[Histonet] FW: Release of blocks to research facilities

[James Watson]

Bill is correct, CAP is actually the least of your worries.  There are many regulations about human tissue used in research (I do not know them all), but patient consent is essential and in some cases the patient must actually agree to the specific research project.  Here we have regulations about control block tissue that we use, we cannot get tissue directly from a local hospital.   Also the laws are different in each country.  There is a lot of bioethics involved.

http://bioethics.od.nih.gov/humantissue.html

Human Tissue Ownership and Use in Research: What Laboratorians and Researchers Should Know
http://www.clinchem.org/content/56/11/1675.full.pdf




James Watson HT  ASCP
GNF  Genomics Institute of the Novartis Research Foundation
Scientific Technical Leader II, Histology
Tel    858-332-4647
Fax   858-812-1915
jwatson <@t> gnf.org

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of WILLIAM DESALVO
Sent: Tuesday, March 17, 2015 8:45 AM
To: Abbott, Tanya
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: Re: [Histonet] FW: Release of blocks to research facilities

There are other issues, besides CAP, that you should consider when releasing blocks.
1. A block is a medical record. Has the patient consented to release for research?
2. If the block is released prior to 14 days discharge and there are any charges, the charge must be sent to your hospital. Post 14 days the charges are sent to insurance and patient.
3. Will the research lead to a commercial product? Again, written patient consent.
4. You may be able to charge the research facility for sending the block. Administrative costs.
5. Communicate with patient is a must.
6. Get written consent and have the receiving facility verify they will handle properly, retain or return the block d you will get copies of data for patient file.

Make sure you reduce your risk.

Sent from my iPhone

> On Mar 17, 2015, at 5:38 AM, Abbott, Tanya <TanyaAbbott <@t> catholichealth.net> wrote:
> 
> I did call the CAP and they stated first of all, that it is a very confusing checklist component! But I was told that the research facility is taking on the ownership of the block, and we need to ensure that whoever we are sending our blocks to are following the proper retention protocols.
> 
> From: Abbott, Tanya
> Sent: Monday, March 16, 2015 3:33 PM
> To: 'histonet <@t> lists.utsouthwestern.edu'
> Subject: Release of blocks to research facilities
> 
> CAP checklist ANP.12500 refers to "Record Retention". I am looking specifically at NOTE 2: "Regarding extra-institutional release of blocks for research purposes."
> I am wondering how everyone handles this, especially if you have only 1 block on newly diagnosed patient and the Doctor wants it sent out for research.
> Thanks in advance for your help! Tanya
> 
> Tanya G. Abbott
> Manager Technologist
> Histology/Cytology
> St Joseph Medical Center
> (phone) 610-378-2635
> 
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