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Quality Control
63問 • 5ヶ月前
  • Almira Coleen
  • 通報

    問題一覧

  • 1

    Quality Control

    System of ensuring accuracy and precision in the laboratory by including QC reagents in every series of measurement

  • 2

    System of ensuring accuracy and precision in the laboratory by including QC reagents in every series of measurement

    Quality Control

  • 3

    Quality Control is to ensure analytical results that are corect by testing ___________ that resemble patient samples

    Known samples

  • 4

    Quality Control involves monitoring of ___________ and detecting _________ during testing to prevent inaccurate patient test reports

    Analytical Process , Analytical Errors

  • 5

    Quality Control

    System of ensuring accuracy and precision in the laboratory by including QC reagents in every series of measurement, Ensure analytical results are correct by testing known samples that resemble patient samples, Involves monitoring of analytical processes and detecting analytical errors during testing to prevent inaccurate patient test reports

  • 6

    Parameters of Quality Control

    Sensitivity , Specificity , Accuracy , Precision , Practicability , Reliability , Diagnostic Sensitivity , Diagnostic Specificity

  • 7

    Ability of an analytical method to measure the smallest concentration of the analyte

    Sensitivity

  • 8

    Ability of an analytical method to measure only the analyte of interest

    Specificity

  • 9

    Nearness or closeness of the assayed value to the true/target value

    Accuracy

  • 10

    Detailed or how much of the analyte can be identified in the sample

    Recovery

  • 11

    Detailed. If specific compounds affect the laboratory tests

    Interference

  • 12

    Assess inaccuracy (error) in patient sample

    Sample Comparison

  • 13

    Accuracy testing:

    Recovery , Interference , Sample Comparison

  • 14

    Ability of an analytical method to give repeated results on same sample that agree with one another (Reproducibility)

    Precision

  • 15

    Degree by which a method is easily repeated

    Practicability

  • 16

    Ability of an analytical method to maintain accuracy and precision over an extended period of time

    Reliability

  • 17

    Ability of an analytical method to detect the proportion of individuals with the disease

    Diagnostic Sensitivity

  • 18

    Generate more True-Positives and few False-Negatives

    Diagnostic Sensitivity

  • 19

    For Screening tests

    Diagnostic Sensitivity

  • 20

    Ability of the analytical method to detect the proportion of individuals without the disease

    Diagnostic Specificity

  • 21

    Detect True-Negatives and very few False-Positives

    Diagnostic Specificity

  • 22

    For Confirmatory tests

    Diagnostic Specificity

  • 23

    Sensitivity

    Ability of an analytical method to measure the smallest concentration of the analyte

  • 24

    Specificity

    Ability of an analytical method to measure only the analyte of interest

  • 25

    Accuracy

    Nearness or closeness of the assayed value to the true/target value

  • 26

    Recovery

    Detailed how much of the analyte can be identified in the sample

  • 27

    Interference

    detailed if specific compounds affect the laboratory tests

  • 28

    Sample Comparison

    Assess inaccuracy (error) in patient sample

  • 29

    Precision

    Ability of an analytical method to give repeated results on same sample that agree with one another (Reproducibility)

  • 30

    Practicability

    Degree by which a method is easily repeated

  • 31

    Reliability

    Ability of an analytical method to maintain accuracy and precision over an extended period of time

  • 32

    Diagnostic Sensitivity

    Ability of an analytical method to detect the proportion of individuals with the disease

  • 33

    Diagnostic Sensitivity

    Generate more True-Positives and few False-Negatives

  • 34

    Diagnostic Sensitivity

    For Screening tests

  • 35

    Diagnostic Specificity

    Ability of the analytical method to detect the proportion of individuals without the disease

  • 36

    Diagnostic Specificity

    Detect True-Negatives and very few False-Positives

  • 37

    Diagnostic Specificity

    For Confirmatory tests

  • 38

    Kinds of Quality Control

    Intra lab (Internal QC), Interlab (External QC)

  • 39

    Analyses of control samples together with patient specimen

    Intralab (Internal QC)

  • 40

    Involves Proficiency testing programs that periodically provide samples of unknown concentrations to participating clinical labs

    Interlab (External QC)

  • 41

    Detects changes in performance and operation

    Intralab (Internal QC)

  • 42

    For long-term maintenance of accuracy

    Interlab (External QC)

  • 43

    For daily monitoring of accuracy and precision of methods

    Intralab (Internal QC)

  • 44

    Determine state-of-the-art interlaboratory performance

    Interlab (External QC)

  • 45

    Interlab Gold Standard:

    College of American Pathologists

  • 46

    Intralab (Internal QC)

    Analyses of control samples together with patient specimen, Detects changes in performance and operation, For daily monitoring of accuracy and precision of methods, Detects random and systematic errors on a daily basis and one-week cycle

  • 47

    Interlab (External QC)

    Involves Proficiency testing programs that periodically provide samples of unknown concentrations to participating clinical labs, For long-term maintenance of accuracy , Determine state-of-the-art interlaboratory performance, Gold Standard: College of American Pathologists (CAP)

  • 48

    EQA Provider:

    Validation, preparation and distribution of sample and mock clinical cases , Assessment of the results by a team of assessors , General report and individual comments + certificate if successful

  • 49

    Laboratory:

    Analysis , Test results (+written diagnostic reports), Discussion with the laboratory

  • 50

    External Quality Control:

    Validation, preparation and distribution of samples and mock clinical cases > Analysis > Test results (+ written diagnostic reports) > Assessment of the results by a team of assessors > General report and individual comments + certificate if successful > Discussion with the laboratory

  • 51

    Ultimate goal: Ensure that patient results are accurate and reliable

    Proficiency Test Program

  • 52

    Proficiency Test Program Ultimate Goal:

    Ensure that patient results are accurate and reliable

  • 53

    Allows laboratory to compare and evaluate test results with other labs that use the same methods, reagents and equipment

    Proficiency Test Program

  • 54

    Proficiency Test Program: To ___________, investigate _________ and _________ guide

    improve test performance , analytical error , troubleshooting

  • 55

    Objectives of Quality Control: To check

    Stability of the equipment, Quality of reagents, Technical/Operator errors

  • 56

    QC Materials/Solutions: General chemistry use ________ of control solutions

    2 levels

  • 57

    QC <Materials/Solutions: New instrument and/or new reagent lot = analyte QC material for ________

    20 consecutive days

  • 58

    QC Materials/Solutions should:

    Observe proper reconstitution and stability

  • 59

    Characteristics of an Ideal QC Material:

    Resemble human sample - human/bovine , Inexpensive , Stable for long periods , No communicable diseases , No matrix effects , With known analyte concentrations (assayed) , Convenient packaging for easy dispensing and storage

  • 60

    Expected values or acceptable values with upper and lower limits

    Control Limits (Control Values)

  • 61

    Control Limits is calculated from the:

    Mean and SD

  • 62

    Ideal control limit = between

    +/- 2SD

  • 63

    New reagent lot number:

    Use newly calculated mean and limit

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    問題一覧

  • 1

    Quality Control

    System of ensuring accuracy and precision in the laboratory by including QC reagents in every series of measurement

  • 2

    System of ensuring accuracy and precision in the laboratory by including QC reagents in every series of measurement

    Quality Control

  • 3

    Quality Control is to ensure analytical results that are corect by testing ___________ that resemble patient samples

    Known samples

  • 4

    Quality Control involves monitoring of ___________ and detecting _________ during testing to prevent inaccurate patient test reports

    Analytical Process , Analytical Errors

  • 5

    Quality Control

    System of ensuring accuracy and precision in the laboratory by including QC reagents in every series of measurement, Ensure analytical results are correct by testing known samples that resemble patient samples, Involves monitoring of analytical processes and detecting analytical errors during testing to prevent inaccurate patient test reports

  • 6

    Parameters of Quality Control

    Sensitivity , Specificity , Accuracy , Precision , Practicability , Reliability , Diagnostic Sensitivity , Diagnostic Specificity

  • 7

    Ability of an analytical method to measure the smallest concentration of the analyte

    Sensitivity

  • 8

    Ability of an analytical method to measure only the analyte of interest

    Specificity

  • 9

    Nearness or closeness of the assayed value to the true/target value

    Accuracy

  • 10

    Detailed or how much of the analyte can be identified in the sample

    Recovery

  • 11

    Detailed. If specific compounds affect the laboratory tests

    Interference

  • 12

    Assess inaccuracy (error) in patient sample

    Sample Comparison

  • 13

    Accuracy testing:

    Recovery , Interference , Sample Comparison

  • 14

    Ability of an analytical method to give repeated results on same sample that agree with one another (Reproducibility)

    Precision

  • 15

    Degree by which a method is easily repeated

    Practicability

  • 16

    Ability of an analytical method to maintain accuracy and precision over an extended period of time

    Reliability

  • 17

    Ability of an analytical method to detect the proportion of individuals with the disease

    Diagnostic Sensitivity

  • 18

    Generate more True-Positives and few False-Negatives

    Diagnostic Sensitivity

  • 19

    For Screening tests

    Diagnostic Sensitivity

  • 20

    Ability of the analytical method to detect the proportion of individuals without the disease

    Diagnostic Specificity

  • 21

    Detect True-Negatives and very few False-Positives

    Diagnostic Specificity

  • 22

    For Confirmatory tests

    Diagnostic Specificity

  • 23

    Sensitivity

    Ability of an analytical method to measure the smallest concentration of the analyte

  • 24

    Specificity

    Ability of an analytical method to measure only the analyte of interest

  • 25

    Accuracy

    Nearness or closeness of the assayed value to the true/target value

  • 26

    Recovery

    Detailed how much of the analyte can be identified in the sample

  • 27

    Interference

    detailed if specific compounds affect the laboratory tests

  • 28

    Sample Comparison

    Assess inaccuracy (error) in patient sample

  • 29

    Precision

    Ability of an analytical method to give repeated results on same sample that agree with one another (Reproducibility)

  • 30

    Practicability

    Degree by which a method is easily repeated

  • 31

    Reliability

    Ability of an analytical method to maintain accuracy and precision over an extended period of time

  • 32

    Diagnostic Sensitivity

    Ability of an analytical method to detect the proportion of individuals with the disease

  • 33

    Diagnostic Sensitivity

    Generate more True-Positives and few False-Negatives

  • 34

    Diagnostic Sensitivity

    For Screening tests

  • 35

    Diagnostic Specificity

    Ability of the analytical method to detect the proportion of individuals without the disease

  • 36

    Diagnostic Specificity

    Detect True-Negatives and very few False-Positives

  • 37

    Diagnostic Specificity

    For Confirmatory tests

  • 38

    Kinds of Quality Control

    Intra lab (Internal QC), Interlab (External QC)

  • 39

    Analyses of control samples together with patient specimen

    Intralab (Internal QC)

  • 40

    Involves Proficiency testing programs that periodically provide samples of unknown concentrations to participating clinical labs

    Interlab (External QC)

  • 41

    Detects changes in performance and operation

    Intralab (Internal QC)

  • 42

    For long-term maintenance of accuracy

    Interlab (External QC)

  • 43

    For daily monitoring of accuracy and precision of methods

    Intralab (Internal QC)

  • 44

    Determine state-of-the-art interlaboratory performance

    Interlab (External QC)

  • 45

    Interlab Gold Standard:

    College of American Pathologists

  • 46

    Intralab (Internal QC)

    Analyses of control samples together with patient specimen, Detects changes in performance and operation, For daily monitoring of accuracy and precision of methods, Detects random and systematic errors on a daily basis and one-week cycle

  • 47

    Interlab (External QC)

    Involves Proficiency testing programs that periodically provide samples of unknown concentrations to participating clinical labs, For long-term maintenance of accuracy , Determine state-of-the-art interlaboratory performance, Gold Standard: College of American Pathologists (CAP)

  • 48

    EQA Provider:

    Validation, preparation and distribution of sample and mock clinical cases , Assessment of the results by a team of assessors , General report and individual comments + certificate if successful

  • 49

    Laboratory:

    Analysis , Test results (+written diagnostic reports), Discussion with the laboratory

  • 50

    External Quality Control:

    Validation, preparation and distribution of samples and mock clinical cases > Analysis > Test results (+ written diagnostic reports) > Assessment of the results by a team of assessors > General report and individual comments + certificate if successful > Discussion with the laboratory

  • 51

    Ultimate goal: Ensure that patient results are accurate and reliable

    Proficiency Test Program

  • 52

    Proficiency Test Program Ultimate Goal:

    Ensure that patient results are accurate and reliable

  • 53

    Allows laboratory to compare and evaluate test results with other labs that use the same methods, reagents and equipment

    Proficiency Test Program

  • 54

    Proficiency Test Program: To ___________, investigate _________ and _________ guide

    improve test performance , analytical error , troubleshooting

  • 55

    Objectives of Quality Control: To check

    Stability of the equipment, Quality of reagents, Technical/Operator errors

  • 56

    QC Materials/Solutions: General chemistry use ________ of control solutions

    2 levels

  • 57

    QC <Materials/Solutions: New instrument and/or new reagent lot = analyte QC material for ________

    20 consecutive days

  • 58

    QC Materials/Solutions should:

    Observe proper reconstitution and stability

  • 59

    Characteristics of an Ideal QC Material:

    Resemble human sample - human/bovine , Inexpensive , Stable for long periods , No communicable diseases , No matrix effects , With known analyte concentrations (assayed) , Convenient packaging for easy dispensing and storage

  • 60

    Expected values or acceptable values with upper and lower limits

    Control Limits (Control Values)

  • 61

    Control Limits is calculated from the:

    Mean and SD

  • 62

    Ideal control limit = between

    +/- 2SD

  • 63

    New reagent lot number:

    Use newly calculated mean and limit