Clinical Laboratory Improvement Amendments (CLIA) Personnel Qualifications and Responsibilities: High Complexity Testing
Description
This intermediate-level course provides a brief overview of the requirements, duties, and credentials of personnel who perform or oversee high complexity testing subject to Clinical Laboratory Improvements Amendments (CLIA) regulations. The course includes a progressive scenario that introduces personnel engaged in high complexity testing in a CLIA-certified laboratory.
Note: This course is only intended to offer a general summary of CLIA personnel qualification and responsibilities. It does not take the place of written law or regulations.
Audience
This intermediate course is intended for clinical and public health laboratory staff and others who are involved in CLIA non-waived, high complexity testing across various specialties and subspecialties, and those working with tests that the Food and Drug Administration (FDA) has not classified into a specific specialty or subspecialty.
Accessibility
Course content is closed captioned, where applicable, and optimized for a screen reader.
Objectives
At the end of this course, learners should be able to:
- Recall the fundamental requirements of the CLIA regulations for laboratory testing.
- Identify the CLIA-required personnel positions involved in the clinical laboratory testing process for laboratories that perform high complexity testing.
- Recognize the CLIA personnel qualifications required for individuals in a laboratory that performs high complexity testing.
- Verify the responsibilities of specific personnel for accurate and reliable high complexity testing throughout the testing process.
- Recognize their role as a team member who performs or oversees high complexity testing.
Continuing Education (CE)
The Centers for Disease Control and Prevention, Division of Laboratory Systems is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 1.0 contact hour(s) of P.A.C.E.® credit.
P.A.C.E.® Course Number: 288-036-25.
See CDC Course Accreditation Document for more details.
To receive Continuing Medical Education (CME), follow the steps below by August 1, 2027.
1. Complete the course in OneLab REACH.
2. Pass the posttest at 70%.
3. Copy the passcode provided after passing the posttest.
4. Go to CDC TRAIN and register for the Clinical Laboratory Improvement Amendments (CLIA) Personnel Qualifications and Responsibilities: High Complexity Testing WB4914) course.
5. Check the box for each type of CE you wish to apply for when registering for the course.
6. Select the **Mark Completed** button on the course page in TRAIN.
7. Enter the passcode when prompted.
8. Complete the evaluation in CDC TRAIN.
You can access your CME certificates and transcript by visiting **Your Learning** in TRAIN.
Disclosure
Subject matter experts and presenters wish to disclose they have no conflict of interest or other relationships with the manufacturers of commercial products, suppliers of commercial services, commercial supporters or other organizations related to the course.