**Guidelines for documenting the quality of Phase I wild poliovirus
laboratory containment activities**

**- Laboratory survey**

**- National inventory**

**The Department of Vaccines and Biologicals would like to thank the
partners whose financial and technical support has made the development
of this document possible:**

**United States Agency for International Development (USAID) Quality
Assurance Project, Bethesda MD, USA**

**Contents**

Purpose 2

Introduction 3

Phase I: Laboratory survey and Inventory 3

Phase II: Global Certification 3

Approaches to demonstrating the quality of laboratory survey and
inventory 4

Essential components of high quality laboratory survey and inventory 5

Development of guidelines for documenting the quality of laboratory
survey and

inventory 5

The Guidelines 6

Instructions 6

Component 1. Political endosement and support 7

Political support 7

Legislation 7

Multi-sector involvement 8

Effects of decentralisation 9

Component 2. The National Plan of Action 10

Responsibility for the plan 10

Realistic timeframe for activities 10

Personnel and funding resource allocation 11

Multi-sector involvement 11

Effects of decentralisation 12

Component 3. The National Containment Coordinator 13

Sufficient political or adminsitrative stature 13

High level of competence 13

Availability of sufficient time and support 14

Component 4. The National Laboratory List 16

Process of establishing the list 16

Completeness of the list 16

Management of the list 17

Component 5. The Laboratory Survey 19

Thoroughness of the survey 19

Completeness of responses 19

Quality of the surey 20

Management of survey data 21

Component 6. The National Laboratory Inventory 22

Thoroughness of the inventory process 22

Quality of responses 22

Management of the inventory data 23

Maintenance of the inventory 24

# Purpose

To provide countries with guidelines on documenting the thoroughness and
accuracy of conducting the Laboratory Survey and establishing the
National Inventory of laboratories that wish to retain wild poliovirus
infectious materials.

# Introduction

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 Global
Commission has established the requirements for laboratory containment
of wild polioviruses, and the 2^nd^ edition of the *Global action plan
for laboratory containment of wild polioviruses* describes those
requirements in detail. Guidelines on how to implement the requirements
have been issued and adapted by the WHO Regions.

The Global Certification Commission requirements for containment of wild
polioviruses are described in two phases: the Laboratory Survey and
Inventory Phase and the Global Certification Phase.

## Laboratory Survey and Inventory Phase

This phase covers the period when the numbers of polio-free countries
and Regions are increasing, but wild polioviruses continue to circulate
somewhere in the world. During this phase, countries are required to:

-   Survey all biomedical laboratories to identify those with wild
    poliovirus infectious or potential infectious materials and
    encourage destruction of all unneeded materials.

-   Develop a National Inventory of laboratories that retain such
    materials and submit this to the Regional Certification Commission.

-   Instruct laboratories retaining wild poliovirus infectious or
    potential infectious materials to institute enhanced biosafety
    level-2 (BSL-2/polio) measures for safe handling.

-   Plan for implementation of the Global Certification Phase.

## Global Certification Phase

This phase begins when one year has elapsed without isolation of wild
poliovirus anywhere in the world. During this phase nations:

-   Notify biomedical laboratories that poliovirus transmission has been
    interrupted.

-   Instruct laboratories on the National Inventory to elect one of the
    following three options:

    -   Render materials non-infectious for poliovirus or destroy them
        under appropriate conditions.

    -   Transfer wild poliovirus infectious and potential infectious
        materials to laboratories capable of meeting the required
        biosafety standards.

    -   Implement biosafety requirements appropriate for the laboratory
        procedures being carried out (BSL-2/polio or BSL-3/polio).

-   Document completion of all containment requirements for global
    certification.

## Approaches to documenting the quality of Phase I containment activities

In addition to the number of laboratories retaining wild poliovirus
materials, Regional Certification Commissions have requested National
Certification Committees to provide information on the number of
laboratories in the National Laboratory List and the number of
laboratories surveyed. Information on the types of laboratory listed,
the sectors they belong to, and the thoroughness of the survey process
has also been sought. From the outset a strong recommendation for
implementation of the *Global Action Plan* was to incorporate a
requirement of authorising signatures at each administrative level. This
requirement has gone some way towards ensuring the information collected
at all levels is both complete and accurate. However, with the
implementation of National Laboratory Surveys and establishment of
National Inventories, so questions have arisen regarding the
completeness and accuracy of the information being collected at national
level. Because of inherent differences between countries, the processes
used to establish the national surveys, and readiness to accept and
authorise the results, have differed significantly from country to
country.

In attempting to assess the quality of implementation of activities
carried out, there are essentially two alternative approaches to
consider:

-   A [standards-based external evaluation:]{.underline} a more
    structured evaluation, which would involve establishing a consensus
    set of process and outcome standards and related indicators of
    performance that all countries would be expected to achieve.
    Accreditation and Certification are types of such external
    evaluations. Different levels for the different indicators would
    have to be developed for different types of countries (e.g. simple,
    small countries vs. large, diverse countries). These levels may be
    determined after review and comparison of early country containment
    survey and inventory results to date. This type of approach is often
    used when the activity evaluated takes place repeatedly and
    indefinitely, such as hospital accreditation.

-   A [best practices assessment:]{.underline} a less structured
    evaluation based on a flexible appraisal of whether best practices
    principles of the survey and inventory process had been followed.
    The basic principles that should govern the design and
    implementation of each major containment activity would be
    established and a structure developed to allow each country to
    provide a detailed description of how each principle was followed.
    Written descriptions of the activities undertaken would provide
    evidence as to whether best practices had been followed and
    therefore, whether the expected results of the best practices for
    each component are likely to have been achieved.

Having reviewed available containment data from more than 50 countries
it became apparent that country-to-country variation in population size,
administrative structure, health infrastructure, industrial development
and political complexion makes the development of a purely
standards-based approach very difficult. In addition, the
standards-based approach requires significant time to develop and test
standards and indicators, and significant resources to carry out
external surveys. Given the fact that the survey and inventory are
activities that are done only once, the utilisation of resources for a
standards-based approach is not justified. Moreover, there is no
evidence that it would be a more valid approach. Therefore, it is more
appropriate to develop an approach that assesses the performance of a
country using a flexible best-practices model for the activities
required to carry out the National Laboratory Survey and establish a
National Laboratory Inventory. Developing a best practices model begins
with determining the essential components of the laboratory survey
phase.

## Essential components of a high quality laboratory survey and inventory phase of containment activities

A review of laboratory survey and inventory data and activities from
more than 50 countries reveals the following six essential components of
a successful program:

1.  Strong political endorsement and support for containment

2.  A realistic National Plan of Action

3.  An effective Containment Coordinator and National Task Force

4.  A comprehensive National Laboratory List

5.  A high quality Laboratory Survey

6.  A complete and active National Laboratory Inventory

## Development of guidelines for documenting the quality of laboratory survey and national inventory activities

Having determined the essential components of activities required for
meeting containment requirements and the best possible outcome for each
of those components, a model has been established of the best practices
that could be applied to achieve the desired results. The best practices
model describes a series of key features and activities that must be
undertaken in order to achieve a high quality result. Because of the
many differences between countries, the ways in which key features are
implemented and the detail of activities undertaken will differ. By
describing in detail their implementation of the containment
requirements, countries can compare the activities they have undertaken
with those of the best practices model.

The following guidelines have been developed to assist countries in
describing and documenting the details of activities they have carried
out in response to the requirements for Certification. Each of the
essential components has been divided into a number of sections with
explanations of the types of activities that are required to achieve a
best practices outcome. Countries are requested to provide descriptions
of the activities they carried out to achieve the outcomes in each
section. Areas of activity to be considered in their descriptions are
provided in each section and should be referred to before completing the
section.

**The Guidelines**

The primary purpose of these guidelines is to allow self-evaluation of
laboratory survey and inventory activities before requesting the
National Certification Committee to endorse and forward documentation to
the Regional Certification Commission. Additionally, they provide a
systematic framework for producing a written description of the
laboratory survey and inventory activities undertaken by the country
which can be assessed by Regional Certification Commissions.

The guidelines are designed for use at a time when the survey is
complete and the inventory is in place. However, countries beginning the
survey process may also wish to review the guidelines when establishing
and implementing quality containment activities to ensure that their
planning is complete.

Correct use of the guidelines will provide each country with a
description of the process followed in implementing the Phase I
laboratory containment activities. When presented together with any
numerical data requested by the Regional Certification Commission, the
account will provide strong evidence in support of the thoroughness of
the National Laboratory Survey process leading to the establishment of
the National Laboratory Inventory.

## Instructions 

Read the following 6 components of a successful laboratory survey and
inventory and produce a written description of the country\'s activities
using the example topics given in the boxes titled \"country
requirement\". The final product should be a written description of the
country\'s laboratory survey and inventory activities that addresses
each topic in sufficient detail to provide compelling evidence of a high
quality program. If some topics do not apply to the country situation,
please indicate this in the text and state the reason they do not apply.

**[Component 1. Political endorsement and support]{.smallcaps}**

## Political support

> Implementation of the laboratory survey and inventory activities
> requires active cooperation and collaboration from a wide range of
> government ministries, departments, agencies and institutions. To
> obtain this cooperation, the process must have the authority to compel
> collaboration from the different sectors; and this usually requires
> high-level political support. In many countries, particularly those
> with a strongly hierarchical political or administrative structure,
> the level of authority required to ensure multi-sector collaboration
> can only come from the office of the head of state or head of
> government. In other countries, particularly those with established or
> proposed legislation that applies to the containment process, it may
> be sufficient to obtain political and administrative support only from
> the head of the legislative body.
>
> **Best practices result:**
>
> High-level political support for containment, with the
> responsibilities and authority for implementation of the laboratory
> survey and inventory phase activities agreed and accepted by all
> sectors.

## Legislation

> Many countries have national legislation that applies or could be
> applied to some aspects of the polio laboratory containment process.
> This legislation may include the requirement for biomedical
> laboratories to be registered with a government department or agency,
> for microbiology and pathology laboratories to operate under
> recognised biosafety conditions, for employers to ensure the safety of
> their workers, etc. This legislation may be used to give authority to
> the polio laboratory containment process and persuade institutions and
> laboratories to comply with containment requirements.
>
> **Best practices result:**
>
> National or community legislation was used effectively to enforce
> compliance with the laboratory survey and inventory activities.

## Multi-sector involvement

> Implementation of the Phase I containment activities involves many
> sectors in addition to the health sector. The education, research,
> environment, industry and defence sectors, among others, may also have
> laboratories storing wild poliovirus infectious materials. These
> sectors must also be involved in the laboratory survey process,
> ensuring that laboratories under their authority are aware of the
> containment requirements and are implementing them.
>
> **Best practices result:**
>
> A broad basis of involvement in containment was established.

## Effects of decentralisation

> Many countries have devolved responsibility for implementation of
> services, particularly health-related services, to sub-national
> authorities. In many cases national government offices have very
> little direct authority over how the sub-national authorities
> implement national policies and directives. In some cases sub-national
> autonomy is extended even further and sub-national authorities are not
> bound to follow national directives. Where a decentralised systems
> exists, it is essential that all sub-national authorities responsible
> for implementation of Phase I containment activities are fully
> involved in the process, and that no geographical or political
> sub-units of countries are excluded.
>
> **Best practices result:**
>
> Where authority has been devolved to sub-national administrations
> there was full involvement of all sub-national authorities in Phase I
> containment activities.

# Component 2. The National Plan of Action

## Responsibility for the Plan

> An effective Plan of Action must accurately reflect the national
> situation with regard to local knowledge, national concerns and a
> practical consideration for potential constraints and limitations.
> Ideally, the Plan should be the result of consensus by a group of
> technically competent individuals representing a range of national
> institutions. Approval for the Plan should come from a high political
> or administrative level, and be given some official status. This
> confers importance and status on the Plan and additional authority on
> those charged with implementing it.
>
> **Best practices result:**
>
> A comprehensive, well written, nationally supported Plan was
> established and used to implement Phase I containment activities.

## Realistic timeframe for activities

> In order to maintain progress with containment activities, Regional
> Certification Commissions have set criteria for achievement of Phase I
> containment activities before regional certification of polio free
> status. The National Plan of Action should reflect projected dates for
> regional certification and recognize that time will be required to
> meet all criteria by those dates. The Plan should provide a clear and
> realistic description of when each step in meeting the requirements
> will be completed.
>
> **Best practices result:**
>
> The Plan included a realistic timeline complete with achievement
> milestones.

## Personnel and funding resource allocation

> Implementation of laboratory containment activities requires
> resources, both personnel and funding. The National Plan of Action
> should acknowledge this fact, estimate the requirements and identify
> sources. It is possible that sufficient resources will not be
> available from within the country, in which case support could be
> sought from the international community. The Plan should include
> details of any planned advocacy for national and international
> support.
>
> **Best practices result:**
>
> The Plan included an appropriate resource allocation.

## Multi-sector involvement

> Phase I laboratory containment activities involve a wide range of
> institutions and laboratories, covering several sectors. The plan
> should include details of how containment will be implemented in each
> of these sectors.
>
> **Best practices result:**
>
> All appropriate sectors were included in the Plan.

## Effects of decentralisation

> A strong National Plan of Action that accurately reflects the
> political and administrative realities of the country is essential to
> effective implementation of Phase I containment activities. A Plan
> that fails to acknowledge the administrative effects of
> decentralisation, and fails to engage sub-national authorities from
> the outset, will be a poor plan. Experience has shown that a poor Plan
> makes effective implementation of Phase I containment requirements
> very much more difficult.
>
> **Best practices result:**
>
> The Plan called for full involvement of National and Regional
> authorities.

# Component 3. The National Containment Coordinator

## Sufficient Political or Administrative Stature

> The role of National Containment Coordinator carries a significant
> amount of responsibility. The Coordinator must interact effectively
> with many different government departments and with non-governmental
> organizations. The coordinator must have sufficient political,
> administrative or social stature to command attention and to have
> institutions and laboratories comply with requirements. In many cases
> the Coordinator will be dependent for political and administrative
> support upon the ministry or department of health and the National
> Certification Commission, and it is essential that the Coordinator can
> easily call on this support when needed.
>
> **Best practices result:**
>
> The Coordinator has sufficient status and authority within the
> country.

## High level of Competence

> The ideal containment Coordinator should have extensive background
> experience in laboratory biosafety and public health administration.
> However, such individuals are very rare, and it is more likely that
> the Coordinator would have experience in only one of these fields, or
> a closely related field. The Coordinator is therefore dependent on
> others to provide technical support in areas other than their own
> specialties. For this reason it is essential that the Coordinator can
> call upon other experts to make the most appropriate and effective
> decisions in implementing containment activities.
>
> **Best practices result:**
>
> The Coordinator had access to sufficient technical ability and
> resources.

## Availability of Sufficient Time and Support

> The National Task Force and Containment Coordinator play an essential
> and demanding role in the implementation of containment activities.
> Coordination of containment activities, from overseeing development of
> the National Plan, through creating the laboratory list and carrying
> out the survey, to establishing the inventory and preparing final
> documentation, is detailed and time consuming. It is essential that
> the Coordinator has sufficient working time available to carry out
> these tasks, and that other professional commitments do not prevent
> implementation of the activities. In all but the smallest countries
> the workload associated with coordinating containment activities will
> exceed the capacity of a single individual. It is essential,
> therefore, that the Coordinator has access to both administrative and
> technical support. In some countries this support has been in the form
> of commercial companies that were contracted to carry out the
> laboratory survey on behalf of the government, or to manage and
> analyse the survey data.
>
> **Best practices result:**
>
> The Coordinator had enough time to carry out the work required, and
> the workload was appropriately managed.

#  

# Component 4. The National Laboratory List

## Process of establishing the list

> Before a survey of laboratories can be undertaken it is necessary to
> identify all possible laboratories that should be included in the
> survey. This is achieved by establishing a national list of
> laboratories. It is important that the list is as inclusive as
> possible: all laboratories with any possibility of storing wild
> poliovirus materials must be included. The most common way of
> achieving this is to include all laboratories with any capacity to
> handle biological materials, including diagnostic, research, teaching
> and industrial production laboratories. In many countries some sectors
> maintain laboratory lists for registration, control or funding
> purposes. These lists can be used as starting material for the
> national laboratory list. In all cases it is essential to use the
> knowledge and experience of experts within the country, the heads of
> public health authorities, professors and leading scientists to ensure
> that all sectors are covered and all laboratories are included in the
> list.
>
> **Best practices result:**
>
> A comprehensive National Laboratory List was established in an
> appropriate and thorough manner.

## Completeness of the List

> The List should include every laboratory in the country with any
> possibility of storing wild poliovirus materials. It is impossible to
> prove that every appropriate laboratory in the country has been
> included in the List, but it can be shown that every sector with
> laboratories is well represented and that no sector has been
> forgotten. It is also essential that there is a process from updating
> the List: containment activities take place over several years and
> during that time a number of laboratories are likely to open, close or
> change function in almost every country.
>
> **Best practices result:**
>
> All appropriate laboratories were included in the List.

## Management of the List

> Good data management is essential, particularly for the National
> Laboratory List as this may contain details of several thousand
> laboratories. The List must be maintained in a searchable format, from
> which details such as laboratory addresses and names of contact
> persons can easily be retrieved. The format of the List should also
> allow easy analysis, so that summaries, breakdowns and reports can be
> generated. It should also be possible to update the List when new or
> additional information is received.
>
> **Best practices result:**
>
> The data is current, well managed and appropriately maintained.

**Component 5. The Laboratory Survey**

## Thoroughness of the Survey

> The laboratory survey should include every laboratory considered to
> have any possibility of retaining wild poliovirus infectious
> materials. The usual practice is to send survey questionnaires to
> every laboratory on the national laboratory list. However, under
> certain circumstances decisions may be made to exclude some
> laboratories from the survey. If laboratories in the list have been
> excluded from the survey it is important to document the reasons for
> this exclusion.
>
> **Best practices result:**
>
> All appropriate laboratories on the National Laboratory List were
> included in the National Laboratory Survey.

## Completeness of responses

> A 100% response rate is the goal of every survey carried out. This
> goal, however, is rarely achieved at the first attempt, and numerous
> follow-up attempts are often required to obtain all responses. There
> are many reasons for failing to respond to the questionnaire, and some
> laboratories require clarification of the questions or additional
> information before they feel capable of providing a response. There is
> no "minimum acceptable" level of response to the survey, but any
> country that fails to achieve a response rate close to 100% should be
> able to provide documentation on the attempts made to obtain responses
> together with some explanation of why responses could not be obtained.
>
> **Best practices result:**
>
> A high level of response (close to 100%) to the Survey was obtained.

## Quality of the Survey

> Analysing the results for missing information, inconsistencies and
> recognised errors, can demonstrate survey quality. A follow up on that
> analysis is required to determine the true situation. Survey results
> that are accepted and reported without such scrutiny are of unknown
> quality, and should not be accepted by Regional Certification
> Commissions. If less than a 100% survey response rate is obtained a
> risk assessment of the non-responding laboratories is required. If
> non-responders are considered to have a high probability of retaining
> wild poliovirus infectious materials, every effort must be made to
> obtain a survey response from them, and the survey will not be
> considered complete until a response is obtained. At the discretion of
> the national containment coordinator and the National Certification
> Committee, selected laboratories may be visited to verify the
> responses given in the survey. This is particularly important for
> laboratories that provide survey responses that were considered
> unexpected on the basis of local knowledge.
>
> **Best practices result:**
>
> Results of the Survey were analysed and findings of the analysis were
> acted upon.

## Management of Survey data

> As with management of the national laboratory list, good data
> management of the survey results is essential. Survey data must be
> maintained in a searchable format, from which details can easily be
> retrieved and summaries, breakdowns and reports can be generated. It
> should also be possible to update the survey database when new or
> additional information is received.
>
> **Best practices result:**
>
> The Survey data are well managed and maintained, in a format allowing
> rapid analysis and updating.

# Component 6. The National Laboratory Inventory

## Thoroughness of the inventory process

> The Regional Certification Commission will be looking for evidence
> that every laboratory retaining wild poliovirus infectious materials
> at the time of the completion of the laboratory survey is on the
> National Laboratory Inventory. The process by which the Inventory was
> created should be fully documented, and any inconsistencies or
> differences between the Laboratory Survey results and the Inventory
> must be fully explained.
>
> **Best practices result:**
>
> All laboratories with wild poliovirus infectious materials are on the
> National Inventory.

## Management of the Inventory data

The National Inventory and supporting documents are prepared and
presented to the National Certification Committee for review,
endorsement, and submission to the Regional Certification Commission as
a component of National Documentation for Certification of Polio
Eradication. National Inventories of laboratories with wild poliovirus
infectious materials will be compiled into Regional Inventories
maintained by the WHO Regional Offices; good data management is
therefore essential.

> **Best practices result:**
>
> The National Laboratory Inventory data are well managed and
> maintained.

## Maintenance of the Inventory

> The National Inventory is an active record, maintained as a current
> list of laboratories to be notified to initiate the appropriate
> containment procedures one year after detection of the last wild
> poliovirus. The next phase of the laboratory containment process will
> require laboratories on the National Inventory to fully catalogue all
> wild poliovirus infectious materials retained, and it is essential
> that laboratories on the Inventory are aware of this requirement in
> advance.
>
> **Best practices result:**
>
> The Inventory remains current and accurate and the laboratories listed
> have been informed to operate under BSL-2 /polio and to prepare for
> global certification.