Accreditation Flashcards
What is the point of accreditation?
How do we know our labs are safe?
What is accreditation?
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
Who is responsible for legal framework across Europe?
(2)
Provision of accreditation services across Europe
European co-operation for Accreditation (EA) is the co-ordinating organisation for the national European accreditation infrastructure
How is legal framework spread across Europe?
(5)
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
What is the system of accreditation
(4)
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
Who is responsible for accreditation in Ireland?
The Irish National Accreditation Board (INAB)
What ISO is lab accreditation
ISO 15189 sincce 2003
Since when has the blood bank required accreditation
Nov 2008
List some international accreditation bodies
United Kingdom Accreditation Service - UKAS
Clinical Pathology Accreditation - CPA
College of American Pathologists - CAP
What is HIQA?
Health Information and Quality Authority
What is HIQA responsible for?
(4)
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
Is accreditation voluntary?
At present the demand for accountability and quality service is driving the accreditation process
When is accreditation imposed
Blood transfusion service by HSE (EU directive)
In the USA and Australia, accreditation is mandatory
Why is it crucial for accreditation in public Lab’s
More critical for public Lab’s now due to potential procurement procedure for services
Why is accreditation important
(4)
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
What are scopes of accreditation?
(2)
It lists all of the activities that your laboratory is accredited perform
Discipline specific - blood blank - specific test
What is the process of accreditation?
(5)
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
List the steps in accreditation
(7)
Enquiry
Self assessment
Application
Preassessment
Preassessment Visit
Assessment
Recommendations
Write about the enquiry step of accreditation
Notify INAB of your intention to seek registration
Write about the self assessment step of accreditation
Lab reviews its current procedures and documentation against the requirements of the applicable accreditation standard, INAB regulation and INAB terms and conditions
Write about the application step of accreditation
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
Write about the preassessment step of accreditation
The lead assessor reviews the applicant’ documentation to establish whether the lab has the necessary resources and capability to meet accreditation requirements
Write about the preassessment visit step of accreditation
(2)
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
Write about the assessment step of accreditation
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
