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2.1 Professional Practice > Accreditation > Flashcards

Accreditation Flashcards

1
Q

What is the point of accreditation?

A

How do we know our labs are safe?

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2
Q

What is accreditation?

A

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

Based on compliance with international and European standards

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3
Q

Who is responsible for legal framework across Europe?
(2)

A

Provision of accreditation services across Europe

European co-operation for Accreditation (EA) is the co-ordinating organisation for the national European accreditation infrastructure

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4
Q

How is legal framework spread across Europe?
(5)

A

One national accreditation body (NAB) per member state

Independent, not-for-profit

Appropriately resourced by Member State

NABs to be members of EA

Balanced participation of interested parties

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5
Q

What is the system of accreditation
(4)

A

An accreditation body which, oversees the assessments and grants accreditation (and may also set standards)

The standards with which a laboratory must comply in order to gain acccreditation

The inspectors who seek to establish compliance with the standard by conducting the assessment

The user

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6
Q

Who is responsible for accreditation in Ireland?

A

The Irish National Accreditation Board (INAB)

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7
Q

What ISO is lab accreditation

A

ISO 15189 sincce 2003

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8
Q

Since when has the blood bank required accreditation

A

Nov 2008

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9
Q

List some international accreditation bodies

A

United Kingdom Accreditation Service - UKAS

Clinical Pathology Accreditation - CPA

College of American Pathologists - CAP

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10
Q

What is HIQA?

A

Health Information and Quality Authority

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11
Q

What is HIQA responsible for?
(4)

A

Responsible for driving quality and safety in Ireland’s health and social care services through

Leaders in developing and implementing a world class health service accreditation system for Ireland

Whole hospital accreditation

Through accreditation programmes management and staff are helped to identify the strengths of their hospital as well as areas for improvement

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12
Q

Is accreditation voluntary?

A

At present the demand for accountability and quality service is driving the accreditation process

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13
Q

When is accreditation imposed

A

Blood transfusion service by HSE (EU directive)

In the USA and Australia, accreditation is mandatory

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14
Q

Why is it crucial for accreditation in public Lab’s

A

More critical for public Lab’s now due to potential procurement procedure for services

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15
Q

Why is accreditation important
(4)

A

It recognises competence

It acknowledges that being in compliance with recognise standards is important

Accreditation guides organisations in identifying their strengths and provides opportunities for improvement

It also allows for better understanding of the objectives and complexities of the work of the organisation

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16
Q

What are scopes of accreditation?
(2)

A

It lists all of the activities that your laboratory is accredited perform

Discipline specific - blood blank - specific test

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17
Q

What is the process of accreditation?
(5)

A

The user laboratory decides they want to go for accreditation

They notify/apply to the accreditation body (INAB)

INAB employ an inspector who has expertise in the area

The inspector determines if the user lab is working to the standards and makes recommendations to INAB

INAB will either refuse or grant accreditation

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18
Q

List the steps in accreditation
(7)

A

Enquiry

Self assessment

Application

Preassessment

Preassessment Visit

Assessment

Recommendations

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19
Q

Write about the enquiry step of accreditation

A

Notify INAB of your intention to seek registration

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20
Q

Write about the self assessment step of accreditation

A

Lab reviews its current procedures and documentation against the requirements of the applicable accreditation standard, INAB regulation and INAB terms and conditions

21
Q

Write about the application step of accreditation

A

Key information requested includes the specific tasks (tests, calibrations, insepctions, examinations, etc) for your accreditation, copies of the management system documentation and technical procedures, and information on accommodation (facilities, buildings, rooms and the like), equipment and quality control activities

22
Q

Write about the preassessment step of accreditation

A

The lead assessor reviews the applicant’ documentation to establish whether the lab has the necessary resources and capability to meet accreditation requirements

23
Q

Write about the preassessment visit step of accreditation
(2)

A

In some instances the lead assessor will visit the lab to review the facilities and any equipment that is part of the activities being assessed

An opportunity for the lab to discuss its application more thoroughly with the team and for the team to discuss the format of the assessment visit

24
Q

Write about the assessment step of accreditation

A

The most important part of the assessment consists of on-site observations of the laboratory.

The object of assessment is to establish by observation whether the work of the laboratory is conducted in accordance with the relevant accreditation standard and INAB regulations.

Assessors need to form a general impression of the organisation’s capability, and in particular the suitability of the equipment / facilities for the work for which accreditation is sought.

Equally, they need to assess the competence of the staff and the effectiveness of the management system in ensuring that errors are avoided

25
Q

Write about the recommendation step of process of application
(4)

A

The summary report form summarises the assessors’ findings, highlights matters needing corrective actions/plans and records the assessment team’s agreed recommendations to INAB concerning the award of accreditation

Award accreditation unconditionally

Award accreditation conditional on the satisfactory clearance of all nonconformities as raised during the assessment within the agreed timeframe

Refuse accreditation

26
Q

Write about the recommendation step of process of application
(4)

A

The summary report form summarises the assessors’ findings, highlights matters needing corrective actions/plans and records the assessment team’s agreed recommendations to INAB concerning the award of accreditation

Award accreditation unconditionally

Award accreditation conditional on the satisfactory clearance of all nonconformities as raised during the assessment within the agreed timeframe

Refuse accreditation

27
Q

When are nonconformities categories

A

At the assessment team private meeting

28
Q

How are nonconformities cateforised

A
  1. A ‘minor’ nonconformity is the failure to comply with the scheme requirements e.g.
  2. A ‘major’ nonconformity is the failure to comply with the scheme requirements to the extend that would compromise the confidence that is placed in the accredited activity, or where quality arrangements are demonstrably inadequate or absent for a major aspect of a labs work
29
Q

What happens following the granting of INAB accreditation
(2)

A

The lab will receive annual surveillance assessment and reassessment visit

These monitor compliance with the relevant accreditation standard and INAB regulations

30
Q

Why are standards needed?

A

The effectiveness of any accreditation system is crucially dependent on the standards adopted and on the objectivity of assessment of compliance

31
Q

What is a standard

A

A level of excellence or quality

32
Q

What should be standardised in the laboratory
(2)

A

All operational activities associated with the collection, transport, reception and registration of specimens or samples, their analysis and reporting should be standardised

In all accredited systems there is a requirement for extensive documentation

33
Q

What is an ISO

A

International Organisation for Standardisation

34
Q

What is ISO?

A

A network of the national standards institutes of 156 countries

35
Q

How many ISO members are there per country

A

1 member per country

36
Q

Where is the central secretariat for ISO and what do they do?

A

Geneva, Switzerland

They coordinates the system

37
Q

What is the ISO

A

It is the world’s largest developer of standard

38
Q

What does the ISO do?

A

Its principal activity is the development of technical standards, ISO standards also have important economic and social repercussions

39
Q

What is ISO 9000 Family concerned with?

A

Quality Management

40
Q

What does ISO 9000 relate to?
(3)

A

The customer’s quality requirements

Applicable regulatory requirements while aiming to enhance customer satisfaction

To achieve continual improvement of its performance in pursuit of these objectives

41
Q

What is ISO 15189 concerned with?

A

Quality Management in the Medical Laboratory

Used for self evaluation and accreditation by INAB in Irish Hospital Laboratories

42
Q

What are the five steps to ISO Standards

A

Scope
Normative references
Terms and definitions
Management requirements
Technical requirements

43
Q

What are SOPS

A

Standard Operating Procedures

44
Q

What are SOPs

A

A set of instructions
Provide for standardisation
Laboratory procedure, process and quality control

Good quality assurance based on SOPs

45
Q

What is the SOP Format
(13)

A

Scope
Responsibility
References
Definitions
Reagents and equipment
Specimen collection and special considerations

Performance of test
Limitations
Recording and calculation of results
IQC
Maintenance
Risk assessment
Cross referencing

46
Q

What are the two noticeable aspects of impact

A

Workload
Additional positions

47
Q

Write a note on workload
(3)

A

Management of the process

Often done in-house by staff grades

Meetings, communications

48
Q

Write a note on the additional positions

A

Quality manager
Safety officer

49
Q

Write a note on the benefits of SOPs
(6)

A

Provide a quality service
Achieve and maintain quality standard
Obtain funding, equipment etc
Assure external users of quality service
Competition (private sector)
Specific tests-selling point

2.1 Professional Practice (10 decks)

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