WHO-AFRO Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) Dr. Fausta Mosha, Director, National Health Laboratory, Ministry of Health and Social Welfare, Tanzania * 1

Introduction 1/3 Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA): WHO-AFRO, CDC, ASLM, CHAI Initiative Graduated recognition of quality improvement Technical support and mentoring by ASLM and WHO-AFRO Support and recognize implementation of QMS in medical labs to allow provision of safe, timely and accurate results Cost: MOH mobilizes resources MoH mobilizes resources as part of Country Strategic Implementation Plan Stepwise process towards obtaining accreditation nationally, regionally or internationally recognized accreditation standards compliant with the ISO 15189 standard. Intended to encourage, support and recognize implementation of QMS in medical laboratories so that African laboratories can provide safe, timely and accurate results for patient care and public health purposes. *

Introduction 2/3 Expected to have a catalytic effect: SLIPTA Key Elements Progressive Implementation of Quality Systems National Strategic and Operational Plans WHO QMS and SLMTA Tools: Quality Improvement of Laboratories : Graduated Recognition Serves as pathway that recognizes conformity over time marked by graduated recognition of quality improvement of laboratory performance. Expected to have a catalytic effect: quality improvement in individual laboratories Incorporating goals into national strategic and operational plans, sensitizing policy makers and laboratory staff on accreditation, nurturing development of laboratories in the African region. *

Finalized SLIPTA Guidance Policy And Checklist Introduction 3/3 Finalized SLIPTA Guidance Policy And Checklist WHO ASLM CDC MoH AFENET CLSI AMREF SADCAS KENAS KIT ZINQAP Clinton Foundation Others *

ASLM SLIPTA Independent Advisory Group ASLM SLIPTA-Certified Auditors SLIPTA Stakeholders MoH SLIPTA Focal Point WHO AFRO SLIPTA Focal Point MoH Laboratory /Other ASLM SLIPTA Secretariat ASLM SLIPTA Independent Advisory Group ASLM SLIPTA-Certified Auditors

SLIPTA Process 1. Prioritized laboratory submits Initial Application to MoH Focal Point Meet criteria in country strategic implementation plan-MoH & local implementing partners provide mentoring/TA to laboratory Candidate laboratory conducts self-assessment using SLIPTA Checklist, must meet minimal score of (TBD) points 2. Submission of application for SLIPTA enrollment-criteria met Laboratory submits final application to MOH SLIPTA Focal Point for consideration MOH sends to ASLM SLIPTA Secretariat If application meets SLIPTA criteria-considered Enrolled Laboratory

SLIPTA Process (2) 3. ASLM SLIPTA Secretariat contacts auditor team lead 4. Auditor Team (AT) selected, Secretariat coordinates audit visit 5. AT conducts audit utilizing SLIPTA Checklist 6. AT submits initial findings, including nonconformities and recommendations, to ASLM Secretariat and Laboratory *

SLIPTA Process (3) Major and minor nonconformities to be defined * 9. Secretariat submits findings to Independent Advisory Group (IAG) 7. Laboratory takes corrective actions within four weeks Works with AT for TA/guidance Encouraged to share audit report with MoH to rectify nonconformities 8. AT reviews corrective actions and sends final report to ASLM SLIPTA Secretariat Major nonconformities: AT conducts follow up visit, submits final report Minor nonconformities: Laboratory submits documentation of corrective actions to AT for review and AT submits final report to SLIPTA Secretariat Major and minor nonconformities to be defined *

SLIPTA Process (4) Major and minor nonconformities to be defined * 10. IAG provides feedback to ASLM SLIPTA Secretariat 11. IAG makes final determination of star recognition, issues certificate 12. ASLM SLIPTA Secretariat sends certificate to MoH/ Laboratory Valid: two years Applications for renewal: six months before certificate expiry Major and minor nonconformities to be defined *

Strengthening Laboratory Management Towards Accreditation - SLMTA What is SLMTA? An innovative structured task-based training and mentoring program developed to effect immediate, measurable improvement in laboratories using their existing resources

Basic SLMTA Facts – Content 10 Modules 1 - Productivity Management # Lab management tasks taught: 66 2 - Work Area Management 3 - Inventory Management # training hours: 50+ # of tools and job aides: 100+ 4 - Procurement Management 5 - Equipment Maintenance 6 - Quality Assurance # of training activities: 45 7 - Specimen Management 8 - Laboratory Testing 9 - Test Result Reporting 10 - Documents & Records

Progression toward Accreditation Readiness SLMTA Enables Countries to Implement SLIPTA with Subsequent Recognition End Point National, Regional, or International Accreditation Body 5 Star 4 Star 3 Star SLMTA SLMTA is a structured lab improvement tool that helps a lab climb the steps and get ready for accreditation 2 Star > 95 % 1 Star 85-94 % The WHO-AFRO accreditation process is unique in that, instead of using a ‘pass’ or ‘fail’ system, the program is divided into tiers, allowing laboratories to move up the tiers incrementally as the percentage of benchmarks met increases. The WHO AFRO accreditation does: Uses internationally accepted standards adapted to the local environment Scalable to meet lab complexity requirements Uses an incremental, step-wise approach that is objectively measurable over time Uses a positive, reinforcing approach to continuous quality improvement 75-84 % 0 Star ↑ Score on external evaluation using a checklist 65-74 % 55-64 % Progression toward Accreditation Readiness

Spread of the SLMTA ownership “Movement” Rollout South East Asia Africa 2010 2011 2012 Vietnam Cambodia Nigeria Cote d’Ivoire Ethiopia Ghana Cameroon Uganda Central America and Caribbean Region Kenya Rwanda Burundi Tanzania Angola Malawi Bahamas Zambia Mozambique Haiti Zimbabwe Dominican Republic Botswana Guatemala Jamaica Swaziland Honduras El Salvador Nicaragua Lesotho Costa Rica Barbados Panama Trinidad

Progress To-date Secretariat established 12 Auditors trained in September, 2011 Guidance document and checklist finalized Application forms on the ASLM website, www.asflm.org Advisory body formed and met in November, 2011

Thank you Betam emeseghenalehu Asante sana *