Frequently Asked Questions

The CLIA (Clinical Laboratory Improvement Amendments) 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. You are considered as having a laboratory or as a laboratory if you perform any testing as defined by CLIA.

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:
     • If clinical laboratory tests are performed.
     • If testing and billing for the test (e.g., Medicare, Medicaid, private insurance, or the patient).
     • If testing and not charging for the test.
     • If the facility performing the test is a "hospital within a hospital."
     • Performing grossing of a tissue specimen and reading of the smear.
     • Performing only tissue grossing, dissection, orientation, mapping, and inking.
     • Performing only the professional part (reading/examination of the tissue smear).
     • If the facility performs PAP smear screens.
 

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

• Any laboratory that only performs testing for forensic purposes and results are not released for patient treatment.
• Any facility that only performs pre-employment drug screens and results are NOT used to send an employee to a treatment program.
• Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of, the health of individual patients.
• Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) in which drug testing is performed that meets SAMHSA guidelines and regulations. However, a CLIA certificate is needed for all other testing conducted by a SAMHSA-certified laboratory.
 

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.

Yes. Illinois facilities must have a CLIA certificate and out-of-state facilities must be CLIA certified in their state. Follow the requirements listed under “Health Screening Events” that can be found on this website.

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.

No. Phlebotomists are not required to be licensed in 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 as established in writing by the facility medical director or completion of a training program by a certified training institution.

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.

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).

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

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:

     • Zoning, local and state of Illinois Clinical Laboratory and Blood Bank Act requirements as described under 210 ILCS 25/7-104 from Ch. 111 1/2, par. 627-104 Sec. 7-104.

     • Request for specimen collection must be from a licensed physician or one authorized by law. Refer to state act 210 ILCS 25/7-104 from Ch. 111 1/2, par. 627-104 Sec. 7-104.

     • The collection of specimens must be done by a technical personnel of a clinical laboratory or trained health professional employee (e.g., physician, phlebotomist, nurse, or other medical professional) may collect blood, or remove stomach contents, or collect material for smears and cultures, under the direction or upon the written request of a licensed physician or dentist.
 

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.

• Certificate of Waiver (COW): Issued to a laboratory that performs only CLIA waived tests.
• Certificate for Provider Performed Microscopy (PPM) Procedures: This type of certificate allows the facility to perform only CLIA waived and specific microscopy PPM tests.
• Certificate of Registration: Issued to allow the laboratory to perform CLIA waived, PPM, and non-waived (moderate or high complexity) testing until the laboratory is surveyed (inspected). Once the laboratory is inspected and found in compliance, a final certificate of compliance or accreditation is issued.
• Certificate of Compliance (COC): Issued once the laboratory is inspected and found in compliance. This type of certificate allows the laboratory to perform CLIA waived, PPM, and non-waived (moderate and/or high complexity) testing. (Inspection is conducted by the state CLIA program).
• Certificate of Accreditation (COA): Issued once the laboratory is inspected and found in compliance. This type of certificate allows the laboratory to perform CLIA waived, PPM, and non-waived (moderate and/or high complexity) testing. Inspection is conducted by the laboratory selected CMS approved accredited agency - AABB, AOA, ASHI, COLA, CAP, or JCAHO.
 

All types of certificates are effective for two years and renewable.

CLIA waived certificate = $180 (every two years)

CLIA PPM certificate = $240 (every two years)

CLIA compliance or accredited (every two years and fee is based on number of tests and specialties)

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 U.S. Food and Drug Administration (FDA).

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.”

• You may call the vendor of the test(s). The FDA provides that information to the vendors.
• You may visit the FDA website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm. The site will help determine the tests categorization as waived or non-waived (i.e., moderate or high complexity).
 

• Complete a CLIA application (Form CMS-116) available on this website under “Laboratory Certificate Application Process,” or by visiting the CMS CLIA website at https://www.cms.hhs.gov/clia.
• Completed forms can be submitted via email to DPH.CLIA@Illinois.gov, faxed to 217-782-0382, or mailed to IDPH CLIA Laboratory Certification Program, 525 W. Jefferson St., Fourth Floor, Springfield, IL 62761.
 

• Applications for certificates of CLIA waived only require the CMS-116 application; however, HOME HEALTH CARE facilities must include a copy of their Illinois Home Health Care License.
• For certificates of CLIA PPM, compliance, and accreditation, review the document “Laboratory Personnel Qualifications” located on this website under “Laboratory Certificate Application Process,” and include copies of the qualifying documents for the proposed laboratory director. Applications of this type will not be processed without these documents and your application process will be delayed.
 

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.

CLIA waived certificate allows the facility to perform only tests categorized as CLIA waived. CLIA PPM certificate allows the facility to perform CLIA waived and PPM tests.

CLIA certificate of compliance (COC) or accreditation (COA) allows the laboratory to perform CLIA waived, PPM, and non-waived (moderate and/or high complexity) tests.

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.

Applications can be mail to IDPH-CLIA Program, 525 W. Jefferson St., Fourth Floor, Springfield IL, 62761, or fax to 217-782-0382.  You may contact our office for assistance at 217-782-6747.

Once the application is received and processed (1 to 5 business days) you will be notified by mail. A fee coupon will be generated 1 to 2 weeks later by the federal program and sent to your designated mailing address. Once payment is received, a certificate will be sent (1 to 2 weeks). The application process takes an average of 4 to 6 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.

Payment by internet or credit card is only available for *renewal payments. Payments for new CLIA certificates can only be made by check or money order and sent by U.S. mail. (FedEx or UPS will not deliver to P.O. Box numbers). Once the certificate bill is received, mail your payment to the address on the bill.
 

CLIA Laboratory Program
P.O. Box 3056
Portland, OR 97208-3056
 

Write your CLIA identification number on the check or money order and include the billing coupon with your payment. Your assigned CLIA number can be found in the billing coupon.

Renewal billing coupons for CLIA certificates of wavier, PPM, and certificates of accreditation are automatically mailed at nine, six, and three 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:

     • Go to www.pay.gov.
     • On the left side of the home page, under Find Public Forms/Search Public Forms, type “CLIA” and click go.
     • Click on the link, CLIA Laboratory User Fees.
     • Fill out the form to pay your fee.
     • Print the confirmation that your payment has been sent and retain it for your records.
 

You may begin testing once you receive your CLIA certificate.

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. That 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 state CLIA program between 3 to 12 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.

Yes.  Certificates are issued per location.

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.

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.

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

CMS Exception 2:
     • Your facility must either be not for profit, or a federal, a state, or local government.
     • A not-for-profit federal 501(c) (3) tax determination letter must be included with your application.
     • You can only perform a total of 15 different tests (this can be all waived, moderate, or a combination of both).
     • All labs under the certificate may only perform tests within the 15 tests listed on the CMS-116 application.
 

Under CMS Exception 3 for hospitals: A single certificate to cover all of the hospital satellite laboratories may be issued, providing that 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.

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

Criteria: a) A shared laboratory is located in a common area. b) Two or more sole practicing physicians or group practices share the expenses necessary to operate the laboratory. c) 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. d) 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 site under “CLIA Certificate Change Requests.”

Multiple laboratories that do not use the same testing personnel may operate at the same physical location (e.g., same building or suite, as applicable) with separate CLIA numbers, as long as each laboratory can demonstrate the following:

     •  Each laboratory is responsible for complying with the applicable CLIA requirements.

     •  Each laboratory must operate as a separate and distinct entity.

     •  Each laboratory must have a unique name and CLIA certificate.

     •  Each laboratory must maintain entirely separate records and demonstrate independent operation.

     •  Each laboratory test reports must clearly identify the laboratory that performed the test.

     •  Each laboratory must develop policies to prevent proficiency testing (PT) sharing or information between labs.

     •  Each laboratory should enroll in a separate  PT program using different PT providers.
 

Multiple laboratories that operate at the same physical location and use the same testing personnel and equipment must meet the following conditions:

     •  All records (e.g., quality control, procedure manuals, personnel competency) must be kept separate and distinct for each laboratory and must clearly show each laboratory is operating independently.

     •  Each laboratory must have a unique name.

     •  The hours of operation must be specified, separate, and distinct for each laboratory.

     •  The times of testing cannot overlap and cannot be simultaneous.

     •  Each laboratory’s test reports must clearly identify the laboratory that performed the test.

     •  Each laboratory must develop policies to prevent PT sharing or information between labs.

     •  Each laboratory should enroll in a separate PT program using different PT providers.

Yes.  For all types of CLIA certification you must notify your state 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 changes in technical supervisor.

Yes.  You may use forms available on this site under “CLIA Certificate Change Requests.”

You may use forms available on this site under “CLIA Certificate Change Requests” and keep the same certificate.

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. Know that the new owners will be required to include a new CMS-116 application with their request.

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.

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

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 office at 217-782-6747. We will need to verify the cost of your bill. Once the cost of your renewal bill is determined, follow the steps below.

1. Payment can be sent via U.S. mail (NO FedEx or UPS). Mail a check or money order to: CLIA LABORATORY PROGRAM, P.O. BOX 3056, PORTLAND, OR 97208-3056.
2. With your payment, include the name and address of your facility, and write your CLIA number on the FACE of the 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 $180; PPM is $240.
3. Payments by credit card or internet can now be accepted by following these instructions:

• Go to www.pay.gov.
• On the left side of the home page, under Find Public Forms/Search Public Forms, type “CLIA” and click go.
  
• Click on the link, CLIA Laboratory User Fees.
  
• Fill out the form to pay your fee.
  
• Print confirmation that your payment has been sent and retain it for your records.
  

For instruction on how to reactivate an expired certificate, contact our office at 217-782-6747.

If the expired date is greater than six months, you will be required to submit a new CMS-116 to the Illinois CLIA Certification 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 2 to 3 weeks to your designated mailing address.

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

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 our office at 217-782-6747.

For CLIA waived and PPM, refunds are sent back automatically; however, it may take up to six months. For refunds on certificates of compliance or accredited, call our office at 217-782-6747.

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

Do not pay the bill. Contact our office by e-mail or U.S. Mail and provide an official termination date.

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

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