CLIA REQUIREMENT FOR WAIVED GLUCOSE TESTING?

Do you have a link to these changes?  I had not heard about any changes

We have our glucometers under the hospital CLIA license, separate from the laboratory CAP and CLIA license as well.  We have always done proficiency testing for our glucometers, although I don't believe it has been a requirement.  We use API for the Nova StatStrip glucometer PT and use their verification program as well.  This PT program allows one meter to be tested originally and reported, and then for the verification program the samples can be run and reported on up to 20 additional meters.  This just gives us a good sampling of our 50 meters to be involved in the PT and I try and rotate around units and employees performing the PT.  

I believe the CMS rule you have listed just means that if you do perform PT on waived testing, all the same rules must be followed that align with the regulations for non-waived testing PT. This would include the rule that PT referral is not allowed.  

Thank you Ashlee. I may have interpreted it incorrectly then. It sounds like PT for waived testing is optional, but if we choose to do it, we must follow the same regulations for PT referral as non-waived testing.

Andrea- here is the link to the document that I was referring to.

CMS Fact Sheet - CLIA PT Changes
https://www.cms.gov/files/document/clia-1988-proficiency-testing-regulations-related-analytes-and-acceptable-performance-cms-3355-f.pdf

We run waived testing under TJC WT Chapter accreditation (during hospital survey).
We do not order/conduct proficiency testing in waived testing sites for any waived test including POC performed glucose testing.

I would interpret this CMS rule the same as Ashlee H., above.

If the waived testing is only under CLIA (not under TJC, CAP, COLA, etc) then it's pretty simple.   
Per CMS: Participation in PT is required under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) statute for laboratories that perform moderate or high complexity testing.  
PT is not required for waived testing under just CLIA alone.  Only initial training is required, annual competency not required.   Just follow manufacturers instructions without any modification.
But, if you choose to do PT, then you must follow the CLIA rules on PT testing.

We are moderately complex and COLA accredited.  Although  not required our inspectors have cited good laboratory practice and want to see waived treated the same as non - waived  so we currently do PT from API as Ashley replied.  We also do annual competency which is starting to be a beast!

I think I would have challenged that citation for waived testing PT.  In their standard, they encourage PT.  To me encourage and required are 2 different things.   I agree it is good practice but sometimes it is difficult to support if there are many different waived sites spread out across miles of your territory.  Not to mention the cost.    What we plan to institute, internally, is periodic audits with internal unknown specimens.  

I'm with James Beck and Ashlee H on how I interpret. 

Ashlee H - thanks for mentioning the API POC glucose proficiency test and the verification program. This is interesting to me to be able to use the product in this manner. Thanks!