Quality Management

Question 1

Systematic, integrated set of activities to establish and control the work process from preanalytical through postanalytical processes,

Answer 1

Quality management system

Question 2

Preventive measure
Monitors performance starting from ordering to reporting

Answer 2

Quality assurance

Question 3

Analytic phase-

Answer 3

Testing

Question 4

Post analytic phase

Answer 4

Release of results

Question 5

System of ensuring accuracy and precision in the laboratory

Answer 5

Quality control

Question 6

Quality control is concerned only on the

Answer 6

Analytical phase

Question 7

Process of ensuring that analytical results are correct by testing known samples that resemble patient samples→ known as

Answer 7

QC sample or control

Question 8

both accurate and precise

Answer 8

Reliable

Question 9

Is the ability of an analytical method to measure the smallest concentration of the analyte of interest

Answer 9

Sensitivity

Question 10

It only measure the analyte of interest

Answer 10

Specificity

Question 11

The nearness or closeness of the value to the true value or the target value

Answer 11

Accuracy

Question 12

true value or the target value

Answer 12

Mean

Question 13

• The ability of an analytical method to give repeated results to the same sample that agree with one another
• The values are near each other

Answer 13

Precision or reproducibility

Question 14

The degree to which a method is easily repeated

Answer 14

Practicability

Question 15

Able to maintain both accuracy and precision even over an extended period of time

Answer 15

Reliability

Question 16

Ability of an analytical method to detect the proportion of individual’s WITH the disease

Answer 16

Diagnostic sensitivity

Question 17

Ability of an analytical method to detect the proportion of individual’s WITHOUT the disease

Answer 17

Diagnostic specificity

Question 18

Diagnostic specificity is able to detect

Answer 18

True negatives

Question 19

Kinds of quality control

Answer 19

Interlab QC/ External QC
Intralab QC/ Internal QC

Question 20

Involves proficiency testing (EQAS) programs that periodically provide samples of unknown concentration to participating clinical laboratories

Answer 20

Interlab QC/ External QC:

Question 21

Proficiency testing

Answer 21

EQAS

Question 22

• Analysis of control samples together with the patient specimens (within lab)
• This type of QC is able to detect both random and systematic errors

Answer 22

Intralab QC/ Internal QC

Question 23

Intralab QC/ Internal QC can detect

Answer 23

Both random and systematic errors

Question 24

your internal QC is run everyday, minimum number of samples in a month should be

Answer 24

20

Question 25

Errors encountered in the collection, preparation and measurement of samples, including transcription and releasing of lab results

Answer 25

Variations

Question 26

- Due to chance -Can vary for sample to sample

Answer 26

Random error

Question 27

- detected as positive or negative bias - Often related to calibration problem, deteriorate reagent or control

Answer 27

Systematic error

Question 28

Human error

Answer 28

Clerical error

Question 29

Used to observe values of control materials over time to determine reliability of the analytical method

Answer 29

Quality control chart

Question 30

Used to observe values of control materials over time to determine reliability of the analytical method

Answer 30

Quality control chart

Question 31

This occurs when that data set is accurately described by your standard deviation and your mean

Answer 31

Gaussian curve ( bell curve )

Question 32

- Calculates the difference between QC results and your target means - It can identify consistent bias problems - Requires implementation computer

Answer 32

Cumulative sum graph

Question 33

Compare results obtained on a high and low serum from different laboratories

Answer 33

Youden twin plot

Question 34

- Most widely used QC chart in the laboratory -Can observe a trend or a shift or an outlier

Answer 34

Shewart Levey Jennings Chart

Question 35

Shewart Levey Jennings Chart errors

Answer 35

Trend, shift, outlier

Question 36

Is formed when control values increase or decrease for a minimum of 6 consecutive days

Answer 36

Trend

Question 37

Cause of trend

Answer 37

Deterioration of reagents

Question 38

This is formed when control values distribute themselves on one side of the mean for a minimum of 6 consecutive days

Answer 38

Shift

Question 39

Cause of shift

Answer 39

improper calibration of the instrument

Question 40

A control value that is far form the main set of values

Answer 40

outlier

Question 41

more accurate SD

Answer 41

low SD

Question 42

- dispersion of values - how hey are far away from the mean, how close they are from each other (precision)

Answer 42

standard deviation

Question 43

data that cluster about one point

Answer 43

central tendency

Question 44

refers to raw data arranged in ascending (or descending) order

Answer 44

array

Question 45

refers to the the interval between the largest and smallest value in the data set

Answer 45

range

Question 46

tells how many times each value occurs

Answer 46

frequency distribution

Question 47

is the measure of the degree of variance from a mean value

Answer 47

standard deviation

Question 48

all the data are close to the mean

Answer 48

SD is small

Question 49

are values that fall within the preset acceptable limits

Answer 49

confidence limits

Question 50

is a substance with exact value and purity associated with it

Answer 50

standard

Question 51

- is a substance with a particular value that has been determined by the manufacturer - often used to adjust an instrument to certain values prior to running samples - may be a standard or vice versa

Answer 51

calibrator