Rapid HIV Testing Guidance for Licensed Article 28 Facilities

The New York State Department of Health supports the use of rapid tests in medical settings in order to increase access to early HIV diagnosis and for treatment and prevention services. A licensed Article 28 facility that wishes to provide HIV rapid testing must either hold a clinical laboratory permit in the category of HIV testing or be registered with the Department of Health as a limited service laboratory.

A facility with a licensed clinical laboratory may choose to offer rapid HIV testing as part of the menu of services, under the supervision of the laboratory. Laboratories operating under permit must update their permit by completing an "Add an Analyte" Form, and comply with quality control standards suitable for the permitted laboratory status. Additionally, a licensed health facility may need to amend its operating certificate to conduct HIV testing off-site in non-medical settings, such as in a community site.

Questions and additional information on permit requirements may be directed to CLEP at (518) 485-5378 or by e-mail to CLEP@health.state.ny.us . Application forms can be obtained by visiting the CLEP web site at http://www.wadsworth.org/labcert/clep/clep.html and clicking on the "Permit Application Materials" link. Forms can be submitted electronically, faxed or by mail to:

Clinical Laboratory Evaluation Program
NYSDOH Wadsworth Center
Empire State Plaza
P.O. Box 509
Albany, NY 12201-0509

Permitted laboratories should refer to their PFI and CLIA numbers when contacting CLEP.

Requirements

All licensed health facilities and Laboratories that are interested in offering rapid test on site or at HIV screening events or off-site in community settings (i.e., on-site at a CBO) must fulfill a few simple requirements, as outlined below.

Be registered. Limited service laboratories must, if they have not already done so, advise the NSYDOH Clinical Laboratory Evaluation Program (CLEP) of the testing product that they are adding to their permit.

Provide a written protocol. Laboratories seeking to offer Rapid HIV testing must provide CLEP with a written protocol that addresses product issues such as temperature monitoring and maintenance, adequate lighting, level testing surface, kit and reagent (controls) storage, confidentiality, proper disposal of regulated medical waste, arrangements and tracking of confirmatory testing, and follow up to ensure that individuals who test positive are linked to medical care.

Ideally, the protocol should be provided at the time a laboratory submits an update to their Limited Testing Laboratory Registration. If a protocol is not provided, or the submitted protocol is not acceptable, CLEP will contact the laboratory by telephone. An outline regarding protocol development is available at: http://www.health.state.ny.us/diseases/aids/testing/rapid/samppro.htm .

Let CLEP know of the location(s) and schedule of testing. Advance notice of location(s) at which testing will be offered enables CLEP to respond to inquiries or concerns. Therefore, CLEP should be notified in advance, in writing to the above address. If advance notice is not possible, due to, for example, a change in anticipated location, CLEP will accept faxed or e-mail notification provided in the laboratory has an acceptable protocol in place:

Fax: James Holland, CLEP at (518) 485-5414
E-mail: JMH33@health.state.ny.us

Limited service laboratories should refer to their PFI and CLIA numbers when contacting CLEP.

Questions. Questions concerning CLEP requirements for the addition of test devices can be directed to: James Holland, CLEP at JMH33@health.state.ny.us or at (518) 402-4141.

Instructions for Amending an Operating Certificate

A health facility licensed pursuant to Article 28 that seeks to conduct or participate in HIV screening events must have - or must add - the service designation "Health Fairs" to its operating certificate. This designation allows the facility to offer services, including HIV screening, at addresses not listed on its operating certificate. The facility must maintain a record of the locations where HIV screening events are offered but does not need to submit a list of these locations with its request to amend the operating certificate. The designation "Health Fairs" can be added by sending a letter directed to the:

Information and Technology Services Group
New York State Department of Health
Hedley Park Place, 6th Floor
433 River Street
Troy, NY 12180-2299

Related questions may be directed to the Project Management Unit at (518) 402-0911.