• University of Iowa
• Hospitals and Clinics

The Clinical Laboratory Improvement Act (CLIA) and the Physician’s Office Laboratory

Sponsored by The University of Iowa Roy J. and Lucille A. Carver College of Medicine

Editor:

Ronald D. Feld, Ph.D.*

Associate Professor of Pathology
Carver College of Medicine
The University of Iowa

Date of Original Release for CME Credit:

• December 1995

Date of Most Recent Reviews:

• December 1998
• November 2001
• November 2004
• December 2006
• December 2007
• January 2009

The next formal review of this program will be January, 2010. Comments from participants are reviewed on an ongoing basis to ensure that material and links are updated regularly.

*Dr. Feld has no relevant financial relationships that would create a conflict of interest for this CME activity.

Table of Contents

In January 2004, CMS issued survey procedures for the final quality control regulations that were issued and took effect on April 24, 2003. You should go to the following site to review the new guidelines: http://www.cms.hhs.gov/clia/appendc.asp. January 2004 marks the start of a new inspection cycle under the updated rules. Each laboratory is allowed one educational survey allowing time to meet the updated requirements.

A summary of the changes can be found at http://www.cms.hhs.gov/clia. Read brochure #1 "How do they affect my laboratory". There are additional brochures that help explain the new requirements.

• Introduction
• Registration
• Authors
• How to Read the CLIA Regulation Interpretive Guidelines: Laboratories
• CDC Wonder
• Centers for Medicare and Medicaid Services

Updates

• Other Laboratory Information and Web Sites

CME Credit Modules

• Clinical Chemistry in the Physician's Office Laboratory
• Endocrinology in the Physician's Office Laboratory
• Hematology in the Physician Office Laboratory Section I
• Laboratory Safety and Waste Disposal
• Microbiology in the Physician's Office Laboratory
• Personnel Regulations
• Pre-Analytical Factors Affecting Laboratory Results Emphasis: Phlebotomy
• Procedure Manuals
• Proficiency Testing
• Quality Assurance
• Quality Control
• Selecting and Using a Reference (Referral) Laboratory
• Selecting Reagent Kits and Instruments
• The Inspection Process
• The Lab Staff and Technical Consultant
• The Physician Office Laboratory Risk Management
• Therapeutic Drug Monitoring and Drug Abuse Screening
• Understanding and Reducing Laboratory Errors
• Urinalysis: Part I
• Urinalysis: Part II

Continuing Medical Education policies

If you have questions or comments, please contact CME Reviewers.