The Clinical Laboratory Improvement Amendment (CLIA) standards continue to be updated nearly two decades after their implementation, and compliance with them remains key to laboratory reimbursement under Medicare and Medicaid. One of the most significant changes has been an increased focus on quality, as revised quality system requirements have been implemented along with tighter standards for inspections. In addition, newly proposed changes to the CLIA cytology proficiency testing program could have a major impact on individuals undergoing such testing.

One of the most significant changes has been an increased focus on quality, as revised quality system requirements have been implemented along with tighter standards for inspections.

At the same time, the Food and Drug Administration (FDA) is continuing to focus on regulatory oversight of analyte-specific reagents (ASRs) and in-vitro diagnostic multivariate index assays (IVDMIAs).

Join Washington G-2 Reports for this 90-minute webinar about how the Centers for Medicare and Medicaid Services (CMS) is proposing to modify its cytology proficiency testing standards, as well as how it has modernized its quality control standards and tightened its inspection process. You’ll also find out what initiatives are in the works and what you can expect in the future.

Plus, find out what the FDA has in store for the coming year in terms of lab oversight, what the most common deficiencies are, and how to quantify and reduce errors in your lab.

During this program, you will:

• Find out about the newly proposed changes to the CLIA cytology proficiency testing program (announced January 15)
• Learn what quality control policy changes CMS has in store for the future
• Understand what changes in approach CMS has made to its inspections
• Find out what proficiency testing regulation changes are being considered
• Hear about major deficiencies identified and discover the steps you can take to improve quality
• Find out what FDA is planning in terms of lab oversight for the coming year

You’ll also have the opportunity to ask questions in our interactive Q&A portion of the program.

FEATURED FACULTY

Judy Yost, MA, MT (ASCP)
Director, Division of Laboratory Services, Centers for Medicare and Medicaid Services

Robert L. Becker, Jr., MD, PhD
Chief Medical Officer
Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Moderator:

Kimberly Scott
Senior Editor, Washington G-2 Reports