CME – Quality Control for the Laboratory

Number of Credits

4.5 CME




Cynthia Cardelino, MLT(ASCP), MT(HEW)

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.

Course Details:

This on-line 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 addresses the quality control (QC) requirements for non-waived laboratory testing, as stipulated by the CMS CLIA ’88 regulations. QC is an integral part of the total testing process and an essential element for producing accurate test results in the clinical laboratory. The lessons include everything from tips for selecting control materials to quality assessment of QC, and additional resources and helpful forms are offered.

At the conclusion of this course, the learner will be able to:

  • Summarize quality control and its purpose
  • Predict problems that can be detected by quality control
  • Compare the three types of quality control materials
  • Outline calibration, calibration verification, and verification of performance specifications
  • Utilize the applicable quality control requirements for routine tests
  • Outline the contents of a quality control program
  • Interpret statistical terms associated with quality control
  • Decide when and how to perform quality control
  • Compare methods for determining quality control acceptability
  • Apply the requirements for reviewing quality control
  • Utilize appropriate corrective actions for unacceptable quality control
  • Summarize the requirements for quality control documentation
  • Choose quality assessment activities that are appropriate for evaluating quality control

This course will take 4.5 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):

  • 4.50 Enduring Materials, Self-Study AAFP Elective Credit(s) – Quality Control for the Laboratory

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.


Module 1

  • Introduction to Quality Control
  • QC Materials
  • Related Processes
  • CLIA QC Requirements
  • QC Policies and Procedures
  • Graded Exam 1

Module 2

  • Statistics of QC
  • Performing QC
  • Reviewing QC
  • Corrective Actions
  • QC Documentation
  • Quality Assessment of QC
  • Graded Exam 2
  • Resources

Free, current version of Internet Explorer, Chrome, Firefox, or Safari. (Some older browsers could produce error messages or not display the content correctly.)

Free, current version of Adobe Reader.

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.