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Laboratories holding a permit or applying for a permit must complete a reapplication annually.Successful reapplication includes the following, at a minimum:Submission of the web-based re-application on eCLEP, accessible from the Health Commerce…

Health Commerce SystemThe Health Commerce System (HCS) is the secure website for web-based interactions with the New York State Department of Health which includes eCLEP, the application tool for clinical laboratories to submit…

Laboratories seeking a permit must have an initial on-site survey before a permit is issued and before patient testing can be performed. A surveyor from the Department will contact the laboratory to schedule an initial on-site survey. Out-of-state…

Proficiency Testing Guide 2026PT Designation Tutorial 2026 Proficiency Testing RequirementsLaboratories applying for or holding a New York State clinical laboratory permit must successfully participate in proficiency testing with a CMS-approved…

Only laboratories that hold a New York State clinical laboratory permit are authorized to perform testing on specimens originating from New York.  Review of laboratory-developed tests (LDT) begins after the clinical laboratory permit…

[collapse collapsed]Patient Service Centers (PSC)A laboratory holding clinical laboratory permit may operate patient service centers (also known as collecting stations) which are defined as a facility, fixed or mobile, for the collection, drawing…

[collapse collapsed]Standards Open for CommentProposed revisions to the New York State Clinical Laboratory Standards of Practice, General Systems Standards, are available for review and comment.  Please send comments regarding these…

The Laboratory of Inorganic and Nuclear Chemistry (LINC) specializes in measuring many toxic metals/metalloids in environmental and clinical matrices, often at trace (10 to 104 µg/L or 0.01 to 100 µg/g) or even ultra trace (<10 µg/L or <0.01…

All laboratories applying for or holding a clinical laboratory permit must successfully participate in proficiency testing for tests/analytes offered by the laboratory where proficiency testing is mandated by New York (refer to PT Guide).…

For tests described in 42 CFR 493 subpart H and 42 CFR 493 subpart I, laboratories must successfully participate in proficiency testing at least as frequently as described in those subparts. There must be at least two Mycobacteriology events per…

Laboratories applying for or holding a New York State clinical laboratory permit must: Notify the Department of the provider and survey to be used to satisfy proficiency testing requirements.  Laboratories designate PT using the eCLEP…

Biological Research Areas[collapse collapsed]The RibosomePrincipal Investigator: Rajendra K. Agrawal, PhDProtein synthesis (or translation) is a fundamental process in all forms of life. An understanding of the molecular mechanisms underlying…

The infrastructure for biological EM at the Wadsworth Center covers the full range of electron microscopes and accessories needed for state-of-the-art imaging and elemental mapping. High-end cryo-TEMs [collapse collapsed]JEOL JEM-3200FSC/…

Four Decades of Innovation in Biological Electron MicroscopyPioneered electron microscopy of live cells, and electron diffraction of protein crystals, in liquid water Invention of the “single-particle” method for 3-D reconstruction of non-…

Article 30 of New York State Public Health Law was amended in 2024 granting oversight of transfusions occurring in an ambulance and the storage of blood by ambulance services to the Bureau of Emergency Medical Services.  Please contact EMS.…

Please note that all payments made via check or money order must be drawn from a United States bank in United States dollars.  Laboratories located outside the United States must contact CLEP at clep@health.ny.gov to determine an…

Proficiency Testing ReviewThe CMS-approved providers release results and enrollment information to the Department for review. Unsatisfactory, unacceptable, or unsuccessful performance in any proficiency testing event may lead to sanctions as…

Participating laboratories must maintain the following documentation of the processing of proficiency testing materials for review by Department staff as required. Review of this documentation may occur during the on-site survey. Each step…

In recognition of the fact that the Clinical Laboratory Reference System has requirements that are equal to or more stringent than the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the System was granted exempt status by the federal…