Terrés SAM

Language: Spanish
References: 34
Page: 3-15
PDF size: 563.49 Kb.

ABSTRACT

Background: According to the Mexican National Standard 166 Clinical Laboratories must be directed by a sanitary responsible who shall: 1) Ensure that the laboratory has established an internal quality control program, 2) participates on at least one proficiency program, 3) approves the evaluation of each test included, 4) develops research in order to solve any detected problem of not approved tests. Traditionally quality programs do not integrate Internal and External Quality Control as whole, and do not consider biological variation or medical relevance as part of the evaluation. Objective: To document the basis on which a reengineering exercise was developed in order to generate an integral quality control program capable to: Integrate internal and external process on real time; measure analytical and biological variations as parameters of medical relevance; afford a better interlaboratory comparison; solid and opportune decision making; Non conformity management and finally; achieve a significant cost-reduction in terms of time, money and effort. Method: In order to radically redesign the system, this exercise was initiated through a situational analysis to understand strength and weakness of existing programs, a strategic planning of a prototype was followed where basic fundaments and statistic formulas were applied over commonly available technological platforms. Results: QC-Process® an automated quality interlaboratories control program that operates on internet through www.qualitat.com.mx was developed. This system includes items from the pre-analytical stage including parameterization of each analyte according to methodology and analyzers, reference limits management to calculate biological variation and respective relation to analytical variation with Tonks and Aspen formulas. A friendly capture is achieved for three control levels of up to 95 analytes of four different lab departments. Westgard multi rules and Levey Jennings graphics are automatically applied. Resulting data are summarized on specific formats which are shared from internal to external quality comparisons which are processed and updated weekly at the WebSite. For the post-analytical stage a specific format is used to manage non-conformities. Discussion: ISO Laboratory Standards have evolved toward Standard 15189, where medical relevance and data comparability are two of the main concerns. Medical quality has been defined as providing the patient the maximum benefit with the lowest risk and cost. This means from the laboratory perspective the ability to generate defendable and unquestionable results. According to Hammer & Champy, Reengineering is the fundamental revision of structures and process to radically redesign a system in order to achieve spectacular improvements on quality, service, opportunity and costs. This in sum implies the transformation of industrial systems with the utilization of technological resources.

REFERENCES

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29. Terrés SAM, González SR, Alba S, Mejía DR et al. Armonización de los programas de evaluación externa de la calidad rumbo a la certificación de la NOM-166 Resumen del simposium celebrado en el XXIII Congreso Mexicano de Patología Clínica en la ciudad de Veracruz el 1 de noviembre de 2003. Rev Mex Patol Clin 2004; 51 (1): 30-32.

30. Terrés SAM, Alcántara Gómez LE. Glicemia. Límites de referencia biocronológicos y niveles de decisión clínica. Rev Mex Patol Clin 1999; 46: 133-143.

31. Terrés SAM, Razo Morales D. Fórmula roja: Límites de referencia biocronológicos y niveles de decisión clínica. Rev Med IMSS 2000; 38 (4): 313–321.

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

33. Terrés SAM. 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.

34. Terrés SAM, Martínez Miranda E. Cronobiología: Niveles hormonales en mujeres mexicanas. Rev Med IMSS 2000; 37 (5): 341–348.