Quality Fundamentals Course

This course is developed for the early-career laboratory professional to provide a foundation in Quality Systems and Quality Management. It is comprised of six (6) modules covering key topic areas (view the syllabus for more information):

  1. Quality System Basics
  2. Organization, Facilities, Resources
  3. Equipment and Suppliers
  4. Process Control
  5. Documents, Records and Nonconformances
  6. Audits and Corrective/Preventive Action

The key topic areas cover elements relevant to developing an understanding of the fundamentals of a Quality program. Each module includes a video, additional supporting reading materials and knowledge checks. At the conclusion of each module, learners are provided three knowledge check questions designed to reinforce learning (two attempts on each knowledge check are provided). Although there is no required passing score, learners are encouraged to review the appropriate sections of the video or reading materials when questions are missed to ensure a better understanding of the content.

Learning Objectives

Upon completion of this course, learners should be able to:

  • Describe a Quality Management System and its elements.
  • Apply elements of a Quality Management System within a laboratory setting.
  • Identify resources for developing, defining and maintaining elements of the Quality Management System.

Access & Pricing

This course is offered online as independent, self-paced study through AABB’s Education Platform. After registering for the course, each learner will receive automatic access to the program. Access is granted for one year from the date of registration.


Individual Registration Pricing:

  • AABB Individual Member: $135
  • Individual Nonmember: $185

Discount for Multiple Registrations:

  • Institutions will receive 15% off the list price when purchasing four (4) or more registrations. The list price for each individual student will be determined by the institution’s AABB membership status (not each individual’s membership status).

How To Register

Individuals can register online via the AABB Store. Individuals will be prompted to create an account if they do not already have an established account in the Store. Payment confirmation will be provided immediately after registering.

Institutions that want to purchase registrations for learners must complete and return the Institutional registration form. Payment confirmation will be provided within 2-5 business days.

Educational Highlights from Each Module

Module 1: Quality System Basics
Key points covered include the importance of Quality, and an overview of Quality Systems and Quality Management System. Module includes:

  • Video (7:12 minutes)
  • Reading: AABB Technical Manual, 20th Edition, Chapter 1 – Quality Management Systems: Principles and Practice

Module 2: Organization, Facilities, Resources
Key points covered include organization, executive management, and training and competence. Module includes:

  • Video (13:14 minutes)
  • Reading: US Code of Federal Regulations – 42 CFR 493 - Laboratory Requirements

Module 3: Equipment and Suppliers
Key points covered include equipment, suppliers and incoming supplies. Module includes:

  • Video (7:52 minutes)
  • Reading: US Code of Federal Regulations – 21 CFR 606.60 – Equipment

Module 4: Process Control
Key points covered include process control, validation, and change control. Module includes:

  • Video (10:15 minutes)
  • Reading: FDA General Process Validation – General Principles and Practices

Module 5: Documents, Records and Nonconformances
Key points covered include documents, document control, nonconformances and errors. Module includes:

  • Video (11:25 minutes)
  • Readings:
    • US Code of Federal Regulations – 21 CFR 606
    • Error reporting templates excepted from Error Management: Turning a Negative Situation into a Positive One, AABB Press, 2022

Module 6: Audits and Corrective/Preventive Action
Key points covered include audits, quality monitors, and corrective/preventative action. Module includes:

  • Video (12:35 minutes)
  • Readings: Root Cause Analysis Tools:
    • Five Whys Tool for Root Cause Analysis
    • How to Use the Fishbone Tool for Root Cause Analysis
    • Guidance for Performing Failure Mode and Effects Analysis with Performance Improvement Projects

Activities for Successful Completion of the Course

Watch the video for each module, review the additional reading materials and complete the knowledge checks provided with each module. Learners can view the modules multiple times during their access period. After completing all the modules, a course evaluation is required before the course is marked as complete and continuing education credits are awarded. Since this is a self-paced program, learners may decide how much time is needed to review and study the materials. It is estimated the course will take approximately 2-3 hours to complete.

CE Credits

This course is eligible for three (3) continuing education credits/contact hours for General Participation, California Nurse, California Lab Personnel or Florida Lab Personnel. The number and type of credits awarded for this course was determined by the estimated program completion time. This course is not eligible for continuing medical education credit for physicians. For more information on each credit type please visit AABB’s Continuing Education Credits webpage. A continuing education certificate of completion will be immediately provided upon reviewing all modules and completion of the course evaluation. Learners will also be able to access the continuing education certificate in the My Transcripts section of the AABB Education Platform.

Course Faculty

This course was developed and presented by Holly M. Rapp, BS, MT(ASCP)SBB, CQA(ASQ), CMQ/OE. After graduating from Alderson-Broaddus College in Philippi, WV with a degree in Medical Technology, Rapp spent more than two decades as a medical technologist with supervisory roles at various hospitals and blood centers across the United States. In 1999, she joined AABB as a lead assessor and was promoted to AABB’s Director of Accreditation and Quality in 2002, a position she held until she retired in 2017. Rapp is recognized internationally as an expert in Quality in the blood and biotherapies field, and now helps facilities around the world develop and maintain quality assurance programs as an independent consultant. Rapp is based in Myrtle Beach, SC.