Laboratory Analysis for DOE

["Carbaugh, Eugene H" <gene.carbaugh@pnl.gov>]

Without knowing a little more about your query, it's hard to comment but I'll
make a stab with regards to bioassay.

In the realm of excreta radiochemical bioassay, the DOE regulation
10CFR835..402(d)(1) requires that internal dose programs be accredited (or
exempted) in accordance with DOELAP Laboratory Accreditation Program for
Radiobioassay.  The inidividual radiochemcial labs are not the ones holding the
accreditation, but rather the DOE site dosimetry program.  A DOELAP appraisal is
required of any radiochemical lab that services a DOE site bioassay program
seeking DOELAP accreditation.  That appraisal is not a prerequisite for service
but its performance will likely be a contractual requirement of the DOE site.
The intent of this whole process is to provide an radiochemical bioassay
accreditation comparable in concept to the DOELAP (and NVLAP) accreditation of
external dosimetry services.  A DOELAP website has been created at
http://doelap.eh.doe.gov but the site is still under development.  The DOE
technical standards dealing with this particular accreditation are 

DOELAP Administration
http://tis.eh.doe.gov/techstds/standard/std1111/std1111.pdf
DOELAP for Radiobioassay
http://tis.eh.doe.gov/techstds/standard/std1112/std1112.pdf

I am not aware of anyone discouraging laboratories from "getting approval."
The problem is actually that there is no mechanism for a lab to get
accreditation UNLESS it is servicing a DOE site.  In other words, DOELAP is not
providing accreditation appraisals to labs who might be seeking to do business
with a site - it only certifies labs that are providing services.  There is
nothing to prevent a DOE site from awarding a contract to a "non-accredited" lab
with the provision that it will undergo an accreditation appraisal as part of
the contract.  


A separate issue to which you may be referring is a recent audit by the DOE
Inspector General's Office that suggested that DOE sites should be utilizing a
single "complex-wide contract" for certain bioassay analyses as a cost-effective
measure.  This audit finding has caused a lot of concern among DOE sites because
the referenced "complex-wide contract" was in reality a single site's contract
that included a clause permitting other DOE sites to submit samples under this
contract for the same price.  Unfortunately, that contract was not developed
with the input or knowledge of other sites, and consequently does not address
the site-specific program requirements for performance, reporting, and qualtity
provisions.  The IG audit recommendation has caused more than a little angst
with some DOE site internal dosimetry programs.  A committee consisting of DOE
site/contractor technical representatives is being formed to address the
possibility of such a contract in the future.  For more info on this, checkout
the following url:  http://bidug.pnl.gov

I hope this provides some clarification to your question and concern.  

	Gene Carbaugh, CHP (also DOELAP Radiobioassay Appraiser and DOELAP
Oversight Board Member)
	Hanford Internal Dosimetry Program
	Pacific Northwest National Laboratory
	gene.carbaugh@pnl.gov

Date: Fri, 18 Feb 2000 11:38:29 EST
From: Holloway3@aol.com
To: radsafe@romulus.ehs.uiuc.edu
Subject: Laboratory Analysis for DOE
Fellow Radsafers,

I have heard some complaints recently that the way a DOE contractor is 
managing its contracts  for external radiochemical analyses is reducing 
competition and making it harder for small laboratories to compete with the 
larger ones. Specifically, I have heard that laboratories need some sort of 
approval or accreditation in order to do the work and that the management of 
the program ( a contractor ) is discouraging new laboratories from getting 
the required approval.  I am interested in comments either addressed to me 
individually or the whole list.  Please reply to  holloway3@aol.com
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