HOSA Book PDF - Clinical Laboratory Introduction

LESSON Introduction 1-1 to the Clinical...

LESSON Introduction 1-1 to the Clinical Laboratory LESSON OBJECTIVES After studying this lesson, the student will: Explain the function of a medical or clinical laboratory. Discuss the organization of a typical hospital clinical laboratory. Describe the functions of the different levels of laboratory personnel. List the major departments of a typical clinical laboratory and name a test that would be performed in each department. List three examples of nonhospital clinical laboratories and describe the function of each. Explain how clinical laboratories are regulated. Explain the relationships between Centers for Medicare and Medicaid Services (CMS), Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), and clinical laboratories. Discuss benefits of point-of-care (POC) testing. Explain how the Health Insurance Portability and Accountability Act (HIPAA) affects the laboratory and laboratory workers. Discuss the use and value of electronic health records (EHRs). Describe the purpose and scope of quality assessment programs in the clinical laboratory. Explain the reason for proficiency testing. Explain the purpose of laboratory accreditation. Define the glossary terms. GLOSSARY accessioning / the process by which specimens are logged in, labeled, and assigned a specimen identification code accreditation / a voluntary process in which an independent agency grants recognition to institutions or programs that meet or exceed established standards of quality American Association of Blood Banks (AABB) / international association that sets blood bank standards, accredits blood banks, and promotes high standards of performance in the practice of transfusion medicine anticoagulant / a chemical or substance that prevents blood coagulation bacteriology / the study of bacteria blood bank / clinical laboratory department where blood components are tested and stored until needed for transfusion; immunohematology department; transfusion services; also the refrigerated unit used for storing blood components (continues) 5 55 Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it. 6 UNIT 1 THE CLINICAL LABORATORY Centers for Disease Control and Prevention (CDC) / central laboratory for the national public health system Centers for Medicare and Medicaid Services (CMS) / the agency within the Department of Health and Human Services (DHHS) responsible for implementing CLIA ’88 Clinical and Laboratory Standards Institute (CLSI) / an international, nonprofit organization that establishes guidelines and standards of best current practice for clinical laboratories; formerly National Committee for Clinical Laboratory Standards (NCCLS) clinical chemistry / the laboratory section that uses chemical principles to analyze blood and other body fluids Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) / a federal act that specifies minimum performance standards for clinical laboratories coagulation / the process of forming a fibrin clot College of American Pathologists (CAP) / organization that offers accreditation to clinical laboratories COLA / agency that offers accreditation to physician office laboratories, hospitals, clinics, and other healthcare facilities; formerly the Commission on Office Laboratory Accreditation Department of Health and Human Services (DHHS) / the governmental agency that oversees public healthcare matters; also called HHS electronic health record (EHR) / comprehensive, portable electronic patient health record electronic medical record (EMR) / a digital form of a patient chart created in a physician’s office or a hospital where a patient received treatment epidemiology / the study of the factors that cause disease and determine disease frequency and distribution Food and Drug Administration (FDA) / the division of the Department of Health and Human Services (DHHS) responsible for protecting the public health by ensuring the safety and efficacy of foods, drugs, biological products, medical devices, and cosmetics Health Care Financing Administration (HCFA) / see Centers for Medicare and Medicaid Services (CMS) hematology / the study of blood and the blood-forming tissues HIPAA / Health Insurance Portability and Accountability Act of 1996 immunohematology / the study of the human blood groups; in the clinical laboratory, often called blood banking or transfusion services immunology / the branch of medicine encompassing the study of immune processes and immunity Joint Commission (JC) / an independent agency that accredits hospitals and large healthcare facilities; formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Laboratory Response Network (LRN) / a nationwide network of public and private laboratories coordinated by the Centers for Disease Control and Prevention (CDC) with the ability for rapid response to threats to public health microbiology / the branch of biology dealing with microbes mycology / the study of fungi National Committee for Clinical Laboratory Standards (NCCLS) / see Clinical and Laboratory Standards Institute (CLSI) pathologist / a physician specially trained in the nature and cause of disease phlebotomist / a healthcare worker trained in blood collection physician office laboratory (POL) / small medical laboratory located within a physician office, group practice, or clinic plasma / the liquid portion of blood in which the blood cells are suspended; the straw-colored liquid remaining after blood cells are removed from anticoagulated blood point-of-care testing (POCT) / testing outside the traditional laboratory setting; also called bedside testing, off-site testing, near-patient testing or alternative-site testing proficiency testing (PT) / a program in which a laboratory’s accuracy in performing analyses is evaluated at regular intervals and compared to the performance of similar laboratories Provider-Performed Microscopy Procedure (PPMP) / a certificate category under CLIA ’88 that permits a laboratory to perform waived tests and also permits specified practitioners to perform on-site microscopy procedures quality assessment (QA) / in the laboratory, a program that monitors the total testing process with the aim of providing the highest-quality patient care reference laboratory / an independent regional laboratory that offers routine and specialized testing services to hospitals and physicians Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it.  LESSON 1-1 INTRODUCTION TO THE CLINICAL LABORATORY 7 serology / the study of antigens and antibodies in serum using immunological methods; laboratory testing based on the immunological properties of serum serum / the liquid obtained from blood that has been allowed to clot standard operating procedure (SOP) / established procedure to be followed for a given operation or in a given situation with the purpose of ensuring that a procedure is always carried out correctly and in the same manner virology / the study of viruses waived test / a category of test defined under CLIA ’88 as being simple to perform and having an insignificant risk for error INTRODUCTION perform the tests. Laboratory personnel standards differ for each of these categories. The more complex the test, the more highly Laboratories that perform chemical and microscopic tests on trained the testing personnel must be. Each laboratory must ob- blood, other body fluids, and tissues are called clinical or medi- tain a certificate stating its classification. cal laboratories. These laboratories play a major role in patient States can enact their own regulations regarding the opera- care and are found in a variety of settings, both government and tion of laboratories. However, state standards must be at least as private. A clinical laboratory can be in a large institution, offer stringent as federal regulations and must not violate or counteract sophisticated services, and employ many highly trained workers federal regulations. who interact daily with patients and other allied health person- nel in the institution. Clinical laboratories can also be small, with only one or two employees. TYPES OF CLINICAL Today clinical laboratories as well as other healthcare de- livery systems face a variety of challenges. These include coping LABORATORIES with rapidly rising costs, maintaining quality personnel, keeping Clinical laboratories can be placed into two groups: hospital up with advancing technologies, and complying with increased laboratories and nonhospital laboratories. Although most people governmental regulations. These issues must be addressed with- think of hospitals when they think of clinical laboratories, labo- out sacrificing the quality of patient care. This lesson describes ratories can also be in clinics, group practices, physician offices, the types of clinical laboratories and their organization, function, nursing homes, veterinary offices, government agencies, industry and regulation. settings, and military installations. Some clinical laboratories, such as regional reference laboratories, are independent from medical facilities that provide direct patient care. REGULATION OF CLINICAL In December!2010, the Department of Health and Human LABORATORIES Services (DHHS), Centers for Medicare and Medicaid Ser- vices (CMS), formerly known as the Health Care Financing All clinical laboratories that perform tests on human specimens Administration (HCFA), listed more than 221,000 private and (except for research laboratories) are regulated by both federal and commercial laboratories as providing services to humans in the state agencies. The Clinical Laboratory Improvement Amend- United States. This number does not include laboratories limited ments of 1988 (CLIA ’88), a revision of the Clinical Laboratory to research or veterinary laboratories. Improvement Act of 1967, specifies minimum performance stan- Table!1-1 lists the numbers of CMS-registered clinical labo- dards for all clinical laboratories. The objective of CLIA ’88 is to ratories by type of facility. From the pie chart shown in Figure!1-1, improve and ensure the quality of laboratory testing. Even though it can be seen that more than half of the registered laboratories are CLIA was passed in 1988, the amendments have been continually in physician office laboratories (POLs). Although far more labora- revised, updated, clarified, refined, and strengthened. tories are in the POL category than in any other category, hospital The Division of Laboratory Services, under the Centers for and reference laboratories perform the overwhelming majority of Medicare and Medicaid Services (CMS, www.cms.gov/clia/) has laboratory tests. CMS data show that more than 60% of registered the responsibility for implementing CLIA ’88. All clinical sites laboratories perform only waived tests. However, these account that perform laboratory tests on humans must register and obtain for only about 10% of the total test volume. a certificate from the CMS to be legally allowed to operate. Under CLIA ’88, laboratories are classified as performing: Waived tests Hospital Laboratories Tests of moderate and high complexity Clinical laboratories are found in private hospitals, university Provider-performed microscopy procedures (PPMP) teaching hospitals, and government-operated institutions such as The classifications are based on the difficulty or complexity of military hospitals and veterans’ hospitals. The clinical laboratory the test procedures and the level of training required to accurately is one of many hospital departments (Figure! 1-2). The level of Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it. 8 UNIT 1 THE CLINICAL LABORATORY Numbers of Registered CLIA Laboratories by Facility Type Adapted from CLIA Database, December 2010 4% 27.70% Hospital POL Home Health Nursing Facility Dialysis Facility Pharmacy © Cengage Learning 2012 2.40% Other 51% 2.30% 6.70% 6% FIGURE!1-1 Pie chart showing registered CLIA laboratories by facility type (Adapted from CMS, CLIA database, December!2010) Hospital Organization chart Board of Directors Hospital Administrator (CEO) Foundation Medical Staff Marketing Chief Financial Public Relations Officer (CFO) Volunteer Services Chief Medical Officer Nursing Services Support Services Clinical Services Physician Services Information Systems Environmental Medical Staff Services Nursing Administration Clinical Laboratory/ Finance Services Quality Management Staff Pathology Business Office Nutrition Risk Management Nursing Education Pharmacy © Cengage Learning 2012 Accounts/Billing Chaplain Infection Prevention Nursing Units Imaging Medical Records Social Services Accreditation Transport Services Respiratory Therapy Human Resources Central Supply Departmental Medical Phys/Occ/Speech Computer Information Directors Therapy Systems Medical Specialties Psychiatry Surgical Specialties Clinics FIGURE!1-2 Example of a hospital organizational chart services available from a hospital laboratory is usually determined (more than 300!beds) handle large volumes of work and perform by the size of the hospital. A laboratory in a small hospital (fewer complex tests (Figure!1-3). than 100! beds) performs primarily routine test procedures; complicated or infrequently requested tests are sent to reference Nonhospital Clinical laboratories. Laboratories In a clinical laboratory in a medium-size hospital (up to 300! beds), routine tests as well as many more complicated test Nonhospital clinical laboratories can be publicly (government) procedures are performed. Only the most recently developed or privately operated. They provide a variety of services and em- tests, infrequently requested tests, or tests with high levels of ployment for many skilled workers. In the United States in 2010, complexity or requiring special instrumentation need to be sent the majority of registered clinical laboratories were in nonhospital to reference laboratories. Clinical laboratories in large hospitals settings (Table!1-1). Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it.  LESSON 1-1 INTRODUCTION TO THE CLINICAL LABORATORY 9 TABLE!1-1. Numbers and types of CLIA-registered clinical laboratories performing tests on humans, December!2010. (Source: Adapted from Division of Laboratory Services, CMS/CLIA Database) TYPE OF LABORATORY NUMBER Ambulance 3687 Ambulatory surgical center 5051 © Cengage Learning 2012 Community clinic 6376 Comprehensive outpatient 313 rehabilitation facility Ancillary testing site in healthcare facility 2849 Renal dialysis facility 5044 FIGURE!1-3 A clinical laboratory in a large hospital Health fair 616 Health maintenance organization 672 Home health agency 13,433 Physician Office Laboratories Hospice 2378 Physician office laboratories (POLs) are laboratories in a physi- Hospital 8731 cian’s office or physicians’ group practice. In 2010, more than half of all CMS-registered clinical laboratories were classified Independent 5357 as POLs. The increased availability of rapid-test kits and small, Industrial 1820 easy-to-operate analyzers has broadened the scope of testing in Insurance 55 the POL. Several laboratory tests, such as hemoglobin, hemato- Intermediate care/mentally handicapped 1195 crit, urine reagent strip, urine pregnancy test, blood glucose, and occult blood, are classified as waived tests (Table!1-2) and can be Mobile laboratory 1592 performed in the POL by multiskilled personnel such as medical Pharmacy 5412 assistants. As defined by CLIA, waived tests are simple laboratory School/student health facility 2049 tests and procedures that “have an insignificant risk of an errone- Skilled nursing facility/nursing facility 14,831 ous result.” The Food and Drug Administration (FDA) deter- Physician office 113,124 mines which tests meet the criteria of being simple and with low risk for error. The FDA currently lists over 100 analytes for which Other practitioner 3209 waived tests are available. Tissue bank/repository 69 Blood bank 457 Reference Laboratories Rural health clinic 1570 Reference laboratories are usually privately owned, regional laboratories that do high-volume testing and offer a wide vari- Federally qualified health center 1109 ety of tests. Large hospitals use reference laboratories primar- Assisted living facility 987 ily to perform complex or infrequently ordered tests. Small Prison 210 hospitals or physicians’ offices use their services for a wide Public health laboratory 526 range of tests. Reference laboratories provide courier service Other 19,071 to transport specimens from the collection site to the testing laboratory. Total 221,793 Government Laboratories: Federal The central laboratory for the national public health system is the determine the causes. This function of the CDC has gained much Centers for Disease Control and Prevention (CDC) in Atlanta, public attention because of its role in investigating emerging Georgia. This agency provides consulting services to state public infectious diseases and multidrug resistant microbes that have ap- health laboratories and to individual physicians in unique cases. peared worldwide in recent years. The CDC provides educational materials and safety guidelines The CDC also coordinates the Laboratory Response for workers in a variety of healthcare areas, as well as for the gen- Network (LRN). This laboratory network was established to eral public. ensure that state and private laboratories are equipped to respond Epidemiology is another important function of the CDC. effectively to threats to public health, such as biological or chemi- t Data are gathered concerning the origin, distribution, and oc- cal bioterrorism events, emerging infectious diseases, or natural currence of various diseases, and outbreaks are investigated to disasters. Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it. 10 UNIT 1 THE CLINICAL LABORATORY TABLE!1-2. Examples of analytes* for which there TABLE!1-3. Types of certificates issued under CLIA are CLIA waived tests (as published by FDA, 2010) ’88 and the activity(ies) each certificate permits Hemoglobin by copper sulfate CERTIFICATE ACTIVITY PERMITTED Hemoglobin by single instrument with direct Certificate of Permits a laboratory to perform only readout Waiver (COW) CLIA-waived tests Blood glucose by meters cleared for home use Certificate of Permits the laboratory to conduct Glycated hemoglobin (HbA1c) Registration moderate- or high-complexity laboratory testing (or both) until Fecal occult blood the laboratory is determined by Lyme disease antibodies survey to be in compliance with CLIA HIV antibodies regulations Spun hematocrit Certificate of Issued to a laboratory operating Ovulation tests by color comparison Compliance under a certificate of registration (COC) after an inspection finds the Urine pregnancy tests by visual color comparison laboratory to be in compliance with Urine qualitative dipstick tests all applicable CLIA regulations Microalbumin Certificate of Issued to a laboratory that has Rapid strep test from throat swab Accreditation been accredited by a CMS-approved Erythrocyte sedimentation rate (COA) accrediting organization and allows moderate- and high-complexity Immunoassay for Helicobacter pylori testing Prothrombin time Certificate for Allows a physician, mid-level Fructosamine PPMP practitioner, or dentist to perform Cholesterol; high-density lipoprotein (HDL) and low- only select permitted microscopy density lipoprotein (LDL) cholesterol procedures but no other tests of Infectious mononucleosis antibodies complexity; this certificate also permits the laboratory to perform * This list contains only a few of the more than 100 analytes waived tests for which waived tests are available. A complete up-to-date list can be found on the FDA web site, www.fda.gov Government Laboratories: State Accreditation. Table! 1-3 explains conditions under which each certificate would be issued. Each U.S. state and territory has a clinical laboratory operated Under CLIA ’88, laboratories with a certificate of waiver (usually) by the state’s department of public health. These state can only perform waived tests, tests determined to be simple, to laboratories provide testing and consulting services to hospitals, have insignificant risk for error, and to pose no harm or risk to pa- physicians, and clinics within the state. tient if the test is performed incorrectly. Many of the tests in this Services available from state laboratories vary from state category began as tests that could be performed at home, such to state. In general, state laboratories perform tests mandated by as glucose testing, or home pregnancy tests. (Examples of some state regulations, for example, premarital blood tests and phenyl- analytes for which there are waived tests are listed in Table!1-2.) ketonuria (PKU) testing of newborns. State laboratories also offer Because of advances in technology, the number and types of tests not routinely available in other laboratories such as culture waived tests have increased, and the number of laboratories per- of fungi, viruses, and mycobacteria (which include the pathogens forming waived tests has grown tremendously since CLIA ’88 causing tuberculosis); tests for parasites; confirmatory tests for re- implementation. portable infectious diseases such as HIV infection; and some envi- Laboratories with a PPMP certificate perform microscopy- ronmental testing. Special-case specimens to be sent to the CDC based tests during the course of a patient visit on specimens that for testing are usually sent via state public health laboratories. are not easily transportable. Examples of PPMP include urine microscopic examination and wet mounts. Most POLs perform only waived tests; others perform more CLIA CERTIFICATE CATEGORIES complex (nonwaived) tests. Most hospital laboratories perform The five CLIA certificate categories are (1) Certificate of moderate- to high-complexity tests. Laboratories performing Waiver, (2) Certificate for PPMP, (3) Registration Certificate, moderate- to high-complexity tests must have a certificate of reg- (4) Certificate of Compliance, and (5) Certificate of istration, compliance, or accreditation. These laboratories must Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it.  LESSON 1-1 INTRODUCTION TO THE CLINICAL LABORATORY 11 also adhere to mandated personnel guidelines, comprehensive re- Clinical Laboratory Personnel cordkeeping, and quality assessment programs; participate in profi- ciency testing programs; and be subject to government inspections. Laboratory Director The director of the hospital laboratory has customarily been a ORGANIZATION OF THE HOSPITAL pathologist, a physician specially trained in the nature and cause of disease. Hospital pathologists usually oversee two branches of LABORATORY pathology, anatomical pathology and clinical pathology. The ana- The organization schemes of most hospital laboratories follow a tomical pathology department includes cytology, histology, and general outline (Figure! 1-4) that can vary slightly depending on autopsy services. The clinical laboratory department can also be the size of the laboratory. In recent years, some laboratories have called clinical pathology or clinical laboratory services. changed department and personnel titles to reflect the terminol- Under CLIA ’88, persons other than pathologists can qualify ogy used in the CLIA ’88!rules. Table!1-4!lists personnel titles as to be clinical laboratory director. The type of CMS certificate stated in CLIA ’88 and gives the commonly used equivalent titles. held by the laboratory determines the qualifications for a director. The personnel qualifications for each category are specified in the In general, the laboratory director must be licensed by the state Clinical Laboratory Improvement Amendments of 1988, Final in which the laboratory operates; hold the degree of doctor of Rule (Federal Register, Vol. 7, No. 40, February!28, 1992). medicine, doctor of osteopathy, or an earned doctorate in a related Hospital Administrator Chairman/Director of Clinical Laboratories Associate Director Laboratory Anatomical Quality Improvement & Manager Pathology Professional Development Program Director Technical Director Personnel/ Transfusion Clinical Laboratory Research & Staffing Services Sciences Development Specimen Chemistry/ Quality Assessment Processing Special Testing Coordinator Laboratory Molecular Information Diagnostics Systems (LIS) Immunology Microbiology Ancillary Hematology/ Testing Urinalysis © Cengage Learning 2012 Customer Point of Services Care FIGURE!1-4 Organizational chart of a typical hospital laboratory Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it. 12 UNIT 1 THE CLINICAL LABORATORY TABLE!1-4. Titles of clinical laboratory personnel as listed in CLIA ’88 Final Rule and commonly used equivalent titles CLIA ’88!JOB TITLE EQUIVALENT JOB TITLE Laboratory director Laboratory director (usually a pathologist) Technical supervisor Laboratory manager Chief technologist © Cengage Learning 2012 Clinical consultant Consultant Technical consultant or Department head general supervisor Section head Section supervisor Technical specialist FIGURE!1-5 A clinical laboratory professional at work Testing personnel Medical technologist Medical laboratory scientist and updated at specified intervals. (CLSI was formerly known as Clinical laboratory scientist the National Committee for Clinical Laboratory Standards, or Medical laboratory technician NCCLS, until their name change in 2005.) Clinical laboratory technician Laboratory assistant General Supervisor and Department Head Each department has a general supervisor or department head responsible for the quality of work performed in the department, clinical field; hold certification from an appropriate body; and have training employees, and evaluating employee performance. Gen- supervisory and clinical laboratory experience. The laboratory di- eral supervisors report to the technical supervisor. rector has ultimate responsibility for all laboratory operations. Testing Personnel Small hospitals might not have a full-time pathologist on staff or on-site. Depending on the qualifications of the labora- Testing personnel perform the laboratory analyses (Figure! 1-5). tory director, laboratories in these hospitals can be required to These include medical technologists, medical laboratory scientists, contract with certified individuals to serve as clinical consultants clinical laboratory scientists, medical laboratory technicians, and and technical consultants. These consultants assist the laboratory clinical laboratory technicians. Nonlaboratory personnel such as director in matters of test appropriateness and interpretation or in medical assistants and nursing staff often perform tests in POLs technical matters relating to test methods. and point-of-care testing or testing in other settings outside the laboratory proper. Clinical laboratory personnel qualifications are Technical Supervisor and Laboratory discussed in Lesson!1-2, The Clinical Laboratory Professional. Manager Directly under the laboratory director’s authority is the technical Departments of the Clinical supervisor or laboratory manager (Figure!1-4). This is someone Laboratory educated in the clinical laboratory sciences with additional busi- ness or management training or experience. The number of departments in clinical laboratories varies. Clini- The technical supervisor (laboratory manager) is respon- cal chemistry, hematology, microbiology, blood bank, and support sible for the day-to-day operation of the laboratory. The technical services (phlebotomy and specimen processing) usually operate supervisor is also responsible for setting personnel standards, as departments or sections, each with its own department head establishing training and evaluation procedures, establishing ap- or general supervisor (Figure!1-4). The subdivisions within each propriate quality assessment programs, observing and document- department differ from one laboratory to another. Large laborato- ing employee performance and competence, and making sure that ries often have separate departments for urinalysis, coagulation, all regulatory mandates are followed. immunology, and parasitology. The technical supervisor is responsible for making avail- able to all personnel an up-to-date procedure manual contain- Hematology ing detailed instructions for every procedure performed in the Most hematology tests involve studying the cellular components laboratory. This is called the standard operating procedure of blood. Hematology procedures can be qualitative or quantita- (SOP) manual. The Clinical and Laboratory Standards In- tive. The quantitative procedures include counts of the various stitute (CLSI) develops standards of current best practice for blood components, such as the number of leukocytes (white clinical laboratory procedures. Laboratory procedure manuals blood cells), erythrocytes (red blood cells), or platelets; hemoglo- must follow CLSI standards, and the manual must be reviewed bin and hematocrit tests are commonly performed and can aid in Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it.  LESSON 1-1 INTRODUCTION TO THE CLINICAL LABORATORY 13 diagnosis of anemia. These tests can be performed manually but Immunology are usually performed on a cell counter or hematology analyzer. Immunology can be a separate department or, in small laborato- Many analyzers are capable of performing several hematological ries, a part of another department such as blood bank or microbi- procedures simultaneously. ology. In the past, this department was called serology because In qualitative procedures, blood components are observed serum was the specimen most often used in the tests. In the im- for qualities such as cell size, shape, and maturity. Using a micro- munology department, many tests are based on antigen-antibody scope, a laboratory worker can view a blood smear to determine methods. Among tests performed in this section are those for the types of leukocytes present; estimate the size, shape, and pregnancy, arthritis, and autoimmune diseases. Tests for infec- hemoglobin content of erythrocytes; or estimate the number of tious mononucleosis, HIV infection, influenza, hepatitis, sexually platelets. Cell abnormalities, including immature leukocytes or transmitted diseases, and other infectious diseases are also per- erythrocytes, are noted during microscopic examination of the formed using immunological methods. blood smear. In large laboratories, complicated tests such as special stains Blood Bank/Transfusion Services to classify leukemic cells might be performed in a hematology sec- The blood bank department is also called immunohematology tion called special hematology. Some tests in special hematology or transfusion services. Procedures performed in this department are performed manually. are critical to patient well-being. If a transfusion is required, the Coagulation. Coagulation tests are used to diagnose and mon- patient’s ABO group and Rh type are determined by blood bank itor patients who have defects in their blood-clotting mechanism technologists. Before blood is transfused, stored components of or are being treated with anticoagulants, drugs that prevent blood donor blood are tested for compatibility with patient blood. The coagulation. Coagulation tests can be performed in the hematology blood bank department might also have the capability to collect department or, in large laboratories, in a separate department. Auto- special blood donations or process donated blood into special- mated coagulation testing systems, which were once used primarily ized components. The blood bank is the only area of the clinical in larger laboratories, are now available in small, easy-to-use models laboratory for which there are no waived tests. that allow even small POLs to have the capability of performing Microbiology some coagulation procedures. Plasma, the liquid portion of antico- agulated blood, is the specimen used for most coagulation studies. The microbiology department is responsible for culturing and identifying microorganisms. Urinalysis. Like coagulation, urinalysis can be a separate department in a large laboratory or a subdivision of another Bacteriology. Bacteriology procedures make up the major- department, usually hematology or chemistry. In the urinalysis ity of the work in microbiology. Bacteria can be isolated from department, physical, chemical, and microscopic examinations specimens such as sputum, wounds, blood, urine, or other body of urine specimens are performed. These tests can be performed fluids by inoculating the specimen to culture media. Organisms manually or using automated methods. that grow in the culture are identified, and susceptibility tests are performed to determine the most effective antibiotic treatment. Clinical Chemistry In the clinical chemistry department, test procedures can be This is done by exposing the bacterial culture to different anti- biotics and observing their effect on the organism’s growth. Au- 5 performed on plasma, serum, urine, and other body fluids such tomated systems that can detect growth of an organism, identify as spinal fluid and joint fluid. Serum is the liquid part of blood an organism, and determine its antibiotic susceptibility are widely remaining after a clot has formed. Serum is obtained by collecting used in bacteriology. blood without anticoagulant, allowing it to clot, and centrifuging it to separate blood cells from the serum. Many chemistry ana- Virology and Mycology. Procedures involving virology, lyzers can perform assays using plasma; this eliminates the time the study of viruses, and mycology, the study of fungi, are usu- delay required for blood to clot if serum is used. ally performed in the microbiology department. Often specimens Clinical chemistry is the largest department in most laborato- for virology and mycology are sent to a reference laboratory ries. Procedures performed in the clinical chemistry department in- for culture and identification. Because cultures of pathogenic clude blood glucose, cholesterol, assays of heart and liver enzymes, fungi as well as mycobacteria must be handled with special care, and electrolytes (chloride, bicarbonate, potassium, and sodium). specimens suspected of containing these organisms are usually Common subdepartments in clinical chemistry are special chem- inoculated to media and then sent to a reference laboratory for istry and toxicology. Procedures such as electrophoresis and mea- identification. surement of hormone levels are performed in special chemistry. In Parasitology. In parasitology, usually a part of the toxicology, blood or urine can be analyzed to determine the drug microbiology department, patient specimens are examined for involved in an overdose or blood levels of prescribed drugs. parasites. Fecal samples are examined microscopically for evi- The types of chemistry analyzers have increased rapidly in dence of intestinal parasites such as intestinal ameba, tapeworms, the last several years (see Lessons! 6-3 and 6-4). Many of these or hookworms. Immunological tests are performed to detect analyzers provide a wide range of test procedures yet are relatively parasite antigens in fecal samples. Tests for blood parasites, such simple to operate. Thus, it is possible for even the smallest labo- as the malarial parasite, are usually performed in the hematology ratory to perform some routine chemistry tests. department. Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it. 14 UNIT 1 THE CLINICAL LABORATORY Laboratory Support Services request. After the request is received, the laboratory will begin the test process—collecting the specimen; performing Laboratory tests begin with the laboratory request form, the test; and interpreting, recording, reporting, and charting which must be completed before the test is performed. This results. can be a written request (Figure!1-6) or a computer-generated © Cengage Learning 2012 FIGURE!1-6 Example of a laboratory request form Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it.  LESSON 1-1 INTRODUCTION TO THE CLINICAL LABORATORY 15 Most hospital laboratories have a separate department bar-coded specimen labels with patient data. Advantages of labo- responsible for collecting and processing specimens. This de- ratory information systems include: partment is called by a variety of names such as support services, Elimination of charting errors phlebotomy, or specimen collection and processing. Phleboto- Improved efficiency mists are the specially trained laboratory personnel who collect the blood specimens; sometimes this responsibility is shared by Automatic identification of abnormal or unusual test results nursing personnel. Matching of patient specimens to test results In small laboratories, specimens are usually taken directly Prevention of unauthorized testing and reporting to the appropriate laboratory department. Many hospitals have pneumatic delivery systems that provide rapid delivery of specimens to the laboratory from the patient room, nursing Point-of-Care Testing station, outpatient clinic, surgery, emergency room, or intensive Rapid advancements in technology make possible rapid changes care unit. in all aspects of health care. One of the major changes in the clini- In larger laboratories, specimens are delivered to a central cal laboratory has been the implementation and increased use accessioning area where they are processed, logged into the of point-of-care testing (POCT). POCT brings the laboratory computer using the barcodes on their labels (Figure! 1-7), and test to the patient rather than obtaining a specimen from the pa- given a specimen identification code before being distributed to tient and transporting it to the laboratory for testing. This makes the departments for testing. High-volume laboratories use ro- laboratory test results available more rapidly, providing improved botic specimen processing systems, automated systems that per- patient care. form many of the manipulations usually performed by laboratory POCT is commonly used in settings such as clinics, health personnel. Actions that can be automated include accessioning; maintenance organizations (HMOs), nursing homes, home health sorting according to test ordered and preparation required; cen- care, physician offices, emergency departments, intensive care trifugation; decapping, labeling, and aliquoting specimens; and units, and surgery suites. POCT is also referred to as bedside transporting to testing instruments or storage. Robotic systems testing, near-patient testing, off-site testing, or alternative-site increase efficiency, improve specimen integrity, reduce errors, testing. and contribute to personnel safety by reducing exposure to the The evolution of small, simple-to-use analyzers that pro- specimen. vide rapid results has led to widespread POCT implementation. Handheld portable analyzers can measure substances such as hemoglobin, glucose, cholesterol, and electrolytes, and results Laboratory Information Systems can be directly uploaded to the central LIS. Most POC analyzers Large laboratories have integrated laboratory information systems require only a drop of blood, usually obtained by fingerstick. The (LIS) that improve efficiency and reduce errors. In hospitals, the majority of nonhospital POCT tests are CLIA-waived. LIS can be linked into the institution-wide computer system. The emergence and growth of POCT has created the op- Computerization in the laboratory and hospital has reduced portunity for more collaboration between the laboratory and errors in specimen identification and tracking. Specimens are la- other members of the healthcare team. Although nonlaboratory beled with preprinted bar-coded labels that match bar-coded test personnel from the nursing service, surgery, or emergency de- requisitions and patient identification bracelets. Data can be en- partment teams can perform the tests, the laboratory is usually tered directly into the computer system using bar-code scanners. responsible for selecting instrumentation, training personnel, de- Even small laboratories usually have a system for preprinting veloping procedure manuals, and monitoring quality assessment procedures and instrument maintenance. QUALITY ASSESSMENT Q IN THE LABORATORY Q For many years, clinical laboratories have had programs in place to monitor the quality of laboratory results. These program requirements expanded under CLIA ’88 and associ- ated legislation. All laboratories now must have comprehensive programs to evaluate, monitor, and improve overall laboratory © Cengage Learning 2012 performance. These programs have evolved through many changes, beginning as quality control (QC), progressing to quality assurance and broader programs such as total qual- ity management (TQM) and continuous quality improve- ment (CQI). The name recommended by CMS is quality FIGURE!1-7 Use of bar codes and patient identification assessment (QA), part of a comprehensive quality system numbers allows computer accessioning and reduces (QS). In this text the symbol is used to emphasize quality Q pre-analytical errors assessment considerations in a method or activity. Copyright 2012 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s). Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it. 16 UNIT 1 THE CLINICAL LABORATORY CURRENT TOPICS ELECTRONIC HEALTH RECORDS (EHRS) physician. The EMR remains in the hospital or medi- Information technology (IT) is an integral part of cal practice where the record originated. Physicians all facets of our lives, so it is not surprising that on a hospital’s medical staff can have remote ac- health information is going “electronic.” One sec- cess to view a patient’s hospital records, but the tion of the 1996 HIPAA (the Administrative Simpli- records remain hospital property and responsibility. fication provisions) requires that national standards If a patient requires a copy of their medical record, for sharing electronic health information be es- or a specialist requires information from a primary tablished, with special attention to ensuring the care physician, the medical record will still have to be privacy and security of personal health data. The printed to be shared. overall intent of the provisions is to improve patient Patient care and the efficiency of healthcare de- care and healthcare efficiency and reduce health- livery can be improved by making it possible to care costs. easily share health information. Unlike EMRs, elec- tronic health records (EHRs) are comprehensive Electronic Medical Records vs. Electronic digital records that give a broad view of a patient’s Health Records: What is the difference? health. EHRs contain information compiled from all physicians and facilities involved in a patient’s care Many physicians and hospitals have been using elec- over time. tronic medical records (EMRs) for years. An EMR is a digital form of a patient chart created in a physi- cian’s office or a hospital where a patient received Benefits of EHRs treatment (Figure! 1-8). Hospital EMRs allow physi- cians, surgeons, and specialists to easily monitor test EHRs are designed to be constantly updated, por- results and changes in a patient’s condition while table, and accessible by all who provide patient care, they are hospitalized. However, the hospital elec- and also by the patient. An EHR can travel with the tronic record does not follow patients when they are patient, allowing electronic sharing of patient medi- discharged and return to the care of their personal cal information with specialists, laboratories, and other healthcare providers, whether in the same