[Histonet] RE: CAP vs. CLIA

Thu May 17 11:40:38 CDT 2012

" CAP does not consider us testing personnel. How they come by this is a mystery to me.   "

The "test" is the interpretation of results - providing diagnostic decisions on stains. Histology staff perform the stains - apply reagents to a slide following a pre-determined protocol. The pathologist, or someone he delegates it to, does the interpretation. 

In the clinical lab the techs actually validate results. Most of these are machine-produced numbers so the tech is validating that the machine works correctly. But since they are "signing out" the result they are considered as doing the testing. 

Cytotechs interpret slides  and produce an independent result that they sign off and report out. They are doing high complexity testing.

A clin lab tech who reads micro slides, plates or whatever and provides a result that they alone sign off on before sending out the result are doing high complexity testing. 

Tim Morken
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 Horn, Hazel V
Sent: Thursday, May 17, 2012 9:17 AM
To: 'Blazek, Linda'; 'Jesus Ellin'; 'Willis, Donna G.'; 'Courtney Pierce'
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] RE: CAP vs. CLIA

I certainly agree with you Jesus.  I felt like my face had been slapped.  

Hazel Horn
Supervisor of Histology/Autopsy/Transcription Anatomic Pathology Arkansas Children's Hospital
1 Children's Way | Slot 820| Little Rock, AR 72202
501.364.4240 direct | 501.364.1302 office | 501.364.1241 fax hornhv <@t> archildrens.org archildrens.org

100 YEARS YOUNG!
JOIN THE PARTY AT
ach100.org

-----Original Message-----
From: Blazek, Linda [mailto:lblazek <@t> digestivespecialists.com]
Sent: Thursday, May 17, 2012 9:27 AM
To: 'Jesus Ellin'; Horn, Hazel V; 'Willis, Donna G.'; 'Courtney Pierce'
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: RE: CAP vs. CLIA

You hit the nail on the head!

Linda

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Jesus Ellin
Sent: Thursday, May 17, 2012 10:24 AM
To: 'Horn, Hazel V'; 'Willis, Donna G.'; 'Courtney Pierce'
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] RE: CAP vs. CLIA

I am going to have to go there,, sorry all I know I am going to stir-up a hornets nest, but here it goes, don't we think that this is done in lue of the fact that CAP are representing the Pathologist interest and not the interest of the Technicians.  Times have changed and the CAP is asking for more and more from Anatomic Pathology questions every year, not only to include technical, but also instrumentation (simple and complex), as well as information systems, predictive markers, Digital Pathology ( a huge one), etc.  I think the CAP need to re-evaluate this and re consider what high complexity testing is, because CLIA defines it not the CAP.  Remember CAP enforces CLIA regulation as well as their own.  I would challenge this.  I feel the staff under me do more than turn a wheel, or place tissue in a mold.  With Passion comes a need to start to create change, we need this done.

Jesus Ellin  HT/PA ASCP, BSBE,MSBE
Yuma Regional Medical Center
Anatomic Pathology Supervisor

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V
Sent: Thursday, May 17, 2012 7:05 AM
To: 'Willis, Donna G.'; 'Courtney Pierce'
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] RE: CAP vs. CLIA

It was a CAP e alert dated April 2, 2012

Hazel Horn
Supervisor of Histology/Autopsy/Transcription Anatomic Pathology Arkansas Children's Hospital
1 Children's Way | Slot 820| Little Rock, AR 72202
501.364.4240 direct | 501.364.1302 office | 501.364.1241 fax hornhv <@t> archildrens.org archildrens.org

100 YEARS YOUNG!
JOIN THE PARTY AT
ach100.org

-----Original Message-----
From: Willis, Donna G. [mailto:Donna.Willis <@t> baylorhealth.edu]
Sent: Thursday, May 17, 2012 8:42 AM
To: Horn, Hazel V; 'Courtney Pierce'
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: RE: CAP vs. CLIA

I have to say I disagree with this interpretation.  The commentary in the 7/11/2011 checklists indicates that regulations apply to "A laboratory must evaluate and document the competency of all testing personnel for each test system. A TEST SYSTEM is the process that includes pre-analytic, analytic, and post-analytic steps used to produce a test result or set of results."  To me this includes both histology and pathology office staff.

This is the opinion on myself and our compliance person.  Hazel can you tell us where to find the CAP quote.

Thanks,

Donna Willis, HT/HTL (ASCP)
Histology Lab Manager
Baylor University Medical Center-Dallas
ph. 214-820-2465 office
ph. 214-725-6184 mobile
donna.willis <@t> baylorhealth.edu

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V
Sent: Thursday, May 17, 2012 7:26 AM
To: 'Courtney Pierce'
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] RE: CAP vs. CLIA

CAP does not consider us testing personnel. How they come by this is a mystery to me.   In a recent memo from CAP it describes this:

" Why does CAP require the completion of the "Laboratory Personnel Evaluation Roster" form and when was this process implemented? 

As part of CAP's deemed status with CMS as an accrediting organization, CMS required CAP to implement a more stringent process to document that accredited laboratories have appropriately qualified personnel and adequate documentation of personnel qualifications. The Laboratory Personnel Evaluation Roster form requires laboratories to confirm that personnel files contain the information necessary for laboratories to be in compliance with the CLIA personnel qualification regulations and CAP Checklist requirements prior to the inspection. It is also used by the inspection team to assist in the auditing of the records during the inspection to confirm compliance with the Checklist requirements. The process of completing the personnel form took effect in August 2009."

And goes on to say:
"Do I need to list histologists on the Laboratory Personnel Evaluation Roster?  

Typical histologist duties (e.g., fixation, embedding, microtomy, staining and cover slipping) are not considered testing. Therefore, it is not necessary to list these personnel on the roster. However, if the histologist is performing any part of the macroscopic tissue examination which is considered high complexity testing, it is necessary to list those personnel on the roster. Such personnel must provide documentation at minimum of an associate's degree/transcripts or high school diploma or equivalent for individuals performing grossing at the same laboratory prior to September 1, 1997."

Hazel Horn
Supervisor of Histology/Autopsy/Transcription Anatomic Pathology Arkansas Children's Hospital
1 Children's Way | Slot 820| Little Rock, AR 72202
501.364.4240 direct | 501.364.1302 office | 501.364.1241 fax hornhv <@t> archildrens.org archildrens.org

100 YEARS YOUNG!
JOIN THE PARTY AT
ach100.org

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Courtney Pierce
Sent: Wednesday, May 16, 2012 2:27 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] CAP vs. CLIA

Can someone help me with the High Complexity Test with CAP vs. CLIA.
Thanks
Courtney Pierce
IHC Specialist
Quintiles
Translational R&D - Oncology
Innovation
Navigating the new health

610 Oakmont Lane
Westmont, IL 60559

Office: + 630-203-6234
courtney.pierce <@t> quintiles.com

clinical | commercial | consulting | capital

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