AltaMed Health Services Corporation
Policy and Procedures
Policy:
Routine HIV Screening in
HealthCare Setting using
Rapid Test
Distribution:
Issuing Department:
HIV Services
Effective Date:
Policy #:
NEW.
Revised: N/A
Approval by:
REG/STD:CDC- HIV Testing
Recommendations
Purpose:
The Clearview Complete Rapid HIV 1/2 Antibody Test is approved as a waived test for use with
whole blood specimens obtained by fingerstick or venipuncture. It is intended for use as a point-ofcare test. Whole blood test results are read no sooner than 15 minutes but no later than 20 minutes
after the Clearview Complete HIV 1/2 device has been initiated.
Policy:
It is the policy of AltaMed Health Services to provide their patients with HIV testing and
screening that meets the 2006 CDC Revised Recommendation for HIV Testing of Adults,
Adolescents, and Pregnant Women in Health-Care Settings. AltaMed authorizes Back Office
Staff (MA/LVN or RN) to offer the HIV Rapid Test to every patient older than 18 years of age,
or to patients 13 to 17 years of age if attending medical visit alone (i.e. FamilyPACT). If patient
accepts; back office staff will order and perform this CLIA Waived Test per “Standing Order
P&P page 4”.
For patients in all health-care settings:
 HIV screening is recommended for patients in all healthcare settings after the patient is
notified that testing will be performed unless the patients declines (opt-out screening)
 Persons at high risk for HIV infection should be screened for HIV at least annually.
 Separate written consent for HIV testing should not be required; general consent for
medical care should be sufficient to encompass consent for HIV testing.
 Prevention counseling should not be required with HIV diagnostic testing or as part of
HIV screening programs in health-care settings.
For pregnant women:
 HIV screening should be included in the routine panel of prenatal screening results for all
pregnant women.
 HIV screening is recommended after the patient is notified that testing will be performed
unless the patients declines (opt-out screening)
 Separate written consent for HIV testing should not be required; general consent for
medical care should be sufficient to encompass consent for HIV testing.
 Repeat screening in the third trimester is recommended in certain jurisdictions with
elevated rates of HIV infection among pregnant women
Procedure:
1.
After check-in process is done by the front office; the patient is escorted to the
examination room by back office staff.
Page 1 of 4
AltaMed Health Services Corporation
Policy and Procedures
Policy:
Routine HIV Screening in
HealthCare Setting using
Rapid Test
Distribution:
Issuing Department:
HIV Services
Effective Date:
Policy #:
NEW.
Revised: N/A
Approval by:
REG/STD:CDC- HIV Testing
Recommendations
2.
Back office staff completes all vitals and appropriate nurse documentation per NextGen
EHR Manual.
3.
Back Office also completes all required templates per NextGen EMR Manual including
any alerts for HIV screening.
4.
Rapid HIV Screening is offered to patients 18 years and older, or patients 13 to 17 years
of age who attend medical visits alone. If accepted, the patient is escorted to the lab or
nurse station for processing. Back Office staff approved to administer the test will
additionally inform the patient that they cannot leave the clinic until their results are
provided in 15 minutes after initiating the test, and that if reactive they will need to draw
blood to confirm their result.
4.1.
Patients who are 13 to 17 years of age, and present to the medical visit with a
parent/guardian do not require parental consent to agree to be screened for HIV
but are NOT offered an HIV test by the Back Office staff . HIV tests for patient
13 to 17 years of age are to be offered an HIV test using blood draw by the
medical provider only once the parent/guardian has been asked to leave the room.
4.2.
If patient does not accept the rapid test, the medical provider will counsel patient
on the importance of getting tested for HIV and will ask again, giving patient the
option of blood draw or rapid test.
5.
Follow the Step-by Step Test Procedure for CLIA waived Settings with use of whole
blood from finger stick. (Attachment A) and provide patient with Subject Information
Notice for the test. (Attachment B)
6.
Once the testing unit displays a reactive (preliminary positive) or a non-reactive
(negative) result between 15 and 20 minutes, the nursing staff will record patient’s result
on the Rapid Testing Patient Log (Attachment C) and verbally notify the medical
provider, in person, of the result.
7.
Negative is delivered to patient by medical provider or medical assistant. (Attachment D)
In general, those patients who test “negative” to a rapid HIV test require no additional
follow-up. Medical assistant or provider should, however, inform patients that rapid HIV
tests might not be able to detect antibodies to HIV in persons recently infected (the time
during which the rapid tests may not detect infection is called the “window period”).
Therefore, staff members who offer the test, as well as those who provide the result,
should inform all patients that if they believe they may have been infected recently
(within the last three months) they should be tested again in three months.
8.
All “reactive” rapid HIV tests require follow-up and “reactive” result must be disclosed
Page 2 of 4
AltaMed Health Services Corporation
Policy and Procedures
Policy:
Routine HIV Screening in
HealthCare Setting using
Rapid Test
Distribution:
Issuing Department:
HIV Services
Effective Date:
Policy #:
NEW.
Revised: N/A
Approval by:
REG/STD:CDC- HIV Testing
Recommendations
by medical provider. At the time a provider informs a patient of his or her “reactive” test
result, the provider should reinforce that the result is preliminary and that additional
blood work is needed to determine HIV status. (Attachment E)
9.
Blood for a Western Blot is drawn for confirmation of HIV infection.
10.
Patient is given a handout further explaining “Reactive result” (Attachment F)
11.
After drawing the Western Blot, the patient will be given a follow-up appointment in 5
clinic days to receive the results of the Western Blot test. The patient will also be
informed that they will receive a 20 dollar gift card incentive for attending their
scheduled appointment, regardless of a negative or positive confirmatory result.
12.
Next, the medical assistant who administered the rapid test will contact the linkage to
care coordinator or case manager to inform them of the reactive result and of the date
scheduled for patient’s follow-up appointment for confirmatory results. The linkage to
care coordinator/case manager will provide the patient appropriate counseling and
referral services at the time of the confirmatory result appointment.
13.
At follow-up appointment, the medical provider will disclose the results of the Western
Blot. After disclosing the HIV- or HIV+ result, the Linkage to Care Coordinator will be
called in and introduced to the patient.
13.1.
If the Western Blot is negative for HIV, the LTC Coordinator will counsel the
patient on test results, windows period, and risk reduction.
13.2.
If the Western Blot is positive for HIV, the LTC Coordinator will:
13.2.1. Provide emotional support and/or crisis intervention at time of disclosure.
13.2.2. Schedule a medical appointment within the AltaMed network or refer to
an outside medical clinic before the patient leaves their visit.
13.2.3. Schedule an appointment for case management a week after scheduled
medical appointment
13.2.4. Explain Partner Services to patient, and inform the patient that a Public
Health official will be contacting them to offer partner services.
(Attachment D)
13.2.5. Within 72 hours of providing a positive test result will send information to
the local health department for Partner Services.
Page 3 of 4
AltaMed Health Services Corporation
Policy and Procedures
Policy:
Routine HIV Screening in
HealthCare Setting using
Rapid Test
Distribution:
Issuing Department:
HIV Services
Effective Date:
Policy #:
NEW.
Revised: N/A
Approval by:
REG/STD:CDC- HIV Testing
Recommendations
13.2.6. Provide prevention counseling, if appropriate during time of disclosure.
13.2.7. Inform Clinic Testing Supervisor of HIV+ patient
13.2.8. Consent to be contacted by care coordinator/case manager.
14.
If the Western Blot result comes back negative, the patient should be instructed to return
in three months for another test, as it may be that the Western Blot cannot detect
recent infection due to the window period.
15.
If the result of the Western Blot is indeterminate, blood should be drawn for a second
test. However, if the initial Western Blot comes back positive, the person is confirmed to
have HIV infection.
Quality Control Check: Follow Clearview Complete HIV 1/2 HIV Laboratory Procedures and
Quality Assurance Plan
Attachments








Attachment A- Clearview Complete HIV 1/2 Quick Reference – Test Procedure
Attachment B- Rapid Testing Patient Log
Attachment C- Subject Information Notice
Attachment D- Revealing a Negative Result
Attachment E- Reactive Rapid HIV Test Result: A Step-by Step Response
Attachment F- Reactive Result Handout
Attachment G- Partner Services
Attachment H- HIV Rapid Test Quality Control Log and Instructions
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