CLIA was established in 1988 with the goal of updating existing regulations related to the licensing of clinical laboratories, following the initial CLIA '67 rule. CLIA '88 regulations addressed test complexity, proficiency testing, quality assurance, and other clinical laboratory processes establishing quality standards for clinical laboratory testing for patient diagnosis and treatment.
CLIA waived tests are generally simple test that are non-technical. There are over 1,400 test systems that have been waived. Most tests meet the following requirements:
Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.
Use unprocessed specimens (whole blood or oral fluid).
Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
Are cleared by the FDA for home use.
If your lab is conducting only waived testing, you must have a valid Certificate of Waiver (COW) from CLIA and your lab will not be routinely inspected. However, COW labs may be randomly inspected as part of a compliance investigation to ensure that they are only performing waived testing.
To qualify for a certificate of waiver, your lab must only perform tests that have received the CLIA waived status. If you meet this requirement, simply fill out the application form CMS-116 at the CMS website or from your state health. The COW is valid for two years. Information required is straightforward and includes:
Type of Laboratory
Hours of Laboratory Testing
Number of Waived Tests performed annually (estimate)
Individuals Involved in Laboratory Testing
For any lab that wants to manage risk, maintain the highest standards of quality and enhance patient safety, PT should be part of your ongoing quality assurance checks.In response to those COW labs that elect to participate in PT, MLE responded by preparing special modules of two-sample proficiency modules, designed for the CLIA-waived testing laboratory needs. Please refer to the current MLE Catalog on the Enrollment Information page for more information.
A value-added service to enhance the quality and safety of patient care. The e-mail notification service will provide Class I and Class II recall information and field corrections pertaining to waived test devices.
Additionally, MLE provides:
Notification of changes or additions to the CLIA list of waived laboratory tests from CMS.
A wide array of cost-saving Waived Testing Modules for continued quality assurance at a lower cost.
A reminder prompt for notifications involving Microbiology tests, to ensure regulatory compliance for any remaining non-waived analytes.
To receive “E-Notify on Waived Tests” and the “Recalls and Field Corrections: Devices—Class I and Class II” report, send an e-mail to email@example.com and request to be added to the recipient list. In the e-mail request, be sure to include your MLE ID number.
Contact us with any questions at 202-261-4510 or via email at firstname.lastname@example.org.