Assessment: Norms and Accreditation

Question 1

Recognition as delivering accurate and reproducible results

Answer 1

Laboratory Assessment

Question 2

Recognition in lab quality

Answer 2

Accreditation

Question 3

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

Answer 3

Laboratory Assessment

Question 4

Implements international or national standards

Answer 4

Laboratory Director

Question 5

Seeks information about appropriate norms and standards

Answer 5

Laboratory Director

Question 6

Seeks information about accreditation and certification processes

Answer 6

Laboratory Director

Question 7

Uses outcomes to provide better service

Answer 7

Laboratory Director

Question 8

Must have initiative for accreditation

Answer 8

Laboratory Director

Question 9

Explains the process for meeting standards to staff

Answer 9

Quality Manager

Question 10

Organizes the laboratory in preparation for assessments

Answer 10

Quality Manager

Question 11

The one that assesses medtechs/laboratorians

Answer 11

Quality Manager

Question 12

Aware of requirements

Answer 12

Laboratorian

Question 13

Contributes to meeting standards

Answer 13

Laboratorian

Question 14

Aware of assessment processes

Answer 14

Laboratorian

Question 15

Helps prepare for assessment

Answer 15

Laboratorian

Question 16

Medtechs are called ______

Answer 16

Laboratorian

Question 17

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

Answer 17

Normative document

Question 18

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

Answer 18

Normative document

Question 19

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

Answer 19

Standard document

Question 20

Type of document
that is developed by ISO and CLSI

Answer 20

Standard document

Question 21

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

Answer 21

Regulation

Question 22

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

Answer 22

Self-developed Standards

Question 23

Give advantages of Self-Developed Standards

Answer 23

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

Question 24

Give disadvantages of Self-Developed Standards

Answer 24

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

Question 25

International organizations include:

Answer 25

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

Question 26

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

Answer 26

International Organization for Standardization (ISO)

Question 27

What country is ISO located?

Answer 27

Geneva, Switzerland

Question 28

How many country does ISO serve?

Answer 28

157 countries

Question 29

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

Answer 29

Clinical and Laboratory Standards Institute (CLSI)

Question 30

National standards bodies in the European Economic Community and associated countries

Answer 30

European Committee for Standardization (CEN)

Question 31

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

Answer 31

World Health Organization (WHO)

Question 32

Give criteria for a certain organization to be accredited in WHO

Answer 32

- 150 samples processed annually - Participates regularly - Nag rereport palagi ng case sa WHO

Question 33

National Standards and Technical Guidelines: Based on international standards Adapted to the culture and general condition of the country

Answer 33

Country-specific standards

Question 34

National Standards and Technical Guidelines: Supplement ISO standards with technical guidance for use in laboratories Can address a specific kind of testing

Answer 34

Guidelines

Question 35

National Standard of France

Answer 35

GBEA (Guideline for Good Analysis Performance)

Question 36

National Standard of Thailand

Answer 36

BLQS (Bureau of Laboratory Quality Standards)

Question 37

National Standard of U.S

Answer 37

CLIA (Clinical Laboratory Improvement Amendments of 1988)

Question 38

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

Answer 38

Certification

Question 39

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

Answer 39

Accreditation

Question 40

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

Answer 40

Licensure

Question 41

Elements of an Accreditation Process

Answer 41

Accreditation Body Standards Assessors User laboratory

Question 42

Give examples on commonly used standards on CERTIFICATION

Answer 42

 ISO 9001:2000  ISO 14000

Question 43

Give examples on commonly used standards on ACCREDITATION

Answer 43

❑ ISO 17025 ❑ ISO 15189  WHO polio standards

Question 44

Give examples on commonly used standards on REGULATION

Answer 44

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

Question 45

Scope of ISO 17025

Answer 45

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

Question 46

Scope of ISO 15189

Answer 46

Medical Laboratory Particular requirements for quality & competence Based on ISO 17025:1999 & 9001:2000

Question 47

What does Accreditation term "Consensus" mean?

Answer 47

general agreement

Question 48

What does Accreditation term "Normative Statement" mean?

Answer 48

required and essential part of the standard includes the word “shall”

Question 49

What does Accreditation term "Informative Statement" mean?

Answer 49

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

Question 50

What does Accreditation term "Compliance" mean?

Answer 50

meets both the text and the spirit of a requirement

Question 51

What does Accreditation term "Non-conformity" mean?

Answer 51

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

Question 52

What does Accreditation term "Verification of conformity" mean?

Answer 52

confirmation by examination of evidence

Question 53

True or False: Accreditation DOES NOT guarantee success, it is only one step along the quality journey

Answer 53

True

Question 54

True or False: It is an ACCOMPLISHMENT to receive accreditation

Answer 54

True

Question 55

True or False: It is an ACHIEVEMENT to maintain accreditation

Answer 55

True