Clinical Laboratory Evaluation Program
Submissions Guidelines for Test Approval
[Submissions Guidelines
for Test Approval: online fillable PDF form]
Revised 10/27/06
Subsection 58-1.10 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 shall perform only those assays that have been validated or verified at the site where the assay will be performed; must hold the appropriate permit category for the test; and must meet all other requirements related to personnel and proficiency testing.
I. The following types of assays may be offered by the laboratory without the prior approval of the Department:
- Assays cleared or approved by the FDA that have not been modified to change the intended use * or any test that meets the definition of a standard method. A standard method is defined as an assay that has an established record of reliability and clinical validity, and which employs a standardized protocol that is universally applied in laboratories that employ the method for the analyte, such application being consistent with industry standards recognized by leading authorities in laboratory science. The laboratory must complete and submit a Notification to Add or Delete Analytes" form, available on our website at www.wadsworth.org/labcert/clep/clep.html (click on the Permit Application Materials link). The Department will review validation during the next on-site survey and may, upon audit, request specific validation data.
- Commercially distributed assays that are labeled for Investigational Use Only (IUO), provided the assays have not been modified to change the intended use *. The laboratory must complete and submit Section I of this document along with a copy of the package insert and sample reports. The Department will review validation during the next on-site survey and may, upon audit, request specific validation data. Typically, complete submissions (as outlined in Section II) are requested for molecular-based infectious agent, oncology, and genetic assays.
- Assays that fall within an area covered by an exemption granted to the Laboratory by the Department for a given test category, which may be further limited by technology or method (See below).
II. A laboratory must acquire Department approval prior to offering the following types of assays:
- Commercially distributed assays labeled for Research Use Only (RUO) and those assays using Analyte Specific Reagents (ASRs). The patient report should bear any disclaimer required by the federal government such as that required for ASRs. For these assay types, laboratories must complete and submit Section I of this document along with a copy of the package insert and sample reports showing the disclaimer. Additional data, including complete procedure and validation, may be requested for review. Typically, complete submissions (as outlined in Section II) are requested for molecular-based infectious agent, oncology, and genetic assays.
- FDA approved assays or IUO and RUO assays that have in any way been modified from their intended use * as described in the package insert or are employed in conjunction/combination with any in-house developed reagent or assay. For these assay types, laboratories must complete Section I of this document, and submit a description of the modification and a summary of the validation performed. Additional data, including complete procedure and validation, may be requested for review.
- For in-house developed methods laboratories must complete Section I of this document, and submit documentation of initial and on-going validation as outlined in Section II.
* A change in intended use is a change in the specimen type; the type of analysis (e.g., qualitative vs. quantitative); the purpose of the assay (e.g., screening, diagnosis, prognosis, monitoring, and confirmation); or the target population(s) as specified by the FDA or outlined in the package insert. Submission of validation data is not required for minor procedural modifications to tests such as incubation times or sample volume; validation for these modifications will be reviewed as part of the on-site survey.
III. A laboratory may be able to receive an exemption under certain conditions:
1) A laboratory may receive a limited exemption from the submission of validation data for each test through the approval of a comprehensive validation protocol. To qualify for such an exemption in the applicable category or categories (which may be restricted further to technology or method) a laboratory must submit the following:
- A description of the type of assays or modifications to intended use to be exempted, and
- A standardized protocol for method validation that includes all the applicable elements of Section II of these Submission Guidelines. The plan should include a description of general principles and laboratory-specific practices for assay development and initial validation, an algorithm for assay validation using reference assays and/or clinical findings, and laboratory-specific protocols for on-going validation, including quality control procedures and quality assurance indicators. The algorithm for assay validation should describe the characteristics and number of specimens that are necessary to achieve a stated confidence level in the determination of assay performance characteristics, reference intervals, clinical sensitivity, specificity and/or predictive value, as applicable for the assay. The plan must describe the identification of critical steps in the test procedure and the quality control measures taken to control and monitor assay performance for consistent and reliable results.
2) In order to be considered for an exemption, a laboratory must first have a sufficient number of representative methods approved through the full validation review process, to demonstrate that the validation protocol is followed on a consistent basis over time. Key elements of acceptable validation packages would include:
- Organization: Submissions routinely contain all the required elements outlined in Section II of these guidelines and the package is well organized so that the reviewer(s) can easily identify and evaluate these elements.
- Validation data: The laboratory routinely submits validation data for an appropriate number of specimens; includes an acceptable range of values; provides data for all specimen types that will be used in clinical testing; and provides a narrative summary of the data with clearly drawn conclusions.
3) Subsequent to the granting of the limited exemption, the laboratory may begin offering additional assays covered by the exemption once they have notified the department. Notification must be made using Section I of these guidelines, and must be accompanied by a summary description of the validation performed, including a summary of the data analysis, and sample reports for all possible outcomes, including test interpretation.
4) The department will conduct random audits of these assays, requesting additional information as necessary (which may include a full validation package as outlined in Section II of these guidelines). If these submissions are found to be deficient so as not to support performance claims or there is evidence that the approved validation protocol is no longer being followed, any approvals granted under the exemption will be re-examined.
Proprietary submissions:
Please note that materials submitted, including related data packages, cannot be returned to the laboratory. All materials are automatically treated in a manner that ensures confidentiality. In addition, if documents are marked "proprietary," laboratories will be given an opportunity to block information release if a request for the material is filed under the NYS Freedom of Information Law (FOIL), by presenting evidence that the materials contain trade secrets. Marking should minimally appear on the cover page of each unit of material. Documents not marked, or marked with terms such as "confidential" will not block release of the submission through a FOIL request.
Please submit the completed form (and attachments as necessary) by mail, email or on compact disc to:
- Clinical Laboratory Evaluation Program
Wadsworth Center
New York State Department of Health
PO Box 509
Empire State Plaza
Albany, NY 12201-0509
Attn: Assay Validation Review. - Email: CLEPCERT@health.state.ny.us
Rev. 10/06