[Histonet] FDA Final Rule

2025-02-24 Thread Histology via Histonet
Hello Histo World,

Is anyone out there still using RUO or IHC antibody not approved by the FDA?  
If so, what are your plans moving forward?  Any idea how much it costs to 
register with the FDA as a device manufacturer and what each antibody will 
cost?  I've watched all the webinars but I still have so many questions.  I 
want to know how other labs are responding.

Thank you for responding,

Mehndi Helgren
Lab Manager
757-664-7901
Dominion Pathology Labs.
733 Boush St. Suite 200
Norfolk, VA  23510

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Re: [Histonet] Are Histology Supervisors required to have HT for CAP

2024-12-26 Thread Histology via Histonet
I do not think that is a requirement of CAP.  I have not seen anywhere in the 
checklist where a histo tech has to be certified.  This is because being a 
histo tech not considered to be moderate or high complexity testing.


Mehndi Helgren
Lab Manager 
757-664-7901
Dominion Pathology Labs.
733 Boush St. Suite 200
Norfolk, VA  23510

  

-Original Message-
From: Eileen Akemi Allison via Histonet  
Sent: Monday, December 23, 2024 8:20 AM
To: Histonet 
Subject: [Histonet] Are Histology Supervisors required to have HT for CAP

Good morning and Happy Holiday’s:

This may sound like a stupid question, but is it a requirement for histology 
supervisors to have an HT ASCP Certification for CAP?  For as long as I can 
remember, I just naturally assumed to be able to pass a CAP inspection, the 
supervisor had to be HT ASCP Certified.  I ask because I recently came across 
two labs here in California who’s supervisors are not certified.  I looked up 
the CAP guidelines and they addressed testing personneL, (pathologists) but 
couldn’t find information for the supervisor.

Best regards,
Akemi

Akemi Allison-Tacha BS, HT/HTL (ASCP)
Pathology Laboratory Manager at Golden State Dermatology
370 N Wiget Lane, Suite 250, Walnut Creek. CA 94598
(925) 278-7592 Ext: 10079
Mobil:: (408) 335-9994
Email: aalli...@gsdermca.com 
Website: www.goldenstatedermatology.com 
 
To know is to care, to care is to act, to act is to make a difference.

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Re: [Histonet] LDT's Regulatiions by the FDA

2024-06-26 Thread Histology via Histonet
I don't see the attachment.  Can you try again?


Mehndi Helgren
Lab Manager 
757-664-7901
Dominion Pathology Labs.
733 Boush St. Suite 200
Norfolk, VA  23510



-Original Message-
From: Paula via Histonet  
Sent: Tuesday, June 25, 2024 2:23 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] LDT's Regulatiions by the FDA

Hello,

 

Has anyone read about the new regulations for the LDTs (Laboratory Developed
Tests) that were passed by the FDA?

Does anyone have any comments about it?

If the new LDT requirements by the FDA don't get overturned, we are looking at 
a lot of paperwork, labor, and consulting/attorney expenses for running IHC's 
in 2025 and forward.

 

I've attached an article in the June issue of Laboratory Economics for your 
reference. The subject starts on page 1, then continues to pages 3 and 4.

 

Thank you,

Paula Lucas

Lab Manager

Bio-Path Medical Group

 

 

 

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Re: [Histonet] Moderate vs High Complexity for routine histology

2023-10-24 Thread Histology via Histonet
Histology is considered moderate by CAP and CLIA



-Original Message-
From: James P Montgomery via Histonet  
Sent: Friday, October 20, 2023 4:04 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Moderate vs High Complexity for routine histology

Hello,

Is routine histology considered moderate or high complexity by CAP?  It looks 
like CLIA doesn't even assign a complexity rating as far as I can tell.  I know 
grossing is considered high complexity but what about routine processing, 
embedding, cutting, and special/IHC/ISH staining?  I've had a CAP inspector say 
histotechs are moderate, but a QA manager felt they were high complexity.

Thanks

James



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[Histonet] cryostat

2021-08-09 Thread Histology via Histonet
Hello,

Trying to get everyone's opinion on cryostats.  We have had the Leica CM1850 
forever and it is not being supported by Leica anymore.  Thinking of trying a 
different company maybe Tanner or Rankin.  What does everyone use and like.  We 
do not cut Mohs, only DIFs.  Maybe 1 a day.

Thanks to all,

Mehndi Helgren

Dominion Pathology Laboratories
733 Boush Street
Suite 200
Norfolk, VA 23510
757-664-7901

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[Histonet] Lyme disease

2020-11-19 Thread Histology via Histonet
Does anyone perform IHC for Lyme disease (Borrelia burgdorferi) on paraffin 
blocks?  I'm looking for a good antibody and a place to buy control slides.

Thanks to all!

Mehndi Helgren

Dominion Pathology Laboratories
733 Boush Street
Suite 200
Norfolk, VA 23510
757-664-7901

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[Histonet] comparable eosin

2020-09-09 Thread Histology via Histonet
Hi everyone,

We have always got our Eosin from BBC Biochemical.  Well, they were bought out 
by StatLab and I am trying to find a comparable Eosin from what we were using.  
We used "Skin Eosin" catalog #3680 composed of:  water, denatured ethanol, 
eosin y, and glacial acetic acid.  I've done some searching and haven't found 
anything like it.  Is anyone else having this problem or have any advice?

Thanks!

Mehndi Helgren

Dominion Pathology Laboratories
733 Boush Street
Suite 200
Norfolk, VA 23510
757-664-7901

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[Histonet] Leica ST5020 vs Spectra

2020-05-01 Thread Histology via Histonet
Hi all,

We have a Leica ST5010 that we have had forever and love.  We have gotten a lot 
busier and need to eliminate the backup we currently get every day waiting to 
load the racks.  I think we need an extra oven or 2.  So we are looking into 
updating and will probably go with the ST5020 or the Spectra.  Can anyone share 
their thoughts about these 2 stainers?  We will probably only use this for one 
program (H&Es, no specials).  Particularly, I am interested in the reagent 
usage.  Do you have to use certain reagents and dump or rotate when the machine 
says?  Any thoughts are greatly appreciated.

Thanks,

Mehndi Helgren


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Re: [Histonet] Histonet Digest, Vol 196, Issue 3

2020-03-04 Thread NWL - Histology via Histonet
Re: Histonet digest Incomplete sectioning of blocks.

I had to manage this situation a few year back and found that the best place to 
capture this is at the waterbath. QC reviews I.e numbers of return slides 
categorised into fault type can be collated over a month and displayed easily 
to a team of people. This data can also be a useful KPI of your labs processes. 
You can then use as evidence if you had to go down the route of a capability 
process with a single member of staff.

Do you microscopically check each slide that is sent out?

Cheers
Stuart Beaver

Head of Histology
Nationwide Laboratories
Poulton-le-Fylde
UK

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Subject: Histonet Digest, Vol 196, Issue 3

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[Histonet] fume hoods for grossing

2019-06-06 Thread Histology via Histonet
Hi Histonetters,

I'm trying to see what kind of exhaust/fume hoods people are using in small 
grossing labs.  We are moving into a new space and I want to make sure the 
ventilation at the gross board is adequate.  I don't think an actual grossing 
station is in the budget.

Thanks,

Mehndi Helgren
Dominion Pathology Laboratories
733 Boush St.
Suite 200
Norfolk, VA  23510
757-664-7901

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[Histonet] Not DAB IHC waste

2019-02-22 Thread Histology via Histonet
Hi all,

Does anyone use only red or magenta detection for IHCs instead of DAB?  We do 
not use DAB and are trying to figure out if our waste is hazardous or not.  Any 
insight would be helpful.

Thanks,

Mehndi Helgren

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[Histonet] Leica SCN400 slide carriers

2018-09-20 Thread Histology via Histonet
Hi Histonet,

I would like to ask if anyone has (or knows who may have) any spare slide 
carriers for the Leica SCN400 scanning microscope. Is anyone currently using 
this model and how does it perform?

Best wishes

Stuart Beaver BSc(Hons)
Head of Veterinary Histology/Cytology
+447568543761
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[Histonet] table for cutting

2018-09-17 Thread Histology via Histonet
Does anyone use a table to put their microtome and cut?  I'm trying to find one 
and I want to make sure that it is stable enough for cutting.

Thanks,

Mehndi Helgren
Dominion Pathology Laboratories
733 Boush St.
Suite 200
Norfolk, VA  23510
757-664-7901

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Re: [Histonet] Giemsa vs Diff Quik

2018-09-08 Thread Histology via Histonet
Hi,

Have you tried leishman staining? I have an automated protocol for he thermo 
gemini if you want one? Failing that I do have the manual step protocol and all 
you need is a jar of leishman powder, methanol and pH6.8 phosphate buffet 
tablets

Stuart Beaver BSc(Hons)
Head of Veterinary Histology/Cytology
+447568543761

On 6 Sep 2018, at 21:37, Bob Richmond 
mailto:rsrichm...@gmail.com>> wrote:

Joseph A. Esposito at McClain Laboratories on Long Island asks:

The laboratory I work at has been using the Diff Quik for years now as a
stain for fine needle aspirates. Recently, when we tried to reorder a Diff
Quik stain kit from our usual suppliers, we have found it to be on
backorder. This has caused us to begin to consider the Giemsa stain as an
alternative to the Diff Quik. Does anyone have any experience with using
both stains and how they compare to each other? Would the Giemsa be a
suitable alternative to replace the Diff Quik?<<

Diff-Quik® (spelt like that!) is an old registered trademark for a rapid
two-step Romanowsky stain. A number of Web sites inform me today that this
trade name has been discontinued, I suppose because the name has been so
commonly used generically.

There have long been a number of generic fast two-step Romanowsky stains
available, with a xanthene dye (presumably eosin Y) as solution 1, and a
proprietary mixture of thiazine dyes as solution 2. In my experience with
at least five of these, they all worked pretty much indistinguishably from
brand-name Diff-Quik.

There are a number of stains called Giemsa, also Romanowsky stains, but
often slower than the "quick" stains. There is probably no advantage to
using them for any reason.

In my eightieth year, I remember with nostalgia the old Wolbach Giemsa
technique for tissue sections. Tissue must be fixed in a dichromate
fixative, traditionally Zenker/Helly, sections stained in four successive
Giemsa baths, the last one overnight, and differentiated with 10%
colophonium rosin in alcohol with microscopic control. (I've actually done
this stain myself.)

Bob Richmond
Samurai Pathologist
Maryville TN

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Re: [Histonet] Elephant Tissues

2018-09-06 Thread Histology via Histonet
Hi Jennifer,

If it is skin extending the fixing and processing time should cure any 
processing issues. If after this it’s still not working a short pre fix in 
khales fixative and surface softening before sectioning with 0.02% sodium 
hydroxide may help.

Hope this helps!

Stuart Beaver BSc(Hons)
Head of Veterinary Histology/Cytology
+447568543761

On 5 Sep 2018, at 22:46, P Sicurello 
mailto:pat...@gmail.com>> wrote:

Jennifer,

I have worked on mouse, rat, rabbit, sea lion, harbor seal, killer whale,
giraffe, and even human mummy tissues.  With the exception of the mummy
tissue being a bit dry, they all embedded and cut like human tissue.

What is it that is making them hard to cut?

Sincerely,

Paula Sicurello, HTL (ASCP)CM

Histotechnology Specialist

UC San Diego Health

200 Arbor Drive

San Diego, CA 92103

(P): 619-543-2872



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On Wed, Sep 5, 2018 at 10:38 AM Jennifer Phinney via Histonet <
histonet@lists.utsouthwestern.edu> 
wrote:

Hello Histonetters,
Does anyone have experience processing and cutting elephant tissues?  Any
tips, tricks, or advice?  My lab has had some elephant cases recently and
the tissues are unexpectedly (to us) difficult to cut.

Thanks for any help,
Jennifer Phinney QIHC
Kansas State University
Veterinary Diagnostic Lab
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[Histonet] benchtop fume hoods

2018-05-10 Thread Histology via Histonet
Hi all,

Can anyone share what type of benchtop fume hoods they are using in the lab?  
This would be for manual coverslipping and grossing.

Thanks in advance!



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[Histonet] Silver waste

2018-03-26 Thread Histology via Histonet

Hi All.  Happy Monday!

Would anyone share how they collect, store, and dispose of silver waste from 
manual special stains such as GMS, Melanin Fontana-Masson, and Calcium Von 
Kossa?

Thanks in advance!
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[Histonet] Ventana Red Detection Kits

2018-03-06 Thread Histology via Histonet
HELP!!!

Ventana is out of all Red detection kits until the end of the month.  We are a 
small lab that only uses the red detection.  Is everyone switching to DAB or 
are there other options?  If switching to DAB, are you revalidating every 
antibody?  And how many cases per antibody?

Thanks for all input.

 Mehndi Helgren
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[Histonet] Special GI fixative

2018-02-27 Thread Histology via Histonet
Hi all,

Does anyone use a special fixative for their GI specimens?  I was thinking of 
trying something called GI fix.  Ingredients are basically formalin and zinc 
chloride.  Our tissue is always super brittle and dry even with a very short 
processing schedule.  Any thoughts would be greatly appreciated.

Thanks,

Mehndi Helgren



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[Histonet] Fridge and freezer temps

2018-02-05 Thread Histology via Histonet
Hi All,

I'm trying to figure out how everyone keeps their refrigerator and freezer 
temperatures in a certain range.  I have 2 house refrigerators with freezers on 
top.  We have the min/max thermometers.  I cannot get the freezer to stay 
between 0 and -8 degrees without affecting the fridge temp.  Are other labs 
using better quality equipment?  What are the ranges you are using for both 
fridge and freezer.  Our is 2 to 8 for fridge and 0 and -8 for freezer.

Thanks to all,

Mehndi Helgren
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Re: [Histonet] Histonet Digest, Vol 170, Issue 4 Extra unstained paraffin embedded tissue slides (Kristina Johnson)

2018-01-04 Thread Histology via Histonet
Hi Kristina,

You can always cut a section from a blank block of wax and cover over the 
unstained uncoverslipped sections and let them air dry before filing them away.

Regards

Stuart Beaver BScHons
Head of Veterinary Histology


Histology Department NationWide Laboratories

(A trading business of National Veterinary Services Ltd)

23 Mains Lane

Poulton-Le-Fylde

Lancashire FY6 7LJ

Tel: +44 1253 899215

Fax: +44 1253 891934

Web site: www.nwlabs.co.uk

Email: histol...@nwlabs.co.uk

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On 4 Jan 2018, at 18:03, 
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Today's Topics:

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[Histonet] Histopathology positions available in central Massachusetts

2017-07-21 Thread Mass Histology via Histonet
Because of a continued increased in workload, Mass Histo is expanding our
day shift and soon will be adding a second shift.  We're looking for
experienced grossing technicians, histologists, specimen procurement techs
(with knowledge of CPT coding) and lab aids.  We offer a pleasant working
environment, great pay and great benefits.

Look us up at www.masshistology.com

Thanks

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[Histonet] HT job in VA

2017-05-15 Thread Histology via Histonet
We have an HT position open in Norfolk, VA. M-F 6am-2Pm.   Must be certified.  
No recruiters please.
Email resume to hi...@pathlab.us or fax to 757-664-9122
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[Histonet] PGP 9.5 at 50 microns

2016-08-10 Thread Histology via Histonet
Hi All,

I need help.  My doctors want to start doing some diabetic nerve testing.  They 
need a PGP 9.5 IHC done on a frozen section cut at 50 microns.  Does anybody 
have any experience on something like this?  If so, I would love some help.

Thanks,

Mehndi Helgren

Dominion Pathology Labs
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[Histonet] HT needed in Norfolk, VA

2016-05-12 Thread Histology via Histonet
Hi all,

I have a position open for Histo Tech with a private dermpath lab in Norfolk, 
VA.  Must have HS/GED be ASCP certified as a HT or HTL.  Experience needed in 
routine and IHC.  Full time M-F  with morning hours.  Fax confidential resume 
to 757-664-9122   Attn:  Administrator



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[Histonet] Freeze Spary Ban continued

2016-03-01 Thread Histology via Histonet
FYI:

Mercedes Medical DOES contain the banned chemical.

StatLab's 1,1,1,2 Tetrafluoroethane is banned.  This is also called HFC 134a

Still checking other brands.

-Mehndi


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[Histonet] Freeze Spray Ban

2016-02-29 Thread Histology via Histonet
Hi All,

Just got an alert stating that the EPA is banning HFCs found in Freeze Spray 
effective July 20th.  Does anybody use a spray that does not contain this 
banned chemical?  If so, please let me know where you get it.

Thanks,

Mehndi Helgren
Dominion Pathology Labs  "DPL"
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[Histonet] Herpes Zoster (VZV)

2016-02-18 Thread Histology via Histonet
Hi everyone-

Will anyone share where they get their Herpes Zoster antibody from for FFPE?  I 
currently get it from abcam and run them on a Ventana Ultra.  It seems once a 
year or so, the antibody just stops working and I have to call abcam and they 
send me a new one and it usually works.  This is the only antibody that I have 
this problem with and I'm not sure what's happening.  Any help would be great.

Thanks,

Mehndi Helgren
"DPL"
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[Histonet] GI biopsies processing

2016-01-11 Thread Histology via Histonet
Hi All,

Can anyone share their processing set up for GI biopsies?  No matter what I do, 
our tissue seems dry.  Any input would be great.

Thanks in advance,

Mehndi Helgren
Dominion Pathology Labs.
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[Histonet] GMS and Gram stains

2015-10-02 Thread Histology via Histonet
Hi All Netters,

I need to get a better GMS and Gram stain.  If anyone could share their 
protocols where they get the solutions that would be fantastic.

Thanks,

Mehndi Helgren

Dominion Pathology Labs
Norfolk, VA (AKA Hurricane Central)  :)


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