CLIA Certification Information

CLIA Overview

All current FDA cleared ophthalmic diagnostic tests require CLIA certification to purchase, use and bill CMS for testing. CLIA point of care lab tests are classified as 1) Waived 2) Moderate Complexity 3) High Complexity.  All AXIM EYE diagnostic tests require a Moderate Complexity certification to purchase, conduct testing and bill CMS for testing.

AXIM employs a full-time CLIA expert that is available to all current or potential customers of AXIM Eye to assist with the application process or to address any questions – or the current CLIA application process is below.

CONTACT OUR CLIA EXPERT FOR ASSISTANCE WITH THE APPLICATION PROCESS

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CLIA Application Process

NOTE: In New York and California, only MDs & DOs currently meet the State Lab Director requirements needed for certification and operation of moderate complexity point-of-care lab tests; on their patients. Optometrists do not currently meet the requirements for performing moderate complexity tests in those states. In all other states, MDs, DOs and ODs (optometrists) may serve as Lab Directors. Additionally, ODs are waived from having to take the CLIA 20 CME course.

CLIA certificates for moderate complexity lab testing are called Certificates of Registration (COR). Each COR is good for two (2) years and costs $150, to cover Federal CLIA’s costs for issuing the certificate. This fee is paid to Federal CLIA once every two years.

The Complete CLIA Application Packet: The following is a list of all items that must be included in the CLIA Lab Director application. 

  • Form 116: completed and signed. The State of Washington is the only state that does not use the Form 116; rather, it uses the Accredited Medical Test Site License Application.
  • Copy of Diploma: MDs or DOs, and ODs where allowed
  • Copy of CV
  • Copy of State License, and
  • Copy of 20 CME course certificate for MDs & DOs, issued by course provider. (ODs do not have to take the 20 CME course; no certificate is required.

NOTE: Send NO money in the application packet. Within about six weeks following submission, Federal CLIA will send an invoice for the Federal Certificate Fee. This must be paid before CLIA will issue the clinic’s CLIA Provider Number. Once the CLIA number is issued, patient testing may begin.

Completing the Form 116:  

  • Section 1 – GENERAL INFORMATION:
  1. Check Initial Application if the clinic has NEVER held a CLIA certificate. 
  2. If clinic holds a CLIA “Waived” certificate, check Change in Certification Type. 
  3. Check Other only if a correction is being made to an existing certificate (name change, address change, etc.)
  4. If clinic currently hold a CLIA certificate, add their CLIA number. If they do not hold a certificate, leave blank.
  5. Facility Name: Add formal name of clinic (example: Evergreen Eye Center)
  6. Federal Tax ID Number: Obtain this number from clinic and insert.
  7. E-Mail Address: Fill in the address of the Lab Director
  8. Telephone & Fax Numbers: Fill in. 
  9. Facility Address: Insert name of Building (if any) as wells Suite number (if any)
  10. Mailing/Billing Address: Insert this if different from Facility address.
  11. Number, Street: Insert clinic street address (NO PO Boxes)
  12. City, State Zip: Fill in. 
  13. Name Of Director: Include FULL name of Lab Director. Make sure to include middle initial.
  • Section II – Type of Certificate Requested (see: CLIA vs. COLA Discussion)
  1. Check Certificate of Compliance if the clinic has elected to use the State Health Department to perform on-site inspection, once every two years.
  2. Check Certificate of Accreditation – COLA If the clinic has elected to use a private non-profit accreditation agency for their inspections.
  • Section III – TYPE OF LABORATORY
  1. Check Physician Office
  • Section IV – HOURS OF LABORATORY TESTING
  1. Fill in the normal clinic operating hours.
  • Section V – MULTIPLE SITES
  1. Check NO
  • Section VI – WAIVED TESTING
  1. Include those CLIA waives tests the clinic is currently performing, if any. If they are considering additional waived tests, consider adding the following tests: A1c (glucose), osmolarity, Adenovirus, MMP9
  • Sections VII – PPM TESTING
  1. Check NO.
  • VIII – NON-WAIVED TESTING
  1. Under the SPECIALTY/SUBSPECIALTY column, DIAGNOSTIC IMMUNOLOGY, check General Immunology. 
  2. Under the SPECIALTY/SUBSPECIALTY column, Chemistry, check Routine.
  3. Under the ACCREDITING ORGANIZATION column, insert COLA next to each test type ONLY if the clinic elects to use COLA for on-site inspections. If the elect not to use COLA, leave these boxes blank.
  4. Under the ANNUAL TEST VOLUME column, insert 750 in the boxes next to DIAGNOSATIC IMMUNOLOGY and CHEMISTRY.
  5. At the bottom of the extreme right column, under TOTAL ESTIMATED ANNUAL TEST VOLUME, insert the total number 1500.
  • Section IX – TYPE OF CONTROL
  1. Check 04 Proprietary
  • Section X – DIRECTOR AFFILIATION WITH OTHER LABORATORIES
  1. Leave section blank

Additional Information:

  • Clinics MUST apply for and receive individual CLIA certificates for each location. Multiple office locations must have multiple CLIA certificates, each requiring individual applications. In the case of multiple applications being submitted at the same time, one does not have to provide additional copies of the CVs, diplomas and licenses; just an additional Form 116 per additional location. 
  • Each Lab Director may supervise up to five (5) different locations.
  • Testing Personnel (Techs) must have a high school diploma or equivalent. 
  • Each MD/DO Lab Director will also serve as the Clinical Consultant, Technical Consultant and Testing personnel.

CLIA 20 CME Course Requirements – Discussion

Ophthalmologists (MDs & DOs) are required to sign up, take and pass an on-line 20 CME course BEFORE submitting their completed application packet to the State Department of Health. This course takes approximately 8 to 10 hours to complete online. There are several options for taking the course. These are: 

  1. COLA: This accrediting agency offers an on-line mechanism for taking the required course. It may be accessed at: labuniversity.org. Cost: $495
  2. University of Iowa: This online course is sponsored by the University of Iowa College of Medicine and may be accessed at: medicine.uiowa.edu/cme/clia; and costs $425.

All courses contain 20 individual educational modules. Each module carries 1.0 AMA Category 1 credit and MAY qualify toward meeting each physician’s annual CME licensing requirement

CLIA 20 CME Course Requirements – Discussion

Ophthalmologists (MDs & DOs) are required to sign up, take and pass an on-line 20 CME course BEFORE submitting their completed application packet to the State Department of Health. This course takes approximately 8 to 10 hours to complete online. There are several options for taking the course. These are: 

  1. COLA: This accrediting agency offers an on-line mechanism for taking the required course. It may be accessed at: labuniversity.org. Cost: $495
  2. University of Iowa: This online course is sponsored by the University of Iowa College of Medicine and may be accessed at: medicine.uiowa.edu/cme/clia; and costs $425.

All courses contain 20 individual educational modules. Each module carries 1.0 AMA Category 1 credit and MAY qualify toward meeting each physician’s annual CME licensing requirement

CLIA vs. COLA – Discussion

Each CLIA Lab Director applicant may select which method they prefer for the performance of the required on-site inspection; performed once every two years.

CLIA: Electing to use CLIA means the clinic elects to have a State Department of Health inspector perform the on-site inspection. This type of inspection is preferable if the clinic does not mind “government inspectors” performing this task. These inspections tend to be more focused on confirming regulatory compliance and enforcement as opposed to providing helpful guidance. 

If this method is selected, the Lab will be certified with a Certificate of Compliance (Form 116). Inspection fees are generally much less (varies by state) than COLA and only have to be paid AFTER the inspection. The initial inspection is generally scheduled within the first six months of lab certification and operation. 

COLA: Electing to use COLA means the clinic elects to have a non-profit private accrediting agency perform the on-site inspections. This type of inspection is preferable if the clinic prefers NOT to have government inspectors perform this task. Using COLA inspections generally involves a much higher level of initial and continuing compliance support, guidance and assistance. 

If COLA is selected, the Lab will be certified under a Certificate of Accreditation (Form 116). Inspection fees cost $1200 for each two year period and MUST be paid up-front, as part of the initial application. Once paid, COLA will issue a Letter of Enrollment that must be included in the initial application packet. The initial COLA inspection is generally scheduled within the first six months of lab certification and operation.