Main Body
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
Laboratory Director/Assistant Director
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-238(i) |
PDF |
| Certificate of Qualification Application |
DOH-238 |
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-2571a |
PDF |
| Changes in Registration Status |
DOH-2571a |
PDF |
| Application to Exceed Cytotechnologist Work Standard |
DOH-3796 |
PDF |
Facility Personnel
Laboratories applying for a permit must complete and submit a spreadsheet listing all technical personnel employed in the laboratory.
| 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 |
HTM |
| 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
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 Analytes |
DOH-3519f |
PDF |
| Notification of Change to Add/Delete Categoryies |
DOH-3519g |
PDF |
Limited Service Laboratory Materials
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, must register with the Department using the forms in this section. Also included in this section are forms to provide the required notification of changes in operations
necessary to maintain a valid CLIA number.
| Limited Service Laboratory Registration Instructions |
DOH-4081i |
PDF |
| Limited Service Laboratory Registration Application |
DOH-4081 |
PDF |
| Multi-Site Network Add Testing Location Instructions |
DOH-4081MS |
PDF |
| Multi-Site Network Add Testing Location Application |
DOH-4081MS |
PDF |
| Notification of Change in Laboratory Name |
DOH-4236f |
PDF |
| Notification of Change in Laboratory Director |
DOH-4236b |
PDF |
| Notification of Change in Laboratory Owner |
DOH-4236c |
PDF |
| Notification of Change in Laboratory Location |
DOH-4236d |
PDF |
| Notification to Add and/or Delete Analyte(s) |
DOH-4236e |
PDF |
| Laboratory Practice Standards for Blood Lead Screening |
|
PDF |
| Guidance for following Standard Practices in Laboratory Medicine |
|
PDF |
Patient Service Center Application
Laboratories holding permits may conduct screening events with the approval of the Department, use the form in this section to apply.
| Instructions for Patient Service Center |
DOH-1589 |
PDF |
| Application for Patient Service Center |
DOH-1589 |
PDF |
Health Fairs (Community Screening)
| 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.
| Request Approval 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.
