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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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
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.
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
“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.”
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.
Who is SMILE? • Contract resource between NIH/NIAID-DAIDS & Johns Hopkins University • Staff of 11 with a wide range of laboratory experience
A year in the life of a SMILE supported lab… How our tools work to achieve these goals.
Laboratory Audits Independent assessments are performed annually by PPD or DAIDS Based on the standards of Good Clinical Laboratory Practice (GCLP)
Good Clinical Laboratory Practice(GCLP) • Organization and Personnel • Testing Facilities Operation • Verification of Performance Specifications • Quality Management • Equipment, Physical Facilities • Personnel Safety
Audits and Action Plans • Audit report sent to SMILE • Action Plan is prepared • Networks designate critical items • Action Plan and audit sent to lab
SMILE Site Assistance and Training • Email • Phone • Web conference • Adobe Connect • At conferences • On site
Audits occur only once per year. How do we monitor laboratory performance continuously throughout the year?
Proficiency Testing Proficiency Testing (PT) is a means of evaluating a laboratory's performance through analysis of unknown samples provided by an external source.
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
Before we order EQA we need more information • Protocol analytes • Instrumentation in use • Back-up plans • Specimen flow Protocol Analyte List (PAL)
How does SMILE use proficiency testing? • Monthly review and monitoring of EQA results • Evaluation • Review • Tracking and summary • Reporting
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
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)
Let’s recap the year… • Audit • Action Plan • EQA • Monthly reports sent DAIDS
Summarizing the data • EQA Exceptions • Delinquent Investigations • Tracking Log
Additional benefits of SMILE • Experience • Discounted costs and improved services • Consistency • Flexibility • Collaboration
In conclusion… How does SMILE work to achieve the goals of Clinical Laboratory Research Resources?
4. Increased appreciation of labs for good laboratory practices that translates to better local service.
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
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