shelley facente, thomas knoble, omar menendez, teri dowling
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Training & Quality Assurance for a Rapid Test Algorithm: Lessons from Implementation , San Francisco, CA 2007. Shelley Facente, Thomas Knoble, Omar Menendez, Teri Dowling San Francisco Department of Public Health, HIV Prevention Section Kevin Delaney - PowerPoint PPT PresentationTRANSCRIPT
Shelley Facente, Thomas Knoble, Omar Menendez, Teri DowlingSan Francisco Department of Public Health, HIV Prevention Section
Kevin DelaneyDivision of HIV/AIDS Prevention, NCHHSTP, Centers for Disease Control and Prevention
HV Diagnostics ConferenceAtlanta, GA
December 2007
Rapid Testing began in San Francisco in May 2003, with a pilot at one community-based organization, Glide Health Services.
At this time, there are 17 publicly-funded agencies offering rapid HIV testing.
Client assumed HIV-negative
Client assumed HIV-positive
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ReactiveOraQuick
ReactiveStat-Pak
Non-reactive Stat-Pak
ReactiveUni-Gold
Non-reactiveUni-Gold
Non-reactiveOraQuick
* All results following a reactive OraQuick are confirmed via EIA and IFA/WB in the SFDPH Microbiology Lab
Identify necessary resources and staff
Develop and pilot standard operating procedures for the study and sites
Develop and conduct training for all staff
Develop a quality assurance program
CDC funded SF and LA for this study• Included staff salaries, supplies, lab costs, and
travel
San Francisco hired two full-time staff:• One to coordinate the intervention sites• One to coordinate a system for linkage to care
Three other SF staff are devoted part-time:• One to coordinate the study as a whole (.25 FTE)• One to coordinate study data (.5 FTE)• One to coordinate HIV surveillance (.1 FTE)
Each of the five intervention sites identified:
A coordinator responsible for HIV counseling and testing at the site
• Some have a separate person responsible for managing the laboratory procedures
A core group of people who would be trained as technicians to run the second and third rapid tests after a reactive OraQuick
Phlebotomist(s) to be on-site at all times testing is offered
A plan for data collection was developed and forms were created or modified to ensure:• study objectives are measured• quality of study procedures are continuously monitored
A comprehensive study protocol was developed and submitted along with an application to the IRB at UCSF and CDC
All sites were required to complete site-specific protocols according to a template provided by the SFDPH
After meeting with CDC, test manufacturers, and test counselors, two trainings were developed:
•Technicians 8 hour training To date, over 25 technicians have been trained
•Counselors 3 hour training To date, over 100 counselors have been trained
All counselors at each
intervention site were required
to attend a 3-hour training
(many were offered) to review and practice new
counseling messages
Observation Observation • Intervention Site Coordinator conducts weekly site visits to:
observe testing processes, observe counseling messages being used, review quality assurance logs (i.e. temp or control logs), and provide technical assistance
until such time that he is confident that sites are entirely self-sufficient and running with high quality
Running Controls
Competency Assessment Testing (CAT)
Model Performance Evaluation Program (MPEP)
Adjusting Data Collection
Observation
Running ControlsRunning Controls• Each certified tester is required to run controls for each
type of test at least once per month, to keep up skills
Competency Assessment Testing (CAT)
Model Performance Evaluation Program (MPEP)
Adjusting Data Collection
Observation
Running Controls
Competency Assessment Testing (CAT)Competency Assessment Testing (CAT)• Every three months, each certified tester is observed and
documented running both a Stat-Pak and Uni-Gold test.
• If any of these testers do not pass competency, they must retest and pass or lose their certification and cannot run the tests
Model Performance Evaluation Program (MPEP)
Adjusting Data Collection
Observation
Running Controls
Competency Assessment Testing (CAT)
Model Performance Evaluation Program Model Performance Evaluation Program (MPEP)(MPEP)• Each site is enrolled in CDC’s MPEP and the site
laboratory manager must correctly run all six MPEP samples for the OraQuick Advance, Stat-Pak, and Uni-Gold tests twice per year
Adjusting Data Collection
Observation
Running Controls
Competency Assessment Testing (CAT)
Model Performance Evaluation Program (MPEP)
Adjusting Data CollectionAdjusting Data Collection• Tracking and linking each type of test run for a client
• Adapting current logs (temp storage, control) to capture new tests
• Modifying current databases to collect and analyze additional tests and results, including linkage information
Staff and resources must be adequate
A data collection plan must be developed and refined before implementation
A slow roll-out is essential
Our two full-time staff make this possible
Each site having its own coordinator, in constant communication, is also vital
Time to train all counselors and technicians should not be minimized
When you have 5 sites and over 125 counselors and technicians, being clear and consistent is key
Determine up front what data points are needed to ensure quality monitoring and meet study objectives
You can be flexible if things are not working, but adding or changing requirements all the time leads to frustration and failure
Plan carefully, train well, and begin slowly
It takes months to develop a program that works for everybody and uses good lab practices – be prepared
Plan for a smaller pilot program and then scale upward
Communication is key• The CDC, the SFDPH, the city public health lab, and
all site coordinators have been in constant communication throughout planning and implementation
• Accurate results, safety, and sensitive counseling with strong linkages to needed medical care and support services are shared goals for all
San Francisco Department of Public Health
AIDS Office, HIV Prevention SectionSan Francisco, CA
Shelley Shelley FacenteFacenteStudy Data Coordinator
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Omar Omar MenendezMenendez
Coordinator for Linkages415-5703-7280
Teri DowlingTeri DowlingPrincipal Investigator
Thomas KnobleThomas KnobleIntervention Site
Coordinator415-703-7279
Kevin DelaneyKevin DelaneyCDC Project Officer
Centers for Disease Control and Prevention
Division of HIV/AIDS Prevention, NCHHSTPAtlanta, GA