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If your lab is conducting only waived testing, then 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. Tests waived by CLIA:
- Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.
- Pose no reasonable risk of harm to the patient if the test is performed incorrectly.
- Are cleared by the FDA for home use.
- Conduct testing that is considered non-technical requiring little or no difficulty.
Why You Should Consider Proficiency Testing for Waived 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.
E-Notification Service—Waived Testing Info Delivered to your Email Account.
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 firstname.lastname@example.org and request to be added to the recipient list. In the e-mail request, be sure to include your MLE ID number.