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Index
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IMMUNO AND SERO
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MIDTERMS
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Quality Assurance and Quality Control
level: Quality Assurance and Quality Control
Questions and Answers List
level questions: Quality Assurance and Quality Control
Question
Answer
Importance of quality assurance and control: Improves the ____ and ____ of testing Ensures the clinician that the_____ has been done in best way
Accuracy and reliability Test Method
Meaning of the organization CLIA?
CLINICAL LABORATORY IMPROVEMENT AMMENDMENT
TJC
THE JOINT COMMISSION
COLA
COMMISSION ON OFFICE LABORATORY ACCREDITATION
CAP
COLLEGE OF AMERICAN PATHOLOGIST
IOS
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
OSHA
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
STANDARD FOR CLINICAL LABORATORIES
ISO 15189
A WELL WRITTEN ELECTRONIC OR PAPER REQUST FORM WITH COMPLETE PATIENT INFORMATION AND TYPE OF SPECIMEN TO BE TESTED.
TEST REQUISITION-
PATIENTS SHOULD BE CAREFULLY IDENTIFIED AND SPECIMENS SHOULD BE LABELLED PROPERLY (MOST COMMON SOURCE OF ERROR)
PATIENT ID AND LABELLING-
ASSESSMENT ROUTINE FOR ALL PROCEDURES. CONFIDENCE LIMIT IS ONE WAY TO DETERMINE REPRODUCIBILITY OF TESTS PROCEDURES
APPROPRIATE TESTING METHOD
INACCURATE RESULTS THAT CAN BE ELIMINATED BY MONITORING OF EQUIPMENT, REAGENT AND OTHER SUPPLY
SYSTEMATIC
INACCURATE RESULTS THAT IS ISOLATED ERRORS OUTSIDE THE SYSTEM
SPORADIC
A PROGRAM THAT MONITORS OR EVALUATES THAT MAKE SURE A CERTAIN PRODUCT, SERVICE OR FACILITY IS IN A STANDAR QUALITY.
QUALITY ASSURANCE-
THIS CONSIT OF PROCEDURES THAT DETECT ERRORS. IN LABORATORY SETTING, EQUIPMENTS ARE COMMONLY TESTED FOR THESE PROCEDURES TO YIELD THE BEST RESULTS
QUALITY CONTROL
A SUBSTANCE WITH A KNOWN VALUE IS COMPARED TO THE RESULT OF THE MACHINE TESTED WITH THE CALIBRATOR. (ACCURACY)
STANDARD/ CALIBRATOR-
A SUBSTANCE WITH A KNOWN VALUE IS COMPARED TO THE REFERENCE RANGE SET ON THE EQUIPMENT. (PRECISION)
CONTROL
CLOSENESS OF MEASUREMENT TO A SPECIFIC VALUE
ACCURACY
CLOSENESS OF THE TEST RESULTS WITH EACH OTHER WHEN TESTED REPEATEDLY.
PRECISION
HOW ONE ACHIEVE ACCURACCY AND PRECISION? USE OF PROPERLY ____ PROCEDURES STATISTICALLY VALID COMPARISONS OF NEW METHODS WITH ESTABLISHED REFERENCE METHODS USE OF KNOWN ______– IN OUR CASE, DAILY PARTICIPATION IN ______
STANDARDIZED VALUES (CONTROLS) PROFICIENCY PROGRAMS
USED TO COMPARE THE STANDARD DEVIATION OF TWO SAMPLES.
COEFFICIENT OF VARIATION (CV)-
ABILITY OF THE TEST TO DETECT AN ANALYTE OR SUBSTANCE EVEN IN VERY LITTLE OR SMALL AMOUNT
SENSITIVITY
ABILITY OF THE TEST TO DETECT THE TARGET ANALYTE OR SUBSTANCE
SPECIFICITY
NUMBER OF PATIENTS WITH POSITIVE TEST RESULTS WHO HAVE THE DISEASE COMPARED TO ALL TESTED WITH POSITIVE RESUTS.
POSITIVE PREDICTIVE VALUE
NUMBER OF PATIENTS WITH NORMAL TEST RESULTS WHO DO NOT HAVE THE DISEASE COMPARED TO ALL TESTED WITH NORMAL RESULTS
NEGATIVE PREDICITVE VALUE-
EXTERNAL PROGRAMS SET BY CLIA TO MONITOR LABORATORIES.
PROFICIENCY TESTING
NEQAS
NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME
MAIN CLINICAL CHEMISTRY
LUNG CENTER OF THE PHILIPPINES (LCP)
MAIN MICROBIOLOGY AND PARASITOLOGY
RESEARCH INSTITUTE FOR TROPICAL MEDICINE (RITM)
MAIN IMMUNOLOGY AND SEROLOGY-
STD-AIDS COOPERATIVE CENTRAL LABORATORY (SACCL)
MAIN HEMATOLOGY SITE
NATIONAL KIDNEY AND TRANSPLANT INSTITUTE (NKTI)
MAIN BLOODBANK SITE
RESEARCH INSTITUTE FOR TROPICAL MEDICINE (RITM)
SUBSTANCE SIMILAR TO COMPOSITION OF HUMAN BLOOD THAT IS CAREFULLY MADE TO TEST OR MONITOR LABORATORY EQUIPMENTS
CONTROL SPECIMENS
FACTORS RESPONSIBLE FOR “CONTROL OUT OF RANGE”
DETERIORATION OF REAGENTS FAULTY INSTRUMENT DIRTY LABWARES LACK OF ATTENTION USE OF METHODS NOT IN MANUAL USE OF POOR TECHNIQUES STATISTICS
A STATISTICALLY MEASURED RANGE OF VALUE REPRESENTED BY HEALTHY INDIVIDUALS . TYPICALLY SHOWN BY GAUSSIAN CURVE.
REFERENCE RANGE
INDIVIDUALS SELECTED FOR REFERENCE RANGE MAY VARY BY AGE, SEX, ETHNICITY, CIRCADIAN RHYTHM.
True
______ IS DONE WHEN A NEW PROCEDURE IS INTRODUCED IN THE LAB. NEW PROCEDURE COULD BE NEW PRINCIPLE, NEW MANUFACTURER, OR NEW SET OF MACHINE. THIS NEW PROCEDURE IS THEN COMPARED TO THE EXISTING PROCEDURE IF THEY YIELD EXACT RESULTS.
PARALLEL TESTING