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Test Approval

Subsection 58-1.10(g) of Part 58 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York states that all technical procedures employed in a laboratory shall be of proven reliability and generally accepted by leading authorities in the specialties of laboratory medicine and/or approved by the Department. 

A laboratory can perform only those assays for which the analytic and clinical performance characteristics have been established (validated), or if already established (typically by the test manufacturer), verified at the site where the assay will be performed. The laboratory must also hold the appropriate permit category for the test and must meet all other requirements related to on-site survey Standards, personnel requirements, and proficiency testing. The Application Procedures section below describes the types of tests that require specific review and approval from the Department and provides forms and instructions for submitting test validation materials.  Due to the variety of test methods available, ancillary requirements, notification forms and checklists for submissions in certain specialties are also included. Contact Program staff for questions, or for guidance on situations not explained here.

Application Procedures

Making a submission

Begin by selecting the appropriate checklist for your category:

If you do not see your category listed, please use the General Checklist. Compile all requested documentation and index the documents as requested.

Complete the Risk Attestation Form to accompany the submission. The Risk classification of the assay will be assigned by the Clinical Laboratory Reference System. The assigned risk classification will define the mode of review the submission will receive: 

Risk category Submission required Approval Review required Review priority
High Yes No Yes High
Moderate Yes Conditional1,2 Yes Medium
Low Yes Full1,2 No3 --
Provided the laboratory holds the appropriate permit category.
The Department reserves the right to withhold approval at its discretion.
The Department reserves the right to review all applications at its discretion.

Review the full Risk-based Laboratory Developed Test Approval Policy. Note that the Risk-based Laboratory Developed Test Approval Policy only applies to laboratories holding a NYS clinical laboratory permit in the appropriate category(ies) of testing. Risk Attestation Forms ARE NOT required when the laboratory is newly applying for a permit or a permit category.

Submit all documents in both hard copy and one identical electronic copy (provided as a pdf on a CD or flash drive) to the address provided on the first page of the appropriate Submission checklist. The electronic version must follow the Digital Submission Guidelines below.

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.

Mark the cover page of each unit of material with the words “proprietary”, “confidential” or similar to indicate the desire to protect these documents from immediate release based on a Freedom of Information Law (FOIL) request.  If so marked, the laboratory will be advised of any FOIL requests for those documents and will be provided an opportunity to block release by presenting evidence that the materials contain trade secrets.

DO NOT include additional items not requested or not needed to provide context of the assay procedure, reporting or how the analytic and clinical performance was etablished.

Digital Submission Guidelines

Laboratories must comply with the digital submission requirements set forth below or the entire validation submission will be rejected. The laboratory will be notified by email that the submission is not acceptable and why. The laboratory will be required to re-submit the electronic copy in an acceptable manner before review of the materials will proceed. Laboratories are required to submit both paper and PDF electronic versions of complete validation packages. The electronic version (CD or flash drive joined securely to the hard copy) is expected to be an exact duplicate of the paper submission.

Differences between the paper and electronic copy are allowable, provided the electronic copy is more inclusive. In some cases, paper submission of certain material is not feasible (e.g., raw data and statistical analysis program data). The electronic copy must contain all the elements/data required for the submission as defined in each submission checklist, while the paper copy may include a placeholder that cross-references the location of that information in the electronic copy.

  • Paper and electronic copies must be organized in the manner required in the appropriate submission checklist.
  • Electronic copies must follow the prescribed file naming convention (as indicated below) to ensure efficient administrative processing and review, and be limited to as few files as possible. 
  • For PDF documents generated from a scanned copy rather than from the source document, optical character recognition (OCR) must be performed.   We recognize that use of OCR may not be feasible in some cases for documents with figures and images. 
  • A single PDF document cannot exceed 50 MB in size.
  • Based on experience with the size and scope of validation materials over the previous decade, we anticipate that a single PDF file should be able to contain the elements defined in the sub-sections of the relevant submission checklist.  However, when the submission of raw data is required, we will allow up to five files to be submitted, each of which must be 50 MB or less in size.  If additional files are required, please contact CLEP.  When more than one file is submitted for a particular sub-section, follow the naming convention below to ensure efficient review.
  • A project ID (PID) will be assigned to the submission by CLEP staff and this PID will be appended to the filename(s).  The laboratory will be notified of the PID by email confirming receipt of the submission.

File-Names for Method Validation Submissions:

  • General Checklist Sections 1 and 2: <PFI>_CoverPage_<DATE>
  • General Checklist Section 3.1: <PFI>_SOPM_<DATE>
  • General Checklist Section 3.2: 
    • <PFI>_Requisition_<DATE> 
    • <PFI>_Report_<DATE>
  • General Checklist Section 3.3: <PFI>_References_<DATE>
  • General Checklist Section 3.4 including Validation Studies, Representative Specimen Run and Quality Control Data: <PFI>_Validation_<DATE>

Multiple files:

  • <PFI>_Validation_Vol1_<DATE>
  • <PFI>_Validation_Vol2_<DATE>        
  • <PFI>_Validation_Vol3_<DATE>, etc

For tests that require informed consent: 

  • <PFI>_Consent_<DATE>  

Risk Attestation Form:

  • <PFI>_RiskForm_<Date>  (must be submitted as a stand-alone file)           

File-Names for Laboratory Responses:

  • The laboratory should include a complete, point-by-point response to our Clinical Laboratory Reference System (CLRS) review comments and requested information should be submitted in a single OCR PDF document not exceeding 50 MB including the assigned project ID (PID).  When more than one file is submitted follow the naming convention below to ensure efficient review: <PFI>_PID#####_Response_<DATE>
  • Multiple files:

Proper authority to require submissions in an acceptable format is granted to the department under section 576.2 of the New York State Public Health Law. Section 576.2 of NYS PHL states "The department may require clinical laboratories and blood banks to submit, in a form prescribed by the department, periodic reports of test performed and such other information as the department may require to carry out the provisions of this title."

Tracking a submission

Laboratories can track the progress of test approval submissions via the Test Approval Status link on the eCLEP home page available on the Department’s Health Commerce System (HCS).  Approved methods are shared with referring laboratories, consumers and health care providers upon request, so it is important to regularly review your list of approved methods to ensure a method is still being offered by your laboratory. Once a submission is received and logged, it is assigned a Project ID (PID) number and included in the Test Approval Status list showing the current status. If a test or test method has been discontinued, you may send an email as described below.

To inquire about a submission, you can send an email the CLEP Validation Unit. Please reference your laboratory’s four-digit permanent facility identifier (PFI) and the PID number in the subject line of your email.

Deleting a test

  • To delete a test considered to be an LDT from the test approval listing, email the CLEP Validation Unit.
  • To delete an FDA-approved test or standard method from the laboratory’s reported test menu reported via paper prior to 2012 or via an initial permit application, please submit a delete test form
  • If reported via eCLEP, please request deletion via eCLEP.

Non-Permitted Laboratory Test Requests

New York State Public Health Law (Article 5, Title V, Section 574) and regulations (Subsection 58-1.10 (g) of 10NYCRR) require that all specimens obtained within New York State be tested by a laboratory that holds a New York State clinical laboratory permit, including test-specific approval when required. Explicit test-specific approval is not required for tests designated as FDA-cleared, approved or exempt. Notification to add such tests to the laboratory’s test menu is still required. Due to the rarity of many diseases, testing for all potential conditions may not be available from permit-holding laboratories or there may be adequate justification for use of a specific laboratory that does not hold a permit. In these cases, the department’s approval must be received prior to submitting a specimen collected in New York State for testing by a non-permitted laboratory or a permitted laboratory that does not hold approval for that particular test. All laboratories performing testing, however, must hold a valid CLIA number. The Clinical Laboratory Evaluation Program (CLEP) administers this process and monitors the volume and frequency of requests.