The NIAID SMILE resource (November 2006) DAIDS clinical trials outside the US: Furthering the...
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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
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Who are the partners?
DCLOT
PPD
Non-Network
SMILE
Sites
Networks
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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.
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Our Mission:
To Provide Quality Assurance Support for DAIDS-Funded HIV Clinical Trial
Laboratories (Non-US)
To Maintain a Web-Based Repository ofRecords and Resources
SMILEPatient Safety Monitoring in International Laboratories
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“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.”
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We aim to achieve1. 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
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• Contract resource between NIH/NIAID-DAIDS & Johns Hopkins University
• Staff of 11 with a wide range of laboratory experience
Who is SMILE?
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How does SMILE work to achieve the goals of our contract?
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A year in the life of a SMILE supported lab…
How our tools work to achieve these goals.
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Laboratory AuditsIndependent assessments are performed
annually by PPD or DAIDS
Based on the standards of Good Clinical Laboratory Practice (GCLP)
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Good Clinical Laboratory Practice(GCLP)
• Organization and Personnel• Testing Facilities Operation• Verification of Performance Specifications• Quality Management• Equipment, Physical Facilities• Personnel Safety
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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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SMILE Site Assistance and Training
• Phone
• Web conference
– Adobe Connect
• At conferences
• On site
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Audits occur only once per year.
How do we monitor laboratory performance
continuously throughout the year?
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Proficiency Testing
Proficiency Testing (PT) is a means of evaluating a laboratory's performance through analysis of unknown samples
provided by an external source.
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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
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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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How does SMILE use proficiency testing?
• Monthly review and monitoring of EQA results
– Evaluation
– Review
– Tracking and summary
– Reporting
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EQA Summary Schedule
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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
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SMILE Investigation Form
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Root cause analysis
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Where do we store all of this documentation?
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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)
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Resources on pSMILE.org
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1.Audit
2.Action Plan
3.EQA
4.Monthly reports sent DAIDS
Let’s recap the year…
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Summarizing the data
• EQA Exceptions
• Delinquent Investigations
• Tracking Log
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SMILE and the labs
SMILE and the
networks
SMILE and PPD
SMILE and DAIDS
SMILE and IQA and
VQA
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Additional benefits of SMILE
• Experience• Discounted costs and improved services• Consistency• Flexibility• Collaboration
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How does SMILE work to achieve the goals of Clinical Laboratory
Research Resources?
In conclusion…
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1. Safety of trial subjects
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2. Safety of those performing tests
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3. Quality of the laboratory data.
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4. Increased appreciation of labs for good laboratory practices that translates to better local service.
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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
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DAIDS clinical trials outside the U.S. -furthering the quality of laboratory
operations
The NIAID SMILE resourceDr. Robert E. Miller, M.D.—Principal Investigator
Kurt L. Michael, M. Ed., MT (ASCP)—SMILE Project Manager