The Westgard Rules

What's New: January 2014

Posted by Sten Westgard, MS

The Elephant in the Laboratory

2014 promises a wave of changes to healthcare laboratories in the US and around the world. As cost pressures mount, quality is becoming more important, whether we realize it or not. When we make cuts, lean our workflows, choose the cheapest method, we take for granted that quality isn't being compromised. Are we really sure about that?

Has your Lab made its New New Year's Resolution? Did it involve Quality?

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Quality Goal Update, 2014

We are grateful that the SEQC group has allowed us to publish the 8th update to the biologic variation database. This marks 15 years of evidence-based quality goals.
This update includes changes in specifications for some very common analytes as well as new analytes added to the database for the first time.

• Biologic Variation Database, the 2014 update
• Desirable Specifications for Allowable Total Error

We're also grateful to the RCPA, who alerted us to changes and updates in their own set of Allowable Limits of Performance:

• RCPA Allowable Limits of Performance

 

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ALT Quality: Can any method hit the mark?

Continuing with our series examining quality requirements and goals and the performance of methods, we turn to Alanine Aminotransferase (ALT). We examine the different goals offered and evaluate what current methods are capable of achieving. Interestingly, the Ricos goal in this case is the largest, not the smallest goal

What happens when the evidence-based goal is the largest?
 

FDA to ISO 15197: Not good enough

Posted by Sten Westgard, MS

Here's an interesting quotation from the recent FDA draft guideline on blood glucose meters:

"Sections A-F below indicate the types of device performance information that you should include in a 510(k) submission for a BGMS device. Although many manufacturers design their BGMS validation studies based on the International Standards Organizations document 15197, FDA believes that the criteria set forth in the ISO 15197 standard do not adequately protect patients using BGMS devices in professional settings, and does not recommend using these criteria for BGMS devices." [emphasis added]

Now, note that there is a difference between the ISO 15197 standard for glucose meters that came out in 2003 and the more recent one from 2013, which has tighter guidelines. Is the FDA saying even the most recent guideline isn't good enough?

You don't see that very often.

NY: Glucose Meters Going Off-Label?

Posted by Sten Westgard, MS

Back in 2010, FDA hosted a series of public meetings about problems with glucose meters. 4 years later, we're beginning to see significant repercussions.

The New York State Department of Health has sent a letter to Laboratoy Directors informing them that many common uses of glucose meters will henceforth be considered "off-label":

"To date, FDA has approved (or cleared) glucose meters for the quantitative
measurement of whole blood glucose for use by healthcare professionals or lay users
as an aid in monitoring the effectiveness of a diabetes control program....

"The FDA has reminded clinical laboratory regulatory agencies that “Intended Use” in the
package insert or product manual does not include diagnosis of, or screening for,
diabetes. Other off-label uses of glucose meters include the monitoring of glycemic
control of non-diabetic patients in hospitals; use on critically ill patients; and use in
health fairs and other community events to screen the public for diabetes.

"Laboratories that use glucose meters for purposes or in populations beyond the
Intended Use in the package insert or device manual are considered to be engaging in
off-label use. The Centers for Medicare and Medicaid Services (CMS) have instructed
us that the laboratory must be informed that in the event of such off-label use, the
glucose meter defaults to high complexity and the laboratory must meet the CLIA
requirements for high complexity testing. In New York State, this means that the testing
would require a New York State clinical laboratory permit in the category of Clinical
Chemistry and only personnel licensed by the New York State Education Department
would be eligible to perform the testing. In addition, the laboratory would be required to
fully establish the analytic and clinical performance specifications (i.e. validate) of all
such devices for any change from Intended Use in their patient population. Until such
requirements have been met, the use of glucose meters in health fairs, other community screening events, and/or critical care settings must be discontinued."

If a glucose meter goes "off-label" - it is no longer a waived device, but instead it becomes HIGH COMPLEXITY, which requires many more studies before it can be validated for use.

This is a very big deal, but since NY is one of the few states that has its own regulations, most other labs will be waiting to see what happens with CMS regulations, accreditation guidelines, etc.

One way to look at this: in the four year gap, manufacturers had the opportunity to improve analytical performance of glucose meters, but obviously chose not to. This is the consequence.

Stay tuned, this will be a bumpy ride!

 

2013 Wrap-Up: Westgard Web

Posted by Sten Westgard, MS

Just a few highlights of what happened in 2013:

• more than 500,000 unique visitors
• more than 820,000 visits
• more than 4.3 million pages viewed
• AND NOW MORE THAN 500 ARTICLES AVAILABLE ONLINE.

Those stats don't actually include visits to the course portal, online store, and this blog, which would make the figures even larger.

Thanks to all of you you visit, read, and digest our offerings. We hope to make the website even better for you in 2014.