CHAPTER IV: QUALITY CONTROL IN CLINICAL CHEMISTRY

Question 1

a degree to which a set of inherent characteristics fulfills requirements

Answer 1

QUALITY

Question 2

What is the ISO for Quality?

Answer 2

(ISO 9001:2008)

Question 3

part of quality management focused on fulfilling quality requirements

Answer 3

QUALITY CONTROL

Question 4

System of assuring the quality of total laboratory performance

Answer 4

QUALITY CONTROL

Question 5

Quality control is done __________.

Answer 5

Periodically

Question 6

Involves the periodic systematic surveillance of__________________

Answer 6

people, tools, methods and reagents

Question 7

part of quality management focused on providing confidence that the
quality requirements will be fulfilled

Answer 7

QUALITY ASSURANCE

Question 8

Set of activities or plan that aims to maintain the highest degree of excellence for the diagnosis & treatment of disease and maintenance of health

Answer 8

QUALITY ASSURANCE PROGRAM

Question 9

establishes norms that must be met

Answer 9

Quality Control Surveillance System (QCCS)

Question 10

established to offer education of why errors occur; provide a program to
remedy defects

Answer 10

Q.C. Corrective System

Question 11

established to prove that corrective measures have produced favorable results.

Answer 11

Objective Q.C. Parameters

Question 12

A substance of known composition

Answer 12

STANDARD

Question 13

Its value is established by an analytical procedure different from that used in the clinical laboratory

Answer 13

STANDARD

Question 14

A substance which resembles the unknown specimen (patient’s sample)

Answer 14

CONTROL MATERIAL

Question 15

Analyzed daily together with the unknown

Answer 15

control material

Question 15

The values obtained from the assays are used for the computation of the mean and the SD

Answer 15

CONTROL MATERIAL

Question 16

Excess non-hemolyzed sera without gross lipemia are collected daily in the laboratory and pooled for storage in the refrigerator

Answer 16

Pooled sera

Question 17

Excess non-hemolyzed sera _______gross lipemia are collected _____ in the laboratory and pooled for _______ in the refrigerator

Answer 17

without
daily
storage

Question 18

How many liters of pooled sera is collected for the MT to centrifuge it?

Answer 18

1-2 Liters

Question 19

When 1 – 2 liters are collected, centrifuge to remove _____________

Answer 19

gross contamination

Question 20

Under pooled sera, after centrifuging it, ___________ into aliquots of __ each

Answer 20

filter and divide
5 mL

Question 21

Under pooled sera, after centrifuging, filtering and aliquoting. What is the next step?

Answer 21

Stopper and store at -20°C

Question 22

extent to w/c the measurement approximates the true value of the quantity being measured

Answer 22

accuracy

Question 23

a.k.a reproducibility; degree to w/c repeated results agree to each other

Answer 23

Precision

Question 24

– ability of a method to detect a particular substance w/o the interference of some other substances present in the sample

Answer 24

specificity

Question 25

ability of a method to detect even the smallest amount of that particular substance tested for

Answer 25

Sensitivity

Question 26

ability of a method to maintain its accuracy & precision over an extended of time

Answer 26

Reliability

Question 27

degree to w/c the method is easily repeated

Answer 27

Practicability