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49 Cards in this Set
- Front
- Back
Overall process that encompassesmethod, quality assurance, benchmarking and other aspects that provide for quality improvement as a means to meet set standard |
Quality Management |
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This is used to verify the acceptability of new methods prior to reporting patient results |
Method Evaluation |
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Once a method has been implemented, it is essential that the laboratory ensures it remains valid over time, this is achieved by what process? |
Quality Control |
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All concepts fall under this umbrella where the entire testing process is directed with the overall goal improving the accuracy of laboratory results. |
Quality Management |
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This includes maneuvers encountered in the pre-analytic, analytic, and post-analytic phases of testing |
Quality Assurance |
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This is part of analytical phase |
Quality Control |
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It is a system of ensuring accuracy and precision |
Quality Control |
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It is a process that monitors the characteristic of analytical processes and detects analytical errors during testing |
Quality Control |
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What are the objectives of Quality Control? |
To check the; • stability of the machine • quality of the reagents • technical errors |
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What are the kinds of Quality Control? |
• Intralaboratory • Interlaboratory |
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It an internal quality control, involves analyses of control samples together with the patient's specimen |
Intralaboratory Quality Control |
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It is important for daily monitoring of accuracy and precision of analytical methods, and detects both random and systematic error |
Intralaboratory Quality Control |
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It refers to external quality control, that involves proficiency testing program |
Interlaboratory Quality Control |
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It maintains long-term accuracy, with a difference of >2 in the results indicate non-agreement |
Interlaboratory Quality Control |
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Characteristics of ideal QC Materials |
• Resembles human sample • Inexpensive and stable for long periods • No communicable diseases • No known matrix effect • With known analyte concentration • Convenient packaging for easy dispensing and storage |
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In analytical variations, what are the types of error in laboratory testing? |
• Random Error • Systematic Error • Clerical Error |
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It is present in all measurements due to chance or an unpredictable cause |
Random Error |
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It refers to pipetting error, mislabeling, temperature, fluctuation, improper mixing of sample and reagent |
Random Error |
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It influences observations consistently in one direction |
Systematic Error |
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It refers to calibration error, deterioration of reagents, unstable reagent blanks, contaminated solutions, failing instrumentations, changes in standard concentration |
Systematic Error |
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It refers to the highest frequency is due to handwritten labels and request forms |
Clerical Error |
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is most commonly used histogram in Quality Control, it allows the laboratory to apply multiple rules and detect errors even without the aid of the computer |
Shewhart Levey-Jennings Chart |
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It is used to identify analytical errors |
Westgard Control Rules |
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This rule refers to one control value exceeds 2SD; Warning rule; RE |
12S Rule |
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This rule refers to one control value exceeds 3SD; Reject; Random Error |
13S Rule |
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This rule refers to two consecutive control values exceed 2SD; reject; Systemstic Error |
22S Rule |
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This rule refers to the range of difference between the last 2 control values exceeds 4SD |
R4S Rule |
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This rule refers to four consecutive control values exceed 1SD; Reject; Systematic Error |
41S |
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This rule refers to ten consecutive control value are on the same side of the mean: Reject: Systematic Error |
10x |
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What are the patterns in QC charts that indicate errors |
• Shift • Trend • Outliers |
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It is formed by control values that distribute themselves on one side or either side of the mean for 6 consecutive days. |
SHIFT |
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SHIFT usually indicates what error? |
CALIBRATION ERROR |
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It is formed by control values that continue to increase or decrease over a period of 6 consecutive days passing through the mean |
TREND |
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TREND usually indicate what error? |
DETERIORATION OF REAGENT |
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It is highly deviating control values caused by random systemic errors, almost the same value or range together with other data |
OUTLIER |
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It refers to the closeness of the result to the true or actual value |
ACCURACY |
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It is the ability to produce a series of results that agree closely with each other. It is commonly expressed in terms of coefficient of variation |
Precision |
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The precision is also called |
REPRODUCIBILITY |
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It involves the analysis of at least 2 levels of control every 24 hours for 20 days, important for the daily monitoring of accuracy and precision of analytical methods |
INTERNAL/INTRALABORATORY QC |
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It is an algorithm in which a current laboratory results in compared with results obtained on a previous specimen from the same patient |
DELTA CHECK |
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It involves testing samples of unknown concentration of analytes sent periodically by regulatory agencies to participating laboratories |
EXTERNAL/INTERLABORATORY QC - PROFICIENCY TESTING |
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Is is the ability of analytical methods to measure the smallest concentration of analytes on interest |
Sensitivity |
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It is the ability of an analytical method to measure only the analyte of interest |
Specificity |
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It is the degree by which a method is easily repeated |
Practicability |
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It is an ability of an analytical method to maintain accuracy and precision over an extended period of time |
Reliability |
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It is the ability to detect the proportion of individuals with a disease who tested positively wih the test |
Diagnostic Sensitivity |
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Ability of the test to detect proportion of individuals without the disease whontest negatively for the disease |
Diagnostic Specificity |
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Ability if a method to detect the smallest concentration of a given analyte |
Analytic Sensitivity |
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Ability of a method to detect only the analyte it is designed to determine |
Analytic Specificity |