Quality Control

Question 1

A process of ensuring that analytical results are correct by testing known samples (control solutions) that resemble patient samples

Answer 1

Quality control

Question 2

involves the process of monitoring characteristics of the analytical processes and detects analytical errors during testing and ultimately prevents the reporting of inaccurate patient test results.

Answer 2

Quality control

Question 3

measures the Smallest concentration of analyte

Answer 3

Analytical Sensitivity

Question 4

measure only the analyte of interest

Answer 4

Analytical specificity

Question 5

detect the proportion of individuals with that disease who test positively with the test

Answer 5

Diagnostic sensitivity

Question 6

Screening tests require high sensitivity so that no case is missed

Answer 6

Diagnostic sensitivity

Question 7

detect the proportion of individuals without the disease who test negative for the disease

Answer 7

Diagnostic specificity

Question 8

Confirmatory tests require high specificity so that no case is missed

Answer 8

Diagnostic specificity

Question 9

nearness/closeness to the value

Answer 9

Accuracy

Question 10

r e p e a t e d r e s u l t s o n t h e s a m e s a m p l e

Answer 10

Precision

Question 11

Method can easily be repeated

Answer 11

Practicability

Question 12

difference of two recent measurements from the same patient.

Answer 12

Delta check

Question 13

maintain accuracy and precision over an extended period of time.

Answer 13

Reliability

Question 14

Used to determine whether there is a statistically significant difference in the means of two groups of data

Answer 14

T test

Question 15

Used to determine whether there is a statistically significant difference between the SD of two groups of data

Answer 15

F test

Question 16

is a systematic action necessary to provide adequate confidence that
laboratory services will satisfy the given medical needs for patient care. It encompasses the pre-analytical, analytical, and post-analytical phases of testing in contrast to Quality Control which involves only the analytical phase

Answer 16

Quality Assurance

Question 17

A population probability that is symmetric about the mean.

Answer 17

Gaussian Curve (Bell Shaped Curve)

Question 18

Confidence values (in parametric distribution of values) of the Gaussian Curve

Answer 18

68.2%（+1 S D ）
95.5% (+2SD)
99.7% (+3SD

Question 19

a laboratory result that may present a life threatening situation that sometimes is
not readily identified

Answer 19

Critical/Panic Value

Question 20

Often related to calibration problems, detorioration of reagents and control materials, unstable and
inadequate reagent blanks, contaminated solutions, failing instrumentations.

Answer 20

Systematic error

Question 21

An error that influences observations consistently in one direction

Answer 21

Systematic error

Question 21

Influences the accuracy of the procedure

Answer 21

Systematic error

Question 22

Two kinds of Systematic Error

Answer 22

Constant Error
Proportional/Slope/Percent Error

Question 23

Systematic error measures

Answer 23

Mean

Question 24

Due to chance, instrument, operator and environmental conditions.

Answer 24

Random error

Question 25

Type of error which varies from sample to sample. Influences the precision of the procedure.

Answer 25

Random error

Question 26

KINDS OF QUALITY CONTROL for monitoring; detects systematic & random errors, use of manufacturer-derived controls, control values known

Answer 26

Intralab

Question 27

KINDS OF QUALITY CONTROL provide samples of unknown conc' of analytes to participating laboratories.

Answer 27

Interlab

Question 28

OBJECTIVES OF QUALITY CONTROL

Answer 28

1. T o check t h e stability of the machine. 2 . To check the quality of the reagents. 3 . To check technical (operator) errors

Question 29

Most widely used quality control chart

Answer 29

Shewhart Levey-Jennings Chart

Question 30

Uses Westgard Control Rules

Answer 30

Shewhart Levey-Jennings Chart

Question 31

Quality control chart that is Used to compare results obtained on a high and low control serum form different laboratories

Answer 31

Youden/Twin Plot

Question 32

main cause is the deterioration of reagents

Answer 32

Trend

Question 33

caused by improper calibration of the instrument

Answer 33

Shift

Question 34

caused by random or systematic errors

Answer 34

Outliers

Question 35

The method of choice to measure systematic error/inaccuracy

Answer 35

WESTGARD CONTROL RULES

Question 36

WESTGARD CONTROL RULES no longer used as a rejection o r warning when 1 control exceeds the mean +/- 2SD

Answer 36

12s

Question 37

WESTGARD CONTROL RULES reject a run when one control result exceeds the mean +/- 3SD

Answer 37

1 3s

Question 38

WESTGARD CONTROL RULES reject a run when the last 2 control results exceed either +/- 2SD

Answer 38

2 2s

Question 39

WESTGARD CONTROL RULES reject a run when the last 4 consecutive control exceeds the mean +/- 1SD

Answer 39

4 1s

Question 40

WESTGARD CONTROL RULES reject a run if a result exceeds +/-4SD

Answer 40

R 4s

Question 41

WESTGARD CONTROL RULES reject a run when ten consecutive rules are on the same side of the target mean.

Answer 41

10x

Question 42

Is a universal responsibility

Answer 42

TOTAL QUALITY MANAGEMENT [TQM]

Question 43

Aims to minimize defects or variations, enhancing accuracy and precision by reducing errors in testing and reporting results. The main goal is to reduce the number of defects to zero

Answer 43

Six sigma

Question 44

5 steps of Six Sigma:

Answer 44

1. Define 2. Measure 3. Achieve 4. Improve 5. Control

Question 45

Focuses on reducing non-value- adding activities (waste),such as waiting times, transportation, and e x c e s s processing in laboratory workflows.

Answer 45

Lean system

Question 46

5s of lean system

Answer 46

Sort Set in order Shine Standardize Sustain

Question 47

PDCA of lean system

Answer 47

Plan Do Check Act