Approaches to improving laboratory quality Dr. Linda Oskam KIT - PowerPoint PPT Presentation

1 Approaches to improving laboratory quality Dr. Linda Oskam KIT Biomedical Research, Amsterdam, the Netherlands L.Oskam@kit.nl

2 ORGANIZATION and MANAGEMENT MEASUREMENT RESOURCES THE WORK AND IMPROVEMENT A a a a A a a a Personnel H h h h a a a B b b b Safety A a a a Assessments a a a H h h h a a a B b b b h b b H h h h B b b b h b b h b b G g g g X Y Z X C c c c G g g g X Y Z X C c c c g g g Y Z c c G g g g X Y Z X C c c c g g g Y Z c c g g g Y Z c c D d d d F f D d d d E e e e d d d D d d d F f f f f f F f d d d E e e e d d d e e e E e e e e e e e e e Occurrence A a a a A a a a Equipment a a a Process Control a a a H h h h B b b b H h h h B b b b A a a a h b b h b b a a a H h h h B b b b h b b G g g g X Y Z X C c c c G g g g X Y Z X C c c c Management g g g Y Z c c g g g Y Z c c G g g g X Y Z X C c c c D d d d D d d d g g g Y Z c c F f F f E e e e d d d E e e e d d d D d d d e e e e e e F f f f f f E e e e d d d e e e Purchasing & Document & A a a a A a a a Customer service A a a a a a a a a a a a a H h h h B b b b H h h h B b b b H h h h B b b b h b b h b b h b b Inventory Records G g g g X Y Z X C c c c G g g g X Y Z X C c c c G g g g X Y Z X C c c c g g g Y Z c c g g g Y Z c c g g g Y Z c c D d d d D d d d D d d d F f F f F f f f f f d d d d d d d d d E e e e E e e e E e e e e e e e e e e e e Facilities & Information Process A a a a A a a a A a a a a a a a a a a a a H h h h B b b b H h h h B b b b H h h h B b b b h b b h b b h b b Safety management improvement G g g g X Y Z X C c c c G g g g X Y Z X C c c c G g g g X Y Z X C c c c g g g Y Z c c g g g Y Z c c g g g Y Z c c D d d d D d d d D d d d F f F f F f f f f f E e e e d d d E e e e d d d E e e e d d d e e e e e e e e e PRE-ANALYTICAL ANALYTICAL POST -ANALYTICAL Sample Sample Sample Sample Sample Sample Sample Sample Recording Reporting Storage Disposal request collection transport reception registration preparation processing examination of results of results of sample of sample

3 Levels of quality implementation Quality management: coordinated activities to direct and control an organization with regard to quality activities and techniques to achieve and maintain the quality of a product, process or service. Quality system: the organizational structure, resources, processes and procedures Quality assurance: prevention of quality problems through planned and systematic activities around processes Quality control: steps taken during the generation of a product or service to ensure product/service quality. Amsterdam, The Netherlands www.kit.nl

4 Licensing, certification and accreditation Licensing: issued by authorities, to allow an activity that would otherwise be forbidden. It may require proving a capability. Certification: confirmation of certain characteristics of an organization. This confirmation is often provided by external assessment. Accreditation: process in which certification of competency , authority, or credibility is presented. Amsterdam, The Netherlands www.kit.nl

5 National laboratory policy and strategic plan development Sign of political commitment • Provides direction • Provides criteria for accepting or refusing • activities Makes sure the country is in the driving • seat Essential for developing sustainability • Amsterdam, The Netherlands www.kit.nl

6 Education A well-trained workforce with up to date knowledge is essential for • well-functioning laboratories • Pre-service training should reflect daily practice • In-service for refresher or additional knowledge Training epidemic, but quality of trainings is variable • National laboratory policy can give direction to education • development Implementation of a QMS means laboratory decides training needs • Amsterdam, The Netherlands www.kit.nl

7 Management and leadership skills Most laboratory managers have technical background, not • managerial background Management and leadership skills are crucial • Management training initiatives : • • SLMTA (Strengthening Laboratory Management Towards Accreditation) • LQMS (Laboratory Quality Management System Training) • WHO Leadership Course for Laboratory Directors Amsterdam, The Netherlands www.kit.nl

8 Proving your quality: Accreditation • Laboratory testing is increasingly recognized as being crucial for diagnosis, treatment, screening and public health  Laboratories want to provide reliable results  Clients want to be certain of the results they get  Funding agencies want to know that there is no waste of resources The most widely used accreditation scheme for medical laboratories is ISO 15189: Medical laboratories — Particular requirements for quality and competence Uganda NTRL accreditation process 2008-2013 Before After Amsterdam, The Netherlands www.kit.nl

9 Needs in establishing a Quality Management System PROBLEM: Standards don’t provide (daily) guidance on implementing requirements • Standard requirements translated into activities • Explanation on why and how and when to carry out activities • Examples of documents, background information on quality management aspects, etc. No laboratory should have to reinvent the wheel.

10 GLI tool The Global Laboratory Initiative has developed the “Stepwise Process towards TB Laboratory Accreditation” • Online tool • Designed to guide National TB Laboratories to ISO 15189:2007 accreditation (soon to be updated to ISO 15189:2012) • Translation of complete ISO 15189 into activities • Divided over 4 phases of implementation with each phase having a specific focus • Supplemented with descriptions on the why and how • Links to additional materials (TB CAP, SLMTA, LQMS) • Checklists for monitoring progress

11 GLI tool – 4 phases

12 GLI tool Available online at: www.GLIquality.org Tool for ALL clinical and public health laboratories that want to • achieve ISO 15189 accreditation Available mid-2013 in English •

13 Laboratory network structure Most patients ISO 15189 Amsterdam, The Netherlands www.kit.nl

14 Laboratory network evaluation Not for individual laboratories, but for laboratory networks • Evaluates network management • To ensure quality of all laboratories in the network • Based on predefined standards • John Ridderhof will present on microscopy network • evaluation Amsterdam, The Netherlands www.kit.nl

15 Designing a tiered quality management system for different levels of laboratories ISO 15189 as the basis • Identify and select the key elements (principles) of ISO 15189 • Standardization • Competence • Traceability • Controls • Customer satisfaction • Design activities and tools that are suitable for lower level • laboratories For licensing or certification • Amsterdam, The Netherlands www.kit.nl

16 Improving laboratory quality - summary National laboratory policies and strategic plans • Well trained technical and managerial staff • (National reference) laboratories striving for ISO 15189 • accreditation • GLI tool • LQSI tool Network evaluation • Tiered quality systems • Amsterdam, The Netherlands www.kit.nl

17 Acknowledgements KIT GLI tool Tjeerd Datema Martin Baker (Univ. Massachusetts) Mirjam Engelberts Chris Gilpin (GLI) Peter Hessels John Ridderhof (CDC) Paul Klatser Jerod Scholten (KNCV) Stella van Beers Tom Shinnick (CDC) Armand van Deun (The Union) NTRL Uganda LQSI tool Moses Joloba Christine Korsah Kenneth Musisi Sébastien Cognat (WHO Lyon) Katrina Roper (WHO Lyon) NTRL Benin Dissou Affolabi Franck Faihun Amsterdam, The Netherlands www.kit.nl

Thank you Amsterdam, The Netherlands www.kit.nl

Examples of specific tools and activities Laboratory handbook • Registration book • Plastified work instructions • Equipment logbooks • Monthly work meetings • Standardized statistics with interpretation tool • Amsterdam, The Netherlands www.kit.nl

Accreditation or certification? Each laboratory individually or laboratory networks? • According to a national or international standard? • Accreditation: • • Only by offical accreditation body, member of ILAC Certification: • • By national body Amsterdam, The Netherlands www.kit.nl

Creating advantages of accreditation or certification License • Payment by insurance • Inclusion in social franchising schemes • Rebates on consumables/tests from national medical stores • Additional training possibilities • Amsterdam, The Netherlands www.kit.nl