Training Quality Assurance for a Rapid Test

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 Division of HIV/AIDS Prevention, NCHHSTP, Centers for Disease Control and Prevention HV Diagnostics Conference Atlanta, GA December 2007

A bit of background… 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.

The Rapid Test Algorithm = Non-reactive Ora. Quick Reactive Stat-Pak Reactive Ora. Quick = Client assumed HIV-negative Client assumed HIV-positive Non-reactive Stat-Pak Reactive Uni-Gold Non-reactive Uni-Gold * All results following a reactive Ora. Quick are confirmed via EIA and IFA/WB in the SFDPH Microbiology Lab

Planning 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

Identify necessary resources and staff 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)

Identify necessary resources and staff 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 Ora. Quick Phlebotomist(s) to be on-site at all times testing is offered

Develop and pilot standard operating procedures for the study and sites 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

Develop and conduct training for all staff 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

Counselor Training All counselors at each intervention site were required to attend a 3 -hour training (many were offered) to review and practice new counseling messages

Develop a quality assurance program 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

Develop a quality assurance program Observation Running 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

Develop a quality assurance program Observation Running Controls 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

Develop a quality assurance program Observation Running Controls Competency Assessment Testing (CAT) Model Performance Evaluation Program (MPEP) • Each site is enrolled in CDC’s MPEP and the site laboratory manager must correctly run all six MPEP samples for the Ora. Quick Advance, Stat-Pak, and Uni-Gold tests twice per year Adjusting Data Collection

Develop a quality assurance program Observation Running Controls Competency Assessment Testing (CAT) Model Performance Evaluation Program (MPEP) Adjusting 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

Lessons Learned Staff and resources must be adequate A data collection plan must be developed and refined before implementation A slow roll-out is essential

Staff and resources must be adequate 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

A data collection plan must be developed and refined before implementation 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

A slow roll-out is essential 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

Thank you! Teri Dowling Shelley Facente 415 -554 -9167 Teri. Dowling@sfdph. org 415 -554 -9136 Shelley. Facente@sfdph. org Thomas Knoble Omar Menendez Principal Investigator Intervention Site Coordinator 415 -703 -7279 Thomas. Knoble@sfdph. org Study Data Coordinator for Linkages 415 -5703 -7280 Omar. Menendez@sfdph. org San Francisco Department of Public Health AIDS Office, HIV Prevention Section San Francisco, CA Kevin Delaney CDC Project Officer 404 -639 -6142 khd 8@cdc. gov Centers for Disease Control and Prevention Division of HIV/AIDS Prevention, NCHHSTP Atlanta, GA