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Section 8: GLOSSARY
Acceptable Control Range
the range of results that indicate adequate performance when analyzing
a control sample. The range is shown in the control's product insert.
correctness; freedom from error. The accuracy of results can be
measured by comparing them to results accepted as correct, or by
comparing them with those from another laboratory (this is "relative
a chemical added to a blood collection tube, usually in order to
prevent the blood from clotting (anticoagulant).
a fine mist in which solid or liquid particles are dispersed.
a dried, sticky substance extracted from various red algae and used as
a gel in preparing solid culture media.
the clumping together of antigen-bearing cells, bacteria, or particles
in the presence of specific antibodies. Also called "clumping."
These have been called "panic" values. They reflect the points at which
a physician needs to be immediately informed because of the clinical
seriousness of the result.
a small portion of a measured volume of a substance taken representing
as a sample
the laboratory procedure that enables measurement of the amount of an
the substance or constitute being measured (e.g., glucose, sodium,
a substance formed in the body in response to a foreign substance (an
that interacts only with that substance.
a chemical used to prevent blood from clotting.
any substance which, injected into an organism, causes the development
a serum that contain antibodies.
American Society of Clinical Pathologists (largest certifying
organization for laboratory professionals.)
free from infection or septic material; sterile.
the measurement of the amount of a constituent in a specimen; a test.
a book of reference pictures. There are a variety of published
urinalysis, and gram stain atlases available.
an instrument that sterilizes material by subjecting it to steam under
Dilution and lysing fluid for blood cell counts may have particulate
contaminants which would be counted as cells by an automated counter,
thus falsely elevating the
different cell counts.
when specimens are kept and run all together at a later time.
a measure of the departure from accuracy. A numerical difference
between the mean of a set of replicate measurements and the true value
of the sample.
agents that pose some risk of infection to the laboratory staff,
janitorial staff that cleans the office, and the public at large
through environmental contamination.
Calibrated (of a measuring
graduated into appropriate units.
the process by which readings obtained from an instrument or other
measuring device are related to known concentrations of an analyte.
a material, solution, or freeze-dried preparation used in calibration.
The concentration of the analytes in a calibrator is known to be within
a particular range. Calibrators may be a primary or a secondary
the attraction between a liquid and a solid that causes the liquid to
rise, as for example, into a capillary tube.
any one of the small vessels that form a network throughout the body
for the interchange of substances between the blood and tissue fluid.
cells and organisms have certain shapes and configurations which are
characteristic and which permit their identification.
an instrument that separates the lighter portions of a solution,
mixture, or suspension from the heavier portions by centrifugal force.
Clean Catch Midstream
This is a type of urine specimen collection which minimizes contamination
by cleaning off the urethral are washing out of the urethra with urine,
the flow, and then restarting it.
Clinical Laboratory Improvement Act of 1988 (Federal standards for all
benefit of human patients.
CO2 Rich Atmosphere
a facility that performs tests or investigative procedures for the
Some organisms, most commonly Neisseria species, have complex
growth requirements, including an atmosphere rich in carbon dioxide
the process by which various coagulation factors in the blood interact
to form a clot.
Coefficient of Variation
a statistical measure of the ratio of the standard deviation of a
series of measurements to the mean of the measurements. Expressed as a
percentage, the coefficient of variation (CV) shows the precision of
Commission of Laboratory Assessment (a private, non-profit accrediting
organization for POL's.)
the measurement and analysis of color by comparison with a standard in
terms of brightness, hue, or purity.
a microorganism, chemical, or other material that makes something
impure by contact or mixture with it.
a material, solution, lyophilized preparation, or pool of collected
serum designed to be used in the process of quality control. The
concentration of the analytes of interest in the control material are
known within limits ascertained during its preparation, and confirmed
the growing of microorganisms or living tissue cells in special media;
the growth of the microorganisms or cells.
a substance or preparation used for the cultivation and growth of
the numerical or qualitative results of a test from which conclusions
Department of Health and Human Services.
a laboratory test or measurement that helps determine the cause or
nature of a disease. Laboratory tests are often called "in vitro
the liquid (usually distilled water) used to reconstitute a
freeze-dried control or
the mixing of a diluent and calibrator, or control, or patient sample.
dilution is the progressive dilution of a substance in a series of
tubes in predetermined ratios.
enzyme-linked immunosorbent assay; a diagnostic test used to detect
either antigens or antibodies in a patient's specimen.
a compound produced in a cell and capable of greatly increasing the
rate of a chemical reaction.
a red blood cell, one of the elements in peripheral blood.
an agent that causes disease.
Evaluation of Performance
Periodically, (at lease once a year), the physician laboratory director
should perform a performance appraisal of the laboratory staff.
False Negative (Result)
or constituent in question.
False Positive (Result)
or condition in question.
Full Regulation State
a negative test result for a patient who is positive for the condition
a positive test result for a patient who is negative for the
a state in which the laboratory regulation program includes
provisions for licensure, proficiency testing, quality control,
personnel requirements, and inspection.
the lowering of glucose concentration in a blood sample by the action
in the red blood cells.
the measurement of a substance by determining its weight or specific
Health Care Financing Administration.
a mass of blood, usually clotted, under the skin in an organ, space, or
tissue caused by a break in the wall of a blood vessel.
(also called packed cell volume) the volume percentage
of erythrocytes red blood cells) in whole blood.
(adjective hemolytic) the breakdown of red blood cells in serum of
plasma, freeing the hemoglobin from the cells. When this happens, the
serum or plasma becomes reddish. Hemolysis interferes with some
laboratory tests. Beta hemolysis is the production of
a clear zone surrounding a bacterial colony on blood agar medium, which
is characteristic of certain pathogenic bacteria such as Group A
a clinical laboratory that is accountable administratively to the
hospital's central management and medically to its organized medical
staff. Most hospital laboratories are physically located in hospitals
but co-location is not required.
(adjective icteric) a condition in which there is too much bilirubin in
the blood; jaundice. An icteric serum sample looks dark yellow ( it may
even look greenish). An icteric
- sample may produce erroneous test results.
a diagnostic test that uses a specific antibody or antigen to detect
the presence of an analyte.
Inaccuracy see Bias.
term used to describe the testing procedure when the results from a
control sample or series of control samples are within the acceptable
any microorganism that can invade body tissue and multiply, causing
the development of microorganisms in a medium. See the Culture
Procedures chapter in the guidelines.
a clinical laboratory that is independent of all other providers of
direct patient care.
implanting microorganismsor other substances into a culture medium to
allow them to grow. The microorganism or substance implanted is the inoculum.
an on-site visit to the laboratory by state program inspectors to
determine whether the facility is complying with laboratory program
a Latin term, meaning "in glass," used to describe diagnostic tests,
which analyze process that occur inside the body (in vivo) from samples
of body fluids in glass (test tubes) or other controlled artificial
Manufacturers usually will list suggested preventative maintenance with
specified time intervals.
quality control chart; a graph or table that shows results of control
tests over a period of time; used in a quality control program.
the requirement that the laboratory receive a separate license,
certification or accreditation from a governmental agency as a
prerequisite of doing business.
Limited Regulation State
a state in which the laboratory regulation program includes some but
not all of the aspects of a full regulation state.
(adjective lipemic) a condition in which too much fat or lipids are in
the blood. A lipemic serum sample looks milky and turbid, and may
produce erroneous results.
freeze-dried; a lyophilized calibrator, control, or reagent has been
specially dried to make its analytes more stable. It must be
refrigerated to maintain its stability, and is reconstituted by adding
an appropriate diluent.
the measure of the range (the linear range) of concentration of an
analyte over which a method or test produces consistent (i.e., linear,
straight line) and accurate results.
These agents rupture cells.
the average of the numerical results obtained from a series of
The food that is used for culturing microorganisms.
analytical method; the instructions including procedures, material,
equipment and everything else needed for an analyst to perform an
a small, usually microscopic, living organism; types include bacteria,
viruses, molds, yeasts, and protozoa .
the form and structure of an organism, organ, or part.
National Committee for Clinical Laboratory Standards (publishes
information manuals for laboratories)
(expected Values, Reference Values) a range of values established for
each analyte that includes the results expected when performing a test
on a healthy person.
Out of Control
term used to describe the testing procedure when the results from a
control sample are outside the acceptable control range.
In the office setting this reagent is used yo test organisms that are
thought to be Neisseria gonorrhoea (GC).
(adjective pathogenic) a microorganism that causes a disease.
There should be a personnel file on each member of the laborat ory
staff. It should include a resume of training and experience, school
transcripts (if relevant), formal certification or license (if this is
required by your state), references, job description which delineates
responsibilities, incident and accident records, records of continuing
education, and copies of the performance evaluations.
education and experience requirements for the professional and
technical laboratory personnel.
This is a specimen from the throat used for performing a rapid antigen
detection strep test or a throat culture.
the cutting of a vein, or the puncture of a vein to collect blood. A
phlebotomist is the person who collects blood by venipuncture (venous
the measurement or analysis of light emitted by a substance.
Reflectance photometry is the principle used in most instruments that
read dry reagent strips.
Physicians' Office Laboratory
a laboratory, located in a physician's office, used to perform tests or
procedures as an adjunct to treating his or her patients.
a glass or transparent plastic tube used to measure small quantities of
liquid. A volumetric pipette is an extremely accurate, single-line
pipette used to reconstitute calibrators and controls.
the liquid part of blood after it has been mixed an anticoagulant and
spun down in
This involves streaking, smearing, or depositing with a loop or
pipette, some of a specimen onto the surface of solid food (media) that
is used to grow microorganisms.
Microorganisms are grown on special food (media) which is placed in a
small plastic container ("petri dish"). This combination of media and
plastic container is called a "plate."
the measure of the closeness of the results obtained when analyzing the
same sample more than once; the measure of agreement between replicate
a laboratory manual that contains the methods, materials, and other
information needed to do a test.
informational material that comes with instruments, reagents, and other
laboratory products giving instructions for the use of the product and
other information required of the manufacturer by the U.S. Food and
analytes of unknown concentration that are sent to laboratories
participating in proficiency testing programs.
a program in which samples are sent to a group of laboratories for
analysis. The results are tabulated by the program's sponsor, and a
participating laboratory can compare its results with those of other
laboratories that use the same method.
a standard set of instructions for performing a procedure, such as a
test or an evaluation. See the guideline on Method/Instrument
Selection, Evaluation, and Operation.
a comprehensive set of policies, procedures, and practices necessary to
make sure that the laboratory's results are reliable. QA includes record
keeping, calibration and maintenance of equipment, quality control,
proficiency testing, and training.
the set of laboratory procedures designed to ensure that the test
method is working properly and that the results meet the diagnostic
needs of the physician. QC includes testing control samples, charting
the results, and analyzing them statistically.
this term is applied to tests that give results expressing the
numerical amount of an analyte in a specimen. This is in contrast to qualitative tests that detect whether a particular
analyte, constituent, or condition is present.
the ability of a reagent to produce its proper chemical reaction.
Reagents can lose their reactivity if they are misused, mishandled, or
a substance that produces a chemical reaction in a sample that allows
an analyte to be detected and measured.
to add a diluent to a freeze-dried calibrator, control, or reagent.
Reference Interval see Normal Values.
It is sometimes necessary to determine the accuracy of a specific
testing method. One way of doing this is to test materials with known
accurately determined concentrations (target concentrations) for the
method under investigation. These materials with the specified target
values are called "reference materials."
These are the limits of laboratory values of populations without
to repeat an experiment or an analysis in order to check the accuracy
of the results. Each repeat is a replicate (pronounced rep-Ii- kit) test or measurement.
Re-producibility see Precision.
the value obtained by analysis for a particular analyte in a particular
This is a form of some kind which indicates the name of the patient,
the date, the name of the physician requesting the test and the tests
that are to be performed.
a group of measurements by a particular method over a period of
,,- time during which the accuracy and precision of the method are
expected to be stable.
the part of a specimen that is used for analysis.
the ability of a test to give a positive result for patients that have
the disease or condition they are tested for; measured as the ratio of
positive tests in those that have the disease; expressed as a
the liquid part of the blood after it has coagulated and then been spun
down in a centrifuge.
the ability of a test to give a negative result for patients that do
not have the disease or condition they are tested for; measured as the
ratio of negative tests to the total number of tests in those that do
not have the disease or condition; expressed as a percentage.
the portion of a body fluid (for example, blood or urine) that is
collected from the patient.
dividing a sample in half, and
testing half in your laboratory and
having the other half tested in another laboratory, and then comparing the
results. This is a
technique for testing accuracy.
the ability of a specimen, reagent, or control to maintain a constant
concentration of the analyte. Reagents and controls must be handled and
stored properly and used before their expiration dates to maintain
their stability. Specimens must be collected, handled, and processed
This is a formal process by which a measurable quantity produced by a
chemistry instrument (this can be voltage) is related to the
concentration of a particular chemical.
a reference material that is of fixed and known chemical composition
and capable of being prepared in essentially pure form. Also: Any
certified reference material that is generally accepted or officially
recognized as the unique standard for the assay regardless of its level
of purity of analyte content.
a reference material, the analyte concentration of which has been
ascertained by reference to a primary standard.
a statistical measurement of the degree of variation from the mean ofa
series of measurements. It is a measure of precision or
a procedure for detecting the presence or the amount of an analyte.
the quantity of a substance required to produce a reaction with a
particular amount of another substance. The amount of one substance
required to correspond with a particular amount of another substance. Agglutination titer is the highest dilution of a serum that
causes clumping of particulate antigens.
a term applied to analytical instruments specifying the number of tests
that can be performed in a given time.
products used in the laboratory which may contain substances that pose
some danger to the laboratory worker.
the study of the origin, nature, and effects of poison. Toxicological
analyses are used to detect the amount of a substance that can be
poisonous at a particular concentration.
(adjective turbid) cloudiness; distribution of a substance in a
solution making it unclear or cloudy.
the statement of the number, in the units of the method, obtained for
an analyte in a particular sample. See result.
the procedure for collecting a blood sample from a vein. This is called
blood mixed with an anticoagulant but not spun down in a centrifuge.
5. . COLA Checklist Glossary
6. . NCCLS Physician Office Laboratory Procedure Manual