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National Laboratory Inventory for Global Poliovirus Containment ---United States, November 2003

In anticipation of the interruption of wild poliovirus (WPV) transmission, the United States has joined 122 other poliomyelitis-free countries in taking steps to minimize the risk for reintroducing WPV from laboratories to communities. In October 2002, a nationwide survey of laboratories and biomedical institutions (e.g., universities) that oversee multiple laboratories was conducted to identify those that might be holding WPV-containing materials and to establish a national inventory of institutions and laboratories retaining such materials (1). A total of 32,429 laboratories and biomedical institutions listed in multiple databases were mailed letters to alert laboratories of the impending global eradication of polio and encourage disposal of unneeded WPV-containing materials. The national inventory is a list of institutions and laboratories whose staff will be kept informed of eradication progress and appropriate WPV-containment procedures. This report summarizes use of the survey to create the national inventory.

In the survey, institutions and laboratories were categorized as 1) those most likely to possess WPV-containing materials (i.e., academic institutions, federal government departments, industrial facilities, and state and local health departments), 2) those that may possess such materials (i.e., clinical laboratories certified* for complex testing in microbiology), and 3) those least likely to possess such materials (i.e., clinical laboratories certified for noncomplex testing in microbiology). The least likely to possess category was included to establish whether stored WPV-containing materials existed in small clinical laboratories (e.g., private physicians' offices) licensed to perform noncomplex tests. Institutions and laboratories were asked to review records, search storage areas, and provide electronically (i.e., by e-mail or fax) the numbers of laboratories included in the search and names of laboratories storing WPV-containing materials, along with types of materials and amounts; those that did not respond by the requested date were mailed follow-up letters and contacted by telephone.

Total responses in the three categories accounted for 105,356 individual laboratories. A total of 5,585 (100%) institutions and laboratories in the categories of most likely to possess and may possess WPV-containing materials responded to the survey. A total of 24,206 (90%) of 26,844 institutions and laboratories categorized as least likely to possess such materials also responded (Table 1). Because none of the 24,206 respondents reported storing WPV-containing materials, follow-up of the remaining 2,638 (many of which were no longer in business) was discontinued.

The quality and completeness of the survey and inventory were validated by a search of scientific literature published by U.S. laboratories during 1993--2003 that referred to 1) polioviruses of any origin; 2) enteric diseases in countries where polio is endemic; or 3) viruses that share common enteric origins, replicate on poliovirus-permissive systems, or both (e.g., picornaviruses, rhinoviruses, and rotaviruses). The search identified six institutions and laboratories not included in the 2002 survey database; none stored WPV-containing materials.

A report on the national inventory was endorsed and accepted by the National Vaccine Advisory Committee Workgroup on Poliovirus Laboratory Containment. As of November 2003, the national inventory consisted of 122 institutions and 180 laboratories retaining WPV-containing materials. Of the 180 laboratories, 87 are listed as storing infectious materials; 56, potentially infectious materials§; and 37, both types of materials (Table 2).

Reported by: Task Force for Child Survival and Development, Decatur, Georgia. National Vaccine Program Office, U.S. Dept of Health and Human Svcs. Office of the Director, National Center for Infectious Diseases; Global Immunization Div, National Immunization Program, CDC.

Editorial Note:

The goal of the Global Polio Eradication Initiative is to interrupt transmission of WPV in all countries by the end of 2005. In 2003, six countries remained endemic for polio, the lowest number ever. The Global Commission for the Certification of the Eradication of Poliomyelitis will declare the world free of WPV transmission when all regions of the World Health Organization (WHO) have documented the absence of WPV transmission for a period of >3 years and when all WPV-containing materials in laboratories are contained adequately (4).

Completion of the national inventory of institutions and laboratories retaining WPV-containing materials is phase I of the containment program (3). The United States joins 81 other countries in the polio-free WHO Western Pacific, European, and Americas Regions with completed inventories. The remaining countries of these regions and many polio-free countries in regions where polio is endemic are expected to complete inventories during 2004.

Phase II of containment will begin after 1 year has elapsed without isolation of WPV worldwide (3). At that time, the U.S. Department of Health and Human Services (DHHS) will notify laboratories that poliovirus transmission has been interrupted and instruct institutions and laboratories listed on the national inventory to destroy WPV infectious and potentially infectious materials or implement biosafety measures appropriate for laboratory procedures being performed (biosafety level [BSL]-2/polio or BSL-3/polio [3]). DHHS will submit documentation of laboratory containment to the American Regional Commission for Certification of Poliovirus Laboratory Containment and Verification of Polio-Free Status.

Successful completion of the national inventory was possible through support of the biosafety community, professional organizations, departments of the federal Executive Branch, and the nation's biomedical institutions and laboratories. Continued support and cooperation will ensure the inventory remains current. Institutions and laboratories with any change in storage status of WPV-containing materials should notify CDC's Poliovirus Laboratory Containment Program, e-mail plcp@cdc.gov.

References

  1. CDC. National laboratory inventory as part of global poliovirus containment---United States, June 2002. MMWR 2002;51:646--7.
  2. U.S. Department of Health and Human Services. Medicare, Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications. Federal Register 2003; 68:3639--714. Available at http://www.gpoaccess.gov/fr/retrieve.html.
  3. World Health Organization. Global action plan for laboratory containment of wild polioviruses, 2nd ed. Geneva, Switzerland: World Health Organization, 2003; document no. WHO/V7B/03.11.
  4. Department of Vaccines and Biologicals. Report of the third meeting of the Global Commission for the Certification of the Eradication of Polio, July 9, 1998. Geneva, Switzerland: World Health Organization, 1999; document no. WHO/EPI/Gen/981.17.

* The Clinical Laboratory Improvement Act of 1988 established quality standards for all laboratories to ensure accuracy, reliability, and timeliness of clinical tests (2).

Clinical materials from confirmed WPV and vaccine-derived poliovirus (VDPV) infections, environmental sewage, or water samples in which such viruses or replication products of such viruses are present (3).

§ 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 it was suspected that WPVs or VDVPs were present, and products of such materials in poliovirus-permissive cells or animals (3).


Table 1

Table 1
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Table 2

Table 2
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