Tools, Technologies and Training for Healthcare Laboratories

A Hopeful Year 2009

The new year brings with it a new administration, and possibly a new effort to fix the US healthcare system. What does that mean for laboratories, testing, and quality?



December 2008
James O. Westgard, PhD

[Editor's note: this essay contains some discussion of politics]

As we near the end of December, it is -7 F on the thermometer and +31 inches on the snow gauge. The winter shows all indications of being a bad one, at least here in Wisconsin, but the next year shows many signs of hope in the US. We have new leadership in our government, a more centrist political disposition, (we hope) less partisanship in our political process, and a high priority for reform of our healthcare system. Many wonder if healthcare reform will be compromised by the financial and business crises facing the country, but I think such reform will be necessary as part of resolving those crises. Businesses and even the medical community are now supportive of fixing healthcare!

I am encouraged by the appointment of Tom Daschle as the Secretary for Health and Human Services and also as the “healthcare czar.” I don’t know much about Daschle, except that he comes from South Dakota, which makes him a neighbor and gives me some sense of his background and character. Although I’m originally from North Dakota, remember that at one time “Dakota Territory” included both North and South Dakotas, so anyone from Dakota is a neighbor who will befriend another Dakotan at any time or place. Likewise, I think Daschle will befriend all Americans in their need for better healthcare. I realize that there is little logic in that reasoning, but character and commitment will be the key ingredients of the new leadership.

I still worry about the need for improvements in the quality of laboratory services because the financial crisis will provide an ongoing rationale for minimizing the cost of laboratory testing at the possible expense of quality. The CLIA regulations went in the same direction as the US financial regulations, i.e., reduced or lenient regulation to aid business, which here includes the healthcare business as well as manufacturers and suppliers. Certainly CMS’s efforts to reduce QC through supposedly “equivalent QC” follows the pattern of reduced regulations. CMS’s support of “alternative QC” based on manufacturer’s risk assessment is another step in that direction. While we hear a lot about the need to review the regulatory process for financial institutions, there is no evidence that anyone understands that the same may be true for laboratories. Lax regulation of quality by CLIA may be turning our testing sub-prime.

I have a high respect for manufacturers' efforts to improve measurement technology, but there is always a need for independent review and assessment of that technology and its performance in routine applications. We rely on the FDA to approve new methods and analytic systems, but remember that the FDA works on the principle of “truth in labeling." The FDA primarily checks that the manufacturer has data to support the claims that are made, not that performance is acceptable for the intended clinical applications, which requires define goals for quality. The FDA has begun to advise manufacturers of “waived” testing devices to define a goal for analytical quality and to document its achievement, but that approach has not yet been applied to the 510k process for approval of “non-waived” tests. Let’s hope that they move in that direction soon.

Analytical quality will become more critical as programs for “Pay-for-Performance” (P4P) are implemented. Some of these are already underway and Medicare is taking a step in that direction by implementing P4P incentives for quality improvement. As we saw this year with the wave of "never event" non-payment policies, other healthcare payers willl follow Medicare's lead on this issue. We will see these P4P efforts evolve and expand in the next few years.

On the surface, P4P seems like a reasonable approach, but there is little research that shows it really works! Undoubtedly, laboratory tests will be included as measures of performance because they provide "hard numbers" upon which to judge performance. However, the use of laboratory tests in this way assumes that the test results are comparable from method to method and laboratory to laboratory and over time. Such comparability depends on traceability, i.e., the availability of reference methods and materials to provide a traceable chain between a laboratory method and “trueness.” Furthermore, such comparability in principle (traceability) needs to be monitored and documented by External Quality Assessment and Proficiency Testing surveys. Yet such surveys today show much method to method variation for many laboratory tests. We still have much work to do if laboratory tests are to provide reliable and rugged measures for such applications.

Thus, the need for analytical quality in laboratory tests is becoming more important in this age of evidence-based medicine and the advent of P4P programs. This reliance on quantitative quality for P4P lays bare the assumption that the quality of laboratory testing is adequate for clinical care. Even though most professionals outside the laboratory have little understanding of the actual performance issues, they seem convinced that they can base future payment decisions on those testing results.

I often find myself having to defend the need for analytical quality in today’s patient safety era (with its emphasis on pre-analytic and post-analytic errors). Having been singled out by Clinical Laboratory News as “one of the most outspoken critics of the EQC guidelines…” (CLN, November 2008, Risk Management for Clinical Labs), I’m sure some people are tired of hearing me speak out on this issue. But somebody needs to do it and I find myself having to take on that role given the absence of concern by our professional organizations, which is evidenced by their acceptance, if sometimes only grudging, of EQC and their support for AQC. It will be interesting to see what they have to say about P4P!

Yet there is reason for hope that analytical quality will receive the attention it needs! There’s nothing like putting a price tag on something to increase interest. I believe P4P will bring more attention to the issues related to analytical quality. Also, the CLSI process of developing the risk management guidelines is proceeding slowly, despite the fact that these documents are supposed to be on the “fast-track.” There are still opportunities for CLSI member organizations to review and comment on these guidelines before they become final. Healthcare, in general, will be under the microscope in the next few years and that will also bring to light the issues with quality in laboratory testing.

Ultimately, each of us will have to exert our influence if quality is to be achieved in laboratory testing and in healthcare. We each have different opportunities to do this, different ways of making our voices heard, and one of the most important is taking care of quality in our daily work. Quality in healthcare often happens because individuals make the effort to do the right thing right. Individuals often save the day for quality, in spite of the many difficulties in their daily work. That’s why you are such an important part of the process of achieving quality in healthcare!

The rewarding part of quality for those of us at Westgard QC is your continued interest and support. We know we have a loyal audience that is dedicated to providing quality laboratory services. Our biggest hope for the New Year is that we can continue to work with you and help you in your efforts to improve quality.

From the whole staff (and family) at Westgard QC, Seasons Greetings, Happy New Year, and Thank You for your continued patronage, support, and friendship.

James O. Westgard, PhD, is a professor emeritus 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.