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Scottish Quality Management Discussion Group. ”Quality of service....... is more than CPA compliance”. Presented By; J.D.Keegan Friday 23rd November. 2007 Jim Keegan FCQI. FRSA. Executive Consultant & Healthcare Sector Manager – CDL Previously; Managing Director, International Diamond Certification Ltd. Head of Certification, KPMG (UK) Corporate Business Manager, SGS (GVA) UK Executive Group Member, SGS (UK) National Manager, Scotland, SGS Management Systems Assessor, SGS Management Systems Assessor, Lloyds Register QA. Collinson Dutton Ltd Multi –Disciplinary Management Consultancy and Training Organisation. (IBMS Company Member) Experienced provider of Advisory and Training Services to Healthcare Sector. Recently; Consultancy and Internal Auditor Training to Pathology Laboratories seeking or maintaining CPA Accreditation. What is Quality ? Several accepted general definitions; • Conformance to Requirements • Fitness for Purpose Importantly; • Whatever you are doing ….Getting it Right, First Time, Every Time! The CPA Standard The standard is presented in eight sections: A. Organisation and Quality Management System * B. Personnel C. Premises and environment D. Equipment, Information Systems and Materials E. Pre-examination Process F. Examination Process G. Post Examination Process H. Evaluation and Quality Improvement * Only sections A and H relate to activities that were perhaps not routinely applied in Medical Laboratories. CPA Standard in Context • It’s requirements are Minimum – not Absolute • Deals only with the CPA aspects of the Laboratory Operation. • Does not cover all aspects of the Laboratories QA Management System • CPA defines the “Ingredients” of a standard system • YOU decide how best to use those ingredients • YOU document the system to establish a common basis defining how YOUR process operates. • YOUR chosen system to satisfy CPA must enhance and not detract from current lab practice. • YOUR system does not require 100’s of procedures !!! Management System System Structure Describes the specific activities of the Pathology Department (including laboratories Systems Manual Processes and Procedures Other Quality Documents System Hierarchy Describes the quality system in accordance with stated quality policy and objectives and accreditation standard Describes other detailed work documents (forms, report templates, etc) CPA Standard.......... “The Purpose of complying with CPA Standards is to add value to the service. Standards that do not do this should be challenged or the way in which the Standard is being applied should be changed. Standards are not meant to be followed blindly merely in order to achieve accreditation” .....Cheryl Blair, CPA (UK). Performance Improvement Ongoing Quality & Performance Improvements - must be focus of Pathology Labs. ….Getting it Right, First Time, Every Time. . . . .Testing quicker, more accurately. . . . . Operating at maximum cost effectivity. CPA ‘Improvement Tools’ Audit (You should not need an external body to advise how YOUR system is operating ?.....) • It is essential for a Laboratory to evaluate and determine its OWN performance against internal objectives as well as external requirements. • To identify and address current problems. • To identify further opportunities for improvement. CPA ‘Improvement Tools’ MANAGEMENT REVIEW “...of the quality management system to identify any changes required to meet the needs and requirements of users, and any action needed to ensure the continuation of the service” (CPA. Clause A 11) Management Review ...Why ? Management Systems are dynamic and not static.....They evolve and change over time... ( in response to inherent developments in people , processes, equipment...and not least, statutory legislation). There is a strong emphasis to review the operation, effectiveness and continued suitability of the Management System. Management Review ...Why ? Specifically; • To review Quality Policy and ensure it is still suitable / appropriate. • To update new Quality Objectives for continual improvement. • To review & update existing Processes for effectiveness. • To review & update Procedures to ensure continued suitability. • To review & update Resources (personnel, equipment, infrastructure, environment, materials, etc) to ensure continued suitability. Senior Lab Management • Must sincerely embrace the need for QMS and independent Certification. • Must realise that it is not enough to merely appoint a BMS as QA Manager - they cannot abdicate THEIR responsibility • Must commit to training those BMS’s appointed to QA Roles. • Must manage better integration of on-site Laboratories. • Must recognise ‘spend’ associated with seeking improvement as an investment and not ‘cost’. Performance Improvement Ongoing Performance Improvements must be focus of Pathology Labs. CPA approval in itself is a beginning, a start..... Not the finish. The Future Pathology Integrated Management Systems. One Management System Covering ; MHRA Information / Data Security Human Tissue Act Environment Health & Safety Investor in People Lean Processing ?..... Six Sigma Operating Techniques ? Benchmarking ?...Asset Management ? Contact Details Jim Keegan. Executive Consultant & Health Sector Manager CDL 19 Berkley Street London W1J 8ED Tel : 020 7290 5770 Mobile : 07860 969537 E-mail : [email protected]