[Histonet] Personel

Jesus Ellin JEllin at yumaregional.org
Mon Nov 28 08:03:32 CST 2016

I hope that everyone had a great weekend and a good thanksgiving,, 

Just to shed some light on the subject on the matter to have things in perspective,  when I called CAP and here is what the Rep shared with me,  it wasn't the interpretation  or the result but rather the QA/QC of the result.  
See below:  now here is the rub on this, as a person doing Special Stains, IHC, Digital Path and ISH,,  we as TECH's QA/QC before we hand into the Pathologist, our controls are supposed to be reviewed by the tech to make sure the reaction took  place, we don't say it looks brown, or red, or hey the colorful,, WE confirm the reaction, cause if not we redo.  This is what ALSO the CAP states that we do because it does say Pathologist or Designee , and it's the QA/QC step.  By no means are we resulting or giving Diagnosis/interpretation.  This is where I am having trouble with this statement, about testing/interpretation,, it has nothing to do with that at all.  CLIA also doesnt define QA/QC , just resulting/interpretation.

They are the same Steps that are being followed on digital path, were imaging of the slides require a person of High Complexity testing to be doing the scanning.  Again this is another QA/QC step, so I get all the stuff about CLIA and reporting, but CAP is specific and we are doing the QA/QC of this testing.

I also had a conversation about whether Licensure was acceptable or not,,  without meeting the requirements, and I was told NO,, they need to meet the minimum requirements as stated in CLIA for high complexity testing,, again something to look at.

I then called ASCP to ask them about where they stood with this and was told we only do the licensure not the regs.

I called CMS to get a better understanding stating the issue, as for them the person interpreting and reporting is the Pathologist, but if CAP requires that the QA/QC be done with those regs,, then that is more than is required, but that is their regulation and to be adhered too.

Funny thing then when you go the CLIA website you get the high complexity testing, you can see where the testing methodologies are and can see when the test system came about. 

I know this is going to be a debatable situation and I have to agree with Tim,, please standardize and let us know,, but it is clear what they are saying about results, testing , interpretation and now QA/QC..  

Thoughts anyone,, but I see that this is going to change histology as a whole, since now this is being added too the mix.  I am not saying it is right or wrong,, but it does put forth effort that we need to classify what we do and also try to align the test system accordingly, because QA/QC is almost everything,, you can put this on instrumentation, protocols, procedures, etc.  

Also what do we do with those that have been doing this for years,, that have the knowledge and also the background,, again I don't wish to open up PANDORA's box,, I also know we are all going to look at this differently,, but the facts are we are changing and if we do not own the processes we currently do, someone else will that's for sure.

Jesus Ellin

**REVISED** 08/17/2016
ANP.21395 Special Stains/Studies Phase II
For special stains, including histochemical stains, and studies using immunologic and
ISH methodology, positive and negative controls are verified and recorded as acceptable
prior to or concurrent with the reporting of patient results and records maintained.

NOTE: Controls must be verified and recorded as acceptable by a pathologist or designee
(provided the designee meets high complexity testing qualifications).

Positive tissue controls must contain the component specific to the special stain that is being
applied to the specimen.
Immunohistochemical tests using polymer-based detection systems (biotin-free) are sufficiently
free of background reactivity to obviate the need for a negative reagent control and such controls
may be omitted at the discretion of the laboratory director following appropriate validation.
If interpretation of the special stain or study is performed by a different laboratory, there must
be a procedure for the laboratory performing the stain or study to verify the acceptability of
the controls before transfer, if the controls are not sent with the patient slides (regardless of
the outside laboratory's accrediting organization). Records of this verification must be readily

ANP.23041 Testing Personnel Qualifications Phase II
Personnel who are responsible for evaluating or accepting the imaging system data are
qualified as high-complexity testing personnel.
NOTE: The qualifications to perform high complexity testing can be accessed using the following
link: CAP Personnel Requirements by Testing Complexity.
available to the laboratory performing the interpretation.

-----Original Message-----
From: Morken, Timothy [mailto:Timothy.Morken at ucsf.edu] 
Sent: Wednesday, November 23, 2016 5:12 PM
To: Jennifer Valentine-Williams; Jesus Ellin
Cc: Histonet
Subject: RE: [Histonet] Personel

Jennifer, short answer:

It is not that histology is not a "high complexity test." The issue is, who is defined as "testing personnel." All histology tests are high complexity. But in anatomic pathology the pathologist is the only designated "testing personnel" according to CLIA regs because they are the only personnel interpreting and reporting results. 

No one else in histology interprets or reports results, so all other work in histology is considered "processing." 

The confusion between AP and Clin Lab is that Med Techs do report out results and so are "testing personnel" under CLIA.

CAP is trying to apply regs to AP that were written for Clin Lab. They not fit well....

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

-----Original Message-----
From: Jennifer Valentine-Williams [mailto:jennifer.valentine-williams at neogenomics.com] 
Sent: Wednesday, November 23, 2016 2:02 PM
To: Morken, Timothy; Jesus Ellin
Cc: Histonet
Subject: RE: [Histonet] Personel

I would like to branch off from this topic...  Should a lab aid be allowed to load/unload slides/reagents from an automated IHC machine?
Should they be permitted to print the labels that tell the machine which tests to run?

I say no, but others say otherwise, so I'm interested in what everyone else here thinks.

All lab tests have pre and post analytical components and I believe they all contribute to the High-complexity status of the "test".  It surely cannot be that the interpretation is the only portion that is considered the "High-complexity test".  I am open to hearing why this may be the case though.

Jennifer Valentine-Williams, HT (ASCP)

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