[Histonet] CAP inspect- It's not about you(lab), it is about me(inspector)

Morken, Timothy Timothy.Morken <@t> ucsfmedctr.org
Thu Jun 6 14:45:04 CDT 2013

FDA cannot inspect a lab that only uses commercially available reagents for their testing. FDA only has authority over the manufacturers of reagents, and even then only the "active ingredient," ie, the Anylate Specific Reagent. 

However, FDA is interested because so many labs are making up their own tests, mainly for genetic/molecular tho even the Her2 interpretation and test variability issues attract attention from FDA. Are labs really qualified to do high quality validation testing? That is what FDA is curious about....and should a lab be considered a "manufacturing" facility if they make up their own test, especially if they make their own genetic probes. 

All the rest you mention is under the purview of the deemed agents for CLIA - CAP and Joint Commission. They both inspect to ensure the CLIA regulations are followed, but use different approaches towards the same end. As more variety of testing is implemented, they have to interpret how the regulations apply to the new tests. CLIA has to sign off on what they do, so it is not something done without oversight. 

It could be that POL's are pushing the limits on what they can handle with the personnel they have. At our institution we have a large support staff for quality assurance and regulatory compliance. They keep track and work on a lot of the issues so I don't have to spend my time doing that. A POL would need to hire consultants to get the same level of support. I suspect many can't afford that so have to scrape by figuring it out for themselves. 

Tim Morken
Supervisor, Electron Microscopy/Neuromuscular Special Studies
Department of Pathology
UC San Francisco Medical Center

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Linda
Sent: Thursday, June 06, 2013 12:25 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] CAP inspect- It's not about you(lab), it is about me(inspector)

Greetings All,
I just went through my Physician Office Laboratory(POL) inspection recently.
We all have to go through CAP inspections.  Yes, it is a voluntarily process.  We all work very hard and make sure everything is spit shined when they come into our pseudo-homes.
With all the CAP rules changing, all the multitude of sections verses just Lab general, Anatomic Path, and if you do cytology, that section. Now, with the non-exist traditional hospital laboratory being replaced with a central location to serve many hospitals.  Or now, as am I, a physical owned lab, with no pathologist on site.  And as always, being understaffed, required to produce more in a shorter amount of time, etc., essentially not feeling the "love".
Do you feel the laboratory inspection process should change too?
I am not endorsing or refuting any of the suggested process changes, they are thoughts that I actually have heard through the society grapevine.  Such as being taken over by the FDA, or having paid inspection teams, or some other process in-between?  A different set of inspectors who understand that POLs,  are the test(analytical) process and not the post-analytical process(the path report).
I send out to histoland the question interested in your thoughts.
Linda Dee, BGS, HT(ASCP) 
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