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Clinical Laboratory Evaluation Program - Applications and Forms

CLEP

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 HTM
Ownership and Controlling Interest Disclosure Instructions DOH-3486i PDF
Ownership and Controlling Interest Disclosure Statement DOH-3486 PDF
Category Questionnaires     HTM
Business Practice Guidelines   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 already holding a permit must provide notification of operational changes using the forms in this section in order to maintain a valid permit.
Instructions for Notification of Changes DOH-3519i PDF
Notification of Change in Laboratory Name or Owner Name DOH-3519a PDF
Notification of Change in Laboratory Director DOH-3519b PDF
Notification of Change in Assistant Director DOH-3519c PDF
Notification of Change in Laboratory Owner DOH-3519d PDF
Notification of Change in Laboratory Location DOH-3519e PDF
Notification of Change to Add/Delete Tests DOH-3519f PDF
Notification of Change to Add/Delete Categories DOH-3519g 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 Request

Requests for permission to use a laboratory that does not hold a permit, or does not have approval for a specific assay, may be granted in special circumstances. Use the form in this section to request permission.
Management of non-permitted laboratory requests - Email sent 7/28/11   PDF
Proposed non-permitted laboratory policy and algorithm   PDF
Request Approval Form Instructions   PDF
Request Approval Form   PDF

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