There has been a good deal of experience in the U.S. with this since
the implementation of CLIA (The Clinical Laboratory Improvement Act
of 1988) in around 1991-92 and with the beginning of Board Certification
in Human Molecular Genetics in 1990 and the subsequent exam in 1993.
I, myself, served on an inspection team for the College of American
Pathologists (in Chicago, which effectively operates as an oversight
body through CLIA), in a well-known lab. in Boston. They passed with
flying colors, though the insepection was rigorous.
One of the reasons I am leaving my current job is that neither my
department chairman nor Dean of the Medical School will provide sufficient
resources to allow me to pass such a rigorous inspection.
Therefore, I'm off to UCSF to become board certified...
If you have more questions about the rigors of being a well certified lab,
please feel free to call or EMAIL.
Bert Gold, Ph.D.
Director, Molecular Pathology Laboratory, Temple U.
and (hopefully) Board Eligible
Human Molecular Geneticist