IOWA CLIA Laboratory Certification Program
CLIA and The State Hygienic Laboratory
In 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA), establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The federal law states any laboratory or facility that performs laboratory testing of human specimens for the purpose of providing information for the diagnosis, prevention or treatment of disease or impairment of, or the assessment of the health of, human beings is required to obtain a CLIA certificate and to meet certain requirements.
This rule applies whether or not the facility bills Medicare, Medicaid, private insurances, the patient, or provides the service at no charge. The type of CLIA certificate a laboratory must have depends on the type of testing the laboratory performs. The State Hygienic Laboratory (SHL) is under contract with the Iowa Department of Inspections and Appeals and the Centers for Medicare & Medicaid Services (CMS) to oversee the CLIA Laboratory Program for the State of Iowa. The Hygienic Laboratory administers the program and provides laboratory surveyors to conduct clinical laboratory inspections.
The CMS CLIA website has a wealth of information including CLIA educational brochures and the State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services.
What CLIA certificate types are available?
This certificate type is issued to laboratories in which only waived testing is performed. These tests are simple laboratory examinations and procedures that are so simple and accurate that the likelihood of erroneous results is negligible. The only requirement for waived testing is that the laboratory must follow the manufacturer's instructions exactly. It is recommended that each laboratory follow Good Laboratory Practice, which includes performance and documentation of training for each individual performing testing.
This certificate is issued to laboratories in which personnel qualified as a physician, midlevel practitioner or dentist perform one or more of the nine microscopy examinations designated as provider-performed microscopy procedures. PPM tests are considered moderately complex, therefore, the laboratory must comply with CLIA regulations for moderate complexity testing. This certificate also permits the laboratory to perform waived testing.
This certificate is initially issued to a new laboratory that has applied for a Certificate of Compliance or a Certificate of Accreditation. It permits the laboratory to perform moderate and/or high complexity testing until a survey is performed and the laboratory is found to be in compliance with the CLIA regulations or the accrediting organization’s requirements, as applicable. This certificate also permits the laboratory to perform PPM and/or waived testing.
This certificate is issued to laboratories in which a survey conducted by the CLIA State Agency (SA) determines that the laboratory is in compliance with all applicable CLIA requirements. Under this certificate type, the laboratory is permitted to perform moderate and/or high complexity testing, as well as PPM and waived testing. Routine surveys are conducted on a biannual basis.
This certificate is issued to laboratories in which a survey conducted by an Accreditation Organization (AO) of the laboratory’s choosing, determines that the laboratory is in compliance with all applicable AO requirements. The AO must be CMS approved and conducts biannual surveys (for an additional fee) instead of the CLIA SA. Under this certificate, the laboratory is permitted to perform moderate and/or high complexity testing, PPM, and waived testing.
How do I obtain a CLIA certificate?
Any laboratory wishing to apply for a CLIA certificate must complete the CMS-116 application. The Iowa State Agency requires the individual listed as the laboratory director to sign page 5 of the application. In addition, if applying for a certificate of provider perform microscopy, certificate of compliance or certificate of accreditation, the laboratory must also submit a copy of the laboratory director’s qualifications and current Iowa license (when applicable).
When applying for a CLIA certificate, what documentation is required to qualify the laboratory director?
When applying for a Certificate of Provider Performed Microscopy Procedures (PPM), a Certificate of Compliance, or a Certificate of Accreditation, the laboratory director must be qualified to oversee non-waived testing. The documentation required for director qualification is dependent on the type of certificate for which the laboratory applies:
|
Certificate Type |
Qualification Requirements |
|
Waiver |
No additional documentation required |
|
PPMP |
A copy of the current IA state license A copy of the medical diploma/transcript: MD, DO, midlevel practitioner, or dentist. *(Diploma or transcript from an accredited institution) |
|
Compliance, Accreditation |
For a more detailed list consult §493.1405 of the Code of Federal Regulations For a laboratory performing high complexity testing:
For more detailed list consult §493.1443 of the Code of Federal Regulations
|
*Individuals who have degrees from foreign schools must have an evaluation of their credentials to determine the equivalency of their education to an education obtained in the United States.
Application Submission
Completed forms may be sent or emailed to:
Iowa CLIA Laboratory Program
State Hygienic Laboratory
UI Research Park
2490 Crosspark Road
Coralville, IA 52241-4721
Email: shl-clia@uiowa.edu
The Iowa State Agency will process all CLIA applications upon receipt. Once the application is processed, a fee coupon will be generated and sent to the laboratory. After payment is posted to the laboratory’s account, the new certificate will be printed and mailed. The entire process will take between 6 – 8 weeks. CLIA certificates and fee coupons are generated and mailed from the U.S. Department of Health & Human Services in Baltimore, MD.
- Certificate of Waiver = $240 every two years
- Certificate of Provider Performed Microscopy = $296 every two years
- Certificate of Registration = $123 one-time fee
- Certificate of Compliance and Certificate of Accreditation = fees are specific to the State of Iowa and are based upon the number of specialties and volume of testing performed by the laboratory. Contact the Iowa State Agency for a current fee schedule.
Effective 01/27/2024, the CLIA program implemented additional fees for replacement and revised certificates.
Replacement certificates: If a laboratory loses its certificate or it is destroyed and the laboratory requests a replacement certificate (with no changes to the certificate type or demographic information), a replacement certificate fee will be charged.
Revised certificates: If a facility changes demographic information such as a facility name, address, or laboratory director AND they request a new certificate be printed documenting the new information, the facility will be charged a revised certificate fee.
Certificate Type | Cost of Replacement Certificate | Cost of Revised Certificate |
Certificate of Waiver | $75 | $95 |
Certificate of Provider Performed Microscopy | $75 | $150 |
Certificate of Registration | $75 | $150 |
Certificate of Accreditation | $75 | $95 |
Certificate of Compliance | $75 | $150 |
The facility should not send payment with the application. The CLIA program is a Federal program and all payments must be submitted to the Federal Lockbox and not to the State Agency.
The CLIA program accepts check and credit card payments. Credit cards are the preferred and quickest payment option. If submitting payment by credit card, go to the website: Pay.gov - Home.
If submitting payment by check, please include the CLIA number of the facility on the check. Submit payment to:
CLIA Laboratory Program
PO Box 3056
Portland, OR 97208-3056
CMS – Paperless Option
CMS now offers a paperless option. To opt into the paperless option, email the Iowa State Agency at shl-clia@uiowa.edu with the laboratory’s CLIA number and email address to which CLIA fees and certificates should be delivered. CMS encourages the use of a business email address or one to which multiple staff have access. When your laboratory opts into the paperless option, you get:
· Email notifications from CMS
· Electronic fee coupons (no longer paper coupons)
· Your CLIA certificate sooner. No need to wait for it to come in the mail
How do I get a replacement or revised certificate?
Requests for replacement or revised certificates must be submitted in writing to the Iowa State Agency by postal mail or email at the following:
Iowa CLIA Laboratory Program
State Hygienic Laboratory
UI Research Park
2490 Crosspark Road
Coralville, IA 52241-4721
Email: shl-clia@uiowa.edu
Need a copy of your CLIA certificate?
All CLIA certificates printed after 3/29/2024 will be posted to the CMS QCOR Website. On the left side of the Home page, click on CLIA Laboratory Lookup. Enter the facility’s CLIA number and click search. In the next screen, click on the name of your facility and a gray box will appear. Within the gray box is a certificate URL link. Click on the link, and it will display the most recent CLIA certificate. Note: If any changes have been made to the CLIA certificate since it was printed, the certificate WILL NOT display the updated information. For a CLIA certificate that has the most up to date information, the laboratory will need to request a revised certificate and pay an additional fee.
How do I make demographic changes to a CLIA certificate?
All demographic changes (name of facility, address, phone number, etc.) must be submitted in writing. Include the CLIA number of the facility and the information needing updated. Written notification can be emailed or sent to:
Iowa CLIA Laboratory Program
State Hygienic Laboratory
UI Research Park
2490 Crosspark Road
Coralville, IA 52241-4721
Email: shl-clia@uiowa.edu
What is the process for renewing a CLIA certificate?
CLIA certificates are renewed automatically. For Certificates of Waiver, Provider Performed Microscopy and Accreditation, the renewal fees are mailed six months prior to the expiration date of the certificate. Once payment is posted, the new certificate will arrive 2-3 weeks prior to the current certificate’s expiration date.
For Certificates of Compliance, one year prior to the expiration date, the laboratory will receive a compliance (survey) fee. Once payment is posted for the compliance fee, the laboratory will receive a Pre-survey packet to be completed and the survey will be scheduled 6 – 9 months prior to the expiration date of the current CLIA certificate. After the survey is completed and the laboratory submits an acceptable plan of correction/allegation of compliance (if applicable), the laboratory will receive a certificate fee. Once payment for the certificate fee is posted, the new certificate will arrive 2-3 weeks prior to the current certificate’s expiration date.
CLIA Fee coupons are generated and mailed from the U.S. Department of Health & Human Services in Baltimore, MD.
What forms must be completed for a change in ownership?
In order to make a change in ownership for a facility located in Iowa, the laboratory must complete and return the CMS-116 application form and a Change in Ownership form. The Change in Ownership form varies from State to State. To request a Change in Ownership form for Iowa, please email our office at shl-clia@uiowa.edu. Once the forms are completed, they can be emailed to shl-clia@uiowa.edu. If you would like to make a change in ownership for a laboratory outside of Iowa, please contact your state agency.
How do I update the laboratory director on a CLIA certificate?
Certificate of Waiver: All laboratory director changes must be submitted in writing, include the CLIA number of the facility and the name of the new laboratory director.
Certificate of Provider Performed Microscopy: The laboratory must complete the Form: CMS-116 Application AND send a copy of the new laboratory director’s medical diploma and current Iowa license.
Certificate of Accreditation: The laboratory must submit laboratory director changes to their accrediting organization.
Certificate of Compliance: The laboratory must complete the Form: CMS-116 Application AND send a copy of the new laboratory director’s qualifications: diploma, current Iowa license (when applicable), and 20 CME course (for MD/DO).
How do I terminate a CLIA certificate for a laboratory that is no longer performing testing?
Requests to terminate CLIA certificates must be submitted in writing to the Iowa CLIA State Agency. The following must be included in the request:
- CLIA ID number
- Laboratory name
- Reason for termination
- Effective date of termination
Completed requests can be emailed or sent to:
Iowa CLIA Laboratory Program
State Hygienic Laboratory
UI Research Park
2490 Crosspark Road
Coralville, IA 52241-4721
Email: shl-clia@uiowa.edu
Is a CLIA certificate required for a laboratory that collects specimens, but sends them to another for testing?
A CLIA certificate is not required if the facility is only collecting specimens. It is also not required for immunizations, PPD (skin tuberculin) or breath alcohol testing (BAT).
CDC Resources
CDC Ready, Set, Test-This educational booklet was developed by the Centers for Disease Control (CDC) to provide information and example logs for waived testing; it is written for laboratories that hold a CLIA Certificate of Waiver. https://www.cdc.gov/lab-quality/docs/waived-tests/ReadySetTest_2024_Final.pdf
For additional educational materials regarding waived testing, visit the CDC’s Waived Tests Homepage. https://www.cdc.gov/lab-quality/php/waived-tests/index.html
CDC Provider Performed Microscopy Procedures - This educational booklet was developed by the CDC to provide information and example logs for PPM testing; it is written for laboratories that hold a CLIA Certificate of Provider Performed Microscopy. https://www.cdc.gov/lab-quality/docs/PMP_Booklet_7252019.pdf
For additional educational materials regarding PPM testing, visit the CDC’s Performed Microscopy Procedures Homepage. https://www.cdc.gov/lab-quality/php/ppmp/index.html.
CLIA Corner Newsletter
The State Hygienic Lab's CLIA Corner is a quarterly publication that covers topical news and subjects for the clinical laboratory. It can be a beneficial tool used to assess the laboratory’s compliance with the CLIA regulations and to ensure the laboratory is providing accurate and reliable test results. For additional information about the CLIA Laboratory program, go to www.cms.gov/CLIA
CLIA Corner Fourth Quarter 2024: Proficiency Testing (PT) Corrective Action: when is it necessary and what is required?; The Iowa CLIA Program has a new website
CLIA Corner Third Quarter 2024: Personnel competency assessment policies; Procedure manual requirements; and BD BACTECTM Blood Culture bottle shortage.
CLIA Corner Second Quarter 2024: CMS-3355-F Final Rule: Proficiency Testing Changes
CLIA Corner First Quarter 2024: Increase in CLIA fees; Explanation of the CLIA fee process; and Option to receive electronic certificates and certificate fees.
CLIA Corner Third Quarter 2023: The Public Health Emergency for COVID has ended- what does that mean for laboratory testing?
CLIA Corner Second Quarter 2023: Requirements for non-waived, non-manual coagulation test systems
CLIA Corner First Quarter 2023: General CLIA information: Types of CLIA certificates, applying for a certificate, making changes to certificates, fees associated with CLIA, renewal process for certificates, and terminating CLIA certificates.
CLIA Corner Fourth Quarter 2022: Quality Control (QC) Requirements for Non-waived Test Systems