RCS Continuing Education Units

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Quality Management in an IVF Laboratory

  • Course Title: Quality Management in an IVF Laboratory
  • Start Date: March 14, 2016
  • End Date: May 6, 2016
  • Duration: 8 Weeks
  • Delivery Method: Online Course
  • Credit Hours: 2 CEUs (20 contact hours) Approved ABB and 2 Credit Hours Graduate Level Coursework EVMS

Continuing Education Information

This course has received official approval from the American Board of Bioanalysis (ABB) as a Professional Enrichment Educational Renewal (PEER) for continuing education activity.

Session Content

The goal of this course is to teach the participants about Quality Management of IVF Facilities in the context of various governance bodies (JACHO, CAP, COLA, ISI, CLIA, FDA, etc) as they apply to the Reproductive laboratory.  The 5 areas of Quality Management discussed in the course are QA and QC, Training/Continuing Education, Internal and External Proficiency Testing, Competency Assessment, and Risk Management.  Each week there will be a lecture, reading (book and current literature), projects, and discussions about the projects.  

Instructional Methods

This is an asynchronous 8 week online course; all materials are posted in a learning management system and include the presentation as a video lecture, powerpoint, current literature and/or readings from the required text book.  Participants will create and develop a portfolio of materials for use in their own practice and will interact with each other and the faculty in discussion groups for a better understanding and interpretation of the literature and best practices as outlined below.  A pre and post-test and evaluation will demonstrate effectiveness of the CE module.  

Performance Objectives

  • Describe/Define the process of Quality Assessment (QA) and distinguish it  from  Quality Control (QC)
  • List the elements of a Quality Assessment Program; design, implement and asses (review) a QA Plan
  • Create an effective QA review process
  • Compare and contrast the differences between: Accreditation, Licensing, Certification, Standards, and Guidelines.
  • Describe the basic structure, function and requirements of the various governance bodies (JACHO, CAP, COLA, ISO, CLIA, FDA, etc) as they apply to the Reproductive laboratory. 
  • Define “risk” and “risk management”, develop a risk management program and identify laboratory and hospital accrediting bodies as well as regulations that impact laboratory risk management.
  • Identify risk management concerns associated with the laboratory’s pre-analytic, analytic, and post-analytic phases of testing.
  • Know the difference between training and competency.
  • Describe the six required elements of competency assessment, know who can perform it and how often it must be performed.
  • Be able to create competency assessment forms and documentation.
  • Define and Describe the types of PT as well as the regulatory requirements for enrollment and performance.
  • Identify common errors that can occur when submitting PT results, the potential consequences of PT failures as well as how to investigate and resolve PT failures.


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