ACTIVITY NUMBER: EMBM006
ACTIVITY TITLE: IVF Laboratory Operations and Risk Management
ACCREDITATION STATEMENT
The American Society for Reproductive Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CREDIT DESIGNATION STATEMENT
The American Society for Reproductive Medicine designates this enduring material for a maximum of 4 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
PEER Credits
The American Society for Reproductive Medicine sponsors Professional Enrichment Education Renewal (PEER) credit through the American Board of Bioanalysis. This activity has been pre-approved for 4 PEER credits by the American Board of Bioanalysis under course number 66470.
To claim PEER credits:
- Complete the course
- Complete post-course evaluation:
- Fill in all required fields.
- If you hold a Florida license and plan to claim ABB PEER credits, be sure to include your license information in the required fields at the end of the evaluation.
- ASRM will submit all learner completions to ABB for issuance of PEER credits. PEER credits are posted within 30 days of completion.
ABB issues PEER credits directly; ASRM certificates or transcripts cannot be used to claim credits with ABB.
Release Date: October 15, 2014
Expiration Date: December 30, 2025
Reviewed and Updated: March 1, 2026
Expiration Date: March 1, 2029
Estimated Time to Complete Activity: 4 hours
NEEDS ASSESSMENT and IDENTIFICATION OF PRACTICE GAP
Modern assisted reproductive technology (ART) laboratories operate in an increasingly complex environment where patient safety, laboratory security, and optimal clinical outcomes depend on rigorous training across infection control, laboratory safety, fertilization biology, and quality-management systems. As fertility treatments expand, clinicians and embryologists must be fully versed in current recommendations for infectious-disease screening, vaccination, and treatment prior to ART, as well as strategies to minimize transmission risks for both patients and staff. At the same time, evolving Occupational Safety and Health Administration (OSHA) requirements and regulations for handling hazardous laboratory materials—including chemicals, liquid nitrogen, pressurized gas cylinders, and bloodborne pathogens—demand consistent, up-to-date competency with safety equipment, personal protective equipment (PPE), and routine safety instruction. Laboratory teams must also be prepared to maintain continuity of care during local and national emergencies, ensuring the protection of personnel, patients, cryopreserved tissues, records, and essential equipment. Parallel to these safety demands is the need for deeper understanding of the cellular and biochemical events underlying fertilization, recognition of normal and abnormal fertilization patterns, and mastery of the culture conditions and insemination techniques that maximize fertilization success. Because laboratory and clinical errors can jeopardize outcomes, practitioners must be able to identify areas prone to mistakes, implement robust quality systems, apply checklists, and conduct effective root-cause analyses that engage both laboratory and clinical staff in constructive problem-solving. Collectively, these needs highlight the necessity for comprehensive education that strengthens infection-control practices, laboratory safety, emergency preparedness, clinical embryology proficiency, and error-prevention frameworks to ensure the highest standards of care in ART programs.
EDUCATIONAL OBJECTIVES
At the conclusion of this educational activity, participants should be able to:
1. Discuss recommended infectious-disease evaluation, vaccination, and treatment protocols prior to fertility care and identify strategies that minimize transmission risk for patients and staff undergoing assisted reproductive technology (ART).
2. Describe OSHA’s role in ART laboratory safety, identify essential safety equipment and PPE requirements, and summarize regulations for handling chemicals, liquid nitrogen, pressurized gases, and bloodborne pathogens in the fertility laboratory.
3. Discuss the impact of local and national emergencies on ART operations and describe appropriate actions to ensure the safety of personnel, patients, cryopreserved tissues, records, and critical equipment during disasters or operational disruptions.
4. Describe the cellular and biochemical events of fertilization, identify normal and abnormal fertilization patterns, and recall best-practice in vitro culture and insemination/ICSI techniques that support optimal fertilization rates.
5. Identify error-prone processes in the clinic and laboratory, discuss structured checklists and root-cause analysis methods, and explain corrective-action and quality-assurance procedures that support consistent, reliable ART outcomes.
TARGET AUDIENCE
This activity is designed to meet the educational needs of new and experienced clinicians, laboratory scientists and allied health professionals with an interest in ART laboratory technologies for the evaluation and treatment of the infertile couple.
ACGME COMPETENCIES
Medical Knowledge
Patient Care
Professionalism
SUCCESSFUL COMPLETION REQUIREMENTS
Successful completion of this educational activity requires the learner to:
· View a course overview page containing all CME and disclosure information, including acknowledgment of any commercial support and disclosure of unlabeled use.
· Complete a 10-question pre-exam prior to each module. Learners should note any pre-exam questions answered incorrectly for clarification during module study.
· Participate in the interactive activity: audio narration is synchronized with lesson materials and can be advanced, stopped, or reversed as desired.
· Complete a post-exam after each lesson with feedback of correct/incorrect answers, scoring a minimum of 70% in two attempts.
· Complete the evaluation survey.
· Print certificate of completion.
DISCLOSURES FOR PLANNERS AND FACULTY
Planners
Stephanie Nichols-Burns, M.S, P.H.D, HCLD: Nothing to Disclose
Sarah Ramaiah, PhD, MSEd: Nothing to Disclose
Chevis N. Shannon, DrPH, MBA, MPH, MERC: Nothing to Disclose
Jeffery Hayes, PhD: Nothing to Disclose
Maina Gvakharia, M.D., PhD: Nothing to Disclose
Content Developers and Reviewers
Melanie Clemmer, H.C.L.D, PH.D.: Nothing to Disclose
Arthur Chang, PH.D., HCLD, ELD: Nothing to Disclose
Kristen Ivani, PH.D.: IVF Store - Sci Advisory Board (Self)
Navid Esfandiari, PH.D., HCLD: Nothing to Disclose
Amy Sparks, PH.D.: Nothing to Disclose
Charlene Alouf, PhD HCLD MBA: Invitae - Direct Stockholder (Self); Invitae - Full-Time Company Employee (Self); Genomic Prediction - Full-Time Company Employee (Self)
Reshel Tal, MD, PhD: Nothing to Disclose
Speaker/Presenter
Kimball Pomeroy, PH.D.: Ivy Fertility - Company Officer (Self); Ivy Fertility - Full-Time Company Employee (Self)
Arthur Chang, PH.D., HCLD, ELD: Nothing to Disclose
Navid Esfandiari, PH.D., HCLD: Nothing to Disclose
(*contributed to the original course only)
Planners
*Susan Gitlin, PhD: Ownership/Stock: Merck; Walgreen Company
*Andrew R. La Barbera, PhD: Nothing to Disclose
*Richard H. Reindollar, MD: Nothing to Disclose
*Nancy Bowers, BSN, RN, MPH: Nothing to Disclose
Content Developers and Reviewers
*Morgan Amick, BS: Nothing to Disclose
*Anthony Anderson, DSc: Nothing to Disclose
*Marlane Angle, PhD: Consultant: Previvo
*C. Brent Barrett, PhD: Consultant: ReproSource Fertility Diagnostics
*Charles Bormann, PhD: Nothing to Disclose
*Bruce Carr, MD: Grant/Research: AbbVie, Medicines 360; Speakers Bureau: Shionogi, Noven, Pfizer
*Marcelle Cedars, MD: Grant/Research: Nora Therapeutics; Ferring Pharmaceuticals
*Grace Centola, PhD: Consultant: New England Cryogenic Center; Cryos International-NY, Central Park Fertility
*Carli Chapman, MS: Nothing to Disclose
*Ri-Cheng Chian, PhD: Other: Cooper Surgical/SAGE Company
*Susan Crockin, JD: Consultant: BMS, Merck, Prometheus; Advisory Board: GSK, CoStim, Aveo; Speakers Bureau: Pfizer Canada, BMS
*Judith Daar, JD: Nothing to Disclose
*Erma Drobnis, PhD: Nothing to Disclose
*Kathryn Go, PhD: Nothing to Disclose
*Kay Graff, MS: Consultant: Steptoe Therapeutics; Employee: Pelton & Crane
*Elizabeth Grill, PsyD: SouthEastern Fertility: Speakers Bureau
*Shalini Gunawardena, RN, BSN: Walgreen's Nursing Advisory Board
*Lee Higdon, PhD: Nothing to Disclose
*Kristen Ivani, PhD: Nothing to Disclose
*Sangita Jindal, PhD: Nothing to Disclose
*Emily Jungheim, MD: Spouse is paid consultant: Abbvie, Genentech, Spectrum, Celgene; Speakers bureau: Genentech
*Levent Keskintepe, DVM, PhD: Nothing to Disclose
*Ann Kiessling, PhD: Nothing to Disclose
*Rebecca Krisher, PhD: Grant/Research: Serono
*Martin Langley, BS: Nothing to Disclose
*Michael Lee, MS: Consultant: Cook Medical
Bruce Lessey, MD, PhD: Nothing to Disclose
*Dennis Matt, PhD: Nothing to Disclose
*David McCulloh, PhD: Consultant: Infertility and IVF Medical Associates of Western NY; ReproART; Biogenetics Corporation; Employee: NYU Langone Medical Center
*Peter McGovern, MD: Nothing to Disclose
*Yves Menezo, DSc, PhD: Consultant: Nurilia
*Z. Peter Nagy, MD, PhD: Direct stockholder: My Egg Bank; Paid consultant: Origio, Fertilitech; Speakers bureau: Merck MSD
*Mike Neal, MSc: Nothing to Disclose
*Fariba Nehchiri, MSc: Nothing to Disclose
*Sergio Oehninger, PhD: Nothing to Disclose
*Kimball Pomeroy, PhD: Nothing to Disclose
*Thomas (Rusty) Pool, PhD: Other: Auxogyn
*Marc Portmann, MHA, MT: Nothing to Disclose
*Catherine Racowsky, PhD: Consultant: Nora Therapeutics
*Michael Reed, PhD: Nothing to Disclose Lisa Rinehart, JD: Nothing to Disclose
*William Roudebush, PhD: Nothing to Disclose
*Denny Sakkas, PhD: Consultant: Good Start Genetics; Other: Fertilitech, Origio
*Mitchel Schiewe, PhD: Nothing to Disclose
*Ira Sharlip, MD: Consultant: Pfizer, Lilly, Absorption, Vyrix
*Scott Smith, PhD: Product Review: Biocoat
*Amy Sparks, PhD: Nothing to Disclose Laurel Stadtmauer, MD: Nothing to Disclose
*Jason Swain, PhD: Consultant: Irvine Scientific
*Tyl Taylor, MSc: Consultant; Spouse employed: Biodiseño
*Helen Tempest, PhD: Nothing to Disclose
*James Toner, MD, PhD: Speakers bureau: Merck
*Nathan Treff, PhD: Nothing to Disclose
*Tom Turner, MS: Nothing to Disclose
*Matthew VerMilyea, PhD: Consultant: Auxogyn, Irvine Scientific, Genea Biomedx
*Michael Vernon, PhD: Nothing to Disclose
*Diane Wright, PhD: Nothing to Disclose
*Hang Yin, PhD: Nothing to Disclose
It is the policy of ASRM to ensure balance, independence, objectivity, and scientific rigor in all its educational activities. All faculty/speakers participating in this activity are required to disclose any relationships they may have with companies whose products or services could be mentioned, allowing participants to determine the objectivity of the presentations. The content and views presented in this activity are those of the faculty/speakers and do not necessarily reflect those of ASRM. Any discussion of the off-label, experimental, or investigational use of drugs or devices is not allowed. The disclosure statements were reviewed by the CME Subcommittee and the Executive Program Committee of ASRM, and any perceived conflicts of interest were resolved in accordance with the ACCME’s policies and Standards of Integrity and Independence in Accredited Continuing Education.
STATEMENT OF SUPPORT
No commercial support has been provided for this activity.