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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 non-waived diagnostic laboratories, including testing personnel, technical consultants, supervisors, and laboratory directors. This course examines the CLIA requirements for laboratory director responsibilities that apply to clinical laboratories and discusses ways to document compliance. This course explains the following CLIA required responsibilities: general, procedural, proficiency testing, quality control, and personnel responsibilities to achieve CLIA compliance. The course includes a glossary and links to additional resources.
At the conclusion of this course, the learner will be able to:
- Summarize the laboratory director responsibilities for a moderate complexity laboratory
- Summarize the laboratory director responsibilities for a high complexity laboratory
- Illustrate ways for the laboratory director to meet each lab director responsibility
- Given a specific laboratory scenario, decide if laboratory director responsibilities are being met
This course will take 1 hour 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):
- 1.00 Enduring Materials, Self-Study AAFP Elective Credit(s) – Laboratory Director Responsibilities
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.
- Welcome
- General
- Procedural
- Proficiency Testing
- Quality Control
- Personnel
- Conclusion
- Graded Exam
- Resources
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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.