Monitoring the Switch from tOPV to bOPV

Guidelines for DevelopingNational Monitoring Plans

13 March 2016

Please note: This document is an update of a version released in August 2015.The main changes in the March 2016 version concern the new steps in the ‘Prepare’ phase and the new

tools and forms provided in the Annexes.

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Table of ContentsAcronyms.................................................................................................................................................................3

Introduction.............................................................................................................................................................4What are the general principles of this document?.............................................................................................6Recap – Monitoring on a page..............................................................................................................................7

1. Plan..................................................................................................................................................................81.1. Develop a Monitoring Structure...............................................................................................................81.2. Timeline of Activities..............................................................................................................................101.3. Switch Validation Indicators...................................................................................................................101.4. Identify Human and Financial Resources................................................................................................11

2. Prepare...........................................................................................................................................................122.1. Develop data collection tools.................................................................................................................122.2. Develop training materials.....................................................................................................................142.3. Identify Facilities for Monitoring............................................................................................................142.4. Develop Micro-Plans...............................................................................................................................152.5. Develop Contingency Plans.....................................................................................................................162.6. Recruit supervisors & monitors..............................................................................................................162.7. Train supervisors & monitors..................................................................................................................182.8. Pre-position supervisors & monitors......................................................................................................18

3. Validate..........................................................................................................................................................193.1. Monitors visit cold chain stores and service delivery points...................................................................193.2. Data Reported and Aggregated..............................................................................................................213.3. Develop validation report.......................................................................................................................21

4. Follow-Up.......................................................................................................................................................224.1. tOPV Withdrawal....................................................................................................................................224.2. Problems Identified during Monitoring..................................................................................................23

Annexes.................................................................................................................................................................24Annex A: Monitoring tOPV Disposal...................................................................................................................24Annex B: Categorizing Risk of tOPV Use.............................................................................................................26

Risk of tOPV Stored and Used During the Switch...........................................................................................26Annex C: Example Forms....................................................................................................................................31

Form 1: Sample Independent Monitoring Data Collection Tool....................................................................31Form 2: Sample National Switch Validation Data Aggregation Tool..............................................................32Form 3: National Validation Report: Switch from tOPV to bOPV...................................................................34Instruction Sheet: National Switch Data Aggregation Form & Validation Report...........................................35tOPV Disposal Form – Supervisors..................................................................................................................39

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AcronymsAFP Acute Flaccid ParalysisbOPV Bivalent Oral Polio VaccineDPT3 Third dose of diphtheria-pertussis-tetanus vaccineDSO District Surveillance OfficerEPI Expanded Programme on ImmunizationIPV Inactivated Polio VaccineNGO Non-governmental OrganizationNIP National Immunization Program. Sometimes used interchangeably with EPIOPV3 Third dose of Oral Polio VaccinetOPV Trivalent Oral Polio VaccineUNICEF United Nations Children’s FundWHO World Health Organization

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IntroductionThe World Health Assembly has endorsed the SAGE recommendation for a synchronized switch from tOPV to bOPV in all 156 OPV using countries and regions during a two week period in April 2016 (April 17-May 1, 2016, if endorsed by SAGE in October 2015). A key component of a successful switch involves effective monitoring of health facilities after the national switch date in all countries to ensure that tOPV is no longer available for administration. Ensuring that tOPV is no longer being administered or in the cold chain is a country responsibility. This document outlines for countries GPEI’s recommended monitoring strategy for withdrawal of all tOPV from cold chain storage points. The document provides step by step guidance on planning, preparing, collecting and reporting data, and corrective actions for monitoring the switch (Box 1).

The key objectives of the monitoring strategy are to: 1) Conduct site visits at all cold chain stores from the national to the district levels (where the largest

quantities of tOPV will generally be stored at the time of the switch), as well as selected service delivery points (health facilities), in order to verify removal of these stocks from the cold chain;

2) Take corrective action to remove tOPV stocks from the cold chain if found and mark these stocks for disposal;

3) Assess performance of the switch; and 4) Assess the status of bOPV and IPV distribution at monitored facilities.

Monitoring the withdrawal of tOPV from cold chain stores and service points is a separate process from the certification of containment or destruction of poliovirus at laboratories and vaccine production facilities.

The destruction and containment of poliovirus at laboratories and vaccine production facilities described in the Global Action Plan to Minimize Poliovirus Facility-associated Risk after Type-specific Eradication of Wild Polioviruses and Sequential Cessation of Routine OPV Use (known as GAP-III) is a separate process from the withdrawal of tOPV. As a result, the requirements for the certification of the containment or destruction of poliovirus at laboratories and vaccine production facilities do not apply to the monitoring of tOPV withdrawal. However, switch monitoring activities may occur simultaneously with efforts to certify containment or destruction of poliovirus at laboratories and vaccine production facilities and may involve the same key staff.

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BOX 1: MONITORING OVERVIEW

Objectives of Switch Monitoring Ensure and validate withdrawal of tOPV (primary) Assess introduction of bOPV (secondary) Assess distribution of IPV (secondary)

Independent Monitoring Period: completed within 2 weeks of the national switch date in April 2016

Planning and preparing for the monitoring:a. Convene a committee (e.g., National Switch Validation Committee) that is

independent from switch implementation activities to provide monitoring oversight and validate switch

b. Develop TORs for the Switch Monitorsc. Adapt data collection tools and reporting mechanism for the independent

monitoringd. Hire and train the Switch Monitors

Monitoring site selection: a. Independently monitor ALL facilities down to the district levelb. Independently monitor a SAMPLE of the service points (health care facilities) using a

risk-based, purposive strategy described in Section 3.

Corrective action: All monitoring efforts should be linked with corrective action (in other words, removal of tOPV from the cold chain).

Reporting: Monitors should report data daily to the Monitoring Supervisor / Coordinator, who aggregates the data and submits to the National Switch Validation Committee. The National Switch Validation Committee should report the validation results to the World Health Organization within two weeks of the national switch date.

Additional monitoring: Supportive supervision visits can supplement independent monitoring of health facilities to provide additional verification of the adequate withdrawal of tOPV from the cold chain. These additional monitoring activities for tOPV withdrawal should be completed as soon as possible, while tOPV disposal should occur within 3 months of the switch; these activities can be conducted through regular activities of national immunization programs.

NOTE: The data collected through supportive supervision visits are not part of the validation process that should occur within 2 weeks of the national switch date.

What are the general principles of this document?

What is included in this document?

This document provides a framework for countries to consider when developing and implementing their plans for monitoring the switch. This document focuses on the minimal recommendations for monitoring the withdrawal of tOPV, the introduction of bOPV, and the distribution of IPV (health facilities should have both bOPV and IPV stocks on the National Switch Day) during the two weeks following the switch. Countries can go beyond these recommendations by adding more activities and indicators that are specific to their National Immunization Program goals.

This document can also be adapted to a field guide for training based on local needs.

Who is the target audience?

Members of the National Switch Validation Committee, country policy makers, program managers, logisticians, and consultants who are involved in the planning, preparation, and implementation of the switch are the primary target audience. This document explains how to establish a system that will provide timely and useful data for validating the switch.

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Recap – Monitoring on a page

The table below summarizes the key activities of the monitoring activities.

Inde

pend

ent M

onito

ring

Perio

d

Plan

By September 2015 Develop monitoring structure Determine timeline of activities Develop indicators for switch validation Identify human and financial resources needed

Prepare

October 2015 – February 2016 Adapt Independent Monitoring data collection and aggregation tools Develop training materials Create roster of facilities to monitor Recruit supervisors and monitors Train supervisors and monitors Develop micro-plans Develop contingency plans

National Switch Day

A day chosen during the last 2 weeks of April 2016(Date to be finalized by SAGE in October 2015)

Validate

April 2016 - During the two weeks after the National Switch Day Monitors visit cold chain stores and service delivery points Data reported and aggregated Develop validation report

Follo

w-u

p M

onito

ring

Perio

d Follow-Up

2-3 months ongoing after the switch Additional monitoring of tOPV withdrawal as needed Correcting identified problems Monitoring tOPV disposal as desired

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1. Plan

1.1. Develop a Monitoring Structure

Identify the staff that will be included in monitoring activities at each level of the health system. Review the descriptions of each of the key players for the monitoring structure below and determine which National Immunization Program staff will be used, if other health workers will be needed, and if partner organizations should also be included in the monitoring activities.

National Switch Validation Committee: A body independent from switch implementation activities that is authorized by the government to validate the switch and certify that tOPV has been withdrawn from the cold chain. A country’s National Certification Committee could be used for this purpose if it is active, or members of the National Switch Validation Committee could be drawn from the National Certification Committee or other authorities not part of the Switch Management Committee.

Monitoring Coordinators or Supervisors: Staff independent from switch implementation activities that are responsible for managing monitors and collecting and responding to data. Coordinators and supervisors:

Identify cold chain stores to be visited Select service delivery points to be visited Develop and provide training material Facilitate logistics for the training and transportation of independent monitors. Facilitate reproduction and distribution of data collection tools and guidelines for monitors. Develop a micro-plan for independent monitors and their supervisors. The plan will be accompanied by

a map and will assign each monitor to areas to be monitored each day

WHO or UNICEF Country Offices may provide coordinators to manage switch monitoring. In larger countries, separate switch monitoring supervisors may be needed for individual states, provinces, or districts. However,

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Plan Prepare Validate Follow-Up

Develop monitoring structure Determine timeline of activities Develop indicators for switch validation Identify human and financial resources needed

such state and local switch monitoring supervisors should ultimately report to a national switch coordinator who will work with the National Switch Validation Committee.

Independent Monitors: Persons who will assess the cold chain storage sites and service points with a data collection tool. These persons should not be directly involved with the organizations implementing the switch itself because their independence from those organizations is important for allowing them to provide honest assessments.

Switch Management Committee (not part of monitoring structure): Plans, manages, and oversees all activities relating to the switch, including identification of the sites to

be monitored at the regional and national levels Receives updates on monitoring activities and findings Takes appropriate programmatic action in case large amounts of tOPV are found at cold chain stores or

service points and/or IPV and bOPV is not available.

Working groups used during SIAs could potentially serve as regional or national Switch Management Committees.

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Box 2: What does “independent” mean?

For monitoring the switch, “independent” refers to the use of coordinators/supervisors and monitors who are not directly involved with executing the switch and are therefore more likely to provide unbiased assessments of the switch’s implementation. These individuals may come from the health sector and may be employed by the government or come from local NGOs or universities. However, if these individuals were directly involved with switch execution or planning activities in a given region or district, they should not participate in monitoring activities in these areas, but can participate in other regions or districts where they have not been directly involved with executing the switch. Independent coordinators and monitors may be from other countries, but it is not necessary to have international monitors for switch validation.

Overall, individuals who can provide unbiased, credible assessments of how well the switch has been performed are well suited to be being involved with switch monitoring.

1.2. Timeline of ActivitiesDetermine the major activities to schedule for switch monitoring. The exact activities and their timing may vary by country. April 2016 CalendarSun Mon Tue Wed Thu Fri Sat3 4 5 6 7 8 9

10 11 12 13 14 15 16

17 18National Switch Day

19 20 21 22 23

24 25 26 27 28 29 30

1 2National Validation Day

3 4 5 6 7

8 9 10 11 12 13 14

Pre-Switch Activities: Identify monitors - 1-2 months before switch Notify monitors of switch activities - 1 month before switch Train monitors - 2-4 weeks before switch Develop monitoring plans for which cold chain stores or service points will be visited by each monitor -

1-2 weeks before switch Distribute data collection tools to monitors - 1 week before switch

2 week Switch Validation Activities: Monitors collect information on switch performance during the 2 weeks after the National Switch Day Monitors withdraw tOPV if found at any site Monitors and their supervisors report information to the National Switch Validation Committee within 3

days of the assessment and no later than 2 weeks after the National Switch Day Data aggregated by National Switch Validation Committee and reported to the Switch Management

Committee. - Continuous process, but should ideally be completed within 2 weeks of the National Switch Day

Post-Switch Activities: After validation, provide supportive supervision for 2-3 months to increase confidence that tOPV has

been fully withdrawn from all service points Dispose of all tOPV- As soon as possible, but no later than 3 months after the National Switch Day

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Stop use of tOPV and remove tOPV from the cold chain. Begin use of bOPV and disposal of tOPV

Two-week window for monitoring cold chain stores, collecting and reporting validation data

Complete disposal of tOPV as soon as possible, but no later than 3 months after National Switch Day

1.3. Switch Validation IndicatorsNational Immunization Program and health sector staff, including the Switch Management Committee, will need to determine the core indicators to validate that the switch has occurred at each level of the cold chain. The following indicators should be considered the minimum needed for Switch validation, with the indicators related to tOPV being the most important:

The number and percent of cold chain stores and service points where tOPV is present Among cold chain stores and service points with tOPV, the number and percent of sites at which at least

one tOPV vial was found inside the cold chain Among cold chain stores and service points with tOPV, the number and percent of sites at which at least

one vial of tOPV was found outside the cold chain The number and percent of cold chain stores and service points with bOPV The number and percent of cold chain stores and service points with IPV

See Annex C for an example of a data collection form that can be used to collect the information needed for these minimum indicators from cold chain stores and service points.

Additional indicators can be included if the National Immunization Program program is interested in collecting other types of information. Data collection forms and the monitoring structure can be adapted to the needs of the country National Immunization Program program and their current management structure.

1.4. Identify Human and Financial Resources

Based on the planned activities, identify the human resources that will be needed with any other resources such as transportation, supplies, data reporting tools, etc. The budget tool that was provided to the National Switch Management Committee can be used for estimations.

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2. Prepare

2.1. Develop data collection tools

Monitors will need to use data collection tools (for an example Form 1 in Annex C, see Note: The forms includedin this guide include the core indicators that are needed to validate the switch. Additional indicators can be included if switch monitors are tasked with collecting information on other immunization activities.) in order to capture all of the information needed to validate the switch. Depending on the rigor of the validation process, the forms can vary in length and depth. The forms should include enough questions to capture the information needed for the minimum indicators for validating the switch.

The forms can also include instructions for what monitors should do if they find tOPV at a cold chain store or service point. For some countries, SMS or other electronic mechanisms can be used to collect the information needed for switch validation.

Collection tools can be a simple paper based form that compiles the required information to compute the minimum indicators required (for an example see Annex C: Sample Independent Monitoring Data Collection Tool, available in word and excel).

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Plan Prepare Validate Follow-Up

Develop data collection and aggregation tools

Develop training materials Create roster of facilities to monitor Develop micro-plans Develop contingency plans Recruit supervisors and monitors Train supervisors and monitors

Table 1. Data fields collected by toolsSimple collection tool Complete collection tool

Facility type/name: Date of the visit Number of vials of tOPV found tOPV kept in or outside of the cold

chain:o In the cold chaino Outside of the cold chain

bOPV present at the facility:o Yeso No

IPV present at the facility:o Yeso No

Facility type/name:o National (name)o Regional (name)o District (name)o Service Point (name)

Date of the visit Date of the switch on site tOPV present at the facility:

o Yeso No

Number of vials of tOPV found tOPV kept in or outside of the cold chain:

o In the cold chaino Outside of the cold chain

Plans for tOPV:o Destroy it on-siteo Keep it out of the cold chaino Transport it to a tOPV disposal siteo Wait for someone to pick up the tOPV

Reasons for not disposing or transferring the tOPVo Unaware of need to dispose of or transfer

tOPVo Did not receive clear guidelineso Need additional assistanceo Did not have time yet to do it.

Destination for tOPV withdrawn bOPV present at the facility:

o Yeso No

Staff started to administer the bOPV or distribute it for administration

o Yeso No, but plan to start administering or

distributing the vaccine soono No, and have no plans to start

administering or distributing the vaccine IPV present at the facility:

o Yeso No

Staff started to administer the bOPV or distribute it for administration

o Yeso No, but plan to start administering or

distributing the vaccine soono No, and have no plans to start

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Simple collection tool Complete collection tooladministering or distributing the vaccine

2.2. Develop training materials

The training material should cover the following topics: Information about the switch Purpose of the monitoring activity, its objectives and the role of independent monitors Timeline of the independent monitoring Description of the behaviour and profile of an independent monitor and his/her interaction with health

workers Description of the tasks of the independent monitor Review of tools (forms) used: exercise and examples Addressing concerns, previous mistakes and handling misleading information Developing independent monitoring micro-plan and how to follow it Diplomacies for tOPV disposal activities.

Sample training module available at: http://www.who.int/immunization/diseases/poliomyelitis/endgame_objective2/oral_polio_vaccine/monitoring/en/

2.3. Identify Facilities for Monitoring

The goal here is to identify which facilities in the cold chain need to be visited for the efficient validation of tOPV withdrawal and bOPV introduction. The recommended risk-based purposive (in other words, non-random) sampling monitoring strategy is intended to rapidly identify the cold chain stores and service points possibly holding the largest stocks of tOPV after the switch and facilitate immediate corrective action.

Steps:1. Generate a line-list of cold chain stores that stock tOPV from the national to the district level (in other

words, all national, regional, and district cold chain stores) along with their last known tOPV stock levels (if possible). Monitors should visit all of these stores.

2. Generate a line-list of the service points that can store tOPV in a working refrigerator or freezer for more than 1 night. The monitors, based on standardized criteria set by the national level, should visit a sample of these service points. Select 10% of the service points with the highest population. Prioritize facilities that have:

tOPV received just before the switch A history of non-compliance with immunization program policies DPT3 coverage <80% Management issues Other high risk characteristics (see Annex B)

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This strategy will provide complete information on all cold chain stores from the national to the district level and will provide information on many service points. These data will provide reasonable assurance of a successful national switch within two weeks of the national switch date.

Results from the sampled service points will not be generalizable to all service points. Therefore, countries are encouraged to ensure tOPV withdrawal from all service points through supportive supervision during the 2-3 months that follow the completion of independent monitoring.

Figure 1 below further illustrates how the purposive sampling should be conducted at the service point (health facility) level.

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2.4. Develop Micro-Plans

Using the list of stores that need to be monitored (all stores from the national to the district level) as well as the list of service points that need to be visited based on the purposive sampling strategy; micro-plans should be developed for each independent monitor (or monitoring team, if district or region is large). These micro-plans should include the following:

Schedule of stores to be visited over the monitoring period after the National Switch Day Mechanisms and procedures for reporting to supervisors Protocol for mop-up with stores if they cannot be visited on schedule Policies for what to do if tOPV is found Contact information for all stores to be visited Contact details of coordinators and supervisors (to be added when recruited).

Next, determine the modes of communication and data flow for each of the key participants. Consider the following:

Is there a mechanism already in place for information sharing? How frequently will information be shared between switch monitoring participants? What information?

Is the mechanism used to share information up the monitoring system (for example, from monitors to supervisors or coordinators) as well as down the monitoring system (for example, from the National Switch Validation Committee to the coordinators)?

How will information be shared with the individuals implementing the switch? How quickly can information be passed from one participant to the next?

2.5. Develop Contingency Plans

Consider developing contingency plans for switch monitoring. For example: What will be done if not all of the cold chain stores and the selected service points are visited during the

monitoring period following the National Switch Day? What will be done if the number of service points that need visits increases because many of the initial

service point visits indicate that there have been problems with tOPV withdrawal?

Many problems can be dealt with during the mop-up monitoring period, but some problems may need to be dealt with during the independent monitoring phase.

2.6. Recruit supervisors & monitors

It is recommended that one supervisor be recruited per region. The independent monitors should not be directly involved with implementing the switch itself so that they can provide unbiased assessments of the implementation of the switch. In-country partner organizations, such as non-governmental organizations, universities, or professional groups, may be able to assist with providing people or other resources.

Main responsibilities for the supervisors: Provide the independent monitors with lists of sites to be assessed Provide training to independent monitors

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Ensure that the independent monitors are able to travel to their assigned sites and move from one to another as required.

Visit independent monitors in the field to check on the quality of work. Observe performances of independent monitors and provide adequate feedback with corrective

measures as needed. Be available for independent monitors to contact by phone at all times during monitoring period. Arrange periodic debriefings with independent monitors, including at the end of the independent

monitors’ period of work Collect the forms from independent monitors, review quality and reliability of data collection process,

and correct if required Compile and analyse the data Send summaries of findings to individuals coordinating the implementation of the switch in the area of

the supervisors’ responsibility. Investigate to identify reasons for leftover tOPV and/or no introduction of bOPV and/or IPV. Advise switch implementation staff on corrective actions in case tOPV is found at cold chain stores or

service points and/or IPV and bOPV is not available. Provide the monitoring coordinator with any information needed to write the report for validation. Facilitate the payment of the Independent monitors

Main responsibilities for the Independent Switch Monitors: Carry out the field monitoring activity Complete the monitoring forms provided Submit the completed forms daily to the supervisors Report to supervisor details about left over of tOPV and/or no introduction of bOPV and/or IPV Record any additional observation that may be helpful in identifying problems with the immunization

program Remove any tOPV found on visits to cold chain stores and service points unless the amount of tOPV

found is so large as to make this impractical. Hand over tOPV removed to supervisor or deliver to disposal site as specified in the micro-plan.

Suggested criteria for selecting independent monitors Education:

o Completed at least a high school or secondary school level (BEPC)o Have a good mastery of the official language of the countryo Be able to speak the local language and be able to operate in the local culture.

Behaviour: o Behave in line with the customs of the community visited o Observe basic politeness rules: greetings, giving reasons for the visito Have the ability to work in a team and under pressureo Know how to reformulate questions to make them more understandable without losing the

substance Experience:

o Some familiarity with logistics or the health care systemo More experience will likely be needed for inspecting larger cold chain store facilities such as

national or regional cold chain stores18

Cultural aspects: o Be familiar with the country’s cultures and the languages and able to interview cold chain and

health facility staffo Same ethnic and religious group as members of communities who may not cooperate with

members of different ethnic or religious groups

2.7. Train supervisors & monitors

The training should be conducted immediately prior to the switch in order to complete the entire monitoring activity within the shortest time possible. Trainers

The national independent monitoring coordinator with the assistance of WHO/UNICEF staff should do an initial training of trainers.

Following the national training of trainers, local training should be conducted by trained persons including consultants where needed.

Organization of training A maximum of 30 trainees at one time is desirable. The method should focus on practical operational

issues with exercises and role-play to ensure the participation and involvement of the participants. Supervisors must attend the training and have additional sessions to train them on quality supervision

and to highlight their roles and responsibilities during the activity.

The monitors should be trained on: Roles and responsibilities Using micro-plans Verifying the absence of tOPV at selected facilities Removal of tOPV if any residual tOPV is found in facilities Completing recording forms to avoid data quality problems Communicating and reporting outcome of facility visits to supervisor If appropriate, confirming that there is a plan for tOPV disposal at each facility, if disposal has not been

completed

2.8. Pre-position supervisors & monitors

Supervisors and monitors must travel to their respective locations according to the plan and be ready to start the independent monitoring in their designated sites on the National Switch Day. Supplies required for independent monitors and supervisors:

ID cards and reference letter; Phone credit; Data Collection Tools; Instruction sheets; Plastic bag and stickers in case tOPV is found; Notepad; Pens.

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3. Validate

The validation process should include all tasks from the start of monitoring activity until the validation report is developed, approved by the National Switch Validation Committee, sent to the ministry of health, and reported to the WHO country office. The figure below shows a timeline with milestones, which can vary from country to country with the goal of the validation process being completed within two weeks of the National Switch Day.

Figure 2: Example timeline to validate the switch

3.1. Monitors visit cold chain stores and service delivery points

Beginning on the day after the National Switch Day, all independent monitors should systematically monitor vaccine cold chain stores and service points as described:

National to District level stores: Independent monitors will visit 100% of the vaccine cold chain stores from the national to the district level. If tOPV is found, the monitor will be expected to remove the vial(s) from the cold chain and facilitate delivery to disposal site as described in the collection plan developed by the Switch Logistics Working Group prior to the switch, document his/her findings, and report to the supervisor. If the amount of tOPV found is large (would require another vehicle to transport), the monitor may not be able to remove all of the tOPV and a follow-up visit may be needed to confirm that tOPV has been correctly withdrawn.

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Plan Prepare Validate Follow-Up

Begin Monitoring Switch Day - Day 0

Complete Data Collection Day 5

Compile Data and Share

ReportDay 11

Switch Validated Day 14

Monitors visit cold chain stores Data reported and aggregated Develop validation report

Service points: Independent monitors will monitor a sample of the facilities as described above. Finding tOPV in the cold chain should prompt corrective action (removal of tOPV) and may trigger visits to additional sites for verification of tOPV withdrawal.

In case one or more tOPV vials (opened or unopened) are found in the cold chain of the service points: The monitor will remove the vials from the cold chain and transport them to the nearest district or

region disposal site according to the disposal plan. The monitor may wait to transport the tOPV to the disposal site until after he or she has completed his or her other monitoring activities.

The supervisor will select an additional 5% of health facilities for monitors to visit.

If one or more tOPV vials containing vaccine (opened or unopened) are found in the additional 5% of visited facilities, a sweep of all service points should be conducted for the whole district. Sweeping would mean an intensified monitoring exercise with involvement of more district, regional and national staff, etc.

This strategy should continue until supervisors and coordinators feel all tOPV has been withdrawn from the cold chain, even if this extends beyond the country validation date. If the visits to the service points will extend beyond the two weeks following the National Switch Day, then they should fall under the usual National Immunization Program’s supervision.

The graphic below further illustrates how the purposive sampling would be conducted at the service point (health facility) level.

Figure 3: Site Visits and Corrective Action by Independent Monitors

Decision to Sweep a District or Region

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• Sweeping district: If tOPV is found after the second round of monitoring (i.e., additional 5% of sites), the Monitoring Coordinator with the support of district immunization staff is responsible for overseeing a SWEEP of entire district

• Sweeping region: If 2 or more districts require sweeps, then involve regional and national staff to conduct a broader assessment of the entire region

3.2. Data Reported and Aggregated

Independent monitors o Hand over all data collection forms (see example in Annex C: Form 1-Sample Independent

Monitoring Data Collection Tool) to their supervisors on a daily basis or discuss findings over the phone.

Coordinators/Supervisorso Collect the data from the independent monitors and review the quality of informationo Compile the data collected into an aggregation tool (see example in Annex C: Form 2-Sample

National Switch Validation Data Aggregation Tool)o Follow-up with monitors who have not turned in forms for their assigned facilities, according to

their micro-planso Send data to sub-national and national coordinatoro Aggregate results for National Switch Validation Committee to reviewo Determine if any programmatic action is needed to remove tOPV if it is found in numerous cold

chain stores, and, if so, what action is needed National Switch Validation Committee

o Will declare monitoring completed once it is satisfied that all national to district level cold chain stores have withdrawn tOPV and that no further assessments or sweeps of service points are needed under the guidelines described above.

o Will make the ultimate decision about whether or not the country can validate that there is no longer tOPV being administered or present in the cold chain after the National Switch Day.

o May request the Switch Management Committee to gather additional information if they feel they do not have enough data to validate the switch.

o Will report findings of the switch to national government, who should then send the report to the WHO.

3.3. Develop validation report

After the National Switch Validation Committee has concluded whether or not the country can validate that there is no longer tOPV being administered or present in the cold chain after the National Switch Day, the committee should report its findings to the national government (see Annex C: Form 3-National Validation Report). The national government should in turn report on the status of the switch, including a validation of the switch, to the country and regional office of the World Health Organization.

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4. Follow-Up

Although the vast majority of the switch monitoring activities should take place during the 2 weeks immediately following the National Switch Day, countries are encouraged to conduct mop-up activities through supportive supervision in order to ensure that tOPV has been sufficiently removed from the cold chain and that the risk of tOPV administration after the switch is low. The mop-up activities will also address problems with bOPV and IPV introduction identified during the initial two weeks of monitoring. National Immunization Program staff can carry out this mop-up activity during routine supervision. The mop-up should occur as soon as possible after the switch and last no later than 2-3 months after the National Switch Day.

Countries may also consider developing a plan for monitoring tOPV disposal, which would be carried out over a longer period than the 2 weeks of independent monitoring focused on tOPV withdrawal. Disposal of tOPV may not be completed within the first two weeks following the National Switch Day, but disposal of tOPV and monitoring of that disposal should be completed also within 2-3 months after the National Switch Day (see the waste management section of the logistics guideline).

4.1. tOPV Withdrawal

While independent monitoring data collected during the first two weeks after the switch date are needed for validation, mop-up activities through supportive supervision will further increase confidence in successful withdrawal of tOPV. As the information on tOPV withdrawal collected from sampled service points will not be generalizable to all service points, visits by National Immunization Program supervisors or district surveillance officers to these sites is an important component of a successful switch.

National to District level cold chain stores: If the amount of tOPV found at a specific cold chain store was too large to pick-up during the monitoring period, a follow-up visit may be needed to confirm that tOPV has been correctly withdrawn. This follow-up visit may happen following the two weeks of independent monitoring but should be prioritized and conducted as soon as possible.

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Plan Prepare Validate Follow-Up

Additional monitoring of tOPV withdrawal Correcting identified problems Monitoring tOPV disposal Future activities

Service points: Identification of tOPV remaining in the cold chain at sampled service points should prompt monitoring visits to 5% additional service points, a sweep of service points in a district, or both. Some or all of these additional visits or sweep activities may need to occur following the two weeks of independent monitoring but needs to happen as soon as possible.

As the information on tOPV withdrawal collected from sampled service points will not be generalizable to all service points, visits by National Immunization Program supervisors or district surveillance officers to service points, particularly ones not visited by independent monitors, is an important component of a successful switch. These supportive supervision visits should occur as soon as possible after the switch and no later than 2-3 months after the switch date.

4.2. Problems Identified during Monitoring

Problems with bOPV and IPV distribution identified through switch monitoring should have been reported to National Immunization Programs’ staff, but may not have triggered further assessments by switch monitors or immediately triggered sweeps of additional service points. All activity to follow-up on problems with bOPV and IPV distribution and to assess the effectiveness of that follow-up will be handled through a National Immunization Program’s existing methods of tracking vaccine distribution and coverage.

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Annexes Annex A: Monitoring tOPV Disposal

See section 3.4.4 of the Switch Implementation Guidelines for additional information on the WHO recommendations for the disposal of tOPV”

In addition to monitoring tOPV withdrawal, bOPV introduction, and IPV distribution, countries may also want to develop efficient mechanisms for assessing if tOPV is being promptly disposed of. Depending on a country’s resources and preferences, some disposal activities may happen during the two weeks following the switch, simultaneously with the independent monitoring of the switch, while others may occur more than two weeks after the switch. Disposal of tOPV should occur as soon as possible, but no longer than 3 months after the National Switch Day. Planners should refer to the waste management section of the Logistics Guideline to develop a disposal monitoring plan.

As explained in the Logistics Guideline, prior to the switch it will be important: To conduct an inventory of all disposal equipment, recording if equipment is working and the volume of

material (vials, if possible) that the equipment can dispose of in 1 day. To develop a tOPV collection plan in sufficient detail that the movement of tOPV from collection to

disposal sites can be predicted and monitored. Individual plans may need to be developed at the national, regional, and district levels of the health system and within each district.

The Logistics Guideline also describes options for collection and handing of tOPV, including: Supervisors pick up tOPV from cold chain stores and take to disposal site Staff from cold chain stores drop-off tOPV at a disposal site tOPV can be amassed from multiple health structures at district level and then can be moved to a

regional or national disposal site and disposed of

A collection/disposal plan should show the schedule for the planned movement and disposal of tOPV, which is useful for planning supervisory visits. For example, all cold chain stores using a particular disposal site could move their tOPV to that site on the same day or could move their tOPV to the disposal site on different days.

Due to the two week time limit on the operations of the independent monitors, they can help identify that tOPV has been removed from a cold chain store or service point and confirm that plans are in place for disposal. However, it is unlikely that the monitors will be able to confirm that tOPV has been disposed, where it has been disposed of, and when. However, information collected in the independent monitors’ data collection tool, along with information collected during supportive supervision visits, can be used to help track whether or not the cold chain stores and service points have returned their tOPV and where it has been sent for disposal.

Monitoring tOPV disposal 1. Monitoring of tOPV disposal should focus on disposal of tOPV from national, regional, and district cold

chain stores because the volumes of tOPV stored at those facilities is potentially much greater than the volume of tOPV stored at service points.

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2. Cold chain store and service points should fill a short form or sticker listing the number of vials of tOPV that are being sent for disposal

3. Preferably, the same information will be printed on the sticker that goes on the bags when withdrawing the tOPV from the cold chain.

4. Disposal sites can use a form to check off when tOPV from a given cold chain store or a service point has been received and disposed of (see Annex C for an example tOPV Disposal Form).

i. Alternative solutions, such as electronic data management systems, could also be used to record vials of disposed tOPV

5. Supervisors should visit tOPV disposal sites to make sure that tOPV has been collected and promptly disposed of. The records kept by the disposal site staff may be very helpful to the supervisors.

a. If the supervisor visits a disposal site and finds that it either has not received tOPV from all expected stores or has not finished disposing of the tOPV it has received, he or she should schedule a repeat trip. Multiple repeat trips may be needed before all expected tOPV has been collected and disposed of.

6. Monitors record the amount of tOPV that a cold chain store or a service point sends for disposal and the site of disposal using a data collection tool during visits to cold chain stores and service points (see Annex C for an example Independent monitoring Data Collection Tool Error: Reference source notfound)

7. Supervisors should ideally cross-check the amount of tOPV reported as having been sent for disposal by cold chain stores with the amount of tOPV that disposal sites record as having been received and destroyed to ensure that all vials were destroyed

8. Information collected on disposal of tOPV should be compiled and sent to the Switch Management Committee.

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Annex B: Categorizing Risk of tOPV Use

Suggested criteria for identifying High Risk districts/sub districts: AFP surveillance:

o Recent or on-going wild poliovirus circulation, either suspected or confirmed from AFP surveillance or environmental surveillance.

o Clusters of AFP cases.o Recent polio compatible cases o Silent or underreporting areas o Locality where the supervision is weak

Immunization: o Low routine immunization coverage with DTP3 or OPV3o Under-performance in previous campaigns o Discrepancies in numbers of children vaccinated between administrative data and coverage

surveyso History of stock-outs o Poor communications with or reporting to National Immunization Program or EPI

Demographic and geographic characteristic: o Densely populated areaso Slums, displaced populations, refugee camps, crowded and highly populated urban area with

dense high-rise buildings, mobile communities including nomads and seasonal workers, conservative communities, areas with administrative instability, management problems or insecurity, etc.

o Border and hard to reach districts/areas

Risk of tOPV Stored and Used During the SwitchLevel of Supply

Chain Hypothetical scenario of tOPV storage and useLikelihood of occurrence

District and higher store levels

Storage of large stocks of tOPV in the cold chain at district level and subsequent distribution to service points after the switch either intentionally (for example, in response to stockout of bOPV) or unintentionally (for example, because of confusion with bOPV)

Low-Medium

Service points

Short term

Service points continue to use tOPV during the first month following the switch.

Low

Long term

Service points store tOPV after the switch and use it months after the switch, either accidentally or intentionally during a bOPV stockout.

Low- Medium

Use of scavenged tOPV

If cold chain stores or service points withdraw tOPV from the cold chain but do not promptly dispose of it, that tOPV may be scavenged and used for immunization or non-immunization purposes.

Low

Note: The forms included in this guide include the core indicators that are needed to validate the switch. Additional indicators can be included if switch monitors are tasked with collecting information on other immunization activities.

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Annex C: Example Forms

Form 1: Sample Independent Monitoring Data Collection Tool

Date of Monitoring: ____________________ Name of Monitor: _____________________________

Level of cold chain: Primary: _____ Sub-National (Regional/Provincial): _______ Lowest distribution level (District): ______ Service Delivery Point (Fixed site): ________

Name of administrative level: ____________________________

Store Location or Name

tOPV in cold chain

(Yes = 1No = 0)

tOPV out of cold

chain without

label “Do not

use” (Yes = 1No = 0)

bOPV in cold

chain (Yes = 1No = 0)

IPV in cold

chain (Yes = 1No = 0)

# vials disposed or

pending disposal at

time of monitoring

# vials destroyed at service point by report date

Disposal method

(Multiple codes okay)* Corrective

actions** (Multiple

codes okay)

Status (ongoing

or completed

Due date, if ongoing

A B C D E F G H I J K1

2

3

4

5

6

7

8

9

10

TOTAL # stores

*Codes for disposal method: (1): Autoclave (2): Boiling (3): Incineration (4): Encapsulation (5): Burial (6): Burning (7): Other **Codes for corrective action: (1): tOPV withdrawn (2): Onsite re-training (3): Officials at higher administrative level notified (4): Other (please specify)

Form 2: Sample NATIONAL Switch Validation Data Aggregation ToolSECTION 1 – Vaccine Stores

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Draft National Switch Data Aggregation Tool & Report_17 Feb 2016

Table 1: Aggregate INDEPENDENT MONITORING data for vaccine stores to lowest distribution level (excluding service points)

Indicators

Total # stores

Vaccine Stores Monitored

tOPV in cold chain

tOPV out of cold chain

without label “Do not use”

bOPV available

IPVavailable Disposal of tOPV

Administrative Level

#stores % #

stores %* # stores % #

stores %* # stores %*

# vials withdrawn for disposal

by report date

Disposal method

(Multiple codes

okay)**A B C D E F G H I J K L M N

Primary (National)

Sub-National (Regional or Provincial)

Lowest distribution level (District)

*denotes percent of monitored stores**Codes for disposal method: (1): Autoclave (2): Boiling (3): Incineration (4): Encapsulation (5): Burial (6): Burning (7): Other Table 2: Corrective action (to the lowest distribution level, excluding service points) If tOPV is found in the cold chain or outside it without labeling

Level of cold store Location of cold store Corrective actions implemented*** (Multiple codes okay) Status (ongoing or completed) Due date, if ongoing

1 2 3 4 5

1.2.3.4.5.6.***Codes for corrective action: (1): tOPV withdrawn (2): Onsite re-training (3): Officials at higher administrative level notified (4): Other (please specify)

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Draft National Switch Data Aggregation Tool & Report_17 Feb 2016

SECTION 2 – Service Delivery Points (ie, health centers with fixed vaccination services) :

Table 3: Aggregate INDEPENDENT MONITORING data for service delivery points by region (or district if desired by country)

Indicators

Total #

# Monitored tOPV in cold chain

tOPV out of cold chain

without label “Do not use”

bOPV in cold chain

IPVin cold chain Disposal of tOPV

Region

#points % #

points %* # points % #

points %* # points %*

# vials withdrawn for disposal

by report date

# vials destroyed at service point

by report date

A B C D E F G H I J K L M N

Region 1

Region 2

Region 3

*denotes percent of monitored stores

Table 4: If tOPV sweep is required in district, list corrective action:District Number of service

points swept Corrective actions implemented** Status (ongoing or completed) Due date, if ongoing

B B C D E

1.2.3.4.5.6.7.8.**Codes for corrective action: (1): tOPV collected from all facilities (2): Onsite retraining at sites with tOPV in cold-chain or unlabeled for destruction (3): Officials at higher administrative level notified (4): Other (please specify)

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Form 3: NATIONAL VALIDATION REPORT: Switch from tOPV to bOPV

Country: Date of Switch:

Table 1 : For each indicator identified below, check Yes or No. Please insert comments as appropriate:

Indicators Yes No Comments

A Switch has been validated* by country

B If Yes, report date;If No, report additional corrective action needed & expected date of validation**

C Independent monitoring used for Switch

D Switch will continue to be monitored through routine EPI reporting

E Switch Validation Committee reviewed validation data

*Defined as 0% detection of tOPV in cold chain or outside without appropriate label**Codes for corrective action (multiple may be listed): (1) Region sweep (2) District(s) sweep (3) Re-training (4) Request for additional data (5) Other (please specify)

Table 2 : For each cold chain level, report aggregate INDEPENDENT national monitoring data on tOPV and bOPV after National Switch Day.

Indicators Site monitoring

tOPV in cold chain or outside without

proper label

bOPV at site

IPVat

site***

Excess # tOPV vials disposed

or needing disposal (at

time of report)Administrative Level

Total # Monitored % % * % * % *

A B C D E F G H

Primary (National)

Sub-National (Regional or Provincial)

Lowest distribution level (District)

Service delivery point (fixed vaccination services)

***If IPV has been introduced*Denotes percent of monitored sites

National Switch Validation Committee Chairperson or designee (Name, signature, & date)

Minister of Health or government designee (Name, signature, & date)

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Action: Complete form and submit to WHO Country OfficeResponsible authority : Ministry of Health supported by National Switch Validation CommitteeReporting deadline: 2 weeks after National switch date or latest 15 May 2016

Instruction Sheet: National Switch Data Aggregation Form & Validation Report

“Validation” of the Switch: Two forms are used to aggregate and report independent monitoring data collected within 2 weeks of the National Switch date and validation of the switch. The primary data indicators for validating the switch are 0% detection of tOPV in the cold chain or outside cold chain without appropriate label (for example, “Do not use/Destroy”) at any level of monitored stores (as recommended in the WHO Monitoring Guidelines). If problems with the switch are detected, corrective action should be taken by the government.

In addition, the monitoring and validation process is also an opportunity to ensure bOPV and IPV availability (if introduced). It is important to note that disposal is not expected to be complete before validation but receiving available data at the time of report is still useful.

Form 1: Independent Monitoring Data Collection Tool : to be completed by independent monitors and submitted to reporting official at the administrative level on a daily basis

Form 2: National Switch Data Aggregation Tool : to be completed by National authorities after independent monitoring at subnational levels. Data form should be submitted for review by the National Switch Validation Committee (NSVC) or National Certification Committee (NCC) or other designated Committee

Form 3: National Switch Validation Report: After review by the NVSC or NCC of Form 2, this form should be completed by the National authorities and signed by the designated government authority. Government should submit form to WHO Country Office.

Responsible Authority: National Government

Action: Complete the two attached forms within 2 weeks of the National Switch Date, starting with Forms 1 and 2 which will inform Form 3.

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Action: Complete after NSCV/NCC review, obtain relevant signatures, and submit to WHO Country Office within 2 weeks of National Switch Date (or

latest by 15 May 2016)

Purpose: To summarize findings of Switch Validation review by NSVC/NCC and MOH

Form 3: National Switch Validation Report

Action: Submit aggregation forms to NSVC/NCC within 1-2 weeks of the National

Switch Date.

Purpose: National EPI Program to aggregate data on Switch monitoring indicators submitted by subnational levels. Note: Subnational levels

may modify the form for their own use.

Forms 1 & 2: Independent Monitoring Data Collection &

National Aggregation Tool

Draft National Switch Data Aggregation Tool & Report_29 Jan 2016

Complete a separate table for each administrative level being monitored. List:-Date of monitoring-Name of monitor-Select level of cold chain: Primary (National; Sub-National (Regional or Provincial); Lowest distribution level

(District); or Service delivery point (Health post with fixed vaccination services)-List name or location of the administrative level: (e.g., State Name, District Name)

Column A: Location or Name of the cold store or service delivery point Column B: Is tOPV found in the cold chain? Yes = 1; No = 0 Column C: Is with tOPV outside cold chain, not properly packed in plastic bag or container labeled (e.g., “Do not

use/Destroy”)? Yes = 1; No = 0 Column D: Is bOPV found in the cold chain? Yes = 1; No = 0 Column E: Is IPV found in the cold chain? Yes = 1; No = 0 Column F: Total number of tOPV vials disposed or pending disposal at that level, by monitoring date. For service

deliver points, this may be the number of tOPV vials returned (or planned) for destruction either to district cold chain store or to off-site waste management facility. The best estimate for this is likely the excess tOPV withdrawn based on the stock ledger. NOTE: To avoid double counting, do not include tOPV vials sent in to this level after the Switch Date from other levels for disposal.

Column G: Number of tOPV vials that were destroyed on-site by report date, if any. Column H: Enter methods used for tOPV disposal using the codes provided, multiple methods can be recorded. Column I: List the corrective actions implemented**, in any, using provided codes. Column J: List the status of the corrective action as ongoing or completed Column K: If corrective action is ongoing, list anticipated due date of completion.

Tally the totals for Columns B-G. Submit these forms on a daily basis to the reporting official for the administrative level being monitored.** Note: According to the WHO Monitoring Guidelines :

1) Cold stores from National to the Lowest Distribution Level (District): 100% of the cold stores should be independently monitored. Corrective action should be taken for any tOPV in the cold chain or not properly packed in plastic bag or container labeled (e.g., “Do not use/Destroy”). tOPV should be withdrawn from the cold chain and reported to the administrative official.

2) Service Delivery Points: Use the risk-based purposive sampling to monitor selected service delivery points or health posts with fixed vaccination services. If tOPV is found in the cold chain of the initial 10% of the selected monitoring sites and again in the subsequently selected 5% of the sites, then sweep (tOPV monitoring) of all service delivery points in the district is required in coordination with the administrative official for the district.

Instructions for FORM 1 – Independent Monitoring Data Collection Tool : NOTE: These forms are intended to be used by the Independent Monitors. Complete separate form for each administrative level (primary, subnational, district, and service delivery points with fixed vaccination services).

33

Draft National Switch Data Aggregation Tool & Report_29 Jan 2016

Step 1: Complete Section 1, Table 1: Aggregate INDEPENDENT MONITORING data for vaccine stores to lowest distribution level (excluding service points)

Column A: Type of vaccine store, if the country have more than 3 levels of vaccine store then add more lines Column B: Total number of stores by level in the country Column C: Number of stores independently monitored Column D: Percent of stores independently monitored: (C/B)*100 Column E: Number of stores with tOPV in cold chain Column F: Of those monitored, % of stores with tOPV in cold chain: (E/B)*100 Column G: Number of stores with tOPV outside cold chain, not properly packed in plastic bag or container labeled (eg,

“Do not use/Destroy”) Column H: Of those monitored, % of stores with tOPV outside cold chain not packed without label: (G/B)*100 Column I: Number of stores with bOPV in cold chain among those monitored Column J: Of those monitored, percent of stores with bOPV: (I/B)*100 Column K: Number of stores with IPV in cold chain (if IPV has been introduced in the country) Column L: Of those monitored, percent of stores with IPV among those monitored: (K/B)*100 Column M: Total number of tOPV vials disposed or pending disposal at that level, by report date. The best estimate for

this is likely the excess tOPV withdrawn based on the stock ledger. NOTE: To avoid double counting, do not include tOPV vials sent in to this level after the Switch Date from other levels for disposal.

Column N: List all methods of disposal used by this level for tOPV destruction using provided codes. Multiple codes may be selected. If other, please specify.

Step 2: Complete Section 1, Table 2 -- Corrective Action: For corrective action taken at stores in each level, list the level of cold chain, location of the cold chain and the corrective actions implemented using provided codes. List the status of the corrective action (ongoing or completed) and if ongoing, due date of completion.

Step 3: Complete Section 2, Table 3 Aggregate INDEPENDENT MONITORING (WHO Monitoring Guidelines) and DISPOSAL data for service delivery facilities with fixed vaccination services, by Region Column A: Region or Province name (if desired by country, these may be aggregated by District) Column B: Total number of total Service delivery facilities in country Column C: Number of service delivery facilities that were independently monitored Column D: Percent of independently monitored service delivery facilities: (C/B)*100 Column E: Number of sites with tOPV in cold chain Column F: Of those monitored, percent with tOPV in cold chain: (E/B)*100 Column G: Number of sites with tOPV outside cold chain, without proper label Column H: Of those monitored, percent with tOPV outside cold chain without proper label: (G/B)*100 Column I: Number of sites with bOPV in cold chain Column J: Of those monitored, percent with bOPV in cold chain: (I/B)*100 Column K: Number of sites with IPV in cold chain (if IPV has been introduced in country) Column L: Of those monitored, percent with IPV in cold chain: (K/B)*100 Column M: Number of tOPV vials returned (or planned) for destruction either to district cold chain store or to off-site

waste management facility. Best estimate for this may be excess tOPV based on stock ledger Column N: Number of tOPV vials that were destroyed on-site by the service delivery facility by report date

Step 4: Complete Section 2, Table 4: For corrective action taken at the service delivery level, list all districts that required sweep of tOPV according to the independent monitoring guidelines (e.g., tOPV was found in the initial 10% of the selected monitoring sites and again in the subsequently selected 5% of the sites). For each sweep, list the district, number of service points swept, and corrective actions implemented. Note: the form may be modified at district level to list the individual service points that had tOPV in the cold chain.

Instructions for FORM 2 -- National Switch Aggregation Tool: NOTE: These forms are intended to be used by the NATIONAL AUTHORITIES, using data from independent monitoring (Form 1), and may be modified for each administrative level (subnational and district) as deemed appropriate

Instructions for FORM 3 – National Switch Validation Report34

Draft National Switch Data Aggregation Tool & Report_29 Jan 2016

Responsible Authority: After review by NSVC/NCC of Form 2, Ministry of Health will complete this form and obtain the appropriate signatures from the Government designee and Chairperson of the NSCV/NCC

Outcome of this report : is to Validate that tOPV is appropriately removed from the cold chain in the National EPI Program; secondary objective is to ensure bOPV is available at all levels.

Reporting deadline : is within 2 weeks of the National Switch Date or latest 15 May 2016

Step 1: Complete Table 1: Check ‘Yes’ or ‘No’ for each indicator for the National Validation of the Switch. Insert comments as appropriate.

Row A : Select if Switch has been validated by country after review by the NSVC/NCC or other designated Committee. The primary data indicators for validating the switch includes 0% detection of tOPV in the cold chain or outside cold chain without appropriate label (for example, “Do not use/Destroy”) at any level (as recommended in the WHO Monitoring Guidelines) with the locally implemented corrective action if necessary.

Row B . If switch is validated, provide date of validation; if not validated, list planned corrective actions using provided codes and expected date of validation by country. Examples of corrective actions may include additional sweep of district(s) or region(s), or request for collection of additional data.

Row C : State if independent monitoring was used to validate the switch. Row D : State whether the switch indicators will continue to be monitored through ongoing routine

EPI reporting and supportive supervision. Examples may include: adding switch indicators to the monthly reports from health facilities to districts, and from districts to the next administrative level, as well as ensuring that supervisors and managers are monitoring for tOPV absence and availability of bOPV and IPV when assessing health facility’s information system.

Row E : Select if the NSVC, NCC, or other designated committee reviewed switch validation dataStep 2: Complete Table 2: Summarize the aggregated national data on tOPV using Form 1 ( National Switch Data Aggregation Tool) and accompanying instructions.

Column A: Administrative level for vaccine stores and service delivery points Column B: Total number of sites (vaccine stores and service delivery points) at each administrative level in

country Column C: Number of sites (vaccine stores and service delivery points) that were independently monitored Column D: Percent of independently monitored sites: (C/B)*100 Column E: Of those monitored, percent of sites with tOPV in cold chain or without proper label: (E/C)*100 Column F: Of those monitored, percent of sites with bOPV: (F/C)*100 Column G: Of those monitored, percent of sites with IPV: (G/C)*100 Column H: Of those sites monitored, total number of vials of tOPV disposed or needing to be disposed

Step 3: Obtain signatures from Chairperson of the NSVC/NCC (or designated committee) and the MOH designee who affirms National validation of the switchStep 4: Submit form electronically to the WHO Country Office.

[Print these instructions on the backside of each accompanying form]

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tOPV Disposal Form – Supervisors(Monitor fills out)

Disposal Site Name: Supervisor name: Supervisor phone number:Region: District:

Disposal Site Name

Level of Disposal Site*

Region District Date of Visit

tOPV Disposal Completed?

# of tOPV vials disposed of to date

Date of Visit

tOPV Disposal Completed?

# of tOPV vials disposed of to date

Date of Visit

tOPV Disposal Completed?

# of tOPV vials disposed of to date

12345678910111213141516171819

Total*Write one of the following types of facilities: National store, Regional store, District store, Service Point (SP).

Form may be modified as needed to suit needs of country.

36