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Minimum standards for practices offering assisted reproductive technologies: a committee opinion (2021)


This document is designed to provide a framework for assisted reproductive technology (ART) programs that meet or exceed the requirements suggested by the Centers for Disease Control and Prevention for certification of ART laboratories. 

Technical advances in assisted reproductive technology (ART) and expansion of the scope of who is treated are the best examples of our rapidly evolving field. Periodically, the American Society for Reproductive Medicine (ASRM) reviews and publishes updated guidelines, guidance documents, and committee opinions to define the minimum standards for ART programs inclusive of human embryology and andrology laboratories. This document is designed to guide ART programs by setting criteria that meet or exceed the requirements suggested by the U.S. Centers for Disease Control and Prevention (CDC) for certification of ART laboratories (1), and it replaces the previous standards of the same name, last published in 2019. This document is not designed to cover all clinical situations or practices but rather should be reviewed carefully by ART program and laboratory directors to ensure that their programs’ practice reflects current recommendations. More detailed guidance on laboratory procedures is presented in the Practice Committee reports ‘‘Cryostorage of Reproductive Tissues in the in Vitro Fertilization Laboratory’’ (2) and ‘‘Recommended Practices for the Management of Embryology, Andrology, and Endocrinology Laboratories’’ (3).  

DEFINITIONS 

Assisted reproductive technology encompasses a variety of clinical treatments and laboratory procedures, which includes the handling of human oocytes, ovarian tissue, sperm, testicular tissue, or embryos in vitro, with the intent of establishing a pregnancy immediately or in the future. This includes but is not limited to in vitro fertilization (IVF), embryo biopsy, preimplantation genetic testing (PGT), embryo cryopreservation, embryo donation, and gestational carrier IVF (4). 

Personnel 

There should be a contingency plan in place for all personnel essential to a program in case of illness, absence, or departure of an individual from the program. The purpose of the contingency plan is to ensure that critical operations within the laboratory and practice are covered without interruption. A single individual may fulfill the requirement for expertise in one or more areas. An ART program must include the following personnel. 

Directors. 

  • A designated overall practice director, medical director, and laboratory director. One individual may fulfill more than one of these positions, but the medical director must be a licensed physician. 

Physicians. 

  • A physician who has completed an American Board of Obstetrics and Gynecology (ABOG) or American College of Graduate Medical Education (ACGME) approved fellowship in reproductive endocrinology and infertility (REI) and is board certified or an active candidate for board certification in REI by the ABOG. 
  • A physician experienced in male reproduction. If this individual is not a urologist, a consultant urologist with expertise in male reproductive surgery should be available. 

Nurses. 

  • A nurse with training and/or experience in reproductive medicine and coordination of clinical ART care. 

Laboratory. 

  • An embryology laboratory director who meets the requirements described in specialized training and experience. 
  • An individual experienced in laboratory procedures in andrology. 
  • An individual with specialized training and experience in gamete, embryo, and gonadal tissue cryopreservation techniques, respectively, when gamete, embryo, and/or gonadal tissue cryopreservation is offered. 
  • An individual with specialized training in gamete biology and micromanipulation techniques, if oocyte, gonadal tissue, and/or embryo micromanipulation techniques are offered. 
  • Appropriate personnel to perform hormone assays. An outside laboratory that has demonstrated adequate competence, quality control, and service may be used for rapid assays of all the necessary reproductive hormones. Such hormone assays should be performed by a laboratory that meets Clinical Laboratory Improvement Amendments of 1988 (CLIA) standards. 

Auxiliary. 

  • An individual with specialized training and experience in gynecologic ultrasonography who provides the monitoring of follicular development. This role may be filled by a physician, nurse, or ultrasound technician. 
  • A mental health professional (MHP) with expertise in fertility counseling. If a MHP is not employed by the program, a consultant MHP should be available. 
  • An individual with specialized expertise in genetics and genetic counseling. If the individual is not employed by the program, a consultant geneticist and genetic counselor should be available. 


SPECIALIZED TRAINING AND EXPERIENCE
 

Practice Director 

The practice director should be a member in good standing of ASRM. The practice director is that individual who will assume responsibility and accountability for the activities of the practice related to ART. The practice director is the individual responsible for official communication with the Society for Assisted Reproductive Technology (SART), its registry, or its designees, and for ensuring that the practice follows the SART requirements for membership. The practice director does not have to be a physician. 

Medical Director 

As of January 1, 2000, a program’s medical director must be board certified in REI by ABOG or be an active candidate for the same. The medical director is responsible for verification of data reported to SART. The medical director should be a member in good standing of ASRM. 

Physician Performing Oocyte Retrievals and Embryo Transfers 

Physicians performing oocyte retrievals should have adequate training to perform diagnostic ultrasound and have performed an adequate number of aspirations under direct supervision to demonstrate proficiency within a practice that meets these standards. Physicians performing embryo transfer should have performed an adequate number of embryo transfers under direct supervision to demonstrate proficiency within a practice that meets these standards or have successfully completed a certificate course using an embryo-transfer simulator. Satisfactory completion of this training should be documented by the practice or medical director. Each physician should continue performing a mini-mum number of aspirations and embryo transfers per year to maintain his or her proficiency. 

It is recommended that physicians involved in the supervision of ovarian stimulation and oocyte-retrieval procedures be responsible for ultrasound monitoring of follicular development. Physicians responsible for ultrasound follicular monitoring should have familiarity with basic ultrasound principles and equipment. These physicians should have evidence of training and the requisite competence to adequately perform diagnostic ultrasound examinations. Completion of an ABOG or ACGME-approved fellowship program in REI satisfies the ultrasound training requirement. 

Nurses 

Licensed nurses in the ART setting provide or direct education, counseling, support, and nursing care to patients seeking assistance becoming pregnant. This role requires knowledge of anatomy and physiology, the normal menstrual cycle, pathophysiology, treatment options, and diagnostic tests.  

Other Auxiliary Personnel 

Other roles in the ART setting may include personnel such as medical assistants with specialized training in patient-care management and technical procedures for the ART patient. 

Embryology Laboratory Director 

The embryology laboratory director should be an individual with demonstrated knowledge of all laboratory aspects of ART. To qualify as an embryology laboratory director, the individual should fulfill the following requirements: 

  • Have an earned doctorate degree (Ph.D.) from an accredited institution in a chemical, physical, or biological science as the major subject, or a medical degree (M.D. or D.O.) from an accredited institution or have qualified as a laboratory director before July 20, 1999. 
  • Effective January 1, 2006, for all new laboratory directors, hold a High-complexity Clinical Laboratory Director (H.C.L.D.) or Embryology Laboratory Director (E.L.D.) certification or its equivalent from the American Board of Bioanalysis (ABB). Laboratories that participate in high-complexity procedures (i.e., quantitative sperm preparations and some hormone analyses) must be supervised by a laboratory director that is certified as an H.C.L.D. 
  • Have expertise and/or specialized training in biochemistry, cell biology, and physiology of reproduction with experience in experimental design, statistics, and problem solving. 
  • Have 2 years of documented pertinent experience in a program performing IVF-related procedures. This experience should include: 
    • Familiarity with laboratory quality control, inspection, and accreditation procedures. 
    • Detailed knowledge of cell culture, ART, and andrology procedures performed in human systems. 
    • At least 6 months of training (may be concurrent with documented experience) and completion of at least 60 ART procedures under supervision. A procedure is defined as a combination of the examination of follicular aspirates, insemination, documentation of fertilization, and preparation for embryo transfer. Satisfactory completion of this period of training should be documented by the laboratory director of the training practice. 
    • At least 24 hours of accredited continuing education every 2 years in ART or clinical laboratory practice. Demonstrated technical competence in the embryology laboratory by documenting performance of specific procedures and results that are within acceptable standards for that program. 

The responsibilities of the embryology laboratory director include: 

  • Formulating laboratory policies and protocols and communicating with the medical director regarding patient progress and protocols as they affect the laboratory aspects of treatment. 
  • Providing accessibility for on-site, telephone, or electronic consultations with on-site laboratory personnel as needed. Ensuring that the physical plant (space, facilities, and equipment) and environmental conditions of the laboratory are appropriate and safe. 
  • Maintaining aseptic conditions in the laboratory. Ensuring that patient confidentiality is maintained throughout the laboratory ART process. 
  • Providing all laboratory personnel unrestricted access to an approved procedural manual (print or electronic) and establishing and maintaining a laboratory quality assurance program. 
  • Providing consultation to physicians and others in the practice, as appropriate, regarding laboratory aspects of treatment. 
  • Employing a sufficient number of qualified laboratory personnel to perform the quality laboratory procedures. 
  • Ensuring that there is a personnel contingency plan in case of emergency. 
  • Ensuring that all personnel receive appropriate training for the ART laboratory procedures to be performed, obtain the required number of annual continuing education hours, and demonstrate continued competence for the ART laboratory procedures performed. 


Off-Site Embryology Laboratory Director
 

An ‘‘off-site’’ laboratory director is one whose primary directorship is at another physical facility, which has a separate identification number (e.g., SART number) and a separate medical director. An off-site director has the same responsibilities as an on-site director. While the laboratory is actively treating patients, the off-site director is required to physically visit the laboratory with a frequency that will ensure the proper functioning of the laboratory and ensure appropriate patient care. An off-site laboratory director should be physically present at the supervised laboratory for no less than four visits per year. The off-site laboratory director should be readily available to on-site laboratory personnel by fax, phone, video conference, or e-mail for any issues that may arise. The off-site director must be present on-site for any scheduled accreditation or certification procedures. A laboratory director should direct no more than five separate embryology laboratories (5).  

Embryology Laboratory Supervisor 

The embryology laboratory may have one or more qualified laboratory supervisors who, under the direction of the laboratory director, provide day-to-day supervision of laboratory personnel performing ART procedures. In small ART programs, an embryology laboratory director can function as the embryology laboratory supervisor. However, if the medical director is also the laboratory director, there should be a separate designated laboratory supervisor. Likewise, if the embryo laboratory director is primarily located off-site, there should be a separate designated laboratory supervisor. 

 The embryology laboratory supervisor should either meet the qualification requirements designated for laboratory director or fulfill the following requirements: 

  • Have an earned bachelor’s or master’s degree in chemical, physical, biological, or medical technology, or clinical or reproductive laboratory science from an accredited institution. In programs with an off-site laboratory director, the laboratory supervisor must be E.L.D., Technical Supervisor (T.S.), or General Supervisor (G.S.) certified by the ABB (or grandfathered in), or its equivalent in education and experience. 
  • Have documented training, which includes performing, at a minimum, at least 60 ART procedures under supervision.  

In addition to meeting these requirements, the embryology laboratory supervisor should:  

  • Obtain at least 24 hours of documented continuing education every 2 years in ART or clinical laboratory practice. 
  • Perform at least 20 ART procedures per year to maintain proficiency.  

Responsibilities of the embryology laboratory supervisor include: 

  • The day-to-day supervision and oversight of the embryo laboratory. 
  • Laboratory director responsibilities as authorized in writing by the embryology laboratory director. 


Embryology laboratory technologist
 

Embryology laboratory technologists who perform ART laboratory procedures should either meet the qualification requirements for laboratory supervisor or fulfill both of the following requirements: 

  • Have an earned bachelor’s or master’s degree in chemical, physical, biological, or medical technology, or clinical or reproductive laboratory science from an accredited institution. 
  • Have documented training, which includes performing, at a minimum, at least 30 ART procedures under continuous supervision of the laboratory director or supervisor. 

In addition to meeting these requirements, the embryology laboratory technologist should: 

  • Obtain at least 24 hours of documented continuing education every 2 years in ART or clinical laboratory practice. 
  • Perform a satisfactory number of ART procedures per year to maintain proficiency. 
  • Have appropriate experience and documented training in cell culture, sperm–egg interaction, or related areas of animal reproduction. The embryology laboratory technologist works under the supervision of a laboratory director or supervisor. Programs for the appropriate training of embryology laboratory technologists should be in place with documentation of completion for each.  


INFORMED CONSENT
 

Assisted reproductive technology practices should conform to the ASRM/SART recommendations concerning informed consent (6–13). SART has published consent forms that its members can use or adapt to their medical practice (14). The laboratory must have evidence of informed consent for all procedures prior to their performance. It is expected that practices will comply with all applicable local, state, and federal guidelines.  

ETHICAL AND EXPERIMENTAL PROCEDURES 

ASRM’s Ethics Committee has issued a report on the ethical considerations of ART procedures (15). All ART procedures should be performed in accordance with the recommendations contained in that report as well as all other reports from the ASRM Ethics Committee. Procedures considered experimental must be conducted with the approval of an institutional review board for human research or equivalent committee.  

RECORD KEEPING 

As of the publication of this document, U.S. federal law requires all ART practices to participate in the CDC ART registry data collection system. Furthermore, the law requires that each practice release or permit the release by the registry of clinic-specific success rates along with the identity of the clinic. ASRM and SART member practices must adhere to all relevant ASRM, SART, and Federal Trade Commission policies and procedures relating to advertising and the use of ART outcome statistics. The embryology laboratory must retain records of all its policies and procedures as well as personnel employment, training, evaluations, and continuing education activities. In addition, documentation of the proper identification, outcome, and disposition of all gametes, gonadal tissue, and embryos is important. This documentation should identify all clinical and laboratory personnel who have handled gametes, gonadal tissue, and embryos during each procedure.  

The laboratory must maintain these records for a period of time specified by federal, state, and local laws or for 10 years beyond the final disposition of all specimens obtained during each patient’s ART cycle, whichever is later. All paper records must be maintained on-site for 2 years; electronic records must have appropriate safeguards against data loss. In the event that the laboratory ceases operation, provisions must be made for these records to be maintained according to the time frame required.  

Acknowledgments: This report was developed under the direction of the Practice Committees of the American Society for Reproductive Medicine, Society for Assisted Reproductive Technology, and Society of Reproductive Biologists and Technologists as a service to its members and other practicing clinicians. Although this document reflects appropriate management of a problem encountered in the practice of reproductive medicine, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs of the individual patient, available resources, and institutional or clinical practice limitations. The Practice Committees and the Boards of Directors of the American Society for Reproductive Medicine, Society for Assisted Reproductive Technology, and Society of Reproductive Biologists and Technologists have approved this report. 

 This document was reviewed by ASRM members, and their input was considered in the preparation of the final document. The following members of the ASRM Practice Committee participated in the development of this document. All Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest based on the relationships disclosed did not participate in the discussion or development of this document. Alan Penzias, M.D.; Kristin Bendikson, M.D.; Tommaso Falcone, M.D.; Susan Gitlin, Ph.D.; Clarisa Gracia, M.D., M.S.C.E.; Karl Hansen, M.D., Ph.D.; Micah Hill, D.O.; William Hurd, M.D., M.P.H.; Sangita Jindal, Ph.D.; Suleena Kalra, M.D., M.S.C.E.; Jennifer Mersereau, M.D.; Randall Odem, M.D.; Catherine Racowsky, Ph.D.; Robert Rebar, M.D.; Richard Reindollar, M.D.; Mitchell Rosen, M.D.; Jay Sandlow, M.D.; Peter Schlegel, M.D.; Anne Steiner, M.D., M.P.H.; Dale Stovall, M.D.; Cigdem Tanrikut, M.D.  

REFERENCES 

  1. Centers for Disease Control and Prevention. Implementation of the Fertility Clinic Success Rate and Certification Act of 1992: a model program for the certification of embryo laboratories. Fed Regist 1999;64:39374. 
  2. Practice Committees of the American Society for Reproductive Medicine, Society for Reproductive Biologists and Technologists, Society for Assisted Reproductive Technology. Cryostorage of reproductive tissues in the in vitro fertilization laboratory: a committee opinion. Fertil Steril 2020;114: 486–91. 
  3. Practice Committee of the American Society for Reproductive Medicine, Practice Committee of the Society for Assisted Reproductive Technology, Practice Committee of the Society of Reproductive Biologists and Technologists. Recommended practices for the management of embryology, andrology, and endocrinology laboratories: a committee opinion. Fertil Steril 2014; 102:960–3. 
  4. Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, et al. The international glossary on infertility and fertility care, 2017. Fertil Steril 2017;108:393–406. 
  5. Electronic Code of Federal Regulations. CLIA Regulations Standards and Certification: Laboratory Requirements (42 CFR 493). Title 42, Chapter IV,Subchapter G, Part 493, Section 1445. Available at: https://wwwn.cdc. gov/clia/Regulatory/default.aspx. 
  6. Practice Committee of the American Society for Reproductive Medicine. Recommendations for gamete and embryo donation: a committee opinion. Fertil Steril 2013;99:47–62. 
  7. Practice Committees of the American Society for Reproductive Medicine and Society for Assisted Reproductive Technology. Recommendations for practices utilizing gestational carriers: an ASRM Practice Committee guideline. Fertil Steril 2017;107:e3–10. 
  8. Ethics Committee of the American Society for Reproductive Medicine. Consideration of the gestational carrier: a committee opinion. Fertil Steril 2018;110:1017–21. 
  9. Ethics Committee of the American Society for Reproductive Medicine. Informed consent and the use of gametes and embryos for research: a committee opinion. Fertil Steril 2014;101:322–5. 
  10. Ethics Committee of the American Society for Reproductive Medicine. Donating spare embryos for stem cell research: a committee opinion. Fertil Steril 2013;100:935–9. 
  11. Ethics Committee of the American Society for Reproductive Medicine. Interests, obligations, and rights of in gamete donation: an Ethics Committee opinion. Fertil Steril 2019;111:664–70. 
  12. Ethics Committee of the American Society for Reproductive Medicine. Fertility preservation and reproduction in patients facing gonadotoxic therapies: an Ethics Committee opinion. Fertil Steril 2018;110:380–6. 
  13. Ethics Committee of the American Society for Reproductive Medicine. Fertility treatment when the prognosis is very poor or futile: an Ethics Committee opinion. Fertil Steril 2019;111:659–63. 
  14. Society for Assisted Reproductive Technology. Member resources: consent forms. Available at: https://www.sart.org/professionals-and-providers/sart-members/. 
  15. Ethics Committee of the American Fertility Society. Ethical considerations of assisted reproductive technologies. Fertil Steril 1994;62:1–12. 

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Guidance on the limits to the number of embryos to transfer: a committee opinion (2021)

ASRM's guidelines for the limits on the number of embryos to be transferred during IVF cycles have been further refined ... View the Committee Opinion
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Role of tubal surgery in the era of assisted reproductive technology: a committee opinion (2021)

This document reviews surgical options for reparative tubal surgery and the factors that must be considered when deciding between surgical repair and IVF.
View the Committee Opinion
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Journal Club Global - Recurrent Implantation Failures in ART: Myth or Reality?

Classically, implantation failures in ART were believed to result from alterations in embryo or endometrium quality.
View the Video
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The role of immunotherapy in in vitro fertilization: a guideline (2018)

Adjuvant immunotherapy treatments in in vitro fertilization (IVF) aim to improve the outcome of assisted reproductive technology (ART) in both the general ART population as well as subgroups such as patients with recurrent miscarriage or implantation failure. View the Committee Opinion
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Using family members as gamete donors or gestational carriers (2017)

The use of adult intrafamilial gamete donors and gestational surrogates is generally ethically acceptable when all participants are fully informed. View the Committee Document
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Financial ‘‘risk-sharing’’ or refund programs in assisted reproduction: an Ethics Committee opinion (2016)

Financial ‘‘risk-sharing’’ fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. View the Committee Document
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Correct coding for laboratory procedures during assisted reproductive technology cycles

This document provides updated coding information for services related to assisted reproductive technology procedures. View the Coding Committee Document
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Recommended practices for the management of embryology, andrology, and endocrinology laboratories: a committee opinion (2014)

A general overview for good management practices within the endocrinology, andrology, and embryology laboratories in the United States. View the Recommendation
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Best practices of ASRM and ESHRE: a journey through reproductive medicine (2012)

ASRM and ESHRE are the two largest societies in the world whose members comprise the major experts and professionals working in reproductive medicine. View the Committee Joint Guideline