Laboratory Quality Management System

Question 1

Vital function of Management

Answer 1

Laboratory Quality Management System

Question 2

What we after?

Answer 2

Quality Assurance

Question 3

Coordinated activities to direct an organization with regard to quality

Answer 3

Quality Management System

Question 4

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

Answer 4

Quality Assurance

Question 5

One of the Earliest Concept of quality management movement

Answer 5

Quality Control Pass

Question 6

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

Answer 6

Shewhart

Question 7

When was quality control were applied in laboratory?

Answer 7

1940s

Question 8

Most recent method that is of importance to the laboratory

Answer 8

Galvin’s work on
MICRO-SCALE ERROR REDUCTION

Question 9

Smallest principle applicable to Quality Assurance

Answer 9

MICRO-SCALE ERROR REDUCTION

Question 10

ISO STANDS FOR

Answer 10

International Organization for Standards

Question 11

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

Answer 11

ISO 9000

Question 12

Addresses general quality management system requirements and applies to laboratories.

Answer 12

ISO 9001:2000

Question 13

Medical Laboratories-particular requirements for quality and competence

Answer 13

ISO 15189:2007

Question 14

General requirements for the competence of testing and calibration laboratories.

Answer 14

ISO/IEC 17025:2005

Question 15

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

Answer 15

Clinical and Laboratory Standards Institute

Question 16

Uses a consensus process involving many stakeholders for developing standards.

Answer 16

Clinical and Laboratory Standards Institute

Question 17

Two Documents that are very important for clinical laboratory

Answer 17

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

Question 18

Representation of the Population

Answer 18

Sample

Question 19

Representative of the Sample

Answer 19

Specimen

Question 20

TAT
The time that we received the sample

Answer 20

Turnaround Time

Question 21

Latin: statin (urgent)
Short Turnaround Time

Answer 21

STAT

Question 22

Sample Management Components

Answer 22

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

Question 23

Analytical Phase of Process Control

Answer 23

Quality Control

Question 24

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

Answer 24

Quality Control

Question 25

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

Answer 25

Quality Control

Question 26

The result is in the prescribed condition

Answer 26

In Control

Question 27

The result is outside the range

Answer 27

Out of Control

Question 28

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

Answer 28

Quantitative Test

Question 29

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

Answer 29

Qualitative Test

Question 30

For fine tuning Has a specific concentration

Answer 30

Calibration

Question 31

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

Answer 31

Controls

Question 32

Graphs to plot control values

Answer 32

Levey Jenning's Test

Question 33

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

Answer 33

Controls

Question 34

Purpose of controls

Answer 34

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

Question 35

Critical Value means

Answer 35

Life Threatening

Question 36

Types and Source of Control Material

Answer 36

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

Question 37

Source of Control Material

Answer 37

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

Question 38

Tempture range of Frozen

Answer 38

0- (-20)

Question 39

Most preferred Control material since it has longer shelves life

Answer 39

Freeze-dried (Lyophilized)

Question 40

Points that are distributed around central location

Answer 40

Variability

Question 41

The number that occurs most frequently

Answer 41

Mode

Question 42

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

Answer 42

Median

Question 43

The arithmetic average of results

Answer 43

Mean

Question 44

Normal Distribution is also called as

Answer 44

Gaussian Distribution Gaussian Bell Distribution

Question 45

The closeness of a measurement to it's true value

Answer 45

Accuracy

Question 46

The amount of variation in the measurement

Answer 46

Precision

Question 47

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

Answer 47

Bias

Question 48

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

Answer 48

68.3%

Question 49

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

Answer 49

95.5%

Question 50

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

Answer 50

99.7%

Question 51

Used to measure precision

Answer 51

Coefficient Variation

Question 52

The most common method for the graphing of the range controls

Answer 52

Levey-Jennings Chart

Question 53

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

Answer 53

James Westgard

Question 54

Variation in QC results that show no pattern

Answer 54

Random

Question 55

Out of SD (Outliers)

Answer 55

Random Error

Question 56

Not acceptable error and indicates shift or trend

Answer 56

Systematic

Question 57

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.

Answer 57

Assessment (Audits)

Question 58

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

Answer 58

Audit

Question 59

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

Answer 59

Audit/Assessment

Question 60

Assessments conducted by groups or agencies from outside the laboratories

Answer 60

External Audits

Question 61

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

Answer 61

External Audit

Question 62

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

Answer 62

Internal Audit

Question 63

External Auditors

Answer 63

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

Question 64

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

Answer 64

Standards

Question 65

Allows laboratory to look at it's own processes

Answer 65

Internal audit

Question 66

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

Answer 66

External Quality Assessment (EQA)

Question 67

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.

Answer 67

Proficiency Testing

Question 68

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

Answer 68

Rechecking or Retesting

Question 69

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

Answer 69

On site Evaluation

Question 70

Management Process

Answer 70

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

Question 71

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

Answer 71

Normative Documents

Question 72

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.

Answer 72

Standard Documents

Question 73

Any standard that is mandated by governmental agency or authoritative body

Answer 73

Regulation

Question 74

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

Answer 74

ISO (International Organization for Standardization)

Question 75

Central Secretariat of ISO

Answer 75

Geneva, Switzerland

Question 76

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

Answer 76

CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE)

Question 77

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

Answer 77

CEN (EUROPEAN COMMITTEE FOR STANDARDIZATION)

Question 78

Developed several standards for disease specific diagnostic laboratories

Answer 78

World Health Organization (WHO)

Question 79

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

Answer 79

JCI (JOINT COMMISSION INTERNATIONAL)

Question 80

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

Answer 80

CAP (COLLEGE OF AMERICAN PATHOLOGIST)

Question 81

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

Answer 81

CAP (COLLEGE OF AMERICAN PATHOLOGIST)

Question 82

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

Answer 82

CERTIFICATION

Question 83

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

Answer 83

ACCREDITATION

Question 84

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

Answer 84

Licensure

Question 85

Agreement between delegations representing all the stakeholders concerned

Answer 85

Consensus

Question 86

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

Answer 86

Normative Statement

Question 87

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

Answer 87

Informative Statement

Question 88

Meets both the text and the spirit of a requirement

Answer 88

Compliance

Question 89

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

Answer 89

Non-conformity

Question 90

Conformation by examination of evidence

Answer 90

Verification of Conformity

Question 91

Transcribe PDCA

Answer 91

Plan-Do-Check-Act

Question 92

Identify the problems and potential sources of system weakness or error

Answer 92

Plan

Question 93

Put plan into actions. Implement whatever plans have been developed

Answer 93

Do

Question 94

Refers to the monitoring process

Answer 94

CHECK

Question 95

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

Answer 95

Act

Question 96

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

Answer 96

Lean

Question 97

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

Answer 97

Six Sigma

Question 98

Aka Metrics

Answer 98

Quality Indicators

Question 99

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

Answer 99

Quality Indicators

Question 100

It starts that quality objective should be measurable

Answer 100

ISO 9001 [5.4.1]

Question 101

The evidence can be gathered and counted

Answer 101

Measurable

Question 102

The laboratory has the capability of gathering the evidence it needs

Answer 102

Achievable

Question 103

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

Answer 103

Interpretable

Question 104

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

Answer 104

Actionable

Question 105

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

Answer 105

Balanced

Question 106

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

Answer 106

Engaging

Question 107

Consider indicators with both short term and long term implications

Answer 107

Timed

Question 108

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

Answer 108

Retiring a Quality Indicator