Lesson 5: QUALITY MANAGEMENT SYSTEM

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119 Terms

1

Traditional

TRADITIONAL OR TOTAL QUALITY

Acceptable quality

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Total Quality

TRADITIONAL OR TOTAL QUALITY

Proactive system

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3

Total Quality

TRADITIONAL OR TOTAL QUALITY

System process

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4

Traditional

TRADITIONAL OR TOTAL QUALITY

Department focused

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5

Traditional

TRADITIONAL OR TOTAL QUALITY

Quality as expense

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6

Total Quality

TRADITIONAL OR TOTAL QUALITY

Us relationship

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7

Total Quality

TRADITIONAL OR TOTAL QUALITY

Quality defined

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8

Traditional

TRADITIONAL OR TOTAL QUALITY

Defects by workers

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9

Traditional

TRADITIONAL OR TOTAL QUALITY

Management-controlled worker

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10

Total Quality

TRADITIONAL OR TOTAL QUALITY

Manage by fact

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11

Total Quality

TRADITIONAL OR TOTAL QUALITY

Continuous quality improvement

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12

Traditional

TRADITIONAL OR TOTAL QUALITY

Status quo

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13

Traditional

TRADITIONAL OR TOTAL QUALITY

Manage by intuition

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14

Total Quality

TRADITIONAL OR TOTAL QUALITY

Empowered worker

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15

Total Quality

TRADITIONAL OR TOTAL QUALITY

Defects by system

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16

Traditional

TRADITIONAL OR TOTAL QUALITY

Intangible quality

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17

Traditional

TRADITIONAL OR TOTAL QUALITY

We vs. they relationship

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18

Total Quality

TRADITIONAL OR TOTAL QUALITY

Quality as means to lower cost

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19

Total Quality

TRADITIONAL OR TOTAL QUALITY

Organization-focused

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20

Traditional

TRADITIONAL OR TOTAL QUALITY

End-process focus

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21

Total Quality

TRADITIONAL OR TOTAL QUALITY

Error-free quality

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22

Traditional

TRADITIONAL OR TOTAL QUALITY

Reactive system

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23

Quality Management System

All of laboratory’s policies, processes, procedures and resources needed to achieve quality testing.

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24

Quality Assurance/Assessment

Process by which laboratory ensures quality results by close monitoring preanalytical, analytical, and postanalytical stages of testing.

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Quality Control

Part of the analytical phase of Quality Assurance (QA)

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Quality Control

process of monitoring results from control samples to verify accuracy of patient results.

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QUALITY CONTROL

It is part of the process management component of the quality system that integrates good laboratory practices to ensure correct patient results.

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QUALITY CONTROL

It is the process of ensuring that analytical results are correct by testing known samples that resemble patient’s sample and comparing their determined values with their expected values (control values).

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Quality Assurance

QUALITY ASSURANCE OR QUALITY CONTROL

Process-oriented

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Quality Control

QUALITY ASSURANCE OR QUALITY CONTROL

Product-oriented

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31

Quality Control

QUALITY ASSURANCE OR QUALITY CONTROL

Try to find defects and correct them while making the product

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32

Quality Control

QUALITY ASSURANCE OR QUALITY CONTROL

all about detection

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Quality Assurance

QUALITY ASSURANCE OR QUALITY CONTROL

all about prevention

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34

Quality Assurance

QUALITY ASSURANCE OR QUALITY CONTROL

Plan to avoid defect in the first place

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35

Quality Assurance

QUALITY ASSURANCE OR QUALITY CONTROL

involves processes managing quality

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Quality Control

QUALITY ASSURANCE OR QUALITY CONTROL

used to verify the quality of the product

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machines, reagents, errors

OBJECTIVES OF QUALITY CONTROL

  • To check the stability of the __________

  • To check the quality of ________

  • To check technical ________

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Control Solutions

Patient-like; should be tested in the same manner as patient samples

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39

Control Solutions

The accuracy of any assay depends on this

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40

Level I, Level II, Level III

In Clinical Chemistry, there are 3-Levels of Control solutions

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normal

Level I of Control Solution means

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abnormal low

Level II of Control Solution means

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abnormal high

Level III of Control Solution means

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Control Solutions

These are either Liquid or lyophilized

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Control Solutions

Composed of one or more analytes of known concentration

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Pooled serum, Commercial control

Types of Quality Control

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Human, Bovine

Two types of pooled serum

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Human

This pooled serum is more expensive but preferred

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Bovine

This pooled serum is the most common animal source

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Commercial control

Usually lyophilized for stability

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Assayed, Unassayed

Two kinds of Commercial Control

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Assayed

This commercial control is more expensive; company analyzed control and established reference range

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Unassayed

This commercial control is without values; get reference range

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Commercial controlI

Requires reconstitution

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incorrect control values

Incorrect mixing of commercial control will lead to

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Intralaboratory Quality Control, Interlaboratory Quality Control

Types of Quality Control

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Intralaboratory Quality Control

This is also known as Internal Quality Control

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External Quality Control

This is also known as Interlaboratory Quality Control

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Random and Systematic Error

What does Internal Quality Control?

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Daily

How often do we monitor Internal Quality Control?

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External Quality Control

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

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External Quality Control

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

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College of American Pathologists Proficiency Program

The gold standard for clinical laboratory external QC testing

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External Quality Control

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

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External Quality Control

Unknown samples must be tested by the laboratorians who regularly perform analysis of patient specimens using the same reagents and equipment for actual patient specimens, and the results are submitted to the program provider, preferably as soon as every analysis is done.

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External Quality Control

Analysis of the unknown samples should be completed within the usual time as for the routine samples.

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External Quality Control

Unknown accuracy samples should be treated like a patient specimen to determine the true essence of the accuracy.

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testing period

Results of the proficiency testing must not be shared with their laboratories during

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non-proficiency test scheme

If there is no available proficiency testing program for certain analyte, it is required to implement a what?

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External Quality Control

If there is no available proficiency testing program for certain analyte, it is required to implement a non-proficiency test scheme.

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every 6 months

Reference standards should be monitored how often?

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Calibration

It is the process of verification by comparing the accuracy of the measuring instrument against a reference standard.

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Reference Standards

This are substances with known concentration used

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Primary, Secondary

Two types of standards

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primary standard

Is an ultra high purity grade compound used in analysis involving assay, identification or purity tests.

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Secondary standards

Also known as working standards

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Secondary standards

These are also high purity grade materials which are quantified in relation to primary standards and put to routine use in laboratories.

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Secondary standards

Limited validity depending on stability of the material and before expiry should be prepared for future use.

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Levey-Jennings Chart

The most common intralaboratory quality control chart used in Clinical Chemistry laboratory; considered as the Gaussian Curve on its side.

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falls with the control limits

When the observed value ____________, it can be interpreted that the method is performed adequately.

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Points falling outside

________________ the control limits suggest that problems may be developing.

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Multi-rules

These were formulized by the Western Electric Company and later applied to the clinical laboratory by Westgard and Groth.

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Multi-rules

establish a criterion for judging whether an analytic process is out of control.

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20

Prior to implementing a new lot number of QC material, both levels of QC material must be analyzed for ___ days.

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Shift

abrupt change in analytic processes.

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Trend

gradual change in analytic processes

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12s

In Westgard Rules, one control observation exceeding the mean +-2s.

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13s

In Westgard Rules, one control observation exceeding the mean +- 3s

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22s

In Westgard Rules, two control observations consecutively exceeding the same +2s or -2s.

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R4s

In Westgard Rules, one control exceeding the +2s and another exceeding the -2s.

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41s

In Westgard Rules, four consecutive control observations exceeding +1s or -1s.

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10x

Ten consecutive control observations falling on one side or the other of the mean (no requirement for SD size.)

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12s

This westgard rule is a warning rule that initiates testing of control data by other rules.

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13s

This westgard rule has high sensitivity to random error

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22s

This westgard rule has high sensitivity to systematic error

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R4s

This westgard rule has detection of random error

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41s, 10x

This westgard rule/s has detection of systematic error

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98

Random Error

No trend or means of predicting it.

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Systematic Error

Will be seen as a trend in a data

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Random Error

Occurs once; non-repeating.

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