• DSHS HIV/STD Program

    Post Office Box 149347, MC 1873
    Austin, Texas 78714

    Phone: (512) 533-3000

    E-mail the HIV/STD Program

    E-mail data requests to HIV/STD Program - This email can be used to request data and statistics on HIV, TB, and STDs in Texas. It cannot be used to get treatment or infection history for individuals, or to request information on programs and services. Please do not include any personal, identifying health information in your email such as HIV status, Date of Birth, Social Security Number, etc.

    For treatment/testing history, please contact your local Health Department.

    For information on HIV testing and services available to Persons Living with HIV and AIDS, please contact your local HIV services organization.

Guidelines for Conducting HIV and HCV Rapid Testing

I. Introduction

One of the key strategies of the National HIV/AIDS Strategy for the United States is to increase the number of individuals who are aware that they are infected with HIV in the early stages of their infection. Additionally, the National Action Plan for the Prevention, Care and Treatment of Viral Hepatitis recognizes that persons infected with viral hepatitis need to be identified early in the course of their infection. The use of point of care rapid HIV and HCV test increases the number of persons who know their test results, especially among hard to reach populations and in settings with low return rates.

However, increasing the access to HIV and HCV rapid testing will only benefit the target populations if they are given accurate information and test results. To ensure that this occurs, the TB/HIV/STD Section (Section) and the Texas Department of State Health Services (DSHS) issued Guidelines for Conducting HIV and HCV Rapid Testing (Guidelines).

The Guidelines were created for use by any non-laboratory site that wants to implement HIV and HCV rapid testing. DSHS-funded testing sites must demonstrate the ability to adhere to the Guidelines and must ensure that the HIV rapid test is being used in the most appropriate populations and in the most appropriate venues.

The Guidelines are aimed at two specific areas of a HIV and HCV testing organization: requirements for oversight/managerial entities of the testing program and requirements for program testing staff who will be conducting the HIV and HCV rapid tests.

II. Requirements for HIV/HCV Rapid Testing

Because HCV rapid testing requires staff to collect whole blood samples and conduct diagnostic testing, the Board of Directors or governing body of organizations offering HIV and HCV rapid testing must recognize the implications of performing these clinical procedures. While the chance for infection through occupational exposure is lower with oral fluid rather than a blood sample, governing bodies should still consider following the universal precaution procedures developed by the Centers for Disease Control and Prevention: www.cdc.gov/niosh/topics/bbp/universal.html

For HIV and HCV rapid testing sites that use professional clinical staff for the collection of testing samples, adhering to these administrative guidelines will not have a great impact. However, other testing facilities may find it difficult to meet the additional guidelines because of limited resources.

Agencies wishing to use DSHS resources for HIV and HCV rapid testing must submit evidence to the Section that their governing body has researched and established policies and procedures to reflect the effect HIV or HCV rapid testing will have on their facility, including:

  • Assurances that their current insurance and other liability coverage is appropriate;

  • Legal implications for conducting medical and laboratory procedures;

  • Standing delegation orders from its medical authority;

  • Provisions for medical waste disposal; and

  • Guidelines and standards developed by the Occupational Safety and Health Administration (OSHA) for occupational exposure through bloodborne pathogens.

III. Programmatic Requirements for Governing Bodies of HIV/HCV Rapid Testing Sites

Sites using HIV and HCV rapid using DSHS resources must maintain policies and procedures to address quality assurance and training requirements. Copies of these policies and procedures must be provided to DSHS.

A. Quality assurance requirements

Any program offering rapid HIV or HCV testing is considered a laboratory under the Clinical Laboratory Improvements Amendments (CLIA) and must meet certain quality assurance requirements. CLIA defines a laboratory as any facility that performs examinations, including rapid tests, on humans. A facility can be a clinic or hospital with an on-site lab, a voluntary counseling and testing site, or an outreach setting. Only laboratories that are CLIA certified can use the rapid test technology without the CLIA certificate of waiver.

CLIA Waiver
CLIA certificate of waiver can be obtained at the DSHS Healthcare Facilities page.

Click on the “CLIA Application Form” and follow the instructions to fill out the form.

The staff at the Health Facility and Licensing Compliance Division at DSHS can assist you in obtaining a CLIA certificate of waiver. Please read the instructions on their application carefully. They offer the following helpful information:

  • The $150.00 processing fee must be submitted every two years;

  • Do not send fees to the Texas Department of State Health Services; and

  • Applications must be submitted to the designated Health Facility Compliance (HFC) Zone for approval. A map of statewide zones (with their contact information) can be found in the application.

Creating and Implementing a Quality Assurance Plan
In addition to obtaining a certificate of waiver (if needed), testing sites using DSHS resources must adhere to the Centers for Disease Control and Prevention (CDC) guidance on quality assurance plans, found at: wwwn.cdc.gov/clia/Resources/WaivedTests/default.aspx

Much of this guidance can also be used to integrate HCV rapid testing. All HIV and/or HCV testing sites must submit a quality assurance plan to the TB/HIV/STD Section for approval.

Maintaining Client Confidentiality
HIV and HCV rapid testing sites must have policies and procedures in place that delineate how the program will maintain client confidentiality and secure the privacy of the client information.

B. Training Requirements

All DSHS-funded HIV and HCV testing sites must document that staff using the HIV or HCV rapid tests have received training in:

  • HIV/STD Risk Reduction Groundwork (on-line training) or through the HIV Connection;

  • Foundations of Counseling and Testing Pre-Course (on-line training);

  • Foundations of Counseling and Testing (includes post-counseling on positive HIV/HCV results);

  • The correct use of the rapid test from the manufacturer;

  • Basic training on HIV and HCV, such as the web based trainings: Risk Reduction Groundwork and the Basics of Hepatitis; and

  • The correct method of reporting test results through the DSHS programmatic database.

Training requirements provided by DSHS for all DSHS funded agencies conducting HIV/HCV testing can be viewed on the HIV/STD training page.

C. Referrals and Linkages

HIV and HCV rapid testing sites must demonstrate that they can refer clients to appropriate medical and social services, including:

  • HIV treatment and care;

  • HCV confirmatory testing resources and appropriate medical follow up;

  • STD testing and treatment, as medically indicated;

  • Immunization services for hepatitis A and B;

  • Substance abuse treatment services;

  • Mental health services; and

  • Any other appropriate program as indicated through post-test counseling

D. Other Recommendations

In addition to the requirements above it is strongly recommended that HIV and HCV rapid testing sites create procedures that address, at a minimum:

  • Initial point of contact within your agency for clients seeking HIV and HCV testing;

  • Screening questions;

  • Appointment schedule process;

  • When preliminary and confirmatory samples for testing are collected; best practice is to conduct a HIV confirmatory test using a blood specimen immediately following the preliminary positive result

  • The process used for persons waiting test results (environment, confidential setting, time, etc.);

  • The type of documentation the client will receive, if any, of their test result; and

  • Follow up for clients who leave prior to receiving test result.

IV. Quality Assurance Monitoring Responsibility

When obtaining a CLIA certificate of waiver, every testing site makes assurances to the federal Centers for Medicare and Medicaid Services (CMS) that they will conduct and use the CLIA waived test according to the test manufacturer. Additionally, the testing site makes assurances that they will monitor CLIA waived testing at their facility to ensure quality and reduce errors. The testing site conducting CLIA waived testing has the responsibility ensure accurate, error-free testing. DSHS will conduct periodic monitoring of DSHS-funded HIV and HCV rapid testing sites to ensure quality assurance guidelines are in place. The CMS will also inspect a waived testing facility if a complaint is made, if the site is performing tests not included in the certificate of waiver or if there is a risk of harm to a patient due to inaccurate testing.

Sites conducting HIV/HCV rapid testing are highly encouraged to review the CDC web developed course: “Ready? Set? Test! Patient Testing is Important. Get the Right Results.” The training is available on the TRAIN Texas website.

The goal of this course is to promote reliable, high quality testing and enhance patient safety by explaining steps of the waived testing process and to provide the learner with additional resources to assist on the job. The training lasts approximately one hour and offers the following continuing education credits:

  • CME: 1.0 (physicians);

  • CNE: 1.0 (nurses);

  • CPE: 0.1 (pharmacists); and

  • CEU: 0.1 (other health care professionals).

V. DSHS Program Contacts

For additional questions pertaining to HCV or HIV rapid testing, please contact:

VI. Reference Tables for HIV and HCV Rapid Testing Requirements and Recommendations

Requirements for HIV and HCV Rapid Testing Sites
  Requirements for HIV and HCV Rapid Testing Sites
1. Must maintain an unexpired CLIA Certificate of Waiver.
2.

Governing or oversight body must have policies that reflect the rapid testing site is aware of:

  • Legal implications and liabilities for conducting CLIA waived laboratory testing.
  • Standing delegation orders from their medical authority.
  • Procedure for dispensing of medical waste.
  • Procedures and guidelines to address an occupational exposure.
3.

All appropriate training for using the rapid testing, including:

  • Training from the manufacturer of the rapid test.
  • “HIV/STD Risk Reduction Groundwork.”
  • “Foundations of Counseling and Testing Pre-Course” (on-line training).
  • “Foundations of Counseling and Testing” (includes post-counseling on positive HIV/HCV results).
  • Basic training on HIV and HCV, such as the web based trainings: Risk Reduction Groundwork and the Basics of Hepatitis.
  • The correct method of reporting test results through the DSHS programmatic database.
4.

Must demonstrate that they can refer clients to appropriate medical and social services, including:

  • HIV treatment and care.
  • HCV confirmatory testing resources and appropriate medical follow up.
  • STD testing and treatment, as medically indicated.
  • Immunization services for hepatitis A and B.
  • Substance abuse treatment services. Mental health services.
  • Any other appropriate program as indicated through post-test counseling.
5. Must have policies and procedures in place to secure client information and maintain client confidentiality.

 

Strong Recommendations for HIV and HCV Rapid Testing Sites
  Strong Recommendations for HIV and HCV Rapid Testing Sites 
1. Designate an initial point of contact within your agency for clients seeking HIV and HCV testing.
2. Develop a list of screening questions.
3. Maintain a flexible appointment schedule process that can accommodate counselors spending adequate time giving client’s positive post test counseling results.
4. Designate when preliminary and confirmatory samples are collected; the best practice is to conduct a HIV confirmatory test using a blood specimen immediately following the preliminary positive result.
5. Develop a process that accommodates and appropriate space for clients waiting on test results (environment, confidential setting, time, etc.).
6. Develop the type of documentation the client will receive, if any, of their test result.
7. Develop a procedure to follow up with clients who leave prior to receiving test result.

Last updated May 10, 2018