How to Apply for a Certificate of Waiver.

PART I: GENERAL INFORMATION For a new application, leave the CLIA identification
number blank. The number will be assigned when the application is processed. Be
specific when indicating the name of your facility, particularly when it is a component of a
larger entity, for example The Diabetes Clinic in XYZ Hospital. For a physician’s office, you
can use the name of the physician. The information provided is the name that will appear
on your certificate. The Director should be the individual who is responsible for testing
operations.

Facility street address must be the actual physical location where testing is performed,
including floor, suite and/ or room, if applicable. DO NOT USE A POST OFFICE BOX
NUMBER OR A MAIL DROP ADDRESS FOR THE NUMBER AND STREET OF THE
ADDRESS. If the laboratory has a separate mailing or billing address, complete that
section of the application.

PART II: TYPE OF CERTIFICATE REQUESTED: Check “Certificate of Waiver”

PART III: TYPE OF LABORATORY: Select the type of laboratory designation that is most
appropriate for your facility from the list provided. If you cannot find your designation within
the list, contact your State agency for assistance.

PART IV: HOURS OF LABORATORY TESTING: Provide only the times when actual
laboratory testing is performed in your facility.

PART V: MULTIPLE SITES: Only hospitals or government labs are allowed to have
multiple sites. You can only qualify for the multiple site provision (more than one site under
one certificate) if you meet one of the CLIA regulatory exceptions outlined on the form. In
general, each testing site must have an individual Certificate of Waiver unless it is a mobile
lab or all are located on the same hospital campus.

PART VI: WAIVED TESTING: Indicate the total annual volume of waived tests you perform.
If you are not currently performing any tests, estimate the number you will perform during
the coming 12 months.

PART VII: NONWAIVED TESTING: Leave blank

PART VIII: TYPE OF CONTROL: Control means “ownership” in most cases. Select the
code which most appropriately describes your facility. Proprietary/for profit entities must
choose “04”.

PART VIX: DIRECTOR AFFLIIATION WITH OTHER LABORATORIES: List all other
facilities for which the director is responsible.

PART X. INDIVIDUALS INVOLVED IN LABORATORY TESTING: Complete part A only.
Enter the total number of individuals who perform waived tests. Do not count individuals
who only collect specimens or perform clerical duties.

Once the completed FORM HCFA-116 has been returned to the applicable State agency
and processed, a fee remittance coupon will be issued. The fee remittance coupon will
indicate your CLIA identification number and the amount due for the certificate ($150 for a
Certificate of Waiver). The CLIA identification number must be included on all Medicare
claims you submit for waived tests. If you need additional information concerning CLIA, or
completion the form, contact your State agency.