National Quality Assurance standards for AEFI 5urveillance Programme (2016), MoHFW,6ol

Summary

The Government of lndia's Universal lmmunization Program (ulP) is the largest public health
programme with increasing number of vaccines offered to the public free of cost. One of the

components of the UIP programme is the Adverse Events Following lmmunization (AEFI)

surveillance programme, which monitors and tracks adverse events occurring in the field. The

National AEFI Surveillance and Response Operational Guidelines of 2015 provides the guidance
to maintain and improve AEFI surveillance system in the country. One of the initiatives to

improve the AEFI surveillance system is to develop and implement a Quality Management
System (QMS) for AEFI surveillance at all levels. One of the tools for the QMS is the National

Quality Assurance Standards (NQAS) forthe Adverse Events Following lmmunization

(AEFI)Su rveillance Programme. This was developed and approved by the Ministry of Health and
Family Welfare (MOHFW), Gol in 2016 through multiple consultations with quality assurance

and public health experts as well as clinicians, communication specialists, programme managers

at state and district levels, etc.

The Standards provide a framework for quality assurance and quality improvement for the AEFI

surveillance programme at national, state, district and health facility levels. The NQAS also has

checklists which can be used for conducting frequent assessments against the proposed

standards. The objective of the Standards and the checklists is to provide a tool for frequent
self-assessments (or external assessments) leading to incremental but sustainable

improvements in AEFI surveillance processes and activities at all levels. The assessment

protocols and scoring system to help understand, plan and conduct assessments at each level.
The annexures contain Key Performance lndicators for national/state/district levelsand format for
preparing assessment rePorts.

Obiectives

To formulate different standards and to gauge the quality of AEFI surveillanceprogra m'

To improve vaccine safety and maintenance or restoration of the confidence of cOmmunity In

immunization programme
 National Quality Assurance standards for AEFI surveillance Programme (2016), MoHFW, Gol

. To derive methods to eliminate different problems hindering effective implementation owing to

training and monitoring issues

Approach

Comprehensive-TheNQAS covers all aspects of AEFI surveillance ranging from notification to action

taking following ca usa lity assessment.

Contextual- All the standards are inspired from current processes and priorities of AEFI surveillance
program in lndia.Peculiarities and specific quality issuesare addressed with due weightage in
consultation with experts and managers.

Aspirational - While the NQAS covers current processes, it also looks at raising the bar and
including processes which are anticipated to be focus areas in the future such as monitorinB of
social media for AEFI concerns, monitoring of minor AEFls, signal detection processes, etc.

User Friendly- The standards are designed to be practical and easy-to-administer. lt avoids complex

language and jargon related to quality.

Evidence based-The standards described are based on available documentation such as records,

reports, meeting minutes, reported data, etc. and are in compliance with technical guidelines
released by MOHFW.

a Obiectivity -The assessment criteria is explicit and well defined to reduce assessor variability and
requirement of specialtraining for assessors. Sources of information, records, etc. to gauge status is

specifically mentioned and detailed in the means of verification a8ainst each measurable element.

. Critical examination of currentprocesses with benchmarks for improvements to make processes

more efficient

The standards formulated can be used across all levels and by all personnel

Considers all contemporary and well accepted attributes of quality measurement followed globally

The standards are not only restricted to reporting and investigation and core areas of AEFI

surveillance but also cover other areas such as communication, risk management, convergence and

coordination.

Entire system or process is user-friendly for easy understanding and implementation

 National Quality Assurance Standards for AEFI Surveillance Pro8ramme (2016), MoHFW, Gol

Areas of Concern and Measurable Elements

The NQAS assesses the AE Fl surveillance programme under ei8ht Areas of Concernunder which there

are five Standards with Measurable Elements under each Area of Concern. The eight Areas of Concern

are as follows:

A.Notification and reporting- There will be five standards under this Area of Concern for all levels
starting from the point of vaccination to the national level.

B. lnvestigation- This Area of Concern covers the initial and final investigation processes with focus on

special case investigations.

C. Causality Assessment-The standards under this Area of Concern gauges the criteria and processes for
selection / eligibility of cases for causal assessment using predetermined tools and algorithm.

D. Operational Management-This Area of concern covers the operational aspects and available

processes and resources in the programme nranagers' office, functionality of AEFI committees, and

other activities such as training and capacity building, etc. across all levels.

E. Communication-The standards under this Area of Concern covers strategy and processes of regular
communication including management of inforrnation dissemination on social media.

F. convergence-This Area of Concern covers coordination and convergence between multiple

stakeholders involving drug regulators, other professionals, academics, civil, administrative and law

enforcing bodies.

G. Monitoring and feedback- These standards a re related to collating information from different

sources to identify unreported cases, giving feedback to states and districts for pending of reports,

completeness, holding of AEFI committee meetinBs, non-reporting districts/states at pre-defined

intervals, etc.

H. euality Management System-The five starrdards under this Area of Concern coversdevelopment
quality policy, implementation of processes for internalassessment and risk manaBement.
 National Quality Assurance Standards for AEFI Surveillance Programme (2016), MoHFW, Gol

The four facility level checklists with measurabk'elements for use by assessors (both internal and

external) to evaluate the AEFI surveillance programme against the standards focus on different areas as
per the functions of the facilities:

1. lmmunization clinic/session site-This covers the processes for notifying, reporting of minor, severe
and senior in AEFI registers, immediate reporting of severe and serious AEFls, reporting from private

sector, role in investigations, operational management processes involving stakeholders (ANMS,

ASHAS, AWWS, health supervisors, community volunteers, private sector medical personnel, etc.)
training and capacity building and prevention and management of AEFIS in the periphery. lt also
covers communication, convergence and processes for internal assessment and periodic reviews as

well as risk mitigation.

2. District level-ln this the focus is on monitoring of the AEFI surveillance programme by the DIO and
District AEFI Committee and case investiUation procedures and timelines. Special investigation
procedures are also a focus areas. Mei)surable indicators cover communication and media
management as well as capacity building and training activities for all medical and paramedical staff.

Coordination with health facilities, professional associations and other stakeholders such as civil
administration is covered under this checklist. Monitoring of key performance indlcators is also
covered under this checklist as well as risk mitiSation.

3. State level-The checklist focuses on monitonng of performance indicators (timeliness, completeness,

missed cases, non-reporting districts, etc.) and causality assessments (completeness, following
algorithms and processes, etc.) by State AEFI Committees as well as special case investigation
procedures at state level. The other focus areas feedback, operational management, coordination

and convergence with stakeholders, commur.rication and media and risk management'

4. National level- The national processes focus on monitoring of performance indicators of states and

AEFI committees, feedback, special investigations, causality assessment processes, action taking

against results of causality assessment {includinS siEnal detection processes), maintenance of

databases, development of tools for capa(ity building (training, communication, information and
media management). The roles and responsibilities of the programme division, secretariat and
national level stakeholders including the national AEFI committee, drug regulators,
pha rmacovigila nce partners, etc. and coordaration and convergence are focus areas in the checklist.
 National Quality Assurance Standards for AEFI Surveillance Programme (2016), MoHFW, Gol

These Standards and formats are to be used by programme managers and quality assurance experts at
all levels for periodic self-assessments for continuous and sustainable improvement in quality of AEFI

surveillance leading to certification.

 National Quality Assurance Standards for lmmunization sites
Checklist for lmmunization Sites 11
Assessment Summary
Date of
Nam€ of the lmmunization rltes

Type of As5essment (lnternal/External)

Date

lmmunization Sites Score Card

Area of Conc€rn wise Score Total Score
Notification & Reporting s0%

B
lnvestitatioh s0%

D
Operational Management 50o/o

F
Communication

Convergence
s00/.

50o/o
so%
Quality Management System
H s0%

Maior Gaps ObseNed

1

Strenrths / Good Practicer

1

Recommcndations/ Opportunltes f or lmprov€ment

2
3

5
Signature of Assessors

Ref.no Area of Conaerns Saore Received Maximum Score PercentaBe

Notification & Reporting

B lnvestigation
D Operational Management
E Communication
F Convergence
H Quality Mana8ement SsYtem
TotalScore

Arruranc€ standa.ds lor AEFI SUN€illan.e

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Names of Assessors Names of
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 National Quality Assurance Standards for National
Checklist for National
Assessment Summary
r
Date of
Name of the unit
Assessment
Names of
Names of Assessors
Assessees

Action plan
Type of Assessment (lnternal/External)
Submission Date

Area of Concern wise Score Total Score

Notification &
A so%
Reporting
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Causality Assessment
c 50%

Operational
D 50%
Management
E

F
Communication
Convergence
50%
50%
so%
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G 50%
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quality Management
H System s2%

Maior Gaps Observed

I
2
3
4
5
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1

2
3
4
5
Recommendations/ Opportunites for lmprovement
1

2
3
4
5
Sixnature of Assessors
Date

Ref.no Area of Concerns Score Received Maximum Percentage

Score
 Notification &
A
Reporting
B lnvestigation
Causality Assessment
c

Operational
D

E Communication
lr
F Convergence
Monitoring &
G
Feedback
Quality Management
H Ssytem

Total Score

National Quality Assurance Standards tor AEFI Surveillance programme

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 National Quality Assurance Standards for State
Checklist for State 11
Assessment Summary
oate of

llnternal/External)
Dat€

District Score Card

Area of Concern wise Score Total Score
Notification &
50%
Reporting
B lnvestigation 5004
Causality
c SOYo
As5essment
Operational
500/"

F
Management
Communication
Convergence
500/"
50%
50%
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G 50%
Feedback
Quality
H ManaSement so%
Sy5tem

Maior Gaos ObreNed

1

sirenPths / Good Practices

1

R€comm€ndations/ Oppoaunllcs tor lmProvem€nt

I

si.nature oI Assessors

Ref.no Area of concerns Score Received Maximum Percentage

Score
Notification &
Reporting
B lnvestitation
Causality
c
Assessment
operational
D
Management
E Communication
F Convergence
Monitoring &
G
Feedba.k
 quality
H Manatement
5s6em
TotalScore

Nation.lQua,ityAssuranc€StandardsforAEFt 5urv€i an.eprotramme

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