Quality Management

Front 1

Overall process that encompassesmethod, quality assurance, benchmarking and other aspects that provide for quality improvement as a means to meet set standard

Back 1

Quality Management

Front 2

This is used to verify the acceptability of new methods prior to reporting patient results

Back 2

Method Evaluation

Front 3

Once a method has been implemented, it is essential that the laboratory ensures it remains valid over time, this is achieved by what process?

Back 3

Quality Control

Front 4

All concepts fall under this umbrella where the entire testing process is directed with the overall goal improving the accuracy of laboratory results.

Back 4

Quality Management

Front 5

This includes maneuvers encountered in the pre-analytic, analytic, and post-analytic phases of testing

Back 5

Quality Assurance

Front 6

This is part of analytical phase

Back 6

Quality Control

Front 7

It is a system of ensuring accuracy and precision

Back 7

Quality Control

Front 8

It is a process that monitors the characteristic of analytical processes and detects analytical errors during testing

Back 8

Quality Control

Front 9

What are the objectives of Quality Control?

Back 9

To check the;

• stability of the machine

• quality of the reagents

• technical errors

Front 10

What are the kinds of Quality Control?

Back 10

• Intralaboratory

• Interlaboratory

Front 11

It an internal quality control, involves analyses of control samples together with the patient's specimen

Back 11

Intralaboratory Quality Control

Front 12

It is important for daily monitoring of accuracy and precision of analytical methods, and detects both random and systematic error

Back 12

Intralaboratory Quality Control

Front 13

It refers to external quality control, that involves proficiency testing program

Back 13

Interlaboratory Quality Control

Front 14

It maintains long-term accuracy, with a difference of >2 in the results indicate non-agreement

Back 14

Interlaboratory Quality Control

Front 15

Characteristics of ideal QC Materials

Back 15

• Resembles human sample

• Inexpensive and stable for long periods

• No communicable diseases

• No known matrix effect

• With known analyte concentration

• Convenient packaging for easy dispensing and storage

Front 16

In analytical variations, what are the types of error in laboratory testing?

Back 16

• Random Error

• Systematic Error

• Clerical Error

Front 17

It is present in all measurements due to chance or an unpredictable cause

Back 17

Random Error

Front 18

It refers to pipetting error, mislabeling, temperature, fluctuation, improper mixing of sample and reagent

Back 18

Random Error

Front 19

It influences observations consistently in one direction

Back 19

Systematic Error

Front 20

It refers to calibration error, deterioration of reagents, unstable reagent blanks, contaminated solutions, failing instrumentations, changes in standard concentration

Back 20

Systematic Error

Front 21

It refers to the highest frequency is due to handwritten labels and request forms

Back 21

Clerical Error

Front 22

is most commonly used histogram in Quality Control, it allows the laboratory to apply multiple rules and detect errors even without the aid of the computer

Back 22

Shewhart Levey-Jennings Chart

Front 23

It is used to identify analytical errors

Back 23

Westgard Control Rules

Front 24

This rule refers to one control value exceeds 2SD; Warning rule; RE

Back 24

12S Rule

Front 25

This rule refers to one control value exceeds 3SD; Reject; Random Error

Back 25

13S Rule

Front 26

This rule refers to two consecutive control values exceed 2SD; reject; Systemstic Error

Back 26

22S Rule

Front 27

This rule refers to the range of difference between the last 2 control values exceeds 4SD

Back 27

R4S Rule

Front 28

This rule refers to four consecutive control values exceed 1SD; Reject; Systematic Error

Back 28

41S

Front 29

This rule refers to ten consecutive control value are on the same side of the mean: Reject: Systematic Error

Back 29

10x

Front 30

What are the patterns in QC charts that indicate errors

Back 30

• Shift

• Trend

• Outliers

Front 31

It is formed by control values that distribute themselves on one side or either side of the mean for 6 consecutive days.

Back 31

SHIFT

Front 32

SHIFT usually indicates what error?

Back 32

CALIBRATION ERROR

Front 33

It is formed by control values that continue to increase or decrease over a period of 6 consecutive days passing through the mean

Back 33

TREND

Front 34

TREND usually indicate what error?

Back 34

DETERIORATION OF REAGENT

Front 35

It is highly deviating control values caused by random systemic errors, almost the same value or range together with other data

Back 35

OUTLIER

Front 36

It refers to the closeness of the result to the true or actual value

Back 36

ACCURACY

Front 37

It is the ability to produce a series of results that agree closely with each other. It is commonly expressed in terms of coefficient of variation

Back 37

Precision

Front 38

The precision is also called

Back 38

REPRODUCIBILITY

Front 39

It involves the analysis of at least 2 levels of control every 24 hours for 20 days, important for the daily monitoring of accuracy and precision of analytical methods

Back 39

INTERNAL/INTRALABORATORY QC

Front 40

It is an algorithm in which a current laboratory results in compared with results obtained on a previous specimen from the same patient

Back 40

DELTA CHECK

Front 41

It involves testing samples of unknown concentration of analytes sent periodically by regulatory agencies to participating laboratories

Back 41

EXTERNAL/INTERLABORATORY QC - PROFICIENCY TESTING

Front 42

Is is the ability of analytical methods to measure the smallest concentration of analytes on interest

Back 42

Sensitivity

Front 43

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

Back 43

Specificity

Front 44

It is the degree by which a method is easily repeated

Back 44

Practicability

Front 45

It is an ability of an analytical method to maintain accuracy and precision over an extended period of time

Back 45

Reliability

Front 46

It is the ability to detect the proportion of individuals with a disease who tested positively wih the test

Back 46

Diagnostic Sensitivity

Front 47

Ability of the test to detect proportion of individuals without the disease whontest negatively for the disease

Back 47

Diagnostic Specificity

Front 48

Ability if a method to detect the smallest concentration of a given analyte

Back 48

Analytic Sensitivity

Front 49

Ability of a method to detect only the analyte it is designed to determine

Back 49

Analytic Specificity