Ab: Antibody ABGs: Arterial blood gases ABN: Advanced Beneficiary Notice of Noncoverage ABO: Blood Group ACTH: Adrenocorticotropic hormone ADA: American Diabetes Association ADH: Antidiuretic hormone Ag: Antigen AIDS: Acquired immune deficiency syndrome ALP: Alkaline phosphatase ALT: Alanine aminotransferase AMT: American Medical Technologists ANA: Antinuclear antibody aPTT: Activated partial thromboplastin time (PTT) ASAP: As soon as possible ASCP: American Society for Clinical Pathology ASO: Antistreptolysin O AST: Aspartate aminotransferase BBPs: Bloodborne pathogens bid: Two times daily BMI: Body mass index BMP: Basic metabolic panel BNP: Brain natriuretic peptide BSI: Body substance isolation BT: Bleeding time BUN: Blood urea nitrogen Bx: Biopsy C&S: Culture and sensitivity Ca: Calcium CAP: College of American Pathologists CBC: Complete blood count CDC: Centers for Disease Control and Prevention CEA: Carcinoembryonic antigen CK: Creatine kinase CK-BB, -MB, -MM: Creatine kinase isoenzymes Cl: Chloride CLIA ‘88: Clinical Laboratory Improvement Amendment of 1988 CLSI: Clinical and Laboratory Standards Institute CMP: Comprehensive Metabolic Panel CMS: Centers for Medicare & Medicaid Services CMV: Cytomegalovirus CO 2 : Carbon dioxide COC: Chain of custody COLA: Commission on Laboratory Assessment COPD: Chronic obstructive pulmonary disease CPT: Current procedural terminology CRP: C-reactive protein

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Constance L. Lieseke, CMA (AAMA), PBT, MLT(ASCP) Medical Assisting Faculty and Program Coordinator Business and Technology Division Olympic College Bremerton, Washington Elizabeth A. Zeibig, PhD, MLS(ASCP) Associate Dean for Graduate Education Doisy College of Health Sciences Associate Professor Department of Clinical Laboratory Science Saint Louis University St. Louis, Missouri F. Davis Company 1915 Arch Street Philadelphia, PA 19103 fadavis Copyright © 2012 by F. Davis Company Copyright © 2012 by F. 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 permis sion 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: Andy McPhee Manager of Content Development: George W. Lang Developmental Editor: Karen Lynn Carter Design and Illustration 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

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Histology/Pathology: Tissue samples examined for abnormal function and form. Test Your Knowledge 1- Which laboratory department would perform a test to see if someone had a pathogenic microorganism in a wound? (Outcome 1-3) WHY IS LABORATORY TESTING PERFORMED? Laboratory testing is critical for appropriate patient treatment. The results obtained from a blood test or evaluation of other types of specimens from the human body are essential for the health-care provider to gain information that is not available through the patient history or physical examination. Health-care providers generally order laboratory tests for at least one of these reasons:

Test Your Knowledge sections offer self-assessment questions coded to the appropriate learning outcomes and are strategically placed throughout the chapter. Tables, figures, and procedures coded to CAAHEP and ABHES standards complement the organized, logically presented chapter content. Following a chapter sum mary readers have an opportunity to review content through a series of questions and a chapter case study, a component called Time to Review. A list of resources and suggested readings is included at the end of each chapter. The feature What Does It All Mean? is located at the end of each section and reiterates the purpose of the section and its importance to medical assistants and other health-care professionals. The case study intro duced in On the Horizon is revisited here and discussed. This discussion does not include the answers to ques tions posed for consideration. The answers to those questions may be found in the Instructor’s Guide. An interactive CD-ROM is packaged with this text, allowing students an opportunity to apply their knowl edge in a variety of situations. There are a total of 29 exercises available in the following formats: Don’t Tip the Scale, Drag and Drop, Multiple Choice, Picture It, and Quiz Show. Students will find an additional 12 interactive activities on the F. Davis website at davisplus. com/ keyword Lieseke. Instructors will find an electronic test bank, chapter-by-chapter PowerPoints, and numerous other instructional resources on DavisPlus. In addition to the core chapter content, a compre hensive list of abbreviations is included at the begin ning of the book for quick reference. A list of all CAAHEP and ABHES competencies covered in each chapter also appears in the front of the book, to quickly access information about specific procedures. A list of reference ranges for common laboratory tests are included in the appendices and a complete glossary of key terms follows. We’ve made every effort to create an accurate, reader friendly, informative text that contains practical infor mation about the clinical laboratory and the medical assistant’s role in it. We hope you find this book to be a rich and rewarding resource for your studies. — Constance A. Lieseke Elizabeth A. Zeibig vii Nikki A. Marhefka, EdM, MT(ASCP), CMA (AAMA) Medical Assistant Program Director Central Penn College Summerdale, Pennsylvania

Complete blood counts (CBCs) and other hematology testing Hospital laboratories may also offer another method for testing samples, called point-of-care testing (POCT). Point-of-care tests are actually performed at the patient’s bedside rather than in the laboratory, using a portable instrument that gives immediate results. These tests may be performed by laboratory personnel or in some situations by other hospital employees who have been trained to perform the testing. Reference Laboratories Reference laboratories perform more tests annually than either POLs or the hospital laboratories, processing perhaps thousands of specimens per day. These tests in clude those that are performed at hospital laboratories, but reference laboratories may offer specialized testing that is not performed at either hospital laboratories or POLs. Specimens may

6-1 Microscope Use, 99 6-2 Operating the Centrifuge, 105 8-1 Venipuncture Using the Evacuated Tube System, 154 8-2 Venipuncture Using a Syringe, 162 8-3 Venipuncture Using the Butterfly (Winged Infusion) System, 169 8-4 Blood Collection From a Capillary Puncture, 176 8-5 Creation of Peripheral Blood Smear, 186 8-6 Quick Stain of Peripheral Smear Using Camco Quik Stain II, 190 9-1 Instructing a Patient for Collection of a Clean-Catch Midstream Urine Specimen for Urinalysis and/or Culture, 199 9-2 Instructing a Patient for Collection of a 24-Hour Urine Specimen, 207 10-1 Collection of a Throat Specimen for Culture or Strep Screen, 225 10-2 Blood Culture Collection Procedure, 230 10-3 Gram- Staining Procedure, 245 10-4 Quadrant Streaking Inoculation Procedure, 248 13-1 CLIA–Waived Hemoglobin Testing Using the HemoCue Hemoglobin Analyzer, 290 13-2 CLIA–Waived Hematocrit Testing Using the StatSpin CritSpin Microhematocrit Centrifuge and Digital Reader, 295 14-1 Perform CLIA–Waived Sediplast Westergren Erythrocyte Sedimentation Rate, 308 15-1 CLIA–Waived Prothrombin Time/INR Testing Using the CoaguChek S Instrument, 320 17-1 Performance of HbA1c Using Bayer’s A1c Now plus System, 363 17-2 Performance of Whole Blood Glucose Testing, 366 18- Cholesterol Testing Using the Cholestech LDX® System, 374 18-2 Electrolyte Testing Using an Abbott iSTAT Chemistry Analyzer, 381 20-1 Observation and Documentation of Urine Physical Properties, 408 21-1 CLIA–Waived Chemical Examination of Urine Using Manual Reagent Strip Method, 425 21-2 Chemical Examination of Urine Using Automated Reagent Strip Method, 427 21-3 Fecal Occult Blood Testing Using Guaiac Method, 432 21-4 Fecal Occult Blood Testing Using iFOB Quickvue Method, 434 22-1 Preparation of Urine Sediment for Microscopic Examination, 448 22-2 Focusing the Urine Sediment Under the Microscope, 450 24-1 Perform a CLIA-waived Rapid Strep Screening, 477 24-2 CLIA- waived Mononucleosis Testing Using an OSOM Mononucleosis Testing Kit, 479 24-3 CLIA–Waived Urine HCG Testing Using the Beckman Coulter Icon 25 Testing Kit, 483 xv

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Cholesterol testing Physician office laboratories may also provide testing that is more complex if staff members are properly Chapter 1 The Clinical Laboratory 7 trained to perform such procedures. More details about the Clinical Laboratory Improvement Amendment and the classification of laboratory tests are provided in Chapter 2. Hospital Laboratories Hospital laboratories generally offer laboratory test ing that meets the needs of their respective institution. For instance, if a hospital specializes in a certain type of surgical procedure or treatment, the hospital labora tory will offer extensive testing in that specialty area, in addition to the standard tests required to monitor the health of the other patients in the hospital. In most situations, hospital laboratories perform high volumes of routine test procedures. Hospital laboratories may also serve as a reference laboratory for the local com munity, especially for STAT testing needs. (STAT tests are those that require immediate results.) Tests performed at a hospital laboratory may include the following:

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If the test was ordered as STAT, it needs to be drawn and processed immediately. It may be necessary to contact a laboratory courier to pick up the sample immediately, or to notify the technician that there is a STAT order. Continued 14 Section I Overview of the Laboratory Procedure 1-1: Completing a Laboratory Requisition— cont’dProcedure Rationale 11. Check the requisition for an ICD-9 code for each test to be performed. If a code is not present, con tact the health-care provider or check the chart to obtain a code. 12. Have the patient wait in a comfortable environ ment until the sample can be collected. Place the requisition in an appropriate location to alert other staff members that a specimen collection is waiting. reimbursement for laboratory services. It is specifically used for patients who have Medicare Part B as their primary insurance coverage. The purpose of an ABN is to inform Medicare-covered patients that payment may be denied for a specific laboratory test and that the patient will be billed for the full cost of that test if he or she chooses to have it performed. The ABN al lows the patients to make an informed decision about whether they wish to have the tests performed, with the realization that they may be responsible for the total cost. The ABN must be verbally reviewed with the pa tient, and any questions about potential reimburse ment must be answered before it is signed, whether or not the patient wishes to have the laboratory work per formed. This process must occur before the specimen is collected from the patient. The person collecting the specimen must ensure that the test ordered has been identified on the ABN form and that there is docu mentation of the anticipated reason for noncoverage. Figure 1- shows an example of an ABN. The em ployee filling out the form also must provide an esti mated cost in writing so that the patient knows what the financial responsibility may be if he or she decides to have the laboratory test performed. The patient’s decision about having the test performed must be doc umented on the form, along with the patient’s signa ture and that day’s date. The patient must receive a copy of the form after it is signed, and a copy must also be kept on file with the laboratory. Medicare coverage for laboratory tests may be denied for various reasons, including frequency of testing, the diagnosis provided by the health-care provider for a spe cific test, or because the test ordered is considered exper imental. Whenever a patient with Medicare coverage has An ICD-9 code is necessary for every test for success ful reimbursement. Sometimes the employee who fills out the requisition is not the same person who will collect the sample. a specimen collected, the laboratory employee responsible for the specimen collection must verify whether the test ordered will be covered by Medicare for the reason that the test is ordered. The regulations affecting coverage are different for geographical regions across the country, and change frequently. Most laboratories now have a way to verify coverage by using a computer database, but it can be difficult to keep abreast of changes. It is unlawful to have every Medicare patient fill out an ABN “just in case”; it is the responsibility of those collecting the speci men to make their best effort to verify coverage before an ABN is signed. The format for this Advance Beneficiary Notice of Noncoverage document is defined by the Centers for Medicare & Medicaid Services (CMS), and is updated periodically (CMS document number CMS-R- 131). Medicare bases its decision for coverage on “medical necessity” rules, which define those tests that the agency deems medically necessary for specific health conditions, and how frequently these tests should be performed. It is important to remember that just be cause Medicare has limited coverage on specific tests, the patient should never be told that the health-care provider gave a “bad code” or that the test was ordered for the “wrong reason.” Test Your Knowledge 1- What is the purpose of an ABN? (Outcome 1-7) Laboratory Directory As discussed, laboratory requisitions often provide in formation about what type of tube to use for a blood draw for a specific test by using a code or symbol, but CB LABORATORY 2692 Millenium Rd. • Seattle, WA 98103 425-353- Chapter 1 The Clinical Laboratory 15 ADVANCE BENEFICIARY NOTICE (ABN) Patient’s Name: John Smith Identification Number : 23995500 ADVANCE BENEFICIARY NOTICE OF NONCOVERAGE (ABN) NOTE: If Medicare doesn’t pay for the Laboratory Test(s) Below you may have to pay. Medicare does not pay for everything, even some care that you or your health-care provider have good reason to think you need. We expect Medicare may not pay for the Laboratory Test(s) below. Laboratory Test(s): Reason Medicare May Not Pay: Estimated Cost: PROSTATIC SPECIFIC AG TSH WHAT YOU NEED TO DO NOW: Denied as too frequent Denied for your condition $50 $41.

he clinical laboratory plays a vital role in patient care. Diagnostic puzzles are solved each day by us ing results obtained from testing procedures performed on blood, tissue, and other body fluids. Quality patient care depends on excellent laboratory practices, so it is important to build a solid understanding of the structure and function of the clinical laboratory before performing testing procedures. This chapter explains the reasons that laboratory testing may be ordered and identifies the types of laboratories where testing is performed. The role of the medical assistant in the clinical laboratory as well as the roles played by other laboratory personnel are also introduced. To expand understanding of how the clini cal laboratory operates, the flow of information in the laboratory setting is also explained. THE CLINICAL LABORATORY A clinical laboratory is any place where specimens from the human body may be collected, processed, examined, or analyzed. With this broad definition in mind, then, a laboratory might be someone’s home, a long-term care facility, the office of a health-care provider, a free clinic, a hospital, a small facility used strictly for specimen col lection and processing, or a large and complex reference laboratory. As of January 2010, the Centers for Medicare & Medicaid Services identified more than 216,000 clin ical laboratories in the United States. 1 To simplify our discussion of the various types of laboratories, we will classify them into three basic groups as described below (Table 1-1). Physician Office Laboratories Physician office laboratories (POLs) are clinical laborato ries within physician offices where laboratory testing is carried out on specimens obtained from the practices’ own patients. More than half of all the laboratories in the United States are POLs. This type of laboratory can be advanta geous because the results for tests performed on site are available quickly and patient treatment can begin immedi ately if necessary. Testing and specimen collection in these office laboratories may be accomplished by various mem bers of the health-care team, such as medical assistants, 1 Data From CLIA Update—January 2010 Division of Laboratory Services Centers for Medicare & Medicaid Services Laboratories by Type of Facility cms/CLIA/downloads/factype.pdf TABLE 1- Types of Laboratories and Sample of Testing Performed Type of Laboratory Testing Performed Physician office CLIA-waived tests laboratory Moderate complexity testing (with appropriate training, staffing, and supervision) Microscopic examinations (performed by health-care provider or qualified staff) Hospital laboratory CLIA-waived tests CLIA moderate- and high-complexity tests (based on the needs of the patients served in the facility) Point-of-care testing Microscopic examinations Reference laboratory CLIA-waived tests Moderate- and high-complexity tests Microscopic examinations clinical or medical laboratory technicians who have been trained in laboratory testing, or phlebotomists who are trained to draw blood and perform some simple laboratory procedures. These ambulatory (outpatient) laboratories generally perform low complexity tests that are designated as Clinical Laboratory Improvement Amendment–waived (CLIA-waived) tests by the U. Food and Drug Adminis tration (FDA). CLIA-waived tests are laboratory examina tions and procedures that use simple and accurate methods requiring very little interpretation to report correct results. These tests may include the following:

Clinical Laboratory Improvement Amendment of 1988 29 CHAPTER 3. Laboratory Safety and Preventing the Spread of Disease 35 Infection Control and Laboratory Safety 37 Core Concepts of Infection Control 37 Laboratory Safety 48 Diseases Caused by Bloodborne Pathogens in the Laboratory Setting 55 Postexposure Follow-up Procedure 58 CHAPTER 4. Assuring Quality 63 Assuring Quality in the Laboratory 64 Quality Control and Quality Assurance 64 What Is Quality? 65 Other Methods of Assuring Laboratory Quality 73 CHAPTER 5. Legal and Ethical Issues 83 Legal and Ethical Issues in the Laboratory Environment 84 Laws and Ethics 84 Legal Concepts Affecting Patient Interactions 85 Health Information Portability and Accountability Act 88 Ethics 90 Risk Management and the Medical Assistant 92 CHAPTER 6. Laboratory Equipment 95 Laboratory Equipment 96 Equipment Used for Automated Clinical Laboratory Improvement Amendment– Waived Testing 107 SECTION II. Specimen Collection and Processing 118 CHAPTER 7. Overview of Specimen Collection and Processing 121 Specimen Ordering 122 Patient Identification 125 Patient Preparation 126 Specimen Collection at Home 127 Items That Must Be Documented With Specimen Collection 127 Labeling Information 128 Chain of Custody 128 CHAPTER 8. Collection and Processing of Blood Samples 133 Anatomy and Physiology of the Cardiovascular System 135 Site Selection 138 Contraindications and Areas to Avoid 140 Venipuncture Equipment 143 Methods Used for Venipuncture 146 Blood Collection Tubes 147 Order of Draw for Venipuncture 150 Capillary Punctures 150 Preparation for Blood Collection 152 Specimen Processing 153 Potential Negative Outcomes of Venipuncture and Capillary Puncture 184 Other Processing Procedures 186 Preparation of a Peripheral Blood Smear for Staining 186 Wright’s Stain Procedure 189 xxi xxii Contents CHAPTER 9. Collection and Processing of Urine Samples 195 Types of Urine Specimens 196 Urine Specimen Processing 210 CHAPTER 10. Collection and Processing of Samples for Microbial Studies 215 Microbiology Sample Collection Guidelines 218 Detailed Microbiology Sample Collection Procedures 223 Special Sample Collection and Processing Procedures 240 Processing Microbiology Samples 244 Microbiology Test Results 251 SECTION III. Hematology and Coagulation 256 CHAPTER 11. Overview of Hematology, Nikki A. Marhefka 259 Hematopoiesis—Blood Cell Formation 260 Types of Blood Cells in the Circulating Blood 263 Analysis of the Formed Elements 266 CHAPTER 12. Complete Blood Count With Differential, Nikki A. Marhefka 269 Complete Blood Count 270 Automated Analyzers for Complete Blood Count Testing 279 CHAPTER 13. Hemoglobin and Hematocrit, Nikki A. Marhefka 285 Hemoglobin 286 Hemoglobinopathies 287 Hemoglobin Testing 288 Hematocrit 293 The Relationship of Hemoglobin and Hematocrit Values 299 Anemia 299 CHAPTER 14. Erythrocyte Sedimentation Rate, Nikki A. Marhefka 303 Erythrocyte Sedimentation Rate 304 Plasma Proteins Affecting the Erythrocyte Sedimentation Rate 304 The Influence of Red Blood Cells on the Erythrocyte Sedimentation Rate 305 Reference Ranges 305 Clinical Significance of Erythrocyte Sedimentation Rate Testing 305 Erythrocyte Sedimentation Rate Determination 306 Potential Sources of Error for the Erythrocyte Sedimentation Rate Procedure 307 CHAPTER 15. Coagulation Studies 313 Purpose of Coagulation Studies 314 Mechanisms of Blood Clotting 315 Disorders Diagnosed or Monitored With Laboratory Coagulation Tests 316 Laboratory Tests Used to Diagnose Coagulation Disorders or Monitor Anticoagulant Therapy 318 Specimen Requirements for Coagulation Testing 327 SECTION IV. Cl inical Chemistry 332 CHAPTER 16. Overview of Clinical Chemistry 335 Clinical Chemistry 336 Specimen Types Used for Clinical Chemistry Analysis 337 CLIA–Waived Clinical Chemistry Test 338 Other Common Clinical Chemistry Tests 340 Reference Ranges 342 Potential Sources of Error 342 CHAPTER 17. Glucose Testing 349 Glucose Utilization and Control Mechanisms 351 Pathophysiology of Glucose Metabolism 352 Types of Glucose Tests Performed 356 Glucose Testing Methods 361 CHAPTER 18. Other Select Chemistry Tests 371 Lipid Testing 372 Electrolytes 378

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Roxanne Alter, MS, MT(ASCP) Assistant Professor Clinical Laboratory Science Program University Nebraska Medical Center School of Allied Health Professions Omaha, Nebraska Lou M. Brown, MT(ASCP), CMA (AAMA) Program Director Medical Assisting and Phlebotomy Wayne Community College Goldsboro, North Carolina Catherine Chevalier, CMA (AAMA), CPT, AS Externship Coordinator and Assistant Professor Medical Assisting Hesser College Manchester, New Hampshire Susan Conforti, EdD, MT(ASCP)SBB Assistant Professor Medical Laboratory Technology Program Farmingdale State College School of Health Sciences Farmingdale, New York Andrea Renea Craven, MLT, RMA, BCLS Instructor Medical Assisting Richmond Community College Hamlet, North Carolina Anne Davis-Johnson CMA (AAMA) Medical Assisting Instructor Health Sciences Central Carolina Community College Lillington, North Carolina Deborah R. Flowers, MS Instructor Medical Assisting Guilford Technical Community College Jamestown, North Carolina Mary Gjernes, MLT(ASCP), CLT, CMA (AAMA) Director Medical Assisting Program Presentation College Allied Health Department Aberdeen, South Dakota Cheri Goretti, MA, MT(ASCP), CMA (AAMA) Associate Professor and Coordinator Medical Assisting and Allied Health Programs Quinebaug Valley Community College Danielson, Connecticut Debbie Heinritz, MT(ASCP), CLS(NCA) Instructor Clinical Laboratory Technician Program Northeast Wisconsin Technical College Health Sciences Department Green Bay, Wisconsin Lynne Hendrick, CMA (AAMA) Instructor and Chair Medical Assistant Program Globe University Minnesota School of Business Elk River, Minnesota Hiba M. Ismail, MLS(ASCP) Instructor Health and Human Services Youngstown State University Youngstown, Ohio Sharon M. King, RT(CSMLS), BS, MEd, H(ASCP) Instructor Allied Health Massasoit Community College Canton, Massachusetts xi xii Reviewers Michelle Mantooth, MSc, MLS(ASCP), CG (ASCP) Faculty Allied Health Trident Technical College Charleston, South Carolina Patrice Nadeau, MS MT(ASCP) Program Director, Medical Assistant Health and Human Services Dakota County Technical College Rosemount, Minnesota Joyce B. Thomas, CMA (AAMA) Instructor Medical Assisting Central Carolina Community College Pittsboro, North Carolina Lynette M. Veach, CMA, MLT(ASCP) Former adjunct faculty member Medical Assisting Technology Columbus State Community College Columbus, Ohio Jo Ann Wilson, PhD Professor, Director of Professional Programs Biological Sciences Florida Gulf Coast University Fort Myers, Florida Stacey F. Wilson, MT/PT(ASCP), CMA (AAMA), MHA Program Chair Medical Assisting Cabarrus College of Health Sciences Concord, North Carolina Carole A. Zeglin, MS, BS, MT, RMA Asst. Professor/Director Medical Assisting/ Phlebotomy Programs Health Professions Westmoreland County Community College Youngwood, Pennsylvania Dianna Zometsky, CMA (AAMA), CMM Medical Assisting Instructor Health Science Lorenzo Walker Institute of Technology Naples, Florida

SECTION V. Urinalysis 388 CHAPTER 19. Urinalysis 391 Historical Perspective of Urinalysis 392 Anatomy and Physiology of the Urinary System 393 Sequence of Urine Production and Excretion 396 Clinical Significance of Urine Testing Results 396 Quality Assurance for Urine Testing Procedures 398 Standard Precautions Used When Analyzing Urine Specimens 398 Types of Urine Specimens 398 CHAPTER 20. Physical Characteristics of Urine 401 Physical Characteristics of Urine 402 Potential Sources of Error 407 CHAPTER 21. Chemical Examination of Urine and Feces 413 Urine Analytes and Their Clinical Significance 414 Potential Sources of Error 420 Safety Precautions 422 Quality Control Procedures 422 Urine Testing Methods 422 Confirmatory Urine Testing 424 Fecal Occult Blood Testing 430 CHAPTER 22. Microscopic Examination of Urine 439 Reasons for Performing Urine Microscopic Examinations 440 Common Formed Elements in the Urine and Their Clinical Significance 440 Methods Used for Urine Microscopic Examinations 447 Reporting Urine Microscopic Results 447 Role of the Medical Assistant in Microscopic Urine Examination Procedures 452 Quality Control and Quality Assurance Procedures for Urine Microscopic Examinations 452 Contents xxiii SECTION VI. Immunology 456 CHAPTER 23. Immunology 459 Immunity and Immunology 460 The Immune Process 461 How Immunity Is Acquired 464 Failure of Our Immune Systems 465 Blood Types 465 Immunology Testing Methods 468 Common Serology Tests Performed in Reference or Hospital Laboratories 468 CLIA–Waived Tests Commonly Performed in the Physician Office Laboratory 469 CHAPTER 24. Immunological Based Rapid Testing 473 Immunology Methods and Procedures 474 Rapid Testing 475 Common CLIA–Waived Rapid Tests and Their Clinical Significance 476 APPENDIX A: Reference Ranges 491 APPENDIX B: Answers to Test Your Knowledge Questions 493 APPENDIX C: Tube Guide for BD Vacutainer Venous Blood Collection 505 GLOSSARY 507 INDEX 529 On the Horizon Laboratory testing is an essential component of effec tive patient care. The results obtained from labora tory testing provide valuable information that assists physicians and other primary health providers with the diagnosis and monitoring of disease. Relevance for the Medical Assistant (Health- Care Provider) Medical assistants and other health-care support personnel are frequently involved in the collection of samples for laboratory testing. In many settings, Case in Point It is the first week of your student practicum at Maple Grove Clinic. You have been assigned to work for Dr. Pueblo under the direction of your clinical instructor, Doris. The sec ond patient of the day is Mr. Hershey. You observe Doris interact with Mr. Hershey and perform the preliminary ap propriate tasks associated with Mr. Hershey’s appointment. After examining the patient, Dr. Pueblo emerges and in forms Doris that he will be ordering laboratory tests. Doris takes this opportunity to introduce you to the laboratory. Questions for Consideration:

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Laboratory Departments Why Is Laboratory Testing Performed? The Role of the Medical Assistant in the Clinical Laboratory Information Flow in the Clinical Laboratory Laboratory Requisitions Advance Beneficiary Notice of Noncoverage Laboratory Directory Laboratory Reports Three Phases of Laboratory Testing Summary Time to Review Case Study Resources and Suggested Readings Learning Outcomes After reading this chapter, the successful student will be able to: 1-1 Define the key terms for this chapter. 1-2 Describe the different types of laboratories pre sented in the text and the common tests available in each. 1-3 Identify the different departments in a hospital or reference laboratory and list some of the tests performed in these departments. 1-4 Provide several reasons that laboratory testing might be performed. 1-5 Explain the roles a medical assistant might play in a laboratory setting. 1-6 List and justify the various pieces of information that must be included on a laboratory requisition. 1-7 Explain the concept of Advance Beneficiary No tice of Noncoverage (ABN) and how it affects laboratory reimbursement. 1-8 Explain the purpose of a laboratory directory, as well as how a laboratory directory may be used when preparing to collect a specimen. 1-9 Compare and contrast the function of a labora tory requisition and a laboratory report. 1-10 Identify the different phases of laboratory test ing, and explain the flow of the laboratory testing process. 1-11 Provide examples of preanalytical, analytical, and postanalytical procedures and how they affect the quality of laboratory testing. 5 6 Section I Overview of the Laboratory CAAHEP/ABHES STANDARDS CAAHEP 2008 Standards II.A: Distinguish between normal and abnormal test results KEY TERMS ABHES Standards • None Advance Beneficiary Notice of Noncoverage (ABN) Ambulatory Asymptomatic CLIA-waived Complexity CPT code Efficacy Hospital laboratories ICD-9 code Laboratory Laboratory directory Laboratory report Laboratory requisition Normal ranges Panels Physician office laboratories (POLs) Plasma Point-of-care testing (POCT) Profiles Quality control (QC) Reference laboratories Reference ranges Serum Specimens STAT

Patient (Last, First, MI) Chapter 1 The Clinical Laboratory 11 774911 CB LABORATORY Sex Male Female Patient Number Date of Birth (required) Room # 774911 CLIENT ACCOUNT NO. 790338 Shore Physicians 13 Waterview Dr. Guarantor Required if insurance or patient billing Address Day Phone PM Phone 774911 Seattle, WA 98103 City State Zip 774911 CALL RESULTS TO: FAX RESULTS TO: 425-377-8571 425-792-1608 INSURANCE INFO (PLEASE ATTACH COPY OF CARD, W/GROUP # & ADDRESS) 774911 ORDERING PRACTITIONER - FULL NAME(S) REQUIRED DRS NAME (Last, First, MI): ADDL. COPY TO: ADDRESS: 774911 PATIENT RELATIONSHIP TO SUBSCRIBER: SPOUSE CHILD OTHER PHONE: FAX: ADDITIONAL TESTS/COMMENTS - DIAGNOSIS CODES REQUIRED FOR EACH TEST ORDERED Collection Code: B = LIGHT BLUE FS = FROZEN SERUM L = LAVENDER R = RED TOP (PLAIN) S = SERUM (GOLD TOP OR TIGER TOP) U = URINE Specimen Information STAT Phone ( ) TESTS HIGHLIGHTED IN RED OR MARKED WITH A Δ MAY REQUIRE A SIGNED ADVANCE BENEFICIARY NOTICE (ABN), IF BILLING MEDICARE. ADDITIONAL LCD TESTS NOT LISTED MAY REQUIRE AN ABN. orFax ( )Collected by Date Drawn Time DrawnA. P. Fasting Random 24 Hour Urine Volume CPT Tests or Panels ICD9-CM CPT Tests or Panels (cont’d) ICD9-CM CPT Single Tests (cont’d) ICD9-CM CPT Single Tests (cont’d) ICD9-CM Panel or Single tests may be selected Panel or Single tests may be selected 82378 CEA 84702 Beta HCG Quant S S 80051 Electrolytes Panel 80069 Renal Function Panel 82550 CK (CPK) S S S 84146 Prolactin S 84295 84132 82435 Sodium Potassium Chloride S S S 84100 Phosphorus S 80162 80101 Digoxin Drug, Screen, Urine R U 84153 G 85610 PSA PSA Screen PT with INR S S B 82374 Carbon Dioxide S 80061 Lipid Profile S x7 Is pt. taking Coumadin? Y N 80048 Basic Metabolic Panel S 82465 Cholesterol S 82728 Ferritin S 85730 PTT B 80051 Na, K, CL, CO S 84478 Triglycerides S 82746 Folate FS Is pt. taking Heparin? Y N 84520 82310 82465 82947 80053 80048 82040 84075 82247 84450 BUN Calcium Creatinine Glucose Comprehensive Metabolic Panel Basic Metabolic Panel Albumin Alkaline Phos. Bilirubin, Total SGOT/AST S S S S S S S S S S 83718 80074 86709 86705 87340 86803 HDL Cholesterol Acute Hepatitis Panel Hepatitis A Antobidy IGM Hepatitis B Core Antibody IGM Hepatitis B Surface Antigen Hepatitis C Antibody S S S S S S 83001 82977 83036 85014 85018 86701 83540 83550 83615 FSH Gamma GT Hgb A1C (Glycohemo) Hematocrit Hemoglobin HIV 1 Ab w/Western Blot confirmation Iron Iron Binding (TIBC) LD (LDH) FS S L L L S S S S 85044 86592 86762 85651 84480 84479 84439 84436 84403 80198 84443 Retic Count RPR Rubella Ab Sed Rate T3 Total T3 Uptake T4 Free T4 Total Testosterone Total Theophylline TSH L S S L S S S S S R S 84460 SGPT/ALT S CPT Single Tests ICD9-CM 83002 LH Luteinizing Hormone FS 81001 Urinalysis w/Micro, 84155 80076 82040 Total Protein Hepatic Function (Liver) Panel Albumin S S S 86900 86901 86850 ABO Blood Group RH (D) Type Antibody Screen L, R L, R L, R 80178 83735 86308 80184 Lithium Magnesium Mono Phenobarbital R S S R 82575 84156 84540 auto if indicated Urine Creatinine Clearance 24 hr Urine Total Protein 24 hr Urine Urea Nitrogen 24 hr U U/S U U 82247 82248 84450 84460 Bilirubin, Total Bilirubin, Direct AST/SGOT ALT/SGPT S S S S 82150 86038 82607 86141 Amylase Antinuclear Antibody B- 12 Vitamin hs-CRP S S FS S 80185 85049 84703 81025 Phenytoin/Dilantin Platelet Count Auto Pregnancy, Qual. Serum Pregnancy, Qual. Urine R CPT Microbiology ICD9- CM L Aerobic Culture Source S U Anaerobic Culture 84075 Alkaline Phos. S 80156 Carbamazepine/Tegretol R REQUIRED LAST CODE Source 84155 Total Protein S 85025 85007 CBC w/auto diff Manual Diff. L L DATE TIME A. P. Other Source Other Tests Only tests or Medicare Approved Panels that are medically necessary for the diagnosis or treatment of a Medicare or Medicaid patient will be reimbursed. Screening tests will not be reimbursed and should not be submitted for payment. The OIG states that a physician who orders medically unnecessary tests for which Medicare or Medicaid reimbursement is claimed may be subject to civil penalties under the False Claims Act. Figure 1-1 Sample laboratory requisition. Current Procedural Terminology © 2011 American Medical Association, All Rights Reserved. 12 Section I Overview of the Laboratory document the tests that are to be performed for a pa tient. The form is filled out by the health-care provider who orders the test or by the provider’s office staff. This requisition must be complete with various data linking the patient to the tests ordered, and must provide billing information for that patient. The laboratory staff will use this requisition to enter the orders into their database for the patient, and the form is often used for reimburse ment procedures as well. Although all laboratories may use unique formats, standardized information should be present on all requisitions for testing and reimbursement purposes:

Urinalysis: The physical appearance of urine is assessed, and urine chemical and microscopic analysis is per formed. - Microbiology/Parasitology: Identification of patho genic microorganisms and antibiotic sensitivity testing. • Cytology: Examination of various specimens for ab normal cells, chromosomal studies, Pap smears. • Coagulation: Specimens testing for the presence of various clotting factors.

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Nancy M. Jones-Bermea, BS (Education), BA (Education), BS (Business Administration) Professor, Business and Technology Division Olympic College Bremerton, Washington ix

appropriately trained individuals in alterna tive settings, such as in physician offices. Medical assistants and phlebotomists may be called upon to perform this testing. It is thus imperative that individu als who collect or oversee collection of samples for laboratory testing, perform laboratory tests, or interpret laboratory test results be educated in this important area of medicine. The purpose of this text is to introduce the reader to the clinical laboratory. The text is organized into six sections. Each of these sections is presented as a com plete package. Section I covers the structure and organi zation of the clinical laboratory and important consider ations, including regulations, safety, quality, legal and ethical issues, and laboratory equipment. Section II introduces the importance of techniques associated with proper specimen collection and handling. The remaining sections are dedicated to specific laboratory tests organized by general type: hematology, chemistry, urinalysis, and immunology. Each section opens with On the Horizon, an overview of the chapters in that section. On the Horizon consists of a content overview, and a description of the relevance of the content to medical assistants and other health-care professionals. A patient scenario called Case in Point follows, and then a series of questions about upcoming content, called Questions for Consideration. Completing this section are brief narratives that summarize each chapter in the section. Chapters begin with a Chapter Outline for easy refer ence. Learning Outcomes appear next. These serve as a helpful resource to guide readers as they study chapter content. A list of References to the Commission on Accreditation of Allied Health Education Programs (CAAHEP) and the Accrediting Bureau of Health Education Schools (ABHES) standards appear after the Learning Outcomes. Key Terms then follow organized in alphabetical order. Each key term is bolded and defined, as appropriate, where the term first appears in the text.

CSF: Cerebrospinal fluid DIC: Disseminated intravascular coagulation Diff: White blood cell differential DOB: Date of birth DVT: Deep vein thrombosis Dx: Diagnosis EBV: Epstein-Barr virus ECG/EKG: Electrocardiogram EDTA: Ethylenediaminetetraacetic acid EIA: Enzyme immunoassay ESR: Erythrocyte sedimentation rate FBS: Fasting blood sugar FDA: Food and Drug Administration FDPs: Fibrin degradation products FOBT: Fecal occult blood testing FPG: Fasting plasma glucose FSH: Follicle-stimulating hormone FTA-ABS: Fluorescent treponemal antibody-absorbed FUO: Fever of unknown origin G/gm/g: Gram GGT: Gamma glutamyl transferase GH: Growth hormone GTT: Glucose tolerance test HAI: Health-care acquired infection H. pylori: Helicobacter pylori H&H: Hemoglobin and hematocrit HAV: Hepatitis A virus HBIg: Hepatitis B immune globulin HBsAg: Hepatitis B surface antigen HBV: Hepatitis B virus HCG: Human chorionic gonadotropin HCl: Hydrochloric acid HCO 3 – : Bicarbonate Hct: Hematocrit HCV: Hepatitis C virus HDL: High-density lipoprotein HDN: Hemolytic disease of the newborn Hgb: Hemoglobin HgbA1c; HbA1c: Hemoglobin A1c HHS: United States Department of Health and Human Services HIPAA: Health Information Portability and Accountability Act HIV: Human immunodeficiency virus HLA: Human leukocyte antigen ICD-9: International Classification of Procedures, 9th edition IFG: Impaired fasting glucose iFOB: Immunoassay fecal occult blood Ig: Immunoglobulin IGT: Impaired glucose tolerance IM: Infectious mononucleosis INR: International normalized ratio xvii xviii Abbreviations K: Potassium KOH: Potassium hydroxide LD: Lactate dehydrogenase LDL: Low-density lipoprotein LH: Luteinizing hormone Li: Lithium LPN: Licensed practical nurse Lytes: Electrolytes MCH: Mean corpuscular hemoglobin MCHC: Mean corpuscular hemoglobin concentration MCV: Mean corpuscular volume MIC: Minimum inhibitory concentration mg: Milligram Mg: Magnesium MI: Myocardial infarction mL: Milliliter MRSA: Methicillin-resistant Staphylococcus aureus MSDS: Material safety data sheets MSH: Melanocyte-stimulating hormone Na: Sodium NFPA: National Fire Protection Association NIH: National Institutes of Health NP: Nasopharyngeal NPO: Nothing by mouth O&P: Ova and parasites O 2 : Oxygen OGTT: Oral glucose tolerance test OPIM: Other potentially infectious materials OSHA: Occupational Safety and Health Administration P: Phosphorus Pap: Papanicolaou test and stain for detection of cervical cancer PAP: Prostatic acid phosphatase PEP: Postexposure prophylaxis PHI: Protected health information PKU: Phenylketonuria Plt: Platelet POCT: Point-of-care testing POL: Physician office laboratory Pp: Postprandial (after eating) PPE: Personal protective equipment PPM: Provider- performed microscopy PPMP: Provider- performed microscopy procedures Prl: Prolactin PSA: Prostate-specific antigen PST: Plasma separator tube PT: Protime or Prothrombin time PTH: Parathyroid hormone QA: Quality assurance QC: Quality control qh: Every hour qid: Four times a day QNS: Quantity not sufficient RA: Rheumatoid arthritis RACE: Rescue, Alarm, Contain, Extinguish RBC: Red blood cell Retic: Reticulocyte count RF: Rheumatoid factor Rh: Rh (Rhesus) factor present on red blood cells RIA: Radioimmunoassay RN: Registered nurse RPM: Rotations or Revolutions per minute RPR: Rapid plasma regain RSV: Respiratory syncytial virus Sed Rate: Erythrocyte sedimentation rate SG: Specific gravity SST: Serum separator tube STAT: Urgent or immediately STD: Sexually transmitted disease T&C: Type and crossmatch T3: Triiodothyronine T4: Thyroxine TAT: Turnaround time TB: Tuberculosis TC: Throat culture TSH: Thyroid-stimulating hormone VDRL: Venereal Disease Research Laboratory VLDL: Very Low-density lipoprotein WBC: White blood cell WHO: World Health Organization