National Laboratory Inventory for Global Poliovirus Containment ---European Region, June 2006
In May 1999, the World Health Assembly reaffirmed the commitment of the World Health Organization (WHO) to eradicate poliomyelitis and urged all member states to begin the process leading to the laboratory containment of wild poliovirus (WPV) (1). The WHO global action plan for laboratory containment of WPV begins with a survey of all biomedical facilities (Phase I). The purpose of the survey is to alert institutions and facilities to the need for containment, encourage reduction of WPV materials, and develop a national inventory of facilities holding such materials. The objective of Phase I is to provide a facility database for use in all subsequent steps toward global poliovirus containment. This report describes completion of Phase I containment by the European Region, the first of the six WHO regions to accomplish this goal.
In 1999, the European Regional Office (EURO) initiated the containment process with 1) a pilot inventory of WPV materials in the 37 national laboratories in the European Region Polio Laboratory Network and 2) collaborative pilot surveys in five countries (France, Germany, Netherlands, Russia, and the United Kingdom). In January 2000, the European Regional Commission for the Certification of the Eradication of Poliomyelitis (RCC) approved the Action Plan for Laboratory Containment of Wild Polioviruses in the WHO European Region (2). As a result, in February 2000, EURO sent a letter to the ministries of health (MOHs) of the 52 member states announcing the containment initiative and asking each country to nominate a national task force on containment, a national containment coordinator, or both, and to prepare national plans of action. In addition, in May 2000, EURO distributed Guidelines for Implementation of Laboratory Containment of Wild Polioviruses (3), including sample letters, questionnaires, and inventory forms. During 2000--2005, EURO provided daily technical guidance, sponsored 46 consultant visits, and convened eight subregional containment workshops to assist countries during the Phase I process.
Strategies for generating the facility database differed among countries according to population size, administrative and health infrastructure, and economic development. To ensure the database included all facilities that might have infectious or potentially infectious WPV materials, facility lists were compiled from telephone directories, the Internet, purchased lists from vendors, professional organizations, advice from consultants, and data from MOHs. Facilities listed included hospitals, universities and other schools, water companies, private laboratories, private industries, vaccine producers, and nutrition research laboratories. Preexisting national lists of biomedical diagnostic laboratories were available in 43 countries where registration is required by law. Lists outside the health sector were compiled with the assistance of other government ministries responsible for environmental control, agriculture, natural resources, economic affairs, and defense. The use of multiple lists helped ensure that the database was comprehensive.
The most commonly used survey method consisted of two stages. In the first stage, all laboratories in the national database received a letter from the appropriate health authority 1) describing the containment initiative, 2) defining infectious* and potentially infectious WPV materials, and 3) asking laboratories to complete an attached return form to declare whether such materials were present or had been destroyed. Facilities that failed to return the form within the prescribed period were recontacted by letters, telephone calls, or site visits. Facilities that reported WPV materials received a second letter reminding them of the importance of working with such materials under biosafety level 2 conditions as described in the WHO Global Action Plan for Laboratory Containment of Wild Polioviruses (1) and requesting additional details on the nature and amount of materials for development of the national inventory. Facilities that failed to respond within the allotted time were recontacted.
Seventeen countries with highly centralized health systems excluded all basic clinical services laboratories because they did not have freezer storage capacity. The largest numbers of laboratories in this category were in Russia (29,336) and Kazakhstan (1,172). In other countries, all clinical service laboratories were excluded after the survey had determined that laboratories in this category lacked freezer storage capacity and did not retain clinical materials or products of materials. Private diagnostic laboratories in France were excluded because of existing regulations that required destruction of clinical samples after 1 week. The survey process in 45 countries was facilitated by MOH authority granted by existing health laws and regulations. Five countries amended regulations or developed new regulations to provide MOH authority to conduct the survey. France and Switzerland, both of which use inactivated poliovirus vaccine, included questions in their surveys regarding Sabin poliovirus materials in addition to WPV materials.
By March 2006, all 52 member states of the European Region had completed national surveys covering a total of 55,748 laboratories. Twenty-seven countries reported neither infectious nor potentially infectious WPV materials. Twenty-five countries reported a total of 265 laboratories in 164 institutions with infectious (116 laboratories) and potentially infectious (149) WPV materials. The majority of the laboratories retaining WPV materials were located in Western Europe, with the highest number of laboratories in the United Kingdom (103), followed by France (56), Germany (22), and Switzerland (13). Thirteen of the 25 countries with WPV materials reported one or two laboratories retaining WPV materials. Universities constituted the highest percentage of institutions retaining such materials, followed by public health institutions and hospitals. In 20 countries, one or more laboratories reported destroying all previously retained WPV materials during the course of the survey.
Each country submitted national documentation of survey and inventory quality to EURO in accordance with WHO Guidelines for Documenting the Quality of Phase I Wild Poliovirus Laboratory Containment Activities (4). National documentation was assessed by two independent panels of laboratory professionals convened by EURO. The first panel assessed documentation for survey and inventory deficiencies and assessed the need for additional information. The second panel reviewed the revised submissions from each country and made recommendations to EURO and RCC to approve or to request additional information before approval. In June 2006, RCC accepted the EURO containment report and declared Phase I complete.
Reported by: World Health Organization Regional Office for Europe, Copenhagen, Denmark. Immunization, Vaccines, and Biologicals Dept, World Health Organization, Geneva, Switzerland. Global Immunization Div, National Center for Immunization and Respiratory Diseases (proposed), CDC.
The European Region is the first WHO region to have completed Phase I of the WHO plan for laboratory containment of WPVs. In the WHO Western Pacific Region, all but two countries (China and Japan) have completed Phase I. The WHO Americas Region aims to complete the survey and inventory by the end of 2006. In total, Phase I activities have been completed in 100 (74%) of the 135 countries in the three WHO regions certified as polio free (i.e., the Americas, European, and Western Pacific regions). In addition, all countries that did not report polio in 2005 in the WHO South East Asia and Eastern Mediterranean regions have reported completion of the survey and inventory. Containment activities in the African Region are primarily focused on countries in the southern and eastern parts of the continent, with seven countries reporting completion of Phase I. Poliovirus containment activities are now an integral component of polio eradication in countries of all six WHO regions. In all WHO regions to date, results of the facility survey and inventory indicate that countries appreciate the necessity for post-eradication poliovirus destruction and containment. The majority of countries have indicated their intention to destroy WPV materials once eradication has been achieved.
Since publication of the second edition of the WHO Global Action Plan for Laboratory Containment of Wild Polioviruses in 2004 (1), WHO has established the goal for all countries to stop routine use of oral poliovirus vaccine (OPV) when WPV circulation is interrupted (5). Achieving that goal depends largely on assurances from each country that sufficient safeguards exist to ensure that facility-associated risk for reintroduction of wild or OPV/Sabin polioviruses will not outweigh the benefits of OPV cessation.
The forthcoming third edition of the WHO Global Action Plan to Minimize Poliovirus Facility-Associated Risk in the Post-Eradication/Post-OPV Era (6) proposes to 1) minimize facility-associated poliovirus risk by destroying WPV and Sabin poliovirus strains in all facilities, except in <20 facilities worldwide that serve essential functions (e.g., vaccine production, quality control, reference, or research) and 2) meet all safeguards against transmission. In the third edition, the components of Phase I are unchanged, as are the objectives associated with the facility database and inventory. Phase II, which will begin upon completion of the Phase I national surveys and inventories, will provide guidance to countries for establishing long-term national policies for post-eradication/post-OPV cessation and regulations to enforce these policies.
- World Health Organization. WHO global action plan for laboratory containment of wild polioviruses. 2nd edition. Geneva, Switzerland: World Health Organization; 2004 (WHO/V&B/03.11). Available at http://www.polioeradication.org/content/publications.
- World Health Organization. Action plan for laboratory containment of wild polioviruses in the WHO European Region. Copenhagen, Denmark: World Health Organization; 2000.
- World Health Organization. Guidelines for implementing the pre-eradication phase of the global action plan for laboratory containment of wild polioviruses. Geneva, Switzerland: World Health Organization; 2000. Available at http://www.who.int/biologicals/publications/meetings/areas/vaccines/polio/en/index.html.
- World Health Organization. WHO guidelines for documenting the quality of Phase I wild poliovirus laboratory containment activities. Geneva, Switzerland: World Health Organization; 2003.
- World Health Organization. Framework for national policy makers in OPV-using countries. Geneva, Switzerland: World Health Organization; 2005. Available at http://www.polioeradication.org/content/publications/opvcessationframeworkenglish.pdf.
- World Health Organization. WHO global action plan to minimize poliovirus facility-associated risk in the post-eradication/post-OPV era. Geneva, Switzerland: World Health Organization. In press.
* Clinical materials from confirmed WPV (including vaccine-derived poliovirus) infections, environmental sewage, or water samples in which such viruses are present, and replication products of such viruses (e.g., cell culture isolates, reference stocks, and laboratory derivatives) (1).
Feces, respiratory secretions, environmental sewage, and untreated water samples of unknown origin or collected for any purpose at a time and in a geographic area where presence of WPVs (including vaccine-derived polioviruses) was suspected, and the products of such materials in poliovirus-permissive cells or animals (1).
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