Re: Daily Digest

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From:Louise Burrell <lburrell@pathbox.wustl.edu> (by way of histonet)
To:histonet <histonet@magicnet.net>
Reply-To:
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Hi--I cut frozens and store immediately at -80*.  It works well.
sincerely,
Louise Burrell


On Sat, 5 Dec 1998, HistoNet Server wrote:

>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 01:44:37 -0600
> From: Mike Kirby <mikek@mail.saimr.wits.ac.za>
> Subject: Delivery of specimens
>
>
> To echo the words of the other Histonetters, no, Cel Rutledge, you are not
> alone, the problem of leaking specimen containers is world wide and is as
> old as our profession.
> We tackled the problem in two ways, firstly, we educated our messengers as
> to the necessity of delivering the specimen entact, and that they have the
> right to refuse to touch or collect anything that appears to be leaking.
> They carry cell phones so that we can have "on site discussions" with our
> more difficult customers.
> 	We also issued a "spillage pack" to each messenger, which consists of a
> plastic bottle of Sodium Hypochlorite, wads of paper toweling, heavy duty
> plastic bags, gloves, masks, biohazard stickers and tape, and a face
> shield, in the event of a spillage while in transit.
> 	We then tackled all our suppliers, and as Barry Rittman advised, we
> pointed out the possible legal implications, the inconvenience to the
> patients, and that they would suffer the wrath of the Doctor/Surgeon
> concerned and not us.
> 	The problem will never be entirely stopped, but we have noticed a
>marked
> reduction in the receipt of leaking specimens.
>
> Mike Kirby
> Chief Safety Officer
> S.A.I.M.R
> Johannesburg
> R.S.Africa
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 01:45:00 -0600
> From: "Mick Rentsch" <ausbio@nex.com.au>
> Subject: Glyoxal
>
> Can anyone suggest what concentration Glyoxal should be used at as a
> substitute for 10%NBF, and is it better with Saline or buffered to pH
> 6.8-7.2.
> I also am interested if your IHC peroxidases are at least equal to or better
> than 10%NBF fixed tissue.
> The Merck Index suggests that dissolving the Glyoxal presents special
> hazards, does anyone have any experience?
> All contributions gratefully accepted.
> Mike Rentsch (Downunder)
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 04:30:58 -0600
> From: Alex Brown <AlexB@nayrshire.scot.nhs.uk>
> Subject: Re: PLAP
>
> Many thanks to all who responded to my question about PLAP. The replies
> were very helpful.
>
> 	Alex.
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 05:16:19 -0600
> From: lpwenk@mail.netquest.com
> Subject: Re: delivery of specimens
>
> Cel Rutledge wrote:
> >
> Besides refusing to accept the specimen and sending it back (which
> several other people have suggested) and/or doing training so that
> the couriers (?sp) understand the danger to themselves of
> formaldehyde exposure, there are a couple of other things we have
> tried. It has also helped with mismatched specimens and paperwork
> being written wrong.
>
> 1. Have the person delivering the specimen sign in their name and
> time. We have a clip board by the drop off point, and they have to
> sign in. This is especially helpful when a lone container comes
> down when no one was at the desk (everyone running around taking
> care of 6 zillion other things). So it isn't as big as a suprise, as
> in "When did this come down?"
>
> It also helps because we can call up and report any problems, and
> state specifically that so-and-so dumped the jars and they spilled.
> We also kept a QC log, listing the problems, and sent this back to
> the supervisor (?monthly at first, now I think quarterly). Seeing
> an official QC log seems to help also.
>
> 2. We did not return the specimen if there was a problem (leaking,
> paperwork, etc.) We also were concerned about it becoming lost,
> or no one fixing it so it would be returned in the next load
> without being fixed. Plus, if it leaked on the way down to our
> area, it was going to leak on the way back, exposing more
> people and areas.
>
> So we would call the OR, or the courier service, or the outpatient
> clinic, whatever, and someone had to come down (pathology is in
> the basement, of course) and fix the problem. This was also
> recorded on the QC sheet - who fixed it and the time.
>
> Trust me, when they  have to walk all the way back to our
> area to fix something, they quit making mistakes as often.
> And if it was the OR head nurse who had to do it (like paperwork
> mixups), this was soon in THEIR reports and training sessions.
>
> It was also recorded on the QC what time they fixed it and who
> fixed it. So if the clinician called, they could be told why there
> was a delay, and how long it took for someone to come down to fix it.
> This also helped motivate people to not make so many mistakes, and to
> fix it fast when there was a problem.
>
> Mistakes still happen, but they seem to be fewer. Thankfully.
>
> Just some different ideas on how to try to fix the problem. And
> as someone said, you HAVE to have the complete backing of the
> pathologist in charge of this area, and the pathologist in charge
> of the entire department. The legal aspects of formaldehyde
> exposure (or mislabeled specimens) is a good point, and hopefully
> can override their concern for turn-around time.
>
> Good luck.
>
> > We have been having a problem with the condition of surgical specimens
> > that are delvered to pathology.  We have a central messenger center that
> > collects specimens from the clinics and surgery on a regular time
> > schedule.  They pick up specimens and then deliver them to pathology.  The
> > immediate problem is the careless with which they are handled.  They
> > "toss" them into a plastic or paper bag and then empty them on the
> > receiving desk.  To ones complete amazement-they leak. The clinics,
> > surgery and messenger supervisors have been contacted, warned, threatened,
> > verbally abused, begged and pleaded with, but still no end in sight to the
> > problem.
> >
> > We have explained the problem with contamination, having to redo the
> > paperwork, and the time consuming effort involved in  handling this
> > problem, but nothing.  It is a double headed problem, but I feel that if
> > the messengers would not turn them every which way then the containers
> > that were not sealed correctly would not leak.
> >
> > The clinics are furnished bags with special pockets for paperwork on the
> > outside of the bag while the specimen goes inside, unfortunately the put
> > the paper inside with the leaky specimen.
> >
> > I would like some suggestions as to how other hospitals receive their
> > specimens.  Is this common?  Or, are we just lucky?
> >
> > Cel Rutledge
> > San Francisco General Hospital
>
> - --
> Peggy A. Wenk, HTL (ASCP)
> Anatomic Pathology
> Wm. Beaumont Hospital
> 3601 W. 13 Mile Rd.
> Royal Oak, MI 48073-6769
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 06:46:13 -0600
> From: Catherine Bennett <bresee@pilot.msu.edu>
> Subject: Re: FW: bcl-2
>
> Joyce Weems:
>
> One of our colleagues has been doing BCL-2 IHC successfully for some time now
> in rat tissues using the BCL-2 antibody from PharMingen (San Diego, CA).  He
> just got the paper published and the methods section is all very clear.
> Briefly, the tissues were fixed in Zinc Formalin, decalcified in formic acid,
> and stained using somewhat standard IHC with an added antigen retrieval step.
>
> The paper is "Expression of the BCL-2 Protein in Nasal Epithelia of F344/N
> Rats
> during Mucous Cell Metaplasia and Remodeling."  by J. Tesfaigzi, J.
>Hotchkiss,
> J. Harkema (1998) in Am. J. Respir. Cell Mol. Biol., Vol 18, p 794-799.
>
> Good luck!
>
>
> Weems, Joyce (by way of Histonet) wrote:
>
> > I am resending this from last week because I've not had any response!
> > J:>)
> > >----------
> > >From:  Weems, Joyce
> > >Sent:  Friday, November 27, 1998 9:34 AM
> > >To:    'Histonet'
> > >Subject:       bcl-2
> > >
> > >Hey you experts!
> > >
> > >What have you found to be the best method of determining overexpression of
> > >bcl-2 and bcl-1? Specimen type, etc. PCR, Immunoperoxidase, etc?
> > >
> > >Thanks for all your help!
> > >Joyce
> > >
>
> - ---------------------------------------------------------
> Catherine "Katie" Bresee Bennett
> Laboratory for Experimental Pathology
> 212G Food Safety + Toxicology Center
> Michigan State University
> East Lansing, MI 48824
> - ----------------------------------------------------------
> ph:  517-432-4940
> fx:   517-353-9902
> - ----------------------------------------------------------
> bresee@pilot.msu.edu
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 08:01:04 -0600
> From: Catherine Bennett <bresee@pilot.msu.edu>
> Subject: Re: label program
>
> I use Microsoft Word to make custom labels using 1) the label function
> under tools or 2) by making a table with fixed width and heights depending
> on the type of labels I'm trying to print on.
>
> Also, I have heard about a company, Computer Imprintable Label Systems
> (Beverly, MA, 1-888-921-8877), that will work with you to make any kind of
> custom label system that you can do up on the computer.  Their labels come
> in all sorts of flavors, including high/low temp resistant, removable,
> paper, polyester, bar-code, etc.  Their web site is www.cils-labels.com.
> I assume they aren't cheep, but they look good for big labs.
>
> Edward Henry wrote:
>
> > I am looking for a multiple label generating program for histology and
> > cytology slides.  Currently, the lab is typing slide labels and I'd
> > like to move-up to the 90's.  Any suggestions?
> >
> > Edward Henry, Manager
> > Holy Cross Health Systems
> > Silver Spring, MD
>
>
> - ---------------------------------------------------------
> Catherine "Katie" Bresee Bennett
> Laboratory for Experimental Pathology
> 212G Food Safety + Toxicology Center
> Michigan State University
> East Lansing, MI 48824
> - ----------------------------------------------------------
> ph:  517-432-4940
> fx:   517-353-9902
> - ----------------------------------------------------------
> bresee@pilot.msu.edu
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 08:01:50 -0600
> From: Catherine Bennett <bresee@pilot.msu.edu>
> Subject: Re: IHC in GMA
>
> Our group has done IHC in GMA in the past, at least for BrdU detection.
> I can fax the protocol to you if you call me.
>
> - ---------------------------------------------------------
> Catherine "Katie" Bresee Bennett
> Laboratory for Experimental Pathology
> 212G Food Safety + Toxicology Center
> Michigan State University
> East Lansing, MI 48824
> - ----------------------------------------------------------
> ph:  517-432-4940
> fx:   517-353-9902
> - ----------------------------------------------------------
> bresee@pilot.msu.edu
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 08:42:50 -0600
> From: rkline@emindustries.com
> Subject: Controls
>
> Anyone interested in making extra money?  We are in need of normal human
> controls slides.  We're looking for small intestine, liver, and kidney.
> Not fussy, but would prefer someone from New Jersey.
>
> Rande Kline HT (ASCP)
> Technical Services
> EM Science
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 08:43:30 -0600
> From: "Hinton, Sandy" <sahinton@utmb.edu>
> Subject: RE: IHC Disclaimer and non-commercial Ab's
>
> According to the information I've received we do need to use the disclaimer
> on "home brew" antibodies.
> Sandy Hinton
>
> > ----------
> > From: 	Tim Morken[SMTP:timcdc@hotmail.com]
> > Sent: 	Thursday, December 03, 1998 7:53 PM
> > To: 	histonet@pathology.swmed.edu
> > Subject: 	IHC Disclaimer and non-commercial Ab's
> >
> > What about diagnostic antibodies made non-commercially. Do we need a
> > disclaimer for those?
> >
> >
> > Tim Morken, B.S., EMT(MSA), HTL(ASCP)
> > Infectious Disease Pathology
> > Centers for Disease Control
> > MS-G32
> > 1600 Clifton Rd.
> > Atlanta, GA 30333
> > USA
> >
> > email: tim9@cdc.gov
> >        timcdc@hotmail.com
> >
> > FAX:  (404)639-3043
> >
> > ----Original Message Follows----
> > Date: Thu, 03 Dec 1998 09:29:50 -0500
> > From: beverly.miller@shandon.com
> > Subject: RE: IHC Disclaimer
> > To: Robert.Lott@bhsala.com, histonet@pathology.swmed.edu
> >
> > Let me add some slight clarification to Robert's explanation=2E IHC
> > primary=20=
> > antibodies generally fall into class I, with a few in class II=2E The
> > class=20=
> > I antibodies are exempt from having to go through the FDA submission=20=
> > process before marketing, but the class II ones are not exempt=2E As
> > this=20=
> > submission process costs the manufacturer a significant amount of
> > money,=20=
> > you may find that some of the class II antibodies (ER,PR, Ki-67 and
> > the=20=
> > like) are sold not as IHCs, but as ASRs, as the ASRs are exempt from=20=
> > submission=2E It is conceivable that a company could also market class
> > I=20=
> > antibodies as ASRs, but as there is really no advantage to the company
> > in=20=
> > doing this, I doubt that you'll see this=2E The bottom line, as
> > Robert=20=
> > said, is that the labeling the company puts on the product governs=20=
> > whether you need the ASR disclaimer or not=2E As an aside, detection=20=
> > reagents that do not include a primary antibody fall into the
> > general=20=
> > purpose reagent category and will be labeled For Laboratory Use=2E They
> > can=20=
> > be incorporated into an IHC assay without any restrictions=2E
> >
> > Bev Miller
> > Shandon Lipshaw
> >
> >  -----Original Message-----
> > From: Robert=2ELott@bhsala=2Ecom [SMTP:PC :Robert=2ELott@bhsala=2Ecom]
> > Sent: Wednesday, December 02, 1998 8:03 PM
> > To: histonet@pathology=2Eswmed=2Eedu
> > Subject: Re: IHC Disclaimer
> >
> >  << File: ENVELOPE=2ETXT >>
> >
> > --------------------------------------------------------------------------
> > =20=
> >  --
> >
> >
> > Sandy,
> > Better yet=2E=2E=2E better than trying to decipher the Federal Register,
> > read
> > the
> > article in the November CAP Today, Vol=2E12, No=2E 11 concerning the
> > disclaimer=2E
> >
> >
> > The bottom line is that the disclaimer is NOT required on IHC assay
> > results=2E
> > The FDA defines IHC reagents as "in vitro diagnostic devices=2E=2E=2E
> > intended
> > to
> > identify, by immunological techniques, antigens in tissue or cytologic
> > specimens=2E"
> >
> >
> > The new FDA requirements (which went into effect Aug 17th) for use of
> > IHC reagents, required that manufacturers of IHC reagents discontinue
> > using
> > the research or investigational purposes labeling and instead adhere to
> > "new labeling and approval" requirements=2E This is essence takes them
> > out
> > of
> > the ASR category=2E
> >
> >
> > Unlike ASRs (analyte specific reagents; or componenents of "home-brew
> > tests"),
> > IHC reagents are labeled with directions for use and performance
> > claims=2E
> > Manufacturers cannot make performance claims about ASRs=2E
> >
> >
> > Therefore, laboratories are NOT required to to use a disclaimer
> > statement=20=
> >
> >
> > on
> > IHC reports as long as the components of your IHC assay are not labeled
> > "ASRs"
> > by the manufacturer=2E  As long as you buy the components of your
> > IHC=20=
> > assays
> > from a manufacturer that has been through the FDA labeling and=20=
> > performance
> > approval process you're OK=2E This goes for primary antibodies and=20=
> > detection
> > systems=2E
> >
> >
> > Robert Lott, HTL(ASCP)
> > Baptist Health System
> > Birmingham, AL
> >  ------------------( Forwarded letter 1 follows )--------------------
> > Date: Tue Dec 01 20:00:34 1998
> > From: ptakes@stereotaxis=2Ewustl=2Eedu
> > Sender: HistoNet@Pathology=2Eswmed=2Eedu
> > Subject: Re: IHC Disclaimer
> >
> >
> > Sandy:
> >
> >
> > The disclaimer in the Federal Register notice will likely be required by
> > CAP for
> > tests where an ASR is used, in accordance with FDA requirements=2E
> > Please
> > note
> > that FDA now requires labs use that disclaimer, and labs employing ASRs
> > now
> > fall
> > within FDA's jurisdiction for compliance with the report label
> > regulations=2E
> > See
> > Clinical Laboratory News 24(4):10, April, 1998=2E
> >
> >
> > Peter
> >
> >
> >  --
> > Peter A=2E Takes, Ph=2ED=2E, RAC
> > Director, Clinical & Regulatory Affairs
> > STEREOTAXIS, Inc=2E
> > Ph=2E 1-314-615-6964; Pager: 841-9351
> > ptakes@stereotaxis=2Ewustl=2Eedu
> >
> >
> >
> >
> > Hinton, Sandy (by way of Histonet) wrote:
> >
> >
> > > This may be a subject that has been discussed previously but if so I
> > was off
> > > the network at that time=2E
> > > I have a copy of the Federal Register relating to the ruling on
> > > Immunohistochemistry reagents=2E
> > > My question is what disclaimer is CAP requiring us to add to final
> > Surgical
> > > Pathology reports, to address Immunohistochemistry procedures?
> > > Please feel free to email or FAX (409) 772-4676, your response=2E
> > > Thanks
> > > University of Texas Medical Branch at Galveston
> > > Sandy Hinton
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> > ______________________________________________________
> > Get Your Private, Free Email at http://www.hotmail.com
> >
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 11:02:17 -0600
> From: Lynn Gardner <gardnerl@horus.ophth.uiowa.edu>
> Subject: Letter that can help
>
> Dear all I just received this letter from one of my collegues and it is
> real to the best of our knowledge please read:
>
> Please take a minute and read this
> >     Be sure you read the end of this message
> >
> >     Subject: fwd: Slow Dance
> >
> >     S L O W   D A N C E:
> >
> >     Have you ever watched kids on a merry-go-round
> >     Or listened to the rain slapping on the ground?
> >     Ever followed a butterfly's erratic flight
> >     Or gazed at the sun into the fading night?
> >     You better slow down
> >     Don't dance so fast
> >     Time is short
> >     The music won't last
> >     Do you run through each day on the fly
> >     When you ask "How are you?" do you hear the reply?
> >     When the day is done, do you lie in your bed
> >     With the next hundred chores running through your head?
> >     You'd better slow down
> >     Don't dance so fast
> >     Time is short
> >     The music won't last
> >     Ever told your child,
> >     We'll do it tomorrow
> >     And in your haste, not see his sorrow?
> >     Ever lost touch,
> >     Let a good friendship die
> >     'Cause you never had time to call and say "Hi"?
> >     You'd better slow down
> >     Don't dance so fast
> >     Time is short
> >     The music won't last
> >     When you run so fast to get somewhere
> >     You miss half the fun of getting there.
> >     When you worry and hurry through your day,
> >     It is like an unopened gift....
> >     Thrown away...
> >     Life is not a race.
> >     Do take it slower
> >     Hear the music
> >     Before the song is over.
> >
> >     PLEASE FORWARD THIS TO HELP THIS LITTLE GIRL
> >
> >     Dear All,
> >
> >          I just received this mail from a friend of mine in my
> > College.
> >     Please respond to it. It will just mean employing a little bit of
> > time
> >     and won't cost you a penny. All it needs is the heart for you to
> > send
> >     this mail. PLEASE pass this mail on to everybody you know. It is
> > the
> >     request of a little girl who will soon leave this world as she has
> >
> >     been a victim of the terrible disease called CANCER. Thank you for
> > your
> >     effort, this isn't a chain letter, but a choice for all of us to
> > save
> >     a little girl that's dying of a serious and fatal form of cancer.
> >
> >     Please send this to everyone you know...or don't  know.  This
> > little girl
> >     has 6 months left to live, and as her dying wish, she wanted to
> > send a
> >     chain letter telling everyone to live their life to fullest, since
> > she
> >     never will. She'll never make it to prom, graduate from high
> > school, or
> >     get married and have a family of her own.  By you  sending this to
> > as
> >     many people as possible, you can give her and her family a little
> > hope,
> >     because with  every name that this is sent to, The American Cancer
> >
> >     Society will donate 3 cents per name to her treatment and recovery
> >
> >     plan.  One guy sent this to 500 people!!!!  So,I know that we can
> > send
> >     it to at least 5 or 6.  Come on you guys.... take 10-15  minutes
> >     scrolling this and forwarding it to EVERYONE. Just think it could
> > be
> >     you one day. It's not even your money ,just your time!!!
> >
> >     PLEASE PASS ON
> >
> >     Dr. Dennis Shields, Professor
> >     Department of Developmental and Molecular Biology
> >     Albert Einstein College of Medicine of Yeshiva University
> >     1300 Morris Park Avenue
> >     Bronx, New York 10461
> >     Phone 718-430-3306
> >     Fax       718-430-8567
> >
> >     Heidi Gonzales
> >     Accounts Receivable/Collections
> >     University of California, Davis
> >     One Shields Avenue
> >     Davis, CA 95616-8709
> >     530-752-7793
> >     530-752-5718-FAX
> >     E-mail: hlgonzales@ucdavis.edu
> >
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 11:02:54 -0600
> From: Nita Searcy 949-6843 <SEARNJ@Integris-Health.com>
> Subject: Questions
>
> At the present time, we are planning a "move" from a hospital based lab to a
> "core" lab. I am having many meetings with many player-Pathologists,
> administators, etc. I have many questions -has anyone done this
>recently-would
> you consider me asking you some questions personally? We have several
> scenarios
> on the table-no decisions , as yet but I do have input and want to make good
> sound decisions WHEN the big guys give me more info to work with. I would be
> happy to call you- Nita Searcy @ 405-943-7363
>                    searnj@integris-health.com
> example-are there regulatioons that state parameters regarding slides besides
> the CAP-"readily accessable" and what REALLY works best?? Thanks!
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 11:03:41 -0600
> From: "Peter A. Takes" <ptakes@stereotaxis.wustl.edu>
> Subject: Re: IHC Disclaimer and non-commercial Ab's
>
>  Tim:
>
> Now you're in a truly tricky area.  Many factors and other issues to
>consider,
> largely dependent on where the Abs come from and who uses them for what.
>From
> an
> FDA perspective, if the Abs are made by the docs at your institution, and
>used
> internally, then that falls within their practice of medicine exclusion, and
> the
> extent of responsibility falls to the physicians.  FDA cannot, by rule,
> regulate
> the practice of medicine.  However, there may be HCFA issues involved,
>and you
> must be sure the tests are validated.  No disclaimer from an FDA approach.
>
> If the Abs are non-commercial, but given or sold to you by another
> institution,
> FDA could get into the picture, because now the Abs are changing hands for
> clinical use, and this can cause a problem greater than the disclaimer.
> Although
> the Ab availability is not publicized, a commercial transaction of sorts has
> taken
> place.  More a problem for the source of the Ab than the end user.  However,
> if
> your institution performs billable tests for outside institutions for
> diagnostic
> purposes, now FDA can potentially enter the picture.  Although the Abs
>are not
> specifically commercialized, the tests employing them, in principle, are, and
> FDA
> could possibly get into the picture.  Labeling of the 'products' and
> subsequent
> disclaimers would only be one of the issues in this case.
>
> A regulatory attorney might correct me on some of the finer points here, but
> my
> view of the current rules would be that these should be valid concerns.
> Especially in the unlikely event of an aberrant diagnosis.
>
> Peter
> - --
> Peter A. Takes, Ph.D., RAC
> Director, Clinical & Regulatory Affairs
> STEREOTAXIS, Inc.
> Ph. 1-314-615-6964; Pager: 841-9351
> ptakes@stereotaxis.wustl.edu
>
>
> Tim Morken wrote:
>
> > What about diagnostic antibodies made non-commercially. Do we need a
> > disclaimer for those?
> >
> > Tim Morken, B.S., EMT(MSA), HTL(ASCP)
> > Infectious Disease Pathology
> > Centers for Disease Control
> > MS-G32
> > 1600 Clifton Rd.
> > Atlanta, GA 30333
> > USA
> >
> > email: tim9@cdc.gov
> >        timcdc@hotmail.com
> >
> > FAX:  (404)639-3043
> >
> > ----Original Message Follows----
> > Date: Thu, 03 Dec 1998 09:29:50 -0500
> > From: beverly.miller@shandon.com
> > Subject: RE: IHC Disclaimer
> > To: Robert.Lott@bhsala.com, histonet@pathology.swmed.edu
> >
> > Let me add some slight clarification to Robert's explanation=2E IHC
> > primary=20=
> > antibodies generally fall into class I, with a few in class II=2E The
> > class=20=
> > I antibodies are exempt from having to go through the FDA submission=20=
> > process before marketing, but the class II ones are not exempt=2E As
> > this=20=
> > submission process costs the manufacturer a significant amount of
> > money,=20=
> > you may find that some of the class II antibodies (ER,PR, Ki-67 and
> > the=20=
> > like) are sold not as IHCs, but as ASRs, as the ASRs are exempt from=20=
> > submission=2E It is conceivable that a company could also market class
> > I=20=
> > antibodies as ASRs, but as there is really no advantage to the company
> > in=20=
> > doing this, I doubt that you'll see this=2E The bottom line, as
> > Robert=20=
> > said, is that the labeling the company puts on the product governs=20=
> > whether you need the ASR disclaimer or not=2E As an aside, detection=20=
> > reagents that do not include a primary antibody fall into the
> > general=20=
> > purpose reagent category and will be labeled For Laboratory Use=2E They
> > can=20=
> > be incorporated into an IHC assay without any restrictions=2E
> >
> > Bev Miller
> > Shandon Lipshaw
> >
> >  -----Original Message-----
> > From: Robert=2ELott@bhsala=2Ecom [SMTP:PC :Robert=2ELott@bhsala=2Ecom]
> > Sent: Wednesday, December 02, 1998 8:03 PM
> > To: histonet@pathology=2Eswmed=2Eedu
> > Subject: Re: IHC Disclaimer
> >
> >  << File: ENVELOPE=2ETXT >>
> >
> >
>
>--------------------------------------------------------------------------=20=
>
>>  --
> >
> > Sandy,
> > Better yet=2E=2E=2E better than trying to decipher the Federal Register,
> > read
> > the
> > article in the November CAP Today, Vol=2E12, No=2E 11 concerning the
> > disclaimer=2E
> >
> > The bottom line is that the disclaimer is NOT required on IHC assay
> > results=2E
> > The FDA defines IHC reagents as "in vitro diagnostic devices=2E=2E=2E
> > intended
> > to
> > identify, by immunological techniques, antigens in tissue or cytologic
> > specimens=2E"
> >
> > The new FDA requirements (which went into effect Aug 17th) for use of
> > IHC reagents, required that manufacturers of IHC reagents discontinue
> > using
> > the research or investigational purposes labeling and instead adhere to
> > "new labeling and approval" requirements=2E This is essence takes them
> > out
> > of
> > the ASR category=2E
> >
> > Unlike ASRs (analyte specific reagents; or componenents of "home-brew
> > tests"),
> > IHC reagents are labeled with directions for use and performance
> > claims=2E
> > Manufacturers cannot make performance claims about ASRs=2E
> >
> > Therefore, laboratories are NOT required to to use a disclaimer
> > statement=20=
> >
> > on
> > IHC reports as long as the components of your IHC assay are not labeled
> > "ASRs"
> > by the manufacturer=2E  As long as you buy the components of your
> > IHC=20=
> > assays
> > from a manufacturer that has been through the FDA labeling and=20=
> > performance
> > approval process you're OK=2E This goes for primary antibodies and=20=
> > detection
> > systems=2E
> >
> > Robert Lott, HTL(ASCP)
> > Baptist Health System
> > Birmingham, AL
> >  ------------------( Forwarded letter 1 follows )--------------------
> > Date: Tue Dec 01 20:00:34 1998
> > From: ptakes@stereotaxis=2Ewustl=2Eedu
> > Sender: HistoNet@Pathology=2Eswmed=2Eedu
> > Subject: Re: IHC Disclaimer
> >
> > Sandy:
> >
> > The disclaimer in the Federal Register notice will likely be required by
> > CAP for
> > tests where an ASR is used, in accordance with FDA requirements=2E
> > Please
> > note
> > that FDA now requires labs use that disclaimer, and labs employing ASRs
> > now
> > fall
> > within FDA's jurisdiction for compliance with the report label
> > regulations=2E
> > See
> > Clinical Laboratory News 24(4):10, April, 1998=2E
> >
> > Peter
> >
> >  --
> > Peter A=2E Takes, Ph=2ED=2E, RAC
> > Director, Clinical & Regulatory Affairs
> > STEREOTAXIS, Inc=2E
> > Ph=2E 1-314-615-6964; Pager: 841-9351
> > ptakes@stereotaxis=2Ewustl=2Eedu
> >
> > Hinton, Sandy (by way of Histonet) wrote:
> >
> > > This may be a subject that has been discussed previously but if so I
> > was off
> > > the network at that time=2E
> > > I have a copy of the Federal Register relating to the ruling on
> > > Immunohistochemistry reagents=2E
> > > My question is what disclaimer is CAP requiring us to add to final
> > Surgical
> > > Pathology reports, to address Immunohistochemistry procedures?
> > > Please feel free to email or FAX (409) 772-4676, your response=2E
> > > Thanks
> > > University of Texas Medical Branch at Galveston
> > > Sandy Hinton
> >
> > ______________________________________________________
> > Get Your Private, Free Email at http://www.hotmail.com
>
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 13:03:02 -0600
> From: "Linda Gorman" <lgorman1@kumc.edu>
> Subject: paraffin blocks
>
> Does someone have a reference for proper storage of paraffin blocks?
>  Thanks
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 13:03:33 -0600
> From: twest@bcm.tmc.edu (Teresa West)
> Subject: HistoNet subscription
>
> subscribe
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 13:03:56 -0600
> From: "Koutney, Janice" <JKoutney@cytometry.com>
> Subject: disposable blades
>
> Hi Everyone,
> Can anyone tell me where we can purchase AccuEdge low profile disposable
> blades other than VWR/SP?
> Thank You,
> Janice Koutny HT(ASCP)
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 15:21:01 -0600
> From: Lynn Gardner <gardnerl@horus.ophth.uiowa.edu>
> Subject: Extreme number of the same message
>
> To Whom It May Concern,
>
> I am receiving at least five or six copies of the same information from
> people could someone please find out what is going on, it would be much
> appreciated. Thanks
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 15:22:17 -0600
> From: "P. Emry" <emry@u.washington.edu>
> Subject: Net duplicuts
>
> I got the all-time high in duplicate messages from the histonet..7.
> Is that my computer or histonet?  Anything I should do?
> Trisha
> U of Washington, Seattle
>
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 15:23:16 -0600
> From: "Steven P. Postl 847-935-3736" <POSTL.STEVEN@Igate.Abbott.Com>
> Subject: Phone number request
>
> Does anyone have the current phone number for Lamar and Wanda Grace
>                                        Jones?  Thank you.
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 15:24:24 -0600
> From: "J. A. Kiernan" <jkiernan@julian.uwo.ca>
> Subject: Re: Glyoxal
>
> On Fri, 4 Dec 1998, Mick Rentsch wrote:
>
> > Can anyone suggest what concentration Glyoxal should be used at as a
> > substitute for 10%NBF, and is it better with Saline or buffered to pH
> > 6.8-7.2.
> > The Merck Index suggests that dissolving the Glyoxal presents special
> > hazards, does anyone have any experience?
>
>   According to the Sigma catalogue, glyoxal is available commercially
>   only as its hydrated trimer (formed when glyoxal reacts with itself
>   and water). They sell this as solid ($17.90 for 100 g) and as a
>   40% aqueous solution ($24.80 for 100 g).
>
>   Pearse's Histochemistry (4th ed, Vol 1, p. 104) mentions it
>   rather briefly, giving a reference to Nakaya et al 1969 Biochim
>   Biophys Acta 194:301. On p. 60 Pearse includes glyoxal in a
>   list of 16 substances he tested as vapour-phase fixatives for
>   freeze-dried objects. He didn't comment on its efficacy.
>
>   It would seem reasonable to dilute the glyoxal trimer with
>   an isotonic sodium phosphate buffer. I do not know how this
>   would compare with the commercially available ready-mixed
>   glyoxal-containing fixatives. It ought to be cheaper to
>   make your own.
>
>  John A. Kiernan,
>  Department of Anatomy & Cell Biology,
>  The University of Western Ontario,
>  LONDON,  Canada  N6A 5C1
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 15:24:58 -0600
> From: Louise Burrell <lburrell@pathbox.wustl.edu>
> Subject: RNA protocols (i.e. peripheral blood)
>
> Dear everyone----I am having a lab meeting Monday---where I need to get
> permission "from higher ups" to fax you all.  There should not be any
> problems, however I did not want any of you to think I let the balls
> drop---so to speak:)
>
>
> Thanks in advance.........
>
>
> Louise Burrell
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 15:25:22 -0600
> From: Nora Fox <nefox@leland.Stanford.EDU>
> Subject: saving sections in the ultra-cold
>
> Hello all.  Happy holidays!!
>
> Do any of you cut frozen sections and store them for later staining (IHC)?
> Have you ever had problems with this?  Any advice on dos & don'ts?
>
> Thanks.
>
> Nora
>
> Nora Fox
> Division of Orthopaedic Surgery
> Stanford University
> Edwards R144, MC 5341
> 300 Pasteur Drive
> Stanford, CA 94305
> phone: (650)725-2746
> fax:  (650)723-6396
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 15:26:48 -0600
> From: rkline@emindustries.com
> Subject: Re: delivery of specimens
>
> I forgot to send my reply to all.
> - ---------------------- Forwarded by Rande Kline/EMI/Merck on 12/04/98 03:09
> PM ---------------------------
>
>
> Rande Kline
> 12/03/98 04:05 PM
>
> To:   Cel Rutledge <gocelgo@itsa.ucsf.edu>
> cc:
> Subject:  Re: delivery of specimens  (Document link not converted)
>
> Cel,
>
> You have a problem.   It's control time.  I remember this part all too
> well.
>
> This is what I instituted when I was a supervisor and had similar problems.
> I hope this will give you some ideas.
>
> A log book was kept in the receiving area, which was pathology.  When a
> specimen was sent it had to be logged in and signed by the person
> delivering it .  Pathology signed that is was recieved.  that it was
> received.  It was signed received only if it was recieved properly. The
> clinical sites also had their own log for which the dept signed upon
> receipt.   A log book was carried by the messenger service but filled out
> by clinical sites ( each site had their own logs ) or wherever they were
> picked up from. This was also a good way to eliminate the problem of
> clinical sites claiming they delivered something and they didn't and also
> kept track of what time a specimen was received ( we had a time stamp for
> the requisitons) There was also a log book wherever the pathology
> department made the pick-ups.  The point is specimens were always signed
> for and there was on-going documentation of receipt and time of receipt (
> outside of the information system ).  It was a good way to nip problems in
> the bud.
>
> I don't remember exactly everything in the log book, but for sure it had
> date, patient name, Dr. ,  delivered by, rec'd by, and type of specmen.
>
> Also,  if a specimen was improperly bought into the lab, the clinical site
> was called (not the messenger service ) and they had to correct the
> problem.  The specimens which came down from the OR sometimes had to go
> back up. I even had the guts to call the doctors and tell them that their
> work would not be processed unless the lab slips were completed. There were
> times when there were alot of corrections to make which included many, many
> lab slips to rewrite, bags to change (especially, if there was blood on the
> outside or formalin spillage), and filling containers with formalin.  This
> was no pathology's responsibility.  Pathology's responsiblity was to make
> sure the clinical sites/OR had the materials they needed to submit the
> specimens and of course educate the proud recepients. Secretaries do not
> need to handle lab requests that have stuff on them when they are doing
> reports.  Nor do dirty lab slips need to be handled by anyone. The point
> did get through to all.  I had support from the pathologists which really
> helped.  Weekends would still be a problem at times.  But we all still
> plugged at it.
>
> I think I became a monster.  Hope this helps.  Anytime you want to talk,
> call me.
>
> Rande Kline HT (ASCP)
> Technical Services
> EM Science
> 800-222-0342 x443
>
>
>
>
>
>
>
>
>
> Cel Rutledge <gocelgo@itsa.ucsf.edu> on 12/03/98 01:49:50 PM
>
> To:   Histonet <Histonet@Pathology.swmed.edu>
> cc:
> Subject:  delivery of specimens
>
>
>
>
>
> We have been having a problem with the condition of surgical specimens
> that are delvered to pathology.  We have a central messenger center that
> collects specimens from the clinics and surgery on a regular time
> schedule.  They pick up specimens and then deliver them to pathology.  The
> immediate problem is the careless with which they are handled.  They
> "toss" them into a plastic or paper bag and then empty them on the
> receiving desk.  To ones complete amazement-they leak. The clinics,
> surgery and messenger supervisors have been contacted, warned, threatened,
> verbally abused, begged and pleaded with, but still no end in sight to the
> problem.
>
> We have explained the problem with contamination, having to redo the
> paperwork, and the time consuming effort involved in  handling this
> problem, but nothing.  It is a double headed problem, but I feel that if
> the messengers would not turn them every which way then the containers
> that were not sealed correctly would not leak.
>
> The clinics are furnished bags with special pockets for paperwork on the
> outside of the bag while the specimen goes inside, unfortunately the put
> the paper inside with the leaky specimen.
>
> I would like some suggestions as to how other hospitals receive their
> specimens.  Is this common?  Or, are we just lucky?
>
>
> Cel Rutledge
> San Francisco General Hospital
>
>
>
>
>
>
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 15:27:12 -0600
> From: poobear31@webtv.net (K M)
> Subject: Thank you!
>
> I just wanted to thank everyone for all of the feedback that I have
> recieved in regard to my 20 questions about careers in research.
> They're all greatly appreciated, please keep them coming!
> Also, is anyone else getting quadruple posts from histonet?
> Thanks again,
> Kim
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 19:42:02 -0600
> From: andreah@imclone.com
> Subject: Vessel dye??
>
> Without doing to much investigation on my own, I will pose this quesiton
> and then over the weekend I shall do the searches.  But I thought if
> someone can help me with hands on experience first, that's better by far
> ...
>
> I would like to stain vessels  in a primary culture preparation.  I would
>like
> to impart colour to them so that they can be visualized and photographed
> without staining all cells (or at least not the same colour), or without
> staining collagen ... any hints?? any help would help ... Andrea
> ANDREAH@IMCLONE.COM
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 19:42:43 -0600
> From: andreah@imclone.com
> Subject: Vessel dye?? Part 2
>
> Well here is something I just found, Victoria blue elastic stain ... does
> anyone know about this stain and whether or not it would stain vessels
> adn not collagen??
>
> Andrea
> ANDREAH@IMCLONE.COM
>
>
>
>
> ----------------------------------------------------------------------
>
> Date: 4 Dec 1998 19:44:42 -0600
> From: Gayle Callis <uvsgc@msu.oscs.montana.edu>
> Subject: frozen section storage
>
> We have the best luck with the black plastic boxes (25 slide capacity)
> with a small nylon process bag or lens paper containing silica gel to absorb
> moisture when you bring sections back to room temperature.  We also
> wrap tape around outside to seal box, this may be overkill, but it
> provides label.  Avoid calcium chloride, anhydrous as a substitute
> for silica gel, Drierite (sp?) is also a problem since these exfoliate fine
> particles that float around, could deposit on sections. silica gel stays
> intact
> and is reused for a long time.
>
> Store sections fixed, air dried, in -80C freezer, then bring them
> to room temperature BEFORE opening the lid, 20 - 30 minutes.
>
> also stored slides in plastic slide mailers with snap lids, wrapped
> in foil, either in a plastic zip lock, or two mailers per black slide
> box with silica gel, you can remove one box and keep other for another
> day.
>
> These are frozen sections, have stored unfixed frozens in slide mailers with
> success, but only for a few weeks.  Fixed sections store for longer times
>
> Label with date faithfully!
>
> Hope this helps.
>
> Gayle Callis
>
>
> Here are the messages received yesterday!
>
>




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