[Histonet] RE: Cap ER/PR

2014-10-29 Thread Morken, Timothy
Karen, when this has happened in the past CAP has told me to run the test and 
score it, then when the survey summary comes with the scores and discussion, to 
have the pathologist review and score the answers and document the review. It's 
about the best you can do when something gets missed. You may want to have two 
reviewers sign off in this case. 

Tim Morken
Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies
UC San Francisco Medical Center
San Francisco, CA

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-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Heckford, Karen 
- SMMC-SF
Sent: Wednesday, October 29, 2014 10:08 AM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Cap ER/PR

Good Morning,
Apparently while I was out on disability a CAP ER/PR PM2-A 2014 did not get 
done.  Somehow one of our pathologists got it and forgot she had it.  That 
being said, does anyone have a equivalent test they do instead.  We only do 
this CAP testing to show competency.

Thanks,

Karen Heckford HT ASCP CE
Lead Histology Technician
St. Mary's Medical Center
450 Stanyan St.
San Francisco, Ca. 94117
415-668-1000 ext. 6167
karen.heckf...@dignityhealth.org

  Caution:  This email message, including all content and attachments, is 
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RE: [Histonet] RE: Cap ER/PR

2014-10-29 Thread Jamal
I agree with Tim Morken


Best Regards,


Jamal M. Al Rowaihi Anatomic Pathology Supervisor   | Al Borg
Medical Laboratories |  Mobile +966 503629832|
j.rowa...@alborglaboratories.com 
Palestine St, Al Rajhi Building, P.O. Box 52817, Jeddah 21573, KSA|
Phone: +966 12 670 0099   | Fax: +966 12 676 4984 |
www.alborglaboratories.com


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Morken,
Timothy
Sent: Wednesday, October 29, 2014 8:15 PM
To: 'Heckford, Karen - SMMC-SF'; histonet@lists.utsouthwestern.edu
Subject: [Histonet] RE: Cap ER/PR

Karen, when this has happened in the past CAP has told me to run the test
and score it, then when the survey summary comes with the scores and
discussion, to have the pathologist review and score the answers and
document the review. It's about the best you can do when something gets
missed. You may want to have two reviewers sign off in this case. 

Tim Morken
Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies
UC San Francisco Medical Center
San Francisco, CA

CONFIDENTIALITY NOTICE: This email message, including any attachments, is
for the sole use of the intended recipient(s) and may contain confidential,
proprietary, and/or privileged information protected by law. If you are not
the intended recipient, you may not use, copy, or distribute this email
message or its attachments. If you believe you have received this email
message in error, please contact the sender by reply email and destroy all
copies of the original message.

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Heckford,
Karen - SMMC-SF
Sent: Wednesday, October 29, 2014 10:08 AM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Cap ER/PR

Good Morning,
Apparently while I was out on disability a CAP ER/PR PM2-A 2014 did not get
done.  Somehow one of our pathologists got it and forgot she had it.  That
being said, does anyone have a equivalent test they do instead.  We only do
this CAP testing to show competency.

Thanks,

Karen Heckford HT ASCP CE
Lead Histology Technician
St. Mary's Medical Center
450 Stanyan St.
San Francisco, Ca. 94117
415-668-1000 ext. 6167
karen.heckf...@dignityhealth.org
 
Caution:  This email message, including all content and attachments, is
CONFIDENTIAL and may be of a nature that is LEGALLY PRIVILEGED.  The
information contained in this email message is intended only for the use of
the recipient(s) named above. If the reader of this message is not the
intended recipient or an agent responsible for delivering it to the intended
recipient, you have received this document in error.  Any further review,
dissemination, distribution, or copying of this message is strictly
prohibited.  If you have received this communication in error, please notify
us  immediately by reply email.  Thank you.



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[Histonet] RE: CAP question ANP.22978 - Her2 assay validation

2014-04-30 Thread Vanessa Perez
https://www.biomax.us/tissue-arrays/Breast/

theres the link, they have various kinds, so just choose the one that comes 
with the IHC results



Vanessa Perez Garcia
Pathology Reference Lab
210-892-3746
210-892-3732
vpe...@pathreflab.com

-Original Message-
From: Martha Ward-Pathology [mailto:mw...@wakehealth.edu] 
Sent: Wednesday, April 30, 2014 7:11 AM
To: Vanessa Perez
Subject: RE: CAP question ANP.22978 - Her2 assay validation

Thanks.   I like the idea of the microarray slide as well.   Where did you 
purchase your slide?

martha

-Original Message-
From: Vanessa Perez [mailto:vpe...@pathreflab.com] 
Sent: Tuesday, April 29, 2014 5:18 PM
To: Martha Ward-Pathology; histonet@lists.utsouthwestern.edu
Subject: RE: CAP question ANP.22978 - Her2 assay validation

From what I have read and understand you should be able to do a write up the 
retroactive review based on the PT results.  What we did here was bought a 
microarray slide that came with the HER2/ER/PR results, ran them on our 
machine, and compared our results to the ones that came with the slide.


Vanessa Perez Garcia
Pathology Reference Lab
210-892-3746
210-892-3732
vpe...@pathreflab.com

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Martha 
Ward-Pathology
Sent: Tuesday, April 29, 2014 2:47 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP question ANP.22978 - Her2 assay validation

Hello all,

I have been reading through the most recent revisions and want to see how 
others are handling this question.   The explanation states that it is for new 
and existing assays and that if your validation does not meet current standards 
that you must supplement and bring it into compliance.  Furthermore if you do 
not have any documentation from the initial validation the assay must be fully 
revalidated and documented.

Our lab has been performing the Herceptest from Dako (FDA approved) since 
before 2008 and participating in the HER2 proficiency testing since it was 
first offered.   We have our statistical results comparing our IHC patient 
results to FISH Her2 results since 2008 and we have always done well on our CAP 
proficiency testing (95%-100%).We do inter-pathologist result comparisons, 
using know CAP slides and have 95% to 100% agreements.   

What I do not have however is the original results of the slides that were 
stained to set up the original assay.   Under these circumstances will we need 
to completely revalidate the assay, using the mandated 20+/20- cases, or can we 
simply do a retroactive formal review and write up of our past performances on 
our proficiency testing challenges?

Thanks in advance for your help with this!

 
Martha Ward, MT (ASCP) QIHC
Manager
 
Molecular Diagnostics Lab
Medical Center Boulevard  \  Winston-Salem, NC 27157


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[Histonet] RE: CAP question ANP.22978 - Her2 assay validation

2014-04-29 Thread Vanessa Perez
From what I have read and understand you should be able to do a write up the 
retroactive review based on the PT results.  What we did here was bought a 
microarray slide that came with the HER2/ER/PR results, ran them on our 
machine, and compared our results to the ones that came with the slide.


Vanessa Perez Garcia
Pathology Reference Lab
210-892-3746
210-892-3732
vpe...@pathreflab.com

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Martha 
Ward-Pathology
Sent: Tuesday, April 29, 2014 2:47 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP question ANP.22978 - Her2 assay validation

Hello all,

I have been reading through the most recent revisions and want to see how 
others are handling this question.   The explanation states that it is for new 
and existing assays and that if your validation does not meet current standards 
that you must supplement and bring it into compliance.  Furthermore if you do 
not have any documentation from the initial validation the assay must be fully 
revalidated and documented.

Our lab has been performing the Herceptest from Dako (FDA approved) since 
before 2008 and participating in the HER2 proficiency testing since it was 
first offered.   We have our statistical results comparing our IHC patient 
results to FISH Her2 results since 2008 and we have always done well on our CAP 
proficiency testing (95%-100%).We do inter-pathologist result comparisons, 
using know CAP slides and have 95% to 100% agreements.   

What I do not have however is the original results of the slides that were 
stained to set up the original assay.   Under these circumstances will we need 
to completely revalidate the assay, using the mandated 20+/20- cases, or can we 
simply do a retroactive formal review and write up of our past performances on 
our proficiency testing challenges?

Thanks in advance for your help with this!

 
Martha Ward, MT (ASCP) QIHC
Manager
 
Molecular Diagnostics Lab
Medical Center Boulevard  \  Winston-Salem, NC 27157


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[Histonet] RE: CAP Question, New Reagent Lot Confirmation of

2014-03-27 Thread Davis, Cassie
A pathologist is designated to sign off in our lab.

Cassandra Davis
cda...@che-east.org
302-575-8095



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RE: [Histonet] RE: CAP Annual Results Comparison for FISH/ISH

2014-03-15 Thread joelle weaver
Thank you Dr. Cartun, these numbers are helpful for reference 




Joelle Weaver MAOM, HTL (ASCP) QIHC
 
 From: richard.car...@hhchealth.org
 To: one...@wvuhealthcare.com; histonet@lists.utsouthwestern.edu
 Date: Fri, 14 Mar 2014 20:01:54 +
 CC: 
 Subject: [Histonet] RE: CAP Annual Results Comparison for FISH/ISH
 
 I'm not aware of published benchmarks for FISH/ISH, but if you're doing IHC 
 for ER, PR, and HER2 in breast CA you may find the following information 
 useful:
 
 Lal P, et al:  ER and PR and histologic features in 3,655 invasive breast 
 carcinomas.  Am J Clin Pathol 2005;123:541-546.
 
 ER+ tumors - 74%
 PR+ tumors - 49
 HER2+ tumors - 16%
 
 
 Fitzgibbons PL, et al:  Recommendations for validating ER and PR IHC assays.  
 Arch Pathol Lab Med 2010;134:930-935.
 
 For women over 65 years of age, the % of negative cases should not exceed 20%.
 For low-grade invasive carcinomas, the proportion of negative cases should 
 not exceed 5%.
 
 
 My own data for invasive breast CA:
 
 ER+ tumors - 85%
 PR+ tumors - 70%
 HER2+ tumors - 14%
 
 
 Please keep in mind that with the introduction of new monoclonal antibodies, 
 more sensitive detection systems, and the recommendation that tumors with 
 1% immunoreactive cells be called Positive, the old benchmarks for ER 
 and PR are no longer valid.
 
 Richard
 
 Richard W. Cartun, MS, PhD
 Director, Histology  Immunopathology
 Director, Biospecimen Collection Programs
 Assistant Director, Anatomic Pathology
 Hartford Hospital
 80 Seymour Street
 Hartford, CT  06102
 (860) 972-1596 Office
 (860) 545-2204 Fax
 richard.car...@hhchealth.org
 
 
 
 
 -Original Message-
 From: histonet-boun...@lists.utsouthwestern.edu 
 [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of O'neil, Beth
 Sent: Wednesday, March 12, 2014 2:41 PM
 To: histonet@lists.utsouthwestern.edu
 Subject: [Histonet] CAP Annual Results Comparison for FISH/ISH
 
 Would fellow Histonetters be able to explain how they answer the following 
 CAP question:
 ANP.22970 For immunohistochemical and FISH/ISH tests that provide independent 
 predictive information, the laboratory at least annually compares its patient 
 results with published benchmarks, and evaluates interobserver variability 
 among the pathologists in the laboratory.
 Where would one even find published benchmarks?  Thank you
 
 Beth Ann O'Neil, MT(ASCP)SC, HTL, QIHC
 Histology Supervisor/Technical Specialist West Virginia University Hospitals 
 one...@wvuhealthcare.com
 304-293-7629 (office)
 304-293-6014 (lab)
 
 
 
 
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 information. Any unauthorized review, use, disclosure, or distribution is 
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 contact the sender by reply e-mail and destroy all copies of the original 
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[Histonet] RE: CAP Annual Results Comparison for FISH/ISH

2014-03-14 Thread Cartun, Richard
I'm not aware of published benchmarks for FISH/ISH, but if you're doing IHC for 
ER, PR, and HER2 in breast CA you may find the following information useful:

Lal P, et al:  ER and PR and histologic features in 3,655 invasive breast 
carcinomas.  Am J Clin Pathol 2005;123:541-546.

ER+ tumors - 74%
PR+ tumors - 49
HER2+ tumors - 16%


Fitzgibbons PL, et al:  Recommendations for validating ER and PR IHC assays.  
Arch Pathol Lab Med 2010;134:930-935.

For women over 65 years of age, the % of negative cases should not exceed 20%.
For low-grade invasive carcinomas, the proportion of negative cases should 
not exceed 5%.


My own data for invasive breast CA:

ER+ tumors - 85%
PR+ tumors - 70%
HER2+ tumors - 14%


Please keep in mind that with the introduction of new monoclonal antibodies, 
more sensitive detection systems, and the recommendation that tumors with 
1% immunoreactive cells be called Positive, the old benchmarks for ER and 
PR are no longer valid.

Richard

Richard W. Cartun, MS, PhD
Director, Histology  Immunopathology
Director, Biospecimen Collection Programs
Assistant Director, Anatomic Pathology
Hartford Hospital
80 Seymour Street
Hartford, CT  06102
(860) 972-1596 Office
(860) 545-2204 Fax
richard.car...@hhchealth.org




-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of O'neil, Beth
Sent: Wednesday, March 12, 2014 2:41 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP Annual Results Comparison for FISH/ISH

Would fellow Histonetters be able to explain how they answer the following CAP 
question:
ANP.22970 For immunohistochemical and FISH/ISH tests that provide independent 
predictive information, the laboratory at least annually compares its patient 
results with published benchmarks, and evaluates interobserver variability 
among the pathologists in the laboratory.
Where would one even find published benchmarks?  Thank you

Beth Ann O'Neil, MT(ASCP)SC, HTL, QIHC
Histology Supervisor/Technical Specialist West Virginia University Hospitals 
one...@wvuhealthcare.com
304-293-7629 (office)
304-293-6014 (lab)




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RE: [Histonet] RE: CAP Annual Results Comparison for FISH/ISH

2014-03-13 Thread joelle weaver
are you looking for the stats in the notes for ANP. 22970 (2012) ?
 
overall ER negative breast ca ( invasive DCIS) should not exceed 30% ( lower 
average 20-35% in post menopausal) , lower in well differentiated tumors...etc.
 
I sure CAP can also send or repeat them to you if  you prefer to call them. 
 
 




Joelle Weaver MAOM, HTL (ASCP) QIHC
 
 Date: Thu, 13 Mar 2014 14:06:23 -0400
 From: tbr...@holyredeemer.com
 To: histonet@lists.utsouthwestern.edu
 Subject: [Histonet] RE: CAP Annual Results Comparison for FISH/ISH 
 
 Try calling CAP.  They provided the benchmarks we use for our annual
 statistics for ER/PR.  I don't have the recent CAP checklist handy, but
 on the 9.25.2012 checklist, the benchmarks for ER/PR are published in
 the notes section of the question. I hope this helps. Sincerely, Terri
 
 Terri L. Braud, HT(ASCP)
 Anatomic Pathology Supervisor
 Holy Redeemer Hospital Laboratory
 1648 Huntingdon Pike
 Meadowbrook, PA 19046
 Ph: 215-938-3676
 Fax: 215-938-3874
 
 Message: 3
 Date: Wed, 12 Mar 2014 18:40:53 +
 From: O'neil, Beth one...@wvuhealthcare.com
 Subject: [Histonet] CAP Annual Results Comparison for FISH/ISH
 Would fellow Histonetters be able to explain how they answer the
 following CAP question:
 ANP.22970 For immunohistochemical and FISH/ISH tests that provide
 independent predictive information, the laboratory at least annually
 compares its patient results with published benchmarks, and evaluates
 interobserver variability among the pathologists in the laboratory.
 Where would one even find published benchmarks?  Thank you
 
 Beth Ann O'Neil, MT(ASCP)SC, HTL, QIHC
 Histology Supervisor/Technical Specialist
 West Virginia University Hospitals
 one...@wvuhealthcare.com
 304-293-7629 (office)
 304-293-6014 (lab)
 
 **
 -
 
 
 
 CONFIDENTIALITY NOTICE:
 
 This E-Mail is intended only for the use of the individual or entity to which
 it was sent. It may contain information that is privileged and/or 
 confidential,
 and the use or disclosure of such information may also be restricted under 
 applicable
 federal and state law. If you received this communication in error, please do 
 not
 distribute any part of it or retain any copies, and delete the original 
 E-Mail.
 Please notify the sender of any error by E-Mail.
 
 Thank you for your cooperation.
 
 
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RE: [Histonet] RE: CAP Annual Results Comparison for FISH/ISH

2014-03-13 Thread joelle weaver
sorry , saw the Predictive, missed FISH - getting ready to do this myself. I 
would just call CAP, if I get to do that soon I will send along what 
information they supply.  




Joelle Weaver MAOM, HTL (ASCP) QIHC
 
 From: joellewea...@hotmail.com
 To: tbr...@holyredeemer.com; histonet@lists.utsouthwestern.edu
 Date: Thu, 13 Mar 2014 18:44:37 +
 Subject: RE: [Histonet] RE: CAP Annual Results Comparison for FISH/ISH
 CC: 
 
 are you looking for the stats in the notes for ANP. 22970 (2012) ?
  
 overall ER negative breast ca ( invasive DCIS) should not exceed 30% ( lower 
 average 20-35% in post menopausal) , lower in well differentiated 
 tumors...etc.
  
 I sure CAP can also send or repeat them to you if  you prefer to call them. 
  
  
 
 
 
 
 Joelle Weaver MAOM, HTL (ASCP) QIHC
  
  Date: Thu, 13 Mar 2014 14:06:23 -0400
  From: tbr...@holyredeemer.com
  To: histonet@lists.utsouthwestern.edu
  Subject: [Histonet] RE: CAP Annual Results Comparison for FISH/ISH 
  
  Try calling CAP.  They provided the benchmarks we use for our annual
  statistics for ER/PR.  I don't have the recent CAP checklist handy, but
  on the 9.25.2012 checklist, the benchmarks for ER/PR are published in
  the notes section of the question. I hope this helps. Sincerely, Terri
  
  Terri L. Braud, HT(ASCP)
  Anatomic Pathology Supervisor
  Holy Redeemer Hospital Laboratory
  1648 Huntingdon Pike
  Meadowbrook, PA 19046
  Ph: 215-938-3676
  Fax: 215-938-3874
  
  Message: 3
  Date: Wed, 12 Mar 2014 18:40:53 +
  From: O'neil, Beth one...@wvuhealthcare.com
  Subject: [Histonet] CAP Annual Results Comparison for FISH/ISH
  Would fellow Histonetters be able to explain how they answer the
  following CAP question:
  ANP.22970 For immunohistochemical and FISH/ISH tests that provide
  independent predictive information, the laboratory at least annually
  compares its patient results with published benchmarks, and evaluates
  interobserver variability among the pathologists in the laboratory.
  Where would one even find published benchmarks?  Thank you
  
  Beth Ann O'Neil, MT(ASCP)SC, HTL, QIHC
  Histology Supervisor/Technical Specialist
  West Virginia University Hospitals
  one...@wvuhealthcare.com
  304-293-7629 (office)
  304-293-6014 (lab)
  
  **
  -
  
  
  
  CONFIDENTIALITY NOTICE:
  
  This E-Mail is intended only for the use of the individual or entity to 
  which
  it was sent. It may contain information that is privileged and/or 
  confidential,
  and the use or disclosure of such information may also be restricted under 
  applicable
  federal and state law. If you received this communication in error, please 
  do not
  distribute any part of it or retain any copies, and delete the original 
  E-Mail.
  Please notify the sender of any error by E-Mail.
  
  Thank you for your cooperation.
  
  
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[Histonet] RE: CAP survey Question

2013-12-05 Thread Sue Hunter
We do the same process as Linda does here at Beaumont.
Sue

Sue Hunter, Supervisor
Advanced Diagnostics
Beaumont Health System
Royal Oak MI
248-898-5146
shun...@beaumont.edu



-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Sebree Linda A
Sent: Wednesday, December 04, 2013 4:34 PM
To: 'Vickroy, Jim'; histonet@lists.utsouthwestern.edu
Subject: [Histonet] RE: CAP survey Question

We also have Ultras Jim.  We don't print out the run logs.  IHC personnel 
review the controls before they go to a pathologist in order to catch any 
problems.  The pathologists are supposed to review the controls associated with 
each case they sign out.  Our pathology report has a statement included that 
the negative and positive controls have stained appropriately.  By signing off 
on each case, the pathologist is attesting to the fact that he has indeed 
reviewed the controls...we do not police them.

So far, this works for us.

Linda A. Sebree
University of Wisconsin Hospital  Clinics IHC/ISH Laboratory
600 Highland Ave. 
Madison, WI 53792
(608)265-6596
FAX: (608)262-7174 


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Vickroy, Jim
Sent: Wednesday, December 04, 2013 2:51 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP survey Question


For a long time I have had our IHC techs print out the run logs from each IHC 
run on the Benchmark Ultras.   The techs then check the slides to make sure the 
positive and negative controls have worked properly before the slides are sent 
to the individual pathologists.  The pathologists are also supposed to check 
the controls before looking at the patient slides.   Lately in the interest of 
reducing turnaround time I have been asked why we run the log reports and have 
a tech look over the controls before they send them to the pathologists since 
the pathologist will also evaluate the controls.   I have been doing this 
because I wanted the documentation that someone reviewed the controls each time 
an IHC stain was done.  I believe if the pathologists would document someplace 
that the control slides were reviewed before the patient slides were viewed 
then I could eliminate the techs looking over the controls also.   Problem is 
how are others documenting that the controls are reviewed?  Is this done by the 
techs, the pathologists, or both?  We of course have also used this data for 
quality assurance of our stains.   Thanks for your help.

Jim

James Vickroy BS, HT(ASCP)

Surgical  and Autopsy Pathology Technical Supervisor Memorial Medical Center
217-788-4046



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[Histonet] RE: CAP survey Question

2013-12-04 Thread Sebree Linda A
We also have Ultras Jim.  We don't print out the run logs.  IHC personnel 
review the controls before they go to a pathologist in order to catch any 
problems.  The pathologists are supposed to review the controls associated with 
each case they sign out.  Our pathology report has a statement included that 
the negative and positive controls have stained appropriately.  By signing off 
on each case, the pathologist is attesting to the fact that he has indeed 
reviewed the controls...we do not police them.

So far, this works for us.

Linda A. Sebree 
University of Wisconsin Hospital  Clinics 
IHC/ISH Laboratory 
600 Highland Ave. 
Madison, WI 53792 
(608)265-6596 
FAX: (608)262-7174 


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Vickroy, Jim
Sent: Wednesday, December 04, 2013 2:51 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP survey Question


For a long time I have had our IHC techs print out the run logs from each IHC 
run on the Benchmark Ultras.   The techs then check the slides to make sure the 
positive and negative controls have worked properly before the slides are sent 
to the individual pathologists.  The pathologists are also supposed to check 
the controls before looking at the patient slides.   Lately in the interest of 
reducing turnaround time I have been asked why we run the log reports and have 
a tech look over the controls before they send them to the pathologists since 
the pathologist will also evaluate the controls.   I have been doing this 
because I wanted the documentation that someone reviewed the controls each time 
an IHC stain was done.  I believe if the pathologists would document someplace 
that the control slides were reviewed before the patient slides were viewed 
then I could eliminate the techs looking over the controls also.   Problem is 
how are others documenting that the controls are reviewed?  Is this done by the 
techs, the pathologists, or both?  We of course have also used this data for 
quality assurance of our stains.   Thanks for your help.

Jim

James Vickroy BS, HT(ASCP)

Surgical  and Autopsy Pathology Technical Supervisor Memorial Medical Center
217-788-4046



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[Histonet] Re: Cap is in the house

2013-09-04 Thread Teri Johnson
Good morning from warm, muggy San Diego!

I understand why some folks have a bit of a short fuse with superfluous seeming 
emails from the Histonet. It's the same reason we are not allowed to send 
emails out to all associates at work. Most have an over-active email account 
anyway and it's just another one that takes their time to read.

For those folks, I recommend subscribing to the Histonet digest. You get one, 
maybe two emails a day only, with the complete compilation of the day's 
questions, comments, witty retorts, etc. You can visit here: 
http://lists.utsouthwestern.edu/mailman/listinfo/histonet and change your mail 
delivery.

Otherwise, I recommend a quick scan and liberal use of the delete button.

Teri Johnson
Manager, Histology
GNF - San Diego, CA
858-332-4752

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[Histonet] RE: CAP standard GEN 61300

2013-05-06 Thread Tom McNemar
I am very interested in this as well.  We have an ongoing issue with 
humidity/static.  I have been unable to find anything that lists a recommended 
humidity level for histology.  New construction building codes for labs list 
30% - 80% and the equipment manufacturers list 30% - 80% for their recommended 
operating environment.

Based on two different digital readers, our humidity is sometimes in the 20% 
range (mostly in winter but not always).  A hand operated device reads about 
40% higher than the digitals so I don't quite know what to make of it.

Anyway, I will appreciated any input.

Tom McNemar, HT(ASCP)
Histology Co-ordinator
Licking Memorial Health Systems
(740) 348-4163
(740) 348-4166
tmcne...@lmhealth.org
www.LMHealth.org

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Knutson, Deanne
Sent: Monday, May 06, 2013 8:13 AM
To: 'histonet@lists.utsouthwestern.edu'
Subject: [Histonet] CAP standard GEN 61300

Fellow Histonetters,

I am looking for advice concerning CAP standard GEN 61300 Climate Control.

To those that take humidity records in your lab, what exact % range do you use 
for a normal range?

And what do you do if and when you are out of this range?

Thank you for sharing your workflow info with me.

Deanne Knutson
Anatomic Pathology Supervisor
St. Alexius Medical Center
701-530-6730
dknut...@primecare.orgmailto:dknut...@primecare.org




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Re: [Histonet] RE: CAP standard GEN 61300

2013-05-06 Thread Katelin Lester
We are also going through humidity issues post inspection. Our values are
based on the specifications in the equipment manuals and are 30%-80%. We
use a digital reader. We have been dipping below that and are working to
get the humidity up. We have brought in a small humidifier but it is not
keeping up on very dry days.
It is in our policy to report out of range values to our supervisor and she
is now looking in to a more permanent solution.
We would also appreciate any comments on how other labs have increased
their humidity.

Katelin Lester, HTL
On May 6, 2013 7:47 AM, Tom McNemar tmcne...@lmhealth.org wrote:

 I am very interested in this as well.  We have an ongoing issue with
 humidity/static.  I have been unable to find anything that lists a
 recommended humidity level for histology.  New construction building codes
 for labs list 30% - 80% and the equipment manufacturers list 30% - 80% for
 their recommended operating environment.

 Based on two different digital readers, our humidity is sometimes in the
 20% range (mostly in winter but not always).  A hand operated device reads
 about 40% higher than the digitals so I don't quite know what to make of it.

 Anyway, I will appreciated any input.

 Tom McNemar, HT(ASCP)
 Histology Co-ordinator
 Licking Memorial Health Systems
 (740) 348-4163
 (740) 348-4166
 tmcne...@lmhealth.org
 www.LMHealth.org

 -Original Message-
 From: histonet-boun...@lists.utsouthwestern.edu [mailto:
 histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Knutson, Deanne
 Sent: Monday, May 06, 2013 8:13 AM
 To: 'histonet@lists.utsouthwestern.edu'
 Subject: [Histonet] CAP standard GEN 61300

 Fellow Histonetters,

 I am looking for advice concerning CAP standard GEN 61300 Climate Control.

 To those that take humidity records in your lab, what exact % range do you
 use for a normal range?

 And what do you do if and when you are out of this range?

 Thank you for sharing your workflow info with me.

 Deanne Knutson
 Anatomic Pathology Supervisor
 St. Alexius Medical Center
 701-530-6730
 dknut...@primecare.orgmailto:dknut...@primecare.org



 
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 not intended for your use, please destroy immediately and contact the
 sender of the message.

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 use of the contents of this e-mail and attachments is prohibited. If you
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RE: [Histonet] RE: CAP standard GEN 61300

2013-05-06 Thread WILLIAM DESALVO
To address Gen 61300, you have to check your instrument manuals, and MSDS for 
all your reagents. Create the acceptable ranges and then monitor. Make sure you 
create a process to address out of range issues. We use Tutela Medical devices 
to monitor both temp and humidity. Our facilites installed and maintains 
records.
 
 http://www.tutelamedical.com/

William DeSalvo, BS HTL(ASCP)
Production Manager-Anatomic Pathology
Chair, NSH Quality Management Committee
Owner/Consultant, Collaborative Advantage Consulting

 

 Date: Mon, 6 May 2013 08:12:01 -0700
 From: katelin09...@gmail.com
 To: tmcne...@lmhealth.org
 Subject: Re: [Histonet] RE: CAP standard GEN 61300
 CC: histonet@lists.utsouthwestern.edu; dknut...@primecare.org
 
 We are also going through humidity issues post inspection. Our values are
 based on the specifications in the equipment manuals and are 30%-80%. We
 use a digital reader. We have been dipping below that and are working to
 get the humidity up. We have brought in a small humidifier but it is not
 keeping up on very dry days.
 It is in our policy to report out of range values to our supervisor and she
 is now looking in to a more permanent solution.
 We would also appreciate any comments on how other labs have increased
 their humidity.
 
 Katelin Lester, HTL
 On May 6, 2013 7:47 AM, Tom McNemar tmcne...@lmhealth.org wrote:
 
  I am very interested in this as well. We have an ongoing issue with
  humidity/static. I have been unable to find anything that lists a
  recommended humidity level for histology. New construction building codes
  for labs list 30% - 80% and the equipment manufacturers list 30% - 80% for
  their recommended operating environment.
 
  Based on two different digital readers, our humidity is sometimes in the
  20% range (mostly in winter but not always). A hand operated device reads
  about 40% higher than the digitals so I don't quite know what to make of it.
 
  Anyway, I will appreciated any input.
 
  Tom McNemar, HT(ASCP)
  Histology Co-ordinator
  Licking Memorial Health Systems
  (740) 348-4163
  (740) 348-4166
  tmcne...@lmhealth.org
  www.LMHealth.org
 
  -Original Message-
  From: histonet-boun...@lists.utsouthwestern.edu [mailto:
  histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Knutson, Deanne
  Sent: Monday, May 06, 2013 8:13 AM
  To: 'histonet@lists.utsouthwestern.edu'
  Subject: [Histonet] CAP standard GEN 61300
 
  Fellow Histonetters,
 
  I am looking for advice concerning CAP standard GEN 61300 Climate Control.
 
  To those that take humidity records in your lab, what exact % range do you
  use for a normal range?
 
  And what do you do if and when you are out of this range?
 
  Thank you for sharing your workflow info with me.
 
  Deanne Knutson
  Anatomic Pathology Supervisor
  St. Alexius Medical Center
  701-530-6730
  dknut...@primecare.orgmailto:dknut...@primecare.org
 
 
 
  
  This email may include confidential and privileged information. If this is
  not intended for your use, please destroy immediately and contact the
  sender of the message.
 
  ___
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  This e-mail, including attachments, is intended for the sole use of the
  individual and/or entity to whom it is addressed, and contains information
  from Licking Memorial Health Systems which is confidential or privileged.
  If you are not the intended recipient, nor authorized to receive for the
  intended recipient, be aware that any disclosure, copying, distribution or
  use of the contents of this e-mail and attachments is prohibited. If you
  have received this in error, please advise the sender by reply e-mail and
  delete the message immediately. You may also contact the LMH Process
  Improvement Center at 740-348-4641. E-mail transmissions cannot be
  guaranteed to be secure or error-free as information could be intercepted,
  corrupted, lost, destroyed, arrive late or incomplete, or contain viruses.
  The sender therefore does not accept liability for any errors or omissions
  in the contents of this message, which arise as a result of e-mail
  transmission. Thank you.
 
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[Histonet] RE: CAP checklist question

2013-02-25 Thread Susan.Walzer
We put in a procedure stating that should we change the schedule we will test a 
variety of tissue (10 different types) and have the pathologist assess the run. 
We have not changed a schedule in years but we seek to comply...

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Hannen, Valerie
Sent: Monday, February 25, 2013 1:21 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP checklist question

Hi gang..

I am working on a self-inspection CAP checklist and came across the following:

ANP.23120   Tissue Processor

Tissue processing schedules are validated.   Note: New tissue 
processing schedules must be validated against the standard laboratory 
processing schedule.

  Evidence of compliance:   Written procedure for validation of new tissue 
processing schedules AND
 WC records documenting validation

What do you all make of this??  We have not had any new processing schedules 
introduced into our lab in years. So, I really don't know how to proceed on 
this one.
Any insite will be greatly appreciated.

Valerie A. Hannen, MLT(ASCP),HTL,SU(FL)
Histology Section Chief
Parrish Medical Center
951 N. Washington Ave.
Titusville, Florida 32976
Phone:(321) 268-6333 ext. 7506
Fax: (321) 268-6149
valerie.han...@parrishmed.com


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[Histonet] RE: CAP Gen.55500

2013-02-21 Thread Sharon Scalise
Another area I am wondering about is competency for the PA's.  Anyone have 
something they can share?

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Michelle 
Lamphere
Sent: Thursday, February 21, 2013 3:02 PM
To: 'histonet@lists.utsouthwestern.edu'
Subject: [Histonet] CAP Gen.55500

Good afternoon
We were wondering how other labs handle their training/competencies in response 
to the revised Competency Assessment question in the Gen Lab portion of the 
checklist. (GEN.55500)

1.   How do you do your training before you start your competency?

2.   How do you differentiate initial training from initial competency?

3.   Is semiannually after the date of hire?  Or after training?  Or not 
until after initial competency?  And how does that apply to skills that would 
only be utilized once or twice a year (such as a special stain that you do not 
perform on a routine basis but still offer)?

4.   How do you train without using actual patients?  
Example...accessioning, embedding, processing, etc

5.   What template do you use to incorporate all six elements that are 
listed?

6.   What are you incorporating as your test system?

I really appreciate any insight or advice you can offer.  Thank you!

Michelle M Lamphere, HT (ASCP)
Senior Tech, Histology
Children's Medical Center
1935 Medical District Drive
Dallas, TX  75235
Office :214-456-2798
Histology: 214-456-2318
Fax:  214-456-0779


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[Histonet] RE: CAP Gen.55500

2013-02-21 Thread Morken, Timothy
Michelle, The competencies must be keyed to the persons job description. You 
hired the person with some kind of assurance they could do the work for a 
particular job. They them must be trained into your system for that job. 


1.   How do you do your training before you start your competency?

A:  The training is driven by a checklist of whatever it is they need to be 
trained at. You assume they know how to cut sections but you will orient them 
to the microtome, etc that your lab uses, show them how it works and then have 
them do it.  Once they demonstrate they can do it, you have completed that 
portion of training and you can also sign off their competency.  Then you go 
down the checklist. It may take many months before they complete the entire 
training if they are expected to be general histotechs rotating to all sections.

2.   How do you differentiate initial training from initial competency? 
A: Training first, then competency. Even if they know how to do it, there 
will be differences in the way your lab does it verses what they have done 
elsewhere. The key is for them to know how to do it in your lab and what you 
expect from them.

3AIs semiannually after the date of hire?  Or after training?  Or not 
until after initial competency?  
A: They are hired, they are trained and at 6 months you review their competency 
and give a 6-month evaluation. We keep records of all the cases they do in the 
first 6 months and use that as evidence of competency. You need to determine if 
they are done training, need more work, etc. After that they are reviewed 
annually. (so, initial hire, 6 month competency review, then at 18 months they 
get their first annual review)

3B And how does that apply to skills that would only be utilized once or twice 
a year (such as a special stain that you do not perform on a routine basis but 
still offer)?
A: there will always be some things that are not done very often. We only 
include routine processes in the initial training and competency. They can be 
trained in rare tests at the time those come in. After they are trained we 
require people to do at least one of the rare tests per year, even on a 
control, to maintain competency. If they do not do that they are taken off the 
list of people who can do that test and must retrain.

4.   How do you train without using actual patients?  
Example...accessioning, embedding, processing, etc
A: all LIS have TEST modules that can also be loaded with dummy patients to use 
as training modules as well.
All other histology training can be done initially on excess tissue saved for 
that purpose. You can get bx needles and make your own biopsies to train people 
to embed well. Etc. Make paraffin blocks from excess tissue of various types 
for initial microtome training. Use controls for special stains. Etc. 

5.   What template do you use to incorporate all six elements that are 
listed?
A: We have a standard institution-wide template for this. It is up to each area 
to fill it with the job description that applies and determine how the elements 
are applied. It is a lot of work initially, but pays off in standardized 
evaluations later on.

6.   What are you incorporating as your test system?

A: The test system is your standard procedures, but no one actually takes part 
in the entire system 9ie, tissue procurement to reporting). BUT they must know 
the elements of each part to understand the whole. So, you can educate them 
about the parts that take place outside the lab, but they are trained on the 
parts that take place in your lab that they will actually do. I stress that 
understanding the entire test system and their part in it is very, very 
valuable to their understanding of their role.

Have fun!


Tim Morken
Supervisor, Electron Microscopy/Neuromuscular Special Studies
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 Michelle 
Lamphere
Sent: Thursday, February 21, 2013 12:02 PM
To: 'histonet@lists.utsouthwestern.edu'
Subject: [Histonet] CAP Gen.55500

Good afternoon
We were wondering how other labs handle their training/competencies in response 
to the revised Competency Assessment question in the Gen Lab portion of the 
checklist. (GEN.55500)

1.   How do you do your training before you start your competency?

2.   How do you differentiate initial training from initial competency?

3.   Is semiannually after the date of hire?  Or after training?  Or not 
until after initial competency?  And how does that apply to skills that would 
only be utilized once or twice a year (such as a special stain that you do not 
perform on a routine basis but still offer)?

4.   How do you train without using actual patients?  
Example...accessioning, embedding, processing, etc

5.   What template do you use to incorporate all six 

[Histonet] RE: CAP guideline for fixation time

2013-01-07 Thread Weems, Joyce K.
Our OR and Breast Health staff have done pretty well getting on board with 
this. We rarely have one that hasn't been documented.



We have a place on the requisition (located just under the date field so they 
will see it) where time out of body (for the cold ischemic time), and time into 
formalin is documented. Then we document the rest on the requisition and the 
pathologist takes it from there.







Joyce Weems

Pathology Manager

678-843-7376 Phone

678-843-7831 Fax

joyce.we...@emoryhealthcare.org







www.saintjosephsatlanta.org

5665 Peachtree Dunwoody Road

Atlanta, GA 30342



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contain information that is privileged and confidential.  Any unauthorized 
review, use, disclosure, or distribution is prohibited. If you are not the 
intended recipient, please delete this message, and reply to the sender 
regarding the error in a separate email.



-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Victor A. Tobias
Sent: Friday, January 04, 2013 6:21 PM
To: 'histonet'
Subject: [Histonet] CAP guideline for fixation time



Per CAP guideline, in our reports of predictive markers(ER/PR/Her2), 
Pathologists need to check that the total fixation time of specimens is within 
the CAP guideline. Is this information readily available to the pathologists at 
the time of writing the report? How are others documenting this?



Have a great weekend.



Victor



Victor Tobias HT(ASCP)

Clinical Applications Analyst

Harborview Medical Center

Dept of Pathology Room NJB244

Seattle, WA 98104

vtob...@u.washington.edumailto:vtob...@u.washington.edumailto:vtob...@u.washington.edu%3cmailto:vtob...@u.washington.edu

206-744-2735

206-744-8240 Fax

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[Histonet] RE: CAP guideline for fixation time

2013-01-07 Thread Jesus Ellin
We have it documented within the APLIS, when the order is placed within our 
EMR,, for requisitions we have them document them on the requisition at the 
time it is taking place with a sticker,, but since the most of our orders are 
electronic it is part of the workflow, this is done for all specimens as we see 
the importance of other biomarkers for future

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Weems, Joyce K.
Sent: Monday, January 07, 2013 11:00 AM
To: 'Victor A. Tobias'; 'histonet'
Subject: [Histonet] RE: CAP guideline for fixation time

Our OR and Breast Health staff have done pretty well getting on board with 
this. We rarely have one that hasn't been documented.



We have a place on the requisition (located just under the date field so they 
will see it) where time out of body (for the cold ischemic time), and time into 
formalin is documented. Then we document the rest on the requisition and the 
pathologist takes it from there.







Joyce Weems

Pathology Manager

678-843-7376 Phone

678-843-7831 Fax

joyce.we...@emoryhealthcare.org







www.saintjosephsatlanta.org

5665 Peachtree Dunwoody Road

Atlanta, GA 30342



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-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Victor A. Tobias
Sent: Friday, January 04, 2013 6:21 PM
To: 'histonet'
Subject: [Histonet] CAP guideline for fixation time



Per CAP guideline, in our reports of predictive markers(ER/PR/Her2), 
Pathologists need to check that the total fixation time of specimens is within 
the CAP guideline. Is this information readily available to the pathologists at 
the time of writing the report? How are others documenting this?



Have a great weekend.



Victor



Victor Tobias HT(ASCP)

Clinical Applications Analyst

Harborview Medical Center

Dept of Pathology Room NJB244

Seattle, WA 98104

vtob...@u.washington.edumailto:vtob...@u.washington.edumailto:vtob...@u.washington.edu%3cmailto:vtob...@u.washington.edu

206-744-2735

206-744-8240 Fax

=

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[Histonet] Re: CAP guideline for fixation time for ER/PR/HER2

2013-01-05 Thread Bob Richmond
Time of fixation before ER/PR/HER2:

I haven't had much luck with getting this information. Nobody wants to
deal with the communication issues.

Needle biopsy specimens should be popped into formalin as soon as they
are out of the patient, and the time recorded. What you can't find out
is whether they are willing to fix the specimens before they take the
time to X-ray them. Attempts to find out what they're doing are
futile.

To the OR nurse, a specimen is perfectly fixed all the way through the
instant she drops it into formalin, whether a small lumpectomy or a
Dolly-sized mammoon. Eventually we're going to have to realize that
larger specimens (more than needle biopsy size) require prompt
dissection before fixation, if special studies are to be done.

Bob Richmond
Samurai Pathologist
Maryville TN

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[Histonet] RE: CAP

2012-06-01 Thread Bernice Frederick
We got an A+ rating.

Bernice Frederick HTL (ASCP)
Senior Research Tech
Pathology Core Facility
ECOGPCO-RL
Robert. H. Lurie Cancer Center
Northwestern University
710 N Fairbanks Court
Olson 8-421
Chicago,IL 60611
312-503-3723
b-freder...@northwestern.edu


-Original Message-
From: Jesus Ellin [mailto:jel...@yumaregional.org] 
Sent: Wednesday, May 30, 2012 9:34 AM
To: Bernice Frederick; Fellow HistoNetters
Subject: RE: CAP

Have fun and good luck

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Bernice 
Frederick
Sent: Wednesday, May 30, 2012 7:16 AM
To: Fellow HistoNetters
Subject: [Histonet] CAP

They're here!

Bernice Frederick HTL (ASCP)
Senior Research Tech
Pathology Core Facility
ECOGPCO-RL
Robert. H. Lurie Cancer Center
Northwestern University
710 N Fairbanks Court
Olson 8-421
Chicago,IL 60611
312-503-3723
b-freder...@northwestern.edumailto:b-freder...@northwestern.edu

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[Histonet] RE: CAP

2012-06-01 Thread Wanda.Smith
Congratulations!!


WANDA G. SMITH, HTL(ASCP)HT 
Pathology Supervisor 
TRIDENT MEDICAL CENTER 
9330 Medical Plaza Drive 
Charleston, SC  29406 
843-847-4586 
843-847-4296 fax 

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-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Bernice 
Frederick
Sent: Friday, June 01, 2012 10:41 AM
To: Jesus Ellin; Fellow HistoNetters
Subject: [Histonet] RE: CAP

We got an A+ rating.

Bernice Frederick HTL (ASCP)
Senior Research Tech
Pathology Core Facility
ECOGPCO-RL
Robert. H. Lurie Cancer Center
Northwestern University
710 N Fairbanks Court
Olson 8-421
Chicago,IL 60611
312-503-3723
b-freder...@northwestern.edu


-Original Message-
From: Jesus Ellin [mailto:jel...@yumaregional.org] 
Sent: Wednesday, May 30, 2012 9:34 AM
To: Bernice Frederick; Fellow HistoNetters
Subject: RE: CAP

Have fun and good luck

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Bernice 
Frederick
Sent: Wednesday, May 30, 2012 7:16 AM
To: Fellow HistoNetters
Subject: [Histonet] CAP

They're here!

Bernice Frederick HTL (ASCP)
Senior Research Tech
Pathology Core Facility
ECOGPCO-RL
Robert. H. Lurie Cancer Center
Northwestern University
710 N Fairbanks Court
Olson 8-421
Chicago,IL 60611
312-503-3723
b-freder...@northwestern.edumailto:b-freder...@northwestern.edu

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[Histonet] RE: CAP

2012-05-30 Thread Jesus Ellin
Have fun and good luck

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Bernice 
Frederick
Sent: Wednesday, May 30, 2012 7:16 AM
To: Fellow HistoNetters
Subject: [Histonet] CAP

They're here!

Bernice Frederick HTL (ASCP)
Senior Research Tech
Pathology Core Facility
ECOGPCO-RL
Robert. H. Lurie Cancer Center
Northwestern University
710 N Fairbanks Court
Olson 8-421
Chicago,IL 60611
312-503-3723
b-freder...@northwestern.edumailto:b-freder...@northwestern.edu

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[Histonet] RE: CAP

2012-05-30 Thread Tunde Ajibade
Best of luck.

 Tunde Ajibade BS, HTL(ASCP)QIHC
 Histology Supervisor
 Medical Center Hospital
 Odessa,TX
 Tel:  432-640-2348
 Fax:432-640-2303
 
-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Bernice 
Frederick
Sent: Wednesday, May 30, 2012 9:16 AM
To: Fellow HistoNetters
Subject: [Histonet] CAP

They're here!

Bernice Frederick HTL (ASCP)
Senior Research Tech
Pathology Core Facility
ECOGPCO-RL
Robert. H. Lurie Cancer Center
Northwestern University
710 N Fairbanks Court
Olson 8-421
Chicago,IL 60611
312-503-3723
b-freder...@northwestern.edumailto:b-freder...@northwestern.edu

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Re: [Histonet] RE: CAP vs. CLIA

2012-05-22 Thread Pam Marcum
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

2012-05-21 Thread Amanda Kelley
 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

2012-05-21 Thread Jesus Ellin
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

2012-05-21 Thread Davide Costanzo
 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

2012-05-20 Thread WILLIAM DESALVO










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

2012-05-17 Thread Horn, Hazel V
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. 


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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.

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RE: [Histonet] RE: CAP vs. CLIA

2012-05-17 Thread Pratt, Caroline
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. 


___
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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

2012-05-17 Thread Mike Pence
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
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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

2012-05-17 Thread Willis, Donna G.
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

2012-05-17 Thread Horn, Hazel V
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

2012-05-17 Thread Sheila Haas
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

2012-05-17 Thread Jesus Ellin
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

2012-05-17 Thread Willis, Donna G.
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

2012-05-17 Thread Blazek, Linda
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

2012-05-17 Thread Horn, Hazel V
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

2012-05-17 Thread Morken, Timothy
 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
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-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

2012-05-17 Thread Morken, Timothy
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

2012-05-17 Thread Morken, Timothy
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

2012-05-17 Thread joelle weaver

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

2012-05-17 Thread Morken, Timothy
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

2012-05-17 Thread Jesus Ellin
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

[Histonet] RE: CAP slides

2011-09-01 Thread Settembre, Dana
Her-2 IHC
Dana Settembre

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Coppin, Margaret
Sent: Wednesday, August 31, 2011 5:53 PM
To: Histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP slides

Hello,

 

A few months back, there was a discussion on the list about CAP
Proficiency Test slides that weren't staining as expected.  Some of you
had even contacted CAP and they acknowledged that there had been an
issue.  Any of you whose PT was affected, do you mind jogging my memory
as to which PT's were the problem batch?

 

Thanks in advance as always.

 

Margaret 


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[Histonet] RE: CAP question ANP.22970

2011-02-01 Thread Wanda.Smith
Martha,
I spoke to Joan at CAP just yesterday regarding this question.  I too, am 
getting ready for CAP, so I feel your pain!
She said you can use the benchmarks in the notes under the question in the 
checklist or you can used other published articles that offer benchmark data.  
Just state what your reference is and where it is from.  She also said you can 
use proficiency testing data.  
Hope this helps,
Wanda

WANDA G. SMITH, HTL(ASCP)HT
Pathology Supervisor
TRIDENT MEDICAL CENTER
9330 Medical Plaza Drive
Charleston, SC  29406
843-847-4586
843-847-4296 fax

This email and any files transmitted with it may contain PRIVILEGED or 
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-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Martha Ward
Sent: Tuesday, February 01, 2011 12:57 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP question ANP.22970

We are having our inspection this spring and I am working to get all our 
procedures, etc. ready.  I am having trouble finding benchmark information for 
comparison for HER2 to comply with this question - ...the laboratory at least 
annually compares its patient results with published benchmarks,   We are 
using the Dako Herceptest.  I spoke with Dako tech services and they did not 
have any information.   What are other labs using for a benchmark.

Thanks in advance for all your help.

Martha Ward, MT (ASCP) QIHC
Assistant Manager
Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest University Baptist Medical Center
Winston-Salem, NC 27157
336-716-2104

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[Histonet] RE: CAP question ANP.22970

2011-02-01 Thread Nita Searcy
The published article we use is Hormone Receptor Status  Survival in a 
Population-Based Cohort of Patients with Breast Carcinoma 
www.interscience.wiley.com April 20, 2005

Nita Searcy, HT/HTL (ASCP)
Scott and White Hospital
Division Manager, Anatomic Pathology
2401 S. 31st. Street 
254-724-2438
Temple, Texas, 76502
nsea...@swmail.sw.org


254-724-2438

 wanda.sm...@hcahealthcare.com 2/1/2011 12:42 PM 
Martha,
I spoke to Joan at CAP just yesterday regarding this question.  I too, am 
getting ready for CAP, so I feel your pain!
She said you can use the benchmarks in the notes under the question in the 
checklist or you can used other published articles that offer benchmark data.  
Just state what your reference is and where it is from.  She also said you can 
use proficiency testing data.  
Hope this helps,
Wanda

WANDA G. SMITH, HTL(ASCP)HT
Pathology Supervisor
TRIDENT MEDICAL CENTER
9330 Medical Plaza Drive
Charleston, SC  29406
843-847-4586
843-847-4296 fax

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-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Martha Ward
Sent: Tuesday, February 01, 2011 12:57 PM
To: histonet@lists.utsouthwestern.edu 
Subject: [Histonet] CAP question ANP.22970

We are having our inspection this spring and I am working to get all our 
procedures, etc. ready.  I am having trouble finding benchmark information for 
comparison for HER2 to comply with this question - ...the laboratory at least 
annually compares its patient results with published benchmarks,   We are 
using the Dako Herceptest.  I spoke with Dako tech services and they did not 
have any information.   What are other labs using for a benchmark.

Thanks in advance for all your help.

Martha Ward, MT (ASCP) QIHC
Assistant Manager
Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest University Baptist Medical Center
Winston-Salem, NC 27157
336-716-2104

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BEGIN:VCARD
VERSION:2.1
X-GWTYPE:USER
FN:Nita Searcy
TEL;WORK:4-2438
ORG:;Anatomic Pathology
EMAIL;WORK;PREF;NGW:nsea...@swmail.sw.org
N:Searcy;Nita
TITLE:Manager, Pathology Division
TEL;PAGER:633-2370
END:VCARD

BEGIN:VCARD
VERSION:2.1
X-GWTYPE:USER
FN:Nita Searcy
TEL;WORK:4-2438
ORG:;Anatomic Pathology
EMAIL;WORK;PREF;NGW:nsea...@swmail.sw.org
N:Searcy;Nita
TITLE:Manager, Pathology Division
TEL;PAGER:633-2370
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[Histonet] RE: CAP question for pediatric pathology labs

2010-12-29 Thread Linda Margraf
Dear Ronnie
We at the Children's Medical Center, Dallas do a twice a year slide exchange of 
ten cytopathology cases with another Children's Hospital.  We actually learn a 
lot from this exercise as they critique slide quality as well as diagnoses. All 
the Anatomic pathology faculty take part in case reviews and we meet as a group 
to hear about the results of the other program's review of our cases.  It is 
also much more pertinent to the nature of our pediatric  pathology material 
than the CAP program would be (and the price is negligible).  We have never had 
a CAP inspector have a problem with this type of program. We are careful to 
keep it all well documented in our quality records.
Linda M
Histonet administrator

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Houston, Ronald
Sent: Wednesday, December 29, 2010 8:13 AM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP question for pediatric pathology labs
Importance: High

CYP.00190

Phase I

N/A YES NO

For laboratories that perform non-gynecologic cytopathology, does the 
laboratory participate in a peer educational program in NON-GYNECOLOGIC 
cytopathology (e.g., CAP Interlaboratory Comparison Program in Non-Gynecologic 
Cytopathology NGC)?

How are labs responding to this request for a peer-educational program in 
non-gyn cytopath, as there is no such program for pediatric cytopathology, and, 
in the opinion of our pathologists, the CAP program is useless as far as it 
pertains to pediatrics?

We have had varying responses from inspectors which we have adopted and then 
the next inspector says this isn't good enough and you should be doing 
something else. There has been little to no direction from CAP.

Thanks

Ronnie Houston, MS HT(ASCP)QIHC
Anatomic Pathology Manager

ChildLab, a Division of Nationwide Children's Hospital

www.childlab.com


700 Children's Drive
Columbus, OH 43205
(P) 614-722-5450
(F) 614-722-2899
ronald.hous...@nationwidechildrens.orgmailto:ronald.hous...@nationwidechildrens.org
www.NationwideChildrens.orghttp://www.NationwideChildrens.org

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[Histonet] RE: Cap Question: 2 identifiers for slides

2010-07-01 Thread Nails, Felton
Not yet 

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Scott, Allison D
Sent: Thursday, July 01, 2010 2:37 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Cap Question: 2 identifiers for slides

Is is a CAP requirement to have 2 identifiers on surgical slides?

Allison Scott HT(ASCP)
Histology Supervisor
LBJ Hospital
Houston, Texas 77026
713-566-5287
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[Histonet] RE: Cap Question: 2 identifiers for slides

2010-07-01 Thread Weems, Joyce
Joint Commission does... Use case number and name. 

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Nails, Felton
Sent: Thursday, July 01, 2010 16:10
To: 'Scott, Allison D'; histonet@lists.utsouthwestern.edu
Subject: [Histonet] RE: Cap Question: 2 identifiers for slides

Not yet 

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Scott, Allison D
Sent: Thursday, July 01, 2010 2:37 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Cap Question: 2 identifiers for slides

Is is a CAP requirement to have 2 identifiers on surgical slides?

Allison Scott HT(ASCP)
Histology Supervisor
LBJ Hospital
Houston, Texas 77026
713-566-5287
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[Histonet] RE: CAP cancer protocols and checklists

2010-03-17 Thread hymclab
We have the Meditech Computer system and we have built a data section between 
Micro and Diagnosis namde Synoptic Tumor Protocol nd have canned texts 
available for all tumor types that pull in the required information needed.  
All the Pathologist's have to do is enter the information and hit enter and it 
goes to the next field needed to fill in.  That way it is done consistently and 
within the CAP protocols.

Dawn D. Schneider, HT(ASCP)
Lead Histology Tech
Howard Young Medical Center
240 Maple St.
Woodruff, WI  54568
715-356-8174


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Carol Bryant
Sent: Tuesday, March 16, 2010 4:20 PM
To: Histonet@lists.utsouthwestern.edu
Subject: [Histonet] CAP cancer protocols and checklists

I am interested in how you are implementing the CAP cancer protocols in your 
laboratory?  Are you using synoptic reporting, dictating from the checklists, 
etc?  Any information you can provide would be greatly appreciated.
Thank you in advance for your comments and input.

Carol

Carol Bryant, CT (ASCP)
Cytology/Histology Manager
Pathology Services
Lexington Clinic
Phone (859) 258-4082
Fax (859) 258-4081
cb...@lexclin.com



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[Histonet] RE: cap survays

2009-09-24 Thread Morken, Tim
Technologists can certainly be trained to do the scoring properly but our 
pathologists score them and are fully involved in the evaluations, as well as 
reviewing challenge slides for submission. There are also sometimes 
interpretation questions that have to be done on-line that the pathologists 
have to do, for instance for Her2. You have to ask the question of who is doing 
the interpretation in real life, the techs or the pathologist? The survey is 
supposed to be done the same way you do it in your lab in your daily work so 
take that as the starting point of the discussion.

I think it defeats the purpose if the pathologists are not involved since it is 
a test of the total quality system. Are they or aren't they part of the system? 

Tim Morken
Supervisor, Histology / IPOX
UCSF Medical Center
San Francisco, CA  
 
-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Gonzales, Edith
Sent: Thursday, September 24, 2009 12:50 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] cap survays


To all,

I would like to know what everyone is doing with the cap survay now that it is 
scoring staining performance and not detremining a diagnosis.  Our paths want 
us to score then and they not be involved.  Is this what everone else is doing?

Edie


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[Histonet] RE: CAP

2009-08-10 Thread Joanne Clark


--

Message: 6
Date: Mon, 10 Aug 2009 09:05:44 -0500
From: Vacca Jessica jessica.va...@hcahealthcare.com
Subject: [Histonet] CAP ?
To: Histonet@lists.utsouthwestern.edu
Histonet@lists.utsouthwestern.edu
Message-ID:
938d716cd445614abbb817517557b6f4c8476...@nadcwpmsgcms09.hca.corpad.net

Content-Type: text/plain; charset=iso-8859-1

How does one gather this information in the lab? What are your steps?

GEN.70550  Is there documentation that each of the chemicals in the laboratory 
has been evaluated for carcinogenic potential, reproductive toxicity, and acute 
toxicity; and does the policies and procedure manual define specific handling 
requirements for these chemicals -

Thanks

Jessica Vacca
Histology Supervisor
119 Oakfield Dr
Brandon Fl 33511
(813) 571-5193
(813) 571-5169 FAX
  

We take this one step further than Mr. McNemar.  We take the info from the MSDS 
and have prepared a chart of our toxic chemicals that is kept in the 
documentation of our Lab Safety.  It lists for the chemicals involved the 
specific toxic dangers and any special handling.

Joanne Clark, HT
Histology Supervisor
Pathology Consultants of NM
Roswell, NM



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[Histonet] RE: CAP regs on Histonet

2009-03-11 Thread Terri Braud
For ease of reference, if you are asking, replying, or quoting anything 
pertaining to CAP regs, PLEASE give the CAP checklist number that contains the 
information being discussed.
For those of us trying to keep current, it makes it so much easier to check our 
own records.
Just a suggestion - Terri

Terri L. Braud, HT(ASCP)
Anatomic Pathology Supervisor
Laboratory
Holy Redeemer Hospital and Medical Center
1648 Huntingdon Pike
Meadowbrook, PA 19046
(215) 938-3676 phone
(215) 938-3689 fax


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