If you or your staff perform simple in-office laboratory tests; such as, but not limited to, urine protein, glucose, cholesterol or hematocrit, your medical office will need a CLIA Certificate of Waiver at each test site as referenced here:
“The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver]… are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that--(A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.” CLIA, 42 U.S.C. 263a(d)(3) Examinations and Procedures, as modified by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
For more information about CLIA requirements, follow the links below:
Determine if you need a CLIA Certificate of Waiver
How to obtain a CLIA Certificate of Waiver
Dona Constantine, RN, BS
CAP Senior Risk & Patient Safety Specialist
If you have questions about this article, please contact us. This information should not be considered legal advice applicable to a specific situation. Legal guidance for individual matters should be obtained from a retained attorney.