Lab Certifications

Texas Fertility Center & Austin IVF are certified by multiple agencies to insure quality care for the infertility patients

Most of the quality IVF laboratories in the United States, like Austin IVF, are members of the Society of Assisted Reproductive Technology (SART). This organization sets standards for performance and guidance for behavior and operation for IVF clinics and their laboratories.

SART

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SART’s goal is the improvement of care for the IVF patient. In order to be a member of SART, an IVF laboratory must earn certification through an extensive inspection by one of three organizations.

The College of Pathologists (CAP)

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CAP uses experienced embryologists from major IVF programs as their inspectors. The importance of this is that these individuals work in IVF and they know the laboratory very well. They are committed to making their field better by maintaining rigorous standards that are upheld by thorough inspections of the laboratories. These inspections require both the Embryology lab and the Andrology lab of Austin IVF to maintain quality throughout the year in order to pass this lengthy examination of protocols, techniques, equipment and personnel, as well as documentation of the quality control, assurance and improvement in the labs.

Federal Clinical Laboratory Improvement Act (CLIA)

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In addition to CAP, Austin IVF must also earn a certificate from an organization known as CLIA. This organization was established

by the Federal Clinical Laboratory Improvement Act and is responsible for assuring that clinical laboratories that perform diagnostic testing maintain high standards and are inspected and certified by CAP or one of the other organizations that are deemed to be qualified. Finally, the IVF lab is subject to unannounced inspections by the Federal Drug Administration (FDA). These inspections are to assure that quality practices are employed by all laboratories that process human cells, such as sperm, eggs and embryos.

In addition to the demands of CAP, CLIA and the FDA, there are numerous other state and federal organizations from which our program must obtain certification and/or approval. These are necessary in order to legally operate and to provide quality care for our patients.
For example, our physicians must maintain certification from:

  • Texas Medical Board
  • American Board of Obstetrics and Gynecology
  • Reproductive Endocrinology subspecialty of the American Board of Obstetrics & Gynecology
  • Federal Drug Enforcement Agency (DEA)
  • Texas State Department of Public Safety (DPS)
  • Society of Assisted Reproductive Endocrinology (SART)
  • Travis County Medical Society

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.