Search result: WS/T 442-2024 (WS/T 442-2014 Older version)
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Guideline for clinical laboratory biosafety
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WS/T 442-2024
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| WS/T 442-2014 | English | 1319 |
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Guideline for clinical laboratory biosafety
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WS/T 442-2014
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| Standard ID | WS/T 442-2024 (WS/T442-2024) | | Description (Translated English) | Guideline for clinical laboratory biosafety | | Sector / Industry | Health Industry Standard (Recommended) | | Classification of Chinese Standard | C50 | | Classification of International Standard | 11.020 | | Word Count Estimation | 31,321 | | Date of Issue | 2024-04-02 | | Date of Implementation | 2024-09-01 | | Older Standard (superseded by this standard) | WS/T 442-2014 | | Summary | This standard specifies the basic requirements for biosafety facilities, equipment and management of clinical laboratories in medical institutions. This standard applies to clinical laboratories (referred to as "laboratories") with a biosafety protection level of Level 2, and does not apply to biosafety Level 3 and Level 4 laboratories. |
The main drafting units of this standard. The First Affiliated Hospital of China Medical University, the Clinical Laboratory Center of the Ministry of Health, the 302 Hospital of Beijing People’s Liberation Army,
Peking University People’s Hospital, Jilin Province Clinical Laboratory Center, Shaanxi Province Clinical Laboratory Center, Guangdong Province Clinical Laboratory Center, Jilin University First Medical
Hospital, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing Tiantan Hospital, Beijing Coal General Hospital, Tongji Medical College of Huazhong University of Science and Technology
Ji Hospital, Da'an Clinical Laboratory Center.
The main drafters of this standard. Shang Hong, Mao Yuanli, Ding Jiahua, Ren Jiankang, Zou Weimin, Xu Wei, Wang Qingtao, Kang Xixiong, Qin Xiaoguang, Zhang Jinfeng,
Shen Ziyu, Wang Zhiguo, Zhang Zheng, Sun Zipu, Geng Wenqing, Wang Qian.
This standard specifies the basic requirements for the facilities, equipment and safety management of clinical laboratories at the second level (covering the first level) biosafety protection level.
This standard applies to clinical laboratories involved in the operation of biological factors.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
Classification catalog of medical waste, Ministry of Health, State Environmental Protection Administration,.2003
Provisions on the Standards and Warning Labels for Special Packaging and Containers of Medical Wastes, State Environmental Protection Administration,.2003
3 Terms and definitions
The following terms and definitions apply to the document.
3.1
Aerosol
The particle size suspended in the gas medium is generally 0.001 jim-100 jim solid or liquid particles formed by relatively stable particles.
Scattered system.
3.2
Accident
Unexpected circumstances that cause death, disease, injury, damage, and other losses.
3.3
Biological agent
Microorganisms and biologically active substances.
3.4
Biological safety cabinet; BSC
The operation cabinet with airflow control and high-efficiency air filtration device can effectively reduce the harmful aerosol generated during the experiment to the operator
And environmental hazards.
3.5
Directional airflow
A controlled airflow from an area with a low probability of pollution to an area with a high probability of pollution.
3.6
Hazard
The source or condition that may result in death, injury or illness, property damage, work environment destruction, or a combination of these conditions.
3.7
Hazard identification
The process of identifying existing hazards and determining their characteristics.
3.8
High efficiency particulate air filter; HEPA
The filter usually uses 0.3 im particles as the test object, and the filter efficiency is higher than 99.97% of the air filter under the specified conditions.
3.9
Incident
Circumstances that cause or may cause an accident.
3.10
Clinical laboratory
Perform biology, microbiology, immunology, chemistry, blood immunology, hematology, biophysics, detailed analysis on various specimens taken from the human body
Laboratory for cytology and other tests, and provide clinical medical test services. Applicable to pathogens with level 2 (covering level 1) biosafety protection level
Physical examination does not apply to pathogen examination with the third-level biosafety protection level.
3.11
Clinical laboratory biosafety
Ensure that the biological safety conditions and status of clinical laboratories are not lower than the allowable level, and avoid laboratory personnel, visitors, communities and the environment
Subject to unacceptable damage, comply with relevant regulations, standards and other requirements for clinical laboratories to ensure biosafety responsibility.
3.12
Material safety data sheet; MSDS
A technical bulletin that provides detailed information on the dangers and precautions of a certain material.
3.13
Personal protective equipment; PPE
Equipment and supplies used to prevent individuals from being injured by biological, chemical or physical dangerous factors.
3.14
Risk
A combination of the probability of a hazard and the severity of its consequences.
3.15
Risk assessment
The whole process of assessing the magnitude of the risk and determining whether it is acceptable.
3.16
Risk control
Comprehensive measures taken to minimize risks.
3 doors 7
Disinfection
The process of removing or killing pathogenic microorganisms, but not necessarily killing bacterial buds.
3.18
Sterilization
The process of killing all microorganisms by physical or chemical methods, including killing bacterial buds.
Clinical laboratory risk assessment and risk control
4.1 The clinical laboratory shall establish and maintain laboratory risk assessment and risk control procedures, and continue to carry out risk identification, risk assessment and implementation
Necessary control measures.
4.2 When clinical laboratory activities involve pathogenic biological factors, the laboratory should conduct biological risk assessment. Risk assessment should consider (but not
Limited to) the following.
a) The known or unknown characteristics of biological factors, such as the type, source, infectivity, route of transmission, susceptibility, incubation period, agent
Quantity-effect (response) relationship, pathogenicity (including acute and long-term effects), variability, stability in the environment, and other biological
Interaction with the environment, relevant experimental data, epidemiological data, prevention and treatment plans, etc.;
b) Where applicable, analysis of accidents that have occurred in the clinical laboratory itself or related laboratories;
c) Risks during routine and non-routine activities in clinical laboratories (not limited to biological factors), including all entry into the workplace
The activities of the personnel and the personnel that may be involved (such as the personnel of the contract party);
d) Risks related to facilities and equipment;
e) Where applicable, risks related to laboratory animals;
f) Person-related risks, such as physical condition, ability, pressure that may affect work, etc.;
g) Accidents and risks brought by accidents
h) The risk of misuse or malicious use;
i) The scope, nature and time limit of the risk;
j) Evaluation of the probability of occurrence of the hazard;
k) Analysis of possible hazards and consequences;
D Determine acceptable risks;
m) Where applicable, management measures and technical measures to eliminate, reduce or control risks, and residual risks or new risks after the measures are taken
evaluation of;
n) When applicable, evaluation of the degree of adaptability of operating experience and risk control measures taken;
0) When applicable, emergency measures and expected effect evaluation;
p) When applicable, the assessment of information and resources (including external resources) required to reduce risks and control hazards;
q) Comprehensive assessment of risks, needs, resources, feasibility, practicality, etc.
4.3 The risks of all planned activities should be assessed in advance, including chemical, physical, radiation, electrical, flood, fire, natural disasters, etc.
The risk is assessed.
4.4 Risk assessment should be carried out by experienced professionals (not limited to personnel within the organization).
4.5 The risk assessment process should be recorded. The risk assessment report should indicate the time, the author and the regulations, standards, research reports, authoritative resources
Materials, data, etc.
4.6 Risk assessment or review of risk assessment reports should be carried out on a regular basis. The assessment cycle can be determined according to clinical laboratory activities and risk characteristics.
determine.
4.7 Carry out new clinical laboratory activities, or want to change the evaluated clinical laboratory activities (including related facilities, equipment, personnel,
Scope, management, etc.), risk assessment should be carried out in advance or again.
4.8 When operating abnormal amounts or engaging in special activities, clinical laboratories should conduct risk assessments to determine their biosafety protection requirements and apply
It should be approved by the relevant competent authority.
4.9 The risk assessment should be re-assessed when an incident or accident occurs.
4.10 When there is an unexplained sudden and infectious public health event and it is necessary, the clinical laboratory should be based on clinical data, epidemic
Emergency risk assessment is carried out with medical data and other relevant information available.
4.11 When relevant policies, regulations, standards, etc. change, the risk assessment should be re-assessed.
4.12 When taking risk control measures, it should first consider eliminating hazards (if feasible), and then consider reducing risks (reducing potential hazards)
Probability or severity of occurrence), and finally consider the use of personal protective equipment.
4.13 The process of hazard identification, risk assessment and risk control is not only applicable to the routine operation of clinical laboratories, facilities and equipment, but also applicable
During the cleaning, maintenance or shutdown of clinical laboratories, facilities and equipment.
4.14 In addition to considering the risks of the clinical laboratory’s own activities, the activities of external personnel and the use of externally provided goods or services should also be considered.
risks of.
4.15 Clinical laboratories should have mechanisms to monitor the activities required by them to ensure that relevant requirements are implemented in a timely and effective manner.
4.16 The complexity of clinical laboratory risk assessment and risk control activities depends on the characteristics of the risks in the laboratory. When applicable, the clinical
Laboratories do not necessarily need complex risk assessment and risk control activities.
4.17 The risk assessment report is the basis for the clinical laboratory to take risk control measures, establish a safety management system, and formulate safety operating procedures.
4.18 The data on which the risk assessment is based, the risk control measures to be adopted, and safety operating procedures shall be determined by the national competent authority and the World Health Organization
The guidelines, standards, etc. issued by the Health Organization, the World Organization for Animal Health, the International Organization for Standardization and other institutions or industry authorities are the basis; any new
The technology should be fully demonstrated before use, and when applicable, it should be approved by the relevant competent authority.
4.19 The risk assessment report should be approved by the biosafety authority of the institution where the clinical laboratory is located; the relevant authority of the country not listed
The risk assessment report of the biological factors in the list of pathogenic microorganisms issued by the department shall be approved by the relevant competent authority when applicable.
5 Classification of laboratory biosafety protection level
5.1 According to the protective measures taken for the biological factors to be operated, the laboratory biosafety protection level is divided into 4 levels, with the level 1 protection level the most
Low, level 4 protection level is the highest.
5.2 BSL-1.BSL-2, BSL-3, BSL-4 (BSL, bio-safety level) indicate the corresponding biological
Safety protection level.
5.3 ABSL-1, ABSL-2, ABSL-3.ABSL-4 (ABSL, animal bio-safety level) means that includes engaging in animal live gymnastics
The corresponding biological safety protection level of the laboratory where it is operated.
5.4 According to differences in experimental activities, personal protective equipment and basic isolation facilities, the laboratory is divided into the following situations.
a) Operating laboratories that are generally considered to be non-airborne pathogenic biological agents;
b) Laboratories that can effectively use safety isolation devices (such as biological safety cabinets) to operate routine airborne pathogenic biological agents;
.) Laboratories that cannot effectively use safety isolation devices to operate conventional airborne pathogenic biological factors;
d) Use positive pressure suits with life support systems to operate laboratories that transmit pathogenic biological agents through the air in a regular amount.
5.5 According to the classification list of pathogenic microorganisms issued by relevant national authorities, and on the basis of risk assessment, determine the biological
Safety protection level.
Clinical laboratory design principles and basic requirements
6.1 The site selection, design and construction of clinical laboratories shall comply with national and local planning, environmental protection, sanitation and construction authorities’ regulations and
Claim.
6.2 The fire prevention and safety passages of clinical laboratories should meet the national fire protection regulations and requirements, and the special requirements of biological safety should be considered.
If necessary, you should seek advice from the fire control department in advance.
6.3 The safety and security of clinical laboratories shall comply with the safety management regulations and requirements of relevant national departments for such facilities.
6.4 The building materials and equipment of clinical laboratories shall comply with the regulations and requirements of relevant national departments on the production, sales and use of such products.
Claim.
6.5 The design of clinical laboratories should ensure that the protection level against biological, chemical, radiation and physical hazards is controlled within the assessed accessible level.
Within the scope of acceptance, and prevent harm to the associated office area and adjacent public spaces.
6.6 The corridors and passages of the clinical laboratory should not hinder the passage of people and objects.
6.7 Emergency evacuation routes should be designed, and emergency exits should be clearly marked.
6.8 Install door locks on the door of the room as needed, and the door lock should be able to open quickly in case of emergency.
6.9 When necessary (such as when dangerous materials are being handled properly), there should be warnings and restrictions on the population of the room.
6.10 The risks of misuse, theft and improper use of biological materials, samples, drugs, chemicals, and confidential information should be assessed, and the
Take corresponding physical precautions.
6.11 There should be specially designed safety measures to ensure the storage, transfer, collection, processing and disposal of hazardous materials, and sound safety protection systems should be in place.
Degree, marking and safety protection items.
6.12 Indoor environmental parameters such as ventilation, temperature, humidity, illuminance, noise, and cleanliness in clinical laboratories should meet the requirements of work and hygiene.
Close requirements.
6.13 The design of clinical laboratory should consider the requirements of energy saving, environmental protection and comfort, and should meet the requirements of occupational hygiene and ergonomics.
6.14 Clinical laboratories should have measures to prevent the entry of arthropods and rodents.
6.Clinical laboratories should refer to the secondary biosafety laboratories to achieve zoning and diversion.
7 Clinical laboratory facilities and equipment requirements
7.1 BSL-1 laboratory
7.1.1 The door of the laboratory should have windows and lockable, and the door lock and the opening direction of the door should not hinder the escape of indoor personnel.
7.1.2 Hand wash basin should be provided. The sink should be located near the exit of the laboratory.
7.1.3 There should be a clothing storage or hanging device at the entrance of the laboratory, and personal clothing can be separated from laboratory work clothes.
7.1.4 The walls, ceilings and floors of the laboratory should be easy to clean, impermeable, and resistant to corrosion by chemicals and disinfectants. The ground should be level and non-slip,
Carpet should not be laid.
7.1.5 The laboratory benches and chairs should be stable, and the corners should be rounded to prevent accidental injury.
7.1.6 Laboratory benches, etc. and their placement should be easy to clean, and the test bench should be waterproof, corrosion-resistant, heat-resistant and strong.
7.1.7 The laboratory should have enough space and cabinets to place laboratory equipment and articles.
7.1.8 Laboratory equipment, cabinets, articles, etc. should be placed reasonably according to the nature of the work and process to avoid mutual interference and cross-contamination.
Obstruct escape and first aid.
7.1.9 Natural ventilation can be used in the laboratory. If mechanical ventilation is used, cross contamination should be avoided.
7.1.10 If there are windows that can be opened, mosquito-proof screens should be installed.
7.1.11 Unnecessary reflections and glare should be avoided in the laboratory.
7.1.12 If irritating or corrosive substances are handled, an eyewash device should be installed within 30 m, and an emergency spray device should be installed when necessary.
7.1.13 If handling toxic, irritating, radioactive volatile substances, appropriate negative pressure fume hoods should be equipped on the basis of risk assessment.
7.1.14 If highly toxic or radioactive materials are used, corresponding safety facilities, equipment and personal protective equipment shall be
Relevant regulations and requirements of the Party.
7.1.15 If high-pressure gas and combustible gas are used, safety measures should be taken and should comply with relevant national and local regulations and requirements.
7.1.16 Emergency lighting devices should be provided.
7.1.17 There should be sufficient power supply.
7.1.18 There should be enough fixed power sockets to avoid multiple devices from using a common power socket. There should be a reliable grounding system,
The key nodes are equipped with leakage protection devices or monitoring alarm devices.
7.1.19 The water supply and drainage piping system should not leak, and the sewage should be designed to prevent backflow.
7.1.20 Applicable emergency equipment should be equipped, such as fire fighting equipment, accident handling equipment, first aid equipment, etc.
7.1.21 Applicable communication equipment should be provided.
7.1.22 When necessary, appropriate disinfection equipment shall be provided.
7.2 BSL-2 laboratory
When applicable, it shall meet the requirements of 7.1.
The door of the main body of the laboratory and the door of the laboratory room where the biological safety cabinet is placed should be automatically closed.
There should be conditions for storing spare items outside the laboratory work area.
An eyewash device should be provided in the laboratory work area.
The laboratory or the building where it is located should be equipped with a high-pressure steam sterilizer or other appropriate disinfection equipment.
It should be based on risk assessment.
7.2.6 Corresponding biological safety cabinets should be provided in the laboratory room for handling pathogenic microorganism samples.
7.2.7 The biological safety cabinet shall be installed and used according to the design requirements of the product. If the exhaust air of the biological safety cabinet is circulated indoors, the room should have
Ventilation conditions; if a biological safety cabinet that requires ducted exhaust is used, it should pass through ducts independent of other public ventilation systems in the building
discharge.
7.2.8 There should be a reliable power supply. When necessary, important equipment such as incubators, biological safety cabinets, refrigerators, etc. should be equipped with backup power supplies.
8 Management requirements
8.1 Organization and management
8.1.1 Clinical laboratories (including independent medical testing laboratories) or their medical institutions shall have clear legal status and relevant activities.
qualifications.
8.1.2 The medical institution where the clinical laboratory is located should set up a biosafety committee responsible for consulting, guiding, evaluating, and supervising the laboratory’s biological safety
Security related matters. The person in charge of the clinical laboratory should be at least a competent member of the biosafety committee of the institution.
8.1.3 The clinical laboratory management shall be responsible for the design, implementation, maintenance and improvement of the safety management system, and shall be responsible for.
a) Provide all personnel in clinical laboratories with appropriate powers and resources needed to perform their duties;
b) Formulate prevention policies and procedures involving the leakage of biosafety confidential information;
C) Clarify the organization and management structure of the clinical laboratory, including the relationship with other relevant departments;
d) stipulate the responsibilities, powers and relationships of all personnel;
e) Arrange competent personnel to conduct necessary training and supervision of clinical laboratory personnel based on their experience and responsibilities;
f) Designate a safety officer to give him the responsibility and authority to supervise all activities, including the development, maintenance and supervision of clinical laboratory safety
The responsibility of the whole plan, the power to prevent unsafe behaviors or activities, directly report to the management that determines the clinical laboratory policies and resources
Power to sue;
g) Designate the safety person in charge of each professional group, who is responsible for formulating and submitting the biosafety protection plan and risk to the clinical laboratory management
Evaluation report, safety and emergency measures, professional team personnel training and health supervision plan, safety assurance and resource requirements;
h) Appoint agents for all key positions.
8.1.4 The clinical laboratory safety management system should be compatible with the laboratory scale, the complexity of laboratory activities and the risks.
8.1.5 The biosafety policies, processes, plans, procedures and instructions of clinical laboratories shall be documented and communicated to all relevant persons
member. The clinical laboratory management should ensure that these documents are easy to understand and implementable.
8.1.6 Biosafety management system documents usually include management manuals, procedural documents, safety manuals, operating procedures, records and other documents.
A safety manual for the on-site staff to use quickly.
8.1.7 All personnel should be instructed to use and apply relevant safety management system documents and their implementation requirements, and evaluate their understanding and application
Ability.
8.2 Management responsibility
8.2.1 The clinical laboratory management shall be responsible for the safety of all employees, visitors, contractors, communities and the environment.
8.2.2 Proactively inform all employees, visitors, and contractors of the possible biosafety risks.
8.2.3 The personal rights and privacy of employees shall be respected.
8.2.4 Opportunities for continuous training and continuing education should be provided to employees to ensure that employees are competent for the assigned tasks.
8.2.5 Employees should be provided with necessary immunization plans, regular health checks and medical insurance.
8.2.6 It should be ensured that the clinical laboratory facilities, equipment, personal protective equipment, materials, etc. meet the relevant national safety requirements, and regular inspections and maintenance
To ensure that the design performance is not reduced.
8.2.7 Applicable protective equipment and equipment that meet the requirements should be provided to employees.
8.2.8 Applicable experimental articles and equipment that meet the requirements should be provided to employees.
8.2.9 It should be ensured that employees do not work fatigue and do not engage in work whose risks cannot be controlled or prohibited by national laws and regulations.
Personal responsibility
8.4.1.1 The guidelines and objectives of clinical laboratory safety management should be specified in the safety management manual. The clinical laboratory safety management policy should
Be concise and at least include th......
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