Tools, Technologies and Training for Healthcare Laboratories

Quality Requirements

French EQA performance specifications

One of the leading EQA programs of France is ProBioQual. They have their own set of EQA acceptance limits, which include some copied from the "Ricos goals" but most of them set through analysis of their own participant performance. How do these specifications compare to CLIA and Ricos TEa?

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Final Milan Hierarchy

On November 24th and 25th of 2014, the first EFLM Strategic Conference on 'Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory Medicine' was held. The conference organizers released the official restructured hierarchy in 2015. 

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Milan 2014 Consensus Draft on Quality Specifications

On November 24th and 25th of 2014, the first EFLM Strategic Conference on 'Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory Medicine' was held. On November 24th, at the end of the first day, a DRAFT consensus was handed out (the DRAFT had in fact been written before the meeting was held). However, the conference organizers later requested that this DRAFT not be shared with the public. Here is only a summary of the contents of the DRAFT. The official final Milan Mandate is available, so this document is only useful to comparative purposes now.

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Minimum Specifications from Biological Variation database

When the best isn't possible, How low can you go? The Biologic Variation database, compiled by the Spanish CC society and Dr. Carmen Ricos, not only includes desirable and optimal specifications for imprecision, bias and total error, but also minimum specifications. For labs unable to achieve the recommended level of quality, here at least is the floor on performance. Updated for 2014.

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Optimal Biological Variation database specifications

How good can you get? The Biologic Variation database, compiled by the Spanish CC society and Dr. Carmen Ricos, not only includes desriable specifications for imprecision, bias and total error, but also optimal specifications. For labs in search of "stretch" goals, here's the place to start. Updated for 2014

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CLIA Requirements for Analytical Quality

The tables below contain information on CLIA proficiency testing criteria for acceptable analytical performance, as printed in the Federal Register February 28, 1992;57(40):7002-186. These guidelines for acceptable performance can be used as Analytical Quality Requirements in the Westgard QC Design and Planning process.

 

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