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PEPFAR Quality Control and Method Validation Introduction Presentation Slides

This PDF contains the presentation slides for the Introduction video.

QC Workshop 1 World Health Organization SLIPTA v2: 2015 - Criteria for SLIPTA 5-star MEOOUE OFFICE FOR Africa certification and readiness for Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) Checklist accreditation to international standards Version 2:2015 For Clinical and Public Health Laboratories 1. Test results are reported by the laboratory on at least 80% of specimens within the turnaround time specified (and documented) by the laboratory in consultation with its clients. 2. Validation or verification of test methods used by the laboratory. 3. Internal quality control (IQC) procedures are practiced for all testing methods used by the laboratory. 4. The scores on the two most recent approved proficiency tests are 80% or better. 2 Westgard QC ^ Westgard QC Sten Westgard Iff Add friend Already friends on Quick Links Facebook? What's New? Labs Quality Controls Could your Bab Results you can trust Thermo Cancer markers on the Vista 2nd lock Quality Kickstarter Could your lab catch this error? Patent Percentis Monitoring A recent letter to the Journal of Clinical Pathology showed an example of the consequences of missing a lab error for 10 days. Commendable that this On the Blog laboratory was willing to share its challenges with the wider world. But it raises the question, how many labs could have caught this error? When we the poem? widen our limits with larger SDs and reduce our use of control rules, are we at risk of becoming blind to medically important errors? Empr rates in Vet Labs Content from Ki Privacy : Developers English (United States) Learn more: | Turn off + 100% Westgard E‐newsletter, June 20133 HILS1746 1 Effective Date: 12/6/2016 Does this look like an error to you? Control 1 Values 4 ISO 15189:2012 Overview Management Requirements Technical requirements 4.1 Organization and management 5.1 Personnel responsibility 5.2 Accommodation and environmental 4.2 Quality management systems conditions 4.3 Document control 5.3 Laboratory equipment, reagents, and 4.4 Service Agreements consumables 4.5 Examination by referral laboratories 5.4 Pre‐examination processes 4.6 External services and supplies 5.5 Examination processes 4.7 Advisory services 4.8 Resolution of complaints 5.6 Ensuring quality of 4.9 Identification and control examination processes of nonconformities 5.7 Post‐examination processes 5.8 Reporting of results 4.10 Corrective action 5.9 Release of results 4.11 Preventive action 4.12 Continual improvement 5.10 Laboratory information 4.13 Control of records management 4.14 Evaluation and audits 4.15 Management review WHERE ARE WE? WHERE DO WE EXPECT TO BE? WHERE DO WE WANT TO BE? S 6 HILS1746 2 Effective Date: 12/6/2016 Strengthening Laboratory Management Toward Accreditation How does the QC Workshop connect to the SLMTA Process? 7 Strengthening Laboratory Management Toward Lab Improvement and Accreditation Recommended Program Map Strengthen laboratory management Achieve immediate laboratory improvement Accelerate the process toward accreditation readiness Month 0 Month 1 Month 4 Month 7 Month 12 Month 18 SLMTA Pre-requisites to entry Attendees An 18-month program with a series of workshops for the same group of lab 1. Lab strategic plan managers and policy drafted 2. Lab TWG to drive Getting ready for final accreditation Improvement Improvement Improvement inspection forward Projects Projects Projects 3. QA manager in place Baseline Workshop Workshop Workshop Exit Audit Accreditation 4. Participant committed Audit #1 #2 #3 to same job (3 months) (3 months) (3 months) responsibilities Gap Analysis throughout the 18- & Site Visits Site Visits Site Visits month program Action Plan (preferred) On-going support by partners and CDC in-country staff (on-site mentoring, monitoring of improvement projects) .............. How To Be A Quality Skill-based Online Quality Control Successful SOP Writing BioSafety Management training Virtual Leadership QA Manager System (e.g., SMDP) Development Program (e.g., MSH) Additional Training/Technical Assistance Based on Gap Analysis Optional Complementary Training (offered at ACILT or in‐country by partners) 8 SLIPTA: A framework to encourage, support and recognize the implementation of QMS in medical laboratories in a stepwise manner 5 Star 4 Star 3 Star 2 > 95 % Star SLMTA 1 85‐94 % Star SLMTA is a structured lab improvement tool that helps a lab climb 75‐84 % 0 the steps and get ready for accreditation ↑ Score on Star 65‐74 % external evaluation using a checklist 55‐64 % Progression toward Accreditation Readiness 9 HILS1746 3 Effective Date: 12/6/2016 What Makes This Workshop Unique? Tied closely with the SLMTA training model  Activity‐based  Hands‐on Training  Very Practical Tied closely with the framework and checklist Structured approach to designing QC systems 10 Analytical Quality Hands‐on + Practical + Pictionary – what is that QC term? A human Gaussian Curve Prescriptive = Immediate Impact Demonstrating the “wiggle room” Training Content Closely Linked to SLIPTA Checklist Training Task Activities Checklist Task 6.2 1.5 Laboratory Policies and Standard Operating Procedures Ensure that QC Are policies and/or standard operating procedures (SOPs) for material is laboratory functions, technical and tested according managerial procedures current, available and approved by to SOP authorized personnel? 8.7 Documentation of Examination Procedures Are examination procedures documented in a language commonly understood by all staff and available in appropriate locations? 12 HILS1746 4 Effective Date: 12/6/2016 Emphasis on Action and Tangible Improvement Improvement Projects Supportive site visits with checklist 13 Key Message … Labs are vital. Continuously Desired Outcome improving the quality of patient care delivered by the laboratory Introduction 14 On the Road to Laboratory Improvement Taking a turn towards QC HILS1746 5 Effective Date: 12/6/2016

  • quality control
  • QC
  • accreditation
  • SLIPTA
  • SLIPTA checklist
  • accuracy
  • precision
  • expect to be
  • want to be
  • SQC
  • effective SQC
  • Equations
  • pre-requisite
  • basic QC
  • measures of tendency
  • mean
  • standard deviation
  • SD
  • coefficient of variation
  • CV
  • %CV
  • average
  • percent coefficient of variation