Concepts of Quality Control and Safety in Serologic Testing

Question 1

Referes to the overall process of guaranteeing quality patient care

Answer 1

Quality Assessment or Quality Assurance

Question 2

Variables that occur before the actual testing of the specimen

Answer 2

Pre-analytical factors

Question 3

Processes that directly affect the testing of specimens

Answer 3

Analytical factors

Question 4

Processes that affect the reporting of results and correct interpretation of data

Answer 4

Post- analytical factors

Question 5

Test request

a. Pre-analytical factor
b. Analytical factor
c. Post- analytical factor

Answer 5

A

Question 6

Patient preparation

a. Pre-analytical factor
b. Analytical factor
c. Post- analytical factor

Answer 6

A

Question 7

Specimen collection, handling and storage

a. Pre-analytical factor
b. Analytical factor
c. Post- analytical factor

Answer 7

A

Question 8

Reagents

a. Pre-analytical factor
b. Analytical factor
c. Post- analytical factors

Answer 8

B

Question 9

Instrumentation and equipment: instrument calibration and maintenance

Answer 9

B

Question 10

Testing procedure

A. Pre analytical factor
B. Analytical factor
C. Post analytical factor

Answer 10

B

Question 11

Preventive maintenance

a. Pre-analytical factor
b. Analytical factor
c. Post- analytical factor

Answer 11

B

Question 12

Access to procedure manuals

a. Pre-analytical factor
b. Analytical factor
c. Post- analytical factor

Answer 12

B

Question 13

Competency of personnel performing the test

a. Pre-analytical factor
b. Analytical factor
c. Post- analytical factor

Answer 13

B

Question 14

Communication of test result

a. Pre-analytical factor
b. Analytical factor
c. Post- analytical factor

Answer 14

C

Question 15

Refers to materials, procedures and techniques that monitor the accuracy, precision and reliability of a lab test

Answer 15

Quality control

Question 16

It is performed to ensure that acceptable standards are met during the process of patient testing

Answer 16

Quality control

Question 17

It is used to verify the accuracy and precision of a test and are exposed to the same conditions as the patient samples

Answer 17

External quality control

Question 18

It is the ability to obtain the expected result

Answer 18

Accuracy

Question 19

It is the ability to obtain the same result on the same specimen

Answer 19

Precision

Question 20

It is the ability to maintain both precision and accuracy

Answer 20

Reliability

Question 21

It consists of internal monitoring systems built into the test system

Answer 21

Internal quality control

Question 22

It monitor the correct addition of a patient specimen or reagent, the instruments/reagents interaction and test completion

Answer 22

Internal or procedural controls

Question 23

It monitor a test system’s electronic or electric components

Answer 23

Electric control

Question 24

It is the testing of unknown sample received from an outside agency

Answer 24

Proficiency testing

Question 25

It provides unbiased validation of the qualify of patient test result

Answer 25

Proficiency testing

Question 26

Term: How close the measurement is to the value

Answer 26

Accuracy

Question 27

Term: how close the results are when the same sample is tested multiple times

Answer 27

Precision

Question 28

Term: range of values over which Laboratory can verify accuracy of a test system

Answer 28

Reportable range

Question 29

Term: formerly called a normal value

Answer 29

Reference interval

Question 30

Lowest concentration of a substance that can be detected by a test method

Answer 30

Analytical sensitivity

Question 31

Ability of method to measure the only analyze it is supposed to measure and not the other related substances

Answer 31

Analytical specificity

Question 32

Process of testing and adjusting analyzer’s readout to establish a correlation between measured and actual concentrations

Answer 32

Calibration

Question 33

Reference material with a known concentration of analyte

Answer 33

Calibrator

Question 34

Testing materials of known concentrations (calibrators, controls, proficiency testing samples, patient specimens with known values) to ensure the accuracy of results throughout reportable range

Answer 34

Calibration verification

Question 35

The three levels that calibration verification test:

Answer 35

High, mid point, and low

Question 36

Calibration verification requires how many months when a lot number of reagents changes, following preventive maintenance of repair and when controls are out of range

Answer 36

6 months

Question 37

When is a calibration verification required?

Answer 37

1 when a lot number of reagents changes
2 to follow preventive maintenance or repair
3 when controls are out of range

Question 38

Positive result in a patient who has the disease

Answer 38

True positive (TP)

Question 39

Positive result in a patient who does not have the disease

Answer 39

False positive (fp)

Question 40

Negative result in a patient who does not have the disease

Answer 40

True negative (TN)

Question 41

Negative result in a patient who has the disease

Answer 41

False negative (fn)

Question 42

% Of the population with the disease that tests positive

Answer 42

Diagnostic sensitivity

Question 43

% Of population without the disease that test negative

Answer 43

Diagnostic specificity

Question 44

% Of the time that a positive result is correct

Answer 44

Positive predictive value ((PPV))

Question 45

% Of the time that a negative result is correct

Answer 45

Negative predictive value ((npv))

Question 46

Study to verify the accuracy of a new method

Answer 46

Correlation study

Question 47

Schedule of maintenance to keep equipment in peak operating condition

Answer 47

Preventive maintenance

Question 48

Procedures specified by the manufacturer to evaluate critical operating characteristics of a test system

Answer 48

Function checks

Question 49

Comparison of patient data with previous results

Answer 49

Delta check