April 3, 2009
Dear Laboratory Director:
This letter reviews Department guidelines for laboratories on the release to medical providers of preliminary positive HIV antibody screening results generated in or under the oversight of your laboratory, using rapid or conventional HIV antibody screening tests. Department regulations, specifically Subpart 58-8.4, authorize a clinical laboratory to report a preliminary finding of HIV infection provided a physician or other person legally authorization to receive the test result has affirmatively authorized, in writing, the release of a preliminary positive result (Attachment I). The rule requires a clear statement on the report that the finding if preliminary, results of confirmatory testing will follow and the confirmed results must be considered in making a diagnosis related to HIV infection.
New York State physicians are being reminded by a separate letter that, in some situations, it is important for individuals being tested for HIV to learn of their potential infection prior to completion of confirmatory testing. While such situations may be infrequent, more practitioners may be requesting release of preliminary positive results of HIV testing. Standing orders for release of preliminary positive results may be appropriate in specific settings (e.g., hospital inpatient and other units using conventional testing, high volume clinics, correctional facilities).
Laboratories must have written policies and procedures for provision of preliminary positive results of HIV antibody screening tests, and verify that reports of such results meet requirements described in Department standards (See HIV 17 and its guidance). Policies and procedures should address: storage and retrieval of written authorization to release preliminary positive HIV screening test results; training personnel to distringuish between samples eligible for release of preliminary positive results and those that are not; and quality assurance monitors to ensure timely provision of preliminary and confirmed HIV antibody test results.
Preliminary positive results, together with appropriate counseling, can support changes in risk behaviors and can initiate steps to link persons with confirmed HIV infection to care. Thank you for your laboratory's rold in assuring that individuals who are infected with HIV can learn of their infection as early as possible. Questions concerning release of preliminary positive screening results for HIV may be referred to Mike Neal or Beth Johansen at (518) 485-5378 or by e-mail to CLEP@health.state.ny.us.
Richard Jenny, Ph.D., Director
Clinical Laboratory Evaluation Program
Monica M. Parker, Ph.D
Chief, Laboratory of Blood-borne Diseases