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MT6317 > 1b4. Quality Management > Flashcards

1b4. Quality Management Flashcards

1
Q

A planned and systematic set of quality activities focused on providing confidence that quality requirements will be fulfilled

A

Quality Assurance

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2
Q

Uses quality indicators which is an established measure used to determine how well an organization meets needs and operational and performance expectaitions

A

Quality assurance

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3
Q

Verifying the acceptability of methods prior to reporting patient results

A

Method validation

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4
Q

The ability of a test to detect a given disease or condition

A

Diagnostic sensitivity

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5
Q

The ability of a test to correctly identify the absence of a given disease or condition

A

Diagnostic specificity

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6
Q

Formula for diagnostic sensitivity

A

(TP)/(TP+FN)

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7
Q

Formula for diagnostic specificity

A

(TN)/(TN+FP)

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8
Q

Chance of an individual having a given condition if the test is abnormal

A

Positive predictive value

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9
Q

Chance of an individual does not have a given disease or condition if the test is within the reference interval

A

Negative predictive value

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9
Q

Formula for positive predictive value

A

(TP)/(TP+FP)

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10
Q

Formula for negative predictive value

A

(TN)/(TN+FN)

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11
Q

A quality laboratory process that involves statistical analysis of internal control procedures through use of control materials for method performance assessment and nonstatistical check procedures such as linearity studies and reagent checks

A

Quality control

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12
Q

Examining control materials of known substances along with patient samples to monitor accuracy and precision of the complete examination process

A

Quality control

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13
Q

The value with the highest frequency, always on the top of every distribution curve

A

Mode

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14
Q

The value which divides the variable’s observation in two equal parts and represents the center of the distribution

A

Median

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15
Q

The value which all observations should have if they were equal

A

Mean

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16
Q

Squared standard deviation that measures variability

A

Variance

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17
Q

A percentile expression of the mean and an index of precision

A

Coefficient of variation

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18
Q

Graphical representation of observed values of a control material over time in the context of the upper and lower control limits

A

Levey-Jennings chart

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19
Q

The limit of a Levey-Jennings chart at +/- 1s limit

A

68%

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20
Q

The limit of a Levey-Jennings chart at +/- 2s limit

A

95.5%

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21
Q

The limit of a Levey-Jennings chart at +/- 3s limit

A

99.7%

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22
Q

Gradual loss of reliability in the test system

A

Trend

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23
Q

Abrupt changes in the control mean

A

Shift

24
Q

Sudden and dramatic positive or negative change in test system

A

Shift

25
Q

Shift/Trend:

Deterioration of the instrument light source

A

Trend

26
Q

Lhat ng may gradual = trend XD

A
27
Q

Shift/Trend:

Aging of reagents

A

Trend

28
Q

Shift/Trend:

Sudden failure or change in the light source

A

Shift

29
Q

Shift/Trend:

Change in reagent formulation, reagent lot, room temperature, or humidity

A

Shift

30
Q

Shift/Trend:

Major instrument maintenance

A

Shift

31
Q

Shift/Trend:

Failure in sample system and reagent dispense system

A

Shift

32
Q

Shift/Trend:

Inaccurate calibration/recalibration

A

Shift

33
Q

The westgard rules are developed by ___

A

Dr. James Westgard

34
Q

This establishes a criterion for judging whether an analytical process is out of control

A

Westgard rules

35
Q

This devised a shorthand notation for expressing quality control rules

A

Westgard rules

36
Q

Identify the Westgard multirule:

One control observation exceeding the mean +/-2s

A

1 2s

37
Q

Identify the Westgard multirule:

A warning rule that initiates testing of control data by other rules

A

1 2s

38
Q

Identify the Westgard multirule:

One control observation exceeding the mean +/-3s

A

1 3s

39
Q

Identify the Westgard multirule:

Allows high sensitivity to random error

A

1 3s

40
Q

Identify the Westgard multirule:

Two control observations consecutively exceeding the same +2s or -2s

A

2 2s

41
Q

Identify the Westgard multirule:

Allows high sensitivity to systemic error

A

2 2s

42
Q

Identify the Westgard multirule:

One control exceeding the +2s and another exceeding the -2s

A

R4s

43
Q

Identify the Westgard multirule:

Allows detection of random error

A

R4s

44
Q

Identify the Westgard multirule:

Four consecutive control observations exceeding +1s or -1s

A

4 1s

45
Q

Identify the Westgard multirule:

Allows the detection of systemic error

A

4 1s & 10x

46
Q

Identify the Westgard multirule:

Ten consecutive control observations falling on one side or the other of the mean

A

10x

47
Q

A method used to validate a particular measurement process

A

Proficiency test

48
Q

Specimens that have known concentrations of an analyte for the test of interest

A

Proficiency Sample

49
Q

This lean six sigma component is pioneered by toyota

A

Lean

50
Q

This lean six sigma component is pioneered by motorola

A

six sigma

51
Q

This provides tangible metrics for quality improvement

A

Lean six sigma

52
Q

Lean uses the ___ method and tools like ___ and ___ to achieve continuous improvement

A

PDCA
8 wastes & 5S

53
Q

Six sigma uses ___ method and tools like ___ and ___ to achieve continuous improvement

A

DMAIC
control charts & FMEA

54
Q

This is a common method analogous to the DMAIC method and can be implemented on a smaller scale

A

Kaizen event

55
Q

The kaizen event is implements within ___ days of quality improvement by a cross-functional team that analyzes the current steps associated with a particular process and makes changes to improve its efficiency

A

3-5

56
Q

This represents the capability of a process to meet (or exceed) its defined criteria for acceptability

A

Process sigma

57
Q

Could refer to assay performance, turnaround times, number of rejected samples, specimen transports, or relay of critical values

A

Process sigma

MT6317 (10 decks)

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