Check Your Knowledge of CLIA-Waived Tests

Edition: March 2002 - Vol 10 Number 03
Article#: 1178
Author: Dr. Sheila Dunn

From a new doctor…''I started using those new kits you sold me but Medicare won't pay for them. They say we're not 'authorized' to do them. Can you help?

From a bewildered practice manager…''What the heck is going on here? These waived test kits say that I have to run quality control samples with each new operator. I have 7 nurses. By the time they've all run 2 QC samples, there aren't any left to test patients''!

If you sell rapid diagnostic kits into the doctor's office market, you've probably heard one of the above statements recently. The following information will help you understand just exactly what Uncle Sam has in store for CLIA-waived POLs.

Government Oversight Of Waived Tests?
Last year, HCFA (now CMS) conducted a pilot study in 5 states where waived labs were inspected. CLIA inspectors were astonished to find that well over half of physicians' offices didn't even have instructions for performing the tests, had reagents that were outdated (some were also moldy), were storing kits at room temperature when they should have been refrigerated or vice versa, and myriad other infractions. This news was promptly presented to Congress, HCFA, CDC, the FDA and several national newspapers. Committee meetings were held, big referral labs could barely hold back from saying ''I told you so'' and POLs are nervous. Rightly so.

In 2002, HCFA's pilot study of waived lab inspections is being expanded to several more states, so don't be surprised if you get frantic calls from CLIA-waived accounts that come face to face with a CLIA inspector. It won't be a pretty sight… unless you help them with the straight dope.

But first, take a moment to see what you already know. Test your knowledge of the basics. Those who complete the quiz will find the answers to every possible account query.

1. True or False:
A waived test is just that: CLIA-waived. The account does not have to sign up with the CLIA program.

2. Which of the following tests requires a CLIA certificate?

a. Urine dipsticks

b. ECG

c. TB skin test

d. Pulse oximetry

3. Which of the following tests requires a CLIA certificate?

a. Workplace drug testing

b. Spore tests on autoclaves

c. Flu testing

d. Blood collection

4. You just sold 5 CLIA-waived protime instruments to a practice with 5 locations, one for each location. Congratulations! Now, how many CLIA certificates does this practice need?

a. None

b. One

c. Five

5. True or False: For the example in number 3 above, you must set the account up with proficiency testing.

6. Which of the following tests is not CLIA-waived?

a. Cholesterol panel

b. H. pylori kit

c. PSA tests

d. Fecal occult blood

7. True or False: If the government (Medicare or Medicaid) isn't billed for a test, the account does not have to sign up with CLIA.

8. True or False: More than half of all medical facilities perform at least waived testing.

9. True or False: Accounts can legally begin waived testing once they have filled out HCFA Form 116.

10. The following rules apply to waived testing:

a. Follow the manufacturer's instructions

b. Enroll in proficiency testing

c. Run daily QC

d. Log all specimens

11. Which of the following types of labs are routinely inspected?

a. Waived, PPM, Moderate and High Complexity

b. PPM, Moderate and High Complexity Only

c. Moderate and High Complexity Only

d. High Complexity Only

12. How much does it cost for a physician office to be a waived lab under CLIA?

a. $100 per year

b. $150 per year

c. $100 every two years

d. $150 every two years

13. True or False: Those who perform waived testing must have at least a high school diploma.

• Dipstick/Tablet Urinalysis
• Some Automated Urine Dipstick Readers
• Ovulation Test Kits • Urine Pregnancy Tests
• Sedimentation Rates (manual)
• Fecal Occult Blood/Gastric Occult Blood Tests
• Glucose Tests (whole blood systems)
• Hematocrit (manual)
• Hemoglobin (HemoCue)
• Cholesterol Tests (whole blood systems)
• Hemoglobin A1c Instrument
• Fructosamine Test System
• Rapid Strep Test Kits
• H. pylori Antibody Tests
• Mono Test Kits
• Flu Test Kits
• Lyme Disease Test Kit
• Femexam pH and Amines Test Card
• Prothrombin Time Instruments (whole blood meters)


1. False. Any facility that tests human specimens to diagnose, treat or monitor patients has to sign up with the program.

2. a

3. c

4. c. Each physical location needs a CLIA certificate for the level of testing it performs.

5. False. Unless the account is in Pennsylvania, which has a Level 1, Level 2, and Level 3 system, and several waived tests are considered Level 2, which requires PT.

6. c. I'll be first in line to buy stock in the first company who releases a CLIA-waived PSA test, since Medicare just recently began reimbursing (very highly) for PSA screening.

7. False

8. True.
There's a heck of a lot of testing going on out there, and knowing the kind of information in this article will help you earn this business.

9. True. Except that the account won't get entered in the Medicare system as a waived lab for a few weeks, hence the lag in payments when new facilities begin testing. The account will get a payment denial stating that they are not ''authorized'' to perform the test. At that point, it's time to call the state CLIA office and urge them to process that account's paperwork faster. Another reason for this type of denial is that the account may not have put a QW modifier on the code to indicate that the test performed was waived. Tests that can be both moderate and waived (such as cholesterol) must be submitted with a QW modifier attached to them so that the Medicare carrier knows that the account is performing the waived version of the test. If the QW modifier isn't there, the Medicare carrier says, ''This account isn't registered as a moderate complexity lab under CLIA, but they're trying to bill us for a moderate complexity test!'' and the claim is denied.

10. a. If the manufacturer's instructions say that an account must or shall (e.g., it's required) run two QC samples with each new operator (and most now do), then they legally must do this. If the manufacturer's instructions say something nebulous like ''it's good lab practice (e.g., it's recommended) to run QC every 10 minutes''…. then CLIA inspectors cannot and will not legally mandate that POLs follow these instructions. That's not to say that the inspector won't give the account some ''friendly'' advice encouraging them to do otherwise, but legally, they can't require it. The reality, though, is that less than 2% of waived POLs will ever be randomly inspected and most waived labs don't even realize that there is a package insert in the kit (which is why Uncle Sam is taking action)! Even those waived POLs that do get inspected will only get a written warning to begin following the manufacturer's instructions verbatim. There are no fines, jail terms, cutting off Medicare payments or other such penalties. One solution to the dilemma of ''each new operator must run controls'' is to get each tester his own kit so that QC only has to be run once on each kit. A final solution could be to sell moderate complexity labs moderate complexity kits, where QC is built-in and not required with each operator. Remember that waived test kits must be packaged in sizes less than 25 tests per kit, so this last solution is probably best for large volume, moderately complex labs.

11. c

12. d

13. False.
Anyone who can fog a mirror can perform waived testing, although in the future, we'll probably see a need to document training for waived testing. Rather than mandate inspections for waived labs (see answer to number 10 above), Uncle Sam is leaning towards requiring better training for those who perform waived tests.

About the Author…..

Dr. Sheila Dunn
heads Quality American, Inc., an Asheville NC-based consulting firm that publishes an OSHA Safety Manual, video and newsletter. Quality America;s newest products are “Sharps Injury Reduction Program” video and the HELP Book, an Emergency Action Guide. All products are sold through distribution. For information about Quality America's products and services, call 800-946-9556, or visit Quality America's OnLine Resource Center @