CH # 29: Introduction 2 The Clinical Labratory Flashcards
A substance that is being identified or measured in a laboratory test
Analyte
A mechanism 2 check the precision and accuracy of a test system 2 determine if the system is providing accurate results
Calibration
A tentative diagnosis of a patient’s condition obtained through evaluation of the health history and the physical examination, w/out the benefits of laboratory or diagnostic tests
Clinical diagnosis
A solution that is used 2 monitor a test system 2 insure the reliability and accuracy of test results
Comes w/product insert which list expected ranges 4 test results.
2 types:
-internal (preformed at time of test, if fails then invalidates tests)
-external (used 2 test tester techniques and testing regent
accuracy)
Control
Abstaining from food or fluids(except water) 4 a specified amount of time b4 a collection of a specimen
Fasting
The state in which the body systems r functioning normally and the internal environment of the body is in equilibrium; the body is in a healthy state
Homeostasis
Occurring in the living body or organism
In vivo
The clinical analysis and study of materials, fluids, or tissues obtained from patients 2 assist in diagnosis and treatment of disease
Laboratory test
A complex laboratory test that does not meet the CLIA criteria 4 waiver and is subject 2 the CLIA regulations
Nonwaived test
The liquid part of the blood, consisting of a clear, yellowish fluid that comprises approximately 55% of the total blood volume
Plasma
A printed document supplied by the manufacturer w/a laboratory test product that contains information on the proper use and storage of the product
Product insert
An array of laboratory test 4 identifying a deceased state or evaluating a particular organ or organ system
Profile
A test that indicates whether or not a substance is present in the specimen being tested and also provides an approximate indication of the amount of the substance is present
Qualitative test
The application of methods 2 ensure that test results r reliable and valid and that errors r detected and eliminated
Involves:
- storage and handling of test systems
- stability of components
- calibration
- controls
- collecting and handling specimens
- testing the specimen
- interpreting and reading test results
Quality control
A test that indicates the exact amount of a chemical substance that is present in the body, w/the results being reported in measurable units
Quantitative test
A substance that produces a reaction w/a patient specimen that allows detection or measurement of the substance by the test system
Reagent
3 names 4 a certain established and acceptable parameter or reference ranges/in which the laboratory test results of a healthy individual r expected 2 fall
Reference range
Reference value
Reference interval
Consists of regulations developed in 1988 to improve the quality of laboratory tests in the USA
Their regulations establish 3 categories of tests:
- waived tests (FDA approved tests 4 the public)
- moderate-complexity tests
- high-complexity tests
Clinical Laboratories Improvement Amendments
CLIA
36F-46F
Or
2C-8C
HIPPA refrigerator temperature requirements
Includes information on:
- physicians name and address
- patient’s name and address
- date and time of specimen collection
- laboratory tests desired
- profiles
- source of the specimen
- physician’s clinical diagnosis in ICD format
- medications
- STAT
Laboratory request form
Required conversation to obtain a high quality specimen suitable 4 testing
Possible topics include:
- food consumption
- medication
- activity
- time of day affects laboratory results
- assists the physician in accurate diagnosis and treatment
- time requirement
Patient preparation
A laboratory test performed routinely on a apparently healthy patients 2 assist in the early detection of disease
Routine test
The clear straw colored part of the blood (plasma) that remains after the solid elements and the clotting factor fibrinogin have been separated out of it
Serum
A setup that includes all of the test components required 2 perform a laboratory test
Ex. Testing devices, controls, testing reagents
Test system
A laboratory test that meets the CLIA criteria 4 being a simple procedure that is easy 2 preform and has a low risk of erroneous test results.
Includes tests that have been FDA-approved 4 use by patients at home
Waived test
A small sample of something taken 2 show the nature of the whole
Specimen
Used to mark a specimen that there isn’t enough to run the tests on
QNS
Quantity not sufficient
This list of tests include:
- urine analysis and fecal testing
- hematology (ex.hemoglobin, PT time)
- blood chemistry and immunology (ex.blood glucose, A1C)
- microbiology (streptococcus tests, influenza testing)
CLIA-waived tests
Involves 2 levels of controls that must b preformed on a testing system:
Low-level or level 1 control
High-level or level 2 control
External control requirements
2 or more diseases that may have similar signs and symptoms
Differential diagnosis
