POPS Chapter 1 – Focused HIV Testing, Counseling, and Linkage to Care for HIV Prevention
Subchapters
- 1.1 HIV Testing Recruitment and Outreach
- 1.2 HIV Testing Confidentiality
- 1.3 Reporting Requirements
- 1.4 Required Tasks of HIV Testing
- 1.5 Rapid HIV, Syphilis, and HCV Testing
- 1.6 The Use of Testing Technology to Detect HIV Infection (Confirmatory Testing)
- 1.7 Test Results
- 1.8 Enhanced Assessment for HIV Testing
- 1.9 Counseling and Linkage for Persons Living with HIV
- 1.10 DSHS Laboratory Specimen Submission
This chapter provides guidelines for HIV prevention contractors and subcontractors on the delivery of consistent quality services regarding HIV testing, including syphilis and HCV rapid testing, counseling, and linkage to medical care. These guidelines align with the National HIV/AIDS Strategy to reduce HIV transmission, identify persons living with undiagnosed HIV, enhance timely linkage to medical care, and reduce health disparities. These guidelines assist prevention specialists, HIV testers, outreach workers, Disease Intervention Specialists (DIS), and others who provide testing for HIV, hereinafter referred to as “HIV testers” in offering HIV/STD/HCV testing, counseling, and linkage services to clients at greatest vulnerability for acquiring HIV.
HIV testing services should follow a status-neutral approach. Services should focus on the client’s concerns and situation. Services should also be culturally competent with respect to race, ethnicity, gender, sexual orientation, age, language, literacy, relationship status, and other relevant factors.
These guidelines align with the following: Texas Health and Safety Code, Title 2, Subtitle D Chapters 81, 85, and 93 (relating to Education and Prevention Programs for Hepatitis C); Title 25 of the Texas Administrative Code (TAC) Chapters 97 Subchapter B; and Chapter 98; and Texas House Bill Number 4.
Contractors should also review guidance from the CDC on HIV testing in non-clinical settings.
1.1 HIV Testing Recruitment and Outreach
Each DSHS contractor must select DSHS-identified priority populations for the geographic area where the contractor provides services. DSHS selected these priority populations based on state and local morbidity. To narrow the overall focus population(s) and reach persons most vulnerable to HIV, agencies will need to know what behaviors and other risk factors are related to HIV vulnerability, who is engaging in these behaviors or is affected by these factors, and where to identify the priority population(s). This process will help to tailor messages and services in a way that resonates with the priority population(s) and develop a plan for how to engage these communities. See a list of eligible priority populations.
DSHS expects contractors to develop a recruitment and outreach plan that outlines when, where, and how they will recruit priority population(s). The plan must include specifics about where to reach the priority population(s), as well as the specific recruitment strategies and messages they will use for community engagement to provide HIV testing and other health and supportive services. Contractors must update this plan annually and submit it to DSHS.
To have an effective and innovative program, contractors should dedicate resources to implementing an outreach and recruitment plan. Successful recruitment and outreach programs typically include the following:
- Hire and train specific recruitment staff who are separate from HIV testing or other prevention staff and who are from within the communities served.
- Build partnerships in the community to ensure multidirectional referrals and expand recruitment networks.
- Use innovative approaches for reaching the target population through the Internet and social media.
- Offer tangible reinforcements to reach previously underserved priority populations, generate interest in new services, or obtain buy-in for testing venues where clients with increased vulnerability to HIV could need extra motivation to access HIV testing (e.g., a bar or club).
- Provide supportive services that meet the needs of clients beyond HIV-related care.
A comprehensive recruitment plan supports delivering strategic, culturally competent, community-based recruitment strategies that engage the priority populations and motivate them to access HIV testing services and other prevention interventions.
DSHS expects contractors to collaborate with other organizations that have a history of working with and recruiting the priority population(s). Agencies must seek input from community stakeholders to select the most appropriate program promotion and recruitment strategies. Community stakeholders can also help craft recruitment messages, which may focus on increasing public awareness of services, destigmatizing HIV and HIV testing, and providing key information about HIV and HIV testing.
The six primary categories of recruitment and outreach strategies are the following:
Street-based and venue-based outreach – By engaging the priority testing priority population(s) in their own environment, such as a particular street, neighborhood, hot spot, or venue (e.g., a bar, hotel, or community center). Outreach workers, who may include HIV testing providers, reach the focus population with key messages about HIV and HIV testing. Contractors may also offer HIV testing services in conjunction with street- and venue-based outreach, if appropriate.
Internet outreach – Involves reaching the priority population through online venues, such as chat rooms, social networking sites, hook-up sites, and other mobile geosocial applications. Internet-based outreach helps reach young people and men who have sex with men (MSM) who do not identify as gay or who do not frequent traditional outreach settings.
Internal Referrals – Accessing the priority population through other services offered by the DSHS contractor, such as substance misuse programs, mental health services, evidence-based HIV prevention interventions, STD testing and treatment programs, and HIV medical care (for partners of people already in care).
External referrals – Agencies outside of the DSHS contractor refer persons from the priority population to HIV testing services. External agencies may include substance use programs, mental health services, evidence-based HIV prevention interventions, STD testing and treatment programs, HIV medical care, and homeless shelters. These offsite programs identify people accessing their services and may benefit from HIV testing or other related services – e.g., HIV/STD testing, Anti-Retroviral Treatment and Access to Services (ARTAS), or other risk-reduction interventions. Building strong partnerships with external agencies tending to serve clients at risk of acquiring HIV is important, as is sharing information with them about how to make appropriate referrals to programs.
Social networking – A peer-driven approach to recruitment involves identifying persons living with HIV or individuals vulnerable to HIV from the community to serve as recruiters for your agency. Recruiters deliver key messages and encourage HIV testing among persons at risk of acquiring HIV in their social, sexual, or drug-using networks. Partner referral is a type of social networking that involves recruiters referring their sexual partners to an HIV testing program or other risk reduction interventions.
Social marketing – The use of media (e.g., flyers and brochures, posters, or advertisements using print, radio, television, or social media) to recruit clients into HIV testing programs and other risk reduction interventions. Agencies can develop their own social marketing campaigns but DSHS encourages them to use existing resources, such as those available from the CDC, and tailor them to their community’s specific requirements. The CDC’s Let’s Stop HIV Together is a collection of resources and campaign materials for contractors. Additional materials are also available on the CDC's Effective Interventions page.
1.1.1 Community Advisory Board
Contractors must maintain a Community Advisory Board (CAB) to assist with programmatic decision-making.
At a minimum, your CAB must have the following:
- Bylaws or policies regarding its role in your organization
- A member position description that outlines the role and time commitment required for participation
- Biannual meetings, at minimum
- A record of meeting minutes available for review by DSHS
- A membership reflective of your priority populations
1.1.2 Condom Distribution
Contractors must develop policies and procedures for conducting condom promotion and distribution activities. The goal of condom promotion and distribution is to increase condom availability and use amongst persons with HIV and those at high risk of acquiring HIV and/or other sexually transmitted infections. Contractors must complete a community assessment to determine condom availability, accessibility, and acceptability in the community. Contractors should use this assessment to determine condom distribution sites and identify new distribution partners.
Contractors must set up mechanisms to report how many condoms they distributed during the grant year. Contractors may not resell condoms purchased by DSHS or with DSHS funds, and they must offer them to the community at no cost.
1.2 HIV Testing Confidentiality
In accordance with Texas Health and Safety Code § 81.046, all testing information and results are confidential, whether the client tested confidentially, anonymously, or declined testing. DSHS expects HIV testers to maintain and demonstrate a high level of confidentiality regarding client information and strictly adhere to the policies and procedures of their agencies. To maintain confidentiality, HIV testers must not divulge information to unauthorized persons that could reveal the identity of the client. Trained staff conducting testing services are bound by rules regarding confidentiality specified by the employing agency, the laws of the State of Texas, and the local jurisdiction in which they work.
In accordance with Texas Health and Safety Code §81.103 Confidentiality; Criminal Penalty, a breach of confidentiality is a Class A misdemeanor and is punishable by up to one year in jail and fines of up to $5,000. Violation of confidentiality is also a civil offense that may result in liability for damages plus fines.
The HIV/STD Breach of Confidentiality Response policy (HIV/STD 2011.04) applies to all DSHS employees, IT staff, temporary employees, volunteers, students, DSHS program contractors, and any other person who could potentially view and/or have access to HIV/STD confidential information. All persons affected by this policy, as specified above, are responsible for the reporting of suspected breaches.
1.2.1 Consent for HIV Testing
In accordance with Texas Health and Safety Code §81.105 Informed Consent and Texas Health and Safety Code §81.106 General Consent, a contractor may not perform a test designed to identify HIV transmission without first obtaining the informed consent of the person being tested.
Contractors do not need written consent if there is documentation in the client’s chart that the contractor explained the test to the client and obtained verbal consent. A person who signs a general consent form for the performance of medical tests or procedures is not required to sign a specific consent form relating to HIV testing during the time in which the general consent form is in effect.
Contractors may use an HIV test result performed under the authorization of a general consent only for diagnostic or other purposes directly related to medical treatment of the client. Some institutions may have stricter policies concerning consent for HIV testing than that stated in statutes.
An individual or entity that tests without consent commits a Class A misdemeanor.
1.2.2 Minor Consent
In accordance with Texas Family Code §32.003 Consent to Treatment by Child, a minor may consent to STD diagnosis and treatment that the law requires contractors to report, including HIV, gonorrhea, chlamydia, chancroid, and syphilis regardless of the minor’s age and without the consent of the minor’s parent or guardian.
1.2.3 Anonymous and Confidential Testing
The terms anonymous and confidential have specific meanings regarding HIV testing.
Confidential HIV testing – Confidential testing links a valid name and location information to test documentation, and the contractor places the test results in the client’s medical record. The agency informs clients it will use the location information in their record to contact a client who does not return for results.
Clients may choose to test confidentially or anonymously. The agency maintains test results in a confidential manner, regardless of the method selected by the client.
An anonymous HIV test requires the use of a pseudonym consisting of a first name with a series of numbers (e.g., John 123, Jane 234) on documentation and retains no identifying or locating information beyond the demographic information required for the collection of epidemiological information. Some clients may request a phone call or text when the agency receives their test results. In this instance, the agency may retain the locating information where the client sought the HIV test.
The agency should not place the pseudonym in the client’s medical record. Clients who test anonymously will sign the consent form using the agreed upon pseudonym.
1.3 Reporting Requirements
Contractors must report positive HIV, STD, and preliminary positive results from a rapid HIV test according to the standards and procedures outlined in Chapter 8, HIV/STD Surveillance.
For more information on disease reporting see the DSHS HIV/STD Disease Reporting page.
For more information on reporting rapid HIV test results, refer to Guidelines for Conducting HIV and HCV Rapid Testing.
1.4 Required Tasks of HIV Testing
DSHS contractors funded to provide HIV testing must complete the following tasks, regardless of the testing technology used:
- Obtain informed consent from client.
- Gather sociodemographic information including:
- Year of birth,
- Client state,
- Client county,
- Client zip code,
- Client assigned sex at birth,
- Client current gender identity,
- Client race, and
- Client ethnicity.
- Offer both anonymous and confidential HIV testing.
- Conduct a brief HIV vulnerability assessment including:
- Reason for HIV test,
- Recent sexual and injection drug use behaviors since last HIV test,
- In the past five years, has the client:
- Had sex with a male, female, or transgender person, or
- Injected drugs or substances,
- Date and type of recent risk exposure,
- History of STD diagnosis and treatment, and
- Date of last HIV test and test result.
- Ensure delivery of HIV and STD test results to client in a timely and appropriate manner. The agency must permit staff conducting HIV and STD testing to deliver HIV or STD results, including positive results, in both field and clinical settings.
- Provide basic information about HIV transmission and HIV testing, including:
- Benefits of testing;
- Behaviors that transmit HIV;
- Ways to prevent HIV transmission, including PrEP, nPEP, and Treatment as Prevention (TasP);
- Testing technology used (rapid test, blood draw, or self-test kit); DSHS no longer supports the use of HIV oral fluid testing according to DSHS HIV/STD Policy 2013.02, except for organizations that received approval to conduct self-testing;
- Estimated Detection Period (EDP); EDP is the time estimated from possible exposure to detection specific to the testing technology used. Contractors should refer to manufacturer’s guidelines to determine EDP including relation to retesting and discuss this information with clients;
- When and how the agency will provide test results to client;
- Procedure if client receives a positive diagnosis (e.g., confirmatory, or subsequent testing, introduction of partner services, linkage to care); and
- Procedure if client tests negative and is interested in accessing PrEP.
- Provide clients with population-specific, age appropriate, culturally affirming health messages and materials that address the client’s vulnerability to HIV acquisition and prevention needs, which may include an in-depth session if appropriate for client needs and demands of the setting, including education on Combination Prevention.
- Screen for PrEP and nPEP eligibility, using a locally validated or CDC-supported screening tool. Agencies must have policies and procedures for the provision of navigation services in place, including offering and following up on referrals to clinical providers.
- Screen for and make referrals, as appropriate, to essential support services including:
- Health benefits and navigation enrollment,
- Evidence-based risk reduction interventions,
- Behavioral health services,
- Housing, and
- Social services.
- Ensure the agency collects supplemental testing by venipuncture immediately, on-site, after a point of care HIV and syphilis health check preliminary positive test result. staff conducting HIV and STD testing must have the ability to obtain specimens via venipuncture. Staff must provide HIV and syphilis screening(s) by collecting blood-based specimens, in both field and clinical settings. Staff will perform these tests unless the client refuses.
- Maintain a policy on how to report positive test results, including preliminary positive results, in accordance with disease reporting rules.
- Maintain documentation as required in POPS Chapter 2.
1.5 Rapid HIV, Syphilis, and HCV Testing
Contractors wishing to use DSHS resources for HIV, syphilis, or HCV rapid testing must submit evidence to DSHS that their governing body researched and established policies and procedures to reflect the effect HIV and HCV rapid testing will have on their facility, including:
- Procedures and quality assurance plan for rapid testing
- Assurances that current insurance and other liability coverage is appropriate
- Legal implications for conducting medical and laboratory procedures
- Standing delegation orders from contractor’s medical authority
- Provisions for medical waste disposal
- Guidelines and standards developed by the Occupational Safety and Health Administration (OSHA) for occupational exposure through blood borne pathogens
Contractors should review the Field Use of the Rapid Syphilis Health Check (SHC) Test to help develop policies and procedures.
To use DSHS funds to purchase rapid testing technology, contractors must use a test approved by the Federal Drug Administration (FDA) with Clinical Laboratory Improvement Amendments (CLIA) waived.
1.5.1 Clinical Laboratory Improvement Amendments (CLIA)
Prior to implementing HIV, syphilis, or HCV rapid testing, grantees and subcontractors must have a current CLIA certificate of compliance or waiver.
CLIA establishes quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of client test results, regardless of where the test occurred. CLIA bases the requirements on the complexity of the test and not the type of laboratory where the testing occurs.
CLIA requires facilities that perform even one test, including waived tests on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” to meet certain federal requirements. If a facility performs tests for these purposes, CLIA considers it a laboratory under CLIA. The facility must apply for and obtain a certificate from the CLIA program that corresponds to the complexity of the tests performed.
Contractors can find the CLIA certificate of waiver and certificate application on the HHS CLIA webpage.
The Health Facility and Licensing Compliance Division of DSHS can assist you in obtaining a CLIA certificate of waiver.
1.5.2 Rapid HIV Testing Quality Assurance
Testing personnel must receive training to perform the rapid test, quality control, and other related procedures. Testing personnel must follow the agency's policies and procedures and have a quality assurance plan for rapid testing in addition to following the instructions provided by the manufacturer for how to conduct the test.
The rapid test kit package insert provides text that testers can use as a procedure for steps in the testing process, including pretest information, materials and storage, test performance, and quality control.
Testing personnel must maintain documentation to confirm that they run external controls according to the test manufacturer’s schedule and they store test kits properly.
Helpful information for developing rapid HIV testing quality assurance guidelines can be found on the CDC website.
1.5.3 Standing Delegation Orders
In accordance with Title 22, Texas Administrative Code §193.2, a licensed physician shall supervise any medical care or procedure provided under a testing program. Orders should be available detailing the authorized staff or positions to administer the protocol and what tests and diseases the standing delegation order covers. The physician must review and update the standing delegation order annually.
1.6 The Use of Testing Technology to Detect HIV Infection (Confirmatory Testing)
In accordance with Texas Health and Safety Code §85.003 and §85.032, contractors must provide access to highly sensitive and specific HIV tests to increase the capacity of communities to diagnose patients throughout the course of HIV infection. Unfortunately, strategies limited to antibody detection cannot identify highly infectious persons with acute HIV infection. In addition, multiple studies have demonstrated the inadequacy of oral fluid for rapid and confirmatory testing in identifying early infections, resulting in either negative rapid tests or non-reactive or indeterminate Western Blot confirmatory tests. When a discordant oral fluid sample confirmatory test occurs and a blood specimen is not available, the provider and lab cannot automatically perform a more sensitive fourth generation nucleic acid amplification test (NAAT) that would resolve the discordant test and possibly detect acute HIV infection. These missed diagnoses represent lost opportunities for public health follow-up to link persons with acute HIV infection into care and to reduce the risk of transmission to others.
Contractors must collect confirmatory testing by venipuncture on-site immediately after a point of care (e.g., rapid) preliminary positive test result and submit it to a lab for the new HIV diagnostic algorithm. All indeterminate and non-reactive confirmatory tests must be automatically referred to for NAAT to determine if a client has an acute HIV transmission. You can view the new algorithm on the CDC website.
HIV, gonorrhea, chlamydia, chancroid, and syphilis are reportable diseases. Texas law requires contractors to submit a report of disease to the local and regional health departments. Please review this requirement on the DSHS HIV/STD Disease Reporting page. Reportable conditions include preliminary positive HIV test results.
1.7 Test Results
Contractors should make specific arrangements to ensure clients receive their HIV test results in a timely and appropriate manner. Contractors must establish a reliable process for verifying the client’s identity before providing test results and protecting client confidentiality prior to providing any test results.
Contractors may give negative HIV and syphilis test results by telephone or other technology. Contractors must have policies and procedures that describe under what circumstances they will make negative results available by telephone or other technology and outline the protocol for giving negative results. Programs wishing to provide negative test results via telephone or other technology must make their program’s policies and procedures available to DSHS.
Contractors must permit staff who conduct HIV/STD testing to disclose the reason for contacting the client (e.g., notification of results, follow-up on a preliminary positive, linkage to HIV or STD testing, treatment and care activities, etc.).
Contractors must ensure that clients tested for HIV receive information on combination prevention, including PrEP, nPEP, and TasP, and that they refer these clients to clinical, social, and other needed services as appropriate. Contractors must support combination prevention educational information with DSHS-approved materials.
In accordance with Texas Health and Safety Code §81.109, Counseling Required for Positive Test Results, a client must receive their HIV diagnosis with the immediate opportunity for individual, face-to-face counseling. For this reason, contractors will provide HIV diagnosis and indeterminate test results in person at DSHS, or DSHS-affiliated sites with an immediate opportunity for counseling. If contractors cannot deliver results to persons with an HIV diagnosis (unable to locate, client does not return for results, etc.), they should submit available information on the person to the local or regional health department for public health follow-up. Contractors must note communication with the local or regional health department in the client file.
1.8 Enhanced Assessment for HIV Testing
Not every client who requests an HIV test requires an enhanced assessment. Trained staff use professional discretion based on a brief assessment to determine the level of assessment required. Enhanced assessments are appropriate for those with increased vulnerability to acquiring or transmitting HIV, STDs, and HCV and should integrate combination prevention education. In general, DSHS bases a person’s vulnerability to HIV, STDs, and HCV on their sexual and drug use behavior and the community viral load.
Contractors should base decisions about the duration or extent of a session on several factors, including:
- Setting – In-depth, personalized assessment and prevention counseling may not be feasible in some settings. The intent of some events may be to screen a large number of people in a short amount of time, in which case conducting enhanced assessment would not be appropriate because staff would be able to test and counsel only a small number of clients.
- Client risk profile – If the setting is conducive to individualized counseling, qualified staff should consider the client’s reported vulnerability to HIV acquisition. If the client reports little to no vulnerability for HIV, STDs, and HCV acquisition, there is no need to conduct an enhanced assessment. Instead, staff can provide brief tailored health messages about combination prevention, reducing vulnerability to HIV acquisition, and closing the session. If the client does report increased vulnerability behaviors that may lead to HIV acquisition, the contractor should make an attempt to conduct an enhanced assessment.
- Client willingness – If the client reports behaviors that may increase their vulnerability to HIV acquisition and a readiness to engage in the process of individualized Combination Prevention, qualified staff can proceed with an enhanced assessment. If the client is reluctant, provide tailored health messages, test the client, and let the client know that they may return in the future to continue the discussion of reducing vulnerability to HIV acquisition.
When trained staff determine the need for an enhanced assessment, they should use active communication skills to:
- Determine client concerns, needs, and priorities;
- Provide basic information about HIV, STDs and HCV transmission, and testing;
- Support the client to reach a better understanding of personal HIV/STD vulnerability;
- Discuss combination prevention approach; and
- Make referrals as appropriate.
Contractors maintain appropriate referral networks to provide accessible and appropriate referrals to clients in need of additional services (mental health counseling, substance abuse treatment, intensive case management, etc.).
1.9 Counseling and Linkage for Persons Living with HIV
Contractors must provide clients who have a positive HIV result with the following:
- Face-to-face counseling
- Emotional support to understand the meaning of the test result and access social support
- Explanation of the benefit of initiating and remaining in HIV medical care as well as medication adherence
- Coordinated partner services and public health follow-up with the local or regional health department
- Confirmation of linkage to HIV-medical care (The DSHS standard is to maintain communication with the client for a minimum of 90 days or until the contractor confirms the first HIV medical appointment.)
- Essential support services referrals, as appropriate;
- Ongoing support/navigation services for engagement and re-engagement in HIV-medical care
- A copy of test results to the client for proof of diagnosis (an anonymous test will not include the client’s name.)
Contractors work with a client to establish an HIV-related medical care appointment, follow up with the client, prepare the client for medical care, and confirm the client attended the appointment. This applies to individuals newly diagnosed as well as those previously diagnosed and not currently in HIV-related medical care.
Contractors must immediately link people to HIV medical care based on a preliminary positive result. A confirmatory HIV diagnosis is not required to begin this process.
The support clients need to enter care may differ based on their diagnoses and histories of treatment. To determine which services clients need, providers must verify testing history and participation in HIV-related medical care with disease surveillance staff. This process includes:
- Obtaining written client authorization to allow the local health authority or regional public health department to release information related to the client’s HIV diagnosis and treatment history. Clients should complete and sign an Authorization to Release Confidential Information Form. The form specifies to whom the contractor can release the information, the purpose of the release, and the specific information the contractor can release.
- Sharing the signed Authorization to Release Confidential Information form with the local health authority or regional public health department and obtaining the client’s HIV diagnosis and treatment history.
If the client refuses permission for such verification, the contractor should use the client’s self-report of diagnosis history and participation in care to guide linkage activities.
1.9.1 Confirmation of HIV Medical Care
Contractors must verify and document the client’s attendance at an HIV-related medical appointment. The following are evidence options:
- Verbal or written confirmation from the care provider
- A medical appointment in a care reporting system
- CD4 or viral load test with confirmation of a medical appointment
- Confirmation from an intermediate provider, such as Disease Intervention Specialist (DIS), or case manager
- Self-report from the client. DSHS accepts client self-report in the rare circumstances that the DSHS contractor attempted and could not verify client attendance using the above approaches.
Contractors should make various attempts (phone call, letter, field visit, e-mail, text message) to contact people when trying to link to medical care. They must document the date, time, activity, and result of attempts to link clients. Contractors should continue to attempt to link clients to medical care for a minimum of 90 days.
Contractors must ensure they maintain client confidentiality while attempting to link people to care.
1.10 DSHS Laboratory Specimen Submission
Contractors should visit the DSHS Laboratory website for information on specimen collection, submission, Laboratory testing forms, and shipping. Contractors are not required to use DSHS lab for specimen submission.
List of Helpful Websites and Websites Referenced in Chapter 1
The Use of Testing Technology to Detect HIV Infection (DSHS HIV/STD Section Policy 2013.02)
Information regarding reportable diseases can be found on the DSHS HIV/STD Reporting page
Information on HIV/STD training requirements can be found on the DSHS HIV/STD Workforce Training Center page
DSHS Laboratory information can be found on the DSHS Laboratory Services page
Information regarding Facility Security Agreement and User Security Rights and Confidentiality can be found on the DSHS Lab Remote Data page
CLIA certificate of wavier and certificate application can be found on the HHS Clinical Laboratory Improvement Amendments page
Information for developing rapid HIV testing quality assurance guidelines can be found in the CDC Testing QA Guidelines document
Centers for Disease Control and Prevention