Pre-Examination Procedures in Laboratory Diagnostics

425 Pages·2015·3.844 MB·English

by  Walter G. Guder, Sheshadri Narayanan

Walter G. Guder, Sheshadri Narayanan (Eds.)
Pre-Examination Procedures in Laboratory Diagnostics

Pre-Examination
Procedures in
Laboratory Diagnostics
Preanalytical Aspects and their Impact on the
Quality of Medical Laboratory Results
Edited by
Walter G. Guder and
Sheshadri Narayanan
Editors
Prof. Dr. med. Walter G. Guder
Marianne-Plehn-Str. 4
81825 München
Germany
E-Mail: [email protected]
Prof. Dr. Sheshadri Narayanan
Weill Medical College/Cornell University
Dept. of Pathology & Laboratory Medicine
525 East 68th Street/F-715
New York NY 10021
USA
E-Mail: [email protected]
ISBN: 978-3-11-033165-3
e-ISBN (PDF): 978-3-11-033404-3
e-ISBN (EPUB): 978-3-11-039019-3
Library of Congress Cataloging-in-Publication data
A CIP catalog record for this book has been applied for at the Library of Congress.
Bibliographic information published by the Deutsche Nationalbibliothek
The Deutsche Nationalbibliothek lists this publication in the Deutsche Nationalbibliografie; detailed
bibliographic data are available on the Internet at http://dnb.dnb.de.
© 2015 Walter de Gruyter GmbH, Berlin/Boston
Typesetting: Medienfabrik GmbH, Stuttgart
Cover image: Luchschen/iStock/Thinkstock
Printing and binding: CPI books GmbH, Leck
∞ Printed on acid-free paper
Printed in Germany
www.degruyter.com
Preface
Knowledge in laboratory medicine is advancing at an exponential pace.
Advances in terms of introduction of new technologies and new laboratory tests
are being made in all branches of laboratory medicine.
Another dimension that has impacted on the practice of laboratory medicine in
recent years is the awareness that analytical quality assurance is not sufficient to
ensure safe and medically correct laboratory results since more than 70 % of the so
called “laboratory errors” were found to be due to extra-analytical factors. This intro-
duced the awareness of preanalytical errors affecting laboratory results in the labora-
tory diagnostic process which needed to be recognized.
These developments bring in its wake a host of analytical and preanalytical issues
which need to be uncovered, understood and resolved. While analytical issues can be
approached by way of quality control and standardization, the delineation of prean-
alytical issues requires substantially more effort. Recently this part of the diagnostic
circle became part of accreditation and more recently quality assurance programs.
In conceiving this multi-authored book, our goal was to bring to our readers an
up-to-date perspective on the preanalytical phase from experts in their respective
disciplines. In doing this we have been selective and tailored this book to the exper-
tise of the authors who have contributed to this volume. We thank all coauthors for
their collaboration in this project. As such, and also due to space constraints we may
not have covered all areas of interest to the reader, but we do hope the cited origi-
nal work will help to find answers to the respective questions. After being invited by
deGruyter to write this book, we would like to thank all collaborators, especially Mrs
Julia Reindlmeier, Sabina Dabrowski and Katja Brockmann for their excellent collab-
oration and helpful suggestions.
In balance, we hope this book will be of interest not only to the practitioners of
laboratory medicine, but also to the clinicians who order laboratory tests and use
the results in the treatment of their patients, nurses, medical technologists, phle-
botomists, medical and graduate students.
We and the contributing authors will feel gratified if this book reinforces the
importance of the preanalytical phase in the practice of laboratory medicine and
stimulates research in this field.
Walter G. Guder
Sheshadri Narayanan

Contents
Preface   v
List of Contributing Authors   xi
1 General Part   1
1.1 Introduction and History of the Preanalytical Phase
Guder WG   3
1.2 Requesting Laboratory Tests: Benefits and Limitations of Laboratory
Diagnostic Pathways
Hoffmann G, Aufenanger J, Födinger M, Cadamuro J, von Eckardstein A,
Kaeslin-Meyer M, Hofmann W   11
1.3 Definition of the Influence and Interference Factors in the Preanalytical
Phase
Guder WG   22
1.4 Extraanalytical Procedures and their Management in Total Turnaround Time
Guder WG, Wisser H   27
2 Types of Samples and Anatomic Site of Origin   35
2.1 Arterial, Venous or Capillary Blood ?
Guder WG, Hagemann P   37
2.2 Special Pre-Examination Conditions in Newborns and Pediatric Patients
Vassault A, Couderc R   40
2.3 Venous Blood Sampling (Phlebotomy)
Guder WG, Cornes MP   50
2.4 Arterial Sampling of Blood
Guder WG, Hagemann P   54
2.5 Capillary Sampling of Blood
Cornes MP, Guder WG   59
2.6 Plasma or Serum? Which Anticoagulant to Use?
Guder WG, Narayanan S   64
2.7 Spot or Timed Urine – Preanalytical Aspects of Urinalysis
Guder WG, Delange J   69
2.8 When are other Body Fluids to be Analyzed?
Guder WG   81
2.9 Who is Doing Phlebotomy in Europe?
Simundic A-M   90
viii   Contents
3 Biological Variables Influencing Laboratory Results   95
3.1 Age and Gender Differences – Unavoidable Influences on Laboratory
Results
Guder WG, Narayanan S   97
3.2 Variables during Sampling
Guder WG, Narayanan S   102
3.3 Food, Drinks and Smoking
Narayanan S, Guder WG   115
3.4 Effect of Herbs
Narayanan S, Young DS   123
4 Source and Nature of Interferences of Analytical Procedures   133
4.1 The Hemolytic Sample
Guder WG, da Fonseca-Wollheim F, Schmitt YM, Töpfer G   135
4.2 The Lipemic Sample
Guder WG, Nikolac N, Schmitt YM, Töpfer G   141
4.3 The Icteric Sample
Guder WG, da Fonseca-Wollheim F, Schmitt YM, Töpfer G   147
4.4 Drug Interferences
Sonntag O, Tryding N   152
4.5 Interferences from Blood Sampling Device Materials on Clinical Assays:
I Blood Collection Devices and Their Constituents and Additives
Bowen RAR, Adcock-Funk DM   170
4.6 Influences and Interferences from Blood Sampling Device Materials on
Clinical Assays: II Special Devices and Procedures; Recommendations
Bowen RAR, Adcock-Funk DM   205
5 Sampling Materials and Techniques   217
5.1 Materials and Techniques of Sampling Blood and other Body Fluids.
Contributions of Greiner – Bio One
Ivanov H, Präuer J, Schimpl M, Castelo-Rose G, Wiesner C,
Ehrenfellner T   219
5.2 Materials and Techniques of Sampling Blood by Sarstedt
Seipelt C   231
5.3 BD Preanalytical Systems – Diagnostic Sample Collection
Schlüter K, Church S   238
6 Specimen Processing in the Preanalytical Phase   249
6.1 Sample Transport, Treatment after Arrival, Storage and Disposal
Guder WG, Narayanan S   251
6.2 Preanalytical Workflow Techniques and Procedures
Streichert T, von Meyer A   264
Contents   ix
7 Preanalytical Variables and Rules in Specific Fields of Medical Laboratory
Diagnostics   271
7.1 Hemostaseology
Dempfle C-E, Töpfer G   273
7.2 Hematology including Flow Cytometry of Blood Cells
Banfi G, Guder WG, Narayanan S   282
7.3 Blood Gases, Ions and Electrolytes
Simundic A-M   292
7.4 Clinical Chemistry including Metabolites, Enzymes, Hormones
and Proteins
Narayanan S, Guder WG   298
7.5 Preanalytical Variables in Therapeutic Drug Monitoring
Narayanan S, Agrawal Y   305
7.6 Preanalytical Variables in Microbiology
Narayanan S, Schuetz AN   318
7.7 Biobanking
Leichtle A, Findeisen P   328
8 Quality Assurance and Auditing of the Preanalytical Phase   335
8.1 Auditing of the Preanalytical Phase
Petersmann A., Schlüter K, Nauck M.   337
8.2 Internal Quality Assurance for Preanalytical Phase
Cadamuro J   345
8.3 External Quality Assurance for the Preanalytical Phase
Kristensen GBB, Aakre KM, Kristoffersen AH, Sandberg S   352
9 Annex: Samples and Stability of Analytes   365
Index   399