PEPFAR Quality Control and Method Validation Introduction/Activity 1

ISO Overview Overview Analyticai Training Content Closely Linked to nalytical Does this look like an error to k like an error to Training Contcnt Closely Linked to QC and Method Evaluation Workshop Q a A with Bal Ramsaran, PhD Q a A Strengthening Laboratory Management Toward Lab Improvement and Accreditation v J, v World Health ) World Health World Health Does this look like an error to you? Does this an crrcr to you? System Analytical A framework to encourage, support and SLIPTA: Quality 5 of 234) For the following data sets, calculate the mean (X standard deviation (SD), 2015 - criteria for Organization a scanni On the Road to Laboratory Improvement The of periodic , The of periodic System ISO 151892012 overview ISO 151899012 overview ISO 151899012 Recommended Program Map and percent coefficient of variation (%CV): Quality The of What Makes This Workshop Unique? devicew Fcequency of sam* events frequency OF evenfs frequency of QC fest evenfs Technical requirements Management Requirements Laboratory. ) Fcequency even+s recognize the implementation of QMS in medical recognize the implemen recognize the implem - Goals Goals n of QMS in medical sum OF events Analytic ai Analytical an Shift? QC and Method Evaluation Workshop 8 day workshop focuses on interpretation and Test results are reported by the laboratory on at least 80% of specimens within the WHERE WE ARE Management Requirements Results certification and readiness for certification andl readiness for implementation Look for 11 {5.1, 5.3, 4.9, 5.1, 5.4} {5.1, 53, 4.9, 5.1, 5.4} tumaround time specified (and documented) by the laboratory in consultation with its System number tesfed abnormal and Question: What have you found to be the most Stepwise Laboratory Quality 4.1 Organization and management 5.1 Personnel Personnel Achieve immediate laboratory improvement • Accelerate the process toward accreditation readiness Strengthen laboratory management • Achieve immediate laboratory improvement • Accelerate the process toward accreditation readiness 5. Strengthen laboratory management clients. Turnaround time to be interpreted as time from receipt of specimen in laboratory until Labs are vital. , as ,rom recclpr specimen In laboratory clustering Criteria Precision Quality Emphasis on Action and Tangible IPTA: A framework to encourage. support and 3) QC ased 3) ased Key Message 3) ased +0 3) AL laboratories in a steri Q & A with Bal Ramsaran, PhD Q a A with Bal Ramsaran, PhD Q a A with Bal Ramsaran. PhD Q A with Bal Ramsaran, PhD laboratories in a stepe% laboratories in a stepwise manner laboratories Does this look like an error to you? Improvement Process Towards defec±inj and results reported. DATA NOT COLLECTED ON THIS ELEMENT defec+lnj ON THIS ELEMENT "ay from a,Way from from Need for Neod for Where W here We Expece ased WHERE ARE WEP WHERE WE? Control 1 Values We Expect Westgard QC ' WHI WHERE e Wa Westgard QC QC Control accreditation to international standards and Improvement System System Sys m QC Month 02 Month 0 Mont" 7 Month 02 Month 08 QC and Method Evaluation Workshop Accreditation (SLIPTA) Checklist certilication antl readiness tor responsibility 5.2 Accommodation and Quality We Are To Be Question: What have you found to be the most • Activity-based 8 day work 95% EXPECT ro BE WHERE WEARE processes material is 14. Introduction to Method Evaluation (SOPs) for laboratory quality of patient 2. Validation or verification of test methods used by (preferred) most recent PT challenges will not be awarded any stars, regardless of the checklist score they Could your lab Catch this error? Could your lab catch this error? Introduction 1) {36.83, 35.79, 37.01, 35.72, 36.29, 36.33, 36.54, 36.48, 36.91, 35.87} Qualitv Kickstarter. 15 16 1718 19 21 23 242526 27 30 received upon audit 11 #1 .1 .2 12 21 23 24 26 2728 29 30 11. How Proficient Are We? 4. The Front Line Worker — Applying On-going support by partners and CDC in-country staff (on-site mentoring, monitoring of improvement projects) 4.8 Resolution of complaints 5.4 Pret-examination processes 5 4 Pret-examination processes functions current, available examination procedures. The training of the Patient Percentile Immediate Impact V Tied closely with the framework and checklist 'ERE WE ARE tested according care delivered by laboratory.s the laboratory. Workshop Workshop Multirules WHERE WE ARE 4.9 Identification and control of 5.8 Reporting of results Monitorinq Score and approved by authorized 85-94 % Score on annual on-site inspection is at least 55% (at least 142 pts): inspection is at least 55% (at least 142 pts): A recent letter to the Journal of Clinical Pathology showed an example of the WHERE DO WE EXPECT TO BE WHERE SD = technicians to understand the quality control technicians? to understand the quality control 4 Star personnel? to SOP nonconformities 5.9 Release of results 3. Internal quality control (IQC) procedures are consequences of missing a lab error for 10 days. Commendable that this 5. It Begins with the Right Chart the laboratory laboratory. 12. Using Interlaboratory Comparison V Structured approach to designing QC systems .2 laboratory was willing to share its challenges with the wider world. But it 4o Stars No Stars 4 Star I Star Star 4 Star 75-84 % 3o Stars 5.10 Laboratory information 4.10 Corrective action On the Blog Programs O/ocv = measures required and maintaining the discipline to practiced for all testing methods used by the (193 -18 pts) (193 - pts) (193 - 218 pts) raises the question, how many labs could have caught this error? When we (244 - 258 pts) (0-141 pts) (142 - 166 pts) (167-192 pts) (167 - 192 pts) (219-243pts) z-Online 4.11 Preventöv+fttip Score n To Be A Quality Skill-based Mestqard Rules" Virtual Leadership 75-84% 85-94% 4.11 Preventive action < 55% 55-64 % 65-74 % 65 - 75-84% management Imanagement Successful SOP Writing training Quality Control BioSafety Management Improvement widen our limits with larger SDS and reduce our use of control rules, are we 8.6 Is complete procedure 6. Parallel Testing: Making History 13. Improvement Project Assignment evelopment Progra the poem? QA Manager external evaluation (e.g., 65-74 % System (e.g., MSH) Lead Auditor Signature laboratory.s laboratories at risk of becoming blind to medically important errors? perform these daily requirements — internal QC, 4.12 Continual improvement 4.1) Continual improvement ment manual available at the Date using ac ecklist Additional Training/ Technical Assistance Based on Gap Analysis Additional T aining/ Technical Assistance Based on Gap Analysis Optional Complementary Training Error rates in Vet 4.13 Control of records 4. The scores on the two most recent approved (offered at ACILT or in-country by partners) ffered at ACILT or in-country by partners) Labs 55-64 % 7. Total Error (TE) prompt corrective actions and root cause analysis. 14. Introduction to Method Evaluation 4.14 Evaluation and audits proficiency tests are 80% or better. Westgard E-newsletter, June 2013 4.15 Management review Progression toward Accreditation Readiness 12 10 11 15 Activity 1B: Let's Examine the Basics Accessed 8 April 2014. Demonstrating the "wigg room" 'l