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AARALIN FOR PRACTICAL CC WEEK 8 > QA AND QC > Flashcards

QA AND QC Flashcards

1
Q

medical laboratory requires quality in all steps

A

Quality management system

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2
Q

Quality management systems: Laboratory functions that require quality practices include

A

Environment
Quality procedures
Record keeping
Expert human resource
Quality reagents
Quality equipment and instruments

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3
Q

standardized procedure and
practice contributing to the overall quality
of laboratory test results.

A

Laboratory quality management system

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4
Q

According to ________, the quality of a testing
result does not depend on a single step. But
instead, it requires quality in individual
processes, resources, and overall
organizational structure.

A

LQMS (laboratory quality management system)

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5
Q

is an international standard that
specifies the requirements for quality and
competence in medical laboratories

A

ISO 15189: 2022

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6
Q

This standard guides the development of the
laboratory’s quality management system, technical
solutions, and administrative sections that are the main
factor for a laboratory’s functioning.

A

ISO 15189: 2022

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7
Q

focused on providing confidence
that quality requirements will be fulfilled

A

Quality assurance

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8
Q

ensuring that a specified quality of product is
achieved and maintained.

A

Quality assurance

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9
Q

Important component in the operation of
the clinical laboratory

A

Quality control

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10
Q

Involves systematic monitoring of analytic
processes to detect analytic errors and to
prevent reporting of inaccurate test results

A

Quality control

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11
Q

It is a system of ensuring accuracy and precision in the laboratory by including quality control
reagents in every series of measurements

A

Quality control

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12
Q

It is a process of ensuring that analytical results
are correct by testing known samples that resemble patient samples

A

Quality control

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13
Q

QA IS

A

Proactive
Process oriented
Training
Documentation
Full team
Audit
Creation

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14
Q

QC IS

A

Lab testing
Product oriented
Inspection
Verification
Reactive
Evaluate feedback
Reports

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15
Q

QA & QC

A

Release high quality product
Improve processes procedures
Gain trust of customer
Reduce costs
Find issues before major problems

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16
Q

It is the ability of an analytical method to measure the smallest concentration of the analyte of interest.

A

Sensitivity

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17
Q

It is the ability of an analytical
method to measure only the analyte of interest.

A

Specificity

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18
Q

It is the nearness or closeness of the assayed value to the true or target value

A

Accuracy

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19
Q

3 types of studies: accuracy

A

Recovery, interference, patient sample comparison

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20
Q

determines how much of the analyte can be identified in the sample;

A

Recovery study

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21
Q

determines if specific compounds affect the laboratory tests like hemolysis, turbidity and icteric

A

Interference study

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22
Q

study is used to assess presence of error (inaccuracy) in actual patient sample

A

Sample comparison study

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23
Q

ability of an analytic test to measure a known amount of analyte; a
known amount of analyte is added to real sample matrices

A

Recovery

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24
Q

body component (eg. Fluid, urine etc.) in which the analyte is to be measured

A

Matrix

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25
Q

effect of a compound on the accuracy of detection of a particular analyte

A

Interference

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26
Q

substance that cause interference.

A

Interferent

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27
Q

Study will show whether the method is able to accurately measure
and detect the analyte

A

Recovery study

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28
Q

Study will determine if specific compounds affect determination analyte concentration

A

Interference study

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29
Q

it is used to estimate systemic error in actual patient samples.

A

Comparative study

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30
Q

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

A

Precision or reproducibility

31
Q

It is the degree by which a
method is easily repeated.

A

Practicability

32
Q

It is the ability of an analytical method to maintain accuracy and precision over an extended period of time during which equipment, reagents and personnel may change.

A

Reliability

33
Q

ability of the analytical method to
detect the proportion of individuals with
the disease.

A

Diagnostic sensitivity

34
Q

It indicates the ability of the test to generate
more true-positive results and few false-
negative.

A

Diagnostic sensitivity

35
Q

Test used in diagnostic sensitivity require high sensitivity so
that no case is missed.

A

Screening test

36
Q

ability of the analytical method
to detect the proportion of individuals
without the disease.

A

Diagnostic specificity

37
Q

It reflects the ability of the method to
detect true-negatives with very few false-
positives.

A

Diagnostic specificity

38
Q

Test used in diagnostic specificity require high
specificity to be certain of the diagnosis.

A

Confirmatory testing

39
Q

The likelihood/probability of the test

A

Predictive value

40
Q

the percentage of people with
positive test results who have the disease

A

Positive predictive value

41
Q

the percentage of people with
negative test results who do not have the disease

A

Negative predictive value

42
Q
  • It involves the analyses of control samples together with the patient specimens.
  • It detects changes in performance between the present operation and the “stable” operation.
  • It is important for the daily monitoring of accuracy and precision of analytical methods.
    -It detects both random and systematic errors in a
    daily basis.
  • It allows identification of analytic errors within a
    one-week cycle.
A

Intralab quality control (internal qc)

43
Q

• It involves proficiency testing programs
that periodically provide samples of
unknown concentrations to participating
clinical laboratories.
• It is important in maintaining long-term
accuracy of the analytical methods.
• It is also used to determine state-of-the-art
interlaboratory performance.

A

Interlab quality control (external QC)

44
Q

Gold standard aka

A

Confidence limit

45
Q

Objectives of Quality Control:

A
  1. To check the stability of the machine.
  2. To check the quality of reagents.
  3. To check technical (operator) errors.
46
Q

General chemistry assays used 2 levels of control solutions

A

Normal control and abnormal control

47
Q

immunoassays used 3 levels

A

Normal
High
Low

48
Q

statistical quality control on a new instrument or on new lot numbers of control materials,
the different levels of control material must be
analyzed for ____ day

A

20 day

49
Q

For highly précised assays (with CV less than 1%) such as blood gases, analysis for _____ day

A

5 day

50
Q

Are errors encountered in the collection,
preparation and measurement of samples,
including transcription and releasing of
laboratory results.

A

Variations

51
Q

It is present in all measurements; it
is due to chance.

A

Random error

52
Q

It is an error that influences observations consistently in one
direction (constant difference).

A

Systemic errors

53
Q

it refers to a difference between the target value and the assayed value

A

Constant error

54
Q

it results in greater deviation from the target value due to higher sample concentration.

A

Proportional/percent/ slope error

55
Q

It is the highest frequency of clerical errors occurs wit the use of handwritten labels and request forms.

A

Clerical error

56
Q

It is based on the quantity of error that will negatively affect
clinical decisions.

A

Allowable error (E.)

57
Q

Replication study

A

Random error

58
Q

Recovery study

A

Proportional study

59
Q

Interference study

A

Constant study

60
Q

Comparison of methods

A

Systemic study

61
Q

Replication and comparison

A

Total error

62
Q

is the combination of Six Sigma
methodology and Lean principles.

A

Lean Six Sigma

63
Q

The Six Sigma business management strategy
developed by

A

Motorola Inc. 1980s

64
Q

seeks to improve the performance of
a process by identifying and eliminating
causes of defects and errors, resulting in
eliminating variation in the process.

A

Lean six sigma

65
Q

to eliminate the waste,
such as streamlining a process to reduce wait times
or modifying a process to reduce cost

A

Lean principle

66
Q

they are being increasingly used to reduce
error (Six Sigma) and waste (Lean) within the
health care system.

A

LSS (lean six sigma)

67
Q

Examples of six sigma projects included in our laboratory organization have included

A

Reducing billing error in lab
Reducing blood waste in BB

68
Q

Lean used to measure

A

5S (set, sort, shine, standardize, sustain)
Or 6S (safety)

69
Q

Six sigma used to measure

A

DMAIC ( define, measure, analyze, improve, & control)

70
Q

Seek to quantitatively measure the amount of error or variation that occurs within a system

A

Six sigma metrics

71
Q

ACCURACY: ATM means

A

Accuracy is T test comparing mean

72
Q

PRECISION: SPF means

A

Precision is F test comparing standard deviation

73
Q

Six sigma metrics used to measure

A

Defects (errors) per million opportunities (DPMO).

AARALIN FOR PRACTICAL CC WEEK 8 (3 decks)

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