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CC > Quality Management System > Flashcards

Quality Management System Flashcards

1
Q

Management philosophy and approach that focuses on processes and their improvement as the means to satisfy customer needs and requirements

A

Total quality management

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2
Q

five QP framework

A

QP, QLPs, QC, QA, QI

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3
Q

Necessary to establish measures of performance monitoring,monitoring and ensure that the performance achieved satisfies quality requirements

A

QP

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4
Q

Include analytical processes, general policies, practices, and procedures that define how all aspects of work are done

A

QLPs

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5
Q

Involves statistical control procedures as well as nonstatistical checks

A

QC

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6
Q

Concerned with broader measures of laboratory performance including TAT, patient identification, specimen collection, and test utility

A

QA

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7
Q

Provides a structured problem-solving process to help identify the root cause of a problem and a remedy for that problem

A

QI

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8
Q

Quality improvement tools

A

Six sigma, Lean

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9
Q

Reduction of defects to near zero

A

Six Sigma

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10
Q

Reduction of non-valued activities (wastes)

A

Lean

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11
Q

Categories of wastes

A

DOWNTIME
Defects
Overproduction
Waiting
Non-utilized talent
Transport
Inventory
Motion
Excess processing

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12
Q

DMAIC meaning

A

Define
Measure
Analyze
Improve
Control

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13
Q

Laboratory testing process

A

Pre-analytical
Analytical
Post-analytical

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14
Q

Include test requisition, patient preparation, patient identification, specimen collection, labeling, specimen transport, specimen reception, handling, and preparation

A

Pre-analytical

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15
Q

Include reagents, preventive maintenance of equipment, calibration, analysis of samples, and quality control

A

Analytical

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16
Q

Include verification of calculations and reference range, flagging and notification o panic/critical values, delta checks, reporting of results

A

Post-analytical

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17
Q

An algorithm in which a current laboratory result is compared with results obtained on a previous specimen from the same patient

A

Delta check

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18
Q

Identify: incorrect tube or container

A

Pre-analytical

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19
Q

Identify: Inadequate specimen volume

A

Pre-analytical

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20
Q

Identify: Instrument not calibrated correctly

A

Analytical

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21
Q

Identify: Specimen mix-up

A

Analytical

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22
Q

Identify: interfering substance present

A

Analytical

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23
Q

Identify: Instrument precision problem

A

Analytical

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24
Q

Identify: Incorrect sample volume

A

Analytical

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25
Q

Identify: transcription error

A

Post-analytical

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26
Q

identify: Interfering substances not recognized

A

Post-analytical

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27
Q

Identify: Specificity of test not understood

A

Post-analytical

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28
Q

Ability to maintain accuracy and precision over a period of time during which equipment, reagents, and personnel may change

A

Reliability

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29
Q

Closeness of the result to the true or actua value

A

Accuracy

30
Q

Ability to produce a series of results that agree closely with each other; commonly expressed in terms of coefficient of variation; also called repeatability or reproducibility

A

Precision

31
Q

Involves the analysis of at least 2 levels of control every 24 hours

A

Internal quality control -intralab

32
Q

Important for the daily monitoring of accuracy and precision of analytical methods

A

Internal QC

33
Q

Initial control limits are established by analyzing control materials for at least 20 consecutive days or runs

A

Internal QC

34
Q

Involves testing blind samples (unknown concentration of analytes) sent periodically by regulatory agencies to participating laboratories

A

External quality control-interlab

35
Q

Important for maintaining the long-term accuracy of analytical methods

A

External QC

36
Q

SDI=

A

(Lab result-group mean)/group SD

37
Q

Type of error that is due to chance or an unpredictable cause; does not recur in regular pattern

A

Random error

38
Q

Usually a one-time error

A

Random error

39
Q

Affects precision, indicated by violation of the 12s, 13s and R4s Westgard rules

A

Random error

40
Q

Cause: instrument instability

A

Random error

41
Q

Cause: operator variability eg pipetting error

A

Random error

42
Q

Recurring error inherent in test procedure; influences observations in one direction

A

Systematic error

43
Q

Affects all results. May be constant or proportional

A

Systematic error

44
Q

Cause: deterioration of reagents

A

Systematic error

45
Q

Cause: calibration error

A

Systematic error

46
Q

Cause: dirty photometer

A

Systematic error

47
Q

Cause: change in reagent lot

A

Systematic error

48
Q

Cause: pipettor maintenance error

A

Systematic error

49
Q

Patterns in QC charts that indicat errors

A

Shift
Trend
Outliers

50
Q

Abrupt change in the distribution of control values such that they accumulate on one side of the mean for 6 consecutive days

A

Shift

51
Q

Major cause of shift

A

Calibration error

52
Q

Gradual change in the distribution of values that they continue to increase or decrease over a period of 6 consecutive days

A

Trend

53
Q

Major cause of trend

A

Deterioration of reagents

54
Q

Highly deviating control values caused by random or systematic errors

A

Outliers

55
Q

Interpretation of quality control results

A

CUSUM chart
Tonks-Youden plot
Shewhart Levey-Jennings chart
Westgard control rules

56
Q

Prepared by plotting the CUSUM points or the algebraic sum of the difference between each QC result and the mean on the y axis and the run number on the y axis

A

CUSUM chart

57
Q

Used for interlaboratory comparison of monthly means by plotting the mean value for one sample on the y axis and the mea value for another on the x axis; effective method for comparing both within-laboratory and between-laboratory variability

A

Tonks-Youden plot

58
Q

Most common used QC chart

A

Shewhart Levy-Jennings chart

59
Q

One control value exceeds2 SDs from the target value. Warning rule, initiates testing of other rules

A

12s

60
Q

Error detected in 12s

A

Imprecision

61
Q

One contol value exceeds 3 SDs from the target value

A

13s

62
Q

Error detected in13s

A

Imprecision and systematic bias

63
Q

Range between two leveles of control within a run exceeds 4 SDs

A

R4s

64
Q

Error detected in R4s

A

Imprecision

65
Q

Two consecutive value or values for two QC samples exceed 2 SDs from the targe value in the same direction

A

22s

66
Q

Error detected in 22s

A

Bias

67
Q

Four consecutive control values exceed 1 SD from the target value

A

41s

68
Q

Error detected in 41s

A

Bias trend

69
Q

Eight consecutive values for the same QC sample exceed 1SD in the same direction

A

81s

70
Q

Ten consecutive control values are on the same side of the mean

A

10x

71
Q

Cumulative sum of SDI

A

CUSUM

72
Q

Exponentially weighted moving average

A

EWMA

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