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High Containment Laboratories in Ukraine - Local Resources and Regulations Olena Kysil

High Containment Laboratories in Ukraine - Local Resources and Regulations Olena Kysil lklk@ukr.net *National Taras Shevchenko University of Kyiv ** Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine Istanbul, July 11-13, 2011. Population: 46,2 mln

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High Containment Laboratories in Ukraine - Local Resources and Regulations Olena Kysil

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  1. High Containment Laboratories in Ukraine - Local Resources and Regulations Olena Kysil lklk@ukr.net *National Taras Shevchenko University of Kyiv **Palladin Institute of Biochemistry of the National Academy of Sciences of Ukraine Istanbul, July 11-13, 2011

  2. Population: 46,2 mln • Territory: 603,700sq.km • Europe geographic center is on its territory • Administrative system - a unitary state: • Crimean AR, 24 oblasts, 2 cities – Kyiv • and Sevastopol with separate status • Crossroad and Transit – connecting • West Europe with Trans-Caucasia & • Central Asia:7 land neighboring countries • and 3 across Black Sea

  3. 1. What high containment biological (high BSL) laboratories exist in your country? What are the facilities’ main goals and priorities? ! the classification is inverted towards international 4058 registered microbiological laboratories 2 ones work with microorganisms of the I pathogenic group 402 ones work with microorganisms of the II pathogenic group 3654 ones work with microorganisms of the III-IV pathogenic groups 2 – scientific and practical investigations1,2 390 – epidemiological and diagnostic investigations3 12 – scientific and practical investigations 1, 2 – two labs of SI “Ukrainian I. I. Mechnikov Anti-Plague Research Institute” of the Ministry of Health of Ukraine (Odessa). One of them is of BSL3 level 3 – one lab of Central Sanitary Epidemiological Station of the Ministry of Health of Ukraine is of BSL3 level

  4. 2. What government organizations are responsible for the safety and security of high BSL laboratories? - the Central Regime Commission, which works together with regional Regime Commissions of the State Sanitary Epidemiological Service of Ukraine and regional chief state sanitary doctors of Ukraine (State Sanitary Rules 9.9.5.035-99 and 9.9.5-153-2008) 3. If there are high BSL laboratories in your country, arethere some established criteria for deciding? - to our knowledge there are no established criteria for such a decision.

  5. 4. What standards exist for high BSL laboratories for: a. Engineering and construction? b. Licensing? c. Safety and security? d. Regular oversight and re-certification? 1. The State Sanitary Rules 9.9.5.035-99 "The safety of work with microorganisms of the I-II pathogenic groups” (1999) 2. The State Sanitary Rules 9.9.5.-080-02 "The rules of the organization and the safety of work at microbiological laboratories (departments, units)" (2002) 3. The State Sanitary Rules 9.9.5-153-2008 "The organization of laboratories’ work in the case of investigation of materials containing the biological pathogenic agents by molecular-genetic methods" (2008) 4. The Order of Ministry of Health of Ukraine N183 from 14.12.1992 "On regime of work with pathogenic microorganisms" 5. The Order of Ministry of Health of Ukraine N452 from 06.11.2001 "On strengthening of anti-epidemical regime of work at microbiological laboratories" The project of the Regulation of Cabinet of Ministers of Ukraine, proposed by the Ministry of Health of Ukraine "The question of permit issue for work with the microorganisms of the I-IV pathogenic groups for microbiological laboratories and the functioning of regime commissions on biosafety" (2008) is currently undergoing public discussion.

  6. 5. Have there been any accidents at high BSL labs in your country? According to the information received from the Central Regime Commission during the last twenty years, there were no registered accidents at high containment laboratories in Ukraine. 6. Have any steps been taken to minimize high BSL laboratory accidents? 7. Have any steps been taken to increase security at high BSL facilities? If so, by whom (i.e., regulation, voluntary measures, individual laboratory practices)? - equipping and reconstruction of laboratories (State Programs, International Cooperation with WHO, EU, the USA Department of Defense, Global Partnership Program), - updating of the regulations, - special projects on training of personnel of laboratories, - some projects of individual laboratories: Implementation of the Laboratory Biorisk Management Standard CWA 15793:2008 in the EDI laboratory of the CSES, Development of Best practices guidance by the Anti-Plague Research Institute

  7. Thank you for your attention! Olena Kysil, lklk@ukr.net Istanbul, July 11-13, 2011

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