Transcript Understanding Method Validation

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
Who are the partners?
DCLOT
Networks
PPD
Sites
NonNetwork
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.
SMILE
Patient Safety Monitoring in International Laboratories
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
“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
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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
How does SMILE work to achieve
the goals of our contract?
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)
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Organization and Personnel
Testing Facilities Operation
Verification of Performance Specifications
Quality Management
Equipment, Physical Facilities
Personnel Safety
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
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?
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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
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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
EQA Summary Schedule
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
SMILE Investigation Form
Root cause analysis
Where do we store all of this documentation?
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)
Resources on pSMILE.org
Let’s recap the year…
1.Audit
2.Action Plan
3.EQA
4.Monthly reports sent DAIDS
Summarizing the data
• EQA Exceptions
• Delinquent Investigations
• Tracking Log
SMILE and
the labs
SMILE and
IQA and VQA
SMILE and
DAIDS
SMILE and
the networks
SMILE and
PPD
Additional benefits of SMILE
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Experience
Discounted costs and improved services
Consistency
Flexibility
Collaboration
In conclusion…
How does SMILE work to achieve
the goals of Clinical Laboratory
Research Resources?
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.
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
operations
The NIAID SMILE resource
Dr. Robert E. Miller, M.D.—Principal Investigator
Kurt L. Michael, M. Ed., MT (ASCP)—SMILE Project Manager