QUALITY CONTROL Flashcards
CLINICAL COMES FROM THE GREEK WORD “KLINE” WHICH MEANS?
BED
SEVEN INDEPENDENT BASE UNITS REPRESENTED BY A SYMBOL
SYSTEME INTERNATIONALE
3 CLASSES OF SI UNITS
- BASE
- DERIVE
- SUPPLEMENTAL
RECOMMENDED UNIT FOR REPORTING OF ANALYTES
MOLES OF SOLUTE/ VOLUME OF SOLUTION (MOLARITY)
IT IS RETAINED FOR MEASUREMENT OF HYDROGEN ION CONCENTRATIONS
PH SCALE
A SYSTEM THAT ENSURES THE ACCURACY AND PRECISION IN THE LABORATORY
QUALITY CONTROL
PROCESS OF ENSURING ANALYTICAL RESULTS ARE CORRECT BY TESTING KNOWN SAMPLES THAT RESEMBLE PATIENT SAMPLES
QUALITY CONTROL
ABILITY TO MEASURE THE SMALLEST CONCENTRATION OF INTEREST
SENSITIVITY
ABILITY TO MEASURE ONLY ANALYTE OF INTEREST
SPECIFICITY
NEARNESS OR CLOSENESS OF VALUE
ACCURACY
METHOD TO GIVE REPEATED RESULTS
PRECISION
DEGREE OF METHOD THAT IS EASILY REPEATED
PRACTICABILITY
MAINTAIN ACCURACY AND PRECISION DURING ANY CHANGES
RELIABILITY
TO TEST THOSE WHO HAVE DISEASE AD TEST POSITIVE
DIAGNOSTIC SENSITIVITY
TO TEST THOSE WHO HAVE NOT DISEASE THAT TEST NEGATIVE
DIAGNOSTIC SPECIFICITY
KINDS OF QUALITY CONTROL
- INTRALAB
2. INTERLAB
IT INVOLVES CONTROLS WITH PATIENT SAMPLES
INTRALAB
DETECTS CHANGES BETWEEN PRESENT AND STABLE OPERATION
INTRALAB
IT IS IMPORTANT FOR DAILY MONITORING OF ACCURACY AND PRECISION
INTRALAB
DETECTS BOTH RANDOM AND SYSTEMATIC ERROR
INTRALAB
INVOLVES PROFICIENCY TESTING WITH UNKNOWN CONCENTATION
INTERLAB
IT IS IMPORTANT FOR LONG TERM ACCURACY OF ANALYTICAL METHODS
INTERLAB
IT INDICATES THAT THE LABORATORY IS NOT IN AGREEMENT WITH THE REST OF LABORATORIES WITHIN THE PROGRAM
DIFFERENCE >2
OBJECTIVES OF QUALITY CONTROL
- STABILITY OF MACHINE
- QUALITY OF REAGENTS
- TECHNICAL ERROR
IDEAL QC MATERIAL
- RESEMBLES HUMAN SAMPLE
- INEXPENSIVE AND STABLE
- NO COMMUNICABLE DISEASES
- NO MATRIX EFFECTS
- WITH KNOWN ANALYTE
- CONVENIENT PACKAGING
RECOMMENDED NUMBER OF DAYS TO ANALYZE NEW LOT OR NEW INSTRUMENTS
5 AND 20 DAYS
IT IS CALCULATED FROM THE MEAN AND SD
CONTROL LIMITS
BOVNE-BASED QC MATERIAL ARE NOT FOR
BILIRUBIN
IMMUNOCHEMISTRY
DYE-BINDING
IT IS A RESULT OF IMPROPER PRODUCT MANUFACTURING
MATRIX EFFECT
THIS IS MORE EXPENSIVE BUT CAN BE USED AS EXTERNAL CHECKS FOR ACCURACY
ASSAYED CONTROLS
IT IS PRESENT IN ALL MEASUREMENTS DUE TO CHANCE
RANDOM ERROR
- BOTH POSITIVE AND NEGATIVE
- BASIS FOR VARYING DIFFERENCES BETWEEN REPEATED MEASUREMENTS
RANDOM ERROR
ERROR TAHT INFLUENCES OBSERVATIONS IN ONE DIRECTION CONSISTENTLY
SYSTEMATIC ERROR
- EITHER POSITIVE OR NEGATIVE BIAS
- MEASURE OF AGREEMENT BETWEEN MEASURED QUANTITY AND TRUE VALUE
SYSTEMATIC ERROR
DIFFERENCE BETWEEN TARGET VALUE AND ASSAY VALUE
INDEPENDENT SAMPLE CONCENTRATION
CONSTANT ERROR