as the center) and protect the health of laboratory staff and the public, in accordance with the regulations on biosafety management of pathogenic microorganism laboratories (hereinafter referred to as the regulations), the general requirements for biosafety of laboratories, and the directory of human infectious pathogenic microorganisms, etc These measures are formulated in accordance with the requirements of relevant laws, regulations and standards and the actual situation of the center.
Article 2 These measures are applicable to the laboratory safety and biosafety management of all laboratories in the center.
Article 3 the pathogenic microorganism mentioned in these Measures refers to the microorganism that can cause human or animal disease.
The experimental activities mentioned in these Measures refer to the activities related to the collection, transportation, preservation, research, teaching, detection and diagnosis of pathogenic microorganism (toxin) species and samples.
Chapter II Organization and management
Article 4 the center is responsible for the examination and approval of the new construction, reconstruction and expansion of the first and second level biosafety laboratories. The chief scientific research director of the center is the first person responsible for the safety and biosafety of the center laboratory.
Article 5 the center shall set up a laboratory safety and biosafety Committee (hereinafter referred to as the "safety committee"), which shall be composed of management personnel, researchers, logistics support technicians, biosafety officers, medical consultants, animal experiment managers and the person in charge of the secondary laboratory. To be responsible for consulting, guiding, evaluating and supervising the biosafety related matters of the laboratory, with the main responsibilities as follows:
（1） Review the laboratory construction plan and plan;
（2） Review the laboratory safety and biological risk assessment report;
（3） Review laboratory safety and biosafety management system documents;
（4） Review the biosafety protection level required by the experimental activities of scientific research projects;
（5） Review personnel training assessment and health monitoring plan.
（6） Provide technical guidance and consultation for laboratory experiment activities;
（7） Evaluate the new technology and method used in the experiment;
（8） Evaluate laboratory safety and biosafety incidents and accidents;
（9） Supervise and inspect the implementation of laboratory safety and biosafety management regulations.
Article 6 the center shall establish a laboratory safety and Biosafety Management Office (hereinafter referred to as the safety office) to be responsible for the daily biosafety management of the whole institute, with the main responsibilities as follows:
（1） To formulate relevant systems and measures for safety and biosafety management of the central laboratory;
（2） To be responsible for the approval and record management of primary and secondary laboratories;
（3） Organize and carry out laboratory safety and biosafety inspection (together with the safety committee);
（4） (in conjunction with the human resources department, general office and laboratory) organize the training and assessment of laboratory staff, and organize the health monitoring of laboratory staff;
（5） Assist each laboratory to develop, modify and control the laboratory safety and biosafety management system documents;
（6） Organize the investigation and handling of laboratory safety and biosafety accidents, and report to the superior as required;
（7） Accept the supervision and guidance of the superior competent department on the safety and biosafety of the central laboratory.
Article 7 the person in charge of the central laboratory shall be the first person in charge of the safety and biosafety of the laboratory to which it belongs, and its main responsibilities are as follows:
（1） Responsible for the design, implementation, maintenance and improvement of laboratory safety management system;
（2） Define the organization and management structure of the laboratory, and stipulate the responsibilities, powers and interrelations of all personnel;
（3） Designate the safety director, technical director and project director of each experimental activity, and provide all personnel of the laboratory with appropriate authority and resources to perform their duties;
Article 8 the person in charge of the central laboratory, together with the person in charge of safety, the person in charge of technology and the person in charge of each experimental activity, shall form a laboratory safety management group, whose main responsibilities are as follows:
（1） Prepare the biosafety management system documents of the laboratory, usually including management manual, procedure documents, instructions, operation procedures, records, safety manual and other documents;
（2） Ensure that the laboratory facilities, equipment, personal protective equipment and materials meet the relevant national safety requirements, and regularly check, maintain and update them to ensure the safe operation of the laboratory;
（3） Be responsible for the training and health monitoring of the laboratory personnel;
（4） Be responsible for the examination and approval of experimental projects and personnel;
（5） Responsible for the safety of all staff, visitors, contractors, communities and environment in the laboratory;
（6） Accept the supervision and guidance of the superior competent department on the biosafety of the laboratory.
Chapter III Management of pathogenic microorganisms

Article 9 according to the infectivity of pathogenic microorganisms and the degree of harm to individuals or groups after infection, pathogenic microorganisms are divided into four categories:

The first category of pathogenic microorganism refers to the microorganism that can cause very serious diseases of human or animals, as well as the microorganism that has not been found or has been declared to be eliminated in China.
The second kind of pathogenic microorganism refers to the microorganism that can cause serious diseases of human or animals and is easy to spread directly or indirectly between people, animals and people, animals and animals.
The third kind of pathogenic microorganism refers to the microorganism that can cause human or animal diseases, but generally does not pose serious harm to human, animal or environment, has limited transmission risk, rarely causes serious diseases after laboratory infection, and has effective treatment and prevention measures.
The fourth category of pathogenic microorganism refers to the microorganism that will not cause human or animal diseases under normal circumstances.
The first and second categories of pathogenic microorganisms are collectively referred to as highly pathogenic microorganisms. In principle, experiments involving the first and second categories of pathogenic microorganisms are prohibited by the center.
The tests involving the third and fourth categories of pathogenic microorganisms shall be carried out after reporting to the safety committee in accordance with the relevant provisions of the state, Beijing Municipality and the center.
Article 10 the classification of pathogenic microorganisms related to experimental activities shall be carried out in accordance with the provisions of the directory of pathogenic microorganisms transmitted from human beings and the directory of classification of animal pathogenic microorganisms formulated by the competent department of health and veterinary medicine under the State Council. Risk assessment and classification shall be carried out for pathogenic microorganisms not included in the list.
Article 11 the collection of samples of pathogenic microorganisms (such as clinical blood samples, tissues, etc.) may be under the unified management of the center, and shall be carried out by the staff with relevant professional knowledge and operation skills by using the corresponding biological safety protection equipment, taking effective measures to prevent the spread and infection of pathogenic microorganisms and technical methods and means to ensure the quality of the samples of pathogenic microorganisms.
Article 12 the preservation of pathogenic microbial (toxin) species or samples shall be carried out in accordance with the relevant provisions of the regulations, the measures for the administration of the institutions for the preservation of pathogenic microbial (toxin) species transmitted from human beings and the measures for the administration of the preservation of animal pathogenic microbial (toxin) species.

Chapter IV laboratory management

Article 13 according to the biosafety protection level of the laboratory for its pathogenic microorganisms, the laboratory level is divided into level I, level II, level III and level IV (BSL-1, BSL-2, BSL-3, BSL-4). The first level of protection is the lowest and the fourth level is the highest. The first, second, third, and fourth level laboratories are generally suitable for the operation of the fourth, third, second, and first categories of pathogenic microorganisms, respectively. The pathogenic microorganism of human infection shall be operated according to the laboratory protection level specified in the directory of pathogenic microorganism of human infection.
Primary and secondary laboratories are set up in the center, and tertiary and quaternary laboratories are not set up.

Article 14 management of primary and secondary laboratories

（1） New construction, reconstruction and expansion of primary and secondary laboratories shall be subject to the approval of the office. The application report shall include the risk assessment report of the pathogenic microorganism to be operated in the laboratory, the solution of ventilation and air conditioning system in the laboratory, the selection of biosafety cabinet and autoclave, and the process flow chart.
（2） The laboratory construction should meet the basic requirements of BSL-1 and BSL-2 laboratories (Trial).
（3） After the completion of the laboratory, the application materials shall be submitted to the safety office, which shall handle the filing work in a unified way to the competent department of health or veterinary medicine of Beijing Municipality. The application materials include the record form of Beijing pathogenic microorganism laboratory and experimental activities, the layout plan of the laboratory and other relevant materials required to be submitted by the competent department of health or veterinary medicine of Wuhan city. The paper version of the application materials shall be in triplicate, and the electronic version shall be submitted at the same time.
（4） When the basic information, experimental activities, person in charge and other important matters related to biosafety of the filed laboratory are changed, the change data shall be submitted to the office of biosafety within 15 working days from the date of change, and the latter shall submit the change description to the original filing administrative department of health within 15 working days after receiving the application.
（5） The validity of the laboratory record is 5 years. If it intends to continue to engage in pathogenic microorganism experiment activities after the expiration of the period, it shall apply for filing again within 3 months before the expiration of the period of validity.
（6） The primary and secondary laboratories shall not be engaged in the experimental activities of highly pathogenic microorganisms beyond the scope.
Article 15 the safety office shall organize training for laboratory staff on a regular basis every year to ensure that they master the laboratory technical specifications, operation procedures, laboratory safety and biological safety protection knowledge and practical operation skills, and pass the examination.
Article 16 the safety office shall monitor the health of the laboratory staff, organize the physical examination of them every year, and establish the health files; if necessary, the laboratory staff shall be vaccinated.
Article 17 a laboratory shall establish a laboratory safety file to record the use and safety supervision of the laboratory, important equipment, controlled reagents, dangerous goods, etc.
Article 18 the center shall, in accordance with the provisions of the regulations on the management of medical waste, formulate corresponding environmental protection measures for the wastes generated in the laboratory in accordance with the requirements of the measures for the management of medical waste in medical and health institutions to prevent environmental pollution. Personnel and management personnel engaged in the collection, transportation, storage and disposal of medical waste shall be trained and monitored.

Chapter V laboratory infection control

Article 19 the laboratory shall formulate the emergency response plan for laboratory infection and file it with the safety office.
Article 20 the laboratory shall arrange personnel to take charge of infection control in the laboratory, regularly check the implementation of rules and regulations on Biosafety protection, pathogen (toxin) species and sample preservation and use, safe operation, waste water and gas discharged by the laboratory and other waste disposal, and regularly investigate and understand the health status of laboratory staff.
Article 21 the center shall sign the medical rescue agreement with the medical institutions with the ability to prevent and control infectious diseases. When the laboratory staff have the infection symptoms or signs related to the pathogenic microorganism engaged in by the laboratory, the laboratory principal shall report to the office and send a special person to accompany the medical institutions under the agreement for medical treatment. During the medical treatment, the hospital shall take the recent contact of the pathogenic microorganism into consideration Inform the medical institutions of the type.
Article 22 in case of the leakage of pathogenic microorganism in the laboratory, the laboratory staff shall take control measures to prevent the spread in accordance with the emergency plan, and report to the laboratory principal and the safety office at the same time.
Article 23 after receiving the report, the safety office shall immediately launch the emergency response plan for laboratory infection and organize the biosafety committee to investigate; if it is confirmed that laboratory infection or pathogenic microorganism leakage occurs, it shall report to the competent department of health or veterinary medicine of Changping District, and at the same time take control measures to conduct medical observation or isolation treatment for relevant personnel Cure, close laboratory, prevent diffusion.
Chapter VI Legal Liability
Article 24 in case of any of the following acts, the center shall order it to make corrections within a time limit and give a warning; if it fails to make corrections within the time limit, the main person in charge, the directly responsible person in charge and other directly responsible persons shall be dismissed or dismissed according to law:
（1） Failing to mark biohazard signs and biosafety laboratory level signs at obvious positions in the laboratory;
（2） Failing to report the results of experimental activities and work conditions to the original approval department;
（3） Failing to collect samples that may contain pathogenic microorganisms according to regulations (such as clinical blood samples, tissues, etc.), or failing to make detailed records on the source, collection process and method of the collected samples;
（4） The newly-built, rebuilt or expanded primary and secondary laboratories have not been filed with the competent authorities;
（5） Failing to train the staff regularly according to the regulations, or allowing the staff to go on duty if they fail to pass the examination, or approving the personnel who have not taken protective measures to enter the laboratory;
（6） The laboratory staff fails to comply with the biosafety technical specifications and operating procedures of the laboratory;
（7） Failing to establish or keep the experimental archives in accordance with the provisions;
（8） Failing to formulate emergency response plan for laboratory infection and put it on record.
Article 25 in case of any of the following acts, the center shall order to stop the relevant activities, supervise the destruction or delivery of the pathogenic microorganism used for the experimental activities to the depository institution, and give a warning; in case of causing the spread, epidemic or other serious consequences of infectious diseases, the main responsible person, the directly responsible person in charge and other directly responsible persons shall be dismissed or dismissed according to law If a crime is constituted, criminal responsibility shall be investigated according to law:
（1） Without the biological risk assessment and approval of the safety committee, engaging in the experimental activities of suspected highly pathogenic microorganisms in the primary or secondary laboratory;
（2） Engaging in experimental activities in a laboratory that does not meet the corresponding biosafety requirements;
（3） Using new technologies and methods that have not been evaluated by the biosafety committee to engage in the experimental activities related to highly pathogenic microorganisms;
（4） Where the pathogenic microorganism is stolen, robbed, lost or leaked, or the laboratory staff fails to report or take control measures in accordance with the provisions due to the clinical symptoms or signs of infection related to the pathogenic microorganism engaged in by the laboratory;
（5） Refusing to accept the investigation and evidence collection, sample collection and other activities or taking relevant prevention and control measures by the competent authorities at a higher level according to law;
Chapter VII supplementary provisions
Article 26 matters not covered in these Measures shall be implemented in accordance with the relevant provisions of the state and local competent departments.
Article 27 the central biosafety management office shall be responsible for the interpretation of these measures.
These Measures shall be implemented as of the date of promulgation.

Forms & Regulations

Laboratory safety and biosafety management measures