[Histonet] Personel

Mon Nov 28 11:00:43 CST 2016

Just to throw another wrench in the works, we just had a "friendly" Joint Commission inspection (we are under JC) to preview coming regs. 

The inspector this time, for the first time, said ALL QC must be done by a "qualified pathologist."  Even H&E slide we do before starting stain runs. We have always had techs QC the H&E and special stains. IHC has always been done by a pathologist. Now they want all done by a pathologist. The inspector wouldn't even consider that a tech could do it, whether qualified for high complexity or not.

But the actual "QSA" element they quoted is somewhat ambiguous in that it specifies a qualified pathologist must "...assess the staining quality (for example equipment, methods, stains) of microscopic tissue sections to determine the stains ability to facilitate a diagnosis."

Then it goes on to say the "Laboratory"  performs controls for each type of stain.

We always took this to mean a pathologist approves the validation of stains, but the techs in the lab can do the QC when designated to do so.

Now it is a big question mark.

Again, the Deemed Agency for accreditation (CAP or JC) may institute stricter standards than the original CLIA regs so can say if your techs QC slides, then they must qualify for high complexity testing. CLIA does not consider QC of histology slides to be a "test" so does not require specific qualifications to run QC slides.

Note that a Med Tech already has High Complexity qualifications, is a "testing personnel," reports actual test results and will also do QC as part of their job. So their "QC" situation should not be compared to histology. 

The CAP general checklist item that covers the Clin Lab is not necessarily  applicable to the histo lab. Again, CAP has not stated anywhere an explicit definition of what the high complexity component of IHC staining is. 

However, it seems labs can get around the whole CAP information gap by just having pathologists QC all controls. 

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

-----Original Message-----
From: Jesus Ellin [mailto:JEllin at yumaregional.org] 
Sent: Monday, November 28, 2016 7:47 AM
To: Willis, Donna G.; Morken, Timothy; Jennifer Valentine-Williams
Cc: histonet at lists.utsouthwestern.edu
Subject: RE: [Histonet] Personel

Like I stated there is a lot out there and I agree with you all interpretation of this can vary,, but again our world is changing and I hope our powers at be are being the advocate for these issues,, cause we then are forces to make the interpretations, which I get it we are again asking the Pathologist to do,, but this section in under General Quality Control,, not at all added to the report,, the report itself has this designated as well in that section as well as the section for predictive markers,, So again you can see the confusion and ambiguity of this situation.  We need those advocates to make this clear for us for sure

-----Original Message-----
From: Willis, Donna G. [mailto:Donna.Willis at BSWHealth.org]
Sent: Monday, November 28, 2016 8:25 AM
To: Jesus Ellin; Morken, Timothy; Jennifer Valentine-Williams
Cc: histonet at lists.utsouthwestern.edu
Subject: RE: [Histonet] Personel

My interpretation of this is that for AP the "test" is the reporting of the results.  What is done in the Histology lab to prepare the slides is the pre-analytical portion of the test.  

For the revised ANP. 21395 the pathologist is mentioning in the report the results of the controls therefore it is in concurrent with the report.  We still check our results before taking the slides to the pathologist.

Donna Willis, HT/HTL(ASCP)
Anatomic Pathology Manager

Baylor University Medical Center
3500 Gaston Ave|Dallas, Texas  75246
214-820-2465 office|214-725-6184 mobile
BaylorScottandWhite.com

-----Original Message-----
From: Jesus Ellin via Histonet [mailto:histonet at lists.utsouthwestern.edu]
Sent: Monday, November 28, 2016 8:04 AM
To: Morken, Timothy; Jennifer Valentine-Williams
Cc: Histonet
Subject: [EXTERNAL] Re: [Histonet] Personel

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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