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The NIAID SMILE resource (November 2006) DAIDS clinical trials outside the US: Furthering the quality of laboratory operations The NIAID SMILE resource.

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Presentation on theme: "The NIAID SMILE resource (November 2006) DAIDS clinical trials outside the US: Furthering the quality of laboratory operations The NIAID SMILE resource."— Presentation transcript:

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

2 Who are the partners? DCLOTPPD Non- Network SMILESitesNetworks

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 We aim to achieve 1.Safety of trial subjects. 2.Safety of those performing tests. 3.Quality of the laboratory data. 4.Increased appreciation of labs for good laboratory practices that translates to better local service. Clinical Laboratory Research Resources

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

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 1.Audit report sent to SMILE 2.Action Plan is prepared 3.Networks designate critical items 4.Action Plan and audit sent to lab

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14 SMILE Site Assistance and Training Phone Web conference – Adobe Connect At conferences On site

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

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

18 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

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

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21 How does SMILE use proficiency testing? Monthly review and monitoring of EQA results – Evaluation – Review – Tracking and summary – Reporting

22 EQA Summary Schedule

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24 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

25 SMILE Investigation Form

26 Root cause analysis

27 Where do we store all of this documentation?

28 Document Repository EQA surveys, reviews and investigations on – Available to site labs (privately by log-in) – Available to DAIDS and the Networks Also on – Audits and Action Plans – Site visit reports – Protocols and Protocol Analyte Lists (PAL)

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30 Resources on pSMILE.org

31 1.Audit 2.Action Plan 3.EQA 4.Monthly reports sent DAIDS Lets recap the year…

32 Summarizing the data EQA Exceptions Delinquent Investigations Tracking Log

33 SMILE and the labs SMILE and the networks SMILE and PPD SMILE and DAIDS SMILE and IQA and VQA

34 Additional benefits of SMILE Experience Discounted costs and improved services Consistency Flexibility Collaboration

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

36 1.Safety of trial subjects

37 2. Safety of those performing tests

38 3. Quality of the laboratory data.

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

40 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

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


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