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Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China
Journal of Biosafety and Biosecurity xxx (xxxx) xxx
Contents lists available at ScienceDirect
Journal of Biosafety and Biosecurity journal homepage: www.elsevier.com/locate/jobb
Research Article
Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China Peijun Zhai, Rong Wang, Yongyun Zhou, Dongmei Hu, Junyan li, Yali Zhou China National Accreditation Service for Conformity Assessment (CNAS), China
a r t i c l e
i n f o
Article history: Received 27 November 2018 Accepted 11 December 2018 Available online xxxx Keywords: Accreditation Management Biosafety laboratories
a b s t r a c t Accreditation is now widely used to attest for laboratory competence. Although accreditation was originally used to assess products in testing laboratories and still plays an increasingly important role in international trade, it has been expanded to include laboratories in many social fields, including forensic science, medicine, and animal quarantine reference. The accreditation process provides basic requirements for achieving global recognition for laboratory reports. This paper introduces the concept of accreditation and discusses the origins and development of the accreditation system in Chinese biosafety laboratories. This study also reveals the important role of this system in national biosafety management through an examination of the 14-year development of the Chinese biosafety laboratory accreditation system. Ó 2018 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.
1. Accreditation worldwide 1.1. The concept of accreditation Accreditation is formal certification by a third party. It is the result of a conformity assessment performed to confirm capability in a specific field.1 Here, conformity assessment refers to the verification of whether certain products, processes, systems, personnel, or organizations comply with specific requirements. Conformity assessment bodies refer to institutions that engage in conformity assessment services. This generally includes certification bodies, laboratories, and inspection agencies. In short, accreditation is used to confirm that a conformity assessment body meets specified requirements and is technically capable, thus lending credibility from the government, management, general public, users, and consumers about the data and results in reports issued by the conformity assessment body. Accreditation is a crucial driving force by which conformity assessment bodies can improve managerial and technical capability. Accreditation bodies, conformity assessment bodies, and clients are connected through their different roles and responsibilities in the conformity assessment scheme (Fig. 1).2 As evident in Fig. 1, accreditation remains at the top throughout the entire chain of the conformity assessment and verification process. It is also included in a broader conformity assessment sense;
an accreditation body is, by essence, not a conformity assessment body. During the accreditation process, an accreditation body carries full responsibility for all accreditation activities, which must be in full compliance with specific laws, regulations, standards, protocols, and agreements. The accreditation body should be equipped with specific competence and is accountable for the impartiality of its service. Its decisions must be authentic, accurate, and valid. Meanwhile, accredited conformity assessment bodies are the actual undertakers of conformity assessment. They assume every responsibility for their conformity assessment activities, which are to be conducted impartially and in full accordance with any accreditation requirements. They should also meet any competence specifications.3
1.2. Global accreditation system Accreditation originated in 1947. There are thus over 70 years of accreditation history. Cooperative global and regional laboratory accreditation organizations were gradually established during a period of surging international trade and communication during the 1990s. Today, the global accreditation system consists of the International Laboratory Accreditation Cooperation (ILAC) and many regional organizations, including the Asia Pacific Laboratory
https://doi.org/10.1016/j.jobb.2018.12.008 2588-9338/Ó 2018 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.
Please cite this article as: P. Zhai, R. Wang, Y. Zhou et al., Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j.jobb.2018.12.008
2
P. Zhai et al. / Journal of Biosafety and Biosecurity xxx (xxxx) xxx
Fig. 1. Conformity assessment scheme.
Accreditation Cooperation (APLAC) and the European Accreditation Cooperation Organization (EA). The ILAC currently consists of 120 member-accreditation bodies across the globe. Its mission is to promote the coordination of global accreditation activities and the recognition of accreditation results across national borders (i.e., ‘‘tested once and accepted everywhere”). The pillar measure to achieve that goal is the ILAC Mutual Recognition Arrangement (ILAC MRA). To date, over 100 accreditation bodies have signed the ILAC MRA and have been peer evaluated. ILAC standards include the following: ISO/IEC 17025 for testing and calibration laboratories (General competency requirements for testing and calibration laboratories), ISO 15189 for medical testing laboratories (quality and competence requirements for medical laboratories), ISO/IEC17020 for inspection bodies (conformity assessment requirements for the operation of various types of bodies performing inspection), ISO/IEC17043 for proficiency testing providers (conformity assessment and general requirements for proficiency testing), and ISO/IEC17034 for producers of reference materials (general competency requirements for reference material producers). As indicated by the list above, the ILAC accreditation system focuses on institutional capabilities and laboratory and inspection service quality. This generally involves no direct safety or biosafety concerns. The ILAC also specifies that accreditation bodies across the globe should operate in accordance with ISO/IEC 17011 (conformity assessment requirements for accreditation bodies that accredit conformity assessment bodies) and follow all relevant policies and requirements. The ILAC indicates that all complying bodies should use international standards to accredit both laboratories and inspection bodies. The ILAC system is now the most prestigious accreditation system for laboratories and inspection bodies worldwide. ILAC accreditation is recognized by international and regional organizations across the globe.
2. Accreditation in China 2.1. The Chinese accreditation system China established its own accreditation system in the 1990s to meet the development needs of the socialist market economy. In accordance with the Regulations of the People’s Republic of China on Certification and Accreditation and upon integration of relevant branches from various government departments, the National Certification and Accreditation Administration (CNCA) approved the establishment of the China National Accreditation Service for Conformity Assessment (CNAS). The CNAS was then named as the single state authority in charge of conducting accreditation for conformity assessment bodies across China. Since then, CNAS rep-
resents China in global accreditation affairs and is a full member of the ILAC and APLAC. In accordance with ISO/IEC 17011 (GB/T 27011), CNAS established a standardized accreditation system and now conducts accreditation activities with internationally accepted principles and procedures. By December 31, 2017, CNAS had accredited 9543 conformity assessment bodies in a variety of industries. As one pillar of the National Quality Infrastructure (NQI), accreditation plays a progressively important role in national quality enhancement and economic development. It also provides essential technical support for government administration. There are currently 46 Chinese laws, regulations, and administrative orders that either directly or indirectly accept accreditation results. CNAS has always attached great importance to exchanges and cooperation with international organizations and counterparts. It has signed multilateral mutual recognition agreements (MRAs) with 101 international accreditation institutions in 97 countries and economies. CNAS also sends staff to critical posts in many international organizations and actively participates in the development and revision of various international accreditation policies and requirements. It also works on some ISO standards. CNAS places special emphasis on science and technology; it has recently organized or participated in relevant research in different fields. CNAS continues to identify the evolving conformity assessment needs for national economic development by establishing and innovating new mechanisms and measures to create a solid technical foundation for high-quality Chinese progress. For example, CNAS established the Chinese national biosafety laboratory accreditation system in 2004. 2.2. The Chinese national biosafety laboratory accreditation system The Chinese biosafety laboratory accreditation system is a result of the need to prevent and control major epidemics. The SARS epidemics in 2003 painfully alerted China to an urgent weakness in biosafety laboratory capacity. There was a total lack of unified laboratory biosafety standards and relevant evaluation systems in China at that time. Authorized by the Ministry of Science and Technology, CNAS organized the development of the national laboratory biosafety standards with the cooperation of Chinese health, agricultural, and quality inspection departments. National Compulsory Standard GB19489-2004 ‘‘Laboratories – General requirements for biosafety” was officially released on May 28, 2004. This signified the initiation of a unified and authoritative basis for the construction and evaluation of high-level biosafety laboratories in China. In 2004, the State Council of China promulgated Order 424, ‘‘Regulations on the Bio-safety Management of Pathogenic Microbe Labs” (hereinafter referred to as the ‘‘Regulations”).4 According to its Article 20, (A)BSL-3 and (A)BSL-4 laboratories shall be required to pass national accreditation. In essence, this constitutes compulsory accreditation requirements for high-level biosafety laboratories in China. Upon standardizing its laboratory accreditation system, CNAS developed a series of accreditation documents in accordance with GB19489-2004 ‘‘Laboratories – General requirements for biosafety.” By the end of 2004, CNAS had established a Chinese national biosafety laboratory accreditation system that was capable of accrediting high-level biosafety laboratories. CNAS issued the first national accreditation certificate for highlevel biosafety laboratories on June 2, 2005. As of April 30, 2018, after more than 10 years of conscientious efforts made in accordance with the ‘‘Regulations,” CNAS had accredited a total of 80 biosafety laboratories, including 23 BSL-2 and 57 (A)BSL-3/4 laboratories. During its biosafety laboratory accreditation years, CNAS has been active in scientific research and has organized or participated
Please cite this article as: P. Zhai, R. Wang, Y. Zhou et al., Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j.jobb.2018.12.008
P. Zhai et al. / Journal of Biosafety and Biosecurity xxx (xxxx) xxx
in a number of national or provincial-level biosafety projects. With its continuous contribution and the constant flow of scientific outputs, CNAS has experienced significant progress in its technical capabilities. This has brought increasing credibility to its services. 3. Operation of the national biosafety laboratory accreditation system 3.1. Biosafety laboratory accreditation requirements The Accreditation Criteria for Laboratory Biosafety (CNAS-CL05) is the current document used by CNAS for biosafety laboratory accreditation. It includes relevant terms from GB19489-2008 ‘‘Laboratories - General requirements for biosafety”5 and the Regulations. Chapter 3 specifies the requirements for laboratory risk assessment in CNAS-CL05. This includes risk identification, analysis, control, and management, thus requiring laboratories to establish risk management procedures. These measures emphasize risk assessment as a basis for laboratory management and requires risk control to be an integral part of laboratory biosafety management. Thus, risk assessment management is laboratory management; Chapter 6 provides construction specifications for BSL2-4 biosafety laboratories, including those for floor plans, environmental parameters, HVAC, electrical controls, and water supply and drainage systems. Chapter 7 deals with the establishment and operation of the biosafety management system, including organizational, document management, personnel management, activity management, housekeeping, internal audit and management review, corrective actions, waste disposal, and emergency response issues. Chapter 7 also incorporates relevant requirements into ISO/IEC17025 (general competency requirements for testing and calibration laboratories). Also considering the unique characteristics of biosafety laboratories, this offers detailed specifications on laboratory safety plans, safety inspections, waste disposal, and incident reporting. CNAS has progressively built on its accreditation specifications and procedures according to identified problems and emerging demands during its years of involvement in biosafety laboratory accreditation. It offered implementation details for CNAS-CL05 by releasing CNAS-CL05-A001 ‘‘Guidance on the Application of Laboratory Biosafety Accreditation Criteria: Evaluation of Mobile Laboratories.” It also issued CNAS-CL05-A002 ‘‘Guidance on the Application of Laboratory Biosafety Accreditation Criteria: Evaluation of Key Protective Equipments” concerning biosafety devices (e.g., biosafety cabinets, autoclaves and animal isolation equipment). CNAS facilitated understanding of relevant accreditation documents by publishing supporting documents such as the Accreditation Guide for ABSL-2 Biosafety Laboratories (CNASGL031) for the accreditation of animal biosafety laboratories. 3.2. Biosafety laboratory accreditation procedures and cycles 3.2.1. Application An applicant for laboratory accreditation should have clear legal status and the ability to assume any corresponding legal responsibilities. Such an applicant can be either an independent legal entity or an institution authorized by an independent legal entity. The Regulations indicate that (A)BSL-2 biosafety laboratories should file necessary documents at the health/veterinary department of their local municipality prior to application. (A) BSL-3 and BSL-4 laboratories should first become listed in the national biosafety laboratory system development plan. They should then clear a construction review conducted by the Ministry of Science and Technology before passing the environmental impact assessment and gaining approval from the environmental protection
3
department. The next step is to obtain verification for full compliance with relevant standards, including GB19489-2004 ‘‘Laboratories – General requirements for biosafety” and GB50346 ‘‘Architectural and Technical Code for Biosafety Laboratories.” Entities seeking accreditation are then required to obtain inspection and acceptance by the construction department. After completing the above procedures, biosafety laboratories should establish biosafety management systems and begin trial operation according to the accreditation requirements for biosafety laboratories. Biosafety laboratories may submit accreditation applications to CNAS upon self-evaluation and obtaining satisfactory results during the trial period. Considering the high complexity and huge investments involved in constructing (A)BSL-4 laboratories, CNAS may initiate accreditation activities as soon as a laboratory design is complete. It can then perform the accreditation review process according to three phases (i.e., design document review, installation and trial operation review of key protective equipment, and safety management system and containment capability confirmation). Accreditation certificates may be issued upon completion of the third phase. 3.2.2. Acceptance and review Once an application for laboratory accreditation meets acceptance requirements, CNAS will issue an acceptance notice to the applicant and organize an accreditation review team. The review process is divided into the document review and onsite inspection stages. Document review refers to a process of verification by which the compliance review team assesses the provided application materials through relevant accreditation criteria. On-site inspection refers to a compliance verification by which the review team inspects the floor plan, structure, facilities, equipment, and other hardware. The team will also review the safety management system of the applicant laboratory according to relevant accreditation requirements. 3.2.3. Appraisal and certification The review team inspects documented corrective actions provided by the applicant laboratory and then determines whether to recommend the laboratory to CNAS for accreditation. The CNAS Appraisal Committee will evaluate the overall compliance of each recommended laboratory within the accreditation requirements before making its final decision. The CNAS Secretariat issues a notice of the accreditation decision along with an accreditation certificate for each successful accreditation result. Accreditation is valid for 5 years. 3.2.4. Surveillance assessment and reassessment A surveillance assessment is conducted to verify that accredited laboratories continue to meet requirements throughout the validity period of the accreditation certificate. Accredited (A)BSL-2 and (A)BSL-3 biosafety laboratories should receive regular surveillance reviews before 12-month, 30-month, and 48-month periods after obtaining accreditation. BSL-4 laboratories should receive surveillance reviews every 12 months. Surveillance reviews for (A)BSL-3 and (A)BSL-4 laboratories should be conducted after terminal disinfection of the laboratory. Surveillance reviews do not require application and are often conducted on site. Accredited laboratories shall apply for reassessment six months before the accreditation certificate expires. The reassessment process employs the same cycle and procedures performed upon initial accreditation. 3.2.5. Changes Accredited laboratories must notify the CNAS Secretariat in a written form if any of the following changes take place during the validity period of the accreditation certificate:
Please cite this article as: P. Zhai, R. Wang, Y. Zhou et al., Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j.jobb.2018.12.008
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P. Zhai et al. / Journal of Biosafety and Biosecurity xxx (xxxx) xxx
a) Changes in laboratory name, address, or legal status b) Changes in key management, technical personnel, or safety personnel c) Changes in biological agents or laboratory activities within the same hazard level (according to the List of Pathogenic Microorganisms issued by the national health/veterinary department) d) Changes in equipment or facilities with potential impacts on biosafety containment e) Other changes with potential impacts on the safety of laboratory operation and activities Upon notification and verification of the above changes, the CNAS Secretariat may require another on-site inspection or simply ask for any necessary documents. 3.3. Quality assurance for biosafety laboratory accreditation 3.3.1. Quality management system for institutional operation CNAS established a standardized quality management system that applies to quality manuals, procedures, and tables in accordance with GB/T 27011 (ISO/IEC 17011), ‘‘Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies.” The accreditation documents and procedures listed in the previous chapter are developed in accordance with this document approval process. All key steps of the accreditation service cycle are recorded and traceable to guarantee the validity and accuracy of the biosafety laboratory accreditation process. 3.3.2. Professional biosafety technical support committee The CNAS Biosafety Professional Committee consists of more than 40 experts from a variety of government agencies, health and agricultural laboratory management departments, laboratories, and inspection bodies. All entities have rich biosafety laboratory experience in the fields of management, research, testing, and pharmaceutics. The committee is mainly responsible for contributing expertise in biosafety laboratory accreditation. This includes the review of published technical requirements for accreditation and team-review participation. 3.3.3. Assessor management system for team building CNAS accredited assessors have professional backgrounds in health, agriculture, and university-level academics. These individuals cover disciplines in microbiology, public health, veterinary medicine, management, construction, HVAC, and automation. The CNAS assessor management system prepares accredited assessors through initial training, contracting, follow-up training, and test-
ing. It standardizes all accreditation criteria and enhances the overall quality of the accreditation service. 4. Summary The notion of accreditation originated in the West. It has laid a theoretical foundation and provided evaluation principles for the mutual recognition of both quality and capability. China has addressed the demands of social and economic development by embracing international standards and technical innovations. The nation has further innovated its own biosafety laboratory accreditation system, which has created a solid basis for relevant laws and regulations while providing substantial support for administrative approval. This has played a critical role in the national biosafety framework. The continuous evolution of accreditation standards and requirements has resulted in significant improvements to the design, construction, operation, and management of Chinese biosafety laboratories. Numerous accredited laboratories in China have recently played active roles in worldwide disease control, disaster relief, and counterterrorism. The Chinese national biosafety laboratory accreditation system will soon play an increasingly important role in the national biosafety framework. Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Acknowledgments This work was supported by grants from the Ministry of Science and Technology, People’s Republic of China (the National Key Research and Development Plan, 2016YFC 1202202). References 1. Conformity assessment: Vocabulary and general principles GB/T17000-2005, General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China, China National Standardization Administration, 2005. 2. Conformity assessment: General requirements for accreditation bodies, GB/T 27011-2005, General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China, China National Standardization Administration, 2005. 3. Accreditation: essence and role, Xiao Jianhua, et al., Standards Press of China, 2015. 4. Regulations on the Bio-safety Management of Pathogenic Microbe Labs, Order 424 of the State Council of China, 2014. 5. Laboratories – General requirements for biosafety, GB 19489-2008, 2008.
Please cite this article as: P. Zhai, R. Wang, Y. Zhou et al., Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j.jobb.2018.12.008
Contents lists available at ScienceDirect
Journal of Biosafety and Biosecurity journal homepage: www.elsevier.com/locate/jobb
Research Article
Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China Peijun Zhai, Rong Wang, Yongyun Zhou, Dongmei Hu, Junyan li, Yali Zhou China National Accreditation Service for Conformity Assessment (CNAS), China
a r t i c l e
i n f o
Article history: Received 27 November 2018 Accepted 11 December 2018 Available online xxxx Keywords: Accreditation Management Biosafety laboratories
a b s t r a c t Accreditation is now widely used to attest for laboratory competence. Although accreditation was originally used to assess products in testing laboratories and still plays an increasingly important role in international trade, it has been expanded to include laboratories in many social fields, including forensic science, medicine, and animal quarantine reference. The accreditation process provides basic requirements for achieving global recognition for laboratory reports. This paper introduces the concept of accreditation and discusses the origins and development of the accreditation system in Chinese biosafety laboratories. This study also reveals the important role of this system in national biosafety management through an examination of the 14-year development of the Chinese biosafety laboratory accreditation system. Ó 2018 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.
1. Accreditation worldwide 1.1. The concept of accreditation Accreditation is formal certification by a third party. It is the result of a conformity assessment performed to confirm capability in a specific field.1 Here, conformity assessment refers to the verification of whether certain products, processes, systems, personnel, or organizations comply with specific requirements. Conformity assessment bodies refer to institutions that engage in conformity assessment services. This generally includes certification bodies, laboratories, and inspection agencies. In short, accreditation is used to confirm that a conformity assessment body meets specified requirements and is technically capable, thus lending credibility from the government, management, general public, users, and consumers about the data and results in reports issued by the conformity assessment body. Accreditation is a crucial driving force by which conformity assessment bodies can improve managerial and technical capability. Accreditation bodies, conformity assessment bodies, and clients are connected through their different roles and responsibilities in the conformity assessment scheme (Fig. 1).2 As evident in Fig. 1, accreditation remains at the top throughout the entire chain of the conformity assessment and verification process. It is also included in a broader conformity assessment sense;
an accreditation body is, by essence, not a conformity assessment body. During the accreditation process, an accreditation body carries full responsibility for all accreditation activities, which must be in full compliance with specific laws, regulations, standards, protocols, and agreements. The accreditation body should be equipped with specific competence and is accountable for the impartiality of its service. Its decisions must be authentic, accurate, and valid. Meanwhile, accredited conformity assessment bodies are the actual undertakers of conformity assessment. They assume every responsibility for their conformity assessment activities, which are to be conducted impartially and in full accordance with any accreditation requirements. They should also meet any competence specifications.3
1.2. Global accreditation system Accreditation originated in 1947. There are thus over 70 years of accreditation history. Cooperative global and regional laboratory accreditation organizations were gradually established during a period of surging international trade and communication during the 1990s. Today, the global accreditation system consists of the International Laboratory Accreditation Cooperation (ILAC) and many regional organizations, including the Asia Pacific Laboratory
https://doi.org/10.1016/j.jobb.2018.12.008 2588-9338/Ó 2018 Published by Elsevier B.V. on behalf of KeAi Communications Co., Ltd.
Please cite this article as: P. Zhai, R. Wang, Y. Zhou et al., Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j.jobb.2018.12.008
2
P. Zhai et al. / Journal of Biosafety and Biosecurity xxx (xxxx) xxx
Fig. 1. Conformity assessment scheme.
Accreditation Cooperation (APLAC) and the European Accreditation Cooperation Organization (EA). The ILAC currently consists of 120 member-accreditation bodies across the globe. Its mission is to promote the coordination of global accreditation activities and the recognition of accreditation results across national borders (i.e., ‘‘tested once and accepted everywhere”). The pillar measure to achieve that goal is the ILAC Mutual Recognition Arrangement (ILAC MRA). To date, over 100 accreditation bodies have signed the ILAC MRA and have been peer evaluated. ILAC standards include the following: ISO/IEC 17025 for testing and calibration laboratories (General competency requirements for testing and calibration laboratories), ISO 15189 for medical testing laboratories (quality and competence requirements for medical laboratories), ISO/IEC17020 for inspection bodies (conformity assessment requirements for the operation of various types of bodies performing inspection), ISO/IEC17043 for proficiency testing providers (conformity assessment and general requirements for proficiency testing), and ISO/IEC17034 for producers of reference materials (general competency requirements for reference material producers). As indicated by the list above, the ILAC accreditation system focuses on institutional capabilities and laboratory and inspection service quality. This generally involves no direct safety or biosafety concerns. The ILAC also specifies that accreditation bodies across the globe should operate in accordance with ISO/IEC 17011 (conformity assessment requirements for accreditation bodies that accredit conformity assessment bodies) and follow all relevant policies and requirements. The ILAC indicates that all complying bodies should use international standards to accredit both laboratories and inspection bodies. The ILAC system is now the most prestigious accreditation system for laboratories and inspection bodies worldwide. ILAC accreditation is recognized by international and regional organizations across the globe.
2. Accreditation in China 2.1. The Chinese accreditation system China established its own accreditation system in the 1990s to meet the development needs of the socialist market economy. In accordance with the Regulations of the People’s Republic of China on Certification and Accreditation and upon integration of relevant branches from various government departments, the National Certification and Accreditation Administration (CNCA) approved the establishment of the China National Accreditation Service for Conformity Assessment (CNAS). The CNAS was then named as the single state authority in charge of conducting accreditation for conformity assessment bodies across China. Since then, CNAS rep-
resents China in global accreditation affairs and is a full member of the ILAC and APLAC. In accordance with ISO/IEC 17011 (GB/T 27011), CNAS established a standardized accreditation system and now conducts accreditation activities with internationally accepted principles and procedures. By December 31, 2017, CNAS had accredited 9543 conformity assessment bodies in a variety of industries. As one pillar of the National Quality Infrastructure (NQI), accreditation plays a progressively important role in national quality enhancement and economic development. It also provides essential technical support for government administration. There are currently 46 Chinese laws, regulations, and administrative orders that either directly or indirectly accept accreditation results. CNAS has always attached great importance to exchanges and cooperation with international organizations and counterparts. It has signed multilateral mutual recognition agreements (MRAs) with 101 international accreditation institutions in 97 countries and economies. CNAS also sends staff to critical posts in many international organizations and actively participates in the development and revision of various international accreditation policies and requirements. It also works on some ISO standards. CNAS places special emphasis on science and technology; it has recently organized or participated in relevant research in different fields. CNAS continues to identify the evolving conformity assessment needs for national economic development by establishing and innovating new mechanisms and measures to create a solid technical foundation for high-quality Chinese progress. For example, CNAS established the Chinese national biosafety laboratory accreditation system in 2004. 2.2. The Chinese national biosafety laboratory accreditation system The Chinese biosafety laboratory accreditation system is a result of the need to prevent and control major epidemics. The SARS epidemics in 2003 painfully alerted China to an urgent weakness in biosafety laboratory capacity. There was a total lack of unified laboratory biosafety standards and relevant evaluation systems in China at that time. Authorized by the Ministry of Science and Technology, CNAS organized the development of the national laboratory biosafety standards with the cooperation of Chinese health, agricultural, and quality inspection departments. National Compulsory Standard GB19489-2004 ‘‘Laboratories – General requirements for biosafety” was officially released on May 28, 2004. This signified the initiation of a unified and authoritative basis for the construction and evaluation of high-level biosafety laboratories in China. In 2004, the State Council of China promulgated Order 424, ‘‘Regulations on the Bio-safety Management of Pathogenic Microbe Labs” (hereinafter referred to as the ‘‘Regulations”).4 According to its Article 20, (A)BSL-3 and (A)BSL-4 laboratories shall be required to pass national accreditation. In essence, this constitutes compulsory accreditation requirements for high-level biosafety laboratories in China. Upon standardizing its laboratory accreditation system, CNAS developed a series of accreditation documents in accordance with GB19489-2004 ‘‘Laboratories – General requirements for biosafety.” By the end of 2004, CNAS had established a Chinese national biosafety laboratory accreditation system that was capable of accrediting high-level biosafety laboratories. CNAS issued the first national accreditation certificate for highlevel biosafety laboratories on June 2, 2005. As of April 30, 2018, after more than 10 years of conscientious efforts made in accordance with the ‘‘Regulations,” CNAS had accredited a total of 80 biosafety laboratories, including 23 BSL-2 and 57 (A)BSL-3/4 laboratories. During its biosafety laboratory accreditation years, CNAS has been active in scientific research and has organized or participated
Please cite this article as: P. Zhai, R. Wang, Y. Zhou et al., Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j.jobb.2018.12.008
P. Zhai et al. / Journal of Biosafety and Biosecurity xxx (xxxx) xxx
in a number of national or provincial-level biosafety projects. With its continuous contribution and the constant flow of scientific outputs, CNAS has experienced significant progress in its technical capabilities. This has brought increasing credibility to its services. 3. Operation of the national biosafety laboratory accreditation system 3.1. Biosafety laboratory accreditation requirements The Accreditation Criteria for Laboratory Biosafety (CNAS-CL05) is the current document used by CNAS for biosafety laboratory accreditation. It includes relevant terms from GB19489-2008 ‘‘Laboratories - General requirements for biosafety”5 and the Regulations. Chapter 3 specifies the requirements for laboratory risk assessment in CNAS-CL05. This includes risk identification, analysis, control, and management, thus requiring laboratories to establish risk management procedures. These measures emphasize risk assessment as a basis for laboratory management and requires risk control to be an integral part of laboratory biosafety management. Thus, risk assessment management is laboratory management; Chapter 6 provides construction specifications for BSL2-4 biosafety laboratories, including those for floor plans, environmental parameters, HVAC, electrical controls, and water supply and drainage systems. Chapter 7 deals with the establishment and operation of the biosafety management system, including organizational, document management, personnel management, activity management, housekeeping, internal audit and management review, corrective actions, waste disposal, and emergency response issues. Chapter 7 also incorporates relevant requirements into ISO/IEC17025 (general competency requirements for testing and calibration laboratories). Also considering the unique characteristics of biosafety laboratories, this offers detailed specifications on laboratory safety plans, safety inspections, waste disposal, and incident reporting. CNAS has progressively built on its accreditation specifications and procedures according to identified problems and emerging demands during its years of involvement in biosafety laboratory accreditation. It offered implementation details for CNAS-CL05 by releasing CNAS-CL05-A001 ‘‘Guidance on the Application of Laboratory Biosafety Accreditation Criteria: Evaluation of Mobile Laboratories.” It also issued CNAS-CL05-A002 ‘‘Guidance on the Application of Laboratory Biosafety Accreditation Criteria: Evaluation of Key Protective Equipments” concerning biosafety devices (e.g., biosafety cabinets, autoclaves and animal isolation equipment). CNAS facilitated understanding of relevant accreditation documents by publishing supporting documents such as the Accreditation Guide for ABSL-2 Biosafety Laboratories (CNASGL031) for the accreditation of animal biosafety laboratories. 3.2. Biosafety laboratory accreditation procedures and cycles 3.2.1. Application An applicant for laboratory accreditation should have clear legal status and the ability to assume any corresponding legal responsibilities. Such an applicant can be either an independent legal entity or an institution authorized by an independent legal entity. The Regulations indicate that (A)BSL-2 biosafety laboratories should file necessary documents at the health/veterinary department of their local municipality prior to application. (A) BSL-3 and BSL-4 laboratories should first become listed in the national biosafety laboratory system development plan. They should then clear a construction review conducted by the Ministry of Science and Technology before passing the environmental impact assessment and gaining approval from the environmental protection
3
department. The next step is to obtain verification for full compliance with relevant standards, including GB19489-2004 ‘‘Laboratories – General requirements for biosafety” and GB50346 ‘‘Architectural and Technical Code for Biosafety Laboratories.” Entities seeking accreditation are then required to obtain inspection and acceptance by the construction department. After completing the above procedures, biosafety laboratories should establish biosafety management systems and begin trial operation according to the accreditation requirements for biosafety laboratories. Biosafety laboratories may submit accreditation applications to CNAS upon self-evaluation and obtaining satisfactory results during the trial period. Considering the high complexity and huge investments involved in constructing (A)BSL-4 laboratories, CNAS may initiate accreditation activities as soon as a laboratory design is complete. It can then perform the accreditation review process according to three phases (i.e., design document review, installation and trial operation review of key protective equipment, and safety management system and containment capability confirmation). Accreditation certificates may be issued upon completion of the third phase. 3.2.2. Acceptance and review Once an application for laboratory accreditation meets acceptance requirements, CNAS will issue an acceptance notice to the applicant and organize an accreditation review team. The review process is divided into the document review and onsite inspection stages. Document review refers to a process of verification by which the compliance review team assesses the provided application materials through relevant accreditation criteria. On-site inspection refers to a compliance verification by which the review team inspects the floor plan, structure, facilities, equipment, and other hardware. The team will also review the safety management system of the applicant laboratory according to relevant accreditation requirements. 3.2.3. Appraisal and certification The review team inspects documented corrective actions provided by the applicant laboratory and then determines whether to recommend the laboratory to CNAS for accreditation. The CNAS Appraisal Committee will evaluate the overall compliance of each recommended laboratory within the accreditation requirements before making its final decision. The CNAS Secretariat issues a notice of the accreditation decision along with an accreditation certificate for each successful accreditation result. Accreditation is valid for 5 years. 3.2.4. Surveillance assessment and reassessment A surveillance assessment is conducted to verify that accredited laboratories continue to meet requirements throughout the validity period of the accreditation certificate. Accredited (A)BSL-2 and (A)BSL-3 biosafety laboratories should receive regular surveillance reviews before 12-month, 30-month, and 48-month periods after obtaining accreditation. BSL-4 laboratories should receive surveillance reviews every 12 months. Surveillance reviews for (A)BSL-3 and (A)BSL-4 laboratories should be conducted after terminal disinfection of the laboratory. Surveillance reviews do not require application and are often conducted on site. Accredited laboratories shall apply for reassessment six months before the accreditation certificate expires. The reassessment process employs the same cycle and procedures performed upon initial accreditation. 3.2.5. Changes Accredited laboratories must notify the CNAS Secretariat in a written form if any of the following changes take place during the validity period of the accreditation certificate:
Please cite this article as: P. Zhai, R. Wang, Y. Zhou et al., Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j.jobb.2018.12.008
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a) Changes in laboratory name, address, or legal status b) Changes in key management, technical personnel, or safety personnel c) Changes in biological agents or laboratory activities within the same hazard level (according to the List of Pathogenic Microorganisms issued by the national health/veterinary department) d) Changes in equipment or facilities with potential impacts on biosafety containment e) Other changes with potential impacts on the safety of laboratory operation and activities Upon notification and verification of the above changes, the CNAS Secretariat may require another on-site inspection or simply ask for any necessary documents. 3.3. Quality assurance for biosafety laboratory accreditation 3.3.1. Quality management system for institutional operation CNAS established a standardized quality management system that applies to quality manuals, procedures, and tables in accordance with GB/T 27011 (ISO/IEC 17011), ‘‘Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies.” The accreditation documents and procedures listed in the previous chapter are developed in accordance with this document approval process. All key steps of the accreditation service cycle are recorded and traceable to guarantee the validity and accuracy of the biosafety laboratory accreditation process. 3.3.2. Professional biosafety technical support committee The CNAS Biosafety Professional Committee consists of more than 40 experts from a variety of government agencies, health and agricultural laboratory management departments, laboratories, and inspection bodies. All entities have rich biosafety laboratory experience in the fields of management, research, testing, and pharmaceutics. The committee is mainly responsible for contributing expertise in biosafety laboratory accreditation. This includes the review of published technical requirements for accreditation and team-review participation. 3.3.3. Assessor management system for team building CNAS accredited assessors have professional backgrounds in health, agriculture, and university-level academics. These individuals cover disciplines in microbiology, public health, veterinary medicine, management, construction, HVAC, and automation. The CNAS assessor management system prepares accredited assessors through initial training, contracting, follow-up training, and test-
ing. It standardizes all accreditation criteria and enhances the overall quality of the accreditation service. 4. Summary The notion of accreditation originated in the West. It has laid a theoretical foundation and provided evaluation principles for the mutual recognition of both quality and capability. China has addressed the demands of social and economic development by embracing international standards and technical innovations. The nation has further innovated its own biosafety laboratory accreditation system, which has created a solid basis for relevant laws and regulations while providing substantial support for administrative approval. This has played a critical role in the national biosafety framework. The continuous evolution of accreditation standards and requirements has resulted in significant improvements to the design, construction, operation, and management of Chinese biosafety laboratories. Numerous accredited laboratories in China have recently played active roles in worldwide disease control, disaster relief, and counterterrorism. The Chinese national biosafety laboratory accreditation system will soon play an increasingly important role in the national biosafety framework. Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Acknowledgments This work was supported by grants from the Ministry of Science and Technology, People’s Republic of China (the National Key Research and Development Plan, 2016YFC 1202202). References 1. Conformity assessment: Vocabulary and general principles GB/T17000-2005, General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China, China National Standardization Administration, 2005. 2. Conformity assessment: General requirements for accreditation bodies, GB/T 27011-2005, General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China, China National Standardization Administration, 2005. 3. Accreditation: essence and role, Xiao Jianhua, et al., Standards Press of China, 2015. 4. Regulations on the Bio-safety Management of Pathogenic Microbe Labs, Order 424 of the State Council of China, 2014. 5. Laboratories – General requirements for biosafety, GB 19489-2008, 2008.
Please cite this article as: P. Zhai, R. Wang, Y. Zhou et al., Enhancing the capabilities of biosafety laboratories through the established accreditation system: Development of the biosafety laboratory accreditation system in China, Journal of Biosafety and Biosecurity, https://doi.org/10.1016/j.jobb.2018.12.008