Chapter 8 - Laboratory Testing from POCT to total automation PDF

Chapter 8: Laboratory Testing from Point of Care to Total Automation mation Preamble PowerPoints are a general overview and are provided to help students take notes over the video lecture ONLY. PowerPoints DO NOT cover the details needed for the Unit exam Each student is...

Chapter 8: Laboratory Testing from Point of Care to Total Automation mation Preamble PowerPoints are a general overview and are provided to help students take notes over the video lecture ONLY. PowerPoints DO NOT cover the details needed for the Unit exam Each student is responsible for READING the TEXTBOOK for details to answer the UNIT OBJECTIVES Unit Objectives are your study guide (not this PowerPoint) Test questions cover the details of UNIT OBJECTIVES found only in your Textbook! Chapter 9 Objectives 1. Describe components and elements of a computer and define associated computer terminology 2. Describe and compare the overall product and functions of LIMS and LIS. 3. Define and give examples of pre analytical, analytical and post analytical testing. 4. Describe the five steps in automated analysis. 5. Define point-of-care testing and list common tests. 6. Discuss non-instrument based testing such as pregnancy and fecal occult blood. 7. Compare major advantages and disadvantages to POCT. 8. Identify the four testing categories set forth by CLIA 9. Provide examples of handheld POCT devices 10. Identify 6 characteristics to consider when selecting a point of care instrument. Chapter 9 Objectives (con’t) 11. Define the following: edema aliquot HIPAA antibrachial osteomylitis basilic heparin cephalic petechiae Interface hemolyzed adapter input lancet median cubital hemoconcentration osteochondritis lipemic output hemolysis jaundice / icteric Point-of-Care Testing Point of Care Testing Tests are performed near the patient Purpose is to provide: Smaller blood specimen Reduced TAT Improved patient management Major disadvantage is cost  Point-of-Care Testing Categories of testing from CLIA 1. Waived tests Simple procedures with little chance of negative outcomes 2. Moderately complex tests More complex usually automated 3. Highly complex tests Complex tests; usually manual requiring a technologists assessment 4. Provider-performed microscopy Slide examinations of freshly collected body fluids POCT is mostly in the waived testing category but can be moderate testing also. Point-of-Care Testing Important characteristics of point-of-care testing instruments: 1. Rapid turnaround time 2. Easy portability with single-use disposable reagent cartridges or test strips 3. Easy-to-perform protocol 4. Accuracy and precision of results 5. Minimal QC tracking Point-of-Care Testing 6. Storage at ambient temperature for reagents 7. Bar-code technology 8. Economical cost and maintenance free 9. Software for automatic calibration, system lockouts, and data management 10. Hard copy or electronic data output that interfaces with an LIS or other tracking software Nonautomated Methods Non-automated Methods Done by manual rapid-testing methods Pregnancy kit testing Occult blood Guaiac Slide Test or Hemoccult II Useful in the detection and treatment of colorectal cancer  Handheld equipment Instrument-Based and Automated Methods Contain microprocessors that provide automated testing with calibration and QC on board. POCT Coagulation POCT Hemoglobin POCT Cardiac Enzymes Handheld equipment Most use whole blood Can be used for a number of tests (See Table 9-1): Coagulation: PT or PTT Blood gases Electrolytes Hematocrit Urea Glucose Frequently located in ICU, ED or surgery area of the hospital. Laboratory information system Computerization in Healthcare Computers are being used to Manage data Monitor patients’ vital signs Aid in diagnosis Computer literacy is required Terminology Functions Basic operations Adaptation to computer change Computerization in Healthcare Computers Supercomputer PC HPC PDA Computer networks Linked for the purpose of sharing resources (LAN) Individual stations are called nodes Internet is large, complex system Computers and the Laboratory Sophisticated system Manage patient data Interface with hospital information system Laboratory information system (LIS) Two types of analyzer interface Unidirectional Information only goes one way from analyzer to LIS computer Bidirectional Data can go back and forth between two systems Laboratory Information Systems Selection based on Ease of input Format of output Customized software capabilities Making it operational Online and integrated System managers Integrated systems Laboratory Information System Objectives of LIS File results Accumulate statistics Determine workload Generate report forms Monitor quality assurance and quality control in the laboratory Advantages: accuracy, flexible options, efficiency LIS Specific Tasks ▪ Admit patients ▪ Request test orders ▪ Print labels ▪ Enter results ▪ Inquire about results ▪ Generate report LIS User Identification ID code or Tech code Code may not be confidential Identifies person entering data For purpose of accruing workload Password Strictly confidential Individual access code Logged with every system transaction LIS Request Format Program/function selection by Icons Mnemonic code Numeric system Data entry phase Requisition entry program Same procedure for any system Accession number generated Accession Number ▪ Generated in Specimen Requisition program ▪ A unique number for each specimen ▪ Identified with the specimen as long as it is in the laboratory Bar Code A parallel array of alternately spaced black bars and white spaces The code representing numbers or letters Uses: Patient ID Supply inventory Specimen ID Drug name and dose Interfacing The ability of computers to talk to each other Establishment of CIC Ensure POC analyzers could talk to any LIS Standardizes all data management tools Ensure results would be transferred to main computer and to patient’s chart Guideline resulted in NCCLS standard Automation Overview of Automation Benefits of Automation ▪ Reduction of medical errors ▪ Improved safety for laboratory staff ▪ Faster turnaround time of results ▪ Partially alleviating the impending shortage of skilled laboratory staff Overview of Automation Process of Automation Steps in Automated Analysis ▪ Major steps designed to mimic manual techniques: 1. Specimen collection and processing 2. Specimen and reagent measurement and delivery 3. Chemical reaction phase 4. Measurement phase 5. Signal processing and data handling Overview of Automation Automated Analyzers Clinical Chemistry and Immunochemistry Analyzers Earliest automation done in chemistry Measurement techniques are based on manual approaches (i.e. spectrophotomer methodologies) Immunochemistry analyzers are using chemiluminescence methodologies See tables 9-4, 9-5, and 9-6 for details Automated Analyzers Hematology Instrumentation Auto cell counters: RBC, WBC and platelets Complex analyzers will differentiate the types of WBC’s Discussed in detail in CLBT1040 Methodologies include: Electrical resistance Optical focused laser beams See Table 9-7 for more details Automated Analyzers Urinalysis Instruments are available to semi-automate or totally automate the routine chemical testing in urinalysis and in some cases, microscopic examination Molecular Testing Polymerase chain reaction (PCR) Test that amplifies low levels of specific DNA sequences in a sample to higher quantities for analysis Video Link Western blot Method in which protein or RNA is separated electrophoretically, transferred to membranes and identified through the use of labeled antibodies. Molecular Testing Southern blot Test method that checks for the presence of a DNA sequence in a DNA sample by combining gel electrophoresis and a filter membrane for probe hybridization. Used in Sickle Cell Anemia and Hemophilia A detection. Microarrays (DNA Chips) Bonding or synthesis of numerous specific DNA probes on a stationary support. Miniature gene fragments attached to glass chips. Used in analysis of gene expression in malignancies Postamble READ the TEXTBOOK for the details to answer the UNIT OBJECTIVES. USE THE UNIT OBJECTIVES AS A STUDY GUIDE All test questions come from detailed material found in the TEXTBOOK (Not this PowerPoint) and relate back to the Unit Objectives