Quality America - We Make Compliance Easy!  
Home > Distributor Program > Helpful Articles

Distribution Information

Distribution Application

Contact Information

Product List

Helpful Articles

CLIA-Waived Tests Make For Smart Selling
By Dr. Sheila Dunn

Lab tests (kits, strips, and small-ticket instruments) represent a huge segment of high profit business for medical supply distributors who focus in this area. Because they're relatively small-ticket items, they're easy to sell initially, and the inevitable reorders become the bread-and-butter items that make up a big portion of your monthly GP. As an added bonus, they're not often the focus of price squabbles, like table paper and tongue blades, so you can often maintain a good GP on them.

Who To Target

Over 105,000 practicing physicians in the U.S. perform office-based lab testing, so waived tests can be sold to almost every primary care account–even prisons and schools! In addition, better than one in three patient visits to primary care practitioners involve laboratory tests. Group practices perform more testing than solo practices, of course. Specialties to target include large family, pediatric and internal medicine practices–the bigger, the better.

Uncle Sam often adds to the waived test list, so selling opportunities are ongoing. Two sure bets are:

·         Introducing accounts to newly waived products

·         Converting moderately-complex products to their waived counterparts

How To Sell Them

Selling CLIA-waived tests is a no-brainer, once you've mastered a few easy concepts. If you begin your presentation with "Do you have a lab?" you'll likely hear “No,” even when you can see the boxes of occult blood tests and bottles of urine dipsticks over the person's shoulder. That's because most people (with the exception of a handful of lab nerds like me) imagine labs like they saw in Frankenstein, with bubbling orange and blue beakers and flasks, or space age-type rooms with sophisticated instruments. They may not think of simple “kit” products as lab tests.

These simple tests are often overlooked selling opportunities. Because they’re waived under CLIA, none of the traditional customer objections to lab testing apply. These tests are almost unregulated. Assure timid accounts that signing up with CLIA doesn’t necessarily equate to inviting federal agents bedecked with trench coats and Uzi's into their practice. Waived labs don’t even get inspected! To begin testing, all your accounts need to do is sign up and pay $150 every two years.

How to Get With The [CLIA] Program

Call the Centers for Medicare & Medicaid Services  number in your state (Table 1) and ask for a CLIA application form. It will take your account less than 10 minutes to fill out the form and mail it in. They will be billed $150 every two years and will probably have nothing more to do with the CLIA program.


STEP 1: Call your state Centers for Medicare & Medicaid Services (CMS, http://www.cms.hhs.gov/clia/ssa-map.asp) office and request Form #116 and any other forms that may be required to get a CLIA certificate. For the CMS telephone number in your state, call 410-786-3531 or visit the CMS web site at www.hcfa.gov.


STEP 2: Advise the account to complete CMS Form # 116 and check “Certificate of Waiver” in Section 2.


STEP 3: The account can begin testing once Form # 116 has been returned to CMS. Once CMS receives their payment, the account will receive a CLIA identification number that must be included on all Medicare and Medicaid claims. CLIA certificates (including fees) are renewed every 2 years. 

Who Needs A CLIA Certificate?

Any place that tests human specimens (this includes blood, urine, and assorted other unsavory body fluids) to diagnose, treat or monitor patients has to get with the program, even if they perform only so-called “simple” tests, such as urine dipsticks and microscopic tests. Regardless of whether an account bills Medicare for these tests, they are still required by law to sign up with CLIA.

…And Who Doesn't?

Medical practices that only draw blood to refer out (and do not perform urine dipsticks or other in-house testing) or only perform workplace drug testing are exempt from CLIA. Table 2 indicates when a CLIA certificate is needed and when it isn't.

Table 2. When to Get A CLIA Certificate

Get A CLIA Certificate If You….

Do Not Get A CLIA Certificate If You….

Perform tests from human body fluids that are used to diagnose, monitor or treat disease

Perform tests only for research or other purposes (e.g., workplace drug screening)

Perform simple tests such as blood glucose meters or urine dipsticks

Perform physiological tests only (ECG, spirometry, pulse oximetry, etc.)


Collect specimens and refer elsewhere for testing


Just do autoclave spore checks

Waived Tests On The Rise

The number of tests in CLIA’s unregulated category is increasing daily to include several tests that can be used not only by physicians and law enforcement, but by patients at home, such as nicotine and alcohol tests (got teenagers)? The waived test list now includes most rapid strep tests, several mono and H. pylori kits, instruments for lipid panels and prothrombin time, in addition to the original list of dipstick urine, glucose meters, fecal occult blood, and pregnancy test kits. To search for a particular test's CLIA classification, go to: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm.  To see an abbreviated list of CLIA Waived tests, click CLIA Waived List 2005.

Many accounts have misperceptions about the CLIA regulation and voice their objections when faced with purchasing lab tests (Table 3). Waived tests are easy to sell because the only CLIA quality requirement is that the user follow the manufacturer’s instructions.

For waived tests, no daily quality control is required (unless the manufacturer specifically states this, and many don't), nor is proficiency testing needed. Finally, virtually no waived site will be inspected. The exception is in a handful of states, such as Pennsylvania, where some of the recently waived tests are not yet recognized as waived and are subject to daily QC and proficiency testing.

Table 3. Fact vs. Fiction about CLIA-Waived Tests

Customer Objection

Waived-Test Response

CLIA is too much hassle.

The only requirement for waived tests is to “follow the manufacturer’s instructions”

CLIA is too expensive.

You can recoup the $150 during the first week of testing! And CLIA fees are only collected every two years.

I don’t want to hire a tech.

Anyone who can fog a mirror can perform a waived test.

Once we run our daily quality control we’ll lose money on the test.

Daily QC is not required for waived tests, unless specifically stated in the manufacturer’s instructions (and it isn’t)

I don’t want the feds inspecting my office

Labs that only perform waived tests are not inspected.

Selling Waived Tests To Moderately-Complex POLs

Finally, there's an opportunity to save your accounts a lot of money by switching out their moderately-complex tests with waived ones, where possible. Why? Because they do not need to perform quality control and proficiency testing on waived tests. This can amount to savings of several hundred dollars per year and you'll be the hero.

 The bottom line: Keep your accounts abreast of what's on the waived test list so they can pursue testing opportunities they might not have considered–and you can be a hero in the process!


Home   |   Company Profile   |   OSHA Compliance   |   Lab Testing   |   Products   |   Seminars   |   Distributor Info  |  Order Online

Copyright © Quality America, Inc. All Rights Reserved.       1-800-946-9956 | email us | sitemap | online resource center

Website by Intellitraffic

Quality America Company Profile OSHA Compliance Lab Testing OSHA Products OSHA Seminars OSHA Consulting Order OSHA Compliance Products Online Quality America, Inc.