According to The Lab Guy’s latest Repertoire column, Tim Dumas says that guidelines for CLIA-waived labs could get stricter. Thus far, no changes have been enacted. That said, Repertoire readers should be aware of the possibility.

But where do Reps fit in?

The first thing reps can do is make their customers aware that stricter guidelines for CLIA-waived labs may be enacted at some point in the future. Reps should be familiar with the tests they sell, and have a basic understanding of the CLIA guidelines for waived labs. Refer to the afore-mentioned list of deficiencies and help the office meet the criteria. The MOST common shortfall I see occurs when the office changes the manufacturer of a certain test. Perhaps it changes from a brand name test to a generic one, or from one company’s test to that of another. In these cases, the office must inform the staff to document the new product requirements, date of initiation, and training of all staff on the new test.

Here are some other areas in which reps can assist their customers in CLIA-waived labs:

  • Determine whether the tests need to be stored or refrigerated.
  • Take notice of expiration dates.
  • Offer to train or arrange training for any new staff performing the test.
  • Make sure any test you sell is certified waived. Provide CPT codes if possible.
  • Refer customers to the CLIA/CMS website ( for more “How to” directions.
  • Refer customers to COLA, a physician-directed, independent accreditor of labs, which offers a certificate and a list of tools to help office labs meet these regulations.

To read the full column, click here for the digital issue

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