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mt_2b > Laboratory Quality Management System > Flashcards

Laboratory Quality Management System Flashcards

1
Q

Vital function of Management

A

Laboratory Quality Management System

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2
Q

What we after?

A

Quality Assurance

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3
Q

Coordinated activities to direct an organization with regard to quality

A

Quality Management System

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4
Q

To assure that every step are at utmost accuracy and precision.
After Quality Management System

A

Quality Assurance

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5
Q

One of the Earliest Concept of quality management movement

A

Quality Control Pass

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6
Q

He developed a method for statistical process control in the 1920s, forming the basis for quality control procedures in the laboratory

A

Shewhart

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7
Q

When was quality control were applied in laboratory?

A

1940s

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8
Q

Most recent method that is of importance to the laboratory

A

Galvin’s work on
MICRO-SCALE ERROR REDUCTION

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9
Q

Smallest principle applicable to Quality Assurance

A

MICRO-SCALE ERROR REDUCTION

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10
Q

ISO STANDS FOR

A

International Organization for Standards

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11
Q

Documents provide guidance for quality in manufacturing and services industries, and can be broadly applied to many other kinds of organization.

A

ISO 9000

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12
Q

Addresses general quality management system requirements and applies to laboratories.

A

ISO 9001:2000

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13
Q

Medical Laboratories-particular requirements for quality and competence

A

ISO 15189:2007

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14
Q

General requirements for the competence of testing and calibration laboratories.

A

ISO/IEC 17025:2005

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15
Q

Formerly known as NATIONAL COMMITTEE FOR CLINICAL LABORATOY STANDARDS (NCCLS)

A

Clinical and Laboratory Standards Institute

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16
Q

Uses a consensus process involving many stakeholders for developing standards.

A

Clinical and Laboratory Standards Institute

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17
Q

Two Documents that are very important for clinical laboratory

A

A quality management system model for health care: second edition
Application of a quality management system model for laboratory services: third edition

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18
Q

Representation of the Population

A

Sample

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19
Q

Representative of the Sample

A

Specimen

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20
Q

TAT
The time that we received the sample

A

Turnaround Time

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21
Q

Latin: statin (urgent)
Short Turnaround Time

A

STAT

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22
Q

Sample Management Components

A

Information needed for requisition forms.
Handling urgent request.
Collection, Labelling, preservation and transport.
Safety practices (leaking or broken containers, contaminated forms, other biohazards)
Evaluating, Processing and Tracking Samples
Storage, retention and disposal

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23
Q

Analytical Phase of Process Control

A

Quality Control

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24
Q

It monitors the processes related to the examination phase of testing and allows for detecting errors in testing system.

A

Quality Control

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25
Q

Gives the laboratory confidence that the test results are reliable before patient results are reported

A

Quality Control

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26
Q

The result is in the prescribed condition

A

In Control

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27
Q

The result is outside the range

A

Out of Control

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28
Q

measure the quantity of an analyte present in the sample, and measurements need to be accurate and precise.

A

Quantitative Test

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29
Q

measure the presence or absence of a substance, or evaluate cellular characteristics such as morphology.

A

Qualitative Test

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30
Q

For fine tuning
Has a specific concentration

A

Calibration

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31
Q

It is used to determine if the calibration is okay
The value is a range

A

Controls

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32
Q

Graphs to plot control values

A

Levey Jenning’s Test

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33
Q

Substances that contain an established amount of the substance being tested - the ANALYTE

A

Controls

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34
Q

Purpose of controls

A

Validate the reliability of the test system.
Evaluate the operator’s performance and environmental conditions that might impact result

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35
Q

Critical Value means

A

Life Threatening

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36
Q

Types and Source of Control Material

A

Frozen (0 to -20)
Freeze-dried (lyophilized)
Chemically preserved (liquid form)

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37
Q

Source of Control Material

A

Purchased (Assayed or unassayed)
Made in House (pooled)

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38
Q

Tempture range of Frozen

A

0- (-20)

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39
Q

Most preferred Control material since it has longer shelves life

A

Freeze-dried (Lyophilized)

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40
Q

Points that are distributed around central location

A

Variability

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41
Q

The number that occurs most frequently

A

Mode

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42
Q

The central point of the values when they are arranged in numerical sequence

A

Median

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43
Q

The arithmetic average of results

A

Mean

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44
Q

Normal Distribution is also called as

A

Gaussian Distribution
Gaussian Bell Distribution

45
Q

The closeness of a measurement to it’s true value

A

Accuracy

46
Q

The amount of variation in the measurement

A

Precision

47
Q

The difference between the expectation of a test and an accepted reference method

A

Bias

48
Q

How many percent of the values will fall within -1SD and +1SD of the mean

A

68.3%

49
Q

How many percent of the values will fall within -2SD and +2SD of the mean

A

95.5%

50
Q

How many percent of the values will fall within -3SD and +3SD of the mean

A

99.7%

51
Q

Used to measure precision

A

Coefficient Variation

52
Q

The most common method for the graphing of the range controls

A

Levey-Jennings Chart

53
Q

Clinical chemist who made rules applied to laboratory to avoid rejecting runs that may be acceptable.

A

James Westgard

54
Q

Variation in QC results that show no pattern

A

Random

55
Q

Out of SD (Outliers)

A

Random Error

56
Q

Not acceptable error and indicates shift or trend

A

Systematic

57
Q

Systematic examination if some part (or sometimes all) of the quality management system to demonstrate to all concerned that the laboratory is meeting regulatory, accreditation, and customer requirements.

A

Assessment (Audits)

58
Q

Based on ISO, this is a systematic independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which required criteria are fulfilled

A

Audit

59
Q

Allows the laboratory to understand how well it is performing when compared to a benchmark or standard.

A

Audit/Assessment

60
Q

Assessments conducted by groups or agencies from outside the laboratories

A

External Audits

61
Q

Can include assessments for the purpose of accreditation, certification, or licensure

A

External Audit

62
Q

Where staff working in one area of the laboratory conduct assessments on another area of the same laboratory

A

Internal Audit

63
Q

External Auditors

A

Health Authorities (DOH, NRL, BRL)
Accreditation Bodies
Agencies or major public health programmes that provide funding for programmes

64
Q

Set of rules or policies or procedures design to check the processes of the laboratory

A

Standards

65
Q

Allows laboratory to look at it’s own processes

A

Internal audit

66
Q

A method that allows for comparison of a laboratory’s performance using an external agency or facility

A

External Quality Assessment (EQA)

67
Q

External providers sends unknown samples for testing to a set of laboratories, and the results of all laboratories are analyzed, compare and reported to the laboratories.

A

Proficiency Testing

68
Q

Slides that have been read are rechecked by a reference laboratory
Samples have been analyzed are retested, allowing for interlaboratory comparison.

A

Rechecking or Retesting

69
Q

Usually done when it is difficult to conduct traditional proficiency testing or to use the rechecking or retesting method

A

On site Evaluation

70
Q

Management Process

A

Handling of Samples
Analyses of Samples
Appropriate Record Keeping
Investigation of any deficiencies
Taking corrective action
Communicate

71
Q

Provides rules, guidelines, or characteristics for activities or their result.

A

Normative Documents

72
Q

Document that established by consensus and approved by a recognized body, that provides for common and repeated use, guidlines or characteristics for activities or thier result, aimed at the achievement of the optimum degree of order in a given context.

A

Standard Documents

73
Q

Any standard that is mandated by governmental agency or authoritative body

A

Regulation

74
Q

Worlds largest developer and publisher of international standards
It is a non governmental organization and it forms between the public and private sectors

A

ISO (International Organization for Standardization)

75
Q

Central Secretariat of ISO

A

Geneva, Switzerland

76
Q

A global, non profit, standards developing organization that promotes the development and use of voluntary consensus standards and guidlines within the healthcare community

A

CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE)

77
Q

Founded in 1961
The general terms includes openness, transparency, consensus, and integration

A

CEN (EUROPEAN COMMITTEE FOR STANDARDIZATION)

78
Q

Developed several standards for disease specific diagnostic laboratories

A

World Health Organization (WHO)

79
Q

Was established in 1998
A not for profit, private affiliate of the joint Commission.

A

JCI (JOINT COMMISSION INTERNATIONAL)

80
Q

Worlds largest association composed exclusively of pathologist certified by the American Board of Pathology

A

CAP (COLLEGE OF AMERICAN PATHOLOGIST)

81
Q

Provide accreditation and proficiency testing to medical laboratories through its laboratory quality solution programs

A

CAP (COLLEGE OF AMERICAN PATHOLOGIST)

82
Q

Procedure by which an independent body gives written assurance that a product, process, or service conforms to specific requirements

A

CERTIFICATION

83
Q

The procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out a specific task

A

ACCREDITATION

84
Q

The granting of ability to practice, usually provided by a local government agency.
Usually based on demonstrated knowledge, training, and skills

A

Licensure

85
Q

Agreement between delegations representing all the stakeholders concerned

A

Consensus

86
Q

Information within a document that is a requirement and essential part of the standard, includes world SHALL

A

Normative Statement

87
Q

Information within a document that is information only; often it is in the term of a NOTE

A

Informative Statement

88
Q

Meets both the text and the spirit of a requirement

A

Compliance

89
Q

Failure to fulfill the requirements of a specified process, structure or service

A

Non-conformity

90
Q

Conformation by examination of evidence

A

Verification of Conformity

91
Q

Transcribe PDCA

A

Plan-Do-Check-Act

92
Q

Identify the problems and potential sources of system weakness or error

A

Plan

93
Q

Put plan into actions.
Implement whatever plans have been developed

A

Do

94
Q

Refers to the monitoring process

A

CHECK

95
Q

Take any corrective action that is required and then recheck to be sure that the solution has worked.

A

Act

96
Q

The process of optimizing space, time, and activity in order to improve the physical paths of workflows.

A

Lean

97
Q

Consists of a formal structure for project planning in order to implement change and improvement

A

Six Sigma

98
Q

Aka Metrics

A

Quality Indicators

99
Q

Established measures used to determine how well an organization meets needs and operational and performance expectations

A

Quality Indicators

100
Q

It starts that quality objective should be measurable

A

ISO 9001 [5.4.1]

101
Q

The evidence can be gathered and counted

A

Measurable

102
Q

The laboratory has the capability of gathering the evidence it needs

A

Achievable

103
Q

The laboratory can make a conclusion about the information that is useful to the laboratory

A

Interpretable

104
Q

The indicator information reports a high or unacceptable level of error, it is possible to do something about the problem identified

A

Actionable

105
Q

Consider indicators that examine multiple aspects of the total testing cycle in the pre-examination, examination and post examination phase

A

Balanced

106
Q

Indicators should be examine the work of all staff, not just one group

A

Engaging

107
Q

Consider indicators with both short term and long term implications

A

Timed

108
Q

Use of a quality indicator only as long as it provides useful information.

A

Retiring a Quality Indicator

mt_2b (5 decks)

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