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CC LEC > MIDTERMS: Quality Management > Flashcards

MIDTERMS: Quality Management Flashcards

1
Q

It is widely accepted nowadays that medical decisions are reliant on_______ and to have these values for clinical decision making an individual lab test result must have total error small enough to reflect the biological condition being evaluated.

A

laboratory results

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2
Q

Determining and maintaining accuracy requires considerable effort and cost.
However, the benefits that we are going to gain from such is much more higher than its cost.

A

QUALITY MANAGEMENT

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3
Q

Is important to customers.
It can be assessed and monitored.
It can be improved.

A

QUALITY

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4
Q

Quality’s benefits exceed its_____.

A

cost

Bahala na mahal ang gasto basta taas ang QUALITY. Why? Para magbalik ang customers and maasahan ka

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5
Q

QUALITY
• every consumer is going to seek for high quality products and high quality services. However, what takes us away from quality is actually the_____.

A

quantity

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6
Q

Patients are going to select the best healthcare facility based on the_____

A

quality of services

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7
Q

In the laboratory, our product is the______. Thus, it is important to provide them with accurate, precise, and reliable results in order for them to achieve the right diagnosis.

A

laboratory result

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8
Q

PRE-ANALYTIC phase

A

• Patient/Client Preparation Sample
Collection

• Personal Competency Test Evaluations

• Sample Receipt and Accessioning

• Sample Transport

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9
Q

Most critical phase?

A

Analytic

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10
Q

This is the most crucial phase since this we are going to to the testing of our samples.

A

ANALYTIC

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11
Q

If the values are already acceptable, we are going to report them to the respective physicians or to the patient itself in the form of giving out laboratory result and of course we are going to keep our records for future retrieval.

So it is very important that in all three phases we are going to assure quality, we ensure the safety both patients and employees, and provide excellent quality service.

A

Analytic

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12
Q

Analytic phase

A

Testing

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13
Q

Most often______ is only included in the pre-analytic as well as the post-analytic.

________ is the one who involved in the analytic phase of testing.

A

physician

Medtech

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14
Q

Most of the analyzer is involved in the_____ phase.

A

analytic

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15
Q

POST-ANALYTIC

A

Record keeping
Reporting

+

Access result
Interpret result
Integrate with other clinical info
Clinical action

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16
Q

“Planned and systematic activities to
provide adequate confidence that requirements for quality will be met”

A

Quality Assurance

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17
Q

Measurement of the broader dimension of quality from the perspective of the end-user (client) - Bishop

A

Quality assurance

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18
Q

BENEFITS OF LABORATORY QUALITY ASSURANCE

A

• QA provides evidence of good performance

• Laboratory mistakes are prevented

• Significant improvements in testing performance can be achieved.

• Research findings from the College of American Pathologists, the University of Wiscons, and the Centers for Disease Control and Prevention.

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19
Q

WHY IS QUALITY ASSURANCE OF TESTING IMPORTANT?

A

Public expects high quality

Defines parameters & quality goals

Evaluation & improvement system

Assures reliability & comparability of results

Cost effective

Even the simplest of testing is not foolproof

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20
Q

QUALITY ASSURANCE MODEL

A
  1. Proficiency Testing
  2. Staff
  3. Quality Control
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21
Q

Proficiency Testing also known as

A

EQA

internal or external

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22
Q

-aliquots and reagents are used for

A

Quality Control

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23
Q

One of the key components in providing quality service to the laboratory is the…

A

staff or medical technologist

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24
Q

STAFFING COMPONENTS:

A

• Able to execute responsibilities of director, supervisor, testing personnel

• Appropriate educational credentials

• Appropriate experience

• Receive training

• Competency assessments

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25
Q

is the clinical laboratory involves the systematic monitoring of analytic processes to detect analytic errors that occur during analysis and to ultimately prevent the reporting of incorrect patient test results

A

Quality control

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26
Q

is referring to activities that is involved mainly to measure the errors that is involving the analytical phase of the laboratory process and its ultimate goal is to prevent the reporting of incorrect patient test results mainly to ensure accuracy.

A

Quality control

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27
Q

A testing designed to assess the
“HEALTH” of an analytical method

A

Quality control

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28
Q

Having quality control is essential. It enables us to:

A

Error detection
Error prevention
Measure performance (Bias, imprecision, total error)
Monitor performance
Validate performance

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29
Q

results in lab are used to VALIDATE (confirm) whether the instrument IS operating within pre-defined specifications; concluding that patient test results are reliable.

A

QC

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30
Q

Arrange..

PHYSICIAN
QC
TREATMENT
PATIENT RESULT

A

QC
PATIENT RESULT
PHYSICIAN
TREATMENT

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31
Q

HOW DOES BASIC QUALITY CONTROL WORK?

A

• Run a control sample

• Compare result with expected range of values

• Check to see if the result is right

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32
Q

Is checking if analyzer is producing correct results

A

QC

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33
Q

Quality control is actually measured by

STATISTICAL APPROACHES/CONCEPTS:

A

Central Tendency
Range
Standard Deviation (SD)
Coefficient Variation (CV)

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34
Q

Once we have the values, we are going to PLOT THE DATA (PLOTTING DATA)

A

Levey-Jennings Chart

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35
Q

APPLICATION OF MULTIRULE SYSTEMS

A

• Westgard Rule

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36
Q
  • Measuring or assuring the quality of the procedures in the entire laboratory process from pre-analytical, analytical, and post-analytical
A

QUALITY ASSURANCE

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37
Q
  • Is part of quality assurance
A

QC

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38
Q

It is part of the pillars of quality assurance along with staff and professional competency

A

QC

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39
Q

Focused on the analvtical process of laboratory testing

A

QC

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40
Q

Measuring the entire process

A

QA

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41
Q
  • Ensures that the lab tests are done right
  • To ensure that the results produced by the laboratory from the instrument and the method that we use in analyzing samples are accurate
A

QC

42
Q

“SETTING” the analyzer to give correct results

A

Calibration

43
Q

“CHECKING” if the analyzer is producing correct results

A

Quality control

44
Q

Uses calibrators (standards)
> Reagent purchased by the laboratory

A

Calibration

45
Q

The instrument’s calibration and other analytical processes

A

Quality control

46
Q

Setting the instrument to ZERO - reset the machine

A

Calibration

47
Q

Checking if calibration is done right/if instrument is calibrated properly

A

Quality control

48
Q

In case there is a problem in calibration, therefore,_____ results are usuallv fluctuating - indicating error (problem in calibrating procedure)

A

quality control

49
Q

Calibration

Solution that contains a_____ amount of analyte used to calibrate an assay method

A

known

50
Q

Quality control

QC material or solutions used to monitor the_____ (precision and accuracy) of an assay method once it has been calibrated

A

performance

51
Q

Run prior to QC manually by the laboratory analyst or automatically by the microprocessors
controlling the instrument

A

Calibration

52
Q

Run along-side patient samples and results are calculated from
calibration data as the same manner the patient results are calculated

A

QC

53
Q

is actually going to evaluate the type of calibration that was done on the machine

> In case there is a problem in calibration, because __\\results is not good, then therefore = DO NOT
RELEASE THE PATIENT RESULTS - indicates error

A

Quality control

54
Q

In case that quality control results are good, means_____ is done right and you are confident that you are giving accurate results

A

calibration

55
Q

CRITERIA FOR SELECTION OF
CONTROL MATERIAL

A

Closely mimic (same matrix)

Stable for prolonged periods (at least a year)

Inexpensive

Available in aliquots convenient for daily use

Include at least 2 levels of controls

Convenient packaging for easy dispensing and storage

56
Q

= refers to the substance or
base from which the control material is prepared.

A

MATRIX

57
Q

• If you are going to purchase 1 vial of control material, it will be aliqouted into small amounts and it is going to be consumable for AT LEAST______

It is important that once it is stored, it will be stable for long periods of time

A

6 MONTHS

58
Q

(dehydrated to powder)
control material

A

LYOPHILIZED

59
Q

are much more expensive compared to the reagents that you are going to use in your procedure, but despite the expense, it is going to give us/measure the quality of our procedure - we are still benefiting from it despite its cost

A

Control materials

60
Q

Levels of control in CC

A

2

61
Q

Levels of control in Hema

A

3

62
Q

IMMUNOHEMATOLOGY and HEMATOLOGY, have 3
LEVELS OF CONTROLS:

A

• Normal control
• Abnormally Low Control
• Abnormally High Control

63
Q

Problems:______

Make sure that right amount of diluent will be added to avoid altering the concentrations of the analvtes present in the control materials

A

RECONSTITUTION

64
Q

Usually in the CINICAL CHEMISTRY
AREA, we have_______ FORMS of QC materials

A

LYOPHILIZED FORMS

65
Q

TYPES OF CONTROL MATERIALS

A

Assayed
Unassayed
Homemade

66
Q

Type of control material

• Target value predetermined
o Verify and use
• More expensive

A

Assayed

67
Q

Type of control material

• Target values not predetermined
• Full assay to be established
• Less expensive

A

Unassayed

68
Q

Type of control material

• Pooled sera collected in the laboratory
• Full assay, validation needed

A

“Homemade” or “In-house”

69
Q

“If______ materials are used, the values stated on the _____ sheets should be used only as guides

A

assayed

70
Q

Actual values and standard deviation must be established by____ testing in the laboratory”

A

serial

71
Q

T or F

In assays

Every lab should establish their own range

A

True

72
Q

“The __________recommends that at least 20 measurements should be made on “separate” days when the measurement system is known to be stable”

A

Clinical Laboratory Standard Institute
(CLSI)

73
Q

Describes the closeness of a test value to the actual/target/true value

A

ACCURACY

74
Q

Accuracy can be measured 3 ways

A

Recovery study
Interference study
Comparison of Methods of Study

75
Q
  • in _____ study, you are going to get a small aliquot of a concentrated analyte and add it to a patient sample then you are going to measure the method that you are going to validate or evaluate. It measures how much of an analyte can be detected in the presence of all other compounds in a particular matrix
A

Recovery Study

76
Q
  • this is able to determine if the specific compounds found in the sample can affect the measuring or the accuracy of the lab test.

Remember that these ____ substances can actually alter the results by scattering light, absorbing light, and sometimes it is going to react with your reagents.

A

Interference Study

77
Q

examines the patient sample by the method being evaluated with a reference method or gold standard.

A

Comparison of Methods of Study

78
Q

1._____ - by giving a particular concentrated analyte in the patient sample and then measure it
2._______ - add interfering substances and measure the sensitivity of your reference method despite the process of these interfering substances, you are still able to get the accurate result
3._______ - you are going to compare your new method or procedure with the gold standard of that particular test

A

Recovery Study

Interference Study

Comparison of Methods of Study

79
Q

• The consistency of a series of test results
• The closeness of agreement between independent test results obtained under prescribed condition

A

PRECISION

80
Q

The degree of replication of data

Ability of an analytical method to give repeated results on the same sample that agree with one another

A

PRECISION

81
Q

• Refers to the capacity of a method to maintain both accuracy and precision

A

RELIABILITY

82
Q

This is actually our basis for making a particular method as a gold standard

A

Reliability

83
Q

Capacity to produce the same results on one sample again and again when performed by the
same individual using the
same lot number on the
same instruments

A

REPEATABILITY/PRACTICABILITY

84
Q

Capacity of the method to produce the same results on one sample again and again when performed by
different individuals on
different days using
different sets of reagents

A

REPRODUCIBILITY

85
Q

is the ability of an analytical method to measure the smallest concentration of the analyte of interest

A

Sensitivity

86
Q

is the ability of an analytical method to measure only the analyte of interest

A

Specificity

87
Q

is the ability of the test to detect the proportion of individuals with that
disease who test positive with the test

A

Diagnostic sensitivity

88
Q

is the ability of the test to detect the proportion of individual without the
disease who test negatively for the disease

A

Diagnostic specificity

89
Q

PROFICIENCY TESTING (PT) ALSO KNOWN AS

A

EXTERNAL QUALITY ASSURANCE (EQA)

90
Q

• Occurs when central organization sends out challenge specimens for testing

A

PROFICIENCY TESTING (PT) ALSO KNOWN AS EXTERNAL QUALITY ASSURANCE (EQA)

91
Q

in parasitology the reference laboratory will be your

A

research Institute for Tropical Medicine or your RITM

92
Q

For
example, this serum sample
provided from ______ will be tested for
HEPA and others for HIV as
well as for syphilis

A

San Lazaro hospital or sent from San
Lazaro hospital

93
Q

PURPOSE OF EXTERNAL QUALITY ASSURANCE

A

Early warning-system for problems

Measure of laboratory quality

Valuable benchmarking tool (standardization and traceability)

Indicator of where to direct improvement efforts

Monitor of changes in technology and testing practices (evaluation component)

94
Q

METHOD EVALUATION

  1. First we are going to _____ and most often that test method has to be validated
    2._____method

(in case you don’t agree with your results it’s either you improve or develop improvements on that particular method or you are going to select another method and do another validation)

  1. After validating your method and you think that they are also acceptable, you will now be going to______ the method by including it in your routine testing.
  2. In your______, you are going to test it by running QC
    5.______ (monitor performance) if we will have problems with our QC results then we are going to adjust
  3. _______and we will go back to implementation, make it a part of your routine testing. If the QC results are now okay, all the results that is being run by the said method will now be reported
    7.______

SVIRQAR

A

Select testing method

Validate method

implement

routine testing

QC statistics

adjust/maintain procedure

Results reported

95
Q

• Able to execute responsibilities of director, supervisor, testing personnel
• Appropriate educational credentials
• Appropriate experience
• Receive training
• Competency assessments

A

STAFFING COMPONENTS

96
Q
  • Ability of analytical method to measure the smallest concentration of the analyte of interest (0.005 > 0.5)
A

Analytical Sensitivity

97
Q
  • Ability of an analytical method to measure only the analyte of interest (1 test > 2 tests)
A

Analytical Specificity

98
Q
  • Ability of the test to detect the proportion of individuals with that disease who test positively with the test
A

Diagnostic Sensitivity

99
Q

Focuses on true positives

A

Diagnostic Sensitivity

100
Q
  • Ability of the test to detect the proportion of individual without the disease who test negatively for the disease
A

Diagnostic Specificity

101
Q

Focuses on true negatives

A

Diagnostic Specificity

CC LEC (39 decks)

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