Posted by Sten Westgard, MS
As we noted earlier, the big news from Houston was that CMS will soon be issuing it's IQCP implementation regulations.
In advance of that release, Bio-Rad has issued a White Paper : Looking Ahead to Patient Risk Management.
So, how many controls does Bio-Rad want you to run? More after the jump...
Bio-Rad recommends making a Six Sigma Risk Assessment of the assay, and depending on the result, adapting the QC being run to the Sigma-metric of the test. Here's a simplification of their white paper recommendation:
- For methods above Six Sigma: one QC per day
- For methods between Four and Six Sigma: 2 QC per day
- For methods between Three and Four Sigma: 4 QC per day
- For methods below Three Sigma: "Maximum QC" 9 QC per day and consider running patients in duplicate.
Obviously, there's a big difference between how much QC is recommended for a world class assay and what isrecommended for a poor performing assay. Your control needs may increase 9-fold if you've got bad assays in your laboratory!
It's a bold move by Bio-Rad to release this white paper in advance of the official regulatory announcement. Also courageous that they aren't shy about advising labs to run more controls, possibly a lot more controls, on their poor performing assays.
And notice, nowhere in this recommendation is the advice to reduce QC to once a week or once a month. Now that the EQC protocols, which drastically (and without scientific basis) reduced QC frequency, are going to be terminated, Bio-Rad is taking a leadership position in telling labs to return to a more rational frequency of runnning controls.
When we published Six Sigma Risk Analysis back in 2011, we weren't sure if any company was going to be willing to embrace the concepts of Six Sigma and Risk Analysis and the implications of that data-driven approach. It's very encouraging to see a company like Bio-Rad take that step.
[Late Update: We may have over-interpreted the Bio-Rad White paper. Below follows an official response from Bio-Rad about its intentions for the White Paper and IQCP]
On behalf of Bio-Rad Laboratories,
thank you for the coverage of our white paper, "Looking Ahead to Patient
Risk Management," (Aug 15, 2013). The paper was developed to
address some of the questions that we had been hearing from customers and
in workshops on this topic. We sought to provide not an opinion paper
but rather, an overview of guidelines, standards, and thought leader opinions.
I would like to clarify three points
in your post.
1. You
are correct that the white paper does not contain a recommendation for
reducing QC to once per week or month. Bio-Rad does not officially
recommend a generic QC number or frequency. Here at the Quality
System Division of Bio-Rad, we believe laboratories should set QC based
on realistic assessments of instrument performance and test capability.
We support the use of statistical tools to determine the number of QC,
tools such as Sigma-metrics and Westgard Rules. Initial evaluations
show us that appropriately performed risk assessments could be an effective
tool to determine QC frequency.
2. The
ad referencing the white paper was coincidental to the referenced IQCP
update. In fact, the white paper was released about six months ago.
3. The
credit for the QC recommendations in the white paper does not belong to
Bio-Rad but to a number of laboratory professionals. The white paper
references recommendations from a 2011 CCLM article, “Collective opinion
paper on findings of the 2010 convocation of experts on laboratory quality”,
Clinical Chemistry and Laboratory Medicine. 2011; 49(5):793-802.
Thank you again for raising awareness
for the white paper. We enjoy reading your blog and find the website to
be an excellent resource on laboratory quality. It’s an honor to be mentioned
on your pages.
Andy Quintenz
Scientific & Professional Affairs
Manager
Bio-Rad Laboratories
Quality Systems Division"
Instead of an increase of 9% in control needs a decrease is more probable. Applying TEa and six sigma in a well designed quality control system may save a lot of money, as demonsttated in my guest essay http://www.westgard.com/saving-with-six-sigma.htm.
Posted by: Hans van Schaik | August 23, 2013 at 08:35 AM