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[MT 6317] Clinical Chemistry Laboratory > [1S] UNIT 5: Quality Management > Flashcards

[1S] UNIT 5: Quality Management Flashcards

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1
Q

Coordinated activities to implement the quality policy

A

Quality Management System

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2
Q

Pre/Post/Analytical

Quality assurance

A

Post analytical

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2
Q

Pre/Post/Analytical

Quality planning

A

Pre analytical

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3
Q

Pre/Post/Analytical

Quality control

A

Analytical

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4
Q

Pre/Post/Analytical

Quality improvement

A

Encompasses all phases

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5
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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6
Q

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

A

Quality Assurance

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7
Q

Verifying the acceptability of methods prior to reporting patient results

A

Method Validation

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8
Q

T/F: Method should remain valid over time

A

T

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9
Q

Method validation is validated by the?

A

Quality Control

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10
Q

The laboratory can be validated by their?

A

Diagnostic Efficiency

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11
Q

ability of a test to detect a given disease or condition

A

Diagnostic Sensitivity

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12
Q

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

A

Diagnostic Specificity

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13
Q

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

A

Positive Predictive Value

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14
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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15
Q

closeness of a measure to the true value or
target value

A

Accuracy

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16
Q

LAB ERRORS

○ Mislabelling
○ Transcription
○ Delay transportation

A

Clerical

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16
Q

refers to the results being as close as possible to the true value on a consistent basis

A

Reliability

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16
Q

amount of variation in a series of repeated
measurements

A

Precision

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17
Q

LAB ERRORS

○ Delay turn around time
○ Failure to release results

A

Clerical

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18
Q

LAB ERRORS

Highest frequency of errors especially with the use of handwritten labels and request forms

A

Clerical

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19
Q

LAB ERRORS

Errors of accuracy

A

Systematic

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20
Q

LAB ERRORS

Can either be an increase or decrease but never both

A

Systematic

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21
Q

LAB ERRORS

Common cause is reagent instability / inaccurate control samples

A

Systematic

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22
Q

LAB ERRORS

Seen as gradual shift in the quality control charts

A

Systematic

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23
Q

LAB ERRORS

Errors of precision

A

Random

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24
Q

LAB ERRORS

All of a sudden there is a reading that goes beyond

A

Random

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25
Q

LAB ERRORS

Due to variations in any parts of the system

A

Random

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25
Q

LAB ERRORS

Due to instrument, operator, or environmental condition

A

Random

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26
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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26
Q

LAB ERRORS

Any deviation away from an expected result

A

Random

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27
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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28
Q

QUALITY CONTROL STATISTICS

is the value with the highest frequency.

A

Mode value (Mo)

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29
Q

QUALITY CONTROL STATISTICS

It is always on the top of every distribution curve

A

Mode value (Mo)

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29
Q

QUALITY CONTROL STATISTICS

is the value which divides the variable’s observations in two equal parts.

A

Median value (M)

30
Q

QUALITY CONTROL STATISTICS

It represents the “center” of the distribution.

A

Median value (M)

31
Q

QUALITY CONTROL STATISTICS

is equal to the value which all the observations should have if they were equal

A

Mean value or average value (μ or x )i

32
Q

Squared standard deviation that measures variability

A

Variance

33
Q
  • a percentile expression of the mean
  • An index of precision
A

Coefficient of variation (CV)

33
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

33
Q

LIMITS

95.5% of the data values are within the SD of mean

A

+/- 2s limit

33
Q

LIMITS

68% of the data values are within the SD of mean

A

+/- 1s limit

34
Q

LIMITS

99.7% of the data values within the SD of mean

A

+/- 3s limit

35
Q

gradual loss of reliability in the test system

A

Trend

36
Q

Deterioration of reagents or changes in the concentration of the standards

A

Causes for Trends

37
Q

● Improper wavelength calibration
● Water bath temperature shift
● Deterioration of the instrument light source

A

Causes for Trends

38
Q

Slight alteration of the pH of an enzyme reagent due
to carbon dioxide absorbance from the air or other contaminants

A

Causes for Trends

38
Q

Gradual accumulation of debris in sample / reagent
tubing

A

Causes for Trends

38
Q

● Gradual accumulation of debris on electrode surfaces
● Aging of reagents
● Gradual deterioration of control material

A

Causes for Trends

39
Q

Gradual deterioration of incubation chamber
temperature (enzymes)

A

Causes for Trends

40
Q

● Gradual deterioration of light filter integrity
● Gradual deterioration of calibration

A

Causes for Trends

41
Q

abrupt changes in the control mean

A

Shift

42
Q

Sudden and dramatic positive or negative change in test system

A

Shift

43
Q
  • Sudden failure or change in the light source
  • Change in reagent formulation
  • Change in reagent lot
A

Shift

44
Q
  • Major instrument maintenance
  • Sudden change in incubation temperature (enzymes)
A

Shift

45
Q
  • Change in room temperature or humidity
  • Failure in sampling system
A

Shift

46
Q
  • Failure in reagent dispense system
  • Inaccurate calibration/ recalibration
A

Shift

47
Q

Devised a shorthand notation for expressing quality control rules

A

Westgard Rules

47
Q

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

A

Westgard Rules

48
Q

tao ng Westgard Rules

A

Dr. James Westgard

49
Q

MULTIRULE RULES

● A single control measurement exceeds two
standard deviations from
the target mean
● Action – must consider
other rule violations
● This is a warning

A

12s

49
Q

MULTIRULE RULES

A

Westgard Rules

49
Q

MULTIRULE RULES

● A single control
measurement
exceeds three
standard deviations
from the target mean
◦ Action - Reject

A

13s

50
Q

MULTIRULE RULES

● Two consecutive control
measurements exceed
the same mean plus 2S
or the same mean minus
2S control limit.
◦ Action – Reject

A

22s

50
Q

MULTIRULE RULES

● One control
measurement in a group
exceeds the mean plus
2S and another exceeds
the mean minus 2S.
◦ Action – Reject

A

R4s

51
Q

MULTIRULE RULES

◦ Action- Reject a run when
ten consecutive control
observations are on the
same side of the mean.
This rejection rule is
sensitive to systematic
error.

A

10x

51
Q

MULTIRULE RULES

● Four consecutive control
measurements exceed
the same mean plus 1S
or the same mean minus
1S control limit.
◦ Action – Reject

A

41s

52
Q

EXTERNAL PROFICIENCY TESTING PROGRAMS

Method used to validate a particular measurement process

A

Proficiency Test

52
Q

EXTERNAL PROFICIENCY TESTING PROGRAMS

The results are compared with other external laboratories to give an
objective indication of test accuracy

A

Proficiency Test

53
Q

EXTERNAL PROFICIENCY TESTING PROGRAMS

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

A

Proficiency Samples

54
Q

EXTERNAL PROFICIENCY TESTING PROGRAMS

The testing laboratory does not know the targeted concentration when
tested

A

Proficiency Samples

55
Q

program where participating laboratories are given unknown samples for
analysis

A

External Quality Assessment Scheme (EQAS)

56
Q

administered by the different National Reference Laboratories (NRL) -
almost all NRLs send one set of samples per year

A

External Quality Assessment Scheme (EQAS)

57
Q

samples are to be treated as ordinary human specimens for the usual processing and examination

A

External Quality Assessment Scheme (EQAS)

58
Q

certificate of participation is required for renewal of the laboratory’s license from the DOH-HFSRB

A

External Quality Assessment Scheme (EQAS)

59
Q

T/F: Quality of performance of the participating labs is
assessed through remoteness of results to the predetermined value/results

A

F; closeness of results

59
Q

T/F: EQAP is stipulated in DOH AO 2007-0027 (Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines)

A

T

59
Q

T/F: Quality of performance of the participating labs is
assessed through reference value generated by the participating laboratories through peer group analysis

A

T

60
Q

combination of Six Sigma quality management with Lean Manufacturing Strategy

A

Lean Six Sigma

61
Q

To provide tangible metrics for quality improvement

A

Lean Six Sigma

61
Q

Lean Six Sigma is pioneered by ________ and developed by __________?

A

TOYOTA (Lean)
MOTOROLA (Sigma)

62
Q

Lean Six Sigma DMAIC

A

Define
Measure
Analyze
Improve
Control

62
Q

METRICS IN MEASURING QUALITY IMPROVEMENT: SIX SIGMA METRICS

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

Process Sigma

63
Q

METRICS IN MEASURING QUALITY IMPROVEMENT: LEAN IMPROVEMENT

● Can be implemented on a smaller scale
● 3 to 5 days of quality improvement by a crossfunctional team that analyzes the current steps
associated with a particular process and makes
changes to improve its efficiency

A

Kaizen Event

63
Q

METRICS IN MEASURING QUALITY IMPROVEMENT: LEAN IMPROVEMENT

● Common method
● Analogous to the DMAIC method

A

Kaizen Event

64
Q

METRICS IN MEASURING QUALITY IMPROVEMENT: SIX SIGMA METRICS

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

A

Process Sigma

65
Q

METRICS IN MEASURING QUALITY IMPROVEMENT: SIX SIGMA METRICS

number of defects (errors) per million opportunities (DPMO)

A

Process Sigma

[MT 6317] Clinical Chemistry Laboratory (4 decks)

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