Urinalysis and Body Fluids PDF 6th Edition

3920_FM_i-xv 23/01/14 11:22 AM Page i Urinalysis and Body Fluids SIXTH EDITION Susan King Strasinger, DA, MLS(ASCP)...

3920_FM_i-xv 23/01/14 11:22 AM Page i Urinalysis and Body Fluids SIXTH EDITION Susan King Strasinger, DA, MLS(ASCP) Faculty Associate Clinical Laboratory Sciences Program The University of West Florida Pensacola, Florida Marjorie Schaub Di Lorenzo, BS, MLS(ASCP)SH Adjunct Instructor Division of Laboratory Sciences Clinical Laboratory Science Program University of Nebraska Medical Center Omaha, Nebraska and Phlebotomy Technician Program Coordinator Health Professions Nebraska Methodist College Omaha, Nebraska 3920_FM_i-xv 23/01/14 11:22 AM Page ii F. A. Davis Company 1915 Arch Street Philadelphia, PA 19103 www.fadavis.com Copyright © 2014 by F. A. Davis Company Copyright © 2014 by F. A. Davis Company. All rights reserved. This product is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission from the publisher. Printed in the United States of America Last digit indicates print number: 10 9 8 7 6 5 4 3 2 1 Senior Acquisitions Editor: Christa Fratantoro Manager of Content Development: George W. Lang Developmental Editor: Molly Mullen Ward Art and Design Manager: Carolyn O’Brien As new scientific information becomes available through basic and clinical research, recommended treatments and drug therapies undergo changes. The author(s) and publisher have done everything possible to make this book accurate, up to date, and in accord with accepted standards at the time of publication. The author(s), editors, and publisher are not responsible for errors or omissions or for consequences from application of the book, and make no warranty, expressed or implied, in regard to the contents of the book. Any practice described in this book should be applied by the reader in accordance with professional standards of care used in regard to the unique circumstances that may apply in each situation. The reader is advised always to check product information (package inserts) for changes and new information regarding dose and contraindications before administering any drug. Caution is especially urged when using new or infrequently ordered drugs. Library of Congress Cataloging-in-Publication Data Strasinger, Susan King, author. Urinalysis and body fluids / Susan King Strasinger, Marjorie Schaub Di Lorenzo. — Sixth edition. p. ; cm. Includes bibliographical references and index. ISBN 978-0-8036-3920-1 (pbk. : alk. paper) I. Di Lorenzo, Marjorie Schaub, 1953- author. II. Title. [DNLM: 1. Urinalysis—methods. 2. Body Fluids—chemistry. QY 185] RB53 616.07’566—dc23 2013021830 Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by F. A. Davis Company for users registered with the Copyright Clearance Center (CCC) Transactional Reporting Service, provided that the fee of $.25 per copy is paid directly to CCC, 222 Rosewood Drive, Danvers, MA 01923. For those organizations that have been granted a photocopy license by CCC, a separate system of payment has been arranged. The fee code for users of the Transactional Reporting Service is: 978-0-8036-3920-1/14 0 + $.25. 3920_FM_i-xv 23/01/14 11:22 AM Page iii To Harry—you will always be my Editor-in-Chief —SKS To my husband, Scott; my daughter, Lauren; my sons, Michael and Christopher; my daughters-in-law, Kathleen and Ashley; and my grandsons, Cameron and Joseph. —MSD 3920_FM_i-xv 23/01/14 11:22 AM Page iv 3920_FM_i-xv 23/01/14 11:22 AM Page v Preface As will be apparent to readers, the sixth edition of Urinalysis Each chapter opens with objectives and key terms and and Body Fluids has been substantially revised and enhanced. concludes with multiple choice questions for student review. However, the objective of the text—to provide concise, com- In response to readers’ suggestions, the number of color images prehensive, and carefully structured instruction in the analysis and figures has been significantly increased. The text has been of nonblood body fluids—remains the same. extensively supplemented with tables, summaries, and proce- This sixth edition has been redesigned to meet the changes dure boxes. Case studies in the traditional format and clinical occurring in both laboratory medicine and instructional situations relating to technical considerations included at the methodology. end of the chapters offer students an opportunity to think crit- To meet the expanding technical information required by ically about the material. A new feature, Historical Notes, pro- students in laboratory medicine, all of the chapters have been vides a reference for topics or tests that are no longer routinely updated. Chapter 1 covers overall laboratory safety, precautions performed. Another new feature, Technical Tips, emphasizes relating to urine and body fluid analysis, and the importance of information important to performing procedures. An answer quality assessment and management in the urinalysis laboratory. key for the study questions, case studies, and clinical situations Preexamination, examination, and postexamination variables, is included at the end of the book. Key terms appear in bold- procedure manuals, and current regulatory issues are stressed. face blue color within the chapters. General medical terms Chapter 6 includes numerous additional images showing appear in boldface in the text and are also included in the the various urine microscopic components. In Chapters 7 and Glossary. The abbreviations noted in boldface red color have 8 the most frequently encountered diseases of glomerular, been collected in a convenient Abbreviations list at the back tubular, interstitial, vascular, and hereditary origin are related of the book. An electronic test bank, chapter-by-chapter Power- to their associated laboratory tests. To accommodate advances Points, a searchable digital version of the textbook, resources in laboratory testing of cerebrospinal, seminal, synovial, serous, for instructors, and interactive exercises and animations for and amniotic fluids, all of the individual chapters have been students are provided on the DavisPlus Web site. enhanced, and additional anatomy and physiology sections We thank our readers for their valuable suggestions, which have been added for each of these fluids. An entirely new chapter have guided us in creating this exciting new edition and the (Chapter 15) dedicated to vaginal secretions and covering electronic ancillary supports. proper specimen collection and handling, diseases, and related Susan King Strasinger diagnosis laboratory tests has been added. Marjorie Schaub Di Lorenzo Appendix A provides coverage of the ever-increasing variety of automated instrumentation available to the urinalysis laboratory. Appendix B discusses the analysis of bronchoalveolar lavage specimens, an area of the clinical laboratory that has been expanding in recent years. v 3920_FM_i-xv 23/01/14 11:22 AM Page vi 3920_FM_i-xv 23/01/14 11:22 AM Page vii Reviewers Lorraine Doucette, MS, MLS(ASCP)CM Associate Professor and Medical Laboratory Technician Program Coordinator Anne Arundel Community College Arnold, Maryland Pamela B. Lonergan, MS, MT(ASCP)SC Medical Technology Program Director Department of Nursing and Allied Health Norfolk State University Norfolk, Virginia Jessica Loontjer, MLS(ASCP)CM, LS(ASCP)CM Clinical Instructor, Special Chemistry and Urinalysis/Body Fluids Nebraska Methodist Hospital Laboratory Omaha, Nebraska Michelle Moy, MAd Ed, MT(ASCP)SC Program Director Clinical Laboratory Science Program Loyola University Chicago, Illinois C. Thomas Somma, PhD Associate Professor School of Medical Diagnostics and Translational Sciences College of Health Sciences Old Dominion University Norfolk, Virginia vii 3920_FM_i-xv 23/01/14 11:22 AM Page viii 3920_FM_i-xv 23/01/14 11:22 AM Page ix Acknowledgments Many people deserve credit for the help and encouragement over the years: Donna L. Canterbury, BA, MT(ASCP)SH; they have provided us in the preparation of this sixth edition. Joanne M. Davis, BS, MT(ASCP)SH; M. Paula Neumann, Our continued appreciation is also extended to all of the MD; Gregory J. Swedo, MD; and Scott Di Lorenzo, DDS. people who were instrumental in the preparation of previous We also thank Sherman Bonomelli, MS, for contributing editions. original visual concepts that became the foundation for many The valuable suggestions from previous readers and the of the line illustrations, and the students from the University support from our colleagues at the University of West Florida, of West Florida, specifically Jennifer Cardenas, Shannel Northern Virginia Community College, University of Nebraska Hill, Jelma Moore, and William Laguer, who worked under Medical Center, and Methodist Hospital have been a great asset the guidance of Sherman Bonomelli to produce many of to us in the production of this new edition. We thank each and the new images. Images for Chapter 14 were provided by every one of you. Brenda Franks has provided us with many Carol Brennan, MT(ASCP), Diane Siedlik, MT(ASCP), Chris- valuable documents for reference in this text. The authors thank tian Herdt, MT(ASCP), and Teresa Karre, MD, from Methodist and acknowledge Pamela S. Hilke, MS, CT(ASCP), Education Hospital. Coordinator and Instructor, and Sophie K. Thompson, MHS, We would like to express our gratitude for the help, patience, CT, (ASCP) (IAC), Program Director and Associate Professor of guidance, and understanding of our editors at F. A. Davis: Christa the Cytotechnology Program at the School of Medical Diagnos- Fratantoro, Senior Acquisitions Editor; George Lang, Manager of tic and Translational Sciences, College of Health Sciences, Old Content Development, Health Professions/Medicine; and Molly Dominion University, Norfolk, Virginia, for their contributions M. Ward, Development Editor. We thank all the members of the of spectacular cytology images. F. A. Davis team who were instrumental in bringing this edition We extend special thanks to the people who have pro- to fruition: Elizabeth Stepchin, Alisa Hathaway, Carolyn O’Brien, vided us with so many beautiful photographs for the text and Sharon Lee. ix 3920_FM_i-xv 23/01/14 11:22 AM Page x 3920_FM_i-xv 23/01/14 11:22 AM Page xi Contents PART ONE: Background Suprapubic Aspiration 34 Prostatitis Specimen 34 CHAPTER 1 Pediatric Specimens 34 Safety and Quality Assessment 3 Drug Specimen Collection 35 SAFETY 4 CHAPTER 3 Biologic Hazards 4 Renal Function 39 Personal Protective Equipment 7 Renal Physiology 40 Hand Hygiene 7 Renal Blood Flow 40 Biologic Waste Disposal 9 Glomerular Filtration 41 Sharp Hazards 9 Tubular Reabsorption 43 Tubular Secretion 45 Chemical Hazards 10 Chemical Spills and Exposure 10 Renal Function Tests 46 Chemical Handling 10 Glomerular Filtration Tests 47 Chemical Hygiene Plan 10 Cystatin C 49 Chemical Labeling 10 Tubular Reabsorption Tests 50 Material Safety Data Sheets 10 Tubular Secretion and Renal Blood Flow Tests 52 Radioactive Hazards 11 Electrical Hazards 11 PART TWO: Urinalysis Fire/Explosive Hazards 12 CHAPTER 4 Physical Hazards 13 Physical Examination of Urine 59 QUALITY ASSESSMENT 13 Color 60 Urinalysis Procedure Manual 14 Normal Urine Color 60 Abnormal Urine Color 61 Preexamination Variables 14 Examination Variables 16 Clarity 62 Postexamination Variables 20 Normal Clarity 62 CHAPTER 2 Nonpathologic Turbidity 63 Pathologic Turbidity 63 Introduction to Urinalysis 27 Specific Gravity 63 History and Importance 28 Refractometer 64 Urine Formation 29 Osmolality 65 Urine Composition 29 Reagent Strip Specific Gravity 66 Urine Volume 29 Odor 66 Specimen Collection 30 CHAPTER 5 Containers 30 Chemical Examination of Urine 71 Labels 30 Reagent Strips 72 Requisitions 31 Reagent Strip Technique 72 Specimen Rejection 31 Handling and Storing Reagent Strips 73 Specimen Handling 31 Quality Control of Reagent Strips 73 Specimen Integrity 31 Confirmatory Testing 73 Specimen Preservation 31 pH 73 Types of Specimens 32 Clinical Significance 73 Random Specimen 32 Reagent Strip Reactions 75 First Morning Specimen 33 Protein 75 24-Hour (or Timed) Specimen 33 Clinical Significance 75 Catheterized Specimen 34 Prerenal Proteinuria 75 Midstream Clean-Catch Specimen 34 xi 3920_FM_i-xv 23/01/14 11:22 AM Page xii xii Contents Renal Proteinuria 76 Sediment Examination Techniques 102 Postrenal Proteinuria 76 Sediment Stains 103 Reagent Strip Reactions 77 Cytodiagnostic Urine Testing 105 Reaction Interference 77 Microscopy 105 Glucose 79 Types of Microscopy 107 Clinical Significance 79 Urine Sediment Constituents 110 Reagent Strip (Glucose Oxidase) Reaction 81 Red Blood Cells 110 Reaction Interference 81 White Blood Cells 112 Copper Reduction Test (Clinitest) 81 Epithelial Cells 113 Clinical Significance of Clinitest 82 Bacteria 118 Ketones 82 Yeast 119 Clinical Significance 82 Parasites 119 Reagent Strip Reactions 83 Spermatozoa 120 Reaction Interference 83 Mucus 120 Casts 121 Blood 83 Urinary Crystals 128 Clinical Significance 84 Urinary Sediment Artifacts 138 Hematuria 84 CHAPTER 7 Hemoglobinuria 84 Myoglobinuria 84 Renal Disease 147 Reagent Strip Reactions 84 Glomerular Disorders 148 Reaction Interference 85 Glomerulonephritis 148 Bilirubin 85 Nephrotic Syndrome 149 Bilirubin Production 85 Tubular Disorders 150 Clinical Significance 86 Acute Tubular Necrosis 150 Reagent Strip (Diazo) Reactions 87 Hereditary and Metabolic Tubular Disorders 153 Reaction Interference 87 Interstitial Disorders 154 Urobilinogen 87 Acute Pyelonephritis 155 Clinical Significance 88 Chronic Pyelonephritis 155 Reagent Strip Reactions and Interference 88 Acute Interstitial Nephritis 155 Reaction Interference 88 Renal Failure 155 Nitrite 88 Renal Lithiasis 157 Clinical Significance 88 Reagent Strip Reactions 89 CHAPTER 8 Reaction Interference 89 Urine Screening for Metabolic Disorders 163 Leukocyte Esterase 90 Overflow Versus Renal Disorders 164 Clinical Significance 90 Newborn Screening Tests 164 Reagent Strip Reaction 90 Reaction Interference 91 Amino Acid Disorders 165 Phenylalanine-Tyrosine Disorders 165 Specific Gravity 91 Branched-Chain Amino Acid Disorders 167 Reagent Strip Reaction 91 Tryptophan Disorders 168 Reaction Interference 92 Cystine Disorders 169 CHAPTER 6 Porphyrin Disorders 170 Microscopic Examination of Urine 99 Mucopolysaccharide Disorders 172 Macroscopic Screening 100 Purine Disorders 174 Specimen Preparation 100 Carbohydrate Disorders 174 Specimen Volume 100 Centrifugation 100 Sediment Preparation 101 PART THREE: Other Body Fluids Volume of Sediment Examined 101 CHAPTER 9 Commercial Systems 101 Examining the Sediment 101 Cerebrospinal Fluid 181 Reporting the Microscopic Examination 101 Formation and Physiology 182 Correlating Results 102 Specimen Collection and Handling 182 3920_FM_i-xv 23/01/14 11:22 AM Page xiii Contents xiii Appearance 183 Cell Counts 220 Traumatic Collection (Tap) 184 Differential Count 220 Uneven Blood Distribution 184 Crystal Identification 221 Clot Formation 184 Types of Crystals 221 Xanthochromic Supernatant 185 Slide Preparation 222 Cell Count 185 Crystal Polarization 222 Methodology 185 Chemistry Tests 224 Total Cell Count 186 Microbiologic Tests 224 WBC Count 186 Quality Control of CSF and Other Body Fluid Cell Serologic Tests 224 Counts 186 CHAPTER 12 Differential Count on a CSF Specimen 186 Serous Fluid 229 Cytocentrifugation 186 Formation 230 CSF Cellular Constituents 187 Specimen Collection and Handling 230 Chemistry Tests 193 Transudates and Exudates 231 Cerebrospinal Protein 193 CSF Glucose 196 General Laboratory Procedures 231 CSF Lactate 195 Pleural Fluid 232 CSF Glutamine 195 Appearance 232 Microbiology Tests 195 Hematology Tests 232 Gram Stain 196 Chemistry Tests 235 Microbiologic and Serologic Tests 236 Serologic Testing 197 Pericardial Fluid 236 CHAPTER 10 Appearance 237 Semen 203 Laboratory Tests 237 Physiology 204 Peritoneal Fluid 237 Specimen Collection 205 Transudates Versus Exudates 237 Specimen Handling 205 Appearance 238 Laboratory Tests 238 Semen Analysis 205 Appearance 205 CHAPTER 13 Liquefaction 206 Amniotic Fluid 243 Volume 206 Physiology 244 Viscosity 206 pH 207 Function 244 Sperm Concentration and Sperm Count 207 Volume 244 Sperm Motility 208 Chemical Composition 244 Sperm Morphology 209 Differentiating Maternal Urine From Amniotic Fluid 245 Additional Testing 210 Specimen Collection 245 Sperm Vitality 211 Seminal Fluid Fructose 211 Indications for Amniocentesis 245 Antisperm Antibodies 212 Collection 246 Microbial and Chemical Testing 212 Specimen Handling and Processing 246 Postvasectomy Semen Analysis 213 Color and Appearance 246 Sperm Function Tests 213 Semen Analysis Quality Control 213 Tests for Fetal Distress 246 CHAPTER 11 Hemolytic Disease of the Newborn 246 Neural Tube Defects 247 Synovial Fluid 217 Tests for Fetal Maturity 248 Physiology 218 Fetal Lung Maturity 248 Specimen Collection and Handling 218 Lecithin-Sphingomyelin Ratio 248 Color and Clarity 219 Phosphatidyl Glycerol 249 Foam Stability Index 249 Viscosity 219 Lamellar Bodies 249 3920_FM_i-xv 23/01/14 11:22 AM Page xiv xiv Contents CHAPTER 14 Diagnostic Tests 271 Fecal Analysis 255 pH 271 Physiology 256 Microscopic Procedures 272 Diarrhea and Steatorrhea 257 Vaginal Disorders 277 Diarrhea 257 Bacterial Vaginosis 277 Steatorrhea 258 Trichomoniasis 278 Candidiasis 278 Specimen Collection 258 Desquamative Inflammatory Vaginitis 279 Macroscopic Screening 258 Atrophic Vaginitis 279 Color 258 Additional Vaginal Secretion Procedures 279 Appearance 259 Fetal Fibronectin Test 279 Microscopic Examination of Feces 259 AmniSure Test 279 Fecal Leukocytes 259 APPENDIX A Urine and Body Fluid Analysis Muscle Fibers 259 Automation 283 Qualitative Fecal Fats 260 APPENDIX B Bronchoalveolar Lavage 293 Chemical Testing of Feces 261 Answers to Study Questions and Case Studies and Occult Blood 261 Clinical Situations 297 Quantitative Fecal Fat Testing 262 APT Test (Fetal Hemoglobin) 263 Abbreviations 305 Fecal Enzymes 264 Glossary 307 Carbohydrates 264 Index 315 CHAPTER 15 Vaginal Secretions 269 Specimen Collection and Handling 270 Color and Appearance 271 3920_FM_i-xv 23/01/14 11:22 AM Page xv 3920_Ch01_002-026 23/01/14 9:19 AM Page 2 PART ONE Background Chapter 1: Safety and Quality Assessment Chapter 2: Introduction to Urinalysis Chapter 3: Renal Function 3920_Ch01_002-026 23/01/14 9:19 AM Page 3 CHAPTER 1 Safety and Quality Assessment LEARNING OBJECTIVES Upon completing this chapter, the reader will be able to: 1-1 List the six components of the chain of infection and 1-7 Discuss the components and purpose of chemical the laboratory safety precautions that break the chain. hygiene plans and Material Safety Data Sheets. 1-2 State the purpose of the Standard Precautions policy 1-8 State and interpret the components of the National and describe its guidelines. Fire Protection Association hazardous material labeling system. 1-3 State the requirements mandated by the Occupational Exposure to Blood-Borne Pathogens Compliance 1-9 Describe precautions that laboratory personnel should Directive. take with regard to radioactive, electrical, and fire hazards. 1-4 Describe the types of personal protective equipment 1-10 Explain the RACE and PASS actions to be taken when that laboratory personnel wear, including when, how, a fire is discovered. and why each article is used. 1-11 Recognize standard hazard warning symbols. 1-5 Correctly perform hand hygiene procedures following 1-12 Define the preexamination, examination, and postex- Centers for Disease Control and Prevention (CDC) amination components of quality assessment. guidelines. 1-13 Distinguish between the components of internal 1-6 Describe the acceptable methods for handling and quality control, external quality control, electronic disposing of biologic waste and sharp objects in the quality control, and proficiency testing. urinalysis laboratory. KEY TERMS Accreditation External quality assessment (EQA) Postexposure prophylaxis (PEP) Accuracy External quality control Precision Biohazardous Fomite Preexamination variable Chain of infection Infection control Preventive maintenance (PM) Chemical hygiene plan Internal quality control Proficiency testing Clinical Laboratory Improvement Material Safety Data Sheet (MSDS) Quality assessment (QA) Amendments (CLIA) Occupational Safety and Health Quality control (QC) Clinical and Laboratory Standards Administration (OSHA) Radioisotope Institute (CLSI) Personal protective equipment Reliability Electronic quality control (PPE) Standard Precautions Examination variable Postexamination variable Turnaround time (TAT) 3920_Ch01_002-026 23/01/14 9:19 AM Page 4 4 Part One | Background S A F E T Y received in the clinical laboratory. Understanding how microor- ganisms are transmitted (chain of infection) is essential to preventing infection. All health-care facilities have developed The clinical laboratory contains a variety of safety hazards, procedures to control and monitor infections occurring within many of which are capable of producing serious injury or life- their facilities. This is referred to as infection control. The threatening disease. To work safely in this environment, labo- chain of infection requires a continuous link between an in- ratory personnel must learn what hazards exist, the basic safety fectious agent, a reservoir, a portal of exit, a means of trans- precautions associated with them, and how to apply the basic mission, a portal of entry, and a susceptible host.4 Infectious rules of common sense required for everyday safety for agents consist of bacteria, fungi, parasites, and viruses. The patients, co-workers, and themselves. reservoir is the location of potentially harmful microorganisms, As can be seen in Table 1–1, some hazards are unique to such as a contaminated clinical specimen or an infected the health-care environment, and others are encountered rou- patient. It is the place where the infectious agent can live and tinely throughout life. Safety procedure manuals must be read- possible multiply. Humans and animals make excellent reser- ily available in the laboratory that describe the safety policies voirs. Equipment and other soiled inanimate objects, called mandated by the Centers for Disease Control and Prevention fomites, will serve as reservoirs, particularly if they contain (CDC) and the Occupational Safety and Health Adminis- blood, urine, or other body fluids. Some microorganisms form tration (OSHA), and strict adherence to these guidelines by spores or become inactive when conditions are not ideal and laboratory personnel is essential. The manual must be updated wait until a suitable reservoir is available. The infectious agent and reviewed annually by the laboratory director. The Clinical must have a way to exit the reservoir to continue the chain and Laboratory Standards Institute (CLSI) provides the of infection. This can be through the mucous membranes of guidelines for writing these procedures and policies.1-3 the nose, mouth, and eyes, and in blood or other body fluids. Once the infectious agent has left the reservoir, it must have a way to reach a susceptible host. Means of transmission include: Biologic Hazards 1. Direct contact: the unprotected host touches the patient, The health-care setting provides abundant sources specimen, or a contaminated object (reservoir) of potentially harmful microorganisms. These mi- 2. Airborne: inhalation of dried aerosol particles circulating croorganisms are frequently present in the specimens on air currents or attached to dust particles 3. Droplet: the host inhales material from the reservoir (e.g., aerosol droplets from a patient or an uncapped centrifuge Table 1–1 Types of Safety Hazards tube, or when specimens are aliquoted or spilled) Type Source Possible Injury 4. Vehicle: ingestion of a contaminated substance (e.g., food, water, specimen) Biologic Infectious Bacterial, fungal, 5. Vector: from an animal or insect bite agents viral, or parasitic infections After the infectious agent has been transmitted to a new Sharps Needles, lancets, Cuts, punctures, or reservoir, it must have a means to enter the reservoir. The por- broken glass blood-borne tal of entry can be the same as the portal of exit, which includes pathogen exposure the mucous membranes of the nose, mouth, and eyes, breaks in the skin, and open wounds. The susceptible host can be an- Chemical Preservatives and Exposure to toxic, other patient during invasive procedures, visitors, and health- reagents carcinogenic, or care personnel when exposed to infectious specimens or caustic agents needlestick injuries. Immunocompromised patients, newborns Radioactive Equipment and Radiation exposure and infants, and the elderly are often more susceptible hosts. radioisotopes Stress, fatigue, and lack of proper nutrition depress the im- Electrical Ungrounded or Burns or shock mune system and contribute to the susceptibility of patients wet equipment; and health-care providers. Once the chain of infection is com- frayed cords plete, the infected host then becomes another source able to Fire/ Open flames, Burns or transmit the microorganisms to others.1 explosive organic dismemberment In the clinical laboratory, the most direct contact with a chemicals source of infection is through contact with patient specimens, al- though contact with patients and infected objects also occurs. Physical Wet floors, heavy Falls, sprains, or Preventing completion of the chain of infection is a primary ob- boxes, patients strains jective of biologic safety. Figure 1–1 illustrates the universal sym- From Strasinger, SK, and DiLorenzo, MA: The Phlebotomy Textbook, third bol for biohazardous material and demonstrates how following edition, FA Davis, Philadelphia, 2011, p 52, with permission. prescribed safety practices can break the chain of infection. Figure 1–1 places particular emphasis on laboratory practices. 3920_Ch01_002-026 23/01/14 9:19 AM Page 5 Chapter 1 | Safety and Quality Assessment 5 Break the link Break the link Immunizations Disinfection Patient isolation Infectious agent Hand hygiene Nursery Bacteria precautions Fungi Healthy lifestyle Parasites Susceptible Viruses host Reservoir Patients Humans Elderly Animals Newborns Insects Immuno- Fomites compromised Blood/body Health-care fluids workers Portal of exit Portal of entry Nose Mouth Nose Mucous Mouth membranes Mucous Specimen membranes collection Skin Unsterile equipment Means of transmission Droplet Airborne Break the link Contact Break the link Hand hygiene Vector Sealed biohazardous Standard precautions Vehicle waste containers PPE Sealed specimen Sterile equipment containers Hand hygiene Standard precautions Break the link Hand hygiene Standard precautions PPE Patient isolation Figure 1–1 Chain of infection and safety practices related to the biohazard symbol. (From Strasinger, SK, and DiLorenzo, MA: The Phlebotomy Textbook, FA Davis, Philadelphia, 2011, with permission.) Proper hand hygiene, correct disposal of contaminated of all needles and sharp objects in puncture-resistant contain- materials, and wearing personal protective equipment (PPE) ers. The CDC excluded urine and body fluids not visibly are of major importance in the laboratory. Concern over expo- contaminated by blood from UP, although many specimens can sure to blood-borne pathogens, such as hepatitis B virus contain a considerable amount of blood before it becomes vis- (HBV), hepatitis C virus (HCV), and human immunodefi- ible. The modification of UP for body substance isolation ciency virus (HIV), resulted in the drafting of guidelines and (BSI) helped to alleviate this concern. BSI guidelines are not regulations by the CDC and OSHA to prevent exposure. In limited to blood-borne pathogens; they consider all body 1987 the CDC instituted Universal Precautions (UP). Under fluids and moist body substances to be potentially infectious. UP all patients are considered to be possible carriers of blood- According to BSI guidelines, personnel should wear gloves at borne pathogens. The guideline recommends wearing gloves all times when encountering moist body substances. A major when collecting or handling blood and body fluids contami- disadvantage of BSI guidelines is that they do not recommend nated with blood and wearing face shields when there is danger handwashing after removing gloves unless visual contamina- of blood splashing on mucous membranes and when disposing tion is present. 3920_Ch01_002-026 23/01/14 9:19 AM Page 6 6 Part One | Background In 1996 the CDC and the Healthcare Infection Control and reprocessed appropriately. Ensure that single-use Practices Advisory Committee (HICPAC) combined the major items are discarded properly. features of UP and BSI guidelines and called the new guidelines 6. Environmental control: Ensure that the hospital has Standard Precautions. Although Standard Precautions, as adequate procedures for the routine care, cleaning, and described below, stress patient contact, the principles can also disinfection of environmental surfaces, beds, bedrails, be applied to handling patient specimens in the laboratory.5 bedside equipment, and other frequently touched sur- Standard Precautions are as follows: faces. Ensure that these procedures are being followed. 1. Hand hygiene: Hand hygiene includes both hand 7. Linen: Handle, transport, and process linen soiled with washing and the use of alcohol-based antiseptic blood, body fluids, secretions, and excretions in a man- cleansers. Sanitize hands after touching blood, body ner that prevents skin and mucous membrane exposures fluids, secretions, excretions, and contaminated items, and clothing contamination and that avoids the transfer whether or not gloves are worn. Sanitize hands immedi- of microorganisms to other patients and environments. ately after gloves are removed, between patient contacts, 8. Occupational health and blood-borne pathogens: and when otherwise indicated to avoid transferring Take care to prevent injuries when using needles, microorganisms to other patients or environments. scalpels, and other sharp instruments or devices; when Sanitizing hands may be necessary between tasks handling sharp instruments after procedures; when and procedures on the same patient to prevent cross- cleaning used instruments; and when disposing of used contamination of different body sites. needles. Never recap used needles or otherwise manip- 2. Gloves: Wear gloves (clean, nonsterile gloves are ade- ulate them using both hands or use any other technique quate) when touching blood, body fluids, secretions, that involves directing the point of a needle toward any excretions, and contaminated items. Put on gloves just part of the body; rather, use self-sheathing needles or a before touching mucous membranes and nonintact mechanical device to conceal the needle. Do not remove skin. Change gloves between tasks and procedures on used unsheathed needles from disposable syringes by the same patient after contact with material that may hand, and do not bend, break, or otherwise manipulate contain a high concentration of microorganisms. Re- used needles by hand. Place used disposable syringes move gloves promptly after use, before touching non- and needles, scalpel blades, and other sharp items in contaminated items and environmental surfaces, and appropriate puncture-resistant containers, which are lo- between patients. Always sanitize your hands immedi- cated as close as practical to the area in which the items ately after glove removal to avoid transferring microor- were used, and place reusable syringes and needles in a ganisms to other patients or environments. puncture-resistant container for transport to the repro- 3. Mouth, nose, and eye protection: Wear a mask and cessing area. Use mouthpieces, resuscitation bags, or eye protection or a face shield to protect mucous mem- other ventilation devices as an alternative to mouth- branes of the eyes, nose, and mouth during procedures to-mouth resuscitation methods in areas where the need and patient care activities that are likely to generate for resuscitation is predictable. splashes or sprays of blood, body fluids, secretions, or 9. Patient placement: Place a patient in a private room excretions. A specially fitted respirator (N95) must be who contaminates the environment or who does not (or used during patient care activities related to suspected cannot be expected to) assist in maintaining appropriate mycobacterium exposure. hygiene or environment control. If a private room is not 4. Gown: Wear a gown (a clean, nonsterile gown is ade- available, consult with infection control professionals quate) to protect skin and to prevent soiling of clothing regarding patient placement or other alternatives. during procedures and patient care activities that are 10. Respiratory hygiene/cough etiquette: Educate likely to generate splashes or sprays of blood, body health-care personnel, patients, and visitors to contain fluids, secretions, or excretions. Select a gown that is respiratory secretions to prevent droplet and fomite appropriate for the activity and the amount of fluid transmission of respiratory pathogens. Offer masks to likely to be encountered (e.g., fluid-resistant in the coughing patients, distance symptomatic patients from laboratory). Remove a soiled gown as promptly as others, and practice good hand hygiene to prevent the possible, and sanitize hands to avoid transferring transmission of respiratory pathogens. microorganisms to other patients or environments. The Occupational Exposure to Blood-Borne Pathogens 5. Patient care equipment: Handle used patient care Standard is a law monitored and enforced by OSHA.6,7 These equipment soiled with blood, body fluids, secretions, controls are required by OSHA to be provided by or mandated and excretions in a manner that prevents skin and mu- by the employer for all employees. Specific requirements of cous membrane exposure, clothing contamination, and this OSHA standard include the following: transfer of microorganisms to other patients or environ- Engineering Controls ments. Ensure that reusable equipment is not used for 1. Providing sharps disposal containers and needles with the care of another patient until it has been cleaned safety devices. 3920_Ch01_002-026 23/01/14 9:19 AM Page 7 Chapter 1 | Safety and Quality Assessment 7 2. Requiring discarding of needles with the safety device dermatitis, which produces patches of dry, itchy irritation on activated and the holder attached. the hands; delayed hypersensitivity reactions resembling poison 3. Labeling all biohazardous materials and containers. ivy that appear 24 to 48 hours after exposure; and true, imme- diate hypersensitivity reactions often characterized by facial Work Practice Controls flushing and breathing difficulties. Hand sanitizing immediately 4. Requiring all employees to practice Standard Precau- after removing gloves and avoiding powdered gloves may aid tions and documenting training on an annual basis. in preventing the development of latex allergies. Replacing latex 5. Prohibiting eating, drinking, smoking, and applying gloves with nitrile or vinyl gloves provides an alternative. Any cosmetics in the work area. symptoms of latex allergy should be reported to a supervisor 6. Establishing a daily work surface disinfection protocol. because true latex allergy can be life-threatening.10 Fluid-resistant laboratory coats with wrist cuffs are worn Personal Protective Equipment to protect clothing and skin from exposure to patients’ body 7. Providing laboratory coats, gowns, face shields, and substances. These coats should always be completely buttoned, gloves to employees and laundry facilities for nondis- and gloves should be pulled over the cuffs. They are worn at posable protective clothing. all times when working with patient specimens and are re- Medical moved prior to leaving the work area. They are changed when 8. Providing immunization for the hepatitis B virus free of they become visibly soiled. Disposable coats are placed in con- charge. tainers for biohazardous waste, and nondisposable coats are placed in designated laundry receptacles. Shoes must be 9. Providing medical follow-up to employees who have closed-toed and cover the entire foot. been accidentally exposed to blood-borne pathogens. The mucous membranes of the eyes, nose, and mouth Documentation must be protected from specimen splashes and aerosols. A va- 10. Documenting annual training of employees in safety riety of protective equipment is available, including masks and standards. goggles, full-face plastic shields that cover the front and sides 11. Documenting evaluations and implementation of safer of the face, mask with attached shield, and Plexiglas countertop needle devices. shields. Particular care should be taken to avoid splashes and aerosols when removing container tops, pouring specimens, 12. Involving employees in the selection and evaluation of and centrifuging specimens. Specimens must never be cen- new devices and maintaining a list of those employees trifuged in uncapped tubes or in uncovered centrifuges. When and the evaluations. specimens are received in containers with contaminated exte- 13. Maintaining a sharps injury log including the type and riors, the exterior of the container must be disinfected or, if brand of safety device, location and description of the necessary, a new specimen may be requested. incident, and confidential employee follow-up. Any accidental exposure to a possible blood-borne Hand Hygiene pathogen must be immediately reported to a supervisor. Evalu- ation of the incident must begin right away to ensure appropriate Hand hygiene is emphasized in Figure 1–1 and in the Standard postexposure prophylaxis (PEP). The CDC provides periodi- Precautions guidelines. Hand contact is the primary method cally updated guidelines for the management of exposures and of infection transmission. Laboratory personnel must always recommended PEP.8,9 sanitize hands before patient contact, after gloves are removed, before leaving the work area, at any time when hands have been knowingly contaminated, before going to designated Personal Protective Equipment break areas, and before and after using bathroom facilities. PPE used in the laboratory includes gloves, fluid-resistant Hand hygiene includes both hand washing and using alcohol- gowns, eye and face shields, and Plexiglas countertop shields. based antiseptic cleansers. Alcohol-based cleansers can be used Gloves should be worn when in contact with patients, speci- when hands are not visibly contaminated. They are not recom- mens, and laboratory equipment or fixtures. When specimens mended after contact with spore-forming bacteria, including are collected, gloves must be changed between every patient. Clostridium difficile and Bacillus sp. In the laboratory, they are changed whenever they become no- When using alcohol-based cleansers, apply the cleanser to ticeably contaminated or damaged and are always removed the palm of one hand. Rub your hands together and over the when leaving the work area. Wearing gloves is not a substitute entire cleansing area, including between the fingers and for hand hygiene, and hands must be sanitized after gloves are thumbs. Continue rubbing until the alcohol dries. removed. The CDC has developed hand washing guidelines to A variety of gloves types are available, including sterile and be followed for correct hand washing.1,11 Procedure 1-1 nonsterile, powdered and unpowdered, and latex and nonlatex. demonstrates CDC routine hand washing guidelines.4 More Allergy to latex is increasing among health-care workers, and stringent procedures are used in surgery and in areas with laboratory personnel should be alert for symptoms of reactions highly susceptible patients, such as immunocompromised and associated with latex. Reactions to latex include irritant contact burn patients. 3920_Ch01_002-026 23/01/14 9:20 AM Page 8 8 Part One | Background PROCEDURE 1-1 Hand Washing Procedure 3. Rub to form a lather, create friction, and loosen debris. Equipment Thoroughly clean between the fingers and under the fingernails for at least 20 seconds; include thumbs and Antimicrobial soap wrists in the cleaning. Paper towels Running water Waste container Procedure 1. Wet hands with warm water. Do not allow parts of body to touch the sink. 4. Rinse hands in a downward position to prevent recontamination of hands and wrists. 2. Apply soap, preferably antimicrobial. 5. Obtain paper towel from the dispenser. 3920_Ch01_002-026 23/01/14 9:20 AM Page 9 Chapter 1 | Safety and Quality Assessment 9 PROCEDURE 1-1—cont’d 6. Dry hands with paper towel. 7. Turn off faucets with a clean paper towel to prevent contamination. Biologic Waste Disposal All biologic waste, except urine, must be placed in appropriate containers labeled with the biohazard symbol (Fig. 1–2). This includes both specimens and the materials with which the specimens come in contact. The waste is then decontaminated following institutional policy: incineration, autoclaving, or pickup by a certified hazardous waste company. Urine may be discarded by pouring it into a laboratory sink under a Plexiglas countertop shield. Care must be taken to avoid splashing, and the sink should be flushed with water after specimens are discarded. Disinfection of the sink using a 1:5 or 1:10 dilution of sodium hypochlorite should be per- formed daily. Sodium hypochlorite dilutions stored in plastic bottles are effective for 1 month if protected from light after preparation.12 The same solution also can be used for routinely disinfecting countertops and accidental spills. The solution should be allowed to air-dry on the contaminated area. Ab- sorbent materials used for cleaning countertops and removing spills must be discarded in biohazard containers. Empty urine containers can be discarded as nonbiologically hazardous waste (Fig. 1–3). Sharp Hazards Sharp objects in the laboratory, including needles, lancets, and broken glassware, present a serious bi- ologic hazard, particularly for the transmission of blood-borne pathogens. All sharp objects must be disposed in puncture-resistant, leak-proof container with the biohazard symbol. Puncture-resistant containers should be conveniently located within the work area. The biohazard Figure 1–2 Biohazard symbol. (From Strasinger, SK, and DiLorenzo, sharp containers should not be overfilled and must always be MA: The Phlebotomy Textbook, FA Davis, Philadelphia, 2011, with replaced when the safe capacity mark is reached. permission.) 3920_Ch01_002-026 23/01/14 9:20 AM Page 10 10 Part One | Background removed as soon as possible. No attempt should be made to neutralize chemicals that come in contact with the skin. Chem- ical spill kits containing protective apparel, nonreactive absorbent material, and bags for disposing of contaminated materials should be available for cleaning up spills. Chemical Handling Chemicals should never be mixed together unless specific in- structions are followed, and they must be added in the order specified. This is particularly important when combining acid and water. Acid should always be added to water to avoid the possibility of sudden splashing caused by the rapid generation of heat in some chemical reactions. Wearing goggles and preparing reagents under a fume hood are recommended safety A precautions. Chemicals should be used from containers that are of an easily manageable size. Pipetting by mouth is unac- ceptable in the laboratory. State and federal regulations are in place for the disposal of chemicals and should be consulted. Chemical Hygiene Plan OSHA also requires all facilities that use hazardous chemicals to have a written chemical hygiene plan (CHP) available to employees.13 The purpose of the plan is to detail the following: 1. Appropriate work practices 2. Standard operating procedures 3. PPE 4. Engineering controls, such as fume hoods and flamma- bles safety cabinets 5. Employee training requirements 6. Medical consultation guidelines Each facility must appoint a chemical hygiene officer, who is responsible for implementing and documenting compliance with the plan. Examples of required safety equipment and information are shown in Figure 1–4. Chemical Labeling B Hazardous chemicals should be labeled with a description of Figure 1–3 Technologist disposing of urine (A) sample and (B) their particular hazard, such as poisonous, corrosive, flamma- container. ble, explosive, teratogenic, or carcinogenic (Fig. 1–5). The National Fire Protection Association (NFPA) has developed the Chemical Hazards Standard System for the Identification of the Fire Hazards of Materials, NFPA 704.14 This symbol system is used to inform The same general rules for handling biohazardous firefighters of the hazards they may encounter with fires in materials apply to chemically hazardous materials; a particular area. The diamond-shaped, color-coded symbol that is, to avoid getting these materials in or on bod- contains information relating to health, flammability, reactivity, ies, clothes, or work area. Every chemical in the workplace and personal protection/special precautions. Each category is should be presumed hazardous. graded on a scale of 0 to 4, based on the extent of concern. These symbols are placed on doors, cabinets, and containers. Chemical Spills and Exposure An example of this system is shown in Figure 1–6. When skin contact occurs, the best first aid is to flush the area with large amounts of water for at least 15 minutes, then seek Material Safety Data Sheets medical attention. For this reason, all laboratory personnel The OSHA Federal Hazard Communication Standard requires should know the location and proper use of emergency show- that all employees have a right to know about all chemical haz- ers and eye wash stations. Contaminated clothing should be ards present in their workplace. The information is provided 3920_Ch01_002-026 23/01/14 9:20 AM Page 11 Chapter 1 | Safety and Quality Assessment 11 in the form of Material Safety Data Sheets (MSDSs) on file in the workplace. By law, vendors are required to provide these sheets to purchasers; however, the facility itself is responsible for obtaining and making MSDSs available to employees. In- formation contained in an MSDS includes the following: 1. Physical and chemical characteristics 2. Fire and explosion potential 3. Reactivity potential 4. Health hazards and emergency first aid procedures 5. Methods for safe handling and disposal 6. Primary routes of entry 7. Exposure limits and carcinogenic potential Radioactive Hazards Radioactivity may be encountered in the clinical lab- oratory when procedures using radioisotopes are performed. The amount of radioactivity present in the clinical laboratory is very small and represents little danger; however, the effects of radiation are cumulative related to the amount of exposure. The amount of radiation exposure is related to a combination of time, distance, and shielding. Persons working in a radioactive environment are A required to wear measuring devices to determine the amount of radiation they are accumulating. Laboratory personnel should be familiar with the radioac- tive hazard symbol shown here. This symbol must be displayed on the doors of all areas where radioactive material is present. Exposure to radiation during pregnancy presents a danger to the fetus; personnel who are pregnant or think they may be should avoid areas with this symbol. Electrical Hazards The laboratory setting contains a large amount of electrical equipment with which workers have fre- quent contact. The same general rules of electrical safety observed outside the workplace apply. The danger of water or fluid coming in contact with equipment is greater in the laboratory setting. Equipment should not be operated with wet hands. Designated hospital personnel monitor electrical equipment closely; however, laboratory personnel should con- tinually observe for any dangerous conditions, such as frayed cords and overloaded circuits, and report them to the supervi- sor. Equipment that has become wet should be unplugged and allowed to dry completely before reusing. Equipment also should be unplugged before cleaning. All electrical equipment must be grounded with three-pronged plugs. B When an accident involving electrical shock occurs, the elec- trical source must be removed immediately. This must be done Figure 1–4 Chemical safety aids. A, emergency shower; B, eye wash without touching the person or the equipment involved to avoid station. (From Strasinger, SK, and DiLorenzo, MA: The Phlebotomy transferring the current. Turning off the circuit breaker, unplug- Textbook, FA Davis, Philadelphia, 2011, with permission.) ging the equipment, or moving the equipment using a noncon- ductive glass or wood object are safe procedures to follow. The victim should receive immediate medical assistance following 3920_Ch01_002-026 23/01/14 9:20 AM Page 12 12 Part One | Background A B C Figure 1–5 Chemical hazard symbols. (From Strasinger, SK, and DiLorenzo, MA: The Phlebotomy Textbook, FA Davis, Philadelphia, 2011, with permission.) discontinuation of the electricity. Cardiopulmonary resuscitation Extinguish/Evacuate—attempt to extinguish the fire, if possible (CPR) may be necessary. or evacuate, closing the door As discussed previously, laboratory workers often use Fire/Explosive Hazards potentially volatile or explosive chemicals that require special procedures for handling and storage. Flammable chemicals The Joint Commission (JC) requires that all health-care should be stored in safety cabinets and explosion-proof refrig- institutions post evacuation routes and detailed plans erators, and cylinders of compressed gas should be located to follow in the event of a fire. Laboratory personnel away from heat and securely fastened to a stationary device to should be familiar with these procedures. When a fire prevent accidental capsizing. Fire blankets may be present in is discovered, all employees are expected to take the actions in the the laboratory. Persons with burning clothes should be acronym RACE: wrapped in the blanket to smother the flames. The NFPA classifies fires with regard to the type of burning Rescue—rescue anyone in immediate danger material. It also classifies the type of fire extinguisher that is used Alarm—activate the institutional fire alarm system to control them. This information is summarized in Table 1–2. Contain—close all doors to potentially affected areas The multipurpose ABC fire extinguishers are the most common, 3920_Ch01_002-026 23/01/14 9:20 AM Page 13 Chapter 1 | Safety and Quality Assessment 13 HAZARDOUS MATERIALS floors, bend the knees when lifting heavy objects, keep long CLASSIFICATION hair pulled back, avoid dangling jewelry, and maintain a clean, HEALTH HAZARD FIRE HAZARD organized work area. Closed-toed shoes that provide maxi- Flash Point mum support are essential for safety and comfort. 4 Deadly 4 Below 73 F 3 Extreme Danger 3 Below 100 F 2 Hazardous 2 Below 200 F 1 0 Slightly Hazardous Normal Material 1 0 Above 200 F Will not burn Q UA L I T Y A SSE S SMEN T 2 The term quality assessment (QA) refers to the overall process of guaranteeing quality patient care and is regulated throughout 3 1 the total testing system. Quality system refers to all of the labo- ratory’s policies, processes, procedures, and resources needed to achieve quality testing.15 In a clinical laboratory, a quality assess- SPECIFIC HAZARD W REACTIVITY ment program includes not only testing controls, referred to as quality control (QC), but also encompasses preexamination 4 May deteriorate variables (e.g., specimen collection, handling, and storage), ex- 3 Shock and heat Oxidizer OXY may deteriorate amination variables (e.g., reagent and test performance, instru- Acid ACID 2 Violent chemical ment calibration and maintenance, personnel requirements, and Alkali ALK change Corrosive COR 1 Unstable if technical competence), postexamination variables (e.g., report- Use No Water W heated ing of results and interpretation), and documentation that the Radiation 0 Stable program is being meticulously followed. The original terms pre- analytical, analytical, and postanalytical have been replaced with Figure 1–6 NFPA hazardous material symbols. the International Organization for Standardization (ISO) standard terms of preexamination, examination, and postexamination. Included in a QA program are procedure manuals, internal but the label should always be checked before using. It is im- quality control, external quality control, electronic quality portant to be able to operate the fire extinguishers. The acronym control, calibration or calibration verification, standardization, PASS can be used to remember the steps in the operation: proficiency testing (PT), more formally known as external 1. Pull pin quality assessment (EQA),16 record keeping, equipment main- 2. Aim at the base of the fire tenance, safety programs, training, education and competency assessment of personnel, and a scheduled and documented 3. Squeeze handles review process. Essentially, QA is the continual monitoring of the 4. Sweep nozzle side to side entire test process from test ordering and specimen collection through reporting and interpreting results. Written policies and Physical Hazards documented actions as they relate to the patient, the laboratory, ancillary personnel, and the health-care provider are required. Physical hazards are not unique to the laboratory, Having written remedial actions mandating the steps to take and routine precautions observed outside the work- when any part of the system fails is essential to a QA program. place apply. General precautions to consider are to QA in the urinalysis laboratory—or any other laboratory avoid running in rooms and hallways, watch for wet department—is an integration of many factors. This section Table 1–2 Types of Fires and Fire Extinguishers Type/Composition Fire Type Extinguishing Material of Fire Extinguisher Class A Wood, paper, clothing Class A Water Class B Flammable organic chemicals Class B Dry chemicals, carbon dioxide, foam, or halon Class C Electrical Class C Dry chemicals, carbon dioxide, or halon Class D Combustible metals None Sand or dry powder Class ABC Dry chemicals Class K Grease, oils, fats Class K Liquid designed to prevent splashing and cool the fire. From Strasinger, SK and DiLorenzo, MA: The Phlebotomy Textbook, third edition, FA Davis, Philadelphia, 2011, p.73, with permission. 3920_Ch01_002-026 23/01/14 9:20 AM Page 14 14 Part One | Background will provide a collection of the procedures essential for provid- ing quality urinalysis. In the following chapters, the methods of ensuring accurate results will be covered on an individual URINALYSIS SECTION basis for each of the tests. SPECIMEN ACCEPTABILITY/LABELING Documentation of QA procedures is required by all labora- tory accreditation agencies, including the Joint Commission Prepared by: (JC), College of American Pathologists (CAP), American Associ- ation of Blood Banks (AABB), American Osteopathic Association Initial approval: (AOA), American Society of Histocompatibility and Immuno- Procedure placed in use: genetics (ASHI), and the Commission on Laboratory Assessment (COLA); it is also required for Medicare reimbursement. Guide- Revised: lines published by CAP and the CLSI provide very complete Reason for revision: instructions for documentation and are used as a reference for the ensuing discussion of the specific areas of urinalysis QC Effective Date Supervisor Approval Medical Director Approval and QA.16–18 Reviewed Documentation in the form of a procedure manual is Reviewed required in all laboratories, and this format is used as the basis for the following discussion. Reviewed Reviewed Urinalysis Procedure Manual Reviewed A procedure manual containing all the procedures performed in the urinalysis section must be available for reference in the Figure 1–7 Example of procedure review documentation. (Adapted working area and must comply with the CLSI guidelines. The from the Department of Pathology, St. Joseph Hospital, Omaha, NE.) following information is included for each procedure: principle or purpose of the test, clinical significance, patient preparation, specimen type and method of collection, specimen acceptability between departments and adequate training on the correct pro- and criteria for rejection, reagents, standards and controls, instru- cedures for ordering a test, collecting, and transporting the spec- ment calibration and maintenance protocols and schedules, step- imen improves the turnaround time (TAT) of results, avoids by-step procedure, calculations, frequency and tolerance limits duplication of test orders, and ensures a high-quality specimen. for controls and corrective actions, reference values and critical TAT is defined as the amount of time required from the point values, interpretation of results, specific procedure notes, limita- at which a test is order