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DAIDS clinical trials outside the US: Furthering the quality of laboratory operations The NIAID SMILE resource (November 2006). Who are the partners?. How does DAIDS manage clinical laboratory oversight for HIV trials?.

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Who are the partners?


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    1. DAIDS clinical trials outside the US: Furthering the quality of laboratory operationsThe NIAID SMILE resource(November 2006) Anne Sholander, MT(ASCP), International QA/QC Coordinator, SMILE

    2. Who are the partners?

    3. How does DAIDS manage clinical laboratory oversight for HIV trials? There are currently nearly 170 laboratories outside the US performing DAIDS funded HIV clinical trials.

    4. Our Mission: To Provide Quality Assurance Support for DAIDS-Funded HIV Clinical Trial Laboratories (Non-US) To Maintain a Web-Based Repository of Records and Resources SMILE Patient Safety Monitoring in International Laboratories

    5. “This contract will provide a critically needed comprehensive, uniform program to evaluate the capability of laboratories in developing countries, advise and train when deficiencies are identified, and ensure the ongoing quality of study test results and ultimately the outcome of clinical research performed in these countries.”

    6. Clinical Laboratory Research Resources We aim to achieve • Safety of trial subjects. • Safety of those performing tests. • Quality of the laboratory data. • Increased appreciation of labs for good laboratory practices that translates to better local service.

    7. Who is SMILE? • Contract resource between NIH/NIAID-DAIDS & Johns Hopkins University • Staff of 11 with a wide range of laboratory experience

    8. How does SMILE work to achieve the goals of our contract?

    9. A year in the life of a SMILE supported lab… How our tools work to achieve these goals.

    10. Laboratory Audits Independent assessments are performed annually by PPD or DAIDS Based on the standards of Good Clinical Laboratory Practice (GCLP)

    11. Good Clinical Laboratory Practice(GCLP) • Organization and Personnel • Testing Facilities Operation • Verification of Performance Specifications • Quality Management • Equipment, Physical Facilities • Personnel Safety

    12. Audits and Action Plans • Audit report sent to SMILE • Action Plan is prepared • Networks designate critical items • Action Plan and audit sent to lab

    13. SMILE Site Assistance and Training • Email • Phone • Web conference • Adobe Connect • At conferences • On site

    14. Audits occur only once per year. How do we monitor laboratory performance continuously throughout the year?

    15. Proficiency Testing Proficiency Testing (PT) is a means of evaluating a laboratory's performance through analysis of unknown samples provided by an external source.

    16. What is proficiency testing? • Also called PT or EQA (External Quality Assurance) • Blinded samples sent on a regular schedule • Run as patient samples • Results are compared to peers

    17. Before we order EQA we need more information • Protocol analytes • Instrumentation in use • Back-up plans • Specimen flow Protocol Analyte List (PAL)

    18. How does SMILE use proficiency testing? • Monthly review and monitoring of EQA results • Evaluation • Review • Tracking and summary • Reporting

    19. EQA Summary Schedule

    20. Investigations • Required for EQA failures • SMILE provides assistance, tools and resources • Root cause and prevention of future failure • Documentation of corrective action is end product

    21. SMILE Investigation Form

    22. Root cause analysis

    23. Where do we store all of this documentation?

    24. Document Repository • EQA surveys, reviews and investigations on www.psmile.org • Available to site labs (privately by log-in) • Available to DAIDS and the Networks • Also on www.psmile.org: • Audits and Action Plans • Site visit reports • Protocols and Protocol Analyte Lists (PAL)

    25. Resources on pSMILE.org

    26. Let’s recap the year… • Audit • Action Plan • EQA • Monthly reports sent DAIDS

    27. Summarizing the data • EQA Exceptions • Delinquent Investigations • Tracking Log

    28. Additional benefits of SMILE • Experience • Discounted costs and improved services • Consistency • Flexibility • Collaboration

    29. In conclusion… How does SMILE work to achieve the goals of Clinical Laboratory Research Resources?

    30. Safety of trial subjects

    31. 2. Safety of those performing tests

    32. 3. Quality of the laboratory data.

    33. 4. Increased appreciation of labs for good laboratory practices that translates to better local service.

    34. Some of the things we are proud of… • Laboratories taking the initiative to improve their quality measures on their own • Laboratories striving for (and achieving) CAP, ISO and SANAs accreditation • Laboratories publishing/receiving awards • Recognition from local authorities of improved laboratory quality • Improved safety and increased testing capability and quality of TB diagnostic laboratories

    35. DAIDS clinical trials outside the U.S. -furthering the quality of laboratory operationsThe NIAID SMILE resource Dr. Robert E. Miller, M.D.—Principal Investigator Kurt L. Michael, M. Ed., MT (ASCP)—SMILE Project Manager