Q/A and Q/C Definitions

Question 1

Calibrator

Answer 1

AKA standard. Has a known value. Used to set a machine to specific set points, or in the case of a manual method, a standard has a known value and is used to calculate the patient and control result.

Question 2

Control

Answer 2

Used to make sure that patient results are correct and to validate patient results.

Question 3

Quantitative test

Answer 3

Will have a range that the result should fall within. The range is well established by a proven reference method. NUMERIC
Assayed: reference range is included in the package insert
Unassayed: do not have a predetermined reference range and it needs to be established in the lab.

Question 4

Qualitative

Answer 4

May have a negative or positive control

Question 5

Shelf Life

Answer 5

The time an unopened product is still stable and considered reliable

Question 6

Accuracy

Answer 6

The closeness of the result to the true value (mean)

Question 7

Precision

Answer 7

The ability to get reproducible results

Question 8

Analyte

Answer 8

A constituent of the sample to be measured

Question 9

Assay

Answer 9

To analyse a sample to determine the amount, activity, or potency of an analyte or substance

Question 10

Mean

Answer 10

The average of all values added up and divided by the number of values

Question 11

Range

Answer 11

The difference between the smallest and largest value

Question 12

Median

Answer 12

The middle of a sorted list of numbers

Question 13

Lyphilised

Answer 13

Freeze dried (liquid removed)

Question 14

Bias

Answer 14

The difference between the true value and the value obtained

Question 15

Shiift

Answer 15

A sudden change in control mean which could mean incorrect patient results

Question 16

Trend

Answer 16

A gradual increase or decrease in control values

Question 17

Systematic Error

Answer 17

A trend or shift away from the mean

Question 18

Random Error

Answer 18

An occasional result that falls outside the range

Question 19

Standard Deviation

Answer 19

How close the values are in relation to each other, expresses the average deviation from the mean

Question 20

Coefficient of Variation

Answer 20

The standard deviation expressed as a percentage

Question 21

Westgard Rules

Answer 21

Rules (6 main) used individually or in combination to evaluate quality of the analytical run

Question 22

Troubleshooting

Answer 22

All the steps taken to correct a QC problem or find the cause and solution

Question 23

Carryover

Answer 23

When the end products or substances from one test is transferred to the next test

Question 24

Beer’s Law

Answer 24

The amount of light of a particular wavelength absorbed by a substance across a constant distance

Question 25

Sensitivity

Answer 25

The lowest concentration that can be accurately measured by an assay (lower detection limit)

Question 26

Specificity

Answer 26

How good the assay is at discriminating between the analyte and interfering substances

Question 27

Delta Check

Answer 27

Comparison of current results on a patient to the previous results

Question 28

SDI

Answer 28

A measurement of bias

Question 29

Verification

Answer 29

A process with the aim of establishing the operational limits and performance characteristics of a new method

Question 30

Validation

Answer 30

The process of checking if the method performs to the claimed specifications in a laboratory

Question 31

Correlation Coefficient

Answer 31

Shows the relationship between the 2 methods

Question 32

QA

Answer 32

Policies and procedures that are put in place to ensure accurate results and high standard of customer service is maintained

Question 33

Retention Times

Answer 33

The length that laboratory related things are kept in the lab

Question 34

Physiological variation of results

Answer 34

Differences, fluctuation, or changes of factors

Question 35

Root cause

Answer 35

The fundamental reason for the occurence of a problem

Question 36

Corrective Action

Answer 36

Identification and documentation of the root cause of the problem. Investigating thoroughly to ensure no similar problems could occur Action taken according to the severity of the problem

Question 37

Preventative Action

Answer 37

Taking pro-active steps to ensure a potential problem does not occur

Question 38

Risk Analysis

Answer 38

Identify possible risk areas of processes and procedures that could lead to failure