ASRM PAGES Minimum standards for practices offering assisted reproductive technologies: a committee opinion Practice Committee of the American Society for Reproductive Medicine, Practice Committee of the Society for Assisted Reproductive Technology, and Practice Committee of the Society of Reproductive Biologists and Technologists American Society for Reproductive Medicine, Society for Assisted Reproductive Technology, and Society of Reproductive Biologists and Technologists, Birmingham, Alabama This document is designed to provide a framework for assisted reproductive technology (ART) programs that meet or exceed the require- ments suggested by the Centers for Disease Control and Prevention for certification of ART laboratories. This document replaces the document ‘‘Revised Minimum Standards for Practices Offering Assisted Reproductive Technologies: A Committee Opinion’’ published in 2019. (Fertil SterilÒ 2021;115:578–82. Ó2021 by American Society for Reproductive Medicine.) Key Words: In vitro fertilization, practice management, laboratory director, medical director, record keeping Discuss: You can discuss this article with its authors and other readers at https://www.fertstertdialog.com/posts/32097 echnical advances in assisted ART program and laboratory direc- implantation genetic testing (PGT), reproductive technology (ART) tors to ensure that their programs’ embryo cryopreservation, embryo T and expansion of the scope practice reflects current recommen- donation, and gestational carrier of who is treated are the best exam- dations. More detailed guidance on IVF (4). ples of our rapidly evolving field. laboratory procedures is presented Periodically, the American Society in the Practice Committee reports for Reproductive Medicine (ASRM) ‘‘Cryostorage of Reproductive Tissues Personnel reviews and publishes updated in the in Vitro Fertilization Labora- There should be a contingency plan in guidelines, guidance documents, tory’’ (2)and‘‘Recommended Prac- place for all personnel essential to a and committee opinions to define tices for the Management of program in case of illness, absence, or the minimum standards for ART pro- Embryology, Andrology, and Endo- departure of an individual from the grams inclusive of human embry- crinology Laboratories’’ (3). program. The purpose of the contin- ology and andrology laboratories. gency plan is to ensure that critical op- This document is designed to guide erations within the laboratory and ART programs by setting criteria DEFINITIONS practice are covered without interrup- that meet or exceed the requirements Assisted reproductive technology en- tion. A single individual may fulfill suggested by the U.S. Centers for compasses a variety of clinical treat- the requirement for expertise in one or Disease Control and Prevention ments and laboratory procedures, more areas. An ART program must (CDC) for certification of ART labo- which includes the handling of human include the following personnel. ratories (1), and it replaces the previ- oocytes, ovarian tissue, sperm, testic- Directors. ous standards of the same name, last ular tissue, or embryos in vitro, with A designated overall practice direc- published in 2019. This document is the intent of establishing a pregnancy tor, medical director, and laboratory not designed to cover all clinical sit- immediately or in the future. This in- director. One individual may fulfill uations or practices but rather cludes but is not limited to in vitro more than one of these positions, should be reviewed carefully by fertilization (IVF), embryo biopsy, pre- but the medical director must be a licensed physician. Received December 22, 2020; accepted December 29, 2020; published online February 7, 2021. Physicians. Reprint requests: American Society for Reproductive Medicine, 1209 Montgomery Highway, Birmingham, Alabama 35216 (E-mail: [email protected]). A physician who has completed an American Board of Obstetrics and Fertility and Sterility® Vol. 115, No. 3, March 2021 0015-0282/$36.00 Copyright ©2021 American Society for Reproductive Medicine, Published by Elsevier Inc. Gynecology (ABOG) or American https://doi.org/10.1016/j.fertnstert.2020.12.036 College of Graduate Medical 578 VOL. 115 NO. 3 / MARCH 2021 Fertility and Sterility® Education (ACGME) approved fellowship in reproductive Medical Director fi endocrinology and infertility (REI) and is board certi ed As of January 1, 2000, a program’s medical director must be or an active candidate for board certification in REI by board certified in REI by ABOG or be an active candidate for the ABOG. the same. The medical director is responsible for verification A physician experienced in male reproduction. If this of data reported to SART. The medical director should be a individual is not a urologist, a consultant urologist member in good standing of ASRM. with expertise in male reproductive surgery should be available. Physician Performing Oocyte Retrievals and Nurses. Embryo Transfers A nurse with training and/or experience in reproductive Physicians performing oocyte retrievals should have medicine and coordination of clinical ART care. adequate training to perform diagnostic ultrasound and Laboratory. have performed an adequate number of aspirations under fi An embryology laboratory director who meets the require- direct supervision to demonstrate pro ciency within a prac- ments described in specialized training and experience. tice that meets these standards. Physicians performing em- An individual experienced in laboratory procedures in bryo transfer should have performed an adequate number of andrology. embryo transfers under direct supervision to demonstrate fi An individual with specialized training and experience in pro ciency within a practice that meets these standards or gamete, embryo, and gonadal tissue cryopreservation tech- have successfully completed a certificate course using an niques, respectively, when gamete, embryo, and/or gonadal embryo-transfer simulator. Satisfactory completion of this tissue cryopreservation is offered. training should be documented by the practice or medical di- An individual with specialized training in gamete biology rector. Each physician should continue performing a mini- and micromanipulation techniques, if oocyte, gonadal tis- mum number of aspirations and embryo transfers per year fi sue, and/or embryo micromanipulation techniques are to maintain his or her pro ciency. offered. It is recommended that physicians involved in the super- Appropriate personnel to perform hormone assays. An vision of ovarian stimulation and oocyte-retrieval procedures outside laboratory that has demonstrated adequate compe- be responsible for ultrasound monitoring of follicular devel- tence, quality control, and service may be used for rapid as- opment. Physicians responsible for ultrasound follicular says of all the necessary reproductive hormones. Such monitoring should have familiarity with basic ultrasound hormone assays should be performed by a laboratory that principles and equipment. These physicians should have evi- meets Clinical Laboratory Improvement Amendments of dence of training and the requisite competence to adequately 1988 (CLIA) standards. perform diagnostic ultrasound examinations. Completion of an ABOG or ACGME approved fellowship program in REI sat- Auxiliary. isfies the ultrasound training requirement. An individual with specialized training and experience in gynecologic ultrasonography who provides the monitoring of follicular development. This role may be filled by a Nurses physician, nurse, or ultrasound technician. Licensed nurses in the ART setting provide or direct educa- A mental health professional (MHP) with expertise in tion, counseling, support, and nursing care to patients seeking fertility counseling. If a MHP is not employed by the pro- assistance becoming pregnant. This role requires knowledge gram, a consultant MHP should be available. of anatomy and physiology, the normal menstrual cycle, An individual with specialized expertise in genetics and ge- pathophysiology, treatment options, and diagnostic tests. netic counseling. If the individual is not employed by the program, a consultant geneticist and genetic counselor should be available. Other Auxiliary Personnel Other roles in the ART setting may include personnel such as medical assistants with specialized training in patient-care SPECIALIZED TRAINING AND EXPERIENCE management and technical procedures for the ART patient. Practice Director The practice director should be a member in good standing of Embryology Laboratory Director ASRM. The practice director is that individual who will as- The embryology laboratory director should be an individual sume responsibility and accountability for the activities of with demonstrated knowledge of all laboratory aspects of the practice related to ART. The practice director is the indi- ART. To qualify as an embryology laboratory director, the in- vidual responsible for official communication with the Soci- dividual should fulfill the following requirements: ety for Assisted Reproductive Technology (SART), its registry, or its designees, and for ensuring that the practice follows the Have an earned doctorate degree (Ph.D.) from an accredited SART requirements for membership. The practice director institution in a chemical, physical, or biological science as does not have to be a physician. the major subject, or a medical degree (M.D. or D.O.) from VOL. 115 NO. 3 / MARCH 2021 579 ASRM PAGES an accredited institution or have qualified as a