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PMLS1 Finals 1st Sem > Quality > Flashcards

Quality Flashcards

1
Q

Part of the quality management system is the

A

quality control and quality assurance

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2
Q

order of quality management system

A

sa taas QMS, below it QC and QA

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3
Q

Part of quality management focused on fulfilling
quality requirements

A

quality control

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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

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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

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5
Q

same as test sample. No
components or known substance with its value.

A

control material

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6
Q

GOAL OF QC:

A

detect error and correct them before
patient’s results are reported.

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7
Q

measure the
quantity of a particular substance in a sample.

A

quantitative examinations

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8
Q

measurements in quantitative examinations should be

A

accurate and precise

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9
Q

in HIV the results are either

A

reactive or non-reactive

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9
Q

in HIV the results are either

A

reactive or non-reactive

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10
Q

results
are expressed as an estimate of the measured
substance

A

semi quantitative examination methods

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11
Q

how to set up quality control

A

QC program steps

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12
Q

what are the QC program steps

A
  1. establish written policies and procedures
  2. train staff
  3. assure complete documentation
  4. review qc data
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13
Q

explain the first step of the QC program steps

A
  1. 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
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14
Q

explain the third step of the QC program steps

A
  1. Assure complete documentation
     Once staffs are dependent dapat lahat ng
    figures, entries sa QC
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15
Q

explain the 4th step of the QC program steps

A
  1. Review QC data
     Once data has been created. Review data and
    see what needs to be improved, errors that need
    attention, corrective actions
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16
Q

explain the 4th step of the QC program steps

A
  1. Review QC data
     Once data has been created. Review data and
    see what needs to be improved, errors that need
    attention, corrective actions
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17
Q

measure that must be included during each assay
run to verify that the test is working properly.

A

QC

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18
Q

what does QC ensure

A

accuracy and precision of result

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18
Q

what does QC ensure

A

accuracy and precision of result

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19
Q

Series of analytical measurements used to assess
the quality of the analytical data.

A

QC

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20
Q

refers to the tools
to make the results correct

A

QC

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21
Q

AIM OF QC:

A

ensure that the results generated by test are
correct

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22
Q

QC is the Series of _______measurements used to _____
the _____of the _____

A

Series of analytical measurements used to assess
the quality of the analytical data.

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23
Q

defined as the overall
program that ensures that the final results
results reported by the laboratory are correct.

A

Quality assurance or QA

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24
Q

Overall management plan to guarantee the integrity
of data

A

Quality assurance (QA)

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25
Q

refers to the system to maintain integrity
defensibility of result

A

Quality assurance (QA)

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26
Q

quality assurance in pre analytical is

A

In pre analytical = nagsulat ng name tas tama,
mga sample ay labelled, lahat ng sample
container tama pinaglagyan

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27
Q

quality assurance in post analytical is

A

Post analytical = kung tama pag relay ng info,
kanino nag relay, how to interpretation, tama ba
reference range na ginamit

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28
Q

AIM OF QA

A

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.

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29
Q

AKA proficiency testing.

A

quality assessment

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30
Q

It is a means to determine quality of the results
generated by the laboratory.

A

quality assessment

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31
Q

what does quality assessment determine

A

quality of the result

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32
Q

QA

A

quality assurance

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33
Q
  • It is a challenge to the effectiveness of the QC and QA program
A

quality assessment

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34
Q

2 type of quality assessment

A

2 types: external and internal quality assessment

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35
Q

example of external quality assessment

A

External – HKMTA, Q-probes, NEQAS or
national external quality assurance scheme (
the external assessment program of dept. of
health in the PH)

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36
Q

variables that affect the quality of the result

A
  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
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37
Q

ideal concept which cannot be achieved

A

true value

38
Q
  • Accepted value of a quantifiable property
A

true value

39
Q

= the value approximating the true value, the difference between the two values are negligible.

A

Accepted true value or measured value

40
Q

What we measure in lab.

A

accepted true value or measured value

41
Q

accepted true value AKA

A

measured value

42
Q
  • Result of individual’s measurement of a quantifiable property
A

accepted true value or measured value

43
Q

= discrepancy between the result of a measurement and the true (or accepted true value)

A

Error

44
Q

2 types of error

A

random error and systematic error

45
Q
  • unpredictable in magnitude and sign, when a large number of measurement of same quantity are made under effectively identical conditions
A

random error

46
Q
  • Creates characteristic spread of result for any test method and cannot be accounted for by applying corrections.
A

random error

47
Q
  • Difficult to eliminate but repetition reduces its influences.
A

Random error

48
Q

random error can be minimized by

A

training, supervision, and adherence to standard operating procedures

49
Q
  • Unavoidable error that’s always present in any measurement. Impossible to eliminate.
A

random error

50
Q

exampleof random error

A

Ex. Errors in pipetting, changes in incubating period

51
Q
  • 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
A

systematic error

52
Q
  • Creates a characteristic bias in test results and can be accounted for by applying a correction
A

systematic error

53
Q
  • May be induced by factors like variations in incubation temp., blockage of plate washer, changes in reagent batch or modifications in testing method.
A

systematic error

54
Q

an error that is Avoidable due to controllable variable in a measurement

A

systematic error

55
Q

= how well a measurement agrees with an accepted value.

A

Accuracy

56
Q

= how well a series of measurements agree with each other.

A

Precision

57
Q

it is essential that lab results are

A

accurate reliable and timely

58
Q

tama

A

accurate

59
Q

reproducible results

A

reliable

60
Q

kung kelan kailangan maibibigay agad

A

timely

61
Q

used to make lab results accurately

A

12 essential elements in quality management system

62
Q

coordinated activity to direct and control an organization with regard to quality

A

quality management system

63
Q

process or system in a lab can be divided to

A

pre analytical/examination, analytical examination , post-analytical or examination

64
Q

selects test

A

doctor

65
Q

evaluates test

A

mt

66
Q

parts of pre analytical

A
  1. patient/client prep
  2. sample collection
  3. personnel competency
  4. test evaluation
  5. sample receipt and accessioning
  6. sample transport
67
Q

parts of examination phase

A

quality control testing

68
Q

control sera

A

substance with no value

69
Q

the method used to test a sample

A

control sera

70
Q

napipick kung normal or abnormal patient

A

control sra

71
Q

3 levels of quality

A

low, high, normal

72
Q

stimulates different conditions of patients on whether they are normal, low or high

A

quality

73
Q

part of the post-analytical or post-examination phase

A

record keeping and reporting

73
Q

part of the post-analytical or post-examination phase

A

record keeping and reporting

74
Q

life and death situation

A

panic value or alert value

75
Q

lab tests are influenced by

A
  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
Q

set of coordinated activities that function as building blocks for quality management

A

12 quality system essentials

77
Q

12 quality system essentials

A
  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
Q

NEQAS

A

national external quality assessment scheme

79
Q

2 types of laboratory assessment

A

internal and external

80
Q

professional development or educational units

A

kelangan umattend seminars, etc. para marenew license

81
Q

quality management system ISO

A

ISO 9000:2000

82
Q

statistical process control

A

walker a. shewhart

83
Q

continual improvement

A

w. edwards deming

84
Q

quality toolbox

A

joseph m. jurah

85
Q

quality by requirement

A

philip b. crosby

86
Q

ISO meaning

A

international standards for organization

87
Q

CLSI

A

clinical and laboratory standards institute

88
Q

CLSI was formerly known as

A

nccls

89
Q

model for QA in design ,development production, installation and servicing

A

ISO 9000:2000

90
Q

general requirements for the competence of testing and collaboration laboratories

A

ISO/IEC 17025/2005

91
Q

Quality management in clinical laboratory

A

ISO 15189:2007

92
Q

describes quality system model, 12 essentials

A

HSI-A2 A quality management system model for healthcare

93
Q

HSI-A2 A quality management system model for healthcare applies to

A

all healthcare system

94
Q

HSI-A2 A quality management system model for healthcare aligns to ____ and parallels to _______

A

HSI-A2 A quality management system model for healthcare aligns to ISO 1589 and parallels to ISO 9000

95
Q

For laboratory services

A

GP26-A3 application of quality system management model

PMLS1 Finals 1st Sem (4 decks)

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