October 2007

GP41-A6
Procedures for the Collection of Diagnostic
Blood Specimens by Venipuncture; Approved
StandardSixth Edition
This document provides procedures for the collection of diagnostic
specimens by venipuncture, including line draws, blood culture
collection, and venipuncture in children.
A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.

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Clinical and Laboratory Standards Institute
Setting the standard for quality in clinical laboratory testing around the world.
The Clinical and Laboratory Standards Institute (CLSI) is a not-for-prot membership organization that brings
together the varied perspectives and expertise of the worldwide laboratory community for the advancement of
a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory
standards and guidelines that help laboratories fulll their responsibilities with efciency, effectiveness, and
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GP41-A6
Vol. 27 No. 26
ISBN 1-56238-650-6 Formerly H03-A6
ISSN 0273-3099 Vol. 27 No. 26
Procedures for the Collection of Diagnostic Blood Specimens by
Venipuncture; Approved StandardSixth Edition

Volume 27 Number 26

Dennis J. Ernst, MT(ASCP)
Lisa O. Ballance, BSMT(ASCP)
Roger R. Calam, PhD, DABCC
Ruth McCall, MT(ASCP)
Susan S. Smith
Diane I. Szamosi, MA, MT(ASCP), SH
David J. Warunek, PhD







Abstract

Clinical and Laboratory Standards Institute document GP41-A6Procedures for the Collection of Diagnostic Blood Specimens
by Venipuncture; Approved StandardSixth Edition provides a descriptive, stepwise procedure for the collection of diagnostic
blood specimens by venipuncture. Special considerations for venipuncture in children, line draws, blood culture collection, and
venipuncture in isolation situations are included.

Clinical and Laboratory Standards Institute (CLSI). Procedures for the Collection of Diagnostic Blood Specimens by
Venipuncture; Approved StandardSixth Edition. CLSI document GP41-A6 (ISBN 1-56238-650-6). Clinical and Laboratory
Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2007.

The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through
two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any
given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or
guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in
the CLSI catalog and posted on our website at www.clsi.org. If your organization is not a member and would like to become
one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail:
customerservice@clsi.org; Website: www.clsi.org.











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Number 26 GP41-A6

ii
Copyright

2007 Clinical and Laboratory Standards Institute. Except as stated below, any reproduction of
content from a CLSI copyrighted standard, guideline, companion product, or other material requires
express written consent from CLSI. All rights reserved. Interested parties may send permission requests to
permissions@clsi.org.

CLSI hereby grants permission to each individual member or purchaser to make a single reproduction of
this publication for use in its laboratory procedure manual at a single site. To request permission to use
this publication in any other manner, e-mail permissions@clsi.org.

Suggested Citation

CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
StandardSixth Edition. CLSI document GP41-A6. Wayne, PA: Clinical and Laboratory Standards
Institute; 2007.

Proposed Standard Approved StandardThird Edition
August 1977 July 1991

Tentative Standard Approved StandardFourth Edition
February 1979 June 1998

Approved Standard Approved StandardFifth Edition
March 1980 December 2003

Approved StandardSecond Edition Approved StandardSixth Edition
April 1984 October 2007

















ISBN 1-56238-650-6
ISSN 0273-3099
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Volume 27 GP41-A6

v
Contents

Abstract ...................................................................................................................................... i
Committee Membership........................................................................................................... iii
Foreword ................................................................................................................................. vii
1 Scope ..............................................................................................................................1
2 Introduction ....................................................................................................................1
3 Standard Precautions ......................................................................................................1
4 Definitions......................................................................................................................1
5 Factors That Affect Laboratory Values .........................................................................2
6 Facilities .........................................................................................................................2
6.1 Venipuncture Chairs ..........................................................................................2
6.2 Hospital Area .....................................................................................................2
7 Supplies ..........................................................................................................................3
7.1 Utility Carts ........................................................................................................3
7.2 Blood Collecting Trays ......................................................................................3
7.3 Gloves ................................................................................................................3
7.4 Needles and Holders ..........................................................................................3
7.5 Sterile Syringes ..................................................................................................4
7.6 Venous Blood Collection Tubes ........................................................................4
7.7 Tourniquets ........................................................................................................4
7.8 Antiseptics..........................................................................................................4
7.9 Gauze Pads .........................................................................................................4
7.10 Puncture-Resistant Disposal Container ..............................................................5
7.11 Ice .......................................................................................................................5
7.12 Bandages ............................................................................................................5
7.13 Warming Devices...............................................................................................5
7.14 Test Reference Manual ......................................................................................5
8 Venipuncture Procedure .................................................................................................5
8.1 Step 1: Prepare Accession Order ......................................................................6
8.2 Step 2: Approach and Identify the Patient; Sanitize Hands ..............................6
8.3 Step 3: Verify Patient Diet Restrictions and Latex Sensitivity .........................8
8.4 Step 4: Assemble Supplies ................................................................................8
8.5 Step 5: Position Patient .....................................................................................9
8.6 Step 6: Apply Tourniquet................................................................................10
8.7 Step 7: Put On Gloves .....................................................................................13
8.8 Step 8: Cleanse Venipuncture Site ..................................................................13
8.9 Step 9: Perform Venipuncture ........................................................................14
8.10 Step 10: Order of Draw ...................................................................................17
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vi
Contents Continued)

8.11 Step 11: Release the Tourniquet .....................................................................18
8.12 Step 12: Place the Gauze Pad..........................................................................18
8.13 Step 13: Remove and Dispose of the Needle ..................................................18
8.14 Step 14: Bandage the Arm ..............................................................................18
8.15 Step 15: Label Blood Collection Tubes and Record Time of Collection .......18
8.16 Step 16: Observe Special Handling if Required .............................................19
8.17 Step 17: Send Blood Collection Tubes to the Proper Laboratories ................19
9 Venipuncture in Children and Difficult Collections ....................................................20
9.1 Procedure .........................................................................................................20
9.2 Equipment ........................................................................................................20
10 Additional Considerations ...........................................................................................20
10.1 Monitoring Blood Volume Collected ..............................................................20
10.2 Hematoma ........................................................................................................20
10.3 Hemolysis ........................................................................................................20
10.4 Nerve Damage .................................................................................................21
11 Special Situations .........................................................................................................21
11.1 Timed Intervals ................................................................................................21
11.2 Specific Collection Techniques .......................................................................21
11.3 Indwelling Lines, Heparin or Saline Locks, Vascular Access Devices
(VADs) ..............................................................................................................22
11.4 Fistula ...............................................................................................................22
11.5 IV Fluids ..........................................................................................................23
11.6 Isolation............................................................................................................24
11.7 Emergency Situations ......................................................................................25
References ................................................................................................................................27
Summary of Consensus Comments and Subcommittee Responses ........................................30
Summary of Delegate Comments and Subcommittee Responses ...........................................36
The Quality Management System Approach ...........................................................................40
Related CLSI Reference Materials ..........................................................................................41


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Volume 27 GP41-A6

vii
Foreword

The errors that can occur during the collection and handling of blood specimens are potentially numerous,
and the complications to the patient potentially harmful. Standards for venipuncture can reduce or
alleviate many of these errors in much the same way that quality control standards have reduced errors
within the laboratory.

Without fully implementing global standards, it is less likely that biologically representative specimens
will be obtained from patients and that their results will be comparable from one institution to another. A
comprehensive training program is needed to produce efficient, well-trained phlebotomists who collect
specimens that accurately reflect the patients physiology.

Various comments received on the previous edition of this standard were reviewed and incorporated
where appropriate. All comments and the subcommittees responses are summarized at the end of the
document.

This document replaces the fifth edition approved standard, H3-A5, which was published in 2003. Several
changes were made in this edition; chief among them are new illustrations of the anatomy of the
antecubital area, instructions on recognizing nerve involvement, revised instructions for drawing blood
from patients with vascular access devices, preparing sites for blood culture collections, and an additional
verification step when labeling tubes. References were updated throughout.

Key Words

Accession, blood specimen, phlebotomist, venipuncture

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Volume 27 GP41-A6

Clinical and Laboratory Standards Institute. All rights reserved. 1

Procedures for the Collection of Diagnostic Blood Specimens by
Venipuncture; Approved StandardSixth Edition

1 Scope

This document establishes criteria for the correct collection of blood specimens by venipuncture. These
procedures are intended as a suitable model for adoption by all health care providers responsible for the
collection and handling of blood specimens in both outpatient and inpatient settings.

2 Introduction

Since 1977, CLSI has recognized the quality requirement to direct significant attention toward the
preexamination components of laboratory testing, including the correct collection and handling of blood
specimens. Highly sophisticated testing technology cannot produce a good result from a poor specimen.
Proper specimen collection and handling are of the utmost importance because significant errors occur in
the preexamination phase of laboratory testing.
1


Preexamination errors can be numerous (eg, incorrect patient identification, incorrect order of draw,
incorrect use of additive tubes, labeling errors, incorrect timing of collection, clerical errors). Standard
procedures and protocols are intended to prevent these problems and protect against complications and
patient mismanagement that can otherwise arise when specimens are improperly collected.

3 Standard Precautions

Because it is often impossible to know what isolates or specimens might be infectious, all patient and
laboratory specimens are treated as infectious and handled according to standard precautions. Standard
precautions are guidelines that combine the major features of universal precautions and body substance
isolation practices. Standard precautions cover the transmission of all infectious agents and thus are
more comprehensive than universal precautions, which are intended to apply only to transmission of
blood-borne pathogens. Standard and universal precaution guidelines are available from the US Centers
for Disease Control and Prevention.
2
For specific precautions for preventing the laboratory transmission
of all infectious agents from laboratory instruments and materials and for recommendations for the
management of exposure to all infectious disease, see CLSI document M29.
3


4 Definitions

In the context of this publication, the terms listed below are defined as follows:

accession the steps required to ensure that a specific patient specimen and the accompanying
documentation are unmistakably identified as referring to the same patient.

angle of insertion the angle formed by the surface of the arm and the needle entering the arm.

preevacuation the creation of a vacuum (in a collection tube), induced by either the manufacturer or by
the user immediately before a liquid specimen is taken.

specimen (patient) the discrete portion of a body fluid or tissue taken for examination, study, or
analysis of one or more quantities or characteristics to determine the character of the whole.

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Clinical and Laboratory Standards Institute. All rights reserved. 2

vascular access device (VAD) a device inserted temporarily or permanently into a vein and/or artery to
allow access to the circulatory system for the administration of fluids or medications, or for various
procedures; NOTE: Examples include central venous lines for hyperalimentation or chemotherapy, and
arteriovenous shunts for hemodialysis.

venipuncture the puncture of a vein for surgical or therapeutic purposes, or for collecting blood
specimens for analysis.

5 Factors That Affect Laboratory Values

Interpretation of laboratory data has assumed new importance and attracted increased attention with both
more frequent testing and multiple testing. Even when an analytical procedure is performed correctly and
precisely, variables can affect the test result. Knowledge of these variables and standardization of
laboratory testing procedures are essential for correct interpretation and optimal use of the data.

Major causes of laboratory error can be related to nonanalytical factors, such as specimen collection,
handling, and transport. Nonbiological factors, such as patient misidentification, and biological factors,
such as patient posture and the time a specimen is drawn, all contribute to the total laboratory error.

Physiological factors that influence results include age, activity, bed rest, food ingestion, alcohol
ingestion, menstrual cycle, obesity, oral contraceptives, posture, pregnancy, race, sex, smoking, and time
of day. Many biological phenomena exhibit rhythms, with the circadian rhythm (the change in a 24-hour
period) being the most important to laboratory testing. Many factors with documented effects on
laboratory values are published.
4,5

6 Facilities

If possible, perform the venipuncture in a clean, quiet, and private environment. Reasonably soundproof
rooms for pediatric patients should be considered.

The room should have facilities to allow the phlebotomist to wash his/her hands between patients.
Washing with soap and running water is recommended; however, any standard detergent product
acceptable to personnel may be used. In settings where water is not available, alcohol-based gels or
liquids, hand-wipe towelettes, and cleansing foams can be used.

6.1 Venipuncture Chairs

Venipuncture chairs should be designed for the maximum comfort and safety of the patient.
Consideration should be given to the ergonomic comfort plus easy accessibility to the patient for the
phlebotomist. Both armrests of the chairs should be adjustable so the best venipuncture position for each
patient can be achieved. The chair should have a safety feature (eg, arm rests) to prevent patients from
falling if feeling faint. There is no requirement for specialized commercially available phlebotomy chairs.

6.2 Hospital Area

A central phlebotomy area should be designed to include the following features.

6.2.1 Central Desk

The central desk is a location for a telephone system used to handle emergency request calls, facilities for
processing daily and future requests, and a paging system for contacting the phlebotomist who is
collecting specimens outside the central area.
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Clinical and Laboratory Standards Institute. All rights reserved.

40
The Quality Management System Approach

Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system approach in the
development of standards and guidelines, which facilitates project management; defines a document structure via a
template; and provides a process to identify needed documents. The approach is based on the model presented in the
most current edition of CLSI/NCCLS document HS1A Quality Management System Model for Health Care. The
quality management system approach applies a core set of quality system essentials (QSEs), basic to any
organization, to all operations in any health care services path of workflow (ie, operational aspects that define how
a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or
service, serving as a managers guide. The QSEs are:

Documents & Records Equipment Information Management Process Improvement
Organization Purchasing & Inventory Occurrence Management Customer Service
Personnel Process Control AssessmentsExternal &
Internal
Facilities & Safety

GP41-A6 addresses the QSEs indicated by an X. For a description of the other documents listed in the grid, please
refer to the Related CLSI Reference Materials section on the next page.


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Adapted from CLSI/NCCLS document HS1A Quality System Model for Health Care.

Path of Workflow

A path of workflow is the description of the necessary steps to deliver the particular product or service that the
organization or entity provides. For example, CLSI/NCCLS document GP26Application of a Quality
Management System Model for Laboratory Services defines a clinical laboratory path of workflow which consists of
three sequential processes: preexamination, examination, and postexamination. All clinical laboratories follow these
processes to deliver the laboratorys services, namely quality laboratory information.

GP41-A6 addresses the clinical laboratory path of workflow steps indicated by an X. For a description of the other
documents listed in the grid, please refer to the Related CLSI Reference Materials section on the next page.

Preexamination Examination Postexamination
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Adapted from CLSI/NCCLS document HS1A Quality System Model for Health Care.


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Volume 27 GP41-A6

Clinical and Laboratory Standards Institute. All rights reserved. 41

Related CLSI Reference Materials
*


C38-A Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline (1997). This
document provides guidelines for patient preparation, specimen collection, transport, and processing for the
measurement of trace elements in a variety of biological matrices.

H1-A5 Tubes and Additives for Venous Blood Specimen Collection; Approved StandardFifth Edition (2003).
This document contains requirements for venous blood collection tubes and additives, including technical
descriptions of ethylenediaminetetraacetic acid (EDTA), sodium citrate, and heparin compounds used in blood
collection devices.

H4-A5 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard
Fifth Edition (2004). This document provides a technique for the collection of diagnostic capillary blood
specimens, including recommendations for collection sites and specimen handling and identification.
Specifications for disposable devices used to collect, process, and transfer diagnostic capillary blood specimens
are also included.

H11-A4 Procedures for the Collection of Arterial Blood Specimens; Approved StandardFourth Edition (2004).
This document provides principles for collecting, handling, and transporting arterial blood specimens to assist with
reducing collection hazards and ensuring the integrity of the arterial specimen.

H18-A3 Procedures for the Handling and Processing of Blood Specimens; Approved GuidelineThird Edition
(2004). This document includes criteria for preparing an optimal serum or plasma sample and for the devices used
to process blood specimens.

H21-A4 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays;
Approved GuidelineFourth Edition (2003). This document provides procedures for collecting, transporting,
and storing blood; processing blood specimens; storage of plasma for coagulation testing; and general
recommendations for performing the tests.

M29-A3 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved GuidelineThird
Edition (2005). Based on U.S. regulations, this document provides guidance on the risk of transmission of
infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific precautions for
preventing the laboratory transmission of microbial infection from laboratory instruments and materials; and
recommendations for the management of exposure to infectious agents.

T/DM6-A Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline (1997). This guideline provides
technical and administrative guidance on laboratory procedures related to blood alcohol testing, including
specimen collection, methods of analysis, quality assurance, and reporting of results.

*
Proposed-level documents are being advanced through the Clinical and Laboratory Standards Institute consensus process;
therefore, readers should refer to the most current edition.

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