Rapid HIV Testing: Guidance for Non-Clinical Providers

Rapid test technology has raised a number of questions about implementation requirements in New York State (NYS). The purpose of this guidance is to provide an overview of current requirements that must be met by non-clinical providers, such as community-based organizations, that may be interested in offering HIV antibody testing using a waived rapid test product.

The introduction of rapid tests for HIV must be approached within the overall framework and safeguards provided by existing public health laws and regulations that pertain to HIV counseling and Testing (HIV C & T). The following areas are pertinent for any non-clinical agency considering offering rapid testing. In addition, product information may be obtained directly from the manufacturers.

Registration Required to Offer Rapid Testing

Non-clinical providers must register their testing site(s) with the NYS Department of Health (NYSDOH) Wadsworth Center as a Limited Service Laboratory to offer rapid testing. This registration requires completion of an application form, submission of the application with a fee and submission of a written protocol. The NYSDOH requires designation of a licensed health care practitioner who will function as site director and provide technical and clinical oversight of testing. Please be aware that only individuals currently certified by NYS as laboratory directors, or individuals authorized by law to order and use laboratory tests in their practice, are eligible to be designated as directors of Limited Service Laboratories. A nurse (RN or LPN) or a MSW counselor may not direct testing at a Limited Service Laboratory. The Limited Testing Permit Application and Instructions may be obtained by calling 518-485-5378 or, through the CLEP website.

Authorization for Testing

Tests performed by Limited Service Laboratories must be ordered by a physician or other health care provider, such as a nurse practitioner or physician assistant, who is legally authorized (by NYS professional practice law) to use the results of clinical laboratory tests in the practice of his or her profession. A nurse (RN or LPN) or a MSW counselor may not authorize testing.

Arrangements for Confirmatory Testing for Reactive Results (Preliminary Positive Results)

The standard HIV testing algorithm in the U.S. consists of a screening test, such as an enzyme immunoassay (EIA), followed by confirmatory testing (i.e., western blot) of all samples determined to be preliminary positive or presumptive positive by the screening assay. Confirmatory testing must be accomplished by collection of an oral fluid or venous blood specimen that is submitted by the Limited Service laboratory to a laboratory holding a NYS permit to conduct confirmatory testing. A list of laboratories qualified to perform HIV confirmatory tests may be obtained from the licensing program at 518-485-5378.

Policies and Procedures

Agency policies and procedures for implementation of rapid testing must address confidentiality, informed consent, counseling, record keeping, laboratory quality assurance activities, reporting of results, appropriate referrals to HIV primary care, case management and partner notification for those HIV infected. More information can be found in the NYSDOH Rapid HIV testing Workbook and Guidance document.

Training Related to HIV Counseling and Testing

Trained HIV test counselors play vitally important roles in offering HIV tests and in assuring that all existing requirements are met. Counselors would benefit greatly from attending the courses noted below prior to initiating testing. The courses are available at no charge through the AIDS Institute's Statewide Calendar of HIV/AIDS Training. Three core courses constitute the basic preparation needed to offer HIV counseling and testing; HIV/AIDS Confidentiality Law; HIV Testing Procedures; and Practicing the NYS Domestic Violence Screening Protocol. To view the available AIDS Institute's Statewide Trainings on the Internet, visit the NYSDOH web site. Specific questions may be directed to the training center at which you/your staff wishes to attend training.

Occupational Safety and Safe Disposal of Regulated Medical Waste

Some rapid test procedures involve collection of blood specimens. Safety precautions and staff training consistent with the OSHA requirements for occupational exposure to blood borne pathogens and arrangements for safe and proper disposal of regulated medical waste are required.