Embryology Certificate Course
 

ACTIVITY NUMBER: LABCC100E
 

ACTIVITY TITLE: Laboratory Management Course
 

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 7.5 AMA PRA Category 1 Credits™.   Physicians should only claim credit commensurate with the extent of their participation in the activity.
 

The American Society for Reproductive Medicine has been approved to provide Professional Enrichment Education Renewal (PEER) credit through the American Board of Bioanalysis.  This activity has been approved for 0.75 PEER CEUs through the American Board of Bioanalysis. 
 

Release Date:  October 15, 2014

Reviewed and Updated in 2017

Expiration Date: December 30, 2025
 

Estimated Time to Complete Activity: 7.5 hours

NEEDS ASSESSMENT and IDENTIFICATION OF PRACTICE GAP

Discussion and evidence about reproductive laboratory technologies can be found not only in the scientific literature, but in the popular press and on the Internet as well. New technologies with implications for the treatment of the infertile couple are being developed and advancing rapidly such that even experienced embryologist might benefit from additional educational opportunities.  This online course will provide an easily accessible and detailed content in the field of laboratory management as well as assisting embryologists in identifying strategies for improving the IVF laboratory.
 

EDUCATIONAL OBJECTIVES

At the conclusion of this educational activity, participants should be able to:

1.      Describe the space, equipment, and general procedures used in the IVF laboratory.

2.      Discuss the elements of a Quality Control (QC) program that are required for laboratory certification, identify equipment and facility maintenance requirements, describe bioassay sensitivity to embryotoxins, and discuss options for proficiency testing.

3.      Describe the role of the Occupational Safety and Health Administration (OSHA) in safeguarding lab personnel and list the regulations for handling lab chemicals, liquid nitrogen, pressurized gas cylinders, and bloodborne pathogens.

4.      Outline the steps that will provide insight into the causes of failed fertilization through root cause analysis coupled with the application of checklists for each procedure and process.

5.      Identify areas in the laboratory and clinic where errors are more likely to occur, establish effective quality systems for minimizing errors, and establish procedures for corrective action.

6.      Identify actions to be taken by an assisted reproductive technology (ART) program during an emergency or natural disaster.

7.      Discuss the process for inspection preparation incorporating regulatory and accreditation requirements.

8.      Implement protocols to obtain consent from each patient appropriately and discuss potential legal pitfalls of misidentification of patients, gametes, and embryos.

9.      Distinguish the types of studies classified as research under the Institutional Review Board and describe the rights for subjects’ protection.

10.   Discuss basic principles of bioethics and ethics as they apply to issues in infertility treatment, examine legal issues, and discuss important religious concerns as they impact infertility treatment.

11.   Define professional development and identify mechanisms for embryologists and laboratory staff to meet requirements for professional development.
 

COURSE OUTLINE 

Laboratory Management

1.         The IVF Laboratory

2.         Quality Control

3.         Laboratory Safety

4.         Troubleshooting

5.         Minimizing and Tracking Errors in the ART Laboratory

6.         Emergency Planning 

7.         Regulation, Accreditation, and Inspection Preparedness

8.         Legal Aspects of Patient Interaction in the ART Laboratory

9.         Research and Institutional Review Boards

10.       Ethical, Legal, and Religious Issues in Infertility Treatment

11.       Continuing Professional Development
 

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
Patient Care
Professionalism
Systems-based Practice
 

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 acknowledgement of commercial support and disclosure of unlabeled use, prior to the start of each module.

·        Complete a 10-question pre-exam prior to each module. Learners should note any pre-exam questions answered incorrectly for clarification during module study.  

·        Be given the option of downloading a printed syllabus containing the presentation and narrative.

·        Participate in the interactive activity: Audio narration is synchronized with PowerPoint presentation that can be advanced, stopped or reversed as desired.

·        Complete a 10-question post-exam after each module, 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

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.