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

QA AND QC Flashcards

(73 cards)

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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
effect of a compound on the accuracy of detection of a particular analyte
Interference
26
substance that cause interference.
Interferent
27
Study will show whether the method is able to accurately measure and detect the analyte
Recovery study
28
Study will determine if specific compounds affect determination analyte concentration
Interference study
29
it is used to estimate systemic error in actual patient samples.
Comparative study
30
It is the ability of an analytical method to give repeated results on the same sample that agree with one another
Precision or reproducibility
31
It is the degree by which a method is easily repeated.
Practicability
32
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.
Reliability
33
ability of the analytical method to detect the proportion of individuals with the disease.
Diagnostic sensitivity
34
It indicates the ability of the test to generate more true-positive results and few false- negative.
Diagnostic sensitivity
35
Test used in diagnostic sensitivity require high sensitivity so that no case is missed.
Screening test
36
ability of the analytical method to detect the proportion of individuals without the disease.
Diagnostic specificity
37
It reflects the ability of the method to detect true-negatives with very few false- positives.
Diagnostic specificity
38
Test used in diagnostic specificity require high specificity to be certain of the diagnosis.
Confirmatory testing
39
The likelihood/probability of the test
Predictive value
40
the percentage of people with positive test results who have the disease
Positive predictive value
41
the percentage of people with negative test results who do not have the disease
Negative predictive value
42
- 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.
Intralab quality control (internal qc)
43
• 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.
Interlab quality control (external QC)
44
Gold standard aka
Confidence limit
45
Objectives of Quality Control:
1. To check the stability of the machine. 2. To check the quality of reagents. 3. To check technical (operator) errors.
46
General chemistry assays used 2 levels of control solutions
Normal control and abnormal control
47
immunoassays used 3 levels
Normal High Low
48
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
20 day
49
For highly précised assays (with CV less than 1%) such as blood gases, analysis for _____ day
5 day
50
Are errors encountered in the collection, preparation and measurement of samples, including transcription and releasing of laboratory results.
Variations
51
It is present in all measurements; it is due to chance.
Random error
52
It is an error that influences observations consistently in one direction (constant difference).
Systemic errors
53
it refers to a difference between the target value and the assayed value
Constant error
54
it results in greater deviation from the target value due to higher sample concentration.
Proportional/percent/ slope error
55
It is the highest frequency of clerical errors occurs wit the use of handwritten labels and request forms.
Clerical error
56
It is based on the quantity of error that will negatively affect clinical decisions.
Allowable error (E.)
57
Replication study
Random error
58
Recovery study
Proportional study
59
Interference study
Constant study
60
Comparison of methods
Systemic study
61
Replication and comparison
Total error
62
is the combination of Six Sigma methodology and Lean principles.
Lean Six Sigma
63
The Six Sigma business management strategy developed by
Motorola Inc. 1980s
64
seeks to improve the performance of a process by identifying and eliminating causes of defects and errors, resulting in eliminating variation in the process.
Lean six sigma
65
to eliminate the waste, such as streamlining a process to reduce wait times or modifying a process to reduce cost
Lean principle
66
they are being increasingly used to reduce error (Six Sigma) and waste (Lean) within the health care system.
LSS (lean six sigma)
67
Examples of six sigma projects included in our laboratory organization have included
Reducing billing error in lab Reducing blood waste in BB
68
Lean used to measure
5S (set, sort, shine, standardize, sustain) Or 6S (safety)
69
Six sigma used to measure
DMAIC ( define, measure, analyze, improve, & control)
70
Seek to quantitatively measure the amount of error or variation that occurs within a system
Six sigma metrics
71
ACCURACY: ATM means
Accuracy is T test comparing mean
72
PRECISION: SPF means
Precision is F test comparing standard deviation
73
Six sigma metrics used to measure
Defects (errors) per million opportunities (DPMO).

AARALIN FOR PRACTICAL CC WEEK 8 (3 decks)

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