how to apply for a clia certificate

For detailed information on all aspects of CLIA, please refer to the CLIA website

Q. How do I apply for a CLIA certificate?

  • Download the application and instructions from the CLIA website:
    • Go to the first option on the left side: "How to apply for a CLIA certificate, including Foreign Laboratories Program".
    • Mail completed application to: State of Delaware CLIA Program, Delaware Public Health Laboratory

Q. How do I determine what type of CLIA certificate to apply for?

  • This information can be found on the first page of instructions for completing the CLIA application form, CMS-116.

Q. How do I determine the test complexity of a particular test?

  • On the CLIA website, select the fifth option on the left side pick list: “Categorization of Tests”. Near the bottom of the page you will find “Related Links Outside CMS” which will link to “Test Complexity Database – All Complexities (FDA) Site.”

Q. Should I send a check with my CLIA application?

  • No. Bills are generated by a separate lockbox.

Q. After I submit a CLIA application, how long does it take to get the certificate?

  • A completed CLIA application is entered into a special data system. A lockbox generates a bill which you will receive within two to three weeks. Once your payment is received (you may send it overnight express), it will take another two to three weeks to receive your certificate. Total processing takes approximately four to six weeks.

Q. In what instances can I get a replacement certificate?

Replacement certificates may be obtained in the following instances:

  • Director change.
  • Facility name change.
  • Change in location and /or mailing address.
  • Certificate never arrived.
  • Certificate lost.
  • Note: All changes must be submitted in writing to the State of Delaware CLIA address above. Be sure to include your CLIA ID number.

Q. How long does it take to get a replacement certificate?

  • It takes approximately two to three weeks to receive a replacement certificate. After the Delaware State CLIA Surveyor receives your request, it is submitted to the Philadelphia Regional Office for processing.

Q. Medicare is denying my claim(s), stating I don’t have the correct CLIA certification. What should I do?

  • More often than not, this has nothing to do with the type of CLIA certificate you have. This problem usually occurs when there has been a change in the CPT code or if the CPT code needs a QW added to it. A current list of CPT codes can found on the main CLIA website (refer to first question). Go to the tenth option on the left side, pick list: “Categorization of Tests”. Then, go to “Downloads”.

Q. I am in the process of reviewing our protocol and wanted to ensure we are meeting the requirements set out by the State of Delaware. Our screenings involve a finger stick blood test (utilizing the Cholestech machine, a CLIA waived test), blood pressure and height/weight. We currently maintain our CLIA wavier; however I was writing to inquire if there is any other paperwork or procedures required within your State.

  • The State of Delaware only follows CLIA guidelines. There are no additional requirements unique to Delaware.

Q. How do I file a complaint?

A complaint may be submitted:

Q. What is the State of Delaware's policy on Direct Access Testing?

  • At this time, Delaware allows Direct Access Testing with no limitations; however, individual laboratories within the state may have their own restrictive guidelines.


Category: Insurance

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