Training Name

Clinical Laboratory Improvement Amendments (CLIA) Basic Training

Training Description

This CLIA Basic Training is intended to develop and refine surveyors’ skills and increase surveyors’ understanding of the CLIA requirements. This training intends to cover regulation interpretation, compliance assessment using the Outcome-Oriented Survey Process, and Principles of Documentation for legally defensible citations of deficiencies. This training further intends to improve surveyors’ familiarity with CLIA-related enforcement options and protocols. All CLIA State Agency surveyors are required to complete this training.

Training Objectives: On completion of this training, you will be able to:

• Identify regulatory requirements for CLIA.
  
• Describe the CLIA survey process.
  
• Describe the surveyor’s role in assessing laboratory compliance.
  
• Explain how to determine compliance with CLIA requirements.
  
• Describe the data systems used for CLIA survey and certification.

Training Duration: 30 hours

Completion Requirements: This self-paced CLIA Basic Training includes a mandatory pretest, 15 learning modules, a mandatory posttest, and a CMS-approved training evaluation. Both the posttest and the evaluation must be completed to generate a certificate of completion. To pass the CLIA Basic Training, you must score a minimum of 80 percent on the training posttest.

Training CEUs: N/A

Email for Questions: The training is available on-demand online, 24 hours a day, 7 days a week. For all technical issues and those requiring an urgent response, such as accessing the training, email helpdesk@qsep.org; for all content-related questions, email Clarissa.Boyd@cms.hhs.gov or Keith.Scott@hhs.gov. For all other comments, questions can be submitted during the training using the comment tool.

Training Menu

CLIA Course Pre-Requisite Attestation

The CLIA Surveyor Basic Training – Online course includes several prerequisites, which are listed below. Please review any prerequisite sufficiently to have a working knowledge of the information before accessing the CLIA Surveyor Basic Training – Online

Module 1: Overview of the Regulations and D-Tags

Module 2: Outcome-Oriented Survey Process

Module 3: Principles of Documentation (POD)

Module 4: Proficiency Testing (PT)

Module 5: Subpart J-Facility Administration for Nonwaived Testing

Module 6: Subpart K-Quality System for Nonwaived Testing General Laboratory Systems

Module 7: Subpart K: Quality Systems for Nonwaived Testing Preanalytic Systems

Module 8: Analytic Systems

Module 9: Molecular/Genetic Testing and CLIA Applicability

Module 10: Subpart K-Quality System for Nonwaived Testing Postanalytic Systems

Module 11: Guidance for Histopathology

Module 12: Subspecialty: Cytology

Module 13: Subpart M Personnel

Module 14: Enforcement

Module 15: Application, Certificate, Billing and Data System Processes

﹂ CLIA Surveyor Overview Video

The CLIA Survey Overview video examines the Outcome-Oriented Survey Process that surveyors use to survey clinical laboratories for compliance with the CLIA regulations and cite deficiencies as appropriate.