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Home CLIA & Quality Quality Requirements
Quality Requirements (CLIA and others)
Minimum analytical quality requirements PDF Print E-mail

What's the absolute minimum for quality? In 2012, four Spanish EQA providers formed a working group to promote the use of common minimum quality specifications for clinical tests.

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Minimum Specifications from Biological Variation database PDF Print E-mail

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 PDF Print E-mail

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 PDF Print E-mail

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 PDF Print E-mail

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 PDF Print E-mail

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 PDF Print E-mail

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 PDF Print E-mail

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 PDF Print E-mail

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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Biological Variation Database references PDF Print E-mail

Dr. Carmen Ricos and colleagues update this database on within-subject and between-subject biologic variation. From this data, they also calculate desirable specifications for imprecision, inaccuracy, and total allowable error. We are honored to be able to host this database. This article lists the references that were used to develop the specifications. Updated for 2012.

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