Test Approval Policy
MAKING CHANGES TO YOUR LABORATORY'S TEST MENU
Overview of Notification Process*
- For addition or deletion of FDA-approved/cleared tests, submit an Add/Delete FDA-Approved Test Form*
- To make a large number of additions or deletions
(e.g. > 9), a spreadsheet format will be accepted. - For addition of non-FDA-approved/cleared tests to your test menu, proceed to the Comprehensive Test Approval Policy and Submission Guidelines section below.
- For deletion of non-FDA-approved tests from your test menu, send an email to: CLEPVAL@health.state.ny.us.
- If test changes necessitate a NYS permit category change, submit the Add/Delete Category Form.
- For a list of NYS Permit Categories please refer to our Permit Category Descriptions. A list of common/representative assays/tests and their associated permit category can be found in the CLEP Program Guide.
* 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 - Revised 11/26/2012
- Toxicology
- Trace Elements
- All other categories
NEW POLICY FOR NON-PERMITTED LABORATORY TEST REQUESTS
Adopted 02/27/2012
New York State Public Health Law (Article 5, Title V, Section 574) and regulations (Part 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. 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.
A proposed policy and algorithm to manage non-permitted laboratory test requests was circulated for comment on July 28, 2011. The announcement of the proposed policy and algorithm was sent to all laboratories holding or applying for a New York State clinical laboratory permit (approximately 1,000 facilities). This distribution was sent by e-mail to the facility, laboratory contact person, the director's personal e-mail as identified on their certificate of qualification. The documents are posted at the bottom of the page here.
Please review the policy and algorithm to manage non-permitted laboratory requests and the responses to the comments as the documents have been revised in response to the comments received. In addition, guidance Question & Answers documents were prepared. We expect that some laboratories will need to make adjustments to their management of non-permitted laboratory requests. Please note that the policy and algorithm will be adopted with an effective date of February 27, 2012