Posted by Sten Westgard, MS
Some recent articles on the subject of Quality Indicators have reminded me that analytical quality is to laboratory management much like the laboratory is to the hospital: over-worked, under-appreciated, and assumed to be of reliably excellent quality.
- Laboratory Medicine Quality Indicators: A Review of the Literature, Shahram Shahangian, PhD, MS, and Susan R. Snyder, PhD, MBA, Am J Clin Pathol 2009;131:418-431
- A Summary of Deliberations on Strategic Planning for Continuous Quality Improvement in Laboratory Medicine, Dana Marie Grzybicki, MD, PhD, Shahram Shahangian, PhD, Anne M. Pollock and Stephen S. Raab, MD. Am J Clin Pathol 2009;131:315-320.
Shahangian and Synder reviewed the latest in laboratory quality indicators. Of these 14 indicators, only 2 are concerned with analysis (everything else is pre- or post- analytical. The two indicators are Proficiency Testing Performance and Gynecologic cytology-biopsy discrepancy. The latter indicator is a very specific testing issue - where the discrepancy between test results is stark. The former indicator, PT performance, is somewhat associated with better analytical results, but it is most strongly correlated with itself. That is, the more you do PT, the better you do at PT.
The problem with PT is that, too often, it measures if you are getting the same answer as everyone else, not whether or not you're getting the correct answer. In other words, are you following the herd, or are you going in the right direction? Sometimes following the herd is enough, but it would be more useful to know if labs are getting the right answers. We've taken our own look at PT testing in the Quality of Laboratory Testing series...
Grzybicki et al further report that, at a 2007 CDC conference, the major decisions were to pursue indicators focusing on "preanalytic and postanalytic processes." One interesting finding is that there is a "pervasive and continuous 'black box' laboratory and pathologist culture." That is, people treat the lab as a black box: something goes in, something comes out, without any understanding of what's inside the process. That seems almost like a tautology: if we believe that there aren't any analytical quality issues, we will treat the lab as a black box. And if the lab is a black box, there are no analytical quality issues.
Dr. Westgard has commented before on Quality Indicators before, and we've even discussed the proliferation of indicators on the blog a few years ago. What's becoming more worrisome now is that these Quality Indicators may become the foundation of future reimbursement, pay for performance (P4P), or other judgments.With health reformers searching for money-saving approaches, anyone without an indicator may find themselves squeezed so that other processes can achieve their required indicator levels.
If analytical laboratory quality doesn't have a seat at the Quality Indicator table, then analytical quality will be off the table when the issue of reimbursement is discussed. It's more proof that we are treating laboratory testing as a commodity, where quality is assumed to adequate and every test result and every instrument and every laboratory is the same. That's fine if you like perpetual cost pressures, ever-decreasing margins, or if you believe that employing migrant workers to run tests is an acceptable future for the laboratory. On the other hand, if you think that quality matters in laboratory testing, you need to advocate for a quality indicator.
If we had to suggest an indicator, we might point toward Sigma-metrics, which are easy to grasp and calculate, but have a deep foundation and can be applied in different ways. But that's not necessarily the only possibility.