[Histonet] RE: CAP vs. CLIA

Morken, Timothy Timothy.Morken <@t> ucsfmedctr.org
Thu May 17 12:46:05 CDT 2012 

Jesus wrote:

" 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.  "

Certainly the regulations limit the "high complexity" designation to interpretation of procedure results, but that does not mean a facility does not need very highly trained and competent technologists to do the protocols that lead to good interpretation. It simply highlights the difference between running slides through protocols vs looking at the result and determining a diagnosis. I'm sure most here will see the difference. 

Remember that CAP is a simply a deemed agency of CLIA - that is, CMS (Centers for Medicare and Medicaid, which administers the CLIA regulations) delegates to CAP (and Joint Commission) the authority to accredit laboratories. CAP cannot make up new regulations, only enforce existing CLIA regulations. However, the CLIA regulations are by necessity very general so they can apply to any kind of laboratory operations, current or future. CAP has the leeway to look at what labs are doing and determine if the CLIA regulations apply to those tasks. However, CAP must submit their proposals to CMS/CLIA and CMS/CLIA must pass off on them before they are implemented. 

CAP checklists are far more complex than they were 20 years ago. But the histo lab is far more complex as well, and regulators (as well as the public) are looking much more closely at histology because of some major mistakes that have happened largely due to lack of rigor in testing validation and implementation. A lot of that has to do with small labs doing complex testing (interpretation) with methods they were/are not fully competent to do primarily due to lack of experience and expertise. 

While the accreditation process is getting more onerous, it is also forcing labs to be much more professional in their operations - always a good thing, I think.

Tim Morken

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

Very well said Jesus.  I agree.

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: Jesus Ellin [mailto:JEllin <@t> yumaregional.org]
Sent: Thursday, May 17, 2012 9:24 AM
To: 'Horn, Hazel V'; Willis, Donna G.; 'Courtney Pierce'
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: 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




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-----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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