[Histonet] RE: CAP vs. CLIA

Willis, Donna G. Donna.Willis <@t> baylorhealth.edu
Thu May 17 08:41:51 CDT 2012


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




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-----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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