MIS Biomarker Field Manual (English)

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MAY 17, 2024

BIOMARKER MANUAL:

Training Program for Measuring and
Testing for Biomarkers

[DOCUMENT SUBTITLE]

The DHS Program is a five-year project to assist institutions in collecting and analyzing necessary data
to plan, monitor, and evaluate population, health, and nutrition programs. The DHS Program is funded
by the U.S. Agency for International Development (USAID). The project is implemented by ICF in
Rockville, Maryland USA, in partnership with the Johns Hopkins Bloomberg School of Public
Health/Center for Communication Programs, PATH (formerly, the Program for Appropriate Technology
in Health), Avenir Health, Blue Raster, and EnCompass, IFORD, and AFIDEP.

The main objectives of The DHS Program are to: 1) provide improved information through appropriate
data collection, analysis, and evaluation; 2) improve coordination and partnerships in data collection at
the international and country levels; 3) increase host-country institutionalization of data collection
capacity; 4) improve data collection and analysis tools and methodologies; and 5) improve the
dissemination and utilization of data.

Information about The DHS Program may be obtained from ICF, 530 Gaither Road, Suite 500, Rockville,
MD 20850, USA; Telephone: +1-301-407-6500; Fax: +1-301-407-6501; E-mail: [email protected];
Internet: http:/Awww.dhsprogram.com.

Contents

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3.E. Collecting the blood from a finger Prick............ccccsscccccceesssessaecececesseseaeseceeecessesseaeaeeeeseessessaaeees 21
3.F. Obtaining capillary blood from a Child’S Neel ...........cccccccsssssssecececeesesesneseceeecesseseaeeeeeesessseseeaeees 27
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4.B.

4.C.
4.D.
4.E.
4.F.
4.G.
4.H.
Al.
4.J.
Chapter 5.
5.A.
5.B.
5.C.
5.D.
Chapter 6.
6.A.
6.B.
6.C.

Materials and supplies for preparing, storing and transporting blood SMeaIS...........:::ssccceeeees 34

Handling and storage of SD Bioline P.f rapid diagnostic test (RDT) kit ......... ccc ccccesseeeeeseeees 36
Determine eligibility and obtain informed consent for malaria testing.............cccccscsssssseeeeeees 37
Steps in performing Malaria testing ............ccccccecsssscecececessesssaeeececesseseeseeeescessesesaeaeeeeseessesseaeees 39
Interpreting the results of SD Bioline P.f RDT ...........ccccccssccccecessessssececeeeceseeseaeseeeeeeesseseseaeeeesens 44
Treatment protocol for malaria positive CHIEN ..........ccccccccccsesssssceeeeecessesssneseeeescessessstsaeeeeeens 45
Storage and transport of thick DIOOd SMEAIS .........cccccccesessesssseeececeseesenseaeceeecesseseaeseeeeesessesseaeess 46
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Chapter |. INTRODUCTION AND OVERVIEW

1.A. About this manual

This manual is used as part of the Training Program for Measuring and Testing for Biomarkers,
and provides the core content needed to acquire the following skills during the training:

e How to identify eligible respondents in households for biomarker measurement
e How to obtain informed consent from parents/responsible adults for children

e How to complete the Biomarker Questionnaire

e How to perform capillary blood collection on children

e How to select the appropriate equipment; collect samples; conduct tests and record,
report, and document results for the following, as needed:

= Rapid diagnostic tests (RDTs) [and microscopy] for malaria
= Demonstrate appropriate universal safety precautions
= Demonstrate appropriate disposal of bionazardous waste

1.B. About this training program

Biomarker measurements can serve as diagnostic tools to identify diseases or conditions in their
early stages and can be used as surveillance tools to track changes in disease patterns or to
evaluate intervention programs. In population-based surveys, biomarkers help assess the
prevalence or occurrence of diseases or conditions in a population; they can also be used at a
macro level to measure the long-term effect of policies and programs. In The Demographic and
Health Surveys (DHS) Program, biomarkers are measured to estimate the prevalence of specific
diseases and health conditions at the population level.

This training program is designed to equip biomarker technicians with skills and techniques to
efficiently and effectively measure and test biomarkers in field conditions, and accurately record
and report the results as part of the survey process. In addition, this training program will equip
biomarker technicians to collect, process, and package biological specimens for transport to a
laboratory for testing.

1.C. Training program structure

In combination with classroom instruction and practical experience, this manual will be used to
teach you how to collect blood samples and conduct basic tests to measure biomarkers for the
[YEAR] [COUNTRY] Malaria Indicator Survey (MIS). Before each training session, you should
study this manual and the Biomarker Questionnaire carefully. You are encouraged to ask
questions during training and to discuss problems encountered to avoid making mistakes during
fieldwork. Training consists of the following phases:

e Phase I. The chapters of this manual are reviewed in a classroom setting where you learn

how to identify eligible children; record biomarker measurements or test results in the
Biomarker Questionnaire or on appropriate field forms; and handle technical procedures
involved in blood collection, testing, [storage and transportation of smears], and other
related instructions. You observe the trainers demonstrating the skills. Then, you will have
the opportunity to practice the procedures, with other trainees, which will include finger
pricks for blood collection.

e Phase II. You will visit a health facility and practice measuring biomarkers from children
with the consent of their parent or responsible adult.

e Phase Ill. You will be assigned to a survey trainee team in the field where you will measure
biomarkers from eligible children exactly as you would during the survey. Households that
are visited will be in clusters that are not part of the survey sample.

At the end of the training, your overall performance will be assessed, and the top performers will
be selected to work in the survey.

Your training does not end at the start of fieldwork. Rather, it is a continuous process. Your team
supervisor and the [COUNTRY] MIS coordinators will play important roles in continuing your
training and in ensuring the quality of data you collect throughout the survey. They will:

e Observe your fieldwork activities periodically to ensure that you are conducting yourself
professionally, obtaining informed consent from respondents, and following the sample
collection and biomarker measurement protocol correctly

e Spot check that you visited the correct households and collected blood samples and
measured biomarkers only from eligible respondents;

e Collect blood specimens for transport to the laboratory and consolidate the field record
forms; and

e Meet with you regularly to discuss your performance and assign future work assignments.

Note: A biomarker technician who is not performing at the level necessary to produce the high-
quality data required for a successful [COUNTRY] MIS may be released from service.

I1.D. Overview of the survey

The [YEAR, COUNTRY] MIS is a nationally representative household survey to be conducted
during high malaria transmission seasons to measure a wide range of internationally recognized
malaria indicators to include:

e Household ownership of insecticide-treated mosquito nets and their use, especially by
children under age five years and pregnant women;

e Intermittent preventive treatment against malaria during pregnancy;
e The type and timing of treatment of high fever in children under age five years;

e Diagnostic blood testing of children under five for malaria

The survey gathers background information on the characteristics of household members such
as age and sex as well as information about households including access to electricity, source of
drinking water, and ownership of assets such as radios, vehicles, and farm animals.

The [YEAR] XMIS is the [NUMBER] MIS survey conducted in [COUNTRY] following [INSERT
PREVIOUS MALARIA INDICATOR SURVEYS AND YEAR]. The [YEAR] XMIS will include
malaria RDT [and thick blood smears]. Results from this survey will produce population-based
estimates of malaria prevalence among children age 6-59 months.

1.E. Overview of biomarker measurement

A biomarker may be thought of as a characteristic that can be independently measured and
evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic
response to a therapeutic intervention’. Biomarker measurements can serve as diagnostic tools
to identify diseases in their early stages and can be used as surveillance tools to track changes
in disease patterns or to evaluate intervention programs. In population-based surveys, biomarkers
help assess the prevalence or occurrence of diseases or conditions and can also be used at a
macro level to measure the long-term effect of policies and programs. In the MIS, biomarkers are
measured to report levels of malaria on a population level. Specific to the [YEAR] XMIS, the
following biomarkers will be measured and/or collected: malaria RDT [and thick smears]. This
training manual will discuss the proper biomarker testing and/or collection techniques and how to
appropriately record test results in the biomarker questionnaire, and the malaria brochure or
severe malaria referrals if needed.

Biomarkers measured in the [YEAR] XMIS and what they are used for:

Biomarker Purpose
Histidine-Rich Protein II (HRP-I) Estimate the prevalence of malaria
Malaria parasite Estimate the prevalence of malaria

1.F. Overview of tests in an MIS and the biomarker technician’s role

Malaria is a vector borne infection. Malaria parasites are transmitted into a susceptible host
through the bite of a mosquito. Malaria is a major cause of illness and death especially among
children under 5 years, pregnant women and immunocompromised individuals (WHO, 2017).
[PROVIDE COUNTRY STATS ON MALARIA]

Children age 6-59 months in the XMIS will be eligible for malaria testing.

1 Biomarker Definitions Working Group, National Institutes of Health, 2001

Rapid diagnostic testing (RDT)

Capillary blood from a finger or heel prick will be used for malaria testing. A malaria RDT will be
performed in the household to test the child’s malaria status. If the malaria RDT is positive, the
child will be further screened to determine if he/she has symptoms of severe malaria. Children
with symptoms of severe malaria will be referred to a health facility for immediate attention.
Malaria medication will be provided in the household to children eligible for treatment. The
biomarker technician will provide all households with an informational malaria pamphlet.

Preparation of thick blood smear for microscopy

A thick blood smear will be prepared in the household and transported to the central laboratory
for the detection of malaria parasites by microscopy, the current gold standard method.

1.G. Social media policy

The use of social media and other digital media is now common and continues to grow in
popularity. Platforms and applications including blogs, social networking sites (such as Twitter or
Facebook), video streaming sites (such as YouTube), and digital messaging applications
(WhatsApp), have made it easy for anyone to reach a wide audience very quickly. Public and
private companies and their staff also use these platforms and sites to share work experiences,
images, or videos taken in the workplace, or to seek professional advice from colleagues or
friends. However, in the XMIS, the use of social media may break the promise we make to our
respondents to maintain their privacy and keep all information confidential. The XMIS has also
made a promise to the ICF Institutional Review Board and the [COUNTRY] Institutional Review
Board to maintain anonymity of all survey respondents.

To fulfil our promise to all survey respondents to maintain strict confidentiality, all fieldworkers are
obligated to follow these rules:

Social media rules for maintaining confidentiality of survey respondents

1. Survey staff have an ethical obligation to always maintain respondent privacy and
confidentiality.

2. Limiting access to social media postings by using privacy settings is not enough to ensure
privacy or maintain the confidentiality of respondents.

3. | Do not transmit any respondent-related image or video that includes the respondent,
respondent household members, or their homes, through any social media platform.

4. Do not identify respondents, enumeration areas, or clusters by name through any social
media platform. Do not post any information that may lead to the identification of a
respondent or an enumeration area.

5. Do not take any photos or videos of respondents or their homes — not even if the

respondent gives permission — on personal mobile devices - including mobile phones,
tablets, and cameras.

6. Turn off or disable geolocation or geotagging permissions in social media applications on
personal mobile devices while conducting fieldwork.

7. | Consult with a supervisor before making any work-related postings.

8. Promptly report any violations of privacy or confidentiality.

What is geolocation and geotagging?

Geolocation or geotagging refers to identifying an object (for example a photo) by its location.
Many social media platforms, including Twitter and Facebook, now include geolocation or
geotagging, so users can add location information to their messages. The location information
can be a broad location such as a city or village, or a precise location with the exact latitude and
longitude of the location from which a message was sent. A fieldworker who posts a geolocated
or geotagged social media message from the field violates confidentiality by disclosing the
location of the cluster.

Geolocation or geotagging in social media applications may also have security implications. In
security-risk countries, where fieldwork must undergo stringent protocols to protect field teams, it
is imperative that survey-related staff disable geolocation from their personal devices to not give
away secure locations.

Common Misunderstandings of Social Media

Misuse of social media is often unintentional and the result of misunderstandings of how social
media platforms function. Many factors may contribute to survey-related staff inadvertently
violating survey respondent privacy and confidentiality while using social media.

Test your knowledge:
TRUE or FALSE?

Q 1. A communication or post is private and can only be seen by the intended recipient. True or
False?

FALSE. Why? Once you send or post something, it can be sent by someone else to others,
without you knowing.

Q 2. You can always delete posted content and make it “go away”. True or False?

FALSE. Why? What happens on the Internet, stays on the Internet.

Chapter 2. GENERAL PROCEDURES FOR COMPLETING THE
PAPER QUESTIONNAIRE

Learning objective

e Confirm the eligibility of respondents for biomarker collection

e Understand the elements of informed consent

e Know the structure and content of the Biomarker Questionnaire

e This part of the training manual is designed to familiarize you with the [COUNTRY] MIS
paper questionnaire that you will use for field data collection

2.A. Introduction

This chapter describes the [subsample of households selected for biomarker collection,]
requirements for eligibility and informed consent. To collect the information needed by the
[COUNTRY] MIS, you must understand how to ask each question, what information the question
is attempting to collect, and how to handle problems that might arise during the interview. You
must also know how to correctly record the answers the respondent gives and how to follow
special instructions in the questionnaire.

2.B. Identifying respondents eligible for Biomarker Questionnaire
Eligible respondents

[Not all households are eligible for biomarker measurement and testing.] There are [NUMBER]
households per cluster, [half of which were selected for biomarker collection.] This means you
as a biomarker technician will visit [NUMBER] households per cluster for biomarker collection.]

The hierarchy below summarizes which households are eligible for biomarker collection.

All Households (HHs)
n = [number] HHs

All Selected for Biomarkers
n= [number] HHs

Malaria RDT: Children 6-59 months
{Malaria microscopy: Children 6-59 months]

Adjust the image and all related content to reflect the survey. Once completed, copy and
past into the Introduction and Overview Chapter and Questionnaire PPT.

Not everyone in a household is eligible for biomarker measurement. Within selected households,
those eligible for biomarker measurement and testing are: children age 6 — 59 months (4 years)
who are usual household residents or visitors who have stayed in the house the night before the
household interview took place.

Groups eligible for biomarker measurement Malaria

Children age 6 months—4 years

Obtaining Eligibility from Computer Assisted Personal Interviewing (CAPI)

The Household Questionnaire and Individual Questionnaires use computer assisted personal
interviewing (CAPI) for face-to-face interviews. However, the Biomarker Questionnaire is still
completed on paper. This means that the interviewer will need to transfer the list of eligible
children from the report generated by the CAPI system using information collected in the
Household Questionnaire to the Biomarker Questionnaire. Only then will the biomarker technician
be able to start the process of identifying eligible respondents, obtaining informed consent,
collecting a blood sample and testing for biomarkers.

On the cover page of the Biomarker Questionnaire, the interviewer will record all the information
required to identify the household. When you receive a Biomarker Questionnaire, the interviewer
should have already recorded the following into the identification box:

e Place Name

e Name of Household Head
e Cluster Number

e Household Number

You will notice that for both the Cluster Number and Household Number four boxes are provided.
When a number has fewer digits than the number of boxes provided, the leading zeros should be
filled in. For example, if the cluster number is 1 and household number 3, this information should
be recorded on the cover page (by the interviewer) as cluster number 0001 and household
number 0003.

IDENTIFICATION (1)

PLACE NAME __ Fill with appropriate place name

NAME OF HOUSEHOLD HEAD Fill with appropriate name

CLUSTER NUMBER 10 | 0] 1

HOUSEHOLD NUMBER [0/0 | 0]3 |

Using the CAPI function to list those eligible for individual interviews and biomarkers, the
interviewer will record the number of respondents in the household potentially eligible for
biomarker collection. An example of a list is shown below:

CLUSTER: 9001 HOUSEHOLD: 9003
Name of household head: GENEVIEVE DUPUIS

Children Eligible for Biomarker Collection

Line Sex Age Name

@2 2 02 JULIA FLEURET
04 1 04 = MATT TURBYFILL

Check the cover page of the Biomarker Questionnaire to identify the number of children who are
potentially eligible for biomarker collection. This information can be found under “Fieldworker
Visits.”

[FIELOWORKER] VISITS

DATE

(FIELOWORKER'S) K Where to find the

NEXT WerT, OATE — number of eligible
children

TOTAL ELIGIBLE
CHILOREN

2.C. Verifying information for eligible children

Check each page of the Biomarker Questionnaire; individual children are listed on separate
pages. Verify that the interviewer has completed Qs. 102-106 for each eligible child. If this section
is incomplete, return the questionnaire to the interviewer to fill in Q. 102-106 for each eligible child.

MALARIA TESTING FOR CHILDREN AGE 6 MONTHS TO 4 YEARS
CHECK CAPI OUTPUT FOR "LIST ELIGIBLE INDIVIDUALS/BIOMARKERS"™. RECORD THE LINE NUMBER AND NAME

FOR ALL ELIGIBLE CHILDREN AGE 0-5 YEARS IN QUESTION 102 ON THIS PAGE AND SUBSEQUENT PAGES
STARTING WITH THE FIRST ONE LISTED. IF MORE THAN THREE CHILDREN, USE ADDITIONAL QUESTIONNAIRE(S).

CHILD 1

CHECK CAPI OUTPUT AND RECORD NAME AND LINE NUMBER OF CHILD. NAME

LINE NUMBER

IF MOTHER INTERVIEWED: COPY CHILD'S DATE OF BIRTH (DAY, MONTH, AND
YEAR) FROM PREGNANCY HISTORY.

IF MOTHER NOT INTERVIEWED ASK:
What is {NAME OF CHILD}’s date of birth?

IF MOTHER INTERVIEWED: COPY CHILD'S AGE FROM PREGNANCY HISTORY.

IF MOTHER NOT INTERVIEWED ASK:
How old was {NAME OF CHILD} at {NAME OF CHILD}'s last birthday?

COMPARE AND CORRECT 103 AND/OR 104 IF INCONSISTENT.

CHECK 104: CHILD AGE 0-4 YEARS? YES i: NO ]

CHECK 103: IS THE CHILD AGE 0-5 MONTHS OR OLDER[ | AGE 0-5 T_
IS THE CHILD OLDER? MONTHS

Although Qs. 105 and 106 will be completed by the interviewer, they are described below so that
you will understand how they are used by the interviewer to determine which children are eligible
for malaria testing. It is also good practice to check that they were completed correctly.

Q. 105: CHECK 104: CHILD AGE 0-4 YEARS?

A child whose age in the Household Questionnaire is listed as being age 0-5 is eligible for the
Biomarker Questionnaire, but only those age 6-59 months are eligible for malaria testing. Qs. 105
and 106 are used to identify children in this age range and eliminate those children who are either
too old for testing (age 5 years) or too young for testing (age 0-5 months).

To complete Q. 105, the interviewer will check the age in Q. 104. If it is 0,1,2,3 or 4, they will put
an ‘X’ in the box next to ‘YES’ and proceed to Q. 106. If the child is age 5 or older, they will put
an ‘X’ in the box next to ‘NO,’ and skip to the end of the section, in this example, Q. 135.

Why, you might be thinking, do we have the interviewers enter children in the Biomarker
Questionnaire Qs. 102-104, if we know from the Household Questionnaire that they are too old

(age 5) to qualify for malaria testing? The reason is that often respondents to the Household
Questionnaire are uncertain of the exact age of children in the household and/or they round up a
child’s age.

Example: The respondent to the Household Questionnaire might say a child is age 5 when
in fact the child is age 4, and therefore eligible for testing.

To reduce the chance of mistakenly eliminating children who are eligible for testing, The DHS
Program has made the decision to not rely on the information from the Household Questionnaire
for the exact age of children.

Rather, we will use the date of birth and age information obtained from the child’s mother’s birth
history (for children whose mother were interviewed) or by asking an adult responsible for the
child for the child’s date of birth and age information (for children whose mothers were not
interviewed).

Q. 106: CHECK 103: IS THE CHILD AGE 0-5 MONTHS OR IS THE CHILD OLDER?

Children age 0-5 months (i.e., <6 months), are not eligible for blood collection and are therefore
not eligible for malaria testing. In Q. 106, the interviewer uses the date of birth information entered
in Q. 103 to determine if the child is age 0-5 months or older. If the child is age 1-4 years, they
are clearly older than age 0-5 months and the interviewer should put an X in the box next to
‘OLDER’. If, however, the child is age 0 years, the interviewer needs to determine if they are age
0-5 months or older (age 6-11 months). If they are age 6 months or older, an ‘X’ is put in the box
next to OLDER. If they are 0-5 months, an ‘X’ is put in the box next to ‘AGE 0-5 MONTHS’ and
the skip to Q. 135 is followed.

Example: if you are visiting the household on 9 July [YEAR], a child born 16 January
[YEAR] is not eligible for blood collection. Any child born 10 January [YEAR] or more
recently (February, March, April, May, June, or July [YEAR]) is under age 6 months.
Put an X next to ‘AGE 0-5 MONTHS’ and skip to Q. 135. If the child is 6 months or
older, put an X in the box next to ‘OLDER’.

2.D. Documenting [fieldworker] visits on the cover page

As described above, the interviewer will provide the information on the cover page to identify the
household and the total number of eligible children. It is the responsibility of the biomarker
technician to document when he/she visited the household to collection biomarkers under the
section labeled, [FIELDWORKER] VISIT. You have at least three opportunities to visit the
household to complete the biomarker collection. On your first visit to the household, you will
record the date and write your name. If you do not complete biomarker collection for all the eligible
respondents in your first visit, it will be necessary to make a second visit. You must arrange this
second visit with the respondents or parent/responsible adult and ask when is the best day and
time for you to return. You must record this date and time on the cover page of the Biomarker

Questionnaire at NEXT VISIT. When you return a second time, you must document again the
date of your second visit and write your name. When you have finished a household, on your last
visit, you must enter the date under FINAL VISIT as DAY-MONTH-YEAR and record your TOTAL
NUMBER OF VISITS. It is also acceptable for the first and second visit to occur on the same day
if the respondent or the parent/responsible adult requests it. However, if you return to that
household on the same day and the child still is not present, you are required to make two
additional visits to that household.

Example: In a household there are 3 eligible children. You arrive at the house for your first visit
on 16 July 2020 and complete malaria testing for 2 of the 3 children. You are told by the mother
to return on 17 July at 8:00 AM to test the third child. You make a second visit to the household
on 17 July at 8:00 AM and complete the malaria testing for the third child. You finished testing all
3 children on 17 July and made 2 visits to the household. It is important to complete the
FIELDWORKER VISITS section daily. Do not wait until you finish a household to complete this
section. You will enter your final visit only once you have completed the household. You or the
interviewer can record notes in the NOTES section that pertain to the household or children. For
example, recording the phone number of a respondent or information about the locating the
household.

[FIELDWORKER] VISITS

ne 16 July 2020 | 17 July 2020

FIELDWORKER'S)
ae _Rachel | _ Rachel _

NEXT visit: paTE | 17 7 July 2020 2020 TOTAL NUMBER
OF VISITS
TIME 08:00 AM 00 AM

TOTAL ELIGIBLE
CHILDREN

The language of the questionnaire is already prepopulated. You are responsible for recording
the language of the interview and native language of the respondent using the LANGUAGE
CODES on the cover page. You also must indicate if “YES’ a translator was used by entering 1,
or ‘NO’ a translator was not used by entering ‘2’ in the space provided.

LANGUAGE OF LANGUAGE OF 1 NATIVE LANGUAGE TRANSLATOR
QUESTIONNAIRE** INTERVIEW** OF RESPONDENT** (YES = 1, NO = 2)

LANGUAGE OF “*LANGUAGE CODES:
QUESTIONNAIRE** ENGLISH 01 ENGLISH 03 LANGUAGE 3 05 LANGUAGE 5

02 LANGUAGE 2 04 LANGUAGE 4 06 LANGUAGE 6

2.E. Asking Questions and Reading Informed Consent Statements

It is very important that you ask each question and read the consent statement exactly as it is
written in the questionnaire. Always speak slowly and clearly so that the respondent will have no
difficulty hearing or understanding the question or consent statement. At times you may need to
repeat the question or consent statement to be sure the respondent understands it. In those
cases, do not change the wording, but repeat it exactly as it is written.

If, after you have repeated a question or consent statement, the respondent still does not
understand it, you may have to restate it. Be very careful when you change the wording, however,
that you do not alter the meaning of the original question or consent statement.

Prior to biomarker measurement, one of the primary tasks is to explain the purpose of the
measurement or test to eligible respondents or, in the case of children, to the parent or responsible
adult, and to obtain their consent before collecting blood samples or conducting biomarker
measurements. In the absence of a parent, the consent of a responsible adult who is at least 18
years of age is required. If the parent or responsible adult does not consent to the test, the test
must not be performed.

Process of obtaining informed consent for children:

Process

Children (age 6-59 Obtain the consent of one of the child’s parents, or, in the absence of a

months) parent, the consent of a responsible adult who is at least 18 years of
age. If the parent or responsible adult does not consent to the test, do
not perform the test.

To ensure that these individuals can make an “informed” decision about whether to have their
children tested, the Biomarker Questionnaire includes a consent statement which you must read
to the parent/responsible adult. These consent statements include the following basic elements:

e Introduction and type of study

e Importance of study to the subject and/or others (what will be improved, how results will
be used, benefits to specific others and/or society)

e Procedures — what is going to be done to/with subject

e Reasonably foreseeable risks or discomforts

e Duration of involvement

e Extent to which records will be confidential

e Participation is voluntary; refusal to participate will involve no penalty or loss of benefits

If you have to reword the consent statement so that the respondent understands it, you must still
include these seven elements of informed consent listed above.

You will notice that some questions contain one or more words in parentheses. As shown below,
12

the presence of parentheses indicates that a sentence needs to be adapted to fit the respondent’s
specific situation.

Parentheses that indicate a substitution must be made:
Example:
ASK CONSENT FOR MALARIA TEST FROM PARENT/RESPONSIBLE ADULT:

As part of this survey, we are asking children all over the country to take a test to see
if they have malaria. Malaria is a serious illness caused by a parasite transmitted by a
mosquito bite. This survey will assist the government to develop programs to prevent
and treat malaria. We ask that all children age 6 months through 4 years take part in
malaria testing. The tests require a few drops of blood from a finger or heel. The
equipment used to take the blood is clean and completely safe. It has never been
used before and will be thrown away after each test.

The blood will be tested for malaria immediately, and the results will be told to you
right away. [A few blood drops will be collected on slide(s) and taken to a laboratory
for testing. You will not be told the results of the laboratory testing.] All results will be
kept strictly confidential and will not be shared with anyone other than members of our
survey team.

Do you have any questions? You can say yes or no. It is up to you to decide. Will you
allow {NAME OF CHILD} to participate in the malaria test?

Notice that the word in parentheses is in all capital letters. Words in all caps are instructions
to biomarker technicians that are not meant to be read out loud. Instead, in this example,
you should substitute in the name of child for which you are seeking informed consent for testing.
For instance, if you are seeking informed consent for malaria testing from a woman who has a
son named Barack, ask “Will you allow Barack to participate in the malaria test?”

2.F. Recording Responses

All biomarker technicians should use pens with blue ink to complete all paper questionnaires.
Never use a pencil to complete the survey questionnaire.

There are generally three types of questions in the [COUNTRY] MIS Biomarker Questionnaire: 1)
questions that have precoded responses; 2) questions that do not have precoded responses, i.e.,
those that are “open-ended;” and 3) filters.

Questions with precoded responses

For some questions, we can predict the types of answers a respondent will give or you Know how
the procedure in question was performed. The responses to these questions are listed in the
questionnaire. To record a respondent’s answer, you merely circle the number (code) that
corresponds to the reply. Make sure that each circle surrounds only a single number.

Example:

in
”
r 4
5

Does (NAME) suffer from any of the following illnesses or symptoms:
a) Extreme weakness?

b) Heart problems?

c) Loss of consciousness?

a) EXTREME WEAKNESS 1
b)HEART PROBLEMS . 1
c) LOSS OF CONSCIOUS 1
d) Rapid or difficult breathing? d) RAPID BREATHING

e) Seizures? e) SEIZURES

f) Abnormal bleeding? f) BLEEDING

g) Jaundice or yellow skin? g) JAUNDICE
h) Dark urine? h) DARK URINE

SYRDOOEH

In some cases, precoded responses will include ‘OTHER.’ The OTHER code should be selected
only when the respondent's answer is different from any of the precoded responses listed for the
question or when you have encountered an issue in the field that does not permit you to proceed
with the biomarker collection. Before using the OTHER code, you should make sure the answer
does not fit in any of the specified categories.

Example:

CONDUCT TEST AND RECORD RESULT OF THE MALARIA RDT HERE AND IN [TEST POSITIVE]
THE [INFORMATIONAL PAMPHLET]. (TEST NEGATIVE] ........-.. 2

NOT PRESENT
REFUSED

In this case, an acceptable use of ‘OTHER’ would be receiving permission from the
parent/responsible adult collect blood for malaria testing of the child, but you faced an issue with
the rapid diagnostic test that would not allow you to complete the test.

Recording responses that are not pre-coded

The answers to some questions are not pre-coded but require that you write the appropriate
response in the space provided or the respondent's results.

Example

RECORD NAME OF PARENT/RESPONSIBLE ADULT FOR THE CHILD.

LINE NUMBER

2.G. Marking Filters and Following Skip Patterns
Marking Filters

Filters require you to look back to the answer to a previous question and then mark an ‘X’ in the
appropriate box.

Example:

CHECK 103: IS THE CHILD AGE 0-5 MONTHS OR OLDER AGE 0-5 Hi
IS THE CHILD OLDER? MONTHS 135

To ensure the proper flow of a paper questionnaire, you will sometimes be directed to check a
respondent's answer to an earlier question, indicate what the response was by marking a box
with an ‘X’, and then follow the relevant skip instruction. Questions of this type are called “filters”;
they are used to prevent a respondent from being asked the same question multiple times. Use
caution when answering filters. Filters involve skip patterns so ensure you are following them

correctly.
Following Skip Patters

It is very important not to ask a respondent any questions that are not relevant to his or her
situation. For example, you should not read a malaria consent statement to a parent/responsible
adult of a child age 0-5 months because children in this age group are too young to be tested. In
cases where a particular response makes subsequent questions irrelevant, an instruction is
written in the questionnaire directing you to skip to the next appropriate question.

Example:
CHECK 103: IS THE CHILD AGE 0-5 MONTHS OR OLDER | | AGE 0-5 ‘x
IS THE CHILD OLDER? MONTHS 135

\____,___]

Always follow the skip patterns!

Unless a skip pattern is present, always move directly to the next question.

2.H. Correcting Mistakes

When working with a paper questionnaire, it is very important that you record all answers neatly.
For precoded responses, be sure that you circle the code for the correct response carefully. When
recording responses that are not precoded, the reply should be written legibly so that it can be
easily read. If you made a mistake in entering a respondent’s result, the respondent wishes to
change his/her reply, or you have made a mistake, be sure that you cross out the incorrect
response and enter the right answer. Do not erase an answer. Just put two diagonal lines through
the incorrect response.

Here is how to correct a mistake:

Example:

CONDUCT TEST AND RECORD RESULT OF THE MALARIA RDT HERE AND IN [TEST POSITIVE]
THE [INFORMATIONAL PAMPHLET] [TEST NEGATIVE]

NOT PRESENT

REFUSED

Remember that if you are not careful to cross out mistakes neatly, it may not be possible to
determine the correct answer when the data are entered later into the CAPI system.

2.1.

Key points to remember

The following steps are important to remember when completing the Biomarker Questionnaire:

Children should be measured after the mother is interviewed. If the mother is not
present in the household or does not live in the household, children should be measured
after the responsible adult has given consent for biomarker collection.

Measure and/or test for biomarkers one respondent at a time. All the biomarker
measurements for the [COUNTRY] MIS should be performed on one respondent before
moving on to the next eligible respondent. Complete the measurement of all biomarkers
from one respondent before proceeding to the next. Failure to do so may lead to the results
of one respondent being recorded for another respondent.

Never alter any responses or information transferred by the interviewer from the
CAPI list of individuals eligible for the Biomarker Questionnaire without consulting
the interviewer who completed the Household Questionnaire. Even in cases where there
are concerns about a respondent’s eligibility for testing, proceed with the biomarker
collection. Record in the notes section of the Biomarker Questionnaire a description of
the problem. Provide as many details as possible. The field organization/central office will
decide later what will be done about the test results for the respondent in question.

Read the applicable consent statements to each parent/responsible adult exactly
as they appear in the Biomarker Questionnaire. When you arrive at the household and
begin talking about the blood tests with the respondent, you may informally discuss items
included in the informed consent statement. However, before beginning the testing
procedures, you must still read the informed consent statements exactly as they appear
in the Biomarker Questionnaire. If the respondent finds the statements repetitive, tell him
or her that you are required to read the statements to ensure that they are given all the
appropriate information.

Read the informed consent statements clearly. Practice reading the consent
statements out loud so that you become comfortable delivering them in a clear, natural
voice and manner. Avoid speaking rapidly or in a monotone.

Never attempt to force or coerce consent. Some respondents may be suspicious or
fearful of having their blood collected for biomarker testing. Others may have questions or
want to discuss the procedures before giving consent. Take time to patiently respond to
all questions.

Some parents/responsible adults may be reluctant to allow testing of a child without
consulting someone not present at the time of your visit (for example, a woman may want
to consult her husband before giving permission). In such cases, make an appointment
to return to the household later at an agreed upon time. If you believe it will help, ask
the team supervisor to visit a household where eligible respondents express fear or
reluctance to be tested.

Chapter 3. CAPILLARY BLOOD COLLECTION

Learning objectives

= List supplies for blood collection

= Determine the site of blood collection for the appropriate age group

m List steps involved in obtaining a capillary blood sample from the finger

= Perform steps involved in obtaining a capillary blood sample from the finger
m List steps involved in obtaining a capillary blood sample from the heel

= Apply steps involved in obtaining a capillary blood sample from the heel

= List best practices and precautions to observe when collecting blood

3.A. Introduction

This chapter describes the materials needed for and, the steps involved in, capillary blood
collection.

Capillary blood will be collected as part of the survey to test for malaria. Capillary blood can be
obtained from the palm side of the tip of a finger or from a heel. For children age 12 months and
older, a finger should be used. For children less than age 12 months, the heel should be used.
For children who are undernourished or skinny a heel puncture is also recommended because
the finger tissue can be thin, and the lancet may pierce the bone.

3.B. Materials and supplies for performing finger or heel pricks

The capillary blood drops collected for biomarker testing will be drawn from a finger or heel. The
following supplies and materials will be used in performing the finger or heel prick.

Disposable nitrile gloves: Used to reduce the risk of
bloodborne diseases. Gloves must be worn by the
biomarker technician and by anyone else who may
assist with the blood collection.

Absorbent paper sheets: The surface area where your
supplies will be placed while you collect the blood. Place
the plastic/shiny side of the absorbent sheet face down
(the absorbent side without plastic on it should be facing

up).

| eNDALt
: |
Alcohol preps: Used for cleaning the skin prior to Pe

pricking the finger or heel. ——
ae Ci ae
= = |

Safety lancets: The lancet is a single-use, disposable
device used to prick the fingertip or heel. The blade is
retractable; when in contact with the finger and pressure
is applied, a surgical blade quickly ejects from the
device, punctures the skin, and then automatically
retracts.

€2 BD Microtainer®
Contact-Activated Lancet

Sterile gauze pads: Used to wipe away the first drop(s)
of blood to stimulate capillary blood flow.

Adhesive bandages: Applied to the puncture site to
minimize the risk of infection.

Biohazardous waste bags: Plastic bags that are
provided to hold all the biohazardous waste generated
during the day except sharps. All waste bags are
labeled with “biohazard” logo.

Sharps containers: All biohazardous sharps that have
pointed tips such as lancets, as well as inverted cups,
[applicator sticks, and microscope glass slides].

3.C.

How to put on gloves

Donning (putting on gloves)

Measure your hand using the glove-sizing chart before choosing a glove to reduce the
potential for tearing.

If possible, thoroughly wash hands before donning gloves and after each glove change.
Open glove at the cuff and extend opposite hand until thumb crotch is to the cuff of the
glove.

Once the hand is properly aligned in the glove, move your fingers down into the glove's
fingers.

Roll the cuff of the glove down the wrist until the glove is secure.

Replace gloves frequently, including whenever changing tasks.

Doffing (taking off gloves)

Pull the glove from above the cuff up on the hand inside out to trap potential
contaminants inside the used glove.

Place the used glove into the palm of the opposite hand (which remains gloved).
Repeat step 1 on the opposite hand, trapping the first glove inside the second.
Discard gloves and wash hands.

3.D.

Steps in obtaining capillary blood from the finger

The following steps describe how to obtain a capillary blood drop sample from the finger. They
apply to the collection of samples from children age 12 months and older. Remember, the
informed consent statement must be read, and consent must be granted, for each eligible child
before malaria testing.

Preparing the session

If possible, find an indoor site to encourage privacy. The site should have a table or other
furniture with a flat surface where you can lay out the supplies. A couch, bed, or mat should
be readily available if the child feels faint and needs to lie down. If you must do the testing
outdoors, find a site in the full shade and away from rain, dust, and other environmental
elements that might affect the sample.

Describe to the parent or responsible adult exactly what will be done during the
collection of the blood sample and how they can assist by holding the child on their lap
and holding the child’s hand during the collection of the sample.

When collecting blood from a child, note that the child may be fearful or anxious about
what is going to happen. Therefore, using a calm and reassuring manner is important as
you begin to collect the blood sample. Remember that nonverbal communication is
important, so maintain eye contact with the child as you prepare to take the sample.
Encourage the parent/responsible adult to hold the child on his or her lap and place the
child’s legs in between his or hers so that the child does not kick the table and place his
or her arms around the child.

Figure X-|. How a parent should hold a child for a finger prick.

3.E.

Collecting the blood from a finger prick

Put on gloves before beginning the collection of
the blood sample from the first child.

Kneel on the side of the child opposite to the
hand/heel from which you will collect blood. For
example, if you want to collect the sample from the
left hand, place yourself to the right side of the
child. Do not sit on a chair.

Use the third or fourth finger for collecting
blood. Do not use a finger with a scar, a wound or
cut, swelling, a deformity, a rash, or an infection.

. Ask the parent/responsible adult to warm the
child’s hand by briskly rubbing the child’s fingers
in between their palms.

. Setup your station:
e Take out a clean absorbent paper sheet and
spread the shiny side down over a flat surface

where you will lay out your supplies.

e Open the sterile gauze package. Separate the
two pieces of gauze and lay them down on the
package so they do not touch the absorbent
pad.

e Open the outer package of the adhesive
bandage. Place the bandage on the packaging.
Open the alcohol prep package.

e Remove the blade slot cover of the lancet.
Prepare the lancet for use. Simply twist the
blade slot cover 360° until the cover comes out.
Do not remove the blade slot cover from the
lancet other than as instructed here, as this
may damage the lancet and cause it to
malfunction.

6. With an alcohol prep pad, clean the skin of the
finger thoroughly. If the skin is dirty, use a second
pad. Clean the finger before pricking.

. Allow the finger to air dry completely. Do not

blow on the area to dry the alcohol. Blowing may
allow bacteria to contaminate the site. Allow the
alcohol to air dry. If the finger is not properly dried,
you run the risk of mixing alcohol with the blood. It
takes 15-20 seconds for the alcohol to dry. If the
alcohol used to clean the puncture site mixes with
the blood, it can cause hemolysis of the sample
leading to errors in the test results.

Position the hand palm side facing up. Form a
pad with your index and middle finger behind the
base of the child’s middle finger and your thumb in
front of the child’s finger.

Using a rolling movement of your thumb, push
blood from the base of the finger to the tip. This
action will stimulate a flow of blood to the fingertip.
It may be helpful if the parent or responsible adult
assists you by holding the child’s hand.

Note: Never “milk” the finger. Milking is excessive massaging or squeezing of the finger,
which will cause tissue juice to mix with and dilute the blood. This will result in erroneous
test results. Instead, the biomarker technician should employ only mild pressure by using
the thumb and the index and ring fingers to support the base of the finger.

Biomarker
Tech’s Thumb

Biomarker
Tech’s Index

This position will make the connective tissue underlying the skin more porous and allow
the capillary blood to flow easily after the incision.

10. Hold the lancet by the grooved area on the lancet body
and gently place the white lancet tip against the
skin. Look to confirm that you have selected a good
puncture site and reposition if necessary. Apply
pressure against the fingertip to trigger the lancet to
prick the skin. The lancet will automatically trigger
when the correct amount of pressure is applied. (The tip
of the blade ejects through the blade slot, producing a
micro-incision in the skin, and immediately retracts into
the device.) After pricking the skin, drop the used lancet
into the sharps container.

Note: Avoid placing the lancet on the very tip of the finger, near the fingernail, or on the
sides beyond the palmar area. You can first check the position of the puncture by placing
the lancet against the finger without applying pressure that might trigger the lancet. Re-
adjust the placement of the lancet if needed.

11. When your thumb reaches the fingertip, maintain a
gentle pressure to trap the blood in the fingertip.

12. When the blood appears, use a sterile gauze
pad to wipe away the first blood drop. Collect
the second blood drop for the malaria RDT and [the
third blood drop thick smear].

13. When blood collection is completed, apply a
piece of sterile gauze at the prick site to stop
the blood flow.

14. Apply an adhesive bandage to the prick site.

15. Properly dispose of all materials used in blood
collection:

e Lancets should always be discarded in a sharps
container

e All other materials used in the blood collection
procedure can be discarded in a_ labeled
biohazardous waste bag.

3.F. Obtaining capillary blood from a child’s heel

The heel is the puncture site for children age 6 - 11 months, or malnourished (skinny) children
whose fingers are very thin. A lancet that punctures to a depth of 1.8 — 2.0 mm will be used to
puncture the heel. The following describes the steps that are involved in obtaining a capillary
blood drop from the heel.

1. Prepare to prick outside an imaginary line drawn
from the middle of the big toe to the heel or outside
an imaginary line drawn from the area between the
fourth and fifth toes to the heel. Take care to avoid
the central area of the foot (to avoid injury to the
nerves and tendons) or the center of the heel (to
avoid piercing the heel bone).

Do not
\prick here
\

I
!
I
!
!
I
!
!
!

2. Hold the heel firmly. Apply moderate pressure
near the puncture site by wrapping the heel using
your thumb and second finger.

3. Clean the site with an alcohol prep wipe. Make
sure the site is dry before puncturing the skin with
the lancet. In selecting a puncture site, avoid any
areas of the skin that are broken or infected.

4. Place the blade-slot surface against the skin
and press the trigger. Ensure the free flow of
blood.

5. When the blood appears, use a sterile gauze pad
to wipe away the first one drop of blood, use the
second for malaria testing, [and the third drop for
the thick smear.]

6. Apply an adhesive bandage to the prick site.

7. Properly dispose of all materials used in blood
collection:

e Lancets should always be discarded in a sharps
container

e All other materials used in the blood collection
procedure can be discarded in a_ labeled
biohazardous waste bag.

3.G. Precautions to observe when collecting blood samples”

This section describes the universal (general) precautions to be followed during blood collection.*
You should take precautions when collecting blood to prevent exposure to bloodborne infections
such as hepatitis B or HIV. Follow the steps below to ensure protection against bloodborne
infections.

= If you must prick a child a second time, do not prick the same finger or heel.

= Do not use the same pair of gloves for more than one child. If you have worked
with one child and your gloves do not appear soiled, you must still discard them and
put on a fresh pair of gloves when working with a different child. It is also possible that
you use more than one pair of gloves when working with just one child if the gloves
have become heavily soiled.

= Keep intermittent pressure on the finger or heel during the blood collection process.

= Do not milk the finger: milking the finger may cause the interstitial fluid to mix with
blood and dilute the blood sample giving false results. Also, if a large volume of tissue
fluid mixes with the blood, the sample will be like a plasma sample instead of a whole
blood sample.

= If your gloves are soiled with blood, complete the blood collection process and
change them immediately once you have finished with that child.

2 Adapted from National Committee for Clinical Laboratory Standards (NCCLS) 1997
3 For the universal precautions regarding bloodborne pathogens, see the U.S. Centers for Disease
Control and Prevention guidelines and the U.S. Occupational Safety and Health Administration (OSHA)
standards for protection from exposure to bloodborne pathogen.

3.H.

Wear disposable gloves. Gloves help to prevent skin and mucous-membrane
exposure to blood. Gloves should be worn during blood collection, until the
specimen(s) from a child is collected and all waste materials produced during the
collection are disposed. At that point, the used gloves should be treated as
biohazardous waste. A new pair of latex gloves should be used with each child. Gloves
must never be re-used!

Avoid penetrating injuries. Although gloves can prevent blood contamination of
intact and non-intact skin surfaces, they cannot prevent penetrating injuries caused by
the instruments used for finger or heel pricks. Safety lancet devices reduce the risk of
penetrating injuries.

Do not use lancets for purposes other than a single finger or heel prick to collect
blood for the biomarker testing. The lancets should not be broken or destroyed for
curiosity or other purposes. After the device is used, it should be placed in a puncture-
resistant sharps container.

Wash contaminated areas. If an accident occurs, any skin surfaces or mucous
membranes that become contaminated with blood, should be immediately and
thoroughly washed with running water or a large quantify of water from a bucket or
basin.

Never eat or drink during the testing. Eating or drinking while collecting blood
samples may result in contaminating yourself and is prohibited during the blood
collection and testing procedures.

Properly dispose of all biohazardous materials. All materials coming in contact with
blood must be placed in a biohazardous waste container after use and disposed of
according to the survey’s policy on infectious waste disposal ([see Chapter 6]). Take
precautions when storing and transporting the waste during the fieldwork.

Good blood collection practices

Good position in relation to the child. Position yourself well before you make a puncture
on the child’s finger or heel, such as kneeling below the child’s heart level.

Do not prick the finger or heel if it is cold! Warm the hands (or heel) by asking the
parent/responsible adult to rub the child’s hand or heel vigorously.

Never “milk” the finger. Excessive massaging or squeezing of the finger or foot will
cause tissue juice to mix with and dilute the blood.

Never mix alcohol with the blood. If the alcohol used to clean the puncture site mixes
with the blood, it can cause hemolysis of the sample leading to errors in the testing results.
To avoid this problem, the finger or heel must be air dried completely before being
punctured.

Avoid obstructing blood flow. It is important to hold the finger properly to allow the
accumulation of blood at the puncture site. Holding the finger too tightly can obstruct blood
flow to the finger.

Push lancet in firmly to avoid shallow punctures. A deep puncture should be made for

better blood flow and to have a representative concentration of red blood cells.

Dispose of biohazard materials as they are used. Keep the biohazard bag and sharps
container open during blood collection and drop each disposable item in the appropriate
container as you finish using it.

If blood flow stops before all biomarkers are collected/tested, lay out all new supplies to
make a second prick.

NEVER leave behind or give biohazardous waste to parents/responsible, even if they
request it.

Chapter 4. MALARIA TESTING

Learning objectives

e Define malaria and its causes

e List the supplies for testing for malaria

e List steps for malaria testing

e Demonstrate proper use of the malaria RDT

e [Demonstrate proper storage and transport of malaria slides]*

e List precautions in malaria testing

e List steps in providing test results, treatment for malaria, and referrals for severe
malaria

4.A. Introduction

Malaria is a parasitic disease that is transmitted by the bite of a Plasmodium-infected mosquito.
Symptoms of malaria include fever, chills, headache, and vomiting, in addition to other flu-like
symptoms; if left untreated, severe cases of malaria can quickly become life threatening. In the
[YEAR, COUNTRY] MIS, children age 6- 59 months will be tested for malaria with the [SD Bioline
P.f] rapid diagnostic test (RDT). [The results of the RDT will be confirmed in a laboratory by
microscopic examination of a thick blood smear collected from the same individual. The thick
blood smear allows lab technicians to detect the presence of malaria parasites.] These data will
be used to generate national and regional malaria prevalence estimates.

This chapter presents detailed instructions on using the SD Bioline P.f test kit as well as on
preparing and storing thick blood smears and transferring them to the laboratory. In accordance
with the [COUNTRY] national treatment guidelines, children who test positive for non-complicated
malaria by the RDT will be provided with treatment; the treatment protocol is also described in
this chapter.

4.B. Materials and supplies for malaria testing

In addition to the supplies required for capillary blood collection in Chapter X, and the Biomarker
Questionnaire, the following materials and supplies are required for malaria testing:

4Note: If the [YEAR, COUNTRY] MIS does not include preparation of thick blood smears, this module will need to be

adapted accordingly.
32

SD Bioline P.f. RDT: will be used for home-
based malaria testing. This test detects
malaria antigens (Plasmodium proteins) and
produces results in 15 minutes. It is discussed
in greater detail below.

Sample Collection Cup: Small plastic tubes
with a cup on the end to collect the blood
sample from the finger or heel prick and
deposit it in the sample port of the test device.

Assay Diluent: To facilitate capillary flow of
embedded reagents and the blood sample.

Timer: for precisely timed reading of results

[FIRST LINE ACT]: is provided to children
testing positive for malaria, who do not exhibit
symptoms of severe malaria, or who are not
currently taking medication for malaria.
Children who have tested positive and
received [FIRST LINE ACT] treatment in the
last 2 weeks are not eligible for additional
treatment.

Coartem® 20/120

artemether.
lumefantrin.

4.C. Materials and supplies for preparing, storing and transporting blood smears

Glass microscope _ slides: Used for
preparing thick blood smears. The slides are
non-sterile but clean.

Additional use of the glass slides is to spread
the blood drops on the slide for thin and/or
beveled edge of a slide for thick smear
preparation.

Barcode Labels: The malaria testing in the
[YEAR] [COUNTRY] MIS is anonymous; i-e.,
an individual’s name is never written on the
glass slide. Instead, barcode labels are used
to link the thick smears to the data recorded in
the Biomarker Questionnaire. You will be
provided with sheets of “peel-off adhesive
barcode labels. The barcodes are arranged in
rows. The codes on each label are the same
across one row. A different row of barcode
labels on the sheet should be used for each
individual for whom a thick blood smear is
prepared. In the [YEAR] [COUNTRY] MIS,
barcodes will be used to label all smears.

TT
KeGcél
Te
VIZziIix
UT Ly
WaT7rz
1a
ooDoR
ON
Escep
TOU
W1IFal
ARIEL
32Q6R
TIDES
G4AsT
TT IL
XASGK

Y8B3L

2) UI UT ET
KSGtI KSGE KsG6i
TT TT
Wizix VIZix ViIzIx
IC TT TL
W2Trd W2TTS WeTr2
UT OE Sa Pt
coDoR caDoR ooDeR
TL UT ve AM TL
E3sceP EsceP ESCBP
Cr TAVAUIED AES
ViFsi VIFBI WIFSI
TRUE PHI UL
Ss06R S3Q6R Ssoa6R
LU TT Ly
G4AST G4AST G4A3aT
FL UT

xIS6X

X1S6X X1SEX

NT Td
Kesal
TONE
viz1x
Mt ti Td
weoTrz
ET
coDpoR
141000010
escsr
PUT ti
VIFéI
TENEADIB
S306R
Tih
G4aAsT
UN TT
x1S6x

Cardboard slide tray: The thick blood smears
should be placed in slots inside the carboard
slide tray to drying. The tray protects the thick
smears from dust and insects and facilitates
the safe transport of slides while in the field.

Blue slide storage box: Once out of the field,
dried thick blood smears should be transferred
to a slide box; each box holds 25 slides.

Ziploc® storage bags: Sealable plastic bags
will be used to store the cardboard slide tray
and slide boxes containing the thick blood
smears.

Desiccant packets: Drying agents that
absorb moisture from the air. Desiccants are
used to keep the smears dry during transport
to the laboratory. The granules inside the
packets change color from blue to pink as they
absorb moisture. Treat used desiccants as
biohazardous waste and throw them away ina

biohazardous waste bag.
Microscope Slide Transmittal Form: Used cee seractaraniescnened
to track the movement of the thick smears —
from the field to the laboratory. For each
individual who provided a blood sample, the
Microscope Slide Transmittal Form should
have a barcode with the same unique identifier
as the barcode label attached to the glass
slide and the Biomarker Questionnaire. See
Appendix X for a sample Microscope Slide
Transmittal Form.

Two paper handouts are available to parents/responsible adults:

1. Malaria pamphlet: a one sheet document designed to inform the parent/responsible adult
about the malaria test results within the household, dosages of treatment and contact
information. See Appendix X for an example of the malaria pamphlet.

2. Severe malaria referral form: a slip of paper given to the parent/responsible adult of a
child with severe malaria (defined as a child who tested positive for malaria and has
symptoms of severe malaria See Appendix X for an example of the severe malaria
referral form).

NOTE: Provision of [FIRST LINE ACT] is a requirement of the survey. Children should not be
tested for malaria if [FIRST LINE ACT] is unavailable.

4.D. Handling and storage of SD Bioline P.f rapid diagnostic test (RDT) kit

The SD Bioline P.f RDT is a rapid, qualitative test for malaria. It tests for one antigen, the histidine-
rich protein Il (HRP-II), specific to Plasmodium falciparum (P.f), the major cause of malaria in

[COUNTRY].
Each SD Bioline P.f RDT comes in a self-contained pouch. The kit includes:

Test cassette

Desiccant packet

Sample collection cup

Assay diluent in a dropper bottle
Instructions

SD Bioline P.f RDT

Result window Sample well Dilvent well

1. The sample collection cup is used to collect and deposit the blood sample from the finger
(heel) prick into the sample well in the test device.

2. Assay diluent is added to the diluent well to aid the lateral flow of the blood and reagents
along the strip.

3. After 15 minutes, a control band (C) and test band (T), will appear in the result window
if malaria is detected.

There are handling and storage requirements that should be observed for accurately performing
the SD Bioline P.f RDT:

e Do notuse the device after the expiration date.

e The test device must remain in the sealed pouch until use. Once the device is
open, it must be used immediately. Do not open the sealed pouch more than 5
minutes before doing the test as the device is sensitive to humidity.

e Never mix reagents from different lots.

e Do not use the device if the pouch or device is damaged or if any lines are visible
on the device before contact with the sample.

4.E. Determine eligibility and obtain informed consent for malaria testing

Children: Follow the steps below for malaria testing of eligible children age 6-59 months.

Biomarker technicians will not fill in anything prior to [Q. 106; Q. 118] and onwards are for the
biomarker technician to complete.

[Q.118]: NAME OF PARENT/RESPONSIBLE ADULT FOR THE CHILD

In [Q. 118], record the name of the parent/responsible adult (over the age of 18) for the child. This
person will be asked for their informed consent for malaria testing for that child. You will notice
that below the space for the name is space for a line number. You are NOT responsible for filling
in the line number. The line number of the parent/responsible adult will be populated when the
questionnaire is entered into CAPI.

Do Not Enter Lirfe Number

RECORD NAME AND LINE NUMBER OF PARENT/RESPONSIBLE ADULT FOR THE | NAME
CHILD.

LINE NUMBER OF
PARENT/
RESPONSIBLE ADULT

Q. 120]: ASK CONSENT FOR MALARIA TEST FROM PARENT/RESPONSIBLE ADULT

ASK CONSENT FOR MALARIA TEST FROM PARENT/RESPONSIBLE ADULT: GRANTED
REFUSED :
As part of this survey, we are asking children all over the country to take a test to see if NOT PRESENT/OTHER
they have malaria. Malaria is a serious illness caused by a parasite transmitted by a
mosquito bite. This survey will assist the government to develop programs to prevent
and treat malaria. We ask that all children age 6 months through 4 years take part in
malaria testing. The tests require a few drops of blood from a finger or heel. The
equipment used to take the blood is clean and completely safe. It has never been used
before and will be thrown away after each test.

The blood will be tested for malaria immediately, and the results will be told to you right
away. [A few blood drops will be collected on slide(s) and taken to a laboratory for
testing. You will not be told the results of the laboratory testing.] All results will be kept
strictly confidential and will not be shared with anyone other than members of our
survey team.

Do you have any questions? You can Say yes or no. It is up to you to decide. Will you [FIELDWORKER] NUMBER
allow {NAME OF CHILD} to participate in the malaria test?

After reading the consent statement, record the parent/responsible adult’s response to the request
to allow the child to participate in the testing. If the parent/responsible adult agrees, circle ‘1’
(GRANTED). If the parent/responsible adult refuses to allow the child to participate in the testing,
circle ‘2,’ (REFUSED).

Q. 121]: SIGN NAME AND ENTER [FIELDWORKER] NUMBER

After recording the outcome of the consent process, you must affirm that you have read the
statement to the parent/responsible adult and recorded the results accurately by signing your
name and entering your fieldworker number in the space provided.

Q. 123]: IF CONSENT GRANTED, PREPARE EQUIPMENT AND SUPPLIES FOR THE TESTS
AND PROCEED WITH THE TESTS

At this point, set up your station and proceed with the malaria testing.

4.F.

Steps in performing malaria testing

Prepare the supplies
Following instructions in Chapter

X, prepare blood _ collection
supplies. Remove one malaria
RDT from the kit, [one glass slide
for the thick smear, another slide
to spread the blood drop,] and
timer. Open your capillary blood
collection supplies in the order
mentioned in Chapter X.

2. Place barcode labels:

m Take the first barcode label
from the first complete row on
the sheet of barcode labels
and affix it in [Q. 123] of the
Biomarker Questionnaire.

m Take the second barcode
label from the same row on the
sheet of barcode labels and
affix it on the microscope slide
(with the unique identifier
facing outwards).

mw Take the third barcode label
from the same row on the
sheet of barcode labels and
affix it on the Microscope Slide
Transmittal Form for the
cluster in which you are
working.

PREPARE EQUIPMENT AND SUPPLIES FOR THE TEST(S) AND PROCEED WITH
TESTING.

PLACE 1ST BAR CODE LABEL FOR MALARIA LAB TEST IN SPACE TO THE
RIGHT. PUT THE 2ND BAR CODE LABEL ON THE SLIDE AND THE 3RD ON THE
TRANSMITTAL FORM.

[YEAR] [COUNTRY] [MALARIA INDICATOR] SURVEY|
MICROSCOPE SLIDE TRANSMITTAL FORM (FRONT SIDE)

PUT THE 1ST BAR CODE
LABEL HERE

REFUSED
OTHER

Organize your station — Malaria

m Open the RDT pouch and
retrieve the test cassette, the
sample collection cup and
desiccant packet, taking care
not to touch the membrane
area of the device. Once the
device is open, it must be used
immediately!

m Check the color of the
desiccant packet, it should be
blue. If it is colorless or pink,
discard the device and use
another one.

If consent was granted, collect a
blood sample from the respondent
following the procedure described
in Chapter X. Use a sterile gauze
pad to wipe away the FIRST
large blood drop from the finger
or heel. Use the SECOND large
blood drop for the malaria RDT.

Touch the sample collection cup to
the blood drop at the puncture site,
ensuring that blood fills the entire
cup (5 uL) to run the RDT. Do not
release the finger.

Transfer the blood sample to the
sample well immediately. Ensure
the blood from the sample
collection cup has been
completely absorbed by _ the
sample pad. Put the sample
collection cup in the Sharps
container.

7. Without delay, dispense four drops
of the assay diluent into the
developer well while holding the
bottle vertically.

8. Start the timer for 15 minutes.

9. Collect the THIRD drop of blood
for the preparation of the thick
blood smear. The blood drop
should be about 5 ul or about this
size e. Pick up a slide with a
barcode by its edge. Turn the slide
so the barcode is facing the
respondent’s finger or heel. Touch
the center of the slide to the blood
drop three times to collect three
small blood drops in the shape of
a triangle. Place the slide on the
absorbent sheet.

DO NOT LET THE SLIDE TOUCH
THE FINGER!

10. Prepare the thick smear. Use the
corner of a beveled edge clean
slide to blend the three drops of
blood. Do not “stir’ the blood;
instead, the blood should be
spread evenly in 3 to 5 circular
motions in the same direction.
Start from the inside and work your
way out. Bring the edge/corner of
the mixing slide back to the center
of the blood drop and lift. The
blood smear should have a
diameter of about 1 cmin size. Put
the mixing slide in the sharps
container.

The following shows how thick smears should look:

A thick smear is made by placing three drops of blood (5 ul each) on a
clean, grease-free slide and spreading blood evenly over a small area such
that the blood cells are layered on top of each other. If the thick smear is
made correctly, letters can be barely read if the slide is placed over

newsprint.

The following illustrate some common errors in thick blood smear

preparation which you should avoid:

Corner of mixing slide chipped: Too little blood:

. "y
ie
¥

os .

11. After you have finished blood
collection, wipe any remaining
blood from the prick site with a
sterile gauze pad. Press the
gauze pad against the prick site
until the blood flow has stopped
completely.

12. Apply an adhesive bandage to
the prick site. Advise the parent
or responsible adult, especially
when the child is a toddler, to
carefully watch that the child does
not take off the bandage and put it

Children age 12-59 months (Finger)

in his/her mouth as the child may
choke on it.

13.

After 15 minutes, read the
malaria result. Record the result
code of malaria testing in [Q. 124]
of the Biomarker Questionnaire
and the malaria pamphlet. If the
child was tested, circle ‘1’. If the
child was not present, the
parent/responsible adult refused
to consent to the test, or there was
some other problem, circle the
appropriate code. The _ test
results should not be
interpreted after 30 minutes.

CONDUCT TEST AND RECORD RESULT OF THE MALARIA RDT HERE AND IN [TEST POSITIVE]

THE [INFORMATIONAL PAMPHLET].

[TEST NEGATIVE]
NOT PRESENT
REFUSED
OTHER

14.

Place the blood smears in the
cardboard slide tray. Each
smear should be placed in one
independent slot. Make sure the
smear is facing upwards and not
down. Close the cardboard slide
tray to protect the blood smears
from flies and dust. The blood
smears will dry while in the
cardboard tray in a_ horizontal
position.

*INDEX-

15. Give the malaria pamphlet to the
parent/responsible adult. Inform
the parent/responsible adult of the
result and provide him/her with the
pamphlet. When reporting the
result, briefly explain to the
parent/responsible adult what
his/her child’s malaria result
means, using the informational
pamphlet as a guide.

16. Provide a written referral to the parent/responsible adult of a child with severe malaria, defined
as any child with severe malaria symptoms and/or any child who tested positive for malaria. Inform
the parent/responsible adult about the effects of severe malaria. Record the RDT result on the
severe malaria referral form and encourage the parent/responsible adult to seek follow-up medical
attention for their child.

17. Provide the parent/responsible adult with treatment for a child with malaria. Any child with
malaria who does not have any severe malaria symptoms is eligible for treatment if the
parent/responsible adult consents. Children who are taking or have taken a first line ACT in the past
2 weeks are not eligible for treatment. Instead, the parent/responsible adult is instructed to seek care
if the child has a fever for 2 days after the last dose of the ACT was given.

4.G. Interpreting the results of SD Bioline P.f RDT

There are three possible outcomes of the SD Bioline P.f RDT: negative, positive, and invalid.
A test that is positive will be classified as P. falciparum malaria positive.

The result is NEGATIVE for P. falciparum malaria if only a single pink/pink-purple band
corresponding to the control “C” is observed.

NEGATIVE

A line in “C” and NO LINE in “T”’ means
the patient DOES NOT have falciparum
malaria.

Malaria Ag Pt Ss

The result is POSITIVE for P. fa/cijparum malaria if there is a pink/pink-purple band in both the
test and control areas of the result window.

POSITIVE

Aline in “C” AND a line in “T” means the patient
DOES have falciparum malaria.

Malaria Ag Pf

The test is POSITIVE even if the line in
“T” is faint.

Malaria Ag Pt Neg T = A _
a a
a i

If no control band is observed on the device, the test is invalid. It must be repeated with consent
from the parent/responsible adult using a new device.

INVALID RESULT

NO LINE in “C” and a line or no line in “T”
means the test is INVALID.

Repeat the test using a new RDT if no
control line appears.

4.H. Treatment protocol for malaria positive children

Malaria treatment will be provided to children testing malaria positive in the [YEAR] XMIS.
Following the national malaria treatment guidelines, children will be treated with [FIRST LINE
ACT]. Prior to treating children, it must be determined whether or not the child is in need of
treatment. If the child has taken [ACT] within the previous 2 weeks or is currently taking [ACT] to
treat the malaria, it is not appropriate to give him/her additional medication. Rather, if the child
has already received medication, read the following statement to the parent/responsible adult and
skip to [Q. 129]:

ALREADY TAKING [FIRST LINE MEDICATION] REFERRAL STATEMENT

You have told me that {NAME OF CHILD} had already received [FIRST LINE OF MEDICATION] for malaria. Therefore, |

cannot give you additional [FIRST LINE OF MEDICATION]. However, the test shows that he/she has malaria. If your child has
a fever for 2 days after the last dose of [FIRST LINE MEDICATION], you should take the child to the nearest health facility for
further examination.

For each child with a positive malaria test and who hasn’t taken [FIRST LINE ACT] in the past 2
45

weeks, request consent from the parent/responsible adult to provide [FIRST LINE ACT] using the
following language:

ASK CONSENT FOR MALARIA TREATMENT FROM PARENT/RESPONSIBLE ACCEPTED MEDICINE
ADULT: REFUSED MEDICINE

The malaria test shows that {NAME OF CHILD} has malaria. We can give you free
medicine. The medicine is called [FIRST LINE OF MEDICATION]. [FIRST LINE OF
MEDICATION] is very effective and in a few days it should get rid of the fever and other

symptoms. You do not have to give {NAME OF CHILD} the medicine. This is up to you.
Please tell me whether you accept the medicine or not.

The correct dosage of [ACT] depends on the child’s weight/age:

[ACT] dosage guidelines for children with positive malaria tests

The first dose of [FIRST LINE ACT] should be administered to the child by the biomarker
technician. The nurse/health technician should advise the parent/responsible adult on how to
administer the subsequent doses of [ACT]. The parent/responsible adult should also be told that
the child must be given the full 3 days of medication so that the infection will be cleared. The
nurse/health technician should also advise the parent that additional [ACT] tablets must be
obtained and given to the child if the child vomits within an hour of taking a tablet.

The nurse/health technician should also tell the parent/responsible adult to take the child to a
health facility immediately if the child experiences a fever for 2 days after taking the last dose of
medication.

4.1. Storage and transport of thick blood smears

The blood smears you make in the field for malaria testing must be properly stored. They must
be allowed to dry thoroughly, protected from dust, flies, debris and other contaminants and kept
from high levels of humidity. Follow the guidelines below to maintain high quality blood smears
during storage.

1. After returning from the field each day, you should inspect the slides you collected that
day to check their quality. Be sure to wear gloves during your inspection.

2. You should also check that you have one thick smear for each eligible child you tested
that day, and that each slide has a barcode label. Check that the barcode label in the
Biomarker Questionnaire ([Q. 123]) matches one placed on the Microscope Slide
Transmittal Form. Note any discrepancies and try to resolve them. If you are missing
slides for any child for whom you have recorded that a smear was prepared, you must go
back to the household and ask permission to test the child again.

3. Make sure that you do not touch the smears accidentally with your fingers or with any
materials you carry in the field and that there is no dust or dirt particles embedded in the

blood. If you touch the smear before it has dried thoroughly, you must go back to the
household and ask permission to collect another blood smear.

The next morning before going to the field, you must:

Check the thick smears to make sure that they have dried completely.

Transfer the thick blood smears from the cardboard tray into the slide slots of blue slide
storage box, beginning with the first column.

Place the blue slide storage box in a Ziploc bag containing about 3 to 5 sachets of
desiccant. It is very important that the zip-loc bag remained sealed. The buildup of humidity
can damage blood smears. Monitor the desiccants for color change from blue to pink. As
necessary, remove pink desiccants and replace with new desiccant packets. Each
morning that you are in the cluster, add the additional smears you have collected to the
slide box. You will use one blue slide storage box per cluster. Mark both the slide box and
the Ziploc back with the cluster number.

Transferring the thick smears to the laboratory

Periodically, field coordinators or other members of the [YEAR, COUNTRY MIS] team will visit to
pick up the blood smears and transfer them to the central office and then to the laboratory for
further processing. You will transfer slides for completed clusters only.

To make sure that all the slides are transferred, you must check the slides against the
Microscope Slide Transmittal Form and the Biomarker Questionnaires for each cluster. Please
see an example of the Microscope Slide Transmittal Form in Appendix X. Follow these steps
for in preparation for transferring the slides:

Put on Gloves. Remove the blue slide storage box from the Ziploc bag. Check the
barcode on each thick smear slides against the barcodes on the Microscope Slide
Transmittal Form. Put a check mark in the column labelled TECHNICIAN for each slide
with corresponding barcode found on the Microscope Slide Transmittal Form.

Complete the Microscope Slide Transmittal Form. Count the total number of blood
smears (slides) and record the number in Column (3).

Sign your name in Column (4) and record the date in Column (6). Note any discrepancies
in Column (7).

The team supervisor will re-verify that the barcodes on the smears match the barcodes on
the Microscope Slide Transmittal Form.

Fold the Microscope Slide Transmittal Form along the dotted lines (so that the bar-
coded labels are not folded) and keep it with the slides in the blue slide storage box or
Ziploc bag until the slides are collected by the field coordinator or other staff member who
is picking up the slides for all completed clusters.

6. When the field coordinator collects the slides for completed clusters from the teams,

AJ.

he/she will verify the number of slides on the Microscope Slide Transmittal Form with
the field supervisor. They will then be taken to the central survey office for checking before
being transferred to the laboratory for processing.

Precautions to take during malaria testing

The following are common mistakes made during malaria testing:

Inadequate filling of the malaria RDT. The blood collection device should be filled
correctly with the recommended volume by the RDT kit manufacturer. The entire volume
of blood should be blotted in the sample collection well.

Improperly stored RDTs should not be used for testing. RDTs have specific storage
requirements and should not be used if these storage requirements were not followed.
The containers must be kept closed when not in use to avoid exposure to moisture, which
may destroy the reagents or alter the properties of the test.

Using kit components with different lot numbers. Always use the reagents that are
supplied with the RDT kits. Do not swap buffers or cassettes from different kits.

Not labelling the slide. As the blood smear will be taken to another location where the
microscopic examination will be done, it is critical that the smears are labelled with a
barcode so the result can be matched to the child.

Not using free-flowing blood. It is important that the blood be free flowing, especially
the drops used for preparing the blood smear.

Touching the glass slide with fingers wet with alcohol. This can result in alcohol and
dirt contamination of the glass slide preventing the proper spread and drying of the blood
smear.

Using greasy slides to prepare thick smears. Preparing blood smears on greasy slides

results in smears with holes and streaks, as the grease does not allow the blood to spread
evenly on the slide. These slides cannot be properly read.

Chapter 5. BIOHAZARDOUS WASTE DISPOSAL

Learning objectives

= Define biohazardous waste

= Define biohazardous waste disposal

= How to collect and store biohazardous waste during training and fieldwork
=m Procedures for field disposal of biohazardous waste

=u Methods of destroying biohazardous waste

5.A. Introduction

Any material that has come in contact with blood or other bodily fluids such as lancets, alcohol
swabs, gauze, and gloves are considered to be biohazardous waste (hazardous to other
humans). Safe disposal of such material (biohazardous waste disposal) is crucial to prevent the
transmission and spread of various bloodborne diseases, such as hepatitis B and HIV, among
survey personnel and survey respondents. Biohazardous waste must be collected in
biohazardous waste bags or sharps containers immediately following blood collection and testing,
securely stored and transported, and safely disposed of prior to leaving a cluster. Both
biohazardous waste bags and sharps containers have a special logo warning about biohazardous
content. Sharps containers should be securely closed for safe storage and transportation of used
sharp materials.

5.B. Collecting and storing waste during trainings and fieldwork

During training and while in the field/during data collection, all soiled (containing blood) biomarker
supplies (for example: absorbent sheets, gloves, gauze, etc.), and their packaging will be placed
in a biohazardous waste bag. Items identified as sharps, posing a personal health risk to
biomarker technicians, respondents and anyone disposing of waste (for example: safety-
engineered lancets) will be collected in a sharps container.

Biohazardous Waste Bags

For the [YEAR] [COUNTRY] MIS, three sizes of biohazardous waste bags are provided: small 2-
3 gallon (7.5-11.3 liters), medium 7-10 gallon (26.5-37.8 liters) and large 12-14 gallon (45.4-52.9
liters). The small “household” waste bag will be used to collect all the non-sharps biohazardous
waste from one household. Once the biomarker technician has completed processing all eligible
respondents within a single household, the small biohazardous waste bag should be tied in a knot
making sure to remove any excess air. When traveling from one household to another, all
individually knotted small biohazardous waste bags should be stored in a medium “field” waste
bag for easier transport. Thus, the biomarker technician can carry around one medium
biohazardous waste bag instead of five or so small waste bags. At the team space or vehicle
(wherever the biohazardous waste is being stored), all used medium biohazardous waste bags
should have the excess air removed from them and be transferred for storage into a large “cluster”
waste bag. The large biohazardous bag should hold all the waste collected within a cluster. If

not, a second cluster bag may be used. See the table below for each biohazardous waste bag
and their appropriate use.

Biohazardous Waste Appropriate Use Storage When Filled
Bag

2 to 3-gallon Small household biohazardous waste Store inside of medium
bag biohazardous bag

7 to 10-gallon Stores the small biohazardous waste | Store inside of large biohazardous
bags used in households for easier bags
transport though the field

12 to 14-gallon Stores the medium biohazardous Store at the team space until
waste bags per cluster disposal at a local health facility

If all the waste from one household will not fit into one 2-3 gallon small biohazardous waste bag,
please use another small bag to collect the remaining household waste. Generally, 1-2 large
cluster bags are enough to hold all the waste from one cluster.

Sharps Containers

For the [YEAR] [COUNTRY] MIS, [SIZE] sharps containers are provided. Sharps are any items
used to measure biomarkers (and as a result are contaminated with biohazardous bodily fluids or
blood) that can puncture through the thin plastic bionazardous waste bags. All sharps containers
used in the [XMIS] are made of puncture-proof plastic so any item placed inside of them will not
puncture through the material. This is not the case for the plastic biohazardous waste bags.
Sharp items include, but are not limited to, safety-engineered lancets. [For an MIS, glass slides,
cartridges and pipettes should be considered sharps]. To protect both the biomarker technicians
and the respondents, safety-engineered lancets are used to reduce exposure to blood and
injuries. These lancets are one-time use and thus, the blade permanently retracts into the casing
after being triggered. However, if these lancets are tampered with after use (i.e., taken apart), it
is possible to recover the blade inside the casing, so we place lancets inside the sharps container.
Unlike the biohazardous waste bag, items cannot be recovered from the sharps container once
they are sealed.

Note: you should NEVER attempt to remove any biohazardous waste material once it is
discarded in the biohazardous waste bag or sharps container!

See the table below for sharps containers and their appropriate use.

Sharps Containers Appropriate Use Storage When Filled

5 quarts Sharp biohazardous waste from a Store at the team space until
(4.7 liters) cluster disposal at a local health facility

All sharps containers recommended by The DHS Program have a fill line printed on the outside.
50

Do not fill the sharps containers with material past this line. Sharps containers once sealed cannot
be reused. So once a sharps container is filled, close the lid and dispose of at a designated health
facility. Start each cluster with a new sharps container even if the last sharps container from the
previous cluster has yet to reach the fill line.

Sharps container labels

5.C. Procedures for disposal of biohazardous waste

Biohazardous waste is generated at three stages during the [YEAR] [COUNTRY] MIS: during the
training, during field practice, and during fieldwork. Prior to generating any biohazardous waste,
[Implementing Agency] in partnership with the [Ministry of Health, NACP or other country specific
agencies] must identify health facilities that will dispose of the biohazardous waste collected
according to [Country] national standards. A list of these health facilities and their contact
information should be provided to the team supervisors by the [implementing agency] along with
a letter from the MOH detailing the mission of the survey, introducing the team, and outlining the
services needed from that facility.

At the end of training and after each blood collection within the household, all the non-sharps
materials used during the testing (i.e., gloves, alcohol swabs, and gauze pads) are to be placed
in a 2-3 gallon household biohazardous waste bag. All sharp materials (i.e., lancets and glass
slides) are to be placed in the sharps container. All biohazardous materials should be immediately
placed in the appropriate waste bag or container after use. For instance, once you have pricked
the finger or heel with the lancet, you should place the lancet directly into the sharps container,
do not place the lancet back on the absorbent sheet.

Before proceeding to a new cluster, team supervisors should identify (from the list of facilities
provided by [implementing agency], the local health facility where the waste can be safely
destroyed. Team supervisors should contact the health facility prior to or soon after entering the
cluster to introduce themselves and inform the local health facility that the team intends to dispose
of the biohazardous waste from the cluster(s) there. One health facility may be used for the
disposing of waste from multiple clusters; hence it is considerate to inform the local health facility
ahead of time.

5.D. Methods of destroying/decontaminating biohazardous waste

It is likely that the local health facilities identified by the government for safe disposal of
biohazardous waste during the [YEAR] [COUNTRY] MIS will use one or a combination of the
following methods to destroy or decontaminate the biohazardous waste. The two methods listed
below are the best management options for solid infectious waste for small-scale activities.

Incineration

Incineration is the process of burning biohazardous waste and reducing the waste volume by
about 80%. Incineration can take place in a chamber or drum/brick furnace. Through this method,
99% of microorganisms on biohazardous waste and contaminated sharps are destroyed.
However, the sharps found in ashes can still pose a physical hazard. Open-air incineration is less
effective at disinfecting and has the potential for incomplete burning (leaving behind infectious
material), is more hazardous to the staff involved and runs a greater risk of unburned supplies
being scavenged by people and animals.

Autoclave

Autoclaving is the process of sterilizing waste with steam treating at high temperature and
pressure. In order to be effective, the steam needs to be able to penetrate the waste. Autoclaving
can also be used to sterilize reusable medical waste. We do not autoclave and reuse any of the
materials used in the [YEAR] [COUNTRY] MIS.

A few points to remember when you are collecting and storing biohazardous waste in the field:

e NEVER leave biohazardous waste in households

e Biohazardous waste should NEVER be disposed of in general solid waste containers or
facilities

e Never store anything in the biohazardous waste bags or sharps containers other than
biohazardous waste

e Once closed, the sharps containers cannot be reopened, so take care when moving
through the field not to close the container prior to reaching the fill line

Chapter 6. APPENDIX

6.A. Malaria brochure

LOGO
|

Name of the Household Head:

[NAME OF SURVEY]

Malaria diagnosis:

Positive Negative

TREATMENT FOR
MALARIA PROVIDED:

Malaria diagnosis:

Positive Negative

TREATMENT FOR
MALARIA PROVIDED:

Malaria diagnosis:

Positive Negative

TREATMENT FOR
MALARIA PROVIDED:

Malaria diagnosis:

Positive Negative

TREATMENT FOR MALARIA
PROVIDED:

TREATMENT WITH FIRST LINE: if FIRST LINE. ACT]

Weight in KG Content Dosage*
25 mg XX + 67.5 mg XX

50 XX+ 135 XX
mg ma 1 tablet once a day for 3 days

29kg <18 kg 1-4 years

* If the child has a fever for two days after completing the last dose of [FIRST LINE ACT], you should take him or hertoa
health professional for treatment right away

A\ If your child develops the following
symptoms you should go to the health
facility:

For questions concerning the survey please contact
the following:

Extreme weakness . :

. National Malaria Control Program
Loss of consciousness
Rapid or difficult breathing
Seizures
Jaundice or yellow skin
Dark urine

Abnormal bleeding

[NAME: CELL NUMBER]
[NAME: CELL NUMBER]

[OTHER RELEVANT AGENCY]
[NAME: CELL NUMBER]

6.B. Severe malaria referral

[COUNTRY] MALARIA INDICATOR SURVEY: Severe Malaria Referral

During the YEAR COUNTRY MIS (Name), age

months / years, was tested for malariaon__——/__—=—/___, with a Rapid Diagnostic Test (RDT).

He/she tested positive for malaria, and is displaying the following signs of severe malaria:

___ EXTREME WEAKNESS ____ HEART PROBLEMS

___ LOSS OF CONSCIOUSNESS ___ RAPID OR DIFFICULT BREATHING

___ SEIZURES ___ ABNORMAL BLEEDING

___JAUNDICE OR YELLOW SKIN ____ DARK URINE

He/she appears to be very ill and did not receive treatment for the malaria. THIS CHILD NEEDS TO
BE TAKEN TO A HEALTH FACILITY RIGHT AWAY.

6.C. Slide transmittal form

[YEAR] [COUNTRY] [MALARIA INDICATOR] SURVEY
MICROSCOPE SLIDE TRANSMITTAL FORM (FRONT SIDE)

[FIELDWORKER] NUMBER CLUSTER NUMBER

PERSON
SENDING/

SIGNATURE
(CONFIRMING THAT
EACH SLIDE IS

SIGNATURE
(CONFIRMING COUNT
OF MICROSCOP SLIDES

NOTES

(NOTE ANY DISCREPANCY
IN NUMBERS OF SLIDES)

TOTAL COUNT OF
MICROSCOPE SLIDES

RECEIVING TIME TO FILLIN PRESENT - SEE BACK IN COLUMN 3)

SAMPLES FORM

AFTER
BIOMARKER
TECHNICIAN HAS
DONE HIS/ HER
COUNT

BIOMARKER
TECHNICIAN

TEAM WHEN CLUSTER IS
SUPERVISOR COMPLETED

FIELD WHEN SAMPLES
COORDINATOR | ARE PICKED UP IN
FIELD

UPON ARRIVAL AT
LAB

INSTRUCTIONS

BIOMARKER TECHNICIAN: Upon completion of a cluster, verify that the barcode label on each slide collected in that cluster
corresponds to a barcode label pasted to the back of this transmittal form and vice-versa. Note any discrepancies in Column (7).
Count and record the total number of blood smears (slides) in Column (3). Sign your name in Column (4) and record the date in
Column (6). Fold and store this transmittal form in the Ziploc bag with the box containing the slides.

TEAM SUPERVISOR: After the biomarker technician has verified the slides, the team supervisor will conduct a second verification.
Verify that the barcode label on each slide collected in that cluster corresponds to a barcode label pasted to the back of this
transmittal form and vice-versa. Note any discrepancies in Column (7). Count and record the total number of slides in Column (3).
Sign your name in Column (4) and record the date in Column (6). Fold and store this transmittal form in the box containing the
slides.

FIELD COORDINATOR: Before returning to the laboratory with the slides, you will count and record the total number of blood
smears (slides) in Column (3). Sign your name in Column (5) and record the date in Column (6). Note any discrepancies in Column
(7). Fold and store this transmittal form in the box containing the slides.

RECEIVER AT THE LABORATORY: Upon receiving the blood smears (slides) from the [FIELD COORDINATOR], verify that the barcode
label on each blood smear (slide) collected in that cluster corresponds to a barcode label pasted on the back of this transmittal form
and vice-versa. Count and record the total number of slides in Column (3). Sign your name in Column (4) and record the date in
Column (6). Note any discrepancies in Column (7) and inform the [IMPLEMENTING AGENCY].

Note: This form will be destroyed under the direction of the Lab Director after all blood smears have been stained and read and a_

[YEAR] [COUNTRY] [MALARIA INDICATOR] SURVEY

BLOOD SMEAR (SLIDE) TRANSMITTAL FORM (BACK SIDE)
i — aes [seal

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