1. Roll-out and Implementation of Rapid Testing from a Field Perspective Perspectives from San Francisco Shelley Facente, MPH Rapid HIV Testing Program Coordinator San Francisco Department of Public Health AIDS Office, HIV Prevention Section

2. A bit of background… Rapid Testing began in San Francisco in May 2003, with a pilot at one community-based organization, Glide Health Services. By the end of 2003, 5 agencies were on board, all using the OraQuick rapid HIV-1 antibody test. At this time, there are fourteen publicly-funded agencies offering rapid HIV testing in San Francisco. –4 had previous experience with in-house laboratory testing –4 had previous experience with medical clinic services –6 had no previous experience with medical or lab services.

3. The Challenges For people who’ve never done laboratory testing before, it is a very new experience…demanding new skills and attention to detail. For laboratorians, there is a lot of anxiety about lay-people being responsible for providing an HIV test result to a client!

4. So, how do we work together to ensure that clients receive the best services possible?

5. Ask for the help of lab personnel We asked what was needed to increase their confidence in our rapid testing programs. Most importantly, we took their suggestions. They listened to us as well, about what was practical in our agencies and would meet the needs of our clients. This worked, because the goal for all of us was a program with safe and accurate lab practices.

6. Plan quality assurance early In San Francisco, we focused on bringing agencies on board for the first year or so. Every agency had their own CLIA certificate Every agency developed their own policies & procedures Every agency had their own specific QA plan At the start of the second year, we had the time and staff to focus intensely on quality assurance, especially of data and lab practices. It took awhile to backtrack and fix the problems that had occurred in the first year…. and frustrated everyone

7. What our QA efforts include: Our lab slips were set up to collect start and end times and temperatures. We check all the data. We enrolled in the CDC Model Performance Evaluation Program, which is used in combination with periodic Competency Assessment Tests of test technicians, done at each agency. We require routine data reports that allow us to cross-reference, and find areas where things aren’t lining up, so we know to investigate.

8. What we discovered… There were some test technicians who were not recording appropriate start and end times or temperatures on the lab slips.  There was sometimes confusion over how often to run controls, and how long the control fluid was good for once opened.

9. Why QA is important Because we developed systems for quality assurance that allowed us to notice problems, we were able to take action. The Result? Clients have been retested when indicated. Technical assistance has been provided to clear up confusion. Protocols have been updated and improved. Now, errors are infrequent, and caught early when they do occur.

10. Plan carefully, train well, and begin slowly Rapid testing is a new and exciting technology that revolutionizes the services we are able to provide to clients around HIV. BUT It takes awhile to set up a good program. It takes months to develop a program with good lab practices that works for everyone.

11. Lessons Learned Laboratorians are correct that there are reasons to be concerned about the quality of lab practices when conducted by “lay” people. However, it can be done extremely well. Most of our agencies have never had an invalid test or any other laboratory problem. The key is to be paying attention, and taking action as needed to ensure that lab practices are the best they can be.

12. Communication The good relationship we have between the program coordinators and policymakers at the San Francisco AIDS Office and the director and senior microbiologist at our city public health lab has made all the difference. We have worked together to ensure that individuals testing for HIV in San Francisco are receiving accurate results, and that those running the rapid test are safe when doing so.

13. Thank you! Shelley Facente, MPH Rapid HIV Testing Program Coordinator San Francisco Dept. of Public Health AIDS Office, HIV Prevention Section Shelley.Facente@sfdph.org415-554-9136