LabCE PDF Courses - Introduction to the Medical Laboratory, Part 1 PDF

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Copyright and License Notice for PDF Courses LabCE courses are provided in PDF format for the sole use of LabCE subscribers. Distribution to non-subscribers is prohibited in every form, including electronic and print. Do not make multiple copies of this PDF file. If you are an individual subscriber, you are the only person authorized to use this PDF file. Please do not redistribute it to others inside or outside your organization. Instead, please contact LabCE about obtaining an institutional subscription. This Copyright and License Notice is part of the Terms of Service for LabCE. If you have any questions, please contact us. LabCE retains all copyright to this course and all material contained therein. An Introduction to the Medical Laboratory, Part 1 Authors: Julia Clendenin, Paul Fekete, M.D. FCAP Reviewer: Joshua J. Cannon, MS, MLS(ASCP)CMSHCM Course Instructions Please proceed through the course by clicking on the blue arrows or text links. Use the table of contents to monitor your progress. Your progress will be saved automatically as you proceed through the course, and you may later continue where you left off, even if you use a different computer. You may encounter practice questions within the course, which are not graded or recorded. Course Info This course does not carry any continuing education credits. Level of Instruction: Basic Intended Audience: This course is an elementary introduction to the operation of a clinical medical laboratory. It assumes that the learner has little or no background in medical practice or clinical laboratory science. It is ideal for those who desire an introduction to the operation and function of the laboratory and the qualifications and mindset of those professionals who staff it. This course would be ideal for those contemplating a career in any clinical laboratory field, sales representatives who will be visiting clients in the laboratory and need an introduction to provide context for their future sales contacts, and anyone else interested in the field and desires an introduction. Author Information: Julia Clendenin is a content and graphics developer for MediaLab, Inc. She graduated from Georgia Institute of Technology with a B.S. in Biochemistry and a B.S. in Literature, Media, and Communication. Paul Fekete, M.D. is the former CEO of MediaLab. He formerly served as Assistant Professor of Pathology at Emory University and was Director of Laboratories for Gwinnett Health System near Atlanta, GA. Dr. Fekete has extensive teaching experience and is the author of numerous journal articles and book chapters. He additionally has extensive experience in instructional design. Reviewer Information: Joshua J. Cannon, MS, MLS(ASCP)CMSHCM received his Bachelor of Science and Master of Science in Medical Laboratory Science from Thomas Jefferson University in Philadelphia, PA. He holds Medical Laboratory Scientist and Specialist in Hematology certifications through the ASCP Board of Certification. He was a professor at Thomas Jefferson University for seven years before transitioning into his current role as Content Developer at MediaLab. His areas of expertise and professional passions include clinical hematology and interprofessional education.  Introduction to the The Medical Laboratory Consists of the Medical Laboratory Anatomical Pathology Laboratory and the Clinical Laboratory In a medical facility, the laboratory consists of the anatomical pathology laboratory and the clinical laboratory. The anatomical pathology laboratory is where patient tissues are diagnosed and where pathology reports are generated. It is also where autopsies are performed and reported. The anatomical pathology laboratory is directed and staffed by pathologists, physicians specialized in tissue diagnosis, and histotechnologists, who process tissues into microscopic slides for pathologist interpretation. It is also staffed by other healthcare personnel, including pathologists' assistants. In the clinical laboratory, tests are performed on Laboratory technicians pipette samples for a hemoglobin various specimens, including blood, body fluids, test to cultures, and more. Results are then reported to the determine blood sugar levels in the pathology and clinical laboratory (1). ordering clinician. It is staffed by highly trained professionals known as medical laboratory scientists (MLS) (also known as medical technologists [MT]) and medical laboratory technicians (MLT). It is supervised by MLSs, PhDs, or pathologists. 1. Pivnick, Steve. "Medical group labs renew accreditation." U.S. Air Force, 04 May 2011, https://w w w.keesler.af.mil/New s/Art/igphoto/2000259343/. Accessed 15 August 2020. Overview of the Introduction to the Anatomical Pathology Anatomical Pathology Laboratory Laboratory All tissues removed during surgery, tissue biopsies, cytological specimens, frozen sections, and autopsies are prepared, processed, and analyzed within the anatomical pathology laboratory. It is also known simply as the pathology laboratory. The anatomical pathology laboratory is directed and staffed by pathologists, specialized physicians trained to interpret microscopic tissue slides and make diagnoses. Arguably, the most important of these is the diagnosis of cancer. This includes the determination of the presence or absence of cancer in patient specimens and the determination of the severity and extent of cancer, known respectively as grade and stage. In a pathology laboratory, a pathologists' assistant dissects Physical areas within the typical pathology a heart tissue specimen (2). laboratory include spaces for gross pathology, frozen sections, histology, cytology, and autopsies. Most anatomical pathology laboratories have an area containing microscopes and digital viewing equipment in which pathologists interpret tissue slides previously prepared in the histology laboratory. 2. Bushen, Bethany. “Nothing 'Gross' About It: The Work of a Pathologists' Assistant.” Pathology & Laboratory Medicine: Blog, University of Rochester Medical Center, 13 Apr. 2016, w w w.urmc.rochester.edu/pathology-labs/blog/april-2016/nothing- gross-about-it-a-day-in-the-life-of-a-path.aspx. MediaLab w as given permission to use these images by Lori Barrette on 06 August 2020. Overview of the Introduction to the Anatomical Pathology Anatomical Pathology Laboratory, continued Laboratory The gross pathology laboratory is where patient tissues taken from surgery or other procedures are received, described, and sectioned in preparation for microscopic examination. Pathologists, pathologists' assistants, or technicians perform the initial evaluation and processing while using appropriate physical safeguards and personal protective equipment (PPE). Most tissues received in the gross laboratory are sectioned into small pieces and placed in a formalin solution for fixation. The frozen section laboratory is where fresh tissue taken during surgery is submitted by the surgeon for immediate diagnosis by the pathologist. This is only done when the surgeon needs an immediate diagnosis, typically regarding cancer. The fresh tissue is rapidly frozen and then sectioned into very thin slices using an instrument called a microtome. The tissue slices are then placed on glass slides, stained, and examined by a pathologist using a microscope. The pathologist must provide the diagnosis to the surgeon within 15 minutes. Often, this means the pathologist must make an instant decision on whether or not cancer is present in the specimen. The pathologist then reports the diagnosis to the surgeon in the operating room. The surgeon will decide how to proceed based on the immediate frozen section diagnosis. The histology laboratory is where routine slides are made from the fixed tissue received from the gross pathology laboratory. Automated equipment processes the fixed tissues in various fluids before a histotechnologist embeds the processed tissue into blocks of paraffin or similar synthetic substances. The histotechnologist sections the paraffin- embedded tissue blocks into very thin, almost Top: A pathologists' assistant grosses a breast specimen. transparent sections using a microtome (see last Middle: A pathologists' assistant checks dictation reports in image). The super thin slices of tissue are placed on the gross room. Bottom: A frozen tissue sample that will be cut, stained, and glass slides and stained. Finally, the slides are examined under a microscope by a pathologist. (2). presented to the pathologist for microscopic examination, diagnosis, and reporting. The cytology laboratory is where cytologists prepare and examine tissues and body fluids for the presence of abnormal cells, such as cancer cells. The pathologist then evaluates the specimen and provides a final diagnosis. The autopsy suite is where autopsies are performed by the pathologist and pathologists' assistant and/or morgue diener upon request of the deceased patient's family or physician. The suite is usually adjacent to the hospital morgue. The autopsy procedure includes a review of the patient's medical record, a gross examination of the organs, a microscopic examination of selected tissue samples, and a review of special studies, such as toxicology. Finally, the pathologist generates a comprehensive report with conclusions as to the cause of death and contributing factors. 2. Bushen, Bethany. “Nothing 'Gross' About It: The Work of a Pathologists' Assistant.” Pathology & Laboratory Medicine: Blog, University of Rochester Medical Center, 13 Apr. 2016, w w w.urmc.rochester.edu/pathology-labs/blog/april-2016/nothing- gross-about-it-a-day-in-the-life-of-a-path.aspx. MediaLab w as given permission to use these images by Lori Barrette on 06 August 2020. Introduction to the Clinical Laboratory  Overview of the Introduction to the Clinical Laboratory Clinical Laboratory In the clinical laboratory, tests are performed on various specimens, including blood, body fluids, cultures, and more. Results are then reported to the ordering clinician. Commonly requested tests are performed in-house, while less commonly requested tests may be sent to a reference laboratory. The clinical laboratory can be divided into various departments, each staffed by medical laboratory scientists (MLS) and medical laboratory technicians (MLT). MLSs and MLTs are trained to perform specific tests and to operate and monitor automated instruments within their department(s). Each department is overseen by a qualified supervisor or a lead MLS/MLT. Departments within the clinical laboratory include data management, specimen collection and processing, hematology and coagulation, chemistry, immunology and serology, transfusion services, microbiology, and molecular diagnostics. In all of these departments, specialized automated instruments ensure analysis quality and deliver results to the patient's electronic medical record (EMR). Overview of the Introduction to the Clinical Laboratory, Clinical Laboratory continued The data management department is where the laboratory information system (LIS) and its communication with analyzers are managed. The specimen collection and processing department is where specimens are collected and processed before being sent to the necessary department(s) for testing. Blood is the most common specimen collected and received from outpatient collection areas. Tasks in the specimen collection and processing department are also performed by phlebotomists and medical laboratory assistants (MLA). The hematology department is where cellular components of the blood—red blood cells, white blood cells, and platelets—are tested. Coagulation, or the blood's ability to clot, is also tested in this department. The chemistry department is where blood plasma and serum are tested for various analytes. An example of an analyte is an electrolyte, such as sodium (Na+), chloride (Cl-), and potassium (K+). Urinalysis, or the analysis of urine, is performed in this department or hematology. The transfusion services department is where blood donor units are matched with blood recipients. The transfusion services department receives and tests donor blood components for compatibility with patient samples. It requires high quality control since erroneous compatibility results can cause serious adverse outcomes for the patient. The microbiology department is where microorganisms within a patient specimen are grown for identification, known as "culturing." After microorganisms are cultured, they are tested for identification and other relevant findings, such as antibiotic sensitivity, which reveals the most effective antibiotic treatment for a patient's infection. The molecular diagnostics department is where molecules like DNA and RNA are tested to produce diagnostic results. The most common laboratory technique is the polymerase chain reaction (PCR), which helps identify bacterial or viral infections, including HPV and COVID-19. 3. Gathany, James."This photograph depicted an Enteric Diseases Laboratory Branch (EDLB), Public Health scientist, w ho w as testing bacterial samples for their antimicrobial susceptibility." CDC Public Health Image Library, 2019, https://phil.cdc.gov/Details.aspx?pid=23182. 4. Gathany, James."This photograph depicted an Enteric Diseases Laboratory Branch (EDLB), Public Health scientist, w ho w as setting up a molecular test called a polymerase chain reaction (PCR), in order to detect specific bacterial DNA in a sample." CDC Public Health Image Library, 2019, https://phil.cdc.gov/Details.aspx?pid=23174. Overview of the Ungraded Practice Question Clinical Laboratory True or False: In the clinical laboratory, blood, body fluids, and other specimens are processed and tested. It is staffed by medical laboratory scientists and technicians. Select true or false True False Overview of the Ungraded Practice Question Clinical Laboratory True or False: In the clinical laboratory, blood, body fluids, and other specimens are processed and tested. It is True or False: In the clinical laboratory, blood, body fluids, and other specimens are processed and tested. It is staffed by medical laboratory scientists and technicians. Select true or false True False Feedback TRUE. The clinical laboratory is where patient blood, body fluids, and other specimens are processed, analyzed, and results are reported. It is staffed by medical laboratory scientists (MLS) and medical laboratory technicians (MLT). Blood products are prepared for transfusion here, as well. In contrast, in the anatomical pathology laboratory, tissues are processed, analyzed, and diagnosed by specialized physicians known as pathologists. (see pg. 3, Introduction to the Clinical Laboratory) Who Staffs the Clinical Staff of the Clinical Laboratory Laboratory The clinical laboratory is staffed by highly trained professionals with degrees in medical laboratory science. Medical laboratory science is the health profession that educates people in performing laboratory tests on patient blood and other specimens. These laboratory tests are ordered by physicians and other healthcare providers who use the laboratory test results to diagnose, treat, and manage patients. Medical laboratory scientists (MLS) are trained to work in all departments of the clinical laboratory, but they may work exclusively in one department or A group of clinical laboratory professionals. rotate between departments. MLSs that rotate between departments are known as generalists. There are also supervisory and administrative roles in the clinical laboratory. Below is a list of some of the various specially trained and certified personnel working in the clinical laboratory: Specimen Collection and Processing Personnel Phlebotomist Performs venipuncture on patients to collect venous blood specimens Medical Laboratory Assistant (MLA)  Processes specimens collected by phlebotomists and nurses and performs other tasks Diagnostic Testing Personnel Medical Laboratory Technician (MLT) Performs diagnostic testing in any department of the clinical laboratory Requires a 2-year associate degree and a certification exam Medical Laboratory Scientist (MLS) Performs diagnostic testing in any department of the clinical laboratory Requires a 4-year bachelor's degree in medical laboratory science and a certification exam Note: this title is synonymous with Medical Technologist (MT) and Clinical Laboratory Scientist (CLS), which are still used in the laboratory Most professionals in the clinical laboratory are medical laboratory technicians (MLT) or medical laboratory scientists (MLS) who have been trained and certified in medical laboratory science. According to the U.S. Bureau of Labor Statistics, there were over 330,000 medical laboratory scientists and medical laboratory technicians in the United States in 2018. Laboratory Leadership Personnel Medical Director Oversees laboratory quality and is ultimately responsible for results generated by the clinical laboratory Typically a pathologist or PhD Laboratory Director/Manager Oversees all laboratory duties, maintains laboratory regulations, and supervises staff Manages laboratory budget and capital allocations Lead Technologist/Charge Technologist Manages a specific department of the clinical laboratory Larger clinical laboratories may have additional specialized personnel, including dedicated compliance officers, safety managers, education coordinators, quality managers, and more. Who Staffs the Clinical Ungraded Practice Question Laboratory Which of the following laboratory roles requires a 2-year associate degree? Please select the single best answer Histotechnologist Medical laboratory scientist (MLS) Medical laboratory technician (MLT) Pathologist Who Staffs the Clinical Ungraded Practice Question Laboratory Which of the following laboratory roles requires a 2-year associate degree? Please select the single best answer Histotechnologist Medical laboratory scientist (MLS) Medical laboratory technician (MLT) Pathologist Feedback Of those listed, only MLTs require a 2-year associate degree. MLSs and histotechnologists require a 4-year bachelor's degree. Pathologists are medical doctors who specialize in pathology and laboratory medicine. They require a 4-year bachelor's degree and a Doctor of Medicine (MD) with associated residency. (see pg. 5, Staff of the Clinical Laboratory)  Clinical Laboratory Data Management Departments: Data Management The data management department is staffed by health professionals who manage the laboratory information system (LIS). The LIS is the computer software that handles all patient data, including specimen collection logs, lab orders, and records of all laboratory results. The LIS is interfaced with laboratory analyzers, the hospital information system (HIS), and other external information systems as needed. After test results from the laboratory analyzers are verified, they are released to the LIS, which delivers the results to the patient's electronic medical record (EMR). From there, the patient's care team can access the results and determine patient treatment. An MLT using the LIS to ensure patient results are sent to the EMR (5). 5. Carter, Jake, Staff Sgt. "Senior Airman William Jones, 87th Medical Group medical laboratory technician..." Joint Base McGuire-Dix- Lakehurst, 23 April 2020,https://w w w.jbmdl.jb.mil/New s/Photos/igphoto/2002287202/. Clinical Laboratory Specimen Collection and Processing Departments: Specimen Collection and Processing The specimen collection and processing department is where laboratory specimens are received, accessioned, evaluated for adequacy and urgency, and prepared for testing. Most blood and other specimens are not collected in the clinical laboratory but in various hospital wards, ICUs, emergency departments, and other inpatient and outpatient locations. Some hospital clinical laboratories have a phlebotomy and urine collection area for patients who come directly to the laboratory. The specimen collection and processing department is staffed by MLTs, phlebotomists, and MLAs. In some instances, MLSs are also present, generally as supervisors. When a specimen is received in the laboratory, the staff are responsible for accessioning the specimen. An MLT practicing phlebotomy on a fellow MLT, supervised by The hospital and laboratory staff collect most blood an MLS. specimens from patients using phlebotomy. Also known as venipuncture, phlebotomy is performed by applying a tourniquet and then inserting a small needle into an appropriate vein in the antecubital fossa, forearm, or the back of the hand. The blood is then drawn into collection tubes containing various additives, such as anticoagulants or clot activators, appropriate for specific tests. The tubes are distinguished by a universal color-coded top system: Light blue top: coagulation testing, including prothrombin time and aPTT Lavender top: hematology testing, including the complete blood count (CBC) Speckle top: also known as a serum separator tube, chemistry testing, including the lipid panel Red top: chemistry, immunology, and transfusion services testing, including hepatitis and HIV tests Green top: chemistry testing, including the basic metabolic panel (BMP) Gold top: chemistry and immunology and Evacuated tubes with lavender (EDTA), dark green (sodium serology testing heparin), and blue Pink top: transfusion services testing, including (sodium citrate) tops. ABO and Rh blood typing The staff may also collect urine from outpatients if required for testing. Most urine specimens are known as random specimens since there is no designated collection time. Other urine tests may require specimens to be collected at specific times, such as first in the morning. After accessioning specimens and confirming integrity, the staff may perform additional processing, such as centrifugation. Once specimens are fully prepared, they are sent to the appropriate laboratory departments for testing, sometimes by a track system. Clinical Laboratory Flow of a Patient Specimen from Collection to Departments: Results Specimen Collection and Processing There are several steps that must be completed in There are several steps that must be completed in order to provide test results to the patient care team. These steps may vary slightly from laboratory or department but generally are as follows: 1. A patient specimen is collected in one of several locations, such as hospital wards, outpatient collection areas, and physician offices. 2. The specimen is received in the specimen collection and processing department of the clinical laboratory. 3. The staff accession the specimen, confirm its identity and integrity, and perform any additional processing, such as centrifugation. 4. The specimen is sent to the appropriate laboratory department(s) for testing, sometimes by a track system. 5. The specimen is tested and analyzed manually or by an instrument. 6. The test results are reviewed and verified by an MLS or MLT. If the test results are outside of expected values, the test may be repeated, or a new specimen may have to be collected. 7. The verified test results are released to the LIS. 8. The LIS sends the test results to the EMR. 9. The test results are accessible to the patient's care team via the EMR. The flow diagram to the right shows an example of a blood specimen for hematology testing. Clinical Laboratory Ungraded Practice Question Departments: Specimen Collection and Processing Which of the following laboratory roles is primarily responsible for collecting blood specimens? Please select the single best answer Phlebotomist Medical laboratory technician (MLT) Medical laboratory scientist (MLS)  Pathologist Clinical Laboratory Ungraded Practice Question Departments: Specimen Collection and Processing Which of the following laboratory roles is primarily responsible for collecting blood specimens? Please select the single best answer Phlebotomist Medical laboratory technician (MLT) Medical laboratory scientist (MLS) Pathologist Feedback The primary role of a phlebotomist is collecting blood and other patient specimens. While MLTs and MLSs may also be trained to collect blood, their primary role is to perform diagnostic testing. A pathologist's primary role is to interpret tissue or cellular specimens and clinical test results to provide diagnostic information to clinicians and patients. (see pg. 5, Staff of the Clinical Laboratory) Clinical Laboratory Hematology Departments: Hematology The hematology department is where the cellular components of blood are tested. This includes red blood cells (RBC), white blood cells (WBC), and platelets, which are counted and assessed for abnormalities. The hematology department receives blood specimens in lavender top tubes. The most common tests performed in the hematology department include the complete blood count (CBC) and the white blood cell (WBC) differential. A WBC differential is often performed in conjunction with a CBC. An MLS reviewing and verifying CBC results from a The complete blood count (CBC) is a series of blood hematology analyzer. tests that include: Red Blood Cell (RBC) Count: counts the total number of red blood cells per microliter of blood White Blood Cell (WBC) Count: counts the total number of white blood cells per microliter of blood Platelet Count: counts the number of platelets per microliter of blood Hemoglobin (Hb): measures the amount of hemoglobin in grams per deciliter of blood Hematocrit: measures the packed cell volume; the percent of RBCs compared to the total blood volume The CBC is typically used as a screening test for disorders such as anemia, infection, leukemia, and more. The WBC differential counts the individual types of white blood cells found in the blood. This is different from the WBC count, which enumerates all white blood cells as one numerical value. The WBC differential quantifies the different types of white blood cells, which could include: Neutrophils Lymphocytes Monocytes Eosinophils Basophils If a patient has an infection, a WBC count will show Microscopic images and 3D models of red and white blood cells (6). increased total white blood cells. A physician will refer to the WBC differential and absolute values to determine which specific white blood cells are increased. If the WBC differential shows increased neutrophils, the patient may have a bacterial infection. On the other hand, if the WBC differential shows increased lymphocytes, the patient may have a viral infection. Click "More Info" to see an example of test results for a CBC and WBC Differential (Table 1). 6. Blausen.com staff (2014). "Medical gallery of Blausen Medical 2014." WikiJournal of Medicine 1 (2). DOI:10.15347/w jm/2014.010. ISSN2002- 4436. https://commons.w ikimedia.org/w iki/File:Blausen_0425_Formed_Elements.png. More Info Clinical Laboratory Coagulation Departments: Hematology The coagulation department, often paired with the hematology department, is where a patient's plasma is tested for its ability to clot. Bleeding and clotting disorders are detected and anticoagulant therapy is monitored in this department. The coagulation department receives plasma specimens in light blue-top tubes. The most common tests performed in the coagulation department are the prothrombin time (PT) and the activated partial thromboplastin time (aPTT). The PT is important in monitoring patients on anticoagulants (blood thinners, e.g., warfarin/Coumadin) and diagnosing patients with Sodium citrate coagulation tubes, denoted by their light blood clotting disorders. In many labs, the PT results blue tops. are reported as the international normalized ratio (INR) and denoted as PT/INR. The aPTT is important in diagnosing and monitoring patients with bleeding disorders. It is also important in monitoring patients on IV anticoagulants (e.g., heparin). Clinical Laboratory Ungraded Practice Question Departments: Hematology True or False: Within the specimen collection and processing department, a phlebotomist will use a lavender top tube to collect blood for a complete blood count (CBC). Select true or false True False  Clinical Laboratory Ungraded Practice Question Departments: Hematology True or False: Within the specimen collection and processing department, a phlebotomist will use a lavender top tube to collect blood for a complete blood count (CBC). Select true or false True False Feedback TRUE. Lavender top tubes contain the anticoagulant EDTA, which is necessary for CBC testing in the hematology department (see pg. 11, Hematology). Clinical Laboratory Chemistry Departments: Chemistry The chemistry department is where blood plasma, serum, urine, and body fluid specimens are chemically analyzed. The department is responsible for the highest volume of tests in the clinical laboratory, and it is highly automated. The chemistry department receives plasma specimens in green-top tubes and serum specimens in speckle-top, gold-top, and red-top tubes. The most common tests in the chemistry department include the basic metabolic panel (BMP), comprehensive metabolic panel (CMP), lipid panel, and therapeutic drug monitoring (TDM). The BMP measures eight analytes within blood Plasma and serum specimens in their corresponding tubes plasma: glucose, calcium, sodium, potassium, (7). chloride, CO2, creatinine, and BUN (blood urea nitrogen). The BMP is often used as a screening test. Abnormal results may indicate a wide variety of disorders. For example, elevated glucose levels may indicate diabetes. Elevated creatinine and BUN levels may indicate decreased kidney function. The CMP consists of all the measurements from the BMP plus a liver (hepatic) function panel for a total of 14 analytes. The liver panel measures albumin, bilirubin, liver enzymes, and the total protein within the blood. Liver enzyme levels are important for detecting and monitoring disorders of the liver (e.g., hepatitis). The lipid panel measures four analytes: total cholesterol, HDL, LDL, and triglyceride levels. Total cholesterol measures cholesterol in all lipoprotein particles. HDL, or "good cholesterol," measures the An example of CMP results. cholesterol in high-density lipoprotein particles. It is known as "good cholesterol" because it takes up excess cholesterol and transports it to the liver for removal. LDL, or "bad cholesterol," measures the cholesterol in low-density lipoprotein particles. It is known as "bad cholesterol" because it results in the deposition of cholesterol in blood vessels. Elevated LDL, total cholesterol, and triglycerides increase the risk of atherosclerosis. This panel is used to detect and monitor cardiovascular disease. Therapeutic drug monitoring (TDM) determines the optimal drug concentration within blood plasma by analyzing peak and trough levels. By assessing the peak and trough plasma levels, the physician can adjust the dose of the drug being analyzed to optimize the therapeutic effect and avoid drug toxicity. 7. Atanassova, Vassia (Spiritia). "Blood testing tube w ith separated blood serum (yellow ) and erythrocytes (dark red)." Wikimedia Commons, 05 July 2019, https://commons.w ikimedia.org/w iki/File:Serum- separation_tube.jpg. Accessed 09 November 2020. Clinical Laboratory Urinalysis Departments: Chemistry The urinalysis department, often paired with the chemistry or hematology department, is where urine is visually, chemically, and microscopically examined. Urine specimens are received in sterile cups or urinalysis tubes. The first step in urinalysis is the visual inspection of the urine specimen. The urine is examined for color and clarity. Normal, healthy urine varies from pale yellow (dilute) to amber (concentrated). Normal urine is clear at first and then becomes cloudy when allowed to sit. If the specimen is cloudy or turbid before it sits, the lack of clarity may indicate infection. Unusual odors may also indicate infection. The second step in urinalysis is chemical A dipstick being removed from a urine specimen. examination. Chemical examination is performed by using a urine test strip known as the dipstick or instrumentation. The dipstick contains up to 10 pads, each containing a specific chemical marker for various analytes, including leukocytes, nitrites, urobilinogen, protein, pH, hemoglobin, specific gravity, ketones, bilirubin, and glucose. When the strip is dipped in the urine, the pads turn different colors. The colors are compared against a color scale on the bottle that indicates their quantitative values based on the lightness, darkness, and hue of the colors. This is performed by either a semi- automated analyzer or a trained professional. The third step in urinalysis is the microscopic evaluation. If an abnormality is detected in visual and/or chemical examination, the urine will be microscopically reviewed for formed elements, such as cells, casts, and crystals. For example, if leukocytes and nitrites are positive on the dipstick, Beckman Coulter's automated urinalysis analyzer: AUTION MAX 4030 Urine Chemistry Analyzer (8). the specimen will undergo microscopic examination for the presence of bacteria and leukocytes. 8. Beckman Coulter. "AUTION MAX™ AX-4030 Fully Automated Urine Chemistry Analyzer." Beckman Coulter, https://w w w.beckmancoulter.com/en/products/urinalysis/aution-max- ax-4030. Accessed 10 November 2020. Clinical Laboratory Ungraded Practice Question Departments: Chemistry Which of the following specimens are commonly tested in the chemistry department? More than one answer is correct. Please select all correct answers Plasma Serum Tissue swabs  Urine Clinical Laboratory Ungraded Practice Question Departments: Chemistry Which of the following specimens are commonly tested in the chemistry department? More than one answer is correct. Please select all correct answers Plasma Serum Tissue swabs Urine Feedback Plasma, serum, and urine are examples of common specimens the chemistry department receives. Plasma and serum are used for multiple tests, including basic and complete metabolic panels, Urine is used for macroscopic examination, chemical analysis, and microscopic examination. Tissue swabs are commonly used in the microbiology department for culture and sensitivity testing. (see pg. 14, Chemistry) Clinical Laboratory Immunology and Serology Departments: Immunology and Serology The immunology and serology department is where antigens and antibodies are identified and quantified to determine if an infectious disease, autoimmune disorder, or other immunologic disease is present. This department works closely with the transfusion services, chemistry, microbiology, and molecular diagnostics departments. The immunology and serology department receives serum specimens in red top, gold top, and speckle top tubes. Immunology and serology tests measure the interactions between antigens and antibodies. Antigens are present on pathogens and red blood cells as specific indicators of their identities. Antibodies are produced by a type of white blood cell known as a plasma cell to identify and attack A normal joint versus a joint with rheumatoid arthritis (9). specific antigens that the immune system detects as foreign. The antibody attaches to the antigen on the pathogen or red blood cell. The antigen-antibody complex activates cellular elements that help to destroy and deactivate foreign pathogens. Common infectious diseases detected by immunology and serology testing include hepatitis, HIV, influenza, infectious mononucleosis, and syphilis. Common autoimmune disorders detected and monitored in the immunology and serology department include rheumatoid arthritis, systemic lupus erythematosus (SLE), multiple sclerosis (MS), celiac disease, and Crohn's disease. The immunology and serology department may also perform specialized testing to determine compatibility for transplantation. An example of An illustration of inflamed intestinal walls as a result of such specialized testing is human leukocyte antigen Crohn's Disease (10). (HLA) typing, which matches organ donors with compatible recipients. 9. Servier. "Osteoarthritis and rheumatoid arthritis - Normal joint Osteoarthr -- Smart-Servier.jpg." Wikimedia Commons, 29 September 2019, https://commons.m.w ikimedia.org/w iki/File:Osteoarthritis_and_rheumatoid_arthritis_- _Normal_joint_Osteoarthr_--_Smart-Servier.jpg. 10. BruceBlaus. "Medical illustration of Crohn's Disease." Wikimedia Commons, 09 January 2017, https://commons.w ikimedia.org/w iki/File:Crohn%27s_Disease.png. Clinical Laboratory Transfusion Services Departments: Transfusion Services The transfusion services department, also known as the blood banking department, is where blood components are stored and matched with potential blood recipients. The term "blood bank" also refers to a donor center where people can donate blood, such as the American Red Cross. A blood bank is not always synonymous with the transfusion services department. The transfusion services department receives serum specimens in red top tubes and whole blood specimens in pink top tubes. The most common tests in the transfusion services department include blood typing, antibody screen, and crossmatch. Blood typing determines a patient's blood type by identifying specific antigens on their red blood cells. Blood typing includes ABO and Rh typing. There are four major blood types: A, B, AB, and O. Type O is considered the universal donor since it is compatible with all blood types. Type AB is the universal recipient; a type AB patient can receive any blood type without experiencing harmful effects. Rh typing determines a patient's Rh type by identifying another set of antigens on their red blood cells. There are two major Rh types: positive A compatible blood unit being used for transfusion. and negative. A type A patient can be A+ or A-, with the positive or negative referring to the Rh typing. An Rh+ patient can receive Rh+ and Rh- blood, while an Rh- patient can only receive Rh- blood. Another compatibility test for a potential blood transfusion recipient is the antibody screen. It is used to detect non-ABO antibodies in a patient to determine compatibility with donor blood. An antibody screen is performed to detect unexpected antibodies in the recipient's blood. The final test before transfusion is the crossmatch. The crossmatch is performed by testing donor blood cells with the patient's serum to confirm compatibility. Once compatibility is confirmed, transfusion can safely begin. Clinical Laboratory Microbiology Departments: Microbiology The microbiology department is where pathogenic microorganisms are detected and identified. The department is divided into three general sections: bacteriology, virology, and mycology. Some large hospitals or reference laboratories may also have a parasitology department. The microbiology department receives various specimens from the specimen collection and processing department. Such specimens include blood, body fluids, respiratory specimens, skin scrapings, stool, swabs of various kinds, urine, bone, tissue, and more. A biosafety level is assigned to each laboratory based on the classification of biological agents handled and their associated risks (Table 2). Additional safety training and equipment may be necessary depending on the microbiology department's biosafety level. Table 2. Biosafety Levels and their Associated Risks and PPE. Biosafety Agents Risk of Protection Example Level Causing and Disease Training Standard Well Bacillus subtilis 1 Low PPE and lab known (bacterium) practices Limited lab access, Well disposal Salmonella 2 Moderate known precautions, spp. (bacteria) biosafety A biosafety hood, which creates an enclosed, ventilated area for hoods harsh chemical or biological specimen work. Required handling training, Mycobacterium biosafety 3 Rare High tuberculosis hood work (bacterium) only, specialized PPE Required handling Very high training, (often specialized Ebola with no Very engineering (extremely 4 vaccine rare features to contagious or control air virus) treatment movement, options) specialized PPE  Clinical Laboratory Bacteriology Departments: Microbiology The bacteriology section of the microbiology department is where pathogenic bacteria are cultured and identified, and their antibiotic sensitivities are tested. The first step in bacterial identification is culturing (growing) the bacterium. The specimen is plated on agar-based media or inoculated in broth media or blood culture bottles. The bacteria grown on agar- based media will produce visible colonies that differ in size, shape, and color. For example, Staphylococcus aureus appears as medium-sized, yellow colonies while Streptococcus pneumoniae appears as small, green/gray colonies. Bacteria plated on blood agar media. The second step is isolating a pure colony. There may be instances where normal bacteria can grow alongside the pathogenic bacteria. Therefore, staff must isolate a pure colony of the pathogenic bacterium for identification. The third step is identifying the pure colony. Gram staining and biochemical testing are used to identify the bacterium. Gram staining is performed by staining the isolated colonies on a glass slide. Bacteria can stain pink, indicating they are Gram- negative, or stain purple, indicating they are Gram- positive. Biochemical testing is performed by incubating isolated colonies with different chemicals. The way the colonies react with the chemicals helps determine the bacterium's identity. A biochemical test panel, where bacteria and chemicals are After identification, the final step is determining allowed to react. antibiotic sensitivity. Pure colonies are replated and allowed to interact with antibiotic-infused disks. An effective antibiotic will produce a bacteria-free ring around the disk, known as the zone of inhibition. This indicates that the bacteria may be sensitive to the antibiotic. In the modern bacteriology department, biochemical testing and antibiotic sensitivity are automated and performed simultaneously. While this has made testing more efficient, these automated instruments still rely on traditional techniques and professional review. The future of microbiology instrumentation has shifted from visual examination to high-tech alternatives, including matrix-assisted laser desorption ionization mass spectrometry (MALDI- TOF) and polymerase chain reaction (PCR). MALDI- TOF is a type of mass spectrometry that identifies the bacterium based on its mass and desorption properties. PCR replicates a bacterium's DNA sequence, which can be matched to known sequences of bacterial DNA to diagnose the infection. These instruments provide more detailed and possibly more reliable results in a quicker turnaround time. Clinical Laboratory Molecular Diagnostics Departments: Molecular Diagnostics The molecular diagnostics department is where molecules like DNA and RNA are tested to produce diagnostic results. Molecular diagnostics focuses on three clinical areas: genetics, infectious diseases, and tumor markers. With new genetic testing improving each year, molecular diagnostics is the fastest growing section of the clinical laboratory. Traditionally, molecular diagnostics has been reserved for reference labs, but it has recently expanded its utility within the scope of routine clinical laboratories. Molecular diagnostics can be utilized by both small and large laboratories and can be found in virtually every department of the clinical laboratory. One of the most common tests in the molecular diagnostics department is polymerase chain reaction (PCR). In PCR, patient, viral, or bacterial DNA is extracted from a specimen and replicated to create several copies. That DNA is tested against known DNA samples to find a match. This allows for identifying various bacterial and viral infections, such as human papillomavirus (HPV). Clinical Laboratory Ungraded Practice Question Departments: Molecular Diagnostics Tests for hepatitis B and influenza are performed in which department? Tests for hepatitis B and influenza are performed in which department? Please select the single best answer Urinalysis Hematology Coagulation Immunology/serology Clinical Laboratory Ungraded Practice Question Departments: Molecular Diagnostics Tests for hepatitis B and influenza are performed in which department? Please select the single best answer Urinalysis Hematology Coagulation Immunology/serology Feedback By definition, immunology is the study of the immune system. Serology is the study of serum and how it can be used to determine the presence or absence of a particular disease, particularly those diseases of the immune system and other infectious diseases. Examples of tests that would fall into this category include hepatitis B and influenza. Urinalysis is the area of the laboratory that tests urine. Urinalysis (UA) includes the physical, chemical, and microscopic examination of urine. The hematology department of the clinical laboratory assesses the cellular portion of blood. White blood cells (WBC), red blood cells (RBC), and platelets are counted and evaluated for abnormalities in this department. The coagulation department assesses the plasma's ability to clot. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) measure different clotting factors. (see pg. 17, Immunology and Serology) Clinical Laboratory Ungraded Practice Question  Clinical Laboratory Ungraded Practice Question Departments: Molecular Diagnostics The hematology department performs which tests? More than one answer is correct. Please select all correct answers Complete blood count (CBC) Urine dipstick White blood cell (WBC) differential Complete metabolic panel (CMP) Clinical Laboratory Ungraded Practice Question Departments: Molecular Diagnostics The hematology department performs which tests? More than one answer is correct. Please select all correct answers Complete blood count (CBC) Urine dipstick White blood cell (WBC) differential Complete metabolic panel (CMP) Feedback The hematology department performs CBCs and WBC differentials. The urinalysis and chemistry departments perform urine dipsticks. The chemistry department performs CMPs. (see pg. 11, Hematology) Clinical Laboratory Ungraded Practice Question Departments: Molecular Diagnostics Which department is responsible for performing compatibility tests for patients who may need blood transfusions? Please select the single best answer Hematology Immunology/serology Transfusion medicine Chemistry Clinical Laboratory Ungraded Practice Question Departments: Molecular Diagnostics Which department is responsible for performing compatibility tests for patients who may need blood transfusions? Please select the single best answer Hematology Immunology/serology Transfusion medicine Chemistry Feedback The transfusion medicine department is responsible for performing compatibility tests for patients who may need blood transfusions. The hematology department is responsible for testing the cellular components of the blood. The immunology and serology department is responsible for identifying and quantifying antigens and antibodies to determine if an infectious disease, autoimmune disorder, or other immunologic disease is present. The chemistry department tests blood plasma and serum for various analytes. These tests include BMPs and CMPs. (see pg. 18, Transfusion Services) Other Testing Sites Point-of-Care Testing (POCT) Point-of-care testing (POCT) is broadly defined as diagnostic testing performed at the time and place of patient care, whether inside or outside a healthcare institution. Examples of POC tests include at-home pregnancy tests, HIV testing kits, and blood glucose monitors. POCT devices are typically small, portable, handheld devices or manual kits. This makes them suitable to be performed outside of the clinical laboratory and when there isn't a dedicated space for testing equipment. POCT can be performed in many locations, from hospital settings, like the emergency department and operating room, to a patient's A laboratory professional administering a point-of-care test home. using a POCT also provides rapid turnaround of test results. blood specimen. In some instances, POCT can be performed by non- laboratory staff, depending upon the complexity of the test. Other Testing Sites Physician Office Laboratories (POL) A physician office laboratory (POL) is a laboratory where only a small set of laboratory tests are offered. The tests usually pertain to the physician's specialty or the types of patients the physician sees. POLs were not regulated prior to CLIA, which now regulates them to address the quality of work performed. Most testing that is performed in POLs falls into the waived testing CLIA category. In POLs where only waived testing is performed, there are no CLIA personnel requirements. Examples of tests performed at POLs include urinalysis chemical dipsticks, blood glucose monitors, rapid strep A kits, urine pregnancy kits, and occult blood testing. Other Testing Sites Reference Laboratories Reference laboratories offer a wider array of laboratory tests than smaller and mid-sized hospital laboratories. Clinical laboratories may send tests to reference laboratories because it is more cost- effective; reference laboratories have the equipment or supplies needed for the testing that is infrequently ordered in clinical laboratories. Large hospital laboratories sometimes act as reference laboratories within their hospital network. Most often, however, reference laboratories are independent companies. Examples include LabCorp, Quest Diagnostics, and ARUP. A reference lab has a much higher capacity for a variety of laboratory tests. Other Testing Sites Ungraded Practice Question True or False: Reference laboratories offer a narrower array of laboratory tests than smaller and mid-sized hospitals laboratories. Select true or false True False Other Testing Sites Ungraded Practice Question True or False: Reference laboratories offer a narrower array of laboratory tests than smaller and mid-sized hospitals laboratories. Select true or false True False Feedback FALSE. Reference laboratories offer a wider array of laboratory tests than smaller and mid-sized hospital laboratories. They provide a greater variety of tests in a more cost-effective manner (see pg. 27, Reference Laboratories). References References AACC. (2020). Basic Metabolic Panel (BMP). Retrieved October 26, 2020, from https://labtestsonline.org/tests/basic-metabolic-panel-bmp Allen, Kristen. "21st Medical Group medical laboratory technician views samples in a microscope." 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