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 jwat...@gnf.org -----Original Message----- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of WILLIAM DESALVO Sent: Tuesday, March 17, 2015 8:45 AM To: Abbott, Tanya Cc: histonet@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 <tanyaabb...@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@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 > > This email and attachments contain information that may be confidential or > privileged. If you are not the intended recipient, notify the sender at once > and delete this message completely from your information system. Further use, > disclosure, or copying of information contained in this email is not > authorized, and any such action should not be construed as a waiver of > privilege or other confidentiality protections. > _______________________________________________ > Histonet mailing list > Histonet@lists.utsouthwestern.edu > http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
