Tools, Technologies and Training for Healthcare Laboratories

Quality Requirements

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. Therefore, we will only summarize the contents of the DRAFT. So this is not the real document anymore.

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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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Desirable Biological Variation Database specifications

Updated for 2014! Desirable Specifications for imprecision, inaccuracy, and total allowable error,  calculated from data on within-subject and between-subject biologic variation. This database is updated and compiled by Dr. Carmen Ricos and colleagues. We are honored to be able to host this database.

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Rilibak - German Guidelines for Quality

An unofficial English translation of the RiliBÄK (Richtlinien der Bundesärztekammer). The term ‘RiliBÄK’ is an abbreviation meaning literally the Guidelines ("Rili") of the German Federal Medical Council (BÄK).

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Biological Variation in Patients with Disease

Dr. Carmen Ricos and her colleagues have generously allowed us to post a new database on Biologic Variation within subjects with disease. The previous databases have relied on data from healthy patients. See how the variation changes when you examine patients with different disease states.

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Clinical Quality Requirements

This table contains information on Clinical quality requirement that describe medically important changes in test values, or Decision Intervals (Dint) expressed as a percentage change at a certain Decision Level (Dint = change divided by decision level multiplied by 100 to give a percentage). The sources of the decision intervals presented here are the paper by Skendzel, Barnett, and Platt and a series of recommendations for lipid tests from the National Cholesterol Education Program (NCEP).

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European Biologic Goals

In the early 1990s, a group of European scientists fromed to recommend the best targets for imprecision, inaccuracy, and total error (calculated from biologic variation). This became called the "European Biologic Goals and Calculated Biologic Allowable Total Errors." While later eclipsed by the work of Dr. Carmen Ricos et al (the biodatabase desirable specifications), these quality requirements remain an important resource.

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