(Test Bank) A Manual Of Laboratory And Diagnostic Tests

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A Manual of Laboratory and Diagnostic Tests 7th edition (July 2003): By Frances T Fischbach RN, BSN, MSN By Lippincott Williams & Wilkins Publishers By OkDoKey A Manual of Laboratory and Diagnostic Tests CONTENTS Editors Contributors Dedication Preface Acknowledgments 1 Diagnostic Testing 2 Blood Studies; Hematology and Coagulation 3 Urine Studies 4 Stool Studies 5 Cerebrospinal Fluid Studies 6 Chemistry Studies 7 Microbiologic Studies 8 Immunodiagnostic Studies 9 Nuclear Medicine Studies 10 X-Ray Studies 11 Cytologic, Histologic, and Genetic Studies 12 Endoscopic Studies 13 Ultrasound Studies 14 Pulmonary Function, Arterial Blood Gases (ABGs), and Electrolyte Studies 15 Prenatal Diagnosis and Tests of Fetal Well-Being 16 Special Systems, Organ Functions, and Postmortem Studies Appendix A Standard/Universal Precautions Appendix B Latex and Rubber Allergy Precautions Appendix C Sedation and Analgesia Precautions Appendix D Conversions From Conventional to Systéme International (SI) Units Appendix E Guidelines for Specimen Transport and Storage Appendix F Vitamins in Human Nutrition Appendix G Minerals in Human Nutrition Appendix H Examples of Forms Appendix I Panic or Critical Values Appendix J Effects of the Most Commonly Used Drugs on Frequently Ordered Laboratory Tests (Blood, “Whole” Plasma, Serum, Stool, and Urine) Appendix K Protocols for Hair, Nails, Saliva, Sputum, and Breath Specimen Collection Appendix L Protocols for Evidentiary Specimen Collection in Criminal or Forensic CasesContributors Corrinne Strandell, RN, BSN, MSN, PhD Nursing Research, Home Care and Rehabilitation Specialist, West Allis, WI Bernice Gestout DeBoer, RN, BSN, CPAN Parish Nurse, Covenant Health Care, Milwaukee, WI Mary Pat Haas Schmidt, BS, MT Manager, Laboratory Services, Pre-insurance testing; Instructor, Medical technology, Waukesha, WI Jean Schultz, ES, RT, RD, MS Director of Ultrasound and Radiology Education, St. Luke's Medical Center, Milwaukee, WI Patricia Pomohac, MT (ASCP) Supervisor, Diagnostic Immunology, Department of Pathology, United Regional Medical Services, Inc., Milwaukee, WI Teresa Friedel Abrams, RN, BSN, MSN Geriatric Nurse Specialist, Menomonee Falls Health Care Center, Menomonee Falls, WI Carol Colasacco, CT (ASCP), CMIAC Cytotechnologist, Department of Pathology, Fletcher Allen Health Care, Burlington, VT Emma Felder, RN, BSN, MSN, PhD Professor Emeritus, Nursing, University of Wisconsin-Milwaukee, Milwaukee, WI Ann Shafranski Fischbach, RN, BSN Occupational Health; Case Manager, Johnson Controls, Milwaukee, WI Bonnie Grahn, RN, CIC Infection Control Coordinator, Froedtert Memorial Lutheran Hospital, Milwaukee, WI Roger Groth Ophthalmic Technologist, Eye Institute, Froedtert Memorial Lutheran Hospital, Milwaukee, WI Gary Hoffman Manager, Laboratory for Newborn Screening, State of Wisconsin, Madison, WI Karen Kehl, PhD Assistant Professor-Pathology, Children's Hospital of Wisconsin, Milwaukee, WI Susan Kirkpatrick, MS Genetic Counselor, Waisman Center, Madison, WI Stanley F. Lo, PhD Assistant Professor-Pathology, Children's Hospital of Wisconsin, Milwaukee, WI Lynn Mehlberg, ES, CNMT Director, Quality Assurance-Imaging Department, St. Luke's Medical Center, Milwaukee, WI Deborah B. Martin, RN, BSN Community Health Nurse, Baltimore City Health Department, Maternal and Infant Program Field Office, Baltimore, MD Lorraine Meisner, PhD Cytogenetics, State Laboratory of Hygiene, Madison, WI Christine Naczek, MT (ASCP) Manager, Blood Banking and Pre-Transfusion Testing, Department of Pathology, United Regional Medical Services, Inc., Milwaukee, WI Anne Witkowiak Nezworski, RN, BSN Maternity and Newborn Specialist, Sacred Heart Hospital, Eau Claire, WI Joseph Nezworski, ES, RN, BSN Chief Deputy Medical Examiner, Eau Claire County, Eau Claire, WI Richard Nuccio, BA, MA, MBA, CNMT, RT (ASCP) Global Products, General Electric Medical Systems, Milwaukee, WI Annette O'Gorman, RN, ESN, MSNCSFamily Nurse Practitioner, EM Care S.C., Milwaukee, WI Tracey Ryan, RD Chief Clinical Dietitian, Froedtert Memorial Lutheran Hospital, Milwaukee, WI Julie Saavedra, RN, BA, BSN, CGRN Nursing Manager, Department of Endoscopy, Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL John Shalkham Program Director for School of Cytotechnology, State Laboratory of Hygiene, Clinical Assistant Professor–Department of Pathology, University of Wisconsin, Madison, WI Eleanor C. Simms, RNC, BSN Specialist, Nursing Student Enrichment Program, Coppin State College, Helene Fuld School of Nursing, Baltimore, MD Nancy A. Staszak, RN, BSN, CCRN Education Coordinator-QA & Staff Development, Froedtert Memorial Lutheran Hospital, Milwaukee, WI Frank G. Steffel, BS, CNMT Program Director-Nuclear Medicine Technology, Department of Radiology, Froedtert Memorial Lutheran Hospital, Milwaukee, WI Rosalie Wilson Steiner, RN, BSN, MSN, PhD Community Health Specialist, Milwaukee, WI Thudung Tieu QA/Safety Coordinator, United Dynacare Laboratories, Milwaukee, WI Jean M. Trione, RPh Clinical Specialist, Wausau Hospital, Wausau, WI Beverly Wheeler, RN, BSN, MSN, CS Cardiology; Cardiothoracic Nurse Specialistm, National Naval Medical Center, Bethesda, MD Michael Zacharisen, MD Assistant Professor-Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WIDEDICATION To Michael, Mary, Paul, and MargaretEDITORS FRANCES TALASKA FISCHBACH, RN, BSN, MSN Associate Clinical Professor of Nursing Department of Health Restoration School of Nursing University of Wisconsin-Milwaukee Milwaukee, Wisconsin; Associate Professor of Nursing (Ret) School of Nursing University of Wisconsin-Milwaukee Milwaukee, Wisconsin MARSHALL BARNETT DUNNING, III, BS, MS, PHD Associate Professor of Medicine Department of Medicine Division of Pulmonary/Critical Care Medicine Medical College of Wisconsin, Milwaukee Wisconsin; Director Pulmonary Diagnostic Laboratory Froedtert Memorial Lutheran Hospital Milwaukee, Wisconsin QUINCY MCDONALD Acquisitions Editor SHARON NOWAK/MARIE RIM Editorial Assistant DEBRA SCHIFF Senior Production Editor HELEN EWAN Senior Production Manager ERIKA KORS Managing Editor / Production CAROLYN O'BRIEN Art Director BJ CRIM Design WILLIAM ALBERTI Manufacturing Manager ALEXANDRA NICKERSON IndexerPREFACE PURPOSE The purpose of A Manual of Laboratory and Diagnostic Tests , in this Seventh edition, is to promote the delivery of safe, effective, and informed care for patients undergoing diagnostic tests and procedures and also to provide the clinician and student with a unique resource. This comprehensive manual provides a foundation for understanding the relatively simple to the most highly complex diagnostic tests that are delivered to varied populations in varied settings. It describes the clinician's role in providing effective diagnostic services in depth, through affording the necessary information for quality care planning, individualized patient assessment, analysis of patient needs, appropriate interventions, patient education, patient follow-up, and timely outcome evaluation. Potential risks and complications of diagnostic testing mandate that proper test protocols, interfering factors, follow-up testing, and collaboration among those involved in the testing process be a significant part of the information included in this text. ORGANIZATION This book is organized into 16 chapters and 12 appendices. Chapter 1 outlines the clinician's role in diagnostic testing and includes interventions for safe, effective, informed pre-, intra-, and posttest care. This chapter includes a Patient's Bill of Rights and Responsibilities, a model for the role of the clinical team in providing diagnostic care and services, test environments, reimbursement for diagnostic services, and the importance of communication as key to desired outcomes. The intratest section is expanded to include information about collaborative approaches facilitating family presence during invasive procedures, risk management, the collection, handling, and transport of specimens, infection control, controlling pain, comfort measures, administration of drugs and solutions, monitoring fluid intake and loss, using required equipment kits and supplies, properly positioning the patient for the procedure, managing the environment, and patient monitoring. The reader is referred back to Chapter 1 , Diagnostic Testing, throughout the text for information about the clinician's role and diagnostic services. Chapter 2 , Chapter 3 , Chapter 4 , Chapter 5 , Chapter 6 , Chapter 7 , Chapter 8 , Chapter 9 , Chapter 10 , Chapter 11 , Chapter 12 , Chapter 13 , Chapter 14 , Chapter 15 and Chapter 16 focus upon specific categories that include: Chapter 2: Blood Studies Chapter 3: Urine Studies Chapter 4: Stool Studies Chapter 5: Cerebrospinal Fluid Studies Chapter 6: Chemistry Studies Chapter 7: Microbiologic Studies Chapter 8: Immunodiagnostic Studies Chapter 9: Nuclear Medicine Studies Chapter 10: X-ray Studies Chapter 11: Cytology, Histology, and Genetic Studies Chapter 12: Endoscopic Studies Chapter 13: Ultrasound Studies Chapter 14: Pulmonary Function and Blood Gas Studies Chapter 15: Prenatal Diagnosis and Tests of Fetal Well-Being Chapter 16: Special Systems, Organ Functions, and Postmortem Studies CHAPTER CONTENT AND FEATURES Background rationale Test purpose Interfering factors Description of the procedure protocol and time frames and test completion Reference ranges and normal values, expectations Patient involvement (eg, history of signs and symptoms, body position, breathing instructions, electrode placement, compliance issues, patient right to refuse testing) Method of specimen collection (biohazard guidelines), handling, and transportation Clinical implications with interpretation of abnormal findings, unexpected outcomes, and disease patterns Interventions for pretest patient preparation (medications, fasting), explanation of benefits and risks, intratest patient care (appropriate monitoring, conscious sedation), and posttest patient aftercare (includes monitoring, explanation of further testing and treatment modalities) Special features integrated into the format include: The clinician's role in providing diagnostic services. Clinical Alerts and Education Alerts that signal special cautions. Specific guidelines listed for each test phase. Expected outcomes with evidence-based patient expectations and reference ranges as defined by the specialty. A user-friendly format of the text to support easy information retrieval. Both conventional and SI units are listed and, where possible, age-related reference values are also listed as a component of normal reference values. Numerous examples of test values and clinical considerations for newborn, infant, child, adolescent, and older adult groups where appropriate. A bibliography at the end of each chapter representing a composite of selected references from various disciplines and directs the clinician to information available beyond the scope of this book. Extensive appendices providing the clinician with additional data for everyday practice. Current, complete, and accurate content, which has been compiled from various multidisciplinary sources, then carefully scrutinized and continually reevaluated. NEW INFORMATION IN THE SEVENTH EDITION The addition of many new tests and methodologies includes: Newborn screening for inherited disease Updated Pap smears and protocols for further testing Cytokines Metabolic autopsy Tissue (histology) biopsies and predictive markers for treatment response Tests for bone disease Tests for heart disease, congestive and acute MI disease Microbiological testing, bioterrorism agents, detecting food poisoning, anthrax, plague, and hemorrhagic fever Breast diagnostic and prognostic markers Fetal predictive tests of abnormal development Breath tests for ulcers, alcohol, lactose, etc. Fertility tests Expanded scope of magnetic resonance (MRI) scans Expanded scope of sleep/sleepiness studies in newborns, children, older adults New nuclear tumor and infection scans PET scans combined with CT spiral imaging and ultrasound Ductal lavage for determining Gail Index for breast cancer risk New sentinel node localization LEEP GYN procedure Eye tests for retinal disorders, macular degeneration, visual acuity, and glaucoma Expanded content on keeping records of diagnostic tests, use of proper forms, and standardized patient reports Panels of multiple tests (e.g., metabolic syndrome, syndrome X) within Chapter 6 Chemistry Tests The appendices are completely revised and contain many additions. For example, Appendix D offers information regarding collection of saliva, breath, nail, sputum, and hair specimens. Appendix H provides examples of commonly used forms and infrequently used forms (videotaping, refusal). Appendix L deals with guidelines for collecting evidentiary specimens. Revised chapters include changes in the clinician's role and reflect current laboratory and diagnostic practice standards. Throughout the text, a greater emphasis is placed upon communication skills and collaboration between patients, their significant others, and health professionals from diverse disciplines. When clinicians see patients in the context of what the patient and loved ones are experiencing (ie, situational needs, expectations, previous experiences, and the environment in which they live), only then can they offer meaningful support and care. When patients believe the clinician is on their side, they have an increased sense of control. Identifying with the patient's point of view leads to a more profound level of communication. CURRENT DEVELOPMENTS IN LABORATORY AND DIAGNOSTIC TESTING New technologies foster new scientific modalities for patient assessment and clinical interventions. Thus, the clinician is provided a greater understanding of the long chain of events from diagnosis through treatment and outcomes. In a brief span of years, new technologies have introduced greatly improved developments in total body and brain x-ray scanners; digital and enhanced imaging; magnetic resonance (MR); positron emission tomography (PET) scanners, combination scans such as PET and CT to diagnose cancer and infections; greatly enhanced ultrasound and nuclear medicine procedures; genetic mutation studies; new tests for cancer; new cancer markers for diagnosis and prognosis; sleep disorders tests; technology for fetal testing before birth, and postmortem testing after death. Many new technologies are faster, more patient-friendly, more comfortable, and provide an equivalent or higher degree of accuracy (ie, HIV or hepatitis detection, monitoring for drug abuse or managing therapeutic drug levels). Saliva and breath testing is gaining ground as a mirror of body function and emotional, hormonal, immune, and neurologic status, as well as providing clues about faulty metabolism. Noninvasive and minimally invasive testing, (ie, need only one drop of blood, nail and hair clippings), which is better suited for testing in environments such as the workplace, private home, and other nontraditional health care settings such as churches, is made possible by better collection methods and standardized collection techniques. Newest diagnostic lab technologies include hand-held nucleic acid detectors for specific bacteria and viruses, hand-held miniaturized chip-based DNA analyzers, reagentless diagnostics that introduce the sample (hand, finger, ear lobe, etc.) to magnetic fields, and magnetic resonance spectroscopy (MRS). Non-invasive and minimally invasive diagnostics include infrared light to estimate glucose, rapid oral screen for HIV, proteinomics, functional and molecular techniques. Managed care and its drive for control of costs for diagnostic services exerts a tremendous effect on consumers' ability to access testing services care. This results in mixed access to services, depending upon approval or denial of coverage.A resurgence in the use of traditional, trusted diagnostic modalities, such as electroencephalogram (EEG), is being seen in certain areas. Diseases such as HIV, antibiotic-resistant strains of pathological organisms, and Type 2 diabetes are becoming more prevalent. In the workplace, thorough diagnostic testing is more common as applications are made for disability benefits. Also, requirements for periodic monitoring of exposures to potentially hazardous workplace substances (chemicals, heavy metals), breathing and hearing tests, and TB and latex allergy testing requires skill in administering and procuring specimens. The number of forensic DNA tests being performed has increased tremendously. Concurrently, consumer perceptions have shifted from implicit faith in the health care system to concerns regarding less control over choices for health care and more distrust of the system in general. These trends—combined with a shift in diagnostic care from acute care hospital settings to outpatient departments, physicians' offices, clinics, community-based centers, nursing homes, and sometimes even churches, stores and pharmacies—challenge clinicians to provide standards-based, safe, effective, and informed care. Because the health care system is becoming a community-based model, the clinician's role is also changing. Updated knowledge and skills, flexibility, and a heightened awareness of the testing environment (point of care testing) are needed to provide diagnostic services in these settings. Clinicians must also adapt their practice to changes in other areas. This includes developing, coordinating, and following policies and standards set forth by institutions, governmental bodies, and regulatory agencies. Being informed regarding ethical and legal implications of such things as informed consent, privacy, patient safety, the right to refuse tests, end-of-life decisions, and trends in diagnostic research procedures add another dimension to the clinician's accountability and responsibility. The consequences of certain types of testing (ie, HIV and genetic) and the implications of confidential versus anonymous testing must also be kept in mind. For example, anonymous tests do not require the individual to give his or her name, whereas confidential tests do require the name. This difference has implications in the requirements and process of agency reporting all patients as well as for select groups of infectious diseases such as HIV. Responding to these trends, the Seventh edition of A Manual of Laboratory and Diagnostic Tests is a comprehensive, up-to-date diagnostic reference source that includes information about newer technologies, together with the time-honored classic tests that continue to be an important component of diagnostic work. It meets the needs of clinicians, educators, researches, students, and others whose work and study requires this type of resource or reference manual. Frances Talaska FischbachACKNOWLEDGMENTS It is with sincere gratitude and pleasure that I acknowledge the collaboration of Dr. Marshall B. Dunning for his diligence, extra effort, and graciousness in accomplishing the task of renewal and enhancement for the revision of this text, for the 7th edition, all in a timely manner. I want to give special praise and recognition to my husband, Jack Fischbach, the best researcher I have ever had; to Corrinne Strandell, Mary Pat Schmidt, Bernice DeBoer, Pat Pomohac, and Jean Schultz for their dedication, kindness, support, and generous help in manuscript preparation; to Kathie Gordon, Kathleen Dunning, Deanne Shmitz, and Margaret Fischbach, for carefully arranging, organizing, and typing the manuscript. I would also like to acknowledge and thank all the reviewers, researchers, and consultants who provided ideas for manuscript revision and whose comments to me have helped make the book better. This work would not have been complete without the help and information provided by the librarians and staff of the Todd Wehr Library of the Medical College of Wisconsin, the Marquette University Library, and St. Joseph's Hospital Library; with thanks to Dynacare Laboratories and Medical Science Laboratories, especially for referencing their Laboratory Handbooks, and to the Infection Control Staff, Neuroscience Center, Transplant Services, Transfusion Services, Eye Institute, at Froedtert Memorial Hospital of Milwaukee, Wisconsin. Appreciation and recognition are also due these persons who helped with this and previous editions: my daughters, Mary Fischbach Johnson, BS, MS Ed, and Margaret Fischbach, BA, JD; my son-in-law, Richard Johnson, BA; my daughter-in-law, Ann Shafranski Fischbach, BSN; and the hard work on this edition and in the past of the entire staff at Lippincott Williams & Wilkins, especially Sharon Nowak, Marie Rim, Quincy McDonald, Debra Schiff, Kim Lilly, Kathie Barrie, and, as always, Jay Lippincott. Writing a book is truly a labor of love, and the process makes me humble and thankful to many, many individuals, named and unnamed, who have made it possible. Thanks for a job well done. Frances Fischbach1 Diagnostic Testing A Manual of Laboratory and Diagnostic Tests 1 Diagnostic Testing OVERVIEW OF THE CLINICIAN'S ROLE: RESPONSIBILITIES, STANDARDS, AND REQUISITE KNOWLEDGE Education Alert Chart 1.1 Grading Guidelines for Scientific Evidence Chart 1.2 Basics of Informed Care PRETEST PHASE: ELEMENTS OF SAFE, EFFECTIVE, INFORMED CARE Basic Knowledge and Necessary Skills Testing Environments History and Assessment Reimbursement for Diagnostic Services Chart 1.3 Tests Covered by Most Insurance Carriers Methodology of Testing Interfering Factors Avoiding Errors Proper Preparation Patient Education Testing Protocols Patient Independence Test Results Laboratory Reports Margins of Error Ethics and the Law Patient's Bill of Rights and Patient Responsibilities Cultural Sensitivity INTRATEST PHASE: ELEMENTS OF SAFE, EFFECTIVE, INFORMED CARE Basic Knowledge and Required Skills Infection Control NOTE Collaborative Approaches Risk Management Specimens and Procedures Equipment and Supplies Family Presence Positioning for Procedures Administration of Drugs and Solutions Management of Environment Pain Control, Comfort Measures, and Patient Monitoring POSTTEST PHASE: ELEMENTS OF SAFE, EFFECTIVE, INFORMED CARE Basic Knowledge and Necessary Skills Abnormal Test Results Clinical Alert Follow-Up Counseling Monitoring for Complications Test Result Availability Clinical Alert Referral and Treatment Follow-Up Care Documentation, Record Keeping, and Reporting Chart 1.4 Diseases and Conditions Reportable by Health Care Providers and Others Chart 1.5 Diseases and Conditions Reportable by Laboratory Directors Guidelines for Disclosure Patient Responses to Expected or Unexpected Outcomes Expected and Unexpected Outcomes IMPORTANCE OF COMMUNICATION CONCLUSION BIBLIOGRAPHY OVERVIEW OF THE CLINICIAN'S ROLE: RESPONSIBILITIES, STANDARDS, AND REQUISITE KNOWLEDGE In this era of high technology, health care delivery involves many different disciplines and specialties. Consequently, clinicians must have an understanding and working knowledge of modalities other than their own area of expertise. This includes diagnostic evaluation and diagnostic services. Laboratory and diagnostic tests are tools to gain additional information about the patient. By themselves, these tests are not therapeutic; however, when used in conjunction with a thorough history and physical examination, these tests may confirm a diagnosis or provide valuable information about a patient's status and response to therapy that may not be apparent from the history and physical examination alone. Generally, a tiered approach to selecting tests is used: 1.Basic screening (frequently used with wellness groups and case finding) 2.Establishing (initial) diagnoses 3.Differential diagnosis 4.Evaluating current medical case management and outcomes5.Evaluating disease severity 6.Monitoring course of illness and response to treatment 7.Group and panel testing 8.Regularly scheduled screening tests as part of ongoing care 9.Testing related to specific events, certain signs and symptoms, or other exceptional situations (eg, infection and inflammation [bladder infection or cellulitis], sexual assault, drug screening, pheochromocytoma, postmortem tests, to name a few) ( Table 1.1 ) Table 1.1 Examples of Selecting Tests Diagnostic Test Indication Stool occult blood Yearly screening after 45 years of age Serum potassium Yearly in patients on diuretic agents or potassium supplements; in cases of some cardiac arrhythmias Liver enzyme levels Monitoring patient on hepatotoxic drugs; establish baseline values Serum amylase In the presence of abdominal pain, suspect pancreatitis Thyroid-stimulating hormone (TSH) testSuspicion of hypothyroidism, hyperthyroidism, or thyroid dysfunction, 50 years of age and older Chlamydia and gonorrhea In sexually active persons with multiple partners to monitor for pelvic inflammatory disease Hematocrit and hemoglobin Baseline study; abnormal bleeding; detection of anemia (use CBC results if they are recent) Papanicolaou cervical smear (Pap)Yearly for all women = 18 years of age; more often with high-risk factors (eg, dysplasia, human immunodeficiency virus [HIV], herpes simplex) now checks for human papillomavirus (HPV), chlamydia, and gonorrhea, using DNA Urine culture Pyuria Syphilis serum fluorescent treponemal antibody (FTA) testPositive rapid plasma reagin (RPR) test result Tuberculosis (TB) skin test Easiest test to use for TB screening of individuals < 35 years of age or those with history of negative TB skin tests, for persons in resident homes Fasting blood glucose (FBG) Every 3 years starting at 45 years of age; monitor diabetes control Urinalysis (UA) Signs or history of recurrent urinary tract disease; pregnant women; men with prostatic hypertrophy Prothrombin time (PT) (INR) Monitoring anticoagulant treatment Prostate-specific antigen (PSA) and digital rectal examinationScreen men = 50 years of age for prostate cancer yearly Chest x-ray Monitor for lung lesions and infiltrates; congestive heart failure; anatomic deformities, posttrauma, before surgery, follow-up for positive TB skin test and monitor treatment Mammogram Screen by 40 years of age in women, then every 12–18 months between 40 and 49 years of age, annually = 50 years of age; follow-up for history and treatment of breast cancer; routine screening when strong family history of breast carcinoma Colon x-rays and proctosigmoidoscopyScreen adults for colon cancer beginning at age 45; follow up for presence of hemoglobin- or guaiac-positive stools, polyps, diverticulosis Computed tomography (CT) scansBefore and after treatment for certain cancers, injuries, illness (eg, suspected transient ischemic attack, cerebro-vascular accident; diagnostic evaluation of certain signs/symptoms) DNA testing of hair, blood, skin tissue, or semen samplesTo gather postmortem evidence, in certain criminal cases; to establish identity and parentage Some tests are mandated by government agencies or clinical practice guidelines of professional societies; others are deemed part of necessary care based on the individual practitioner's judgment and expertise or a group practitioner consensus. There is not a consensus as to the frequency of testing (eg, annually or after a certain age). Test selections are based on subjective clinical judgment. Often diagnostic tests or procedures are used as predictors of surgical risk and/or morbidity and mortality rates (eg, maximum oxygen consumption determination to assess risk before esophageal cancer surgery) as the risk may outweigh the benefit. Use of evidence-based guidelines for scheduling, selecting, retaining, or eliminating certain diagnostic tests may help in more effective case management and cost containment. These guidelines use a system that grades the quality of scientific evidence based on published reports of clinical trials, expert consensus, or clinical expertise. Levels of evidence are A to C and E, with A being the best evidence and E referring to expert opinion or consensus ( Chart 1.1 ). Education Alert Not all information on the Internet is reliable.Chart 1.1 Grading Guidelines for Scientific Evidence A.Clear evidence from all appropriately conducted trialsA.Measure plasma glucose through an accredited lab to diagnose or screen for diabetes B.Supportive evidence from well-conducted studies or registriesB.Draw fasting blood plasma specimens for glucose analysis C.No published evidence; or only case, observational, or historical evidenceC.Self-monitoring of blood glucose may help to achieve better control D.Expert consensus or clinical experience or Internet pollsD.Measure ketones in urine or blood to monitor and diagnose diabetic ketoacidosis (DKA) (in home or clinic) As an integral part of their practice, clinicians have long supported patients and their significant others in meeting the demands and challenges incumbent in the simplest to the most complex diagnostic testing. This testing begins before birth and frequently continues after death. The clinician who provides diagnostic services must have basic requisite knowledge to plan patient care and an understanding of psychoneuroimmunology (effects of stress on health status), must make careful judgments, and must gather vital information about the patient and the testing process, to diagnose appropriately within the parameters of the clinician's professional standards ( Table 1.2 ; Chart 1.2 ). Table 1.2 Examples of Inappropriate Tests and Replacement Tests Inappropriate Replacement Prostatic acid phosphatase PSA or free PSA Ammonia AST, GGT Crossmatch (needed if blood is actually to be given) Type and screen Calcium Ionized calcium CBC Hemogram HCV antibody HCV RNA by PCR Iron Ferritin Lupus cell ANA Creatinine Urea CRP ESR PSA, prostate-specific antigen; AST, aspartate transaminase; GGT, gamma-glutamyltransferase; CBC, complete blood count; HCV, hepatitis C virus; PCP, polymerase chain reaction; ANA, antinuclear antibody; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate. Chart 1.2 Basics of Informed Care Manage testing environment using collaborative approach Communicate effectively and clearly Prepare the patient properly Follow standards Consider culture, gender, and age diversity Measure and evaluate outcomes; modify treatment as necessary Manage effective diagnostic services using team approach Interpret, treat, monitor, and counsel about abnormal test outcomes Maintain proper test records The diagnostic testing model incorporates three phases: pretest, intratest, and posttest ( Fig. 1.1 ). The clinical team actively interacts with the patient and his or her significant others throughout each phase. The following components are included with each laboratory or diagnostic test in this text: FIGURE 1.1 Model* for the role** of the clinical team in diagnostic care*** and services.**** Pretest Interventions: Intratest Interventions: Posttest Interventions: 1.Test background information 2.Normal (reference values) 3.Explanation of test 4.Indications for testing1.Actual description of procedures 2.Specimen collection and transport 3.Clinical implications of abnormal results 4.Interfering factors1.Patient aftercare 2.Clinical, education, and procedure alerts 3.Special cautions 4.Interpretation of test results Each phase of testing requires that a specific set of guidelines and standards be followed for accurate, optimal test results. Patient care standards and standards of professional practice are key points in developing a collaborative approach to patient care during diagnostic evaluation. Standards of care provide clinical guidelines and set minimum requirements for professional practice and patient care. They protect the public against less-than-quality care ( Table 1.3). Table 1.3 Standards for Diagnostic Evaluation Source of Standards for Diagnostic ServiceStandards for Diagnostic Testing Examples of Applied Standards for Diagnostic Testing Professional practice parameters of American Nurses Association (ANA), American Medical Association (AMA), American Society of Clinical Pathologists (ASCP), American College of Radiology, Centers for Disease Control and Prevention (CDC), JCAHO health care practice requirementsUse a model as a framework for choosing the proper test or procedure and in the interpretation of test results. Use laboratory and diagnostic procedures for screening, differential diagnoses, follow-up, and case management.Test strategies include single tests or combinations/ panels of tests. Panels can be performed in parallel, series, or both. The guidelines of the major agencies, such as American Heart Association, Cancer Society, and American Diabetes AssociationOrder the correct test, appropriately collect and transport specimens. Properly perform tests in an accredited laboratory or diagnostic facility. Accurately report test results. Communicate and interpret test findings. Treat or monitor the disease and the course of therapy. Provide diagnosis as well as prognosis.Patients receive diagnostic services based on a documented assessment of need for diagnostic evaluation. Patients have the right to necessary information, benefits, or rights, to enable them to make choices and decisions that reflect their need or wish for diagnostic care. Individual agency and institution policies and procedures and quality-control criteria for specimen collection, procedure statement for monitoring the patient after an invasive procedure, and policy for universal witnessed consent situations. Statements on quality improvement standards. Use standards of professional practice and standards of patient care. Use policy for obtaining informed consent/witnessed consent. Use policies for unusual situations.Observe standard precautions (formerly known as universal precautions). Use latex allergy protocols and required methodology of specimen collection. Use standards and statements for monitoring patients who receive conscious sedation and analgesia. Vital signs are monitored and recorded at specific times before and after the procedure. Patients are monitored for bleeding and respiratory or neurovascular changes. Record data regarding outcomes when defined care criteria are implemented and practiced. Protocols to obtain appropriate consents are employed, and deviations from basic consent policies are documented and reported to the proper individual.The clinician wears protective eyewear and gloves when handling all body fluids and employs proper handwashing before and after handling specimens and between patient contacts. Labeled biohazard bags are used for specimen transport. Vital signs are monitored and recorded at specific times before and after the procedure. Patients are monitored for bleeding and respiratory or neurovascular changes. Record data regarding outcomes when defined care criteria are implemented and practiced. Protocols to obtain appropriate consents are employed, and deviations from basic consent policies are documented and reported to the proper individual.State and federal government communicable disease reporting regulations; Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services, Agency for Health Care Policy and Research (AHCPR), and Clinical Laboratory Improvement Act (CLIA)Clinical laboratory personnel and other health care providers follow regulations to control the spread of communicable diseases by reporting certain disease conditions, outbreaks, and unusual manifestations, morbidity, and mortality data. Findings from research studies provide health care policy makers with evidence-based guidelines for appropriate selection of tests and procedures.The clinician reports laboratory evidence of certain disease classes (eg, sexually transmitted diseases, diphtheria, Lyme disease, symptomatic HIV infection; see list of reportable diseases). Personnel with hepatitis A may not handle food or care for patients, young children, or the elderly for a specific period of time. Federal government regulates shipment of diagnostic specimens. MR and CT are used to evaluate persistent low back pain according to AHCPR guidelines. U.S. Department of Transportation Alcohol testing is done in emergency rooms in special situations (eg, following a motor vehicle accident, homicide, or suicide, or an unconscious individual).Properly trained personnel perform blood, saliva, and breath alcohol testing and use required kits as referenced by federal law. Occupational Safety and Health Administration (OSHA)Workplace testing The clinician is properly trained, under mandated guidelines, to administer employee medical surveillance and respirator qualification and fit testing. JCAHO, Joint Commission on Accreditation of Healthcare Organizations; HIV, human immunodeficiency virus; MR, magnetic resonance; CT, computed tomography. If test results are inconclusive or negative and no definitive medical diagnosis can be established, other tests and procedures may be ordered. Thus, testing can become an involved and lengthy process (see Fig. 1.1 ). Understanding the basics of safe, effective, and informed care is important. These basics include assessing risk factors and modifying care accordingly, using a collaborative approach, following proper guidelines for procedures and specimen collection, and delivering appropriate care throughout the process. Providing reassurance and support to the patient and his or her significant others, intervening appropriately, and clearly documenting patient teaching, observations, and outcomes during the entire process are important (see Fig. 1.1 ). A risk assessment before testing identifies risk-prone patients and helps to prevent complications. The following factors increase a patient's risk for complications and may affect test outcomes: 1.Age > 70 years 2.History of falls 3.History of serious chronic illnesses 4.History of allergies (eg, latex, contrast iodine, radiopharmaceuticals, and other medications) 5.Infection or increased risk for infection (eg, human immunodeficiency virus [HIV], organ transplantation, chemotherapy, radiation therapy) 6.Aggressive or antisocial behavior 7.Seizure disorders 8.Uncontrolled pain 9.Gastric motility dysfunction 10.Use of assistive devices for activities of daily living (ADLs) 11.Unsteady gait, balance problems 12.Neuromuscular conditions 13.Weakness, fatigability 14.Paresthesias 15.Impaired judgment or illogical thinking 16.Severe visual problems 17.Hearing impairment 18.Use of diuretics, sedatives, analgesics, or other prescription or over-the-counter (OTC) drugs 19.Alcohol or illegal drug use or addiction The environments in which diagnostic services are provided, the degree of cultural diversity present in the community, and the physical, emotional, social, and spiritual state of the patient all influence the patient's response to the procedure. Including the patient's significant others is a vital component of the entire process and must not be taken lightly or casually dismissed. Testing environments vary. Certain tests (eg, cholesterol screening, blood glucose, electrocardiogram [ECG], lipid profiles, tuberculosis [TB] skin tests) can be done “in the field,” meaning that the service is brought to the patient's environment. Other tests (eg, x-rays using contrast media and those that require special patient preparation, invasive procedures, nuclear medicine procedures, hormone levels, and 24-hour urine testing panels) must be done in a physician's office, clinic, or hospital setting. Magnetic resonance (MR) imaging and ultrasound procedures (eg, echocardiograms) are commonly performed in freestanding or specialty diagnostic centers. Complex tests such as endoscopic retrograde cholangiopancreatography (ERCP), cardiac catheterization, or bronchoscopy may require hospital admission or at least outpatient status. As testing equipment becomes more technologically sophisticated and risks associated with testing are reduced, the environment in which diagnostic procedures take place will also shift. Insurance reimbursement for testing also influences trends. Managed care and case management, together with collaboration among the diverse health care disciplines and the patient, are key factors in determining how and to what degree optimal