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ISSN 0185-6014 (Print)
Órgano oficial de difusión de la Federación Mexicana de Patología Clínica, AC y de la Asociación Latinoamericana de Patología Clínica/Medicina de Laboratorio

2008, Number 1

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Rev Mex Patol Clin Med Lab 2008; 55 (1)

Diabetes mellitus: Six Sigma goals for the analytic control

Terrés-Speziale AM

Language: Spanish
References: 72
Page: 3-16
PDF size: 177.87 Kb.


ABSTRACT

Background: Diabetes Mellitus (DM) is the major public health problem in Mexico where it represents the main death cause on general population. In our country it is estimated that there are more than 4 million patients including a million that have not been diagnosed yet. This condition has a great economical impact that must be attended immediately from the first level of medical attention through reliable and early diagnosis in order to contain the high costs of second and third levels of medical attention. Early diagnosis, based on solid laboratory evidence, is the milestone of effective management and control of disease. It has been estimated that in developed countries more than 80% of medical decisions are being taken on laboratory data while the trend is still improving. Based on these recommendations, National Standards such as NOM-015-SSA2-1994 “For DM Prevention, Treatment and Control” have been established, reviewed and updated periodically. Purpose: To set analytical goals for quality control on the most frequently used laboratory tests that are in use for the Diagnosis, Management and Control of Diabetes Mellitus from the ISO15189:2003 Standard Perspective “Particular Requisites for Medical Laboratories Competence” where traceability to reference methods, uncertainty, biological and analytical variation estimation are emphasized in order to achieve medical relevance. Methods: This is an assessment and discussion of the basic concepts and fundaments of traceability to reference method; and of uncertainty measurement of biological and analytical variation of lab tests in order to estimate group and individual biological variation according to Tonks and Aspen criteria, which are the basis on which Six Sigma analytical goals are set for each measurand. Outcome: On this paper analytical goals for blood, serum and urine lab tests for diagnosis, management and control of DM are presented. Data are offered on table format emphasizing the importance of traceability and validation documentation in order to reduce uncertainty, and to improve medical relevance. In order to be useful not only on medical decisions but also on the proper development, selection and acquisition of Laboratory Systems. Discussion: The key to achieve reliable and opportune DM control is precisely dependent on Clinical Laboratory availability where the need to have analytical goals is clear. If medical relevance is to be accomplished, these goals must be established on the biological variation perspective and not only on technological performance. Proper Laboratory Systems selection depends on adequate understanding of Six Sigma concept. The first step on any quality control system is the setting of proper and challenging goals. The importance of these goals relies not only on good clinical practice but also as a working tool for research labs, industry and public health authorities in order to reduce uncertainty on the development, selection and acquisition of Clinical Diagnosis Laboratory Systems.


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