3.guía CLSI Documento H3 - A6 [PDF]

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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.



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Clinical and Laboratory Standards Institute Advancing Quality in Health Care Testing Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related health care issues. Our process is based on the principle that consensus is an effective and cost-effective way to improve patient testing and health care services. In addition to developing and promoting the use of voluntary consensus standards and guidelines, we provide an open and unbiased forum to address critical issues affecting the quality of patient testing and health care. PUBLICATIONS A document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs.



Most documents are subject to two levels of consensus— “proposed” and “approved.” Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate consensus level. Proposed A consensus document undergoes the first stage of review by the health care community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a line-by-line review of its technical and editorial content. Approved An approved standard or guideline has achieved consensus within the health care community. It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (ie, that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents. Our standards and guidelines represent a consensus opinion on good practices and reflect the substantial agreement by materially affected, competent, and interested parties obtained by following CLSI’s established consensus procedures. Provisions in CLSI standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations. COMMENTS



The CLSI voluntary consensus process is a protocol establishing formal criteria for:



The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document. All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA.



•



the authorization of a project



VOLUNTEER PARTICIPATION



•



the development and open review of documents



•



the revision of documents in response to comments by users



•



the acceptance of a document as a consensus standard or guideline.



Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS



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Health care professionals in all specialties are urged to volunteer for participation in CLSI projects. Please contact us at [email protected] or +610.688.0100 for additional information on committee participation.



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Volume 27 Number 26



H3-A6 ISBN 1-56238-650-6 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: [email protected]; Website: www.clsi.org



(Formerly NCCLS)



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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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Committee Membership Area Committee on Quality Systems and Laboratory Practices Sheila M. Woodcock, MBA, FCSMLS(D) Chairholder QSE Consulting Rose Bay, Nova Scotia, Canada Albert Rabinovitch, MD, PhD Vice-Chairholder Abbott Hematology Santa Clara, California Eric Arendash, MT(ASCP) Centers for Medicare & Medicaid Services Philadelphia, Pennsylvania



Peter L. Minetti, CQA, CQE, CQMgr(ASQ) Fujirebio Diagnostics, Inc. Malvern, Pennsylvania Carl D. Mottram, BA, RRT, RPFT, FAARC Mayo Clinic Rochester, Minnesota Bruce D. Tually, BAppSc, MAppSc Hunter Area Pathology Service New South Wales, Australia Advisors



Lucia M. Berte, MA, MT(ASCP)SBB, DLM; CQA(ASQ) CQM Quality Systems Consultant Broomfield, Colorado



Eileen Carreiro-Lewandowski, CLS(NCA) University of Massachusetts N. Dartmouth, Massachusetts



Theresa Billups, MBA, MT(ASCP)DLM Remel, Inc. Lake Charles, Louisiana



Kay M. Creed Bon Secours Health Partners Laboratories Richmond, Virginia



Margaret M. Grimes, MD Medical College of Virginia Campus Richmond, Virginia



Dennis J. Ernst, MT(ASCP) Center for Phlebotomy Education Ramsey, Indiana



Devery Howerton, PhD Centers for Disease Control and Prevention Atlanta, Georgia



Steven I. Gutman, MD, MBA FDA Ctr. for Devices/Rad. Health Rockville, Maryland



Stephen J. Sarewitz, MD Valley Medical Center Renton, Washington Jennifer Schiffgens, MBA, MT(ASCP) California Pacific Medical Center San Francisco, California Daniel W. Tholen, MS Dan Tholen Statistical Consulting Traverse City, Michigan Staff Clinical and Laboratory Standards Institute Wayne, Pennsylvania Lois M. Schmidt, DA Vice President, Standards Development and Marketing Jennifer K. McGeary, MT(ASCP), MSHA Staff Liaison Melissa A. Lewis Editor



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 Center for Phlebotomy Education



Albert Rabinovitch, MD, PhD Abbott Hematology



Lisa O. Ballance, BSMT(ASCP) North Carolina State Laboratory of Public Health



Susan S. Smith Sarstedt, Inc.



Roger R. Calam, PhD, DABCC St. John Hospital and Medical Center



Diane I. Szamosi, MA, MT(ASCP)SH Greiner Bio-One, North America Preanalytics



Ruth McCall, MT(ASCP) Central New Mexico Community College (Retired)



David J. Warunek, PhD, MBA BD Diagnostics – Preanalytical Systems



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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 6.2



7



Supplies ...................................................................................................................................... 3 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13 7.14



8



Venipuncture Chairs ..................................................................................................... 2 Hospital Area ................................................................................................................ 2 Utility Carts................................................................................................................... 3 Blood Collecting Trays ................................................................................................. 3 Gloves ........................................................................................................................... 3 Needles and Holders ..................................................................................................... 3 Sterile Syringes ............................................................................................................. 4 Venous Blood Collection Tubes ................................................................................... 4 Tourniquets ................................................................................................................... 4 Antiseptics .................................................................................................................... 4 Gauze Pads .................................................................................................................... 4 Puncture-Resistant Disposal Container......................................................................... 5 Ice ................................................................................................................................. 5 Bandages ....................................................................................................................... 5 Warming Devices .........................................................................................................5 Test Reference Manual ................................................................................................. 5



Venipuncture Procedure............................................................................................................. 5 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10 8.11 8.12 8.13 8.14



Step 1: Prepare Accession Order ................................................................................. 6 Step 2: Approach and Identify the Patient; Sanitize Hands ......................................... 6 Step 3: Verify Patient Diet Restrictions and Latex Sensitivity .................................... 8 Step 4: Assemble Supplies ........................................................................................... 8 Step 5: Position Patient ................................................................................................ 9 Step 6: Apply Tourniquet .......................................................................................... 10 Step 7: Put On Gloves ................................................................................................ 13 Step 8: Cleanse Venipuncture Site ............................................................................. 13 Step 9: Perform Venipuncture ................................................................................... 14 Step 10: Order of Draw .............................................................................................. 17 Step 11: Release the Tourniquet ................................................................................ 18 Step 12: Place the Gauze Pad..................................................................................... 18 Step 13: Remove and Dispose of the Needle ............................................................. 18 Step 14: Bandage the Arm ......................................................................................... 18 v



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Contents (Continued) 8.15 8.16 8.17 9



Venipuncture in Children and Difficult Collections ................................................................ 20 9.1 9.2



10



Procedure .................................................................................................................... 20 Equipment ................................................................................................................... 20



Additional Considerations ....................................................................................................... 20 10.1 10.2 10.3 10.4



11



Step 15: Label Blood Collection Tubes and Record Time of Collection .................. 18 Step 16: Observe Special Handling if Required ........................................................ 19 Step 17: Send Blood Collection Tubes to the Proper Laboratories ........................... 19



Monitoring Blood Volume Collected ......................................................................... 20 Hematoma ................................................................................................................... 20 Hemolysis ................................................................................................................... 20 Nerve Damage ............................................................................................................ 21



Special Situations ..................................................................................................................... 21 11.1 11.2 11.3 11.4 11.5 11.6 11.7



Timed Intervals ........................................................................................................... 21 Specific Collection Techniques .................................................................................. 21 Indwelling Lines, Heparin or Saline Locks, Vascular Access Devices (VADs) ........ 22 Fistula ......................................................................................................................... 22 IV Fluids ..................................................................................................................... 23 Isolation ...................................................................................................................... 24 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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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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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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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. 2 This document is protected by copyright. Downloaded on 2/23/2009



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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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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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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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•



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. 6 This document is protected by copyright. Downloaded on 2/23/2009



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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: •



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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 (1)



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Procedure for Seating Patient 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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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. 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. 10 This document is protected by copyright. Downloaded on 2/23/2009



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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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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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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. For Blood Culture Collection



In order to minimize the risk of contamination with skin flora, blood culture collection sites require a 30to 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 8.9.1



Step 9: Perform Venipuncture 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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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. Philadelphia, PA: Lippincott Williams & Wilkins; 2008. Reprinted with permission from Lippincott Williams & Wilkins. http://lww.com.)



contributed by the Center for Phlebotomy Education, Inc.)



(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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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) (2) (3) (4) (5) (6)



Blood culture tube Coagulation tube (eg, blue closure) Serum tube with or without clot activator, with or without gel (eg, red closure) Heparin tube with or without gel plasma separator (eg, green closure) EDTA tube with or without gel separator (eg, lavender closure, pearl closure) 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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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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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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•



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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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 deadspace 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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(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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(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.



(4)



Notify the designated first-aid trained personnel.



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.



(3)



Notify the designated first-aid trained personnel.



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.



(2)



Notify the designated first-aid trained personnel.



11.7.5 Incident Reports Incident reports should be filed according to institutional policy.



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References 1



Nevalainen D, Berte L, Kraft C, Leigh E, Morgan T. Evaluating laboratory performance on quality indicators with the six sigma scale. Arch Pathol Lab Med. 2000;124:516-519.



2



Garner JS, Hospital Infection Control Practices Advisory Committee. Guideline for isolation precautions in hospitals. Infect Control Hosp Epidemiol. 1996;17(1):53-80.



3



CLSI. Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Third Edition. CLSI document M29-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2005.



4



Ladenson JH. Nonanalytical sources of variation. In: Gradwohl’s Clinical Laboratory Methods. 8th ed. St. Louis, MO: C.V. Mosby Co.; 1980:149-193.



5



Guder WG, Narayanan S, Wisser H, Zawata B. Samples: From the patient to the laboratory. Git Verlag GMBH. 1996.



6



Liss GM, Sussman GL, Deal K, et al. Latex allergy: epidemiological study of 1351 hospital workers. Occup Environ Med. 1997;54:335-342.



7



Preventing Allergic Reactions to Natural Rubber Latex in the Workplace. The National Institute for Occupational Safety and Health (NIOSH). DHHS (NIOSH) Publication No. 97-135. 1997.



8



Baur X, Ammon J, Chen Z, Beckmann U, Czuppon AB. Health risk in hospitals through airborne allergens for patients presensitized to latex. Lancet. 1993;342:1148-1149.



9



Yassin MS, Lierl MB, Fischer TJ, O’Brien K, Cross J, Steinmetz C. Latex allergy in hospital employees. Ann Allergy. 1994;72:245-249.



10



Mendyka BE, Clochesy JM, Workman ML. Latex hypersensitivity: an iatrogenic and occupational risk. Am J Crit Care. 1994;3:198-201.



11



CLSI/NCCLS. Tubes and Additives for Venous Blood Specimen Collection; Approved Standard—Fifth Edition. CLSI/NCCLS document H1-A5. Wayne, PA: NCCLS; 2003.



12



Miller JM, Holmes HT. Specimen collection, transport and storage. In: Murray PR, ed. Manual of Clinical Microbiology. 7th ed. Washington, D.C.: ASM Press; 1999.



13



CDC. Guideline for hand hygiene in healthcare settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR. 2002;51(RR16):31-34.



14



AABB. Technical Methods and Procedures of the American Association of Blood Banks. 15th ed. Philadelphia: J.B. Lippincott Company; 2005.



15



Becan-McBride K. Preanalytical phase an important requisite of laboratory testing. Adv Med Lab Prof. 1998;12-17.



16



US Department of Labor and Occupational Safety and Health Administration (OSHA). Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens. Washington, DC: OSHA; Nov. 27, 2001. OSHA Instruction CPL2-2.69.



17



Baer D, Ernst D, Willeford S, Gambino R. Investigating elevated potassium values. MLO. 2006;38(11):24-31.



18



Young D. Effects of Preanalytical Variables on Clinical Laboratory Tests. Washington, DC: AACC Press; 1997.



19



Kovanda B. Multiskilling: Phlebotomy Collection Procedures for the Health Care Provider. Albany, NY: Delmar; 1998.



20



Ernst C, Ernst D. Phlebotomy for Nurses and Nursing Personnel. Ramsey, IN: HealthStar Press; 2001.



21



Sommer S, Warekois R. Phlebotomy Worktext and Procedures Manual. Philadelphia, PA: W.B. Saunders; 2002.



22



Savage R, ed. Q&A. CAP Today. May 1995:63-4.



23



Read DC, Viera H, Arkin CF. Effect of drawing blood specimens proximal to an in-place but discontinued intravenous solution: can blood be drawn above the site of a shut-off IV? Am J Clin Path. 1988;906:702-706.



24



Netter F. Atlas of Human Anatomy. 4th ed. Philadelphia, PA: Saunders; 2006.



25



Abrahams P, Marks S, Hutchings R. Color Atlas of Human Anatomy. 5th ed. St. Louis, MO: Mosby; 2002.



26



Sloan E. Nerve injuries in the hand. Emer Med Clin North Amer. 1993;11(3):651-670.



27



Ernst D. Applied Phlebotomy. Philadelphia, PA: Lippincott Williams & Wilkins; 2005.



28



Ernst D. Phlebotomy on trial. MLO. 1999;31(4):46-50.



29



Ernst D. Four indefensible phlebotomy errors. J Healthcare Risk Mgmnt. 1998;18(2):41-45.



30



Ernst D. Phlebotomy meets the law. Adv Lab Admin. 2001;10(8):27.



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This document is protected by copyright. Downloaded on 2/23/2009



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31



Ernst D. Reduce your risk when you draw blood. RN. 1999;62(12):65,68.



32



Garza D, Becan-McBride K. Phlebotomy Handbook. Appleton & Lange; 1999.



33



Masoorli S, Angeles T, Barbone M. Danger points. How to prevent nerve injuries from venipuncture. Nursing. 1998;35-39.



34



McCall R, Tankersley C. Phlebotomy Essentials. Philadelphia, PA: Lippincott Williams & Wilkins; 2002.



35



Avoiding Phlebotomy Related Lawsuits (video). Available at: www.phlebotomy.com. Ramsey, IN: Center for Phlebotomy Education, Inc.; 2004.



36



Newman B, Waxman D. Blood donation-related neurologic injury: evaluation of 2 years’ worth of data from a large blood center. Transfusion. 1996;36:213-215.



37



Horowitz S. Venipuncture-induced causalgia: anatomic relations of upper extremity superficial veins and nerves, and clinical considerations. Transfusion. 2000;40:1036-1040.



38



Berry P, Wallis W. Venepuncture nerve injuries. Lancet. 1977;1:1236-1237.



39



Roberge R, McLane M. Compartment syndrome after simple venipuncture in an anticoagulated patient. J Emer Med. 1999;17(4):647-649.



40



Pansky B, House E. Review of Gross Anatomy. 2nd ed. London: MacMillan; 1969:206.



41



Strasinger SK, DiLorenzo MS. The Phlebotomy Workbook. 2nd edition. Philadelphia, PA: FA Davis Company; 2003.



42



Mbamalu D, Banerjee A. Review: Classic techniques in medicine; Methods of obtaining peripheral venous access in difficult situations. Postgrad Med J. 1999;75:459-462.



43



Statland BE, Winkel P. Effects of preanalytical factors on the intraindividual variation of analytes in the blood of healthy subjects: Consideration of preparation of the subject and time of venipuncture. CRC Crit Rev Clin Lab Sci. 1977;2:105-144.



44



Calfee D, Farr B. Comparison of four antiseptic preparations for skin in the prevention of contamination of percutaneously drawn blood cultures: a randomized trial. J Clin Microbiol. 2002;40(5):1660-1665.



45



Bates DW, Goldman L, Lee TH. Contaminant blood cultures and resource utilization: the true consequences of false-positive results. JAMA. 1991;265:365-369.



46



Schifman RB, Pindur A. The effect of skin disinfection materials on reducing blood culture contamination. Am J Clin Pathol. 1993;99:536-538.



47



Strand CL, Wajsbort RR, Sturmann K. Effect of iodophor vs iodine tincture skin preparation on blood culture contamination rate. JAMA. 1993;269:1004-1006.



48



Guidi GC, et al. Venous blood stasis during venipuncture influences routine hematologic testing. Clin Chem. 2006;52(Suppl):A24-A25.



49



Lippi G, Salvagno GL, Solero GP, Guidi GC. The influence of the tourniquet time on hematologic testing for antidoping purposes. Int J Sports Med. 2005;26:1-4.



50



Calam RR, Cooper MH. Recommended “order of draw” for collecting blood specimens into additive-containing tubes. Clin Chem. 1982;28:1399.



51



Ernst DJ, Calam RR. NCCLS simplifies the order of draw: a brief history. MLO. 2004;36:26.



52



Gottfried EL, Adachi MM. Prothrombin time (PT) and activated partial thromboplastin time (APTT) can be performed on the first tube. Am J Clin Pathol. 1997;107:681-683.



53



Yawn BP, Loge C, Dale JC. Prothrombin time. One tube or two? Am J Clin Pathol. 1996;105:794-797.



54



Bamberg R, Cottle J, Williams J. Effect of drawing a discard tube on PT and APTT results in healthy adults. Clinic Lab Sci. 2003;161:16-19.



55



McGlasson DL, More L, Best HA, Norris WL, Doe RH, Ray H. Drawing specimens for coagulation testing: Is a second tube necessary? Clin Lab Sci. 1999;12(3):137-139.



56



Serin E, Bugdayei G. Effect of tube filling order on specific coagulation parameters in health subjects. Lab Med. 2007; 38: 556-558.



57



CLSI/NCCLS. Procedures for the Handling and Processing of Blood Specimens; Approved Guideline—Third Edition. CLSI/NCCLS document H18-A3. Wayne, PA: NCCLS; 2004.



58



Young DS, Bermes EW. Specimen collection and processing: Sources of biological variation. In: Tietz NS, ed. Textbook of Clinical Chemistry. Philadelphia, PA: WB Saunders; 1986:494.



59



CLSI/NCCLS. Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Fifth Edition. CLSI/NCCLS document H4-A5. Wayne, PA: NCCLS; 2004.



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60



Miller ES. Blood lost because of phlebotomy. N Engl J Med. 1975;292:319.



61



Nexo E, Christensen NC, Olesen H. Volume of blood removed for analytical purposes during hospitalization of low-birthweight infants. Clin Chem. 1981;27:759-761.



62



VanNewkirk LE, et al. Impact of reducing blood sample size on the incidence of transfusion in a neonatal ICU. Lab Med. 1998;29:306-310.



63



Smoller BR, Kruskall MS, Horowitz GL. Reducing adult phlebotomy blood loss with the use of pediatric-sized blood collection tubes. Am J Clin Pathol. 1989;91:701-703.



64



Hashimoto F. Bleeding less for diagnostics. JAMA. 1982;248:171.



65



Eyster E, Bernene J. Nosocomial anemia. JAMA. 1973;223:73-74.



66



Dale JC, Pruett SK. Phlebotomy – a minimalistic approach. Mayo Clin Proc. 1993;68:249-255.



67



Burns ER, Yoshikawa N. Hemolysis in serum samples drawn by emergency department personnel versus laboratory phlebotomists. Lab Med. 2002;33:378-380.



68



Dubowski KM, Essary NA. Contamination of blood specimens for alcohol analysis during collection. Abst Rev Alcohol Driving. 1983;4:3-7.



69



Peek GJ, Marsh A, Keating J, Ward RJ, Peters TJ. The effects of swabbing the skin on apparent blood ethanol concentration. Alcohol Alcohol. 1990;25:639-640.



70



Jones AW. Severe isopropanolemia without acetonemia: contamination of specimens during venipuncture? Clin Chem. 1995;41:123.



71



Williams RH, Leikin JB. Medicolegal issues and specimen collection for ethanol testing. Lab Med. 1999;30:530-537.



72



CLSI/NCCLS. Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline. CLSI/NCCLS document T/DM6-A. Wayne, PA: NCCLS; 1997.



73



CLSI. Principles and Procedures for Blood Cultures; Approved Guideline. CLSI document M47-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2007.



74



CLSI/NCCLS. Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline. CLSI/NCCLS document C38-A. Wayne, PA: NCCLS; 1997.



75



DesJardin JA, Falagas ME, Ruthazer R, et al. Clinical utility of blood cultures drawn from indwelling central venous catheters in hospitalized patients with cancer. Ann Int Med. 1999;131:641-647.



76



Laxson CJ, Titler MG. Drawing coagulation studies from arterial lines: an integrative literature review. Am J Crit Care. 1994;1:16-24.



77



Soong WJ, Hwang B. Contamination errors when sampling blood from an arterial line. Clin Pediatr. 1993;328:501.



78



Templin K, Shively M, Riley J. Accuracy of drawing coagulation samples from heparinized arterial lines. Amer J Crit Care. 1993;1:88.



79



Ruge DG, Sandin RL, Siegelski SA, Greene JN, Johnson N. Reduction of blood culture contamination rates by establishment of policy for central intravenous catheters. Lab Med. 2002;33:797-800.



80



Clapham MC, Willis N, Mapleson WW. Minimum volume of discard for valid blood sampling from indwelling arterial cannulae. Br J Anaesth. 1987;59:232-235.



81



Molyneaux RD, Papciak B, Rorem DA. Coagulation studies and the indwelling heparinized catheter. Heart Lung. 1987;16:20-23.



82



Rudisill PT, Moore LA. Relationship between arterial and venous activated partial thromboplastin time values in patients after percutaneous transluminal coronary angioplasty. Heart Lung. 1989;18:514-519.



83



CLSI/NCCLS. Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline—Fourth Edition. CLSI/NCCLS document H21-A4. Wayne, PA: NCCLS; 2003.



84



Ong YY, Boykin SF, Barnett RN. You can draw blood from the “IV” arm below the intravenous needle if you put a tourniquet in between. Am J Clin Path. 1979;72:101-102.



85



Watson KR, O’Kell RT, Joyce JT. Data regarding blood drawing sites in patients receiving intravenous solutions. Am J Clin Path. 1983;79:119-120.



86



Dale JC, Pruett SK, Maker MD. Accidental needlesticks in the phlebotomy service of the department of laboratory medicine and pathology at Mayo Clinic Rochester. Mayo Clin Proc. 1998;73:611-615.



87



Pruett S. Needle-stick safety for phlebotomists. Lab Med. 1998;29:754-760.



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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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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: Clinical and Laboratory Standards Institute. All rights reserved.



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“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? •



See the response to comment 14 above.



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. •



See the response to comment 14 above.



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? •



See the response to comment 14 above.



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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. •



See the response to comment 14 above.



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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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.” •



See the response to comment 28 above.



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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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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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.



•



The working group agrees. The text has been modified.



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Section 8.4.4.1, Venous Blood Collection Systems 8.



Second paragraph, second sentence: typographical error—missing closing bracket.



•



This editorial correction has been made.



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.



•



This editorial correction has been made.



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. Clinical and Laboratory Standards Institute. All rights reserved.



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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. •



The working group agrees. The text has been modified.



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. •



The working group agrees. The text has been modified.



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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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. •



The working group agrees. The text has been modified.



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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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 Organization Personnel



Equipment Purchasing & Inventory Process Control



Information Management Occurrence Management Assessments―External & Internal



Process Improvement Customer Service Facilities & Safety



H11



H11



H11



X H1 H4 H11 H18 H21



X H1 T/DM6



H1



H11



Facilities & Safety



Customer Service



Process Improvement



Assessments— External & Internal



Occurrence Management



Information Management



Process Control



Purchasing & Inventory



Equipment



Personnel



Organization



Documents & Records



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.



X H11 M29



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.



X H11



X H1 H11 H21



X C38 H4 H11 H18 H21



X C38 H4 H11



X H18



Sample management



Postexamination Results reporting and archiving



Interpretation



Results review and follow-up



Examination



Examination Sample receipt/ processing



Sample transport



Sample collection



Examination ordering



Preexamination



X T/DM6



Adapted from CLSI/NCCLS document HS1—A Quality System Model for Health Care.



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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. ©



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Active Membership (as of 1 October 2007) Sustaining Members Abbott American Association for Clinical Chemistry AstraZeneca Pharmaceuticals Bayer Corporation BD Beckman Coulter, Inc. bioMérieux, Inc. CLMA College of American Pathologists GlaxoSmithKline Ortho-Clinical Diagnostics, Inc. Pfizer Inc Roche Diagnostics, Inc.



National Center of Infectious and Parasitic Diseases (Bulgaria) National Health Laboratory Service (South Africa) National Institute of Standards and Technology National Pathology Accreditation Advisory Council (Australia) New York State Department of Health Ontario Ministry of Health Pennsylvania Dept. of Health Saskatchewan Health-Provincial Laboratory Scientific Institute of Public Health University of Iowa, Hygienic Lab Industry Members



Professional Members American Academy of Family Physicians American Association for Clinical Chemistry American Association for Laboratory Accreditation American Association for Respiratory Care American Chemical Society American College of Medical Genetics American Medical Technologists American Society for Clinical Laboratory Science American Society for Microbiology American Type Culture Collection ASCP Associazione Microbiologi Clinici Italiani (AMCLI) Canadian Society for Medical Laboratory Science COLA College of American Pathologists College of Medical Laboratory Technologists of Ontario College of Physicians and Surgeons of Saskatchewan Elkin Simson Consulting Services ESCMID Family Health International Hong Kong Accreditation Service Innovation and Technology Commission International Federation of Biomedical Laboratory Science International Federation of Clinical Chemistry Italian Society of Clinical Biochemistry and Clinical Molecular Biology JCAHO JCCLS National Society for Histotechnology, Inc. Ontario Medical Association Quality Management Program-Laboratory Service RCPA Quality Assurance Programs PTY Limited SDS Pathology SIMeL Sociedad Espanola de Bioquimica Clinica y Patologia Molecular Sociedade Brasileira de Analises Clinicas Sociedade Brasileira de Patologia Clinica Turkish Society of Microbiology Washington G2 Reports World Health Organization Government Members Association of Public Health Laboratories BC Centre for Disease Control Centers for Disease Control and Prevention Centers for Disease Control and Prevention – Tanzania Centers for Medicare & Medicaid Services Centers for Medicare & Medicaid Services/CLIA Program Chinese Committee for Clinical Laboratory Standards FDA Center for Devices and Radiological Health FDA Center for Veterinary Medicine Health Canada Massachusetts Department of Public Health Laboratories Ministry of Health and Social Welfare Tanzania



3M Medical Division AB Biodisk Abbott Abbott Diabetes Care Abbott Molecular Inc. Abbott Point of Care Inc. Access Genetics Acupath AdvaMed Advanced Liquid Logic Advancis Pharmaceutical Corporation Advantage Bio Consultants, Inc. Affymetrix, Inc. (Santa Clara, CA) Affymetrix, Inc. (W. Sacramento, CA) Agilent Technologies/Molecular Diagnostics Ammirati Regulatory Consulting Anapharm, Inc. Anna Longwell, PC Aptium Oncology Arpida Ltd A/S Rosco Astellas Pharma AstraZeneca Pharmaceuticals Aviir, Inc. Axis-Shield PoC AS Bayer Corporation – West Haven, CT Bayer HealthCare, LLC, Diagnostics Div. – Elkhart, IN BD BD Biosciences – San Jose, CA BD Diagnostic Systems BD Vacutainer Systems Beckman Coulter, Inc. Beth Goldstein Consultant (PA) Bioanalyse, Ltd. Bio-Development S.r.l. Biomedia Laboratories SDN BHD bioMérieux, Inc. (MO) bioMérieux, Inc. (NC) Bio-Rad Laboratories, Inc. – France Bio-Rad Laboratories, Inc. – Irvine, CA Bio-Rad Laboratories, Inc. – Plano, TX Blaine Healthcare Associates, Inc. Braun Biosystems, Inc. Canon U.S. Life Sciences, Inc. Cempra Pharmaceuticals, Inc. Center for Measurement Standards/ITRI Cepheid Chen & Chen, LLC (IQUUM) Comprehensive Cytometric Consulting Control Lab Copan Diagnostics Inc. Cosmetic Ingredient Review Cubist Pharmaceuticals Cumbre Inc. Dade Behring Inc. – Cupertino, CA Dade Behring Inc. – Deerfield, IL Dade Behring Inc. – Glasgow (Newark, DE) Dade Behring Inc. Marburg GmbH (Germany) Dade Behring Inc. – Sacramento, CA Dahl-Chase Pathology Associates PA David G. Rhoads Associates, Inc. Diagnostic Products Corporation Diagnostica Stago Docro, Inc. DX Tech Eiken Chemical Company, Ltd. Elanco Animal Health Electa Lab s.r.l. Eurofins Medinet Future Diagnostics B.V. Genomic Health, Inc. Gen-Probe Genzyme Clinical Specialty Laboratory Genzyme Diagnostics GlaxoSmithKline GlucoTec, Inc. Greiner Bio-One Inc.



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HistoGenex N.V. Immunicon Corporation Instrumentation Laboratory Japan Assn. of Clinical Reagents Industries Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Kaiser Permanente K.C.J. Enterprises Laboratory Specialists, Inc. LifeScan, Inc. (a Johnson & Johnson Company) Maine Standards Company, LLC Medical Device Consultants, Inc. Merck & Company, Inc. Micromyx, LLC MicroPhage Monogen, Inc. MultiPhase Solutions, Inc. Nanogen Nanogen, Point-of-Care Diagnostics Div. Nihon Koden Corporation Nissui Pharmaceutical Co., Ltd. NJK & Associates, Inc. NovaBiotics (Aberdeen, UK) Novartis Institutes for Biomedical Research Nucryst Pharmaceuticals Olympus America, Inc. Optimer Pharmaceuticals, Inc. Orion Genomics, LLC Ortho-Clinical Diagnostics, Inc. (Rochester, NY) Oxonica (UK) Panaceapharma Pharmaceuticals Paratek Pharmaceuticals, Inc. Pathology Services Inc. Pathwork Diagnostics Pfizer Animal Health Pfizer Inc Phadia AB PlaCor, Inc Powers Consulting Services ProSource Consulting, Inc. QSE Consulting Radiometer America, Inc. RCC CIDA S. A. Replidyne Rib-X Pharmaceuticals Roche Diagnostics GmbH Roche Diagnostics, Inc. Roche Diagnostics Ltd Roche Molecular Systems Sanofi Pasteur Sarstedt, Inc. Schering Corporation Seneca Medical, Inc. Sequenom, Inc. Siemens Medical Solutions Diagnostics Sphere Medical Holding Limited Stirling Medical Innovations Streck Laboratories, Inc. Sysmex America, Inc. (Mundelein, IL) Sysmex Corporation (Japan) Tethys Bioscience, Inc. The Clinical Microbiology Institute TheraDoc Therapeutic Monitoring Services, LLC Theravance Inc. Third Wave Technologies, Inc. Thrombodyne, Inc. Transasia Bio-Medicals Limited Trek Diagnostic Systems Watin-Biolife Diagnostics and Medicals Wyeth Research XDX, Inc. YD Consultant Trade Associations AdvaMed Japan Association of Clinical Reagents Industries (Tokyo, Japan) Associate Active Members 3rd Medical Group (AK) 5th Medical Group/SGSL (ND) 22 MDSS (KS) 48th Medical Group/MDSS (APO, AE) 59th MDW/859th MDTS/MTL Wilford Hall Medical Center (TX) Acadiana Medical Labs, Ltd ACL Laboratories (IL) ACL Laboratories (WI) Adams County Hospital (OH) Air Force Institute for Operational Health (TX) Akron’s Children’s Hospital (OH)



Alameda County Medical Center Albany Medical Center Hospital (NY) Albemarle Hospital (NC) Alfred I. du Pont Hospital for Children All Children’s Hospital (FL) Allegheny General Hospital (PA) Alta Bates Summit Medical Center (CA) American Hospital Dubai (UAE) American University of Beirut Medical Center (NY) Anne Arundel Medical Center (MD) Antelope Valley Hospital District (CA) Arkansas Dept of Health Arkansas Methodist Medical Center (AR) Arnett Clinic, LLC (IN) Asan Medical Center (Seoul) Asante Health System (OR) Asiri Group of Hospitals Ltd. Asociacion Espanola Primera de Socorros Mutuos (Uruguay) Aspirus Wausau Hospital (WI) Atlantic Health Sciences Corp. Augusta Medical Center (VA) Aultman Hospital (OH) Azienda Ospedale Di Lecco (Italy) Baptist Hospital for Women (TN) Baptist Hospital of Miami (FL) Bassett Army Community Hospital (AK) Bay Regional Medical Center (MI) BayCare Health System (FL) Baylor Health Care System (TX) Baystate Medical Center (MA) B.B.A.G. Ve U. AS., Duzen Laboratories (Turkey) BC Biomedical Laboratories (Surrey, BC, Canada) Beebe Medical Center (DE) Belfast HSS Trust, Royal Victoria Hospital (Belfast) Beloit Memorial Hospital (WI) Bonnyville Health Center (Canada) Boston Medical Center (MA) Boulder Community Hospital (CO) Brantford General Hospital (CT) Bridgeport Hospital (CT) British Columbia Cancer Agency – Vancouver Cancer Center (BC, Canada) Bronson Methodist Hospital (MI) Broward General Medical Center (FL) Cadham Provincial Laboratory – MB Health (Canada) Calgary Laboratory Services (Calgary, AB, Canada) California Pacific Medical Center (CA) Cambridge Health Alliance (MA) Camden Clark Memorial Hospital (WV) Cape Breton Healthcare Complex (Canada) Cape Cod Hospital (MA) Cape Fear Valley Medical Center Laboratory (NC) Capital Health/QE II Health Sciences Centre (Nova Scotia) Capital Health - Regional Laboratory Services (Canada) Capital Health System Fuld (NJ) Capital Health System Mercer Campus (NJ) Carpermor S.A. de C.V. (Mexico) Catholic Health Initiatives (KY) Cavan General Hospital (Ireland) CDC/HIV (APO, AP) Central Arkansas Veterans Healthcare System (AR) Central Baptist Hospital (KY) Central Kansas Medical Center (KS) Central Processing & Receiving (BC) Central Texas Veterans Health Care System (TX) Centralized Laboratory Services (NY) Centre Hospitalier Anna-Laberge (Canada) Centura – Villa Pueblo (CO) Chaleur Regional Hospital (Canada) Chang Gung Memorial Hospital (Taiwan) Changhua Christian Hospital (Taiwan) Chesapeake General Hospital (VA) Chester County Hospital (PA) Children’s Healthcare of Atlanta (GA) Children’s Hospital (OH) Children’s Hospital & Research Center at Oakland (CA) Children’s Hospital Medical Center (OH) Children’s Memorial Hospital (IL) Childrens Hosp.- Kings Daughters (VA) Childrens Hospital Los Angeles (CA) Childrens Hospital of Wisconsin (WI) Chilton Memorial Hospital (NJ) Christiana Care Health Services (DE)



Product Name: Infobase 2009 - Release Date: March 2009 City of Hope National Medical Center (CA) City of Houston Dept of Health (TX) Clarian Health – Clarian Pathology Laboratory (IN) Cleveland Clinic Health System Eastern Region (OH) Clinical Labs of Hawaii (HI) CLSI Laboratories, Univ. Pittsburgh Med. Ctr. (PA) Colchester East Hants Health Authority (Canada) Commonwealth of Kentucky Community Care 5 (OH) Community Hospital (IN) Community Hospital of the Monterey Peninsula (CA) Community Memorial Hospital (WI) Connolly Hospital (Ireland) Consultants Laboratory of WI LLC (WI) Contra Costa Regional Medical Center (CA) Cook Children’s Medical Center (TX) Cork University Hospital (Ireland) Corpus Christi Medical Center (TX) Covance CLS (IN) Covance Evansville (IN) Creighton Medical Laboratories (NE) Creighton University Medical Center (NE) Cross Cancer Institute (Canada) Dahl-Chase Pathology Associates PA (ME) Darwin Library NT Territory Health Services (Australia) David Grant Medical Center (CA) Daviess Community Hospital (IN) Deaconess Medical Center (WA) Dekalb Memorial Hospital (IN) DeWitt Healthcare Network (USA Meddac) (VA) DHHS NC State Lab of Public Health (NC) Diagnostic Laboratory Services, Inc. (HI) Diagnostic Services of Manitoba (Canada) Diagnósticos da América S/A (Sao Paulo) Dianon Systems/Lab Corp. (OK) Dimensions Healthcare System (MD) Dr. Everette Chalmers Regional Hospital (NB) Driscoll Children’s Hospital (TX) DSI of Bucks County (PA) DUHS Clinical Laboratories (NC) Dundy County Hospital (NE) Durham VA Medical Center (NC) Dwight D. Eisenhower Medical Center (KS) East Central Health (Canada) East Georgia Regional Medical Center (GA) Eastern Health Pathology (Australia) Edward Hospital (IL) Effingham Hospital (GA) Eliza Coffee Memorial Hospital (AL) EMH Regional Medical Center (OH) Emory University Hospital (GA) Evangelical Community Hospital (PA) Evanston Hospital (IL) Exeter Hospital (NH) Federal Medical Center (MN) Firelands Regional Medical Center (OH) First Health of the Carolinas Moore Regional Hospital (NC) Fisher-Titus Memorial Hospital (OH) Flaget Memorial Hospital (KY) Fletcher Allen Health Care (VT) Fleury S.A. (Brazil) Florida Hospital (FL) Foote Hospital (MI) Fort St. John General Hospital (Canada) Forum Health Northside Medical Center (OH) Fox Chase Cancer Center (PA) Gamma-Dynacare Laboratories (Canada) Gamma Dynacare Medical Laboratories (Ontario, Canada) Garden City Hospital (MI) Garfield Medical Center (CA) Geisinger Medical Center (Danville, PA) Genesis Healthcare System (OH) George Washington University Hospital (DC) Good Samaritan Hospital (NE) Good Samaritan Hospital (OH) Good Shepherd Medical Center (TX) Grand Strand Reg. Medical Center (SC) Gundersen Lutheran Medical Center (WI) Haga Teaching Hospital (Netherlands) Hagerstown Medical Laboratory (MD) Hamad Medical Corporation (Qatar)



Hamilton Regional Laboratory Medicine Program (Canada) Hanover General Hospital (PA) Harford Memorial Hospital (MD) Harris Methodist Fort Worth (TX) Hartford Hospital (CT) Health Network Lab (PA) Health Partners Laboratories Bon Secours Richmond (VA) Health Waikato (New Zealand) Heartland Health (MO) Heidelberg Army Hospital (APO, AE) Hema-Quebec (Canada) Hennepin Faculty Association (MN) Henry Ford Hospital (MI) Henry Medical Center, Inc. (GA) Hi-Desert Medical Center (CA) Hoag Memorial Hospital Presbyterian (CA) Holy Cross Hospital (MD) Holy Family Medical Center (WI) Holy Spirit Hospital (PA) Hopital Cite de La Sante De Laval (Canada) Hôpital Maisonneuve - Rosemont (Montreal, Canada) Hôpital Sacré-Coeur de Montreal (Quebec, Canada) Hopital Santa Cabrini Ospedale (Canada) Hospital Albert Einstein (Brazil) Hospital de Dirino Espirito Santa (Portugal) Hôtel Dieu Grace Hospital Library (Windsor, ON, Canada) Humility of Mary Health Partners (OH) Hunter Area Pathology Service (Australia) Hunterdon Medical Center (NJ) Icon Laboratories (Ireland) IGate Clinical Research Intl., Pvt., LTD (India) Imelda Hospital (Belgium) Indiana University - Chlamydia Laboratory (IN) Institut fur Stand. und Dok. im Med. Lab. (Germany) Institut National de Santé Publique du Quebec Centre de Doc. – INSPQ (Canada) Institute Health Laboratories (PR) Institute of Clinical Pathology and Medical Research (Australia) Institute of Laboratory Medicine Landspitali Univ. Hospital (Iceland) Institute of Medical & Veterinary Science (Australia) Integrated Regional Laboratories South Florida (FL) International Health Management Associates, Inc. (IL) Ireland Army Community Hospital (KY) IWK Health Centre (Canada) Jackson Health System (FL) Jackson Hospital & Clinic, Inc. (AL) Jackson Purchase Medical Center (KY) Jacobi Medical Center (NY) John C. Lincoln Hospital (AZ) John F. Kennedy Medical Center (NJ) John H. Stroger, Jr. Hospital of Cook County (IL) John Muir Medical Center (CA) John T. Mather Memorial Hospital (NY) Johns Hopkins Medical Institutions (MD) Johns Hopkins University (MD) Johnson City Medical Center (TN) JPS Health Network (TX) Kadlec Medical Center (WA) Kaiser Permanente (CA) Kaiser Permanente (MD) Kaiser Permanente Medical Care (CA) Kangnam St. Mary’s Hospital (Korea) Keller Army Community Hospital (NY) Kenora-Rainy River Reg. Lab. Program (Canada) King Fahad National Guard Health Affairs King Abdulaziz Medical City (Saudi Arabia) King Faisal Specialist Hospital (MD) Kingston General Hospital (Canada) Kosciusko Laboratory (IN) Lab Medico Santa Luzia LTDA (Brazil) LabCorp (NC) Labette Health (KS) Laboratory Alliance of Central New York (NY) LabPlus Auckland Healthcare Services Limited (New Zealand) Lafayette General Medical Center (LA) Lakeland Regional Medical Center (FL) Lancaster General Hospital (PA) Landstuhl Regional Medical Center (APO, AE) Langlade Memorial Hospital (WI)



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Langley Air Force Base (VA) LeBonheur Children’s Medical Center (TN) Legacy Laboratory Services (OR) Lethbridge Regional Hospital (Canada) Lewis-Gale Medical Center (VA) L’Hotel-Dieu de Quebec (Quebec, Canada) Licking Memorial Hospital (OH) LifeBridge Health Sinai Hospital (MD) Loma Linda University Medical (CA) Long Beach Memorial Medical Center (CA) Los Angeles County Public Health Lab. (CA) Louis A Johnson Medical Center (WV) Louisiana State University Medical Ctr. (LA) Lourdes Hospital (KY) Madison Parish Hospital (LA) Magnolia Regional Health Center (MS) Magruder Memorial Hospital (OH) Main Line Clinical Laboratories, Inc. (PA) Manipal AcuNova (India) Marquette General Hospital (MI) Marshfield Clinic (WI) Martin Luther King, Jr. Harbor Hospital (CA) Martin Memorial Health Systems (FL) Mary Imogene Bassett Hospital (NY) Marymount Medical Center (KY) Massachusetts General Hospital (MA) Massachusetts General Hospital Division of Laboratory Medicine (MA) Maxwell Air Force Base (AL) MDS Laboratories (Canada) MDS Metro Laboratory Services (BC, Canada) Meadows Regional Medical Center (GA) Mease Countryside Hospital (FL) Mease Dunedin Hospital (FL) Medical Center Hospital (TX) Medical Center of Louisiana at NOCharity (LA) Medical Centre Ljubljana (Slovenia) Medical College of Virginia Hospital (VA) Medical Specialists (IN) Medical Univ. of South Carolina (SC) MediCorp - Mary Washington Hospital (VA) Memorial Health Center, Inc. (WI) Memorial Hermann Healthcare System (TX) Memorial Hospital (OH) Memorial Hospital Miramar (FL) Memorial Hospital Pembroke (FL) Memorial Hospital West (FL) Memorial Medical Center (PA) Memorial Regional Hospital (FL) Mercy Franciscan Mt. Airy (OH) Mercy Hospital (ME) Mercy Medical Center (CO) Mercy Medical Center (OR) Methodist Hospital (MN) Methodist Hospital (TX) Methodist Hospital Pathology (NE) Metropolitan Medical Laboratory, PLC (IA) Middletown Regional Hospital (OH) Mississippi Baptist Medical Center (MS) Mississippi Public Health Lab (MS) Monmouth Medical Center (NJ) Montefiore Medical Center (NY) Morton Plant Hospital (FL) Nassau County Medical Center (NY) National Cancer Center (S. Korea) National Cancer Institute (MD) National Healthcare Group (Singapore) National Institutes of Health, Clinical Center (MD) National Naval Medical Center (MD) National University Hospital Department of Laboratory Medicine (Singapore) Naval Hospital Great Lakes (IL) Naval Hospital Oak Harbor (WA) New England Fertility Institute (CT) New Lexington Clinic (KY) New York City Department of Health and Mental Hygiene (NY) New York-Presbyterian Hospital (NY) New York University Medical Center (NY) Newark Beth Israel Medical Center (NJ) North Bay Hospital (FL) North Carolina Baptist Hospital (NC) North Coast Clinical Laboratory, Inc. (OH) North Mississippi Medical Center (MS) North Shore Hospital Laboratory (Auckland, New Zealand) North Shore-Long Island Jewish Health System Laboratories (NY) Northeast Pathologists, Inc. (MO) Northridge Hospital Medical Center (CA) Northwest Texas Hospital (TX) Northwestern Memorial Hospital (IL) Norton Healthcare (KY)



Ochsner Clinic Foundation (LA) Ohio State University Hospitals (OH) Oklahoma Heart Hospital, LLC (OK) Onze Lieve Vrouw Ziekenhuis (Belgium) Ordre Professionel Des Technologistes Medicaux Du Quebec (Quebec) Orlando Regional Healthcare System (FL) Our Lady of Lourdes Medical Center (NJ) Our Lady of Lourdes Reg. Medical Ctr. (LA) Our Lady of the Way Hospital (KY) Our Lady’s Hospital for Sick Children (Ireland) Overlake Hospital Medical Center (WA) Pathologists Associated (IN) Pathology and Cytology Laboratories, Inc. (KY) Pathology Associates Medical Laboratories (WA) PCA Southeast (TN) Pediatrix Screening Inc. (PA) Pennsylvania Hospital (PA) Penrose St. Francis Health Services (CO) Perry County Memorial Hospital (IN) Peterborough Regional Health Centre (Canada) Physicians Reference Laboratory (KS) Pitt County Memorial Hospital (NC) PPD (KY) Presbyterian Hospital of Dallas (TX) Presbyterian/St. Luke’s Medical Center (CO) Princess Margaret Hospital (Hong Kong) Providence Health Care (Canada) Providence Medford Medical Center (OR) Provincial Health Services Authority (Vancouver, BC, Canada) Provincial Laboratory for Public Health (Edmonton, AB, Canada) Queen Elizabeth Hospital (Canada) Queensland Health Pathology Services (Australia) Quest Diagnostics, Inc Quest Diagnostics, Inc (San Juan Capistrano, CA) Quest Diagnostics JV (IN, OH, PA) Quest Diagnostics Laboratories (WA) Quintiles Laboratories, Ltd. (GA) Rady Children’s Hospital San Diego (CA) Redington-Fairview General Hospital (ME) Régie Régionale Dela Santé Beaséjour (Canada) Regional Health Authority - Central Manitoba Inc (Canada) Regional Health Authority Four (RHA4) (Canada) Regions Hospital (MN) Research Medical Center (MO) Riverside Methodist Hospital (OH) Riverview Hospital (WI) Riyadh Armed Forces Hospital, Sulaymainia (Riyadh, Saudi Arabia) Robert Wood Johnson University Hospital (NJ) Rush North Shore Medical Center (IL) SAAD Specialist Hospital (Saudi Arabia) Sahlgrenska Universitetssjukhuset (Sweden) Saint Elizabeth Regional Medical Center (NE) Saint Francis Hospital & Medical Center (CT) St. Agnes Healthcare (MD) St. Anthony Hospital (OK) St. Anthony Hospital Central Laboratory (CO) St. Anthony’s Hospital (FL) St. Barnabas Medical Center (NJ) St. Christopher’s Hospital for Children (PA) St. Francis Medical Center (MN) St. John Hospital and Medical Center (MI) St. John’s Hospital (IL) St. John’s Hospital (MO) St. John’s Hospital & Health Ctr. (CA) St. John’s Mercy Medical Center (MO) St. Joseph Medical Center (MD) St. Joseph Mercy Hospital (MI) St. Joseph’s Hospital (FL) St. Joseph’s Hospital & Health Center (ND) St. Joseph’s Medical Center (CA) St. Joseph Mercy – Oakland (MI) St. Joseph’s Regional Medical Center (NJ) St. Jude Children’s Research Hospital (TN) St. Louis University Hospital (MO) St. Luke’s Hospital (PA) St. Luke’s Hospital (FL) St. Luke’s Hospital (IA) St. Margaret Memorial Hospital (PA) St. Mary Medical Center (CA) St. Mary’s Health Center (MO) St Mary’s Healthcare (SD) St. Mary’s Hospital and Medical Center (WI) St. Mary’s Medical Center (IN) St. Michael’s Hospital Diagnostic Laboratories & Pathology (Canada) St. Thomas More Hospital (CO) Samsung Medical Center (Korea) San Francisco General HospitalUniversity of California San Francisco (CA)



Product Name: Infobase 2009 - Release Date: March 2009 Sanford USP Medical Center (SD) SARL Laboratoire Carron (France) Saudi Aramco Medical (Saudi Arabia) Scott Air Force Base (IL) Scott & White Memorial Hospital (TX) Seoul Clinical Laboratories (Korea) Seoul National University Hospital (Korea) Seton Medical Center (CA) Shamokin Area Community Hospital (PA) Shape Healthcare Clinic (APO, AE) Sheik Kalifa Medical City (UAE) Shore Memorial Hospital (NJ) Shriners Hospitals for Children (SC) Singapore General Hospital (Singapore) SJRMC Plymouth Laboratory (IN) Sonora Quest JV (AZ) South Bend Medical Foundation (IN) South County Hospital (RI) South Dakota State Health Laboratory (SD) South Florida Baptist Hospital (FL) South Miami Hospital (FL) South Texas Laboratory (TX) Southern Health Care Network (Australia) Southwest Nova District Health Authority (Canada) Specialty Laboratories, Inc. (CA) Spectrum Health - Blodgett Campus (MI) Stanford Hospital and Clinics (CA) Starke Memorial Hospital Laboratory (IN) State of Connecticut Department of Public Health (CT) State of Washington Public Health Labs Steele Memorial Hospital (ID) Stillwater Medical Center (OK) Stirling Medical Innovations (United Kingdom) Stony Brook University Hospital (NY) Stormont-Vail Regional Medical Center (KS) Stratford General Hospital (Canada) Sudbury Regional Hospital (Canada)



Sunnybrook Health Science Center (ON, Canada) Swedish Medical Center (CO) Sydney South West Pathology Service (Australia) Taipei Veterans General Hospital (Taiwan) Taiwan Society of Laboratory Medicine Tampa General Hospital (FL) Temple Univ. Hospital - Parkinson Pav. (PA) Texas Department of State Health Services (TX) The Bermuda Hospitals Board (Bermuda) The Community Hospital (OH) The Credit Valley Hospital (Canada) The Hospital for Sick Children (Canada) The Michener Inst. for Applied Health Sciences (Canada) The Nebraska Medical Center (NE) The New York Hospital Medical Center of Queens (NY) The Ottawa Hospital (Canada) The Permanente Medical Group (CA) The Toledo Hospital (OH) The University of Texas Medical Branch (TX) Thomason Hospital (TX) ThromboVision, Inc. (TX) Timmins and District Hospital (Canada) Touro Infirmary (LA) Tri-Cities Laboratory (WA) Tripler Army Medical Center (HI) Tufts New England Medical Center Hospital (MA) UCLA Medical Center Clinical Laboratories (CA) UCSD Medical Center (CA) UCSF Medical Center China Basin (CA) UMass Memorial Medical Center (MA) UMC of Southern Nevada (NV) UNC Hospitals (NC)



Union Clinical Laboratory (Taiwan) United Clinical Laboratories (IA) Unity HealthCare (IA) Universita Campus Bio-Medico (Italy) Universitair Ziekenhuis Antwerpen (Belgium) University College Hospital (Ireland) University of Alabama-Birmingham Hospital (AL) University of Arkansas for Medical Sci. (AR) University of Colorado Health Sciences Center (CO) University of Colorado Hospital University of Illinois Medical Center (IL) University of Iowa Hospitals and Clinics (IA) University of Kentucky Med. Ctr. (KY) University of Maryland Medical System University of Medicine & Dentistry, NJ University Hosp. (NJ) University of MN Medical Center Fairview University of MS Medical Center (MS) University of Missouri Hospital (MO) University of So. Alabama Children’s and Women’s Hospital (AL) University of the Ryukyus (Japan) University of Virginia Medical Center University of Washington U.S. Army Health Clinic – Vicenza (APO, AE) U.S.A. Meddac (Pathology Division) (MO) U.T. Health Center (TX) UW Hospital (WI) UZ-KUL Medical Center (Belgium) VA (Asheville) Medical Center (NC) VA (Bay Pines) Medical Center (FL) VA (Chillicothe) Medical Center (OH) VA (Cincinnati) Medical Center (OH) VA (Colmery-O’Neil) Medical Center (KS) VA (Dallas) Medical Center (TX) VA (Dayton) Medical Center (OH) VA (Decatur) Medical Center (GA) VA (Fayetteville) Medical Center (AR) VA (Hines) Medical Center (IL)



OFFICERS Robert L. Habig, PhD, President Abbott Gerald A. Hoeltge, MD, President-Elect The Cleveland Clinic Foundation W. Gregory Miller, PhD, Treasurer Virginia Commonwealth University Thomas L. Hearn, PhD, Immediate Past President Centers for Disease Control and Prevention Glen Fine, MS, MBA, Executive Vice President



VA (Indianapolis) Medical Center (IN) VA (Iowa City) Medical Center (IA) VA (Long Beach) Medical Center (CA) VA (Miami) Medical Center (FL) VA New Jersey Health Care System (NJ) VA Outpatient Clinic (OH) VA (Phoenix) Medical Center (AZ) VA (San Diego) Medical Center (CA) VA (Seattle) Medical Center (WA) VA (Tucson) Medical Center (AZ) Valley Health (VA) Vancouver Hospital and Health Sciences Center (BC, Canada) Vanderbilt University Medical Center (TN) Virga Jessezieukenhuis (Belgium) Virginia Regional Medical Center (MN) ViroMed Laboratories (LabCorp) (MN) WakeMed (NC) Walter Reed Army Medical Center (DC) Warren Hospital (NJ) Waterbury Hospital (CT) Waterford Regional Hospital (Ireland) Weirton Medical Center (WV) Wellstar Cobb Hospital Laboratory (GA) Wellstar Douglas Hospital Laboratory (GA) Wellstar Health System (GA) Wellstar Paulding Hospital (GA) Wellstar Windy Hill Hospital Laboratory (GA) West China Second University Hospital, Sichuan University (P.R. China) West Valley Medical Center Laboratory (ID) Westchester Medical Center (NY) Wheaton Franciscan & Midwest Clinical Laboratories (WI) Wheeling Hospital (WV) Whitehorse General Hospital (Canada) William Beaumont Army Medical Center (TX) William Beaumont Hospital (MI) William Osler Health Centre (Canada) Winchester Hospital (MA) Wishard Health Sciences (IN) Womack Army Medical Center (NC) Women’s Health Laboratory (TX) Woodlawn Hospital (IN) York Hospital (PA)



BOARD OF DIRECTORS Susan Blonshine, RRT, RPFT, FAARC TechEd Maria Carballo Health Canada Russel K. Enns, PhD Cepheid Mary Lou Gantzer, PhD Dade Behring Inc. Lillian J. Gill, DPA FDA Center for Devices and Radiological Health Prof. Naotaka Hamasaki, MD, PhD Nagasaki International University



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Valerie Ng, PhD, MD Alameda County Medical Center/ Highland General Hospital Janet K.A. Nicholson, PhD Centers for Disease Control and Prevention Timothy J. O’Leary, MD, PhD Department of Veterans Affairs Klaus E. Stinshoff, Dr.rer.nat. Digene (Switzerland) Sàrl Michael Thein, PhD Roche Diagnostics GmbH James A. Thomas ASTM International



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Product Name: Infobase 2009 - Release Date: March 2009



940 West Valley Road Suite 1400 Wayne, PA 19087 USA PHONE 610.688.0100 FAX 610.688.0700 E-MAIL: [email protected] WEBSITE: www.clsi.org ISBN 1-56238-650-6



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