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http://dx.doi.org/10.5668/JEHS.2014.40.3.187

Development of a Harmonization Standard for Biosafety Risk Assessment of Infectious Disease Laboratories using Management Consulting Methodology  

Yu, Minsu (Division of Biosafety Evaluation & Control, NIH, KCDC Business Consulting Department, Graduate School of Hanyang University)
Publication Information
Journal of Environmental Health Sciences / v.40, no.3, 2014 , pp. 187-203 More about this Journal
Abstract
Objectives: As the demand to deal with pathogens in domestic research institutions has expanded and biological accidents have increased, the need for systematic biosafety management in infectious disease laboratories has grown. According to international standards, risk assessment (RA) is required for biosafety management. However, RA criteria have not been clearly established in Korea, so to this end I have attempted to determine RA criteria meeting international levels Methods: In order to provide RA criteria for application, I analyzed the RA criteria in use in the U.S., Europe and at international organizations. In order to ensure the public nature of the RA criteria, I constructed the research model through modified management consulting methodology reflecting the model of Radnor and O'Mahoney. Results: According to the results of the study, existing laboratory biosafety regulations were comparable to domestic laboratory safety laws. Existing laboratory biosafety standards that are designed around risk factors were found to be insufficient. An RA case to be carried out in infectious disease laboratories at the National Institute of Health of KCDC was identified. Conclusion: To establish a systematic risk management system meeting international standards, it was necessary first to harmonize the systems of national and international standards. In addition, in order to provide specific biosafety management on-site, I recognized a need for methodology and planning strategies to discover biosafety management so that it can be carried out as required through the RA of individual laboratories.
Keywords
Biosafety; Management consulting methodology; Risk assessment; Risk management; Public policy consulting;
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1 Ministry of Health and Welfare.Notification of Genetically Modified experiment, No. 2012-103 on Ministry of Health and Welfare.Gwacheon:Ministry of Health and Welfare Press; 2012.
2 World Health Organization. Laboratory biosafety manual, 3rd ed. Geneva: WHO Press; 2004.
3 Lee MY, Park SJ, Cho EJ, Park SJ, Han SH, Kwon OS. Health Risk Assessment of Cryptosporidium in Tap Water in Korea. J Environ Health Science. 2013; 39(1): 32-42.   과학기술학회마을   DOI
4 European Commission. Harmonised standards. Available: http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm. [accessed 17 March 2014]
5 G Lippitt, R, Lippitt. The consulting Process in Action, 2nd ed. Washington: University Associates Press; 1978.
6 Division of biosafety evaluation and control. Notification of Construct and Operation on Institutional Biosafety Committee. In: Korea Center for Disease Control & Perventation: 2013. Osong: KNID Press; 2013.
7 Jennifer G, Reynolds MS, Natalie B. Developing a Risk Assessment and Management Approach to Laboratory Biosecurity. Applied Biosafety. 2006; 11(1): 24-31.   DOI
8 American Biological Safety Association. ABSA Top5 Training Needs Survey Results. Available: http://www.absa.org/edumenu.html. [accessed 20 March 2014].
9 Lee KM, Nam HY, Shin SH, Choi MK, Choi YJ, Kwon SH, et al. A Survey on Laboratory Biosafety Status of Public Healthcare Centers in Korea. J Bacteriol Virol. 2013; 43(3): 217-228.   과학기술학회마을   DOI
10 Ministry of Science, ICT and Future Planning. Analysis results of Laboratory safety Monitoring instruction on 2013. Available: http://www.msip.go.kr/www/brd/m_211/view.do?seq=1347&srchFr=&srchTo=&srchWord=o¨±³¾«&srchTp=0&multi_itm_seq=0&itm_seq_1=0&itm_seq_2=0&company_cd=&company_nm=&page=17. [accessed 11 Feb 2014]
11 Arben Mullai. Risk management system-risk assessment frameworks and techniques. Rethorinpellonkatu: DaGoB Project Office at Turku School of Economics Press; 2012.
12 Johnson B. Understanding, Assessing, and Communicating Topics Related to Risk in Biomedical Research Facilities, 1st ed. Mundelein: ABSA Press; 2001.
13 European committee for standardization. Laboratory Biorisk Management CWA 15793;2008. Available: www.cen.eu. [accessed 17 March 2014]
14 European BioSafety Association. Survey on the awareness and usage of Laboratory biorisk management CWA 15793:2011 and its guidance document CWA 16393:2012. Available: http://www.ebsaweb.eu/cwa_survey-highlight-survey.html [accessed 29 July 2014].
15 Kubr, Milan. Management Consulting: a Guide to the Profession, 4th ed. Geneve: International Labor Office Press; 2002.
16 Biosafety Clearing House. Cartagena Protocol on Biosafety. Available: http://bch.cbd.int/protocol/text/. [accessed 20 March 2014].
17 Economy chosun. Trend on One-stop seriver provide, expansion on support of public management consulting. Available: http://economychosun.com/ special/special_view.php?boardName= C01&t_num=5689. [accessed 11 Feb 2014].
18 Zoe Radnor, Joe O'Mahoney. The role of management consultancy in implementing operations management in the public sector. IJ Oper Prod Manage. 2013; 33(11-12): 1555-1578.   DOI   ScienceOn
19 National Research Council. Animal Biotechnology: Science-based Concerns. Washington: National Academies Press: 2002. p.75.
20 Biosafety Clearing House. Guidance on Risk Assessment of Living Modified Organisms. Available from: http://bch.cbd.int/onlineconferences/guidance_ra.shtml. [accessed 20 March 2014].