Quality Management System

Question 1

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

Answer 1

Total quality management

Question 2

five QP framework

Answer 2

QP, QLPs, QC, QA, QI

Question 3

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

Answer 3

QP

Question 4

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

Answer 4

QLPs

Question 5

Involves statistical control procedures as well as nonstatistical checks

Answer 5

QC

Question 6

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

Answer 6

QA

Question 7

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

Answer 7

QI

Question 8

Quality improvement tools

Answer 8

Six sigma, Lean

Question 9

Reduction of defects to near zero

Answer 9

Six Sigma

Question 10

Reduction of non-valued activities (wastes)

Answer 10

Lean

Question 11

Categories of wastes

Answer 11

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

Question 12

DMAIC meaning

Answer 12

Define
Measure
Analyze
Improve
Control

Question 13

Laboratory testing process

Answer 13

Pre-analytical
Analytical
Post-analytical

Question 14

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

Answer 14

Pre-analytical

Question 15

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

Answer 15

Analytical

Question 16

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

Answer 16

Post-analytical

Question 17

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

Answer 17

Delta check

Question 18

Identify: incorrect tube or container

Answer 18

Pre-analytical

Question 19

Identify: Inadequate specimen volume

Answer 19

Pre-analytical

Question 20

Identify: Instrument not calibrated correctly

Answer 20

Analytical

Question 21

Identify: Specimen mix-up

Answer 21

Analytical

Question 22

Identify: interfering substance present

Answer 22

Analytical

Question 23

Identify: Instrument precision problem

Answer 23

Analytical

Question 24

Identify: Incorrect sample volume

Answer 24

Analytical

Question 25

Identify: transcription error

Answer 25

Post-analytical

Question 26

identify: Interfering substances not recognized

Answer 26

Post-analytical

Question 27

Identify: Specificity of test not understood

Answer 27

Post-analytical

Question 28

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

Answer 28

Reliability

Question 29

Closeness of the result to the true or actua value

Answer 29

Accuracy

Question 30

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

Answer 30

Precision

Question 31

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

Answer 31

Internal quality control -intralab

Question 32

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

Answer 32

Internal QC

Question 33

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

Answer 33

Internal QC

Question 34

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

Answer 34

External quality control-interlab

Question 35

Important for maintaining the long-term accuracy of analytical methods

Answer 35

External QC

Question 36

SDI=

Answer 36

(Lab result-group mean)/group SD

Question 37

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

Answer 37

Random error

Question 38

Usually a one-time error

Answer 38

Random error

Question 39

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

Answer 39

Random error

Question 40

Cause: instrument instability

Answer 40

Random error

Question 41

Cause: operator variability eg pipetting error

Answer 41

Random error

Question 42

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

Answer 42

Systematic error

Question 43

Affects all results. May be constant or proportional

Answer 43

Systematic error

Question 44

Cause: deterioration of reagents

Answer 44

Systematic error

Question 45

Cause: calibration error

Answer 45

Systematic error

Question 46

Cause: dirty photometer

Answer 46

Systematic error

Question 47

Cause: change in reagent lot

Answer 47

Systematic error

Question 48

Cause: pipettor maintenance error

Answer 48

Systematic error

Question 49

Patterns in QC charts that indicat errors

Answer 49

Shift Trend Outliers

Question 50

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

Answer 50

Shift

Question 51

Major cause of shift

Answer 51

Calibration error

Question 52

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

Answer 52

Trend

Question 53

Major cause of trend

Answer 53

Deterioration of reagents

Question 54

Highly deviating control values caused by random or systematic errors

Answer 54

Outliers

Question 55

Interpretation of quality control results

Answer 55

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

Question 56

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

Answer 56

CUSUM chart

Question 57

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

Answer 57

Tonks-Youden plot

Question 58

Most common used QC chart

Answer 58

Shewhart Levy-Jennings chart

Question 59

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

Answer 59

12s

Question 60

Error detected in 12s

Answer 60

Imprecision

Question 61

One contol value exceeds 3 SDs from the target value

Answer 61

13s

Question 62

Error detected in13s

Answer 62

Imprecision and systematic bias

Question 63

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

Answer 63

R4s

Question 64

Error detected in R4s

Answer 64

Imprecision

Question 65

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

Answer 65

22s

Question 66

Error detected in 22s

Answer 66

Bias

Question 67

Four consecutive control values exceed 1 SD from the target value

Answer 67

41s

Question 68

Error detected in 41s

Answer 68

Bias trend

Question 69

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

Answer 69

81s

Question 70

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

Answer 70

10x

Question 71

Cumulative sum of SDI

Answer 71

CUSUM

Question 72

Exponentially weighted moving average

Answer 72

EWMA