medigraphic.com
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

2006, Number 4

<< Back Next >>

Rev Mex Patol Clin Med Lab 2006; 53 (4)

Estimation of uncertainty and total variability at the clinical laboratory

Terrés-Speziale AM

Language: Spanish
References: 32
Page: 185-196
PDF size: 125.14 Kb.


ABSTRACT

Background: ISO 15189 «Quality Management in the Medical Laboratory» has been developed for clinical laboratories evaluation, quality improvement and accreditation. This standard involves analytical process completely, from pre to post examination stage, giving importance to biological and analytical variability in addition to methodological traceability, test validation and the measurement of uncertainty and medical relevance.
Objective: To clearly and briefly review and document uncertainty biostatistical principles that are applicable to the clinical laboratory including standard error, relative coefficient of variation, standard deviation index and total error as fundamental indicators of quality control.
Material and methods: This is a review article of the scientific literature in which definitions, formulas and practical exercises on uncertainty indicators and total variability in analytical control of quality are documented.
Results: It is clearly demonstrated that the utility of laboratory tests depend on multiple factors, which must be known, supervised and controlled as far as possible through analytical process.
Discussion: The utility of these concepts depends on the routine application of quality indicators, which at the present time is highly feasible, since personal computers are already common tools in almost every clinical laboratory worldwide. Daily estimation of these formulas is actually quite simple leading to a dramatic positive impact on quality improvement of laboratory data when knowledge can be applied in order to control uncertainty.


REFERENCES

  1. ISO/TC 212/WG 1 N41. Diciembre 1998. Organización Internacional de Estandarización ISO/TC 212/WG 1, Manejo de Calidad en el Laboratorio Médico.

  2. Kaplan LA. Determination and application of desirable analytical performance goals: The ISO/TC 212 approach. Scand J Clin Lab Invest 1999; 59: 479-482.

  3. IFCC-WASPaLM. Acreditación de Laboratorio Clínico: Declaración de Política. Rev Mex Patol Clin 2006; 53(3): 174-177

  4. Terrés-Speziale AM. Importancia de la Variabilidad Biológica y de la Relevancia Médica en ISO 15189. Rev Mex Patol Clin 2003; 50: 3.

  5. Castillo SML, Fonseca YME et al. Criterios de desempeño, control y evaluación. En: Mejoría Continua de la Calidad. Guía para los laboratorios clínicos de América Latina. México: Médica Panamericana, 1995: 53-85.

  6. Terrés-Speziale AM. Utilidad de los estudios de laboratorio en el individuo supuestamente sano. Rev Mex Pat Clin 1987; 32: 2.

  7. Terrés-Speziale AM et al. Importancia de los criterios analíticos en el control de calidad. Rev Mex Pat Clin 1985; 32: 3.

  8. Barnett RN. Clinical laboratory statistics. Boston: Little Brown, 1971.

  9. Whitehead TP. Quality control in clinical chemistry. NY: John Willey and Sons, 1977: 135.

  10. 10 Petersen PH, Fraser CG, Kallner A, Kenny D. Strategies to set global analytical quality specifications in laboratory medicine. Scand J Clin Lab Invest 1999; 59: 7.

  11. Westgard JO. The need for a system of quality standards for modern quality management. Scand J Clin Lab Invest 1999; 59: 483-486.

  12. Ricos C, Álvarez F, Cava F et al. Current databases on biological variation: Pros, cons and progress. Scand J Clin Lab Invest 1999; 59: 491-500.

  13. Heuck C, Nageh EL. Quality specifications of clinical laboratory procedures: Developing country needs. Scand J Clin Lab Invest 1999; 59: 559-562.

  14. Winkel P, Statland BE. Interpreting laboratory results: Reference values and decision making. In: Bernard HJ. Clinical diagnosis & management by laboratory methods. 18th ed. Philadelphia: WB Saunders, 1991.

  15. IFCC Expert Panel on Theory of Reference Values. Part 1. The concept of reference values. Clin Chem 1979; 25: 1506.

  16. IFCC Expert Panel on Theory of Reference Values. Part 5. Statistical treatment of collected reference values. Determination of reference limits. J Clin Chem Clin Biochem 1982; 20: 841.

  17. IFCC Expert Panel on Theory of Reference Values. Part 6. Presentation of observed values related to reference values. J Clin Chem Clin Biochem 1983; 21: 749.

  18. Statland BE. Clinical decision levels for laboratory tests. NJ: Medical Economic Books, 1983.

  19. Dean W. Biological aging measurement. Geronto Geriatrics 1998; 1: 64-85.

  20. Terrés-Speziale AM. Influencia de la edad en los valores de referencia del antígeno específico de la próstata en población mexicana. Rev Mex Patol Clin 1998; 45: 85-95.

  21. Terrés-Speziale AM, Alcántara GLE. Glicemia. Límites de referencia biocronológicos y niveles de decisión clínica. Rev Mex Patol Clin 1999; 46: 133-143.

  22. Terrés-Speziale AM, Razo MD. Fórmula roja: Límites de referencia biocronológicos y niveles de decisión clínica. Rev Med IMSS 2000; 38(4): 313-321.

  23. Terrés-Speziale AM, Martínez ME. Cronobiología: Niveles hormonales en mujeres mexicanas. Rev Med IMSS 2000 ; 37 (5): 341–348.

  24. Terrés-Speziale AM. Marcadores biológicos de envejecimiento. Rev Mex Patol Clin 2000; 47 (2): 119-120.

  25. Terrés-Speziale AM. Lípidos: Aplicación de niveles de decisión clínica. Cronobiología en México. Rev Med IMSS 2001; 39 (2): 97-104.

  26. Terrés-Speziale AM. Marcadores biológicos de envejecimiento en el hombre mexicano. Rev Med IMSS 2001; 39 (3): 199–206.

  27. Terrés-Speziale AM. Implications of informatics on health problems in Mexico. Baylor Univ Med Cent Proceedings 1989; 2: 2.

  28. Terrés-Speziale AM. Impacto de la patología clínica y de la biología molecular en el futuro de la medicina. Rev Med IMSS 1998; 36: 341-343.

  29. Terrés-Speziale AM. Medicina del tercer milenio. Rev Med IMSS 1998; 36: 245-252.

  30. Terrés-Speziale AM. Humanismo en el tercer milenio. Rev Med IMSS 2001; 38: 405-415.

  31. Terrés-Speziale AM. Reingeniería de los Programas de Calidad. Rev Mex Patol Clin 2006; 53(1): 3-15

  32. Terrés-Speziale AM. Requisitos para proveedores de esquemas de evaluación externa de la calidad. Rev Mex Patol Clin 2006; 53(1): 3-15




2020     |     www.medigraphic.com