Posted by Sten Westgard, MS [with apologies in advance*]
Take the "Low QC" Quiz to see if your laboratory is suffering from this new condition...
- Do you have a decrease in your desire to QC?
- Do you have a general lack of energy at work caused by QC?
- Have you noticed a decrease in your enjoyment of life, possibly due to QC?
- Are you sad and/or grumpy about QC?
- Has there been a recent deterioration in your ability to trouble-shoot QC?
Answers, after the jump...
If you’ve answered yes to 1 to 3 of these questions, you may be suffering from “Low QC”
“Low QC” is a condition where laboratories feel low about their QC practices. Labs may report a general lack of desire to run QC, even when it’s appropriate. Labs may also have less energy and less staff to run QC. Labs may also report seeing changes in the skills of their employees, who may not understand how to perform QC. Often, these symptoms are accompanied by an overall frustration and confusion about QC. Many labs experience QC dysfunction, an inability to properly interpret QC or trouble-shoot correctly.
The more you know, the easier it is to see that Low QC is a real, treatable condition that affects thousands of labs.
Talk to your medical director about Low QC.
There may be a new treatment plan for your laboratory.
One new solution for “Low QC” is the new IQCP. Called “Individualized Quality Control Plan”, this new approach, prescribed by CMS and CLSI, involves an injection of risk analysis into the quality management system. Through IQCP, laboratories can analyze their risks, determine their stability, and implement new QC procedures. It’s possible that some labs may be able to reduce their QC to just once a week or once a month.
Application of IQCP is simple. Or at least CMS hopes it might be. As of now, CMS has not released any concrete details of how to perform Risk Analysis and Risk Asssessment and convert that into an evidence-based QC frequency. For now, you’ll just need to accept on faith that this new approach is appropriate for your laboratory.
[The traditional approach, better training and education of the laboratory staff, a balanced QC plan composed of good methods and appropriate controls, can also work to alleviate Low QC, but it’s not the quick-and-easy solution that most laboratories seem to be seeking.]
Side Effects
Caution, IQCP may cause...
- Swollen confidence in the accuracy of test results, which may lead to…
- Increased risk of reporting erroneous results, as well as…
- Dry mouth and nausea at the realization that after one week or one month, any out-of-control QC signal means a lot of clinicians have acted on bad test results, which may lead to even more…
- Severe mood swings over the confusion and frustration caused by switching from EQC to IQCP
Contact your regulatory provider right away if you experience any of the side effects listed above. In some serious cases, you may need to cease your use of Risky QC / IQCP and revert to more statistically defensible methods of QC.
For more details about Risk-based QC and IQCP, try to ask your regulatory provider – and if you get any real answers, let us know.
*It's useful to change perspectives once in a while. We recognize that clinicians and patients are susceptible to fads and manias in healthcare, and we in the laboratory are not immune. Outside the US, readers may not be as familiar with the massive marketing push known as "Low T" (low testosterone), which is now getting FDA scrutiny as increased risks of heart attacks are being noted. It's called "disease mongering" in the pharmaceutical world. I'm not sure what we might call it here. Forcing the wrong solution on the right problem, or providing a weak implementation, is one of the big risks in our new Risk QC future.
We don't want to diminish the effort and dedication of the individuals who spent years guiding EP23 to publication. A lot of people worked very hard and expended substantial effort to bring EP23 to fruition. We do not mean to mock them. In the end, however, the heroism of individuals in this process has not been enough to overcome an overall market weakness. When the goal is to reduce QC frequency by any means or justification, however flawed, poor regulations and guidelines will result. We wish the participants of EP23 and regulators of IQCP well and look forward to the emergence of an improved and more scientific policy in the future.
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