Choosing among infertility clinics also involves assessing their laboratory facilities. It is important to know the difference between the various laboratory certification and accreditation programs. The role of the U.S. government is limited and designed to ensure laboratories meet minimum standards or regulations. In addition, individual states govern laboratory practices according to their own regulations.
Professional medical associations also offer certification and accreditation. Participation in these peer run programs is voluntary; however, many of the professional organizations impose regulations that are more stringent than the federal government.
U.S. Federal Government Compliance
Within the federal government, policies, standards and enforcement are divided among several different government agencies. It is a complex system of oversight.
Clinical Laboratory Improvement Amendments of 1988 (CLIA)
CLIA is administered by the Centers for Medicare and Medicaid Services (CMS.) All clinical laboratories providing diagnostic testing for human beings must meet or exceed minimum standards. Pre-implantation genetic diagnosis centers (PGD) are exempt.
Although CLIA oversees compliance, they do not develop policy. Regulations are set by the Health Care Financing Administration (HCFA.) Laboratories are certified according to testing complexities. Laboratories may receive a rating of waived, moderate or high complexity.
Centers for Disease Control and Prevention (CDC)
The CDC does not oversee laboratory practices. It does require that clinics report statistics. These statistics are later published by the CDC. This is a component of the 1992 Fertility Clinic Success Rate and Certification Act (FCSRCA.)
U.S. Food and Drug Administration (FDA)
The FDA does not regulate the business of medicine or its laboratories. Instead, it regulates the use of medications and medical equipment. Currently, the FDA only has jurisdiction over biologicals (tissues/organs) used for transplantation in the treatment of disease.
Professional Organization Certification and Accreditation
Professional associations require laboratories meet the minimum U.S. federal government regulations, in addition to standards developed by peer review boards within the association's specialty.
College of American Pathologists (CAP)
In order to qualify for CAP accreditation, the laboratory must first comply with CLIA regulations. The standards set by CAP exceed those of the federal government.
CAP accreditation requires compliance in four defined standard areas: director and personnel, physical resources, quality management and administration.
CAP accreditation of a laboratory requires that the director has had proper laboratory training. The director of the laboratory must be a board-certified pathologist, qualified physician or an individual with a degree in science, who has been certified in embryology laboratory practices by the American Board of Bioanalysis.
Society for Assisted Reproductive Technologies (SART)
SART requires clinics and their laboratories to comply with advanced standards in reproductive care. Membership requires that the laboratory comply with all CDC requests for data.
In some cases, the infertility clinic will have its own lab on site or nearby. Others may contract with independent laboratories. Do not hesitate to ask the clinic staff about laboratory certification and accreditation.
Your state's Department of Health and Human Services should be able to provide more information on state certification or inspection procedures.
