The objective of implementing the QMS in states, districts and session sites is to improve the quality and efficiency of AEFI surveillance at all levels, keeping in mind the necessity to ensure immunization safety for all vaccine recipients. This document has been prepared to help the state and district immunization programme officers to initiate QMS processes rapidly in the state and districts to attain certification as per NQAS for AEFI surveillance processes

1. National Quality Assurance
Standards
for AEFI surveillance
Presented by
Dr Ankur Raghav
National AEFI Secretariat
Ministry of Health and Family Welfare
Government of India

2. NQAS for AEFI Surveillance System
▰ Recommended by WHO’s assessment of the National Regulatory Authority (NRA)
in 2012
▻ Set up and implement a Quality Management System for AEFI surveillance
processes across the country
▰ Objective - to improve the quality and efficiency of AEFI surveillance processes at
all levels
▰ Trainings and capacity building, documentation and monitoring of QMS
implementation play key roles in quality assurance.
▰ Key activities, focus areas, indicators and benchmarks are identified and defined
▰ Standards for quality assurance in AEFI surveillance
▻ Based on the National Quality Assurance System for Public Health
Facilities
▻ Supported by the Quality Improvement Division of National Health
Systems Resource Center (NHSRC), New Delhi
▻ Requires coordination between immunization team and quality assurance
team at state and district level

3. 2012
WHO recommends
QMS after NRA assessment
2014
Constitution of NQAC in collaboration
with QI, NHSRC
2016
National AEFI
Secretariat assessed and certified
against NQAS
2020
Initiation of QMS activities in selected
states, budgetary norms for QMS has
been approved and disseminate
2023-24
Evolution of National Quality Assurance Standards for AEFI
surveillance
Roll out of the QMS in the States, budget included in
the PIP, trainings and internal assessment started at
state, district and PHC/session site levels

4. 01
02
03
04
Areas of
Concern
Standard
Measurable
Elements Score card
(Session Site, District,
State and National)
Measurable
Elements
Standard
8 40
54
Framework
4

5. Relationship Between Different
Components
5
Measurable
Element
Standard
Area of Concern Notification &
Reporting
Notification
Who is
identified
How the
case notified
Reporting
Weekly/
HMIS/ AEFI
register

6. NQAS for AEFI Surveillance checklists
▰ National level checklist
▰ State level checklist
▰ District level checklist
▰ Immunization site level checklist
6

7. Areas of Concern
7
S. No Area of Concern Immunization site District State National
A Notification & Reporting Y Y Y Y
B Investigation Y Y Y Y
C Causality Assessment NA NA Y Y
D Operational Management Y Y Y Y
E Communication Y Y Y Y
F Convergence Y Y Y Y
G Monitoring & Feedback NA Y Y Y
H Quality Management System Y Y Y Y

8. Area of concern in NQAS and QMS for AEFI Surveillance
8
S. No Areas of concern in NQAS for
public health facilities
Areas of concern in AEFI
Surveillance
A Service Provision Notification and Reporting
B Patient rights Investigation
C Inputs Causality Assessment
D Support services Operational Management
E Clinical services Communication
F Infection control Convergence
G Quality Management Monitoring and Feedback
H Outcome Quality Management System
To assess the quality system under NQAS and AEFI surveillance are broadly categorized into measurable themes known as
“Area of Concerns”. The areas of concern in NQAS for public health facilities and QMS in AEFI surveillance are
different, as can be seen from the table below:

9. Assessment protocol
9
OBSERVATION
(OB)
STAFF INTERVIEW
(SI)
RECORD REVIEW
(RR)
PARENT INTERVIEW
(PI)

10. Scoring Rules
10
▰ 2 marks for full compliance
▰ 1 mark for partial compliance
▰ 0 Marks for Non Compliances

11. Sample checklist
11
01
02
03
04

12. Score card
12
National Quality Assurance Standards for AEFI Surveillance Programme
Checklist for Immunization Sites
Assessment Summary
Name of the Immunization sites: PHC PALANA Date of Assessment:14/04/2023
Names of Assessors: Dr.Ravit Patel Names of Assesses: K N Pateliya
Type of Assessment: Internal Action plan Submission Date : 15/04/2023
Immunization Sites Score Card
Area of Concern wise Score Total Score
A Notification & Reporting 91%
72%
B Investigation 100%
D Operational Management 77%
E Communication 40%
F Convergence 0%
H Quality Management System 62%

13. Eligibility criteria for PHC/ Session site level assessment
13
Internal Assessment
Internal assessment should be
done quarterly by Medical
Officer of the PHC.
PHC becomes eligible for peer
assessment if 50% of the sub
centre score at least 70% in the
internal assessment.
Peer Assessment
Peer assessment of a PHC/Sub-
Center will be conducted by the
Medical Officer of another PHC of
the same district.
Peer assessment will be done for
the PHC and for those sub-
centres under the PHC which
have scored at least 70% in
internal assessment.
External Assessment
NA

14. Eligibility criteria for District level assessment
14
Internal Assessment
DIO/District Quality Assessment
Team will conduct internal
assessment for district level.
District will be eligible for peer
assessment when the district
level achieves at least 70% score
in internal assessment and 50%
of district PHCs score at least
70% in internal assessment.
Peer Assessment
Peer assessment of the district
will be done by District
Immunization Officer/District
Quality Assurance Team of
another district.
Peer assessor will validate
internal assessment scores of
district level and also validate
two PHCs and one sub centre in
each of the two PHCs scoring at
least 70%.
External Assessment
External Assessment will be
done for the district, if the
district scores at least 70%
during peer assessment and
50% of PHCs score at least
70% during peer assessment.
External assessment will be
done by certified external
assessors from NHSRC,
MoHFW.

15. Eligibility criteria for State level assessment
15
Internal Assessment
State Immunization Officer or
State Quality Assurance cell
will conduct the internal
assessment of state.
If state achieves at least 70%
score in internal assessment
and 50% of the districts in the
state will get 70% score in peer
assessment then the State will
be eligible for peer
assessment.
Peer Assessment
Peer assessment of the state
will be done by State
Immunization Officer/State
Quality Assurance Team of
another state/AEFI Secretariat.
External Assessment
State will be eligible for
external assessment if the
state level scores at least 70%
during peer assessment and
50% districts of the state
scores at least 70% during peer
assessment.
External assessment will be
done by external assessors
certified by NHSRC MOHFW.

16. Responsibility of PHC/District/State level officers
16
Responsibility of Medical Officer/ District
Immunization Officer/District Quality Team
1. Medical officer will review
checklists and gap action plans
following quarterly internal
assessment of the sub-centre and
ensure implementation of action
plans for gap closure.
2. Medical officer, PHC will share
internal assessment scores and gap
improvement plans of the PHC and
the sub-centre immunization sites to
the District Immunization Officer for
each quarter.
3. Peer assessment scores of PHC
and sub-centre immunization sites
will be shared by the assessor with
the district.
Responsibility of District Immunization
Officer/District Quality Team
1. District Immunization
Officer/District Quality Team will
conduct an internal assessment for
district level and collate and verify
scores of internal and peer
assessment of PHCs.
2. Plans for peer assessment of
PHCs/sub-centre will be prepared and
implemented by District Immunization
Officer.
3. Peer assessor from another district
will share the assessment report to
the state with a copy to the District
Immunization Officer of the assessed
district.
Responsibility of State Immunization
Officer/State Quality Team
1. State Immunization Officer/State
Quality Assurance cell will collate
and verify district-level internal and
peer assessment scores of all
districts.
2. State Immunization Officer/State
Quality Assurance Cell will plan and
coordinate peer assessment of a
district by another district.

17. Process of QMS for AEFI Surveillance
▰ At the PHC level or session site levels, the focus of the checklists to assess awareness of reporting
criteria of AEFIs, documentation of AEFI Cases, awareness of safety aspects in session sites, and
communication-related to vaccine safety to beneficiaries, feedback from beneficiaries, and support to be
provided during investigations.
▰ At the district levels, the focus is mainly on processes and documentation related to AEFI surveillance at
the DIO’s office, data entry and uploading AEFI case records and reports in SAFE-VAC, conducting
meetings of the District AEFI Committee, coordination and convergence with other stakeholders such as
district hospitals, private hospitals, nursing homes, and practitioners, drug inspectors and faculty from the
medical college, if any, and conducting AEFI investigations.
▰ At the state level, the documentation of cases, reviewing of AEFI surveillance, conducting causality
assessments by state, AEFI committee meetings, coordination with the State Drug Controller, medical
colleges, private sector, etc.

18. Approved budgetary norms and assessment criteria
▰ A budget head created for QMS for AEFI surveillance
activities under UIP.
▰ Budgetary norms for each activity in state and district PIPs
▰ Implementation at state, district, session sites (PHC, sub
centres) simultaneously
▰ Roles of immunization programme managers and quality
assurance officers defined at each levels
▰ Roles of specific health cadres (SEPIOs, DIOs, MOs, and
ANMs) specified

19. Steps for Assessment and Certification
Internal
Assessment
• Assessment is done using a checklist by a team of the same facility
Peer
Assessment
• Assessment is done by a team from another facility of the same level
after the facility/level achieves the necessary scores in the internal
assessment
External
Assessment
• Done by trained experts empanelled by QI Division of NHSRC for state

20. Implementing guidebook of QMS for AEFI
Surveillance in States and Districts
▰ This document has been prepared to help
the state and district immunization
Programme officers to initiate QMS
processes rapidly in the state and
districts to attain certification as per
NQAS for AEFI surveillance processes.
20

21. Implementation Status of Quality
Management System- QMS
21
*Provisional data as of May 2023
RAJ AS THAN
LADAKH
OD ISHA
GU JAR AT
MAHARAS HTRA
MADHY A P RADE SH
BIHAR
KAR NATAKA
UTTAR P RADES H
AS SAM
TAMI L NAD U
TE LAN GANA
AND HRA PRADE SH
PUNJ AB
JHARKHAND
WE ST BE NG AL
ARU NAC HAL P R.
HAR YANA
KERALA
JAM MU & KASH MIR
HIMACHAL P RAD ES H
MANIP UR
MIZO RAM
SIKK IM
A&N ISLANDS
D&N HAV ELI
CHHATTIS G AR H
UTTARAKHAND
ME GH ALAYA
NAG ALAN D
TRI PURA
GO A
DELHI
CHANDIG ARH
DAM AN & DIU
PO NDIC HERR Y
LAKS HADW EE P
State/UT selected for 1st
Phase (FY-2021-22)
State/Ut selected for 2nd
Phase (FY-2022-23)
State/Ut selected for 3rd
Phase (FY-2023-24)
Phase-1 Phase-2 Phase-3
ASSAM A&N ISLANDS
ANDHRA
PRADESH
BIHAR CHHATTISGARH
ARUNACHAL
PRADESH
CHANDIGARH DAMAN & DIU
JAMMU &
KASHMIR
GOA D&N HAVELI JHARKHAND
GUJARAT DELHI LADAKH
HARYANA LAKSHADWEEP MADHYA PRADESH
HIMACHAL
PRADESH
MANIPUR MAHARASHTRA
KARNATAKA MIZORAM PUNJAB
KERALA NAGALAND RAJASTHAN
MEGHALAYA PUDUCHERRY UTTAR PRADESH
ODISHA SIKKIM UTTARAKHAND
TELANGANA TAMIL NADU
WEST BENGAL TRIPURA

22. Thank you