c.tague at Pathologyarts.com
Tue Nov 22 12:42:53 CST 2016
I recently had this same discussion with Jesus, please follow this link he gave me: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm
At the top, enter "Test System / Manufacturer" for example, we enter Ventana, it will list all tests that qualify as High Complexity. There are 4-5 different tab/pages... even operating something as basic as a DAB detection kit appears to qualify as High Complexity...if you enter Leica, then you get much less but the detection kit is listed as High Complexity still so it would serve to reason that someone not qualified for high complexity testing cannot even load slides... maybe they can if a qualified person is the one prepping the machine, loading detection kits and AB's???
High Complexity testing personnel requirements per CAP:
1. MD or DO with a current medical license¹; OR
2. Doctoral degree in clinical laboratory science, chemical, physical or biological science; OR
3. Master's degree in medical technology, clinical laboratory, chemical, physical, or biological science; OR
4. Bachelor's degree in medical technology, clinical laboratory, chemical, physical or biological; OR
5. Associate degree in chemical, physical or biological science or medical laboratory or equivalent education and training (refer to 42CFR493.1489(b) for details on required courses and training); OR
6. Individuals performing high complexity testing on or before April 24, 1995 with a high school diploma or equivalent with documented training may continue to perform testing only on those tests for which training was documented prior to September 1, 1997 (refer to CLIA regulation 42CFR493.1489(b) for details on required training)
From: Morken, Timothy via Histonet [mailto:histonet at lists.utsouthwestern.edu]
Sent: Tuesday, November 22, 2016 10:17 AM
To: Jesus Ellin
Subject: Re: [Histonet] Personel
Jesus, that is very interesting information.
Does anyone know of any CAP accreditation documents that state explicitly that IHC slide staining is high complexity? I have not seen any. If anyone has those documents I'd like to see them. The only reference from CAP about that classification I have seen was in a Q&A session transcript from a CAP webinar on competency testing. The webinar had no information about IHC and complexity. However, a presenter answering a question about whether IHC staining at the bench is a high complexity "test," did state that IHC staining is high complexity so the techs doing the staining must have competency testing. Very strange!
That's not to say I don't think IHC is high complexity - I do, and so is every other test in histology. But under CLIA the testing personnel is the pathologist, not the bench tech. CAP can deem IHC bench testing as high complexity if it wishes (CLIA is a baseline and deemed accrediting agencies, and institutions, can have stricter requirements). But it seems the only way anyone can find out if CAP classifies IHC as high complexity is to call them and ask.
Your comment about new technology is interesting. In a modern scenario, which tech is the person who is "staining" the slide? And which of these is the "high complexity" part of the process?
1) person collating slides to stain
2) Person who programs the stainer
3) Person who dilutes the antibodies (still done!)
4) person who loads reagents on the stainer
5) person who loads the slides on the stainer
6) person who starts the stainer
7) person who unloads the slides from the stainer
8) person who labels and distributes the slides.
9) Person who checks QC slides (BTW, not a "test,").
In our lab these tasks are traded off by many different people throughout the day
How about the person doing the validation of the stain? They are not doing a "test" but they are making the test possible to do.
Just some questions to ponder over the holidays!
Pathology Site Manager, Parnassus
Supervisor, Electron Microscopy/Neuromuscular Special Studies Department of Pathology UC San Francisco Medical Center
From: Jesus Ellin via Histonet [mailto:histonet at lists.utsouthwestern.edu]
Sent: Tuesday, November 22, 2016 9:36 AM
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] Personel
So I know I am going to open Pandoras box,, but have people been paying attention to the Personal requirements from CAP.
I called the CAP and asked them about the criteria concerning Moderate or High complexity testing, after discussing with them the situations, IF you have a tech that is Licensed and Also has a QIHC, but does not minimum requirement Defined by CLIA in education ,, they CAN NOT do any QA/OC of IHC and antibody work up,, as IHC is defined as High complexity testing.
I also asked about the test systems. The grandfather clause is only good for test systems that occurred for those time periods. For instance if CLIA defined the test system after those dates of 1997,, then they are not included and the person cannot perform test and technology created after those dates, since the testing was not in place during the grandfather clause time. In a nut shell meaning if the IHC staining and antibody was developed after those dates,, you are not covered by the grandfather clause to do the testing ,, can some help clear this up,,
So any help on this matter will do
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