[Histonet] RE: CAP vs. CLIA

joelle weaver joelleweaver <@t> hotmail.com
Thu May 17 12:35:08 CDT 2012 

TimI agree with your comments and the interpretation of the regulations( and these are regulations not value judgments). I still think however that CLIA should be updated to include all activities, in all potential settings, that well trained histology personnel may perform. I can think of several histology jobs where output was produced that stood on its own, but did get fed into later processes for clinical interpretation and decision-making.  I just think the picture/definition is rather narrow. I think that if you use the testing phases, our just crosses over some but not all phases( preanalytic & analytic), whereas other testing has post-analytic. Maybe the word should be oversight?  Histology techs sometimes just get offended because emotionally, this feels like it is implied that we don't know or understand our activities or supply technical correction. I think there is similarity to grossing in application, and likewise, histology produces a result that moves to later in the process stream. Though admittedly there is wide variation of skill and experience and different types of roles out there, I do think most of us monitor and "validate" the technical quality of our output, and are very concerned about the patient and the impact of our technical performance has on their outcomes...  



Joelle Weaver MAOM, HTL (ASCP) QIHC
 > From: Timothy.Morken <@t> ucsfmedctr.org
> To: Timothy.Morken <@t> ucsfmedctr.org; HornHV <@t> archildrens.org; lblazek <@t> digestivespecialists.com; JEllin <@t> yumaregional.org; Donna.Willis <@t> baylorhealth.edu; Courtney.Pierce <@t> quintiles.com
> Date: Thu, 17 May 2012 09:50:29 -0700
> CC: histonet <@t> lists.utsouthwestern.edu
> Subject: [Histonet] RE: CAP vs. CLIA
> 
> I should have included grossing. Grossing is high complexity because the person has to use independent judgment when examining and sampling the specimen. They are essentially providing a result of a procedure to be used to get more results down stream.
> 
> Tim Morken
> 
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Morken, Timothy
> Sent: Thursday, May 17, 2012 9:41 AM
> To: Horn, Hazel V; 'Blazek, Linda'; 'Jesus Ellin'; 'Willis, Donna G.'; '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.   "
> 
> 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
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> 
> -----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
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