• rss
  • facebook
  • twitter
  • linkedin
Medical Laboratory EvaluationPurchase MLE PT

Waived Testing

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. Waived tests:

  • 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 waived testing laboratory needs. See our custom selection of waived modules.

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 compliancefor 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 mle@acponline.org and request to be added to the recipient list. In the e-mail request, be sure to include your MLE ID number.

Related Links

CDC Information on Waived Tests

Information on CLIA Waivers

 

Related Information

Upcoming Events

Come visit the MLE Booth #3744 in Chicago at the AACC 2014 Annual Meeting and Clinical Lab EXPO and pick up your free gift!

AACC EXPO
McCormick Place
Chicago, IL
July 27- 31, 2014

Print out your FREE VIP Guest Pass (EXPO Only Admission) and be our guest! Or go to www.aacc.org/2014am use Promo Code 7960 to register online.

Hot Topics

Related Laboratory Websites

ACP Clinical Shorts

Expert Education on Your Schedule

Short videos deliver highly focused answers to challenging clinical situations seen in practice and are a terrific way to earn CME credit on-the-goShort videos deliver highly focused answers to challenging clinical situations seen in practice and are a terrific way to earn CME credit on-the-go. See more.

New: Free Modules from ACP Practice Advisor!

New: Free Modules from ACP Practice Advisor!

Keep your practice moving in the right direction. ACP Practice Advisor is offering four modules that you and your staff can try for free. Get to know the premier online practice management tool at no risk. Explore the modules.