The Future Is Now Global Application Of CLSI And ISO:15189 .
The Future is NowGlobal Application ofCLSI and ISO:15189Quality Management SystemsGlen Fine, MS, MBAExecutive Vice President, CLSIKey Discussion PointsUpon completion of this session, you will be able to: Define Quality Management System (QMS) Compare the organizational characteristics of ISOand CLSI Discuss global momentum of QMS acceptanceand its impact on your lab2
Quality Management SystemThe Quality Management System (QMS) providesa framework for managing and monitoringactivities to address quality standards andachieve organizational goals.3Quality Management SystemPath of WorkflowSequential processes (pre-examination, examination, andpost-examination laboratory activities) that transform aphysician's order into laboratory information.4
Quality Management SystemQuality Systems EssentialsSet of coordinated activities that function as building blocksfor quality management.The CLSI model has12.5Quality Management SystemQMS is a systematic approach of organizing allkey work processes around the path of workflowin the laboratory.HS1-A2: A Quality Management System Model for Health CareGP26-A3: Application of a Quality Management System Model for Laboratory Services6
Practical Tools to Arrive at QualityExamination’s Path of Workflow (work operations)Quality Systems EssentialsSIXSIGMALEANFMEABPM7Quality Systems ModelsThere are two major models for quality managementsystems used globally.ISO:15189 CLSI: GP26-A3 & HS1-A2Broad-based SpecificOverarching standards Practical implementation15 Management Requirementsguidelines8 Technical Requirements 12 Quality Systems EssentialsScalable8
International Organization for StandardizationThe International Organization forStandardization is the largest worldwidefederation of national standards bodies.It focuses on reducing barriers to trade andpromoting international commerce throughstandards development. 157 member countries One country one vote 300 technical committees 3,000 technical work groups9ISO/TC 212ISO technical committee TC 212, Clinical laboratorytesting and in vitro diagnostic test systems, providesstandardization and guidance in the field of laboratorymedicine and in vitro diagnostic test systems (IVD). Established 15 years ago33 participating countries18 observing countriesCLSI is the Executive Secretariat for ISO/TC 21210
ISO/TC 212 - Working GroupsWorking Group 1: Quality and competence in the medicallaboratory (5 standards)Working Group 2: Reference systems (6 standards)Working Group 3: In vitro diagnostic products (6 standards)Working Group 4: Antimicrobial susceptibility testing(2 standards)11ISO/TC 212TC 212 has produced 19 International laboratorystandards. Examples include: ISO 15190:2003Medical laboratories - Requirements for safety ISO 22870:2006Point-of-care testing (POCT) - Requirements for qualityand competence ISO 15189:2007Medical laboratories - Particular requirements for qualityand competence12
ISO Family of Quality Management StandardsISO/TC 1769000ISO/TC207/SC114000EnvironmentISO/TC 210ISO/CASCO1702513485Medical DevicesReference LaboratoryISO/TC 21215189Medical Laboratory13ISO 15189The Core of the 15189 are 15 ManagementRequirements and 8 Technical Requirements.For the most part, these elements align with CLSI’s 12Quality System Essentials.14
CLSIClinical and Laboratory Standards Institute(CLSI) is a not-for-profit developer of globalvoluntary consensus standards.CLSI Board of Directors15CLSI Members & VolunteersDiverse representation from three constituenciesIndustryGovernmentProfessionsIVD ManufacturersPublic Health AgenciesHospitals and LaboratoriesLIS VendorsRegulatory BodiesHealthcare Delivery SystemsStartup CompaniesAccrediting OrganizationsEducational InstitutionsSuppliersOthersProfessional SocietiesTrade Organizations16
CLSI Consensus ProcessGovernmentIndustryProfessionsCLSICLSI has over 200 best practice standards,guidelines and companion products for theclinical lab community.There are over 75 active projectsin development at any given time.18
CLSI – Quality Management SystemCLSI produces several Quality ManagementSystem guidelines HS1 - A Quality Management SystemModel for Health Care GP26 - Application of a QualityManagement System Model forLaboratory Services “The Key to Quality”19CLSI Quality Management SystemCLSI HS1-A2 (2003)CLSI GP26-A3 (2004)20
ISO and CLSI Standards Development ModelsMajor differences between ISO and CLSI model are: Size and scope Standards development model Approach– ISO provides broad-based requirements– CLSI provides detailed, practical guidance Speed to development21The ISO and CLSI IntersectionBoth ISO and CLSI are focused on assistinghealth care testing facilities in achievinglaboratory quality. By implementing a qualitysystem, laboratories can: reduce or eliminate medical error Standardized consistent work processes andprocedures Reduce costs satisfy regulatory requirements achieve quality objectives22
International Acceptance of QualityManagement SystemsOf 50 countries recently surveyed, 35 (60%) havegovernment requirements for laboratory practice.Of the 35 countries with government oversight ofmedical laboratories, approximately 30 (85%) haveQMS-based approach to regulatory andaccreditation requirements.23A Case Study: Namibia24
A Case Study: NamibiaNamibia is located in southwest Africa with apopulation of two million.The laboratory system consists of a nationalnetwork of 34 labs.25A Case Study: NamibiaThe goal for the laboratory system is to achieveSouth African National Accreditation System(SANAS) accreditation (ISO 15189 based) by the3 largest labs in 3 years.Rationale is to: Use an established QMS model for system-wideimplementation of sustainable lab capacity Standardize laboratory systems and processes Implement a system-wide training program resultingin consistent personnel performance Reduce the timeline to expedite implementation26
A Case Study: NamibiaAs a result of system-wide implementation ofstandards Two labs recently received SANAS accreditationOne lab is working on the accreditation processOther labs in network have seen the benefits andhave implemented practical steps towards QMSimplementation27World Health OrganizationThe World Health Organization (WHO),part of the United Nations, carriessubstantial clout, respect andinfluence, particularly in the developing world.WHO has been very active in development,dissemination, and promotion of lab qualitymanagement systems globally, specifically: Recent International conferenceAdvocacy paperQMS training package28
WHO QMS ActivitiesWHO jointly hosted an international conference inLyon, France in April 2008 with the Centers forDisease Control and Prevention (CDC). Attended by 260 senior level Ministry of Health (MOH)officials representing 70 countries Reviewed the status of lab quality management systemsaround the world and strategies to ensure accurate,reliable, and timely lab test results in all countries.29WHO QMS ActivitiesConference delegates endorsed an advocacy paperchampioned by respective governments. Significantcollaborative efforts on: helping to enhance health laboratory quality with aparticular focus in resource-limited settings cultivating proposed guidance on QMS development andimplementation at national level.30
WHO QMS ActivitiesAdvocacy Paper Authored:Each country should establish its own set ofstandards according to country-specific needsbased on internationally recognized standards.National laboratory standards need to take intoaccount local factors, including any pertinentregulations, organization of the country’slaboratory system(s), and resource constraints.31WHO QMS ActivitiesLimited resource countries should take a stagedapproach with scalable implementationrequirements based on complexity of testing.32
QMS Training PackageThrough the collaboration of WHO, CDC, and CLSI,a comprehensive training tool will be available inlate 2008 to any laboratory entity interested inestablishing and training on QMS. Based largely on blended concepts of ISO and CLSIusing a variety of presentations, training aids, andtemplatesScalable for use in smallest to most complexlaboratory settingsSupportive processes for use with an accreditationprogram33What About the United States?CLIA, CLIA, CLIA CLIA is enforced by Centers forMedicare & Medicaid Services (CMS)through direct oversight and on-site inspections. CMS Central Office and CMS Regional Offices State agencies (including states with licensurerequirements) Accreditation organizations (deemed agencies) States with CMS approved state laboratory programs(exempt-status) (New York, Washington)34
What About the United States?Deemed Agencies CAP: currently implementing its corollary ISO:15189programCOLA: accreditation program is ISO:15189-based; offersa variety of related educational products.Joint Commission: under considerationAABB: A pioneer advocate in QMS based accreditationOthers Entities American Association for Laboratory Accreditation(A2LA)35CLIA and QMS The 2003 CLIA regulation changes align arounda Path of Workflow model CLIA clearly encourages US laboratories to alignaround a more holistic Quality ManagementSystems (QMS) approach.36
CLIA and QMSCMS is encouraging labs to adhere to the CLIARegulations by using a Quality ManagementSystem approach.CLSI HS1-A2 (2003)CLSI GP26-A3 (200)37To Add a Final PointAll of the top 10 deficiencies cited by CLIA tiedirectly to a lab’s Quality Management System. §493.1239 The laboratory must establish and followwritten policies and procedures for an ongoingmechanism to monitor, assess, and, when indicated,correct problems identified in the general laboratorysystems requirements §493.1407 The laboratory director is responsible forthe overall operation and administration of thelaboratory, including all systems, processes andprocedures.38
Global Momentum towards QMS Adoption35 countries have implemented or are in somestages of national adoption of QMS model approachto their lab services.WHO has fully adopted the QMS approach on aglobal basis and is in the process of education andtraining.In the US, the CLIA program is aligned around apath of workflow model and encourages labs toadopt a QMS approach to lab licensure andaccreditation.39Global Momentum towards QMS AdoptionThe Future is Now CLSI HS1-A5 (2003)CLSI GP26-A3 (2004)40
Global Momentum towards QMS AdoptionWhere are you in adopting of a holistic QualityManagement Systems approach to managingyour laboratory operations?41How to Contact CLSI Web: www. CLSI.org Email: customerservice@clsi.org Customer Service: 1.610.688.010042
ISO/TC 212 15189 ISO/CASCO 17025 ISO Family of Quality Management Standards 13 ISO/TC207/SC1 14000 ISO/TC 210 13485 Environment Medical Devices Medical Laboratory Reference Laboratory ISO/TC 176 9000 ISO 15189 The Core of the 15189 are 15 Management Requirements and 8 Technical Requirements
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May 02, 2018 · D. Program Evaluation ͟The organization has provided a description of the framework for how each program will be evaluated. The framework should include all the elements below: ͟The evaluation methods are cost-effective for the organization ͟Quantitative and qualitative data is being collected (at Basics tier, data collection must have begun)
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̶The leading indicator of employee engagement is based on the quality of the relationship between employee and supervisor Empower your managers! ̶Help them understand the impact on the organization ̶Share important changes, plan options, tasks, and deadlines ̶Provide key messages and talking points ̶Prepare them to answer employee questions
Dr. Sunita Bharatwal** Dr. Pawan Garga*** Abstract Customer satisfaction is derived from thè functionalities and values, a product or Service can provide. The current study aims to segregate thè dimensions of ordine Service quality and gather insights on its impact on web shopping. The trends of purchases have
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Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. 3 Crawford M., Marsh D. The driving force : food in human evolution and the future.
