SOP Template - Clinical Module

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This procedure was developed from a template generated by the WorldWide Antimalarial Resistance
Network (WWARN). The original template and several other procedures are available on our website
www.wwarn.org. If you download and adjust this document to suit your study design, please retain
this text.
Blood Collection: Peripheral Venipuncture
v1.1
WWARN Clinical Group
WorldWide Antimalarial Resistance Network (WWARN)
www.wwarn.org
WWARN Procedure: Blood Collection: Peripheral Venipuncture v1.1
Page 1/7
This procedure was developed from a template generated by the WorldWide Antimalarial
Resistance Network (WWARN). The original template and several other procedures are
available on our website www.wwarn.org. If you download and adjust this document to suit
your study design, please retain this text.
Suggested citation: Clinical Group, WWARN. 2012. Blood Collection: Peripheral
Venipuncture v1.1. WWARN Procedure
Procedure ID: CLI08
This procedure was developed by:
WWARN Clinical Group
WorldWide Antimalarial Resistance Network
Version History
Version number
Revision(s) & reason for amendment
Date of release
1.0
1.1
Creation of procedure
Updated document format; correction of typographical
errors
3 Jan 2012
3 Feb 2015
For more information, contact:
clinical@wwarn.org
WorldWide Antimalarial Resistance Network (WWARN)
www.wwarn.org
WWARN Procedure: Peripheral Venepuncture for Specimen collection v1.1
Page 2/7
This procedure was developed from a template generated by the WorldWide Antimalarial Resistance
Network (WWARN). The original template and several other procedures are available on our website
www.wwarn.org. If you download and adjust this document to suit your study design, please retain
this text.
Contents
1. Purpose ......................................................................................................................4
2. Scope ..........................................................................................................................4
3. Abbreviations .............................................................................................................4
4. Duties and responsibilities .........................................................................................4
4.1 General information ............................................................................................4
5. Materials and equipment ..........................................................................................4
6. Procedure ...................................................................................................................5
6.1 General guidelines ............................................................................................... 5
6.2 Standard procedure .............................................................................................5
6.3 Time course blood sampling and pharmacokinetic analysis ............................... 6
7. References .................................................................................................................7
WWARN Procedure: Peripheral Venepuncture for Specimen collection v1.0
Page 3/7
This procedure was developed from a template generated by the WorldWide Antimalarial
Resistance Network (WWARN). The original template and several other procedures are
available on our website www.wwarn.org. If you download and adjust this document to suit
your study design, please retain this text.
1. Purpose
This document describes the procedure for obtaining peripheral blood samples for
laboratory testing whilst ensuring:
- patient and staff safety during blood drawing;
- proper specimen identification and labelling;
- proper disposal of sharps and other biohazardous waste.
2. Scope
This procedure is intended for use in clinical trials where patients are attending a
clinic for antimalarial treatment.
3. Abbreviations
i.v.
mL
Intravenous
milliliters
4. Duties and responsibilities
4.1 General information
This section outlines the list of tasks required to complete this procedure. These
tasks should be assigned to individual(s) capable of their execution and their name
entered beside the task listed in Table 1.
Table 1: Tasks required to complete procedure
Study personnel
Verify identify of patient and label tubes
Explain procedure to patient
Draw required amount of blood and fill tubes
5. Materials and equipment
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Alcohol swabs or isopropyl alcohol or chlorhexidine solution for skin
disinfection
10 % household bleach or 4 % chlorhexidine solution and absorbent material
for cleaning up spills and splashes
Disposable gloves
Sterile disposable needles (Vacutainer, syringe, butterfly, intravenous (i.v.)
cannula)
Heparinized saline
Vacutainer holders or syringes
Vacutainer specimen tubes
Tourniquet
Cotton
Puncture-resistant labelled sharps disposable container
WWARN Procedure: Peripheral Venepuncture for Specimen collection v1.1
Page 4/7
This procedure was developed from a template generated by the WorldWide Antimalarial
Resistance Network (WWARN). The original template and several other procedures are
available on our website www.wwarn.org. If you download and adjust this document to suit
your study design, please retain this text.
6. Procedure
6.1 General guidelines

Wear gloves and use aseptic technique during phlebotomy. Gloves should be
changed between patients. Gloves should be worn when handling or
transporting specimens if there is any possibility of direct contact with blood or
other body secretion.

Any blood spills or splashes should be immediately cleaned up with absorbent
material using an approved disinfectant such as dilute 10% bleach or
chlorhexidine solution.

No food or drink should be permitted in the laboratory work area.

Discarded swabs, needles, and other items should be placed in designated
puncture-resistant labelled biohazardous waste containers.
6.2 Standard procedure
I. All required materials for blood drawing should be assembled prior to the
procedure.
II. Explain the blood drawing procedure to the patient and/or parent/guardian.
III. Small children may be placed sitting in an upright position in the lap of an adult.
The preferred sites for phlebotomy are the median antecubital and basilic veins of
the upper extremity. Veins on the dorsum on the hand and other forearm veins
are possible alternative sites. The inner wrist should not be used because of the
risk of damage to the underlying structures.
IV. Label the Vacutainer tubes or other specimen containers in ink by writing the
patient’s initials, patient ID, study day, and date/time of blood draw prior to the
procedure.
V. Verify the patient identity and study number before labelling tubes. Do not
prepare tubes for more than one patient at a time.
VI. A tourniquet may be used to transiently distend veins prior to blood drawing. Do
not leave the tourniquet on the arm for longer than a minute as this is
uncomfortable for the patient and may alter the results of certain laboratory tests.
VII. Disinfect the phlebotomy site by swabbing the skin in small outward circles with an
alcohol swab or cotton swab and chlorhexidine solution. Do not touch the
prepared venepuncture site after disinfecting the skin.
VIII. Using aseptic technique insert the needle of the Vacutainer device, or needle and
syringe, or butterfly needle and syringe, or i.v. cannula, into the vein and draw the
required volumes or tubes of blood. It may be helpful to make counter-traction
distally over the vein to stabilize it for needle puncture.
IX. If using Vacutainer tubes:
a. Draw blood into Vacutainer tubes in the following order:
i. Red top or serum separator (no additive) tubes
ii. Yellow Top (ACD anti-coagulated) tube
iii. Blue Top (buffered sodium citrate anti-coagulated) tube
WWARN Procedure: Peripheral Venepuncture for Specimen collection v1.1
Page 5/7
This procedure was developed from a template generated by the WorldWide Antimalarial
Resistance Network (WWARN). The original template and several other procedures are
available on our website www.wwarn.org. If you download and adjust this document to suit
your study design, please retain this text.
iv. Green Top (lithium heparin anti-coagulated) tube
v. Purple Top (EDTA anti-coagulated) tube
b. If possible, allow the full amount of blood to be drawn by each evacuated tube.
However, careful attention must be paid to Table 2 below indicating the
maximum amount of blood that can be safely drawn from a child each day
(based on the weight and calculated blood volume). If multiple tubes are
needed then small amounts in each tube can be used.
c. After drawing, mix the blood tubes containing additives by inverting several
times. DO NOT SHAKE.
Table 2: maximum daily blood draws for infants
Weight (kg)
2.0-3.5
3.6-5.0
5.1-18.0
Maximum blood draw (mL)
3.5
5
10
X. Release the tourniquet (if used) after drawing blood samples.
XI. Remove the needle from the vein, cover the venepuncture site with a cotton swab,
and apply pressure at the puncture site for 3 minutes or until adequate
haemostasis is visible.
XII. Do not manually recap needles. Place used needles into properly labelled
puncture-proof needle disposal boxes and follow proper disposal procedures.
Visibly soiled or splashed tourniquets and Vacutainer holders should be discarded
into appropriate containers and new equipment used.
XIII. Patients occasionally feel dizzy or faint during phlebotomy. If the participant
faints, stop the phlebotomy procedure, secure the vessel puncture site and lay the
patient flat. Do not allow patients to stand until they have fully recovered.
Summon medical assistance from other clinic staff if necessary.
6.3 Time course blood sampling and pharmacokinetic analysis
I.
II.
III.
IV.
Blood samples should be taken from an in-dwelling i.v. cannula which makes
frequent blood draws more convenient.
To prevent clotting, maintain the cannula with a heparin lock procedure when not
in use.
Prepare a sterile stock solution of heparinized saline with 5,000 units of heparin in
500 mL of normal saline (i.e. 10 units/mL). Using a sterile needle, draw 1 – 2mL
into a fresh, sterile syringe. After the cannula is inserted and the initial blood
sample is drawn, inject approximately 1 mL heparinized saline through a 3-way
tap to ensure the cannula remains unobstructed.
Clear the heparinized saline before the next blood sample is taken by drawing
approximately 1 mL of normal saline or blood through the cannula and discarding
into an appropriate biological waste container.
WWARN Procedure: Peripheral Venepuncture for Specimen collection v1.1
Page 6/7
This procedure was developed from a template generated by the WorldWide Antimalarial
Resistance Network (WWARN). The original template and several other procedures are
available on our website www.wwarn.org. If you download and adjust this document to suit
your study design, please retain this text.
V.
Draw the blood sample and repeat step III.
7. References
WWARN gratefully acknowledges the contribution of Grant Dorsey (University of
California, San Francisco) and Epicentre/MSF (Médecins Sans Frontières) Paris,
France, in the development and review of this procedure.
WWARN Procedure: Peripheral Venepuncture for Specimen collection v1.1
Page 7/7
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