LQMS

Question 1

is a standardized procedure and
practice contributing to the overall quality
of laboratory test results.

Answer 1

Laboratory Quality Management System

Question 2

Involves systematic monitoring of analytic
processes to detect analytic errors and to
prevent reporting of inaccurate test results

Answer 2

Quality control

Question 3

medical laboratory
requires quality in all steps. The test results must be accurate and reliable, and reports must be produced on time without tampering.

Answer 3

Quality Management System

Question 4

quality of a testing
result does not depend on a single step.

Answer 4

Laboratory Quality Management System

Question 5

an international standard that specifies the requirements for quality and competence in medical laboratories.

Answer 5

ISO 15189:2022

Question 6

Quality of process

Answer 6

Quality assurance

Question 7

Quality of product

Answer 7

Quality control

Question 8

requires quality in individual processes, resources, and overall
organizational structure.

Answer 8

Laboratory Quality Management System

Question 9

Laboratory functions that require quality practices

Answer 9

• Environment
• Quality procedures
• Record keeping
• Expert human resource
• Quality reagents
• Quality equipment and instruments

Question 10

more on the process/procedure orientation

Answer 10

Quality assurance

Question 11

More on product orientation

Answer 11

Quality control

Question 12

The practice that encompasses all procedures and activities
directed toward ensuring that a specified quality of product is
achieved and maintained.

Answer 12

quality assurance

Question 13

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

Answer 13

sensitivity

Question 14

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

Answer 14

Specificity

Question 15

Part of the overall goal of quality assurance

Answer 15

quality control

Question 16

It is the nearness or closeness of the assayed value to the true or target
value.

Answer 16

Accuracy

Question 17

It is a process of ensuring that analytical results
are correct by testing known samples that resemble
patient samples.

Answer 17

QC

Question 18

It is one component of the quality assurance
system, and is part of the performance
monitoring that occurs after a test has been
established.

Answer 18

QC

Question 19

three types of accuracy

Answer 19

recovery, interference and
patient sample comparison

Question 20

determines if specific compounds affect the
laboratory tests like hemolysis, turbidity and icteric

Answer 20

interference study

Question 21

determines how much of the analyte can be
identified in the sample

Answer 21

Recovery study

Question 22

study is used to assess presence of error
(inaccuracy) in actual patient sample.

Answer 22

Sample comparison

Question 23

It is the ability of an analytical method to give
repeated results on the same sample that
agree with one another.

Answer 23

Precision or reproducibility

Question 24

It is the ability of an analytical
method to maintain accuracy and precision
over an extended period of time during
which equipment, reagents and personnel
may change.

Answer 24

Reliability

Question 25

It is the degree by which a method is easily repeated.

Answer 25

Practicability

Question 26

It is the ability of the analytical method to detect the proportion of individuals with the disease.

Answer 26

Diagnostic sensitivity

Question 27

It is the ability of the analytical method to detect the proportion of individuals without the disease.

Answer 27

Diagnostic specificity

Question 28

Screening tests require high sensitivity so that no case is missed.

Answer 28

Diagnostic sensitivity

Question 29

Confirmatory tests require high specificity to be certain of the diagnosis.

Answer 29

Diagnostic specificity

Question 30

It reflects the ability of the method to detect true-negatives with very few false- positives.

Answer 30

Diagnostic specificity

Question 31

It indicates the ability of the test to generate more true-positive results and few false- negative.

Answer 31

Diagnostic sensitivity

Question 32

Formula of diagnostic sensitivity

Answer 32

Diagnostic Sensitivity (%)= true positive divided by true positive + false negative x 100

Question 33

Formula of diagnostic specificity

Answer 33

Diagnostic Specificity (%) = true negative divided by true negative + false positive x 100

Question 34

meaning of ATM

Answer 34

Accuracy T-test Mean

Question 35

measured using t-test by comparison of the mean of the value

Answer 35

Accuracy

Question 36

meaning of SPF

Answer 36

Standard deviation Precision F-test

Question 37

measured by f-test by comparison of Standard deviation

Answer 37

Precision

Question 38

The likelihood/probability of the test

Answer 38

Predictive value

Question 39

the percentage of people with positive test results who have the disease

Answer 39

Positive Predictive Value

Question 40

the percentage of people with negative test results who do not have the disease.

Answer 40

Negative Predictive Value

Question 41

Formula of PPV

Answer 41

PPV = True positive divided by true positive + false positive x 100

Question 42

Formula of NPV

Answer 42

NPV = True negative divided by true negative + false negative x 100

Question 43

KINDS OF QUALITY CONTROL

Answer 43

Intralab Quality Control (Internal QC) Interlab Quality Control (External QC)

Question 44

It is important for the daily monitoring of accuracy and precision of analytical methods. DAY TO DAY control

Answer 44

Intralab Quality Control (Internal QC)

Question 45

It is important in maintaining long-term accuracy of the analytical methods.

Answer 45

Interlab Quality Control (External QC)

Question 46

It involves proficiency testing programs that periodically provide samples of unknown concentrations to participating clinical laboratories.

Answer 46

Interlab Quality Control (External QC)

Question 47

It involves the analyses of control samples together with the patient specimens.

Answer 47

Intralab Quality Control (Internal QC)

Question 48

It is also used to determine state-of-the-art interlaboratory performance.

Answer 48

Interlab Quality Control (External QC)

Question 49

A series of unknown samples are sent to the laboratory from the reference laboratory or authorized program provider.

Answer 49

External QC Testing

Question 50

allows each laboratory to compare and evaluate test results or outcomes with those laboratories that use the same methods (reagents and equipment)

Answer 50

Proficiency testing

Question 51

random error

Answer 51

precision

Question 52

systematic error

Answer 52

accuracy

Question 53

considered as a gold standard or confidence limit

Answer 53

+- 2 SD or standard deviation

Question 54

Who check the stability of the machine?

Answer 54

calibrator

Question 55

Who check the quality of reagents?

Answer 55

Quality control reagents

Question 56

What are the 2 levels of controls?

Answer 56

- normal - high

Question 57

What are the 3 levels of immunoassays

Answer 57

- normal - high - low

Question 58

Characteristics of an Ideal QC Material

Answer 58

1. Resembles human sample. 2. Inexpensive and stable for long periods . 3. No communicable diseases. 4. No matrix effects/known matrix effects. 5. With known analyte concentrations (assayed control). 6. Convenient packaging for easy dispensing and storage

Question 59

What is matrix effect

Answer 59

errors caused by manufacturer

Question 60

The test method must be compared always with a method of acceptable accuracy such as____________

Answer 60

Gold standard or reference method

Question 61

Are errors encountered in the collection, preparation and measurement of samples, including transcription and releasing of laboratory results.

Answer 61

VARIATIONS

Question 62

It is present in all measurements; it is due to chance.

Answer 62

Random Error

Question 63

example of random error

Answer 63

- due to instrument - due to environment - due to operator

Question 64

It is an error that influences observations consistently in one direction (constant difference).

Answer 64

systematic error

Question 65

Example of systematic error

Answer 65

- calibration problems - deterioration of reagents and control materials - improperly made standard solutions - contaminated solutions - unstable and inadequate reagent blanks - leaky ion selective electrode

Question 66

what are the three types of systematic error

Answer 66

- Constant Error - Proportional/Slope/Percent Error - Clerical Error

Question 67

it refers to a difference between the target value and the assayed value.

Answer 67

constant error

Question 68

problem with standard deviation

Answer 68

proportional/slope/percent error

Question 69

problem with mean

Answer 69

constant error

Question 70

it results in greater deviation from the target value due to higher sample concentration.

Answer 70

proportional/slope/percent error

Question 71

It is the highest frequency of clerical errors occurs with the use of handwritten labels and request forms.

Answer 71

clerical error

Question 72

It is based on the quantity of error that will negatively affect clinical decisions.

Answer 72

allowable error

Question 73

Indicators of analytic performance

Answer 73

1. internal QC, 2. proficiency testing, 3. accreditation, 4. quality assurance monitoring and 5. laboratory utilization

Question 74

What type of error is Replication study

Answer 74

Random Error

Question 75

What test is used to determine Constant error

Answer 75

Interference study

Question 76

Systemic error

Answer 76

Comparison of methods

Question 77

Proportional error

Answer 77

Recovery study

Question 78

Replication and comparison

Answer 78

Total error

Question 79

Pre-analytical Errors:

Answer 79

1. Incorrect patient identification 2. Improper patient preparation 3. Incorrect specimen collection 4. Mislabeled specimen 5. Incorrect order of draw 6. Incorrect used of tubes for blood collection 7. Incorrect anticoagulant to blood ratio (short draw) 8. Improper mixing of blood and anticoagulant 9. Incorrect specimen preservation 10. Mishandled specimen (transport and storage) 11. Incorrectly interpreted/ordered laboratory test 12. Incomplete centrifugation 13. Incorrect data log-in

Question 80

Analytical Errors:

Answer 80

1. Incorrect sample and reagent volume 2. Incorrect incubation of solution 3. Equipment/instrument malfunction 4. Improper calibration of equipment/calibration error

Question 81

Post-analytical Errors:

Answer 81

1. Unavailable or delayed laboratory results 2. Long turnaround time 3. Incomplete laboratory results 4. Wrong transcription of the patient's data and laboratory results 5. Missing laboratory results 6. Laboratory results submitted to the wrong physician/doctors who did not request for the lab tes

Question 82

Who developed Six Sigma business management strategy?

Answer 82

Motorola, Inc

Question 83

seeks to improve the performance of a process by identifying and eliminating causes of defects and errors, resulting in eliminating variation in the process.

Answer 83

LEAN SIX SIGMA METHODOLOGY

Question 84

to eliminate the waste, such as streamlining a process to reduce wait times or modifying a process to reduce cost.

Answer 84

lean principles work

Question 85

they are being increasingly used to reduce error and waste within the health care system.

Answer 85

lean six sigma

Question 86

reduction of the committed error

Answer 86

six sigma

Question 87

examples of six sigma

Answer 87

- error in the billing - reducing blood wastage in the blood bank

Question 88

example of lean (more on waste in the time)

Answer 88

- turnaround time -wait times - flow or cycle times -

Question 89

What are the 5S in lean principle?

Answer 89

- Set - Sort - Shine - Standardize - Sustain

Question 90

What is the 6S in lean principle

Answer 90

- Set - Sort - Shine - Standardize - Sustain - Safety

Question 91

methodology of six sigma

Answer 91

- Define - Measure - Analyze - Improve - Control

Question 92

Applications of Lean Six Sigma

Answer 92

-1. A universally accepted framework for QI -2. Common language throughout the organization -3. A checklist to guide the process -4. Control measures to sustain improvements and offer long-term monitoring

Question 93

Six Sigma metrics measured using

Answer 93

Defects (errors) per million opportunities (DPMO).