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Clinical Laboratory Evaluation Program - Applications and Forms

Included are forms and applications needed to operate a laboratory, limited testing site, patient service center, health fair, or certify a director. Guide to Program Requirements




Limited Service Laboratories

Materials for facilities or Programs performing only tests that are classified as waived by the FDA and/or tests classified as Provider Performed Microscopy Procedures (PPMP) under CLIA can be found here.




Certificate of Qualification

Laboratories holding or applying for a New York State permit must have a director holding a Certificate of Qualification for each test category.
Certificate of Qualification Instructions DOH-238i PDF
Certificate of Qualification Application DOH-238 PDF
Amendment Request Instructions DOH-238ai PDF
Amendment Request Application DOH-238a PDF
Definition and Scope of CQ Categories   PDF
CQ Categories required to direct Permit Categories   PDF

Cytotechnologists

If applying for a permit in any category of Cytopathology and your laboratory employs cytotechnologists who are not currently registered in New York State, you must submit an Initial Application for each cytotechnologist.
Initial Application Instructions DOH-2571i PDF
Initial Application DOH-2571 PDF
Changes in Registration Status Instructions DOH-2571ai PDF
Changes in Registration Status DOH-2571a PDF
Application to Exceed Cytotechnologist Work Standard DOH-3796 PDF

Facility Personnel

Laboratories must complete a spreadsheet listing all technical personnel employed in the laboratory prior to an onsite survey.
Facility Personnel Spreadsheet (for laboratory surveys) DOH-709 PDF XLS

Laboratory Permit Application Materials

Included in this section are all forms needed to submit an application for a new laboratory permit, for facilities performing any non-waived testing. Laboratories performing any non-FDA approved or in-house developed assays must submit materials to have these assays reviewed and approved for use in New York State: Submission Guidelines, Inspection (Survey) and Proficiency Testing requirements.
Initial Laboratory Permit Application Instructions DOH-3494i PDF
Initial Laboratory Permit Application DOH-3494 PDF
Permit Category Descriptions DOH-4022 PDF
Category Questionnaires   HTM
Disclosure of Ownership and Controlling Interest Statement Instructions DOH-3486i PDF
Disclosure of Ownership and Controlling Interest Statement DOH-3486 PDF
Business Practice Guidelines   PDF
HCS Affiliation request   PDF
Delegated Submitter request   PDF

On-Site Surveys

Use this form to reply to laboratory inspection findings. Inspection / Survey requirements.
Plan of Correction Template DOC

Changes to Laboratory Operations

Laboratories must provide notification of operational changes using eCLEP, available through the Health Commerce System. Deletion of tests from your New York State test menu that were not "added" via eCLEP requires the submission of a Delete Test Form available below. Please note, changes to laboratory ownership in eCLEP also require the submission of the Disclosure of Ownership and Controlling Interest Statement, available in the Laboratory Permit Application Materials section above.

Please contact CLEP at (518) 485-5378 if you experience difficulties accessing eCLEP.

Notification to Delete Test(s) DOH-3519f PDF

Patient Service Center Application

Laboratories holding permits may operate patient service centers or collecting stations, which are defined as a facility, fixed or mobile, operated by a clinical laboratory under permit, for the collection, drawing and/or temporary storage of materials derived from the human body, until forwarded to the clinical laboratory for testing. Laboratories under permit may use the application below to apply.
Instructions for Patient Service Center DOH-1589i PDF
Application for Patient Service Center DOH-1589 PDF
Patient Service Center Change Instructions DOH-1589ai PDF
Patient Service Center Change Form DOH-1589a PDF

Health Fairs (Community Screening)

Laboratories under permit may also conduct screening events with the approval of the Department, use the form in this section to apply. Facilities holding a Limited Service Laboratory registration may conduct Community Screening provided the testing staff are trained in how to perform testing and protocols are maintained to ensure all tests are performed in accordance with the manufacturers' instructions & standards of practice in lab medicine. Limited Service Laboratories proposing to perform rapid HIV and lead testing must submit a protocol to the department for review. Each site seeking approval must understand - and be able to describe - how the test is used in their particular setting.
Instructions for Health Fairs DOH-HFi PDF
Application for Health Fairs DOH-HF PDF

Non-Permitted Laboratory Test Requests

New FAX number for Non-Permitted Laboratory Test Requests,
please update your records accordingly: (518) 449-6917

New Policy 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 below.

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.

Request Approval Form Instructions PDF
Request Approval Form PDF
Complete package with Algorithm, Comments, Questions & Answers PDF

Documents in an alternate format can be requested by sending an e-mail note to CLEP@health.ny.gov.