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About ISO/IEC 15189:2022 & CLIA Requirements for Medical Laboratories

During this ISO 15189 training course, the participant will gain an understanding of the ISO 15189 and CLIA requirements as well as the benefits through discussion, interactive exercises, and lecture. The participant will also be introduced to a new risk-based initiative recently introduced by CMS: The IQCP, or Individualized Quality Control Plan.

Target Attendees

Target learners include Clinical Testing Laboratory Directors, Managers, Auditors, Scientists, or Technicians.

Learning Outcomes

After successful completion of this course, the participant will be able to:
1. Identify documents and records required by the Standard and CLIA
2. Implement actionable clauses
3. Design and apply a risk management system
4. Recognize how and when to implement an IQCP
5. Describe the benefits of the standard in conjunction with CLIA requirements

CEUs Awarded

2.1 CEUs*, 16 Training Hours

Presentation Style

This course will use lecture, discussion and interactive exercises.

Reference

Students are required to bring a copy of the ISO 15189:2022 standard and the CLIA Requirements Document with them furnished by their company or purchase them directly from ISO or other approved document provider prior to the class.

* A2LA WorkPlace Training is accredited by the International Association for Continuing Education and Training (IACET) and is authorized to issue the IACET CEU.