Re: [Histonet] RE: CAP vs. CLIA
Thank You Amanda!!! - Original Message - From: Amanda Kelley akell...@slu.edu To: WILLIAM DESALVO wdesalvo@hotmail.com Cc: histonet histonet@lists.utsouthwestern.edu Sent: Monday, May 21, 2012 9:53:41 AM Subject: Re: [Histonet] RE: CAP vs. CLIA I usually do not comment on the histonet, however this topic is near and dear to my heart. We in Histology are support scientific staff to the Pathologist as much as the Laboratory director is to the Pathologist. Scientific duties, which a pathologist can perform (histological and cytological preparation has been delegated down) to our position. Interpretation of Controls and associated material is often left to us and the Pathologist assistant We determine what the Pathologist can interpret Our expertise directly determines patient outcome, if we are not professional in our decisions then the Pathologist is ineffective in his or hers. The Professional business of running the laboratory is performed by the medical laboratory director, and associate director. These are professional positions within the laboratory where a Pathologist has delegated the managerial responsibility to a subordinate. According to CLIA, this position does not exist, only the Pathologist can truly be the Medical laboratory director. Yet in hospitals across the country many Clinical laboratory Scientist's who don't know anything or have limited knowledge of AP are in charge of our AP labs.Their positions are listed as Laboratory Director. This subordinate is the most important person in the lab, yet they too do not turn out results. They are frequently the highest paid in the lab. Their pay is based on the designation of their scientific and managerial background. I believe we can do the same. The business of the pathology lab would be very difficult for the pathologist to handle without this symbiotic relationship of the scientific businessman to the Pathologist. Likewise a Pathologist can not perform their job without the symbiotic relationship to the histotechnologist.Thereby technically, making our jobs indispensable to the Pathologist much like the laboratory director. Our problem is history, where many pathologists trained their out of work brother in law to do the work. Many rural areas still run their labs this way. As long as there is a path to become a histotech by hiring whomsoever to do the job. We will always be left behind. So I believe if CLIA and CAP can recognize the laboratory Manager as an important professional position delegated by the Pathologist then we should be afforded the same courtesy. On Sun, May 20, 2012 at 10:37 PM, WILLIAM DESALVO wdesalvo@hotmail.comwrote: 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
Re: [Histonet] RE: CAP vs. CLIA
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: jel...@yumaregional.org To: timothy.mor...@ucsfmedctr.org; histonet@lists.utsouthwestern.edu Date: Thu, 17 May 2012 17:52:44 + CC: Subject: [Histonet] RE: CAP vs. CLIA I completely agree with you on this. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto: histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken, Timothy Sent: Thursday, May 17, 2012 10:46 AM To: histonet@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-boun...@lists.utsouthwestern.edu [mailto: histonet-boun...@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@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.wil...@baylorhealth.edu -Original Message- From: Jesus Ellin [mailto:jel...@yumaregional.org] Sent: Thursday, May 17, 2012 9:24 AM To: 'Horn, Hazel V'; Willis, Donna G.; 'Courtney Pierce' Cc: histonet@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
RE: [Histonet] RE: CAP vs. CLIA
Bill I have to agree with you on this, but then again we have always been looked as a step children within the lab. What I see is word play here, Cyto tech and Med Tech (CLS) are to be credited with release of a result. But because there Tech ID number is on the result they are accountable for this. As we move forward in the computer age within Anatomic Pathology we are going to be seeing the same shift, but we need our professional societies, to start to transform our profession. I am talking about algorithm analysis, special stains, IHC, bio banking, etc. There are many decisions that make us more than just a point and push tech, for lack there of a better term. I do agree education is a barrier, but once again how did the CLS (Med Tech), Cyto tech evelove? I do recall when they were taught on the job or through military training, so to say they are better because of a degree is far from the truth. Many MANY tech these days are assets to our profession and as we move forward in the future they we need to look for ways to have properly credentialed and EXPERIANCED staff. I my self am witness to the lack of basic lab knowledge a new grads have, but we are also responsible because our clinical rotation programs are scares and we do not have time to train. The future is full of opportunity for all histology tech, educated and experience, we just need to move forward and have the healthy discussion and make the changes needed in order to establish our profession. From: WILLIAM DESALVO [mailto:wdesalvo@hotmail.com] Sent: Sunday, May 20, 2012 8:38 PM To: Jesus Ellin; Timothy Morken; histonet Subject: RE: [Histonet] RE: CAP vs. CLIA 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
Re: [Histonet] RE: CAP vs. CLIA
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: jel...@yumaregional.org To: timothy.mor...@ucsfmedctr.org; histonet@lists.utsouthwestern.edu Date: Thu, 17 May 2012 17:52:44 + CC: Subject: [Histonet] RE: CAP vs. CLIA I completely agree with you on this. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto: histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken, Timothy Sent: Thursday, May 17, 2012 10:46 AM To: histonet@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-boun...@lists.utsouthwestern.edu [mailto: histonet-boun...@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@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.wil...@baylorhealth.edu -Original Message- From: Jesus Ellin [mailto:jel...@yumaregional.org] Sent: Thursday, May 17, 2012 9:24 AM To: 'Horn, Hazel V'; Willis, Donna G.; 'Courtney Pierce' Cc: histonet@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
RE: [Histonet] RE: CAP vs. CLIA
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: jel...@yumaregional.org To: timothy.mor...@ucsfmedctr.org; histonet@lists.utsouthwestern.edu Date: Thu, 17 May 2012 17:52:44 + CC: Subject: [Histonet] RE: CAP vs. CLIA I completely agree with you on this. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken, Timothy Sent: Thursday, May 17, 2012 10:46 AM To: histonet@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
[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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Courtney Pierce Sent: Wednesday, May 16, 2012 2:27 PM To: histonet@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 RD - Oncology Innovation Navigating the new health 610 Oakmont Lane Westmont, IL 60559 Office: + 630-203-6234 courtney.pie...@quintiles.com clinical | commercial | consulting | capital ** IMPORTANT--PLEASE READ This electronic message, including its attachments, is COMPANY CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED information. If you are not the intended recipient, you are hereby notified that any use, disclosure, copying, or distribution of this message or any of the information included in it is unauthorized and strictly prohibited. If you have received this message in error, please immediately notify the sender by reply e-mail and permanently delete this message and its attachments, along with any copies thereof. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ** The information contained in this message may be privileged and confidential and protected from disclosure. If the reader of this message is not the intended recipient, or an employee or agent responsible for delivering this message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please notify us immediately by replying to the message and deleting it from your computer. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] RE: CAP vs. CLIA
Thank you! -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Thursday, May 17, 2012 8:26 AM To: 'Courtney Pierce' Cc: histonet@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Courtney Pierce Sent: Wednesday, May 16, 2012 2:27 PM To: histonet@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 RD - Oncology Innovation Navigating the new health 610 Oakmont Lane Westmont, IL 60559 Office: + 630-203-6234 courtney.pie...@quintiles.com clinical | commercial | consulting | capital ** IMPORTANT--PLEASE READ This electronic message, including its attachments, is COMPANY CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED information. If you are not the intended recipient, you are hereby notified that any use, disclosure, copying, or distribution of this message or any of the information included in it is unauthorized and strictly prohibited. If you have received this message in error, please immediately notify the sender by reply e-mail and permanently delete this message and its attachments, along with any copies thereof. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ** The information contained in this message may be privileged and confidential and protected from disclosure. If the reader of this message is not the intended recipient, or an employee or agent responsible for delivering this message to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is strictly prohibited. If you have received this communication in error, please notify us immediately by replying to the message and deleting it from your computer. Thank you
RE: [Histonet] RE: CAP vs. CLIA
This is a great info source to have. Thanks, Mike -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Pratt, Caroline Sent: Thursday, May 17, 2012 8:22 AM To: Horn, Hazel V; Courtney Pierce Cc: histonet@lists.utsouthwestern.edu Subject: RE: [Histonet] RE: CAP vs. CLIA Thank you! -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Thursday, May 17, 2012 8:26 AM To: 'Courtney Pierce' Cc: histonet@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Courtney Pierce Sent: Wednesday, May 16, 2012 2:27 PM To: histonet@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 RD - Oncology Innovation Navigating the new health 610 Oakmont Lane Westmont, IL 60559 Office: + 630-203-6234 courtney.pie...@quintiles.com clinical | commercial | consulting | capital ** IMPORTANT--PLEASE READ This electronic message, including its attachments, is COMPANY CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED information. If you are not the intended recipient, you are hereby notified that any use, disclosure, copying, or distribution of this message or any of the information included in it is unauthorized and strictly prohibited. If you have received this message in error, please immediately notify the sender by reply e-mail and permanently delete this message and its attachments, along with any copies thereof. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ** The information contained in this message may be privileged and confidential and protected from disclosure. If the reader of this message is not the intended recipient, or an employee or agent responsible
[Histonet] 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.wil...@baylorhealth.edu -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Thursday, May 17, 2012 7:26 AM To: 'Courtney Pierce' Cc: histonet@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Courtney Pierce Sent: Wednesday, May 16, 2012 2:27 PM To: histonet@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 RD - Oncology Innovation Navigating the new health 610 Oakmont Lane Westmont, IL 60559 Office: + 630-203-6234 courtney.pie...@quintiles.com clinical | commercial | consulting | capital ** IMPORTANT--PLEASE READ This electronic message, including its attachments, is COMPANY CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED information. If you are not the intended recipient, you are hereby notified that any use, disclosure, copying, or distribution of this message or any of the information included in it is unauthorized and strictly prohibited. If you have received this message in error, please immediately notify the sender by reply e-mail and permanently delete this message and its attachments, along with any copies thereof. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
[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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@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.wil...@baylorhealth.edu -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Thursday, May 17, 2012 7:26 AM To: 'Courtney Pierce' Cc: histonet@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Courtney Pierce Sent: Wednesday, May 16, 2012 2:27 PM To: histonet@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 RD - Oncology Innovation Navigating the new health 610 Oakmont Lane Westmont, IL 60559 Office: + 630-203-6234 courtney.pie...@quintiles.com clinical | commercial | consulting | capital ** IMPORTANT--PLEASE READ This electronic message, including its attachments, is COMPANY CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED information. If you are not the intended recipient, you are hereby notified that any use, disclosure, copying, or distribution of this message or any of the information included in it is unauthorized and strictly prohibited. If you have received this message in error, please immediately notify the sender by reply e-mail and permanently delete this message and its attachments, along with any copies thereof. Thank you
Re: [Histonet] RE: CAP vs. CLIA
I received the same alert and interpreted it the same as Hazel did. Also, the state inspector in my facility yesterday had the same interpretation. Sheila Haas Laboratory Manager MicroPath Laboratories, Inc. From: Horn, Hazel V hor...@archildrens.org To: 'Willis, Donna G.' donna.wil...@baylorhealth.edu; 'Courtney Pierce' courtney.pie...@quintiles.com Cc: histonet@lists.utsouthwestern.edu histonet@lists.utsouthwestern.edu Sent: Thursday, May 17, 2012 10:05 AM 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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@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.wil...@baylorhealth.edu -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Thursday, May 17, 2012 7:26 AM To: 'Courtney Pierce' Cc: histonet@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Courtney Pierce Sent: Wednesday, May 16, 2012 2:27 PM To: histonet@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 RD - Oncology Innovation Navigating the new health 610 Oakmont Lane Westmont, IL 60559 Office: + 630-203-6234 courtney.pie...@quintiles.com clinical | commercial | consulting | capital ** IMPORTANT--PLEASE READ This electronic message, including its attachments, is COMPANY CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED information. If you
[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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@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.wil...@baylorhealth.edu -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Thursday, May 17, 2012 7:26 AM To: 'Courtney Pierce' Cc: histonet@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message
[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.wil...@baylorhealth.edu -Original Message- From: Jesus Ellin [mailto:jel...@yumaregional.org] Sent: Thursday, May 17, 2012 9:24 AM To: 'Horn, Hazel V'; Willis, Donna G.; 'Courtney Pierce' Cc: histonet@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@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.wil...@baylorhealth.edu -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Thursday, May 17, 2012 7:26 AM To: 'Courtney Pierce' Cc: histonet@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
[Histonet] RE: CAP vs. CLIA
You hit the nail on the head! Linda -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@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.wil...@baylorhealth.edu -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Thursday, May 17, 2012 7:26 AM To: 'Courtney Pierce' Cc: histonet@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
[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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Blazek, Linda [mailto:lbla...@digestivespecialists.com] Sent: Thursday, May 17, 2012 9:27 AM To: 'Jesus Ellin'; Horn, Hazel V; 'Willis, Donna G.'; 'Courtney Pierce' Cc: histonet@lists.utsouthwestern.edu Subject: RE: CAP vs. CLIA You hit the nail on the head! Linda -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@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.wil...@baylorhealth.edu -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Horn, Hazel V Sent: Thursday, May 17, 2012 7:26 AM To: 'Courtney Pierce' Cc: histonet@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
[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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Blazek, Linda [mailto:lbla...@digestivespecialists.com] Sent: Thursday, May 17, 2012 9:27 AM To: 'Jesus Ellin'; Horn, Hazel V; 'Willis, Donna G.'; 'Courtney Pierce' Cc: histonet@lists.utsouthwestern.edu Subject: RE: CAP vs. CLIA You hit the nail on the head! Linda -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@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.wil...@baylorhealth.edu -Original Message
[Histonet] RE: CAP vs. CLIA
Here is the CLIA method of determining a high complexity test. Taken from : http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124208.htm Tim Morken CLIA Categorization Criteria Each specific laboratory test system, assay, and examination is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the seven criteria listed below. A score of 1 indicates the lowest level of complexity, and the score of 3 indicates the highest level. These scores are totaled. Test systems, assays or examinations receiving scores of 12 or less are categorized as moderate complexity, while those receiving scores above 12 are categorized as high complexity. Note: A score of 2 will be assigned to a criteria heading when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3 Tests may also be categorized as waived.1 Criteria for Categorization (1) Knowledge. Score 1. (A) Minimal scientific and technical knowledge is required to perform the test; and (B) Knowledge required to perform the test may be obtained through on-the-job instruction. Score 3. Specialized scientific and technical knowledge is essential to perform preanalytic, analytic or postanalytic phases of the testing. (2) Training and experience. Score 1. (A) Minimal training is required for preanalytic, analytic and postanalytic phases of the testing process; and (B) Limited experience is required to perform the test. Score 3. (A) Specialized training is essential to perform the preanalytic, analytic or postanalytic testing process; or Substantial experience may be necessary for analytic test performance. (3) Reagents and materials preparation. Score 1. (A) Reagents and materials are generally stable and reliable; and (B) Reagents and materials are prepackaged, or premeasured, or require no special handling, precautions or storage conditions. Score 3. (A) Reagents and materials may be labile and may require special handling to assure reliability; or (B) Reagents and materials preparation may include manual steps such as gravimetric or volumetric measurements. (4) Characteristics of operational steps. Score 1. Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily controlled. Score 3. Operational steps in the testing process require close monitoring or control, and may require special specimen preparation,precise temperature control or timing of procedural steps, accuratepipetting, or extensive calculations. (5) Calibration, quality control, and proficiency testing materials. Score 1. (A) Calibration materials are stable and readily available; (B) Quality control materials are stable and readily available; and (C) External proficiency testing materials, when available, are stable. Score 3. (A) Calibration materials, if available, may be labile; (B) Quality control materials may be labile, or not available; or (C) External proficiency testing materials, if available, may be labile. (6) Test system troubleshooting and equipment maintenance. Score 1. (A) Test system troubleshooting is automatic or self-correcting, or clearly described or requires minimal judgment; and (B) Equipment maintenance is provided by the manufacturer, is seldom needed, or can easily be performed. Score 3. (A) Troubleshooting is not automatic and requires decision-making and direct intervention to resolve most problems; or (B) Maintenance requires special knowledge, skills, and abilities. (7) Interpretation and judgment. Score 1. (A) Minimal interpretation and judgment are required to perform preanalytic, analytic and postanalytic processes; and (B) Resolution of problems requires limited independent interpretation and judgment; and Score 3. (A) Extensive independent interpretation and judgment are required to perform the preanalytic, analytic or postanalytic processes; and (B) Resolution of problems requires extensive interpretation and judgment. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Courtney Pierce Sent: Wednesday, May 16, 2012 12:27 PM To: histonet@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 RD - Oncology Innovation Navigating the new health 610 Oakmont Lane Westmont, IL 60559 Office: + 630-203-6234 courtney.pie...@quintiles.com clinical | commercial | consulting | capital ** IMPORTANT--PLEASE READ This electronic message, including its attachments, is COMPANY CONFIDENTIAL and may contain PROPRIETARY or LEGALLY PRIVILEGED information. If
[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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Blazek, Linda [mailto:lbla...@digestivespecialists.com] Sent: Thursday, May 17, 2012 9:27 AM To: 'Jesus Ellin'; Horn, Hazel V; 'Willis, Donna G.'; 'Courtney Pierce' Cc: histonet@lists.utsouthwestern.edu Subject: RE: CAP vs. CLIA You hit the nail on the head! Linda -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@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
RE: [Histonet] RE: CAP vs. CLIA
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.mor...@ucsfmedctr.org To: timothy.mor...@ucsfmedctr.org; hor...@archildrens.org; lbla...@digestivespecialists.com; jel...@yumaregional.org; donna.wil...@baylorhealth.edu; courtney.pie...@quintiles.com Date: Thu, 17 May 2012 09:50:29 -0700 CC: histonet@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Blazek, Linda [mailto:lbla...@digestivespecialists.com] Sent: Thursday, May 17, 2012 9:27 AM To: 'Jesus Ellin'; Horn, Hazel V; 'Willis, Donna G.'; 'Courtney Pierce' Cc: histonet@lists.utsouthwestern.edu Subject: RE: CAP vs. CLIA You hit the nail on the head! Linda -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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
[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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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.wil...@baylorhealth.edu -Original Message- From: Jesus Ellin [mailto:jel...@yumaregional.org] Sent: Thursday, May 17, 2012 9:24 AM To: 'Horn, Hazel V'; Willis, Donna G.; 'Courtney Pierce' Cc: histonet@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@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
[Histonet] RE: CAP vs. CLIA
I completely agree with you on this. -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken, Timothy Sent: Thursday, May 17, 2012 10:46 AM To: histonet@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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.wil...@baylorhealth.edu -Original Message- From: Jesus Ellin [mailto:jel...@yumaregional.org] Sent: Thursday, May 17, 2012 9:24 AM To: 'Horn, Hazel V'; Willis, Donna G.; 'Courtney Pierce' Cc: histonet@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@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@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 hor...@archildrens.org archildrens.org 100 YEARS YOUNG! JOIN THE PARTY AT ach100.org -Original Message- From: Willis, Donna G. [mailto:donna.wil...@baylorhealth.edu] Sent: Thursday, May 17, 2012 8:42 AM To: Horn, Hazel V; 'Courtney Pierce' Cc: histonet@lists.utsouthwestern.edu Subject: RE: CAP vs. CLIA I have to say I disagree
