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Limited Service Laboratories
Limited Service Laboratories include hospital extension clinics, hospital owned physician practices, nursing homes, home health care agencies, school/student health services, dialysis facilities, ambulatory surgery centers, county health departments…
Certificate of Qualification & Laboratory Director Requirements
New York State Public Health Law requires that all individuals designated as laboratory directors or assistant directors at a clinical laboratory or blood bank holding or applying for a New York State clinical laboratory permit to hold a Certificate…
Cytopathology Requirements
New York State Public Health Law was amended effective December 13, 2024 such that cytotechnologists are no longer required to register with the Department. Compliance with the workload standard is still required. Cytotechnologists:New York…
Clinical Laboratory Evaluation Program - Laws & Regulations
Clinical Laboratory Statute and RegulationsStatute - Public Health LawArticle 5, Title V: Clinical Laboratory and Blood Banking ServicesFollow the link, click "PBH" from the list, click "Title 5" under "Article 5"Article 31: Human Blood and…
Obtain a Permit
Apply for a Clinical Laboratory Permit[collapse collapsed]Information for new laboratoriesAll clinical and forensic laboratories and blood banks located in or accepting specimens from New York State must hold a New York State Department of Health…
Change a Permit
eCLEP Permit Materials Manual[collapse collapsed]Changes in Laboratory Director, Owner or LocationArticle 5, Title V of the New York State Public Health Law specifies that a laboratory permit is void upon a change in laboratory director, owner…
Re-Apply for a Permit
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…
Search Approved Clinical Laboratories
Health Commerce System
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…
On-Site Survey Process
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…
Clinical Laboratory Evaluation Program Proficiency Testing
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…
Test Approval
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…
Patient Service Centers & Health Fairs
[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…
Laboratory Standards
[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…
Trace Elements
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…
Proficiency Test Participation
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).…
Proficiency Testing Frequency
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…
Proficiency Testing Administrative Policies
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…
3D Electron Microscopy Research & Technology Development
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…
3D Electron Microscopy Instrumentation
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/…