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Solution Manual for Basic Clinical Laboratory Techniques, 6th Edition

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    U N I T 1 The Clinical Laboratory UNIT OBJECTIVES After studying this unit, the student will: • Discuss the regulation, organization, and function of the clinical laboratory. • Discuss the qualifications, job functions, and ethical responsibilities of clinical laboratory personnel. • Identify and define selected abbreviations and acronyms commonly used in the clinical laboratory. • Identify, define, and use prefixes, suffixes, and stems in selected medical terms. • Discuss and implement laboratory safety rules that must be followed to guard against biological, chemical, and physical hazards. • Identify common types of labware and demonstrate their correct uses. • Discuss and demonstrate safe use of general laboratory equipment. • Use the metric system to perform measurements and calculations. • Use laboratory math to prepare simple laboratory reagents. • Discuss the importance and use of quality assessment programs in the clinical laboratory. • Use the compound bright-field microscope. • Perform a capillary puncture. • Perform a venipuncture. UNIT OVERVIEW The clinical laboratory is a place where blood, body fluids, and other biological specimens are tested, analyzed, or evaluated. The observations can be qualitative or quantitative. The tests can be performed manually or using automated analyzers. Precise measurements are made and the results

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    are calculated and interpreted. Because of this, laboratory workers must have the skills necessary to perform a variety of tasks. Unit 1 is an introduction to the laboratory environment as a workplace and to the profession of clinical laboratory science, also called medical laboratory science. Key concepts and procedures laboratory professionals need to know to work in the laboratory are described in the introductory unit. The regulation, organization, and function of the clinical laboratory are addressed in Lesson 1-1. Qualifications and job functions of laboratory personnel are reviewed in Lesson 1-2. As an introduction to the structure of medical terms, Lesson 1-3 gives basic information about medical terminology and abbreviations and acronyms used in the laboratory. As other units are studied, additional vocabulary terms will be introduced and defined. Two lessons on laboratory safety (Lessons 1-4 and 1-5) are included in Unit 1 because workers must understand and follow all safety procedures and practices before any laboratory exercises can be performed. Every worker in the clinical laboratory must be thoroughly aware of potential hazards in the workplace and must perform tasks in a manner that keeps them, coworkers, and patients safe. The correct and safe use of general laboratory equipment such as centrifuges, pH meters, autoclaves, and laboratory balances is described in Lesson 1-6. Also explained is the care, use, and cleaning of frequently used labware such as beakers, cylinders, test tubes, and flasks. Because laboratory analyses use metric units, a brief introduction to the metric system is given in Lesson 1-7. Knowledge of the metric system is required for exercises in other units. Basic laboratory calculations, methods of reagent preparation, and the correct use of pipets are explained in Lesson 1-8. Principles, methods, and procedures for ensuring the reliability and accuracy of laboratory analyses are presented in Lesson 1-9, Quality Assessment. These quality assessment principles are included in Unit 1 because they must be integrated into all aspects of laboratory operations, from employee training and evaluation to specimen collection and processing, specimen analysis, and interpretation and reporting of results. The proper care and use of the microscope is included in Unit 1 (Lesson 1-10) because knowledge of its use is required for lessons in the microbiology, hematology, urinalysis, and parasitology units. Lessons 1-11 and 1-12 introduce techniques for collecting capillary and venous blood. Unit 1 is an introduction to the techniques, rules, and skills needed to perform the exercises in Units 2 through 8. Unit 1 can also be used alone as an introduction to the profession of clinical laboratory science. After Unit 1 has been completed, the remaining units can be studied in order of the instructor’s preference depending on available time, laboratory space, and equipment.

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    L ESSON 1-1 Introduction 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.

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    4 Lesson 1-1 ● Introduction to the Clinical Laboratory 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 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 and certification to clinical laboratory personnel 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)

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    Lesson 1-1 ● Introduction to the Clinical Laboratory 5 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 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 Procedures (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 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

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    6 Lesson 1-1 ● Introduction to the Clinical Laboratory TEACHING AIDS AND RESOURCES • Examples of hospital and laboratory organizational charts • Examples of various laboratory requisition forms • Transparencies or overheads of Figures 1-1 through 1-9 • Transparencies or overheads of Tables 1-1 through 1-5 • ’s Resources CD accompanying Basic Clinical Laboratory Techniques, 6th edition, including computerized test bank and PowerPoint LESSON CONTENT I. Introduction II. Regulation of Clinical Laboratories A. CLIA ’88 B. Centers for Medicare and Medicaid Services (CMS) III. Types of Clinical Laboratories A. Hospital Laboratories B. Nonhospital Clinical Laboratories 1. Physician office laboratories 2. Reference laboratories 3. Government laboratories—federal a. Centers for Disease Control and Prevention b. Consultation c. Education d. Epidemiology e. Laboratory Response Network 4. Government Laboratories—State a. Specialty tests b. Confirmation of reportable infectious diseases c. Environmental testing IV. CLIA Certificate Categories A. Certificate of Waiver B. Certificate of Registration C. Certificate of Compliance D. Certificate of Accreditation—Moderate or High-Complexity Tests E. Certificate for Provider-Performed Microscopy Procedures (PPMP)

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    Lesson 1-1 ● Introduction to the Clinical Laboratory 7 V. Organization of the Hospital Laboratory A. Clinical Laboratory Personnel 1. Laboratory director 2. Technical supervisor/laboratory manager 3. General supervisor/department head 4. Testing personnel B. Departments of the Clinical Laboratory 1. Hematology a. Coagulation b. Urinalysis 2. Clinical Chemistry 3. Immunology 4. Blood Bank/Transfusion Services 5. Microbiology a. Bacteriology b. Virology c. Mycology d. Parasitology 6. Laboratory Support Services a. Specimen collection b. Accessioning c. Specimen sorting and processing 7. Laboratory information systems 8. Point-of-care testing (POCT) VI. Electronic Health Records A. Electronic Health Records vs. Electronic Medical Records B. Benefits C. Concerns VII. Quality Assessment in the Laboratory A. Proficiency Testing B. Accreditation VIII. Privacy Issues A. HIPAA B. Computers C. Confidentiality IX. Critical Thinking Problem X. Summary

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    8 Lesson 1-1 ● Introduction to the Clinical Laboratory Critical Thinking Problem and Answer Timothy is a medical assistant working in a small POL. His laboratory operates under a certificate of waiver. The physician requests a microscopic examination of urine for patient Mary Smith. During Timothy’s medical assistant training, he learned to perform microscopic examination of urine, classified by CLIA as a moderate complexity test. 1. What is the appropriate action for Timothy to take? a. Tell the physician that it is not possible to have the test performed. b. Send the specimen to a laboratory approved for performing moderate- to high- complexity testing. c. Perform the test and report the results to the physician. 2. Explain your answer. Even though Timothy has been trained to perform the requested test, which is of moderate complexity, the laboratory where he is employed only has permission to perform waived tests. Laboratories with certificates of waiver use reference laboratories to perform tests that are beyond their permitted level. STUDENT ACTIVITIES 1. Complete the written examination for this lesson. 2. Interview an employee of a clinical laboratory and report on your interview. Inquire about the laboratory’s organization, the types of tests performed, how specimens are received, and how results are recorded and delivered to physicians. Obtain various laboratory test report forms and note the types of tests performed in each department. 3. Tour a hospital laboratory or reference laboratory in your area. 4. Visit a POL and find out the types of tests performed there. Web Activities 1. Select five analytes from Table 1-2. Find information about the analytes from the CMS or FDA web site. List two brands of test kits that qualify as waived for each of the five analytes. 2. Find web sites of three clinical laboratories. Note the types of information provided on each web site. Look for organizational charts for the laboratories and compare them with what you have learned in this lesson about how laboratories are organized. REVIEW QUESTIONS AND ANSWERS 1. What is the function of a clinical laboratory? Clinical laboratories perform chemical and microscopic tests on body fluids and tissues to aid in diagnosis of diseases. 2. Draw an organizational chart of a typical hospital laboratory. See Figure 1-2 in the textbook.

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    Lesson 1-1 ● Introduction to the Clinical Laboratory 9 3. Name five major departments found in a hospital laboratory. Any 5 of the following are acceptable: a. Chemistry b. Microbiology c. Hematology d. Blood bank e. Immunology f. Laboratory support services (Specimen collection and processing) g. Laboratory information systems 4. Name two procedures performed in the hematology department. Any two of the following are acceptable: a. Blood cell counts b. Hemoglobin determinations c. Hematocrit d. Examinations of blood smears e. Coagulation tests 5. Name two tests performed in the chemistry department. Any two of the following are acceptable: a. Glucose b. Electrolytes c. Cholesterol d. Enzymes e. Drug levels f. Hormone levels 6. How does the HIPAA affect workers in the laboratory? Much communication in laboratories is facilitated by computers. Patient information stored in computers must be password-protected so that only authorized personnel can access information. Computer monitors must be positioned so that visitors, other patients, and other nonauthorized personnel cannot view the screen. All patient information must remain private and confidential and must be shared only with authorized persons to facilitate and improve patient care. 7. Name three benefits of electronic health records. Any three of the following are acceptable: a. Better coordination of patient care b. Improved follow-up after hospitalization c. Maintain comprehensive information about patient’s health in one file d. Provide a secure way to share patient information e. Motivate patient to comply with recommendations

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    10 Lesson 1-1 ● Introduction to the Clinical Laboratory 8. List three locations of clinical laboratory facilities other than in hospitals. Any three of the following are acceptable: a. Physician offices b. State and federal government facilities (public health) c. Universities d. Research institutions or facilities e. Reference laboratories 9. Explain the job functions of the laboratory director, technical supervisor, and department head or general supervisor. The laboratory director has ultimate responsibility for all laboratory operations; the director may be a pathologist, a qualified M.D., or a doctoral scientist. The technical supervisor handles the day-to-day operation of the laboratory, sets personnel standards, and supervises employee performance. The department head is responsible for work within a specific department and for training and evaluating employee performance. 10. Who is responsible for creating the laboratory’s SOP manual? The technical supervisor (or laboratory manager) is responsible for the information and keeping the manual up-to-date. 11. What is contained in the SOP manual? It contains the up-to-date instructions for all procedures performed in the laboratory. 12. What is the purpose of CLIA ’88? CLIA ’88 specifies minimum standards for all clinical laboratories. The objective of CLIA ’88 is to ensure quality laboratory testing. 13. What federal agency is responsible for implementing CLIA ’88? CMS (formerly known as HCFA) is responsible for implementing CLIA ’88. 14. What are waived tests? Waived tests are those that are determined by CDC or FDA to be so simple that there is insignificant risk for error. 15. List the five certificates issued under CLIA ’88, and state the activities each certificate permits. a. Certificate of Waiver—permits a laboratory to perform CLIA-waived tests only b. Registration Certificate—permits the laboratory to (temporarily) conduct moderate- or high-complexity laboratory testing (or both) until the laboratory is determined by survey to be in compliance with CLIA regulations c. Certificate of Compliance—issued to a laboratory holding a Certificate of Registration after an inspection finds the laboratory to be in compliance with all applicable CLIA regulations

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    Lesson 1-1 ● Introduction to the Clinical Laboratory 11 d. Certificate of Accreditation—issued to a laboratory that has been accredited by a CMS-approved accrediting organization e. Certificate for PPMP—permits the laboratory to perform waived tests and allows a physician, midlevel practitioner, or dentist to perform microscopy procedures but no other tests of complexity. 16. What is the advantage of proficiency testing? Proficiency testing programs evaluate a laboratory’s performance for accuracy and compare it to that of other laboratories. This allows the laboratory to have confidence in testing methods and to identify deficient areas. 17. How do laboratories become accredited? A facility desiring accreditation invites the accrediting agency to inspect its facility and evaluate its performance to determine if established standards are being met. 18. Define accessioning, accreditation, American Association of Blood Banks (AABB), anticoagulant, bacteriology, blood bank, Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Clinical and Laboratory Standards Institute (CLSI), clinical chemistry, Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), coagulation, College of American Pathologists (CAP), COLA, Department of Health and Human Services (DHHS), electronic health record (HER), electronic medical record (EMR), epidemiology, Food and Drug Administration (FDA), Health Care Financing Administration (HCFA), hematology, HIPAA, immunohematology, immunology, Joint Commission (JC), Laboratory Response Network (LRN), microbiology, mycology, National Committee for Clinical Laboratory Standards (NCCLS), parasitology, pathologist, phlebotomist, physician office laboratory (POL), plasma, point-of-care testing (POCT), proficiency testing, Provider-Performed Microscopy Procedure (PPMP), quality assessment, reference laboratory, serology, serum, standard operating procedure (SOP), virology, and waived test. See Glossary.

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    L ESSON 1-2 The Clinical Laboratory Professional LESSON OBJECTIVES After studying this lesson, the student will: • Give a brief history of medical technology. • List five personal qualities that are desirable in a clinical laboratory professional. • Describe the educational requirements for medical laboratory scientists and technicians. • Explain the functions of accrediting agencies and credentialing agencies. • Discuss the relationship between the laboratory professional and the patient. • Explain the laboratory professional’s responsibility in relation to patient privacy. • Explain the purpose and benefits of professional societies. • Discuss the importance of ethical conduct by laboratory professionals. • Name five areas of employment for clinical laboratory professionals other than in hospital laboratories. • Define the glossary terms. GLOSSARY American Association of Medical Assistants (AAMA) / professional society and credentialing agency for medical assistants American Medical Technologists (AMT) / professional society and credentialing agency for several categories of medical laboratory personnel American Society for Clinical Laboratory Science (ASCLS) / professional society for medical/clinical laboratory personnel American Society for Clinical Pathology (ASCP) / professional society for medical/clinical laboratory personnel and allied health personnel American Society of Phlebotomy Technicians (ASPT) / professional society and credentialing agency for phlebotomists, as well as credentialing agency for specialty areas such as point- of-care technician

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    Lesson 1-2 ● The Clinical Laboratory Professional 13 ASCP Board of Certification (ASCP BOC) / a separate body within the ASCP organizational structure, formed in 2009 by merging NCA with the ASCP BOR and providing certification for medical laboratory personnel clinical laboratory science / the health profession concerned with performing laboratory analyses used in diagnosing and treating disease, as well as in maintaining good health; synonymous with medical laboratory science and medical (laboratory) technology clinical laboratory scientist (CLS) / the NCA term for a professional who has a baccalaureate degree from an accredited college or university, has completed clinical training in an accredited clinical/medical laboratory science program, and has passed a national certifying examination; also called medical laboratory scientist (MLS) or medical technologist (MT) clinical laboratory technician (CLT) / the NCA term for a professional who has completed a minimum of 2 years of specific training in an accredited clinical/medical laboratory technician program and has passed a national certifying examination; also called medical laboratory technician (MLT) Commission on Accreditation of Allied Health Education Programs (CAAHEP) / agency that accredits educational programs for allied health personnel; formerly CAHEA ethics / a system of conduct or behavior; rules of professional conduct Health Insurance Portability and Accountability Act (HIPAA) / 1996 Act of Congress, a part of which guarantees protection of privacy of an individual’s health information medical laboratory science / the health profession concerned with performing laboratory analyses used in diagnosing and treating disease, as well as in maintaining good health; synonymous with clinical laboratory science and medical (laboratory) technology medical laboratory scientist (MLS) / a professional who has a baccalaureate degree from an accredited college or university, has completed clinical training in an accredited medical laboratory science program, and has passed a national certifying examination; synonymous with medical technologist (MT) or NCA certified clinical laboratory scientist (CLS) medical laboratory technician (MLT) / a professional who has completed a minimum of 2 years of specific training in an accredited medical laboratory technician program and has passed a national certifying examination; synonymous with NCA certified clinical laboratory technician (CLT) medical technologist (MT) / a term gradually being replaced but referring to the professions of medical laboratory scientist (MLS) or clinical laboratory scientist (CLS) medical technology / synonymous for clinical laboratory science and medical laboratory science National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) / agency that accredits educational programs for clinical laboratory personnel National Credentialing Agency for Laboratory Personnel (NCA) / a credentialing agency for clinical laboratory personnel that merged with the ASCP Board of Registry (BOR) in 2009 to form the ASCP Board of Certification (BOC) National Phlebotomy Association (NPA) / professional society and credentialing agency for phlebotomists

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    14 Lesson 1-2 ● The Clinical Laboratory Professional TEACHING AIDS AND RESOURCES • Career Information Fact Sheet and Interview Fact Sheet • Clinical/Medical Laboratory Science journals • Information about medical laboratory professions from professional societies • Information about educational programs in clinical/medical laboratory science • Guest speaker: laboratory professional from a local hospital or other laboratory • Transparencies or overheads of Figures 1-10 and 1-11 • Transparencies or overheads of Tables 1-6 through 1-9 • ’s Resources CD accompanying Basic Clinical Laboratory Techniques, 6th edition, including computerized test bank and PowerPoint LESSON CONTENT I. Introduction A. Medical Technology B. Medical Laboratory Science C. Clinical Laboratory Science II. History of Medical Technology A. Early Medical Laboratories 1. Late nineteenth century 2. Primitive B. Modern Medical Laboratories 1. Growth in laboratories after World War I 2. Need for formal education and identification of trained personnel 3. Rapid changes in technology after World War II C. The Clinical Laboratory in the Twenty-First Century 1. Emphases on wellness, geriatrics, home health care, and hospice 2. State-of-art technology 3. Rapid, portable testing 4. ASCP Board of Certification (BOC)—change in certification categories III. Role of the Laboratory Professional IV. Certification Requirements for Laboratory Personnel A. Educational Programs and Accrediting Agencies B. Educational Requirements 1. Medical Laboratory Scientist 2. Medical Laboratory Technician C. Areas of specialization

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    Lesson 1-2 ● The Clinical Laboratory Professional 15 D. Credentialing and certification E. Licensing of Laboratory Professionals V. Other Allied Health Personnel in the Clinical Laboratory A. Phlebotomist / Phlebotomy Technician B. Certified Medical Assistant / Registered Medical Assistant C. Physician Office Laboratory Technician D. Clinical Laboratory Assistant E. Diagnostic Molecular Scientist F. Point-of-Care Technician G. Other Personnel Performing Testing 1. Paramedics 2. Nursing staff VI. Ethics and Professionalism A. Ethics and the Clinical Laboratory Professional 1. Maintain high standards of practice 2. Duty to patients, profession, colleagues, and society 3. Maintain honesty, integrity, and reliability 4. Maintain respect for patients, the profession, and other healthcare professions B. Qualities Desirable in Laboratory Professionals C. Patient Privacy/Confidentiality D. Interactions Between Laboratory Personnel and Patients E. Professional Organizations F. Employment Opportunities VII. Case Study VIII. Summary Case Study and Answer Rob works in the laboratory at Bay Regional Hospital. Each work day before he begins his duties in the laboratory, he helps collect blood from hospital patients. On one occasion, the patient on his collection list was his friend Louis, who had been admitted to the hospital through the emergency department the night before. Rob collected blood from Louis for several laboratory tests and chatted with him briefly before returning to the laboratory. After Rob got home that evening, he received a call from Susan asking for information about their mutual acquaintance Louis, who she heard was in the hospital. Susan said she had called the hospital but they would not release information about Louis and would not even confirm that he was a patient in the hospital. Susan asked Rob if he knew if Louis was hospitalized and if so, why. 1. How should Rob respond to Susan? Even though Rob, Louis, and Susan are mutual friends, Rob should not reveal medical information about Louis, because the hospital was not releasing information.

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