1
Q
Part of the quality management system is the
A
quality control and quality assurance
2
Q
order of quality management system
A
sa taas QMS, below it QC and QA
3
Q
Part of quality management focused on fulfilling
quality requirements
A
quality control
4
Q
Examining “control” of known substances along
with patient samples to monitor the accuracy and
precision of the complete examination (analytic)
process
A
quality control
5
Q
QC examines ___of known substance along ____
A
Examining “control” of known substances along
with patient samples to monitor the accuracy and
precision of the complete examination (analytic)
process
5
Q
same as test sample. No
components or known substance with its value.
A
control material
6
Q
GOAL OF QC:
A
detect error and correct them before
patient’s results are reported.
7
Q
measure the
quantity of a particular substance in a sample.
A
quantitative examinations
8
Q
measurements in quantitative examinations should be
A
accurate and precise
9
Q
in HIV the results are either
A
reactive or non-reactive
9
Q
in HIV the results are either
A
reactive or non-reactive
10
Q
results
are expressed as an estimate of the measured
substance
A
semi quantitative examination methods
11
Q
how to set up quality control
A
QC program steps
12
Q
what are the QC program steps
A
- establish written policies and procedures
- train staff
- assure complete documentation
- review qc data
13
Q
explain the first step of the QC program steps
A
- Establish written policies and procedures.
Dat nakasulat kung pano gagawin or yung
programa ng QC para lahat iisa lang
interpretation. Lahat ng dapat malaman
anditto dat.
Include corrective actions
14
Q
explain the third step of the QC program steps
A
- Assure complete documentation
Once staffs are dependent dapat lahat ng
figures, entries sa QC
15
Q
explain the 4th step of the QC program steps
A
- Review QC data
Once data has been created. Review data and
see what needs to be improved, errors that need
attention, corrective actions
16
Q
explain the 4th step of the QC program steps
A
- Review QC data
Once data has been created. Review data and
see what needs to be improved, errors that need
attention, corrective actions
17
Q
measure that must be included during each assay
run to verify that the test is working properly.
A
QC
18
Q
what does QC ensure
A
accuracy and precision of result
18
Q
what does QC ensure
A
accuracy and precision of result
19
Q
Series of analytical measurements used to assess
the quality of the analytical data.
A
QC
20
Q
refers to the tools
to make the results correct
A
QC
21
Q
AIM OF QC:
A
ensure that the results generated by test are
correct
22
QC is the Series of _______measurements used to _____
the _____of the _____
Series of analytical measurements used to assess
the quality of the analytical data.
23
defined as the overall
program that ensures that the final results
results reported by the laboratory are correct.
Quality assurance or QA
24
Overall management plan to guarantee the integrity
of data
Quality assurance (QA)
25
refers to the system to maintain integrity
defensibility of result
Quality assurance (QA)
26
quality assurance in pre analytical is
In pre analytical = nagsulat ng name tas tama,
mga sample ay labelled, lahat ng sample
container tama pinaglagyan
27
quality assurance in post analytical is
Post analytical = kung tama pag relay ng info,
kanino nag relay, how to interpretation, tama ba
reference range na ginamit
28
AIM OF QA
AIM OF QA: concerned with much more. That the right test is carried out on the right specimen, and that the right result and right interpretation is delivered to the right person at the right time.
29
AKA proficiency testing.
quality assessment
30
It is a means to determine quality of the results
generated by the laboratory.
quality assessment
31
what does quality assessment determine
quality of the result
32
QA
quality assurance
33
- It is a challenge to the effectiveness of the QC and QA program
quality assessment
34
2 type of quality assessment
2 types: external and internal quality assessment
35
example of external quality assessment
External – HKMTA, Q-probes, NEQAS or
national external quality assurance scheme (
the external assessment program of dept. of
health in the PH)
36
variables that affect the quality of the result
1. edu background and training of lab personnel
2. condition of specimen
3. control used in test run
4. reagent
5. equipment
6. interpretation of result
7. transcription of result
8. reposting of result
37
ideal concept which cannot be achieved
true value
38
- Accepted value of a quantifiable property
true value
39
= the value approximating the true value, the difference between the two values are negligible.
Accepted true value or measured value
40
What we measure in lab.
accepted true value or measured value
41
accepted true value AKA
measured value
42
- Result of individual’s measurement of a quantifiable property
accepted true value or measured value
43
= discrepancy between the result of a measurement and the true (or accepted true value)
Error
44
2 types of error
random error and systematic error
45
- unpredictable in magnitude and sign, when a large number of measurement of same quantity are made under effectively identical conditions
random error
46
- Creates characteristic spread of result for any test method and cannot be accounted for by applying corrections.
random error
47
- Difficult to eliminate but repetition reduces its influences.
Random error
48
random error can be minimized by
training, supervision, and adherence to standard operating procedures
49
- Unavoidable error that’s always present in any measurement. Impossible to eliminate.
random error
50
exampleof random error
Ex. Errors in pipetting, changes in incubating period
51
- In the course of a number of measurement of the same value of given quantity remains constant when measurements are made under the same conditions or varies according to a definite law when conditions change
systematic error
52
- Creates a characteristic bias in test results and can be accounted for by applying a correction
systematic error
53
- May be induced by factors like variations in incubation temp., blockage of plate washer, changes in reagent batch or modifications in testing method.
systematic error
54
an error that is Avoidable due to controllable variable in a measurement
systematic error
55
= how well a measurement agrees with an accepted value.
Accuracy
56
= how well a series of measurements agree with each other.
Precision
57
it is essential that lab results are
accurate reliable and timely
58
tama
accurate
59
reproducible results
reliable
60
kung kelan kailangan maibibigay agad
timely
61
used to make lab results accurately
12 essential elements in quality management system
62
coordinated activity to direct and control an organization with regard to quality
quality management system
63
process or system in a lab can be divided to
pre analytical/examination, analytical examination , post-analytical or examination
64
selects test
doctor
65
evaluates test
mt
66
parts of pre analytical
1. patient/client prep
2. sample collection
3. personnel competency
4. test evaluation
5. sample receipt and accessioning
6. sample transport
67
parts of examination phase
quality control testing
68
control sera
substance with no value
69
the method used to test a sample
control sera
70
napipick kung normal or abnormal patient
control sra
71
3 levels of quality
low, high, normal
72
stimulates different conditions of patients on whether they are normal, low or high
quality
73
part of the post-analytical or post-examination phase
record keeping and reporting
73
part of the post-analytical or post-examination phase
record keeping and reporting
74
life and death situation
panic value or alert value
75
lab tests are influenced by
1. lab environment
2. knowledgeable staff
3. reagent and equipment
4. quality control
5. communication
6. process management
7. occurrence management
8. record keeping
76
set of coordinated activities that function as building blocks for quality management
12 quality system essentials
77
12 quality system essentials
1. organization
2. personnel
3. equipment
4. purchasing and inventory
5. process control
6. info management
7. documents and record
8. occurrence management
9. laboratory assessment
10. process improvement
11. customer group services
12. facilities and safety
78
NEQAS
national external quality assessment scheme
79
2 types of laboratory assessment
internal and external
80
professional development or educational units
kelangan umattend seminars, etc. para marenew license
81
quality management system ISO
ISO 9000:2000
82
statistical process control
walker a. shewhart
83
continual improvement
w. edwards deming
84
quality toolbox
joseph m. jurah
85
quality by requirement
philip b. crosby
86
ISO meaning
international standards for organization
87
CLSI
clinical and laboratory standards institute
88
CLSI was formerly known as
nccls
89
model for QA in design ,development production, installation and servicing
ISO 9000:2000
90
general requirements for the competence of testing and collaboration laboratories
ISO/IEC 17025/2005
91
Quality management in clinical laboratory
ISO 15189:2007
92
describes quality system model, 12 essentials
HSI-A2 A quality management system model for healthcare
93
HSI-A2 A quality management system model for healthcare applies to
all healthcare system
94
HSI-A2 A quality management system model for healthcare aligns to ____ and parallels to _______
HSI-A2 A quality management system model for healthcare aligns to ISO 1589 and parallels to ISO 9000
95
For laboratory services
GP26-A3 application of quality system management model
PMLS1 Finals 1st Sem
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