[Histonet] Response to Considering whether starting your own repository due to high quantity of tissues already in your posession that are being discarded and alternately used for profitable gain

Eddie Martin edmartin26 at gmail.com
Thu Aug 1 16:12:50 CDT 2024 

Hello Curt,

Regarding your question:
So running a ref lab for years I've acquired a rather large supply of old
blocks of various tissues, I'm considering turning this into a tissue
bank/repository with the purpose of selling blocks for research and control
purposes... anyone have any experience, what are the requirements to be
compliant??? I have zero experience with this. I'm guessing some release
forms, maybe patient consent forms (IMPOSSIBLE TO GET THOSE FOR BLOCKS THAT
ARE 10 YRS OLD)... release of liability forms... I'm starting at zero so
any insight is appreciated!


*Note 1: I'm neither a pathologist, a lawyer or any kind of adequate legal
counsel. The response below is my opinion only, and my own understanding of
the HIPAA act, and does not reflect the views of the institutions I work at
or the employers I work for:

I kindly suggest you seek permission from your company's medical-legal
office, as they and not yourself individually are covered entities. Any
instance of accessing a patient's medical diagnostic report for non-testing
purposes that is also not assigned to you by a clinician/pathologist of
accessing medically necessary information to perform tasks covered and
protected by the covered entity, including testing necessary to perform for
the patient's medical care and continuation of care is a breach of a
patient's PHI information, whether accessed via hardcopy or electronic or
any other kind of format.  I can easily think of four Federal Acts in place
protecting PHI:

** HIPAA, HITECH, FERPA, GINA

*** Then individual State Laws that each may have even more strict
guidelines in place to protect PHI.

I get that you are trying to repurpose pathology materials, but established
repositories are regulated by the FDA in addition to other federal and
State agencies. Seeking the permission of your company's medical-legal
department is highly suggested before accessing anything. My understanding
of the intricacies of what I'm posting is limited in scope and
understanding. From my understanding of the HIPAA Act above, each instance
of breach must be reported to your company within sixty days of becoming
aware of the breach, unless your local and State authorities have more
stringent laws in place; and may subject your employer and yourself to
breaching the confidentiality, integrity and availability made available in
accessing the PHI, that also outlines standards and penalties for
non-compliance.

In the event the quantity of breaches exceeds 500 individuals impacted, the
covered entity must also report the breach to the Department of Health and
Human Services and provide the information to prominent media outlets to
inform possible patients impacted by the breach within the jurisdiction the
breach had occurred.

Very respectfully,

Eddie Martin, HT, HTL, QIHC


On Thu, Aug 1, 2024 at 1:00 PM <histonet-request at lists.utsouthwestern.edu>
wrote:

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>    1. Tissue repository (Curt Tague)
>    2. Re: Tissue repository (Jay Lundgren)
>    3. Re: Tissue repository (richard cartun)
>    4. Re: Tissue repository (Curt Tague)
>    5. Happy Thursday Histonetters!! (relia1 at earthlink.net)
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> ---------- Forwarded message ----------
> From: Curt Tague <c.tague at pathologyarts.com>
> To: "Histonet at lists.utsouthwestern.edu" <histonet at lists.utsouthwestern.edu
> >
> Cc:
> Bcc:
> Date: Wed, 31 Jul 2024 21:02:20 +0000
> Subject: [Histonet] Tissue repository
> Hi all,
>
> So running a ref lab for years I've acquired a rather large supply of old
> blocks of various tissues, I'm considering turning this into a tissue
> bank/repository with the purpose of selling blocks for research and control
> purposes... anyone have any experience, what are the requirements to be
> compliant??? I have zero experience with this. I'm guessing some release
> forms, maybe patient consent forms (IMPOSSIBLE TO GET THOSE FOR BLOCKS THAT
> ARE 10 YRS OLD)... release of liability forms... I'm starting at zero so
> any insight is appreciated!
>
> Best!
>
> Curt
>
>
>
>
>
> ---------- Forwarded message ----------
> From: Jay Lundgren <jaylundgren at gmail.com>
> To: Curt Tague <c.tague at pathologyarts.com>
> Cc: "Histonet at lists.utsouthwestern.edu" <histonet at lists.utsouthwestern.edu
> >
> Bcc:
> Date: Wed, 31 Jul 2024 17:26:44 -0500
> Subject: Re: [Histonet] Tissue repository
> Sorry Igor, but if you can't get informed consent, it's not legal or
> ethical to sell patients' surgical specimens.  There are laws in all 50
> states. The body or parts thereof have to be explicitly donated.
>
> If you have informed consent, you can sell them for a large profit, as lots
> of non-transplant tissue banks do. That's a multi-million dollar, highly
> profitable industry.  How could it not be, getting something for free, and
> selling it for top dollar.
>
> You might be thinking, "who's going to know?"  In my experience, lots of
> people are nosy and vindictive for no good reason.  You could end up in
> prison.  Consult an attorney.
>
> Sorry to ruin your retirement plans.
>
> Sincerely,
>
> Jay A. Lundgren, M.S., HTL (ASCP)
>
> On Wed, Jul 31, 2024 at 4:02 PM Curt Tague via Histonet <
> histonet at lists.utsouthwestern.edu> wrote:
>
> > Hi all,
> >
> > So running a ref lab for years I've acquired a rather large supply of old
> > blocks of various tissues, I'm considering turning this into a tissue
> > bank/repository with the purpose of selling blocks for research and
> control
> > purposes... anyone have any experience, what are the requirements to be
> > compliant??? I have zero experience with this. I'm guessing some release
> > forms, maybe patient consent forms (IMPOSSIBLE TO GET THOSE FOR BLOCKS
> THAT
> > ARE 10 YRS OLD)... release of liability forms... I'm starting at zero so
> > any insight is appreciated!
> >
> > Best!
> >
> > Curt
> >
> > _______________________________________________
> > Histonet mailing list
> > Histonet at lists.utsouthwestern.edu
> > http://lists.utsouthwestern.edu/mailman/listinfo/histonet
> >
>
>
>
>
> ---------- Forwarded message ----------
> From: richard cartun <rcartun at sbcglobal.net>
> To: "Histonet at lists.utsouthwestern.edu" <histonet at lists.utsouthwestern.edu>,
> Curt Tague <c.tague at pathologyarts.com>
> Cc:
> Bcc:
> Date: Thu, 1 Aug 2024 02:00:26 +0000 (UTC)
> Subject: Re: [Histonet] Tissue repository
>  Hi Curt,
> Does your lab have an in-house legal department?  If so, have you
> consulted with them about this?  The attorneys for the hospital I worked in
> wanted nothing to do with providing patient tissue to outside interests who
> were willing to pay for it.
>
> Richard Cartun
>
>     On Wednesday, July 31, 2024 at 05:02:57 PM EDT, Curt Tague via
> Histonet <histonet at lists.utsouthwestern.edu> wrote:
>
>  Hi all,
>
> So running a ref lab for years I've acquired a rather large supply of old
> blocks of various tissues, I'm considering turning this into a tissue
> bank/repository with the purpose of selling blocks for research and control
> purposes... anyone have any experience, what are the requirements to be
> compliant??? I have zero experience with this. I'm guessing some release
> forms, maybe patient consent forms (IMPOSSIBLE TO GET THOSE FOR BLOCKS THAT
> ARE 10 YRS OLD)... release of liability forms... I'm starting at zero so
> any insight is appreciated!
>
> Best!
>
> Curt
>
> _______________________________________________
> Histonet mailing list
> Histonet at lists.utsouthwestern.edu
> http://lists.utsouthwestern.edu/mailman/listinfo/histonet
>
>
>
>
> ---------- Forwarded message ----------
> From: Curt Tague <c.tague at pathologyarts.com>
> To: richard cartun <rcartun at sbcglobal.net>, "
> Histonet at lists.utsouthwestern.edu" <histonet at lists.utsouthwestern.edu>
> Cc:
> Bcc:
> Date: Thu, 1 Aug 2024 02:28:58 +0000
> Subject: Re: [Histonet] Tissue repository
> Thanks Richard, that’s a concern too, hospitals are certainly going to
> avoid any exposure.
>
> Thanks again!
> Curt
>
> Get Outlook for iOS<https://aka.ms/o0ukef>
> ________________________________
> From: richard cartun <rcartun at sbcglobal.net>
> Sent: Wednesday, July 31, 2024 7:00:26 PM
> To: Histonet at lists.utsouthwestern.edu <histonet at lists.utsouthwestern.edu>;
> Curt Tague <c.tague at pathologyarts.com>
> Subject: Re: [Histonet] Tissue repository
>
> Hi Curt,
>
> Does your lab have an in-house legal department?  If so, have you
> consulted with them about this?  The attorneys for the hospital I worked in
> wanted nothing to do with providing patient tissue to outside interests who
> were willing to pay for it.
>
> Richard Cartun
>
> On Wednesday, July 31, 2024 at 05:02:57 PM EDT, Curt Tague via Histonet <
> histonet at lists.utsouthwestern.edu> wrote:
>
>
> Hi all,
>
> So running a ref lab for years I've acquired a rather large supply of old
> blocks of various tissues, I'm considering turning this into a tissue
> bank/repository with the purpose of selling blocks for research and control
> purposes... anyone have any experience, what are the requirements to be
> compliant??? I have zero experience with this. I'm guessing some release
> forms, maybe patient consent forms (IMPOSSIBLE TO GET THOSE FOR BLOCKS THAT
> ARE 10 YRS OLD)... release of liability forms... I'm starting at zero so
> any insight is appreciated!
>
> Best!
>
> Curt
>
> _______________________________________________
> Histonet mailing list
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>
> ---------- Forwarded message ----------
> From: <relia1 at earthlink.net>
> To: <histonet at lists.utsouthwestern.edu>
> Cc:
> Bcc:
> Date: Thu, 1 Aug 2024 12:25:55 -0400
> Subject: [Histonet] Happy Thursday Histonetters!!
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