MIDTERMS: Quality Management

Question 1

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.

Answer 1

laboratory results

Question 2

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.

Answer 2

QUALITY MANAGEMENT

Question 3

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

Answer 3

QUALITY

Question 4

Quality’s benefits exceed its_____.

Answer 4

cost

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

Question 5

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_____.

Answer 5

quantity

Question 6

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

Answer 6

quality of services

Question 7

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.

Answer 7

laboratory result

Question 8

PRE-ANALYTIC phase

Answer 8

• Patient/Client Preparation Sample
Collection

• Personal Competency Test Evaluations

• Sample Receipt and Accessioning

• Sample Transport

Question 9

Most critical phase?

Answer 9

Analytic

Question 10

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

Answer 10

ANALYTIC

Question 11

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.

Answer 11

Analytic

Question 12

Analytic phase

Answer 12

Testing

Question 13

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.

Answer 13

physician

Medtech

Question 14

Most of the analyzer is involved in the_____ phase.

Answer 14

analytic

Question 15

POST-ANALYTIC

Answer 15

Record keeping
Reporting

+

Access result
Interpret result
Integrate with other clinical info
Clinical action

Question 16

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

Answer 16

Quality Assurance

Question 17

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

Answer 17

Quality assurance

Question 18

BENEFITS OF LABORATORY QUALITY ASSURANCE

Answer 18

• 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.

Question 19

WHY IS QUALITY ASSURANCE OF TESTING IMPORTANT?

Answer 19

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

Question 20

QUALITY ASSURANCE MODEL

Answer 20

1. Proficiency Testing
2. Staff
3. Quality Control

Question 21

Proficiency Testing also known as

Answer 21

EQA

internal or external

Question 22

-aliquots and reagents are used for

Answer 22

Quality Control

Question 23

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

Answer 23

staff or medical technologist

Question 24

STAFFING COMPONENTS:

Answer 24

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

• Appropriate educational credentials

• Appropriate experience

• Receive training

• Competency assessments

Question 25

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

Answer 25

Quality control

Question 26

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.

Answer 26

Quality control

Question 27

A testing designed to assess the "HEALTH" of an analytical method

Answer 27

Quality control

Question 28

Having quality control is essential. It enables us to:

Answer 28

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

Question 29

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

Answer 29

QC

Question 30

Arrange.. PHYSICIAN QC TREATMENT PATIENT RESULT

Answer 30

QC PATIENT RESULT PHYSICIAN TREATMENT

Question 31

HOW DOES BASIC QUALITY CONTROL WORK?

Answer 31

• Run a control sample • Compare result with expected range of values • Check to see if the result is right

Question 32

Is checking if analyzer is producing correct results

Answer 32

QC

Question 33

Quality control is actually measured by STATISTICAL APPROACHES/CONCEPTS:

Answer 33

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

Question 34

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

Answer 34

Levey-Jennings Chart

Question 35

APPLICATION OF MULTIRULE SYSTEMS

Answer 35

• Westgard Rule

Question 36

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

Answer 36

QUALITY ASSURANCE

Question 37

- Is part of quality assurance

Answer 37

QC

Question 38

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

Answer 38

QC

Question 39

Focused on the analvtical process of laboratory testing

Answer 39

QC

Question 40

Measuring the entire process

Answer 40

QA

Question 41

- 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

Answer 41

QC

Question 42

"SETTING" the analyzer to give correct results

Answer 42

Calibration

Question 43

"CHECKING" if the analyzer is producing correct results

Answer 43

Quality control

Question 44

Uses calibrators (standards) > Reagent purchased by the laboratory

Answer 44

Calibration

Question 45

The instrument's calibration and other analytical processes

Answer 45

Quality control

Question 46

Setting the instrument to ZERO - reset the machine

Answer 46

Calibration

Question 47

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

Answer 47

Quality control

Question 48

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

Answer 48

quality control

Question 49

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

Answer 49

known

Question 50

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

Answer 50

performance

Question 51

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

Answer 51

Calibration

Question 52

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

Answer 52

QC

Question 53

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

Answer 53

Quality control

Question 54

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

Answer 54

calibration

Question 55

CRITERIA FOR SELECTION OF CONTROL MATERIAL

Answer 55

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

Question 56

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

Answer 56

MATRIX

Question 57

• 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

Answer 57

6 MONTHS

Question 58

(dehydrated to powder) control material

Answer 58

LYOPHILIZED

Question 59

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

Answer 59

Control materials

Question 60

Levels of control in CC

Answer 60

2

Question 61

Levels of control in Hema

Answer 61

3

Question 62

IMMUNOHEMATOLOGY and HEMATOLOGY, have 3 LEVELS OF CONTROLS:

Answer 62

• Normal control • Abnormally Low Control • Abnormally High Control

Question 63

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

Answer 63

RECONSTITUTION

Question 64

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

Answer 64

LYOPHILIZED FORMS

Question 65

TYPES OF CONTROL MATERIALS

Answer 65

Assayed Unassayed Homemade

Question 66

Type of control material • Target value predetermined o Verify and use • More expensive

Answer 66

Assayed

Question 67

Type of control material • Target values not predetermined • Full assay to be established • Less expensive

Answer 67

Unassayed

Question 68

Type of control material • Pooled sera collected in the laboratory • Full assay, validation needed

Answer 68

"Homemade" or "In-house"

Question 69

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

Answer 69

assayed

Question 70

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

Answer 70

serial

Question 71

T or F In assays Every lab should establish their own range

Answer 71

True

Question 72

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

Answer 72

Clinical Laboratory Standard Institute (CLSI)

Question 73

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

Answer 73

ACCURACY

Question 74

Accuracy can be measured 3 ways

Answer 74

Recovery study Interference study Comparison of Methods of Study

Question 75

- 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

Answer 75

Recovery Study

Question 76

- 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.

Answer 76

Interference Study

Question 77

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

Answer 77

Comparison of Methods of Study

Question 78

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

Answer 78

Recovery Study Interference Study Comparison of Methods of Study

Question 79

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

Answer 79

PRECISION

Question 80

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

Answer 80

PRECISION

Question 81

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

Answer 81

RELIABILITY

Question 82

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

Answer 82

Reliability

Question 83

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

Answer 83

REPEATABILITY/PRACTICABILITY

Question 84

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

Answer 84

REPRODUCIBILITY

Question 85

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

Answer 85

Sensitivity

Question 86

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

Answer 86

Specificity

Question 87

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

Answer 87

Diagnostic sensitivity

Question 88

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

Answer 88

Diagnostic specificity

Question 89

PROFICIENCY TESTING (PT) ALSO KNOWN AS

Answer 89

EXTERNAL QUALITY ASSURANCE (EQA)

Question 90

• Occurs when central organization sends out challenge specimens for testing

Answer 90

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

Question 91

in parasitology the reference laboratory will be your

Answer 91

research Institute for Tropical Medicine or your RITM

Question 92

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

Answer 92

San Lazaro hospital or sent from San Lazaro hospital

Question 93

PURPOSE OF EXTERNAL QUALITY ASSURANCE

Answer 93

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)

Question 94

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) 3. 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. 4. 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 6. _______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

Answer 94

Select testing method Validate method implement routine testing QC statistics adjust/maintain procedure Results reported

Question 95

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

Answer 95

STAFFING COMPONENTS

Question 96

- Ability of analytical method to measure the smallest concentration of the analyte of interest (0.005 > 0.5)

Answer 96

Analytical Sensitivity

Question 97

- Ability of an analytical method to measure only the analyte of interest (1 test > 2 tests)

Answer 97

Analytical Specificity

Question 98

- Ability of the test to detect the proportion of individuals with that disease who test positively with the test

Answer 98

Diagnostic Sensitivity

Question 99

Focuses on true positives

Answer 99

Diagnostic Sensitivity

Question 100

- Ability of the test to detect the proportion of individual without the disease who test negatively for the disease

Answer 100

Diagnostic Specificity

Question 101

Focuses on true negatives

Answer 101

Diagnostic Specificity