[Histonet] Block Storage-another question

Wed Mar 21 16:11:09 CDT 2012

Fellow Histonet Subscribers,

I have been noticing a LOT of misinformation being passed around this site,
much coming from one respondent in particular. This is very troubling, as
our position in healthcare, and the work we do, is so very critical to
patient care and patient outcomes. I would hope that before responding to
questions, people either know what they are talking about, or make it clear
that it is opinion they are expressing, and not necessarily fact. Perhaps
including some reference, or web link to information is practical at times.

Here I have listed below responses to some questions that are outright
false, and the information presented, if followed, in some instances may
put a lab in jeopardy when inspected.

It also appears that we have techs from marine biology centers, and plant
histology labs answering questions pertaining to medicine. I am not sure
how appropriate that is. This is, of course, just my opinion.

*In Response to the question of where to store blocks this was an answer:*

“Both but especially the place where the diagnosis takes place.”

It is not possible to store blocks in BOTH locations. Why would you do
that? And “especially the place where the diagnosis takes place” is
incorrect. The logical place to keep the blocks is where the histology is
performed. If space does not permit long term storage, rent a facility that
is compliant with your state requirements for doing so.

As far as time to keep blocks, CLIA and CAP have different requirements.
Check with your State to see if they are even more stringent than CAP. Here
is what CLIA, and CAP require:

FROM CLIA:

Sec. 493.1105  Standard: Retention requirements

(a)(3)(ii) Blocks. Retain pathology specimen blocks for at least 2 years

from the date of examination.

FROM CAP:

Retention of Laboratory Records
and Materials:

*Surgical Pathology (including bone marrows)*

Wet tissue

2 weeks after final report

Paraffin blocks

10 years

Slides

10 years

Reports

10 years

*In Response to Water Quality this response was noted:*

“No "small laboratory" has the conditions required to perform microbiology
cultures”

This is an inaccurate statement. Size of a lab, and ability to perform work
in a sterile environment are not at all related.

When responding to questions as important as breast fixation times, it
would be helpful to include information like what I included immediately
below  – furthermore, as all of you know, breast tissue fixes differently
depending upon several factors, especially fat content, and thickness of
the sections. The question of best fixation time is not an answerable
question – it is specific to the case itself. Is it cores we are talking
about? Is it a dense fibrous lumpectomy? Is it a fatty mastectomy? There is
no perfect answer to that question.

*What are the changes made to minimum fixation times?*

The minimum fixation time for HER2 has been clarified and we recommend that
samples for HER2 testing be fixed a minimum of 6 hours. The original
statement that smaller samples can be fixed for less than 6 hours is not
supported by the literature. We recommend that sample for HER2 testing be
fixed a minimum of 6 hours regardless of sample size.

*WWhat about changes to maximum fixation times? The HER2 fixation time of
6-48 hours is not consistent with that of the ER/PgR fixation time of 6-72
hours.*

We are unable to find evidence to support increasing the HER2 fixation time
and therefore recommendations for fixation times in neutral buffered
formalin are unchanged (6-48 hours for HER2 and 6-72 hours for ER/PgR). The
data about the stability of ER and PgR at intervals of 48-72 hours suggest
that changing this interval for HER2 testing will not result in adverse
testing results. However, there is a lack of specific published studies for
HER2 IHC that included specimens with low levels of HER2 expression that
would be more vulnerable to fixation time changes.

*What are the changes made to minimum fixation times?*

The minimum fixation time for HER2 has been clarified and we recommend that
samples for HER2 testing be fixed a minimum of 6 hours. The original
statement that smaller samples can be fixed for less than 6 hours is not
supported by the literature. We recommend that sample for HER2 testing be
fixed a minimum of 6 hours regardless of sample size.

On Wed, Mar 21, 2012 at 1:27 PM, Rene J Buesa <rjbuesa <@t> yahoo.com> wrote:

> Both but especially the place where the diagnosis takes place.
> René J.
>
> --- On Wed, 3/21/12, Cynthia Pyse <cpyse <@t> x-celllab.com> wrote:
>
>
> From: Cynthia Pyse <cpyse <@t> x-celllab.com>
> Subject: RE: [Histonet] Block Storage-another question
> To: "'Rene J Buesa'" <rjbuesa <@t> yahoo.com>, "'Ann Angelo'" <
> thisisann <@t> aol.com>, histonet <@t> lists.utsouthwestern.edu, "'FeltonNails'" <
> flnails <@t> texaschildrens.org>
> Date: Wednesday, March 21, 2012, 11:25 AM
>
>
> If the pod lab is in NJ and the "reading" lab is in NY, which guide lines
> do
> you follow. NYS requires us to save our blocks for 20 years. Due to storage
> issues, I would rather the pod lab store the blocks.
> Cindy
>
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu
> [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Rene J
> Buesa
> Sent: Wednesday, March 21, 2012 10:20 AM
> To: 'Ann Angelo'; histonet <@t> lists.utsouthwestern.edu; FeltonNails
> Subject: RE: [Histonet] Block Storage
>
> Depending on the state regulations and the laboratory policies,blocks are
> stored during different periods of time before being discarded. I used to
> store them for 9 years.
> René J.
>
> --- On Wed, 3/21/12, Nails, Felton <flnails <@t> texaschildrens.org> wrote:
>
>
> From: Nails, Felton <flnails <@t> texaschildrens.org>
> Subject: RE: [Histonet] Block Storage
> To: "'Ann Angelo'" <thisisann <@t> aol.com>, "histonet <@t> lists.utsouthwestern.edu
> "
> <histonet <@t> lists.utsouthwestern.edu>
> Date: Wednesday, March 21, 2012, 9:00 AM
>
>
> This is a very sticky issue, when I setup inhouse labs I always present the
> argument that during inspections the lab that produces a report should have
> access to all test material which includes blocks and slides per the CAP
> checklist.
> Ann trying approaching it from that angle.
>
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu
> [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Ann Angelo
> Sent: Tuesday, March 20, 2012 6:58 PM
> To: histonet <@t> lists.utsouthwestern.edu
> Subject: [Histonet] Block Storage
>
> Does anyone know if a laboratory in NJ is required to keep the blocks they
> perform Technical component  on if they do not perform the professional
> component....or should they have the facility performing the professional
> component store them?  Who is ultimately responsible? Ann
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-- 
*David Costanzo, MHS, PA (ASCP)*
Project Manager
*Blufrog Path Lab Solutions*
9401 Wilshire Blvd. Ste 650
Beverly Hills, CA 90212