Standards for IVF Laboratories & Problems

• ART [assisted reproductive technologies] laboratories that perform diagnostic tests, such as analysis of semen or blood, must be certified under the federal Clinical Laboratories Improvement Amendments of 1988 (CLIA). Regulations issued by the Centers for Medicare and Medicaid Services (CMS), which administers the CLIA program, include provisions addressing quality control and assurance, educational and professional qualifications for technical and supervisory staff, and inspection and enforcement procedures.9 Among other provisions, these regulations require that laboratories establish and follow written quality control procedures described in a procedures manual, and maintain records of all quality control activities. The laboratory's manual must also include remedial action policies and procedures. The regulations also provide for federal officials to perform announced or unannounced inspections and employee interviews. In addition, the regulations contain provisions for enforcement and permit the imposition of sanctions on non-complying laboratories.
• CLIA requirements apply to laboratory facilities engaged in the "examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings." Whether and to what extent CLIA does or should apply to embryology laboratories performing ART-related tests and procedures is a matter of current debate. – from Genetics and Public Policy Center http://www.dnapolicy.org/policy/art.jhtml.html
• The application of CLIA, ensuring quality control in diagnostic clinical laboratories, is minor in the context of ART labs—applying only to andrological and endocrinological diagnostic activities when performed for the sake of themselves; CLIA is inapplicable when these tests are performed as an adjunct to the provision of ART services. from the President’s Council on Bioethics http://www.bioethics.gov/reports/reproductionandresponsibility/chapter2.html
• In 1999, CDC issued a model program. The program includes standards for the performance of laboratory procedures, records maintenance, laboratory personnel qualifications, and criteria for laboratory inspection and certification. It also includes a provision by which states may qualify to adopt and administer the program if they submit an attestation to CDC agreeing to certain requirements. According to CDC, no state has submitted such an attestation, but some states may have used the model as a basis for developing their own regulations or guidelines.– from Genetics and Public Policy Center http://www.dnapolicy.org/policy/art.jhtml.html
• The final version of the model program, incorporating comments received by the CDC, was published in the Federal Register on July 21, 1999. Under the program, embryo laboratories may apply to their respective states for certification. Those laboratories that choose to do so are inspected and certified by states or approved accreditation organizations. Certification is valid for a two-year period. The Secretary, through the CDC, has authority to inspect any laboratory that has been certified by a state to ensure compliance with the standards. The penalty for noncompliance under the model program is revocation of certification. A key limitation of the program is that neither the Secretary nor the states may establish “any regulation, standard or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technologies.” Even if a state were to adopt the program, there is no requirement that laboratories apply for certification; it is entirely voluntary. – from the President’s Council on Bioethics http://www.bioethics.gov/reports/reproductionandresponsibility/chapter2.html

Have such policies been broken and what have been the consequences, if any?

• It is difficult to uncover information about this except as highly publicized cases that have made it into the media. The American Society for Reproductive Medicine (ASRM), a professional association, restricts information on Guidelines, Statements and Opinions and Ethics Reports of the ASRM Practice Committee to members only. To join, you have to pay $175 - $250 depending on your status OR purchase individual opinions at their online store for $10 - $35.
• Some fertility clinics do post information on their web sites about what kinds of factors to consider when choosing a clinic: The credentials of the Laboratory Director and Medical Director must be considered. An ART laboratory should have a director who is a Ph.D. with Certification as a High Complexity Laboratory Director (HCLD). Laboratory Directors without these credentials may lack the expertise required to insure the necessary level of quality control that is critical to the success of an ART program. The Medical Director of an ART laboratory should be a Reproductive Endocrinologist (RE) who is Board Certified in Obstetrics/ Gynecology and Reproductive Endocrinology and Infertility. Medical Directors who are not Board Certified Reproductive Endocrinologists may not have had formal training in ART, may have failed the examinations required for certification or in some unfortunate cases may have not even attempted to become certified. Board Certification is the ultimate demonstration of proficiency and accomplishment. It is your assurance that the physician recognizes the importance of excellence in the performance of his or her practice and exerts maximal effort to keep up with the latest advances in this rapidly changing field. Secondly, the laboratory should be certified by the College of American Pathologists (CAP) and should report their data to the Society of Assisted Reproductive Technology (SART). -- from Southern California Center for Reproductive Medicine (in Newport Beach, CA) http://www.socalfertility.com/faq/faq.shtml

Who would do the "requiring" -- state, federal, professional organizations, or..?

• ART is a medical service provided by physicians and other health care providers. As such, it constitutes part of the "practice of medicine" and is outside the scope of FDA's regulatory authority. However, many of the materials and components used in ART are medical products subject to FDA regulation under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and/or the Public Health Service Act (PHS Act).
• Some professional societies, such as the American Society for Reproductive Medicine (ASRM) issue guidelines for standards of practice and reporting as well as for topics related to treatments for infertility and gamete donation. Although these guidelines are voluntary and not part of state or federal law, they are at times viewed as evidence of standards of practice in legal settings or where evaluation of clinical practice is required.
• The 1992 Fertility Clinic Success Rate and Certification Act requires all U.S. clinics performing ART to report data annually to the CDC for every ART procedure initiated. Clinics submit their data to CDC through the Society for Assisted Reproductive Technology (SART) reporting system. According to CDC, not all clinics in the United States that perform ART report data. -- from Genetics and Public Policy Center http://www.dnapolicy.org/policy/art.jhtml.html

How do such policies and actual practices vary from state to state; country to country?

• Some states have laws and regulations addressing ART. In general, the focus at the state level has been on ensuring informed consent for the transfer and donation of embryos. Several states have regulations concerning licensing and certification requirements for all health care facilities, that may also include ART programs. -- from Genetics and Public Policy Center http://www.dnapolicy.org/policy/art.jhtml.html
• There is no standardization either of treatment procedures or of reporting results in American Clinics. – from Gilbert, Scott, Tyler, Anna, and Zackin, Emily. (2005) Bioethics and the new embryology. New York: W.H. Freeman.
• Most of the standards for ART programs are set by relevant professional organizations, including SART, the American Association of Tissue Banks (AATB), the College of American Pathologists, and the American Board of Bioanalysis. Laboratories that perform the diagnostic tests related to assisted reproduction, such as semen or hormonal analysis, must be certified under the federal Clinical Laboratories Improvement Act (CLIA). Some states, including New York, also have certification requirements for clinical laboratories. Clinical laboratory certification requirements do not apply to assisted reproduction techniques that are viewed as procedures rather than diagnostic tests. – from http://www.health.state.ny.us/nysdoh/taskfce/execsum.htm

(original page by jrc. All italics are mine, signifiying information that I consider is most relevant to the scenario)