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Laboratory Management > Assessment: Norms and Accreditation > Flashcards

Assessment: Norms and Accreditation Flashcards

1
Q

Recognition as delivering accurate and reproducible results

A

Laboratory Assessment

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2
Q

Recognition in lab quality

A

Accreditation

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3
Q

Recognition of compliance with the quality standards and norms used for the assessment

A

Laboratory Assessment

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4
Q

Implements international or national standards

A

Laboratory Director

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5
Q

Seeks information about appropriate norms and standards

A

Laboratory Director

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6
Q

Seeks information about accreditation and certification processes

A

Laboratory Director

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7
Q

Uses outcomes to provide better service

A

Laboratory Director

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8
Q

Must have initiative for accreditation

A

Laboratory Director

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9
Q

Explains the process for meeting standards to staff

A

Quality Manager

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10
Q

Organizes the laboratory in preparation for assessments

A

Quality Manager

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11
Q

The one that assesses medtechs/laboratorians

A

Quality Manager

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12
Q

Aware of requirements

A

Laboratorian

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13
Q

Contributes to meeting standards

A

Laboratorian

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14
Q

Aware of assessment processes

A

Laboratorian

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15
Q

Helps prepare for assessment

A

Laboratorian

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16
Q

Medtechs are called ______

A

Laboratorian

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17
Q

Type of document that provides rules, guidelines or characteristics for activities or their results

A

Normative document

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18
Q

Type of document that contains recommendations ng manufacturer pag bibili ng reagents (insert)

A

Normative document

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19
Q

Type of document that established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context

A

Standard document

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20
Q

Type of document
that is developed by ISO and CLSI

A

Standard document

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21
Q

Type of document
that any standard that is mandated by a governmental agency or authoritative body

A

Regulation

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22
Q

Own accreditation requirements established by many agencies, organizations, or regions

A

Self-developed Standards

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23
Q

Give advantages of Self-Developed Standards

A

optimized for local use, recognized local strengths and weaknesses
 can be developed in progressive steps
 can lead to full international recognition

24
Q

Give disadvantages of Self-Developed Standards

A

 may be narrow or biased
 may not be recognized by other organizations

25
Q

International organizations include:

A

▪ ISO (International Organization for Standardization)
▪ CLSI (Clinical and Laboratory Standard Institute)
▪ CEN (Comité Européen de Normalisation) –European Committee for Standardization
▪ WHO

26
Q

What organization is the world’s largest developer and publisher of international standards?

A

International Organization for Standardization (ISO)

27
Q

What country is ISO located?

A

Geneva, Switzerland

28
Q

How many country does ISO serve?

A

157 countries

29
Q

What organization promotes the development and use of voluntary consensus standards and guidelines within the health care community

A

Clinical and Laboratory Standards Institute (CLSI)

30
Q

National standards bodies in the European Economic Community and associated countries

A

European Committee for Standardization
(CEN)

31
Q

What organization has developed several standards for disease-specific diagnostic laboratories, such as polio, tuberculosis, influenza, measles

A

World Health Organization (WHO)

32
Q

Give criteria for a certain organization to be accredited in WHO

A
  • 150 samples processed annually
  • Participates regularly
  • Nag rereport palagi ng case sa WHO
33
Q

National Standards and Technical Guidelines:

Based on international standards

Adapted to the culture and general condition of the country

A

Country-specific standards

34
Q

National Standards and Technical Guidelines:

Supplement ISO standards with technical guidance for use in laboratories

Can address a specific kind of testing

A

Guidelines

35
Q

National Standard of France

A

GBEA (Guideline for Good Analysis Performance)

36
Q

National Standard of Thailand

A

BLQS (Bureau of Laboratory Quality Standards)

37
Q

National Standard of U.S

A

CLIA (Clinical Laboratory Improvement Amendments of 1988)

38
Q

Procedure by which a third party gives written assurance that a product, process or service conforms to specific requirements.

A

Certification

39
Q

Procedure by which an authoritative body gives formal recognition that a body or person is competent to care out specific tasks.

A

Accreditation

40
Q

Granting of ability to practice provided most often by a local governmental agency, usually based on demonstrated knowledge, training and skills.

A

Licensure

41
Q

Elements of an Accreditation Process

A

Accreditation Body
Standards
Assessors
User laboratory

42
Q

Give examples on commonly used standards on CERTIFICATION

A

 ISO 9001:2000
 ISO 14000

43
Q

Give examples on commonly used standards on ACCREDITATION

A

❑ ISO 17025
❑ ISO 15189
 WHO polio standards

44
Q

Give examples on commonly used standards on REGULATION

A

 US CLIA Regulations
 French GBEA
 UN Transport of Dangerous Goods Regulations

45
Q

Scope of ISO 17025

A

General
requirements
for competence

Does not cover compliance with regulatory and safety requirements for laboratory operations

46
Q

Scope of ISO 15189

A

Medical
Laboratory
Particular
requirements
for quality & competence

Based on ISO
17025:1999
&
9001:2000

47
Q

What does Accreditation term “Consensus” mean?

A

general agreement

48
Q

What does Accreditation term “Normative Statement” mean?

A

required and essential part of the standard

includes the word “shall”

49
Q

What does Accreditation term “Informative Statement” mean?

A

information (often a ‘note’) that may be explanatory, or cautionary, or provide an example

50
Q

What does Accreditation term “Compliance” mean?

A

meets both the text and the spirit of a requirement

51
Q

What does Accreditation term “Non-conformity” mean?

A

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

52
Q

What does Accreditation term “Verification of conformity” mean?

A

confirmation by examination of evidence

53
Q

True or False:

Accreditation DOES NOT guarantee success,
it is only one step along the quality journey

A

True

54
Q

True or False:

It is an ACCOMPLISHMENT
to receive accreditation

A

True

55
Q

True or False:

It is an ACHIEVEMENT
to maintain accreditation

A

True

Laboratory Management (9 decks)

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