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CLINICAL CHEM > QUALITY CONTROL > Flashcards

QUALITY CONTROL Flashcards

1
Q

A DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILLS REQUIREMENTS (ISO 9001:2008)

A

QUALITY

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2
Q

PART OF QUALITY MANAGEMENT FOCUSED ON FULFILLING QUALITY REQUIREMENTS (ISO 9000:2000)

A

QUALITY CONTROL

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3
Q

WHAT IS THE OTHER NAME OF QUALITY CONTROL

A

STATISTICAL PROCESS CONTROL

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4
Q

SYSTEM OF ASSURING THE QUALITY OF TOTAL LABORATORY PERFORMANCE

A

QUALITY CONTROL

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5
Q

INVOLVES SYTEMATIC MONITORING OF ANALYTIC PROCESS IN ORDER TO DETECT ANALYTIC ERRORS THAT OCCUR DURING ANALYSIS

A

QUALITY CONTROL

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6
Q

PART OF QUALITY MANAGEMENT FOCUSED ON PROVIDING CONFIDENCE THAT THE QUALITY REQUIREMENTS WILL BE FULFILLED (ISO 9000:2000)

A

QUALITY ASSURANCE

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7
Q

MONITORING OF SPECIMEN AQISISIO, TURN AROUND TIME, OR PROFICIENCY TESTING OF MATERALS

A

QUALITY ASSURANCE

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8
Q

SET OF ACTIVITIES OR PLAN THAT AIMS TO MAINTAIN THE HIGHEST DEGREE OF EXCELLENCE FOR TH DIAGNOSIS AND TREATMEN OF DISEASE AND MAINTENANCE OF HEALTH

A

QUALITY ASSURANCE PROGRAM

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9
Q

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets costumer and applicable situations

A

ISO 9001 : 2008

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10
Q

Quality management in medical Laboratories (guidelines

A

ISO15189

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11
Q

SYSTEM CONCEPTS of QUALITY CONTROL

A
  1. QCCS- Quality Control Surveillance System
  2. Q.C. Corrective System
  3. Objective Q.C. Parameters
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12
Q

establishes norms that must be met

A

QCCS

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13
Q

Established to offer education of why errors occur; provide a program to remedy defects

A

Q.C. Corrective System

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14
Q

Established to prove that corrective measures have produced favorable results

A

Objective Q.C. Parameters

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15
Q

Objectives of Q.C.

A
  • check the quality of machines
  • check the quality of reagents
  • check technical (operational) errors
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16
Q

Initially applied and principle statistically analyzing QC to the clinical lab in the1950s

A

Control Limits ( Control Values)

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17
Q

ideal control limit

A

+/- 2SD

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18
Q

A substace of known concentration

A

Standard

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19
Q

More applicable to identifying when an error has occured

A

Quality control

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20
Q

more applicable to preventng an error from occuring

A

Quality Assurance Program

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21
Q

CONTROL of PRE-ANALYTICAL VARIABLES
FACTORS:

A
  1. Patient identification
  2. Proper preparation of patient
  3. Specimen collection, separation & processing
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22
Q

CONTROL OF ANALYTICAL VARIABLES
MAIN FACTORS:

A
  1. Choice of analytical methodology
  2. Calibration procedures
  3. Proper documentation of analytical variables
  4. Proper labeling & use of reagents
  5. Preventive maintenance of analytical instruments
  6. Periodic calibration of pipetting devices
  7. Periodic checking of °T of refrigerator & heating units
  8. Periodic checking of procedure manuals
  9. Monitoring of technical competence
  10. Inventory of control materials
  11. Control assurance that safety measures are operational
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23
Q

CONTROL of POST-ANALYTICAL VARIABLES
FACTORS:

A
  1. Verification of calculations of the final results
  2. Check test results for possible transcription errors
  3. Results should be easy to read & interpret
  4. Timeliness of reporting values to patient chart
  5. Procedures for informing physicians about results that require immediate attention
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24
Q

FACTORS Involved in QUALITY CONTROL

A
  • standard
  • control material
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25
Q

Substance of known composistion

A

Standard

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26
Q

Its valu is established by an analytical procedure different from that used in the clinical laboratory

A

Standard

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27
Q

Substance which resembles the unknown specimen (patient’s sample)

A

Control material

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28
Q

analyzed daily together with the unknown

A

Control material

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29
Q

the values obtained from the assays are used for that computation of the mean and the SD

A

Control material

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30
Q

types of control material

A

A. Commercial control sera
B. Pooled sera

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31
Q

Excess non-hemolyzed sera without gross lipemia are collected daily in the laboratory and
pooled for storage in the refrigerator

A

Pooled sera

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32
Q
  • When 1 – 2 liters are collected, centrifuge to remove gross contamination
  • Filter and divide into aliquots of 5 mL each
A

Pooled sera

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33
Q

-
Stopper and store at -20°C
-
Thaw as needed and mix well before use

A

Pooled sera

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34
Q

extent to w/c the measurement approximates the true value of the quantity being
measured

A

Accuracy

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35
Q

a.k.a reproducibility; degree to w/c repeated results agree to each other

A

Precision

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36
Q

ability of a method to detect a particular substance w/o the interference of some
other substances present in the sample

A

Specificity

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37
Q

ability of a method to detect even the smallest amount of that particular substance
tested for

A

Sensitivity

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38
Q

ability of a method to maintain its accuracy & precision over an extended period of
time

A

Reliability

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39
Q

degree to w/c the method is easily repeated

A

Practicability

40
Q

➢ A statement of the extent of random variation in any series of measurement
➢ A measure of the distribution of values around the mean

A

Standard Deviation

41
Q
  • Square of the standard deviation
  • Used to detect significant differences between groups of data
  • Determine contributions of various factors to the total variation
A

Variance

42
Q
  • Percentile expression of the mean
  • Measure of the relative magnitude of variability
A

Coefficient of variation

43
Q

QUALITY CONTROL Associated Activities

A
  1. Assay of control samples
  2. Instrument maintenance
  3. Statistical Data Analysis
  4. Proficiency testing survey
44
Q

Aspects which the laboratory should avoid or minimize

A
  1. Analytical Balance
  2. Random Analytical Variability
  3. Errors
45
Q

Types of Analytical Bias

A

a) Proportional bias
b) Constant bias
c) Combined bias

46
Q

❖ Reported values do not fall along the line of slope when graphed
❖ Reported lab results do not correspond to the correct value

A

Analytical Balance

47
Q
  • Refers to laboratory analyses that are subject to imprecision
A

Random Analytical Variability

48
Q

Types of random analytical variability

A

A. Proportional variability
B. Constant variability

49
Q

Problem on Accuracy (Bias)

A

Systematic Error

50
Q

Problem on Precision (CV)

A

Random Error

51
Q

can be systematic or personnel-related

A

Errors

52
Q

Types of error

A

A. Random Errors
B. Systematic Errors

53
Q

 Sources cannot be completely controlled or identified
 Increase the extent of variability of results

A

Random Errors

54
Q

Causes of random errors

A
  1. Pipets & volumetric glassware w/ manufacturing variation; electronic & optical variations in
    instruments (e.g. spectrophotometers)
  2. Variations in the cuvet
  3. Variations in timing & °T control
  4. Variations in light, evaporation & °T on serum sample
  5. Interferences from other substances in the sample
55
Q

Displace the mean value on one direction (may be up or down), but do NOT affect the overall
variability as shown by the SD value

A

Systematic Errors

56
Q

Causes of systematic errors

A
  1. Aging phenomena – decomposition of reagents during storage
  2. Personal bias of the analyst
  3. Laboratory bias
  4. Inter- & intra-individual bias
  5. Experimental errors or changes in the methods
57
Q

Types of systematic errors

A
  1. Trend
  2. Shift
58
Q

CAUSES of UPWARD TREND:

A

o Expired lamps/photocells
o Denatured standard
o Contamination of reagents

59
Q

CAUSES of DOWNWARD TREND

A

o Standards that are too concentrated
o Contamination of reagent

60
Q

Series of values on the control chart that continue to increase or decrease for at least a
period of six (6) consecutive days

A

Trend

61
Q

Values that distribute themselves on one side of the mean for at least six (6)
consecutive days

A

Shift

62
Q

CAUSES of DOWNWARD SHIFT

A

o Increased concentration of standard & reagents
o Contaminated reagents
o Inaccurate timer
o Under-heating in analysis
o Contaminated glassware

63
Q

CAUSES of UPWARD SHIFT

A

o Partial electrical failure in instrument
o New standard is over-diluted
o Denatured standard that has stabilized
o Improperly prepared reagent
o Inaccurate timer
o Deteriorated indicator
o Dirty glassware
o Overheating in °T-sensitive analysis

64
Q

Q.C. procedures performed on a daily basis within individual laboratories

A

INTRALABORATORY / INTERNAL

65
Q

INTRALABORATORY / INTERNAL Monitoring is carried out using

A

o Levey – Jennings Chart
o Westgard Multi-rule Chart
o CUSUM Technique (cumulative sum)

66
Q

Performed on a less frequent basis (e.g. 3x a year) to compare performance b/w or among
laboratories

A

INTERLABORATORY / EXTERNAL

67
Q

graphical representations that display the control observation as a
function or time

A

quality control charts

68
Q

 Control results are plotted on the Y-axis (ordinate) vs time on the X-axis (abscissa)

A

LEVEY – JENNINGS CHART

69
Q

 All control values are w/in ± 2SD
 One outlier in 20 determinations

A

IN-CONTROL

70
Q

 Presence of two or more outliers
 Presence of a Trend
 Presence of a Shift

A

OUT-OF-CONTROL

71
Q

a control value that goes beyond ±2SD

A

Outlier

72
Q

Commercial control sera is reconsituted using

A

5mL of distilled H2O

73
Q

dehydrated to powder

A

Lyophilized

74
Q

Pathologic control and color red packaging

A

Quantipath

75
Q

Green

A

Quantiform

76
Q

3 types of studies determined by:

A

A. Recovery study
B. Interference study
C. Sample comparison

77
Q

determines how much of the analytes can be identified in the sample

A

Recovery study

78
Q

specific compounds affect the lab test

A

interference study

79
Q

used to assess the presence of error in an actual patient sample

A

Sample comparison study

80
Q

what is caused by systematic error

A

Inaccuracy

81
Q

what is caused by random error

A

imprecision

82
Q

measure of central tendency associated with symmetrical or normal distribution

A

arithmetic mean

83
Q

Characteristics of a human sample

A
  1. resembles human sample
  2. inexpensive and stable for long periods
  3. no communicable disease
  4. no matrix effects/ known matrix effects
  5. with known analyte concentration
  6. convenient packaging for easy dispersion and storage
84
Q

reported values are higher/ lower than the expected values

A

proportional bias

85
Q

reported values are higher/ lower than expected but constant concentration

A

constant bias

86
Q

commonly caused by a bias in volumetric dispensing of the specimen aliquot

A

proportonal variability

87
Q

commonly observed in analytical procedures that are influenced by the turbidity of the specimen

A

constant variability

88
Q

to prove there is proportional bias

A

recovery experiment

89
Q

causes of outlier

A
  • contamination of a single specimen
  • faulty pipette
  • incorrect dilution of test
  • incorrect control sera
90
Q

if value is only one but exceeded +/- 2SD

A

1,2 s

91
Q
  • method used to validate a particular measurement process
  • diff. labs analyze the same sample several times in a year
A

proficiency testing survey

92
Q

specimens that have known concentration of an analyte for the test of interest

A

proficiency sample

93
Q

labs in a geographic region use the lots of QC specimen each day for their internal QC programs

A

Regional QC programs

94
Q

steps in implementing quantitative QC

A
  • obtain control material
  • run each control 20 times over 30 days
  • calculate mean +/- 1,2,3 SD
95
Q

preferred rather than a pooled sera

A

Bovine QM

96
Q
A

CLINICAL CHEM (7 decks)

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