Integration of data derived from biological variation into the quality management system.
BACKGROUND
[corrected] Data on within- and between-subject biological variation are available for around 250 analytes commonly used in medical laboratories.


METHODS
Integration of this data into the quality system occurs at all three levels of laboratory activity: (a) Preanalytic process: biological variation provides the basis for selecting the most appropriate specimen for analysis, for defining sample stability and for deciding suitable timing between samplings; (b) analytic process: biological variation-derived goals are fundamental for designing internal quality control procedures, and for evaluating laboratory performance; and (c) postanalytic process: delta checks based on within-subject biological variation values are used for validating results and for interpreting serial results from a patient.


CONCLUSIONS
The biological variation is a pillar for managing quality in laboratory medicine.
Ricós
Carmen
C
Analytical Quality Commission, Spanish Society of Clinical Biochemistry And Molecular Pathology, Spain. cricos@hg.vhebron.es
Alvarez
Virtudes
V
Cava
Fernando
F
García-Lario
José Vicene
JV
Hernández
Amparo
A
Jiménez
Carlos Víctor
CV
Minchinela
Joana
J
Perich
Carmen
C
Simón
Margarita
M
D001774:Blood Chemical Analysis; D002984:Clinical Laboratory Information Systems / Q000592:standards*; D019411:Clinical Laboratory Techniques / Q000592:standards*; D003625:Data Collection / Q000592:standards*; D006801:Humans; D007755:Laboratories, Hospital; D013677:Medical Laboratory Science; D011786:Quality Control; D015203:Reproducibility of Results; D013048:Specimen Handling; D013597:Systems Analysis