ILLINOIS DEPARTMENT OF PUBLIC HEALTH

Bruce Rauner, Governor

CLIA Clinical Laboratory Improvement Amendments
Lab Worker

Frequently Asked Questions

What is a laboratory?

The CLIA definition of a laboratory is a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings. If you perform any testing as defined by CLIA, you are considered as having a laboratory or as a laboratory.

Who needs a CLIA certificate?

If a facility performs tests on materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings, you must apply for a CLIA certificate that corresponds to the complexity of tests performed.

The following are some examples that require a CLIA certificate:

I only perform medical procedures. Do I need a CLIA certificate?

No. Medical procedures that involve incisions with instruments performed to repair damage or arrest disease in a living body does not require a CLIA laboratory certificate.

What type of laboratory testing does NOT require a CLIA certificate?

Do I need a CLIA certificate to perform pre-employment drug screens?

If you are only doing pre-employment drug screens tests and test results are not used to send the employee to a treatment program, a CLIA certificate is not required.

Do I need a CLIA certificate to conduct health screening events?

Yes. Illinois facilities must have a CLIA certificate and out-of-state facilities must be CLIA certified in their state. Follow the requirements listed in this "Health Screening Event Requirements and Approval Request" document.

If home health agencies assist patients in their homes to self test, do they need a CLIA certificate?

No. If the nurse or employee only assists the patients and provides the patients self testing result to the doctor, a certificate is not required. If the nurse or employee conducts the test, a certificate is required.

Is a phlebotomist required to have a CLIA certificate and license in the state of Illinois?

No. Phlebotomists are not required to be licensed in the state of Illinois or have a CLIA certificate to draw blood samples; however, a phlebotomist must have a high school diploma or higher education with documentation that the individual has completed a training program for proper patient care in blood drawing. Training must be established in writing by the facility medical director or completion of a training program by a certified training institution.

Do I need to have a CLIA certificate to send clinical samples to other state(s) for testing?

No, but samples can only be sent to a CLIA or state certified laboratory that is in good standing and with a current laboratory certificate.

I am an out of state laboratory. Do I need an Illinois CLIA laboratory certificate or permit to receive and test specimens in my state?

No. The requirements are for your facility to be CLIA certified and in good standing; however, you must provide instructions for specimen collection, processing and a copy of your CLIA certificate to the submitter(s).

We only draw blood samples that are sent to a lab for testing. Do we need a CLIA certificate?

If laboratory tests are NOT performed, a CLIA certificate is not required.

Are specimen collection sites allowed in the state of Illinois, and do they need a CLIA certificate?

Independent collections sites do not require a CLIA certificate; however, before establishing any collection site for the sole purpose of collecting samples intended for laboratory testing by a CLIA certified laboratory, the facility must meet the following requirements:

I do not bill Medicare or Medicaid for laboratory tests. Do I need a CLIA certificate?

If you perform any category of laboratory tests, such as CLIA Waived, PPM (Provider Performed Microscopy) or non-waived (moderate or high complexity), you are required to have a CLIA certificate. Billing has nothing to do with whether or not you need a CLIA certificate.

What certificate types are available?

What is the cost for a CLIA certificate? How long are they effective?

All types of certificates are effective for two years and renewable. CLIA waived certificate is $150 (every two years), CLIA PPM certificate is $200 (every two years), and CLIA compliance or accredited (every two years and fee is based on number of tests and specialties).

What is a CLIA waived test? A PPM test? And a non-waived test?

CLIA waived tests are categorized as "simple laboratory examinations and procedures that have an insignificant risk of an erroneous result."

A PPM test is a microscopy examination in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during the course of a patient's visit. These tests are categorized as moderate complexity.

A non-waived test is a laboratory test procedure that can be either moderate and/or high complexity. The test complexity is determined by the Food and Drug Administration (FDA).

Where can I find a list of CLIA waived, PPM and non-waived tests?

The most current lists can be found by visiting the CMS CLIA website at www.cms.hhs.gov/clia or you may review the temporary lists posted on this website under "Medicare CPT Codes."

How can I find if a test is moderate, high complexity, waived or non-waived?

How do I apply for a CLIA certificate?

What additional documents are required for a Certificate of CLIA waived, PPM, compliance and accreditation?

Where can I find information about CLIA laboratory personnel qualifications?

Information can be found on this website under "Laboratory Certificate Application Process," "Laboratory Personnel Qualifications" or by visiting the CMS CLIA website at www.cms.hhs.gov/clia.

What type of tests can I perform under each type of laboratory certificate?

Where do I find the CMS-116 form?

The CLIA application (Form CMS-116) is available on this website under "Laboratory Certificate Application Process," or by visiting the CMS CLIA website at www.cms.hhs.gov/clia.

Where do I mail the application?

Applications can be mailed to IDPH CLIA Program, 525 W. Jefferson St., Fourth Floor, Springfield IL, 62761 or fax to 217-782-0382; or you may contact the IDPH CLIA Program for assistance at 217-782-6747.

How long does it take to get my CLIA certificate?

Once the application is received and processed (one to five business days), you will be notified by mail. One to two weeks later, a fee coupon will be generated by the federal program and sent to your designated mailing address. Once payment is received, a certificate will be sent (one to two weeks). The application process takes an average of four to six weeks.

NOTE: If your application is for a CLIA certificate of compliance or accreditation, you will receive a certificate of registration. This type of certificate is temporary; however, once you are inspected and found in compliance, a new bill will be sent to your facility and, once paid, a new certificate will be issued.

Can I pay the certificate fee by phone or credit card? And where do I send the payment?

Payment by Internet or credit card requires a CMS-issued CLIA number. New applicants must wait until you receive your user fee invoice from CMS; your CLIA number will be on the invoice. Payments by credit card or Internet can be accepted by following these instructions:

If you wish to pay by mail, follow the instructions on the fee coupon attached to the invoice you receive from CMS. Write your CLIA number on the FACE of the check, as stubs may become detached during processing.

When can I begin testing?

You may begin testing once you receive your CLIA certificate.

Will my laboratory receive a survey inspection?

If your application is for a CLIA certificate of compliance or accreditation, you will be inspected. First, you will receive a temporary certificate of registration and should begin testing once received, which will allow you to establish your laboratory records that will be reviewed during the inspection. If you applied for a certificate of compliance, you will be inspected by the CLIA Program in between three to twelve months. If you applied for a certificate of accreditation, you will be inspected by the accredited agency at their discretion and before your certificate of registration expiration date. Once you are inspected and found in compliance, a new bill will be sent to your facility and, once paid, a new CLIA certificate of compliance or accreditation will be issued.

If I have more than one laboratory at different addresses, do I need a CLIA certificate for each location?

Yes, certificates are issued per location.

Is it possible to have one CLIA certificate and perform temporary testing at different locations?

If you meet the CMS exception 1, you may request an endorsement for temporary testing in your certificate.

CMS Exception 1: Laboratories that are not at a fixed location, that is, laboratories that move from testing site to testing site, such as mobile units providing laboratory testing, health screening fairs or other temporary testing locations may be covered under the certificate of the designated primary site or home base, using its address.

We are a home health agency that employs 15 nurses that will perform waived testing in patients' homes. What type of certificate is required?

Your facility meets CMS – Exception 1 and can be issued a single certificate of waiver. You may request that by completing a new CMS-116 application that can be found on this website. The home base for your certificate will be the address where your agency is located and the patients' homes will be considered as the temporary testing sites.

We are not-for-profit. Can we have multiple laboratory locations under the same CLIA Certificate?

If you meet the not-for-profit CMS exception, you may register all your laboratories under one certificate.

CMS Exception 2:

We are a university with hospital. Can we have multiple laboratories under the same CLIA certificate?

Under CMS Exception 3 for hospitals: A single certificate to cover all of the hospital satellite laboratories may be issued, providing that all of the satellite labs are located at contiguous buildings on the same campus or within the same physical location or street address as the hospital and are under the same laboratory director, OR a separate certificate may be issued for each of the satellite laboratories based on the type of testing performed. The hospital exception stands alone and cannot be mixed or combined with other CMS exceptions.

Can I share my CLIA certificate and laboratory with other physicians practicing in the same location?

If you meet the following criteria, you may share your certificate and lab:

  1. A shared laboratory is located in a common area.
  2. Two or more sole practicing physicians or group practices share the expenses necessary to operate the laboratory.
  3. Laboratory testing in a shared laboratory is directed by one qualified individual who is responsible for the overall operation, quality assurance and administration of the laboratory.
  4. Independent practices sharing the certificate can ONLY perform the test complexity or category allowed under the shared laboratory CLIA certificate.

Facilities performing tests at a different location and not in the shared laboratory testing area will require their own CLIA certificate. To declare your certificate as shared, you may use forms available on this website under "CLIA Certificate Change Requests."

Is it possible to have two CLIA certificates in the same testing location?

If the following conditions are met, two entities may operate in the same site with separate CLIA numbers:

Do I need to notify the CLIA program if I make any changes in my laboratory?

Yes. For all types of CLIA certification you must notify the CLIA Program or your accredited organization within 30 days of any changes in ownership, name, location and director. In addition, laboratories performing high complexity testing are required to report any changes in technical supervisor.

If I make any changes in my test menu, do I need to notify the state CLIA program?

Yes. You may use forms available on this website under "CLIA Certificate Change Requests."

We have a new lab director and are moving to a new location. Do I need to apply for a new certificate?

You may use forms available on this website under "CLIA Certificate Change Requests" and keep the same certificate.

I sold my practice. Can I transfer my CLIA certificate to the new owners?

Yes. The new owners can request a transfer by completing a "Disclosure or Change of Ownership" found under "CLIA Certificate Change Requests" on this website. New owners will be required to include a new CMS-116 application with their request.

I would like to request a change in certificate type. How can I do that?

For changes of CLIA waived and PPM certificates to that of compliance or accredited, submit a new CMS-116 application and include the lab director qualifying documents. Note that if you are requesting a certificate change to that of accreditation, you will be required to first be accepted by your selected accredited agency before submitting any CMS-116 application. If your certificate change is from compliance or accreditation to a CLIA waived or PPM certificate, you may use available forms on this website under "CLIA Certificate Change Requests" or submit a new CMS-116 application.

I am no longer performing laboratory testing. How can I cancel my certificate?

You may cancel your certificate by sending a written signed notification to the IDPH CLIA Program. Once your request is received, an acknowledgment letter or e-mail will be sent from the IDPH CLIA Program.

How do I renew my CLIA certificate?

Renewal billing coupons for CLIA certificates of wavier, PPM and certificates of accreditation are automatically mailed out beginning six months prior to the current certificate expiration date. Fee coupons for CLIA certificate of compliance renewals are mailed 12 months prior to the current certificate expiration date. You may send your renewal payment by mail or pay online by following the instructions below:

I lost my renewal bill and my CLIA certificate is about to expire. How can I send the payment?

For CLIA waived and PPM certificates, you may renew your certificate by following the instructions below. If you have a certificate of compliance or accreditation, call the IDPH CLIA Program at 217-782-6747. The IDPH CLIA Program will need to verify the cost of your bill. Once the cost of your renewal bill is disclosed, follow the steps below.

  1. Payment can be sent via U.S. Postal Service (NO FedEx or UPS). Mail a check or money order to:

    CLIA Laboratory Program
    P.O. Box 530882
    Atlanta, GA 30353-0882

  2. With your payment, include the name and address of your facility, and write your CLIA number on the FACE of check or money order, as stubs may become detached during processing. If possible, include a copy of the old CLIA certificate. CLIA waived fee is $150, PPM is $200.
  3. Payments by credit card or Internet can now be accepted by following these instructions:
    • Go to www.pay.gov.
    • In the search engine on the Pay.gov page, type “CLIA” and click Search.
    • Under “CLIA Laboratory User Fees,” click Continue to the Form.
    • Follow the steps listed to pay your fee.
    • Print your confirmation that payment has been sent and retain it for your records.

I forgot to renew my certificate and now it has expired. Can I still pay and reactivate my certificate?

You may reactivate your certificate if it is within six months of the expired date by following the instructions below:

  1. Payment can be sent via U.S. Postal Service (NO FedEx or UPS). Mail a check or money order to:

    CLIA Laboratory Program
    P.O. Box 530882
    Atlanta, GA 30353-0882

  2. With your payment, include the name and address of your facility, and write your CLIA number on the FACE of check or money order, as stubs may become detached during processing. If possible, include a copy of the old CLIA certificate. CLIA waived fee is $150, PPM is $200. If you have a certificate of compliance or accreditation, call the IDPH CLIA Program at 217-782-6747. The IDPH CLIA Program will need to verify the cost of your bill.
  3. Payments by credit card or Internet can now be accepted by following these instructions:
    • Go to www.pay.gov.
    • In the search engine on the Pay.gov page, type “CLIA” and click Search.
    • Under “CLIA Laboratory User Fees,” click Continue to the Form.
    • Follow the steps listed to pay your fee.
    • Print your confirmation that payment has been sent and retain it for your records.

My certificate expired more than six months ago. How can I reactivate my certificate?

If the expired date is greater than six months, you will be required to submit a new CMS-116 to the Illinois CLIA Program. You may request reactivation by selecting the box marked "Other" at the top of page and specify "certificate reactivation." Once your request is processed, a new bill will be sent within two to three weeks to your designated mailing address.

I already paid for the renewal of my certificate. When can I expect the new CLIA Certificate?

New certificates are mailed out approximately two weeks before the expiration date on the old certificate.

I have already sent my payment. Why am I getting another bill?

On occasion checks or money orders are lost or misplaced. Check with your bank to see if your check has been cashed. If cashed, ignore the bill; however, if not, call the IDPH CLIA Program at 217-782-6747.

I sent two renewal payments by mistake. How can I ask for a refund?

For CLIA waived and PPM, refunds are returned automatically; however, it may take up to six months. For refunds on certificates of compliance or accredited, call the IDPH CLIA Program at 217-782-6747.

I no longer need my CLIA certificate. Can I cancel the certificate and request a refund?

Unfortunately, there are no refunds, even if the certificate was never used.

Our laboratory is closing and I received a renewal bill. Do I need to pay?

Do not pay the bill. Contact the IDPH CLIA Program by e-mail or mail and provide an official termination date.

My certificate is current, but I received a notice from Medicaid that it is about to expire in 30 days. Why?

Normally Medicaid updates records monthly; however, on occasions updates are delayed. Make a copy of your current up-to-date CLIA certificate, and mail or fax to Medicaid with a copy of the Medicaid notice.

I need to change my Tax ID on the CLIA certificate. How can I do that?

You can change your Tax ID by completing a "Disclosure or Change in Ownership" form that can be found in this website under "CLIA Certificate Change Requests."

525 W. Jefferson St., Fourth Floor • Springfield, IL 62761 • Phone (217) 782-6747 • Fax: (217) 782-0382

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