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 or may register a Limited Service Laboratory for waived rapid HIV testing that is performed as part of point-of-care or direct patient care testing, under the supervision of the laboratory. Laboratories operating under permit must update their permit by completing an "Add Test" Form (DOH-4236(e)), and comply with quality control standards suitable for the permitted laboratory status. Limited Service Laboratories must obtain approval to perform rapid HIV testing by submitting an "Add Test" form and a protocol describing how the testing will be performed in compliance with the manufacturer's requirements. 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 CLEPLtd@health.state.ny.us . Application forms can be obtained by visiting the CLEP web site at http://www.wadsworth.org/clep 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.
The facility must maintain a record of the locations where HIV screening events are offered but are not required to submit a list of these locations to CLEP for prior approval. Limited Service Laboratories must hold Community Screening approval to hold these events.
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.