1. UKAS experience
Julita Jaudzemaite 2016

2. KGC
The North West Thames Regional Genetics Service (Kennedy-Galton Centre) is based at Northwick Park Hospital, Harrow, as part of the London North West Healthcare Trust (the Trust)
Provides an integrated cytogenetic and molecular genetics diagnostic service to residents of North West London, Hertfordshire and Bedfordshire.
The laboratory is CPA accredited (CPA reference numbers 1773 & 2148 ).

3. ISO
ISO (International Organization for Standardization) is taken from the Greek word ‘isos’ meaning equal
The International Organization for Standardization is a worldwide federation of national standards bodies from more than 160 countries
Internationally recognised standard
Better Communication with with partners
Adoption of this standard in clinical laboratories gains an edge with reputation and user confidence
ISO 15189:2012 ‘Medical laboratories -- Requirements for quality and competence’

4. UKAS
The United Kingdom Accreditation Service (UKAS) is the sole national accreditation body for the United Kingdom
In 2009 CPA became a wholly owned subsidiary of UKAS as part of a strategy to modernise pathology services in the UK
UKAS managing transition from all CPA accredited laboratories to UKAS accreditation (ISO 15189; 2012)

5. Inspections
Assessed against CPA and ISO standards simultaneously
Assessing for competence
Aim to look at all process in conjunction not as a separate areas
Non conformances raised against one or both sets of standards
Clearing findings 8 weeks (CPA) 12 weeks(ISO)
A four year cycle.Three surveillance activities and one with a full team on site for year (reassessment)
Subsequent inspections ISO only
Improvement actions must come from the laboratory for all the raised findings

6. CPA and ISO: what’s different?
Different approach and expectations of assessment
Overlap with CPA standards but additional requirements
Some key differences which will need to be assessed

8. Quality Management System Requirements Overview
Assurance
Ethical conduct
Internal audits
Non conformities and corrective/preventive action
Responsibility and Documentation
Documented responsibilities and authorities
Quality policy, objectives, manual
Control of records

9. Technical Operational Requirements Overview
Personnel:
Personnel qualification and job description
Training
Competence assessment
Performance review
Personal development

10. Technical Operational Requirements Overview
Facilities and environmental controls
Facilities maintenance and control
Temperature mapping
Room Temperature Records
Air conditioners
Storage facilities

11. Technical Operational Requirements Overview
Assessment and Control
Reagents, equipment and consumables acceptance testing
Equipment calibration and traceability
Equipment maintenance and repair
Reagents, equipment and consumables records
Reagents and consumables inventory management

12. Technical Operational Requirements Overview
Laboratory Information management
Access to data and information
Validated by supplier
Verified for function by the laboratory before introduction
Protected from unauthorized access

13. Advice Hectic couple of days Everyone will be involved
Majority of lab staff will be witnessed at some point
Meetings prior to the visit
Consistency through the whole department
The turnaround time targets

14. Advice Assessors can go around asking questions
You might be asked about the quality policy: where to find it?
You might be asked about the equipment you are using, so know: has it been serviced recently? What would you do if isn’t working?
Make sure that equipment are in range
They are aiming to prove that you meet the standards not that you don't!!!

15. Summary
Covers the essential elements for medical laboratories to demonstrate the quality and competence of their services
An evidence based international standard
Changes are in specific areas but impact on the whole standard