Complete the form below and return by mail only with $200 application fee.

Initial Limited Service Laboratory Registration Application DOH-4081_[1]

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.  Registrants may only perform the tests listed on the registration certificate issued by the Department. Certificates are valid for two years from the date issued.

MULTI-SITE REGISTRATIONS: Government owned laboratories or sites operated under the same not-for profit corporation may file for a multi-site registration. 

• To initiate a multi-site registration, please complete the Initial Limited Service Laboratory Registration Application form for the primary site and a Limited Service Laboratory Multi-Site Application form for each secondary site.
• If adding a secondary site to an existing CLIA registration number, complete Limited Service Laboratory Multi-site Application.

Limited Service Laboratory Multi-Site Application_[2]

Registration certificates for all locations in the network will be sent to the Primary Site location. 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 DOH-4236(b)_[3]
• Change in Laboratory Owner Information_[4]
• Change in Laboratory Location_[5]
• Add and/or Delete Test Procedures Form_[6]
• Change in Laboratory Name_[7]

Be aware that completed change forms and any accompanying documentation may be returned BY ONE METHOD ONLY, via fax or email, with a high quality scan via email being the preferred method.  The submission of duplicate 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.

Amended registration certificates will be issued/mailed on the effective date of the change.

Test additions and deletions do not go in effect until an amended certificate has been issued demonstrating the requested change.

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

Renewal registration certificates will be mailed approximately two weeks prior to the current certificate expiration date.

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. 
• 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_[8].

1. Considerations Prior to Submitting an Initial Registration Application_[9]
2. Considerations Before, During and After Testing_[10]
3. Initial Registration Application_[11]
4. Multi-network Registration Application_[12]
5. Considerations for Rapid HIV Testing_[13]
6. Considerations for Rapid Hepatitis C Testing_[14]
7. Registration Application Reapplication_[15]
8. Changing a Registration Certificate_[16]

Standard Practices in Laboratory Medicine for Limited Service Laboratories_[17]

Centers For Disease Control Publication “Good Laboratory Practices for Waived Testing Sites_[18]”      

Amendments to Article 5, Title V Public Health Law effective August 7, 2008 Subsection 579 Scope and Exceptions and Subsection 580 Construction_[19]

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

• Follow the link_[20], enter "579" in the search box and click "Public Health Law 579"

• Search FDA Database for Approved Test Devices_[21]       
• Search FDA Database for IVD Over-The-Counter Lab Test Devices_[22]   
• Search FDA Database for COVID-19 EUA 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]  
• NYS Office of Alcoholism and Substance Abuse Services_[30]