**Final Report**

### 

### **Laboratory Containment of Wild Poliovirus in The United States**

**Phase I**

**The National Inventory of Institutions/Laboratories Retaining Wild
Poliovirus Materials**

**January 15, 2004**

The National Vaccine Program Office

Department of Health and Human Services

Submitted By

**Poliovirus Laboratory Containment Preparedness**

A joint project of

The Task Force for Child Survival and Development, 750 Commerce Drive,
Decatur GA 30033\*

Walter R. Dowdle, PhD

Kim Koporc, MPH

And

The National Center for Infectious Diseases, Office of the Director,
Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA
30333

Alison Mawle, PhD

Sandra Browning, BS, MT(ASCP)I

\* Contract Number 200-2001-00106

# Acknowledgements

Key to the success of the national laboratory survey and inventory was
the strong support and commitment of Tommy Thompson, Secretary,
Department of Health and Human Services (HHS) and his enlistment of
participation by all other relevant Departments and Agencies of the
Executive Branch. Special thanks go to the Interdepartmental Working
Group, its Chair, Eve Slater, Assistant Secretary for Health, HHS, and
those within the Departments who facilitated surveys. We gratefully
acknowledge the assistance of the Office of the Assistant Secretary for
Postsecondary Education, the US Department of Education in developing
the database of relevant academic institutions and sending letters to
Presidents/Chancellors endorsing the survey.

We deeply appreciate the encouragement of the National Vaccine Advisory
Committee (NVAC), chaired by Georges Peter; the advice and
recommendations of the NVAC Polio Laboratory Containment Workgroup,
chaired by Ann Arvin; and the assistance of the National Vaccine Program
Office provided by Bruce Gellin and Steven J. Sepe.

We are grateful to the numerous professional and scientific
organizations that helped spread the word on containment, especially the
Association of Public Health Laboratories, American Society for
Microbiology and the American Biological Safety Association that
provided crucial opportunities for public debate through presentations
and publications. Special recognition goes to Betsy Gilman Duane, Wyeth
Research, and Robin Luttrell, Emory University, whose leadership paved
the way for collaboration with industry and academia, respectively.

We gratefully acknowledge Deborah Wilson, Occupational Safety and Health
Division, National Institutes of Health, and Olen Kew and Mark
Pallansch, Division of Viral and Rickettsial Diseases, Centers for
Disease Control and Prevention (CDC), for their support during the
formative stages of the Survey. Special thanks go to John Hancock,
Public Health Practice Program Office, CDC, who helped us understand the
CLIA database; the National Immunization Program, Global Immunization,
CDC for its support, including the use of its immunization hotline;
Robert J. Allen, graphic specialist; Rosemary James, web development
specialist; Alex Belov, computer programmer; Clifford Dix, printing
specialist, all from CDC/OD; Dale Nordenburg, Associate Director,
Information Resources Management; Connie Dorner, computer project
manager; Jared Sarkisian, computer programmer; John Stevens, computer
specialist, Patricia Carroll, data entry, Lois Foster, administrative
assistance, all from National Center for Infectious Diseases/OD: and
Zadya Lundgren of the Task Force, who tirelessly performed the
literature search.

Finally, we wish to acknowledge the thousands of Responsible Facility
Officials, laboratory directors, and administrative staff that made this
National Survey and Inventory possible.

Walter Dowdle, Director Poliovirus Laboratory Containment Preparedness

**Table of Contents**

[Acknowledgements iii](#acknowledgements)

[1 Executive Summary 1](#executive-summary)

[2 Introduction 2](#introduction)

[3 Authorization and delegation of responsibility
3](#authorization-and-delegation-of-responsibility)

[4 Developing the US Action Plan 4](#developing-the-us-action-plan)

[5 Implementing the US Action Plan 5](#implementing-the-us-action-plan)

[**5.1** **Implementing the Trial Survey**
5](#implementing-the-trial-survey)

[**5.2** **Implementing the Pilot Survey**
6](#implementing-the-pilot-survey)

[**5.3** **Enlisting multi-sector support**
7](#enlisting-multi-sector-support)

[**5.4** **Enlisting professional society support**
8](#enlisting-professional-society-support)

[**5.5** **Communicating with the laboratory community**
11](#communicating-with-the-laboratory-community)

[6 Preparing for the National Survey
12](#preparing-for-the-national-survey)

[**6.1** **Compiling the Survey Database**
12](#compiling-the-survey-database)

[**6.2** **Developing Survey Forms/Packets and The Website**
15](#developing-survey-formspackets-and-the-website)

[7 Implementing the National Survey
15](#implementing-the-national-survey)

[8 Analyzing results of the National Survey
18](#analyzing-results-of-the-national-survey)

[9 Compiling the National Inventory
18](#compiling-the-national-inventory)

[10 Quality Assessment of Survey and National Inventory
27](#quality-assessment-of-survey-and-national-inventory)

[**10.1** **Results of the Literature Search**
27](#results-of-the-literature-search)

[**10.2** **Meetings with Biosafety Officers**
31](#meetings-with-biosafety-officers)

[**10.3** **Follow-up** 32](#follow-up)

[11 Planning for Global Certification (Phase II)
32](#planning-for-global-certification-phase-ii)

[**11.1** **Roles and Responsibilities**
33](#roles-and-responsibilities)

[**11.2** **Conclusions and Recommendations**
34](#conclusions-and-recommendations)

[12 Summary 36](#summary)

#  {#section-1 .unnumbered}

# 1 Executive Summary

The world will be declared free of wild poliovirus transmission when the
Global Commission for the Certification of the Eradication of
Poliomyelitis is satisfied that all Regions of the World Health
Organization (WHO) have documented the absence of wild poliovirus
circulation for at least three consecutive years and that all wild
poliovirus materials in laboratories are adequately contained.

Steps toward containment are described in the WHO *Global action plan,*
2^nd^ edition, and consist of a Laboratory Survey and Inventory (Phase
I) and Global Certification (Phase II). Phase I begins when Regions are
polio-free. Phase II begins when one year has elapsed without isolation
of wild poliovirus anywhere in the world.

Phase I was initiated in the US in November 2000 when the Assistant
Secretary for Health (ASH), Department of Health and Human Services
(HHS), and Surgeon General delegated responsibility to the National
Vaccine Program Office (NVPO) for development and implementation of the
US Action Plan. The Laboratory Survey was initiated in October 2002 with
letters of notification from the ASH to 32,429 academic, federal
government, hospital, industry, private, and state and local government
institutions/laboratories.

The US National Survey of 32,429 academic, federal government, hospital,
industry, private, and state and local government
institutions/laboratories, comprising a total of 105,356 individual
laboratories is complete. All 5,585 institutions/laboratories
categorized as **most likely to possess** or **may possess** wild
poliovirus materials responded to the Survey. Of the 26,844
institutions/laboratories categorized as **least likely to possess**
such materials, (90%) responded. None of the 24,206 responders reported
wild poliovirus materials. As the objective of surveying this group of
small clinical laboratories (i.e. private physicians' offices)
laboratories was to quantify risk, follow up of the remaining 2,638 was
discontinued. The quality and completeness of the Survey was confirmed
by a literature search over the past 10 years. The US National Inventory
(Phase I) consists of 122 institutions listing 180 laboratories that
retain wild poliovirus materials.

In early 2004, the WHO Regional Office for the Americas will request the
Secretary, HHS to submit the National Inventory (Phase I) for review by
the Regional Certification Commission. This report provides the
Inventory and supporting documentation for that submission and describes
the next steps in the US toward containment as required for global
certification of polio eradication.

# 2 Introduction

In 1988, the World Health Assembly (WHA) resolved to eradicate polio by
the year 2000. At that time, paralytic poliomyelitis was endemic in 125
countries on 5 continents with an estimated 350,000 cases annually. The
year 2000 goal was not met, but progress continues toward the
interruption of wild poliovirus transmission. The last indigenous case
in the Americas was in 1991; in the Western Pacific Region, 1997; and in
the European Region, 1998. Naturally occurring wild poliovirus type 2
has not been detected anywhere in the world since the last recorded case
in October 1999. In 2002, endemic polio remained in 7 countries.

The world will be declared free of wild poliovirus transmission when the
Global Commission for the Certification of the Eradication of
Poliomyelitis is satisfied that all Regions of the World Health
Organization (WHO) have documented the absence of wild poliovirus
circulation for at least three consecutive years and all wild poliovirus
materials in laboratories are adequately contained. The purpose of
containment is to minimize the risk of reintroduction of wild
polioviruses from the laboratory to the community.

The *Global action plan for laboratory containment of wild polioviruses,
2^nd^ Edition* ([Annex
1](../Annex%201%20Global%20Action%20Plan/WHO-VB-03-729.pdf)) describes
containment as consisting of the Laboratory Survey and Inventory (Phase
I) and Global Certification (Phase II). Phase I begins when Regions are
polio-free. Phase II begins when one year has elapsed without isolation
of wild poliovirus anywhere in the world. During Phase I, polio-free
nations alert laboratories located in academic, federal government,
hospital, industry, private, and state and local government facilities
to the impending eradication of polio, encourage destruction of all
unneeded wild poliovirus materials, and compile a national inventory of
all biomedical laboratories choosing to retain such materials.

During Phase II, nations notify laboratories to either dispose of all
wild poliovirus infectious or potentially infectious materials, or
implement biosafety requirements appropriate for the risk of working
with such materials. One year after notification, nations will submit
its final national inventory and documentation of wild poliovirus
laboratory containment to the WHO Regional Office for review by Regional
and Global Certification Commissions.

This report describes the activities undertaken in the United States
during Phase I and submits the US National Inventory of
Institutions/Laboratories Retaining Wild Poliovirus Materials (as of 26
November 2003) to the National Vaccine Advisory Committee for review and
comment.

# 3 Authorization and delegation of responsibility 

In May 1999, the WHA reaffirmed the commitment of WHO to eradicate polio
and urged all member nations to begin the process leading to laboratory
containment of wild polioviruses.

On November 14, 2000 ([Annex
2](../Annex%202%20Letters%20Establishing%20PLCP/Letter%20from%20ASH%2014%20Nov%202000.rtf)),
the Assistant Secretary for Health (ASH) and Surgeon General delegated
responsibility for development and implementation of the United States
Action Plan for the Laboratory Inventory Phase to the National Vaccine
Program Office (NVPO). The National Vaccine Advisory Committee (NVAC)
serves as the de facto national committee for oversight of wild
poliovirus laboratory containment.

On March 7, 2001 ([Annex
2](../../../../../../../../Group%20Data/Polio%20Containment/FINAL%20REPORT/Final%20Report/Annex%202%20Letters%20Establishing%20PLCP/Allyne-%20March%207%202001.rtf)),
the Director of the WHO Regional Office for the American Region (Pan
American Health Organization, PAHO) wrote to the Secretary, HHS
requesting US commitment to guarantee containment of wild polioviruses
stored in laboratories.

On June 13, 2001, the Secretary, HHS replied to the Director ([Annex
2](../../../../../../../../Group%20Data/Polio%20Containment/FINAL%20REPORT/Final%20Report/Annex%202%20Letters%20Establishing%20PLCP/Thompson%20-%20June%2013%202001.doc))
"the United States is fully committed to PAHO's Executive Committee
Resolution CE126.R4 urging Member States "to initiate activities related
to the containment of any laboratory material that may harbor specimens
of wild poliovirus."

In October 2001, under the authority granted by Section 301 of the
Public Health Service Act (42 U.S.C. § 241), NVPO initiated Poliovirus
Laboratory Containment Preparedness (PLCP) to develop and implement a
nationwide survey and compile an inventory of institutions/laboratories
retaining wild poliovirus materials.

NVPO contracted with the Task Force for Child Survival and Development
([Annex 3](../Annex%203%20PLCP%20Contract)) to serve as the focus of
PLCP based on its direct involvement in the development and
implementation of the Global Action Plan in other WHO Regions.

The PLCP staff was headed by Dr. Walter R. Dowdle, consultant to the
World Health Organization (WHO) on the Global Poliomyelitis Eradication
Initiative and formerly Deputy Director and Acting Director of the
Centers for Disease Control and Prevention (1987-1994). As Director of
PLCP, Dr. Dowdle was responsible for ensuring that the overall
objectives of PLCP were achieved effectively and efficiently.

Ms. Kim Koporc, MPH, the communications coordinator, was responsible for
development and implementation of the communications component of the
Action Plan and coordination with NVPO on development of the web page,
survey instruments and database. Dr. Dowdle and Ms. Koporc were
employees of The Task Force, and their salaries and activities were
fully funded and supported by the Centers for Disease Control and
Prevention (CDC), contract number 200-2001-00106.

Ms. Sandra Browning, BS, MT(ASCP)I, was an employee of the National
Center of Infectious Diseases (NCID), CDC, responsible for development
and management of the database and inventory and liaison between The
Task Force, CDC, and NVPO. The Task Force and CDC contracted for
additional support as necessary for data entry, telephone follow-up to
non-responding laboratories, and literature research.

# 4 Developing the US Action Plan 

The US Action Plan ([Annex
4](../Annex%204%20US%20Action%20Plan/US%20Action%20Plan.doc)) was
developed in four stages. In the first stage, a plan was drafted using
the framework of the WHO *Global Action Plan* and leveraging the
experiences of other nations that had already initiated or completed the
Laboratory Inventory Phase. Second, biosafety and laboratory containment
experts reviewed the draft action plan and provided feedback. Third,
processes (i.e. communication, data collection and entry) were developed
through trial surveys of collaborating private and government
institutions. Fourth, the processes were refined in a pilot survey of
376 randomly selected institutions and 143 government laboratories.

The final Action Plan consisted of five components:

1)  Enlist full support and cooperation of Executive-branch Departments,
    professional societies, and accrediting agencies in the survey
    process

2)  Build the framework and database for the Survey of biomedical
    laboratories in the US

3)  Implement the survey process

4)  Compile the Inventory

5)  Establish guidelines and mechanisms for US compliance with post
    global certification containment requirements.

The target for completing all components was September 30, 2003. The
timeline and objectives for each component are described in [Annex
4](../Annex%204%20US%20Action%20Plan/Timeline%20Components%201-5%20(7-29-03).xls).

Relevant public health service agencies and individuals reviewed the
draft Action Plan:

-   February 7, 2001: The concept of a National Survey for Laboratory
    Containment of Wild Poliovirus was introduced at a national meeting
    of the Clinical Laboratory Improvement Advisement Committee.

-   February 15, 2001: PLCP staff met with a representative from the
    Canada Poliovirus Laboratory Containment Office and discussed early
    US plans in the context of Canada's poliovirus laboratory
    containment activities already in progress.

-   July 20, 2001: Progress was reviewed with Acting Principal Deputy
    Assistant Secretary for Health, Dr. Arthur Lawrence

-   January 24, 2002: The designated ASH, Dr. Eve Slater, was briefed on
    the status of the Action Plan.

-   February 6, 2002: PLCP Director reviewed draft Action Plan with
    NVAC.

-   March 7, 2002: the Interdepartmental Working Group, chaired by the
    ASH, reviewed the Action Plan objectives and timeline (see Section
    5.3).

-   March 19, 2002: At the request of the ASH, Dr. Maurice Hilleman,
    Director Emeritus of Merck Institute for Vaccinology, communicated
    feedback on the Action Plan in a letter to the PLCP Director and
    ASH.

-   June 4, 2002: PLCP Director presented a revised Action Plan to NVAC.

-   WHO global polio containment staff commented on the Action Plan on
    an ad-hoc basis.

The PLCP Director made pre-development presentations on laboratory
containment at the:

-   CDC Biosafety Symposium of January 1999

-   NVAC Meeting on February 8, 2000

-   American Society for Microbiology General Meeting on May 21, 2000

-   The Infectious Disease Society of America on September 9, 2000.

# 5 Implementing the US Action Plan

# 5.1 Implementing the Trial Survey

Trial surveys were carried out at CDC, National Institutes of Health
(NIH), Emory University, Wyeth, and the Arizona State Health Laboratory.
Trial survey reporting forms were designed consistent with the *WHO
Guidelines for Implementing the Pre-eradication Phase of the Global
Action Plan for Laboratory Containment of Wild Polioviruses*. PLCP
worked closely with these institutions to refine the forms and processes
for the pilot and national surveys.

The objectives of the trial surveys were to pre-test the survey forms
and the informational brochures and to gain an appreciation of the
reporting mechanisms within government, private and academic
institutions. Major lessons regarding the survey process were that:

-   Institutions with larger bureaucracies needed additional guidance on
    implementing the Survey.

-   Key terms (i.e. "infectious," "potential infectious," "wild") needed
    clarification.

-   Communications needed to clearly convey that a 100% response was the
    goal; whether or not the laboratory retained wild poliovirus
    materials.

Documentation of the CDC, Emory and Wyeth trial surveys is included in
[Annex 5](../Annex%205%20Trial%20Survey). NIH and Arizona State Health
Laboratory successfully conducted their surveys autonomous of PLCP.

# 5.2 Implementing the Pilot Survey

An announcement of the intent to perform a pilot survey for the US
Action Plan was published in the Federal Register on October 11, 2001,
(vol. 66, no. 197). The only comment received was from a representative
of the American Type Culture Collection (ATCC) who suggested that the
Survey also include modified polioviruses. The ATCC was informed that
such materials had been included.

The application for approval of the pilot survey was submitted to the
Office of Management and Budget (OMB) via CDC Office of Program Planning
and Evaluation (OPPE) on January 8, 2002. Answers to questions from OMB
were submitted on February 11, 2002. Final approval for the pilot survey
was received March 18, 2002, and the pilot began in June and ended in
September 2002. ([Annex
6](../../../../../../../../Group%20Data/Polio%20Containment/FINAL%20REPORT/Final%20Report/Annex%206%20OMB%20Applic%20for%20Pilot))

A total of 519 laboratories/institutions were invited to participate in
the pilot survey and grouped into six categories:

-   Academic

-   Federal government

-   Hospital

-   Industry

-   Private

-   State and local government.

Of the 376 non-federal government institutions surveyed during the
pilot, 298 (79%) responded. In combining both the preliminary and pilot
surveys, a total of 306 institutions responded, representing a total of
2,951 laboratories. Of these, 46 (1.6%) retained wild poliovirus
materials.

Although the primary purpose of the pilot survey was to pre-test the
revised survey forms and newly developed communication materials, it was
also used to test a web-based data submission application and a Windows
desktop-based data retrieval/analysis application. The web-based data
submission application provided a means for respondent entities to
furnish data via the Internet, and was authored in Active Server Pages
(ASP). The Windows desktop-based component provided a means for
specified application stakeholders to access, review and manipulate the
data, and was authored in Visual Basic.

Lessons learned from written comments, interviews and calls to the
toll-free number were as follows:

-   A clear statement was needed as to why laboratories had been
    included in the survey even though they did not work with wild
    polioviruses.

-   Survey information and packets were not always disseminated from the
    academic Office of the President down to the biosafety officer or
    laboratory director, requiring PLCP staff to identify and
    simultaneously inform the biosafety officer.

-   Larger institutions preferred electronic formats of the survey
    documents, which made it easier for them to disseminate information.

-   A clearer distinction between passwords and identification numbers
    was needed to reduce confusion and frustration for respondents
    logging on the website to submit results.

-   Some CLIA labs (i.e. physicians' offices) did not have access to the
    Internet. Most respondents mailed or faxed forms, which required
    advanced planning for CDC resources to process completed forms.

-   The provision of institutional worksheets along with reporting forms
    proved to be confusing and of little value to the inventory process,
    which led to streamlining the two documents into one for the
    National Survey.

-   A CD tutorial that provided an introduction and detailed
    instructions for completing the forms proved not to be helpful and
    was discontinued.

-   The words "survey" and "inventory" were confusing. "Survey" was
    equated with poll taking by many participants, who therefore assumed
    it was unimportant. "National Survey" was replaced with "National
    Inventory" in all later materials.

# 5.3 Enlisting multi-sector support 

On November 26, 2001, the Secretary, HHS wrote to his counterpart at
each relevant US Executive Department and Agency requesting that a
representative be appointed to participate in a Working Group on
Containment ([Annex
7](../Annex%207%20Inter-Departmental%20Working%20Group/DOD%20correspondence.rtf)).
The purpose of the Working Group was to give each Department/Agency an
opportunity to provide input and assistance in the development and
implementation of the US Action Plan. Participants included:

-   Department of Agriculture

-   Department of Commerce

-   Department of Education

-   Department of Energy

-   Department of Defense

-   Department of Interior

-   Department of Justice

-   Department of Labor

-   Environmental Protection Agency

-   National Science Foundation

On March 7, 2002, the ASH convened The Interdepartmental Working Group
to review the Action Plan objectives and timeline. ([Annex
7](../Annex%207%20Inter-Departmental%20Working%20Group))

PLCP staff worked closely with each of the Departments/Agencies during
the survey process. All Departments/Agencies completed surveys except
for the Department of Education and the National Science Foundation,
which had no direct jurisdiction over biomedical laboratories. The
Department of Education played an important role by assisting PLCP staff
in developing a database of relevant academic institutions. The
Assistant Secretary for Postsecondary Education sent a letter of support
for the Inventory to Presidents/Chancellors of all academic institutions
on the database ([Annex
8](../../../../../../../../Group%20Data/Polio%20Containment/FINAL%20REPORT/Final%20Report/Annex%208%20Dept%20of%20Education/Proposed%20Letter%20from%20Assistant%20Secretary.doc)).

# 5.4 Enlisting professional society support

On May 28, 2002, a letter from the ASH was sent to the following 31
professional societies requesting assistance in raising awareness of the
National Inventory ([Annex
9](../../../../../../../../Group%20Data/Polio%20Containment/FINAL%20REPORT/Final%20Report/Annex%209%20Professional%20Societies/Letter%20from%20ASH%20to%20Prof%20Societies.rtf)).
Communication packets were sent June 6, 2002.

1.  American Academy of Pediatrics

2.  American Association for Advancement of Science

3.  American Association for Laboratory Animal Science

4.  American Association for Pharmaceutical Scientists

5.  American Biological Safety Association

6.  American Hospital Association

7.  American Institute of Biological Sciences

8.  American Medical Association

9.  American Public Health Association

10. American Society for Clinical Laboratory Science

11. American Society for Clinical Pathologists

12. American Society for Laboratory Animal Practitioners

13. American Society for Medical Technology

14. American Society for Microbiology

15. American Society for Tropical Medicine and Hygiene

16. American Society for Virology

17. Association of Analytical Communities

18. Association of Clinical Research Professionals

19. Association of Independent Research Institutes

20. Association of Public Health Laboratories

21. Association of University Technology Managers

22. Biotechnology Industry Organization

23. Clinical Laboratory Management Association

24. College of American Pathologists

25. Federation of American Societies for Experimental Biology

26. Foundation for Biomedical Research

27. Infectious Diseases Society of America

28. Joint Commission on Accreditation of Healthcare Organizations

29. Laboratory Animal Management Association

30. National Association of Biomedical Research

31. Pharmaceutical Research and Manufactures of America

Action by societies may have taken different forms. However, the
following were confirmed to have posted information in their
newsletters, on their websites, and/or sent letters to their membership:

1.  American Biosafety Association

2.  American Medical Association

3.  American Society for Clinical Pathology

4.  American Society for Medical Technology

5.  American Society for Microbiology

6.  American Society for Virology

7.  Association of Clinical Research and Professionals

8.  Association of Public Health Laboratories

9.  Biotechnology Industry Organization

10. Clinical Laboratory Management Association

11. Joint Commission on Accreditation of Healthcare Organizations

12. National Foundation for Infectious Diseases

On December 3, 2002, PLCP followed up with a letter to the original 31
professional societies requesting them to remind their membership of the
December 31, 2002 deadline for submitting survey results ([Annex
9](../../../../../../../../Group%20Data/Polio%20Containment/FINAL%20REPORT/Final%20Report/Annex%209%20Professional%20Societies)).

PLCP also utilized the Biosafety List Serve, sponsored by the
Massachusetts Institute of Technology. This communication channel proved
to be highly effective in reaching biosafety officers of universities
and biotechnology and pharmaceutical companies -- institutions **most
likely to possess** wild poliovirus materials.

PLCP personnel attended conferences and annual meetings of public and
private agencies to discuss the strategies for implementing the National
Survey, raising awareness, and generating support. Presentations
included posters and/or talks. Individual contacts were made by phone,
e-mail, and mailings. Activities to enlist support were ongoing
throughout the first year:

[Poster Display]{.underline}

January 28, 2002 -- 7^th^ National Symposium on Biosafety

March 24-27, 2002 -- International Conference on Emerging Infectious
Diseases (Courtesy of NCID)

June 10, 2002 -- Biotechnology Industry Organization (Courtesy of
National Institute of Standards and Technology, Department of Commerce)

October 24, 2002 -- Infectious Diseases Society of America (Courtesy of
NCID)

[Presentations]{.underline}

February 7, 2001 -- Clinical Laboratory Improvement Advisory Committee

February 8, 2001 -- National Symposium on Biosafety

May 21, 2001 -- American Society for Microbiology

June 11, 2001 -- Association of Public Health Laboratories

July 17, 2001 -- International Conference on Emerging Infectious
Diseases

September 9, 2001 -- Infectious Diseases Society of America

March 25, 2002 -- Emerging Infectious Diseases Conference

May 15, 2002 -- New England Biological Safety Association (NEBSA)

May 20, 2002 -- American Society for Microbiology

June 19, 2002 -- Association of Public Health Laboratories

September 19, 2002 -- Mid-Atlantic Biological Safety Association (MABSA)

September 26, 2002 -- Chesapeake Area Biological Safety Association
(ChABSA)

October 21, 2002 -- Roundtable Discussion at the Annual National Meeting
of ABSA

November 22, 2002 -- Technical Advisory Group, PAHO

December 17, 2002 -- Board of Scientific Counselors, NCID

[Publications]{.underline}

Dowdle WR. 2001. Polio Eradication: Turning the Dream into Reality. ASM
News, **67:**397-400.

Centers for Disease Control and Prevention, 2002. Laboratory
Surveillance for Wild Poliovirus and Vaccine-Derived Poliovirus,
2000-2001. Morbidity and Mortality Weekly Report, **51:**369-371.

Centers for Disease Control and Prevention, 2002. Notice to Readers:
National Laboratory Inventory as Part of Global Poliovirus Containment
-- United States, June 2002. Morbidity and Mortality Weekly Report,
**51:**646-647.

Dowdle WR, Gary HE, Sanders R, van Loon AM. 2002. Can Post-Eradication
Laboratory Containment of Wild Polioviruses be Achieved? Bulletin of the
World Health Organization, **80:**311-315.

Dowdle WR. 2002. Poliovirus National Inventory of Biomedical
Laboratories Begins. ASM News, **68:**478-479.

Gilman EA, Luttrell R. 2002. The Poliovirus Laboratory Containment Pilot
Survey: The Experiences of Wyeth and Emory University. Applied
Biosafety, **73:**137-140.

Koporc K, Browning S, Dowdle W. 2002. National Inventory of Biomedical
Laboratories that May Possess Wild Poliovirus Materials. Applied
Biosafety, **73:**133-136.

Centers for Disease Control and Prevention, 2002. Global Progress Toward
Laboratory Containment of Wild Polioviruses -- July 2001-August 2002.
Morbidity and Mortality Weekly Report, **51:**993-996.

Centers for Disease Control and Prevention, 2003. Laboratory
Surveillance for Wild and Vaccine-Derived Polioviruses, January 2002-
June 2003. Morbidity and Mortality Weekly Report, **52:**913-916.

# 5.5 Communicating with the laboratory community

Key messages included the following:

-   Wild polioviruses will be eradicated.

-   The only sources of wild polioviruses will be in biomedical
    laboratories.

-   Laboratory containment is crucial to prevent reintroduction of
    poliovirus from the laboratory to an increasingly non-immune
    community.

-   All biomedical laboratories that may have infectious or potentially
    infectious materials are participating in the Survey.

-   Purpose of the Survey is to:

```{=html}
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```
-   Alert laboratories to the impending eradication of polio

-   Encourage the destruction of all unneeded wild poliovirus materials

-   Establish a national inventory of laboratories retaining poliovirus
    infectious and potentially infectious materials

When appropriate, communication materials included a statement of
support from the Secretary, HHS. Communication materials were produced
and distributed in the survey packets, handed out at meetings, posted on
the PLCP website
([www.cdc.gov/od/nvpo/polio](http://www.cdc.gov/od/nvpo/polio)), and
included in media packets to professional societies for publication
(i.e. public service announcements, journal articles). Poster samples,
the informational brochure, and an expanded list of frequently asked
questions posted on the website are in [Annex
10](../Annex%2010%20Communication%20Materials).

# 6 Preparing for the National Survey

The Federal Register Notice for the National Survey was published on May
10, 2002 (Vol. 67, No. 91). No public comments were received. On July
10, 2002, the proposal to conduct the National Survey was submitted to
CDC/OPPE, who reviewed and forwarded it to OMB on July 17, 2002. OMB
approval to perform the National Survey was received September 16, 2002
([Annex 11](../Annex%2011%20OMB%20National%20Survey)).

# 6.1 Compiling the Survey Database

The database of institutions was generated from a variety of sources
including:

-   All institutions/laboratories certified to perform bacteriology,
    mycobacteriology, parasitology, or virology testing under the
    Clinical Laboratory Improvement Amendments (CLIA) [^1]

-   All academic institutions listed on the US Department of Education
    database of post-secondary colleges and universities and the
    Carnegie Foundation database of institutions classified as
    doctoral/research universities.

-   All biotechnology and pharmaceutical institutions listed on the
    websites of Pharma.com and the Biotechnology Industry Organization
    ([www.bio.org](http://www.bio.org/)).

-   All Executive Branch Agencies/Departments with biomedical
    laboratories under their jurisdiction were responsible for
    implementing surveys.

-   All state and territorial public health laboratories.

The database was further organized into the following categories
(Figure1):

-   **Most likely to possess** wild poliovirus materials: This category
    included large academic, federal government, industrial research
    facilities and state public health laboratories.

-   **May possess** wild poliovirus materials: This category included
    CLIA clinical microbiology laboratories certified for complex
    testing in virology and bacteriology.

-   **Least likely to possess** wild poliovirus materials: This category
    included CLIA clinical microbiology laboratories certified for
    non-complex testing in virology and bacteriology. These laboratories
    were not anticipated to retain such materials, but inclusion in the
    Survey was necessary to quantify the risk.

CLIA laboratories certified for diagnostic tests other than microbiology
were excluded.

The database includes the following information:

-   Source of institution name (i.e. Department of Education, CLIA)

-   Institution/laboratory name and address

-   Type of institution

-   CLIA identification number

-   Contact information for Responsible Facility Official (RFO)

-   Total number of labs surveyed

-   Survey results, including number of labs retaining material,
    principal lab function, type of material and approximate amount of
    material retained

-   Record of data entry by date.

# 6.2 Developing Survey Forms/Packets and The Website

The survey form, instructional materials, and information brochures used
in the National Survey were the final products of the trial survey, the
pilot survey, and multiple open reviews. The survey form requested
institutions/laboratories to indicate whether they do or do not possess
wild poliovirus infectious and/or potential infectious materials**.** If
such materials were present, respondents were requested to indicate the
types of materials and estimated numbers of units retained.

The PLCP website included answers to the most commonly asked questions,
survey forms and instructions, background information and polio
eradication and laboratory containment. The website also included a link
to submit survey results. Respondents logged on using the identification
(ID) number and password included in their survey packets ([Annex
12](../Annex%2012%20Survey%20Packet)).

A helpline and e-mail were established to assist respondents with
questions.

# 7 Implementing the National Survey 

On October 1, 2002, a letter from the ASH was sent to all institutions
on the database notifying them of the upcoming Survey and the importance
of responding. On October 11, 2002, the PLCP Director sent a follow-up
survey packet that included a cover letter with an ID number and
password for submitting results on the Internet, informational brochure,
instructions, survey form, and a self-addressed-postage-paid return
envelope.

Letters reminding institutions of the December 31, 2002 deadline for
responding were sent on December 5 to those listed in the category of
**most likely to possess** wild poliovirus materials (academic,
biotechnology and pharmaceutical institutions). After the December
deadline, reminder letters were sent to non-responding institutions in
all categories. Beginning April 28, letters were followed up with
telephone calls to the remaining non-responding institutions categorized
as **most likely to possess** or **may possess** wild poliovirus
materials. The process described below is summarized in Figure 2. [Annex
13](../../../../../../../../Group%20Data/Polio%20Containment/FINAL%20REPORT/Final%20Report/Annex%2013%20National%20Survey%20Correspondence)
provides sample copies of all correspondence.

-   December 5, 2002 -- First reminder letter (850) sent to
    non-responding academic institutions (369) and pharmaceutical and
    biotechnology companies (481).

-   February 1, 2003 -- First reminder letter sent to 17,765
    non-responding CLIA laboratories.

-   March 4, 2003 -- Second reminder letter sent to remaining 74
    non-responding academic institutions and 41 pharmaceutical and
    biotechnology companies.

-   April 28, 2003 --Telephone reminders began to the remaining 55
    academic institutions and pharmaceutical and biotechnology
    companies.

-   May 23, 2003 --Telephone reminders began to 419 CLIA labs that **may
    possess** wild poliovirus materials.

-   July 1, 2003- Second reminder letter sent to 4,456 non-responding
    CLIA laboratories

-   August 7, 2003 -- Follow-up with laboratories that **most likely
    possess** and **may possess** continues until 100% response rate is
    achieved

-   November 20, 2003 -- 100% response rate achieved.

![](media/image1.wmf)

# 8 Analyzing results of the National Survey

All 5,585 institutions/laboratories categorized as **most likely to
possess** or **may possess** wild poliovirus materials responded to the
Survey (Figure 3 and Table 1). Of those categorized as **least likely to
possess** such materials, 24,206 of the 26,844 (90%) responded.

The primary purpose of including laboratories **least likely to
possess** in the Survey was to quantify risk. Laboratories in this
category are small, mostly located in physicians' offices, and licensed
to perform only non-complex testing. The annual turnover within this
category is high. Of the non-responders, 499 (19%) could not be located
or were no longer in operation. Because none of the 24,206 responders
reported wild poliovirus materials, the risk of any of the remaining
2,638 laboratories in this category (if they exist) having such
materials was exceedingly small. The NVAC Workgroup, at its review on
October 8, 2003, recommended discontinuing follow-up with this category
([Annex
14](../Annex%2014%20%20October%208%20NVAC%20Workgroup%20Minutes/10-8-03%20NVAC%20Workgroup%20Minutes.doc)).

# 9 Compiling the National Inventory

The US National Inventory for Phase I consists of 122 institutions
retaining wild poliovirus materials in 180 laboratories (Table 2). Table
3 ([Annex
15](../Annex%2015%20National%20Inventory/Table%202%20National%20Inventory%20Report%2011-30-03.xls))
summarizes the institutional reports listing the number of laboratories
holding either infectious (87), potential infection materials (56), or
both (37). Other information from the National Inventory, including
names of responsible facility officials and principal investigators,
identification of individual laboratories, and volumes of materials
being held, are not provided.

The Secretary, HHS will submit the names of institutions, types of
material (infectious or potential infectious) retained, and the number
of laboratories holding such materials to the WHO Office for the Region
of the Americas and the Regional Certification Commission

Table 1. Institutions responding to National Survey by Category

  ---------------- ----------------------- -- ---------------- ----- -- ---------------- -------
  **Categories**   [Institutions in           **Institutions            **Institutions   
                   Database]{.underline}      Responding**              with Materials** 

                                                                                         

                   \#                         \#               \%       \#               \%

  **Most Likely to                                                                       
  Possess**                                                                              

  Academic         437                        437              100      63               14

  Federal          13                         13               100      5**\*\***        38
  Government                                                                             

  Industrial       668                        668              100      24               4

  State and Local  98                         98               100      17               17
  Gov.                                                                                   

                                                                                         

  Total            1216                       1216             100      109              9

                                                                                         

  **May Possess**                                                                        

  *All CLIA        4369                       4369             100      8                0.1
  certified to*                                                                          

  *perform                                                                               
  complex*                                                                               

  *testing in                                                                            
  microbiology*                                                                          

                                                                                         

  **Least Likely   26,844                     24,206           90       0                0
  to Possess**                                                                           

  *All CLIA                                                                              
  certified*                                                                             

  *Non-Complex                                                                           
  Testing*                                                                               

  *Labs*                                                                                 

                                                                                         

                                                                                         

  *Total*          32,429**\***               29,791           92       117              0.3

                                                                                         

                                                                                         

  **\***                                                                                 
  Represents a                                                                           
  total of 105,356                                                                       
  laboratories                                                                           
  surveyed                                                                               

                                                                                         

  **\*\***                                                                               
  Departments                                                                            
  ---------------- ----------------------- -- ---------------- ----- -- ---------------- -------

# Table 2. US National Inventory of Institutions/Laboratories Retaining Wild Poliovirus Materials

+-----------------------------------------+-------+---+-----+----+----+
| Name                                    | City  | S | I   | P  | Bo |
|                                         |       | t | nfe | ot | th |
|                                         |       | a | cti | en |    |
|                                         |       | t | ous | ti |    |
|                                         |       | e |     | al |    |
+-----------------------------------------+-------+---+-----+----+----+
|                                         |       |   | Ma  | In |    |
|                                         |       |   | ter | fe |    |
|                                         |       |   | ial | ct |    |
|                                         |       |   |     | io |    |
|                                         |       |   |     | us |    |
+-----------------------------------------+-------+---+-----+----+----+
|                                         |       |   |     | Ma |    |
|                                         |       |   |     | te |    |
|                                         |       |   |     | ri |    |
|                                         |       |   |     | al |    |
+-----------------------------------------+-------+---+-----+----+----+
|                                         |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| [ACADEMIC]{.underline}                  |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Associated Regional & University        | Salt  | U | 0   | 1  | 0  |
| Pathology Laboratories U of UT          | Lake  | T |     |    |    |
|                                         | City  |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Baylor College of Medicine              | Ho    | T | 1   | 0  | 1  |
|                                         | uston | X |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Brown University                        | Provi | R | 1   | 0  | 0  |
|                                         | dence | I |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Clemson University                      | Cl    | S | 0   | 1  | 0  |
|                                         | emson | C |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Columbia University - Health Sciences   | New   | N | 0   | 0  | 1  |
| Division                                | York  | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Duke University- Duke University        | D     | N | 2   | 0  | 0  |
| Medical Center                          | urham | C |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Eastern KY University, Rowlett 103      | Ric   | K | 0   | 1  | 0  |
|                                         | hmond | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Eastern Virginia Medical School         | No    | V | 0   | 1  | 0  |
|                                         | rfolk | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Emory University                        | At    | G | 2   | 2  | 0  |
|                                         | lanta | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Hackensack University Medical Center    | Hacke | N | 0   | 0  | 1  |
|                                         | nsack | J |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Harvard University                      | B     | M | 2   | 0  | 0  |
|                                         | oston | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| IIT Research Institute                  | Ch    | I | 1   | 0  | 0  |
|                                         | icago | L |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Louisiana State University - Health     | New   | L | 0   | 0  | 1  |
| Sciences Center, New Orleans            | Or    | A |     |    |    |
|                                         | leans |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Louisiana State University - Science    | Shrev | L | 1   | 0  | 0  |
| Center, Shreveport                      | eport | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Medical College of Ohio - Hospital      | T     | O | 0   | 0  | 1  |
| Laboratory                              | oledo | H |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Middle Tennessee State University       | Mu    | T | 1   | 0  | 0  |
|                                         | rfree | N |     |    |    |
|                                         | sboro |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| New Mexico State University             | Las   | N | 1   | 0  | 0  |
|                                         | C     | M |     |    |    |
|                                         | ruces |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| New York University                     | New   | N | 0   | 1  | 0  |
|                                         | York  | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| New York University Medical Center      | New   | N | 1   | 1  | 0  |
|                                         | York  | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Oakland University                      | Roch  | M | 0   | 1  | 0  |
|                                         | ester | I |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Purdue University                       | West  | I | 2   | 0  | 0  |
|                                         | Lafa  | N |     |    |    |
|                                         | yette |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Saint Louis University                  | St.   | M | 0   | 1  | 0  |
|                                         | Louis | O |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Southern Research Institute             | Fred  | M | 0   | 0  | 1  |
|                                         | erick | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Stanford University                     | Sta   | C | 4   | 0  | 0  |
|                                         | nford | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| SUNY Downstate Medical Center           | Bro   | N | 0   | 1  | 0  |
|                                         | oklyn | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| SUNY Stony Brook                        | Stony | N | 1   | 0  | 0  |
|                                         | Brook | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| SUNY Upstate Medical University         | Syr   | N | 1   | 1  | 2  |
|                                         | acuse | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Syracuse University                     | Syr   | N | 1   | 0  | 0  |
|                                         | acuse | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| The Pennsylvania State University       | Unive | P | 0   | 0  | 1  |
|                                         | rsity | A |     |    |    |
|                                         | Park  |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| The Scripps Research Institute -        | La    | C | 2   | 0  | 0  |
| Medical Laboratory                      | Jolla | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| The Wistar Institute                    | Ph    | P | 0   | 1  | 0  |
|                                         | ilade | A |     |    |    |
|                                         | lphia |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Tufts University - School of Veterinary | B     | M | 0   | 1  | 0  |
| Medicine-Grafton                        | oston | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Alabama - Birmingham      | Birmi | A | 2   | 1  | 0  |
|                                         | ngham | L |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of California - Berkeley     | Ber   | C | 1   | 0  | 0  |
|                                         | keley | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of California - Davis        | Davis | C | 1   | 0  | 0  |
|                                         |       | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of California - Irvine       | I     | C | 2   | 0  | 0  |
|                                         | rvine | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of California - Los Angeles  | Los   | C | 1   | 0  | 1  |
|                                         | An    | A |     |    |    |
|                                         | geles |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of California - San Diego    | La    | C | 0   | 0  | 1  |
|                                         | Jolla | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of California - San          | San   | C | 1   | 0  | 0  |
| Francisco                               | Fran  | A |     |    |    |
|                                         | cisco |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Chicago                   | Ch    | I | 0   | 0  | 1  |
|                                         | icago | L |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Colorado - Health         | D     | C | 1   | 0  | 0  |
| Sciences Center                         | enver | O |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Connecticut               | S     | C | 1   | 1  | 0  |
|                                         | torrs | T |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Florida                   | G     | F | 1   | 0  | 0  |
|                                         | aines | L |     |    |    |
|                                         | ville |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Georgia                   | A     | G | 0   | 3  | 0  |
|                                         | thens | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Hawaii                    | Hon   | H | 1   | 0  | 0  |
|                                         | olulu | I |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Idaho                     | M     | I | 0   | 1  | 0  |
|                                         | oscow | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Maryland                  | Co    | M | 1   | 0  | 0  |
|                                         | llege | D |     |    |    |
|                                         | Park  |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Massachusetts - Medical   | Worc  | M | 1   | 0  | 0  |
| School                                  | ester | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Minnesota                 | M     | M | 0   | 1  | 0  |
|                                         | innea | N |     |    |    |
|                                         | polis |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of New Hampshire             | D     | N | 0   | 0  | 1  |
|                                         | urham | H |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of North Carolina            | C     | N | 0   | 0  | 1  |
|                                         | hapel | C |     |    |    |
|                                         | Hill  |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of South Dakota - Sioux      | Sioux | S | 0   | 1  | 0  |
| Falls                                   | Falls | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of South Dakota - Vermillion | Vermi | S | 0   | 1  | 0  |
|                                         | llion | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Southern California       | Los   | C | 1   | 0  | 0  |
|                                         | An    | A |     |    |    |
|                                         | geles |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Texas - Austin            | A     | T | 0   | 1  | 0  |
|                                         | ustin | X |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Texas - James P Luby -    | D     | T | 0   | 0  | 1  |
| Dallas                                  | allas | X |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Texas - MD Anderson       | Ho    | T | 2   | 0  | 0  |
| Cancer Center                           | uston | X |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Texas Galveston -         | Galv  | T | 0   | 1  | 0  |
| Galveston Pathology Clinical Services   | eston | X |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Texas Galveston - UT      | Galv  | T | 2   | 0  | 0  |
| Medical Branch                          | eston | X |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Virginia                  | Charl | V | 1   | 1  | 1  |
|                                         | ottes | A |     |    |    |
|                                         | ville |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Washington                | Se    | W | 2   | 3  | 0  |
|                                         | attle | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Wisconsin - Madison       | Ma    | W | 2   | 0  | 0  |
|                                         | dison | I |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Utah State University                   | Logan | U | 1   | 0  | 0  |
|                                         |       | T |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
|                                         |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| [FEDERAL]{.underline}                   |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Department of Defense                   | Falls | V | 0   | 2  | 0  |
|                                         | C     | A |     |    |    |
|                                         | hurch |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Department of Agriculture               | Belts | M | 2   | 0  | 0  |
|                                         | ville | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| HHS - Centers for Disease Control and   | At    | G | 0   | 12 | 1  |
| Prevention                              | lanta | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| HHS - Food and Drug Administration      | Rock  | M | 3   | 0  | 0  |
| (CBER)                                  | ville | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| HHS - National Institutes of Health     | Bet   | M | 2   | 2  | 0  |
|                                         | hesda | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Environmental Protection Agency         | Cinci | O | 0   | 0  | 1  |
|                                         | nnati | H |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| VA - Los Angeles, CA                    | Los   | C | 1   | 0  | 0  |
|                                         | An    | A |     |    |    |
|                                         | geles |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| VA - Northern California Health Care    | Mar   | C | 1   | 0  | 0  |
| System - Martinez, CA                   | tinez | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| VA - San Diego, CA                      | San   | C | 0   | 0  | 1  |
|                                         | Diego | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| VA - West Haven, CT Medical Center      | West  | C | 0   | 1  | 0  |
|                                         | Haven | T |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
|                                         |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| [HOSPITAL]{.underline}                  |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Baylor College of Medicine -Texas       | Ho    | T | 1   | 0  | 0  |
| Children\'s Hospital, Diagnostic        | uston | X |     |    |    |
| Virology Laboratory                     |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Children's Hospital, Department of      | Col   | O | 0   | 0  | 1  |
| Pathology, Columbus Ohio                | umbus | H |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Lahey Clinic Medical Center             | Burli | M | 0   | 0  | 1  |
|                                         | ngton | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Oklahoma University Medical Center      | Okl   | O | 0   | 0  | 1  |
|                                         | ahoma | K |     |    |    |
|                                         | City  |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| St. Joseph\'s Hospital and Medical      | Ph    | A | 0   | 0  | 1  |
| Center, Clinical Laboratory             | oenix | Z |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| The Children\'s Hospital of             | Ph    | P | 1   | 0  | 1  |
| Philadelphia                            | ilade | A |     |    |    |
|                                         | lphia |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| The Children\'s Hospital, Denver        | D     | C | 0   | 0  | 1  |
|                                         | enver | O |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| University of Arkansas-Little Rock,     | L     | A | 1   | 0  | 0  |
| University Hospital Clinical Lab        | ittle | R |     |    |    |
|                                         | Rock  |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
|                                         |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| [INDUSTRIAL]{.underline}                |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Abbott Laboratories                     | A     | I | 1   | 0  | 0  |
|                                         | bbott | L |     |    |    |
|                                         | Park  |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Acambis, Inc                            | Camb  | M | 1   | 0  | 0  |
|                                         | ridge | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| American Type Culture Collection        | Man   | V | 2   | 0  | 0  |
|                                         | assas | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Aventis Pasteur                         | Swift | P | 1   | 0  | 0  |
|                                         | water | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| BioPort Corporation                     | La    | M | 1   | 0  | 0  |
|                                         | nsing | I |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| BioReliance Corporation                 | Rock  | M | 1   | 0  | 0  |
|                                         | ville | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Bristol-Myers Squibb Company            | New   | N | 1   | 1  | 0  |
|                                         | York  | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Celgene Corporation                     | W     | N | 0   | 3  | 0  |
|                                         | arren | J |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Compunet Clinical Laboratories          | D     | O | 0   | 1  | 0  |
|                                         | ayton | H |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Eli Lilly & Company                     | In    | I | 0   | 0  | 1  |
|                                         | diana | N |     |    |    |
|                                         | polis |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Fox Chase Cancer Center                 | Ph    | P | 2   | 0  | 0  |
|                                         | ilade | A |     |    |    |
|                                         | lphia |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Immunosol, The Inverse Genomics         | San   | C | 1   | 0  | 0  |
|                                         | Diego | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| MDS Pharma Services, Bothell            | Bo    | W | 1   | 0  | 0  |
|                                         | thell | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Microbiotest, Inc                       | Ster  | V | 1   | 0  | 0  |
|                                         | lilng | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Pfizer Inc                              | New   | C | 0   | 1  | 0  |
|                                         | L     | T |     |    |    |
|                                         | ondon |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Pharmacia Corporation                   | Kala  | M | 2   | 0  | 0  |
|                                         | mazoo | I |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| PTC Therapeutics, Inc                   | South | N | 1   | 0  | 0  |
|                                         | Plain | J |     |    |    |
|                                         | field |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Quest Diagnostics Nichols Institute     | Chan  | V | 1   | 0  | 0  |
|                                         | tilly | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Ribozyme Pharmaceuticals, Inc           | Bo    | C | 0   | 0  | 1  |
|                                         | ulder | O |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Schering Plough Corporation             | Kenil | N | 1   | 0  | 0  |
|                                         | worth | J |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Specialty Laboratories                  | Santa | C | 1   | 0  | 0  |
|                                         | M     | A |     |    |    |
|                                         | onica |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| V.I. Technologies (Vitex)               | Wate  | M | 1   | 0  | 0  |
|                                         | rtown | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| ViroPharma, Inc                         | Exton | P | 1   | 0  | 0  |
|                                         |       | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Wyeth                                   | Ma    | N | 1   | 0  | 0  |
|                                         | dison | J |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
|                                         |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| #### STATE AND LOCAL                    |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| California State Public Health          | Ric   | C | 0   | 0  | 1  |
| Laboratory                              | hmond | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Commonwealth of Virginia Public Health  | Ric   | V | 0   | 0  | 1  |
| Laboratory                              | hmond | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Delaware Public Health Laboratory       | S     | D | 0   | 1  | 0  |
|                                         | myrna | E |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Erie County Medical Center Healthcare   | Bu    | N | 1   | 0  | 0  |
| Network                                 | ffalo | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Florida Department of Health, Bureau of | Tampa | F | 0   | 1  | 0  |
| Laboratories                            |       | L |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Georgia Public Health Laboratory        | De    | G | 0   | 0  | 1  |
|                                         | catur | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Illinois Department of Public Health -  | Ch    | I | 0   | 0  | 1  |
| Chicago Laboratory                      | icago | L |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Indiana Department of Public Health     | In    | I | 0   | 1  | 0  |
|                                         | diana | N |     |    |    |
|                                         | polis |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Kansas Department of Health &           | T     | K | 0   | 0  | 1  |
| Environment                             | opeka | S |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Los Angeles County Public Health        | Los   | C | 1   | 0  | 0  |
| Department                              | An    | A |     |    |    |
|                                         | geles |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Maryland State Department of Health and | Balt  | M | 1   | 0  | 0  |
| Mental Hygiene                          | imore | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| New York State Department of Health -   | A     | N | 0   | 0  | 2  |
| Wadsworth Center                        | lbany | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Orange County Health Care Agency        | Santa | C | 0   | 1  | 0  |
|                                         | Ana   | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| San Diego County Public Health          | San   | C | 1   | 0  | 0  |
| Laboratory                              | Diego | A |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| South Dakota Department of Health       | P     | S | 0   | 0  | 1  |
|                                         | ierre | D |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Westchester County Department of Labs   | Val   | N | 0   | 0  | 1  |
| and Research                            | halla | Y |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
| Wisconsin State Laboratory Of Hygiene   | Ma    | W | 0   | 0  | 1  |
|                                         | dison | I |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
|                                         |       |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+
|                                         |       |   | 87  | 56 | 37 |
|                                         | TOTAL |   |     |    |    |
+-----------------------------------------+-------+---+-----+----+----+

#  

Table 3. Institutions Retaining Wild Poliovirus Materials by Category

  ---------------- ---------------- -- ---------------- ----------------- ---------- -----------
  **Categories**   **Institutions      **Laboratories                                
                   Retaining           Retaining                                     
                   Materials**         Materials**                                   

                                       **Infectious**   **Potential       **Both**   **Total**
                                                        Infectious**                 

                                                                                     

  **Most Likely to                                                                   
  Possess**                                                                          

  Academic         63                  49               29                16         94

  Federal          10                  9                17                3          29
  Government                                                                         

  Industrial       24                  22               6                 2          30

  State and Local  17                  4                4                 10         18
  Gov.                                                                               

                                                                                     

  Total            114                 84               56                31         171

                                                                                     

  **May Possess**                                                                    

  *All CLIA        8                   3                0                 6          9
  certified to*                                                                      

  *perform                                                                           
  complex*                                                                           

  *testing in                                                                        
  microbiology*                                                                      

                                                                                     

  **Least Likely   0                   0                0                 0          0
  to Possess**                                                                       

  *All CLIA                                                                          
  certified*                                                                         

  *Non-Complex                                                                       
  Testing*                                                                           

  *Labs*                                                                             

                                                                                     

                                                                                     

  **Total**        **122**             **87**           **56**            **37**     **180**
  ---------------- ---------------- -- ---------------- ----------------- ---------- -----------

# 

# 10 Quality Assessment of Survey and National Inventory

#  

This report was prepared using as guidance the self-evaluation WHO
*Guidelines for documenting the quality of phase I wild poliovirus
laboratory containment-laboratory survey and inventory* ([Annex
16](../Annex%2016%20Draft%20WHO%20Documentation%20Guidelines/Laboratory%20survey%20and%20inventory%20quality%20assessment%20FINALa.doc)).
Additional quality assessment tools included a literature search for the
years 1993-2003 for institutions/laboratories that may have been missed,
post-survey discussions with institutional biosafety officers, and
letters of confirmation to institutions listed on the Inventory.

# 10.1 Results of the Literature Search

The completeness and quality of the National Survey and Inventory was
assessed by a search of the scientific literature through PubMed from
1993 to the present. The purpose of the search was three-fold: 1) to
identify relevant US institutions/laboratories that were not included in
the National Survey, 2) to identify institutions/laboratories at high
risk of having potential infectious wild poliovirus clinical materials,
and 3) to initiate a Phase II database of institutions/laboratories
working with viruses at risk of wild poliovirus contamination.

The criteria used in conducting the PubMed literature search was limited
to the English language, US mentioned anywhere within the citation, and
laboratory studies. The PubMed database for 2002 and the first half of
2003 listed 7,080 publications on the infectious agents initially
selected for review (Table 4 and Figure 4).

Table 4. Agents Selected for Review

+-----------------------------------+-----------------------------------+
| # Viruses                         | # Bacteria                        |
+-----------------------------------+-----------------------------------+
| -   Poliovirus                    | -   Cholera                       |
|                                   |                                   |
| -   Rhinovirus                    | -   Typhoid fever                 |
|                                   |                                   |
| -   Enterovirus                   | -   *Campylobacter*               |
|                                   |                                   |
| -   Coxsackievirus                | -   *Shigella* or Shigellosis     |
|                                   |                                   |
| -   Echovirus                     | -   *Escherichia coli*            |
|                                   |                                   |
| -   Picornavirus                  | -   *Salmonella* or Salmonellosis |
|                                   |                                   |
| -   Adenovirus                    |                                   |
|                                   |                                   |
| -   Hepatitis A and E virus       |                                   |
|                                   |                                   |
| -   Rotavirus                     |                                   |
+-----------------------------------+-----------------------------------+

At that rate, a 10-year review would consist of more than 40,000
citations. However, more than half of the citations (4,106) for 2002-3
mentioned *E. coli* and/or *Salmonella* species. The majority of these
citations were found to describe bacteriological studies related to
domestic agricultural products and services, foods and the environment,
which were not useful for identifying laboratories at risk of storing
wild poliovirus materials. Consequently, *E. coli* and *Salmonella* sp.
were excluded from further search.

Similarly, analysis of the 137 US adenovirus citations in only the first
half of 2003 revealed 4 relevant laboratory publications, one
agricultural and 3 human respiratory disease studies. Three of the 4
publications had been previously identified in the enterovirus search.
The remaining 133 (97%) laboratory publications described the use of
adenoviruses or adeno-associated viruses for gene transfer research in
neurology, cardiovascular, ophthalmology, endocrinology, and other
specialized fields. These highly specialized laboratories were
considered unlikely environments for wild poliovirus contaminated
materials and adenovirus citations were excluded from further analysis.

Figure 4: Initial PubMed Literature Search for 2002 and 2003 --
Bacterial and Viral (n=7080)

![](media/image2.wmf){width="8.916666666666666in"
height="5.083333333333333in"}

The PubMed search for US citations on the remaining agents (Figure 5)
was organized as follows:

A.  Publications describing any laboratory use of polioviruses of any
    origin (attenuated or wild).

B.  Publications describing any laboratory studies of human enteric
    diseases involving clinical specimens from polio endemic countries
    (search for hepatitis virus A and E, rotaviruses, *V. cholera*, *S.
    typhosa*, *Shigella sp*., *Campylobacter* sp. and any country in
    Africa, the Middle East, and South East Asia listed in the *Global
    Action Plan, 2^nd^ ed.*).

C.  Publications describing any laboratory use of viruses that share
    common enteric origins with wild polioviruses and/or replicate on
    poliovirus-permissive systems (search for coxsackievirus, echovirus,
    enterovirus, hepatitis virus A and E, picornavirus, and rhinovirus).

![](media/image3.wmf){width="8.75in" height="4.808333333333334in"}Figure
5: Selected PubMed Literature Search for 2002 and 2003 -- Bacterial and
Viral (n=1906)

The number of institutions is likely over-represented through the number
of agents included in the search and the length of the search period (10
years), the latter greatly increasing the chance that an institution
would appear multiple times. The inclusion of an institution in the
database for one or more categories does not necessarily imply current
institutional activity. Academic institutions are associated with areas
of research primarily because of the interests of one or more principle
investigators, who may come and go. Some institutions ceased work in a
strong program area when the principal investigator retired. Other
institutions gained research programs, while still others lost programs,
as principle investigators changed venues, taking programs with them,
often including stored stocks and research materials. A listing on a
category database means that the institution has a history of working in
that area and has some potential for having wild poliovirus materials,
but that potential may vary widely.

Group A: The PubMed search identified 44 institutions with publications
on polioviruses of any origin ([Annex
17](../Annex%2017%20PubMed%20Literature%20Search/Group%20A.xls) -- Group
A). Of the 44 institutions identified, all but 2 had responded to the
National Survey ([Annex
17](../Annex%2017%20PubMed%20Literature%20Search/Institutions%20not%20found%20on%20the%20National%20Inventory.doc)
-- Table I). One of the non-respondents was a start-up biotechnology
company, now defunct, but previously working with non-infectious
poliovirus replicons. The second was a small community college using
attenuated poliovirus as a model for a ground water project. Follow-up
revealed the project was discontinued several years ago.

In a related incident, a major biotechnology center that had reported no
wild polioviruses was found to have published on wild viruses several
years earlier. Follow up with the center revealed they had destroyed all
wild poliovirus materials, in keeping with the national request to
dispose of such materials no longer needed.

Group B: Nineteen institutions were identified as participating in
studies involving clinical materials from 15 polio endemic countries in
Africa (9), the Middle East (2) and South East Asia (4) ([Annex
17](../Annex%2017%20PubMed%20Literature%20Search/Group%20B.xls) -- Group
B). Countries most frequently involved were India, Pakistan, Bangladesh,
and Egypt. Of the 19 US institutions, laboratories most often cited were
federal, supported by the Departments of Defense (Army, Navy, and USUHS)
and Health and Human Services (CDC and NIH). The remaining 11
institutions were universities historically involved in collaborative
infectious disease projects in developing countries. Whether the US
collaborator processed and stored potential infectious clinical
specimens is not always apparent from the publications. All 19
institutions identified as collaborators in laboratory studies in polio
endemic countries had participated in the National Survey.

Group C: Ninety-eight (98) institutions were identified with
publications describing any laboratory use of viruses that share common
enteric origins with wild polioviruses and/or replicate on
poliovirus-permissive systems ([Annex
17](../Annex%2017%20PubMed%20Literature%20Search/Group%20C.xls) -- Group
C). Six institutions/ laboratories were identified that were not also
listed on the survey database ([Annex
17](../Annex%2017%20PubMed%20Literature%20Search/Institutions%20not%20found%20on%20the%20National%20Inventory.doc)
-- Table I). One was a research and development laboratory in a water
service company working with enterovirus detection systems. One was a
community college with an environmental project using hepatitis virus A.
Two were non-profit, foundation laboratories performing basic research
using enteroviruses and rhinoviruses respectively. The remaining two
were biotechnology start-up companies, one working with rhinoviruses and
the second, now defunct, developing antiviral agents. The 5 active
institutions were placed on the survey database upon receipt of
completed reports. This list of institutions/laboratories working with
viruses at risk of wild poliovirus contamination constitutes the first
step in building the Phase II (certification) database of laboratories
that require special attention.

Of the 122 institutions listed on the National Inventory, the search
identified 64 (52%). As expected, best results were found with
institutions with strong publishing traditions. The literature search
confirmed 51(72%) of the 71 academic institutions on the Inventory as
having poliovirus materials, but confirmed less than a quarter of the
industrial institutions and only 12% of the state and local government
institutions, which were primarily diagnostic laboratories that
published infrequently (Table 5).

> Table 5. Sensitivity of literature search for finding institutions on
> the National Inventory
>
> Category Number of institutions
>
> Search Inventory %
>
> Academic\* 51 71 72
>
> Federal government 5 10 50
>
> Industrial 6 24 25
>
> State and Local Gov. 2 17 12
>
> Totals 64 122 52
>
> \*Includes CLIA hospitals

The results of the literature search were validated by a simple reverse
PubMed search for any publication on poliovirus attributed to any of the
institutions on the National Inventory. Publications were found from 2
industries on the Inventory that had not been found in initial
literature search, yielding a 97% (64/66) accuracy for the initial
search ([Annex
17](../Annex%2017%20PubMed%20Literature%20Search/Institutions%20on%20the%20National%20Inventory%20also%20found%20in%20the%20literature%20search.doc)
-- Table II). The reasons for failing to identify these 2 industries in
the first round could not be explained.

In summary, the literature search confirmed the quality and completeness
of the US Survey and the Inventory. The search identified 6 institutions
to be added to the survey database. None was considered high risk and
none was found that had been omitted from the National Inventory.

# 10.2 Meetings with Biosafety Officers

Follow-up discussions provided important anecdotal evidence of survey
quality. PLCP staff held discussions at the meeting of the New England
Biological Safety Association (NEBSA) in Boston, June 9, 2003, the
Annual Meeting of the ABSA in Philadelphia, October 15, 2003, and with
individual institutional biosafety officers.

Discussions revealed institutions had clearly taken the Survey seriously
with many laboratories destroying wild poliovirus materials that no
longer met programmatic needs. It was also clear that the extraordinary
response rate in this Survey, in the absence of penalties, was likely
influenced by the Select Agents survey required by the Public Health
Security and Bioterrorism Response Act of 2002. Preparations for the
poliovirus survey preceded the Select Agents survey. However, by the
time the poliovirus survey began in October 2002 many laboratories were
already in the process of cleaning freezers, reviewing holdings and
compiling inventories. Many institutions reported combining the two
surveys. High-level administrators and legal staff at all major
institutions were well aware of the liabilities incurred from
non-compliance with the Select Agent legislation.

# 10.3 Follow-up

Telephone calls were made to respondents when responses were
inconsistent, unclear, or unexpected. Letters confirming the number of
laboratories surveyed and the names of laboratories retaining wild
poliovirus materials were sent to the President, CEO, Director or RFO of
each institution reporting retention of wild poliovirus materials
[(Annex
18](../Annex%2018%20Confirmation%20Letters/Illinois%20Institue%20of%20Tech%20and%20IIT%20Research%20Inst.doc)).

# 11 Planning for Global Certification (Phase II) 

Planning for global certification (Phase II) is the final step in Phase
I of the *Global Action Plan*. Phase II begins when one year has elapsed
without isolation of wild poliovirus anywhere in the world. At which
time nations will:

1.  Notify biomedical laboratories that poliovirus transmission has been
    interrupted.

2.  Contact laboratories on the national inventories and instruct them
    to render materials non-infectious for poliovirus or destroy under
    appropriate conditions; transfer wild poliovirus infectious and
    potential infectious materials to laboratories capable of meeting
    the required biosafety standards; and/or implement biosafety
    measures appropriate for the laboratory procedures being performed
    (BSL-2/polio or BSL-3/polio).

3.  Document the completion of all containment requirements for global
    certification.

Planning needs for Phase II are described in the *WHO guidelines for
national documentation of wild poliovirus laboratory containment for
Global Certification* ([Annex
19](../Annex%2019%20Draft%20Global%20Certification%20Guidelines/Phase%20II%20Wild%20Poliovirus%20Containment%20Sep%205.doc)).
In summary, strategies must be developed to notify the general
biomedical laboratory community that poliovirus transmission has been
interrupted and to instruct institutions on the National Inventory to
implement containment requirements. Procedures must be developed for
identifying and communicating with biomedical laboratories in the **most
likely to possess** or **may possess** categories that were newly formed
or not included in the Phase I Survey, as well as those at risk of
acquiring wild poliovirus after completion of the Survey. Standard
institution/laboratory reporting requirements must be established,
national biosafety specifications must be adopted, and national policies
must be approved for verifying and recording implementation.

# 11.1 Roles and Responsibilities

HHS has overall responsibility for Phase II as the national counterpart
of WHO. The roles and responsibilities of HHS operational components are
as follows.

*The National Vaccine Program Office* (NVPO) represents the Secretary,
HHS and provides oversight of national laboratory containment activities
and policies in coordination with the Office of Global Health Affairs,
HHS. NVPO convenes the National Vaccine Advisory Committee.

*The National Vaccine Advisory Committee* (NVAC) serves as the US
National Certification Committee for wild poliovirus containment. The
NVAC Polio Laboratory Containment Workgroup meets three times a year to
review, provide technical advice, and recommend actions to the full
committee on containment issues and documentation to be submitted to the
Regional Certification Commission (RCC) for Global Certification.
Specific charges to the Workgroup are to review and advise on:

-   The National Plan of Action for implementing Phase II.

-   The proposed mechanism for notifying the laboratory community that
    wild polio circulation has been interrupted.

-   Documentation that all institutions retaining or likely to retain
    wild poliovirus materials have been contacted and have implemented
    appropriate biosafety requirements.

-   Phase II National Inventory completeness and accuracy.

-   The final HHS documentation on containment to be submitted to WHO
    Regional Office for the Americas and the Regional Certification
    Commission.

*The Office of the Director, National Center for Infectious Diseases*
(NCID), CDC is the steward for the Phase I national survey database.
NCID ensures that the database is stored on a secure server with
restricted access. NCID convenes, at least annually, representatives of
the National Immunization Program (NIP) and the Public Health Practice
Program to ensure uninterrupted maintenance and integrity of the
database. NCID serves as a member of the CDC "Consortium on
Containment", provides technical advice and input into materials
developed by CDC, and participates in NVAC Workgroup meetings.

*The Global Immunization Division* (GID), NIP, CDC, functions as the
Office of Poliovirus Laboratory Containment Preparedness (PLCP) for all
containment activities. It maintains the PLCP Website and the active
electronic database of the National Inventory. It plans and develops
strategies for implementation of Phase II, and provides technical
liaison between the US containment effort and WHO offices in Geneva and
the Region of the Americas. It convenes on a regular basis a CDC
"Consortium on Containment" for input on technical and policy issues.
The consortium consists of NCID (OD and the Division of Viral and
Rickettsial Diseases), the Office of Health and Safety, the Public
Health Practices Program Office, and other CDC interests as appropriate.
It consults and regularly communicates with HHS agencies on containment
policies. It serves as the secretariat for the three annual meetings of
the NVAC Workgroup.

# 

# 11.2 Conclusions and Recommendations

The following conclusions and recommendations also incorporate comments,
suggestions, and advice from the NVAC Workgroup.

[Maintaining the National Inventory]{.underline} -- The loss of key
personnel, program momentum, and institutional memory becomes a major
risk with lapse of time between the 2003 national survey and inventory
and Global certification. This risk may be reduced by:

-   Keeping the Inventory current as institutions report any changes in
    status

-   Communicating at regular intervals with institutions on the
    Inventory and the general laboratory community, keeping them
    informed of progress toward polio eradication and new developments
    in containment policies

-   Using communication channels such as the biosafety list serve
    (<biosafty@MITVMA.MIT.edu>), the ABSA website
    ([http://www.absa.org]{.underline}), the PLCP website, biomedical
    laboratory oriented publications, mailings, and presentations at
    biomedical laboratory conferences (see sections 5.3-5.5)

###### Maintaining the PLCP Website -- The PLCP website proved to be a valuable resource for those responsible for responding to the national survey. In preparing for global certification, the PLCP website can used to:

-   Update the National Inventory by providing a web-based data
    submission application to revise contact information and status

-   Provide polio eradication progress reports and new developments in
    containment policies

-   Promote laboratory containment goals and objectives

Specifically, the PLCP website should include:

-   Results of Phase I National Survey/Inventory with acknowledgement of
    all who participated, especially Responsible Facility Officials,
    Biosafety Officers, and Laboratory Directors

-   Links to WHO for current eradication progress and relevant documents

-   New or revised biosafety procedures, practices, and policies

[Developing the Survey Database for Phase II]{.underline} -- Experience
in developing the Phase I survey database suggests the same general
strategy is valid for Phase II. The guiding principle in identifying
institutions/laboratories is the "type of specimen" likely to be stored.
However, two observations from Phase I deserve mention. First was the
absence of any wild poliovirus materials among more than 24,000 CLIA
laboratories certified to perform non-complex tests in microbiology.
Second was finding through the literature search 2 additional community
colleges with virology projects. Unproductive efforts and potential gaps
in the Phase II Survey may be reduced by:

-   Excluding CLIA laboratories certified for performing only
    non-complex tests in microbiology, focusing, instead, on updating
    the list of CLIA laboratories certified for complex testing

```{=html}
<!-- -->
```
-   Reviewing the list of more than 4,000 small colleges for relevant
    departments of biology, chemistry or environmental health and
    assessing the need to place them on the Survey or reach them through
    special communications

```{=html}
<!-- -->
```
-   Comparing the updated lists of institutions registered with the
    Office of Human Research Protection, HHS
    (<http://ohrp.osophs.dhhs.gov/index.html>), the Carnegie Foundation
    database of institutions classified as doctoral/research
    universities
    (<http://www.carnegiefoundation.org/Classification/index.htm>), and
    the Phase I database of academic institutions for new additions

```{=html}
<!-- -->
```
-   Searching the public membership lists of the Biotechnology Industry
    Organization ([www.bio.org](http://www.bio.org/)) and the
    Pharmaceutical Research and Manufacturers of America
    ([www.phrma.org](http://www.phrma.org/)) for new laboratories

-   Exploring the use of indexing services to identify laboratories
    associated with industry, environmental sampling, and testing
    services

## [Performing the literature search]{.underline} -- The literature search proved to be a valuable tool for assessing quality and completeness of the survey database and the National Inventory and for developing a database of institutions/laboratories working with viruses at risk of wild poliovirus contamination. To achieve its full potential, planning for Phase II should include: {#performing-the-literature-search-the-literature-search-proved-to-be-a-valuable-tool-for-assessing-quality-and-completeness-of-the-survey-database-and-the-national-inventory-and-for-developing-a-database-of-institutionslaboratories-working-with-viruses-at-risk-of-wild-poliovirus-contamination.-to-achieve-its-full-potential-planning-for-phase-ii-should-include .unnumbered}

-   Exploring options to increase sensitivity of the literature search

-   Updating the search for institutions/laboratories at risk

-   Seeking professional advice to achieve highest search quality

[Improving the mechanics of the Survey]{.underline} -- Lessons learned
in Phase I that could improve and greatly facilitate the Phase II
process include:

-   Using a bar coded electronic survey system to decrease the amount of
    manual data entry and eliminate many of the common entry problems

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-   Creating ID and Passwords for electronic submission that do not
    include 1, 0, and lower case L, and O to avoid confusion of certain
    lower case letters with numbers

-   Discontinuing the electronic time limit for entry of survey results
    to avoid errors and the need for participants to re-enter the
    website or PLCP personnel to contact participants to complete the
    information

-   Utilizing the CLIA ID as an identifier on the hard copy survey form
    as well as on the front page of the desktop application to ensure
    easier data entry, complete information, and faster analysis of the
    electronic database

-   Developing the survey database at least a year in advance to permit
    time for identifying institutions using more than one name and /or
    address

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-   Differentiating between mailing address and location address to
    reduce the amount of returned mail

-   Checking the database six months in advance of the survey to
    facilitate identifying institutions no longer in operation

-   Providing knowledgeable assistance through the use of a phone
    help-line and e-mail to ensure complete submissions.

[Preparing for OPV (Sabin) poliovirus control]{.underline} -- At some
point shortly after, or possibly before, global certification, decisions
will be made on post eradication polio immunization strategies
worldwide. One possible outcome is universal cessation of OPV use and
the requirement for Sabin poliovirus control in the laboratory at a
level yet to be determined. Because OPV is no longer licensed in the US,
this country will have fewer challenges than OPV-using countries in
reducing such viruses in the laboratory environment. However,
considerable efficiency could be gained in the US by evaluating
strategies for post-certification control of OPV virus at the same time
preparations are being made for Phase II.

[Exploring the post-eradication option of classifying wild poliovirus as
a select agent]{.underline} -- Because the success of the current survey
and inventory is due in part to the environment created by enforcement
of the Select Agents Act, some have proposed that wild poliovirus should
be designated as a select agent after eradication. Doing so would
eliminate confusion from multiple containment tracts, simplify Phase II
implementation, and increase confidence in national laboratory
containment. Other advantages include uniform national policies for
validating institutional holdings, certifying containment facilities and
practices, and distributing poliovirus materials. The advantages, as
well as the disadvantages, of designating wild poliovirus a select agent
deserve careful exploration.

# 12 Summary

The US National Survey of 32,429 academic, federal government, hospital,
industry, private, and state and local government
institutions/laboratories, comprising a total of 105,356 individual
laboratories is complete. All 5,585 institutions/laboratories
categorized as **most likely to possess** or **may possess** wild
poliovirus materials responded to the Survey. Of the 26,844
institutions/laboratories categorized as **least likely to possess**
such materials, (90%) responded. None of the 24,206 responders reported
wild poliovirus materials. As the objective of surveying this group of
small clinical laboratories (i.e. private physicians' offices)
laboratories was to quantify risk, follow up of the remaining 2,638 was
discontinued. The quality and completeness of the Survey was confirmed
by a literature search over the past 10 years.

The US National Inventory (Phase I) consists of 122 institutions listing
180 laboratories that retain wild poliovirus materials.

In early 2004, the WHO Regional Office for the Americas will request the
Secretary, HHS to provide the National Inventory (Phase I) and
documentation for review by the Regional Certification Commission. This
report provides the National Inventory and supporting materials for that
submission and describes the next steps toward containment in the US
required for global certification of polio eradication.

# 

[^1]: Congress passed amendments to CLIA in 1988 establishing quality
    standards for all laboratory testing to ensure the accuracy,
    reliability and timeliness of patient test. The final CLIA
    regulations were published on February 28, 1992. To enroll in the
    CLIA program, laboratories must register by completing an
    application, pay fees, be inspected, if applicable, and become
    certified.