Posted by Sten Westgard, MS
The newly proposed changes in Proficiency Testing (PT) Criteria have made many people uncomfortable. We have received numerous messages worried about the implications, including a little bit of panic. While we provided a very critical review about the long-term impact, let's turn to the short-term future:
First, let's make sure we understand that these are proposed goals. Nothing is final yet. The public comment period ended in April (2019), so we're still waiting to hear from the committees about what will actually become adopted into the regulations. The committee will undoubtedly weigh the submitted public comments and they may possibly make modifications to the criteria.
Second, even if the goals emerge from the public comment period intact, I expect there will still be a phase-in period, so that it may be one or two years before these new goals get their real teeth. You won't have to achieve new analytical quality overnight.
Third, as stated explicitly in the proposed criteria, these new goals are only meant to be used for "PT scoring." If that is indeed all you are worried about, I don't expect that the new criteria will have a major impact to the labs. PT failure rates are low throughout the US, historically they've been in the 1 to 5% range. The CLIA committee performed explicit simulations and wanted to minimize failures to just 1 or 2%. So they are still building goals that 98-99% of current labs with current instruments can pass. So they are not intending to generate a radical change for PT pass rates.
The biggest change will be for Sigma-metrics. Because those are far more demanding of analytical performance. If labs apply these new CLIA goals for their sigma-metrics they will see their numbers drop, and the need for more rules, more controls, and more frequency of running controls, becomes a real possibility.
As our articles noted, the government is trying to dodge responsibility for such things by stating the goals are only for PT scoring. As if PT scoring has nothing to do with clinical care. Of course, that's absurd, but CMS just doesn't want to take responsibility to forcing labs to do more QC effort. They must explicitly calculate the financial impact of their regulations now, and if tightening goals means labs must spend more on QC, that means the regulations are more expensive, which, in the current US political climate, is toxic.
But as goals around the world are tightening, if analytical performance is not good enough, we will indeed need more QC effort and expense. While CLIA goals may only be "catching up" to where other EQA/PT and biological goals are now, this is part of a global trend toward more demanding performance specifications. Ultimately, this is a strong "nudge" to the manufacturer that they need to continue to improve their engineering, as well as motivation to laboratories to select only the best instrumentation.
So, as the Hitchhiker's Guide to the Galaxy states, don't panic. But do bring a towel....
Comment submitted to CLIA PT evaluations regulation committee
https://www.regulations.gov/document?D=CMS-2019-0019-0090
Posted by: Gary Shires | April 30, 2019 at 09:59 AM