UKAS experience Julita Jaudzemaite 2016

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 ).

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’

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)

Inspections Assessed against CPA and ISO 15189 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 15189 only Improvement actions must come from the laboratory for all the raised findings

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

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

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

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

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

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

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

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!!!

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