[Histonet] RE: CAP vs. CLIA

Sun May 20 22:37:56 CDT 2012

I seemed to have missed something or it might have been all the fresh sea air I got in Tampa at the FSH, but I do not understand the outrage expressed towards CLIA and CAP because we are not listed as testing personnel. I applaud everyone's passion for Histotechnology and the outrage that we are not allowed to fully participate in the test system model, but I think we should be directing more of our outrage to the individuals working in Histotechnology that are not and will not take responsibility to increase the professionalism of our profession and our own acceptance of the current state of Histotechnology.        

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. As good as we are and as complex parts of the Histotechnology process may be, Histotechnicians, Histotechnologists and Pathology Assistants do not meet the standard stated and do not participate in the post-analytic phase, produce and release patient results. We simply are not able to be credentialed as is the Medical Technologists and Cytotechnologist. I am not saying any one laboratory professional group is better than the other, just that to be considered testing personnel, we must be properly credentialed.  
Collectively, we as a discipline, science and group should be working to upgrade our education requirements and training so that we can become fully invested partners with the Pathologist. We, not CAP or CLIA, must greatly increase our professionalism before we can truly be considered competent to work in the post-analytical phase. I cannot today accept that every working Histotechnician, Histotechnologist and Pathologist Assistant is able to produce the "result and release". I am quite sure that every Medical Technologist and Cytotechnologist is capable and competent to produce and release a patient result. As things stand today, Histotechnology and all of us the working in this discipline are a support function to the one person in our discipline, the Pathologist, that is educated, trained, credentialed and competent to produce and release a patient result. I also believe there are many opportunities within our process available now, such as histochemical staining for organisms, that could allow us to participate in the post-analytic step. There will be many more as personalized medicine continues to transform Histotechnology. That said, how can we honestly promote our participation in the post-analytic phase, when there are far too many individuals (good, decent and hard working) that work every day, in every type and complexity of lab, that do not have a formal secondary education, have participated in defined clinical trials or have completed a certification exam (required and necessary credentials). Just think how many practitioners of Histotechnology are out there working today that are not properly credentialed. Now think if you know of any Medical Technologist or Cytotechnologist are working that do not have the required credentials.  We have many obstacles to increasing the professionalism of Histotechnology; wide and varied backgrounds, lack of standards, lack of automation, lack of certification, but I do not think that CAP or CLIA should be considered one of them. This problem is completely our responsibility. We first have to demand proper credentials, no exceptions, no matter the problem, before we can expect other laboratory professionals to support us in increasing our professionalism and participation in the healthcare delivery system. As important the need for a robust accreditation process, healthy discussion must take place before real change can happen. I suggest we direct our passion and outrage to demand proper credentials to work in Histotechnology and then demand full participation in the test system and proper recognition by all laboratory professionals. 

William DeSalvo, B.S., HTL(ASCP)

> From: JEllin <@t> yumaregional.org
> To: Timothy.Morken <@t> ucsfmedctr.org; histonet <@t> lists.utsouthwestern.edu
> Date: Thu, 17 May 2012 17:52:44 +0000
> CC: 
> Subject: [Histonet] RE: CAP vs. CLIA
> 
> I completely agree with you on this.
> 
> -----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 10:46 AM
> To: histonet <@t> lists.utsouthwestern.edu
> Subject: [Histonet] RE: CAP vs. CLIA
> 
> 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
> 
> 
> 
> 
> 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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