Enhancing Biosafety and Biosecurity: Quality Management in High-Containment Laboratories

Yıl 2024, , 105 - 112, 04.07.2024

Fatma Altıntaş , Ahmet Koluman

https://doi.org/10.35864/evmd.1366594

Öz

Quality Management in high-containment laboratories plays a pivotal role in ensuring the safe handling of biological agents and toxins, thereby mitigating potential biorisks. This paper provides a comprehensive exploration of the key aspects of Quality Management Systems (QMS) tailored to the unique challenges of high-containment laboratories. It delves into the significance of QMS in enhancing biosafety and biosecurity measures, safeguarding laboratory personnel, the community, and the environment. The paper also discusses the integration of international standards, risk management strategies, and the role of top management in fostering a culture of safety. Through this examination, it becomes evident that a robust QMS not only ensures compliance but also promotes continual improvement and innovation in high-containment laboratory operations, ultimately advancing the field of biosafety and biosecurity.

Anahtar Kelimeler

Biological agents, biological risks, biosafety, QMS

Biyogüvenlik ve Biyogüvenliğin Geliştirilmesi: Yüksek Korumalı Laboratuvarlarda Kalite Yönetimi

Öz

Yüksek korumalı laboratuvarlarda Kalite Yönetimi, biyolojik ajanların ve toksinlerin güvenli bir şekilde ele alınmasını sağlamada ve böylece potansiyel biyolojik riskleri azaltmada çok önemli bir rol oynamaktadır. Bu makale, yüksek korumalı laboratuvarların kendine özgü zorluklarına göre uyarlanmış Kalite Yönetim Sistemlerinin (KYS) temel yönlerinin kapsamlı bir incelemesini sunmuştur. Biyogüvenlik ve biyogüvenlik önlemlerinin geliştirilmesinde, laboratuvar personelinin, toplumun ve çevrenin korunmasında KYS'nin önemini ele almıştır. Çalışmada ayrıca uluslararası standartların entegrasyonu, risk yönetimi stratejileri ve üst yönetimin güvenlik kültürünü teşvik etmedeki rolü de tartışılmıştır. Bu inceleme sayesinde, sağlam bir KYS'nin yalnızca uyumluluğu sağlamakla kalmayıp aynı zamanda yüksek muhafazalı laboratuvar operasyonlarında sürekli iyileştirme ve yeniliği teşvik ettiği ve nihayetinde biyogüvenlik ve biyogüvenlik alanını ilerlettiği anlaşılmıştır.

Anahtar Kelimeler

Biyolojik ajanlar, biyolojik riskler, biyogüvenlik, KYS

Kaynakça

• Allen, L. C. (2013). Role of a quality management system in improving patient safety— laboratory aspects. Clinical Biochemistry, 46(13-14), 1187-1193.
• Altenstetter, C. (2012). Medical device regulation in the European Union, Japan and the United States. Commonalities, differences and challenges. Innovation: The European Journal of Social Science Research, 25(4), 362-388.
• Aravind, D., & Christmann, P. (2011). Decoupling of standard implementation from certification: Does quality of ISO 14001 implementation affect facilities’ environmental performance?. Business Ethics Quarterly, 21(1), 73-102.
• Audu, R. A., Sylvester-Ikondu, U., Onwuamah, C. K., Salu, O. B., Ige, F. A., Meshack, E., ... & Idigbe, E. O. (2012). Experience of quality management system in a clinical laboratory in Nigeria. African journal of laboratory medicine, 1(1), 1-5.
• Ausher, R., Ben-Ze'ev, I. S., & Black, R. (1996). The role of plant clinics in plant disease diagnosis and education in developing countries. Annual review of phytopathology, 34(1), 51- 66.
• Bachner, P., Howanitz, P. J., & Lent, R. W. (1994). Quality improvement practices in clinical and anatomic pathology services: a College of American Pathologists Q-Probes study of the program characteristics and performance in 580 institutions. American journal of clinical pathology, 102(5), 567-571.
• Bakanidze, L., Imnadze, P., & Perkins, D. (2010). Biosafety and biosecurity as essential pillars of international health security and cross-cutting elements of biological nonproliferation. BMC public health, 10(1), 1-8.
• Barman, M. P., Rahman, T., Bora, K., & Borgohain, C. (2020). COVID-19 pandemic and its recovery time of patients in India: A pilot study. Diabetes & Metabolic Syndrome: Clinical Research & Reviews, 14(5), 1205-1211.
• Bremond, J., & Plebani, M. (2001). IVD industry role for quality and accreditation in medical laboratories. Clinica chimica acta, 309(2), 167-171.
• Cai, Y., Hao, Z., Gao, Y., Ping, W., Wang, Q., Peng, S., ... & Zhang, N. (2020). Coronavirus disease 2019 in the perioperative period of lung resection: a brief report from a single thoracic surgery department in Wuhan, People’s Republic of China. Journal of Thoracic Oncology, 15(6), 1065-1072.
• Callihan, D. R., Downing, M., Meyer, E., Ochoa, L. A., Petuch, B., Tranchell, P., & White, D. (2021). Considerations for Laboratory Biosafety and Biosecurity During the Coronavirus Disease 2019 Pandemic: Applying the ISO 35001: 2019 Standard and High-Reliability Organizations Principles. Applied Biosafety, 26(3), 113-122.
• Casey, E., & Souvignet, T. R. (2020). Digital transformation risk management in forensic science laboratories. Forensic science international, 316, 110486.
• Castka, P., & Balzarova, M. A. (2008). Social responsibility standardization: Guidance or reinforcement through certification? Human systems management, 27(3), 231-242.
• Chan, K. H., Sridhar, S., Zhang, R. R., Chu, H., Fung, A. F., Chan, G., ... & Yuen, K. Y. (2020). Factors affecting stability and infectivity of SARS-CoV-2. Journal of Hospital Infection, 106(2), 226-231. Chua, K. B., & Gubler, D. J. (2013). Perspectives of public health laboratories in emerging infectious diseases. Emerging microbes & infections, 2(1), 1-6.
• Coelho, A. C., & García Díez, J. (2015). Biological risks and laboratory-acquired infections: a reality that cannot be ignored in health biotechnology. Frontiers in bioengineering and biotechnology, 3, 56.
• D. M. (2018). Laboratory focus on improving the culture of biosafety: statewide risk assessment of clinical laboratories that process specimens for microbiologic analysis. Journal of clinical microbiology, 56(1), 10-1128.
• Dirnagl, U., Kurreck, C., Castaños‐Vélez, E., & Bernard, R. (2018). Quality management for academic laboratories: burden or boon? Professional quality management could be very beneficial for academic research but needs to overcome specific caveats. EMBO reports, 19(11), e47143.
• Domingo, J. L. (2022). An updated review of the scientific literature on the origin of SARS- CoV-2. Environmental Research, 215, 114131.
• Elfiky, A. A. (2020). Anti-HCV, nucleotide inhibitors, repurposing against COVID-19. Life sciences, 248, 117477. Evans, S. W., Beal, J., Berger, K., Bleijs, D. A., Cagnetti, A., Ceroni, F., ... & van Passel, M. W. (2020). Embrace experimentation in biosecurity governance. Science, 368(6487), 138-140.
• Filonchyk, M., Hurynovich, V., & Yan, H. (2021). Impact of COVID-19 pandemic on air pollution in Poland based on surface measurements and satellite data. Aerosol and Air Quality Research, 21(7), 200472.
• Ghernaout, D., Aichouni, M., & Alghamdi, A. (2018). Overlapping ISO/IEC 17025: 2017 into big data: A review and perspectives. International Journal of Science and Qualitative Analysis, 4(3), 83-92.
• Gill, C. O., & Jones, T. (1997). Assessment of the hygienic characteristics of a process for dressing pasteurized pig carcasses. Food Microbiology, 14(1), 81-91.
• Global Biolabs (2023). Global BioLabs Report. https://www.globalbiolabs.org/. Hauschild, A. C., Eick, L., Wienbeck, J., & Heider, D. (2021). Fostering reproducibility, reusability, and technology transfer in health informatics. Iscience, 24(7).
• Heires, M. (2008). The international organization for standardization (ISO). New Political Economy, 13(3), 357-367.
• Hou, M., Song, D. L., Shi, Z. L., & Yuan, Z. M. (2019). Quality management in a high- containment laboratory. Journal of Biosafety and Biosecurity, 1(1), 34-38.
• Huang, Y., Huang, J., Xia, H., Shi, Y., Ma, H., & Yuan, Z. (2019). Networking for training Level 3/4 biosafety laboratory staff. Journal of Biosafety and Biosecurity, 1(1), 46-49.
• Kimman, T. G., Smit, E., & Klein, M. R. (2008). Evidence-based biosafety: a review of the principles and effectiveness of microbiological containment measures. Clinical microbiology reviews, 21(3), 403-425.
• Kreuder Johnson, C., Hitchens, P. L., Smiley Evans, T., Goldstein, T., Thomas, K., Clements, A., ... & Mazet, J. K. (2015). Spillover and pandemic properties of zoonotic viruses with high host plasticity. Scientific reports, 5(1), 14830. Lee, M. S., Kim, E. Y., & Lee, S. W. (2017). Experience of 16 years and its associated challenges in the Field Epidemiology Training Program in Korea. Epidemiology and health, 39.
• Moreira, F. G., Ramos, A. L., & Fonseca, K. R. (2021). Safety culture maturity in a civil engineering academic laboratory. Safety science, 134, 105076.
• Moritz, R. L., Berger, K. M., Owen, B. R., & Gillum, D. R. (2020). Promoting biosecurity by professionalizing biosecurity. Science, 367(6480), 856-858.
• Munson, E., Bowles, E. J., Dern, R., Beck, E., Podzorski, R. P., Bateman, A. C., ... & Warshauer, Nishiura, H., Linton, N. M., & Akhmetzhanov, A. R. (2020). Initial cluster of novel coronavirus (2019-nCoV) infections in Wuhan, China is consistent with substantial human-to-human transmission. Journal of clinical medicine, 9(2), 488.
• Peng, H., Bilal, M., & Iqbal, H. M. (2018). Improved biosafety and biosecurity measures and/or strategies to tackle laboratory-acquired infections and related risks. International journal of environmental research and public health, 15(12), 2697.
• Ruiz‐Medina, B. E., Varela‐Ramirez, A., Kirken, R. A., & Robles‐Escajeda, E. (2022). The SARS‐CoV‐2 origin dilemma: Zoonotic transfer or laboratory leak?. BioEssays, 44(1), 2100189.
• Singh, S., Parmar, K. S., Makkhan, S. J. S., Kaur, J., Peshoria, S., & Kumar, J. (2020). Study of ARIMA and least square support vector machine (LS-SVM) models for the prediction of SARS-CoV-2 confirmed cases in the most affected countries. Chaos, Solitons & Fractals, 139, 110086.
• Su, Z., McDonnell, D., Ahmad, J., Cheshmehzangi, A., Li, X., Meyer, K., ... & Xiang, Y. T. (2020). Time to stop the use of ‘Wuhan virus’,‘China virus’ or ‘Chinese virus’ across the scientific community. BMJ Global Health, 5(9), e003746.
• Trinchero, E., Farr-Wharton, B., & Brunetto, Y. (2019). A social exchange perspective for achieving safety culture in healthcare organizations. International Journal of Public Sector Management, 32(2), 142-156.
• Vlachos, N. A., Michail, C., & Sotiropoulou, D. (2002). Is ISO/IEC 17025 accreditation a benefit or hindrance to testing laboratories? The greek experience. Journal of food composition and analysis, 15(6), 749-757.
• Wijkström, E. N., & McDaniels, D. (2013). Improving regulatory governance: International standards and the WTO TBT Agreement. Journal of World Trade, 47(5).
• Zaki, A. N. (2010). Biosafety and biosecurity measures: management of biosafety level 3 facilities. International journal of antimicrobial agents, 36, S70-S74.
• Zhu, H., Wei, L., & Niu, P. (2020). The novel coronavirus outbreak in Wuhan, China. Global health research and policy, 5, 1-3.