QUALITY CONTROL Flashcards

(89 cards)

1
Q

CLINICAL COMES FROM THE GREEK WORD “KLINE” WHICH MEANS?

A

BED

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2
Q

SEVEN INDEPENDENT BASE UNITS REPRESENTED BY A SYMBOL

A

SYSTEME INTERNATIONALE

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3
Q

3 CLASSES OF SI UNITS

A
  1. BASE
  2. DERIVE
  3. SUPPLEMENTAL
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4
Q

RECOMMENDED UNIT FOR REPORTING OF ANALYTES

A

MOLES OF SOLUTE/ VOLUME OF SOLUTION (MOLARITY)

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5
Q

IT IS RETAINED FOR MEASUREMENT OF HYDROGEN ION CONCENTRATIONS

A

PH SCALE

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6
Q

A SYSTEM THAT ENSURES THE ACCURACY AND PRECISION IN THE LABORATORY

A

QUALITY CONTROL

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7
Q

PROCESS OF ENSURING ANALYTICAL RESULTS ARE CORRECT BY TESTING KNOWN SAMPLES THAT RESEMBLE PATIENT SAMPLES

A

QUALITY CONTROL

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8
Q

ABILITY TO MEASURE THE SMALLEST CONCENTRATION OF INTEREST

A

SENSITIVITY

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9
Q

ABILITY TO MEASURE ONLY ANALYTE OF INTEREST

A

SPECIFICITY

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10
Q

NEARNESS OR CLOSENESS OF VALUE

A

ACCURACY

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11
Q

METHOD TO GIVE REPEATED RESULTS

A

PRECISION

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12
Q

DEGREE OF METHOD THAT IS EASILY REPEATED

A

PRACTICABILITY

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13
Q

MAINTAIN ACCURACY AND PRECISION DURING ANY CHANGES

A

RELIABILITY

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14
Q

TO TEST THOSE WHO HAVE DISEASE AD TEST POSITIVE

A

DIAGNOSTIC SENSITIVITY

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15
Q

TO TEST THOSE WHO HAVE NOT DISEASE THAT TEST NEGATIVE

A

DIAGNOSTIC SPECIFICITY

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16
Q

KINDS OF QUALITY CONTROL

A
  1. INTRALAB

2. INTERLAB

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17
Q

IT INVOLVES CONTROLS WITH PATIENT SAMPLES

A

INTRALAB

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18
Q

DETECTS CHANGES BETWEEN PRESENT AND STABLE OPERATION

A

INTRALAB

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19
Q

IT IS IMPORTANT FOR DAILY MONITORING OF ACCURACY AND PRECISION

A

INTRALAB

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20
Q

DETECTS BOTH RANDOM AND SYSTEMATIC ERROR

A

INTRALAB

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21
Q

INVOLVES PROFICIENCY TESTING WITH UNKNOWN CONCENTATION

A

INTERLAB

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22
Q

IT IS IMPORTANT FOR LONG TERM ACCURACY OF ANALYTICAL METHODS

A

INTERLAB

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23
Q

IT INDICATES THAT THE LABORATORY IS NOT IN AGREEMENT WITH THE REST OF LABORATORIES WITHIN THE PROGRAM

A

DIFFERENCE >2

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24
Q

OBJECTIVES OF QUALITY CONTROL

A
  1. STABILITY OF MACHINE
  2. QUALITY OF REAGENTS
  3. TECHNICAL ERROR
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25
IDEAL QC MATERIAL
1. RESEMBLES HUMAN SAMPLE 2. INEXPENSIVE AND STABLE 3. NO COMMUNICABLE DISEASES 4. NO MATRIX EFFECTS 5. WITH KNOWN ANALYTE 6. CONVENIENT PACKAGING
26
RECOMMENDED NUMBER OF DAYS TO ANALYZE NEW LOT OR NEW INSTRUMENTS
5 AND 20 DAYS
27
IT IS CALCULATED FROM THE MEAN AND SD
CONTROL LIMITS
28
BOVNE-BASED QC MATERIAL ARE NOT FOR
BILIRUBIN IMMUNOCHEMISTRY DYE-BINDING
29
IT IS A RESULT OF IMPROPER PRODUCT MANUFACTURING
MATRIX EFFECT
30
THIS IS MORE EXPENSIVE BUT CAN BE USED AS EXTERNAL CHECKS FOR ACCURACY
ASSAYED CONTROLS
31
IT IS PRESENT IN ALL MEASUREMENTS DUE TO CHANCE
RANDOM ERROR
32
- BOTH POSITIVE AND NEGATIVE | - BASIS FOR VARYING DIFFERENCES BETWEEN REPEATED MEASUREMENTS
RANDOM ERROR
33
ERROR TAHT INFLUENCES OBSERVATIONS IN ONE DIRECTION CONSISTENTLY
SYSTEMATIC ERROR
34
- EITHER POSITIVE OR NEGATIVE BIAS | - MEASURE OF AGREEMENT BETWEEN MEASURED QUANTITY AND TRUE VALUE
SYSTEMATIC ERROR
35
DIFFERENCE BETWEEN TARGET VALUE AND ASSAY VALUE INDEPENDENT SAMPLE CONCENTRATION
CONSTANT ERROR
36
CONSTANT DIFFERENCE BETWEEN COMPARATIVE AND TEST METHOD REGARDLESS OF CONCENTRATION
CONSTANT ERROR
37
GREATER DEVIATION FROM TARGET VALUE DUE TO HIGHER SAMPLE
PROPORTIONAL/SLOPE/PERCENT ERROR
38
TEST METHOD AND COMPARATIVE METHOD ARE PROPORTIONAL TO ANALYTE CONCENTRATION
PROPORTIONAL/SLOPE/PERCENT
39
HIGHEST FREQUENCY OF CLERICAL ERROR
HANDWRITTEN LABELS AND REQUEST FORMS
40
IT IS THE FIRST STEP IN METHOD EVALUATION THAT ESITIMATES RANDOM STUDY
PRECISION STUDY
41
NONLAB PERSONNEL WERE RESPONSIBLE FOR ___ OF THE ERRORS IN LAB RESULTS
29%
42
ASSOCIATED WITH NORMAL OR SYMMETRICAL DISTRIBUTION
MEANS
43
AN INDEX OF PRECISION
COEFFICIENT OF VARIATION
44
IT IS A MEASURE OF VARIABILITY
VARIANCE
45
ARE USED TO COMPARE THE MEANS OR SD OF 2 GROUPS
INFERENTIAL STATISTICS
46
DETERMINE THE DIFFERENCE BETWEEN MEANS OF 2 GROUPS
T-TEST
47
DETERMINE THE DIFFERENCE BETWEEN SD OF 2 GROUPS
F-TEST
48
DIFFERENCE BETWEEN DATA POINT AND MEAN DIVIDED BY SD
STANDARD DEVIATION INDEX
49
CHART ACCURATELY DESCRIBED BY SD AND MEAN
GAUSSIAN CURVE
50
CHART: - MULTIPLE ANALYSES - CLOSE TO MEAN - FOCUSES ON DISTRIBUTION OF ERRORS
GAUSSIAN CURVE
51
IT CALCULATES BETWEEN QC RESULTS AND TARGET MEANS
CUMULATIVE GRAPH/CUSUM
52
CHART - IDENTIFIES CONSISTENT BIAS PROBLEMS - EARLIEST INDICATION OF SYSTEMATIC ERRORS - 1(3S) RULE
CUSUM GRAPH
53
IN CUSUM GRAPH RESULTS ARE OUT OF CONTROL WHEN
SLOPE >45 | >2. SD
54
CHART | - TO COMPARE RESULTS ON HIGH AND LOW CONTROL
YOUDEN/TWIN PLOT
55
POINTS FALLING FROM CENTER BUT WITHIN 45 DEGREE LINE
PROPORTIONAL ERROR
56
POINTS FALLING FROM CENTER BUT NON ON 45 DEGREE LINE
CONSTANT ERROR
57
MOST WIDELY USED SYSTEM IN LABORATORY
LJ CHART
58
- MULTIPLE RULES | - GRAPHIC REPRESENTATION OF ACCEPTABLE LIMITS OF VARIATION
LJ CHART
59
- CONTROL VALUES EITHER INCREASE OR DECREASE FOR 6 CONSECUTIVE DAYS
TREND
60
MAIN CAUSE OF TREND
DETERIORATION OF REAGENTS
61
CONTROL VALUES ARE ON ONE SIDE OR SIDE OF MEAN
SHIFT
62
IT CAUSE SHIFT IN THE REFERENCE RANGE
TRANSIENT INSTRUMENT DIFFERENCES
63
MAIN CAUSE OF SHIFT
IMPROPER CALIBRATION OF INSTRUMENTS
64
ACCEPTABLE RANGE
95% OR 2SD
65
DEGREE OF FLATNESS OR SHARPNESS OF VALUES HAVING GAUSSIAN DISTRIBUTION
KURTOSIS
66
CONTROL VALUE THAT IS A SIGN OF POTENTIAL PROBLEM
2S AND 3S
67
CONTROL VALUES THAT WOULD REQUIRE CORRECTIVE ACTION PLAN
3S
68
RECOGNIZED TAHT SIMPLE UPPER AND LOWER CONTROL LIMITS ARE NOT ENOUGH RULE THAT INDICATES OUT OF CONTROL VALUES
WESTGARD CONTROL RULES
69
1(2S), 1 (3S), R(4S)
RANDOM ERRORS
70
2(2S) 4 (1S) 10X
SYSTEMATIC ERROR
71
COMBINATON OF CONTROL RULES AND CONTROL CHART
MULTIRULE SHEWHART PROCEDURE
72
RECOMMENDED THAT AT LEAST 40 SAMPLES AND 100 SAMPLES TO RUN RANDOM AND SYSTEMATIC ERRORS
WESTGARD
73
DUPLICATE ANAYLSES PERFORMED WITHIN
4 HOURS
74
IT CAN BE INCREASED TO DETECT SMALLER SYSTEMATIC ERRORS BY INCREASING NUMBER OF OBSERVATIONS
SENSTIVITY OF MULTIRULE PROCEDURE
75
SET OF CONTROL AND PATIENT SPECIMEN ASSAYED, EVALUATED AND REPORTED.
ANALYTICAL RUN
76
MOST COMMONLY USED PATIENT BASED QC TECHNIQUE
DELTA CHECK
77
TEH DIFFERENCE BETWEEN 2 CONSECUTIVE MEASUREMENTS OF THE SAME ANALYTES ON THE SAME INDIVIDUAL
DELTA CHECK
78
USED TO MEASURE SYSTEMATIC ERRORS TAHN THE ANALYTE
INTERFERENCE EXPERIMENTS
79
WHAT ARE THE INTERFERENCES
``` HEMOGLOBIN LIPIDS ANTICOAGULANTS BILIRUBIN PRESERVATIVES ```
80
MEASURED CONCENTRATION = ACTUAL CONCENTRATION WITHOUT MODIFICATION OF METHOD
LINEAR RANGE OR DYNAMIC RANGE
81
DETECTS SAMPLE CONTAMINATION, INADEQUATE VOLUME, SUDDEN PROBLEM WITH METHOD, INCORRECT RECORDING
PHYSIOLOGIC VALUE OR ABSURD VALUE
82
MOST COMMONLY USED POCT
PORTABLE WHOLE BLOOD GLUCOSE METERS
83
ENVISIONED AS A TRIPOD WITH PROGRAM DEVELOPMENT, ASSESSMENT AND MONITORING
QUALITY ASSURANCE
84
THESEA RE ALL SYSTEMATIC ACTIONS FOR ADEQUATE CONFIDENCE TAHT LAB SERVICES WILL SATISFY MEDICAL NEEDS
QUALITY ASSURANCE
85
TO DELIVER QUALITY SERVICES AND PRODUCTS TO CUSTOMERS
PRIMARY GOAL OF QUALITY ASSURANCE
86
IT WILL SHOW WHETEHER A METHOD MEASURES ALL ANALYTES OR ONLY PART OF IT SYSTEMATIC ERROR
RECOVERY EXPERIMENT
87
5 FACTORS WHEN ESTABLISHING REFERENCE INTERVALS
1. COMPOSITION OF REFERENCE POPULATION 2. CRITERIA 3. PHYSIOLOGIC AND ENVIRONMENTAL CONDITIONS 4. SPECIMEN COLLECTION 5. METHODS
88
IT IS NEEDED TO DERIVE RELIABLE ESTIMATES OF REFERENCE INTERVALS
120 INDIVIDUALS
89
IT IS ONLY THE NEEDED SAMPLE IF LABORATORIAN DETERMINES TEST INSTRUMENT AND SUBJECT ARE THE SAME WITH MANUFACTURER'S INSERT
20 INDIVIDUALS