VPD Surveillance Guidelines - Punjab

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The document provides guidelines for strengthening vaccine preventable disease surveillance in Punjab province. It was developed by the WHO Punjab EPI team to standardize VPD surveillance across districts.

The guidelines aim to provide WHO-recommended standards for conducting surveillance of vaccine-preventable diseases to help understand disease burden, epidemiology, and inform vaccine policy and strategy in Punjab.

The guidelines provide a set of standards for establishing and improving existing VPD surveillance at district levels, including for epidemiology, disease control objectives, public health intervention, and support from WHO.

Reviewed & Cleared

16-02-21

A GUIDE FOR STRENGTHENING


VACCINE PREVENTABLE DISEASES
(VPDs) SURVEILLANCE

JUNE, 2020
2nd Edition

PROVINCIAL EPI
DIRECTORATE GENERAL HEALTH SERVICES, PUNJAB, LAHORE.

Tel: 042-99201143 & 99204397 Fax: 042-99200405 email: [email protected]

1
CONTRIBUTORS
DEVELOPED BY
• Dr. Muhammad Mazhar Qureshi National Professional Officer EPI
WHO Punjab, Lahore.
• Dr. Muhammad Imran Qureshi Technical Officer EPI
WHO Punjab, Lahore.

REVIEWED BY
• Dr. ASM Amjad Hossain Consultant VPD Surveillance
WHO Punjab, Lahore.
• Dr. Naeem Majeed Technical Focal Person (RI), EPI Punjab

PATRONIZED BY
• Dr. Muhammad Haroon Jehangir Khan Director General Health Services,
Govt. of the Punjab, Lahore.
• Dr. Muhammad Saeed Akhtar Director Health Services EPI,
Govt. of the Punjab, Lahore.
• Dr. Bashir Ahmed Director Health Services EPI,
Govt. of the Punjab, Lahore.

SUPPORTED BY
• Dr. Osama Mere Medical Officer EPI,
WHO Country Office, Islamabad.
• Dr. Jamshaid Ahmed Head, WHO Sub-Office,
Punjab, Lahore.

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ACKNOWLEDGMENT

We are thankful to Dr. Osama Mere, MO (EPI), WHO country office; Pakistan who assigned
the WHO-Punjab EPI team to develop VPD surveillance guidelines including community-based
surveillance. Dr. Jamshaid Ahmed, Head WHO Sub-Office Punjab extended commendable support
during the development of guidelines. We recognize the support of the WHO HQ team, who
developed revised guidelines in 2018 and made it public to adopt and use in the country context.

We also pay thanks to Dr. Muhammad Mazhar Qureshi, National Professional Officer EPI,
WHO Punjab, Lahore, and Dr. Muhammad Imran Qureshi, Technical Officer EPI, WHO Punjab,
Lahore, who exerted their full efforts for the development of VPD Surveillance guidelines in the local
context.

We are highly obliged to Dr. Muhammad Haroon Jehangir Khan, Director General Health
Services, Punjab for his guidance and support in the development and modification of VPD
surveillance guidelines in the local context for implementation in the field. It is also encouraging for
field workers to allow them to get benefit from these guidelines.

We are also thankful to the Provincial Expanded Program on Immunization (EPI), Directorate
General Health Services, Government of the Punjab, Primary & Secondary Healthcare Department,
Lahore to allow and use these guidelines by the District Health Authorities. Many officers gave
generously of their time in the review. Dr. Shakeel Ahmed Gondal, Additional Director EPI, and
Dr. Azhar Iqbal Medical Officer EPI played a vital role in the review and suggested many updates.
Particular appreciation is noted for Mr. Muhammad Sajid & Mr. Abaid ur Rehman, who supported
the review sessions.

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PREFACE 2nd Edition
The purpose of this document is to provide the World Health Organization (WHO)-recommended
standards for conducting surveillance for vaccine-preventable diseases (VPDs). VPD surveillance
provides vital information to help the province understand disease burden and epidemiology to inform
vaccine policy and strategy. This document is intended to provide a set of standards that districts should
consider in establishing and improving existing VPD surveillance. Districts will use these standards
for local epidemiology, disease control objectives and strategies. While the primary audiences of this
document are mid-level-managers, it is important to recognize that standardized global surveillance
data are useful for developing global vaccination policy.
The guidelines presented here are intended for use by the surveillance persons, providing important
information for public health intervention at the district, provincial, and national levels, with support
from WHO and in collaboration with the Ministry of National Health Services Regulations and
Coordination (MoNHSRC), Government of Pakistan. VPD Surveillance and Response System is
established at EPI Cell Punjab under the guidance of Director General Health Services, Punjab and
under the supervision of Secretary Primary & Secondary Healthcare Government of Punjab. The
purpose of surveillance is to empower decision-makers to lead and manage more effectively by
providing timely, useful evidence and these guidelines will enable district surveillance officers to carry
on surveillance tasks as per the expectations and need.
The purpose of these guidelines is to identify, manage, and prevent outbreaks of vaccine-preventable
diseases. They will assist in the investigation and management of outbreaks and are designed to guide
investigations from the time a report is received, through the initial investigation to the control and
clean-up phases. This will help to achieve MR elimination targets in the province. The Guidelines also
identify educational opportunities.

(Dr. Bashir Ahmed)


Director Health Services EPI,
Directorate General Health Services, Punjab, Lahore.
Date: June 10th, 2020.

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PREFACE 1st Edition

Disease Surveillance is an important tool for monitoring disease incidence and measuring control
measures. Expanded Program on Immunization (EPI) provides vaccination against 10 deadly
diseases. Surveillance of vaccine-preventable diseases (VPDs) had been an important component
of EPI since its start. Initially, aggregate surveillance had been started. Measles is one of the leading
causes of childhood morbidity and mortality among vaccine-preventable diseases in the globe as
well as in Pakistan. Even today, one in 7 children still remain without protection against measles.
According to the PDHS 20017-18, only 85.4% of children aged 12 – 23 months received a valid
dose of measles vaccine.

Pakistan endorsed the measles mortality reduction goal set at the UN special session on Children
in May 2002 and World health assembly in 2003. We are committed to achieve 95% coverage
among children with measles vaccine by the end of 2020 and achieve measles elimination status
by the same period following a joint WHO-UNICEF strategy.

As a part of the ongoing strategy to achieve, the goal for the measles elimination Government of
Pakistan through the EPI program has successfully conducted a nationwide Measles Catch-up
Campaign in 2007 – 2008. This was the largest ever childhood immunization campaign in the
globe targeting approximately 65 million children and achieving more than 95% coverage.

After achieving a satisfactory level of population immunity among the susceptible through this
campaign, it had expected that the disease burden will significantly reduce which is already being
observed by the experts. In the year 2008, a strong case-based surveillance system was established
in the country. Standard guidelines for case-based measles surveillance were prepared and printed
in 2008. In spite of that, the country faced a number of epidemics afterward. In the year 2013, the
country faced a major epidemic where almost 25000 children suffered from measles only in
Punjab. The surveillance system failed to predict the epidemic. Two mass immunization campaigns
were conducted against measles in 2013 and early 2015 in Punjab. The number of measles cases
reduced significantly. EPI Punjab team considered it seriously that the system failed to predict the
2013 measles epidemic. So, the system was revitalized, a number of training were conducted and
a series of review meetings brought the surveillance at a satisfactory level.

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In the year 2015, case-based surveillance was started under the EPI Punjab umbrella for four
diseases i.e. measles, diphtheria, pertussis, and neonatal tetanus. AFP surveillance under the PEI
program has already been established in Punjab. The strong VPD surveillance system was able to
predict an increased number of outbreaks in the province. EPI Punjab with support from WHO
conducted a measles risk assessment for the districts in 2017. At that time one-fourth of the districts
were at high risk.

WHO HQ updated the VPD surveillance guidelines in 2018. It was mandatory to introduce the
VPD surveillance system in the province according to new guidelines. EPI Punjab with technical
support of WHO has adopted new VPD surveillance guidelines in the local context and standard
guidelines for the province have been developed. This booklet will help District Surveillance
Coordinators (DSCs) as a pocket guide. Surveillance of Adverse Events Following Immunization
(AEFI) is also added which was not in the previous guidelines. Another component, which adds
quality to this document is a small paragraph on community-based surveillance (CBS).

I am sure this guideline will help us to set a standard surveillance system and investigation
procedure for VPD cases and outbreaks and will contribute a lot in our measles elimination efforts.

I sincerely hope that our health managers and other concerned disease control personnel will read
this manual and it will help them to undertake their duties more efficiently and adequately.

Finally, I wish to offer my sincere thanks to everybody concerned, who are engaged in saving the
children from the menace of measles and other vaccine-preventable diseases.

(Dr. Muhammad Saeed Akhtar Ghuman)


Director Health Services EPI,
Directorate General Health Services, Punjab, Lahore.
Date: November 25th, 2019.

6
CONTENTS

CONTRIBUTORS .................................................................................................................................................... 2
ACKNOWLEDGMENT ............................................................................................................................................ 3
PREFACE 2nd Edition ............................................................................................................................................. 4
PREFACE 1st Edition ............................................................................................................................................. 5
Abbreviations and acronyms ............................................................................................................................. 10
Chapter 1: Introduction & Purpose of the Field Guide ...................................................................................... 11
1.1. Objectives................................................................................................................................................ 11
1.2 Target Audience ....................................................................................................................................... 11
1.3 Applicability of the principles for other disease surveillance .................................................................. 12
Chapter 2: Overview of VPD Surveillance .......................................................................................................... 12
2.1 VPD Surveillance ...................................................................................................................................... 12
2.2. VPD Surveillance Objectives ................................................................................................................... 12
2.3 Definitions of control, elimination, and eradication: ............................................................................... 14
CHATER 3: VPD surveillance design characteristics ........................................................................................... 15
3.1 Criteria for prioritization of communicable disease surveillance: ........................................................... 18
3.2 Key Components of a Surveillance System .............................................................................................. 19
CHAPTER 4: Case-Based surveillance of priority diseases ................................................................................. 20
4.2 Measles/ Rubella Surveillance ................................................................................................................. 21
4.2.1 Disease and vaccine characteristics .................................................................................................. 21
4.2.2 Case Detection, Suspected case definition: ...................................................................................... 21
4.2.3 Case investigation: ............................................................................................................................ 21
4.2.4 Sample collection and Lab testing: ................................................................................................... 21
4.2.5. Final case classification .................................................................................................................... 22
4.2.6 Data collection and case reporting: .................................................................................................. 25
4.2.7 Measles/ Rubella surveillance indicators:......................................................................................... 25
4.3 Diphtheria Surveillance ............................................................................................................................ 27
4.3.1 Diphtheria Disease and vaccination: ................................................................................................. 27
4.3.2 Case Detection, Suspected case definition: ...................................................................................... 28
4.3.3 Case investigation: ............................................................................................................................ 28
4.3.4 Sample collection and Lab testing: ................................................................................................... 28
4.3.5 Final Case Classification: ................................................................................................................... 28
4.3.6 Data collection and case reporting: .................................................................................................. 29
4.3.7 Diphtheria surveillance indicators: ................................................................................................... 29
4.4 Neonatal Tetanus ..................................................................................................................................... 31
4.4.1 Disease and vaccination characteristics............................................................................................ 31
7
4.4.2 Case Detection, Suspected case definition ....................................................................................... 31
4.4.3 Case investigation ............................................................................................................................. 31
4.4.4 Sample collection and Lab testing .................................................................................................... 31
4.4.5 Final case classification ..................................................................................................................... 31
4.4.6 Data collection and case reporting: .................................................................................................. 32
4.4.7 Public Health response ..................................................................................................................... 32
4.4.8 Neonatal tetanus indicators.............................................................................................................. 32
4.5 Pertussis Surveillance............................................................................................................................... 33
4.5.1 Disease and vaccination characteristics............................................................................................ 33
4.5.2 Case Detection, Suspected case definition: ...................................................................................... 34
4.5.3 Case investigation ............................................................................................................................. 34
4.5.4 Sample collection and Lab testing .................................................................................................... 34
4.5.5 Final case classification: .................................................................................................................... 35
4.5.6 Data collection and case reporting: .................................................................................................. 35
4.5.7 Pertussis surveillance indicators ....................................................................................................... 36
CHAPTER 5: Case reporting, analysis, action, and feedback .............................................................................. 38
5.1 VPD Surveillance Reporting Channel & Schedule .................................................................................... 38
5.2 Data analysis and interpretation.............................................................................................................. 39
5.2.1 Determining patterns ........................................................................................................................ 39
5.3 Taking action on surveillance reports and data analysis: ........................................................................ 43
5.3.1 Immunization response .................................................................................................................... 44
5.3.2 Outbreak response............................................................................................................................ 44
5.4 Case Response for VPDs ........................................................................................................................... 48
5.5 Feedback .................................................................................................................................................. 49
5.5.1 To reporting sites .............................................................................................................................. 49
5.5.2 To the community: ............................................................................................................................ 49
5.5.3 Calculating vaccine effectiveness:..................................................................................................... 49
CHAPTER 6: Setting up and monitoring surveillance ......................................................................................... 53
6.1 Setting up passive surveillance ................................................................................................................ 53
6.2 Setting up sentinel surveillance ............................................................................................................... 53
6.3 Setting up active surveillance .................................................................................................................. 54
6.3.1 Identify surveillance officers (District surveillance coordinator) ...................................................... 54
6.3.2 Seek the cooperation of health facilities .......................................................................................... 54
6.3.3 Frequency of active surveillance visits .............................................................................................. 55
6.3.4 Content of an active surveillance visit .............................................................................................. 55
6.4 Collecting information for a surveillance system: ................................................................................... 56
6.5 Monitoring surveillance quality ............................................................................................................... 57
8
6.5.1 Performance indicators ..................................................................................................................... 57
6.6 Case Confirmation .................................................................................................................................... 57
6.6.1 Methods ............................................................................................................................................ 57
6.6.2 Epidemiological associations ............................................................................................................ 58
6.6.3 Laboratory confirmation ................................................................................................................... 58
CHAPTER 7: Adverse Events Following Immunization (AEFI) ............................................................................. 60
7.1 Definition of AEFI ..................................................................................................................................... 60
7.2 Cause-specific categorization of AEFI (CIOMS /WHO 2012) .................................................................... 60
7.3 Steps for Establishing Immunization Safety Surveillance System ............................................................ 63
7.4 Reportable AEFIs: ..................................................................................................................................... 63
7.5 Reporting Steps: ....................................................................................................................................... 64
7.6 Reporting Timeline: .................................................................................................................................. 65
7.7 Roles and Responsibilities in immunization safety Surveillance:............................................................. 65
7.8 Action and follow-up to AEFI ................................................................................................................... 65
7.8.1 Patient care ....................................................................................................................................... 65
7.8.2 Management of suspected anaphylaxis or collapse ......................................................................... 66
7.8.3 Follow-up actions .............................................................................................................................. 66
7.9 Communication ........................................................................................................................................ 68
CHAPTER 8: Community Based Surveillance (CBS) ............................................................................................ 70
8.1 Definition of Community-based Surveillance .......................................................................................... 70
Objectives of Community Based Surveillance.................................................................................................... 70
8.2 Integrated Disease Surveillance ............................................................................................................... 71
8.3 Priority diseases for CBS........................................................................................................................... 71
8.4 Case definition of priority diseases for community-based surveillance: ................................................. 71
8.5 Steps for establishing Community-Based Surveillance ...................................................................... 72
8.6 Sources of information for community-based surveillance..................................................................... 73
8.7 Training package for community surveillance Informants (CSI) .............................................................. 74
8.7.1 Objectives of the Training ................................................................................................................. 74
8.7.2 Training Modules .............................................................................................................................. 74
Annexures: ..................................................................................................................................................... 75

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Abbreviations and acronyms
AFP Acute flaccid paralysis
AC Assistant Commissioner
ADC Additional Deputy Commissioner
AEFI Adverse event following immunization
BMGF The Bill and Melinda Gates Foundation
bOPV Bivalent oral polio vaccine
CDC The U.S. Centers for Disease Control and Prevention
CHW Community health worker
DC Deputy Commissioner
DHO District Health Officer
DPCR District Polio Control Room
DPEC District Polio Eradication Committee
DSRC District Surveillance Review Committee
EOC Emergency Operations Centre
EPI Expanded Programme on Immunization
ERC Expert Review Committee
FGD Focus group discussions
GPEI Global Polio Eradication Initiative
HR&MP High-risk and mobile population
IEC Information, Education, and Communication
IDIMS Integrated Disease Information Management System
IHR International Health Regulations
IPV Inactivated polio vaccine
ITD Intratypic differentiation
KAP Knowledge, Attitudes, and Practices
LQAS Lot quality assurance sampling
M/o NHSR&C Ministry of National Health Services, Regulations & Coordination
mOPV Monovalent oral polio vaccine
NEAP National Emergency Action Plan for Polio Eradication
NEOC National Emergency Operations Centre
NID National Immunization Days
NIH National Institute of Health
NPAFP Non-polio acute flaccid paralysis
NPEV Non-polio enterovirus
NSC National Steering Committee
OPV Oral polio vaccine
PCM Post-campaign monitoring
PEI Polio Eradication Initiative
PEOC Provincial Emergency Operations Centre
RRL Regional Reference Laboratory
RRU Rapid Response Unit
SIA Supplementary immunization activities
SOPs Standard operating procedures
tOPV Trivalent oral polio vaccine
UC Union Council
UCMO Union Council Medical Officer
UNICEF United Nations Children’s Fund
UPEC Union Council Polio Eradication Committee
VDPV Vaccine-derived poliovirus
VPD Vaccine-preventable disease
WASH Water, sanitation and hygiene
WHO World Health Organization
WPV Wild poliovirus

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Chapter 1: Introduction & Purpose of the Field Guide
1.1. Objectives
Public health surveillance is the continuous and systematic collection, analysis, and
interpretation of health-related data needed for the planning, implementation, and evaluation of public
health practice1. Surveillance for VPDs is qualitatively like other types of disease surveillance in
design2. VPD surveillance is vitally important for its potential to inform policy decisions and monitor
immunization programmes, including vaccine introduction, coverage, and potential use for outbreak
response. The information in this Field Guide forms the technical basis for the establishment of
surveillance activities within districts and provinces to meet immunization programme objectives. The
Guide may be used for basic in-service training, field supervision, and monitoring of surveillance
performance.

In keeping with the global targets for control, elimination, and eradication of EPI targeted
conditions, the Field Guide contains detailed steps to establish and monitor surveillance for Measles,
Diphtheria, Pertussis, and Neonatal Tetanus (NNT). The section on Adverse Events Following
Immunisation (AEFI) is relevant and applicable to all vaccines used in the EPI programme.
Surveillance for AEFI is for monitoring immunization safety and contributes to the credibility of the
programme. Even though surveillance for the other EPI diseases is not included in this Guide, the
principles of surveillance discussed in the Guide are relevant and applicable to them.

After studying this Field Guide, readers will know:


1. The national EPI goals, objectives, and targets of Pakistan
2. EPI Pakistan disease control strategies;
3. The definition and purpose of surveillance of vaccine-preventable diseases (VPDs) and
actions to be taken in response.
And be able to:
1. Detect, report and investigate conditions targeted for EPI surveillance: Measles/rubella,
diphtheria, pertussis and neonatal tetanus (NNT)
2. Collect and send blood (and throat swab where indicated) specimens from a suspected
measles case (fever with rash)
3. Collect and send throat swab specimens from a suspected diphtheria and pertussis case
4. Analyze and interpret data on communicable disease patterns and trends
5. Take appropriate action in response to a case or outbreak
6. Monitor surveillance indicators
7. Review and take corrective measures to improve the surveillance system
8. Provide feedback to all stakeholders
9. Compile and submit weekly reports to the next level
1.2 Target Audience
This Field Guide is primarily intended for all healthcare workers involved in EPI targeted
conditions and VPD surveillance, including Medical Officer at the health facility level; DDHOs,
DSV/ASV; District Surveillance Coordinator (DSC), and District Health Officer. However, all health
professionals involved in the delivery of immunization services will benefit from this Guide. The
Office of Program Manager EPI should ensure that the guideline on and used by all relevant officials
at all levels within a province.

1
World Health Organization. WHO health topics: public health surveillance. Geneva: World Health Organization; 2014
(http://www.who.int/topics/public_health_surveillance/en/).
2 Gregg MB. Field epidemiology. Oxford, New York: Oxford University Press; 2008.
11
1.3 Applicability of the principles for other disease surveillance
The principles and steps of a fully functional surveillance system can also be applied to control
any of the communicable conditions and other non-communicable conditions in addition to the EPI
program.

Chapter 2: Overview of VPD Surveillance


2.1 VPD Surveillance
Public health surveillance is the continuous and systematic collection, analysis, and interpretation of health-
related data needed for the planning, implementation, and evaluation of public health practice3.

2.2. VPD Surveillance Objectives

Table 1: VPD surveillance objectives, key characteristics, example


Surveillance Objectives Key Characteristics Example
Monitoring disease Detection of all cases; risk Polio eradication; measles and
elimination or eradication factors; molecular neonatal tetanus (NT) elimination
efforts epidemiology
Detection of outbreaks and Clusters of VPD; unusual or Diphtheria outbreaks; pandemic or
rare strain identification highly virulent influenza virus
new pathogens
Evidence for new vaccine VPD epidemiology; trends; Pneumococcal, rotavirus disease
burden for vaccine introduction
introduction or optimizing disease burden
decisions; changing schedules for
vaccine schedules tetanus or pertussis vaccine

Evaluation of immunization Characterize gaps in The vaccination history of measles


immunization programme and cases can help identify geographic
programme performance
epidemiologic patterns of areas and age groups with low
and defining the need for cases (for example, age,
vaccination coverage to inform
geographic location)
supplementary immunization targeting of future measles vaccine
campaigns
Vaccine effectiveness, Trends in VPD case counts Test-negative case-control studies of
impact on disease burden, or pre- and post-vaccine vaccine effectiveness
both introduction
Changes in disease strains or Molecular or serologic Seasonal influenza vaccine
formulation; pneumococcal serotype
types characterization of cases
replacement after pneumococcal
conjugate vaccine (PCV)
introduction

3
World Health Organization. WHO health topics: public health surveillance. Geneva: World Health Organization; 2014
(http://www.who.int/topics/public_health_surveillance/en/).
12
The type of surveillance for a specific vaccine-preventable disease depends on the attributes of the disease and
the objectives of the disease control programme ––control, elimination, or eradication (see section 2.3). Some
diseases have more than one disease control objective, according to national and regional goals.

13
Table 2: Purpose of surveillance of selected vaccine-preventable diseases:
Surveillance activity

Provide evidence
Disease Monitor
Vaccine-preventable Find all cases on disease
control trends, predict Identify
burden,
and detect circulating
disease* or chains of epidemiology of
Objective outbreaks and
disease and strains
transmission identify at risk
impact of
populations
immunization

Tuberculosis Control X

Diphtheria Control X

Haemophilus X X
Influenzae Type-b
(Hib)

Hepatitis-B Control X X

Measles Elimination X X

Neonatal Tetanus Elimination X

Pertussis Control X

Pneumococcal Control X X
Disease

Poliomyelitis Eradication X X

Rotavirus Control X

2.3 Definitions of control, elimination, and eradication:


Control:
Reduction of disease incidence, prevalence, morbidity or mortality to a level that is acceptable as a result of
deliberate efforts, but still requires continued efforts to maintain the reduction e.g. Diphtheria, Pertussis

Elimination:
Reduction to zero incidence of a specified disease in a defined geographical area as a result of deliberate efforts,
but still requires continuous intervention efforts e.g. Measles and maternal & neonatal tetanus elimination

Eradication:
Reduction to zero of the worldwide incidence of infection caused by a specific agent, the complete interruption
of transmission, and the extinction of the causative agent so that it no longer exists in the environment;
intervention measures are no longer needed e.g. Smallpox

14
CHATER 3: VPD surveillance design characteristics4

Once the objectives of surveillance are set, it is necessary to create a surveillance system design that meets the
objectives. Consider the following questions to inform the system design:
➢ Is it necessary to capture all of the cases, or is some subset or fraction acceptable? VPDs that have
elimination or eradication goals will require a system that can capture all cases.
➢ What level of detailed case information is necessary to inform public health action?
➢ Do adequate resources exist to pursue detailed information for every case, or could greater efficiency
be achieved through focused surveillance in high-yield scenarios or integration with other surveillance
systems?
Consider the characteristics below during the surveillance design process. These may be dependent on the
existing public health system and infrastructure within a country. Although these characteristics are presented
below as either/or, many surveillance systems contain a mixture of elements. For example, a system may have
both passive and active elements or be both facility and community-based.

AGGREGATE VS. CASE-BASED In aggregate surveillance, only a tally of the number of cases is collected
and reported from clinic admission registers, logbooks or other records. No individual-level data is collected,
but cases may be aggregated by subgroups such as age, sex or locality. In contrast, case-based surveillance
requires the collection and reporting of detailed information on each case of a VPD. Examples of such details
include age, sex, residence, vaccination status and risk factors. Individual-level data from case-based
surveillance may sometimes be aggregated into summary reports.

NATIONWIDE VS. SUBNATIONAL VPD surveillance can be nationwide or intentionally limited to a defined
part of the country. Subnational surveillance might be considered if the VPD burden is confined to a certain
region of the country, or if there is greater capacity to conduct high-quality surveillance in a particular
geographic area. However, the cases captured through subnational surveillance might not be representative of
those occurring throughout the entire country. When interpreting subnational surveillance data, always consider
whether the surveillance population is representative of the larger population. For VPDs with control goals,
subnational surveillance may be acceptable for determining risk factors or evaluating the impact of a vaccine.
For VPDs targeted for elimination or eradication, nationwide surveillance that strives to detect all cases is
essential.

POPULATION-BASED VS. SENTINEL-SITE Population-based surveillance attempts to capture all cases in


a well-defined catchment population (for example, the entire population of a country). When the catchment
population is defined, you can use the total population number as the denominator to calculate VPD incidence.
This makes it possible to understand the impact of a vaccine on disease burden over time and compare VPD
incidence across countries or regions. Sentinel-site surveillance refers to a system that captures cases at one or
more specialized sites, such as hospitals, clinics, or pharmacies. Sentinel surveillance can provide useful
information about the impact of the vaccine, epidemiology and risk factors, and pathogens causing disease, such
as circulating strains. Data collected in a well-designed sentinel system can also be used to signal trends, identify
outbreaks and monitor the burden of disease in a community, providing a rapid, economical alternative to other
surveillance methods. Catchment populations of sentinel sites are usually hard to define and can vary over time,
so it is difficult to know the total population (denominator) required to calculate disease incidence.

4
World Health Organization. WHO health topics: public health surveillance. Geneva: World Health Organization; 2014
(http://www.who.int/topics/public_health_surveillance/en/).
15
The following criteria should be considered in selecting a sentinel health facility:

• it should be willing to participate.


• it serves a relatively large population that has easy access to it.
• it has medical staff sufficiently specialized to diagnose, treat, and report cases of the disease under
surveillance.
• it has a high-quality diagnostic laboratory.

Table 3: Sentinel Surveillance sites and type in Punjab:


Sentinel Site GPDS IBD Rota CRS Typhoid

1) Children Hospital, Lahore ✓ ✓ ✓ ✓ ✓

2) Mayo Hospital, Lahore ✓ ✓

3) Services Hospital, Lahore ✓

4) Benazir Bhutto Hospital, Rawalpindi ✓ ✓ ✓

5) Children Hospital, Multan ✓

6) Nishtar Hospital, Multan ✓ ✓

7) Allied Hospital, Faisalabad ✓

FACILITY-BASED VS. COMMUNITY-BASED Facility-based surveillance usually detects more severe cases
seeking care at health facilities, including outpatient clinics, doctors’ offices, hospitals, and emergency
departments. Access to clinical diagnosis and laboratory confirmation generally make facility-based
surveillance easier to conduct than community-based surveillance. Often conducted in conjunction with facility-
based surveillance, community-based surveillance can potentially detect less severe VPD illness or diseases not
normally captured at health facilities because they are considered a normal part of childhood (such as measles)
or have an associated stigma (such as death from neonatal tetanus). For polio eradication, a community-based
surveillance strategy is critical in order to detect all cases, regardless of severity, and break chains of
transmission. For community-based surveillance, additional resources are required to sensitize and follow up
with community informants, and the yield of true cases can be low.

ACTIVE VS. PASSIVE: Passive case detection means that health facility staff detect and report cases, while
active surveillance means that designated public health surveillance staff are directly involved in detecting cases.
For example, surveillance staff may do a regular review of facility registers and have regular contact with
clinicians regarding potentially missed cases. Compared to passive methods, active surveillance is more
resource-intensive and expensive; it is often used for VPDs in the elimination or eradication phase, or to
characterize VPD epidemiology or vaccine impact in discrete populations or sentinel sites.

16
A passive surveillance system relies on the cooperation of health-care providers— laboratories, hospitals, health
facilities, and private practitioners—to report the occurrence of a vaccine-preventable disease to a higher
administrative level. Once the data have been received, they must be compiled and then analyzed to monitor
disease patterns and identify possible outbreaks. Passive surveillance involves the regular collection and
reporting of surveillance data and is the commonest method used to detect vaccine-preventable diseases. In our
country with a passive surveillance system, every health facility is required to send a weekly report of all cases
of the vaccine-preventable disease on a standard form (form-B). Even if no case is detected in a facility, still a
‘Zero Report’ needs to be submitted.
Active surveillance is more difficult to set up and expensive to conduct. It does not replace passive surveillance
but complements it. If conducted regularly it has the following advantages:

• helps to improve the timeliness and accuracy of case detection and reporting.
• enables rapid case investigation, including taking laboratory specimens.
• is closely linked to the laboratory system through individual case identification.
• enables timely action to be taken in response to the detected case.
Presently, only AFP surveillance is being conducted with active surveillance. WHO and government staff visits
hospitals and clinics periodically and search for any missed AFP case. However, measles and NNT cases are
also to be included in active surveillance.

Active case search; The term ‘active search’ is used to describe searches for cases in the community. In active
search, health staffs usually go door-to-door asking about cases of the disease in question. Active search may
also be conducted where an outbreak is ongoing (such as commercial centers, working areas, schools,
universities etc.). This is a very resource-intensive way of finding cases, requiring many people and large
amounts of money, and is used only in certain situations, e.g. during measles outbreak to locate all cases.

CLINICAL VS. LABORATORY-BASED The distinction between these two types of surveillance is not the
involvement of a laboratory test, but rather whether case detection is initiated based on clinical diagnosis or
laboratory test results. Many surveillance systems start with a clinical definition to capture suspect cases (for
example, a syndrome like diarrhea or fever-rash), and then use laboratory tests to confirm cases. In laboratory-
based surveillance, a laboratory result confirming a VPD case is the starting point for inclusion in surveillance.
Laboratories or hospitals report these laboratory-confirmed cases to public health authorities, either as part of
national disease reporting requirements or sentinel surveillance networks. A laboratory-based surveillance
approach is best implemented when a majority of patients with specified signs and symptoms are laboratory
tested as part of existing clinical practice. Data management systems are essential for linking lab and
epidemiologic (clinic-based) data.

17
Table 4: Comparison of characteristics of major surveillance design
Design of surveillance

Nationwide
routine/passive Sentinel surveillance Active surveillance
surveillance

Population under Whole country Cases are seen and All cases attending
surveillance treated at selected health selected health
facilities facilities

Outcome Cases and deaths Incidence Cases and deaths in Cases and deaths in
measures rates Trends in the selected health facilities selected health facility
epidemiology Full case investigation
with details on each
case

Advantages Can provide accurate rates Requires limited Can represent the
and data on the burden if resources Can be whole country Directs
reporting is complete and managed easily Can eradication or
supported by reliable contribute to the basic elimination
laboratory results understanding of disease programmes. Can be
burden expanded to include
additional diseases as
required Rapid
detection of outbreaks

Disadvantages Needs extensive clinical and Cannot be used to Resource-intensive


laboratory capacity and calculate incidence rates Requires dedicated
resources Reporting is Is not representative of staff, transport,
rarely complete and timely the whole country management Heavy
Heavy demands on data demands on data
management management

3.1 Criteria for prioritization of communicable disease surveillance:

The following are criteria for prioritizing communicable disease surveillance, including VPDs:
❖ disease burden and endemicity (natural level of disease occurrence)
❖ severity and case fatality ratio
❖ epidemic potential
❖ potential for the emergence of virulence or changing pattern
of disease
❖ prevention and control, and elimination potential
❖ the social and economic impact
❖ international reporting regulations, such as International Health Regulations
❖ public perception of risk
❖ logistical feasibility (for example, syndromic surveillance already exists)

18
3.2 Key Components of a Surveillance System
An effective VPD surveillance system must have the following components in place:

• Health facility and community level surveillance officers and points of contact
• District, provincial and national level surveillance staff, managers and administrative support
• Training materials and job aides outlining reporting procedures, case definitions, and other information
• Reporting tools such as case investigation forms, reporting forms, active surveillance logs, mobile devices
and airtime
• Computer hardware and software for data entry and management (district, provincial and national level)
• Specimen collection, field processing and cold storage supplies such as ice packs and refrigerators
• Courier service to transport specimens to testing laboratory
• Laboratory testing supplies, reagents, and tools for linking test results to epidemiological data
• Transportation resources (vehicles and fuel) for supervisory staff
• Data managers and analysts (district, provincial and national level)
• Data visualization and dashboard tools
• Data dissemination plan and materials (epidemiologic reports and bulletins, workshops, etc.)
• Feedback mechanism to districts and health facilities
• Monitoring and evaluation tools to assess and improve surveillance quality

19
CHAPTER 4: Case-Based surveillance of priority diseases

4.1 Steps of Case-based surveillance


Successful VPD surveillance requires alignment with the objectives, meticulous planning, and ongoing
attention to the daily operations at each step of surveillance. Surveillance infrastructure, including the
reporting network and laboratory capacity, must first be established. Figure 3.1 illustrates the 8 steps of VPD
surveillance. This chapter will provide a detailed clarification of these steps for each VPD surveillance.

Case-Based Surveillance

Case Detection

Notification and Verification

Case Investigation

Sample Collection and Lab Testing

Case Classification

Case Reporting

Data Analysis and Interpretation

Feedback and Dissemination

Public Health Action

20
4.2 Measles/ Rubella Surveillance
4.2.1 Disease and vaccine characteristics
4.2.1.1 Measles:
Measles is one of the most infectious human diseases and can cause serious illness, lifelong complications,
and death. Prior to the availability of the measles vaccine, measles infected over 90% of children before they
reached 15 years of age. These infections were estimated to cause more than two million deaths and between
15 000 and 60 000 cases of blindness annually worldwide.5
It is caused by a paramyxovirus virus, manifesting as a febrile rash illness. The incubation period for measles
usually is 10–14 days (range 7–23 days) from exposure to symptom onset. Initial symptoms (prodrome)
generally consist of fever, malaise, cough, conjunctivitis, and coryza. The characteristic maculopapular rash
appears two to four days after the onset of the prodrome. Patients are usually contagious from about four days
before rash onset until four days after its appearance.
Measles complications such as pneumonia, diarrhea, and encephalitis can occur in up to 30% of persons
depending on age and predisposing conditions, such as young age, malnutrition and immunocompromising
conditions.
The measles vaccine is a live attenuated virus vaccine; it is given in Pakistan as the following:
➢ Measles1: 9 months
➢ Measles2: 15months

4.2.1.2 Rubella:
Rubella is an acute viral disease traditionally affecting susceptible children and young adults. Its public health
importance is due mainly to the teratogenic potential of the virus, causing harm to an embryo or fetus. The
incubation period of rubella is 14 days, with a range of 12–23 days.
Rubella-containing vaccines (RCV) are live attenuated virus vaccines, most often combined with measles
vaccine.

4.2.2 Case Detection, Suspected case definition:


A suspected case is one in which a patient with fever and maculopapular (non-vesicular) rash, or in whom a
health-care worker suspects measles/ Rubella.

4.2.3 Case investigation:


As mentioned previously, case investigation is the responsibility of the District Surveillance Coordinator
(DSC), he should investigate all suspected cases, and collect the samples for laboratory testing. A clinician
should notify public health authorities of any suspected measles/ Rubella cases within 24 hours of
identification, and investigation should be done within 48 hours of notification. The investigation form must
be filled and samples must be collected from each case. Additionally, the collection of data on potential risks
of exposure and spread among contacts to identify transmission patterns and ways to interrupt chains of
transmission.

4.2.4 Sample collection and Lab testing:


Sample collection is the responsibility of the DSC; samples can also be collected through some other doctor or
VPD Surveillance focal person in health facilities. Several different types of specimens can be collected from
suspected measles cases based on the timing of the investigation. Collect specimens on the first contact with
the case; do not wait for the ideal window or the case might be lost to follow up. An adequate specimen for
antibody detection is defined as a sample collected within 28 days after rash onset that consists of ≥ 0.5 mL of
sera. The volume of whole blood to be collected is defined in Table 3 based on age. In some regions where

5
Global Measles and Rubella strategic plan 2015-2020
21
suitable testing is available, you may also use a sample of oral fluid or dried blood on a filter paper (≥ 3 fully
filled circles).

Table 5: Measles/ Rubella samples:


Storage & Transport
Type of Specimen Type of Test Volume Time of collection
Condition

older children and adults; Whole blood: 4–8°C (never freeze


4–7 mL of blood whole blood) for up to 24 hours or
for 6 hours at 20–25°C before the
Antibody detection
serum is separated from clotted
Serum (By Venepuncture) (Measles/Rubella specific younger children; 1 mL ≤ 28 days after rash onset.
blood through centrifugation.
IgM)
Serum should be stored 4–8°C
until shipment to laboratory, ideally
infants; 0.5mL no longer than 7 days

Throat, nasal or Ideally sample should be


nasopharyngeal swabs or collected within 5 days Dedicated stick4–8°C
nasopharyngeal aspirates (Throat Swab)
Detection of viral RNA by
Swab Still, it can be collected
RT PCR
up until 14 days after
Oral Fluid Dedicated stick4–8°C
onset of rash for virus
detection (Oral Fluid)

Figure 4.1: Throat swab Figure 4.2: Nasopharyngeal Figure 4.3: Oral fluid
swab swab

4.2.5. Final case classification


The final classification of all suspected cases is the responsibility of DSC, who should classify immediately
upon receipt of the laboratory report. All Measles/ Rubella cases must be documented in the VPD surveillance
and response system. The classification should include all cases even those of which samples were not collected.
The later must be presented in the monthly District Surveillance Review Committee (DSRC) meeting. The
committee then would classify the cases either as epidemiologically linked, clinically compatible or probable.
The explanation of the final case classification is provided in table 4 and figure 6.

22
Table 6: Final case classification
Final Case Classification Measles Rubella
suspected case of measles that has been confirmed positive suspected case of Rubella that has been confirmed positive
Laboratory-confirmed by testing in a proficient laboratory, and vaccine-associated by testing in a proficient laboratory, and vaccine-associated
illness has been ruled out illness has been ruled out

A suspected case of measles that has not been confirmed A suspected case of Rubella that has not been confirmed by
by a laboratory, but was geographically and temporally a laboratory, but was geographically and temporally related
related with dates of rash onset occurring 7–23 days apart with dates of rash onset occurring 12–23 days apart from a
Epidemiologically linked
from a laboratory-confirmed case or epidemiologically laboratory-confirmed case or epidemiologically linked
linked measles case another or another epidemiologically Rubella case another or
linked measles case. another epidemiologically linked rubella case.

A suspected case with fever and maculopapular (non- A suspected case with maculopapular (non-vesicular) rash
vesicular) rash and at least one of cough, coryza or and fever (if measured) and at least one of arthritis/arthralgia
conjunctivitis, but no adequate clinical specimen was taken or lymphadenopathy, but no adequate clinical specimen was
Clinically compatible
and the case has not been linked a laboratory-confirmed taken and the case has not been linked epidemiologically to a
case of measles or other epidemiologically to laboratory-confirmed case of rubella or other communicable
communicable disease. disease.

A suspected case that has been investigated and discarded A suspected case that has been investigated and discarded as
as a non-measles when one of the following is true: a non-rubella when one of the following is true:

→ negative laboratory testing in a proficient laboratory on → negative laboratory testing in a proficient laboratory on
an adequate specimen collected during the proper time an adequate specimen collected during the proper time
period after rash onset period after rash onset
Discarded case → epidemiological linkage to a laboratoryconfirmed → epidemiological linkage to a laboratoryconfirmed
outbreak of another communicable disease that is not outbreak of another communicable disease that is not
measles measles
→ confirmation of another etiology, regardless
→ confirmation of another etiology of whether it meets the definition of
epidemiological linkage
→ failure to meet the clinically compatible measles case → failure to meet the clinically compatible rubella case
definition. definition.

23
Figure 4.4: Final Classification measles/ rubella

MEASLES:
LABORATORY
POSITIVE

RUBELLA:
ADEQUATE
LABORATORY
SPECIMEN
POSITIVE

SUSPECTED MEASLES/
CASE RUBELLA:
LABORATORY
NEGATIVE

EPIDEMIOLOGICALLY LINKED
TO LABORATORY-CONFIRMED OR EPIDEMIOLOGICALLY
NO OR
ANOTHER EPIDEMIOLOGICALLY LINKED
INADEQUATE
LINKED MEASLES CASE MEASLES
SPECIMEN

EPIDEMIOLOGICALLY LINKED
EPIDEMIOLOGICALLY
TO LABORATORY-CONFIRMED OR
LINKED
ANOTHER EPIDEMIOLOGICALLY
RUBELLA
LINKED RUBELLA CASE

EPIDEMIOLOGICALLY
NO DISCARDED:
LINKED TO A
EPIDEMIOLOGICAL NON-MEASLES,
DIFFERENT
LINKAGE NON-RUBELLA
DISEASE
TO MEASLES
OR RUBELLA
CONFIRMED DOES NOT MEET
CASE CLINICAL DISCARDED:
CASE
NON-MEASLES,
DEFINITION NON-RUBELLA
FOR MEASLES
OR RUBELLA
MEETS
CLINICAL
CLINICALLY
CASE
COMPATIBLE
DEFINITION
MEASLES
FOR MEASLES
MEETS
CLINICAL
CLINICALLY
CASE
COMPATIBLE
DEFINITION
RUBELLA
FOR RUBELLA

24
4.2.6 Data collection and case reporting:

Note: Measles vaccine-associated reaction:

A suspected case that meets all five of the following criteria:

1. The patient had a rash illness, but did not have cough or other respiratory
symptoms related to the rash
2. The rash began 7–14 days after vaccination with a measles-containing vaccine
3. The blood specimen, which was positive for measles IgM, was collected 8–56
days after vaccination
4. A thorough field investigation did not identify any secondary cases
5. Field and laboratory investigations failed to identify other causes, or genotype A
was isolated from the suspected case (genotype A is only vaccine-related and
does not occur as wild-type infection).

Complete investigation.
An adequate investigation includes the collection of all the following data elements from each suspected
measles or rubella case:
1- name or identifiers,
2- place of residence,
3- place of infection (at least to district level),
4- age (or date of birth),
5- sex,
6- date of rash onset,
7- date of specimen collection,
8- measles-rubella vaccination status,
9- date of all measles-rubella vaccination,
10- date of notification,
11- date of investigation
12- travel history.

4.2.7 Measles/ Rubella surveillance indicators:


While measles and rubella have several common indicators with other VPDs, they also have specific
indicators that are related to measles/ rubella elimination. Countries committed to the elimination goals must
achieve these indicators.

Table 7: Measles/ Rubella indicators


SURVEILLANCE INDICATOR TARGET HOW TO CALCULATE
ATTRIBUTE (NUMERATOR /
DENOMINATOR)
TIMELINESS OF Percentage of surveillance ≥ 80% # of surveillance units in the
units reporting to the country reporting by the
REPORTING
national level on time, deadline / # of surveillance
units in the country x 100

25
SURVEILLANCE INDICATOR TARGET HOW TO CALCULATE
ATTRIBUTE (NUMERATOR /
DENOMINATOR)

even in the absence of


cases

TIMELINESS AND Percentage of all suspected ≥ 80% # of suspected cases of measles


measles and rubella cases or rubella for which an
COMPLETENESS OF
adequate investigation was
INVESTIGATION that have had an adequate
initiated within 48 hours of
investigation initiated notification / # of suspected
within 48 hours of measles and rubella cases x 100
notification

SENSITIVITY Reporting rate of ≥ 2/ # suspected cases that


discarded non-measles 100,000 have been investigated
non-rubella cases at the Population/ and discarded as a non-measles
national level 12 months and non-rubella case using

REPRESENTATIVENESS Percentage of subnational ≥ 80% # of subnational units


Administrative units (at the achieving ≥ 2 per
province level or
100,000 population
its administrative
discard rate /
equivalent) reporting at
# of subnational units
least 2 discarded non-
measles non-rubella cases x 100
per 100,000 population per
year

SPECIMEN Percentage of suspected ≥ 80% # of suspected cases with an


cases with adequate adequate specimen tested in a
COLLECTION
proficient lab / # of suspected
specimens for detecting
AND TESTING cases – # of suspected cases of
acute measles or rubella
measles or rubella that are not
ADEQUACY tested by a laboratory and are
infection collected and
tested in a proficient (a) confirmed as measles or
laboratory rubella by epidemiological
linkage or (b) discarded as non-
measles and non-rubella by
epidemiological linkage to
another laboratory-confirmed
communicable disease
case x 100

26
SURVEILLANCE INDICATOR TARGET HOW TO CALCULATE
ATTRIBUTE (NUMERATOR /
DENOMINATOR)

VIRAL Percentage of Laboratory ≥ 80% # of outbreaks for which


confirmed Outbreaks with adequate samples have been
DETECTION
samples adequate for submitted for viral detection / #
of outbreaks
detecting measles virus
collected and tested in identified x 100
an accredited laboratory

TIMELINESS Percentage of specimens ≥ 80% # of specimens received


received at the laboratory
OF SPECIMEN within 5 days of collection
within 5 days of collection
TRANSPORT by laboratory / # of
specimens x 100
TIMELINESS Percentage of IgM results ≥ 80% # of IgM test results reported
reported to national public within 4 days of specimen
OF REPORTING
health authorities receipt / # of specimens
LABORATORY received by lab
by the laboratory within 4
RESULTS days of specimen receipt x 100

4.3 Diphtheria Surveillance


4.3.1 Diphtheria Disease and vaccination:
Diphtheria is caused by Corynebacterium species, mostly by toxin-producing Corynebacterium diphtheriae
and rarely by toxin-producing strains of C. ulcerans and C.pseudotuberculosis. The most common type of
diphtheria is classic respiratory diphtheria, whereby the exotoxin produced characteristically causes the
formation of a pseudomembrane in the upper respiratory tract and damages other organs, usually the
myocardium and peripheral nerves. Acute respiratory obstruction, acute systemic toxicity, myocarditis, and
neurologic complications are the usual causes of death. Case fatality ratios up to 10% have been reported in
diphtheria outbreaks, and are higher in settings where diphtheria antitoxin (DAT) is unavailable.6
In Pakistan, Diphtheria toxoid, the vaccine to prevent Diphtheria, is within the Penta vaccine, that is given to
infants as the following:

❖ Penta1: 6 weeks
❖ Penta2: 10 weeks
❖ Penta3: 14 weeks

https://www.who.int/immunization/monitoring_surveillance/burden/vpd/WHO_SurveillanceVaccinePreventable_04_D
iphtheria_R2.pdf?ua=1
27
4.3.2 Case Detection, Suspected case definition:
An illness of the upper respiratory tract characterized by the following:
➢ pharyngitis, nasopharyngitis, tonsillitis or laryngitis
AND
➢ adherent pseudomembrane of the pharynx, tonsils, larynx and/or nose. A diphtheria pseudomembrane
is an exudate that is greyish, thick, firmly adherent, and patchy to confluent. Dislodging the
pseudomembrane is likely to cause profuse bleeding.

4.3.3 Case investigation:


Case investigation is the responsibility of the District Surveillance Coordinator (DSC), he should investigate
all suspected cases, and collect the samples for laboratory testing. A clinician should notify public health
authorities of any suspected diphtheria case within 24 hours in order to arrange for DAT to be given to the
case. DSC should investigate the case within 48 hours of report regardless of the case’s vaccination status.
Close contacts must be identified. All suspected diphtheria cases should be isolated and samples must be
collected prior to antibiotic treatment. Cases should then be treated promptly without waiting for laboratory
confirmation. Completeness of the investigation form must be ensured during the case investigation.

4.3.4 Sample collection and Lab testing:


Sample collection is the responsibility of the DSC; samples can also be collected through some other doctor or
VPD Surveillance focal person for VPD patients in health facilities. Specimens are stored temporarily in the
refrigerator at the health facility and sent to the district. DSC arranges the specimen to be shipped in the
reverse cold chain to the lab present in the National Institute of Health (NIH), Islamabad. Table 2 clarifies the
details of the sample collection.
Table: Diphtheria Sample collection:
Storage & Transport
Type of Specimen Sample collection Type of Test Time of collection
Condition
(Use a specific applicator
provided. The sample should Dedicated stick is used
be obtained under direct where specimens are placed
Pharyngeal Swab
visualization, preferably from Specimens should ideally be in appropriate transport
1. Isolation of
the edge of or directly beneath taken prior to starting media (Amie’s transport
the pseudo membrane). Corynebacterium spp. medium medium).
antibiotics. However, take
2.Detection of toxin from Transport these to the
samples even if antibiotics
(Use a specific applicator culture Positive specimen have already been started laboratory promptly at
provided. Sample should be o
2–8 C in the designated
Nasal Swab
collected from the nares using a cold chain
cotton-tipped applicator).

4.3.5 Final Case Classification:


The final classification of all suspected cases is the responsibility of DSC, who should classify immediately
upon receipt of the laboratory reports. All Diphtheria cases must be documented in the VPD surveillance and
response system. The classification should include all cases even those of which samples were not collected.
The later must be presented in the monthly District Surveillance Review Committee (DSRC) meeting. The
committee then would classify the cases either as laboratory-confirmed, epidemiologically linked, clinically
compatible or discarded.

4.3.5.1 Laboratory-confirmed case.


A laboratory-confirmed case is a person with Corynebacterium spp. isolated by culture and positive for toxin
production, regardless of symptoms. Toxigenicity must be confirmed by the phenotypic Elek test in all

28
instances. Polymerase chain reaction (PCR) can complement surveillance and may qualify as laboratory-
confirmed after reviewing the epidemiology and clinical manifestations of the case.

4.3.5.2 Epidemiologically linked case.


An epidemiologically linked case meets the definition of a suspected case and is linked epidemiologically to a
laboratory-confirmed case. In this situation, a person has had intimate respiratory or physical contact with a
laboratory-confirmed case within the 14 days prior to the onset of the sore throat.

4.3.5.3 Clinically compatible case.


This type of case meets the definition of a suspected case and lacks both a confirmatory laboratory test result
and an epidemiologic linkage to a laboratory-confirmed case.

4.3.5.4 Discarded case.


A discarded case is a suspected case that meets either of these criteria:
Corynebacterium spp. but negative Elek test (nontoxigenic Corynebacterium)
OR
negative PCR for the diphtheria toxin (tox) gene.

4.3.6 Data collection and case reporting:


➢ For data collection information, please refer to Annex 1, Diphtheria investigation form.
➢ For Case reporting, please refer to Chapter 8.

4.3.7 Diphtheria surveillance indicators:


Many of Diphtheria surveillance indicators are common for other VPDs. A list of Diphtheria indicators is
provided in table 8.

Table 8: Diphtheria indicators

29
SURVEILLANCE INDICATOR TARGET HOW TO CALCULATE
ATTRIBUTE (NUMERATOR /
DENOMINATOR)

COMPLETENESS Percentage of designated ≥ 80% Total number of reports received / total


OF REPORTING sites reporting diphtheria number of reporting sites x 100 (for
data, even in the absence of given time period)
cases (zero reporting)

TIMELINESS OF Percentage of surveillance ≥ 80% # of surveillance units in the country


REPORTING units reporting to the national reporting by the deadline / # of
level on time, even in the surveillance units in the country x 100
absence of cases

ADEQUACY OF Percentage of all suspected ≥ 80% # of suspected cases of diphtheria for


diphtheria cases that have which an adequate investigation
INVESTIGATION
had an adequate investigation
was done / # of suspected diphtheria
cases x 100

TIMELINESS OF Percentage of all suspected ≥ 80% # of suspected cases of diphtheria for


diphtheria cases that have which an investigation initiated within
INVESTIGATION
had an investigation initiated
48 hours of notification / # of
within 48 hours of suspected diphtheria cases x 100
notification

SPECIMEN Percentage of suspected ≥ 80% # of suspected cases of diphtheria with


diphtheria cases with two 2 specimens collected / # of suspected
COLLECTION
diphtheria cases x 100
specimens collected
(pharyngeal swab and
a nasal swab)

TIMELINESS Percentage of suspected ≥ 80% # of suspected cases of diphtheria with


diphtheria cases with a specimen collected before antibiotics
OF SPECIMEN
specimens taken before / # of suspected diphtheria cases with a
COLLECTION antibiotic administration specimen collected x 100

TOXIGENICITY Percentage of specimens ≥ 80% # specimens tested for toxigenicity by


tested for toxigenicity by Elek testing / # of specimens received
TESTING RATE
Elek x
Testing 100

TIMELINESS Percentage of specimens ≥ 80% # of specimens received within 2 days


received at the laboratory of collection by laboratory / # of
OF SPECIMEN
within 2 days of collection specimens x 100
TRANSPORT

30
TIMELINESS Percentage of specimens ≥ 80% # of specimens tested by culture with
tested by culture with results results reported within 3 days of
OF REPORTING
specimen receipt / # of specimens
reported within 3 days of
LABORATORY
receipt of specimen tested by culture x 100
RESULTS

4.4 Neonatal Tetanus


4.4.1 Disease and vaccination characteristics
Tetanus is caused by toxigenic strains of Clostridium tetani, a gram-positive bacterium. C. tetani spores are
ubiquitous in the environment. NT most often occurs through the cutting of the umbilical cord using non-
sterile techniques or applying non-sterile traditional remedies to the umbilical cord stump, but infection of the
umbilical stump is not always evident. Deliveries carried out by persons with unclean hands or on a
contaminated surface are also risk factors for maternal and neonatal tetanus (MNT). Tetanus is not
transmissible from person to person.
In Pakistan, tetanus toxoid containing vaccines (TTCV) is included in the Penta vaccine that is given as the
following:
❖ Penta1: 6 weeks
❖ Penta2: 10 weeks
❖ Penta3: 14 weeks

4.4.2 Case Detection, Suspected case definition


A suspected case for NT is a case that meets either of these two criteria:
➢ Any neonate who could suck and cry normally during the first two days of life and developed tetanus-
like illness or death between 3 and 28 days of age
OR
➢ Any neonate who died of an unknown cause during the first month of life.

4.4.3 Case investigation


Each suspected NT case or death should be investigated by trained staff to confirm or discard the case, ideally
within seven days of notification. The sooner the mother and persons who attended the birth are visited, the
more likely they are to be available and remember relevant details.

4.4.4 Sample collection and Lab testing


Neonatal tetanus is clinically diagnosed; no sample is collected.

4.4.5 Final case classification


4.4.5.1 Confirmed case.
A confirmed case is any suspected NT case found during case investigation to have all three of the following:

31
➢ Normal ability to suck and cry during the first two days of life
AND
➢ Could not suck normally between 3 and 28 days of age
AND
➢ Developed muscle stiffness and/or spasms (jerking).

4.4.5.2 Discarded case.


A discarded case is one that has been investigated and does not satisfy the clinical criteria for confirmation or
has an alternate diagnosis.

4.4.5.3 Not investigated.


Any suspected case not investigated, or without information available on age and symptoms to confirm the
case, should receive the final classification of not investigated.

4.4.6 Data collection and case reporting:


➢ For data collection information, please refer to Annex 3, Neonatal Tetanus investigation form.
➢ For Case reporting, please refer to Chapter 8.

4.4.7 Public Health response


The mother of the suspected NT case and any other unprotected woman of reproductive age in the community
should receive TTCV as indicated (two doses separated by four weeks) to protect her and her infants during
future births. If possible, the mother should be provided a TTCV dose before leaving the hospital, as part of
outreach vaccination organized in conjunction with case investigation, or within six months of confirming the
NT case.

4.4.8 Neonatal tetanus indicators

Table 9: Neonatal Tetanus indicators


SURVEILLANCE HOW TO CALCULATE
ATTRIBUTE INDICATOR TARGET (NUMERATOR /
DENOMINATOR)

COMPLETENESS Percentage of designated ≥ 90% # sites reporting NT /


sites reporting NT data,
OF REPORTING # designated reporting
even in the absence of
cases (zero reporting) sites for NT surveillance x 100
(for a given time period)

TIMELINESS OF Percentage of designated ≥ 80% # of surveillance units in the


sites reporting NT data country reporting by the deadline
REPORTING
on time, even in the / # of designated reporting sites
absence of cases (zero for NT surveillance x 100
reporting)

32
COMPLETENESS Proportion of NT ≥ 90% # of NT case investigations / # of
OF suspected cases that suspected NT cases reported x
INVESTIGATION 100
have been investigated
(only among cases
reported from health
facilities)

TIMELINESS OF Percentage of all ≥ 80% # suspected NT cases


suspected cases investigated within 7 days of
INVESTIGATION
investigated within 7 notification / # suspected NT
days of notification cases investigated x 100

ADEQUACY OF Percentage of ≥ 80% # of suspected NT cases for


investigated suspected which an adequate investigation
INVESTIGATION
cases with complete was completed with collection of
information for all core 12 core variables / # of suspected
variables NT cases investigated x 100
ACHIEVEMENT Percentage of districts 100% # districts with < 1 NT case per
1000 live births / total # districts
AND with < 1 NT case per
x 100
MAINTENANCE OF
1 000 live births
MNTE

ADEQUATE CASE Percentage of confirmed 100% # of mothers of NT cases that


NT cases for which the received a TTCV dose in
RESPONSE
mother received a TTCV conjunction with case detection
dose in conjunction with or
case detection or investigation / total # of NT case
investigation investigations x 100

4.5 Pertussis Surveillance


4.5.1 Disease and vaccination characteristics
Pertussis (whooping cough), caused by Bordetella pertussis, is endemic in all countries. Pertussis is
transmitted from infected to susceptible individuals by airborne droplets.
There are three phases of symptoms.
➢ Catarrhal stage: In the early catarrhal stage, pertussis is highly contagious, with a secondary attack
rate of up to 90% among non-immune household contacts. Untreated patients may transmit the
infection for three weeks or more following the onset of typical coughing attacks, although
communicability diminishes rapidly after the catarrhal stage.
➢ Paroxysmal stage: The paroxysmal stage is marked by more frequent and spasmodic coughing, and it
is during this stage when the classic whoop can be heard (but not always present).
33
➢ Convalescent stage: The convalescent stage is marked by less frequent and less severe coughing.
The aim of pertussis vaccination is to reduce the risk of severe disease in infants and young children, the
vaccine is included in the Penta vaccine that is given as the following:
❖ Penta1: 6 weeks
❖ Penta2: 10 weeks
❖ Penta3: 14 weeks

4.5.2 Case Detection, Suspected case definition:


A suspected case is a person of any age with a cough lasting ≥ 2 weeks, or of any duration in an infant or any
person in an outbreak setting, without a more likely diagnosis and with at least one of the following
symptoms, based on observation or parental report:
➢ Paroxysms (fits) of coughing
➢ Inspiratory whooping
➢ Post-tussive vomiting, or vomiting without other apparent cause
➢ Apnea (only in < 1 year of age)
OR
➢ clinician suspicion of pertussis.
Note that pertussis in immunized or previously infected individuals can present without the classic signs of
pertussis, and therefore might not be captured by the above case definition.

4.5.3 Case investigation


Case investigation is the responsibility of the District Surveillance Coordinator (DSC), he should investigate
all suspected cases, and collect the samples for laboratory testing. A clinician should notify public health
authorities of any suspected diphtheria case within 24 hours, and case investigation should be done within 48
hours. Every suspected case should have a case investigation form completed and a specimen collected.
Suspected cases should be advised to avoid contact with young infants, children, and women in late pregnancy
for the three weeks post-onset or until five days of antibiotic treatment are completed, whichever is first.
Contact tracing should be established for the identification of other suspected cases in the community.

4.5.4 Sample collection and Lab testing


In case-based surveillance, a specimen should be collected from every suspected case. The timing of the
cough should determine the type of specimen to be collected for case-based surveillance. A sample for both
culture and PCR should be collected simultaneously up until four weeks after cough onset.
Investigation and sample collection are done by District Surveillance Coordinator (DSC) or through hospitals’
clinicians or a health facility focal person for VPD surveillance. Specimens are stored temporarily in the
refrigerator at the health facility and sent to the district level. DSC arranges the specimen to be shipped in the
reverse cold chain to the lab present in the National Institute of Health (NIH), Islamabad.

Table 10: Pertussis sample collection


Storage & Transport
Type of Specimen Type of Test Volume Time of collection
Condition
B. pertussis isolation by Ideally, a sample for culture
2 Swab (one for culture and
Nasopharyngeal Swabs cell culture. should be collected until four Dedicated stick4–8°C
one for PCR)
PCR weeks after cough onset,

34
4.5.5 Final case classification:
4.5.5.1 Laboratory confirmation.
A laboratory-confirmed case is a person who meets the suspected case definition with laboratory confirmation
by one of the following:
➢ isolation of B. pertussis
OR
➢ detection of genomic sequences of B. pertussis by means of polymerase chain reaction (PCR) assay, if
polymerase chain reaction (PCR) meets performance criteria.
OR
➢ elevated IgG antibodies to pertussis toxin in an individual ≥ 11 years of age, one year or longer after
last vaccine dose.

4.5.5.2 Epidemiologically linked.


An epidemiologically linked case is a person meeting the suspected case definition with close contact to a
laboratory-confirmed case (or another epidemiologically linked case in an outbreak setting) in the three weeks
prior to the onset of cough.
➢ Close contact is defined as having face-to-face exposure to a case, which includes household or
family contact, people having stayed overnight in the same room with a case, and people having direct
contact with respiratory, oral, or nasal secretions with a laboratory-confirmed case.

4.5.5.3 Possible.
A person who meets the suspected case definition but does not meet confirmed classification as defined above
should be considered a possible case. This includes suspected cases who did not have laboratory testing done
and those who tested negative.

4.5.6 Data collection and case reporting:


➢ For Case reporting, please see paragraph 4.5.3

35
4.5.7 Pertussis surveillance indicators

Culture: +ve NonToxigenic


Corynebacterium coryne- Discarded
ELEK-ve TOX GENE bacterium

Culture: -ve
Corynebacterium Discarded
PCR: - veTOX GENE

Laboratory Specimen Review


collected No Contact Epidemilogical
with cases picture and classify
Culture: -ve
C.Diphtheria Contact with
SUSPECTED CASE: An illness
PCR: +ve Tox Gene/ a Lab- Eoidemiologically
of upper respiratory tract
Not performed confirmed linked cases
characterized by the
case Contacts
following:
Pharyngitis, nasopharyngitis, with
tonsillitis, or laryngitis Cultrue +
Culture: +ve Toxigenic
AND Laboratory Coryneba
Corynebacterium Corynebacteri
Adherent pseudomembrane Confirmed case cerium
ELEK +ve Tox Gene um
of the tonsils, pharynx, nose ELEK +
or larynx.

Epidemiologically
Yes
linked case
Laboratory specimen NOT Close contact with a
collected Lab-Confirmed case?
Clinically
Yes
Compatible case

Table 11: Pertussis surveillance indicators


SURVEILLANCE HOW TO CALCULATE
ATTRIBUTE INDICATOR TARGET (NUMERATOR /
DENOMINATOR)
COMPLETENESS Percentage of designated ≥ 80% # designated reporting units
units reporting pertussis reporting pertussis / # designated
OF REPORTING
data, even in the absence reporting units for pertussis
of cases surveillance x 100 (for a given time
period)

TIMELINESS OF Percentage of designated ≥ 80% # of designated reporting units in


units reporting to the the country reporting by the
REPORTING
national level on time,

36
even in the absence of deadline / # of designated reporting
cases units in the country x 100

ADEQUACY OF Percentage of all suspected ≥ 80% # of suspected cases of pertussis for


pertussis cases that have which an adequate investigation
INVESTIGATION
had an adequate was done / # of suspected pertussis
investigation cases x 100

TIMELINESS OF Percentage of all suspected ≥ 80% # of suspected cases of pertussis for


pertussis cases which an investigation is initiated
INVESTIGATION
within 48 hours of notification / #
that have had an
of suspected pertussis cases x 100
investigation initiated
within 48 hours of
notification

SPECIMEN Percentage of suspected ≥ 80% # of suspected cases of pertussis


with at least one specimen collected
COLLECTION pertussis cases with at
/ # of suspected pertussis
least one specimen
ADEQUACY
collected cases x 100

TIMELINESS Percentage of specimens ≥ 80% # of specimens received


OF SPECIMEN received at the laboratory within two days of collection by
within two days of laboratory / # of specimens x 100
TRANSPORT
collection

TIMELINESS OF Percentage of PCR ≥ 80% # of specimens tested by PCR with


specimens with results results reported within two days of
REPORTING PCR
reported within two days receipt / # of specimens tested by
LABORATORY of receipt of specimen
PCR x 100
RESULTS for PCR

TIMELINESS Percentage of culture ≥ 80% # of specimens tested by culture


specimens with results with results reported within seven
OF REPORTING
days of receipt / # of specimens
reported within seven days
CULTURE tested by culture x 100
of receipt of specimen for
LABORATORY culture

RESULTS

37
CHAPTER 5: Case reporting, analysis, action, and feedback

5.1 VPD Surveillance Reporting Channel & Schedule


The focal person at each reporting health facility must be oriented on the use of recording and
reporting forms. Reporting must capture the detailed information of every reported case of vaccine
preventable disease. There are two types of reporting, the immediate reporting where all health facilities must
report immediately all cases of priority VPDs to the district authorities, and the weekly reporting, where HFs
must report even if cases were zero, hence, Zero reporting. The reporting in some HFs in some provinces is
done electronically, however, this does not subside the manual documentation at each level of the health
system. This helps in the verification of reported cases and surveillance system reviews. The reporting
Timeliness is as clarified below:

• At present, prompt weekly reporting (including zero reporting) is required. The standard VPD reporting
forms should be used at each respective level
• The reporting week ends on Saturday at 3:00 pm. Patients seen after 3:00 pm should be reported in the
following week.
• Every Saturday at 4:00 pm, the information from each reporting site (health facility, hospitals etc.)
should be compiled and the Health Facility Form completed. It must be sent whether a case was reported
or not and even if, the cases have been reported on DSS.
• By Monday the form should be sent from the reporting site to the district level; District Health Authority
(DHA), District Health Officer (DHO)/Chief Executive Officer (CEO), or District Surveillance
Coordinator (DSC) where reports will be reviewed, compiled, analyzed, and appropriate action taken as
necessary. The District Reporting Form must be completed weekly at each district.
• From district level the compiled data should be sent by Tuesday till 4:00 pm to the provincial level
(Provincial Surveillance Officer). The Provincial Reporting Form must then be completed at the
provincial level.
• From the provincial level, the data will be compiled and sent to the central level by Thursday 10 am for
analysis and inclusion in the weekly bulletin to be issued on a weekly basis.
• Reporting forms are attached in the end as annexures.
• Technical supervision and support for the flow of information from the field should be provided at the
district, provincial and central levels.

Table 12: Timeline and responsibility of weekly VPD Surveillance reporting


Level Day Time Responsible Received by

Health Facility to Every Saturday 4:00 PM Health Facility In Deputy District


Tehsil/Town charge Health Officer

Tehsil/Town to District Every Monday 10:00 Deputy District District


Am Health Officer Surveillance
Coordinator
District to Province Every Tuesday 4:00 PM District Provincial
Surveillance Surveillance
Coordinator Officer
Province to National Every Thursday 4:00 PM Provincial National
Surveillance Surveillance
Officer Officer

38
Figure: Data Flow Chart for VPD Surveillance Data

Regional & Global Offices

Federal EPI Cell Weekly EPI Surveillance


Bulletin

Provincial EPI Cell


NIH
Laboratory
District
VPD Surveillance and
Tehsil/Town Response System

Health Facility

5.2 Data analysis and interpretation

The District Surveillance Coordinators must do the basic data analysis at the field level with the support of the
Data Entry Operator (DEO). The data is then forwarded to the provincial level and then to the central level for
further interpretation, analysis and feedback. The most important data elements to be analyzed are the number
of illnesses and deaths, the location of these events, and the comparison to usual disease trends.

District Surveillance Coordinators/District Epidemiologist


➢ Review, analyze and respond to the alerts on a daily basis (if reported from the health facility focal
person by a telephonic call or SMS) and on a weekly basis, with assistance from PEI.
➢ Provide technical guidance on public health interventions needed to control the spread of vaccine
preventable diseases.
➢ Provide feedback to reporting sites to keep them motivated for regular reporting and inform about the
main health problems in the area.
➢ Share the information with the decision makers for policy decisions and resource mobilization.

Analysis is essential for understanding how well an immunization programme is performing and for identifying
gaps. Data analysis also provides the basis for taking action, be it introducing new vaccines, targeting
communities at risk or modifying programme design.

5.2.1 Determining patterns

Data are often analyzed with three questions in mind.

39
5.2.1.1 Is there a pattern over time?

Extract the date of onset of symptoms for all reported cases. The number of cases occurring in a month or in a
week is then calculated. This data is plotted with the weeks or months on the X axis and the number of cases on
the Y axis. Any clustering of cases over the reporting periods (month or week) will immediately become visible.
In case of some short but explosive outbreaks (e.g. cholera, etc.) the number of cases by day may need to be
plotted. Seasonal variations in the incidence of some diseases (for example, influenza and measles) are more
noticeable than for other diseases (such as tuberculosis). When immunization coverage increases, seasonal
variations may become blurred.
Figure 8. Number of confirmed measles cases per month. Punjab 2014-Jun 2020

LAB CONFIRMED MEASLES CASES


Measles
250 SIA 2018
200

150

100

50

0
Aug

Apr

Aug

Aug

Apr

Aug
Apr

Mar

Apr

May
Mar

May

May

Mar

May

Mar
Feb

Sep

Feb

Sep

Feb

Sep

Feb

Sep
Jan

Jan

Jan

Jan
Jun
Jul

Nov
Dec

Jun
Jul

Nov
Dec

Jun
Jul

Nov
Dec

Jun
Jul

Nov
Dec
Oct

Oct

Oct

Oct
2016 2017 2018 2019

Some diseases naturally occur periodically as epidemic years followed by non-epidemic years for instance polio
Typically, an epidemic year will be followed by one or more years with relatively few cases of the disease, until
another epidemic year occurs. Increasing immunization coverage changes the epidemic pattern so that the time
between epidemics increases.

When disease incidence reaches low levels due to effective immunization activities, the epidemic pattern might
not be evident. In analyzing surveillance data, consider the influence of epidemic patterns by asking yourself:

• How does this year’s pattern compare with those of previous years?
• Can the increase (or the decrease) be explained? Consider interventions such as improvements in routine
immunization coverage or mass immunization campaigns as shown in Figure 8C.

Figure: Number of Measles cases per

40
Analysis of disease data over a long period can show trends that are important for monitoring programme
performance, such as a decrease in measles. Trend analysis by time can reveal patterns that can help in finding
suitable control measures or predicting the likely extent of disease in the future.

5.2.1.2 Is there a pattern over place?

The place where the case was residing at the time of onset of symptoms must be determined for all reported
cases. The location of cases is then plotted on a map either manually or with the help of computerized mapping
programmes. Any spatial clustering of cases will immediately become visible.

It is important to determine whether a group of cases is clustered in place and time. This is often best displayed
by plotting the location of cases on a local map and writing the date of onset next to each case. This information
can be used to guide interventions, such as immunization response.

Figure 8D. Distribution of Lab Confirmed Measles & Rubella Cases Punjab 2019

41
5.2.1.3 Is there a pattern by person?
Minimal data on a case, describing the person affected by the disease (for example age, sex, immunization status
and location) can help to target interventions appropriately.

Vaccination Status of Lab Confirmed Measles Cases by Age Group 2019

80 0 0
70 6
0
60
0
50
40
40 78 54
30 47

20
27 0
10 4 6
3
6 6 3 0
0 3 1
YOUNGER THAN 9 9-23 MONTHS 2-4 YEARS 5-9 YEARS 10-19 YEARS 20 YEARS OR
MONTHS UNKNOWN

Zero One Dose Two Doses Not Known

Lab confirmed Measles Cases by Sex 2019

42
119

166

Male Female

5.3 Taking action on surveillance reports and data analysis:

It is important to determine whether the increase in the number of reported cases is due to an increase in disease
incidence or to better reporting when a surveillance system is implemented in a region with no previous
surveillance or poor surveillance.
If an unusual increase in the number of cases of a vaccine-preventable disease is reported, action in the form of
surveillance and immunization might be required. The nature of the surveillance and immunization responses
is often determined by the disease and by national policies, many of which are listed in Annex 1. The increase
in cases might, however, be associated with problems in the immunization coverage or system, such as the cold
chain or vaccine supply, which require a response.

Always look carefully for the underlying causes of reported increases in vaccine preventable
diseases in order to propose an effective intervention to control and prevent disease
transmission.

The surveillance response may involve:

• searches for additional unreported cases (active search).


• detailed investigation of cases (case investigation form).
• confirmation of suspected cases (laboratory confirmation).
• analysis of data to understand the situation in time, place and person.
• reporting conclusions and results of the analysis to appropriate levels taking suitable public health
precautions to minimize spread of the disease – Action.
• treatment of cases and contacts appropriately.

Action may depend on the quality and detail of data on time, place and person, for example, whether full case
investigations or only simple counts of cases are available.
43
5.3.1 Immunization response

The immunization response to an increase in the number of reported cases will vary greatly, depending on the
disease and current policies. Some diseases, such as polio, require urgent, large-scale supplementary
immunization, as recommended by global policy laid down by the World Health Assembly. For others, such
as measles and neonatal tetanus, the magnitude of the immunization response depends on national or local
policy (see Annex 1).

5.3.2 Outbreak response

For many VPDs, one of the objectives of surveillance is to detect and respond to disease outbreaks and
epidemics. For most diseases, an outbreak is defined as an increase in the number of cases over the normally
expected number; for some diseases like polio and measles, an outbreak investigation is often initiated upon
detection of a single case7. Surveillance plays an important role in both outbreak detection and response.
Ongoing VPD surveillance can detect an increase in VPD cases, which upon further investigation might be
classified as an outbreak. Surveillance data should allow the characterization of the initial outbreak in terms of
person, place, and time to guide effective response.
Ideally, there is no area in the country without an established VPD surveillance system. In rare cases where
VPD surveillance is not established, surveillance can be set up after an outbreak has been identified. For
example, if a VPD outbreak is detected through other methods (such as rumours in the community) in an area
without pre-existing VPD surveillance, then surveillance might rapidly be established in the outbreak area to
further characterize the outbreak and guide the response. Surveillance can also measure the impact of the public
health response to the outbreak.

5.3.2.1 Definition of Outbreak


I. Diphtheria:
A single laboratory-confirmed case of diphtheria should trigger a public health response.
Two temporally and geographically (within one union council or adjacent community) linked
cases, of which at least one is laboratory-confirmed, is considered an outbreak of diphtheria.
II. Measles:
A single laboratory-confirmed measles case should trigger an aggressive public health
investigation and response in an elimination setting.
An outbreak is defined as two or more laboratory-confirmed cases that are temporally related
(with dates of rash onset occurring 7–23 days apart, normally in one union council) and
epidemiologically or virologically linked or both.
III. Rubella:
A single laboratory-confirmed case should trigger an aggressive public health investigation and
response in an elimination setting.
An outbreak is defined as two or more laboratory-confirmed cases that are temporally related (with dates of
rash onset occurring 12–23 days apart) and epidemiologically or virologically linked.

7
Gregg MB. Field epidemiology. Oxford, New York: Oxford University Press; 2008. & Teutsch SM, Churchill RE.
Principles and practice of public health surveillance. Oxford, New York: Oxford University Press; 2000.

44
5.3.2.2 Steps in Outbreak Investigation
All districts should have district outbreak-response teams that should be comprised of some or all the following:

• District Surveillance Coordinator


• District Health Officer (Preventive Services);
• Concerned Deputy District Health Officer (DDHO)
• Focal persons for EPI activities, such as DSV/ASV
• Appropriate health workers from health facilities, such as paediatrician, medical officers
• Any partner’s staff e.g. Polio Eradication Officer (PEI)

If a VPD outbreak is identified, an investigation should be conducted by District Surveillance Coordinator


or other public health officials, or both. The investigation of outbreaks of disease, including VPDs, is often
broken down into the following series of steps8:
Step 1. Visit the area concerned.
Alert your superiors to the suspected outbreak immediately, and inform them of any necessary resources you
will need to investigate and control it.

Step 2. Verify the diagnosis and confirm the existence of an outbreak.


Establish an outbreak case definition (or modify the existing one used in VPD surveillance). Perform clinical
examinations and undertake appropriate laboratory investigations of suspected cases. Use a disease-specific
case investigation form, and complete one form per suspected case.

Step 3. Conduct case-finding and data collection:


Sometimes the outbreak response is initiated after only one or two suspected cases have been found, and there
may be cases that have not been reported. The search for and finding of unreported cases may determine what
action should be taken even before these cases have been confirmed. The search for additional cases must
include health facilities and the community.

• Health facilities: Visit the health facilities serving your catchments area. Talk to the doctors and health
workers or nurses to see if they are seeing suspected cases of the disease you are investigating. Visit
hospital wards and outpatient departments, and search all patient registers for cases that fit the case
definition or diagnoses consistent with the disease under investigation.
• The community: Visit the communities from which cases were seen in the health facilities. Talk to
community leaders and others who might have influence in the community. If feasible, organize a rapid
house-to-house search of the affected area(s) to find similar cases.

8
Centers for Disease Control and Prevention. Principles of epidemiology in public health practice, third edition: an
introduction to applied epidemiology and biostatistics. Atlanta, USA: Centers for Disease Control and Prevention;
2011 (https://www.cdc.gov/ophss/csels/dsepd/ss1978/index.html).

45
Alert all reporting sites in your catchments area and ask for daily reports of suspected cases. Determine the
extent of the outbreak by visiting or calling health facilities in neighboring areas. Depending on the disease, you
might need to trace contacts.

Step 4. Describe the outbreak.


From the case investigation forms, create a line list. Include laboratory results as soon as these become available.
Decide if sufficient laboratory results are available or whether more specimens are required; e.g. if a laboratory
confirms the clinical diagnosis of measles in a suspected measles outbreak, specimens need not be collected
from all cases; however, if the laboratory results show that the cases are due to rubella, more specimens might
be needed to establish whether the outbreak is purely of rubella or a mixed measles and rubella outbreak.

Step 5. Analyze the data


Analyze the information available in case investigation forms. Draw an epidemic curve and a spot map. In
addition, analyze the immunization status and ages of cases. Generate and test hypotheses regarding the source
and cause of outbreak. A detailed analysis will allow description of the chain of events leading to the outbreak
and the progress of control measures.

Step 6. Implement control and prevention measures (vaccination for VPDs among other public health
interventions):
It is usually possible to manage an outbreak by implementing a range of activities, which include rapid
identification of new cases, treatment or management of cases and sometimes segregation or isolation to prevent
additional spread. Specifically, attention must be paid to

• Case management (e.g. administration of antibiotics for diphtheria cases and vitamin A for measles).
• Surveillance and correction of problems in the surveillance system (e.g. active surveillance to find more
cases; review of completeness of zero reporting and timeliness of reporting).
• Identification of other problems in the immunization system (e.g. evaluation of components such as
coverage, cold chain, training and manpower).

• Mass Immunization Campaigns in selective or larger areas depending upon epidemiology and stage of
eradication/elimination

Step 7. Reporting and documentation.


Analyze the lessons learnt from the outbreak investigation and response, and write a report.
One of the most important parts of an outbreak investigation is ensuring that the lessons learnt are communicated
and acted upon. The report should include details of the outbreak, the investigation, the response to date,
problems identified in the immunization system that are related to the outbreak, and recommendations to
prevent further outbreaks.

Step 8: Strengthen VPD surveillance and the immunization programme, and potentially change vaccine
policy.

46
5.3.2.3 Changes to VPD Surveillance during Outbreaks
• The objectives might shift from measuring disease burden or vaccine impact to providing data for
implementation and evaluation of immediate disease control measures.
• The mode of case-finding might shift from passive to active. This may mean that instead of waiting for
health facilities to report cases, surveillance officers will contact facilities and other sources of case
detection or require case tallies from them on a regular basis, often daily. Surveillance officers might also
go to the community to find unreported cases.
• The surveillance case definition might be modified in an outbreak setting. The localization of the outbreak
in place and time might lead the inclusion of these components in the case definition.
• For some VPDs, once the outbreak is laboratory-confirmed, case confirmation may shift to
epidemiologically linked for greater efficiency9.
• The role of the laboratory in surveillance might change from that of confirming all cases to confirmation
of cases in new geographic or epidemiologic groups and characterizing the pathogen in order to assist the
response (for example, antimicrobial resistance testing for bacteria, genotyping for polio, strain testing for
influenza). If a backlog of specimen testing exists, testing recently collected samples will provide more
timely information for the response.
• Close communication between surveillance and laboratory staff is necessary.
• A list of cases might be required during the outbreak to efficiently track individual cases and better define
the epidemiology (generate epidemic curves).
• Case investigations and data elements collected can change during an outbreak. Special emphasis on
obtaining vaccination status of cases is important, to distinguish vaccine failure from lack of vaccination.
There might be an emphasis on risk factors of interest for the outbreak (for example, specific water
sources for cholera and typhoid). In addition, for VPDs that spread person to person, information on
contacts will become important during outbreaks, particularly if measures to prevent disease in contacts
are instituted (such as antibiotic prophylaxis for meningococcal meningitis and diphtheria).
• The frequency of reporting might increase to daily during an outbreak. Sometimes a zero-reporting
approach will be taken in an outbreak, if not already being done, to assure that facilities are actively
seeking new cases every day.
• Situational reports (or “sitreps”) are often used to give regular, structured information about the status of
the investigation and response. More requests for information from media sources are likely, and
communication messages to a non-technical audience need to be considered.

9
Lipsitch M, Hayden FG, Cowling BJ, Leung GM. How to maintain surveillance for novel influenza A H1N1 when there
are too many cases to count. Lancet. 2009;374(9696):1209-11.

47
5.4 Case Response for VPDs
The following table describes case response for any reported VPD case, mop-up in case of a laboratory-
confirmed case, and outbreak response for a lab-confirmed outbreak.

Table 13: Case Response for VPDs


Situation Extent of Response Response

One suspected VPD 30 houses around • Find new cases of the same VPD. If a
the residence of the case available, complete investigation,
case take specimens and enter into the line
list.
One confirmed case 40 houses on each • Vaccinate all due and defaulter children
side of the residence under 2 years of age
of the case Total: • Give a dose of measles (measles), MR
160 (measles or rubella) or DTP/DT
(diphtheria & pertussis) to all children
Lab Confirmed Outbreak Whole UC under 5 years of age
(As describes above) • Give all pregnant women a dose of TT
if required.

Figure: Epidemic curve of Measles Cases of Punjab in 2014-20

250

200

150

100

50

0
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

2014 2015 2016 2017 2018 2019 2020

48
5.5 Feedback

5.5.1 To reporting sites


Feedback to reporting sites encourages their continued involvement and commitment. Feedback can consist of
urgent feedback for an outbreak or individual cases; specific feedback such as the laboratory results of each
case of acute flaccid paralysis.

The main reasons for providing feedback are to:


• facilitate the use of data by providing an analysis in greater depth.
• place local data in the context of district data, to allow comparison of disease incidence and Programme
performance; visualize the extent of outbreaks
• increase the motivation of data providers by acknowledging their hard work and making them aware
that their data is analyzed and used.
• improve the accuracy and promptness of reports.
• verify with the peripheral levels that the data received are correct.

Methods of providing feedback are:


• periodic meetings and discussions with the staff.
• supervisory visits to district office and health faculties.
• quarterly newsletters highlighting important achievements and problems.
• talking to health facility staff when they visit district offices.

5.5.2 To the community:


As a mid-level manager, you should encourage your staff to inform communities about services, and always
involve local politicians, religious leaders, school officers and teachers, community group leaders and parents
in planning and implementing disease control activities, including immunization.

Community cooperation during house-to-house active searches is essential, as community members often can
provide comprehensive, accurate information about travel and movement between communities that can be
invaluable for mapping the spread of disease.

5.5.3 Calculating vaccine effectiveness:


It is often useful to be able to calculate vaccine effectiveness (also known as vaccine efficacy). This calculation
is a useful tool for measuring how well a particular vaccine is working in the field. It is especially helpful for
mid-level managers, as it may help them to identify problems in the quality of the Programme, such as
inadequate storage of vaccines.

49
Consider the example of Toba Tek Singh below, which appeared to have uncontrolled outbreak of measles
disease despite high immunization coverage. In your response, you should have identified the following possible
reasons for this:

• incorrect coverage data.


• incorrect disease data.
• incorrect diagnosis of measles (that is, this was not an outbreak of measles but of some other clinically
similar disease).

But did you consider that the data were correct and there really is an uncontrolled outbreak of measles disease
despite high immunization coverage?
It is possible. One explanation might be that the measles vaccine was damaged due to poor storage, possibly in
the Rajanpur district store before being distributed to each health facility.
Calculating the vaccine effectiveness could clarify whether the situation in Rajanpur district is due to a data
problem, a diagnosis problem or a storage problem (in rare circumstances, it might be due to all three). To
calculate vaccine effectiveness, you should use the following formula Figure 8E. Formula for calculating
vaccine effectiveness

[PCV (1-PPV)]
Vaccine effectiveness = 1 -
[(1 - PCV)PPV]
Where :

PCV is the proportion of cases vaccinated


PPV is the proportion of the population that is vaccinated (i.e. vaccine coverage).

Warning: Mid-level managers must perform this calculation if they are concerned about the effectiveness of a
vaccine, rather than relying on a visual assessment of the data, as visual assessment can be misleading.
For example: In District Toba Tek Singh, there is 99% measles immunization coverage (PPV) and 75% of
measles cases are vaccinated against the disease (PCV). This may appear to be a high proportion, and possibly
indicative of a vaccine effectiveness problem, but,
[0.75 (1-0.99)]
Vaccine effectiveness = 1 -
[(1 - .75)0.99]
0.0075
Vaccine effectiveness = 1 -
0.2475

Vaccine effectiveness = 1 - 0.030303

Vaccine effectiveness = 0.969 = 97%

50
Therefore, the effectiveness of the measles vaccine in District Toba Tek Singh is 97%, which is satisfactory,
and it is incorrect to blame the vaccine. This situation often occurs in areas where there is high immunization
coverage.

Table 14: Surveillance and response activities for selected diseases


What
symptoms Recommended
Vaccine-
Disease control should be type(s) of
Preventable Case definition
objectives reported
Diseases surveillance
(syndromic
reporting)

Polio Eradication of All cases of (1) Any child Active: all hospitals, All AFP cases
the virus. acute flaccid under 15 years clinics, and other paralytic
paralysis of age with sites seeing children illness
(AFP) should sudden are visited regularly suspected
to find AFP cases. should
be reported onset of floppy
All reported or investigated
paralysis OR
rumoured outbreaks within
(2) any person of should be specimens
any age with investigated should apart
paralytic illness immediately. within 14
if polio is
suspected
Measles Depending on All cases of (1) Any person Control phase: Control
the national fever with in whom a Routine monthly phase: During
measles goal: rash should be clinician reporting of to document
reported and suspects measles aggregated data on measles
1. Control
investigated. infection, OR clinical measles confirmation
phase: control
cases: by location, may
of disease and (2) Any person
age group and approximately
prevention of with fever AND
immunization status. Elimination
deaths. Reduce maculopapular
phase: of
the number of (non-vesicular) Elimination phase:
every
measles deaths rash AND Active case-based
suspected
by 90% by 2010 cough, coryza surveillance should
Samples for
(compared to (runny nose) or be conducted and
measles be
2000 estimates). conjunctivitis every case should be
collected
(red eyes). reported and
2. Elimination
investigated
phase: Achieve
immediately.
and maintain
interruption of
indigenous
measles
transmission.
Regional goals
vary.

51
What
symptoms Recommended
Vaccine-
Disease control should be type(s) of
Preventable Case definition
objectives reported
Diseases surveillance
(syndromic
reporting)

Neonatal Elimination of All cases of Any neonate Active surveillance High Risk
Tetanus disease as a neonatal with normal in selected hospitals, areas: as part
public health deaths (deaths ability to suck in combination with of the Low
problem (i.e. before a baby and cry during AFP and measles. Risk areas:
less than 1 NT is 28 days the first 2 days
case per 1000 old) should be of life
live births in reported.
AND who,
every district).
between 3 and
28 days of age,
cannot suck
normally
AND becomes
stiff or has
spasms (i.e.
jerking of the
muscles).

Diphtheria Control of Severely ill An illness Routine monthly Investigate all


disease and children with characterized by reporting of specimens
prevention of sore throat. laryngitis OR aggregated data. where
epidemics. pharyngitis OR
Active surveillance
tonsillitis AND
in areas known to be
the presence of
at high risk or
an adherent
outbreak situation.
membrane of the
tonsils, pharynx,
and/ or nose.
Pertussis Control of Children with A person with a Routine monthly Investigate all
disease and persistent fits cough lasting at reporting of specimens
prevention of of coughing least two weeks aggregated data. where
deaths. Active surveillance
especially if AND with at
in areas known to be
accompanied least one of the
at high risk or
by a ‘whoop’ following
outbreak situation
at the symptoms:
end of each (1) Paroxysms
bout and (i.e. fits) of
vomiting. coughing, (2)
Inspiratory
whoop, or (3)
post-tussive
vomiting

52
What
symptoms Recommended
Vaccine-
Disease control should be type(s) of
Preventable Case definition
objectives reported
Diseases surveillance
(syndromic
reporting)

(i.e. vomiting
immediately
after coughing)
without other
apparent cause.

CHAPTER 6: Setting up and monitoring surveillance

6.1 Setting up passive surveillance

In consultation with the national, provincial and district programme manager, a list should be drawn up of all
health facilities (both public and private) and practitioners who are likely to see cases of the disease. Most
countries already have some form of passive disease surveillance system; however, these might have to be
strengthened and should be supervised regularly. The institutions and persons should be visited and briefed
about case definition, frequency of reporting, reporting format, deadlines for each report and the address to
which the report should be sent. They should be instructed to send a periodic report even if no cases are seen
during the reporting period.

When no cases are seen, ‘zero reporting’ is used, with a ‘0’ in the report, also known as negative reporting. This
is important to ensure the completeness of reporting for monitoring the quality of the surveillance system and
gives provincial and national authorities’ confidence that the surveillance system is operational, even if no
disease is identified. A simple table should be maintained to track the completeness of reporting. Tracking form
for 0 reporting is provided in the annexure.

6.2 Setting up sentinel surveillance

Sentinel surveillance is the collection and analysis of data by designated institutions selected for their
geographical location, medical specialty and ability to diagnose and report data accurately. Generally, sentinel
surveillance is useful for answering specific epidemiological questions, but, because sentinel sites may not
represent the general population or the general incidence of the disease, they might be of limited use for
analyzing national disease patterns and trends.

53
Table 15: Overview of sentinel surveillance method:
System description Advantages Disadvantages

Limited catchments area Easy to collect data on Although less costly than population
individual patients based surveillance, may still require
significant investment in personnel
and resources

Comprises network of hospitals Less costly and less Data may be biased or skewed
and laboratories selected from demanding on resources
among all hospitals and
laboratories in the surveillance
area

Usually includes largest hospitals Flexible system design Data are not generalizable to the
in the area population of the area

Pre-evaluation needed to select Useful for documenting Does not allow collection of data on
appropriate sentinel sites trends incidence

Allows routine
monitoring of resistance
to antibiotics

6.3 Setting up active surveillance

The following steps are involved in establishing an active surveillance system. It requires personnel at the senior
management level who will manage active surveillance, train staff at various levels and help select the reporting
sites.

6.3.1 Identify surveillance officers (District surveillance coordinator)

Surveillance officers will be the focal points responsible for visiting designated active surveillance sites in the
network, conducting core investigations and making follow-up visits. These could be staff already engaged in
related activities, such as district immunization workers.

6.3.2 Seek the cooperation of health facilities

54
The choice of active surveillance reporting sites depends on several factors, including the disease under
surveillance and the behavior of the community towards illness. The selection should be made in consultation
with persons at the senior management level, and they may include hospitals, clinics, private practitioners and
traditional healers. Following are few steps for setting active surveillance:

• the surveillance officer should make an effort to meet busy health-facility staff personally to obtain their
commitment, cooperation and continued involvement in active surveillance.
• it is useful to conduct an introductory meeting at which the hospital staff, clinicians and health workers
are provided with information, such as booklets or posters, to improve their knowledge about the disease
and to explain the rationale for conducting active surveillance.
• at the meeting, the standard case definitions should be introduced, and it should be emphasized that all
cases that fit the case definition must be reported, even if the diagnosis is uncertain.
• clinicians must be assured that the results of laboratory investigations will be sent to them as soon as
they are available.

One staff member in each facility should be identified who will be the focal person for that institution,
responsible for assisting in active case detection and reporting.

6.3.3 Frequency of active surveillance visits


In addition to active case detection by staff, regular surveillance visits to the reporting site should be conducted
by the surveillance officer. The frequency of visits to any particular site is determined by the likelihood of
suspected cases being admitted, so that timely epidemiological investigations can take place. If the likelihood
of a suspected case being seen at the institution is high, the surveillance officer should make weekly visits; if
the likelihood is medium, the visits can be monthly, and if the likelihood is low, the visits can be quarterly.

6.3.4 Content of an active surveillance visit


The five key steps in an active surveillance visit are summarized below and given in more detail in Annex 3.

1. Visit all places in a hospital where cases might be found. Cases might be seen in both outpatient
departments and inpatient wards. For instance, an uncomplicated case of measles will be seen and
treated in an outpatient department, while a measles case with complications might be admitted to the
paediatric ward, and measles cases with neurological symptoms might be admitted to a neurology ward.
2. Examine all records that might yield information. Outpatient registers, inpatient registers, discharge
summaries, laboratory request forms and hospital record rooms can all yield useful information.
3. Consult anyone who might know of a case. It is always preferable first to contact the focal point of the
institution on every visit, who might already have a list of cases or records. Then, meetings should be
arranged with department heads, chiefs of units in the department, resident doctors, staff nurses in-
charge of indoor wards, laboratory chiefs and doctors in the emergency room.
4. Collect the information on suspected cases on standard questionnaires according to the disease.
5. Take appropriate action when a case is found. The staff nurse or doctor on duty should be informed
that a suspected case has been found, and the case should be worked up on a standard questionnaire.
Appropriate specimens should be collected and sent to the designated laboratory, and arrangements
should be made for follow-up examinations and feedback of laboratory results to the reporting hospital.

55
Appropriate infection control measures should be implemented in the health facility to prevent disease
transmission.
Active surveillance visits should be monitored closely. One way to keep a record is to note on the margins of
the hospital or clinic registers the date of the visit, name of the person examining the records and the number of
cases that were detected during the visit. Permission to write on the registers should be obtained from the
institutions’ authorities beforehand.

6.4 Collecting information for a surveillance system:

There is wide variation in the level of detail required from surveillance data collected. No matter what type of
surveillance is chosen, the starting point is a standard case definition.

Standard case definitions

A standard case definition is an agreed set of criteria, usually clinical, used to decide if a person has a particular
disease. Use of standard definitions ensures that every case is detected and reported in the same way, regardless
of where or when it occurred or who identified it.

As soon as a case meets the standard case definition it is labeled as a ‘suspected’ case. Once necessary steps
for confirmation of diagnosis have been undertaken, including appropriate laboratory tests, and the diagnosis is
confirmed, the case is labeled as a ‘confirmed’ case.

Cases to be investigated

The objectives of the disease control programme must be considered when deciding on the number of cases to
be investigated;

1. The diseases under eradication or elimination are included in the case-based surveillance, every AFP,
Measles, rubella, diphtheria, pertusis and NT cases to be investigated by the District Surveillance
Coordinators and / or by the attending physician. Every AEFI case should be investigated.
2. If the disease is to be controlled, it may not be necessary to investigate every case, and it might be
sufficient to investigate the index case(s) of a cluster to confirm the diagnosis and to do an active search
to determine the extent of the cluster/outbreak.
3. Use case investigation forms to investigate cases. These are disease specific. Information is usually
collected face to face, sometimes requiring visits to the home, hospital or community. The quality of
data recorded on the form is extremely important, as it will be used to decide whether public health
action is necessary.

56
6.5 Monitoring surveillance quality

Monitoring is the systematic, continuous examination of data, measurement of progress, identification of


problems and formulation of solutions and planning of interventions. It should be conducted regularly and, when
necessary, lead to corrective action. A range of strategies can be used to monitor the quality of surveillance,
some of which are summarized below.

6.5.1 Performance indicators

To get the most out of monitoring the quality of a surveillance system, including the data that are reported, there
must be a set of performance and quality indicators against which progress and accomplishment can be
measured. These will vary by disease but can include the following:

• completeness of weekly reporting (including ‘zero’ reports).


• timeliness of weekly reporting (including ‘zero’ reports).
• investigation of cases within 48 hours of being reported.
• proportion of cases for which specimens were collected and sent to a laboratory.
• mapping of reporting sites to ensure that all areas are covered.

Avoiding duplication/missing:
Care must be taken to avoid double-counting cases when reporting them to a higher level. Double- counting is
accidental inclusion of the same case more than once. This is possible for cases (AFP, Measles, rubella,
diphtheria, pertussis and NT) that are reported immediately, for instance when both active and passive reporting
systems are operating for the same disease. All VPDs are also being reported on web based dashboard DSS. It
happens that some cases entered in one system may be missed in other system. Care must be taken to report the
same number of cases in every system. One way to avoid duplication/missing is to make a list of cases (Line
Listing) and check for identical entries e.g. names and addresses or case numbers. Standard Operating Procedure
is as follows:

• Daily in the morning check for entries of IDIMS and dashboard. Harmonize two entries to be same. If, one
entry is missing in one system, enter it in the other system as well.
• Download the updated line list of VPDs from both systems. It should be the same. Case Investigation Form
(CIF) for AFP, suspected measles and suspected NT should be filled and entries in the line list should be
corrected as per investigation. Date of sample collection should be entered on dashboard.
• At the end of the week, match form B with AFP line list and send electronic copy of weekly VPD line list
on form B to the provincial office.
• At the end of each month, on receipt of DHIS reports, the number of each diseases on dashboard should be
matched and DHIS report be sent to the provincial office.

6.6 Case Confirmation

6.6.1 Methods

A case reported from the periphery, meeting the standard case definition is called a ‘suspected’ case. A
suspected case has the signs and symptoms of the disease and meets the standard case definition. Suspected
cases need to be investigated further. If a suspected case has an epidemiological link to another confirmed case
57
and/or has positive laboratory tests, it is ‘confirmed’. Laboratory confirmed cases do not need to demonstrate
an epidemiological link to a confirmed case because laboratory confirmation alone is sufficient to confirm a
case.

The laboratory tests necessary to confirm cases of the other vaccine-preventable diseases, the clinical pictures
and case definitions are described in Annex 2. Tetanus is the only vaccine-preventable disease for which the
clinical case definition is sufficient for confirmation, as laboratory confirmation and epidemiological links are
often not possible.
Laboratory confirmation flow-charts

Suspect measles cases

Adequate blood No adequate blood

specimen specimen

IgM negative IgM positive Epidemiologic link to No epidemiologic link to

laboratory confirmed case laboratory confirmed case

Discard Laboratory confirmed Clinically confirmed

6.6.2 Epidemiological associations

An epidemiological association can be proven when a case can be linked back to contact with a laboratory-
confirmed case any time during the infectious period For example, an epidemiological association for measles
might be as follows: 15 days ago, a child with measles confirmed by a blood test attended a party with another
child, who now has a rash. The incubation period of measles is 7–18 days and rarely up to 21 days. The usual
period between exposure and development of rash is around 14 days.

6.6.3 Laboratory confirmation

58
For laboratory confirmation, results must be available for specimen(s) that have been collected, shipped and
tested adequately, and indicate acute infection. For example, a laboratory confirmation for measles might be the
presence of measles specific immunoglobulin M (IgM) antibodies in the serum in a sample collected 4–28 days
after the onset of rash.

Annex 2 describes the necessary laboratory tests for confirming cases. Specimens of blood, cerebrospinal fluid,
stools or nasopharyngeal secretions might be required, depending on the disease. Guidelines are available for
the collection and shipment of specimens. Before collecting specimens, call or otherwise contact the laboratory
to find out the exact requirements, because the specimens might not be analyzed if they were incorrectly
collected, handled or shipped, or if the accompanying documentation is insufficient.

Are laboratory specimens needed for every case?


For vaccine-preventable diseases subject to eradication or elimination, laboratory specimens are needed from
every suspected case. For example, stool samples should be taken from all cases of acute flaccid paralysis
and blood samples from suspected measles cases in countries like Pakistan, who are in the elimination phase.

For other vaccine-preventable diseases, including those subject to control, specimens are not always needed
from every case, and it may be sufficient to take a sample of specimens (as per national policy) to confirm an
outbreak. Note that no specimens are required for neonatal tetanus, because a clinical diagnosis can
confirm the disease.

59
CHAPTER 7: Adverse Events Following Immunization
(AEFI) 10
7.1 Definition of AEFI
AEFI is any untoward medical occurrence that follows immunization and which does not necessarily
have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or
unintended symptom (complained by the patient) or abnormal laboratory finding or sign (found by the
doctor) or disease.

7.2 Cause-specific categorization of AEFI (CIOMS /WHO 2012)


Table 16: There are 5 categories of AEFI according to cause
Cause-specific type of Definition
AEFI

Vaccine product-related An AEFI that is caused or precipitated by a vaccine due to one or


more of the inherent properties of the vaccine product.
Reaction

Vaccine quality defect-related An AEFI that is caused or precipitated by a vaccine that is due to
Reaction one or more quality defects of the vaccine product, including its
administration device as provided by the manufacturer.

Immunization error related An AEFI that is caused by inappropriate vaccine handling,


reaction (formerly “programme prescribing or administration and thus by its nature is
error”)
preventable.
Immunization anxiety-related An AEFI arising from anxiety about the immunization.
Reaction
Coincidental event and anxiety. An AEFI that is caused by something other than the vaccine
product, immunization error, or immunization anxiety, but a
temporal association with immunization exists.

As Immunization error related AEFI is the most concerning category in program perspective; it’s
discussed in detail:

10
Global Manual on Surveillance of AEFI,
https://www.who.int/vaccine_safety/publications/aefi_surveillance/en/, Sep 2014
:60
Table 17: Immunization error-related reactions (formerly “programme error”)
Immunization error Related reaction

Error in vaccine Exposure to excess heat or Systemic or local reactions due to changes in the
handling cold as a result of physical nature of the vaccine, such as agglutination
inappropriate transport, of aluminum-based excipients in freeze-sensitive
storage or handling of the vaccines
vaccine (and its diluents
where applicable)

Use of a product after the expiry Failure to protect as a result of the loss of potency or
date nonviability of an attenuated product

Error in vaccine Failure to adhere to a Anaphylaxis, disseminated infection with a LAV


prescribing or contraindication
non-adherence to
recommendations Failure to adhere to vaccine Systemic and/or local reactions, neurological,
for use indications or prescription (dose muscular, vascular or bony
or schedule) injury due to incorrect injection site, equipment or
technique

Use of an incorrect diluent or Failure to vaccinate due to incorrect diluent, reaction


injection of a product other than due to inherent properties of whatever was
the intended vaccine administered other than the intended vaccine or
diluent
Error in
administration

An incorrect sterile technique or Infection at/beyond the site of injection


inappropriate procedure with a
multidose vial

Table 18: Common minor vaccine reactions:


Local reaction(Pain, Fever (greater Irritability, malaise and
Vaccine
swelling, redness than 38ºC non-specific symptoms

BCG Common - -

Oral Polio Vaccine - Less than 1% Less than 1%


(OPV)

Pentavalent (due to Up to 50% Up to 50% Up to 60%


Pertussis)

PCV Up to 50% ~5% Very common

Measles Up to 10% 5%–15% Up to 5% (rash)

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Tetanus Toxoid Up to 10% b Up to 10% Up to 25%

• Diarrhoea, headache, and/or muscle pains.


• Rate of local reactions likely to increase with booster doses, up to 50% to 85%.
• With whole cell Pertussis vaccine. Acellular Pertussis vaccine rates are lower.

Table 19: Rare serious vaccine reactions


Vaccine Reaction Onset interval Rate per
Million doses

BCG Supporative adenitis 2–6 months

BCG osteitis Up to several years 100–1000

Disseminated BCG-it is 1–12 months

Oral Polio Vaccine associated paralytic


Vaccine poliomyelitis (VAPP) 4–30 days Up to 0.4 b
(OPV)

Pentavalent Persistent (>3 hours) inconsolable 0–48 hours 1000–60 000


(due to screaming
Pertussis)

Seizures
0–3 days 600 c

Hypotonic hyporesponsive episode


0–24 hours 30–990
(HHE)

Anaphylaxis/shock
0–1 hour 1–6

PCV

Measles Febrile seizures 5–12 days 330

Thrombocytopenia (low platelets) 60 days 30

Anaphylaxis 0–1 hour 1

Tetanus Brachial neuritis 2–28 days 5–10


Toxoid

Anaphylaxis 0–1 hour 1–6

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Sterile abscess 1–6 weeks 6–10

• Reactions (except anaphylaxis) do not occur if already immune (~ 90% of those receiving a
second dose); children over six years are unlikely to have febrile seizures.

• VAPP risk is higher for first dose (12 per 1.4–3.4 million doses) compared to 1 per 5.9
million for subsequent doses, and 1 per 6.7 million doses for subsequent contacts.

Seizures are mostly febrile in origin, and rate depends on past history, family history and age, with a
much lower risk in infants under the age of four months.

7.3 Steps for Establishing Immunization Safety Surveillance System


The following steps needed to develop an immunization safety surveillance system:

1. Clarify and agree on the roles and responsibilities of both the immunization programme and the
DRAP in immunization safety surveillance. It is important to designate an institute to implement
immunization safety surveillance. The roles and responsibilities of the different categories of
staff involved in immunization safety surveillance should be clearly identified.
2. Develop a protocol with clearly defined objectives for immunization safety surveillance,
including strategies, structure, activities, and resources.
3. Obtain legal provision for vaccine pharmacovigilance and government commitment.
4. Establish a provincial expert committee for causality assessment and for high-level technical
support and decision-making.
5. Develop and disseminate a list of events or criteria to be reported (and investigated), their case
definitions, standard investigation procedures, and AEFI reporting and investigation forms.
6. Ensure that staff are aware that monitoring and evaluation of activities are both important and
necessary. Train staff in reporting, data analysis, and investigation and report preparation,
according to the level at which each function is carried out.
7. Develop training materials and training modules suitable for the country’s immunization and
safety surveillance programme.
8. Develop a feedback system to update regularly the AEFI surveillance system (including statistics,
investigation findings, new developments).
9. Develop a communication plan to address concerns about, and information on, immunization and
safety surveillance.
10. Consider establishing a legal framework for a compensation scheme or social support scheme,
where applicable. If a legal framework is developed, ensure that it is within the government’s
health and/or social welfare policy.

7.4 Reportable AEFIs:


Any AEFI that is of concern to parents or health-care workers should be reported. In particular, health
workers must report:

• serious AEFI;
• signals and events associated with a newly introduced vaccine;
• AEFI that may have been caused by an immunization error;
• All cases requiring hospitalizations that are believed by health workers, or the public, to be
related to immunization.
• All deaths that are believed by health workers, or the public, to be related to immunization.
• Significant events of unexplained cause occurring within 30 days after vaccination;
• Events causing significant parental or community concern.

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7.5 Reporting Steps:

In most systems the following steps are used to report AEFI.

Peripheral and hospital health workers submit a routine


surveillance report that includes AEFI, to their supervisors at
the district level.

The district supervisors then compile the data for reporting


to higher levels using a summary form.

Managers consider whether or not AEFI, and which AEFI,


should be reported directly to the central level.

Reports should be made on a standard AEFI Report Form. At a minimum, the AEFI report needs to
include:

• a description of the event including date and time of onset of AEFI;


• timing of the event in relation to immunization;
• vaccine(s) given including batch number;
• patient’s identifying details including address and family member contact.

:64
Additional items, such as patient information (age, ethnicity, gender), vaccine information
(manufacturer, lot number), and administration information (date of immunization, site and route of
injection) could be included.

7.6 Reporting Timeline:


The reportable AEFI should be reported upward within 24 hours of detection by a health worker with
assistance of community volunteers. This timely report allows for:

• quick identification of any Programme errors that might be present.


• implementation of early corrective strategies before other peoples is exposed to the same error.
• members of the community seeing that their health and concerns are taken seriously.

Health facility workers submit a routine surveillance report that includes AEFI, to their supervisors at
the district level.

The district supervisors then compile the data for reporting to higher levels using a summary form.
Managers consider whether or not AEFI, and which AEFI, should be reported directly to the central
level.

7.7 Roles and Responsibilities in immunization safety Surveillance:


Table20: Roles and responsibilities of province, district, and health facility
Health facility District Level Provincial & National Level
❖ Detection of AEFI ❖ Reporting of AEFI ❖ Reporting of AEFI
❖ Recording of AEFI ❖ Investigation of AEFI ❖ Investigation of AEFI
❖ Reporting of AEFI ❖ Corrective action ❖ Causality assessment
❖ Clinical Management ❖ Analysis of AEFI data ❖ Corrective and preventive
❖ Public education/ actions
communication ❖ Analysis of AEFI
❖ Monitoring, supervision, and
training
❖ Public education/
communication

7.8 Action and follow-up to AEFI


Responding to AEFI may involve immediate short-term activities or/and long-term follow-up
activities. Follow-up activities should be based on findings of investigations, causality assessments
and recommendations by the investigation/expert committees. Major follow-up actions may have an
impact on the national immunization programme, as well as on regional and global programmes and
planning.

7.8.1 Patient care


It is of utmost importance to ensure that proper and early treatment is received by affected vaccinees
(patients), regardless of the diagnosis. Mild symptoms such as mild fever and pain are likely to be of
short duration and can be managed by assuring and educating parents during immunization. Health
:65
workers need to know how to recognize AEFI, how to treat them or refer them to a clinician/hospital,
and must report AEFI as soon as possible (as recommended in the country guidelines).

7.8.2 Management of suspected anaphylaxis or collapse


after vaccination Sudden and severe events occurring post-vaccination, especially syncope, are
frequently reported as anaphylaxis. However, anaphylaxis following vaccination is considered to be
very rare and the risk (in general) is 1-2 cases per million vaccine doses. The onset of anaphylaxis can
occur after several minutes (> 5 minutes) but rarely up to two hours following vaccination. The
progression of symptoms is rapid and usually involves multiple body systems, almost always with
skin involvement (generalized erythema and/ or urticaria), as well as signs of upper and/or lower
respiratory tract obstruction and/or circulatory collapse. In young children (though anaphylaxis occurs
at any age) limpness, pallor or loss of consciousness may reflect hypotension. In general, the more
rapid the onset, the more severe is the reaction. Symptoms limited to only one system can occur,
leading to delay in diagnosis. Biphasic reactions where symptoms recur 8-12 hours after onset of the
original attack, and prolonged attacks lasting up to 48 hours, have been described. Events happen
without warning. Emergency equipment must be immediately at hand whenever immunizations are
given. All vaccinators must be familiar with the practical steps necessary to save life
following anaphylaxis Each vaccinating centre must have an emergency kit with adrenaline.
The expiry date of the adrenaline should be written on the outside of the emergency kit and the whole
kit should be checked three or four times a year. It is important to note that health-care workers may
misdiagnose syncope attack as anaphylaxis and administer adrenaline as a part of the emergency care.
If the correct dose of adrenaline according to age and weight is administered via the intramuscular
route, no harm is likely to occur. However, an overdose, by administering intravenous or intra-cardiac
adrenaline or by repeated administration, may cause harm.
For all cases of suspected anaphylaxis it is important all symptoms and signs are well documented by
health-care providers (e.g. immunization providers, ambulance records, Emergency Department
clinical notes). The Brighton Collaboration case definition for anaphylaxis should be consulted for a
list of possible symptoms and signs of the condition, and subsequent review can ascertain if the case
definition of anaphylaxis is met. Elevated mast cell tryptase is included in the case definition and
potentially this could be helpful, but it is rarely considered in a primary care or emergency department
setting where children are likely to present post-immunization. Because anaphylaxis is very rare, other
causes of sudden and severe symptoms postimmunization that occur more commonly than
anaphylaxis need to be considered. Table 20 lists those conditions which may be mistaken for
anaphylaxis.

7.8.3 Follow-up actions


Depending on the nature of the event(s), the number of people affected, and community perceptions,
an investigation may be conducted. In general, it is not advisable to discontinue the immunization
programme while awaiting the completion of the investigation. If AEFI causality is not established –
depending on the nature of the event, its extent and whether it is ongoing – a further investigation or
epidemiological study may be warranted. However, it must be accepted that in some cases the
relationship to vaccine will never be clear.

:66
Diagram of action needed for reported AEFI

AEFI reported to, presenting at, or occurring in


any health facility

Health Worker:

• Treats the patient or transfers to higher level treatment if needed


• Communicates with the parents and community
• Responds to rumors or public enquiry
• Fills in a case investigation from

Is this a serious adverse event1?

NO YES

Monitor for
clustering2

Cluster?
Send report immediately
to supervisor to initiate
YES investigation of cause

No

Causing serious concern in


the community or Correct the problem
negative publicity

NO YES

1
Defined as serious if it results in a) Death, b) Hospitalization, c) Disability and d) Life Threatening.
2
A cluster is defined as an AEFI which occurs with unusual frequency; 1) by vaccine, 2) by type reaction,
or 3) by locality / facility.

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7.9 Communication
Although managing a country’s immunization programme requires in-depth knowledge of the
technical aspects of vaccination, programme managers are also increasingly being asked to respond to
communications issues caused by real or perceived AEFI. Communication with parents, the
community, health staff and the media need to be carried out under many circumstances, from
launching new vaccines and putting in place mass immunization campaigns to issuing reminders to
maintain vaccinations up to date. When a vaccine safety investigation is under way as a result of a
report of an AEFI, communications involve keeping the public informed about the investigation, the
results, and actions already taken or to be taken regarding the AEFI. At the same time, it is crucial to
highlight the benefits of immunization even while communicating about an investigation. Trust is a
key component in the exchange of information at every level. Premature statements about the cause of
the event before the investigation is complete should be avoided. If the cause is identified as
immunization-related error, it is vital not to lay personal blame on anyone, but to focus on system-
related problems that resulted in the error(s) and the steps being taken to correct them. In
communicating with the community, it is useful to develop links with community leaders and local
health workers so that information can be rapidly disseminated. Maintaining lines of communication
with the community is important throughout the investigation. Upon completion of the investigation,
the cause of the event(s) must be communicated to the community. This communication must include
information about the steps being taken to remedy the situation and to prevent a recurrence, if such
steps are needed.
Communication with stakeholders: There are many parties to whom communications should be
tailored in order to meet their particular needs. During communication the following things should be
ensured
➢ listen empathetically to concerns;
➢ reassure and support but do not make false promises;
➢ communicate frequently;
➢ build up and maintain relationship among the stakeholders;
➢ inform audiences about possible common adverse events and how to handle them;
➢ prepare fact sheets on adverse events and other key information for all audiences;
➢ continuously communicate during the investigation period in order to ensure understanding
both of the situation and of the balance of risk and benefit of vaccination.
➢ Do not apportion blame, especially not on the health worker(s), but focus on the correction
and quality of the national immunization system.
➢ Keep health workers updated on the investigation process, progress, and findings.
Vaccine safety information needs to be shared with other stakeholders in order to ensure the
dissemination of correct information and, by doing so, to ensure the smooth functioning of the
national immunization programmme. This may be done in two stages: sharing preliminary
information at the initial stage and sharing the final data/report after completion of the
investigation/causality assessment.
Communicating with the Media: The media (newspapers, radio, television and the Internet) play an
important role in public perception. Understanding what the media want from a story will assist
communication with them. In certain situations, media coverage can lead to public concern about
immunization. In these situations, it is important to coordinate with professional organizations, health
professionals and health-care workers before responding to or addressing the media. The coordination
should include preparation on dealing with public concern about this issue in order to minimize any
potential harm to the immunization programme. Reporters are highly trained professionals and are
and their perspective must be properly understood. The media are interested in stories that will attract
attention. While the success of a vaccination programme can attract attention, so can a programme
that has not gone as planned. Dramatizing and personalizing events can both highlight success as well
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as create a sense of panic about an AEFI with a particular vaccine product – regardless of whether the
AEFI is unrelated to immunization (coincidental) or is a localized immunization error. One other
important fact is the media want early responses to their questions: therefore, waiting for the
conclusion of an investigation is rarely possible. Information may need to be disseminated early and
often, and it is vital to be honest about what is known and what is not known, and to avoid being
evasive and unresponsive.

Key Messages: Communication messages should be as simple as possible. Use simple words and
short sentences. It is helpful to tell a story, if possible. Create a “word picture” (a graphic or vivid
verbal description) to get the message across. The key messages should be kept to a minimum and
should include some of these facts:
➢ The benefit of immunization in preventing certain diseases is well proven. VPDs caused
millions of deaths and a huge amount of disability before the introduction of vaccines, and
that situation would return without continued use of vaccines.
➢ It is risky not to immunize (risk of disease and complications).
➢ Vaccines may/do cause reactions, but these are rarely serious.
➢ Immunization safety is of paramount importance and maintaining confidence in immunization
programmes depends on it.
➢ Any suspicion of a problem is investigated (an advantage of well-established immunization
safety surveillance). This investigation is an example of such an action being taken. There are
many sources of key messages such as these. They should be consulted and tailored to the
local culture and understanding
Press Statement: All the information to be conveyed in a media conference should be prepared in
advance and included in a press statement/press release. An effective press statement/ press release
must specifically answer the six Ws and should include a one-page (400500 words maximum)
account written in short sentences outlining:
➢ a complete account of the event, framed in its context (e.g. an isolated event or a cluster of
AEFI, or a coincidental event);
➢ no technical jargon;
➢ an outline of actions taken or planned (such as the AEFI investigation);
➢ a description of the possible cause of the event;
➢ an assurance that corrective action will be taken, and what steps have already been taken;
➢ reference to any relevant publication or website for further information;
➢ the sender’s name and spokesperson’s details;
➢ quotes from key officials, after seeking their permission (the quotes must be positive and
carry the key messages);
➢ repetition of the key message.
Follow-up actions with communications
Keeping promises: If it has been promised that updates about the investigation will be disseminated,
make sure that this is done by the promised date. If the findings have been delayed, ensure that the
delay is communicated.
Providing answers to unanswered questions: If a question cannot be answered for any reason, get
back to the requestors with the answers as soon as possible.
Keeping the public informed about subsequent developments: If any decision or action is taken at
the highest levels following the AEFI investigations, or during the investigations, and the public must
know about it, keep them informed though a press release to the media or other locally appropriate
means.

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Crisis Management: A crisis is a situation in which a real or potential loss of confidence in the
vaccine or in the immunization programme is triggered by information about an AEFI. Crises can
often be avoided through foresight, care and training. If managed properly, the investigation and
management of a vaccine safety situation will boost public confidence and acceptance and ultimately
strengthen the immunization programme. Things to consider in crisis management:
➢ Anticipate. Do not wait until a crisis occurs. Prepare for the unavoidable. Develop a good
relationship with the media. Good public awareness and understanding of the immunization
programme is necessary.
➢ Train staff at all levels to respond adequately. Develop confidence in responding to the public and the
media (particularly the local media) properly and correctly.
➢ Confirm all facts and prepare before making any public comments.
➢ Prepare a plan to react to a crisis when it occurs. This has to be done in advance,

CHAPTER 8: Community Based Surveillance (CBS)


8.1 Definition of Community-based Surveillance11
Community-based Surveillance (CBS) is an active process of community participation in
detecting, reporting, responding to, and monitoring health events in the community.

The scope is limited to systematic on-going collection of data on events and diseases by using simplified
case definitions and forms and reporting to health facilities for verification, investigation, collation,
analysis, and response as necessary. It is included in a routine surveillance system for;
a. the pre-epidemic period (to provide early warning or alerts)
b. the period during an epidemic (to actively detect and respond to cases and deaths)
c. the post-epidemic period (to monitor progress with disease control activities)
Community-based Surveillance (CBS) should also include a process to report rumors and
misinformation of unusual public health events occurring in the community including media reporting.
Media reporting (Electronic, Print, Social) of all suspected cases of vaccine-preventable diseases should
be taken seriously and investigated in time.
Immediate reporting of all suspected cases of vaccine-preventable diseases must be ensured from all
the health facilities including Teaching Hospitals, DHQs, THQs, RHCs, BHUs, Dispensaries, MCH
Centers, CMH, Fouji Foundation Hospitals, PAF Hospitals, Social Security Hospitals, Railway
Hospitals, Private Hospitals, Private Clinics. Linkages should be developed with General Practitioners,
Pharmacists, Community Midwives (CMWs), Lady Health Workers (LHWs), Traditional Healers,
Faith Healers, Traditional Birth Attendants (TBAs), Teachers and directly from the community. All
reporting and investigation tools should be provided to these reporting units so that these can be filled
by the reporting officer.

Objectives of Community Based Surveillance

11
Integrated disease surveillance and response in the African Region: a guide for establishing community-based
surveillance. 2014, https://www.afro.who.int/sites/default/files/2017-06/a-guide-for-establishing-community-
based-surveillance-102014_0.pdf

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CBS is encouraged to create a sense of responsibility, urgency, and ownership and to ensure
maximum coordination and cooperation at the community level. This could be done through
sensitization meetings, training workshops, supervisions by the surveillance team, advocacy campaigns,
and using different media channels, including WhatsApp, local cable, FM etc. for circulation of disease
surveillance messages from time to time.

The tasks for CBS are detection, reporting, investigation, and response for priority diseases
and events in the community.:
1. Use simplified case definitions to identify priority diseases and events in the community.
2. Participating in verbal autopsies to determine the causes of death.
3. Immediate notification to the nearest health facility for prompt investigation and response
4. Involving local leaders in describing disease events and trends in the community.
5. Supporting health workers during the case or outbreak investigation and contact tracing.
6. Participating in risk mapping of potential hazards and in training including simulation exercises.
7. Participating in response activities including home-based care, and sensitization of the community
on the adoption of behavior facilitating the containment of the outbreak.
Using feedback from the Health Facility In-charge to take necessary action, including health
education and community participation.

8.2 Integrated Disease Surveillance


The main basis of integrated disease surveillance is data collection for action for important public
health diseases and events.
In this case, CBS is intended for improving public health surveillance and response by linking
communities with their local health facilities. The health sector can then leverage community structures
for better surveillance, disease prevention, and disease control.

8.3 Priority diseases for CBS


Depending on the local epidemiological profile, priority diseases for CBS can be selected to
address local diseases and conditions including unusual events and Adverse Events Following
Immunization (AEFI). Priority diseases or events for community-based surveillance in Punjab are acute
flaccid paralysis, suspected measles/rubella, suspected neonatal tetanus unusual cluster of health events,
and AEFI. Nationally adopted VPD surveillance guidelines cover the key signs and symptoms to
include in simplified surveillance case definitions relevant to the community level.

8.4 Case definition of priority diseases for community-based


surveillance:

Table21: Case definitions for community-based surveillance


Disease / Event Case Definition

Acute Flaccid Recent or sudden onset of floppy paralysis/muscle weakness in a child aged
Paralysis (AFP) less than 15 years of age

Measles / Rubella A suspected measles/rubella case is a patient with fever and maculopapular
(non-vesicular) rash.

Neonatal Tetanus A suspected case for NT meets either of these two criteria:

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o
Any neonate who could suck and cry normally during the first
two days of life and developed tetanus-like illness or death
between 3 and 28 days of age OR
o Any neonate who died of an unknown cause during the first
month of life.
Unusual cluster of Any emerging disease or event of an unknown or unidentifiable cause
health events resulted in the suffering or death of many people (3 or more cases) from
similar symptoms in a community within one week.

Adverse Adverse event following immunization is any untoward medical occurrence


which follows immunization, and which does not necessarily have a causal
event
relationship with the usage of the vaccine.
following
immunization
(AEFI)

8.5 Steps for establishing Community-Based Surveillance

1. Community-based surveillance team structure


i. The priority diseases are prevalent in Punjab, Pakistan. Many of the cases of these priority diseases
don’t attend in the health facility. Some of the cases attend the health facility very late. So,
community-based surveillance is crucial for early diagnosis and public health management in the
incipient stage of the outbreak. To ensure early notification, Punjab province is going to introduced
community-based surveillance in every community. One Community Surveillance Informant (CSI)
will be selected from the community for 1000-1500 population. The service of the Community
Surveillance Informant (CSI) will be solely voluntary. Preference for selection of Community
Surveillance Informants (CSIs) will be given to Lady Health Workers (LHW), School Health &
Nutrition Supervisors (SH&NS), Vaccinators, CDC Supervisors, Sanitary inspectors, Sanitary
Petrols, Lady Sanitary Petrols, Lady Health Supervisors (LHS), Community midwives (CMW),
Union Council Polio Officer (UCPO), Union Council Communication Officer (UCCO), Social
Mobilizer (SM), Faith Healers, Traditional Healers, Community leaders, Media representatives,
Civil Society Organizations, Skilled birth attendants (SBAs), School health teachers, PEI
Volunteers, etc.
ii. The general criteria for the selection of Community Surveillance Informants (CSIs) will be: 1. The
person should be a respected and well-connected individual with the inhabitants of the community.
2. Completed secondary level education 3. Capable of sending mobile messages and using mobile
applications.
iii. The CSIs will notify about the priority disease over the phone / SMS / mobile app. The reporting
will be soon included in the provincial community surveillance database. Immediate system
generated notification will be sent to to the pertinent health facility surveillance focal person.
iv. The CSI will send a zero reporting SMS to the surveillance focal person on every Saturday evening
by 5 PM if there is no CBS reporting in that week.
v. Terms of reference, role, and responsibilities of CSI should be well defined and followed.

2. Orientation on the identification of notifiable diseases, conditions and public health events
at the community level
i. Capacity building of the Community Surveillance Informants (CSI) enlisted in a community-
based surveillance network on simplified VPDs case definition in local language for easy
understanding and follow up. A one-day orientation on case definition and reporting procedure
will be conducted.
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ii. A one-day refresher orientation for the CSIs will be conducted in every 6 months.
iii. List of priority diseases or conditions for the CBS prepared based on VPD surveillance
guidelines and will be widely distributed.
iv. An appropriate list of simplified community case definitions to facilitate case detection and
monitoring will be widely distributed and followed.
v. Provision of brochures on simplified VPDs case definition to be displayed and used at the
community level.
vi. Posters, banners, brochures on community surveillance will be developed and will be widely
displayed.
vii. There will be planned refresher training of the CSIs during different training and meetings
viii. The required resource will be budgeted and mobilized.

3. Reporting a suspected case or public health event and maintaining records at the
community level
i. Community Surveillance Informant (CSI) will have a register to record suspected cases of
priority diseases.
ii. CSI will immediately inform (through phone, SMS, mobile app) to the health facility
surveillance focal person.
iii. CSI will send a weekly zero report SMS on Saturday at 5 PM if there is no case notified.
iv. Sensitization of Preventive outreach team, LHWs and CMWs for reporting all suspected VPD
cases and AEFI cases immediately and a record review by health facility in-charge during the
monthly meetings at the health facility level
v. A surveillance hotline will be set up in the province to receive calls. SMS, WhatsApp message,
skype message from any person in the community.

4. Investigating and confirming a suspected public health event in a local community


i. After receiving a notification; the health facility surveillance focal person will immediately
record the suspected case and will arrange an investigation within 72 hours.
ii. Mostly the investigation will be done by the health facility in-charge / surveillance focal person.
iii. VPD Surveillance tools should also include AEFI reporting forms for use if any such case is
reported from the health facility or from the community.
iv. The health facility in-charge / surveillance focal person will complete the surveillance
procedure according to the Punjab VPD surveillance guideline.
v. Follow up of the cases should be done according to the SOP.

5. Supervising a community-based surveillance structure


i. Sharing of results and feedback to the Community Surveillance Informant (CSI) who have
reported any case.
ii. Providing feedback to the community
iii. The head of the EPI Technical committee (Health Facility In-charge) will be responsible to
ensure smooth operations of community-based surveillance including record-keeping and
investigation of the reported cases. They will inform the district surveillance coordinator about
all reported cases from the health facility as well as from the community.
iv. LHS will ensure the regular reporting from LHW.
v. Periodical evaluation of community-based surveillance status and quality.

8.6 Sources of information for community-based surveillance


A functioning CBS surveillance network should connect with key sources of information. This includes
but is not limited to the following sources of information:
i. All community-based health workers including Skilled birth attendants (SBAs), School health
and nutrition supervisors constitute privileged sources of information due to their connections

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with the local community and their presence in the field, especially in remote areas where
access to primary health care is scarce.
ii. Community, traditional, youth, or religious leaders and civil society: these individuals and
groups may provide informal reports of unusual health events or health risks that they witness
in their communities.
iii. Media: local, national, and international media are important sources of information for CBS.
Events such as clusters of cases, outbreaks, and unexpected and unusual deaths may be covered
by local newspapers or radio reports before they are detected and reported by local health
services. Facebook, WhatsApp, Local Cable, TV, Twitter etc. can provide such information.
iv. Traditional medicine and traditional health practitioners and healers: a large number of the
population depends on traditional medicine for primary health care. Alternative medicine
(Homeopathics, herbalists, for example) complementary medicine and nonconventional
medicine.
v. Faith healers setups can be used as a source of information on unusual events.
vi. Families are also sources of information.
vii. Community health workers conducting door-to-door activities such as primary healthcare and
family planning services provided by LHWs can collect information about whether anyone in
the household has been ill.

8.7 Training package for community surveillance Informants (CSI)


8.7.1 Objectives of the Training
The specific objectives of this training are to enable participants to:
• identify the priority diseases and events of public health importance
• report suspected cases or conditions or events to the next level
• understand their role in tracing the event when surveillance team coming to the community.

8.7.2 Training Modules

Suggested training outline for CBS focal points is as follows in line with the VPD surveillance
guidelines and training modules:
Lesson 1 - Identifying cases and events: simplified community case definitions, priority diseases,
conditions, and events.
Lesson 2 - Reporting suspected cases, conditions, or events to the next level.

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Annexures:
EXPANDED PROGRAM ON IMMUNIZATION
WEEKLY VPD SURVEILLANCE REPORT, HEALTH FACILITY

Health Facility : __________________________________ Union Council: ______________________ Tehsil/Taluka:__________________________

District/Agency:_________________________ Province/Area: _______________ Date of report received in EDO (H) office: ____/____/____

Epi Week No.:_____ Date: From ____/____/____ To ____/____/____ Year: ________

AFP:________ Childhood TB:_______Diphtheria: _______________ Pertussis:______NT:________Measles:________AEFI:_________________

Total No. of Date of last


Address Clinical
Sr. Type of Father's name of the Age Date of Onset vaccine dose
Name of the case (House #, street, village, Sex Presentation of
No. case* case (month) dd/mm/yy doses received
mahalla, UC, Cell Number) the case
received dd/mm/yy
1 2 3 4 5 6 7 8 9 10 11

Notes: *Type of case means AFP, Measles, NT, Pertusis, Diphtheria, Childhood TB etc.

Prepared by: Date: Health Facility In-charge


Name: Name:
Designation: Designation:

EXPANDED PROGRAM ON IMMUNIZATION


WEEKLY VPD SURVEILLANCE
District/Province weekly VPD report compilation form/line list

District: ______________________ Province/Area: ______________________ # of Reporting unit*: ___________________ # of Report received: ______________________

EPI Week No:____________ Year: ______________

AFP:________ Childhood TB:_________________ Diphtheria: __________ Pertussis:____________ NT:________ Measles:________ AEFI:_________________


Age groups: 0-9=1 10-23=2 24-59=3 60-119=4 120-239=5 >240=6 9=Unknown

Date of No. of Clinical


Week of Tehsil/ Age in Sex Date of Onset Date of last Date of Specimen
S. No Name of Reporting Unit* Type of Cases** Month EPID No.*** Name Father"s Name Contact No. Village/ Mahalla UC District Age Group Investigation**** Vaccination Presentation of
onset Town months (M/F) (dd/mm/yy) dose received collection******
(dd/mm/yy) doses received the Case

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

Compiled by: Date: District/ Province Surveillance focal person: EDO (Health) Provincial Manager- EPI:
Name: Name: Name:
Designation: Designation: Designation:

Note
* Reporting unit: For district level compilation, 'Reporting unit' will be respective reporting health facility. For Provincial leave compilation, 'Reporting unit' will be respective reporting district
** Type of case means AFP, Measles, NT, Pertusis, Diphtheria, Childhood TB etc.
*** Case epid number: Only applicable for AFP and Measles cases. To be filled at district level
**** Date of investigation: Only applicable for AFP, Measles and NT cases. To be filled at district level from CIF
***** Date of specimen collection: Only applicable for AFP and Measles cases. To be filled at district level from CIF

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EXPANDED PROGRAMME ON IMMUNIZATION
Measles Case Investigation Form
PART I: For Use by Reporting Facility and CEO
Name of Reporting Health Facility:
______________________________________________________________________
Union Council: ___________Tehsil/Town: __________________District: ________________Province:
_______________
Date Patient Visited Hospital: _____/_____/_______ Date of notification: _____/_____/________
PAK/Province Code/District ID/Year/Msl/Case Serial # # # #
Patient's Name: ______________________________ Father's Name: __________________________________________
Date of Birth: ____/_____/_______ Age: ____Months Sex: Male/ Female Contact No:
______________________
Address of Patient: Village/Street/Mahalla:______________________________ Union Council:
____________________ Tehsil/Town______________________ District: _________________________
Province/Area:___________________
Date of rash onset: _____/_____/_____ Fever: Yes/No Cough: Yes/No Coryza: Yes/No Conjunctivitis:
Yes/No
Others: ______________________________ Complications:
_________________________________________________ Measles vaccine doses received in
Routine EPI: Zero/ One/ Two Date of last dose of measles vaccination: ___/___/___
Number of additional Measles vaccine doses received during Measles campaign/case response/mop-up: _____________
Type of specimen (circle): Serum Throat Swab Oral Fluid
Date of Specimen Collection: ____ / _____/ _______ _____/_____/_______ _____/_____/________
Date of Specimen S e n t to Lab: ____ / _____/_______ ____ / _____/_______ _____/_____/________
Lab Result to be Sent to: (CEO-H, DSC, Provincial and Federal officials):
Name: ___________________________ Telephone/FAX: ____________________ Email:
__________________________
Address:
___________________________________________________________________________________________
Did patient travel from home within 23 days before rash onset? Yes________ No_________ If “Yes” places visited:
Village/UC:__________________ Tehsil:_____________ District:______________ When & for how
long:_____________
Name of person completing the form: ___________________________________________________________________
Designation: ______________________ Signature: ________________D a t e of investigation: _____/_____/________
PART II: For Use by Receiving Laboratory
Type of specimen (circle): Serum Throat Swab Oral Fluid
Date specimens received at lab: _____ /____ / _______ _____/_____/_______ _____/_____/_______
Lab Number: ________________ _________________
_________________
Condition of specimen: Good / Poor Good / Poor Good / Poor
Quantity Adequate: Yes No Yes No Yes No
Reverse Cold Chain OK Yes No Yes No Yes No
Specimen Received by:
Name & Designation: ______________________ ______________________
_____________________
Date of Lab Test done: _____ / ____ / _______ _____/_____/_______
_____/_____/_______
Type of test done: _______________________ ______________________
_____________________

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Test result: _______________________ ______________________
_____________________
Comment: _________________________________________________________________________________________
Report sent by: Name& Designation: ____________________ Signature: _______________ Date: _____/_____/_______
Result received by the district: _____ / ____ / _______ _____/_____/_______ _____/_____/_______

PART III: Final Classification


Outcome: Hospitalized/ Alive / Dead If died then Date of death: _____/_____/________
Final Classification: Laboratory Confirmed Measles / Laboratory Confirmed Rubella / Epi-Linked Measles/Epi-Linked
Rubella / Clinically Compatible Measles / Clinically Compatible Rubella / Discarded / Any other diagnosis (please
specify)
Classified by: Name & Designation: ______________________ Signature: ______________ Date: _____/_____/_______
Please send the 1st copy of this CIF to the laboratory with specimen, 2nd copy to be sent to CEO (Health) office and 3rd copy to be
kept in the reporting health facility. CEO office must ensure to send completely filled scan copy to provincial EPI Cell Punjab.

EXPANDED PROGRAMME ON IMMUNIZATION


Diphtheria Case Investigation Form
PART I: For Use by Reporting Facility and CEO (Health)
Name of Reporting Health Facility: __________________________________________________________________
Date Patient Visited Hospital: _____/_____/_____ Tehsil/Town: _____________ District: __________________
EPID No: PAK/PB/…………/………/Dip/…………………
( PAK/PB/District ID/Year/Dip/Case Serial # # # #)
Patient's Name: ______________________________ Father's Name: _____________________________
Date of Birth: _____/_____/_____ Age: _________Months Sex: Male/ Female
Address of Patient: Village/Street/Mahalla____________________________________________________________
Union Council: ______________________ Tehsil/Town: _______________________________________________
District: ________________________________Contact No: _____________________________________________
Clinical Presentation: Sore Throat, Low Grade Fever, Adherent Membrane ………………………………………….
Date of onset: ____/____/_____ Date of reporting: ____/____/_____ Date of investigation: ____/____/_____
Number of DPT containing vaccine doses received (circle): Nil/ One/ Two / Three
Date of last dose of vaccination with DPT containing vaccine: _____/_____/_____
Type of specimen (circle): Throat swab Nasal swab
Date of Specimen Collection: ____ / _____/ _____ _____/_____/_____
Date of Specimen S e n t to Lab: ____ / _____/_____ ____ / _____/_____
Travel History: __________________________________________________________________________________
Lab Result to be Sent to: (CEO-H, DSC, Provincial and Federal officials)
Name: _____________________________ Telephone/FAX: _________________ Email: ______________________
Address: _______________________________________________________________________________________

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Name of person completing the form: ________________________________________________________________
Designation: _________________________ Signature: ______________D a t e : _____/_____/_____

PART II: For Use by Receiving Laboratory


Type of specimen (circle): Throat swab Nasal swab
Date specimens received at lab: _____ /____ / ____ _____/_____/_____
Lab Number: ________________ _________________
Condition of specimen:
Quantity Adequate: Yes No Yes No
Cold Chain OK Yes No Yes No
Specimen Received by:
Name: ____________________ ____________________
Designation: _____________________ ____________________
Date of Lab Test done: _____ / ____ / _____ _____/_____/_____
Type of test done: ______________________ ____________________
Test result: _______________________ _____________________
Comments: ____________________________________________________________________________________
Report sent by: Name: _____________________________ Signature: ____________________
Designation: ________________________ Date: _____/_____/_____
Outcome: Alive / Hospitalized / Dead if dead then date of death: _____/_____/_____
Final Classification: Lab Confirmed Diphtheria / Linked epidemiologically to a laboratory confirmed Diphtheria case /
Clinically Compatible Diphtheria (a case that meets the clinical case definition), Discarded (Lab result is negative)
1st copy to be sent to laboratory with specimen, 2nd copy to CEO (Health) office and 3rd copy to be kept in
the reporting health facility

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EXPANDED PROGRAMME ON IMMUNIZATION
Pertussis Case Investigation Form
PART I: For Use by Reporting Facility and CEO (Health)
Name of Reporting Health Facility: __________________________________________________________________
Date Patient Visited Hospital: _____/_____/_____ Tehsil/Town: _____________ District: __________________
EPID No: PAK/PB/…………/………/Per/…………………
(PAK/PB/District ID/Year/Per/Case Serial # # # #)
Patient's Name: ______________________________ Father's Name: _____________________________
Date of Birth: _____/_____/_____ Age: _________Months Sex: Male/ Female
Address of Patient: Village/Street/Mahalla____________________________________________________________
Union Council: ______________________ Tehsil/Town: _______________________________________________
District: ________________________________Contact No: _____________________________________________
Clinical Presentation: Paroxysms (i.e. fits) of coughing, Inspiratory whoop, Post cough vomiting ………………….
Date of onset: ____/____/_____ Date of reporting: ____/____/_____ Date of investigation: ____/____/_____
Number of DPT containing vaccine doses received (circle): Nil/ One/ Two / Three
Date of last dose of vaccination with DPT containing vaccine: _____/_____/_____
Type of specimen (circle): Throat swab Blood serum
Date of Specimen Collection: ____ / _____/ _____ _____/_____/_____
Date of Specimen S e n t to Lab: ____ / _____/_____ ____ / _____/_____
Travel History: __________________________________________________________________________________
Lab Result to be Sent to: (CEO-H, DSC, Provincial and Federal officials)
Name: _____________________________ Telephone/FAX: _________________ Email: ______________________
Address: _______________________________________________________________________________________
Name of person completing the form: ________________________________________________________________
Designation: _________________________ Signature: ______________D a t e: _____/_____/_____
PART II: For Use by Receiving Laboratory
Type of specimen (circle): Throat swab Blood serum
Date specimens received at lab: _____ /____ / ____ _____/_____/_____
Lab Number: ________________ _________________
Condition of specimen:
Quantity Adequate: Yes No Yes No
Cold Chain OK Yes No Yes No
Specimen Received by:
Name: ____________________ ____________________
Designation: _____________________ ____________________
Date of Lab Test done: _____ / ____ / _____ _____/_____/_____
Type of test done: ______________________ ____________________
Test result: _______________________ _____________________
Comments: ____________________________________________________________________________________
Report sent by: Name: _____________________________ Signature: ____________________
Designation: ________________________ Date: _____/_____/_____
Outcome: Alive / Hospitalized / Dead if dead then date of death: _____/_____/_____
Final Classification:
Lab Confirmed Pertussis (A case that meets the clinical case definition and is laboratory-confirmed) / Linked
epidemiologically to a laboratory confirmed Pertussis case/ Possible (if a case that meets the clinical case definition
but is not laboratory-confirmed)

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1st copy to be sent to laboratory with specimen, 2nd copy to CEO (Health) office and 3rd copy to be kept in
the reporting health facility.

EXPANDED PROGRAMME ON IMMUNIZATION

NEONATAL TETANUS CASE INVESTIGATION FORM

(Please complete the form without blanks and use dates according to the given pattern: DD/MM/YYYY

Name of Reporting Unit: _________________________________ Type of Case: Suspected NNT/Clinical NNT

Type of reporting unit: Government Dispensary/BHU/RHC/THQ/DHQ/Teaching

Hospital/Military/Community/Other

EPID. No. PAK/PB/………. /………/NNT/……………. (e.g. PAK/PB/District ID/Year/NNT/0000)

I. PATIENT IDENTIFICATION

Name of respondent: __________________________ Relationship to baby: _____________________

Patient name: ________________________________ Father’s name: __________________________

Date of birth: ____/____/____ Age: _______ days Sex: M  F  Contact No: ________________

Address of Patient: Village/Street/Mohallah: ________________________________________________

UC: _________________ Tehsil/Town: _________________________ District: _______________________

Date of onset: ___/___/____ Date of Notification: ___/___/______ Date of Investigation: ___/___/______

How many pregnancies has the mother had (regardless of outcome, including this one)? __________________

II. CLINICAL INFORMATION

1. Did the baby suck normally for at least the first 2 days of life? YES  NO  Unknown 

2. Did the baby stop suck after the first 2 days? YES  NO  Unknown 

3. Baby’s age at which illness was suspected by the mother/ informant? ________________Days

4. Did the baby have the following signs?

• Spasm when stimulated by touch, sound or light? YES  NO  Unknown 

• Developed “pursed lips” and/or clenched fists? YES  NO  Unknown 

• Become rigid or stiff as illness progressed? YES  NO  Unknown 

• Had tremors, fits or stiffness? YES  NO  Unknown 

5. Did the baby have fever when stiff? YES  NO  Unknown 

6. Did the baby die? YES  NO  Unknown 

7. IF YES, Date of death: ____/____/____ Age at the time of death: ________ Days

III. MOTHER’S HISTORY:

Immunization history by: Card:  Memory:  Both:  Unknown: 


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How many TT doses did the mother receive during the last pregnancy: __________________?

How many TT doses did the mother received before the last pregnancy (on any occasion): ______?

If by card, give dates: 1. ____/____ /____ 2. ____ /____ /____ 3. ____/____/____ 4. ___/___/___

5. ____/___/___

Mother’s antenatal care history

How many antenatal care visits were made during this last pregnancy? ________________________________

Delivery practices

Place of delivery? Government Dispensary  BHU  RHC  THQ  DHQ  Teaching Hospital  Military

 Community  Other 

Who assisted with the delivery? Doctor:  Midwife:  Nurse:  TBA:  Relative:  Nobody:  Other: 

Was a delivery kit used to deliver the baby? YES  NO  Unknown 

What was used to cut the cord? Clean scissor  clean blade  clean knife  other 

If other, specify:

_______________________________________________________________________________

Was any substance put on the cord stump? YES  NO  Unknown 

If yes, specify:

_________________________________________________________________________________

IV. TREATMENT AND OUTCOME:

Was the sick baby taken to a health facility? YES  NO  Unknown 

If yes, give name of health facility: ____________________________________________________________

What was the final outcome for the baby? Hospitalized  Alive  Dead 

Final diagnosis by the health facility: ___________________________________________________________

Visit the health facility if there is doubt whether the case died of neonatal tetanus

V. CASE RESPONSE

Has the mother received TT since the birth of this baby? YES  NO  Unknown 

Did other women in same locality receive TT in response to the case? YES  NO  Unknown 

VI. CONCLUSION:

What does the respondent say was the cause of the baby’s death?

_________________________________________

On the basis of the evidence, was this a case of neonatal tetanus? Confirmed case:  Suspected case: 

Discarded case:  Unable to classify: 

Name of investigator: ___________________________________ Designation: _________________________

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Expanded Programme on
Immunization
AEFI CASE INVESTIGATION FORM
An AEFI case investigation should be initiated within 24 hours of notification of Serious AEFI

Name of case: Sex: M _____F _____


Date of birth: ___ /____/_____ Age: years months weeks
Father/Husband’s name: _____ __
Village: UC ___________ Tehsil/Taluka ____________________
District: Province: _____________________________

Clinical information
Major complaints (put tick as appropriate):

a) BCG Lymphadenitis f) Convulsion


b) Severe Local Reaction g) Unconsciousness
c) Injection site abscess h) Respiratory Distress
d) Fever i) Swelling of body or face
e) Rash j) Others (Pls specify)

Type of AEFI: Minor ( ) Serious ( )


Yes No
Is the case hospitalized:

If Yes, Name and address of the hospital


Information regarding vaccine and vaccination

Date of vaccination:
Name of vaccine(s) received on this day:
Name of manufacturer & Batch/Lot no. of vaccine(s): Expiry date of
vaccine(s):

Name and address of vaccination centre:

Name & designation of person who vaccinated:

Submit this report to the local health facility in-charge within three days. In case of
emergency, report to the local health facility in-charge immediately

Name and designation of the reporting person Date: / /


Copy of all AEFI reports to be sent to the CEO (H) office along with weekly Form B by following Tuesday

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Investigation ID: PAK / / /AEFI / Name of reporting Officer:

Date AEFI reported: Designation:


Date investigation started: Contact No:

Demographic data of the patient:


Name of the child: Date of Birth/Age:
Sex: ❑ Male ❑ Female
Name and cast of Father:
Address: House/Street No. Village: Union Council:
Tehsil/Taluka/Town: District: Province: Contact No:

Place of vaccination: ( ) Govt. health facility ( ) Private health facility ( ) Other (specify)
Vaccination in: ( ) Campaign ( ) Routine ( ) Other (specify)

Address of vaccination site:

Vaccines Manufacturer Lot no./batch no. Expiry Date

Most Recent Immunization History:


Date and time of Vaccine & dose Site of Vaccination Center Vaccinated by
vaccination number administration

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Information about the vaccines and diluents administered to the patient:

a) I n case of multidose vial, was vaccination given:

• within the first few doses of the vial Yes / No


• Within the last doses of the vial administered Yes / No
• Unknown Yes / No

b) Was there an error in prescribing or non-adherence to recommendations for use of this vaccine?
Yes/No /Unable to assess
Based on your investigation, do you feel that the vaccine (ingredients) administered could
c) have been unsterile?
Yes / No / Unableto assess

d) Based on your investigation, do you feel that the vaccine's physical condition (e.g. colour,
turbidity, foreign substances etc.) was abnormal at the time of administration?
Yes/ No / Unableto assess
Yes /No /
e) Based on your investigation, do you feel that there was an error in vaccine Unable to assess
reconstitution/preparation by the vaccinator (e.g. wrong product, wrong
diluent, improper
mixing, improper syringe filling etc.)?
f) Based on your investigation, do you feel that there was an error in vaccine Yes/No/
handling (e.g. Unable to assess

break in cold chain during transport, storage and/or immunization session


etc.)?

g) Based on your investigation, do you feel that the vaccine was administered Yes /No /
Unable to assess
incorrectly
(e.g. wrong dose, site or route of administration, wrong needle size, not
following good injection practice etc.)

h) Number immunized from the concerned vaccine vial/ampoule


Yes/ No /
Unable to assess

i) Yes / No /
Number immunized with the concerned vaccine in the same session Unable to assess

j) Number immunized with the concerned vaccine having the same Yes/ No /
Unable to assess
batch number in other locations. Specify locations:

Is this case a part of a cluster? Yes / No /


k)
Unable to assess

i. If yes, how many other cases have been detected in the cluster?

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a. Did all the cases in the cluster receive vaccine from
the same vial?
b. If no, number of vials used in the cluster (enter
details separately)

Suspected vaccine which caused AEFI:

Describe the adverse event in detail:


H/O present illness: (Signs and symptoms in chronological order from the time of vaccination):

Date of onset of AEFI: Time of onset of AEFI:


Date of hospitalization: Time of hospitalization:
Date of death: Time of death:
Autopsy done? ( ) Yes (date) _ ( ) No
Planned on (date) Time
Attach report (if available)
Source of information ( all that apply):

Examination by the investigator Documents Verbal Autopsy Other

Name of the person who first examined/treated the patient:


Name of other persons treating the patient:
Other sources who provided information (specify):
If Verbal autopsy, please mention source:

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Examination Findings:
Pulse /min Temp °F

BP mm of Hg Heart Rate /min


Resp. Rate /min Lungs (wheeze, creps,
ronchi)
Skin change Size of skin lesion cm
Cyanosis Pupil (reaction to light)
Kernig’s sign Neck stiffness
Level of Consciousness Lymph Node

Jerks
Cranial nerve abnormality

Other Abnormal Signs (if any):

Treatment:

Provisional
Final

Diagnosis:

Outcome:
Died
Disabled
Recovering
Recovered completely
Unknown

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Additional information about the patient: (write yes or no, if yes specify)
Remarks (If yes
Criteria Finding provide details)
Past history of similar event Yes / No / Unkn
Adverse event after previous vaccination(s) Yes / No / Unkn
History of allergy to vaccine, drug or food Yes / No / Unkn
Pre-existing illness (30 days) / congenital disorder Yes / No / Unkn
History of hospitalization in last 30 days, with cause Yes / No / Unkn
Patient currently on concomitant medication? Yes / No / Unkn
(If yes, name the drug, indication, doses & treatment dates)
Family history of any disease (relevant to AEFI) or allergy Yes / No / Unkn
For adult women
• Currently pregnant? Yes (weeks) / No / Unknown
• Currently breastfeeding? Yes / No

For infants
The birth was
Full-term pre-term post-term.
Birth weight:

Delivery procedure was:


Normal Caesarean Assisted (forceps, vacuum etc.) with complication

Community investigation:
No. of cases immunized with suspected vaccine in same session:
No. of cases of same adverse events found in immunized children/women:
No of cases of same adverse events found in unimmunized children/women:

EPI Management Practice (fill up this section by asking and observing practice):
Write yes or no where applicable, if yes

Specify

EPI store:

Temp inside ILR (ºC) :


Temp of freezer (ºC) :
Correct procedure of storing vaccines, diluents and :
syringes followed

Any other object (other than EPI vaccines and :


diluents) in the ILR or freezer

Partially used reconstituted vaccines in the ILR :


Unusable vaccines (expired, no label, VVM stage 3 & :
4, Frozen) in the ILR

Unusable diluents (expired, manufacturer not :


matched, cracked, dirty ampoule) in the store
Transportation:
Type of vaccine carrier used :
Vaccine carrier packed properly :
Vaccine carrier sent to the EPI site on the same day of :
vaccination
Vaccine carrier returned from the EPI site on the same day of :
vaccination
Conditioned ice-pack used :
Reconstitution:
Correct procedure followed :
Correct amount of diluent used :
Used separate syringe for each vial :
Matching diluent used :
Injection technique:
Correct dose and route :
Non- touch technique followed :
Vial shaked before each injection :
Contraindication assessed :

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How many AEFI reported from vaccination sites of the same :
worker in the last 30 days?
Training on EPI received by the vaccinator: (specify the last :
training including date)

Laboratory investigation(s) conducted?


Yes No
If yes, mention the tests (attach copy of the reports)

Assessment:

Conclusion about cause of AEFI: tick categories, rank if more than one cause:

Programme error Vaccine Reaction Coincidental Injection Unknown


Reaction
Non-sterile injection Known vaccine
Vaccine prepared reaction at expected
incorrectly rate
Faulty administration Vaccine lot problem
technique/site Others:
Faulty vaccine
transportation
Faulty vaccine storage
Other
Confidence about conclusion on main cause of AEFI:
Certain Probable Possible
Reason(s) for conclusion:

Corrective Actions:

Recommendations:

Additional Notes (attach additional paper):

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Investigation Team Details:

1. Name: Designation Signature

2. Name: Designation Signature

3. Name: Designation Signature

4. Name: Designation Signature

5. Name: Designation Signature

6. Name: Designation Signature

7. Name: Designation Signature

Date Investigation Completed: / /

Notes:

1) Investigation team will submit the filled in AEFI investigation form to EDO
(Health) office or equivalent. Attach all medical records e.g. prescription,
treatment sheet (if patient is hospitalised), laboratory investigation reports (if
any), death certificate & autopsy report (in case of death, if any), photos etc. with
the investigation form.
2) EDO (Health) or equivalent will send a copy of the investigation report with all
attachments to the Provincial and Federal EPI office as soon as it is completed
and not later than a week after completion of investigation.
3) In case of cluster, use separate investigation form for each case.

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