5 - Fundamental Concepts of TQM (Commonly Used Terms)

Question 1

Defined as conformance with the requirements of users and costumers. It refers to the satisfaction of the needs and expectations of users and costumers. The focus on users and costumers is important, particularly in the healthcare setting to which laboratory services belong to. Users of laboratories are often physicians and their costumers are patients and other parties who pay the bills

Answer 1

Quality

Question 2

Cost must be understood in the context of this. If it is conformance to requirements, then its cost must be understood in terms of “cost of conformance” and “cost of nonconformance”.
- Cost of _________ are divided into prevention cost and appraisal cost
- Cost of consist of internal and external failure cost.
- For a laboratory testing process, calibration is a good example of a cost incurred to prevent problems, QC is a cost for appraising performance, repeat run is an internal failure cost for poor analytical performance and repeat requests for tests because of poor analytical quality are an external failure cost.

Answer 2

Quality; conformance; nonconformance

Question 3

Degree to which a measured value of an entity agrees with its true value. Best measured through reference methods and peer group comparison.

Answer 3

Accuracy

Question 4

Degree to which measured values of an entity agree with each other. Good _______ does not always connote accuracy. Measured through determining ______________ and coefficient of variance.

Answer 4

Precision; precision; standard deviation

Question 5

A combination of accuracy and precision. Should be the goal of all laboratory workers.

Answer 5

Reliability

Question 6

Ability of the method to detect slight differences in concentration. High __________ means few false _________ and is desirable in screening tests.

Answer 6

Sensitivity; sensitivity; negatives

Question 7

The ability of a method to determine solely the compound it is supposed to measure. High __________ means few false ________ and is desirable for confirmatory tests.

Answer 7

Specificity; specificity; positives

Question 8

Describes the many fluctuations in a data that will interfere in the measurement of a substance in question.

Answer 8

Variance