The Westgard Rules

RCPA ALP Update, 2010

Posted by Sten Westgard, MS

The Royal College of Pathologist of Australasia (RCPA), in association with the Australasian Association of Clinical Biochemists (AACB), have revised the Allowable Limits of Performance (ALP's) for 42 analytes in the Chemical Pathology QAP.The link will take you to the press release explaining the changes.

We have update the list of ALP's on the Westgard website to reflect these changes.

Notably, 21 analytes had tighter quality requirements applied, 8 had looser quality requirements applied, and 13 remained largely the same.

The rationale behind the changes? The previous guidelines had been set somewhat arbitrarily around 30 years ago. The new numbers reflect an approach that is closer to the allowable errors derived from known within-subject biologic variation (aka the Ricos et al biodatabase).

It's nice to see that organizations are updating their quality requirements to take into account new information and science. Even better to see that the requirements are moving in the direction of evidence-based goals, rather than goals set by committees or surveys.

It takes a good deal of courage to change one of these goals. We have heard for several years that a group in the US is supposed to be considering an update of the CLIA goals for proficiency testing. However, nothing has changed here. When the probability is that most goals will get tighter, it's easy to assume that neither labs nor manufacturers are keen to see changes.

New Course: Risk Analysis Guidelines

Posted by Sten Westgard, MS

Risk Analysis Guidelines
Westgard QC is proud to announce the launch of a new course in Risk Analysis and Management for Medical Laboratories. (Register now and get discounted enrollment!)

 

Risk Analysis Guidelines provides an introduction and overview of the guidelines and standards that govern Risk Management practices in the laboratory.

Risk Management is coming to the medical laboratory. CLSI guidelines and ISO standards strongly advocate that medical laboratories implement Risk Management as a way to assure quality in testing processes. While Risk Management is  commonplace in other fields, it is new to the medical laboratory, particularly in the US.

This online course will introduce participants to the CLSI guidelines EP18, EP22, and EP23, which provide a general framework for Risk Management in the laboratory, for both manufacturer and customer. The ISO standards 22367, 14971, and 15189 will also be introduced. As ISO accreditation becomes more dominant worldwide and grows in popularity in the US, the ISO requirements for the use of Risk Management are increasingly important.

While this course discusses aspects of CLSI guidelines and ISO standards, the focus is on the actual Risk Analysis Tools themselves - the practical techniques that laboratories can put to use to improve their quality systems:

• FMEA (Failure Mode Effects Analysis)
• Criticality, Hazard scores, and Risk Matrices
• Process Flowcharts
• Sigma-metric QC Decision charts
• Quality Control Plans

For a limited time, you can register for this online course at a discount.

Visit the Risk Guidelines course homepage for more details.

[Please Note: this course does not include copies of the CLSI guidelines or ISO standards. Participants who wish to purchase these documents, are encouraged to purchase the relevant guidelines and standards through the respective organizations. For those who do not purchase the documents or standards, this online course provides an overview and introduction to those documents. Participants may be able to use this course to decide which documents apply to their specific situation and make informed purchasing decisions.]

Biodatabase update alert, 2010

From Dr. Carmen Ricos, on behalf o the SEQC-Analytical Quality Commission:

"Table of Quality specifications 13-09-2010

"Because of a requirement from various readers, data for Thyroglobulin have been revised together with one author of the two papers compiled. In this way, it has been seen that both papers used different units to express the within and between -subject coefficients of variation (CV_I y CV_G, respectively) , the fact that had not been realized when preparing our quality specifications table.  Now, once all data are expressed in percentages, the values are: CV_I= 14%, CV_G=39% and consequently, the specifications are: imprecision (CV%)= 7.0, bias (SE%)= 10.4  and total error (TE%) = 21.9.

"We want to express our thanks to the readers for their help, as well as to apologize for the disturbances this error could have caused. Please, take the present revision of the Specifications table for further uses.

"Sincerely yours,

"SEQC- Analytical Quality Commission"

The biodatabase on Westgard Web has been updated to reflect this correction.

[A hat tip to the alert Westgard Web reader who saw the original entry and insistently asked a question - which prompted the Ricos group to double-check and ultimately correct an error. ]

Best Practices Update 2010

Posted by Sten Westgard, MS

Do you recall a few years ago there were reports that came out assessing the state of Proficiency Testing (PT) as well as a 2007 National Status Report on Laboratory Medicine? Well, that same group - The CDC Laboratory Medicine Best Practices Team - has been hard at work, and just released some new findings on Patient Specimen Identification, Critical Value Reporting, and Blood Culture Contamination.

Getting a better grip on Glucose Meter Quality

Sten Westgard, MS

Is it time for a tighter quality requirement for glucose meters?

Fresh on the heels of Dr. George Klee's review of setting performance specifications, as well as the recent FDA public meeting on glucose meter quality, Dr. Klee and Dr. Brad Karon of the Mayo Clinic and Dr. James C. Boyd of the University of Virginia recently published a study that used simulation modeling to determine performance criteria for glucose meters:

"Glucose Meter Performance Criteria for Tight Glycemic Control Estimated by Simulation Modeling", Brad S Karon, James C. Boy, and George G. Klee, Clinical Chemistry 56:7; 1091-1097 (2010)

Wanted: a few lab software testers

Posted by Sten Westgard, MS

Westgard QC is looking for a few good software testers.

This isn't a free software offer. This is something where we need your evaluation, your feedback, and some of your time. In exchange, you'll get a copy of the software in question without charge. We're looking to find some labs where there isn't a Levey-Jennings charting and/or Method Validation software package already available on the instrument, LIS, or middleware.

English fluency is an important factor - we need you to be able to easily express your reactions, your experiences with the software, your suggestions, etc. in written English comments.

Note: this testing is not for QC Design software. Our EZ Rules software is in a stable state and no upgrades are in the air. This testing opportunity is about software for other tasks, like charting and method validation.

If you're interested, please contact us at [email protected] by telling us about yourself and your laboratory.

A Pet Peeve about Precision

Posted by Sten Westgard, MS

Attending the AACC/ASCLS convention predictably results in one frustration. Walking through the poster sections, you find that many of the method validation abstracts are only performing within-run precision studies.

What's so bad about that?

Repeat after me: it's not about the repeatability...