From: Vancleave, Vince
Sent: Wed 11/7/2007 2:39 PM
Cc: Webster, John A. M.D.
Subject: Still not sure about this low complexity or not
"The thing you have to remember, Vince, is that CLIA and CAP are two
different, completely separate entities. CLIA is government controlled
and CAP is private. Whereas CAP recently decided to separate grossing
into two different complexities, CLIA has not. Bottom line...if you are
CLIA licensed you MUST follow the CLIA standard. If not, then you can do
whatever you like.
Charles Embrey Jr., PA(ASCP)"
Charles makes a great point but:
I'm just not sure I'm sold on this yet, b/c also in the CLIA regs it states in sec. 493.559 about exemption from CLIA, via using a private accreditation agency (which is what CAP is), and states clearly that this agency can only be deemed acceptable if their requirements for the laboratory are equivalent or more stringent and the laboratory would meet CLIA requirements if the laboratory had not been granted deemed status.
Ya'll are right, this is a mess!
So, wouldn't this essentially mean that according to CLIA, since CAP is an acceptable private agency, they are giving the ok for CAP's decision on this? Wouldn't CAP be unallowed to do what they do if it was less stringent than CLIA? I also find nothing in the entire CLIA 88' that indicates that this would not be ok. In fact, CLIA has a criteria for categorization of complexity: http://www.fda.gov/cdrh/clia/categorization.html . And in their database of tests that they have said has to absolutely be a certain way, I find no reference to tissue description, gross examination, tissue examination, or processing.
Have I stumped anyone yet, or is there some more things I am missing? I really appreciate all ya'lls willingness to re-visit this issue again. I guess I am a stuborn monkey!
Vince Van Cleave, BS, PA(ASCP), HTL, HT
Laboratory Manager and Pathologist Assistant
Clinical Pathology Associates
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