Clinical Chemistry I 0202304 Lecture Notes PDF

Clinical Chemistry I 0202304 Instructor: Mohammad QABAJAH E-mail: [email protected] Week 11 Automation & POC 2 Automation in Clinical Chemistry - The process whereby an analytical instrument performs many tests with only minimal involvement of an analyst;...

Clinical Chemistry I 0202304 Instructor: Mohammad QABAJAH E-mail: [email protected] Week 11 Automation & POC 2 Automation in Clinical Chemistry - The process whereby an analytical instrument performs many tests with only minimal involvement of an analyst; also defined as the controlled operation of an apparatus, process, or system by mechanical or electronic devices without human intervention - The modern clinical laboratory uses a high degree of automation Why Automation? Increase Capacity Reduce Faster Errors TAT Laboratory Automation Space Personnel Optimisation Utilization  Steps Automated in the Diagnostic Laboratory Prepare order Collect sample Transport to lab Sample retrieval Accession sample Store samples Centrifuge Post-Analytical Dispose of waste Decap tubes Pre-Analytical Post-sort Pre-sort/aliquot Transmit test results Transport to analyzer Technical validation Analytical Definitions - Batch analysis: Many specimens are grouped in the same session - Random-access analysis: Performing a collection of specimens sequentially and each specimen is analyzed for a different selection of tests - Sequential analysis: Each specimen in a batch enters the analytical process one after another, and each result or set of results emerges in the same order as the specimens are entered - Carry-over: Transport of a quantity of analyte or reagent from one specimen reaction into and contaminating a subsequent one Definitions - Multiple-channel analysis: Multiple analytical processes (results is obtained on a single specimen); similar to random-access analysis - Single-channel analysis: Single process (only results for a single analyte are produced); similar to batch analysis - Parallel analysis: Series of processes at the same time and parallel - Throughput: Number of specimens processed by an analyzer during a given period of time Types of Analyzers Continuous Flow - Tubing flow of reagents and patients samples Discrete (Centrifugal analyzer) - Separate testing cuvettes for each test and sample - Random and/or irregular access Continuous Flow - Samples were aspirated into tubing  sample holder - Bring in reagent - Create a chemical reaction - Pump into a flow-through cuvette for spectro-photometer Discrete Analyzers - Separation of samples and reagents in a separate container - Multiple tests at a time. - They are the most popular - Carryover to a minimum - Increases the cost: disposable products Total Laboratory Automation Specimen Preparation Specimen Processing Specimen Loading and Aspiration Reagent Handling and Storage (on board thermal control) Inventory Identification Open system Closed system Chemical Reaction Phase - Type of Reaction Vessel and Cuvette - Timing of Reactions - Mixing of Reactants - Forceful dispensing - Magnetic stirring - Vigorous lateral displacement - A rotating paddle - The use of ultrasonic energy - Thermal Regulation Measurement Approaches - Photometry/Spectrophotometry - Reflectance Photometry - Fluorometry - Turbidimetry and Nephelometry - Chemiluminescence and Bioluminescence - Electrochemical SIGNAL PROCESSING AND DATA HANDLING: Computerized - Electromechanical operation of the analyzer - Acquisition, processing, and storage of operational data - Interfacing with the instrument operator - Communication with mainframe computers Automation for the Clinical Laboratory - Chemistry - Hematology - Immunoassay - Coagulation - Microbiology - Nucleic acid testing Areas of Automation - Urine Analyzers - Cell Counters - Nucleic Acid Analyzers - Microtiter Plate Systems - Automated Pipetting Stations - POCT Analyzers - Clinical chemistry analysers Technician Responsibility Follow manufacturer instruction for - Scheduled calibration - Scheduled maintenance - Daily - Weekly - Monthly -.. -.. Point of Care Testing Point-of-care testing (POCT) has been defined by the College of American Pathologists (CAP) as “those analytical patient-testing activities provided within the institution, but performed outside the physical facilities of the clinical laboratories.” Place of Analysis - Physician’s offices - Operating rooms - Emergency rooms - Intensive Care Units - Home health care - Patient performed Personnel Issues - Most often performed by non-laboratorians - Physicians - Nurses or nurses aides - Respiratory technicians - Not specifically trained in the requirements for accurate testing and interpretation Examples of POCT devices Troponin Measurement Blood Gas measurement by optical sensors or optodes advantage to electrochemical: Calibration HbA1C Laboratory Support - Laboratory still responsible for results - Therefore responsible for training and management of POCT programs - Laboratory must build a structure to support and facilitate POCT See YOU Next Lecture ☺ Clinical Chemistry I 0202304 Instructor: Mohammad QABAJAH E-mail: [email protected] Week 12 Laboratory Information Systems - LIS 2 Laboratory Information Systems A method a laboratory uses to manage its data and disperse the results to designated areas The sum of … Hardware, software, people, procedures and data Information Technology Why? - Management of the information explosion - Quality assurance - Reduction of data entry errors - Need for faster sample/results turnaround time General Considerations - Different labs have different requirements - Procedures and outcomes differ - But all can use the systems approach to identifying their needs and implementing solutions Types of Laboratories - Research - Analytical Services - Manufacturing How do you determine what you need and how to get it? Systems Approach to defining needs and specifications for a LIMS Information Management System Consists of: - Computers - People - Procedures/Processes LIS: Digitalizing Information What information ? Levels of information ̵ Preanalytical ̵ Analytical ̵ Postanalytical ̵ Integration with HMIS Testing phase LIS involvement in the testing process Preanalytic - Patient demographics transmitted from registration system to LIS - Tests requested by computerized physician order entry or manual test requisitions - LIS converts test requests into orders and creates accession number for that order - LIS provides collection lists of pending orders to phlebotomy service - LIS creates barcoded specimen labels for tube labeling - LIS electronically transmits orders to analyzer performing test - LIS directs specimen for processing and analysis Testing phase LIS involvement in the testing process Analytic - LIS creates instrument worklists - LIS stores quality control data - LIS verifies that results fall within reportable range and no flags requiring attention have been generated - LIS autoverification finalizes result or a technologist reviews and releases the final result Testing phase LIS involvement in the testing process Postanalytic - LIS sends electronic message with final result to clinical information system - If test result is a critical value, the LIS alerts the - laboratory staff to contact care unit emergently clinical staff interpret results and act - LIS sends test information to billing system Special Requirements - Data Privacy - Data Security (access control) - Safety See YOU Next Lecture ☺