Barboza-Quintana O, Garza-Guajardo R, Méndez-Olvera N, Áncer-Rodríguez J

Language: Spanish
References: 14
Page: 218-225
PDF size: 103.73 Kb.

ABSTRACT

Our environment is becoming more globalized every day, it demands changes at a exponential speed which promotes the necessity of control of our organizations in a different way to the one we have historically made. Moreover, the laboratories of pathology are organizations that could be adapted to models of measurement of quality which gives trust in the capacity of the process, products and they are able to supply the basis of continual improvement. However in Mexico does not exist any official rule or norm to obtain a certification for a laboratory of Anatomic Pathology. Objective: a project was structured with the proposal of testing a quality assurance process for the Anatomic Pathology and Cytopathology Laboratory of the “Hospital Universitario” of the UANL, according with the ISO 9001 - 2000, during the year 2004. Methods: The process of studying, measurement, analysis and improvement were planned and implemented with the main goal of satisfy the needs of our users. Besides this, an internal inspection was held, as a result of this, some required changes were made in order to obtain a final revision from a certified company. Conclusions: We reached the first Certification ISO9001 - 2000 in Latin America for an Anatomic Pathology Laboratory.

REFERENCES

1. Medicare, Medicaid and CLIA programs; regulations implementing the Clinical. Laboratory Improvement Amendments of 1988 (CLIA)-HCFA. Final rule with Comment period. Fed Regist 1992; 57 (40): 7002-7186.

2. Commission on Laboratory Accreditation. Laboratory Accreditation Program Anatomic Pathology and Cytopathology, 2004. College of American Pathologists.

3. Inhorn SL, Shalkham JE, Mueller GB. Quality assurance programs to meet CLIA requirements. Diag Cytopathol 1994; 11 (2): 195-200.

4. Dorsey DB. Evolving concepts of quality in laboratory practice. A historical overview of quality assurance in clinical laboratories. Arch Pathol Lab Med 1989; 113 (12): 1329-1334.

5. Secretaría de Salud. Norma Oficial Mexicana NOM-166-SSA-1-1997, para la Organización y Funcionamiento de los Laboratorios Clínicos. Enero 13, 2000.

6. Kawai T. Accreditation of clinical laboratories based on ISO standards. Rinsho Byori 2004; 52 (11): 900-905.

7. Kubono K. Quality management system in the medical laboratory ISO15189 and laboratory accreditation. Rinsho Byori 2004; 52 (3): 274-288.

8. Aoyagi T. ISO 15189 medical laboratory accreditation. Rinsho Byori 2004; 52 (10): 860-865.

9. Kenny D. ISO and CEN documents on quality in medical laboratories. Clin Chim Acta 2001; 309 (2): 121-125.

10. John Ovretveit. What are the best strategies for ensuring quality in hospitals? The Karolinska Institute Medical Management Centre, Stockholm, November 2003; 1-25.

11. Walton M. The deming management method. A perigee book. New York: Berkley Publishing Group, 1986.

12. ISO.DIS Quality management systems–Requirements. ISO 9000. Geneva: ISO, 2000.

13. Terrés-Speziale AM. Importancia de la variabilidad biológica y de la relevancia médica en la Norma ISO 15189. Rev Mex Patol Clin 2003; 50 (3): 118-129.

14. International Organization for Standardization. ISO/TC 212/WG 1, Quality management in the clinical laboratory. Revised ISO/CD 15189, (December 1998).