The Austin IVF laboratory is certified by the
College of American Pathologists, or CAP. All IVF
laboratories that desire certification/approval from
the Society of Assisted Reproductive Technology
(SART) must be certified by either CAP, an
organization referred to as the Joint Commission on
Accreditation of Hospital Organizations (JCAHO)
which certifies hospital based laboratories or the
New York State Health Department (only certifies
laboratories that operate in New York). CAP uses
embryologists from major IVF programs around the
country as their inspectors, and the CAP inspection
process is very rigorous – requiring weeks of
advance planning and preparation. The process
involves an inspection, not only of our laboratory
techniques, equipment, and personnel, but also of
our procedures, protocols, quality
assurance/control, and documentation of all of the
above.
The andrology laboratory part of Austin IVF is
certified by an organization called CLIA which was
established under the Federal Clinical Laboratory
Improvement Act. This is a totally separate
organization from CAP and the inspection process is
also very different. We have to maintain
certification from each of these two organizations
in order to be able to operate.
In addition to the major certifications above, there
are numerous other state and federal organizations
that our program must obtain certification/approval
from in order to legally operate. For example, our
physicians have to maintain certifications/approvals
from the Texas Medical Board, the American Board of
Obstetrics and Gynecology, the Reproductive
Endocrinology subspecialty section of the American
Board of Obstetrics and Gynecology, the Federal Drug
Enforcement Agency (DEA), the Texas state department
of Public Safety (DPS), the Society of Assisted
Reproductive Endocrinology (SART), the Travis County
Medical Society, etc. In fact, a recent study
suggested that the average RE/I medical practice has
to answer to 13 different federal/state
organizations for the licenses and certifications
required to be able to operate.
