Trends

Dr. Westgard recaps some of the most interesting discussions and announcements of the 2009 AACC/ASCLS/CSCLS meeting in Chicago.

AACC/ASCLS/CSCLS 2009:

Renewed Interest in Analytical Quality, but not QC

July 2009

The recent AACC meeting in Chicago gave some indications there is a renewed interest in analytical quality, but QC still remains a compliance issue. Here are some signs.

• A symposium on “Metrology, the Science of Measurement and its Application to the Clinical Laboratory” included a presentation by Dr. Willie Mays from the US NIST (National Institute for Standards and Technology). Dr. Mays began by looking at the current issues for the reform of healthcare, identifying the electronic medical record as a new driving force for improving the analytical quality of laboratory tests. The issue, of course, is how to interpret lab tests produced by different methods and different laboratories if test results are not comparable from method to method, lab to lab, and over time. Most of the US healthcare community assumes test results are comparable, but most laboratory scientists know this is not true. The solution is to have test results that are traceable to the “truth” via a change of reference materials and reference methods.
• In another symposium on “Emerging Regulation and Harmonization Trends for the Clinical Laboratory”, Dr. Alberto Gutierrez discussed the US regulatory model and the lack of any requirements for traceability in the FDA approval processes. Dr. Gutierrez, who is the successor to Dr. Steven Gutman as the head of the Bureau of Medical Devices, noted that the European regulations for traceability are much stronger than anything possible in the US. The US model does not set or require standards for performance, but rather relies on good manufacturing practices and documentation of claims of performance.
• In that same symposium, Dr. Randie Little from the University of Missouri discussed the progress of the NGSP in improving the comparability of HbA1c test results and the increasing pressure for improvement through standardization, certification, and proficiency testing. In particular, PT is being used as a driving force by tightening the criteria for acceptable performance in those laboratories utilizing the CAP PT program, which specified an allowable error of 15% in 2007, 12% in 2008, and 10% in 2009, and will be tighten further to 8% in 2010 and 6% in 2011.

As part of the AACC Industry program, we were pleased to see Dr. Ronald Laessig receive the Louis J. Dunka Service Award, in recognition of a lifetime of work on behalf of the diagnostic industry and the medical laboratory. His wife, Joan, was there to receive the award on his behalf.

The AACC Industry program also included updates on emerging CLSI protocols.

• Dr. Jan Krouwer reported on a new standard EP-27 “How to construct an error grid for diagnostic assays.” This standard is driven in part by FDA’s guidelines for approval of “waived tests”, which recommend manufacturer’s specify a total error requirement and demonstrate test performance using the graphical presentation of an error grid.
• Dr. James Nichols discussed progress with EP-22 and EP-23 (Laboratory Quality Control Based on Risk Management). Both of these documents are in the process of approval by the Area Committee and should be released this year.
• In response to questions about the EP risk management documents and their potential effect on CMS’s EQC guidelines, Greg Cooper (Chairman of the CLSI Evaluation Protocols Area Committee) commented that it was not yet clear how “risk management QC” fit with the CMS guidelines. A new version of the “State Operations Manual” is being drafted, and in review by some of the CLSI members, they noted there was no mention of the new EP-22 and EP-23 standards. Some in the audience expressed the opinion that the current EQC guidelines would probably stand as originally proposed, in spite of the emerging EP standards on “risk management QC.”

We were disappointed to hear that EQC is expected to survive in its current form, in spite of the time and effort invested to develop a more comprehensive approach to “alternative QC” via CLSI. Some 5 years has elapsed since CMS proposed the EQC guidelines in the SOM, and in spite of CMS’s role to involve CLSI in resolving the concerns about the validity of the EQC validation protocols, CMS now seems poised to ignore the CLSI work that they sponsored.