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CLINICAL CHEMISTRY 1 > L1-QUALITY ASSURANCE > Flashcards

L1-QUALITY ASSURANCE Flashcards

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1
Q
  • Ensures that the final results reported by the lab are correct.
A

QUALITY ASSURANCE

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2
Q

-Ensuring accuracy and precision in the lab

A

QUALITY CONTROL

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3
Q

TYPES OF QC
- AKA Internal Quality Control
- analyses of control samples together with patient specimens

A

INTRALAB

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4
Q

TYPES OF QC
- AKA External Quality COntrol
- Involves proficiency testing programs

A

INTERLAB

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5
Q

OBJECTIVES OF QUALITY CONTROL:

A

T - to check the stability of the machine
T - to check the quality of the reagent
T - to check the technical error

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6
Q

TYPES OF QC
- sends out specimen to labs to test, results are sent back and results are compared

A

INTERLAB

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7
Q

Characteristics of an Ideal QC Material:

A
  1. With known analyte concentrations
  2. Inexpensive and stable for long periods
  3. No communicable diseases
  4. No matrix effect
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8
Q

TYPES OF REAGENT
- without any analyte added

A

REAGENT BLANK

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8
Q

QUALITY CONTROL PARAMETERS
- Refers how well the test measures what it is supposed to measure.
- accuracy of the test
- how close the result to its true value

A

VALIDITY

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8
Q

TYPES OF REAGENT
- Most specific analytical solution
- value will tell the CONCENTRATION OF THE UNKNOWN
- ONLY 1 ANALYTE

A

STANDARD REAGENT

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9
Q

QUALITY CONTROL PARAMTERS
- Refers to how well the test performs in use over time.

A

RELIABILITY

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9
Q

TYPES OF REAGENT
- Value will DETERMINE ACCURACY and PRECISION
- MANY ANALYTE

A

CONTROL REAGENT

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9
Q
  • Done on apparently healthy indiv
  • not a basis for treatment
A

SCREENING TEST

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10
Q

Indicating a person does not have the disease when, in fact, he/she does not

A

TRUE NEG

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10
Q
  • Done on sick indiv
  • basis for treatment
A

DIAGNOSTIC TEST

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11
Q

Indicating a person has the
disease when, in fact, he or she
does not

A

FALSE POSITIVE

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11
Q

Indicating a person has the
disease when, in fact, he or she
does

A

TRUE POSITIVE

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12
Q

Indicating a person does not have the disease when, in fact, he or she does

A

FALSE NEG

13
Q
  • Ability of test to detect the smallest amount of analyte
A

SENSITIVITY

14
Q

Ability of test to identify correctly those who have the disease (a) from all individuals with
the disease (a+c)

A

DIAGNOSTIC SENSITIVITY

15
Q

➔ Ability of test to detect substances without interferences

A

SPECIFICITY

16
Q
  • Highest value - lowest value
A

RANGE

16
Q

Ability of the test to identify correctly those who do not have the disease (d) from all individuals free from the disease (b+d)

A

DIAGNOSTIC SPECIFICITY

17
Q

TYPES OF ERROR
- constant when measurements are made under the same conditions
Causes: deterioration of reagents, improperly made standard solutions, contaminated solutions, calibration problems, failing instrumentation

A

SYSTEMATIC ERRORS

17
Q

Measures of dispersion

A

STANDARD DEVIATION AND VARIANCE

18
Q

Index of precision

A

COEFFICIENT OF VARIATION

19
Q

SYSTEMATIC ERRORS CAUSES:

A

deterioration of reagents, improperly made standard solutions, contaminated solutions, calibration problems, failing instrumentation

20
Q

TYPES OF ERRORS
➔ Unpredictable errors; often due to instrument, operator, and environmental conditions
➔ Causes: pipetting error, mislabeling of
samples, temperature fluctuation, improper
mixing of sample and reagent

A

RANDOM ERRORS

21
Q
  • The most commonly used histogram in QC
A

JENNY-JENNINGS CHART

22
Q
  • Results from QC fall within the
    confidence limit
A

IN CONTROL

23
Q
  • The values of the control fall
    outside the confidence limit
A

OUT OF CONTRL

24
Q

Formed by the control that continues to
either increase or decrease for a period of 6 or more consecutive days

A

TREND

25
Q

Formed by the control that distributes
themselves on one side (above or below) of the mean, with no tendency toward either a
consistent fall or rise

A

SHIFT

26
Q
  • Developed by Dr. James O. Westgard
    ➔ Based on statistical concepts which is a
    combination of decision criteria or rules to
    assess if a system is in control
A

WESTGARD MULTIRULE SYSTEM

27
Q

➔ How close the measured value is to the true value due to systematic error, which can be either constant or proportional

A

ACCURACY

28
Q

-AKA LINEAR/DYNAMIC RANGE
- Range of analyte concentrations that can be directly measured without dilution,
concentration, or other pretreatment

A

Analytic Measurement Range

29
Q
  • Ability of a method to detect small quantities
    or small changes in concentrations of an
    analyte
A

ANALYTIC SENSITIVITY

30
Q

➔ AKA Cross-reactivity
➔ Ability of a method to detect only the analyte it is designed to determine

A

ANALYTIC SPECIFICITY

31
Q

➔ Range of analyte that a method can
quantitatively report, allowing for dilution,
concentration, or other pretreatment used to Extend AMR

A

CLINICALLY REPORTABLE RANGE

32
Q

➔ Type of systematic error in the sample
direction and magnitude; the magnitude of
change is constant and not dependent on the amount of analyte

A

CONSTANT ERROR

33
Q
  • Effect of a compound/s on the accuracy of the detection of a particular analyte
A

INTERFERENCE

34
Q

➔ Substances that cause interference

A

INTERFERENTS

35
Q

➔ Lowest amount of analyte accurately detected by a method

A

LIMIT OF DETECTION

36
Q

➔ Lowest amount of analyte that can be
reported while achieving a precision target
(e.g. lowest concentration at which a CV of 10% may be achieved)

A

LIMIT OF QUANTIFICATION

CLINICAL CHEMISTRY 1 (2 decks)

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