CLIA Compliance - From Quality Control to Inspections - Comprehensive Training Package (3 Courses)

The Clinical Laboratory Improvement Amendment (CLIA) regulatory requirements can be difficult to understand and follow. Are you sure your laboratory is in compliance with the various requirements?

To help clinical laboratories ensure regulatory compliance, we have created this package of 3 CLIA webinar recording CDs covering topics such as CLIA guidelines on quality control; calibration, calibration verification and method validation; and how to prepare for, and handle, the CLIA laboratory inspection.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don’t have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics:

• CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment
• Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation
• The CLIA Laboratory Inspection: Failure is not an Option

Who will benefit?

These webinar recording CDs will be beneficial to the following:

Clinical Lab personnel; the Physician Office Lab personnel; Reference Lab personnel; Lab Directors; Quality Assurance Managers and auditors; Laboratory Personnel; Laboratory Supervisors; Nurses, Medical Assistants, or anyone filling a laboratory role; Instrumentation specialist; and Medical supply reps.

Webinars included in the Package:

CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment (Duration: 60 minutes)

This Clinical Laboratory Improvement Amendments (CLIA) training is aimed at CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests.

Areas Covered in the Webinar:

• Quality Assurance vs Quality Assessment : Why the Change?
• Quality Assessment Systems
• Quality Control – Waived Testing
• Quality Control – Non-Waived Testing
• EQC
• EP 23
• Q & A Session

Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation (60 minutes)

The Clinical Laboratory Improvement Amendments (CLIA) training outlines the CLIA standards for frequency, methodology and also give examples of practical application.

Areas Covered in the Webinar:

• What do calibration, calibration verification and method validation mean?
• When each of these processes should take place.
• What systems are required to use these processes and which ones are not.
• Requirements for validation of new test systems.
• Remedial action if these processes are unsuccessful or have unexpected results.
• Reasoning behind each process and why they are necessary.

The CLIA Laboratory Inspection: Failure is not an Option (60 minutes)

This CLIA Laboratory Inspection training will discuss the salient features of laboratory inspection as per CLIA inspection guidelines.

Areas Covered in the Webinar:

• General Guidelines for a Successful Inspection
• Preparation is the Key
• The Laboratory Walk-Thru
• Personnel Training/Competency Documentation
• Quality Control: The Core of the Inspection Process
• Quality Assessment Plan: What Do You Measure?
• Patient Chart/EMR Review
• Inspection Follow-up and Response

Instructor Profile: