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 living with Human Immunodeficiency Virus (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 with hepatitis C virus (HCV) need to be diagnosed early in the course of infection. The use of HIV and HCV point of care (POC) tests increases the number of persons who know their test results, especially among hard-to-reach populations and in settings with low return rates.

Yet, increasing the access to HIV and HCV POC testing will only benefit the priority populations if they are given accurate information and test results. To ensure that this occurs, the DSHS TB/HIV/STD Section (Section) issued Guidelines for Conducting HIV and HCV Rapid Testing (Guidelines).

The Guidelines were created for use by any non-laboratory site that wants to put in place HIV and HCV POC testing. DSHS-funded testing sites must show the ability to adhere to the Guidelines and must ensure that the HIV and HCV POC tests are 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 POC Testing

Because HIV and HCV POC testing requires staff to collect whole blood samples and conduct confirmatory diagnostic testing, the Board of Directors or governing body of organizations offering these tests 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 CDC. 

For HIV and HCV POC testing sites that use professional clinical staff for the collection of testing samples, adhering to these administrative guidelines will not have a great impact. Yet, 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 POC 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 POC 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 POC Testing Sites

Sites performing HIV and HCV POC tests 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 HIV or HCV POC 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 POC 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 POC test technology without the CLIA certificate of waiver.

CLIA Waiver
CLIA certificate of waiver can be obtained at the HHS Health Care 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 $180.00 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 CDC guidance on quality assurance plans.

Much of this guidance can also be used to integrate HIV and HCV POC 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 POC 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 POC tests have received training in:

• The correct use of the rapid test from the manufacturer;
   
• Basic training on HIV and HCV, such as Foundations of Testing and Navigation, and 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 POC testing sites must show 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 needed.
   

D. Other Recommendations

In addition to the requirements above it is recommended that HIV and HCV POC testing sites create procedures that address, at the least:

• Initial point of contact within your agency for clients seeking HIV and HCV testing;
   
• Screening questions;
   
• Appointment schedule process;
   
• Privacy practices and disease reporting requirements;
   
• 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 before 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 track CLIA-waived testing at their facility to ensure quality and reduce errors. The testing site conducting CLIA-waived testing has the responsibility to ensure accurate, error-free testing. DSHS will conduct periodic monitoring of DSHS-funded HIV and HCV POC 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 CLIA certificate of waiver or if there is a risk of harm to a patient due to inaccurate testing.

Sites conducting HIV/HCV POC 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 extra 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 POC testing, please contact the program. 
 

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