Tools, Technologies and Training for Healthcare Laboratories


Final Rule vs Final Word on Quality

On April 28, 2004, the AACC held its audioconference on “CLIA’88: Recent Changes, Future Directions,”. During that conference, the speakers were asked to respond to "our" position on "equivalent QC procedures." To respond to those responses, we want to clarify our concerns about "Eqc."

May 2004

On April 28, 2004, the AACC held its audioconference on “CLIA’88: Recent Changes, Future Directions,”. During that conference, the speakers were asked to respond to "our" position on ????quivalent QC procedures.” We provide the discussion below to clarify our concerns about the CLIA Final Rule and the CMS recommendations on “equivalent QC procedures.” These comments are adapted from the concluding chapter of our book CLIA Final Rules for Quality Systems: Quality Assessment Issues and Answers, published by Westgard QC in May 2004. More detailed discussions of the technical merits, or lack thereof, can be found in other materials on this website. See the following:

Now that we've reached the final5 release of the CLIA Final Rule, the question undoubtedly comes to mind: Is this the final word on Quality? After a decade in the making, after all the exhaustive effort and debate, do laboratories finally have a useful set of regulations that will serve them and their customers for the foreseeable future?

It should be apparent to the reader of articles and essays on this website that we are not impartial observers of these regulations. As the CLIA regulations have emerged and evolved, we have been consistent advocates for doing what’s right to manage quality, rather than accepting the minimal requirements for compliance with government regulations. We have attempted to demonstrate the best ways to satisfy government regulations and, at the same time, do what’s right to assure laboratory test results will be reliable for patient care.

During the time the CLIA rules were evolving to the final state, laboratories (mainly) needed only to follow the manufacturers’ directions, with minimal requirements to validate the performance of their methods and minimal requirements for QC to monitor ongoing method performance. The Final Rule puts more responsibility on the laboratory, less responsibility on the manufacturer, and less responsibility on the government.

In principle, this is good because professional standards of practice will be higher than the minimum regulations for compliance! In practice, we worry that laboratories today may not have the technical expertise and staffing to assume the increased responsibilities. After a decade of reductions in the education and training required for laboratory staff, in part due to CLIA’s reductions in personnel standards, and now faced with serious staffing shortages, laboratories today may not have the resources needed to assume these responsibilities and implement effective quality assessment systems.

Quality or compliance?

While we may disagree with the minimalist approach for compliance, we do understand that the regulators face a difficult problem. CMS inspections still reveal there are many laboratories where there is little if any QC being done and little capability to do any better. In talking to people from CMS and CDC about the issue of equivalent QC and our proposal to use sigma metrics to assess the data collected in the evaluation protocol, they have indicated it is unrealistic to assume that all laboratories can calculate a mean and SD. While this helps us understand the nature of the problem, we don’t believe the solution is to continue to “dumb down” the regulations and practice guidelines. Lowering standards to increase compliance does nothing to improve and assure the quality of laboratory testing for the American public.

For many laboratories, it may be disturbing to hear that government regulations are not sufficient to provide proper guidance for their quality management practices. Cost pressures are very real today; quality pressures are mainly talk! Higher levels of institutional management often believe (accept) that compliance with government regulations is all that is necessary. This, in spite of the growing recognition that patient safety is now the #1 goal and concern in healthcare today. Quality in laboratory testing is fundamental to assuring patient safety. If laboratories don’t provide correct test results, the patient is in great danger of being misdiagnosed and mistreated.

Manufacturers have a serious dilemma! They have often urged the government to reduce the regulatory requirements and, in some cases, may be directly responsible for certain amendments, such as the new “equivalent QC procedures”. However, they are now finding that the quality produced by their analytical systems in the field is being limited by the technical resources and expertise in the field. For most manufacturers, whether they like it or not, their liabilities are increasing and at some point it will be necessary to support higher standards than today’s minimums for compliance. Some are addressing this issue by developing improved analyzers that include improved quality systems, but such progress may actually be impeded by changes in the Final Rule. Strangely enough, the new equivalent QC guidelines may actually limit the use of innovative QC technology already cleared via the FDA 510K product approval process. The government’s own quality system is limited by inconsistencies in the programs administered by different agencies.

We believe the road to improvement in quality and quality management practices in the clinical laboratory must begin with professional organizations, not regulatory agencies. After ten years of CLIA, it is pretty clear that quality has not been improved by a regulatory approach. The immediate needs for improvement would best be addressed through laboratory professional organizations, e.g., CAP, ASCP, CLMA, AACC, ASCLS, etc. It is possible that ISO standards will eventually become the default standards for quality in US laboratories, but that would require they be accepted and integrated into the inspection guidelines and checklists of “deemed providers”. ISO standards already supercede national government regulations in the minds of manufacturers, and they could also achieve that status in the minds of laboratorians. But that will take more time.

The Final Rule is not the Final Word!

We now look forward to seeing how the Final Rule and the related interpretative guidelines are accepted and implemented in the real world. We think that the actions concerning equivalent QC procedures will be critical and may predict the future of laboratory testing in this county. Has laboratory testing become a commodity to be regulated by the government at the lowest possible standard of practice? Or will the professional responsibilities of laboratory scientists assert a higher standard? There is clearly an opportunity to re-assert professional leadership!

The actions of CAP and JCAHO will be critical. For example, if they adopt the CMS guidelines for equivalent QC procedures, then Eqc will become a reality. If they recommend a more rigorous qualification of systems for Eqc, then a higher standard of practice will be maintained in the many laboratories they inspect and accredit. Their decisions on equivalent QC will probably set the standard and direction for the next few years.

Other professional organizations, such as AACC, ASCP, ASCLS, CLMA, etc., also need to take a stand for quality. The scientific aspects of laboratory testing need to be affirmed, the educational and training needs must be addressed, and the business aspects of efficient organizational performance must be carefully considered. However, US business practices do not exemplify good conduct and adequate consideration of the public good. As healthcare organizations become more businesslike, they may be in danger of making the same mistakes.

Who really has the Final Word?

Will laboratories embrace Eqc? That will be another benchmark and predicator of the future of laboratory medicine. As long as cost and staffing issues are paramount, there will be intense pressure to adopt any practice that reduces the effort and apparent cost of QC. However, you do not have to adopt Eqc or any other practice that compromises quality care. Individuals in laboratories can insist on doing what’s right for patient care, instead of accepting that compliance with regulations is good enough.

We hope that we have provided you with some of the tools to assure quality, as well as some motivation to exercise your professional responsibility. We firmly believe that doing the right thing right is the best advice and guidance we can give you. We believe that is the answer for today’s questions on compliance. Stop worrying about compliance and strive to achieve excellence. That’s our best advice, what happens now with quality in your laboratory is up to you. You have the final word on quality!

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.

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