[Histonet] clinical trial blocks

Tench, Bill Bill.Tench <@t> pph.org
Mon Oct 18 10:58:44 CDT 2010

The fundamental philosophy that we have is that we do not want to stand
in the way of the patient receiving any kind of treatment.  That being
said, we also have the policy that whether or not we "own" the material
(patients are actually suppose to sign an admission consent that says
they give up any ownership rights), we are clearly the legal custodians
of the material, and as such are responsible for insuring that no
irreparable distruction occurs.  So, we prefer to not send out blocks
unless the clilnical trial says there are no alternatives.  We contact
them and ask if we can send recuts from which they can obtain the
information they desire.  We also review what we have.  If we have only
one section, we cut a recut for the file before sending out any blocks.
If we have only one block, with not much in it, we again discuss the
issue with the trial coordinator.  We do insist on return of the block,
and assuming that there is an outside review of the material, we insist
on a copy of the report.  We also have the patient sign a release
informing them that they need to understand that this process may
exhaust any tissue that would be useful for some other new treatment
which may come up down the line. Since we have to pull this material for
review and usually make recuts, we bill the clinical trial.  Years back,
they never had any budget allowances for this, and it was always a
hassle.  More recently, we get a lot less BS.  They know they have to
pay, and they do.  Unfortunately, nothing is free any more.
Bill Tench
Associate Dir. Laboratory Services
Chief, Cytology Services
Palomar Medical Center
555 E. Valley Parkway
Escondido, California  92025
Bill.Tench <@t> pph.org
Voice: 760- 739-3037
Fax: 760-739-2604

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