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Test Approval Policy

MAKING CHANGES TO YOUR LABORATORY'S TEST MENU

Overview of Notification Process*

* As situations differ, CLEP reserves the right to request additional information. Contact CLEPVAL@health.state.ny.us with questions.


COMPREHENSIVE TEST APPROVAL POLICY AND SUBMISSION GUIDELINES

Please refer to the Comprehensive Test Approval Policy and Submission Guidelines for a complete description. The appendices discussed in the Policy can be obtained below.

Appendices - Category-specific Guidance

Cellular Immunology
Cytogenetics FISH
Forensic Identity
Genetic Testing – Molecular
Microbiology molecular assays
Oncology molecular assays
NGS guidelines for somatic genetic variant detection - Updated and Revised January 2014
Toxicology - for non-traditional matrices and for representative assays during permit application.
Trace Elements - for non-traditional matrices (See Trace Elements Standard 11)
General Checklist (all other assays)

Toxicology - TSMQ Policy Update

Laboratories holding a permit in the categories of Clinical and Forensic Toxicology (Initial and Comprehensive) and/or Therapeutic Substance Monitoring/Quantitative Toxicology are no longer required to submit validation materials when adding commercially available tests and LDTs performed in whole blood, plasma, serum, oral fluid, urine or sweat. However, laboratories must continue to notify the Clinical Laboratory Evaluation Program when new tests are added to the laboratory's menu. Toxicology - TSMQ Policy Update October 2010

Important Reminders and Updates for the Assay Validation Approval Process
Posted 3/28/2014

  • Permitted laboratories must not offer the testing until the laboratory receives the Conditional Approval Letter. Please note that we reserve the right to withhold conditional approval where there are significant concerns.
  • Ensure your laboratory's assay design, validation, and other required elements are fully complete and final before making the submission. Once a complete validation package has been entered into the review system, we cannot accept changes/additional information while the review is in progress. If there are necessary and unavoidable modifications/additions to a submission, then the laboratory must notify the CLEP Validation Unit. The current review project may be inactivated and a complete new submission may be required, based on the nature of the modifications.
  • We realize that your laboratory's test may have unique features. Please keep in mind that all assay validation packages are thoroughly reviewed by Wadsworth Center's Clinical Laboratory Reference System scientists and the packages should be organized in a manner that facilitates a seamless review. Additional items not requested or not needed to provide context of the assay procedure, reporting or how the the analytic and clinical performance was established, should not be included.

† holding a NYS CLinical Laboratory Permit in the appropriate category