Introducing The Getting Started Series by SEKISUI Diagnostics

Welcome! In an ongoing effort to support both our current and prospective customers, we identified a need for information and education that can help those new to in-house testing get their point-of-care lab up and running. Thus, The Getting Started Series by SEKISUI Diagnostics, LLC, has been created. We invite you to follow along as we dive into some of the common questions and pain points customers have when getting started running point-of-care testing in their medical office practice. In this first chapter of the series, we’ll cover CLIA Waivers and CLIA Certificates. Let’s get into it!

What Is CLIA?

CLIA stands for The Clinical Laboratory Improvement Amendment, which began in the late 1960s, to create regulations and safety standards for U.S. laboratories. Today, it is a federal program that establishes quality standards to protect patient safety and improve healthcare for laboratory testing performed on humans. It regulates specific types of tests performed, who can perform them, training and education for personnel, quality control, and the timeliness and accuracy of test results. The Centers for Medicare & Medicaid Services (CMS) oversee it and use CLIA to determine a laboratory’s level of quality (1). As of March 2024, CMS reports a total of 317,545 labs in the U.S., with 122,451 being Physician Office Labs (POLs) (2).

There are three main CLIA testing categories: CLIA-waived tests, moderately complex tests, and high complexity tests. The testing method, technology, and skill level needed to interpret results will dictate which of the three categories a test falls under. CLIA testing categories are assigned to the test or instrument used for testing, based on who can run the test and interpret the results (3). A CLIA-waived test is simple to perform and carries a low risk of incorrect results. CLIA does not have specific personnel requirements for CLIA-waived tests, however, your state may have specific regulations that would also dictate personnel specifics for your in-house laboratory.

Before you can get started applying for your CLIA-waiver, first determine what tests you’ll be running in-house and the instrumentation or technologies you’ll utilize to perform those tests. Working with your manufacturer representative or a collaborative team of distribution and manufacturer reps can provide resources to help you identify which CLIA categories your chosen tests fall under, and the waiver or licensure requirements you’ll need to meet before you can begin testing.

How Do I Apply for a CLIA-waiver?

Once you have a clear idea of the types of tests you’ll be performing and the technologies you’ll utilize, you are ready to begin the process of obtaining the appropriate CLIA waiver or license. So, how do you do it? What are the steps? We’ve outlined the 4-step process of applying for a CLIA waiver below, with links to resources.

Step 1: Gather relevant information for your application

• Test Types: Create a clear, detailed list of the tests you will be running, for which you require the CLIA waiver
• Manufacturer Information: Include the names of the manufacturers for each test in your list. Request information on their guidelines for quality control and documentation for the tests you will be using.
• CPT Codes: Make sure you have the correct corresponding CPT codes for each of the tests you’ll be running in-house. These are important for your application and for future billings.

Pro Tip: Working with a manufacturer rep or a team that includes both distribution and manufacturer reps is beneficial here. Your rep(s) will often have access to a lot of the information you need here. Don’t hesitate to ask for help!

Step 2: Download relevant forms and information from the CMS website and your State Health Department website

• The CMS website is a great resource for finding the forms and information you need for this process. You can also use this direct link to download the CMS Form 116 for your application.
• Be sure to check your state’s health department website to confirm whether additional forms or requirements are necessary.

Step 3: Fill Out the Application

• Form CMS 116 is simple to fill out. In case of confusion, here are a few tips below.
  • Under ‘type of laboratory,’ you would select ‘certificate of waiver.’
  • The provider or practice owner would typically be listed under ‘lab director information.’
  • Be sure to include all the CLIA-waived tests you plan to perform with their corresponding CPT codes – remember that you can ask your sales rep(s) for assistance with those.

Step 4: Submit Your Application and Pay Required Fees

• The most straightforward step of all, now it’s time to submit your application with the required application fees.

Click here if you’d like to talk with a SEKISUI Diagnostics sales representative about our CLIA-waived point-of-care solutions

References

1. Center for Medicare & Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). Centers for Medicare & Medicaid Services. [Online] Centers for Medicare & Medicaid Services, January 2025. https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments.
2. Centers for Medicare & Medicaid Services. Division of Clinical Laboratory Improvement and Quality Centers for Medicare & Medicaid Services March 2024. s.l. : Centers for Medicare & Medicaid Services, 2024.
3. University of California San Francisco. Clinical Laboratory Testing. UCSF Clinical Research Resource HUB. [Online] 2020. https://hub.ucsf.edu/clinical-laboratory-testing.