Number of Credits
This online educational activity has been designed to meet the needs of physicians operating an office laboratory; healthcare professionals working as medical laboratory staff in nonwaived diagnostic laboratories, including testing personnel, technical consultants, supervisors, and laboratory directors. This course examines the CLIA requirements for quality assessment that apply to clinical laboratories and discusses ways to achieve and document compliance. This course explains the following topics: quality systems, quality assessment, the QA plan and its implementation, and regulatory compliance. The course includes a glossary and links to additional resources.
At the conclusion of this course, the learner will be able to:
- Illustrate the process of Quality Assessment (QA)
- Differentiate between QC and QA
- Summarize the concept of Quality Systems
- Outline the quality systems that require QA reviews
- Design a QA plan that meets the requirements
- Summarize the benefits of a QA plan
- Formulate an effective QA review process
- Implement a QA plan
- Maintain the required QA documentation
This course will take 1.5 hours to complete and there are no prerequisites. A credit certificate will be issued upon completion of the course evaluation and post-test with a score of 80% or better.
This CME activity has been designed to change learner competence and focuses on the American Board of Medical Specialties areas of patient care, practice-based learning and systems-based practice.
The AAFP has reviewed Laboratory Director CME Program, and deemed it acceptable for AAFP credit. Term of approval is from 10/01/2021 to 10/01/2022. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Credit approval includes the following session(s):
- 1.50 Enduring Materials, Self-Study AAFP Elective Credit(s) – Quality Assessment Basics
AAFP Prescribed credit is accepted by the American Medical Association as equivalent to AMA PRA Category 1 Credit™ toward the AMA Physician’s Recognition Award. When applying for the AMA PRA, Prescribed credit earned must be reported as Prescribed, not as Category 1.
- Introduction to Quality Assessment
- Introduction to the QA Plan
- Module 1 Graded Exam
- Developing a QA Plan
- Implementing a QA Plan
- Module 2 Graded Exam
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It is the policy of the AAFP and LabUniversity that the faculty, authors, planners, and other persons who may influence content of this CME activity disclose all relevant financial relationships with commercial interests* in order to allow CME staff to identify and resolve any potential conflicts of interest. Faculty must also disclose any planned discussions of unlabeled/unapproved uses of drugs or devices during their presentation. For this educational activity all conflicts of interests have been resolved and detailed disclosures are listed below:
Author and Course Reviewer: Cynthia Cardelino, MLT(ASCP), MT(HEW)
No relevant financial relationships to disclose, No discussion of unlabeled/unapproved uses of drugs/devices during presentation.
* The ACCME defines a commercial interest as any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests.