Document text
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://www.dhsprogram.com.
Contents
Chapter
1.A.
1.B.
1.C.
1.D.
1.E.
1.F.
1.G.
Chapter
2.A.
2.B.
2.C.
2D,
2.Ey
2.F.
2.G.
2H:
2.1.
Chapter
3.A.
3.B.
a
3.D.
3.E.
3.F.
3.G.
3.H.
Chapter
4A.
4.B.
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Chapter1. 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:
How to identify eligible respondents in households for biomarker measurement
How to obtain informed consent from parents/responsible adults for children
How to complete the Biomarker Questionnaire
How to perform capillary blood collection on children
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 biohazardous 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
1
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:
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.
Phase Il. You will visit a health facility and practice measuring biomarkers from
children with the consent of their parent or responsible adult.
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
Spot check that you visited the correct households and collected blood samples and
measured biomarkers only from eligible respondents;
Collect blood specimens for transport to the laboratory and consolidate the field
record forms; and
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.
1.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:
Household ownership of insecticide-treated mosquito nets and their use, especially
by children under age five years and pregnant women;
Intermittent preventive treatment against malaria during pregnancy;
The type and timing of treatment of high fever in children under age five years;
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:
Histidine-Rich Protein II (HRP- | Estimate the prevalence of malaria
1 Biomarker Definitions Working Group, National Institutes of Health, 2001
II)
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.
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
4
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
5
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
100% |
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.
Children age 6 months-4 years x
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
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: @001 HOUSEHOLD: 0003
Name of household head: GENEVIEVE DUPUIS
Check the cover page Children Eligible for Biomarker Collection of the
Biomarker Se ——————— Questionnaire
to identify the number ron So Tene ate eesae yep aaa octet of children
who are potentially g2 2 @2 JULIA FLEURET eligible for
biomarker collection. 4 1 @4 MATT TURBYFILL This
information can be found under
“Fieldworker Visits.”
FINAL VISIT
DATE
wae Where to find the
number of eligible
children
TOTAL ELIGIBLE
CHILDREN
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
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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.
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 io 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.
_ 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
10
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 O-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
11
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
16 July 2020 | 17 July 2020
DATE
[FIELDWORKER'S]
NAME
Next visit: pate | 27 7 July 2020 2020 TOTAL NUMBER
OF VISITS
time | 08:00 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’
12
in the space provided.
LANGUAGE OF LANGUAGE OF 1 NATIVE LANGUAGE 1 TRANSLATOR
QUESTIONNAIRE* INTERVIEW** OF RESPONDENT** (YES = 1, NO = 2)
LANGUAGE OF **LANGUAGE CODES:
QUESTIONNAIRE** EN G LI Ss H 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- | Obtain the consent of one of the child’s parents, or, in the
59 months) absence of a 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
13
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)
¢ 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, 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
14
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:
<
m
an
Zz
re)
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
SYCBOREHN
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
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
15
appropriate response in the space provided or the respondent’s results.
Example
RECORD NAME OF PARENT/RESPONSIBLE ADULT FOR THE CHILD. Monica
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 C1
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 pd
IS THE CHILD OLDER? MONTHS 135
\—___,___
Always follow the skip patterns!
Unless a skip pattern is present, always move directly to the next question.
16
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 RD¥ 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.
e 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.
e 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
17
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.
18
Chapter 3. CAPILLARY BLOOD COLLECTION
Learning objectives
m List supplies for blood collection
m Determine the site of blood collection for the appropriate age group
@ List steps involved in obtaining a capillary blood sample from the finger
i
Perform steps involved in obtaining a capillary blood sample from the
finger
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.
19
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).
Alcohol preps: Used for cleaning the skin prior
to pricking the finger or heel.
20
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.
Sterile gauze pads: Used to wipe away the
first drop(s) of blood to stimulate capillary blood
flow.
€) BD Microtainer®
Contact-Activated Lancet
Adhesive bandages: Applied to the puncture
site to minimize the risk of infection.
21
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)
1. Measure your hand using the glove-sizing chart before choosing a glove to
reduce the potential for tearing.
2. If possible, thoroughly wash hands before donning gloves and after each
glove change.
3. Open glove at the cuff and extend opposite hand until thumb crotch is to the
cuff of the glove.
4. Once the hand is properly aligned in the glove, move your fingers down into
the glove's fingers.
5. Roll the cuff of the glove down the wrist until the glove is secure.
6. Replace gloves frequently, including whenever changing tasks.
Doffing (taking off gloves)
1. Pull the glove from above the cuff up on the hand inside out to trap potential
contaminants inside the used glove.
2. Place the used glove into the palm of the opposite hand (which remains
gloved).
22
as
4.
3.D.
Repeat step 1 on the opposite hand, trapping the first glove inside the
second.
Discard gloves and wash hands.
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
1,
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-1. How a parent should hold a child for a finger prick.
23
3.E. Collecting the blood from a finger prick
1. Put on gloves before beginning the
collection of the blood sample from the first
child.
2. 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.
3. 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.
4. Ask the parent/responsible adult to
warm the child’s hand by briskly rubbing
the child’s fingers in between their palms.
Bi
Set up your station:
e Take out a clean absorbent
supplies.
e Open the _ sterile gauze
Separate the two pieces of
lay them down on the pack
do not touch the absorbent p
e Open the outer package of t
bandage. Place the bandég
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
25
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.
26
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.
27
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.
28
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.
29
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
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. ]
30
6. Apply an adhesive bandage to the prick
site.
7. Properly dispose of all materials used in
blood collection:
Lancets should always be discarded in a
sharps container
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.
? 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.
31
3.H.
If your gloves are soiled with blood, complete the blood collection
process and change them immediately once you have finished with that
child.
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
32
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.
33
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.
34
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
35
[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.
UTA
YSB3L
UT DE UT ST AT
KesGésI KSGtI K3sGSl
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36
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.
37
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 in a biohazardous waste bag.
Microscope Slide Transmittal Form:
Used 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.
[YEAR] [COUNTRY] [MALARIA INDICATOR] SURVEY|
MICROSCOPE SLIDE TRANSMITTAL FORM (FRONT SIDE)
(FIELOWORKER] NUMBER
(CLUSTER MUMaER
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.
example of the malaria pamphlet.
2. Severe malaria’ referral form:
a slip of paper given to
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).
See Appendix X for an
the
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
38
The SD Bioline P.f RDT is a rapid, qualitative test for malaria. It tests for one
antigen, the histidine-rich protein II (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
Resuttwindow Samplewell 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 not use 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
39
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.
.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 Lite Number
RECORD NAME AND LINE NUMBER OF PARENT/RESPONSIBLE ADULT FORTHE | NAME
CHILD.
LINE NUMBER OF
PARENT/
RESPONSIBLE ADULT
_ 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.
. 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
1. 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 a P l ace ba rcod e la be l Ss: PREPARE EQUIPMENT AND SUPPLIES FOR THE TEST(S) AND PROCEED WITH
2 TESTING. PUT THE 1ST BAR CODE
LABEL HERE
a Take the first barcode 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
label from the _ first TRANSMITTAL FOR REFUSED
OTHER
complete row on_ the
sheet of barcode labels
and affix it in [Q. 123] of
the Biomarker
Questionnaire.
W@ Take the second barcode
label from the same row
on the sheet of barcode
labels and affix it on the
microscope slide (with the
4l
unique identifier facing
outwards).
W@ 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.
[YEAR] [COUNTRY] [MALARIA INDICATOR] SURVEY|
MICROSCOPE SLIDE TRANSMITTAL FORM (FRONT SIDE)
‘CLUSTER MUMBER.
TEAM | WHEN CLUSTER IS
SUPERVISOR ‘COMPLETED
FIELD baal
cooroinator |
receiver at |,
IMPLEMENTING
AGENCY
ue
3. Organize your station -
Malaria
HM 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.
42
4.
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
yuL) 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.
Dispense / Distribuer
Distribuir / Dispensar
€ Pan &t
ahaa
Without delay, dispense four
drops of the assay diluent
into the developer well while
holding the bottle vertically.
43
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 «.
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
cm in size. Put the mixing
slide in the sharps container.
44
The following shows how thick smears should look:
over newsprint.
The following illustrate some common errors in thick blood smear preparation
which you should avoid:
Corner of mixing slide chipped:
A thick smear is made by placing three drops of blood (5 ul
each) on ae 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
Too little blood:
e
J
11.
12.
13.
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.
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 in his/her
mouth as the child may
choke on it.
After 15 minutes, read the
malaria result. Record the
result code of malaria testing
Children age 12-59 months (Finger)
Children age 6-11 months (Heel)
124 | CONDUCT TEST AND RECORD RESULT OF THE MALARIA RDT HERE AND IN
THE [INFORMATIONAL PAMPHLET].
[TEST POSITIVE]
[TEST NEGATIVE]
NOT PRESENT
REFUSED
OTHER
Onk Na
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.
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.
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
46
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. fa/cijparum 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.
The result is POSITIVE for P. fa/ciparum malaria if there is a pink/pink-purple
band in both the test and control areas of the result window.
POSITIVE
A line in “C” AND a line in “T” means the patient
DOES have falciparum malaria.
The test is POSITIVE even if the line in
“T” is faint.
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.
47
INVALID RESULT
NO LINE in “C” and a line or no line in “T”
means the test is INVALID.
| Mataria Ag Pt '
| Malaria Ag Pt > 7
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 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
48
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:
4. Check the thick smears to make sure that they have dried completely.
5. Transfer the thick blood smears from the cardboard tray into the slide slots of
blue slide storage box, beginning with the first column.
6. 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
49
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:
1. 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.
2. Complete the Microscope Slide Transmittal Form. Count the total
number of blood smears (slides) and record the number in Column (3).
3. Sign your name in Column (4) and record the date in Column (6). Note any
discrepancies in Column (7).
4. The team supervisor will re-verify that the barcodes on the smears match the
barcodes on the Microscope Slide Transmittal Form.
5. 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, 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.
4.J). Precautions to take during malaria testing
The following are common mistakes made during malaria testing:
50
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.
51
CHAPTER 5. BIOHAZARDOUS WASTE DISPOSAL
Learning objectives
m Define biohazardous waste
Define biohazardous waste disposal
How to collect and store biohazardous waste during training and fieldwork
Procedures for field disposal of biohazardous waste
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.
52
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 Appropriate Use Storage When Filled
Waste Bag
2 to 3-gallon Small household biohazardous Store inside of medium
waste bag biohazardous bag
7 to 10-gallon Stores the small biohazardous Store inside of large
waste bags used in households for biohazardous bags
easier 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
biohazardous 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
53
container!
See the table below for sharps containers and their appropriate use.
Sharps Containers Appropriate Use Storage When Filled
5 quarts Sharp biohazardous waste froma | 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. 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
54
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
55
Biohazardous waste should NEVER be disposed of in general solid waste
containers or facilities
Never store anything in the biohazardous waste bags or sharps containers
other than biohazardous waste
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
56
CHAPTER 6. APPENDIX
6.A. Malaria brochure
LOGO [NAME OF SURVEY] LOGO
|
Name of the Household Head:
Malaria diagnosis: Malaria diagnosis: Malaria diagnosis: Malaria diagnosis:
Positive Negative Positive Negative Positive Negative || Positive Negative
TREATMENT FOR TREATMENT FOR TREATMENT FOR TREATMENT FOR MALARIA
MALARIA PROVIDED: MALARIA PROVIDED: MALARIA PROVIDED: PROVIDED:
TREATMENT WITH FIRST LINE: [FIRST LINE ACT]
Weight in KG Content Dosage*
25 mg XX + 67.5 mE XX
29kg <18 ky; 1-4 50 XX+ 135 XX
1 tablet once a day for 3 days
* 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 Ifyour child develops the following For questions concerning the survey please contact
symptoms you should go to the health the following:
facility:
e Extreme weakness
e Loss of consciousness
¢ Rapid or difficult breathing [NAME: CELL NUMBER]
¢ Seizures [NAME: CELL NUMBER]
e Jaundice or yellow skin
¢ Dark urine
¢ Abnormal bleeding [OTHER RELEVANT AGENCY]
[NAME: CELL NUMBER]
National Malaria Control Program
6.B. Severe malaria referral
[COUNTRY] MALARIA INDICATOR SURVEY: Severe Malaria Referral
During the YEAR COUNTRY MIS (Name), age __
____ months / years, was tested for malaria on , 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
58
6.C. Slide transmittal form
[YEAR] [COUNTRY] [MALARIA INDICATOR] SURVEY
MICROSCOPE SLIDE TRANSMITTAL FORM (FRONT SIDE)
[FIELDWORKER] NUMBER
PERSON
SENDING/
RECEIVING
SAMPLES
SIGNATURE
(CONFIRMING THAT
EACH SLIDE IS
TIME TO FILLIN TOTAL COUNT OF PRESENT - SEE BACK
FORM MICROSCOPE SLIDES
SIGNATURE
(CONFIRMING COUNT
OF MICROSCOP SLIDES
IN COLUMN 3)
CLUSTER NUMBER
NOTES
(NOTE ANY DISCREPANCY
IN NUMBERS OF SLIDES)
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_
59
[YEAR] [COUNTRY] [MALARIA INDICATOR] SURVEY
BLOOD SMEAR (SLIDE) TRANSMITTAL FORM (BACK SIDE)
cusrerwumacr |_| [|_|
fel amen em] Pm] ence mm