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CEN Standard on Medical Physics Services: Structure of Standards

Derek Pearson, ECMP 2014, 11 – 14 September 2014, Athens, Greece

Derek Pearson

IPEM representative on the EFOMP Working Group CEN Standard on:

Medical Physics Services

derek.pearson@no3.clara.net

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Standard development process• Informal national standard development – iCEPSS

• based on an existing international accreditation standard – ISO 15189

• goes beyond ISO 15189 but should confer accreditation to ISO 15189 to meet wider certification requirements (ISO 15189 provides assurance to ISO 9001:2008 certification standard)

• Formal national standard development – BSI• Working group established to develop BSI 70000• Generic standard supported by technical notes that are

specialism specific e.g. Radiotherapy Physics

• Proposal to take forwards the BSI standard to CEN as a European standard

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Structure - iCEPSS

• Improving Clinical Engineering and Physical Science Services• UK project managed by the Academy for Healthcare Science

and the Institute of Physics and Engineering in Medicine • Accreditation rather than certification to demonstrate that

services are fit for purpose• Accreditation provided by an independent accreditation

body • Includes Peer Review• Currently >30 standards spread over 5 domains and aligned

with the requirements of ISO 15189

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The standards domains

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The standard structure

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Domain 5: Clinical Scientific Service

• The purpose of the Clinical Scientific Service domain is to ensure the delivery of safe, effective, timely and high quality services. This is achieved through adoption of clinical scientific practices appropriate to patients or service users; effective management of service-- specific risk and ‐emergencies; and the review of existing and new clinical scientific practice to develop and improve the service.

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Key performance indicators set at 4 levels (A-D) for each Standard/Criteria. Accreditation level set at B with best practice identified as A and two pre-accreditation levels (C,D).

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Structure - BSI• Scope• Normative references – other BSI standards that are

essential for interpretation of the standards• Terms and definitions• Management requirements

• Overall system requirements

• Technical requirements• Personnel, training and competence• Facilities• Specific service requirements

• Standards will be generic but allow for development of technical notes that give specialism specific guidance

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CEN Service Standard – CEN guide 15

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Structure CEN standard• Title• Foreword• Introduction• Scope• Normative References• Terms and definitions• General clauses setting out requirements that follow the

service • Service requirements• Education requirements• Organisation requirements

• Annexes – normative and informative – can include curriculum requirements• Bibliography

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Issues• Timetable to publish BSI standard – Jan 2016• EFOMP representation on BSI standards group• Timetable for CEN production 3-4 years – potential

publication in 2019/20• Align standard with other national/international

accreditation standards• Diversity of services vs specificity of CEN standards• iCEPSS standards are available on the Academy for

Healthcare Science for public consultation until 14th November www.ahcs.ac.uk

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iCEPSS Service specific guidance• Each criteria is associated with example evidence that

is:• Specific to each specialty where necessary• Supported by a knowledge base for guidance as to best

practice

• MFR4 C2 There are systems in place to ensure the correct installation, calibration, operation, performance and maintenance of technologies • Radiotherapy - IMRT

• Evidence – procedure for the implementation of a treatment planning system for IMRT

• IPEM report 96 Guidance for the Clinical Implementation of Intensity Modulated Radiation Therapy