Los Angeles Times (10.29.03) - Thursday, October 30, 2003
Despite Food and Drug Administration approval of a 20-minute
finger-prick HIV test nearly a year ago, fewer than a dozen
California sites offer it. Health officials say strict state
testing guidelines and confusion about how to implement the
test have limited its introduction in California.
In several instances, officials are not advertising what sites
are conducting the new test for fear of being overrun with
patients. But the heart of the problem, state health officials
say, is the fact that California has some of the most
stringent regulatory testing guidelines in the country.
Federal regulations require that any site offering blood tests
outside of traditional laboratory settings apply for a waiver.
In addition, California requires test givers to have at least
a high school diploma and go through more extensive training
than the federal government requires.
Many of those expected to give the test are HIV counselors who
often have little or no experience administering blood tests.
Most of them have worked with tests that use an oral swab, and
have not had to deal with many of these state and federal
"It's been a little confusing figuring out how this test fits
in with our current system and all the rules that surround
it," said Deanna Sykes, who has overseen implementation for
California's Office of AIDS.
An 11-site pilot testing program scheduled for late May began
in only four locations because many lacked measures
guaranteeing the test's safety and accuracy, officials said. A
recent Los Angeles proposal for 26 testing sites was held up
for several weeks because state health officials were unsure a
group application was technically valid. After checking with
federal officials, the state decided it was all right;
however, it could still be months before counselors are
By processing waivers more quickly and offering training,
state health officials hope there could be as many as 702
rapid testing sites statewide by next summer. The Legislature
is also expected to consider a bill early next year that would
condense some of the training into one session.