Trends

• Forget about government clearance of manufacturer's QC instructions
• Use quality goals to guide method validation and QC
• Implement multistage QC designs
• Implement patient-data QC to complement reference-sample QC
• Focus on detection of systematic errors
• Apply quality system approach to monitor the total testing process
• What's it all about, Alfie?
• New computer planning tools
• New QC software
• Bottom-line management vs quality management
• References

June 2000

A conference on "New Approaches to Quality Control" was held in Chicago May 11-12, 2000. Sponsored by the American Association for Clinical Chemistry (AACC) and the British Association for Clinical Biochemistry (ACB), this conference is also scheduled for September 28-29 in Cambridge, UK. The day and a half of presentations were strong on theory and ideas, but weak on practical guidelines and tools for implementation. I won't make any attempt to cover all the presentations in this review. My intent is to summarize some of the important recommendations, offer some insights into the practical application of these new approaches, and describe how to support the planning and implementation of improved quality systems in healthcare laboratories.

Forget about government clearance of manufacturer's QC instructions

I'll begin with one of the last speakers, Judith Yost, who is Director of the Division of Laboratories and Acute Care Services at the Health Care Financing Agency (HCFA). She spoke about the final, final, final, final, final CLIA regulations that will hopefully be published before the end of the year 2000. While unable to provide details of the specific language in the final regulations until they're published in the Federal Register, she did state there was no provision for clearance of manufacturer's QC instructions by the Food and Drug Administration (FDA). QC clearance was a major component of the original regulations and has been postponed again and again and now postponed forever. Finally it's clear that government clearance of manufacturer's QC instructions won't occur!

Why is this so important? Up till now, the QC guidelines for moderately complex methods stated that laboratories could follow the manufacturer's QC instructions if those instructions were cleared by the FDA. In the absence of such clearance, those methods would be treated as highly complex methods that are subject to more stringent QC guidelines. For highly complex methods, "the laboratory must evaluate instrument and reagent stability and operator variance in determining the number, type, frequency of testing calibration and control materials and establish criteria for acceptability used to monitor test performance during a run of patient specimen(s)" [see reference 1, paragraph 493.1218(b)].

Will laboratories now be held responsible for determining appropriate quality control? If so, how should laboratories take into account the instrument and reagent stability and operator variance in establishing their QC procedures? What should laboratories do to provide the appropriate number, type, and frequency of testing of calibration and control materials? How should laboratories establish appropriate criteria for monitoring routine runs?

In the discussion that follows, I'll show you how the new QC approaches can be used to improve quality control and also address the CLIA issues for establishing appropriate QC procedures.

Use quality goals to guide method validation and QC design

The importance of relating QC to defined quality goals was discussed by Dr. Carl Garber, who is Corporate Director of Statistical Applications for Quest Diagnostics. Dr. Garber provided an overview of the process for establishing and managing a laboratory testing process and showed how quality goals should first be used in validating the imprecision and inaccuracy of analytical methods and then for selecting appropriate QC procedures. This approach certainly addresses the CLIA requirement for evaluating instrument and reagent stability and operator variance in establishing QC procedures to monitor routine performance. A more detailed planning procedure is provided by NCCLS's recent update of its guidelines for statistical quality control [2].

Dr. Garber also described how information about the total testing process was integrated into a "multi-component statistical process control" computer program called SmarTech^TM, which is being deployed throughout Quest laboratories. This program makes use of control results, patient results, sample conditions, calibration information, patient demographics, and other rule-based information. While this program is proprietary and not available to other laboratories, it illustrates many of the capabilities that are needed in new QC technology.

 

We invite you to read the rest of this article

This complete article and many more essays can be found in the Nothing but the Truth about Quality manual, available in our online store. You can also download the Table of Contents and additional chapters here.