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 RequirementsLimited 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 |
| Ownership and Controlling Interest Disclosure Instructions |
DOH-3486i |
PDF |
| Ownership and Controlling Interest Disclosure Statement |
DOH-3486 |
PDF |
| Business Practice Guidelines |
|
PDF |
| HCS Affiliation request |
|
PDF |
| Delegated Submitter request |
|
PDF |
On-Site Surveys
Changes to Laboratory Operations
Laboratories must provide notification of operational changes using eCLEP,
available through the Health Commerce System. The forms below will only be accepted for processing while eCLEP is in
"Read-Only Mode" for your laboratory. Read-Only Mode indicates that the previous changes submitted through eCLEP
are pending processing by the program.
| 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 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.state.ny.us.
