Workshops
Training event: ISO 15189:2022 - The New Standard For The Competence Of Medical Laboratories
| A two-day training workshop by the Pancyprian Union of Chemists and the Eurachem Education & Training Working Group |
Overview
The Division of Quality Assurance of the Pancyprian Union of Chemists (PUC) and Eurachem organised a two-day training course on the accreditation of medical laboratories, focusing on the publication of the revised standard ISO 15189:2022. The topic of accreditation of medical laboratories is of interest especially in the light of recent developments with regard to other documents, i.e. legislation, standards and guides (including Eurachem guidance) which were also discussed.
The training course, one of a series of successful events organised by PUC and Eurachem, presented and discussed the new standard, providing the opportunity for interaction between laboratory personnel and other stakeholders. About 50 medical scientists, including colleagues from Cyprus, Greece, Palestine and Poland, participated in the event.
Information about the event, available presentations, and a summary of the discussions, are provided below.
Scope and Information
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Scope
The scope of the training was to:
- present the new standard ISO 15189:2022 (the Standard)
- discuss critical issues of interest to medical laboratories with regard especially to changes and new requirements
- update the awareness for additional needs
- present recent publications (Eurachem guides and others)
- based on the experience of laboratories, discuss problems and solutions
Workshop information
Date: 16-17 March 2023 Venue: Cleopatra Hotel, Nicosia, Cyprus Programme Programme (PDF, 760 kB) Details and invitation Course details and invitation (PDF, 210 kB) Registration: Registration is closed for this event. Programme
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Programme
The event programme, with information about scheduled speakers, can be viewed in PDF format here.
The programme is listed below.
Day 1 - Thursday 16 March 2023
Welcome and introductions
- Welcome addresses
- Eurachem Education & Training WG
- Association of Clinical Laboratory Directors, Biomedical and Clinical Laboratory Scientists
- PUC (Division of Quality Assurance)
- Presentation of the tutors and the participants
Technical programme
- Introduction – Scope and expectations of the training
- Kyriacos Tsimillis, Division of Quality Assurance, PUC
- The new standard; what is changing
Kyriacos Tsimillis and Despina Charalambous
- Comparison with the 2012 version (in brief)
- The structure of the standard - Terminology
- The new provisions - An introduction – POCT requirements
- Transition to the new standard
- Laboratory activities - Scope of accreditation
- Provisions of the new ISO 15189 Standard
Kyriacos Tsimillis and Despina Charalambous- General requirements
- Structural and governance requirements
Break
- Provisions of the new ISO 15189 Standard (continued)
Kyriacos Tsimillis and Despina Charalambous
- Resource requirements – Personnel – Facilities – Equipment
- Process requirements
Lunch break
- Metrological traceability - ISO 17511*
- Elvar Theodorsson [Remote]
- Regulation in in vitro diagnostics
- Elvar Theodorsson [Remote]
Break
- Technical requirements: Steps to be followed by laboratories
- Irini Leimoni
- Exercise 1
- Discussion on Exercise 1
Day 2 – Friday 17 March 2023
- Discussion on Exercise 1 (cont.)
- Control of data and information management
- Kyriacos Tsimillis and Despina Charalambous
- The management system - Options A and B
- Kyriacos Tsimillis and Despina Charalambous
- Risks and opportunities
- Kyriacos Tsimillis and Despina Charalambous
Break
- Measurement uncertainty*
- Mike Ramsey [Remote]
- Uncertainty arising from sampling
- Mike Ramsey
- Exercise 2
Lunch break
- Discussion on Exercise 2 (cont.)
Break
- Management requirements: Steps to be followed by laboratories
- Irini Leimoni
- Genetic Epidemiology of SARS-CoV-2 Infection in Cyprus
- Leontios Kostrikis
- Concluding remarks and close
- Kyriacos Tsimillis, Division of Quality Assurance, PUC
- Welcome addresses
Summary
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Event summary
Organiser's summary
Following the successful events of the years before the pandemic, the Division of Quality Assurance of the Pancyprian Union of Chemists and the Education and Training Working Group of Eurachem, organised a two-day training programme in Nicosia.
About 50 medical scientists, including colleagues from Cyprus, Greece, Palestine and Poland participated in the event which was highly appreciated mainly for the interaction following the presentations by Mike Ramsey (MR), Elvar Theodorsson (ET), Irini Leimoni (IL), Vicki Barwick (VB), Leontios Kostrikis (LK), Despina Charalambous (DC) and Kyriacos Tsimillis (KT). Dr Kostrikis was invited to give his lecture reflecting his wide experience on SARS-CoV-2.
Despite the fact that two of the speakers (MR and ET) interacted on-line, their presentations were well appreciated and activated an interesting discussion. Both of them spent much more time attending the training than what was required for their presentations. VB sent her introductory presentation as a video message.
Two exercises were included in the programme; Exercise 1 was introduced by ET and was based on the document “Questions and answers for enhancing the understanding of metrological traceability” (authored by ET and reviewed by the JCTLM Traceability Education & Promotion Working group and by other beneficiaries of the JCTLM). Exercise 2 addressed the risks issue.
Most of the participants coming from laboratories had experience of the previous standard and the accreditation of their laboratories; in general, their level of awareness was such as to ensure an interesting interaction.
Participant feedback
Participant feedback was positive with the great majority of participants indicating that the content was good and their expectations were met.
Participant suggestions for future workshops included:
- Increased depth for each ISO provision in the Standard
- More information/guidance about genetic testing
- More discussion on the new requirements in particular
- Exercises on how to calculate MU and more interpretation on traceability
- More cases related to medical laboratories, especially management as the main concern in the new version
- More exercises, particularly more clinical examples and practical cases
- A seminar specially on risk assessment
- Workshops on validation & verification and metrological traceability.
- Details
- Last Updated: Saturday, 20 May 2023 16:45