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Laboratory Management > Norms and Accreditation > Flashcards

Norms and Accreditation Flashcards

1
Q

This is done to confirm that an establishment follow rules and standards.

A

Assessment

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2
Q

These personnel are responsible for having the initiative to accredit a laboratory.

A

Laboratory Director

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3
Q

These personnel are usually medical technologists and they do tasks up to standard and are aware of the assessment process.

A

Laboratorians

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4
Q

These are documents that provides rules, guidelines or characteristics for activities or their results.

A

Normative Documents

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5
Q

These are documents established by consensus and approved by a recognized body.

A

Standard Documents

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6
Q

These are any form of standard that is mandated by a governmental agency or authoritative body.

A

Regulation

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7
Q

In the Philippines, this is the organization that manages regulations.

A

Department of Health

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8
Q

These are developed accreditation requirements to be used in owned agencies, organizations, or regions.

A

Self-developed Standards

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9
Q

These are some of the advantages of Self-developed Standards.

A

Optimized locally, progressive, and possible international recognition.

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10
Q

These are the weaknesses of Self-developed Standards.

A

Can be biased and may not be recognized.

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11
Q

These are the 4 standard bodies.

A
  1. ISO (International Organization for
    Standardization)
    2.CLSI (Clinical Laboratory Standardization Institute)
  2. CEN (Comite Europeen de Normalisation or European Committee for Standardization)
  3. WHO (World Health Organization)
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12
Q

These are the number of countries that is included in the ISO.

A

157 countries

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13
Q

This is the world’s largest developer and publisher for international standards.

A

International Organization for Standardization (ISO)

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13
Q

This is the percentage of ISO personnel who needs to be in favor for a new standard to be developed.

A

75%

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14
Q

This is a global, non-profit organization that promotes healthcare guidelines and documents developed by experts.

A

Clinical Laboratory Standard Institute (CLSI)

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15
Q

This is a national standard body in Europe and includes openness, transparency, consensus, and integration in its general terms.

A

European Committee for Standardization (CEN)

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16
Q

This is an organization that has developed several standards for disease-specific diagnostic laboratories, such as polio, tuberculosis, influenza, and measles.

A

World Health Organization (WHO)

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17
Q

This is the number of samples annually processed in polio laboratories.

A

150 samples

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18
Q

These are standards that are based internationally and are adapted to the culture and general condition of the country.

A

Country-specific Standards

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19
Q

These are only supplements to the ISO standard with laboratory technical guidance such as addressing specific kinds of tests.

A

Guidelines

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20
Q

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

A

Certification (ISO/IEC 17000)

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21
Q

These are procedures by which an authoritative body gives formal recognition that a body or person is competent to care out specific tasks

A

Accreditation (ISO 15189)

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22
Q

This is defined as granting of ability to practice provided most often by a local governmental agency, usually based on demonstrated knowledge, training and skills.

A

Licensure

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23
Q

These are the 4 elements of an accreditation process.

A

Accreditation Body, Standards, Assessors, and User Laboratory.

24
Q

These are examples of Certification Standards.

A

ISO 9001:2000 and ISO 14000

25
Q

These are examples of Accreditation Standards.

A

ISO 17025 and ISO 15189

26
Q

These are examples of Regulations.

A

US CLIA Regulation, GBEA, and UN Transport of Dangerous Goods Regulation.

27
Q

These are examples of National Standards.

A

GBEA (France), BLQS (Thailand), and CLIA (US)

28
Q

This ISO document encompasses tests calibration sampling.

A

ISO 17025

29
Q

This ISO document encompasses requirements for competency in order to be confirmed or recognized.

A

ISO 15189

30
Q

These are the order of laboratory recognition.

A

Licensure, Certification, then Accreditation

31
Q

This term represents a general agreement in the absence of strong and compelling objection.

A

Consensus

32
Q

This term is required and essential for standardization and includes the word “shall.”

A

Normative Statement

33
Q

This term often includes a ‘note’ that may be for explanatory, cautionary, or exemplary purposes.

A

Informative Statement

34
Q

This term meets both text and spirit of a requirement.

A

Compliance

35
Q

This term is the failure to fulfill a requirement specified by process, structure, or service.

A

Non-conformity

36
Q

This term is the confirmation by examination of evidence.

A

Verification of Conformity

37
Q

This must be done before every patient sample.

A

Quality Control

38
Q

These are tests given to reference laboratories to test their accuracy.

A

Proficiency Testing

39
Q

True or False; Accreditation guarantees success and is the only requirement for the whole quality journey.

A

False, accreditation does not guarantee success and is only one step along the quality journey.

40
Q

True or False: Accredited laboratories tend to perform better in proficiency testing and have a working quality system management.

A

True

41
Q

True or False: Accreditation is viewed as the achievement.

A

False, accreditation is only an accomplishment, and the real achievement is maintaining accreditation.

42
Q

This is the meaning of IEC.

A

International Electrotechnical Commission

43
Q

These are the required personnel in the CEN and where it located.

A

30 National Members, 7 Associates, 2 Councilors and is located in Brussels, Belgium

44
Q

This element of the accreditation process sets the standard.

A

Accreditation Body

45
Q

This element of the accreditation process are the ones that you must comply with to become accredited.

A

Standards

46
Q

This element of the accreditation process seeks to establish compliance with standards through giving assessments.

A

Assessors

47
Q

This element of the accreditation process must comply with the set of standards by being assessed.

A

User Laboratory

48
Q

This characteristic of an accrediting body must require their own accredited status via national or international.

A

Approved

49
Q

This characteristic of an accrediting body must be knowledge and skilled in the standard against they accredit.

A

Knowledgable

50
Q

This characteristic of an accrediting body states that they are established in standards.

A

Standard-based

51
Q

This characteristic of an accrediting body is based on evidences rather than impression and people cannot write their own rules.

A

Objective

52
Q

This characteristic of an accrediting body must have trained and skilled staff and maintained via professionalism.

A

Competent

53
Q

This process of accreditation states that the path towards meeting standards and recognition is rarely straightforward.

A

Commitment

54
Q

This process of accreditation states the path towards accreditation takes time.

A

Planning

55
Q

This process of accreditation states that application standards require knowledge of the standards and how to interpret them.

A

Knowledge

56
Q

This process of accreditation states that the process of accreditation may require reorganization, restructuring, trained staff, and additional equipment.

A

Resources

57
Q

This is important so that clients can have confidence and have claims about quality, performance, and reliability.

A

Value of Accreditation

58
Q

This is a valuable tool to determine the effectiveness of the quality management systems.

A

Accreditation

Laboratory Management (11 decks)

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