[Histonet] Advice about human autopsy samples in a purely research core lab

[Caroline Miller]

Hi Histoland!

I work in a small histology and microscopy core (2 members of staff)  
in San Francisco at the Gladstone Institutes (affiliated with UCSF).  
We have recently had an enquiry from a private autopsy service (with  
LLC in their name) about human autopsy samples for processing,  
cutting, HE staining and maybe a few special stains here and there.

My institutes would like to have a contract in place for this work to  
cover our bases and I would like some advice on what to include in  
that contract.

I have asked about regulations, and they say that their information is  
private and not something monitored by outside agencies like CAP,  
JCAHO, because they are not a diagnostic lab dealing with living  
patients. They say that JCAHO doesn't apply because they are not  
delivering health care.

They also say that: "An autopsy is not a surgical/therapeutic or "lab  
test" procedure by any states law except Connecticut. " and HIPPA  
doesn't apply because the patient is deceased.

I have worked with human tissue before, I ran a histo lab in London UK  
so I am well aware of the UK laws, but unfortunately not the US ones.

So I ask the histoland: Is this all true? Are there any sticking  
points we may run into with the regulations? How could we phrase the  
contract so that there is no chance of come-back? Big questions, I  
know, but any advice would be gratefully received

Yours
Caroline

Caroline Miller, M.Sc, DIC, AIBMS
Manager
Histology and Microscopy Core
J David Gladstone Institutes
1650 Owens St
San Francisco
CA 94158

Tel: 415 734 2566
Fax: 415 355 0824
Cell: 415 218 7297

http://www.gladstone.ucsf.edu/gladstone/site/histology/
cmiller <@t> gladstone.ucsf.edu