PathWays Case Study: Nov. 24

We’ve added new categories to our PathWays case studies. Readers will now find cases covering a range of laboratory leadership, management, and quality-improvement topics. These new cases promote a comprehensive approach to laboratory medicine and pathology and also prepare readers for obtaining and maintaining certification.

The Taking Essential Steps for Testing (TEST) Act of 2012 was passed to give the Centers for Medicare and Medicaid Services (CMS) alternatives to harsh penalties (revocation of CLIA certificate, laboratory director banned from directing any clinical laboratory for two years) imposed against clinical laboratories and laboratory directors for accidental referral of proficiency testing (PT) samples.

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Brad Karon, M.D., Ph.D.

Brad Karon, M.D., Ph.D.
Consultant, Division of Clinical Core Laboratory Services
Mayo Clinic
Associate Professor of Laboratory Medicine and Pathology,
Mayo Clinic College of Medicine


April Josselyn

April Josselyn is a Marketing Associate at Mayo Medical Laboratories. She is the editor of Mayo Clinic PathWays and supports corporate communications strategies and internal communications. She has worked at Mayo Clinic since 2012. Outside of work, April enjoys the outdoors and being "hockey mom" for her two sports-crazed boys.


You should have included the signature case for the Test Act; namely how it occurred at the The Ohio State University Wexner Medical Center. The only situation where even a Wolverine would agree that they were wronged.

It would be beneficial to know if the sample being sent and then received by the testing laboratory was labeled as a PT sample.

My pain started a little in the right side of my stomach, now it’s in my right side over to up above my hip. When I lay on my right side, it feels like there is something in there…like the size of a baseball or softball. What can this be?? Thank you!!

Hi Margie, unfortunately, we cannot diagnose conditions, provide second opinions or make specific treatment recommendations through this correspondence. If you would like to seek help from Mayo Clinic, please call one of our appointment offices (Arizona: 800-446-2279 Florida: 904-953-0853 Minnesota: 507-538-3270). Thank you.

I am a retired CLIA surveyor.& I am glad that CLIA has softened their position on unintentional PT referral…I always felt that revocation of a certificate was pretty harsh . However, nowadays all laboratorians should be more familiar with the PT requirements of CLIA.

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