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

[1S] UNIT 5: Quality Management Flashcards

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
LAB ERRORS Seen as gradual shift in the quality control charts
Systematic
23
LAB ERRORS Errors of precision
Random
24
LAB ERRORS All of a sudden there is a reading that goes beyond
Random
25
LAB ERRORS Due to variations in any parts of the system
Random
25
LAB ERRORS Due to instrument, operator, or environmental condition
Random
26
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
Quality Control
26
LAB ERRORS Any deviation away from an expected result
Random
27
Examining control materials of known substances along with patient samples to monitor accuracy and precision of the complete examination process
Quality Control
28
QUALITY CONTROL STATISTICS is the value with the highest frequency.
Mode value (Mo)
29
QUALITY CONTROL STATISTICS It is always on the top of every distribution curve
Mode value (Mo)
29
QUALITY CONTROL STATISTICS is the value which divides the variable’s observations in two equal parts.
Median value (M)
30
QUALITY CONTROL STATISTICS It represents the “center” of the distribution.
Median value (M)
31
QUALITY CONTROL STATISTICS is equal to the value which all the observations should have if they were equal
Mean value or average value (μ or x )i
32
Squared standard deviation that measures variability
Variance
33
* a percentile expression of the mean * An index of precision
Coefficient of variation (CV)
33
Graphical representation of observed values of a control material over time in the context of the upper and lower control limits
Levey-Jennings Chart
33
LIMITS 95.5% of the data values are within the SD of mean
+/- 2s limit
33
LIMITS 68% of the data values are within the SD of mean
+/- 1s limit
34
LIMITS 99.7% of the data values within the SD of mean
+/- 3s limit
35
gradual loss of reliability in the test system
Trend
36
Deterioration of reagents or changes in the concentration of the standards
Causes for Trends
37
● Improper wavelength calibration ● Water bath temperature shift ● Deterioration of the instrument light source
Causes for Trends
38
Slight alteration of the pH of an enzyme reagent due to carbon dioxide absorbance from the air or other contaminants
Causes for Trends
38
Gradual accumulation of debris in sample / reagent tubing
Causes for Trends
38
● Gradual accumulation of debris on electrode surfaces ● Aging of reagents ● Gradual deterioration of control material
Causes for Trends
39
Gradual deterioration of incubation chamber temperature (enzymes)
Causes for Trends
40
● Gradual deterioration of light filter integrity ● Gradual deterioration of calibration
Causes for Trends
41
abrupt changes in the control mean
Shift
42
Sudden and dramatic positive or negative change in test system
Shift
43
* Sudden failure or change in the light source * Change in reagent formulation * Change in reagent lot
Shift
44
* Major instrument maintenance * Sudden change in incubation temperature (enzymes)
Shift
45
* Change in room temperature or humidity * Failure in sampling system
Shift
46
* Failure in reagent dispense system * Inaccurate calibration/ recalibration
Shift
47
Devised a shorthand notation for expressing quality control rules
Westgard Rules
47
Establish a criterion for judging whether an analytical process is out of control
Westgard Rules
48
tao ng Westgard Rules
Dr. James Westgard
49
MULTIRULE RULES ● A single control measurement exceeds two standard deviations from the target mean ● Action – must consider other rule violations ● This is a warning
12s
49
MULTIRULE RULES
Westgard Rules
49
MULTIRULE RULES ● A single control measurement exceeds three standard deviations from the target mean ◦ Action - Reject
13s
50
MULTIRULE RULES ● Two consecutive control measurements exceed the same mean plus 2S or the same mean minus 2S control limit. ◦ Action – Reject
22s
50
MULTIRULE RULES ● One control measurement in a group exceeds the mean plus 2S and another exceeds the mean minus 2S. ◦ Action – Reject
R4s
51
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.
10x
51
MULTIRULE RULES ● Four consecutive control measurements exceed the same mean plus 1S or the same mean minus 1S control limit. ◦ Action – Reject
41s
52
EXTERNAL PROFICIENCY TESTING PROGRAMS Method used to validate a particular measurement process
Proficiency Test
52
EXTERNAL PROFICIENCY TESTING PROGRAMS The results are compared with other external laboratories to give an objective indication of test accuracy
Proficiency Test
53
EXTERNAL PROFICIENCY TESTING PROGRAMS Specimens that have known concentrations of an analyte for the test of interest
Proficiency Samples
54
EXTERNAL PROFICIENCY TESTING PROGRAMS The testing laboratory does not know the targeted concentration when tested
Proficiency Samples
55
program where participating laboratories are given unknown samples for analysis
External Quality Assessment Scheme (EQAS)
56
administered by the different National Reference Laboratories (NRL) - almost all NRLs send one set of samples per year
External Quality Assessment Scheme (EQAS)
57
samples are to be treated as ordinary human specimens for the usual processing and examination
External Quality Assessment Scheme (EQAS)
58
certificate of participation is required for renewal of the laboratory’s license from the DOH-HFSRB
External Quality Assessment Scheme (EQAS)
59
T/F: Quality of performance of the participating labs is assessed through remoteness of results to the predetermined value/results
F; closeness of results
59
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)
T
59
T/F: Quality of performance of the participating labs is assessed through reference value generated by the participating laboratories through peer group analysis
T
60
combination of Six Sigma quality management with Lean Manufacturing Strategy
Lean Six Sigma
61
To provide tangible metrics for quality improvement
Lean Six Sigma
61
Lean Six Sigma is pioneered by ________ and developed by __________?
TOYOTA (Lean) MOTOROLA (Sigma)
62
Lean Six Sigma DMAIC
Define Measure Analyze Improve Control
62
METRICS IN MEASURING QUALITY IMPROVEMENT: SIX SIGMA METRICS * represents the capability of a process to meet (or exceed) its defined criteria for acceptability.
Process Sigma
63
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
Kaizen Event
63
METRICS IN MEASURING QUALITY IMPROVEMENT: LEAN IMPROVEMENT ● Common method ● Analogous to the DMAIC method
Kaizen Event
64
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
Process Sigma
65
METRICS IN MEASURING QUALITY IMPROVEMENT: SIX SIGMA METRICS number of defects (errors) per million opportunities (DPMO)
Process Sigma

[MT 6317] Clinical Chemistry Laboratory (10 decks)

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