General Laboratory: Clinical Laboratory: Basic Overview Online Training
The clinical lab provides diagnostic test data to aid in the detection, diagnosis and treatment of disease. Data is used by physicians, nurses, pharmacists and other healthcare professionals.
Welcome to the Clinical Laboratory Overview course. Clinical laboratories provide a vital service in patient healthcare. This course will provide you with details of the purpose, people and procedures that make up this busy and complex healthcare business. Select Next to continue. Identify clinical laboratory specialties and their functions Identify different types of clinical laboratories and various laboratory personnel and their functions Identify different types of specimens analyzed in the clinical lab Identify the importance of the Clinical Laboratory in patient healthcare Identify the role of Regulatory Agencies in the clinical laboratory and procedures that fulfill regulatory requirements Sequence steps in the laboratory workflow process At the end of this course, you will be able to: Select Next to continue. Congratulations. You have completed the Clinical Laboratory Overview. Once you have reviewed the content on this page, you may proceed to the assessment portion of the course. In this course, you have learned how to: Recognize the importance of the Clinical Laboratory in patient healthcare. The clinical lab provides diagnostic test data to aid in the detection, diagnosis and treatment of disease. It is responsible to correctly collect, identify and process specimens, accurately perform tests, report results in a timely manner, and communicate with other healthcare professionals. Identify different types of clinical laboratories and various laboratory personnel and their functions. Typical laboratories are: Hospital Lab Point of Care Lab Reference Lab Physician Office Lab Typical Laboratory personnel and functions include: The Laboratory Medical Director is often a Pathologist who oversees quality control, consults with clinicians to help interpret test results, educates medical staff, provides input to the budge and equipment purchasing decisions, and acts as liaison between the lab and medical personnel. Lab Managers oversee lab administrative functions, prepare the annual budget, act as liaison between hospital administration, the Medical Director and laboratory staff, coordinate quality assurance programs, and collect and evaluate laboratory statistics. Technical Supervisors are responsible for the technical and scientific operation of the laboratory. General Supervisors are responsible for oversight of the personnel and daily laboratory operations. Technologists and Technicians perform testing, monitor and confirm test accuracy, report abnormal findings to the pathologist, evaluate new instrumentation, train laboratory staff and troubleshoot technical problems. Laboratory Support personnel include: Phlebotomists who obtain blood samples from the patient. Processing/ Accessioning Technicians who pick up, receive and process lab samples. Biomedical Engineers who maintain and troubleshooting medical diagnostic equipment and evaluate their safety, efficiency, and effectiveness. LIS Analysts who provide computing resources and are responsible for managing the computers, networks, and databases, that are used in the lab. Recognize the types of specimens analyzed in the clinical lab. Blood sample types include: Venous samples Capillary samples Arterial samples Blood that is allowed to clot produces serum used in analysis procedures. Blood that is anticoagulated results in whole blood or plasma for analysis. Other important sample types are: Urine, Stool, Sputum, CSF, Pleural and Synovial fluids, Culture tubes and swabs, Bone Marrow. Sequence steps in the laboratory workflow process. Sequence steps in the laboratory workflow are: Physician orders the test Sample is collected Sample delivered to the lab Sample is processed Sample is analyzed Results are reported Recognize the role of Regulatory Agencies in the clinical laboratory and procedures that fulfill regulatory requirements. Laboratory Regulatory Agencies publish and enforce ‘best practice’ rules and regulations and may perform periodic inspections to ensure lab compliance. Procedures used to meet regulatory requirements begin with verification of a test method or analyzer before it is put into use such as: Calibration Correlation Reference Range Verification Linearity Additional procedures monitor the ongoing performance of a test method or analyzer and include: Routine Quality Control Interlab QC programs Proficiency testing programs Select Next to continue. Welcome to the CA 600 SWOT Online Training course. A SWOT analysis is a strategic planning method to evaluate Strengths, Weaknesses, Opportunities and Threats. This SWOT Analysis will help you identify Competitor related, as well as Siemens related factors to help you position Siemens Hemostasis Analyzers and the CA600 series. Select Next to review the course objectives. The clinical lab provides diagnostic test data to aid in the detection, diagnosis and treatment of disease. Data is used by physicians, nurses, pharmacists and other healthcare professionals. The responsibilities of the clinical lab include: Correct identification, collection and processing of patient specimens Accurate performance of testing Timely reporting of results Communication with physicians and other healthcare professionals Select Next to continue. There are several types of clinical labs. Select each tab below to learn more about each laboratory. Hospital Laboratory The hospital lab provides testing services requested by the medical staff for both inpatients and outpatients. Point of Care Laboratory (POC) POC labs (which may include some STAT Labs) are smaller testing sites located in areas separate from the central hospital lab such as the Operating Room, Respiratory Department, or Emergency Department. Typically, they are under the management and regulation of the main hospital lab and perform a limited range of tests to provide rapid diagnosis and treatment. Reference Laboratory Reference Laboratories are large, commercial laboratories with locations throughout the country. They perform both routine and specialized laboratory tests and often have small, satellite labs serving several communities that collect specimens to be sent to the main laboratory for testing. Physician Office Laboratory Physician Office labs are owned by one or more physicians and perform routine laboratory testing for their patients. Specialty tests are usually sent to a reference laboratory. There are a variety of personnel who work in the clinical laboratory. In this section, you will learn about their roles and responsibilities. Quality Control A real-time system that uses standards to accurately control materials, and to constantly monitor the accuracy and precision of all tests run in the laboratory. Most labs use a statistical system to monitor when test results fall outside of acceptable limits (standard deviation). Anatomic Pathology A medical specialty that is concerned with the diagnosis of disease based on the gross, microscopic, and molecular examination of organs, tissues, and whole bodies (autopsy). Venipuncture Collection of blood specimen from a vein for laboratory testing. Centrifuge An apparatus that rotates at high speed and by centrifugal force separates substances of different densities such as serum and cell, or urine and sediment. Proficiency Testing A system of testing unknown samples to assess the reliability of the laboratorys analysis. Clinical Pathology A subspecialty of pathology focusing on theoretical and technical aspects of the diagnosis and prevention of disease and patient care; through the use of laboratory methods in clinical diagnosis. Capillary One of the minute blood vessels between the terminations of the arteries and the beginnings of the veins. These blood vessels form an intricate network throughout the body for the interchange of various substances, such as blood gases, nutrients, waste products and water between blood and tissue cells. Aliquot A measured amount of solution (n). To divide a solution into measured amounts (v). Laboratory Personnel Meet the personnel in the clinical laboratory. Slide NumberText BlocksCalloutsAudio ScriptImage File1The Laboratory Medical Director is a Physician (M.D. or D.O.) or a Ph.D. with specialty in a clinical science. Responsibilities include: Overseeing laboratory quality control and proficiency testing Providing laboratory consultations and test interpretations to medical clinicians Evaluating and providing clinical input regarding equipment purchases and new test methods Providing ongoing education for laboratory, nursing, and medical staff regarding laboratory medicine Participating in the preparation of the laboratory annual capital and operations budget Serving as primary representative and liaison of the laboratory to the medical staff Select Next to continue.Note: If audio does not automatically start, select the play arrow in the top left to begin.The Laboratory Medical director is a Physician or a Ph.D. with specialty in a clinical science. Many clinical laboratories are directed by a Pathologist who is a physician that has completed additional specialized training in anatomic and clinical pathology in order to diagnose the cause and nature of disease. They are responsible for the oversight of the entire laboratory.2A Laboratory Manager is typically a Medical Technologist (MT) or a Clinical Laboratory Scientist (CLS) with a bachelor's degree in the sciences. Responsibilities include: Overseeing all laboratory administrative functions Preparing the annual capital and operational budget Serving as a liaison between hospital administration, the Medical Director and laboratory staff Participating in and coordinating quality assurance activities Collecting data and providing laboratory statistics Select Next to continue.A laboratory manager is typically a Medical Technologist (MT) or a Clinical Laboratory Scientist (CLS) with a bachelor's degree in the sciences. 3A Laboratory Supervisor is typically a Medical Technologist (MT) or a Clinical Laboratory Scientist (CLS) with a bachelor's degree in the sciences. Technical Supervisors are responsible for technical and scientific operation of the laboratory. General Supervisors are responsible for oversight of the personnel that conduct and report the tests as well as daily laboratory operations. Select Next to continue.A laboratory supervisor is typically a Medical Technologist or a Clinical Laboratory Scientist with a bachelor's degree in the sciences.4Technologists (MT/CLS) and Technicians (MLT/CLT) typically possess an associate or bachelors degree in the sciences. Responsibilities include: Performing a full range of laboratory tests, using the latest biomedical technology Confirming the accuracy of test results Reporting abnormal findings to the pathologists Communicating test results to the treating physician Evaluating new tests and equipment Monitoring quality control and proficiency testing Training laboratory staff Troubleshooting technical problems Select Next to continue.Technologists and Technicians typically possess an associate or bachelors degree in the sciences. 5There are several personnel that support the daily operations of the lab. Select Next to continue.There are several personnel in the lab that perform support services needed to keep the lab operating efficiently and effective.6A Phlebotomist, or Phlebotomy Technician (PT), works directly with the patient to draw their blood for laboratory tests using standard biohazard safety guidelines. They obtain blood specimens by both venipuncture and capillary collection techniques. Select Next to continue.A Phlebotomist or Phlebotomy Technician works directly with the patient to draw their blood for laboratory tests using standard biohazard safety guidelines.7The Specimen Processing/Accessioning Technician is responsible for: Picking up blood and other specimens from: patient rooms laboratory collection areas emergency rooms nursing homes other areas as needed Receiving specimens and checking for proper and complete patient information and identification. Preparing specimens for analysis by: ensuring correct type and adequate volume centrifuging aliquoting routing to appropriate laboratory section Select Next to continue.The Specimen Processing/Accessioning Technician is responsible for picking up, receiving, checking and preparing specimens for analysis.8The Biomedical Engineer typically has training or a degree in chemical or electrical engineering. Their job responsibilities include: Maintaining and troubleshooting medical monitoring, diagnostic, and therapeutic equipment and devices. Evaluating the safety, efficiency, and effectiveness of laboratory equipment and data processing systems. Select Next to continue.The Biomedical Engineer typically has training or a degree in chemical or electrical engineering.9Laboratory Information Services (LIS) Analysts provide computing resources, training, and support for all divisions of the clinical laboratory. They are responsible for managing the computers, networks, and databases which are integral to preserving the electronic patient records. Select Next to continue.The Laboratory Information Services Analyst provides computing resources, training, and support for all divisions of the clinical laboratory.10Congratulations!You have met many of the personnel that are in the clinical lab.When complete, select the X in the upper-right corner to close this window and continue.Congratulations! You have just met many of the personnel that work in the clinical lab every day. Periodic maintenance procedures include loading a new reagent roll, cleaning the readhead sockets and checking the pipette for leakage. Select the links below to learn how to perform each of these tasks. Most common Laboratory Specimen Types: Blood Urine Additional Laboratory Specimens: Body fluids Sputum Stool Tissue samples Culture swabs Important: Since laboratory specimens may contain disease producing organisms, they are considered biohazardous. It is important to wear protective equipment such as lab coat, gloves and eye protection when working in a clinical lab. Select Next to continue. Congratulations. You have completed the Sysmex UF-1000i Urine Cell Analyzer Maintenance online training course. Listed below are the key points that have been presented. Take time to review the material before you proceed to the final quiz. Venipuncture is often used to obtain a blood sample. A needle is inserted into a peripheral vein. Blood is collected into evacuated collection tubes. Tubes are of different sizes and colored tops often indicate the presence or absence of additives, anticoagulant being an additive type. Select Next to continue. Welcome to the CLINITEK Atlas Automated Urine Chemistry Analyzer Calibration Online Training course. This course includes information regarding when to calibrate, how to run calibrators and how to review the results. Capillary Sample is obtained when a venipuncture is not feasible. Collected from the fingertip, heel or earlobe. Collected into small collection containers called Microtainers®. Select Next to continue. A system shutdown and visual inspection of the vacuum trap chamber should be performed on a daily basis. Select the links below to learn how to perform each of these tasks. Arterial Samples are: Used for special testing such as blood gas analysis. Drawn from the radial artery (1) at the wrist. Collected by a medical technologist, respiratory therapist, nurse, or doctor. Select Next to continue. The materials required to Calibrate the system include sample tubes, the CLINITEK Atlas Calibration Kit, a tube of bleach with a concentration of 5.25 % sodium hypochlorite and a sample rack. Select the link below to learn about each of these materials. Without anticoagulant, blood coagulates (1) to form a blood clot (2). The remaining liquid is called serum (3). The serum is separated from the clot for analysis by placing it in a centrifuge. Blood Collection Tubes Learn more about serum blood collection tubes. Some collection tubes contain a gel separator that helps separate the serum from the clot during centrifugation. This gel will "layer" itself between the clot and the serum during centrifugation to make it easier to pour off the serum sample for processing. When complete, select the X in the upper-right corner to close the window and continue. The Calibration Successful window is displayed after a calibration has passed. If a calibration did not pass, the instrument may display the Problem Reported screen. Shortly after, the specific problem will be listed along with any action needed to resolve the issue. Calibration reports can be printed from the Main Menu by selecting QA Report. Select the links below to learn how to review and print calibration results. An anticoagulant in the collection tube prevents the blood from clotting (1). The whole blood sample (2) can be used for analysis. The anticoagulated sample can be centrifuged to separate the cells (3) to perform analysis on the plasma (4). Select Next to continue. The Hemostasis Market has strong competition in the US and globally. Understanding our competitors in the market is key. You will want to know where their products are positioned in the different market segments and how they compete with our products in the areas of testing, volume and complexity. Understanding is the competitive situation is critical to your success as a Hemostasis Sales Representative. Select the links below to learn more about the US and Global competitive situation. Urine analysis provides important diagnostic information. Types of urine samples: Routine First morning Postprandial Clean-catch Midstream 24 hour Select Next to continue. Select each tab to learn about the different body fluid samples. Cerebral Spinal fluid (1) or CSF is the liquid that surrounds the brain and spinal column. It is removed by puncture of the lumbar region of the back and is analyzed for chemical and cellular changes that occur in infections, hemorrhage, tumors, and degenerative brain disorders. Pleural fluid (1) is fluid that surrounds the lungs. If the amount of fluid increases, it is removed by thoracentesis and analyzed to determine the cause. Both chemical and cellular analysis is performed. Synovial fluid (1) is fluid that surrounds the joints. It is collected by aspiration from the joint cavity and is analyzed to diagnose infection, arthritis, gout, inflammation and tumors in the joint. Select Next to continue. Congratulations. You have completed the Urinalysis WAM Software Results Management Online Training course. Listed below are the key points that have been presented. Take time to review the material before you proceed to the final quiz. Select each tab to learn about other sample types found in the Clinical Laboratory. Stool studies are used to evaluate the function and integrity of the bowel. Stool samples are collected to analyze for the presence of blood or fat or to determine bacterial or parasitic infection. Sputum is matter composed of saliva, mucus and pus expectorated from the lungs and respiratory passages. It is produced by the lungs in response to irritation or infection and is typically analyzed by the microbiology lab for the presence of bacterial, viral or fungal infection. Culture swabs and tubes are used to collect samples for analysis in the microbiology lab. Common collection sites are the throat, wounds, and genital area. The lab isolates the infecting organism, identifies it, and tests its susceptibility to antibiotic treatment. Bone marrow is the tissue that produces blood cells. It is most often removed for analysis by aspiration or biopsy from the sternum or pelvic bone (1) in order to diagnose the cause of cellular abnormalities seen in the blood. Select Next to continue. Select each tab to learn about the different laboratory specialties. Routine chemistry tests for common chemical components such as glucose, cholesterol, and electrolytes. Chemistry procedures may be performed on serum, plasma, urine, or other body fluids. Special Chemistry performs non-routine specialized testing such as special protein analysis, toxicology, electrophoresis, chromatography, and immunoassay testing. Immunoassay analyzes chemical components present in very small quantities in the blood such as hormones, drugs, vitamins and cancer markers. Immunoassay measures components by use of the antigen (1) - antibody (2) binding reaction. Hematology uses whole blood analysis to count and characterize the cells in the blood and the blood cell producing tissue or bone marrow This specialty, also called Coagulation, tests for the proper functioning of both blood clotting (1) and clot dissolution mechanisms by measuring specific factors and components present in plasma. Select Next to continue. Select each tab to learn about additional laboratory specialties. Testing of urine is a part of routine diagnostic and screening procedures. Urinalysis provides analysis of the physical characteristics, chemical and cellular components, or other elements that may be present. Microbiology cultures various kinds of specimens in order to isolate and identify an infecting organism. Microbiology also performs antibiotic susceptibility testing on the organism to help determine optimal treatment. Sub-specialties within the microbiology lab are virology, bacteriology, parasitology, and mycology. The Blood Bank specialty, also called Immunohematology, determines blood types and prepares blood and blood components for transfusion. Molecular analysis focuses on analyzing DNA or RNA to detect, quantify and characterize pathological viruses present in the body or to determine cellular genetic changes that cause disease. The Pathology department prepares slides of body cells and examines them microscopically for abnormalities that may signal the beginning of cancerous growth. Select Next to continue. There are six main steps in how a sample flows through the lab from order creation to final test result. Test is ordered. Sample is collected Sample is delivered to the lab. Sample is processed. Sample is analyzed. Results are reported. Specimen Flow for Laboratory Testing Learn more about the steps Checklist TitleChecklist TypeChecklist ContentSpecimen Flow for Laboratory TestingHTMLSelect each checkbox to learn more about the steps in laboratory workflow. Test is orderedHTML The physician orders the test based upon a suspected or confirmed diagnosis. A laboratory requisition or order form is generated.Sample is collectedHTML A technologist, phlebotomist, or medical staff member such as a nurse, collects the patient specimen. The samples are labeled with the patient name, date and time of collection, and other pertinent information to accurately link the sample with the patient.Sample is delivered to the labHTML The sample and order form is then delivered to the clinical lab for testing. Upon arrival, specimens are received either through a Laboratory Information System or laboratory host computer (LIS), or are manually recorded. If improperly labeled or missing an order form, specimens are not accepted.Sample is processedHTML Received specimens are then processed. For blood specimens, this may include centrifugation to separate the serum or plasma from the clot or cellular components, or aliquoting of a single sample into several portions for analysis in different sections of the lab.Sample is analyzedHTML When ready to be analyzed, specimens are placed into the applicable analyzer and processed to obtain final results. When analysis is complete, test results are verified for accuracy and consistency and are transmitted to the laboratory computer if available.Results are reportedHTML The patient results and normal ranges for the tested specimen are forwarded to the physician, who provides a diagnosis or course of treatment, or orders additional tests as appropriate. When complete, select the X in the upper-rigtht corner to close the window and continue. Regulatory Agencies ensure laboratory accuracy and reliability by: Publishing and enforcing "best practice" rules and regulations Performing periodic inspections The following agencies have websites with available information. CAP: College of American Pathologists CLIA: Clinical Laboratory Improvement Act CLSI: Clinical and Laboratory Standards Institute (formerly NCCLS: National Committee for Clinical Laboratory Standards) CMS: Centers for Medicare & Medicaid Services (formerly HCFA: Health Care Financing Administration) COLA: Commission of Laboratory Accreditation EPA: Environmental Protections Agency FDA: Food and Drug Administration JCAHO: Joint Commission on Hospital Accreditation Select Next to continue. Initial procedures to introduce a new test method or analytical instrument Procedures to monitor performance on an ongoing basis Select Next to continue. Select each tab to learn about the initial verification procedure. This procedure is used to adjust an analyzer to a specific standard so that patient test results are accurate. During calibration, one or more calibrator samples with known values are analyzed and instrument electronics or software is adjusted so that the expected values are obtained. This procedure also is performed later at regular intervals to ensure ongoing accuracy. This procedure compares the test results obtained from a new analyzer to those of an established verified test method. Typically, 30 to 100 samples are tested using both the new and established method. Results from both methods are compared and plotted on a graph to view their correlation. Satisfactory correlation validates that the new analyzer results are reliable. Each test method has a reference, or normal range associated with it. Most normal, healthy people will fall within these result ranges. Normal ranges may vary based on sex and age of the patient. Abnormal results fall outside of these ranges and are used to help diagnose disease or prescribe and monitor treatment. The reference range verification procedure establishes the expected normal ranges for a test method by performing studies using the typical sample population of the lab. This graph shows normal hemoglobin ranges for male(1), female(2), and newborn(3). This procedure establishes the highest concentration limit that can be reliably reported for a particular test method. To perform linearity verification, several commercially produced samples with varying analyte concentrations are processed through the instrument. The expected results (1) versus observed results (2) are then graphed to determine the upper limit of reportability. Select Next to continue. Select each tab to learn about ongoing monitoring procedures. Labs typically use manufactured quality control samples that are processed at regular intervals and monitored to ensure day to day test result accuracy and precision. These QC results often are graphed, and statistical analysis is done to look for problems with precision and shifts or drifts in accuracy. These programs, also called peer data programs, allow laboratories to compare their QC results with those of other laboratories using the same instrumentation. To participate in a program, the lab submits routine QC results to an agency that compiles the results of all participating labs and generates comparison graphs and statistics. Labs using the same instrumentation expect to produce similar test results. If variances occur, the lab investigates to determine the cause and then correct the problem. In this program the regulating agency sends unknown or “blind” samples to the laboratory for analysis. The lab analyzes the samples and submits the results obtained to the agency for comparison to other participating laboratories and to the expected results. Labs then receive a pass or fail status from the regulating agency. Labs that fail are subject to serious consequences and may not be approved to report test results for a method until the problem is addressed. 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