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

PPD

Non-Network

SMILE

Sites

Networks

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 ofRecords and Resources

SMILEPatient 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.”

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

• Contract resource between NIH/NIAID-DAIDS & Johns Hopkins University

• Staff of 11 with a wide range of laboratory experience

Who is SMILE?

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 AuditsIndependent 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

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?

• 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

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

1.Audit

2.Action Plan

3.EQA

4.Monthly reports sent DAIDS

Let’s recap the year…

Summarizing the data

• EQA Exceptions

• Delinquent Investigations

• Tracking Log

SMILE and the labs

SMILE and the

networks

SMILE and PPD

SMILE and DAIDS

SMILE and IQA and

VQA

Additional benefits of SMILE

• Experience• Discounted costs and improved services• Consistency• Flexibility• Collaboration

How does SMILE work to achieve the goals of Clinical Laboratory

Research Resources?

In conclusion…

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 resourceDr. Robert E. Miller, M.D.—Principal Investigator

Kurt L. Michael, M. Ed., MT (ASCP)—SMILE Project Manager