Number of Credits
Price
Author
This course provides CME credit and is only for individuals that are eligible for CME credit (physicians, nurse practitioners, nurses). All others should register for the course under the Laboratory Training category where the course is offered for
P.A.C.E. credit.
This course will assist laboratory directors in understanding and meeting the requirements for verification of performance specifications that are part of the updated CLIA requirements of 2003. For many moderate complexity laboratories this requirement was new, and it has caused some anxiety. Performance specifications are defined and the CLIA requirements and their purpose is explained. To help you perform a verification study, appropriate sample selection is discussed and suggested procedures are provided with example data to demonstrate the process. The course includes printable worksheets and links to additional resources.
Learning Objectives
- Define performance specifications
- Define the CLIA requirements regarding performance specifications and the purpose of the requirements
- Recognize when verification or establishment is required
- Identify the performance specifications that need to be verified for FDA-approved tests
- Identify the performance specifications that need to be established for tests that are not FDA-approved
- List samples appropriate for the study
- Recognize appropriate procedures for performing the study
- Recognize methods for interpreting and determining the acceptability of the study
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.
This Enduring Material activity, Laboratory Director Continuing Education Program, has been reviewed and is acceptable for credit by the American Academy of Family Physicians. Term of approval begins 08/01/2019. Term of approval is for one year from this date. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Approved for 2.0 AAFP Prescribed credits.
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.
This course will take 2 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.
Release Date: 8/1/2017
Expiration Date: 8/1/2018
- Introduction
- The CLIA Requirements
- Sample Selection
- Accuracy and Precision
- Reportable Range and Reference Range
- Establishment of Performance Specifications
- Graded Quiz
- Resources
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It is the policy of the AAFP and COLA Resources, Inc. 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(s). For this educational activity all conflicts of interests have been resolved and detailed disclosures are listed below:
Author: Cynthia Cardelino, MLT(ASCP), MT(HEW)
No relevant financial relationships to disclose, No discussion of unlabeled/unapproved uses of drugs/devices during presentation.
Activity Planner: Verlin K. Janzen, MD, FAAFP
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.