Facilities performing these types of tests must first register with the Clinical Laboratory Evaluation Program by carefully reading the instructions and completing an Initial Limited Service Laboratory Registration Application [2]. Be aware that applications must be returned by mail only (with original signatures). The submission of incomplete application materials will delay the processing and the issuance of registration certificates.  Please allow a minimum of three (3) weeks to process applications from the date that they are received in our office.

Once the Limited Service Laboratory Registration application is approved, an initial registration certificate will be issued. The certificate will serve to verify your enrollment with this Program and will also provide documentation of your CLIA registration number.  If you are applying for a multi-site network registration, carefully read and complete the Limited Service Laboratory Multi-site Application. [3] Registration certificates for all locations in the network will be sent to the Primary Site location. Registrants may only perform the tests listed on the registration certificate issued by the Department. Multi-site network registrants may only perform the tests listed on the registration certificate issued to the Primary Site. Certificates are valid for two years from the date issued.

To document changes in Limited Service Laboratory Registration status, or to add and/or delete tests, fill out the appropriate form below. 

• Change in Laboratory Director [4]
• Change in Laboratory Owner Information [5]
• Change in Laboratory Location [6]
• Add and/or Delete Test Procedures [7]
• Change in Laboratory Name [8]

Be aware that change forms and any accompanying documentation must be returned by mail only (with original signatures). The submission of duplicate (faxed/e-mailed) and/or incomplete paperwork will delay the processing and the issuance of amended registration certificates.  Please allow a minimum of three (3) weeks to process changes from the date that they are received in our office.

Once the Limited Service Laboratory Registration application is approved, an initial registration certificate will be issued.  The certificate will serve to verify your enrollment with this Program and will also provide documentation of your CLIA registration number.  If you are applying for a multi-site network registration, registration certificates for all locations in the network will be sent to the Primary Site location. Registrants may only perform the tests listed on the registration certificate issued by the Department. Multi-site network registrants may only perform the tests listed on the registration certificate issued to the Primary Site.  

Certificates are valid for two years from the date issued.  Approximately three months before a registration expires, you will be sent materials via mail to renew your Limited Service Laboratory Registration and/or Limited Service Laboratory Multi-Site Network Registration.  It is important for laboratories to keep our office informed of changes which may affect the delivery of registration materials, for example:

• Contact Person
• Laboratory Director
• Laboratory Address
• Alternate Mailing Address
• A working Email Address

If we are unable to deliver registration materials to you in a timely manner, your laboratory’s Limited Service Laboratory Registration may lapse. Be aware that reapplications must be returned by mail only (with original signatures).  The submission of incomplete and/or late reapplication materials will delay the processing and the issuance of new registration certificates

The $200.00 Initial Limited Service Laboratory Registration and/or Limited Service Laboratory Registration Reapplication fees should be enclosed with your registration materials.  This fee is non-refundable.

Paying by check or money order: Make the payment out to New York State Department of Health.  Your payment should be mailed with your application and/or reapplication materials. It should include your PFI#, or the complete facility name in the memo area of the check (or check stub).

For making payments in State Financial System (SFS):

• The payment should be classified as "Outside Party", not "Interagency".
• The Vendor ID is:  0430000056
• The Vendor Name is:  DOH CLEU Revenue Account, short name is DOH CLEU R-001
• Select “2” for address to send directly to the CLEP.  This should read Clinical Lab Eval Prog Wadsworth Ctr, PO Box 509 Empire State Plz, Albany, NY 12201-0509
• For Location: enter 'Maincheck' to generate a physical check. This method will ensure that CLEP receives and applies your payment in a timely fashion.  Please do not use 'Mainepay'.
• Please include the PFI of the limited laboratory in the invoice#.  This will ensure the payment is properly applied.
• Please ensure that the information as requested above is reflected on both the Invoice Information Tab and the Payments Tab in SFS
• For an initial application, when the PFI is not known, please include the applicant name as a message in the Payment Method section on the Payments tab in SFS.

Instructions to volunteer ambulance services seeking a fee waiver: Volunteer ambulance services (as defined in Article 30 of the Public Health Law and operated under Section 209-B of the General Municipal Law) seeking a waiver of the $200.00 Initial Limited Service Laboratory Registration Application and/or Limited Service Laboratory Reapplication fees must provide copies of both of the following documents with your application and/or reapplication materials. 

• Application for EMS Operating Certificate, form DOH-206 that was filed with the Bureau of EMS
• Your current EMS Operating Certificate

This documentation may be obtained through the Bureau of EMS Central Office at 518-402-0996, or through the Bureau of EMS [9].

1. Considerations Prior to Submitting an Initial Registration Appplication [10]
2. Considerations Before, During and After Testing [11]
3. Initial Registration Application [12]
4. Multi-network Registration Application [13]
5. Considerations for Rapid HIV Testing [14]
6. Considerations for Rapid Hepatitis C Testing [15]
7. Registration Application Reapplication [16]
8. Changing a Registration Certificate [17]

Amendments to Article 5, Title V Public Health Law effective August 7, 2008 Subsection 579 Scope and Exceptions and Subsection 580 Construction [18]

Article 5, Title V Public Health Law effective August 7, 2008, Subsection 579 Scope and Exceptions

• Follow the link [19], enter "579" in the search box and click "Public Health Law 579"

Standard Practices in Laboratory Medicine for Limited Service Laboratories [20]

Centers For Disease Control Publication “Good Laboratory Practices for Waived Testing Sites [21]”      

Search FDA Database for Approved Test Devices [22]       

Search FDA Database for IVD Over-The-Counter Lab Test Devices [23]     

NYS Department of Education Office of Professions [24]                  

NYS Department of Health AIDS Institute [25]           

NYS Department of Health Blood Lead Testing Information for Laboratories [26]  

NYS Department of Health Bureau of EMS [27]          

NYS Department of Health Hepatitis C Program [28]             

Physician Office Laboratory Evaluation Program [29]