Evidence-Based Practice for Point-Of-Care Testing
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AAC-NICHOLS-06-0901-cover.qxd 12/18/06 7:52 PM Page i The National Academy of Clinical Biochemistry Presents LABORATORY MEDICINE PRACTICE GUIDELINES EVIDENCE-BASED PRACTICE FOR POINT-OF-CARE TESTING Archived AAC-NICHOLS-06-0901-0FM.qxd 12/19/06 8:30 PM Page ii Evidence-Based Practice for Point-of-Care Testing Editor James H. Nichols, Ph.D., FACB Baystate Health Springfield, Massachusetts USA The preparation of this revised monograph was achieved with the expert input of the editors, members of the guidelines committee, experts who submitted manuscripts for each section, and many expert reviewers, who are listed at the end of the document. The material in this monograph represents the opinions of the editors and does not represent the official position of the National Academy of Clinical Biochemistry or any of the cosponsoring organizations. The National Academy of Clinical Biochemistry is the official Academy of the American Association for Clinical Chemistry. Archived © 2006 by the American Association for Clinical Chemistry, Inc. All rights reserved. Single copies for personal use may be printed from author- ized Internet sources such as the NACB’s home page (http://www.aacc.org/AACC/members/nacb), provided it is printed in its entirety, including this notice. Printing of selected portions of the document is also permitted for personal use, provided the user also prints and attaches the title page and cover pages to the selected reprint or otherwise clearly identifies the reprint as having been produced by the NACB. Otherwise, this docu- ment may not be reproduced in whole or in part, stored in a retrieval system, translated into another language, or transmitted in any form without express written permission of the National Academy of Clinical Biochemistry. Such permission may be requested from NACB, 1850 K Street, Suite 625, Washington, DC 20006-2213. Permission will ordinarily be granted, provided the NACB logo and the following notice appear promi- nently at the front of the document: Reproduced (Translated) with permission of the American Association for Clinical Chemistry and the National Academy of Clinical Biochemistry, Washington, DC. AAC-NICHOLS-06-0901-0FM.qxd 12/19/06 8:30 PM Page iii Contents Preface v Introduction vi Guidelines Committee ix NACB Committees x Contributors xi Nonstandard Abbreviations xvi 1 Management 1 Ellis Jacobs, Barbara Goldsmith, Lasse Larrson, Harold Richardson, and Patrick St. Louis Quality Assurance and Medical Error 1 Does Management Improve the Quality of POCT? 2 2 Transcutaneous Bilirubin Testing 5 Steven Kazmierczak, Vinod Bhutani, Glenn Gourley, Scott Kerr, Stanley Lo, Alex Robertson, and Salvador Sena 3 Use of Cardiac Biomarkers for Acute Coronary Syndromes 13 Alan B. Storrow, Fred S. Apple, Alan H.B. Wu, Robert Jesse, Gary Francis, and Robert H. Christenson 4 Coagulation 21 Marcia L. Zucker, Vandita Johari, Valerie Bush, and Srikantha Rao aPTT 21 PT/INR 23 ACT 24 5 Critical Care 30 Paul D’Orazio, Niels Fogh-Andersen, Anthony Okorodudu, Greg Shipp, Terry Shirey, and John Toffaletti Arterial Blood Gases 31 Glucose 34 Lactate 34 Magnesium 35 Cooximetry 36 Electrolytes (Na+,K+,Cl–) 37 Ionized Calcium 37 6 Diagnosis and Management of DiabetesArchived Mellitus 44 Aasne Karine Aarsand, David Alter, Stephen J. Frost, Bob Kaplanis, Atle Klovning, Christopher P. Price, David B. Sacks, Sverre Sandberg, Andrew St John, Ramasamyiyer Swaminathan, and William E. Winter Blood Glucose 44 HbA1c Testing 48 Fructosamine 50 Blood Ketones 50 Urine Albumin 52 7 Drugs and Ethanol 63 Ian D. Watson, Roger Bertholf, Catherine Hammett-Stabler, Brenda Nicholes, Brian Smith, Steve George, Shirley Welch, Alain Verstraete, and Bruce Goldberger Use of POCT for DOA in the Clinical Setting 67 Urine versus Alternative Matrices 68 Nonclinical Applications of POCT for DOA and Ethanol 70 Other Issues 73 iii AAC-NICHOLS-06-0901-0FM.qxd 12/19/06 8:30 PM Page iv iv Contents 8 Infectious Disease 76 Sheldon Campbell, Joseph Campos, Gerri S. Hall, William D. LeBar, Wallace Greene, Donna Roush, James T. Rudrik, Barbara Russell, Robert Sautter Bioterrorism 76 Clostridium difficile 77 Infectious Mononucleosis 78 Chlamydia trachomatis and Neisseria gonorrhoeae 79 Group A Streptococcal Antigen Tests 79 Group B Streptococci 80 Helicobacter pylori 81 Influenza Virus Infection 81 Respiratory Syncytial Virus 82 HIV Testing 82 Trichomonas vaginalis Vaginitis 86 Candida Vulvovaginitis 87 Bacterial Vaginosis 87 9 Occult Blood 95 Stacy Foran Melanson, John Petersen, and Kent B. Lewandrowski 10 Intraoperative Parathyroid Hormone 105 Lori J. Sokoll, Alan T. Remaley, Salvador F. Sena, Frank H. Wians, Jr., Jiaxi Wu, Steven K. Libutti, and Robert Udelsman Primary Hyperparathyroidism 105 Other Parathyroid Diseases 110 Localization 112 Secondary Questions 113 11 pH Testing 120 James H. Nichols, Dawn Taylor, Heike Varnholt, and Leslie Williams 12 Renal Function Testing 126 William Clarke, Stephen J. Frost, Edward Kraus, Maria Ferris, Bernard Jaar, Jean Wu, Sandra Humbertson, Karen Dyer, Eric Schmith, and Katie Gallagher 13 Reproductive Testing 135 Ann M. Gronowski, David G. Grenache, Glenn Markenson, Robin Weiner, Laurence M. Demers, and Patrick St. Louis Urine/Serum hCG Testing 135 Urine LH Ovulation Tests 138 Nonurine Ovulation Tests 141 pH/Nitrazine Tests for Premature Rupture of Membranes 142 Fern Tests for Premature RuptureArchived of Membranes 143 fFN Testing for Premature Delivery 143 Appendix A NACB LMPG Data Abstraction Forms 149 Appendix B Literature Searches 154 Appendix C Acknowledgements 187 AAC-NICHOLS-06-0901-0FM.qxd 12/19/06 8:30 PM Page v Preface This is the 11th in the series of Laboratory Medicine Local Sections (Providence, RI, USA) in November 2003, Practice Guidelines (LMPG) sponsored by the National CLMA Breakout Session and ASCP simulcast audioconfer- Academy of Clinical Biochemistry (NACB). The field of point- ence (Atlanta, GA, USA) in March 2004, the Northern of-care testing (POCT), diagnostic testing conducted close to California American Association for Clinical Chemistry the site of patient care, was divided into disease- and test- (AACC) local section (San Jose, CA, USA) in April 2004, specific focus areas. Groups of expert physicians, laboratori- Teleconference Network of Texas (San Antonio, TX, USA) in ans, and diagnostic manufacturers in each focus area were May 2004, the Beckman Conference (Boston, MA, USA) in assembled to conduct systematic reviews of the scientific liter- May 2004, the AACC Critical and Point of Care Testing ature and prepare guidelines based on the strength of scientific Division/IFCC meeting (Wurzburg, Germany) in June 2004, evidence linking the use of POCT to patient outcome. To our AACC Workshop (Los Angeles CA, USA) in July 2004, 23rd knowledge, this is the most comprehensive review of the point- Annual Southwest Association of Clinical Microbiologists of-care literature to date. (San Antonio, TX) in September 2004, Mid-Atlantic Point of It is hoped that these guidelines will be useful for those Care Coordinators Fall Symposium (Baltimore, MD, USA) in implementing new testing, as well as those reviewing the basis October 2004, East Coast Central Florida POCT Conference of current practice. These guidelines should help sort fact from (Cocoa Beach, FL, USA) in October 2004, Northwest Medical conjecture when testing is applied to different patient popula- Laboratory Symposium (Portland, OR, USA) in October 2004, tions and establish proven applications from off-label and alter- Quality 2005 (Antwerp, Belgium) in March 2005, native uses of POCT. These guidelines will also be useful in EuroMedLab (Glasgow, Scotland) in May 2005, AACC defining mechanisms for optimizing patient outcome and iden- Upstate New York Local Section Spring Meeting (Rochester, tify areas lacking in the current literature that are needed for NY, USA) in May 2005, American Society for Microbiology future research. symposium (Atlanta, GA, USA) in June 2005, AACC work- The guidelines were presented in open forum at the shop (Orlando, FL, USA) in July 2005, College of American AACC Annual Meeting (Los Angeles, CA, USA) in July 2004. Pathologists workshop (Chicago, IL, USA), Dade Portions of these guidelines were also presented at several Microbiology Symposia (Harrisburg, PA, USA) in September meetings between 2003 and 2005: CLMA Breakout Session 2005, and the 8th Annual Fall Clinical Pathology Symposium (Salt Lake City, UT, USA) in June 2003, 37th Brazilian (Louisville, KY, USA) in November 2005. Participants at each Congress of Pathology and Clinical Laboratory Medicine (Rio meeting had the ability to discuss the merits of the guidelines de Janiero, Brazil) in September 2003, Maine Society for and submit comments to the NACB Web site for formal Clinical Laboratory Science Northeast Regional Joint Fall response by the NACB during the open comment period from Conference (Portland, ME, USA) in October 2003, January 2004 through October 2005. A summary of these Association of Clinical Biochemists (Dublin Ireland) in comments and revisions is presented at the end of each section November 2003, LabMed2003 AllianceArchived of Northeast AACC of the guidelines when applicable. v AAC-NICHOLS-06-0901-0FM.qxd 12/19/06 8:30 PM Page vi Introduction Ellis Jacobs, Barbara Goldsmith, Lasse Larrson, Harold Richardson, and Patrick St. Louis In these Laboratory Medicine Practice Guidelines (LMPG), the of therapeutic, rehabilitative, and preventive regimens. Clinical National Academy of Clinical Biochemistry (NACB) is examin- expertise