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To: Multiple recipients of list HUM-MOLGEN <HUM-MOLGEN@NIC.SURFNET.NL>
Subject: ETHI, DIAG: Laboratory standards
From: Hans Goerl <GENETHICS@delphi.com>
Date: Thu, 17 Aug 1995 12:27:40 -0400

1)
X-Sender: olam@ulrik.uio.no
1
-
In Norway we have a new law on medical applications of biotechnology, where
there is opportunity to regulate artificial fertilization, preimplantation
diagnostics, pre- and postnatal genetic testing and gene therapy.

We are currently discussing the criteria for allowing a lab to do genetic
tests, and for allowing specific tests.

One may require the lab to be accredited, by which their way of performing
specific procedures is quality controlled by an external body. By this
procedure they have to do tests in a specific way over long periods.

An alternative, perhaps better suited for research labs and quickly
developing procedures, one may require the lab to get a GLP (Good lab.
practise) certificate.

In both cases an external body will irregularly visit the lab, check the
records and the way work is done.

What is the experience in other countries, have quality controls been
enforced in this way anywhere? I think some Dutch and British labs have
been certified. It would be interesting to hear from these (or be pointed
towards them).

Ola



Ola Myklebost, Dr Philos          Email (org): ola.myklebost@labmed.uio.no
Dept of Tumor Biology             or (machine address): olam@radium.uio.no
Institute for Cancer Research     Tel Office/lab:     +47-2293-4299 (-5422)
The Norwegian Radium Hospital     Switchboard:        +47-2293-4000
Montebello                        Fax:                +47-2252-2421
N-0310 OSLO, Norway               Cellular phone:     +47-9008-7139
                                  Private:            +47-6680-2905

____________________________________________________________________________
2)
Editors note: This reply briefly summarizes what is happening in the United
States. The issues raised are complex and urgent as commercial genetic
testing is spreading worldwide.

In the U.S.  an NIH/ELSI task force headed by Dr. Neil Holtzman of Johns
Hopkins is studying all of these issues. HUM-MOLGEN expects to have a copy
of the report of the first meeting of the task force available shortly.

Among the problems identified are the current inability or unwillingness of
either the FDA or HCFA (Health Care Financing Addministration) to:

1) apply existing regulations prohibiting the use of products approved for
research use in clinical situations

2) regulate the use of "Home Brews"

3) regulate "off-label" use of products approved for one purpose, i.e.
confirmation of diagnosis, but used for another purpose, i.e. predictive
testing

4) establish standards for the accuracy and predictive value of these tests.
This is obviously a difficult problem, because the conditions predicted by
many tests do not become manifest for many years.

The Task Force is also going to investigate the process for licensing of
laboratories. This problem was thought to have been solved in this country
several years ago by the enactment of a Federal law (CLIA). However, the
regulations enacted under CLIA do not apply directly to most genetic
testing. The Task Force is investigating the question of which bodies
(States, professional organizations such as The American College of Medical
Genetics, etcetera) should be entrusted with the authority to accredit
laboratories doing genetic tests.

The Task Force is also considering the issues of informed consent and
counseling in connection with genetic testing.  Two of the relevant
paragraphs concerning these issues, some of which we have recently discussed
in this newsgroup are set forth below.

"A common theme was that interpretation of test results and counseling about
their implications are integral parts of the test itself.  Great care must
be taken in offering tests and communicating test results, especially when
thre is no intervention of proven efficacy for an identified genetic
condition and little or no data on the impact of test results on people
being tested.  Furthermore, the predictive value of these tests can vary
greatly and must be taken into account.  Some interpretative services might
be provided by laboratories, but may prove costly, intrude on the practice
of medicine, and raise liability issues.  The Task Force will consider the
extent of manufacturer and laboratory responsibility in assuring appropriate
test education and past-test interpretation.

     Given the increasing likelihood that primary care providers will be
ordering genetic tests to aid in preventive care, their education in the
essentials of this technology is important.  Task Force members differed
over the extent to which primary caregivers could master the subject.  Even
if sufficiently educated in genetics, the traditional directiveness of
primary care providers in advising patients may be less desirable than the
relative impartiality of genetic counselors.  Nevertheless, some patients
may expect and desire direction in this area.  Genetic counselors could
assume the responsibility of properly interpreting test results, but there
is a shortage of counselors and training programs.  For some tests, such as
Tay-Sachs, providers are less involved; results are often sent to patients
directly."


   
 
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