3.guía CLSI Documento H3 - A6

Product Name: Infobase 2009 - Release Date: March 2009
H3-A6
Vol. 27 No. 26
Replaces H3-A5
Vol. 23 No. 32
Procedures for the Collection of Diagnostic

Blood Specimens by Venipuncture;
Approved Standard—Sixth 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.
This document is protected by copyright. Downloaded on 2/23/2009

Clinical and Laboratory Standards Institute

Advancing Quality in Health Care Testing
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H3-A6
ISBN 1-56238-650-6
Volume 27 Number 26 ISSN 0273-3099
Procedures for the Collection of Diagnostic Blood Specimens by
Venipuncture; Approved Standard—Sixth Edition
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 H3-A6—Procedures for the Collection of Diagnostic Blood Specimens by
Venipuncture; Approved Standard—Sixth 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 Standard—Sixth Edition. CLSI document H3-A6 (ISBN 1-56238-650-6). Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 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guideline, users should replace outdated editions with the current editions of CLSI/NCCLS documents.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
(Formerly NCCLS)

Number 26 H3-A6
Copyright ©2007 Clinical and Laboratory Standards Institute. Except as stated below, neither this
publication nor any portion thereof may be adapted, copied, or otherwise reproduced, by any means
(electronic, mechanical, photocopying, recording, or otherwise) without prior written permission from
Clinical and Laboratory Standards Institute (“CLSI”).
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, contact the Executive Vice President, Clinical and Laboratory
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA.
Suggested Citation
(CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Standard—Sixth Edition. CLSI document H3-A6. Wayne, PA: Clinical and Laboratory Standards
Institute; 2007.)
Proposed Standard Approved Standard—Third Edition

August 1977 July 1991
Tentative Standard Approved Standard—Fourth Edition

February 1979 June 1998
Approved Standard Approved Standard—Fifth Edition

March 1980 December 2003
Approved Standard—Second Edition Approved Standard—Sixth Edition

April 1984 October 2007
ISBN 1-56238-650-6
ISSN 0273-3099
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Volume 27 H3-A6
Committee Membership
Area Committee on Quality Systems and Laboratory Practices
Sheila M. Woodcock, MBA, Peter L. Minetti, CQA, CQE, Stephen J. Sarewitz, MD

FCSMLS(D) CQMgr(ASQ) Valley Medical Center
Chairholder Fujirebio Diagnostics, Inc. Renton, Washington
QSE Consulting Malvern, Pennsylvania
Rose Bay, Nova Scotia, Canada Jennifer Schiffgens, MBA, MT(ASCP)
Carl D. Mottram, BA, RRT, RPFT, California Pacific Medical Center
Albert Rabinovitch, MD, PhD FAARC San Francisco, California
Vice-Chairholder Mayo Clinic
Abbott Hematology Rochester, Minnesota Daniel W. Tholen, MS
Santa Clara, California Dan Tholen Statistical Consulting
Bruce D. Tually, BAppSc, MAppSc Traverse City, Michigan
Eric Arendash, MT(ASCP) Hunter Area Pathology Service
Centers for Medicare & Medicaid New South Wales, Australia Staff
Services
Philadelphia, Pennsylvania Advisors Clinical and Laboratory Standards
Institute
Lucia M. Berte, MA, MT(ASCP)SBB, Eileen Carreiro-Lewandowski, Wayne, Pennsylvania
DLM; CQA(ASQ) CQM CLS(NCA)
Quality Systems Consultant University of Massachusetts Lois M. Schmidt, DA
Broomfield, Colorado N. Dartmouth, Massachusetts Vice President, Standards
Development and Marketing
Theresa Billups, MBA, Kay M. Creed
MT(ASCP)DLM Bon Secours Health Partners Jennifer K. McGeary, MT(ASCP),
Remel, Inc. Laboratories MSHA
Lake Charles, Louisiana Richmond, Virginia Staff Liaison
Margaret M. Grimes, MD Dennis J. Ernst, MT(ASCP) Melissa A. Lewis

Medical College of Virginia Campus Center for Phlebotomy Education Editor
Richmond, Virginia Ramsey, Indiana
Devery Howerton, PhD Steven I. Gutman, MD, MBA

Centers for Disease Control and FDA Ctr. for Devices/Rad. Health
Prevention Rockville, Maryland
Atlanta, Georgia
Acknowledgment
CLSI gratefully acknowledges the working group for their help in preparing the approved-level, sixth
edition of this standard.
Dennis J. Ernst, MT(ASCP), Chairholder Albert Rabinovitch, MD, PhD

Center for Phlebotomy Education Abbott Hematology
Lisa O. Ballance, BSMT(ASCP) Susan S. Smith

North Carolina State Laboratory of Public Health Sarstedt, Inc.
Roger R. Calam, PhD, DABCC Diane I. Szamosi, MA, MT(ASCP)SH

St. John Hospital and Medical Center Greiner Bio-One, North America Preanalytics
Ruth McCall, MT(ASCP) David J. Warunek, PhD, MBA

Central New Mexico Community College BD Diagnostics – Preanalytical Systems
(Retired)
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Volume 27 H3-A6
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
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
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Contents (Continued)
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 H3-A6
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 subcommittee’s 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 H3-A6
Procedures for the Collection of Diagnostic Blood Specimens by

Venipuncture; Approved Standard—Sixth Edition
1 Scope
This document establishes criteria for the correct collection of blood specimens by venipunctur. 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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Number 26 H3-A6
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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Volume 27 H3-A6
6.2.2 Cart Area
The cart area is constructed to allow easy access to the supplies.
6.2.3 Storage Area
The storage area should be large enough to accommodate the necessary supplies.
6.2.4 Counter Space
Counter space should be adequate for efficient sorting and dispatching of specimens.
6.2.5 Sampling Time Recorder
The sampling time recorder (eg, time stampers, bar codes, or information system) should be located for
convenient time recording of specimen collection.
7 Supplies
The following supplies should be available at any location where venipunctures are regularly performed.
7.1 Utility Carts
Utility carts, designed to roll smoothly and silently over all types of surfaces, may be useful. The
phlebotomist may also find it very useful to have a specially designed rack on the top shelf for storing
supplies.
7.2 Blood Collecting Trays
Blood collecting trays or carts may be used. The trays should be lightweight and easy to handle with
enough space and compartments for the various supplies that are needed.
7.3 Gloves
Disposable latex, vinyl, polyethylene, or nitrile gloves provide barrier protection.
Some workers may develop dermatitis from wearing latex gloves for long periods of time. These workers
should experiment with nitrile, polyethylene, or other gloves of various composition; gloves without
powdered lubricant; or they may wear cotton gloves under latex or plastic gloves. Additionally, it is
prudent to ask patients if they have latex hypersensitivity.
Severe hypersensitivity has been reported and cases of anaphylactic shock have occurred. In such
hypersensitive individuals, latex gloves must be avoided.6-10
7.4 Needles and Holders
Needles and holders should be compatible with the tubes selected for use. For more information on
venous blood collection tubes and additives, refer to CLSI document H1.11
Needles and winged blood collection sets are individually color-coded according to their respective gauge
sizes. The gauge number indicates the size of the needle. A large gauge number indicates a small needle,
while a small gauge number indicates a large needle. The sizes for venipuncture range from 19 through
23. Needles must always be sterile.
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Number 26 H3-A6
In order to prevent potential worker exposure, the needle safety feature should be activated immediately
after specimen collection and discarded without disassembly into a sharps container. Additionally, store
needles in a secure location to prevent injury to other personnel (eg, housekeeping) and theft for illicit use.
NOTE: In this standard, all references to needles and winged blood collection sets indicate sharps with
engineered safety features. This also encompasses safety accessories used in combination with
conventional needles.
7.5 Sterile Syringes
In general, venipuncture using a needle and syringe should be avoided for safety reasons. However, it
may be suitable under some circumstances to have sterile syringes of the appropriate size available.
7.6 Venous Blood Collection Tubes
Venous blood collection tubes are sterile and manufactured to withdraw a predetermined volume of
blood. Information regarding the venous blood collection tubes selected for general use should be clearly
displayed in venipuncture areas for easy reference and made available to all personnel who collect blood.
Instructions furnished in the package insert by the manufacturer of venous blood collection tubes and
needles should be available. For information on venous blood collection tubes, refer to CLSI document H1.11
7.7 Tourniquets
Tourniquets or products for use as tourniquets should be available. Examples include:
• Single-use disposable tourniquet, preferably latex-free (see above).
• Blood pressure cuff inflated to 40 mmHg. Do not use higher pressures, as that may impair arterial
blood flow to the extremity.
• Rubber/fabric-type tourniquets with closure tape, plastic clip, buckle, or similar type of fastening.
Tourniquets must be discarded immediately when contamination with blood or body fluids is obvious or
suspected.
7.8 Antiseptics
Antiseptics for skin preparation are necessary. The following are some examples:
• 70% isopropyl or ethyl alcohol;
• 1 to 10% povidone-iodine as swab sticks or chlorhexidine gluconate for blood cultures12 (see Section
8.8.2); and
• nonalcohol-based cleanser for blood alcohol specimens (eg, chlorhexidine).
7.9 Gauze Pads
Small, prepackaged gauze pads (ie, 2 x 2 inches [5.0 x 5.0 cm] or 3 x 3 inches [7.5 x 7.5 cm]) should be
available. Cotton balls are not recommended for postvenipuncture care because of the possibility of
dislodging the platelet plug at the venipuncture site.
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Volume 27 H3-A6
7.10 Puncture-Resistant Disposal Container
An approved puncture-resistant disposal container that is compliant with national or local regulations
must be available for disposal of the contaminated needle assembly. Such containers typically have a
color regulated by each country, and a biohazard symbol.
7.11 Ice
Ice or refrigerant should be available for specimens that require immediate chilling.
7.12 Bandages
Adhesive bandages, preferably hypoallergenic, and/or gauze pads should be available, as well as gauze
wraps for sensitive or fragile skin.
7.13 Warming Devices
Warming devices may be used to dilate blood vessels and increase flow. When using commercial warmers,
follow manufacturers’ recommendations. Warming techniques and devices should not exceed 42 °C.
7.14 Test Reference Manual
A test manual listing the tube and volume requirements for various tests, specimen handling instructions,
and precautions is required by most regulatory agencies.
8 Venipuncture Procedure
The venipuncture procedure is complex and requires both knowledge and skill (refer to Sections 8.1 to
8.17 for detailed information on the procedure). When drawing a blood specimen, the trained
phlebotomist must do the following:
• Step 1. Prepare accession order.
• Step 2. Approach and identify the patient. Sanitize hands.
• Step 3. Verify the patient’s fasting status or diet restrictions, as appropriate, and inquire if the
patient has a latex sensitivity. Select appropriate gloves and tourniquet.
• Step 4. Assemble necessary supplies and select appropriate tubes according to test requests.
• Step 5. Position the patient.
• Step 6. Apply the tourniquet and select the venipuncture site and vein.
• Step 7. Put on gloves.
• Step 8. Cleanse the venipuncture site and allow to dry.
• Step 9. Perform venipuncture; once blood flow begins, request the patient to open his/her hand.
• Step 10. Fill tubes using the correct order of draw.
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Number 26 H3-A6
• Step 11. Release and remove the tourniquet.
• Step 12. Place the gauze pad over the puncture site.
• Step 13. Remove the needle, activate any safety feature, and dispose of the device.
• Step 14. Apply pressure to the site, making sure bleeding has stopped, and then bandage the arm.
• Step 15. Label the tubes and record the time of collection. Some facilities also specify phlebotomist
identification on the tubes.
• Step 16. Observe special handling requirements (if any required).
• Step 17. Send properly labeled blood collection tubes to the appropriate laboratories.
8.1 Step 1: Prepare Accession Order
Each request for a blood specimen must be accessioned to identify all paperwork and supplies associated
with each patient. An organized system will ensure prompt and accurate processing of the various forms
required when performing a venipuncture and analyzing the results. Record all information on the paper
test request form or electronic equivalent.
8.1.1 Information for Test Request Form
The following information should be included:
• patient’s full name and date of birth from identification plate;

• identification number;
• date and time the specimen is obtained;
• accessioning number;
• authorized health care professional’s full name;
• department or location for which the work is done; and
• other information as needed (eg, special comments: intravenous (IV) site, sampling site if other than arm).
In some cases, all needed information is provided on labels generated by a computer information system.
8.2 Step 2: Approach and Identify the Patient; Sanitize Hands
The phlebotomist should identify himself or herself, establish a rapport, and gain the patient’s confidence.
Information given to the patient regarding the intended testing and specimen drawn must be in accordance
with institutional policy. Collectors should disinfect hands between patients in accordance with the
Centers for Disease Control (CDC) Hand Hygiene Guidelines.13 Follow facility policy on obtaining
consent for the procedure. The phlebotomist must NOT perform blood collection against the patient’s or
guardian’s consent. Instead, report the patient’s objections to the physician or nursing station.
8.2.1 Identify Patient
Identification of the patient is crucial. The phlebotomist must ensure that the blood specimen is drawn
from the individual designated on the request form. The phlebotomist must not rely on a bed tag, or on
charts or records placed on the bed, nearby tables, or equipment. The following steps are a suggested
sequence for ensuring patient identification, regardless of the clinical setting.
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Volume 27 H3-A6
8.2.2 Patient Who Is Conscious
Requirements for identifying a patient who is conscious are as follows:
(1) Ask the outpatient to give full name, address, identification number, and/or birth date.
(2) Compare this information with the information on the request form.
(3) Ask the inpatient for the same information, and compare this with the information on the request
form and the patient’s identification bracelet, which must be attached to the patient.
(4) Report any discrepancy, however minor, to the responsible person in the area (as determined by
institutional policy) and have the patient identified by name and identification number before
drawing any specimen. Any discrepancies must be resolved before specimen collection.
(5) Some long-term care facilities do not put identification bracelets on their residents. When drawing
from cognitively impaired patients in these environments, ask a caregiver or family member to
identify the patient by name, address, identification number, and/or birth date. Compare these data
with the information on the request form.
8.2.3 Patient Who Is Unconscious, Too Young, Cognitively Impaired, or Does Not Speak the
Language of the Phlebotomist
In any of these circumstances, the phlebotomist should follow this suggested sequence of steps:
(1) Ask the nurse, a relative, or a friend to identify the patient by name, address, identification number,
and/or birth date. Document the name of the verifier.
(2) Compare these data with the information on the request form. For inpatients, compare these data
with those on the patient’s identification bracelet, which must be attached to the patient.
(3) Report any discrepancy, however minor, to the responsible person in the area (as determined by
institutional policy) and have the patient identified by name and/or identification number before
drawing any specimen.
8.2.4 Patient Who Is Semiconscious, Comatose, or Sleeping
Sleeping patients should be awakened before drawing blood. The phlebotomist must take special care
when drawing blood from semiconscious or comatose patients to anticipate any unexpected movements
or jerking, either while introducing the needle or while it is in place in the arm. A gauze pad should be
readily available and the tourniquet quickly released in the event the needle is violently removed or
repositioned. If the needle accidentally goes much deeper into the arm, the phlebotomist must inform the
physician or nursing station. If unable to identify the patient, then contact the nurse or physician.
Document the name of the verifier.
8.2.5 Procedure for Identifying Unidentified Emergency Patients
The patient must be positively identified when the blood specimen is collected.14 The unidentified
emergency patient should be given some temporary but clear designation until positive identification is
made. For a person who cannot be identified immediately, it is necessary to:
• Assign a master identification number (temporary) to the patient in accord with institutional policy.
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• Select the appropriate test request forms and record with the master identification number.
• Complete the necessary labels either by hand or by computer and apply the labels to the test request
forms and specimens after collection is complete.
• When a permanent identification number is assigned to the patient, make sure the temporary
identification number is cross-referenced to the permanent number to ensure correct identification and
correlation of patient and test result information.
In all cases, the name and permanent or temporary identification designation must be attached to the
patient’s body, either by wristband or some similar device. Except in the case of isolation patients, bed
labels must not be used in place of wristbands.15
8.2.6 Physician Relationship
The physician has priority with the patient. The phlebotomist should not enter the room without
permission while the physician or nurse is consulting with the patient. If the order is stat or the specimen
is a “timed” specimen, the phlebotomist should request permission to draw the blood specimen.
8.3 Step 3: Verify Patient Diet Restrictions and Latex Sensitivity
Some tests require the patient to fast and/or eliminate certain foods from the diet before the blood is
drawn. Time and diet restrictions vary according to the test. Such restrictions are necessary to ensure
accurate test results.
The procedure for holding meals and notifying appropriate personnel that the patient’s blood specimen
has been drawn should be according to institutional policy.
Ask the patient if he/she has a latex sensitivity. Use nonlatex supplies (eg, gloves, tourniquets, bandages)
where appropriate.
Refer to Section 7.3 for information regarding latex sensitivity to gloves and to Section 7.7 for
tourniquets.
8.4 Step 4: Assemble Supplies
8.4.1 Supplies
Phlebotomy devices must reflect the most current local and regional safety regulations.16 The use of
engineering and work practice controls should eliminate occupational exposure or reduce it to the lowest
feasible extent (eg, safety needles, shielded needle devices).
Inspect all supplies for possible defects and applicable expiration dates. The following supplies should be
available at any location where venipunctures are routinely performed:
• blood collection tubes/blood culture bottles;

• needles or winged blood collection sets;
• single-use tubes/needle holders;
• syringes;
• syringe transfer devices;
• a tourniquet;
• alcohol prep pads;
• 1 to 10% povidone-iodine pads, tincture of iodine, or chlorhexidine compounds if blood culture is drawn;
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• nonalcohol-based cleanser if blood alcohol is drawn;

• gauze pads, adhesive bandages, or tape (including hypoallergenic adhesives);
• gloves and other appropriate personal protective equipment; and
• sharps container, consistent with applicable regulations.
8.4.2 Needles
The phlebotomist must select the appropriate needle gauge based on the physical characteristics of the
vein, location of the vein, and the volume of blood drawn.
8.4.3 Syringes
Break the seal on the plunger by moving it within the barrel of the syringe. Expel all air by advancing the
plunger fully forward.
8.4.4 System
The phlebotomist must select the appropriate blood collection system according to the patient’s physical
characteristics.
8.4.4.1 Venous Blood Collection Systems
When venous blood collection tubes are used, the phlebotomist must select the correct types and sizes.
Color-coded closures and labels make it easy to perform this step.
Blood specimens should be collected by venipuncture using a blood collection system that collects the
blood directly into tubes. (For greater detail on venous blood collection tubes and additives, refer to CLSI
document H1.11) If the components are from different manufacturers, they should be checked to ensure
compatibility.
8.4.4.2 Plastic Syringe
In general, the use of a syringe and needle should be avoided for safety reasons. If a syringe is used, a
safety transfer device should be used to transfer blood to the appropriate venous blood collection tube.
8.4.4.3 Blood Collection Set
A winged blood collection set consists of two needles, one for accessing the vein and one for piercing the
stopper of the collection tube, connected with flexible tubing. A tube holder or syringe must be attached
before use.
8.5 Step 5: Position Patient
For patient safety, draw all specimens with the patient seated comfortably in an appropriate chair or lying down.
8.5.1 Procedure for Seating Patient
(1) Ask the patient to sit comfortably in a chair suitable for venipuncture. The chair should have arms
to provide support and prevent falls if the patient loses consciousness. Chairs without arms do not
provide adequate support for the arm or protect fainting patients from falls.
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(2) Have the patient position his/her arm on the slanting armrest and extend the arm to form a straight
line from the shoulder to the wrist. The arm should be supported firmly by the armrest and should
not be significantly bent at the elbow. A slight bend may be necessary to avoid hyperextension.
8.5.2 Procedure for Having Patient Lie Down
(1) Ask the patient to lie on his/her back in a comfortable position.
(2) If additional support is needed, place a pillow under the arm from which the specimen is drawn.
(3) Have the patient extend his/her arm to form a straight line from the shoulder to the wrist.
8.5.3 Foreign Objects in Mouth
No food or liquid, chewing gum, or other objects (eg, glass thermometer) should be in the patient’s mouth
at the time the specimen is drawn.
8.6 Step 6: Apply Tourniquet
A tourniquet is used to increase intravascular pressure, which facilitates vein palpation and filling of the
tube(s) or syringe (see Section 7.7). Without tourniquet application, the collector may not be able to
prioritize the antecubital veins for safety as required in Section 8.6.7. When all available veins are
considered, collectors are more likely to find antecubital veins that are not in close proximity with the
brachial artery or median nerves.
8.6.1 Precautions When Using a Tourniquet
Tourniquet application should not exceed one minute as localized stasis with hemoconcentration and
infiltration of blood into tissue can occur. This may result in erroneously high values for all protein-based
analytes, packed cell volume, and other cellular elements. If a tourniquet has been in place for longer than
one minute, it should be released and reapplied after two minutes. If the patient has a skin lesion at the
intended tourniquet location, consider an alternate draw site, or apply the tourniquet over the patient’s
gown; alternatively, a piece of gauze pad or paper tissue should be used so the skin is not pinched.
8.6.2 Tourniquet Location
Wrap the tourniquet around the arm 3 to 4 inches (7.5 to 10.0 cm) above the venipuncture site.
8.6.3 Blood Pressure Cuff
If a blood pressure cuff is used as a tourniquet, inflate it to no more than 40 mmHg.
8.6.4 Clenching Fist
The veins become more prominent and easier to enter when the patient forms a fist. There must not be
vigorous hand exercise (“pumping”). Vigorous hand pumping can cause changes in the concentration of
certain analytes in the blood.17,18
8.6.5 Select Site
The preferred venipuncture site is the antecubital fossa, which is the area of either arm that is anterior (in
front of) and below the bend of the elbow where a number of large veins lie relatively near the skin’s
surface.
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When antecubital veins are not acceptable or unavailable, veins on the back of the hand are also
acceptable for venipuncture. Veins on the underside of the wrist must not be used, as nerves and tendons
are close to the surface of the skin in this area.
Alternative sites, such as ankles or lower extremities, must not be used without the permission of the
physician because of the potential for significant medical complications (eg, phlebitis, thrombosis, tissue
necrosis).19-21
NOTE: Arterial punctures should not be considered as an alternative to venipuncture for difficult draws.
If this is the only alternative, consult with the patient’s physician.
8.6.5.1 Extensive Scarring
Avoid healed burn areas.
8.6.5.2 Mastectomy
A physician must be consulted before drawing blood from the side on which a mastectomy was
performed because of the potential for complications due to lymphostasis.22
8.6.5.3 Hematoma
Specimens collected through a hematoma area may cause erroneous test results. Phlebotomy must not be
performed on any size hematoma. If another vein site is not available, the specimen is collected distal to
the hematoma.
8.6.5.4 IV Therapy
Preferably, specimens should not be collected from an arm with an IV site (see Section 11.5).23
8.6.5.5 Cannula, Fistula, Vascular Graft
A cannulated arm is used only after consulting the attending physician.
8.6.6 Select Vein
Antecubital vein location varies slightly from person to person; however, two basic vein distribution
arrangements referred to as the “H-shaped” and “M-shaped” patterns are seen most often.24,25 (The H
pattern is so named because the most prominent veins in this pattern—the cephalic, median cubital, and
basilic veins—are distributed on the arm in a way that resembles a slanted H. The most prominent veins
of the M pattern—the cephalic, median cephalic, median basilic, and basilic veins—resemble the shape of
an M.) The H-shaped pattern is seen in approximately 70% of the population.
Refer to Figure 1 for a description of the superficial veins of the anterior surface of the upper extremity in
both the H- and M-shaped patterns.
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Figure 1. Superficial Veins of the Anterior Surface of the Right Upper Extremity. (From: McCall RE,
Tankersley CM. Phlebotomy Essentials. 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2008. Adapted with permission
from Lippincott Williams & Wilkins. http://lww.com.)
8.6.6.1 Factors in Vein Selection
Select the vein carefully. The brachial artery and several major nerves pass through the antecubital area.
Accidental arterial puncture and nerve injury are risks of venipuncture. Prioritizing veins as described in
Section 8.6.7 can minimize the potential for accidental arterial puncture and for nerve involvement. In
addition, avoid veins that are in close proximity to an artery, as indicated by the presence of a pulse.
8.6.6.1.1 Accidental Arterial Puncture
If during the procedure, accidental arterial puncture is suspected (eg, rapidly forming hematoma, rapid
filling of tube), discontinue the venipuncture immediately. Remove the needle, and apply direct forceful
pressure to the puncture site for a minimum of five minutes until active bleeding has ceased. The nursing
staff and physician must be notified and the incident documented according to institutional policy.
NOTE: Consult with supervisory personnel to determine the suitability of the suspected arterial specimen
for testing.
8.6.6.1.2 Nerve Injury
If the patient feels a shooting, electric-like pain, or tingling or numbness proximal or distal to the puncture
site, terminate the venipuncture and remove the needle immediately. Repeat the venipuncture in another
site if needed. Document the incident and direct the patient to medical evaluation if indicated, both
according to facility policy.26-39
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8.6.6.2 Preferred Veins
Draws to the median cubital (H pattern) and median (M pattern) veins are preferred because they are
typically closer to the surface of the skin, more stationary, less painful upon needle insertion, and less
likely to injure nerves if needle placement is not accurate.
The median cubital and median veins are supported anatomically, because they both overlie the bicipital
aponeurosis (a fibrous membrane), which offers some protection to underlying structures such as nerves
and arteries.40 Attempt to locate the median cubital or median vein on either arm before considering
alternative veins. If these are not acceptable, the cephalic (H pattern) and accessory cephalic (M pattern)
veins should be considered next. Due to the proximity of the basilic vein to the brachial artery and the
median nerve, draws from this vein should only be considered if no other vein is more prominent. Above
all, phlebotomists should be aware of the potential for injury associated with each vein and select the vein
that brings the greatest degree of confidence of being accessed successfully without risking nerve or
arterial involvement (see Figure 1).
Although the larger and fuller median, median cubital, cephalic, and accessory cephalic veins (see Figure 1)
are used most frequently, veins on the back of the hand are also acceptable for venipuncture. Veins on the
underside of the wrist must not be used.
8.6.7 Procedure for Locating Veins
Typically, a tourniquet is used to aid in the selection of a vein site unless specific tests require tourniquets
not be used (eg, lactate). A tourniquet is not necessary if veins are large and easily palpated. However, if
only the basilic vein is visible without a tourniquet, one must be applied so the availability of safer veins
(eg, median and/or cephalic) can be assessed (see Section 8.6.2).
Palpation is usually performed using the index finger. The collector’s thumb should not be used to palpate
because it has a pulse beat.41,42 In addition to locating veins, the palpation pressure helps to differentiate
veins from arteries, which pulsate, are more elastic, and have a thick wall.
When vein selection, cleansing, and access take longer than one minute, the tourniquet must be released
and reapplied after two minutes to minimize the effect of hemoconcentration (see Section 8.9.1[9]).43
8.7 Step 7: Put On Gloves
The phlebotomist must put new gloves on before the venipuncture is performed with consideration for
latex sensitivity as discussed in Sections 7.3 and 8.3.
Institutional policy should be followed for isolation patients or other situations that may require donning
of gloves earlier in the procedure.
8.8 Step 8: Cleanse Venipuncture Site
The puncture site must be cleansed to prevent microbiological contamination of either the patient or the
specimen.
8.8.1 Cleansing Method for Venipuncture
(1) Use a gauze pad with 70% isopropyl alcohol solution, or a commercially prepared alcohol pad.
(2) Cleanse the site with a circular motion from the center to the periphery.
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(3) Allow the area to air dry to prevent hemolysis of the specimen, to prevent the patient from
experiencing a burning sensation when the venipuncture is performed, and to allow optimal
antiseptic effect of alcohol.
8.8.2 For Blood Culture Collection
In order to minimize the risk of contamination with skin flora, blood culture collection sites require a 30-
to 60-second friction scrub and disinfection with an appropriate disinfectant. Tincture of iodine, multiple
isopropyl alcohol preps, chlorhexidine gluconate, and povidone/70% ethyl alcohol-combination are
equivalent.44-47
Iodine and chlorhexidine preparations require at least 30 seconds of skin contact to disinfect the site.
Because of iodine’s effect on the thyroid and liver and the potential for allergic reactions, iodine should
be removed from the skin once the procedure is complete. Manufacturers do not recommend using
chlorhexidine gluconate on infants less than two months of age. When using commercially packaged prep
kits, follow the manufacturer’s instructions for use.
Preparing the site typically includes an initial cleansing with 70% isopropyl alcohol, allowing it to air dry,
followed by a friction scrub and application of an iodine or chlorhexidine compound. The antiseptic
should remain in contact with the skin for at least 30 seconds. Strict aseptic technique should be used
throughout the procedure. Blood culture bottles can be filled by drawing blood into a sterile syringe and
then transferred through the use of a safety transfer device. Bottles can also be filled directly through a
winged collection set attached to a tube holder. Blood can be drawn directly into collection tubes
containing sodium polyanetholsulfonate (SPS), then transferred to blood culture medium, but should
never be drawn into tubes containing anticoagulants not designated for blood culture collection. Unless
approved by the manufacturer, filling bottles directly through a needle/tube-holder assembly is not
recommended because of the risk of reflux of the broth media back into the vein and the difficulty of
assessing the volume of blood drawn.
8.8.3 Touching the Site After Cleansing
If the venipuncture proves difficult and the vein must be touched again to draw blood, the site should be
cleansed again.
8.9 Step 9: Perform Venipuncture
8.9.1 Venipuncture Procedure When Venous Blood Collection Tubes Are Used
There are several different blood collection systems available that collect blood specimens using different
principles. For example, there are evacuated tube systems and systems that have a flexible/dual collection
technique that employ either a vacuum—user evacuates the tube immediately before use, referred to as
preevacuation—or aspiration principle of collection. For the proper venipuncture technique using the
blood collection system selected, refer to the manufacturer’s instructions for use.
(1) If preevacuation is required, and the blood collection tubes are not evacuated by the manufacturer,
evacuate the tubes immediately before use according to the manufacturer’s instructions.
(2) If not preassembled by the manufacturer, thread the appropriate needle into the holder until it is
secure.
(3) When drawing blood for cultures, wipe the stopper with a suitable antiseptic solution, according to
the manufacturer’s recommendations. Make certain the stopper is dry before performing the
venipuncture.
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(4) If possible, position the patient’s arm or other venipuncture site in a downward position to prevent
reflux or “backflow” from the collection tube into the vein.
Figure 2. Proper Angle of Insertion. (From: McCall Figure 3. Improper Angle of Insertion. (Figure
RE, Tankersley CM. Phlebotomy Essentials. 4th ed. contributed by the Center for Phlebotomy Education, Inc.)
Philadelphia, PA: Lippincott Williams & Wilkins; 2008.
Reprinted with permission from Lippincott Williams &
Wilkins. http://lww.com.)
(5) Before venipuncture, if required, assemble the tube to the needle/holder according to the
manufacturer’s instructions.
(6) Hold the patient’s arm firmly distal to the intended puncture site. The phlebotomist’s thumb should
be used to draw the skin taut to anchor the vein. The thumb should be 1 to 2 inches (2.5 to 5.0 cm)
below the venipuncture site. NOTE: Anchoring the vein from above is not recommended due to the
risk of an accidental needlestick.
(7) To prepare the patient, inform him/her that the venipuncture is about to occur. NOTE: From this
point on, be prepared to react to a sudden and unexpected loss of consciousness.
(8) With the bevel up, puncture the vein with the needle at an angle of insertion of 30 degrees or less
(see Figure 2). Keeping the needle as stable as possible in the vein, push/connect the first tube onto
the needle using the holder flanges to prevent/restrict needle movement. Maintain the tube below
the site when the needle is in the vein so there is an air space between the incoming blood and the
patient whenever possible.
(9) Proper technique involves applying the tourniquet immediately before venipuncture, then releasing
the tourniquet as soon as blood flow is established. Leaving a tourniquet on too long can produce
significant error from hemoconcentration. For example, one study demonstrated an average 3%
increase (0.4 g/dL) in hemoglobin (Hb) after only one minute of tourniquet time, and an average
7% increase (0.9 g/dL) after three minutes.48 At the high end of Hb concentration, a tourniquet time
of about two minutes creates a statistically significant Hb increase in blood specimens, which can
misclassify athletes in antidoping programs and mislead physicians in diagnosing anemia.49
(10) Allow the tube to fill until the vacuum is exhausted and blood flow ceases. For tubes that contain
additives, this will ensure there is a correct ratio of blood to additive.
NOTE: For systems that collect blood using an aspiration principle of collection rather than a
vacuum, gently pull back on the piston rod until the piston reaches the base of the tube. This will
ensure there is a correct ratio of blood to additive.
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(11) When the blood ceases to flow, remove/disconnect the tube from the needle/holder. The sleeve
recovers the needlepoint that pierces the tube closure, stopping blood flow until the next tube is
inserted/connected to the needle/holder. To obtain additional specimens, insert/connect the next
tube to the needle/holder and repeat the collection procedure. Always remove the last tube collected
from the needle/holder before withdrawing the needle from the vein.
(12) Immediately after drawing each tube that contains an additive, mix the blood gently and thoroughly
by inverting the tube for the required number of inversions as specified by the manufacturer’s
instructions. To avoid hemolysis, do not mix vigorously. For tubes drawn using an aspiration
principle, lock the piston into the base of the tube and snap off the piston rod after mixing.
8.9.2 Venipuncture Procedure Using Needle and Syringe
In general, venipuncture using a needle and syringe should be avoided for safety reasons. If conditions
require a syringe draw, the following procedure is recommended:
(1) Assemble the needle and syringe. Break the seal of the plunger and advance it fully forward,
expelling all air from the barrel of the syringe before use.
(2) Hold the patient’s arm firmly distal to the intended puncture site. The phlebotomist’s thumb
should be used to draw the skin taut. This anchors the vein. The phlebotomist’s thumb should be
1 or 2 inches (2.5 cm or 5.0 cm) below the venipuncture site.
(3) Prepare the patient by informing him or her that the venipuncture is about to occur.
(4) With the bevel up, puncture the vein with the needle at an angle of insertion of 30 degrees or less
(see Figure 2).
(5) Keeping the needle as stable as possible in the vein, slowly withdraw the desired amount of blood.
(6) Release the tourniquet as soon as possible, after the blood begins to flow.
8.9.3 Fill the Tubes if Syringe and Needle Are Used
A venous blood collection tube system is the recommended method for blood collection, as it is a closed
system and is much safer than the syringe draw method. If it is necessary to use a syringe, proceed with
the following recommendations to transfer the blood from a syringe to a blood collection tube:
• Use the same “order of draw” as for a venous blood collection tube system (see Section 8.10).
• To transfer the blood from the syringe to a venous blood collection tube, activate the safety feature of
the needle or winged blood collection set used to withdraw the specimen, remove and discard the
needle or winged collection set, and apply a safety transfer device.
• Insert the tube into the safety transfer device and pierce the stopper with the needle. Allow the tube to
fill without applying any pressure to the plunger until flow ceases. This technique helps to maintain
the correct ratio of blood to additive if an additive tube is being used.
• Mix additive tubes by inversion. Consult the manufacturer’s instructions for number of tube
inversions recommended.
• Rubber stoppers should not be removed from venous blood collection tubes to transfer blood to
multiple tubes.
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8.9.4 Blood Specimen That Cannot Be Obtained
When a blood specimen cannot be obtained, it may be necessary to:
• Change the position of the needle. If the needle has penetrated too far into the vein, pull it back a bit.
If it has not penetrated far enough, advance it farther into the vein. Rotate the needle half a turn.
Lateral needle relocation should never be attempted in an effort to access the basilic vein, since
nerves and the brachial artery are in close proximity.
• Try another tube to ensure the tube selected is not defective (ie, lacks vacuum).
• Unless the exact location of the vein is determined, manipulation other than that recommended above
may be considered probing. Probing is not recommended. Probing can be painful and may produce
arterial perforations, resulting in a hematoma and nerve compression or direct nerve injury.
• It is not advisable to attempt a venipuncture more than twice. If possible, have another person attempt
to draw the specimen, or notify the physician.
8.9.5 Ensure Patient’s Hand Is Open
Opening the patient’s hand reduces the amount of venous pressure as muscles relax. The patient must not
be allowed to pump the hand.
8.10 Step 10: Order of Draw
The following order of draw is recommended for both glass and plastic venous collection tubes when
drawing multiple specimens for clinical laboratory testing during a single venipuncture. Its purpose is
,
to avoid possible test result error due to additive carryover.50 51 All additive tubes should be filled to their
stated volumes (see Section 8.9.1[10]).
(1) Blood culture tube

(2) Coagulation tube (eg, blue closure)
(3) Serum tube with or without clot activator, with or without gel (eg, red closure)
(4) Heparin tube with or without gel plasma separator (eg, green closure)
(5) EDTA tube with or without gel separator (eg, lavender closure, pearl closure)
(6) Glycolytic inhibitor (eg, gray closure)
NOTE: Plastic or glass serum tubes containing a clot activator may cause interference in coagulation
testing. Glass nonadditive serum tubes or plastic serum tubes without a clot activator may be drawn
before the coagulation tube.
NOTE: When using a winged blood collection set for venipuncture and a coagulation tube is the first
tube needed, first draw a discard tube. The discard tube must be used to prime the tubing of the collection
set, which will assure maintenance of the proper anticoagulant/blood ratio in the first tube filled. The
discard tube should be a nonadditive or a coagulation tube, and need not be completely filled.
8.10.1 Coagulation Testing
Prothrombin time (PT) or international normalized ratio (INR) results obtained for normal patients,
patients undergoing oral anticoagulation therapy with warfarin, and normal patient activated partial
thromboplastin time (aPTT) results are not affected if performed on the first tube drawn.52-56 Since it is
not known whether other coagulation testing is affected, it may be advisable to draw a second tube for
other coagulation assays.
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8.11 Step 11: Release the Tourniquet
Release and remove the tourniquet as soon as possible after the blood begins to flow.
8.12 Step 12: Place the Gauze Pad
A clean gauze pad should be placed lightly over the venipuncture site. Cotton balls are not recommended
because of the possibility of dislodging the platelet plug at the venipuncture site.
8.13 Step 13: Remove and Dispose of the Needle
Remove the needle and activate the safety mechanism according to the device manufacturer’s
instructions. If the safety feature activates while the needle is still within the vein, activate the device
according to the manufacturer’s recommendation. Safely dispose of the unit into an easily accessible
sharps container, consistent with applicable regulations. Needles should not be resheathed, bent, broken,
or cut, nor should they be removed from disposable syringes unless attaching a safety transfer device
before disposal. Phlebotomists should anticipate a possible loss of consciousness, and be prepared to react
according to institutional policy. The use of ammonia inhalants may be associated with adverse effects
and is not recommended (see Section 11.7.1).
8.14 Step 14: Bandage the Arm
8.14.1 Normal Conditions
Under normal conditions, the phlebotomist should:
(1) Place the gauze pad over the site, continuing mild pressure. Do not allow patients to bend their arm
up as a substitute for pressure, as this technique is not adequate to prevent hematoma formation
under all circumstances. Patients may apply direct pressure as long as the collector constantly
monitors the site to ensure pressure is adequate.
(2) Check that bleeding has ceased, observe for hematoma, and apply an adhesive or gauze bandage
over the venipuncture site. It is recommended that hypoallergenic adhesives be available.
(3) Tell the patient to leave the bandage on for at least 15 minutes.
8.14.2 Continued Bleeding
The phlebotomist should watch for excessive bleeding. If a hematoma develops or bleeding persists
longer than five minutes, a nurse should be alerted so the attending physician can be notified. Pressure,
applied with a gauze pad, must continue at the site as long as necessary to stop the bleeding. Wrap a
gauze bandage tightly around the arm to keep the pad in place and tell the patient to leave the bandage on
the site for at least 15 minutes.
8.15 Step 15: Label Blood Collection Tubes and Record Time of Collection
The patient and the patient’s blood specimen must be positively identified at the time of collection. Tubes
must be positively identified after filling, not before, with a firmly attached label bearing at least the
following:
• patient’s first and last names;

• identification number;
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Volume 27 H3-A6
• date;
• time (as required, eg, therapeutic drug monitoring); and
• identification of the person collecting the specimen.
The tube must be labeled with the above information before leaving the side of the patient. This may be
accomplished by inscription or a computer-generated label or a bar-code label. There must be a
mechanism to identify the person who drew the blood.14 Where possible, compare the labeled tube to the
patient’s identification bracelet or have the patient verify that the information on the labeled tube is
correct.
If unable to obtain specimens, a record of the reasons and identification of the phlebotomist are necessary.
8.16 Step 16: Observe Special Handling if Required
For accurate results, some specimens require special handling, such as cooling to slow metabolic processes,
transportation at body temperature (37 °C) to prevent precipitation or agglutination, and protection from
light to prevent analyte breakdown. For more information on blood specimen handling and processing, see
CLSI document H18. 57
Examples of tests requiring specimen chilling are:58
• gastrin;
• ammonia;
• lactic acid;
• catecholamines;
• pyruvate; and
• parathyroid hormone (PTH).
NOTE: Some analytes, such as potassium, are negatively affected by chilling. If a potassium test is
ordered with other analytes that require chilling, it should be tested within two hours or collected in a
separate tube.
Examples of tests requiring specimen transportation at 37 °C include:
• cold agglutinin;
• cryofibrinogen; and
• cryoglobulins.
Examples of tests requiring specimen protection from light include:
• bilirubin;
• vitamin A;
• vitamin B6 ;
• beta carotene; and
• porphyrins.
8.17 Step 17: Send Blood Collection Tubes to the Proper Laboratories
Appropriately labeled blood collection tubes should be sent to laboratories designated to perform the
required testing procedures. Maintain proper transport conditions to preserve specimen integrity. For
additional information, refer to CLSI document H18.57
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9 Venipuncture in Children and Difficult Collections
If a venipuncture is requested on a child younger than one year of age, the phlebotomist should consult
with the physician or follow institutional policy. For information on skin puncture blood collection, refer
to CLSI document H4.59
9.1 Procedure
Except where indicated below, follow the procedure for venipuncture of adults as described in Section 8
for pediatric venipuncture.
9.2 Equipment
Venipunctures should be performed using equipment that can help reduce the stress exerted on a vein to
prevent vascular collapse. Examples include a venous blood collection system with a 22- to 23-gauge
needle, or a 22- to 23-gauge (winged) blood collection set.
10 Additional Considerations
10.1 Monitoring Blood Volume Collected
A mechanism should be in place to monitor the amount of blood drawn for pediatric and critically ill
patients, in order to avoid phlebotomy-induced anemia.60-66
10.2 Hematoma
To prevent a hematoma when performing a venipuncture, the phlebotomist should:
• Make sure the needle fully penetrates the uppermost wall of the vein (partial penetration may allow
blood to leak into the soft tissue surrounding the vein by way of the needle bevel).
• Remove the tourniquet before removing the needle.
• Use the major superficial veins.
• Hold the venous blood collection assembly still while collecting the specimen.
• Before bandaging, ensure that the puncture to the vein has sealed by observing for hematoma
formation after pressure is released.
• Apply a small amount of pressure to the area with the gauze pad when bandaging the arm.
10.3 Hemolysis
To prevent hemolysis67 when performing a venipuncture, the phlebotomist should:
• After cleansing, allow the venipuncture site to air dry.
• Never draw blood through a hematoma.
• If using a syringe and needle, make sure the needle is fitted securely on a syringe to avoid frothing.
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Volume 27 H3-A6
• When using a syringe, avoid drawing the plunger back too forcibly.
• Gently invert the blood collection tube to mix additive specimens as recommended by the
manufacturer.
10.4 Nerve Damage
A shooting, electrical pain sensation, tingling, or numbness during the procedure indicates potential nerve
involvement. Generally, potential complications of nerve damage include but are not limited to lack of
mobility of the limb, lack of grip strength, and lingering pain. If nerve involvement is suspected, remove
the needle immediately and perform the venipuncture on a different site, preferably the opposite arm.
11 Special Situations
11.1 Timed Intervals
Some specimens must be drawn at timed intervals because of medications, fasting requirements, and/or
biological variations (circadian rhythm). It is important that collection of specimens for timed tests is
obtained at the precisely specified interval(s).
11.1.1 Examples of Tests Requiring Timed Specimens
• tolerance tests (eg, two-hour postprandial glucose and three-hour glucose tolerance test);
• cortisol; and
• therapy monitoring (eg, PT, aPTT, digoxin, and other drugs).
11.1.2 Documentation
For therapeutic drug monitoring, the dose of the medication and the time of the last dose given, as well as
the time of the specimen collection, should be recorded accurately on the request slip or electronic records
containing collection information.
11.2 Specific Collection Techniques
11.2.1 Blood Alcohol
When drawing a blood specimen for alcohol testing, use a nonalcohol-based cleanser at the venipuncture
site (eg, soap).68-71
Refer to CLSI document T/DM6 for additional details.72
11.2.2 Legal Specimens
Follow appropriate chain-of-custody procedures. Refer to CLSI document T/DM6 for additional details.72
11.2.3 Blood Culture Specimens
There are time and temperature requirements in collection, transport, and storage of specimens for blood
culture. In addition, there are variations in the volume of blood needed for culture. In general, adult blood
cultures require 10 to 20 mL/set and infant blood cultures are done on 1 to 2 mL/set. Refer to the
manufacturer’s instructions for specific blood volume requirements. These requirements may vary
considerably, depending on the device.
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Number 26 H3-A6
Refer to CLSI document M47 for additional details.73
11.2.4 Trace Elements
For collection of blood for trace elements testing (eg, zinc), special metal-free collection containers
should be used. Refer to CLSI document C38 for additional details.74
11.2.5 Immunohematology Specimens
Gel separator tubes must not be used for immunohematology specimens.14 It is important to refer to the
manufacturer’s package inserts for collection tubes and for test methods for other possible gel tube
application limitations.
11.3 Indwelling Lines, Heparin or Saline Locks, Vascular Access Devices (VADs)
NOTE: Without complete, thorough, and documented training, phlebotomists should not draw blood
from VADs. Institutional policy must be followed.
11.3.1 Potential Error
VADs can be successfully left in a vein from 36 to 48 hours for IV administration of medication or as a
port from which to obtain a blood specimen. When obtaining a blood specimen from a VAD, the
components of the blood collection system (VAD, connecting device, syringe, needle, and collection
device) should be checked to ensure compatibility to avoid air leaks, which may cause hemolysis and
incorrect draw volumes. Collection of the blood through lines previously flushed or infused with heparin
should be avoided, if possible.
Obtaining blood specimens from indwelling lines or VADs can be a potential source of test error due to
hemolysis and incomplete flushing of the collection site, resulting in contamination and/or dilution of the
specimen, contributing to inaccurate results.75-78 If the blood must be drawn through a VAD, possible
heparin contamination and specimen dilution can be avoided by correct flushing of the line. Refer to
Section 11.3.2. Maintain careful sterility at all times, both to protect the patient from infection and to
avoid compromising specimens drawn for blood cultures.75,79
11.3.2 Flushing Lines
Because it is normal practice to flush lines with a solution to reduce the risk of thrombosis, lines must be
cleared of this fluid before blood specimens can be drawn for diagnostic testing. An adequate amount of
blood must be withdrawn from the line and discarded before drawing a specimen to ensure that the actual
specimen is not diluted or contaminated with the flush solution. Discard volume is dependent on the dead-
space volume of the particular line. Discarding two times the dead-space volume is recommended for
noncoagulation testing, and 5 mL or six times the dead-space volume for coagulation tests.75,80-84
11.4 Fistula
A fistula is an artificial shunt connection done by a surgical procedure to fuse the vein and artery together.
It is used for dialysis only.
An arm with a fistula should not be used for blood drawing without physician permission. The use of a
tourniquet may lead to complications. Follow facility policy.
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11.5 IV Fluids
,
Drawing blood from an IV arm has the potential risk for erroneous and misleading test results.23,84 85
Whenever possible, blood should be drawn from the opposite arm when an IV fluid (including transfused
blood products) is being administered into a patient’s arm. Blood should not be drawn from that limb
unless there is no alternative and the tests are critical to the care of the patient, as determined by the
physician or nurse. Appropriate precautions must be taken.
Some laboratories use skin puncture blood collection when venous access is not readily available.59
11.5.1 Distal Collection
One study84 showed that when drawing blood from below (distal to) the IV site and applying a tourniquet
between the IV and the venipuncture site, results were satisfactory for 17 of 18 chemistry analytes. The
IV contained glucose and glucose results were unacceptably elevated. Hematology tests were not included
in this study. Another study indicated distal collection was acceptable for several chemistry and
hematologic analytes.85
For distal collection:
(1) Ask the responsible caregiver to turn off the IV infusion for at least two minutes before
venipuncture. Care should be taken to ensure that the flow has been completely discontinued.
(2) Apply the tourniquet. When drawing distal to the IV infusion site, apply the tourniquet between the
IV and the intended venipuncture site.
(3) Perform the venipuncture.
11.5.2 Proximal Collection
In general, collection above (proximal to) an IV is not recommended and should only be attempted when
other alternatives have been exhausted. One study23 looked at blood collection from above the IV after
turning off the IV for one to three minutes. Results were unacceptable for glucose when glucose was in
the IV solution. It is important to note that the authors felt the elevated glucose results were due to
incomplete close-off of the IV.
For collection when the IV is below the antecubital fossa:
(1) Ask the responsible caregiver to turn off the IV infusion for at least two minutes before
venipuncture. Care should be taken to ensure that the flow has been completely discontinued.
(2) Apply the tourniquet 3 to 4 inches (7.6 to 10.2 cm) above the antecubital fossa.
(3) Perform the venipuncture.
11.5.3 Turning Off an IV
If an IV is temporarily closed off, this must only be done by authorized caregivers according to specific
institutional policy.
NOTE: It is recommended that specimens drawn (left or right arm indicated) distal or proximal to an IV
site be identified as such, and documentation should accompany the results. Be aware that “add-on tests”
may not be appropriate for this collection.
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11.6 Isolation
Patients are isolated to prevent disease from spreading to other patients, visitors, or employees.2 Some
hospitals may also provide a different, protective isolation for patients who could be placed at increased
risk from outside contamination.
11.6.1 Isolation Systems
Each hospital determines the system that best provides for their particular mix of patients, visitors, and
employees. In most cases, a color-coded card placed just outside the patient’s room describes the type of
isolation and the precautions taken by those entering the room. It is important to understand and use the
appropriate precautions.
11.6.1.1 Types of Isolation
Recent guidance emphasizes two tiers of infection control precautions: 2
• standard, for all patients; and

• transmission-based.
There are three types of transmission-based isolation precautions: 2
• airborne;
• droplet; and
• contact.
Hospitals have protocols for isolation procedures available through their infection control practitioner,
infection control committee, or hospital epidemiologist. Such a protocol is illustrated in Section 11.6.2.
Some hospitals may provide for disinfection, dedication, or disposal of equipment used in isolation rooms.
11.6.1.2 Clean Area
Gowns, gloves, masks, etc., are kept in a clean area. In some hospitals, a stand containing these supplies
is kept outside the room. Some facilities have an anteroom that serves as the “clean area.” Here, the
person entering the room can gown and apply other protective barriers as necessary before entering the
patient’s room. Physicians’ suit coats, jackets, and other apparel are left here.
11.6.2 Isolation Room
11.6.2.1 Procedures to Follow Before Entering the Isolation Room
(1) Read the isolation sign on the door. It will explain the type of isolation, protective clothing worn,
and the procedure used. Follow these instructions carefully.
(2) Check the orders and assemble an adequate amount of necessary equipment for the patient.
(3) Any supplies taken into the room must be left there, or discarded. Never take trays into the
isolation room.
11.6.2.2 Procedures to Follow in the Isolation Room
(1) Follow institutional policy for donning personal protective equipment.
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Volume 27 H3-A6
(2) Wash hands. Put on gloves.
(3) Place paper towels on the table and place the equipment on one or two towels.
(4) Obtain blood specimens in the usual manner, avoiding any unnecessary contact with the patient and bed.
(5) After mixing, place the filled tubes on a clean paper towel.
(6) Dispose of blood collection assembly into an easily accessible, approved puncture-resistant disposal
container, consistent with applicable regulations, according to institutional policy.
(7) Dispose of the tourniquet in the proper container.
(8) Pick up the tubes from the paper towel and clean the outside of the tube with 1:10 dilution of
bleach. Place tubes in a secondary container, which will contain the specimen if the primary
container breaks or leaks in transit to the laboratory. A plastic bag with a sealable, leakproof closure
can be used.
(9) Label tubes.
(10) Remove gown and gloves and dispose of them in the proper container.
(11) Wash hands.
(12) Turn off the faucet with a clean paper towel so hands are not contaminated.
11.6.3 Exposure
The phlebotomist must immediately report an accidental needlestick or contamination of a break in the
skin by blood or excreta to a supervisor, and follow institutional guidelines.3,86,87
11.7 Emergency Situations
At least one member of available on-site health care personnel should have extensive first-aid training,
including special training in cardiopulmonary resuscitation, so medical attention can be given to a patient
while the physician on call is en route. This individual should be identified to phlebotomists. Emergency
numbers should be posted in phlebotomy drawing areas.
11.7.1 Syncope (Fainting) or Unexpected Nonresponsiveness
The procedure for dealing with a patient who has fainted or is unexpectedly nonresponsive is as follows:
(1) Notify the designated first-aid trained personnel.
(2) Where practical, lay the patient flat or lower his/her head and arms, if the patient is sitting.
(3) Loosen tight clothing.
(4) The use of ammonia inhalants may be associated with adverse effects and is not recommended.
11.7.2 Nausea
The procedure for dealing with a patient who is experiencing nausea is to:
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Number 26 H3-A6
(1) Make the patient as comfortable as possible.
(2) Instruct the patient to breathe deeply and slowly.
(3) Apply cold compresses to the patient’s forehead.
11.7.3 Vomiting
The procedure for dealing with a patient who vomits is to:
(1) Give the patient an emesis basin or carton, and have tissues ready.
(2) Give the patient water to rinse out his/her mouth.
11.7.4 Convulsions
The procedure for dealing with a patient who is having convulsions is to:
(1) Prevent the patient from injuring himself/herself. Do not restrain the movements of the patient’s
extremities completely, but try to prevent him/her from being injured.
11.7.5 Incident Reports
Incident reports should be filed according to institutional policy.
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Volume 27 H3-A6
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CLSI consensus procedures include an appeals process that is described in detail in Section 8 of
the Administrative Procedures. For further information, contact CLSI or visit our website at
www.clsi.org.
Summary of Consensus Comments and Subcommittee Responses

H3-A5: Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Standard—Fifth Edition
General
1. I am questioning the required procedure for anchoring veins prior to venipuncture. The current standard states
that one must only anchor from below. The argument against the “C” (above and below) is that one might stick
oneself; however, over many years of using the “C” positioning, I have not experienced accidental needlesticks.
I would like to present a case for this alternate way of positioning the anchoring hand.
• Although experienced health care professionals with specimen collection responsibilities may feel
comfortable with this technique, this document pertains to seasoned phlebotomists as well as those new to
the procedure. Teaching this positioning puts those new to phlebotomy at an increased risk for accidental
needlestick.
2. I have a suspicion that the literature on venipuncture (including H3-A5) is perpetuating a mistake in naming of
veins. Of course, veins are variable, but the important cautions about avoiding the basilica are, in my opinion,
cautions about avoiding the “innermost vein” that should be more correctly called the median cubital. In my
opinion, there are typically three prominent veins. Starting from the outer side, the literature refers to them as:
1) cephalic (more correctly, accessory cephalic); 2) median cubital (more correctly, the cephalic); and 3)
basilica (more correctly, median cubital). The literature at this point has “run out of options” to name the large
vein that parallels the ulna bone along the underside of the forearm. It seems to me that this must be the true
basilic vein. In my experience, this vein is not visible in the antecubital fossa. I have rarely, if ever, seen anyone
use this vein to draw blood. It would be nice to know the true names of the veins.
• As is evidenced by this comment, there is great variation in the superficial veins of the forearm.
Descriptive text and a modified figure are included in Section 8.6.6 of this sixth edition standard for
clarity.
3. A phlebotomist at our institution was asked to perform a venous collection, via hand vein, on a 14-month-old
patient. I checked the CLSI standards for venipuncture and didn’t see this issue addressed, either to affirm or
prohibit such a practice. Please provide advice on the safety and suitability of this specimen collection
technique, and offer guidelines as to the minimum age at which you would consider hand vein access to be a
safe alternative.
• The working group makes no recommendations on limitations of venipuncture with regard to age.
Institutional policy should be followed.
Section 8.6.1, Precautions When Using a Tourniquet
4. All recent literature I have read is quoting CLSI standards as stipulating that tourniquet application should not
exceed one minute. Is this a misinterpretation of the standard? Referring to Section 8.6.1 of H3-A5, I note that
CLSI is stimulating that “Tourniquet application for preliminary selection should not exceed one minute…”
Other sections referring to the release of the tourniquet, such as Section 8.6.2 (9), state that the tourniquet
should be released “as soon as possible after the blood begins to flow.” Am I then to interpret this standard as
saying that during patient assessment, the tourniquet must be released after one minute? However, during the
actual venipuncture procedure, it should be released as soon as the technician feels its application is no longer
needed for completion of the procedure. The dilemma is in the situation where a large quantity of blood is
required (10 to 15 tubes). If the tourniquet is released right after blood flow begins, the vein is certain to
collapse prior to completion of draw.
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Volume 27 H3-A6
• The exceptional situation described by the commenter would present an unusual case, where “as soon as
possible” might exceed one minute; however, this is not a violation of the standard (ie, Sections 8.9.1,
8.9.2, 8.11). Should there be concern for an unusual situation such as that described, individual
laboratories, in consultation with medical staff, may wish to adopt specific policies to address such issues.
Section 8.6.4, Ensure Patient’s Hand Is Closed
5. The cephalic and accessory cephalic veins should be labeled in the figure so that locations and terminology
match those seen in other phlebotomy and anatomy texts.
• The illustration has been replaced. The new figure identifies the cephalic and accessory cephalic veins as
recommended.
6. Most phlebotomy texts describe the first choice in vein selection as median cubital and the second choice as
cephalic, with the reason given that this vein is usually more prominent, less likely to roll, less painful, and in a
safer area than the other antecubital veins. It has been my experience that the cephalic results in less pain, rolls
less because it is usually better anchored in the tissue, and usually offers a more accessible direction than the
median cubital.
• See the response to comment 2 above.
7. My observation is that drawing from the median cubital vein may actually result in a greater chance of
puncturing the brachial artery or median cutaneous nerve, because of where this bundle passes through the arm
in respect to the vein. Also, because the median cubital vein is not one of the major veins for blood return from
the arm (as are the cephalic and basilic), inadvertent damage during blood collection would be less likely to
affect blood return from the arm than if the cephalic or basilic were damaged.
• References have been added for clarity. The working group has not found reference in the literature to
support the dominance of any one superficial vein.
Section 8.6.6, Preferred Veins (now Section 8.6.6.2)
8. The third paragraph states, “Draws to the median cubital veins are preferred because they are typically closer to
the surface of the skin, more stationary, less painful upon needle insertion, and less likely to injure nerves if
needle placement is not accurate.” Is this a personal preference? It would appear that the cephalic vein is better
anchored and less likely to roll, so it should be preferred. Besides, the median cubital vein branches off of the
basilic and should be avoided if it is located too far on the inner aspect of the arm; not everyone’s anatomy is
the same and if the median cubital is located on the inner aspect, the same risks apply as for the basilic. I
recommend first choice cephalic and second choice median cubital if cephalic is not suitable. Avoid the median
cubital if located on the inner aspect of the baby finger side of the arm.
• The text has been modified and a reference has been added for clarity.
Section 8.6.7.2, Mastectomy (now Section 8.6.5.2)
9. H3-A5 states: “…because of potential harm to the patient due to lymphostasis, a physician must be consulted
before drawing blood from the side on which a mastectomy was performed.” Do you cite any references
concerning the potential harm? What is the source of that information?
• Trauma and infection on the same side of a mastectomy put the patient at increased risk because of
lymphostasis. A supporting reference has been added.
Section 8.6.8, Procedure for Vein Selection (now Section 8.6.7)
10. Is the recommendation to use the index or middle finger a personal preference?
• The text has been revised to clarify the procedure for vein selection. The following recommendation for
locating veins has been introduced in response to this comment:
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Number 26 H3-A6
“Palpation is usually performed using the index finger. The thumb should not be used to palpate because
it has a pulse beat. In addition to locating veins, the palpation pressure helps to differentiate veins from
arteries, which pulsate, are more elastic, and have a thick wall.”
11. Why must a tourniquet be used? If veins are large and easily palpated without a tourniquet, why must it be
used? After all, isn’t the purpose of the tourniquet to encourage visibility of veins?
• It is not necessary to apply a tourniquet when surveying the antecubital area if veins are large and easily
palpated. However, if only the basilic is visible, a tourniquet should be applied to appropriately prioritize
veins for selection.
Section 8.7, Step 7: Put On Gloves
12. This section recommends that the phlebotomist put gloves on before the venipuncture is performed. I’m not
comfortable with having gloves put on after a vein is located, because there will always be situations where
gloves must be donned before the patient’s room is entered.
• Section 11.6.2 explains the procedure when collecting specimens from patients in isolation. Section 8.7
was modified for special considerations for isolation patients or other situations that may require gloving
earlier in the procedure.
Section 8.8, Step 8: Cleanse Venipuncture Site
13. Consider revising Section 8.8 to read as follows: “Allow the area to air dry to prevent hemolysis of the
specimen and to prevent the patient from experiencing a burning sensation when the venipuncture is performed,
and to allow optimal antiseptic effect of alcohol, as mentioned in the skin puncture document.”
• Section 8.8.1(3) has been revised as suggested.
Section 8.8.2, For Blood Culture Collection
14. Section 8.8.2 states “Allow the site to air dry then remove the iodine or chlorhexidine from the skin with
alcohol.” Why should the site be cleaned with alcohol after it has already been sterilized with
chlorhexidine/povidone-iodine? We referred to the cited reference (ie, AABB Manual, 12th edition), which is
extremely outdated. The current AABB Manual (ie, 15th edition) does not state it is necessary to remove the
alcohol.
• Section 8.8.2 has been rewritten.
15. Do you have to clean the site initially with alcohol? If so, why? Does it have to be a two-part scrub at all? In the
past, we have used either chlorhexidine or povidone-iodine, but not both. The blood culture system we use
comes with a povidone-iodine swab only for cleaning the arm. The alcohol wipe is used to clean the top of the
collection bottles. Is this a “violation” if we only do a single scrub? How much leeway do we have here?
16. Please consider revisiting Section 8.8.2 in total. Perhaps it doesn’t have to be so specific. Is there a concept that
it might be rewritten more like the statement in Section 7.8 regarding antiseptics for blood alcohol levels?
Written this way, it tells you what you have to do, without specifically mandating what you have to use to do it.
17. Why remove iodine or chlorhexidine before the collection—why not after? Is the objective not to remove the
iodine from the patients’ skin before leaving them?
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Volume 27 H3-A6
18. I have seen procedures that state not to use iodine to cleanse the bottle stopper due to antibacterial action that
may affect organisms being transferred into the bottle. I don’t believe this is a problem, but perhaps some
mention of this should be made in this section.
Section 8.9.1, Venipuncture Procedure When Venous Blood Collection Tubes Are Used
19. Consider modifying (8) to read, “Keeping the needle as stable as possible in the vein, push/connect the first tube
onto the needle using the holder flanges to prevent/restrict needle movement.”
• The text was modified as suggested.
20. Consider modifying (12) to read, “Immediately after drawing each tube that contains an additive, mix the blood
gently and thoroughly by inverting the tube eight to ten times.”
• Some tube manufacturers recommend five to ten inversions. The text is appropriate.
Section 8.9.4, Blood Specimen That Cannot Be Obtained
21. Consider modifying the third bullet to read, “Manipulation other than that recommended above is considered
probing. Probing is not recommended. Probing is painful to the patient and is potentially dangerous. Probing
may result in vein or artery nicks resulting in a hematoma, and/or nerve compression or injury.”
• The text has been modified to read, “Unless the exact location of the vein is determined, manipulation
other than that recommended above may be considered probing. Probing is not recommended. Probing
can be painful and may produce arterial perforations, resulting in a hematoma and nerve compression or
direct nerve injury.”
Section 8.10.2, Glass and Plastic Venous Blood Collection Tubes (now Section 8.10)
22. Consider modifying the NOTE as follows: “The order of draw has been revised to reflect the increased use of
plastic blood collection tubes. Plastic serum tubes containing a clot activator may cause interference in
coagulation testing, blood-bank testing, and drug levels. Glass nonadditive serum tubes may be drawn before
the coagulation tube.”
• The working group has found no evidence in the literature that additive carryover of clot activator tubes
without gel causes interference in blood bank testing or drug levels.
Section 8.13, Step 13: Remove and Dispose of the Needle
23. Consider modifying the last sentence to read, “The use of ammonia inhalants may be associated with adverse
effects and is not recommended.”
• The text was revised as suggested.
Section 10, Additional Considerations
24. Nerve damage and arterial puncture should be discussed in this section.
• Section 10.4, Nerve Damage and Section 8.6.6.1.1, Accidental Arterial Puncture were added.
Section 11.3, Indwelling Lines or Vascular Access Devices (VADs)
25. Consider modifying the last sentence of the first paragraph to read, “Physician permission is required and
institutional policy should be followed.”
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Number 26 H3-A6
• In those facilities that have trained phlebotomists to draw from VADs, physician’s permission may not be
required. If institutional policy requires physician permission, the passage is accurate as written.
Section 11.4, Heparin or Saline Locks (This section has been deleted.)
26. Section 11.4 suggests that an indwelling winged infusion set (ie, heparin or saline lock) can be successfully left
in a vein from 36 to 48 hours for intravenous administration of medication, or as a vein source to obtain a blood
specimen in order to “save” veins for therapeutic use and also to cause less trauma to the patient. Should they be
used for blood collection?
• Information on heparin or saline lock use in blood collection can be found in Section 11.3.1.
Section 11.5, Fistula (now Section 11.4)
27. Section 11.5 suggests that an arm with a fistula should not be used routinely for blood drawing and that
whenever possible, specimens should be drawn from the opposite arm. This does not seem like a definitive
recommendation. Should they be collected from or not? If this isn’t possible, is it okay to collect from here, or
should the physician be consulting and permission obtained before collecting, or should the physician then be
responsible for collection of the specimen?
• The section has been revised to read, “A fistula is an artificial shunt connection done by a surgical
procedure to fuse the vein and artery together. It is used for dialysis only.
An arm with a fistula should not be used for blood drawing without physician permission.”
Section 11.6, IV Fluids (now Section 11.5)
28. Is there really enough evidence to support collecting above an IV site? If so, the reason should be thoroughly
explained, as this is a deviation from what is currently considered acceptable.
• There is a reference supporting blood collection proximal to an IV, but with specific precautions. Refer to
the revised Section 11.6.
Section 11.7.2.2, Procedures to Follow in the Isolation Room (now Section 11.6.2.2)
29. Consider modifying (11) to read, “Pick up the tubes from the paper towel and clean the outside of the tube with
1:10 dilution of bleach. Place tubes in a secondary container, which will contain the specimen if the primary
container breaks or leaks in transit to the laboratory. A plastic bag with a sealable, leakproof closure can be
used. This should be performed while the phlebotomist is still wearing gloves.”
• The list was reordered to address the commenter’s concern.
30. The response to comment 2 states, “The term ‘active’ has been removed from the text. The text in Sections
8.6.7.4 and 11.6 has been revised to describe the procedure for specimen collection in relation to intravenous
fluids.”
31. The response to comment 3 states, “The directions outlined in Section 10.6 should be followed during
transfusions, as it is described for intravenous fluids.”
• The working group believes the reviewer is referring to comment 4 in Section 11.6, rather than comment
3 in Section 10.6 of the standard.
The working group was not able to find specific references for blood collection precautions during
transfusions. The requirements for blood collection from an IV arm are considered applicable whether
the IV is blood or not.
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Volume 27 H3-A6
32. The response to comment 3 states, “Specimens collected from patients on warfarin sodium (CoumadinTM) are
considered for routine coagulation testing.”
Consider including this statement in the text so that the meaning is clear.
• Section 8.10.1, Coagulation Testing has been revised to respond to the commenter’s concern. The text has
been modified for clarity as follows:
Prothrombin time (PT) or international normalized ratio (INR) results obtained for normal patients,
patients undergoing oral anticoagulation therapy with warfarin, and normal patient activated partial
thromboplastin time (aPTT) results are not affected if performed on the first tube drawn. Since it is not
known whether other coagulation testing is affected, it may be advisable to draw a second tube for other
coagulation assays.
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Number 26 H3-A6
Summary of Delegate Comments and Subcommittee Responses
H3-A6: Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Standard—Sixth Edition
Section 2, Introduction
1. First paragraph, first sentence – “Since 1977, CLSI has recognized the quality requirement to direct significant
attention towards the…” – Grammatical comment: the correct word is toward.
• This editorial correction has been made.
Section 7.13, Warming Devices
2. There is no reference to manufacturer information, to precaution(s), to other pertinent CLSI documents, to

institutional policy, or to documentation of incidents.
• The working group agrees. The text has been modified to respond to the commenter’s concern.
Section 7.14, Test Reference Manual
3. “Should be available” seems mild. For JCAHO- or CAP-accredited facilities, this is a requirement. This manual
is a critical document, provided to all nursing units, clinics, doctors’ offices, home health, and other clients who
utilize laboratory services. At my facility, phlebotomists and all other lab departments were actively involved in
updating the manual. It contains phone and fax numbers for information. Questions can be asked and answered
before the patient is drawn and/or errors are made requiring redraws, changes in treatment, etc. One sentence
minimizes the importance of this information.
• The working group agrees. The text has been modified to respond to the commenter’s concern.
Section 8, Venipuncture Procedure
4. Section 8 lists the steps in the venipuncture procedure. Sections 8.1 to 8.5 do not have all the steps included or
in the same order.
• As recommended, the steps listed have been modified to reflect the pertinent sections.
Section 8.1.1, Information for Test Request Form
5. Should date of birth be included rather than age?
• The working group agrees. The text has been modified as recommended.
Section 8.2.4, Patient Who Is Semiconscious, Comatose, or Sleeping
6. Move the second sentence “Sleeping patients should be awakened before drawing blood” and remove the words
“or sleeping” from the first sentence, since you would wake them.
• The working group agrees. The text has been modified.
Section 8.3, Step 3: Verify Patient Diet Restrictions and Latex Sensitivity
7. Second paragraph, second sentence: “Ask the patient if he/she has a latex sensitivity. Use nonlatex supplies...”
is important and should be a separate paragraph.
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Volume 27 H3-A6
Section 8.4.4.1, Venous Blood Collection Systems
8. Second paragraph, second sentence: typographical error—missing closing bracket.
Section 8.6.5, Select Site
9. The preferred venipuncture site is the antecubital fossa, which is the area of either arm that is anterior (in front
of) and below the bend of the elbow where a number of large veins lie relatively near the skin’s surface.
Section 8.6.6, Select Vein
10. Could the preferred veins be designated in bold to differentiate them from arteries and nerves?
• Preferred veins are discussed at length in the text. Simply bolding them in the illustration may not
designate to the user that they are preferred.
Section 8.6.6.1.2, Nerve Injury
11. There are 14 references. I have never seen so many. Could this be shortened to 24-37? Maybe not, but it is a
serious risk management issue. Can “the incident should be documented according to institutional policy” be
added, as in Section 8.6.6.1.1?
• Formatting and modification of the text has been introduced to accommodate the commenter’s concerns.
Section 8.6.6.2, Preferred Veins
12. Second sentence: Is there a reference for the recommendation to access the median cubital or median vein first?
• The prior sentence, which is referenced, supports the preference.
13. Second sentence: “…draws from this vein…” Should read “the cephalic (H pattern) and median cephalic (M
pattern).” The accessory cephalic may be present with either orientation and is also acceptable.
• The text is correct as written.
Section 8.6.7, Procedure for Locating Veins
14. A tourniquet must be used to aid in the selection of a vein site unless specific tests require that tourniquets not
be used (eg, lactate). What decision processes led to “must be used” compared to the previous edition, which
said, “A tourniquet is used to increase venous filling”? I have to admit that there are a number of situations that
due to the patient’s medical condition, or the placement of the vein we’re using (ie, proximity to bandages)
prevent us from using a tourniquet (as well as the practice of not using for tests such as lactate), and I’m hoping
to get clarification of the statement
• It is not necessary to apply a tourniquet if veins are large and easily palpated. However, if only the basilic
is visible, a tourniquet should be applied to appropriately prioritize veins for selection, as instructed in
Section 8.6.6.
Section 8.8.2, For Blood Culture Collection
15. Second paragraph, first sentence: Are we really “disinfecting” the site?
• The text is accurate as written.
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Number 26 H3-A6
16. Third paragraph, sixth sentence: “…Blood can be drawn directly into collection tubes containing sodium
polyanetholsulfonate (SPS), then transferred to blood culture medium, but should never be drawn…” “Never” is
a strong word; “not” is probably sufficient. At some point, there might be other anticoagulants that are
acceptable for blood cultures.
Section 8.9.2, Venipuncture Procedure Using Needle and Syringe
17. Procedure step 1: I believe the manufacturer suggests breaking the seal before opening the syringe packaging to
avoid syringe contamination.
• The text is acceptable as written.
Section 8.9.3, Fill the Tubes if Syringe and Needle Are Used
18. “Allow the butt to fill without applying any pressure to the plunger until flow ceases.” “Butt” should be
modified to read “tube.”
• The text has been modified as suggested.
Section 8.10, Step 10: Order of Draw
19. “All additive tubes should be filled to their stated volume.” “Volume” should be made plural. Also, in the
NOTE, the word “ration” should read “ratio.”
• These editorial corrections have been made.
Section 8.14.1, Normal Conditions
20. Step (1): There is a reference for this and the reason should be stated here—found to actually increase bruising
when compared to applying pressure with arm extended.
Section 8.15, Step 15: Label Blood Collection Tubes and Record Time of Collection
21. The second and third sentences are the same. One should be removed.
• The working group agrees. The text has been modified to address the commenter’s concern.
22. Too much information on the blood tube may hinder proper identification.
• The text is acceptable as written.
Section 11.3, Indwelling Lines, Heparin or Saline Locks, Vascular Access Devices (VADs)
23. Is there a way to bold this to make it stand out?
• The text has been reformatted to draw the readers’ attention to the statement.
24. This section needs a bit of reorganization to make it flow.
• The working group agrees. The section has been modified.
25. Hyphenate “dead-space volume” consistently throughout the section.
• These editorial changes have been made.

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Volume 27 H3-A6
Section 11.4, Fistula
26. Add a further note that a tourniquet or blood pressure cuff should not be applied to an arm with a fistula.
Section 11.5.1, Distal Collection
27. In Step (3), include: “Collect a discard tube to remove residual infusion solution.”
• The necessity of a discard tube when drawing distal to an IV site is not supported in the literature. The
text is acceptable as written.
Section 11.5.2, Proximal Collection
28. In Step (3), mention collection of discard tube.
• Section 11.5.2 indicates proximal blood collection is a “last resort.” There are no references indicating a
discard tube will make test results valid. The text is acceptable as written.
Section 11.6.2, Isolation Room
29. Instructions on when to label the tubes should be included in the steps for phlebotomy in an isolation room.
• The working group agrees. The section has been modified.
Section 11.6.2.2, Procedures to Follow in the Isolation Room
30. The first point should be: Follow correct procedure (as per institutional policy) for donning of personal
protective equipment (8) or other cleaning solution. Bleach is not used everywhere.
• The bulleted list has been reordered.
31. Steps 1 through 3: This is somewhat misleading. Washing hands, gowning, and gloving are performed outside
the room for most isolation and contact precautions so health care workers have less chance of contaminating
themselves when entering the room.
• The bulleted list has been reordered.
32. Step (8): When were tubes labeled and what effect will cleaning with bleach have on the label and the legibility
of information?
• The section has been modified.
References
33. After the 14 references for nerve damage, I took a closer look at all 81 references. My initial impression was
that there are more current editions of some of the textbooks (phlebotomy) listed. I didn’t investigate this further
to see if there are changes in the newer editions.
• The section references have been updated.
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Number 26 H3-A6
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 HS1—A 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 service’s 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 manager’s guide. The QSEs are:
Documents & Records Equipment Information Management Process Improvement

Organization Purchasing & Inventory Occurrence Management Customer Service
Personnel Process Control Assessments―External & Facilities & Safety
Internal
H3-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.
Customer Service
Assessments—
Purchasing &
Improvement
Organization
Management
Management
Information
Facilities &
Occurrence
Documents
Equipment
& Records
External &
Personnel
Inventory
Control
Process
Process
Internal
Safety
H11 H11 H11 X X H1 H11 X
H1 H1 H11
H4 T/DM6 M29
H11
H18
H21
Adapted from CLSI/NCCLS document HS1—A 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 GP26⎯Application 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 laboratory’s services, namely quality laboratory information.
H3-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

Interpretation
reporting and
Examination
Examination
management
review and
processing
collection
follow-up
archiving
transport
ordering
Sample
Sample
Sample
receipt/
Sample
Results
Results
X X X X X X
H11 H1 C38 C38 H18 T/DM6
H11 H4 H4
H21 H11 H11
H18
H21
Adapted from CLSI/NCCLS document HS1—A Quality System Model for Health Care.
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Volume 27 H3-A6
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 Standard—Fifth 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 Standard—Fourth 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 Guideline—Third 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 Guideline—Fourth 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 Guideline—Third
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.
©

Active Membership
(as of 1 October 2007)
Sustaining Members National Center of Infectious and HistoGenex N.V. Alameda County Medical Center
Parasitic Diseases (Bulgaria) Immunicon Corporation Albany Medical Center Hospital (NY)
Abbott National Health Laboratory Service Instrumentation Laboratory Albemarle Hospital (NC)
American Association for Clinical (South Africa) Japan Assn. of Clinical Reagents Industries Alfred I. du Pont Hospital for Children
Chemistry National Institute of Standards and Johnson & Johnson Pharmaceutical All Children’s Hospital (FL)
AstraZeneca Pharmaceuticals Technology Research and Development, L.L.C. Allegheny General Hospital (PA)
Bayer Corporation National Pathology Accreditation Kaiser Permanente Alta Bates Summit Medical Center (CA)
BD Advisory Council (Australia) K.C.J. Enterprises American Hospital Dubai (UAE)
Beckman Coulter, Inc. New York State Department of Health Laboratory Specialists, Inc. American University of Beirut Medical
bioMérieux, Inc. Ontario Ministry of Health LifeScan, Inc. (a Johnson & Johnson Center (NY)
CLMA Pennsylvania Dept. of Health Company) Anne Arundel Medical Center (MD)
College of American Pathologists Saskatchewan Health-Provincial Maine Standards Company, LLC Antelope Valley Hospital District (CA)
GlaxoSmithKline Laboratory Medical Device Consultants, Inc. Arkansas Dept of Health
Ortho-Clinical Diagnostics, Inc. Scientific Institute of Public Health Merck & Company, Inc. Arkansas Methodist Medical Center (AR)
Pfizer Inc University of Iowa, Hygienic Lab Micromyx, LLC Arnett Clinic, LLC (IN)
Roche Diagnostics, Inc. MicroPhage Asan Medical Center (Seoul)
Industry Members Monogen, Inc. Asante Health System (OR)
Professional Members MultiPhase Solutions, Inc. Asiri Group of Hospitals Ltd.
3M Medical Division Nanogen Asociacion Espanola Primera de Socorros
American Academy of Family AB Biodisk Nanogen, Point-of-Care Diagnostics Div. Mutuos (Uruguay)
Physicians Abbott Nihon Koden Corporation Aspirus Wausau Hospital (WI)
American Association for Clinical Abbott Diabetes Care Nissui Pharmaceutical Co., Ltd. Atlantic Health Sciences Corp.
Chemistry Abbott Molecular Inc. NJK & Associates, Inc. Augusta Medical Center (VA)
American Association for Laboratory Abbott Point of Care Inc. NovaBiotics (Aberdeen, UK) Aultman Hospital (OH)
Accreditation Access Genetics Novartis Institutes for Biomedical Azienda Ospedale Di Lecco (Italy)
American Association for Respiratory Care Acupath Research Baptist Hospital for Women (TN)
American Chemical Society AdvaMed Nucryst Pharmaceuticals Baptist Hospital of Miami (FL)
American College of Medical Genetics Advanced Liquid Logic Olympus America, Inc. Bassett Army Community Hospital (AK)
American Medical Technologists Advancis Pharmaceutical Corporation Optimer Pharmaceuticals, Inc. Bay Regional Medical Center (MI)
American Society for Clinical Advantage Bio Consultants, Inc. Orion Genomics, LLC BayCare Health System (FL)
Laboratory Science Affymetrix, Inc. (Santa Clara, CA) Ortho-Clinical Diagnostics, Inc. Baylor Health Care System (TX)
American Society for Microbiology Affymetrix, Inc. (W. Sacramento, CA) (Rochester, NY) Baystate Medical Center (MA)
American Type Culture Collection Agilent Technologies/Molecular Oxonica (UK) B.B.A.G. Ve U. AS., Duzen Laboratories
ASCP Diagnostics Panaceapharma Pharmaceuticals (Turkey)
Associazione Microbiologi Clinici Ammirati Regulatory Consulting Paratek Pharmaceuticals, Inc. BC Biomedical Laboratories (Surrey, BC,
Italiani (AMCLI) Anapharm, Inc. Pathology Services Inc. Canada)
Canadian Society for Medical Anna Longwell, PC Pathwork Diagnostics Beebe Medical Center (DE)
Laboratory Science Aptium Oncology Pfizer Animal Health Belfast HSS Trust, Royal Victoria Hospital
COLA Arpida Ltd Pfizer Inc (Belfast)
College of American Pathologists A/S Rosco Phadia AB Beloit Memorial Hospital (WI)
College of Medical Laboratory Astellas Pharma PlaCor, Inc Bonnyville Health Center (Canada)
Technologists of Ontario AstraZeneca Pharmaceuticals Powers Consulting Services Boston Medical Center (MA)
College of Physicians and Surgeons Aviir, Inc. ProSource Consulting, Inc. Boulder Community Hospital (CO)
of Saskatchewan Axis-Shield PoC AS QSE Consulting Brantford General Hospital (CT)
Elkin Simson Consulting Services Bayer Corporation – West Haven, CT Radiometer America, Inc. Bridgeport Hospital (CT)
ESCMID Bayer HealthCare, LLC, Diagnostics Div. – RCC CIDA S. A. British Columbia Cancer Agency –
Family Health International Elkhart, IN Replidyne Vancouver Cancer Center (BC,
Hong Kong Accreditation Service BD Rib-X Pharmaceuticals Canada)
Innovation and Technology BD Biosciences – San Jose, CA Roche Diagnostics GmbH Bronson Methodist Hospital (MI)
Commission BD Diagnostic Systems Roche Diagnostics, Inc. Broward General Medical Center (FL)
International Federation of Biomedical BD Vacutainer Systems Roche Diagnostics Ltd Cadham Provincial Laboratory – MB Health
Laboratory Science Beckman Coulter, Inc. Roche Molecular Systems (Canada)
International Federation of Clinical Beth Goldstein Consultant (PA) Bioanalyse, Sanofi Pasteur Calgary Laboratory Services (Calgary, AB,
Chemistry Ltd. Sarstedt, Inc. Canada)
Italian Society of Clinical Biochemistry Bio-Development S.r.l. Schering Corporation California Pacific Medical Center (CA)
and Clinical Molecular Biology Biomedia Laboratories SDN BHD Seneca Medical, Inc. Cambridge Health Alliance (MA)
JCAHO bioMérieux, Inc. (MO) Sequenom, Inc. Camden Clark Memorial Hospital (WV)
JCCLS bioMérieux, Inc. (NC) Siemens Medical Solutions Diagnostics Cape Breton Healthcare Complex (Canada)
National Society for Histotechnology, Inc. Bio-Rad Laboratories, Inc. – France Sphere Medical Holding Limited Cape Cod Hospital (MA)
Ontario Medical Association Quality Bio-Rad Laboratories, Inc. – Irvine, CA Stirling Medical Innovations Cape Fear Valley Medical Center
Management Program-Laboratory Bio-Rad Laboratories, Inc. – Plano, TX Streck Laboratories, Inc. Laboratory (NC)
Service Blaine Healthcare Associates, Inc. Sysmex America, Inc. (Mundelein, IL) Capital Health/QE II Health Sciences
RCPA Quality Assurance Programs PTY Braun Biosystems, Inc. Sysmex Corporation (Japan) Centre (Nova Scotia)
Limited Canon U.S. Life Sciences, Inc. Tethys Bioscience, Inc. Capital Health - Regional Laboratory
SDS Pathology Cempra Pharmaceuticals, Inc. The Clinical Microbiology Institute Services (Canada)
SIMeL Center for Measurement Standards/ITRI TheraDoc Capital Health System Fuld (NJ)
Sociedad Espanola de Bioquimica Cepheid Therapeutic Monitoring Services, LLC Capital Health System Mercer Campus (NJ)
Clinica y Patologia Molecular Chen & Chen, LLC (IQUUM) Theravance Inc. Carpermor S.A. de C.V. (Mexico)
Sociedade Brasileira de Analises Comprehensive Cytometric Consulting Third Wave Technologies, Inc. Catholic Health Initiatives (KY)
Clinicas Control Lab Thrombodyne, Inc. Cavan General Hospital (Ireland)
Sociedade Brasileira de Patologia Copan Diagnostics Inc. Transasia Bio-Medicals Limited CDC/HIV (APO, AP)
Clinica Cosmetic Ingredient Review Trek Diagnostic Systems Central Arkansas Veterans Healthcare
Turkish Society of Microbiology Cubist Pharmaceuticals Watin-Biolife Diagnostics and Medicals System (AR)
Washington G2 Reports Cumbre Inc. Wyeth Research Central Baptist Hospital (KY)
World Health Organization Dade Behring Inc. – Cupertino, CA XDX, Inc. Central Kansas Medical Center (KS)
Dade Behring Inc. – Deerfield, IL YD Consultant Central Processing & Receiving (BC)
Government Members Dade Behring Inc. – Glasgow (Newark, DE) Central Texas Veterans Health Care System
Dade Behring Inc. Marburg GmbH Trade Associations (TX)
Association of Public Health Laboratories (Germany) Centralized Laboratory Services (NY)
BC Centre for Disease Control Dade Behring Inc. – Sacramento, CA AdvaMed Centre Hospitalier Anna-Laberge (Canada)
Centers for Disease Control and Dahl-Chase Pathology Associates PA Japan Association of Clinical Centura – Villa Pueblo (CO)
Prevention David G. Rhoads Associates, Inc. Reagents Industries (Tokyo, Japan) Chaleur Regional Hospital (Canada)
Centers for Disease Control and Diagnostic Products Corporation Chang Gung Memorial Hospital (Taiwan)
Prevention – Tanzania Diagnostica Stago Associate Active Members Changhua Christian Hospital (Taiwan)
Centers for Medicare & Medicaid Services Docro, Inc. Chesapeake General Hospital (VA)
Centers for Medicare & Medicaid DX Tech 3rd Medical Group (AK) Chester County Hospital (PA)
Services/CLIA Program Eiken Chemical Company, Ltd. 5th Medical Group/SGSL (ND) Children’s Healthcare of Atlanta (GA)
Chinese Committee for Clinical Elanco Animal Health 22 MDSS (KS) Children’s Hospital (OH)
Laboratory Standards Electa Lab s.r.l. 48th Medical Group/MDSS (APO, AE) Children’s Hospital & Research
FDA Center for Devices and Radiological Eurofins Medinet 59th MDW/859th MDTS/MTL Wilford Hall Center at Oakland (CA)
Health Future Diagnostics B.V. Medical Center (TX) Children’s Hospital Medical Center (OH)
FDA Center for Veterinary Medicine Genomic Health, Inc. Acadiana Medical Labs, Ltd Children’s Memorial Hospital (IL)
Health Canada Gen-Probe ACL Laboratories (IL) Childrens Hosp.- Kings Daughters (VA)
Massachusetts Department of Public Genzyme Clinical Specialty Laboratory ACL Laboratories (WI) Childrens Hospital Los Angeles (CA)
Health Laboratories Genzyme Diagnostics Adams County Hospital (OH) Childrens Hospital of Wisconsin (WI)
Ministry of Health and Social Welfare - GlaxoSmithKline Air Force Institute for Operational Health Chilton Memorial Hospital (NJ)
Tanzania GlucoTec, Inc. (TX) Christiana Care Health Services (DE)
Greiner Bio-One Inc. Akron’s Children’s Hospital (OH)

City of Hope National Medical Hamilton Regional Laboratory Medicine Langley Air Force Base (VA) Ochsner Clinic Foundation (LA)
Center (CA) Program (Canada) LeBonheur Children’s Medical Center Ohio State University Hospitals (OH)
City of Houston Dept of Health (TX) Hanover General Hospital (PA) (TN) Oklahoma Heart Hospital, LLC (OK)
Clarian Health – Clarian Pathology Harford Memorial Hospital (MD) Legacy Laboratory Services (OR) Onze Lieve Vrouw Ziekenhuis
Laboratory (IN) Harris Methodist Fort Worth (TX) Lethbridge Regional Hospital (Canada) (Belgium)
Cleveland Clinic Health System Hartford Hospital (CT) Lewis-Gale Medical Center (VA) Ordre Professionel Des Technologistes
Eastern Region (OH) Health Network Lab (PA) L’Hotel-Dieu de Quebec (Quebec, Medicaux Du Quebec (Quebec)
Clinical Labs of Hawaii (HI) Health Partners Laboratories Bon Canada) Orlando Regional Healthcare System (FL)
CLSI Laboratories, Univ. Pittsburgh Secours Richmond (VA) Licking Memorial Hospital (OH) Our Lady of Lourdes Medical Center (NJ)
Med. Ctr. (PA) Health Waikato (New Zealand) LifeBridge Health Sinai Hospital (MD) Our Lady of Lourdes Reg. Medical Ctr.
Colchester East Hants Health Authority (Canada) Heartland Health (MO) Loma Linda University Medical (CA) (LA)
Commonwealth of Kentucky Heidelberg Army Hospital (APO, AE) Long Beach Memorial Medical Our Lady of the Way Hospital (KY)
Community Care 5 (OH) Hema-Quebec (Canada) Center (CA) Our Lady’s Hospital for Sick Children
Community Hospital (IN) Hennepin Faculty Association (MN) Los Angeles County Public Health Lab. (CA) (Ireland)
Community Hospital of the Monterey Henry Ford Hospital (MI) Louis A Johnson Medical Center (WV) Overlake Hospital Medical Center (WA)
Peninsula (CA) Henry Medical Center, Inc. (GA) Louisiana State University Medical Ctr. Pathologists Associated (IN)
Community Memorial Hospital (WI) Hi-Desert Medical Center (CA) (LA) Pathology and Cytology Laboratories, Inc. (KY)
Connolly Hospital (Ireland) Hoag Memorial Hospital Lourdes Hospital (KY) Pathology Associates Medical
Consultants Laboratory of WI LLC (WI) Presbyterian (CA) Madison Parish Hospital (LA) Laboratories (WA)
Contra Costa Regional Medical Holy Cross Hospital (MD) Magnolia Regional Health Center (MS) PCA Southeast (TN)
Center (CA) Holy Family Medical Center (WI) Magruder Memorial Hospital (OH) Pediatrix Screening Inc. (PA)
Cook Children’s Medical Center (TX) Holy Spirit Hospital (PA) Main Line Clinical Laboratories, Inc. (PA) Pennsylvania Hospital (PA)
Cork University Hospital (Ireland) Hopital Cite de La Sante De Laval Manipal AcuNova (India) Penrose St. Francis Health Services (CO)
Corpus Christi Medical Center (TX) (Canada) Marquette General Hospital (MI) Perry County Memorial Hospital (IN)
Covance CLS (IN) Hôpital Maisonneuve - Rosemont Marshfield Clinic (WI) Peterborough Regional Health Centre
Covance Evansville (IN) (Montreal, Canada) Martin Luther King, Jr. Harbor Hospital (Canada)
Creighton Medical Laboratories Hôpital Sacré-Coeur de Montreal (CA) Physicians Reference Laboratory (KS)
(NE) (Quebec, Canada) Martin Memorial Health Systems (FL) Pitt County Memorial Hospital (NC)
Creighton University Medical Center Hopital Santa Cabrini Ospedale Mary Imogene Bassett Hospital (NY) PPD (KY)
(NE) (Canada) Marymount Medical Center (KY) Presbyterian Hospital of Dallas (TX)
Cross Cancer Institute (Canada) Hospital Albert Einstein (Brazil) Massachusetts General Hospital (MA) Presbyterian/St. Luke’s Medical Center (CO)
Dahl-Chase Pathology Associates PA (ME) Hospital de Dirino Espirito Santa Massachusetts General Hospital Princess Margaret Hospital (Hong Kong)
Darwin Library NT Territory Health (Portugal) Division of Laboratory Medicine (MA) Providence Health Care (Canada)
Services (Australia) Hôtel Dieu Grace Hospital Library Maxwell Air Force Base (AL) Providence Medford Medical Center (OR)
David Grant Medical Center (CA) (Windsor, ON, Canada) MDS Laboratories (Canada) Provincial Health Services Authority
Daviess Community Hospital (IN) Humility of Mary Health Partners MDS Metro Laboratory Services (Vancouver, BC, Canada)
Deaconess Medical Center (WA) (OH) (BC, Canada) Provincial Laboratory for Public
Dekalb Memorial Hospital (IN) Hunter Area Pathology Service Meadows Regional Medical Center Health (Edmonton, AB, Canada)
DeWitt Healthcare Network (USA (Australia) (GA) Queen Elizabeth Hospital (Canada)
Meddac) (VA) Hunterdon Medical Center (NJ) Mease Countryside Hospital (FL) Queensland Health Pathology Services
DHHS NC State Lab of Public Icon Laboratories (Ireland) Mease Dunedin Hospital (FL) (Australia)
Health (NC) IGate Clinical Research Intl., Pvt., LTD (India) Medical Center Hospital (TX) Quest Diagnostics, Inc
Diagnostic Laboratory Services, Inc. (HI) Imelda Hospital (Belgium) Medical Center of Louisiana at NO- Quest Diagnostics, Inc (San Juan
Diagnostic Services of Manitoba Indiana University - Chlamydia Charity (LA) Capistrano, CA)
(Canada) Laboratory (IN) Medical Centre Ljubljana (Slovenia) Quest Diagnostics JV (IN, OH, PA)
Diagnósticos da América S/A (Sao Institut fur Stand. und Dok. im Med. Lab. Medical College of Virginia Quest Diagnostics Laboratories (WA)
Paulo) (Germany) Hospital (VA) Quintiles Laboratories, Ltd. (GA)
Dianon Systems/Lab Corp. (OK) Institut National de Santé Publique du Quebec Medical Specialists (IN) Rady Children’s Hospital San Diego (CA)
Dimensions Healthcare System Centre de Doc. – INSPQ (Canada) Medical Univ. of South Carolina (SC) Redington-Fairview General Hospital (ME)
(MD) Institute Health Laboratories (PR) MediCorp - Mary Washington Hospital Régie Régionale Dela Santé Beaséjour (Canada)
Dr. Everette Chalmers Regional Institute of Clinical Pathology and (VA) Regional Health Authority - Central
Hospital (NB) Medical Research (Australia) Memorial Health Center, Inc. (WI) Manitoba Inc (Canada)
Driscoll Children’s Hospital (TX) Institute of Laboratory Medicine Memorial Hermann Healthcare System (TX) Regional Health Authority Four (RHA4)
DSI of Bucks County (PA) Landspitali Univ. Hospital (Iceland) Memorial Hospital (OH) (Canada)
DUHS Clinical Laboratories (NC) Institute of Medical & Veterinary Memorial Hospital Miramar (FL) Regions Hospital (MN)
Dundy County Hospital (NE) Science (Australia) Memorial Hospital Pembroke (FL) Research Medical Center (MO)
Durham VA Medical Center (NC) Integrated Regional Laboratories Memorial Hospital West (FL) Riverside Methodist Hospital (OH)
Dwight D. Eisenhower Medical South Florida (FL) Memorial Medical Center (PA) Riverview Hospital (WI)
Center (KS) International Health Management Memorial Regional Hospital (FL) Riyadh Armed Forces Hospital, Sulaymainia
East Central Health (Canada) Associates, Inc. (IL) Mercy Franciscan Mt. Airy (OH) (Riyadh, Saudi Arabia)
East Georgia Regional Medical Ireland Army Community Hospital (KY) Mercy Hospital (ME) Robert Wood Johnson University Hospital (NJ)
Center (GA) IWK Health Centre (Canada) Mercy Medical Center (CO) Rush North Shore Medical Center (IL)
Eastern Health Pathology (Australia) Jackson Health System (FL) Mercy Medical Center (OR) SAAD Specialist Hospital (Saudi Arabia)
Edward Hospital (IL) Jackson Hospital & Clinic, Inc. (AL) Methodist Hospital (MN) Sahlgrenska Universitetssjukhuset (Sweden)
Effingham Hospital (GA) Jackson Purchase Medical Center Methodist Hospital (TX) Saint Elizabeth Regional Medical Center (NE)
Eliza Coffee Memorial Hospital (AL) (KY) Methodist Hospital Pathology (NE) Saint Francis Hospital & Medical Center (CT)
EMH Regional Medical Center (OH) Jacobi Medical Center (NY) Metropolitan Medical Laboratory, PLC (IA) St. Agnes Healthcare (MD)
Emory University Hospital (GA) John C. Lincoln Hospital (AZ) Middletown Regional Hospital (OH) St. Anthony Hospital (OK)
Evangelical Community Hospital (PA) John F. Kennedy Medical Center (NJ) Mississippi Baptist Medical Center (MS) St. Anthony Hospital Central Laboratory (CO)
Evanston Hospital (IL) John H. Stroger, Jr. Hospital of Cook Mississippi Public Health Lab (MS) St. Anthony’s Hospital (FL)
Exeter Hospital (NH) County (IL) Monmouth Medical Center (NJ) St. Barnabas Medical Center (NJ)
Federal Medical Center (MN) John Muir Medical Center (CA) Montefiore Medical Center (NY) St. Christopher’s Hospital for Children (PA)
Firelands Regional Medical Center John T. Mather Memorial Hospital (NY) Morton Plant Hospital (FL) St. Francis Medical Center (MN)
(OH) Johns Hopkins Medical Institutions Nassau County Medical Center (NY) St. John Hospital and Medical Center (MI)
First Health of the Carolinas (MD) National Cancer Center (S. Korea) St. John’s Hospital (IL)
Moore Regional Hospital (NC) Johns Hopkins University (MD) National Cancer Institute (MD) St. John’s Hospital (MO)
Fisher-Titus Memorial Hospital (OH) Johnson City Medical Center (TN) National Healthcare Group (Singapore) St. John’s Hospital & Health Ctr. (CA)
Flaget Memorial Hospital (KY) JPS Health Network (TX) National Institutes of Health, Clinical St. John’s Mercy Medical Center (MO)
Fletcher Allen Health Care (VT) Kadlec Medical Center (WA) Center (MD) St. Joseph Medical Center (MD)
Fleury S.A. (Brazil) Kaiser Permanente (CA) National Naval Medical Center (MD) St. Joseph Mercy Hospital (MI)
Florida Hospital (FL) Kaiser Permanente (MD) National University Hospital Department of St. Joseph’s Hospital (FL)
Foote Hospital (MI) Kaiser Permanente Medical Care (CA) Laboratory Medicine (Singapore) St. Joseph’s Hospital & Health
Fort St. John General Hospital Kangnam St. Mary’s Hospital (Korea) Naval Hospital Great Lakes (IL) Center (ND)
(Canada) Keller Army Community Hospital (NY) Naval Hospital Oak Harbor (WA) St. Joseph’s Medical Center (CA)
Forum Health Northside Medical Kenora-Rainy River Reg. Lab. New England Fertility Institute (CT) St. Joseph Mercy – Oakland (MI)
Center (OH) Program (Canada) New Lexington Clinic (KY) St. Joseph’s Regional Medical Center (NJ)
Fox Chase Cancer Center (PA) King Fahad National Guard Health New York City Department of Health and St. Jude Children’s Research Hospital (TN)
Gamma-Dynacare Laboratories Affairs King Abdulaziz Medical City Mental Hygiene (NY) St. Louis University Hospital (MO)
(Canada) (Saudi Arabia) New York-Presbyterian Hospital (NY) St. Luke’s Hospital (PA)
Gamma Dynacare Medical Laboratories King Faisal Specialist Hospital (MD) New York University Medical St. Luke’s Hospital (FL)
(Ontario, Canada) Kingston General Hospital (Canada) Center (NY) St. Luke’s Hospital (IA)
Garden City Hospital (MI) Kosciusko Laboratory (IN) Newark Beth Israel Medical Center (NJ) St. Margaret Memorial Hospital (PA)
Garfield Medical Center (CA) Lab Medico Santa Luzia LTDA (Brazil) North Bay Hospital (FL) St. Mary Medical Center (CA)
Geisinger Medical Center (Danville, PA) LabCorp (NC) North Carolina Baptist Hospital (NC) St. Mary’s Health Center (MO)
Genesis Healthcare System (OH) Labette Health (KS) North Coast Clinical Laboratory, Inc. (OH) St Mary’s Healthcare (SD)
George Washington University Laboratory Alliance of Central New North Mississippi Medical Center (MS) St. Mary’s Hospital and Medical
Hospital (DC) York (NY) North Shore Hospital Laboratory Center (WI)
Good Samaritan Hospital (NE) LabPlus Auckland Healthcare Services (Auckland, New Zealand) St. Mary’s Medical Center (IN)
Good Samaritan Hospital (OH) Limited (New Zealand) North Shore-Long Island Jewish Health St. Michael’s Hospital Diagnostic
Good Shepherd Medical Center (TX) Lafayette General Medical Center (LA) System Laboratories (NY) Laboratories & Pathology (Canada)
Grand Strand Reg. Medical Center (SC) Lakeland Regional Medical Center (FL) Northeast Pathologists, Inc. (MO) St. Thomas More Hospital (CO)
Gundersen Lutheran Medical Center (WI) Lancaster General Hospital (PA) Northridge Hospital Medical Center (CA) Samsung Medical Center (Korea)
Haga Teaching Hospital (Netherlands) Landstuhl Regional Medical Center Northwest Texas Hospital (TX) San Francisco General Hospital-
Hagerstown Medical Laboratory (MD) (APO, AE) Northwestern Memorial Hospital (IL) University of California San
Hamad Medical Corporation (Qatar) Langlade Memorial Hospital (WI) Norton Healthcare (KY) Francisco (CA)

Sanford USP Medical Center (SD) Sunnybrook Health Science Center Union Clinical Laboratory (Taiwan) VA (Indianapolis) Medical Center (IN)
SARL Laboratoire Carron (France) (ON, Canada) United Clinical Laboratories (IA) VA (Iowa City) Medical Center (IA)
Saudi Aramco Medical (Saudi Swedish Medical Center (CO) Unity HealthCare (IA) VA (Long Beach) Medical Center (CA)
Arabia) Sydney South West Pathology Service Universita Campus Bio-Medico (Italy) VA (Miami) Medical Center (FL)
Scott Air Force Base (IL) (Australia) Universitair Ziekenhuis Antwerpen VA New Jersey Health Care System (NJ)
Scott & White Memorial Hospital Taipei Veterans General Hospital (Belgium) VA Outpatient Clinic (OH)
(TX) (Taiwan) University College Hospital (Ireland) VA (Phoenix) Medical Center (AZ)
Seoul Clinical Laboratories (Korea) Taiwan Society of Laboratory University of Alabama-Birmingham VA (San Diego) Medical Center (CA)
Seoul National University Hospital Medicine Hospital (AL) VA (Seattle) Medical Center (WA)
(Korea) Tampa General Hospital (FL) University of Arkansas for Medical Sci. VA (Tucson) Medical Center (AZ)
Seton Medical Center (CA) Temple Univ. Hospital - Parkinson Pav. (PA) (AR) Valley Health (VA)
Shamokin Area Community Hospital (PA) Texas Department of State Health University of Colorado Health Sciences Vancouver Hospital and Health
Shape Healthcare Clinic (APO, AE) Services (TX) Center (CO) Sciences Center (BC, Canada)
Sheik Kalifa Medical City (UAE) The Bermuda Hospitals Board University of Colorado Hospital Vanderbilt University Medical Center (TN)
Shore Memorial Hospital (NJ) (Bermuda) University of Illinois Medical Center (IL) Virga Jessezieukenhuis (Belgium)
Shriners Hospitals for Children (SC) The Community Hospital (OH) University of Iowa Hospitals and Clinics (IA) Virginia Regional Medical Center (MN)
Singapore General Hospital (Singapore) The Credit Valley Hospital (Canada) University of Kentucky Med. Ctr. (KY) ViroMed Laboratories (LabCorp) (MN)
SJRMC Plymouth Laboratory (IN) The Hospital for Sick Children University of Maryland Medical System WakeMed (NC)
Sonora Quest JV (AZ) (Canada) University of Medicine & Dentistry, NJ Walter Reed Army Medical Center (DC)
South Bend Medical Foundation (IN) The Michener Inst. for Applied University Hosp. (NJ) Warren Hospital (NJ)
South County Hospital (RI) Health Sciences (Canada) University of MN Medical Center - Waterbury Hospital (CT)
South Dakota State Health Laboratory (SD) The Nebraska Medical Center (NE) Fairview Waterford Regional Hospital (Ireland)
South Florida Baptist Hospital (FL) The New York Hospital Medical University of MS Medical Center (MS) Weirton Medical Center (WV)
South Miami Hospital (FL) Center of Queens (NY) University of Missouri Hospital (MO) Wellstar Cobb Hospital Laboratory (GA)
South Texas Laboratory (TX) The Ottawa Hospital (Canada) University of So. Alabama Children’s and Wellstar Douglas Hospital Laboratory (GA)
Southern Health Care Network The Permanente Medical Group Women’s Hospital (AL) Wellstar Health System (GA)
(Australia) (CA) University of the Ryukyus (Japan) Wellstar Paulding Hospital (GA)
Southwest Nova District Health The Toledo Hospital (OH) University of Virginia Medical Wellstar Windy Hill Hospital Laboratory
Authority (Canada) The University of Texas Medical Center (GA)
Specialty Laboratories, Inc. (CA) Branch (TX) University of Washington West China Second University Hospital,
Spectrum Health - Blodgett Campus (MI) Thomason Hospital (TX) U.S. Army Health Clinic – Vicenza Sichuan University (P.R. China)
Stanford Hospital and Clinics (CA) ThromboVision, Inc. (TX) (APO, AE) West Valley Medical Center Laboratory (ID)
Starke Memorial Hospital Laboratory (IN) Timmins and District Hospital U.S.A. Meddac (Pathology Division) Westchester Medical Center (NY)
State of Connecticut Department of (Canada) (MO) Wheaton Franciscan & Midwest Clinical
Public Health (CT) Touro Infirmary (LA) U.T. Health Center (TX) Laboratories (WI)
State of Washington Public Health Labs Tri-Cities Laboratory (WA) UW Hospital (WI) Wheeling Hospital (WV)
Steele Memorial Hospital (ID) Tripler Army Medical Center (HI) UZ-KUL Medical Center (Belgium) Whitehorse General Hospital (Canada)
Stillwater Medical Center (OK) Tufts New England Medical Center VA (Asheville) Medical Center (NC) William Beaumont Army Medical Center
Stirling Medical Innovations (United Hospital (MA) VA (Bay Pines) Medical Center (FL) (TX)
Kingdom) UCLA Medical Center VA (Chillicothe) Medical Center (OH) William Beaumont Hospital (MI)
Stony Brook University Hospital Clinical Laboratories (CA) VA (Cincinnati) Medical Center (OH) William Osler Health Centre (Canada)
(NY) UCSD Medical Center (CA) VA (Colmery-O’Neil) Medical Center (KS) Winchester Hospital (MA)
Stormont-Vail Regional Medical UCSF Medical Center China Basin VA (Dallas) Medical Center (TX) Wishard Health Sciences (IN)
Center (KS) (CA) VA (Dayton) Medical Center (OH) Womack Army Medical Center (NC)
Stratford General Hospital (Canada) UMass Memorial Medical Center (MA) VA (Decatur) Medical Center (GA) Women’s Health Laboratory (TX)
Sudbury Regional Hospital (Canada) UMC of Southern Nevada (NV) VA (Fayetteville) Medical Center (AR) Woodlawn Hospital (IN)
UNC Hospitals (NC) VA (Hines) Medical Center (IL) York Hospital (PA)
OFFICERS BOARD OF DIRECTORS
Robert L. Habig, PhD, Susan Blonshine, RRT, RPFT, FAARC Valerie Ng, PhD, MD
President TechEd Alameda County Medical Center/
Abbott Highland General Hospital
Maria Carballo
Gerald A. Hoeltge, MD, Health Canada Janet K.A. Nicholson, PhD
President-Elect Centers for Disease Control and Prevention
The Cleveland Clinic Foundation Russel K. Enns, PhD
Cepheid Timothy J. O’Leary, MD, PhD
W. Gregory Miller, PhD, Department of Veterans Affairs
Treasurer Mary Lou Gantzer, PhD
Virginia Commonwealth University Dade Behring Inc. Klaus E. Stinshoff, Dr.rer.nat.
Digene (Switzerland) Sàrl
Thomas L. Hearn, PhD, Lillian J. Gill, DPA
Immediate Past President FDA Center for Devices and Radiological Health Michael Thein, PhD
Centers for Disease Control and Prevention Roche Diagnostics GmbH
Prof. Naotaka Hamasaki, MD, PhD
Glen Fine, MS, MBA, Nagasaki International University James A. Thomas
Executive Vice President ASTM International


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Procedures for the Collection of Diagnostic

This document provides procedures for the collection of diagnostic specimens by

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Clinical and Laboratory Standards Institute

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Proposed Standard Approved Standard—Third Edition

Tentative Standard Approved Standard—Fourth Edition

Approved Standard Approved Standard—Fifth Edition

Approved Standard—Second Edition Approved Standard—Sixth Edition

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Area Committee on Quality Systems and Laboratory Practices

Sheila M. Woodcock, MBA, Peter L. Minetti, CQA, CQE, Stephen J. Sarewitz, MD

Margaret M. Grimes, MD Dennis J. Ernst, MT(ASCP) Melissa A. Lewis

Devery Howerton, PhD Steven I. Gutman, MD, MBA

Dennis J. Ernst, MT(ASCP), Chairholder Albert Rabinovitch, MD, PhD

Lisa O. Ballance, BSMT(ASCP) Susan S. Smith

Roger R. Calam, PhD, DABCC Diane I. Szamosi, MA, MT(ASCP)SH

Ruth McCall, MT(ASCP) David J. Warunek, PhD, MBA

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Committee Membership........................................................................................................................ iii

Foreword .............................................................................................................................................. vii

5 Factors That Affect Laboratory Values ..................................................................................... 2

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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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Accession, blood specimen, phlebotomist, venipuncture

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Procedures for the Collection of Diagnostic Blood Specimens by

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5 Factors That Affect Laboratory Values

6.1 Venipuncture Chairs

6.2 Hospital Area

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

6.2.1 Central Desk

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6.2.2 Cart Area

The cart area is constructed to allow easy access to the supplies.

6.2.3 Storage Area

6.2.4 Counter Space

6.2.5 Sampling Time Recorder

7.1 Utility Carts

7.2 Blood Collecting Trays

Disposable latex, vinyl, polyethylene, or nitrile gloves provide barrier protection.

7.4 Needles and Holders

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7.5 Sterile Syringes

7.6 Venous Blood Collection Tubes

Tourniquets or products for use as tourniquets should be available. Examples include:

• Single-use disposable tourniquet, preferably latex-free (see above).

• 70% isopropyl or ethyl alcohol;

• nonalcohol-based cleanser for blood alcohol specimens (eg, chlorhexidine).

7.9 Gauze Pads

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7.10 Puncture-Resistant Disposal Container

7.13 Warming Devices

7.14 Test Reference Manual