Overview of the

Validation Process
Training workshop of Validation Process of
tOPV-bOPV Switch
April, 2016

Switch Validation
Overview
Objectives of Switch Validation
Ensure and confirm withdrawal of tOPV
Assess introduction of bOPV
Assess distribution of IPV

Separate from the monitoring of the process

of the switch
Confirms through a separate process reports
from immunization staff that tOPV has been
withdrawn from the cold chain
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Three Steps to National

Validation
National Switch
Date

MOH conducts independent monitoring

and takes corrective action

Validation Committee reviews and

provides validation recommendation

MOH takes corrective action as necessary

and submits validation report to WHO

Independent Monitoring for

Validation

National stores down to District level:

Independent monitors verify tOPV is removed

from cold chain in ALL vaccine cold chain
stores from the national to the district level
within 2 weeks of the switch day

Service delivery points:

Due to large number of service points, a risk-

based purposive (i.e. non-random) sampling

plan is recommended for independent
monitoring within 2 weeks of switch day

Summary of the Independent Monitoring Process

Primary (national) stores

Independent monitors

Visit 100%
of the
vaccine
stores

Sub-national (Regional
or zonall) stores:

Lowest distribution
level (District)
stores:

Service points (health

facilities)

Monitor sample
delivery points
selected through
the risk-based
purposive

What if tOPV is Found at a zonal, Regional,

or Lowest Distribution Level Store?
tOPV needs to be removed from the cold chain
immediately
tOPV should be disposed of as soon as possible
Monitor needs ensure tOPV has been removed from
cold chain and report findings to supervisor
Since all Zonal, Regional, and lowest distribution
level stores are being visited anyway, finding tOPV
at one of them does not affect monitoring of others
Ensuring Zonal, Regional, and lowest distribution
level stores do not have tOPV in the cold chain after
the switch is the highest priority due to the volumes
of tOPV they usually have
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Facilities down to District

level
Independently monitor
ALL

Risk-based
Purposive
Sampling

For HEALTHCARE facilities,

sample a selected number to
independently monitor
Select 10%

tOPV vial
(opened or
unopened) in
cold chain

Prioritize facilities such as

Highest population or
tOPV doses
receiving tOPV just
before switch
suspected noncompliance
coverage<80%

N
o

Stop &
report to
National
Validation
Committee

Ye
s

REPOR
T
validati
on to
WHO

Select
additional 5%
of high risk
facilities in
same district

Sweep* entire
district

Ye
s

tOPV vial
(opened or
unopened) in
cold chain

No

Stop &
report to
National
Validation
Committee

p denotes intensified monitoring of all other health facilities with

involvement of staff from the regional level or higher

Which Facilities Are

Sampled?
Cold chain facilities down
to District level
Independently monitor ALL

For HEALTHCARE facilities, sample a

selected number to independently
monitor
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Which Facilities Are

Sampled?
Cold chain facilities down
to District level
Independently monitor ALL

For HEALTHCARE facilities, sample a

selected number to independently
monitor
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Which Healthcare Facilities

Should be Independently
Monitored?
Select 10% of health facilities in
each district

Prioritize facilities with:

Most tOPV doses usually in stock
tOPV received just before switch
Highest likelihood of not
stopping tOPV use on time
History of non-compliance with
new policies
Coverage with DTP3 containing
vaccine below 80%

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What Should the Monitors

Look For at Sampled Health
Facilities?
tOPV vial (opened or unopened) in
cold chain

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What if the Monitors Do Not

Find tOPV in the Cold Chain
at Any Facilities?
Stop independent monitoring
visits after initial 10% of
facilities are visited
Report to National Validation
Committee via Monitoring
Coordinators

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What if the Monitors Do Find

tOPV in the Cold Chain at a
Facility?
Select additional 5% of high risk
facilities in same district
Monitors visit each of those facilities
As a result 15% of facilities in that
district are visited

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What Should the Monitors

Look For at Additional
Facilities?

tOPV vial (opened or unopened) in

cold chain

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What if the Monitors Do Find

tOPV in the Cold Chain at
One of the Additional
Facilities in a District?
Sweep entire district

Sweep: Intensified monitoring of

all other health facilities in the
district with involvement of staff
from the regional level or higher

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What if the Monitors Do Not

Find tOPV in the Cold Chain
at Any of the Additional
Facilities?
Stop independent monitoring
visits after initial 10% and
additional 5% of facilities are
visited
Report to National Validation
Committee via Monitoring
Coordinators

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What Happens After All

Independent Monitoring
Visits Are Completed and All
of Their Data is Reviewed?
REPORT
validation to
WHO

17

What if Two or More Districts

in a Region Need to be
Swept?

Regional and national staff should be

involved to conduct a broader
assessment of the region

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Monitoring Structure:
Key Players
Assess the cold
chain storage
sites and
service points
to collect data
Independent
Monitors

Monitoring
Coordinator/
Supervisors

Manages
Switch
monitoring

Validate the
Switch based
on collected
data
switch Validation
Committee*

*National Switch Validation Committee is a body independent from Switch implementation activities that is
authorized to validate the Switch. If exists, the National Certification Committee (NCC) can be used for the purpose.

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Ideal Schedule for

Independent Monitoring
Execution
National Switch
Date

Independent monitoring completed

Typically within 3-5 days of switch date

Data available at zonal level (for review by

Validation Committee)
Typically within 7-10 days of switch date

MOH
takes
immediat
e
corrective
action if
tOPV is
found in
cold chain

MOH submits Validation report to WHO

Within 14 days of switch date
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Monitoring Disposal of tOPV

Monitoring disposal of tOPV is not the
focus of the 2-week switch validation
process
Whether and how to monitor disposal of
tOPV is separate process
Disposing of tOPV will likely take longer
than withdrawing it from the cold chain,
possibly >2 weeks post switch
Disposal of tOPV should ideally be
complete within 3 months of the switch
Same deadline as for laboratory containment
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or destruction of type 2 Sabin strains

Monitoring Disposal of tOPV

Cold chain store sites use short
form or sticker listing the
number of vials sent for disposal
Disposal sites can use a tally
sheet to check off when all of
the tOPV from a given cold chain
store site has been received and
disposed of

Date:
Cold Chain Store Sending
tOPV:

Disposal Site Receiving

Information collected should be

compiled and sent to the Switch
Management Committee.

Vaccine:
Number of vials of tOPV
being sent:

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Follow-up Activities
More important to complete switch well than to stop
all switch monitoring within 2 weeks of switch day
Addressing some problems identified by independent
monitors may require more time than the 2 week
deadline for independent monitoring
Follow-up monitoring may need to be done by
immunization program staff
Routine monitoring through supportive supervision
will further increase confidence in successful
withdrawal of tOPV
Service points not visited by independent monitors should
be visited as soon as possible
Any tOPV found in cold chain should be removed

Verification of tOPV disposal

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Auxiliary Switch Monitoring

through Poliovirus Surveillance
Testing of stool samples from acute flaccid
paralysis cases and environmental sampling
for poliovirus can detect the Sabin type 2
poliovirus found in tOPV
Detection of the Sabin type 2 poliovirus
found in tOPV more than 4 months after the
switch would indicate use of tOPV after the
switch
At a minimum, a follow-up investigation and
report to WHO would be necessary
A successful switch, aided by thorough
validation efforts, will prevent such events 24

Ongoing
Timeline of Activities
supervisory
visits (2-3
months)

PreSwitch
(3months
)
Validation
committee
Identify
monitors
Develop
tools

PostPreSwitch (2
Switch (2 weeks)
weeks)
Collect &
Train
monitors
Develop
microplans
Distribute
data forms

tOPV disposal
Supportive
supervision to
ensure tOPV
withdrawal

report data
Validate switch

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Questions?

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