QUALITY CONTROL Flashcards

(49 cards)

1
Q

Is a system of ensuring accuracy & precision in the laboratory by including quality control reagents in every series of measurements

A

Quality Control

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2
Q

is a systematic action necessary to provide adequate confidence that laboratory services will satisfy the given medical needs for patient care

A

Quality Assurance

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3
Q

material of known concentration used in developing a standard curve and/or instrument calibration

A

Standard

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4
Q

sample of known quantity with several analytes present

A

Control

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5
Q

2 Types of Quality Control

A
  1. Interlab QC

2. Intralab QC

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6
Q

2 Levels of control solutions in General Chemistry

A
  1. Pathologic

2. Non-Pathologic

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7
Q

QC done within the Laboratory

A

Intralab Quality Control

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8
Q

Maintaining long term quality control

Involves proficiency testing programs that periodically provide samples of unknown concentrations to participating clinical laboratories

Determine state-of-the-art of the analytical methods

A

Interlab quality control

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9
Q

Internal QC

A

Intralab Quality Control

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10
Q

External QC

A

Interlab quality control

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11
Q

Gold standard for clinical laboratory external QC testing

A

College of American Pathologists (CAP)

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12
Q

Intralab QC Is done every ______

A

Everyday

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13
Q

Immuno Assays QC Level

A
  1. Low QC
  2. Normal QC
  3. HIgh QC
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14
Q

Ability of an analytical method to measure the smallest concentration

A

Sensitivity

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15
Q

Is the Ability of an analytical method to measure ONLY the analyte of Interest

A

Specificty

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16
Q

Is the Nearness or Closeness of the Assayed value to the true or target value

A

Accuracy

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17
Q

The ability of an analytical method to give repeated results on the same sample that agree with one another

A

Precision

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18
Q

The degree by w/c a method is easily repeated.

A

Practicability

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19
Q

The ability of an analytical method to maintain accuracy & precision over an extended period of time during w/c equipment, reagents, & personnel may change

A

Reliability

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20
Q

Other name for precision

A

Reproducibility

21
Q

The Ability of an analytical method to detect the proportion of individuals with the disease. (Screening tests require high sensitivity)

A

Diagnostic Sensitivity

22
Q

The Ability of an analytical method to detect the proportion of individuals without the disease. (Confirmatory tests require high specificity)

A

Diagnostic Specificity

23
Q

highest frequency occurs with the use of handwritten labels and request forms

A

Clerical Error

24
Q

Random Error Vs. Systematic Error

A

Random Error>Varies from sample to sample
>Present in all measurement
>Due to chance

Systematic Error> Error that influences observations consistently in one directions

25
Example of random error
>Pipetting error >Mislabeling of samples >Temperature fluctuations >Improper mixing of sample and reagent
26
Example of Systematic error
``` >Calibration problems >Deterioration of reagents and control materials >Improper made of standard solutions >Contaminated Solutions >Unstable and inadequate reagent blanks ```
27
measure of central tendency; measure of accuracy; AVERAGE
Mean
28
measure of dispersion of values from the mean; measure of precision; most frequently used measure of variation
Standard deviation
29
index of precision; percentile expression of the mean
Coefficient variation
30
measure of variability
Variance
31
determines whether there is a statistically significant difference between the standard deviations of two groups of data
F-Test
32
determines whether there is a statistically significant difference between the means of two groups of data
T-Test
33
MIDPOINT of the distribution; value of the observation that divides the observation into two equal groups of data
Median
34
most FREQUENT observation
Mode
35
is the difference between the | highest and lowest score in data
Range
36
data element are centered around the mean with most elements close to the mean
Gaussian Curve
37
provides the earliest indication of systematic error (trend); requires computer implementation
Cumulative Sum Graph
38
compare results obtained on | a high and low control serum from different laboratories
Youden/Twin Plot
39
most widely used QC chart in the clinical laboratory; allows laboratorians to apply multiple rules without the aid of computer; identifies both random and systematic error
Shewhart Levey-Jennings Chart
40
Trend Vs. Shift
TREND>Main cause: deterioration of reagents >Control values either increase or decrease for six consecutive days SHIFT> Main caused:Improper calibration > Control values that distribute themselves on one side or either side of the mean for six consecutive days
41
Westgard Rule Random Error
12s 1 3s R 4s
42
Westgard rule Systematic errors
2 2s 4 1s 10x rule
43
1 control value exceeds +/- 2SD; rejection or warning rule
1 2s
44
1 control value exceeds +/- 3SD
1 3s
45
Range/difference etween the highest and lowest control result within an analytical run is 4SD
R 4s
46
2 consecutive control values exceed either +/-2SD
2 2s
47
4 consecutive control values exceed +/-1SD
4 1s
48
10 consecutive control values fall on 1 side or the other side of the mean
10x Rule
49
Interlab qc proficiency testing is done every______
6 months