CLIA Final Rule

Final⁵ CLIA Rule. Part III:
QC - Quality or Compliance?

CLIA recommends you meet the needs of your patients, but only requires that you meet minimum requirements of the regulations. Dr. Westgard examines these minimum requirements for compliance, and compares them to the needs of your patients. (preview)

• Basic Requirements for Analytical Systems
• Responsibilities for Quality
• Minimum Requirements for Compliance
• Quality vs. Compliance

The main focus of the CLIA Final Rule is quality systems for non-waived testing. This section of the rules has been called "quality assurance" in earlier versions. Most of the rules still deal with "control procedures" and the ones that are most difficult to understand are still about quality control.

After waiting for ten years to get the Final Rule, laboratories still need to wait to find out how the final words will be interpreted. The problem is that the Final Rule introduces new terminology and phrases that need further explanation to understand their intended meanings. The final clarifications are expected to appear in the State Operations Manual within the next 6 to 12 months.

Meanwhile, what should you do? Actually, you don't have to do anything until you see those clarifications. Laboratories will have at least one year to come into compliance with the Final Rule, according to Judy Yost, Director of the Division of Laboratory Services, Centers for Medicare and Medicaid Services [Clin Lab News, March 2003, "Moving to One Quality Control Standard for Non-Waived Testing"]. On the other hand, you can be proactive and determine what should be done to assure and improve the quality of testing services in your laboratory, then assess how those plans and actions will fit with the final rules and regulations.

In short, you have a choice between doing what's necessary to be in compliance with the quality regulations and doing what's right to assure the quality of your testing processes. Both are allowable under the CLIA Final Rule. It seems obvious that it would be better for our patients if we focused on assuring quality, reducing medical errors, and improving patient safety, but it is equally obvious that it is both easier and cheaper to settle for compliance.

Want to read the rest of this article?

We invite you to purchase the CLIA Final Rules manual, available through the online store. You can download the Table of Contents and a preview chapter for free.