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QUALITY CONTROL Flashcards

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
Q

IDEAL QC MATERIAL

A
  1. RESEMBLES HUMAN SAMPLE
  2. INEXPENSIVE AND STABLE
  3. NO COMMUNICABLE DISEASES
  4. NO MATRIX EFFECTS
  5. WITH KNOWN ANALYTE
  6. CONVENIENT PACKAGING
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26
Q

RECOMMENDED NUMBER OF DAYS TO ANALYZE NEW LOT OR NEW INSTRUMENTS

A

5 AND 20 DAYS

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27
Q

IT IS CALCULATED FROM THE MEAN AND SD

A

CONTROL LIMITS

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28
Q

BOVNE-BASED QC MATERIAL ARE NOT FOR

A

BILIRUBIN
IMMUNOCHEMISTRY
DYE-BINDING

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29
Q

IT IS A RESULT OF IMPROPER PRODUCT MANUFACTURING

A

MATRIX EFFECT

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30
Q

THIS IS MORE EXPENSIVE BUT CAN BE USED AS EXTERNAL CHECKS FOR ACCURACY

A

ASSAYED CONTROLS

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31
Q

IT IS PRESENT IN ALL MEASUREMENTS DUE TO CHANCE

A

RANDOM ERROR

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32
Q
  • BOTH POSITIVE AND NEGATIVE

- BASIS FOR VARYING DIFFERENCES BETWEEN REPEATED MEASUREMENTS

A

RANDOM ERROR

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33
Q

ERROR TAHT INFLUENCES OBSERVATIONS IN ONE DIRECTION CONSISTENTLY

A

SYSTEMATIC ERROR

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34
Q
  • EITHER POSITIVE OR NEGATIVE BIAS

- MEASURE OF AGREEMENT BETWEEN MEASURED QUANTITY AND TRUE VALUE

A

SYSTEMATIC ERROR

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35
Q

DIFFERENCE BETWEEN TARGET VALUE AND ASSAY VALUE

INDEPENDENT SAMPLE CONCENTRATION

A

CONSTANT ERROR

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36
Q

CONSTANT DIFFERENCE BETWEEN COMPARATIVE AND TEST METHOD REGARDLESS OF CONCENTRATION

A

CONSTANT ERROR

37
Q

GREATER DEVIATION FROM TARGET VALUE DUE TO HIGHER SAMPLE

A

PROPORTIONAL/SLOPE/PERCENT ERROR

38
Q

TEST METHOD AND COMPARATIVE METHOD ARE PROPORTIONAL TO ANALYTE CONCENTRATION

A

PROPORTIONAL/SLOPE/PERCENT

39
Q

HIGHEST FREQUENCY OF CLERICAL ERROR

A

HANDWRITTEN LABELS AND REQUEST FORMS

40
Q

IT IS THE FIRST STEP IN METHOD EVALUATION THAT ESITIMATES RANDOM STUDY

A

PRECISION STUDY

41
Q

NONLAB PERSONNEL WERE RESPONSIBLE FOR ___ OF THE ERRORS IN LAB RESULTS

42
Q

ASSOCIATED WITH NORMAL OR SYMMETRICAL DISTRIBUTION

43
Q

AN INDEX OF PRECISION

A

COEFFICIENT OF VARIATION

44
Q

IT IS A MEASURE OF VARIABILITY

45
Q

ARE USED TO COMPARE THE MEANS OR SD OF 2 GROUPS

A

INFERENTIAL STATISTICS

46
Q

DETERMINE THE DIFFERENCE BETWEEN MEANS OF 2 GROUPS

47
Q

DETERMINE THE DIFFERENCE BETWEEN SD OF 2 GROUPS

48
Q

DIFFERENCE BETWEEN DATA POINT AND MEAN DIVIDED BY SD

A

STANDARD DEVIATION INDEX

49
Q

CHART ACCURATELY DESCRIBED BY SD AND MEAN

A

GAUSSIAN CURVE

50
Q

CHART:

  • MULTIPLE ANALYSES
  • CLOSE TO MEAN
  • FOCUSES ON DISTRIBUTION OF ERRORS
A

GAUSSIAN CURVE

51
Q

IT CALCULATES BETWEEN QC RESULTS AND TARGET MEANS

A

CUMULATIVE GRAPH/CUSUM

52
Q

CHART

  • IDENTIFIES CONSISTENT BIAS PROBLEMS
  • EARLIEST INDICATION OF SYSTEMATIC ERRORS
  • 1(3S) RULE
A

CUSUM GRAPH

53
Q

IN CUSUM GRAPH RESULTS ARE OUT OF CONTROL WHEN

A

SLOPE >45

>2. SD

54
Q

CHART

- TO COMPARE RESULTS ON HIGH AND LOW CONTROL

A

YOUDEN/TWIN PLOT

55
Q

POINTS FALLING FROM CENTER BUT WITHIN 45 DEGREE LINE

A

PROPORTIONAL ERROR

56
Q

POINTS FALLING FROM CENTER BUT NON ON 45 DEGREE LINE

A

CONSTANT ERROR

57
Q

MOST WIDELY USED SYSTEM IN LABORATORY

58
Q
  • MULTIPLE RULES

- GRAPHIC REPRESENTATION OF ACCEPTABLE LIMITS OF VARIATION

59
Q
  • CONTROL VALUES EITHER INCREASE OR DECREASE FOR 6 CONSECUTIVE DAYS
60
Q

MAIN CAUSE OF TREND

A

DETERIORATION OF REAGENTS

61
Q

CONTROL VALUES ARE ON ONE SIDE OR SIDE OF MEAN

62
Q

IT CAUSE SHIFT IN THE REFERENCE RANGE

A

TRANSIENT INSTRUMENT DIFFERENCES

63
Q

MAIN CAUSE OF SHIFT

A

IMPROPER CALIBRATION OF INSTRUMENTS

64
Q

ACCEPTABLE RANGE

A

95% OR 2SD

65
Q

DEGREE OF FLATNESS OR SHARPNESS OF VALUES HAVING GAUSSIAN DISTRIBUTION

66
Q

CONTROL VALUE THAT IS A SIGN OF POTENTIAL PROBLEM

67
Q

CONTROL VALUES THAT WOULD REQUIRE CORRECTIVE ACTION PLAN

68
Q

RECOGNIZED TAHT SIMPLE UPPER AND LOWER CONTROL LIMITS ARE NOT ENOUGH

RULE THAT INDICATES OUT OF CONTROL VALUES

A

WESTGARD CONTROL RULES

69
Q

1(2S), 1 (3S), R(4S)

A

RANDOM ERRORS

70
Q

2(2S)
4 (1S)
10X

A

SYSTEMATIC ERROR

71
Q

COMBINATON OF CONTROL RULES AND CONTROL CHART

A

MULTIRULE SHEWHART PROCEDURE

72
Q

RECOMMENDED THAT AT LEAST 40 SAMPLES AND 100 SAMPLES TO RUN RANDOM AND SYSTEMATIC ERRORS

73
Q

DUPLICATE ANAYLSES PERFORMED WITHIN

74
Q

IT CAN BE INCREASED TO DETECT SMALLER SYSTEMATIC ERRORS BY INCREASING NUMBER OF OBSERVATIONS

A

SENSTIVITY OF MULTIRULE PROCEDURE

75
Q

SET OF CONTROL AND PATIENT SPECIMEN ASSAYED, EVALUATED AND REPORTED.

A

ANALYTICAL RUN

76
Q

MOST COMMONLY USED PATIENT BASED QC TECHNIQUE

A

DELTA CHECK

77
Q

TEH DIFFERENCE BETWEEN 2 CONSECUTIVE MEASUREMENTS OF THE SAME ANALYTES ON THE SAME INDIVIDUAL

A

DELTA CHECK

78
Q

USED TO MEASURE SYSTEMATIC ERRORS TAHN THE ANALYTE

A

INTERFERENCE EXPERIMENTS

79
Q

WHAT ARE THE INTERFERENCES

A 
HEMOGLOBIN
LIPIDS
ANTICOAGULANTS
BILIRUBIN
PRESERVATIVES
80
Q

MEASURED CONCENTRATION = ACTUAL CONCENTRATION WITHOUT MODIFICATION OF METHOD

A

LINEAR RANGE OR DYNAMIC RANGE

81
Q

DETECTS SAMPLE CONTAMINATION, INADEQUATE VOLUME, SUDDEN PROBLEM WITH METHOD, INCORRECT RECORDING

A

PHYSIOLOGIC VALUE OR ABSURD VALUE

82
Q

MOST COMMONLY USED POCT

A

PORTABLE WHOLE BLOOD GLUCOSE METERS

83
Q

ENVISIONED AS A TRIPOD WITH PROGRAM DEVELOPMENT, ASSESSMENT AND MONITORING

A

QUALITY ASSURANCE

84
Q

THESEA RE ALL SYSTEMATIC ACTIONS FOR ADEQUATE CONFIDENCE TAHT LAB SERVICES WILL SATISFY MEDICAL NEEDS

A

QUALITY ASSURANCE

85
Q

TO DELIVER QUALITY SERVICES AND PRODUCTS TO CUSTOMERS

A

PRIMARY GOAL OF QUALITY ASSURANCE

86
Q

IT WILL SHOW WHETEHER A METHOD MEASURES ALL ANALYTES OR ONLY PART OF IT

SYSTEMATIC ERROR

A

RECOVERY EXPERIMENT

87
Q

5 FACTORS WHEN ESTABLISHING REFERENCE INTERVALS

A
  1. COMPOSITION OF REFERENCE POPULATION
  2. CRITERIA
  3. PHYSIOLOGIC AND ENVIRONMENTAL CONDITIONS
  4. SPECIMEN COLLECTION
  5. METHODS
88
Q

IT IS NEEDED TO DERIVE RELIABLE ESTIMATES OF REFERENCE INTERVALS

A

120 INDIVIDUALS

89
Q

IT IS ONLY THE NEEDED SAMPLE IF LABORATORIAN DETERMINES TEST INSTRUMENT AND SUBJECT ARE THE SAME WITH MANUFACTURER’S INSERT

A

20 INDIVIDUALS

CLINICAL CHEMISTRY (6 decks)

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