CHAPTER IV: QUALITY CONTROL IN CLINICAL CHEMISTRY Flashcards
a degree to which a set of inherent characteristics fulfills requirements
QUALITY
What is the ISO for Quality?
(ISO 9001:2008)
part of quality management focused on fulfilling quality requirements
QUALITY CONTROL
System of assuring the quality of total laboratory performance
QUALITY CONTROL
Quality control is done __________.
Periodically
Involves the periodic systematic surveillance of__________________
people, tools, methods and reagents
part of quality management focused on providing confidence that the
quality requirements will be fulfilled
QUALITY ASSURANCE
Set of activities or plan that aims to maintain the highest degree of excellence for the diagnosis & treatment of disease and maintenance of health
QUALITY ASSURANCE PROGRAM
establishes norms that must be met
Quality Control Surveillance System (QCCS)
established to offer education of why errors occur; provide a program to
remedy defects
Q.C. Corrective System
established to prove that corrective measures have produced favorable results.
Objective Q.C. Parameters
A substance of known composition
STANDARD
Its value is established by an analytical procedure different from that used in the clinical laboratory
STANDARD
A substance which resembles the unknown specimen (patient’s sample)
CONTROL MATERIAL
Analyzed daily together with the unknown
control material
The values obtained from the assays are used for the computation of the mean and the SD
CONTROL MATERIAL
Excess non-hemolyzed sera without gross lipemia are collected daily in the laboratory and pooled for storage in the refrigerator
Pooled sera
Excess non-hemolyzed sera _______gross lipemia are collected _____ in the laboratory and pooled for _______ in the refrigerator
without
daily
storage
How many liters of pooled sera is collected for the MT to centrifuge it?
1-2 Liters
When 1 – 2 liters are collected, centrifuge to remove _____________
gross contamination
Under pooled sera, after centrifuging it, ___________ into aliquots of __ each
filter and divide
5 mL
Under pooled sera, after centrifuging, filtering and aliquoting. What is the next step?
Stopper and store at -20°C
extent to w/c the measurement approximates the true value of the quantity being measured
accuracy
a.k.a reproducibility; degree to w/c repeated results agree to each other
Precision
– ability of a method to detect a particular substance w/o the interference of some other substances present in the sample
specificity
ability of a method to detect even the smallest amount of that particular substance tested for
Sensitivity
ability of a method to maintain its accuracy & precision over an extended of time
Reliability
degree to w/c the method is easily repeated
Practicability
