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CBO Rapid Testing Protocol 2008

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CBO Rapid Testing Protocol 2008 Powered By Docstoc
					                                                                                         Revised May 2008


                            STATE OF LOUISIANA
              RAPID HIV TESTING AND PREVENTION COUNSELING
                      QUALITY ASSURANCE PROTOCOL
                       For CBO‟S Using CLIA Waived Rapid Testing Devices



I. DESCRIPTION OF INTERVENTION
The Rapid HIV Testing and Prevention Counseling intervention is defined as one-on-one, client-centered,
risk/harm reduction counseling with persons at risk for HIV infection. The intervention is accompanied
by an OraQuick Advance Rapid HIV-1/2 antibody test (OraQuick), an Uni-Gold Recombigen HIV-1
antibody test (Uni-gold), or a Clearview HIV-1/2 Stat-Pack antibody test (Clearview) that provides
preliminary results in detecting HIV antibodies. OraQuick test specimens can be oral, finger-stick whole
blood, or venipuncture whole blood with results interpreted between 20-40 minutes. Uni-Gold test
specimens can be finger-stick or venipuncture whole blood with results interpreted between 10 and 12
minutes. Clearview test specimens can be finger-stick or venipuncture whole blood with results
interpreted between 15 and 20 minutes

The standards for counseling are based on the integrated CDC HIV Prevention Counseling and Rapid
Testing models, which empower clients to assess their readiness for results, their own risk behaviors and
to develop a realistic and incremental plan for behavior change. More information regarding the CDC
guidelines for HIV Prevention Counseling can be found in MMWR Revised Guidelines for HIV
Counseling, Testing, and Referral, 2001. More information on CDC guidelines for rapid HIV testing can
be found in Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under
the Clinical Laboratory Improvement Amendments of 1988, 2007. Both documents are located on the
CDC website.

The OraQuick, Uni-Gold, and Clearview antibody testing devices referred to in this protocol have each
been classified under the Clinical Laboratory Improvement Amendments (CLIA) as “waived”. CLIA
provides a “limited public health use” exception, under which a licensed laboratory can operate multiple
satellite sites under the umbrella of a single CLIA certificate. Each organization is required to obtain a
CLIA certificate of waiver to conduct Rapid HIV Antibody Testing. ONLY community-based
organizations (CBOs) approved by the HIV/AIDS Program can conduct confirmatory testing under the
supervision and oversight of the Louisiana Office of Public Health.

II. PREREQUISITES TO IMPLEMENTING THE RAPID HIV TESTING AND PREVENTION
COUNSELING INTERVENTION
This section covers what must be done to assure the proper functioning of the HIV rapid test and to
prepare an agency for rapid testing. Before the testing intervention can be performed there are
prerequisites related to physical testing sites, testing supplies, QA protocol, and personnel that must be
satisfied.

Prerequisites for Testing Sites
HIV rapid testing and prevention counseling conducted by CBOs is reserved for high-risk areas as
outlined in the Statewide Prevention Plan and regional priority zip codes. CBOs under contract with the
HIV/AIDS Program should maintain/establish testing sites in areas that have been identified by the
Regional Prevention Coordinator as belonging to one of the priority zip codes in the area or identified as a
site of particular importance/appropriateness for HIV prevention activities (such as a site with a history of
1% new positivity among individuals tested, a site where high risk activities are conducted such as
commercial sex work, etc. or a site where individuals belonging to high risk groups are known to hang
out). All sites must be assessed and approved by the HIV/AIDS Program. Testing sites should yield at




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least a one-percent (1%) newly identified1 positivity rate annually. The percent positivity is defined as the
total number of newly identified positive HIV tests, divided by the total number of tests conducted by the
agency and multiplied by one hundred.

Rapid HIV Testing must also be conducted in locations that will assure optimal accurate processing and
reading of each test. All rapid test sites must provide adequate lighting, temperature control, testing
surface, confidentiality, and counseling area(s).

Organizations contracted to conduct any HIV counseling, testing, and referral must register both fixed and
mobile sites through the OPH HAP Regional Coordinator using the Site Assessment and Registration
Form (see Attachments RT-6). HIV/AIDS Program staff will visit each potential site to determine if it is
appropriate for rapid testing activities. Please allow up to four (4) weeks to process the Site Assessment
and Registration Form. HAP will assign a unique site number and site type code for the new site and mail
a certificate of approval for rapid testing back to the requesting agency once the registration process is
complete.

HAP staff are required to be in attendance during the agency’s first day of rapid HIV testing
implementation.

Sites providing HIV counseling and testing are required to provide a private, confidential setting for HIV
prevention counseling (pre- and post-test) to occur. Crucial elements of a confidential setting include:
            1. Ample space for a private conversation to occur.
            2. Secluded area for counseling session.
            3. Support from site staff to respect privacy of clients.


HIV testing through Office of Public Health contracts is offered to individuals age 13 and older without
parental consent. OraSure confirmatory tests cannot be performed on persons under the age of 13, in
accordance with manufacturers‟ instructions. Failure to comply with a manufacturer‟s instructions is a
violation of a testing site‟s CLIA agreement. Therefore, Persons 12 and younger must be referred to an
early intervention clinic or pediatrician for proper medical attention and assessment of HIV infection.
Agencies providing any HIV testing through the HIV/AIDS Program are required to post a sign in
their reception area stating the age limitations for testing and provide appropriate referrals upon
request.

All testing sites are required to develop and/or maintain written policies on crisis management, sobriety of
clients to obtain services, and confidentiality.

Organizations are responsible for obtaining the proper liability insurance coverage for OraQuick, Uni-
Gold, and/or Clearview testing. OPH HAP may require proof of current and appropriate insurance prior to
the approval of any rapid HIV testing activities.

Organizations must obtain a CLIA certificate independent of the public health laboratory for processing
OraQuick, Uni-Gold and/or Clearview test kits. CLIA application fees are the responsibility of the
organization. Instructions for completion are available through the OPH HAP Regional Coordinator. A
copy of the agency‟s CLIA certificate must be faxed to OPH HAP prior to the initiation of any rapid HIV
testing activities.

Prerequisites for Testing Supplies
Testing sites contracted or approved to conduct rapid HIV testing will use either OraQuick, Uni-Gold
and/or Clearview rapid testing devices – all technologies are CLIA waived, single-use, qualitative
immunoassays to detect antibodies to HIV.

1
 A newly identified positive is a person who tests positive and receives their positive result for the first time.
Persons who were previously diagnosed with HIV and aware of their infection are not counted towards an
organization‟s annual positivity rate.
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   The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test consists of:
       o A single-use testing device and solution vial
       o A reusable test stand, and
       o Disposable single-use specimen collection loops.
   The Uni-Gold Rapid HIV-1 Antibody Test consists of:
       o A single-use testing device
       o A multi-use wash solution bottle (5.0ml)
       o Disposable pipettes for use with venipuncture whole blood and when running controls, and
       o Disposable fingerstick sample collection and transfer pipettes for use with fingerstick whole
           blood
   The Clearview Stat-Pack Rapid HIV-1/2 Antibody Test consists of:
       o A single-use testing device
       o A multi-use wash solution bottle (3.5ml)
       o Disposable single-use specimen collection loops for use with all approved specimen types

   In addition, testing sites will also need:
        o OraQuick, Uni-Gold and/or Clearview controls
        o Disposable absorbent workspace covers
        o Biohazard waste disposal bags
        o Latex/polyurethane/nitrile gloves
        o Sharps Container (for blood specimen testing only)
        o Disposable Lancets (for blood specimen testing only)
        o Thermometers (one for the storing area, one for the refrigerator, one for mobile sites)
        o Timers
        o 10% bleach solution or FDA approved disinfectant
        o OraSure devices for confirmatory testing
        o Coolers for mailing specimen for confirmatory testing (to state OPH lab only)
        o HIV Test forms
        o Informed Consent forms.

Approved supplies will be provided by the HIV/AIDS Program or the OPH state laboratory for HAP
funded rapid testing sites. Agencies may be required to obtain certain items at their own expense. Testing
sites will not be provided additional funds for supplies or phlebotomy services. Up to date documentation
of testing (including HIV Test forms) must be submitted to the HIV/AIDS Program before any supplies
will be sent to a rapid test site

Quality Assurance of Test Kits
Kit Controls must be run under the following circumstances:

           Each newly trained counselor prior to performing rapid testing on patient/client specimens
           When opening a new test kit lot (lot numbers are printed on each box and device)
           Whenever a new shipment of test kits is received
           If the temperature of the test kit storage area falls outside 35-80 degrees Fahrenheit
           If the temperature of the testing area falls outside 59-99 degrees Fahrenheit
           Prior to using test kits at remote locations (when the test kits are used outside of the area
            where they are stored, e.g., mobile vans, outreach testing, prisons/jails, drug treatment
            centers)
           At periodic intervals as dictated by the user facility.

The respective kit controls (OraQuick, Uni-Gold or Clearview) verify that the rapid HIV antibody test is
working properly and that users are able to properly administer and interpret the test. If the results of any
one of the control tests do not match the expected result, rerun all controls. If the repeated control test
run produces unexpected results, do not use any tests from that entire lot number and notify the
HIV/AIDS Program Regional Coordinator immediately.


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Also, each rapid test device contains a built in control feature that demonstrates assay validity. A
reddish-purple control line should appear in the area labeled “C” or “Control” depending on the specific
device being used. The control line must appear in order for the respective test to be valid, whether
or not the sample is reactive or non-reactive. Test results are considered “invalid” when:

           No reddish-purple line appears next to the area labeled “C” or “Control”
           A red background in the result window makes it difficult to read the result after 20 minutes
           If any of the lines are not inside the appropriate control or test line areas.
           The sample well is not completely red after adding a blood specimen (Uni-Gold and
            Clearview tests only).

Prerequisites for Rapid Testing and Prevention Counseling Personnel
All persons conducting Rapid HIV testing must be certified by the HIV/AIDS Program including specific
instruction on the type of rapid test he/she will be using and successfully complete an observation session
with the Regional Prevention Coordinator (see attachment RT-9).

Counselors are required to be skilled in client-centered counseling. Additionally, counselors must be
knowledgeable of a wide variety of harm/risk reduction activities and be comfortable demonstrating
harm/risk reduction skills such as providing condom demonstrations. CBOs funded to conduct this
intervention are responsible for screening potential counselors and reinforcing skills and knowledge with
internal training activities.

Unless it is impossible, clients should only see one counselor. This includes giving test results.
Consistency of the client and counselor relationship helps the client feel secure, reduces
misunderstanding, and promotes the likelihood of effective risk reduction. When follow-up prevention
counseling sessions must be provided by a different counselor, careful record-keeping is recommended to
ensure high-quality counseling.

CT guidelines and protocols change frequently at the national and state levels; as a result, HIV Prevention
Counselors will be required to attend update trainings from time to time in order to maintain active
certification.

Agencies must identify in writing the name of their designated Quality Assurance Coordinator
using the Quality Assurance Coordinator Registration Form (see attachment RT-8) (typically the
same person identified to CLIA as the laboratory director – this could be the Counseling and Testing
Supervisor/Coordinator, Head Nurse, Prevention Manager, etc.).

The Agency‟s rapid testing Quality Assurance Coordinator will be responsible for informing other staff
on updates and/or revisions to the State of Louisiana Rapid HIV Testing and Prevention Counseling
Quality Assurance Protocol as needed. The Quality Assurance Coordinator is also responsible for
ensuring his/her agency is in 100% compliance with the quality assurance protocol including the proper
use, storage and documentation of rapid testing devices/activities. Quality Assurance Coordinators must
be fully trained on the rapid testing device(s) being used at his/her agency and have sufficient experience
with rapid testing (6 months experience rapid testing and at least 200 tests conducted for staff at
established agencies – agencies not new to conducting rapid testing).


III. REQUIRED ACTIVITES WHILE CONDUCTING A RAPID TESTING AND
PREVENTION COUNSELING SESSION WITH A CLIENT
All CBO‟s conducting the HIV Prevention Counseling and Rapid Testing intervention in Louisiana
should model sessions with clients according to the format and guidelines that follow. The Regional
Prevention Coordinator and the HIV Counseling and Testing Supervisor must approve any alternate
model/process of conducting this intervention. Agencies that believe an alternate model/process of
conducting the Rapid HIV Testing and Prevention Counseling intervention should be used must submit
detailed proposals along with any supporting evidence, in writing, to the Regional Prevention

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Coordinator. Agencies will be notified by HAP in writing whether or not it is acceptable for an alternate
model/process of conducting the intervention to be used (see Attachment RT-10 for one page model).


Overview of required activities before the rapid test begins processing (Before Testing)

   Introduce yourself to the client.
   Assess client‟s readiness to receive the results on the same day.
   Offer options for testing.
   Describe the testing process, what type of specimen will be collected, how long the whole process
    will take, and what each of the three possible results mean.
   Explain to client that if a preliminary positive result is received, a confirmatory test should be
    conducted.
   Address Partner Services, including informing the client that if results come back positive, a DIS will
    contact them to offer additional services.
   Offer anonymous and confidential options, and explain what each mean.
   Obtain Informed Consent.
   Provide appropriate subject information pamphlet for the rapid test being conducted.
   Collect and run specimen.

More detail on these steps below:

   Introduce yourself to the client.
    Give the client your name and welcome them to the agency.

   Assess client‟s readiness to receive the results on the same day.
    Ask the client questions to determine their motivation for getting tested and what, if any, support
    system is in place.

   Offer options for testing (oral swap, fingerstick, venipuncture, etc.) that are available at the testing
    site.
    Offer clients the choice of receiving results the same day or at a later date.

   Describe the testing process, what type of specimen will be collected, how long the whole process
    will take, and what each of the three possible results mean.
    It is a part of informed consent for clients to understand what type of specimen will be taken from
    them, how long the rapid testing session will take, and that the three possible results are preliminary
    positive, negative, and invalid. Clients should also be informed what actions will take place after each
    of the results.

   Explain to client that if a preliminary positive result is received, a confirmatory test should be
    conducted.
    According to the CDC, a very important part of counseling persons who have a reactive rapid HIV
    test result is to make sure they understand that the test result is preliminary, and further testing must
    be done to confirm the result. Clients must be asked how they would react to getting a preliminary
    positive result in a rapid time frame in order to determine if testing is beneficial at that time.

    Persons who have identified themselves as HIV positive should not be retested with a rapid test.
    Individuals infected with HIV-1 and/or HIV-2 who take antiretroviral medication can produce false
    negative rapid test results under some circumstances. Self identified HIV infected persons can be
    offered a conventional HIV test and should be referred to case management and/or medical care.



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   Address Partner Services, including that if the client tests positive, a DIS will contact them to offer
    services.
    Emphasize that this is a free and confidential service OPH provides should the client want help in
    contacting partners.

   Offer anonymous and confidential options, and explain what each mean.
    Clients must be offered the option of anonymous or confidential HIV testing. This is in accordance
    with Louisiana law 1300.12 HIV –related testing; consent; exceptions, element E. Anonymous testing
    involves the use of no personal identifiers (i.e. last name, first name, or social security number) that
    would link an individual to his/her test result. Confidential testing indicates that a client is willing to
    provide personal identifiers that can be used to link the individual to his/her rapid HIV test result.
    Confidential testing is strongly encouraged to facilitate the entry into follow-up medical services for
    individuals who have been identified as HIV infected and should be encouraged for all confirmatory
    testing. Persons testing anonymously cannot be contacted – they can only receive test results by
    keeping track of and presenting their “P” number, which corresponds to their HIV test form.

   Obtain Informed Consent.
    It is required that written “Informed Consent” for HIV testing be obtained prior to clients receiving
    any HIV testing. It is recommended that clients testing anonymously write the HIV Test Form
    number on the bottom of the Informed Consent Form. Clients testing confidentially must sign their
    name. Disclosure of HIV test results is strictly governed by the State of Louisiana as noted on the
    reverse side of the consent form

   Provide appropriate subject information pamphlet for the rapid test being conducted.
    The FDA requires that all test subjects receive the “Subject Information” pamphlet produced by the
    manufacturer of the rapid test device being used prior to collecting a specimen for testing. These
    pamphlets are included in each box of the various rapid testing products. Contact your HAP Regional
    Coordinator for additional copies of these pamphlets.

   Collect and run specimen.
    Testers must follow the manufacturer‟s instructions provided by the manufacturer of the rapid test
    device he/she will be using. In addition to manufacturer instructions, identifying stickers from the
    HIV Test form should be placed on the testing device (or on the developer solution vial for OraQuick
    tests) to insure quality control. Not following the manufacturer’s instructions may result in
    inaccurate test results.

Overview of required activities while the rapid test is processing (During Testing)

   Complete the HIV Test Form-Part 1 as much as possible.
   Conduct Steps 2 (Identify personal risk behavior) and 3 (Identify safer goal behaviors) of the
    counseling process.
   Continue to assess client readiness to receive result.

More detail on these steps below:

   Complete the HIV Test form-Part 1 as much as possible.
    Each rapid HIV test shall be documented on the HIV/AIDS Program HIV Test form-Part 1. Forms
    must be completed in their entirety and submitted to the HIV/AIDS Program weekly to be entered for
    reimbursement and/or analysis. Testing sites will not be provided additional supplies if HIV Test
    forms are not submitted to the HIV/AIDS Program.

   Conduct Steps 2 (Identify personal risk behavior) and 3 (Identify safer goal behaviors) of the
    counseling process. Step 2 should explore previous risk-reduction efforts and identify successes and
    challenges in those efforts. Factors associated with continued risk behavior that might be important to

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    explore include using drugs or alcohol before sexual activity, underestimating personal risk,
    perceiving that precautionary changes are not an accepted peer norm, perceiving limited self-efficacy
    for successful change efforts, receiving reinforcement for frequent unsafe practices (e.g., a negative
    HIV test result after risk behaviors), and perceiving that vulnerability is associated with "luck" or
    "fate".

    When considering safer goal behaviors (Step 3), counselors should focus on reducing the client's
    current risk and avoid discussions regarding HIV transmission modes and the meaning of HIV test
    results. However, when clients believe they have minimal HIV risk but describe more substantial risk,
    the counselor should discuss the HIV transmission risk associated with specific behaviors or activities
    the clients describe and then discuss lower-risk alternatives. For example, if clients indicate that they
    believe oral sex with a risky sex partner poses little or no HIV risk, the counselor can clarify that,
    although oral sex with an infected partner might result in lower HIV transmission risk than anal sex,
    oral sex is not a risk-free behavior, particularly when commonly practiced. If clients indicate that they
    do not need to be concerned about HIV transmission among needle-sharing partners if they use clean
    needles, the counselor can clarify that HIV can be transmitted through the cooker, cotton, or water
    used by several persons sharing drugs. With newly identified or uninformed HIV-infected clients, the
    counselor should discuss HIV transmission risks associated with specific sexual or drug-use
    activities, including those in which the client might not be currently engaged. Although the optimal
    goal might be to eliminate HIV risk behaviors, small behavior changes can reduce the probability of
    acquiring or transmitting HIV. Behavioral risk-reduction steps should be acceptable to the client and
    appropriate to the client's situation. For clients with several high-risk behaviors, the counselor should
    help clients focus on reducing the most critical risk they are willing to commit to changing.

   Continue to assess client readiness to receive result.
    Counselors have until the timer goes off, thus indicating the rapid test is finished processing, to assess
    whether the client is ready to receive same day test results. HOWEVER, once the counselor leaves to
    interpret the test result, they must provide the result upon returning to the client.


Overview of required activities after the rapid test has finished processing (After Testing)

   Provide the test result to the client.
   Conduct Steps 4 (Create a client action plan), 5 (Offer referrals and provide support), and 6
    (Summarize and Close).
   Set up follow-up appointment for preliminary positive clients to receive confirmatory result or, if
    necessary, those testing negative to get retested.
   Provide condoms, other harm/risk reduction tools and appropriate literature.
   Complete the remainder of HIV Test form-Part 1.
   Complete other documentation as needed (Part 2 form(s) for clients with positive results and
    Discordant Report forms for clients with negative or indeterminate confirmatory results after a
    preliminary positive rapid test result).
   Correctly dispose of used testing supplies following universal precautions and safe work practices at
    all times.

Continue counseling session based on the results of the test:

Rapid HIV Tests:
       Preliminary Positive:
        Accurately communicate results with client - the result shows signs of HIV antibodies and a
          confirmatory test must be done to be sure.
        Allow time for emotional response. Do not rush the client into conversation.
        Ensure the client understands what the result means.

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          Assess client concerns.
          Offer confirmatory blood or OraSure testing. Clients who have a reactive/preliminary
           positive rapid HIV test results must be offered a follow-up confirmatory test and offered
           referrals to early intervention after receiving their preliminary positive result. Confirmatory
           testing will be provided by CBOs using OraSure devices and sent to the appropriate Office of
           Public Health laboratory. Clinics and health units will draw a blood specimen for
           confirmatory testing. All HIV testing sites are expected to counsel 100% of clients with
           reactive tests.
          Collect specimen. The Louisiana OPH Laboratory is responsible for providing containers for
           transport of specimen as well as providing instructions on how specimen should be stored for
           transport. Some agencies do not use the state lab; follow the instructions for whichever lab is
           being used by the CBO.
          Review the client‟s risk assessment and risk reduction plan.
          Emphasize the importance in taking the same health precautions as a person who may have a
           confirmed HIV positive test result.
          Negotiate additional referrals with client, including potential medical and partner counseling
           referrals.
          Set appointment to return for confirmatory test results.
          Provide condoms and literature as deemed appropriate.
          For clients who have a reactive rapid test, HIV TEST FORM – PART 2 should be completed
           two times: once after the client receives the preliminary positive result and an additional Part
           2 form should be completed after the client receives the confirmatory test results. If the Client
           does not return to receive test results after waiting 10 days past the scheduled appointment
           date (or date of the rapid test), submit the blank HIV TEST FORM – PART 2 to HAP so that
           the Regional OPH DIS office can be contacted to assist with follow-up/client notification
           referrals for follow-up medical care and case management. In this case, mark the box next to
           „CLIENT DID NOT RETURN‟ and write the P number from HIV TEST FORM-PART 1 at
           the top of Part 2.

       Negative:
        Review with the client his/her risk assessment and risk reduction plan.
        Discuss plans for staying negative.
        Assess need to retest.
        Provide condoms and other harm/risk reduction tools and appropriate literature.
        Assess the client‟s need for other referrals.
        Make sure client understands the window period and whether he/she needs to be retested at a
          later date.

       Invalid:
        Explain that there was a problem running the test, either related to the test device or the
          specimen collected.
        Assess client concerns and emotional response.
        Assure client that quality assurance procedures are in place. NOTE: If you have not
          personally checked all storage logs that day, do so before retesting.
        Collect new specimen and run it with new rapid test device or conduct a conventional test
               (OraSure or blood draw) if the client refuses an additional rapid test.
        Provide condoms, other harm/risk reduction tools and appropriate literature.
        Review the client's risk assessment and risk reduction plan. Emphasize the need to take same
               risk reduction precautions as established.

Confirmatory HIV Tests (following a preliminary positive rapid test):

       Negative or Indeterminate (therefore Discordant Result):

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   Discuss possible causes for result (recent infection – low levels of HIV antibodies present or
    other acute viral infections can sometimes make a rapid test read reactive when there truly are
    not HIV antibodies present, etc.).
   The client should be told that their HIV status is not certain at this point - there is a chance
    that they could not be truly infected with HIV but there is also a chance that they are infected
    with HIV. Further testing is needed.
   Explain that this is a discordant result (do not use the terms false positive or false negative as
    these are not appropriate descriptions of this situation)
   Assess client‟s concerns.
   Establish plans for follow-up testing to occur 4 weeks after the initial preliminary positive
    result. It is highly recommended and inline with CDC rapid testing protocol that follow-up
    confirmatory testing be conducted with a blood specimen whenever possible.
   Review the client's risk assessment and risk reduction plan. Emphasize the need to take same
    risk reduction precautions as established during this period of uncertainty.
   Provide condoms, other harm/risk reduction tools and appropriate literature.
   HIV Test form-Part 2 must be completed and returned to the HIV/AIDS Program for every
    client who has a preliminary positive rapid test, a positive/reactive western blot or IFA test
    result and any confirmatory test result (following a preliminary positive rapid test result) even
    if the confirmatory results are not positive/reactive.
   Complete the top sections of the Discordant Result Report form and keep the form in the
    client‟s file until they return for the follow-up test approximately 2 weeks later. Once the
    client has their follow-up confirmatory test, complete the bottom of the Discordant Result
    Report form and send it to HAP as soon as possible. Sites may make a copy of this form to
    keep in the client‟s file.
   If client does not return for follow-up confirmatory testing, counselor should notify
    his/her supervisor and the Regional Prevention Coordinator immediately after it is
    determined by the counselor that the client is lost to follow-up or is likely not to return
    for follow-up testing. The DIS assigned to the CBO should be notified as well so that
    they can begin efforts to follow-up and/or locate the client with the discordant HIV test
    results. In this case, mark the box next to „CLIENT DID NOT RETURN‟ and write the P
    number from HIV TEST FORM-PART 1 at the top of Part 2.

Positive:
 Allow time for an emotional response. Do not rush the client into a conversation.
 Ensure client understands what test result means.
 Make client aware of need for medical evaluation and the availability of treatment.
 Provide medical referral.
 Reassess the client's risk for transmitting HIV infection to others. Discuss partner counseling
   options and discuss the client's plan to inform his/her partners.
 Discuss client's plans to stay healthy, to protect self and others.
 Assist client in identifying necessary referrals. Make appropriate referrals and set
   appointments.
 If working with a positive woman who is pregnant and not in prenatal care, make a referral to
   prenatal care.
 Provide condoms and appropriate literature.
 Address Partner Services again. Clients are to be informed of the importance of contacting
   sex and/or needle sharing partners. A discussion of Partner Services should be provided in
   Step 1 AND after the result is given for reactive (preliminary positive) rapid tests and when
   clients receive confirmed positive test results. Counselors should record clients‟ contact
   information on the appropriate areas of HIV Test Form-Parts 1 and 2 to facilitate referral
   follow up and partner services. Counselors must discuss the Louisiana public health
   policy that provides for DIS to contact all persons testing reactive to HIV to discuss and
   offer partner services.

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           HIV Test form-Part 2 must be completed and returned to the HIV/AIDS Program for every
            client who has a preliminary positive rapid test, a positive/reactive western blot or IFA test
            result and any confirmatory test result (following a preliminary positive rapid test result) even
            if the confirmatory results are not positive/reactive.

Clean Up and Disposal of Testing Supplies
All rapid testing devices should be disposed of in biohazard waste material bags in accordance with local
regulations for infectious waste disposal. All specimens should be handled in accordance with universal
precautions and the manufacturer‟s instructions. Proper disposal of biohazardous waste materials will be
the responsibility of the organization or testing site. HAP will provide assistance with arranging proper
disposal as needed. Shipping or transporting of processed devices/vials outside of the test area is
prohibited, unless stored in a sealed and clearly marked biohazard waste container.



IV. REQUIRED DOCUMENTATION OF HIV TESTING ACTIVITIES

Send all required documentation/forms to:

                        CTR Department
                        Office of Public Health
                        1010 Common Street, STE 1100
                        New Orleans, LA 70112.
                        Fax: (504) 568-7540 *Do not fax any confidential information.

To insure proper confidentiality measures, forms must be enclosed in two envelopes and marked
“confidential” on the inside envelope. Testing information should be addressed to the Office of
Public Health without any reference to “HIV” and/or “AIDS” in either the sender’s address or the
recipient’s address. Forms that are hand delivered will not be accepted unless they are enclosed in two
envelopes and properly address

The destruction of the HIV Test Forms and Informed Consent forms are to occur by shredding ONLY
(cross-cut shredding is recommended). Confidential HIV Test forms, HIV Laboratory Requisition forms,
and Informed Consent forms are to be maintained for seven (7) years or for as long as the medical record
is maintained (not less than 6 years). Anonymous HIV Test forms, Laboratory Requisition forms, and
Informed Consent forms are to be held for three (3) years and then destroyed. HIV Test Forms and
Laboratory Requisition forms must not be handled by fax machine.

Following is a description of all documentation that must be completed and maintained and/or submitted
to HAP along with the submission timeline where applicable.

1. Weekly Submission:

    The following documentation/forms must be sent to HAP at least weekly.

    a) HIV Test form-Part 1: The top white copy of the HIV Test form-Part 1 must be completed and
       submitted to HAP for each rapid HIV test conducted. This must be done at least weekly. The
       two carbon copies may be kept in the client file, or one can be kept and the other shredded.
       Instructions for completing the HIV Test form are available from the OPH HAP Regional
       Coordinator.

    b) HIV Test form-Part 2: This form is completed for every preliminary positive and every
       confirmatory result, regardless of whether it is confirmed positive or not. It should be mailed to
       HAP along with the corresponding Part 1 form immediately after it is completed. For clients who
       do not stay to receive their preliminary positive result or do not return for the scheduled time to

                                                                                                      10
                                                                                          Revised May 2008

         receive their confirmatory result, hold on to Part 2 NO LONGER than 10 working days past the
         missed appointment before submitting it to HAP.

 2. As needed:

     The following documentation should be submitted to HAP as needed.

     a) Supply Order Form: (Attachment RT-5) This form should be completed and faxed to HAP
        when supplies are needed. Please allow at least 4 weeks for processing.

     b) CTR Rapid Site Assessment and Registration Form: (Attachment RT-6) Prior to commencing
        rapid HIV testing activities at any site, this form must be completed by the Regional Coordinator.
        All sites must be registered and approved by the HIV/AIDS Program prior to the start of any
        rapid testing activities. Please allow up to four (4) weeks for approval of each site. A copy of this
        form should be kept on site.

     c) Discordant Test Report: (Attachment RT-7) All confirmatory test results that are negative or
        inconclusive must be followed up with a Discordant Test Report and follow-up testing of the
        client approximately 4 weeks following the initial preliminary positive result. This report should
        be submitted to HAP after the client returns for follow-up testing. Should the client not return for
        the scheduled retesting appointment, return the report no later than 10 days after the missed
        appointment.

3.   Maintain on site:

     The following documentation must be maintained at each agency conducting HIV testing
     activities:

     a) CLIA Waiver Certificate: Each testing agency must obtain a CLIA waiver certificate prior to
        requesting approval for any rapid testing activities from the HIV/AIDS Program. Information on
        obtaining a CLIA waiver certificate can be obtained from the HAP Rapid Test Coordinator. The
        agency‟s CLIA waiver certificate number must be included on every Site Registration Form
        submitted to HAP. Waivers must be current and a copy must be provided to the HIV/AIDS
        Program prior to starting any rapid testing activities.

     b) Test Device Temperature Log: (Attachment RT-1) Documentation of storage room temperature
        must be recorded daily for test kits.

     c) Control Kit Temperature Log: (Attachment RT-2) Documentation of control kit storage
        temperature must be recorded daily for control kits.

     d) Daily Rapid HIV Test Log: (Attachment RT-3) All rapid tests conducted must be recorded on a
        daily test log. These logs are kept in agency files and may be requested by OPH HAP at any time.

     e) Control Kit Log: (Attachment RT-4) All control tests run at the testing site must be logged on
        the Control Log and signed by the Quality Assurance Supervisor. Any corrective action taken as a
        result of control testing must be documented on this log.

     f) Confidentiality Agreements: All agency staff and volunteers must have a confidentiality
        agreement signed and on file at the testing agency.

     g) Counselor Training and Counselor Number Certificates: ONLY counselors certified by HAP
        in Rapid HIV Testing and Prevention Counseling are allowed to conduct the intervention in
        Louisiana. Staff and volunteers conducting rapid testing and prevention counseling activities are
        required to be skilled in client-centered counseling, collecting and processing rapid HIV test
        specimens accurately, and completing forms correctly. Skills and knowledge must be reinforced
        with participation in ongoing training and evaluation activities. The HIV/AIDS Program requires
                                                                                                       11
                                                                                         Revised May 2008

         that all counselors (volunteers and staff) become certified prior to conducting rapid HIV testing
         activities. Certificates must be stored in agency files (see Attachment RT-9).

    h) Rapid Testing and Prevention Counselor Skills Observation Form: Internal monitoring of the
       quality of counseling and test processing for individuals involved in rapid HIV testing activities
       should be conducted using the Rapid HIV Counselor Observation Form. All rapid HIV testing
       staff and volunteers must be observed at least once per year by the agency's Executive
       Director, CTR Program Coordinator or the designated Quality Assurance Coordinator.
       Observation forms should be maintained on site and are subject to review during the HAP
       technical assistance visits.

    i)   Quality Assurance Manual: Agencies conducting rapid HIV testing activities must have a
         quality assurance procedure manual available to certified counselors conducting rapid HIV
         testing at all times. This protocol may be used as the basis for an agency‟s quality assurance
         procedural manual but should be supplemented with agency specific procedures to follow related
         to client referrals, follow-up testing, discordant results, etc that are specific to the agency and
         location where testing activities are being conducted. Further, agencies are required to have
         written confidentiality and crisis referral policies in keeping with applicable laws.



V. CONSEQUENCES OF PROTOCOL VIOLATIONS
Failure to follow Louisiana rapid testing and prevention counseling protocol may result in a cease
of rapid testing activities until protocol issues are resolved or indefinately. Protocol violations
witnessed by or reported to OPH HAP staff will be discussed with the testing site as soon as possible.
Corrective action, if any, will be documented and submitted to the testing site and OPH HAP Counseling
and Testing Supervisor.

         An immediate halt of testing activities can occur when:
          Confidentiality is compromised in the test processing area or through handling of
            documentation.
          Quality assurance records/documents are not maintained as specified in this protocol
          Informed consent is not obtained from clients prior to specimen collection
          Completed HIV Test forms are not stored in a confidential manner and the specified copies
            are not sent to HAP on at least a weekly basis.
          Rapid test kits or other testing supplies are distributed to and/or used by unauthorized entities
            or are unaccounted for.
          Testing is performed in locations not approved by the HIV/AIDS Program.
          The testing site‟s CLIA waiver expires without renewal.
          Confirmatory testing is not offered to a client who has a preliminary positive rapid test result.
          Documentation for clients who test positive for HIV is not filled out completely/correctly
            and/or submitted to HAP at least weekly.
          Clients who test positive for HIV are not referred to appropriate HIV medical treatment
            services and/or follow-up on HIV medical care referrals is not made and/or documented.

According to Louisiana Law RS 40: 1300.13 “Community-based organizations that are funded by the
office of public health to conduct HIV testing services will be required to follow all HIV testing protocols
established by the HIV/AIDS Program of the office of public health.”




                                                                                                      12
                                                                                               Revised May 2008
Attachment RT-1 (maintain on-site)

                                       Test Device Temperature Log

Testing Site:                                                          City:

Testing Kits Location:

Type of Rapid Test Kits:  OraQuick                     Uni-Gold                         Clearview

The high and low temperatures of the test kit storage area should be recorded using a digital thermometer with a
temperature range memory that will display the warmest and coolest temperatures reached in the storage area in-
between checks.
     If temperature falls outside the allowable range, notify quality assurance coordinator immediately.

          Allowable Temp Range:             from: ___ degrees F         to: ___ degrees F


                      Daily Temperature Record for Month:________________Year:_________


  Date            Low                High    Initial      Date        Low           High         Initial
    1                                                      16
    2                                                      17
    3                                                      18
    4                                                      19
    5                                                      20
    6                                                      21
    7                                                      22
    8                                                      23
    9                                                      24
   10                                                      25
   11                                                      26
   12                                                      27
   13                                                      28
   14                                                      29
   15                                                      30
                                                           31

Note any incidents and corrective actions taken below:
                                       Corrective Action
Date:




Quality Assurance Coordinator                                                               Date:

                                                                                                             13
                                                                                                 Revised May 2008

Attachment RT-2 (maintain on-site)

                                       Control Kit Temperature Log

Testing Site: __________________________________ City: __________________

Control Kits location:

Type of Rapid Test Control Kits:             OraQuick              Uni-Gold                          Clearview

The high and low temperatures of the control kit storage refrigerator should be recorded using a digital thermometer
with a temperature range memory that will display the warmest and coolest temperatures reached in the refrigerator
in between checks.
      If temperature falls outside the allowable range, notify quality assurance coordinator immediately.

          Allowable Temp Range:              from: ___ degrees F          to: ___ degrees F


                       Daily Temperature Record for Month:                      Year:_________


  Date            Low                High     Initial       Date         Low         High         Initial
    1                                                        16
    2                                                        17
    3                                                        18
    4                                                        19
    5                                                        20
    6                                                        21
    7                                                        22
    8                                                        23
    9                                                        24
   10                                                        25
   11                                                        26
   12                                                        27
   13                                                        28
   14                                                        29
   15                                                        30
                                                             31

Note any incidents and corrective actions taken below:
                                       Corrective Action
date:




Quality Assurance Coordinator                                                                 Date:


                                                                                                              14
                                                                                                                                                       Revised May 2008
Attachment RT-3 (maintain on-site)

                                                                     Daily Rapid HIV Test Log
                                     (If using multiple rapid testing technologies, use a separate log for each type of rapid testing device)

Test Site:                                         Date of Testing:
(from test kit package – use a separate form for each lot number used)

Type of Rapid Test:             OraQuick                          Uni-Gold                              Clearview

 Rapid Lab         HIV Test form         Room               Time                Time                Rapid Test         Date Client      Lot Number      Test Kit
 Counselor           Number           Temperature        Test Started     Test Result Read            Result            Notified         of Test Kit   Expiration
     #                                                                                                                                                   Date
                                                                                                         tive




                                                                                                       alid




Quality Assurance Coordinator:                                                                   Date:



                                                                                                                                                                    15
                                                                                                     Revised May 2008
Attachment RT-4 (maintain on site)
                                                 Control Kit Log
          (If using multiple rapid testing technologies, use a separate log for each type of rapid testing device)

Test Site:                                                                  Month/Year:

Control Lot #:                                                    Manufacturer’s Expiration Date:

Date Kits Opened:                                            Oraquick control kits are good for 8 weeks after
                                                                                            opening.
Type of Kit Controls:           OraQuick      Uni-Gold        Clearview


                                     NEG       HIV-1              HIV-2
   Date         Counselor #                                   (OraQuick and        Reason for running controls
                                                             Clearview Only)
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail
                                      Pass     Pass         Pass
                                      Fail     Fail         Fail



Quality Assurance Coordinator:                                                                   Date:


Possible reasons for running controls: New Shipment, New Lot Number, Storage or Operating
Temperature Out of Range, Arrived at Outreach Location, Facility Protocol

                                                                                                                     16
                                                                                                        Revised May 2008
Attachment RT-5 (submit to HAP monthly – should accompany rapid test inventory log)

                                     HIV TESTING SUPPLY ORDER FORM
Contact Information (Agency conducting HIV Testing):
Testing Site Name:                                                                        Order Date:
Quality Assurance Coordinator:
Mailing Address:
City, State, Zip:                                                                           Phone Number:
Fax Number:                                                                      E-Mail Address:
CLIA Certificate #:                        (Required for all rapid testing supplies) CLIA Expiration Date:

Please write the number of cases/boxes/packets needed. Please allow a minimum of 4 weeks for
delivery or pick up. Some items may not be available at the time of order or available to your site.
LIST OF SUPPLIES                                    QUANTITY # ORDERED                             For HAP Use
HIV Test forms-Part 1                                100 forms/packet
HIV Test forms-Part 2                               100 forms/packet
Lab Requisition Form                                100 forms/packet
Consent Forms (English)                             100 forms/packet_______________                ______________
Consent Forms (Spanish)                             100 forms/packet_______________                ______________

Sites must have prior approval from OPH HAP before ordering any of the following items:
OraQuick ADVANCE Rapid Test Kits                    100 kits/box
OraQuick ADVANCE Kit Control                        1 kit/box
OraSure Collection Devices                          50 devices/box
Uni-Gold Recombigen Rapid Test Kits                 20 kits/box
Uni-Gold Kit Control                                1 kit/box
Clearview Stat-Pack Rapid Test Kits                 20 kits/box
Clearview Kit Control                               1 kit/box
Digital Memory Thermometer                          Each
Timer                                               Each
XL Gloves  Nitrile  Latex                         100/box
L Gloves  Nitrile  Latex                          100/box
M Gloves  Nitrile  Latex                          100/box
S Gloves  Nitrile  Latex                          100/box
Workspace Covers                                    100/box
Eye Protection                                      Each
Biohazard waste disposal bag                        Each
Sharps Container (limited availability)             Each

Please fax this form to: OPH HAP PURCHASING & SUPPLIES COORDINATOR
                                          Fax number: (504) 568-7044
For HAP Use Only:
HAP Staff Initials:                                                      Date received:______________________________
Rapid Tests Lot #:                                                       Rapid Tests expiration date:___________________
Control Lot #:________________________________                           Control kit expiration date:____________________
ORASURE Lot #:_____________________________                              ORASURE expiration date:____________________
Delivered to (name):                                                      Date delivered: _____________________________
Delivered to (name):                                                      Date delivered:______________________________



                                                                                                                    17
                                                                                               Revised May 2008
Attachment RT-6 (to be completed by Regional HIV Coordinator and submitted as needed)
             HIV Prevention Counseling, Testing and Referral (CTR) Rapid
                       Site Assessment and Registration Form

                        All sites, whether fixed or mobile, must be registered with OPH HAP.
                                       Please allow four (4) weeks for processing.

           Type of Request (check one):

Contact Information (Agency conducting CTR):
Agency:
Mailing Address:
City, State, Zip:
OPH Region:                     Parish:
Phone Number:                                                    Fax Number:
E-Mail Address:                                            CLIA Certificate #:
Is this agency conducting HIV tests as a part of the new CDC initiative? Yes____                  No_____


Executive Director Information:
Name:________________________________________________________________________
Mailing Address: _______________________________________________________________
City, State, Zip: ________________________________________________________________
Phone Number: _______________________ Fax Number: _____________________________
Executive Director‟s Email: ______________________________________________________


Prevention Manager Information:
Name:________________________________________________________________________
Mailing Address: _______________________________________________________________
City, State, Zip: ________________________________________________________________
Phone Number: _______________________ Fax Number: _____________________________
Prevention Manager‟s Email:______________________________________________________


Quality Assurance Coordinator Information:
Name:________________________________________________________________________
Mailing Address: _______________________________________________________________
City, State, Zip: ________________________________________________________________
Phone Number: _______________________ Fax Number: _____________________________
Quality Assurance Coordinator‟s Email:_____________________________________________
Site Information (location where CTR will be conducted):
Name of Site:
Site Address:
                                                                                                         18
                                                                                                     Revised May 2008
City, State, Zip:
Phone Number: __________________________ Fax Number: ___________________________
Detailed Description of Site Type (i.e. clientele, hours of operation, services offered):
______________________________________________________________________________
______________________________________________________________________________
Detailed Description of Test Set-Up(i.e. how will confidentiality be assured, where in the
building will testing happen, etc: ___________________________________________________


Type of Testing Requested (check all that apply):
                                                               aSure


Date: ______________                                 Observed by: _________________________


Check appropriate assessment of testing site:
Work space to process test:                                                                               le
Confidential setting:
Cleanliness:
Lighting:                                                                                                ble
Temperature control:
Supply storage:
Hand washing station:
Record keeping:
Waiting area:

Notations:




For Office Use Only:        Date request received:                                   Date visited:

Recommendation:

HAP Coordinator Initials: ___________ CTR Supervisor's Initials:___________ Date logged into database:

Approved for:

Site #:                              Parent Site #:                                  Site Type:




                                                                                                               19
                                                                                                               Revised May 2008
Attachment 7 (submit after client is retested or when retesting appointment is missed)
                                                      Discordant Test Case Report
This form is to be completed for ALL testing situations that involve a Preliminary Positive/Reactive rapid HIV test result and an
Indeterminate or Negative Western blot or IFA test result. Submit to this form to HAP when client returns for retesting. If
the client does not return for retesting, send the form in at that point.

If the Western blot or IFA confirmatory test result is negative or indeterminate, REPEAT a confirmatory test
on a new blood specimen collected four (4) weeks after the initial preliminary positive result and record the
follow-up test on a new HIV Test Form – Part 1 and at the bottom of this form.

Site Information

Site Name:                                                                               Site City:

Tester:                                                                        Tester#: ____________________________________

Telephone #:                                                                   E-mail Address:


Client Information

HIV Test Form #:

Client ever previously tested?                                     Client ever tested positive?

Contact information obtained?

Vaccination History:

                                                                               Dose 2 Year:

                                                          se 1 Year:           Dose 2 Year:              Dose 3 Year:___________

Initial Rapid HIV Test Device:                                                         -Gold
Test Type:                                                                    Specimen Type:

Date of reactive rapid test:_____/_____/________ Lot #:
                            MM DD YEAR

Test Start Time:           :          AM/ PM            Test Read Time:                     :         AM/ PM

Repeat Test Device (if applicable)                                                       Uni-Gold
Repeat Rapid Test Conducted?                                  If yes, Lot #:

Test Start Time:           :          AM/ PM            Test Read Time:                     :         AM/ PM

Repeat Test Result

Follow-up Blood Test:
                                                                          Check this box if client did not return for the
HIV Test Form#:________________________                                   follow-up blood test

Date of Follow-up test: _____/_____/________
                        MM DD YEAR
If no follow-up test, why:________________________________________________________________________


Quality Assurance Coordinator:                                                                             Date_______________

                                                                                                                            20
                                                                                             Revised May 2008




Attachment RT-8 (submit to HAP as needed)
                                       Quality Assurance Coordinator
                                       Registration/Designation Form

All Agencies conducting Rapid HIV Testing in Louisiana must designate and register a Quality Assurance
Coordinator. The Quality Assurance Coordinator should be a person with significant experience conducting rapid
testing (6 months experience and a minimum of 200 rapid tests conducted) and familiar with storage and operating
procedures/requirements of the rapid testing device(s) used at their agency.

    Submit to HAP immediately whenever the designated Quality Assurance Coordinator changes or when
                         updates/changes to his/her contact information occur.

Rapid Testing Site:_______________________________Site Number:____________________

Date Form Submitted:_______________Submitter:____________________________________

Reason for Submission:
                    ____Newly Designated Quality Assurance Coordinator
                    ____Change in Quality Assurance Coordinator‟s contact information
                    ____Other, specify below:

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

About the Designated Quality Assurance Coordinator:

Name*:                                  _________________________________________
Title*:                                 _________________________________________
Work Address*:                          _________________________________________
                                        _________________________________________
                                        _________________________________________
Counselor Number*:                      ___________________________
Work Phone*:                            (____)______________________
Cell:                                   (____)______________________
Alternate Phone                         (____)______________________
Work Email*:                            _________________________________________
Alternate Email:                        _________________________________________

Number of Months/Years Experience with Rapid Testing:______________

                                *Areas marked with an asterisk are required fields



                        Fax completed form to (504) 568-7044
                             Attention CTR Supervisor

                                                                                                          21
                                                                                Revised May 2008




Attachment RT-9 (maintain on site – for information only)
                        Steps to HIV Counseling and Testing Certification


Steps for Obtaining a Counselor Number:

    1. Attend a combined HIV Prevention Counseling and Rapid Testing course in its entirety
        and leave with a certificate of participation.
    2. Be observed conducting a HIV counseling and rapid testing session by the HIV Regional
        Coordinator.*
    3. The rapid HIV counselor observation form must be completed by the person conducting
        the observation and sent to the HAP Training Coordinator, who will assign you a number
        and mail you a certificate.
*If you are a nurse working at a Public Health Unit, your nurse supervisor will conduct the
observation. If you are working at a substance abuse facility, your OAD Regional Supervisor
will conduct the observation. If you are working at a School Based Health Center, someone from
an approved list of certified HIV counselors through OPH-Adolescent School Health program
will conduct the observation.


Steps for Registering a Rapid Testing Site:

     1. Regional HIV Coordinator must conduct a site visit and make their recommendation on
        the site assessment and registration form. This form will then be given to the CT
        Supervisor.
     2. If the site is favorably observed, CT Supervisor will assign a site number and mail a
        certificate with this number on it. A copy of this certificate must be kept on the site
        premises at all times.



Please Note: Meeting all counselor requirements does not automatically qualify your
agency for site approval. Meeting all site requirements does not automatically qualify your
agency for funding or free testing materials.




                                                                                           22
                                                                                                 Revised May 2008




Attachment RT-10 (maintain on site-for information only)
Louisiana HIV Prevention Counseling and Rapid Testing Service Delivery Model

Step 1a - Introduce and Orient the Client to the Session
 Introduce yourself to the client.
 Assess client‟s readiness to receive the results on the same day.
 Offer options for testing (conventional or rapid).
 Describe the testing process, what type of specimen will be collected, how long the whole process will take, and
    what each of the three possible results mean.
 Explain to client that if a preliminary positive result is received, a confirmatory test should be conducted.
 Address Partner Services, including informing the client that if results come back positive, a DIS will contact
    them to offer additional services.
 Offer anonymous and confidential options, and explain what each mean.
 Obtain Informed Consent.
 Provide appropriate subject information pamphlet for the rapid test being conducted.

Step 1b – Administer the Rapid Test
● Follow applicable universal precautions
● Clearly label the test device being used
● Demonstrate/facilitate specimen collection
● Start Timer

Step 2 – Identify Risk Behaviors and Circumstances
 Engage client in a discussion of risk behavior
 Assess client‟s previous experience with HIV testing and knowledge about HIV/AIDS
 Complete all but results section of HIV Test Form-Part 1

Step 3a – Identify Safer Goal Behaviors
● Give client information on relevant risk and harm reduction strategies
● Use relevant information pamphlets, brochures and/or brief videos
● Have client explain what he/she can do to reduce risk
● Assessing client readiness to receive results can continue up until the timer goes off
● Allow time for client to process and respond

Step 3b – Interpret and Deliver the Test Result (after appropriate time as elapsed)
● Follow applicable universal precautions for handling rapid testing materials
● Interpret Test Result (use a second reviewer if needed and client is not present)
● Return to client and give the results immediately in a simple and direct fashion
● Allow time for client to process and respond

Step 4 – Develop Risk Reduction/Action Plan (can be initiated prior to delivery of test results but should be
modified, as needed, after results are provided)
● Based on the results of the test and the client‟s risk profile, assist the client in developing an action plan to
further protect their health and the health of their partners.
● Document risk reduction plan in client‟s file

Step 5 – Offer Referrals and Provide Support (can be initiated prior to delivery of test results but should be
modified, as needed, after results are provided)
● Make appropriate referrals and negotiate plans to follow up with the client
Step 6 – Summarize and Close the Session



                                                                                                               23
                           Louisiana Office of Public Health Rapid HIV Counselor Observation Form
All HIV prevention counselors and all prospective counselors conducting rapid HIV testing must submit a favorable observation
prior to performing rapid testing on patients/clients. Counselors must be re-observed at least once per year thereafter and copies
of all observation forms must be maintained in the counselor’s personnel file.

1. Name of Rapid Counselor:                                                         _________________________ ________________
                                                                                    Name of person being observed Date trained OR
                                                                                                                  Counselor number

2. Date and Time of Observation:                                                                         ______________________

3. Location of Observation:                                                                               ______________________

Counseling Skills-Before Rapid Test Is Run
4. Counselor offered options in testing procedures.                                     O Well Done O Needs Improvement O Not done
5. Counselor carefully explained rapid testing and potential results.                   O Well Done O Needs Improvement O Not done
6. Counselor carefully explained confidentiality and exposures.                         O Well Done O Needs Improvement O Not done
7. Counselor reviewed consent form and information with client.                         O Well Done O Needs Improvement O Not done
8. Counselor addressed partner services and DIS involvement                             O Well Done O Needs Improvement O Not done
should client test prelim. positive.
9. Counselor gave client subject information pamphlet.                                  O Well Done O Needs Improvement O Not done
10. Counselor assessed whether client was ready to receive results that day.            O Well Done O Needs Improvement O Not done

Counseling Skills-After Rapid Test has Run
11. Counselor accurately communicated result to client.                                 O Well Done O Needs Improvement O Not done
12. Counselor allowed time for client to understand result.                             O Well Done O Needs Improvement O Not done
13. Counselor made appropriate referrals.                                               O Well Done O Needs Improvement O Not done
14. Counselor readdressed risk reduction plan, if appropriate.                          O Well Done O Needs Improvement O Not done
15. Counselor offered confirmatory testing, if appropriate.                             O Well Done O Needs Improvement O Not done
16. Counselor discussed client needs if result is preliminary positive.                 O Well Done O Needs Improvement O Not done
17. Counselor accurately completed HIV Test Form-Part 1.                                O Well Done O Needs Improvement O Not done
18. Counselor accurately completed HIV Test Form-Part 2
if client tested preliminary positive.                                                  O Well Done O Needs Improvement O Not done
19. Counselor offered referral to medical care if result is preliminary positive.       O Well Done O Needs Improvement O Not done

Rapid Test Lab Operation Skills
20. Counselor set up lab space properly prior to the testing.                  O Well Done O Needs Improvement O Not done
21. Counselor adhered to all Universal Precautions.                            O Well Done O Needs Improvement O Not done
22. Counselor carefully instructed/demonstrated how to collect specimen.       O Well Done O Needs Improvement O Not done
(Continuous circular motion between upper lip and gum to lower lip and gum and remove-
One full circle around and no touching tongue, inner cheeks, or roof of mouth) O Well Done O Needs Improvement O Not done
23. Counselor did not contaminate specimen or device.                          O Well Done O Needs Improvement O Not done
24. Counselor did not block holes or move test during processing.              O Well Done O Needs Improvement O Not done
25. Counselor timed the processing accurately.                                 O Well Done O Needs Improvement O Not done
26. Counselor accurately interpreted and documented test result.               O Well Done O Needs Improvement O Not done
27. Counselor disposed of used testing supplies in a biohazard container.      O Well Done O Needs Improvement O Not done

28. Describe in detail any items marked ‘Needs Improvement’ or ‘Not done”




27. Name of Person Conducting Observation: _____________________________________________ ___________________
                                                   Name of person conducting this observation         counselor #
28. Affiliation of Observer to Counselor (i.e. supervisor, regional coordinator) ________________________________________

29. Signature and Date of Observer Named Above: ________________________________________ ___________________
                                                        Signature                                      date
30. Write in below the complete physical mailing address where Counselor Certificate should be mailed:
Name of Organization _______________________________
Street Address or P.O. Box ___________________________ City, State, ZIP _____________________________________

				
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