|
Our Laboratory
We strive for
excellence at GFI Laboratory and have implemented a quality
assurance system to ensure the highest level of performance and
accuracy. We participate in the American Association of Blood
Banks/College of American Pathologists (AABB/CAP) proficiency
testing program for parentage testing laboratories. We are guided
by, and follow, the majority of standards put forth in the the
publication "Standards for Relationship Testing Laboratories, 7th
Edition" produced by the AABB. At this time, the GFI Laboratory is
not accredited.
Accreditation
There are no
government mandated accrediting agencies for relationship testing
laboratories in the United States. Parentage laboratory
accreditation is completely voluntary and is at the sole discretion
of the laboratory. There are agencies that are willing to evaluate
and inspect parentage laboratories for a fee and grant a certificate
to show that the laboratory has met the minimum standards set forth.
Further, there are no formal education programs specific to
parentage testing with specific knowledge and experience coming from
on-the-job training.
Proficiency
Testing
A proficiency test
is designed to test the laboratory's ability to generate accurate
results that conform with the known DNA profiles of the subjects
tested. At the GFI Laboratory, Each DNA analyst is tested 3 times
each year by participating in the AABB/CAP proficiency testing
program for parentage testing laboratories and undergoes blind
evaluations where they do not know they are being tested. We feel
that this is the best way to evaluate the overall process of
reporting accurate results.
Accredited vs.
Non-accredited: Case in Point
No laboratory is
immune to error but every laboratory has the responsibility to put
in place the necessary safeguards to counter errors before they
occur. Recently, we had the opportunity to test a case that had
previously been tested by an AABB/ISO 17025 accredited laboratory
who reports that they "use a 16 marker test and all tests are
repeated to confirm the results". The case report they emailed to their
client, the mother, read that 13 markers had been tested and the alleged father did not match with the child
at one of the markers. The
conclusion stated that "the alleged father could not be excluded and
the probability of paternity was >99%". The report did not indicate
what happened to the 3 missing markers or that a mutation had been
calculated in the combined paternity index. How does this error
occur in an AABB/ISO
17025 accredited laboratory? There seemed to be a
fundamental breakdown in the peer review process.
Our results matched
100% with the other laboratory's results at the 13 markers they
reported. With the 3 missing markers included, our results
indicated that the alleged father was excluded at 2 out of 16
markers. It is our policy that any exclusion be
re-analyzed as if it were a completely new case. This policy allows
us to confirm from two independent analyses that samples were not
switched at the time of DNA extraction and we will not falsely
exclude a father. It is also our policy to rule out a
double marker mutation, which is a rare occurrence, by testing the
mother. Our conclusion
in such cases is "inconclusive" until the mother can be tested. Upon
testing the mother in this case, it was observed that the man was
not the father and was excluded at 8 of 16 markers. This new
conclusion left the mother confused and in a state of disbelief. She
simply did not know who to trust.
Attempts on our part
to contact the AABB/ISO 17025 accredited laboratory, who boasts
processing over 80,000 samples per year, failed after being placed
on hold for 30 minutes and never actually being able to discuss the
case with anyone. We simply wanted to point out to them that a
typographical error in their report had been passed on to their
client and they may want to examine how they review their final
reports.
The sad part is, the
mother would have never had the test performed a second time but for
a disbelieving grandmother who had a feeling that it was not her
son's child. The mother was left with feeling that a third
test was needed from a different lab and the alleged father wonders if he
should allow himself to grow more attached to the child or walk away
from a child that is not his.
The Need for
Accreditation
The case above is
evidence that the AABB/ISO 17025 accredited laboratory needs
accreditation and even with it, they managed to "drop the ball".
Ultimately, it is the laboratory director's responsibility that the
results be accurate and correct. At the GFI Laboratory, we
believe it is important to focus on the ways we can eliminate errors
by establishing sound protocols in our day-to-day operations and
implementing them to the point that no error is tolerable.
Order Online |
