Diabetes mellitus: metas Six Sigma para el control de calidad analítico.

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Bibliographic Details
Title:	Diabetes mellitus: metas Six Sigma para el control de calidad analítico.
Authors:	Terrés-Speziale, Arturo M.¹ aterres@qualitat.cc
Source:	Revista Mexicana de Patologia Clinica. ene-mar2008, Vol. 55 Issue 1, p3-16. 14p. 1 Color Photograph, 2 Diagrams, 5 Charts.
Subjects:	DIABETES, MEDICAL quality control, PUBLIC health, ECONOMIC impact, MEDICAL care costs, SIX Sigma
Geographic Terms:	MEXICO
Abstract (English):	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. [ABSTRACT FROM AUTHOR]
Abstract (Spanish):	Antecedentes: En México, la diabetes mellitus (DM) representa un serio problema de salud pública, ya que en la actualidad es la primera causa de muerte en la población general donde se calcula que hay más de cuatro millones de pacientes, de los cuales un millón aún no ha sido diagnosticado. Este padecimiento tiene un elevado impacto económico que debe ser considerado desde el primer nivel de atención, a través de un diagnóstico confiable y oportuno, para lograr la contención de los costos inherentes al segundo y tercer niveles. El diagnóstico oportuno, basado en evidencias, es la piedra angular del manejo efectivo y eficaz de las enfermedades, dentro del cual el laboratorio clínico juega un rol fundamental. Se calcula que en los países desarrollados más de 80% de las decisiones médicas se toman sobre la base de las pruebas de laboratorio con un costo de menos de 30% y que esta tendencia se sigue incrementando. Con base en estas recomendaciones, organismos nacionales generan Normas Oficiales Mexicanas como por ejemplo la Norma Oficial Mexicana NOM-015-SSA2-1994 "Para la Prevención, Tratamiento y Control de la Diabetes Mellitus", las cuales deben ser revisadas y actualizadas periódicamente. Objetivo: Establecer metas para el control de calidad analítico de las pruebas de laboratorio que se emplean en el diagnóstico y control de la DM desde la perspectiva de la Norma ISO15189:2003. "Requisitos Particulares para la Calidad y la Competencia de los Laboratorios Clínicos" en la que se enfatiza la importancia de la trazabilidad para los métodos de referencia, además de la medición de la variabilidad biológica y analítica para alcanzar la relevancia médica. Métodos: Se revisan los fundamentos y conceptos básicos de trazabilidad al método de referencia, medición de la variabilidad biológica grupal e individual de cada prueba conforme a los criterios de Tonks y Aspen, respectivamente, los cuales son utilizados para establecer metas analíticas hasta el nivel Six Sigma en cada uno de los mesurandos. Resultados: Se presentan cuadros sinópticos con metas analíticas para las pruebas en sangre, suero y orina utilizadas con mayor frecuencia en el diagnóstico y control de la DM. La información es presentada, destacando la importancia de documentar la trazabilidad y validación para reducir la incertidumbre analítica y aumentar la relevancia médica, de manera que además de ser útiles para los clínicos también pueda ser utilizada en el desarrollo, selección y adquisición de sistemas de laboratorio. Discusión: El punto clave para lograr el control confiable y oportuno de la DM se encuentra precisamente en el Laboratorio Clínico donde es clara la necesidad de contar con metas analíticas para el control de calidad que estén basadas en la variabilidad biológica, ya que la relevancia médica de los resultados depende no sólo de un buen control de calidad analítico, sino sobre todo de la buena selección de la tecnología y de métodos diagnósticos capaces de alcanzar las metas analíticas hasta el nivel Six Sigma. Establecer metas analíticas alcanzables y retadoras es el primer paso en cualquier sistema de control; es importante reconocer que las metas no sólo son útiles desde el punto de vista clínico, sino que también pueden ser utilizadas como herramientas de trabajo por los laboratorios de investigación, la industria y las autoridades del sector salud, para reducir el nivel de incertidumbre en el desarrollo, selección y adquisición de métodos diagnósticos, respectivamente. [ABSTRACT FROM AUTHOR]
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Database:	MedicLatina

Description
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. [ABSTRACT FROM AUTHOR]
ISSN:	01856014