Agenda
9:00
- 9:15am
Sign-in, Meet and Greet
9:15 - 10:15am
Rapid HIV AB testing:
Laboratory Issues
Valerie Ng, PhD, MD
10:15-10:45am
Confirmatory Testing: IFA
vs Western Blot
Patricia Nassos, PhD
10:45-11:00am
Q&A and Break
11:00- Noon
Panel Discussion with
multiple clinicians on:
-
Infectious
Disease/HIV, Family & Community
-
Medicine/Substance
Abuse, Emergency Services
Noon
– 1:30pm
Working Roundtable Lunch
(We will send out an email as the event gets closer to let you
know if lunch will be provided or we will be brown-bagging it)
Topic:
What bugs you most about your POC Program?
Share and see if others
have solved issues like:
-
How do you stop POC
personnel from sharing glucose meter passwords?
-
What penalties do you
enact when a POCT is out of compliance?
-
How do you regularly
assess your POCT sites for compliance?
-
How do you manage
your POCT inventory and supplies?
-
What QC is done when
you transport POCT site supplies to other off-campus
sites?
1:30 – 3:00pm
Interactive Session: CLSI
revisions in Progress and POCT Implications ~ Learn what’s being
considered/Influence the process! (EP-18 Risk Mgmt Techniques to
ID/Control Lab Error, EP-22 Presentation of Mfg’s Risk
Mitigation Info for users of in-vitro devices, EP-23 User
Defined QC Protocols based on EP-22).
3:00 – 4:00pm
Q&A
RSVP by April 25th
to Clayton Hooper, SFGH
Clayton.Hooper@sfdph.org, 415-206-3493
Learning Objectives:
1. Rapid HIV antibody
testing:
-
Explain the
differences in test procedure allowing the same test kit to
be used as a “waived" or a "moderately complex" test
-
Explain the
importance of California phlebotomy certification for POCT
personnel in determining which specimen type (oral fluid
versus whole blood versus plasma/serum) can be used for
rapid HIV antibody testing.
-
Explain why you might
implement a more stringent QC program for your POCT "waived"
rapid HIV Ab testing than required by the manufacturerd.
List and describe the regulatory requirements for "waived"
rapid HIV antibody testing
2. Confirmatory HIV
antibody testing:
IFA versus Western Blot
-
Compare and contrast
the advantages and disadvantages of IFA versus Western Blot
for confirmation of the presence of HIV antibody.
-
List the relative
accuracies of IFA versus Western Blot for the confirmation
of HIV antibody presence.
3. CLSI projects in
progress
-
List risk mgmt
strategies used by manufacturers to prioritize and control
residual testing risks
-
List some
circumstances unique to your environment justifying a more
rigorous and stringent QC program than that recommended by
the manufacturer.
-
Understand why and
the basis for QC recommendations from regulatory agencies
differing from that of manufacturers.
-
Describe your POCT
testing environment(s) and how you would apply a risk
management approach to determine your frequency of QC.
Directions to S.F.
General Hospital,
Carr Auditorium, Bldg 3
http://www.dph.sf.ca.us/chn/SFGH/sfghcampusmap.asp
If map doesn’t show up,
use the link above.
-
1001 Potrero Avenue, San
Francisco, 415-206-8000
-
PARKING:
Parking Garage
located between 23rd and 24th. In
the morning the only entrance that may be open is on 24th
street. Cost: $10.00
-
CARR Auditorium
B3:
Located across campus from the Parking Garage. It runs
along 22nd street (it kind of jags from one side
of Potrero to the other).