What is a CLIA Certificate of Waiver?
Did you know there are a total of 260,000 laboratory entities that are CLIA certified in the U.S?
CLIA, an acronym for Clinical Laboratory Improvement Amendments, is a set of government-sanctioned regulations that are to be followed by every U.S. facility or site that tests human specimens for health assessment or to diagnose, prevent, or treat disease. By following these regulations and applying for a waiver, laboratories can become CLIA certified.
In 1988, the U.S Congress passed CLIA to introduce standardized testing measures in the healthcare sector. This was done to ensure that lab testing using human samples follows stringent quality standards to deliver safe results in which the diagnosis, prevention, and treatment of patients could then be assessed.
Whether it is an onsite lab or off-site testing facility, if testing involves human subjects/specimens, complying with CLIA standards is a must.
The CLIA program is governed by three federal agencies:
- The U.S Food and Drug Administration (FDA)
- Centers for Medicare & Medicaid Services (CMS)
- Centers for Disease Control and Prevention (CDC)
Applications requesting CLIA Waivers are reviewed by FDA, the certificate is issued by the CMS, and the CDC is responsible for managing the CLIA Committee (CLIAC).
The type/category (set by FDA) of the diagnostic tests is what determines the applicable CLIA certificate.
Here is the list of five different types of CLIA certificates that a laboratory can apply for, based on the complexity of the tests conducted:
- Certificate of Waiver (CW)
- Certificate for Provider Performed Microscopy Procedures (PPM)
- Certificate of Registration
- Certificate of Compliance
- Certificate of Accreditation
For a lab to be functional, it is mandatory to obtain a CLIA certification. However, there are certain labs where this licensing can be waived.
This article will review the Certificate of Waiver and will provide guidance on how to process its application.
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Certificate of CLIA Waiver Basics
A CLIA Waiver Certificate (CW) is legal proof that a particular testing laboratory performs only waived tests and is allowed to bypass certain CLIA regulations.
With a Certificate of CLIA Waiver, a lab is qualified to conduct waived laboratory tests. The validity of the certificate is two years.
This means the lab can only conduct simple testing that involves uncomplicated laboratory procedures and examinations. Tests other than waived tests cannot be performed.
Labs with a Certificate of Waiver still must meet the following requirements under CLIA:
- Enroll in the CLIA program
- Pay applicable certification fees biannually
- Follow the manufacturer’s instructions to conduct tests
To obtain a CLIA Certificate of Waiver, the lab must fill out and submit the CMS-116 Form on the U.S Department of Health and Human Services website or from your local State Agency.
What is a Waived Test?
Based on the complexity of the tests, CLIA tests are categorized into three levels: waived, moderate complexity, and high complexity tests.
CLIA defines waived tests as “Simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”
Laboratories with a Certificate of Waiver can perform waived tests. These are approved for a waiver under CLIA criteria.
Over 1,400 test systems have been waived as they meet the following requirements:
- Simple, non-technical methodology
- Negligible risk of error in results
- Pose no harm on the patient even if performed incorrectly
- Cleared/approved for home use by the FDA
An example of a waived test is the popular blood glucose testing device used to monitor blood glucose levels at home.
To access the full list of waived tests, visit the FDA website.
How CLIA differs from CAP
CAP is a type of accreditation, and CLIA is a certification; both are responsible for validating high lab testing standards.
The College of American Pathologists (CAP) is an accreditation organization with the authority to accredit laboratories performing tests on human beings and human specimens.
Under the CAP accreditation program, CAP inspection is performed in laboratories to ensure accurate test results, quality assurance, quality control, timeliness, and accurate patient diagnoses.
CLIA, on the other hand, is a set of guidelines, which are to be followed by any functional laboratory. CAP-accredited labs exceed CLIA requirements and assure the most comprehensive laboratory standards. To obtain CAP accreditation, compliance with CLIA standards is needed.
How to Obtain a CLIA Waiver
A step by step guide to preparing a CLIA application is as follows:
- Review the necessary guidelines
The first step is to know all the right guidelines that are to be followed and what you can expect. Begin by reviewing the official Regulations and Guidance, a document that provides a detailed view of the CLIA Waiver protocols, applications, and categorization procedures.
If you are a device manufacturer, then consider these respective CLIA Waiver application recommendations.
- Review your qualifications for a waiver
The next step is to check if your lab and respective personnel fulfill the waiver eligibility criteria. Verify your CLIA qualifications for the waiver before submitting your application.
The CDC has also set recommendations for Good Laboratory Practices for Waived Testing Sites.
- Consider submitting planned protocols through a pre-submission to receive FDA’s feedback early
If your lab is conducting a clinical study, the advantage is that there is room for a “Pre-submission.” A planned protocol or study design can be shared with the FDA for early feedback and can be used to later support your application for a certificate of waiver.
Follow these guidelines for more information.
- Assemble and review your application (CMS-116 from Centers for Medicare & Medicaid Services)
Once you’ve reviewed your qualifications, you can begin the CMS-116 application form. Download Form CMS-116 and review the detailed instructions on completion on Page 6.
You will be asked to fill in the following details:
- Basic laboratory information, including the mailing address
- Laboratory type
- Hours of laboratory testing
- An estimate of the number of waived tests performed annually
- Details of the individuals involved in laboratory tests, including the laboratory director and other personnel involved
- If there are multiple sites
Complete all the sections of the applications and review them carefully. Incomplete applications are rejected.
Use the Laboratory Quick Start Guide To CMS CLIA certification to learn more about the CLIA Waiver application.
- Submit your application
The final step is to send the CMS-116 form to the respective State Agency by mail or email. Make sure all the paperwork is in place, and all fields have been filled.
For in vitro diagnostic devices, applications will be reviewed by the FDA’s Center for Devices and Radiological Health (CDRH).
Once the basic requirements are met and CMS reviews and approve the application, a Certificate of Waiver will be issued. The certificate will include a ten-character alpha-numeric CLIA number. This identification number is unique for every submission and is used for tracking the laboratory.
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How Excedr Helps Labs Meet Their R&D Milestones
The CLIA program ensures quality lab testing in the U.S. For a hassle-free CLIA waiver application process, your lab setup should make sure to uphold high-quality standards and follow all the right guidelines—to accomplish that task more easily, your lab needs high-quality equipment.
However, if your business is operating on a tight budget, purchasing might not make sense financially. Dealing with lenders like a bank often means jumping through countless hoops, but Excedr’s flexible equipment lease program makes equipment procurement simpler. In fact, it’s an excellent, creative solution for both certified and non-certified (but soon to be) testing labs looking to outfit a new space or scale up its operations.
When you lease equipment with us, you can save money on upfront costs and reallocate those savings to other critical areas of business. Furthermore, your equipment is protected under a comprehensive service plan that includes repairs and preventative maintenance.
Reach out to us and learn more about how Excedr can help your lab perform at and uphold high-quality standards!