Understanding CLIA: What is Waived testing? What Does 42 CFR §493.15 Mean?

If your physician office laboratory performs only waived tests, 42 CFR §493.15 is an important regulation to understand. In simple terms, waived tests are considered simple to perform, have a low likelihood of producing an incorrect result, or pose little risk to the patient if performed incorrectly.

However, one of the biggest misconceptions is that waived testing requires little oversight. “Waived” does not mean “unregulated.” While waived testing has fewer regulatory requirements, deficiencies can still occur when staff fail to follow CLIA requirements.

Common waived tests in physician offices include:

• Urine dipstick testing

• Urine pregnancy tests

• Blood glucose testing using FDA-cleared home-use meters

• Fecal occult blood testing

• Ovulation testing

• Some hemoglobin and hematocrit testing

“Waived” Does Not Mean “No Rules”

Waived tests must be performed according to the manufacturer’s instructions for use (IFU). Deviating from those instructions can affect the test's waived status and compliance.

Common Compliance Problems

Physician office laboratories may encounter deficiencies related to:

• Failure to follow package insert/IFU instructions

• Expired or improperly stored reagents and supplies

• Missing or improper quality control documentation

• Improper specimen collection

• Inadequate operator training

• Failure to maintain a current CLIA certificate

The specific test system also matters. For example, a visually read urine dipstick may be waived, while using an automated analyzer to read the test can result in a different complexity classification and additional regulatory requirements. Similarly, replacing an FDA-approved home-use glucose meter with an automated chemistry analyzer using venous blood can significantly change the laboratory's CLIA requirements.

Strategies to Prevent Deficiencies

Waived testing sites should maintain:

✔ Current manufacturer instructions

✔ Staff training records

✔ Required quality control documentation

✔ Reagent inventory and expiration records

✔ Temperature monitoring records

✔ Corrective action documentation

Regular audits can help verify that staff are following procedures and that documentation supports testing activities.

Understanding exactly what your laboratory performs and how it performs those tests is the first step toward maintaining CLIA compliance.

At Total Laboratory Consulting, LLC, we help physician office laboratories identify compliance issues that may be overlooked, even when performing only waived testing. If you have questions about your testing menu or CLIA requirements, reach out to learn how we can help.