CH # 29: Introduction 2 The Clinical Labratory

Question 1

A substance that is being identified or measured in a laboratory test

Answer 1

Analyte

Question 2

A mechanism 2 check the precision and accuracy of a test system 2 determine if the system is providing accurate results

Answer 2

Calibration

Question 3

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

Answer 3

Clinical diagnosis

Question 4

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)

Answer 4

Control

Question 5

Abstaining from food or fluids(except water) 4 a specified amount of time b4 a collection of a specimen

Answer 5

Fasting

Question 6

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

Answer 6

Homeostasis

Question 7

Occurring in the living body or organism

Answer 7

In vivo

Question 8

The clinical analysis and study of materials, fluids, or tissues obtained from patients 2 assist in diagnosis and treatment of disease

Answer 8

Laboratory test

Question 9

A complex laboratory test that does not meet the CLIA criteria 4 waiver and is subject 2 the CLIA regulations

Answer 9

Nonwaived test

Question 10

The liquid part of the blood, consisting of a clear, yellowish fluid that comprises approximately 55% of the total blood volume

Answer 10

Plasma

Question 11

A printed document supplied by the manufacturer w/a laboratory test product that contains information on the proper use and storage of the product

Answer 11

Product insert

Question 12

An array of laboratory test 4 identifying a deceased state or evaluating a particular organ or organ system

Answer 12

Profile

Question 13

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

Answer 13

Qualitative test

Question 14

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

Answer 14

Quality control

Question 15

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

Answer 15

Quantitative test

Question 16

A substance that produces a reaction w/a patient specimen that allows detection or measurement of the substance by the test system

Answer 16

Reagent

Question 17

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

Answer 17

Reference range

Reference value

Reference interval

Question 18

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

Answer 18

Clinical Laboratories Improvement Amendments

CLIA

Question 19

36F-46F

Or

2C-8C

Answer 19

HIPPA refrigerator temperature requirements

Question 20

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

Answer 20

Laboratory request form

Question 21

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

Answer 21

Patient preparation

Question 22

A laboratory test performed routinely on a apparently healthy patients 2 assist in the early detection of disease

Answer 22

Routine test

Question 23

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

Answer 23

Serum

Question 24

A setup that includes all of the test components required 2 perform a laboratory test

Ex. Testing devices, controls, testing reagents

Answer 24

Test system

Question 25

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

Answer 25

Waived test

Question 26

A small sample of something taken 2 show the nature of the whole

Answer 26

Specimen

Question 27

Used to mark a specimen that there isn’t enough to run the tests on

Answer 27

QNS

Quantity not sufficient

Question 28

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)

Answer 28

CLIA-waived tests

Question 29

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

Answer 29

External control requirements

Question 30

2 or more diseases that may have similar signs and symptoms

Answer 30

Differential diagnosis