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CC - PRELIM
L2
| Question | Answer |
|---|---|
| Involves all three phases of testing | QA |
| Overall program that ensures that the final results reported by the laboratory are correct | QA |
| It is concerned with a l factors that affect the test results from pre-analytic, analytic, and post-analytic phases | QA |
| Part of quality assurance | QC |
| Process of ensuring that analytical results are correct - System of ensuring accuracy and precision in the laboratory | QC |
| Done before actual testing, usually during the night shift in laboratories | QC |
| KINDS OF QUALITY CONTROL | 1. INTRAlab 2. INTERlab |
| KINDS OF QUALITY CONTROL ; o Done everyday o Internal quality control o Important in daily monitoring | Intralab Quality Contro |
| KINDS OF QUALITY CONTROL ; o Analyses of control samples together with patient specimens | Intralab Quality Contro |
| KINDS OF QUALITY CONTROL ; o External quality control o Maintains long-term accuracy of methods | Interlab Quality Control |
| Involves proficiency testing programs that periodically provide samples of unknown concentrations of analytes to participating laboratories (ex: NEQAS) | Interlab Quality Control |
| (NEQAS) | National External Quality Assessment Scheme |
| Proficiency program that sends samples laboratories | National External Quality Assessment Scheme |
| TYPES OF REAGENTS | 1. Blank 2. Standard 3. Control |
| TYPES OF REAGENT ; ○ Reagent without sample ○ Reagent without analyte added | blank |
| TYPES OF REAGENT ; substances that can be tested for | analyte |
| TYPES OF REAGENT; ○ Reagents with only one analyte ○ Most specific analytical solution | standard |
| TYPES OF REAGENT; ○ Its value will tell the concentration of the unknown ○ Only run when a specific standard is not running correctly | standard |
| TYPES OF REAGENT; ○ Run everyday ○ Reagent with many analytes ○ Resembles patient sample | Control |
| Control type of reagent has 3 types ... | 1. Commercially Prepared 2. Non-commercially prepared 3. Pooled px sample |
| Commercially prepared ex: | Manufactured by a company |
| Non-commercially prepared ex: | 1) Leftover sera (hemolyzed) 2) Animal blood (cow blood) 3) Expired blood bank plasma 4) Fasting human donor |
| Pooled px sample | Different specimens mixed together |
| REAGENT BOX Includes the following: | a) Specific standard b) Package insert c) Actual reagent d) Standard reagent |
| QC PARAMETERS | 1. Validity 2. Reliability 3. Sensitivity 4. Specificity |
| QC PARAMETER; ○ Accuracy of the test ○ How close the result is to its true value | Validity |
| QC PARAMETER; ○ Refers to how well the test measures what it is supposed to measure ○ Theability to distinguish which individuals have the disease and which do not | Validity |
| QC PARAMETER; ○ AKA: Repeatability, Reproducibility ○ Precision of the test | Reliability |
| QC PARAMETER; ○ How close the values are to one another ○ Refers to how wel the test performs in use over time | Reliability |
| QC PARAMETER; The ability of the test to detect the smallest amount of analyte | Sensitivity |
| refers to the ability of the test to identify correctly those who have the disease from al individuals with the disease | Diagnostic Sensitivity |
| Diagnostic Sensitivity FORMULA | - |
| QC PARAMETER; THE ability of the test to detect substances without interference | Specificity |
| Specificity FORMULA | - |
| refers to the ability of the test to identify correctly those who do not have the disease from al individuals free from the disease | Diagnostic Specificity |
| leads to needed care & treatment | TP |
| ideal result/situation | TN |
| causes unnecessary treatment | FP |
| causes false sense of security | FN |
| TYPES OFERRORS | 1. Systematic 2. Random |
| - Predictable errors | Systematic |
| An error that is constant when measurements are made under the same conditions | Systematic |
| Systematic Error causes? | Deterioration of reagents Improperly made standard solutions Contaminated solutions Calibration problems Failing instrumentations |
| Unpredictable Errors | Random Error |
| Often due to instrument, operator, and environmental conditions | Random Error |
| Random Error causes? | Pipetting error Mislabelling of samples Temperature fluctuation Improper mixing of sample and reagent |
| Quality control chart Most commonly used histogram in quality control | LEVEY-JENNINGS CHART |
| sheets of rectangular coordinate graphing paper where data for sequential analysis are plotted to locate the source of error | Histogram |
| The results of the control fall WITHIN confidence limit | In CONTROL |
| The values of the control fall OUTSIDE the confidence limit | OUT of CONTROL |
| Gradual change - Formed by the control that continue to either increase or decrease for a period of SIX or more consecutive days | TREND |
| Abrupt change in ONE SIDE of the mean With no tendency toward either a consistent fall or rise Formed by the control that distribute themselves on ONE SIDE (above or below) the mean | SHIFT |
| Caused by WILD errors Values which are far from the main set of values | OUTLIERS |
| WESGUARD MULTIRULE SYSTEM is 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 | WESGUARD MULTIRULE SYSTEM |