Roll-out and Implementation Roll-out and Implementation of Rapid Testing from a of Rapid Testing from a

Field PerspectiveField PerspectivePerspectives from San FranciscoPerspectives from San Francisco

Shelley Facente, MPHShelley Facente, MPHRapid HIV Testing Program CoordinatorRapid HIV Testing Program Coordinator

San Francisco Department of Public HealthSan Francisco Department of Public HealthAIDS Office, HIV Prevention SectionAIDS Office, HIV Prevention Section

A bit of background…A bit of background…

Rapid Testing began in San Francisco Rapid Testing began in San Francisco in May 2003, with a pilot at one in May 2003, with a pilot at one community-based organization, community-based organization, Glide Health Services.Glide Health Services.

By the end of 2003, By the end of 2003, 55 agencies were agencies were on board, all using the OraQuick rapid on board, all using the OraQuick rapid HIV-1 antibody test.HIV-1 antibody test.

At this time, there are fourteen At this time, there are fourteen publicly-funded agencies offering rapid publicly-funded agencies offering rapid HIV testing in San Francisco.HIV testing in San Francisco.– 44 had previous experience with had previous experience with

in-house laboratory testingin-house laboratory testing– 44 had previous experience with had previous experience with

medical clinic servicesmedical clinic services– 66 had no previous experience with had no previous experience with

medical or lab services.medical or lab services.

Number of San Francisco Agencies Offering Rapid HIV Testing, by Start Date

0

2

4

6

8

10

12

14

5/03 7/03 9/03 11/03 1/04 3/04 5/04 7/04 9/04 11/04 1/05

Start Date

The ChallengesThe Challenges

For people who’ve never done laboratory For people who’ve never done laboratory testing beforetesting before, it is a very new experience…, it is a very new experience…demanding new skills and attention to detail.demanding new skills and attention to detail.

For laboratoriansFor laboratorians, there is a lot of anxiety , there is a lot of anxiety about lay-people being responsible for about lay-people being responsible for providing an HIV test result to a client!providing an HIV test result to a client!

So, how do we work together to So, how do we work together to ensure that clients receive the ensure that clients receive the

best services possible?best services possible?

Ask for the help of lab personnelAsk for the help of lab personnel

We asked what was needed to increase their We asked what was needed to increase their confidence in our rapid testing programs. confidence in our rapid testing programs.

Most importantly, we took their suggestions. Most importantly, we took their suggestions.

They listened to us as well, about what was They listened to us as well, about what was practical in our agencies and would meet the practical in our agencies and would meet the

needs of our clients.needs of our clients.

This worked, because the goal for all of us wasThis worked, because the goal for all of us wasa program with safe and accurate lab practicesa program with safe and accurate lab practices..

Plan quality assurance earlyPlan quality assurance early

In San Francisco, we focused on bringing In San Francisco, we focused on bringing agencies on board for the first year or so. agencies on board for the first year or so.

Every agency had their own CLIA certificateEvery agency had their own CLIA certificate

Every agency developed their own policies & proceduresEvery agency developed their own policies & procedures

Every agency had their own specific QA planEvery agency had their own specific QA plan

At the start of the second year, we had the time At the start of the second year, we had the time and staff to focus intensely on quality and staff to focus intensely on quality

assurance, especially of data and lab practices.assurance, especially of data and lab practices.It took awhile to backtrack and fix the problems that had It took awhile to backtrack and fix the problems that had

occurred in the first year… occurred in the first year… ..and frustrated everyoneand frustrated everyone

What our QA efforts include:What our QA efforts include:Our lab slips were set up to collect start and end Our lab slips were set up to collect start and end times and temperatures. We check all the data.times and temperatures. We check all the data.

We enrolled in the CDC Model Performance We enrolled in the CDC Model Performance Evaluation Program, which is used in combination Evaluation Program, which is used in combination

with periodic Competency Assessment Tests of test with periodic Competency Assessment Tests of test technicians, done at each agency.technicians, done at each agency.

We require routine data reports that allow us to We require routine data reports that allow us to cross-reference, and find areas where things aren’t cross-reference, and find areas where things aren’t

lining up, so we know to investigate.lining up, so we know to investigate.

What we discovered…What we discovered…

There were some test technicians who were There were some test technicians who were not recording appropriate start and end not recording appropriate start and end times or temperatures on the lab slips.times or temperatures on the lab slips.

There was sometimes confusion over how There was sometimes confusion over how

often to run controls, and how long the often to run controls, and how long the control fluid was good for once opened.control fluid was good for once opened.

Why QA is importantWhy QA is important

Because we developed systems for quality Because we developed systems for quality assurance that allowed us to notice problems, assurance that allowed us to notice problems,

we were able to take action.we were able to take action.

The Result?The Result?Clients have been retested when indicated.Clients have been retested when indicated.

Technical assistance has been provided to clear up confusion.Technical assistance has been provided to clear up confusion.

Protocols have been updated and improved.Protocols have been updated and improved.

Now, errors are infrequent, and caught early when they do occur.Now, errors are infrequent, and caught early when they do occur.

Plan carefully, train well, and begin slowlyPlan carefully, train well, and begin slowly

Rapid testing is a new and exciting Rapid testing is a new and exciting technology that revolutionizes the services technology that revolutionizes the services

we are able to provide to clients around HIV.we are able to provide to clients around HIV.

BUTBUT

It takes awhile to set up a good program. It takes awhile to set up a good program. It takes months to develop a program with It takes months to develop a program with

good lab practices that works for everyone. good lab practices that works for everyone.

Lessons LearnedLessons Learned

Laboratorians are correct that there are reasons Laboratorians are correct that there are reasons to be concerned about the quality of lab to be concerned about the quality of lab

practices when conducted by “lay” people.practices when conducted by “lay” people.

However, it However, it cancan be done extremely well. be done extremely well. Most of our agencies have never had an invalid Most of our agencies have never had an invalid

test or any other laboratory problem.test or any other laboratory problem.

The key is to be paying attentionThe key is to be paying attention, and taking , and taking action as needed to ensure that lab practices action as needed to ensure that lab practices

are the best they can be.are the best they can be.

CommunicationCommunicationThe good relationship we have between the The good relationship we have between the

program coordinators and policymakers at the program coordinators and policymakers at the San Francisco AIDS Office and the director San Francisco AIDS Office and the director and senior microbiologist at our city public and senior microbiologist at our city public

health lab has made all the difference.health lab has made all the difference.

We have worked togetherWe have worked togetherto ensure that individuals testing for HIV in to ensure that individuals testing for HIV in

San Francisco are receiving accurate results, San Francisco are receiving accurate results, and that those running the rapid test and that those running the rapid test

are safe when doing so.are safe when doing so.

Thank you!Thank you!

Shelley Facente, MPHShelley Facente, MPH

Rapid HIV Testing Program CoordinatorRapid HIV Testing Program Coordinator

San Francisco Dept. of Public HealthSan Francisco Dept. of Public Health

AIDS Office, HIV Prevention SectionAIDS Office, HIV Prevention Section

Shelley.Facente@sfdph.orgShelley.Facente@sfdph.org

415-554-9136415-554-9136