Quality Requirements
What's the absolute minimum for quality? In 2015, four Spanish EQA providers updated their earlier consensus goals to expand a common set of minimum performance specifications for tests.
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.
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.
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.
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.
[Please note: by August or October of 2018, the EFLM and SEQC have requested that Westgard.com no longer display this data]
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.
[Please note: by August or October of 2018, the EFLM and SEQC have requested that Westgard.com no longer display this data.]
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. NOTE: This page shows goals that will EXPIRE in July 2024.
The 2014 edition of Desirable Specifications for imprecision, inaccuracy, and total allowable error, calculated from data on within-subject and between-subject biologic variation. This database was updated and compiled by Dr. Carmen Ricos and colleagues, before the EFLM took the helm. As of May 2019, EFLM is managing the new biological variation database. We were honored to host this database for 15 years.
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).
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.