ISO

The 2015 Global Measurement Uncertainty generated dramatically different comments from US laboratories. Whereas ISO 15189 and measurement uncertainty is at least commonly known in the rest of the world, for many labs in the US, this survey was one of the first times they heard about the concept.

MU Survey 2015: US Labs Talk About Measurement Uncertainty

Edited by Sten Westgard, MS
November 2015

In the Fall of 2015, we conducted a survey to gather the views of laboratories around the globe on measurement uncertainty. As is always true for Westgard Surveys, we end the survey by giving every participant an opportunity to speak freely, to add additional comments, questions, compliants and more. Often these responses reveal far more about the state of the laboatory than the simple survey questions do.

Here, then, are the comments from 30 US respondents to the survey. These comments have been edited for clarity (I have corrected spellings and grammar where I thought I could discern the intent of the writer). I have also organized them into arbitrary categories, trying to group them in an logical fashion rather than simply present them in random order. (I apologize if these categories are harsh.) Note that these are all comments from inside the US; the rest of the comments from outside the US are posted on a different page.

• The "Blissfully Ignorant"
• The Need-Some-Helpers
• The CLIA-compliant
• The O-ACA'd
• A Thoughtful Responder
• A (few) Actual MU-users in America

 The “Blissfully Ignorant”

• I have not heard of MU until now :-(
• Some Clarifications about the topic [are needed]
• I am a chemistry specialist and this is the first time I have heard that term. Had to look it up to see what it meant. Will investigate further to see if this is a tool that will be helpful vs. the time needed to calculate MU.
• How would you go about measuring this, as it probably depends upon analyzer methodology?
• [M]easurement uncertainty. This is the first I have heard of it.
• Read an NIH article on MU as I had not experience or clear understanding of the concept. Thanks for showing me something new!!
• To be honest, this is the first time I have heard of MU. I am certainly willing to learn more.
• We are not familiar with what Measurement Uncertainty is , how to calculate it, why it is necessary
• Not at all familiar with the term, how it is determined, or its clinical value.
• We are not very famil[i]ar with this concept.
• [N]ever heard of measurement uncertainty but I will be looking into it!
• I don't even know our lab is knowledge[e]able about this concept. I've been involved with QC and QA reviews but no one has raised the application of this concept.
• I am a bench tech, and I am certain that this issue is addressed somewhere in the background by management.
• The medical staff is clueless on MU. They think the numbers we generate are actual, not part of a range of MU. [T]hey think a change in HCT of 0.5 is significant.
• I had to read up on MU on another published article of Westgard QC since I was unsure what this was referring to. Have been a tech for 43 years and am amazed at some of the 'ideas' that have come about and more importantly, why.
• Honestly, I have not heard of much about measurement Uncertainty. I do wish the "ISO" culture was more recognized in the hospital labs. I would like to learn more about it, Sigma, and the neat factions that Dr Westgard expands upon, but finding time to read a book and figure it out is daunting. I know there are conferences that may help, but until the materials are basically free and/or mandatory, it will be hard to break into this way of thinking. Especially for the many techs that have done it the original Westgard way for 20-30 years. Thanks and I hope to see more!

The Need-Some-Helpers

• I would need more education on the practical use of MU in the clinical laboratory setting to determine and implement it.
• Need to develop education materials on this topic, mainly compare and contrast to total error, to accuracy.
• I would like some more information regarding [mu]
• My CLS staff of 67 needs education. We don't know any labs that are using it.
• It appears to be useful and to adopt it would require additional education including the Medical Director.
• Would like more information about measurement uncertainty use.

The CLIA-Compliant

• In the US if it’s not on the CAP checklist, it is not performed.
• Regulations don't [e]nforce [this]
• We are still trying to deal with IQCP, are you kidding??

The O-ACA’d (Overwhelmed by the Affordable Care Act)

• Low staffing volumes have hindered adding processes in the laboratory.
• Frankly, I don't have time for one more project when what I have works fine.

A Thoughtful Responder

• There are relatively few tests for which MU is truly relevant. In most tests pre- analytic and natural biological variation are far greater determinants of result variation than MU. Nevertheless, clinician awareness of MU is not where it should be, there is work to do

A (Few) Actual MU Users in America

• I have seen laboratories, up to 5, average their uncertainty measurements together and then apply that single measurement to all five laboratories which then does not apply to any specific laboratory of the group.
• We estimate measurement of uncertainty for our environmental labs because it is a requirement of NELAC however it is not used practically, and our providers know less about this than we do so there is no motivation from the providers’ side to use this clinically.
• Initial measurement uncertainty was built using CLSI-51A for blood alcohol testing only (reported upon request). If any other analyte MU was requested we built MU on the fly. While pursuing ASCLD-LAB Tox ISO 17025 accreditation an extensive program according to these standards, which now includes all DUI blood alcohol and DUI drug analyses. We do not determine or report MU for clinical testing, only drug analysis. CAP ISO 15189 auditors recently reviewed our MU process and accepted our approach.
• I use MU in the toxicology department where I run a mass spec.