Sistema de gestión de calidad en fase preanalítica y su influencia en disminución de errores
Palabras clave:
Control de calidad; Laboratorio clínico; Minimizar errores; Implementación correctivos; Mejoramiento de calidad.
Resumen
Se seleccionaron 86 artículos científicos relacionados al tema desde las bases de datos PubMed, Redalyc, Elsevier, Web of Science, Biblioteca Cochrane y SciELO, publicados entre los años 2018 a 2022. De acuerdo a normas establecidas a nivel mundial y en América Latina, la Organización Internacional de Normalización (ISO), enfatiza en el uso de un plan para la consecución de un propósito, que ocurre en cualquier parte del proceso del laboratorio clínico, por tal razón, la utilización de esta normativa ha permitido diseñar indicadores de calidad para controlar los procesos preanalíticos, desde la extracción de la muestra hasta su proceso analítico en el laboratorio, facilitar la colaboración con los centros de extracción y establecer acciones de mejora, lo que ha contribuido a disminuir indicadores de medida de satisfacción del cliente, de tiempo y temperatura de transporte de muestras, rutas de mensajería e incumplimiento en el etiquetado y calidad de las muestras. La evaluación y el control del manejo preanalítico de muestras son esenciales para preservar la integridad y asegurar la calidad de estas. El control de todos los aspectos involucrados en la fase preanalítica debe ser una prioridad en todos los laboratorios.
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Citas
1. Alavi, N., Khan, SH., Saadia, A., Naeem, T., (2020) Challenges in Preanalytical Phase of Laboratory Medicine: Rate of Blood Sample Nonconformity in a Tertiary Care Hospital. EJIFCC.;31(1):21-27. PMID: 32256286; PMCID: PMC7109505.
2. Bajaña R, L., Baque, Z, G., Pincay, P, M., Valero, C, N., (2020) Incidencia en falsos positivos y negativos en los resultados del laboratorista. Pol Con. 2020; 5(6):849-862. Disponible en: https://polodelconocimiento.com/ojs/index.php/es.
3. Cadamuro, J., Bergsten, P., Mörwald, K., Forslund, A., Dahlbom, M., Bergquist, J., Ciba, I., Brunner S, M., Jabbour, J., Weghuber, D. (2022) Deviating glucose results in an international dual-center study. A root cause investigation. Biochem Med (Zagreb). 2022; 32(1):011001. doi: 10.11613/BM.2022.011001. PMID: 34955677; PMCID: PMC8672384.
4. Cadamuro, J., Lippi, G., Meyer, A., Ibarz, M., Dongen, E., Cornes, M., Et al. .(2019) European survey on preanalytical sample handling – Part 2: Practices of European laboratories on monitoring and processing haemolytic, icteric and lipemic samples.On behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical 39 Phase (WG-PRE). Biochemia Medica.; 29 (2). https://doi.org/10.11613/BM.2019.020705
5. Cassim, N., Ramdin, N., Moodly, S., Glencross, D, K., (2022) Cost of running a full-service receiving office at a centralised testing laboratory in South Africa. Afr J Lab Med.;11(1):1504. doi: 10.4102/ajlm.v11i1.1504. PMID: 35937761; PMCID: PMC9350462.
6. Chandra, S., Kusum, A., Gaur, D,S., Chandra, H., ( 2022) Analytical and Post Analytical Phase of an ISO 15189:2012 Certified Cytopathology Laboratory-A Five Year Institutional Experience. J Cytol. 2022; 39(1):37-43. doi: 10.4103/JOC.JOC_90_20. PMID: 35341112; PMCID: PMC8955700.
7. Cornes M. (2020) The preanalytical phase - Past, present and future. Ann Clin Biochem.; 57(1):4-6. doi:10.1177/0004563219867989. PMID: 31324119
8. De la Salle B. (2019) Pre- and postanalytical errors in haematology. Int J Lab Hematol.; 41 Suppl 1:170-176. doi: 10.1111/ijlh.13007. PMID: 31069968.
9. Eren, F., Tuncay, M,E., Oguz, E,F., Neselioglu, S., Erel, O., (2021) The response of total testing process in clinical laboratory medicine to COVID-19 pandemic. Biochem Med (Zagreb). ;31(2):020713. doi: 10.11613/BM.2021.020713. PMID: 34140836; PMCID: PMC8183122.
10. Huf, W., Mohns, M., Garmatiuk, T., Lister, R., Buchta, C., Ettl, B., Köller, U., (2022) Benchmarking diagnostic laboratory performance: Survey results for Germany, Austria, and Switzerland. Wien Klin Wochenschr.;134(3-4):174-181. doi:10.1007/s00508-021-01962-4. PMID: 34709471; PMCID: PMC8552210.
11. Jafri, L., Abid, M,A., Rehman, J., Ahmed, S., Abbas, G., Ali, H., Kanani, F., Ali, U., Alavi, N., Aslam. F., Iqbal, S., Ijaz, A., Munir, M,U., Dildar, S., Nawaz, S, H., Adnan, K., Khan, A, H., Zubairi, A,M., Siddiqui, I., (2022) Development of a virtual classroom for pre-analytical phase of laboratory medicine for undergraduate medical students using the Delphi technique. PLoS One. 2022 Apr 6;17(4):e0264447. doi: 10.1371/journal.pone.0264447. PMID: 35385486; PMCID: PMC8985926.
12. Jnah, A., Yagoubi, M., Seffar, M., El Hamzaoui, S., Hamamouchi, J., Zouhdi, M., (2022)Control of non-conformities in the pre-analytical phase at the Bacteriology Laboratory of the Ibn Sina University Hospital in Rabat (Morocco). Tunis Med. 2022;100(3):247-254. English. PMID: 36005917; PMCID: PMC9387638.
13. Kang, F., Li, W., Xia, X., Shan, Z., (2021)Three years' experience of quality monitoring program on pre-analytical errors in china. J Clin Lab Anal. 2021; 35(3):e23699. doi: 10.1002/jcla.23699. PMID: 33458892; PMCID: PMC7958002.
14. Lima, O, G., Volanski, W., Lippi, G., Picheth, G., Guidi, G, C.,(2017) Pre-analytical phase management: A review of the procedures from patient preparation to laboratory analysis. Scandinavian Journal of Clinical and Laboratory Investigation.; 77(3): 153- 163. https://doi.org/10.1080/00365513.2017.1295317.
15. Lippi, G., Betsou, F., Cadamuro, J., Cornes, M., Fleischhacker, M., Fruekilde, P., Neumaier, M., Nybo, M., Padoan, A., Plebani, M., Sciacovelli, L., Vermeersch, P,, Von M, A., Simundic A, M., (2019) Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Preanalytical challenges - time for solutions. Clin Chem Lab Med.;57(7):974-981. doi: 10.1515/cclm-2018-1334. PMID: 30710481.
16. Lippi, G., Von Meyer, A., Cadamuro, J., Simundic, A,M., (2019) Blood sample quality. Diagnosis (Berl).;6(1):25-31. doi: 10.1515/dx-2018-0018. PMID: 29794250.
17. Mrazek, C., Lippi, M., Keppel, M,H., Felder, T,K., Oberkofler, H., Haschke B, E., Cadamuro, J., (2020) Errors within the total laboratory testing process, from test selection to medical decision-making. A review of causes, consequences, surveillance and solutions.; 30(2):020502. DOI: https://doi.org/10.11613/BM.2020.020502.
18. Nybo, M., Cadamuro, J., Cornes, M,P., Gómez, R, R., Grankvist, K., (2019) Sample transportation - an overview. Diagnosis (Berl).; 6(1):39-43. doi: 10.1515/dx-2018-0051. PMID: 30808159.
19. Romero, A, Gómez, J., Romero, A., Ruiz, C.,(2018) Utilization of a healthcare failure mode and effects analysis to identify error sources in the preanalytical phase in two tertiary hospital laboratories. Biochem Med (Zagreb).; 28(2):020713. doi: 10.11613/BM.2018.020713. PMID: 30022888; PMCID: PMC6039167.
20. Romero, A., Gómez S, J., Romero A, A., Gómez, J, A., Cobos, A., Ramos, M,C., Iglesias, M,R.,(2020) Preanalytical errors in emergency department samples: Investigating error sources. J Med Biochem.;39(4):474-480. doi: 10.5937/jomb0-25263. PMID: 33312064; PMCID: PMC7710373.
21. San Miguel A, De la Fuente, P., Garrote, J., Lobo, R., Lurueña, M., Eiros, J., (2018) Minimización de errores preanalíticos y su repercusión en el control del laboratorio clínico. Revista del Laboratorio Clínico, 11(1): 51-58. 10.1016/j.labcli.2017.02.001.
22. Schneider,F., Maurer, C., Friedberg, R.C.,(2017) International Organization for Standardization (ISO) 15189. Ann Lab Med. ; 37(5):365-370. Disponible en: https://doi.org/10.3343/alm.2017.37.5.365 . PMID: 28643484; PMCID: PMC5500734.
23. Sciacovelli, L., Lippi, G., Sumarac, Z., Garcia del Pino Castro, I., Ivanov, A., De Guire. V., Coskun, C., Aita, A., Padoan, A., Plebani, M.,(2019) Pre-analytical quality indicators in laboratory medicine: Performance of laboratories participating in the IFCC working group “Laboratory Errors and Patient Safety” Project. Clinica Chimica Acta. ; 497: 35-40. https://doi.org/10.1016/j.cca.2019.07.007
24. Simundic, A,M., Bölenius, K., Cadamuro, J., Church, S., Cornes, M,P., Van Dongen-Lases E,C., Eker, P., Erdeljanovic, T., Grankvist, K., Guimaraes, J,T., Hoke, R., Ibarz, M., Ivanov, H., Kovalevskaya, S., Kristensen, G,B., Lima-Oliveira, G., Lippi, G., Von Meyer, A., Nybo, M., De la Salle B, Seipelt, C., Sumarac, Z., Vermeersch, P., (2019) Recommandations communes EFLM-COLABIOCLI relatives au prélèvement sanguin veineux [Joint EFLM-COLABIOCLI recommendation for venous blood sampling]. Ann Biol Clin (Paris).;77(2):131-154. French. doi: 10.1684/abc.2019.1419. PMID: 30998194.
25. Van, H, V., Bench, S., Soto, A, B., Luppa, P, P., Malpass, A., Schilling, U, M., Rooney, K, D., Stretton, A., Tintu, A,N.,(2022) Failure Mode and Effects Analysis (FMEA) at the preanalytical phase for POCT blood gas analysis: proposal for a shared proactive risk analysis model. Clin Chem Lab Med. 2022;60(8):1186-1201. doi: 10.1515/cclm-2022-0319. PMID: 35607775.
26. Zorbozan, N., Zorbozan, O., (2022) Evaluation of preanalytical and postanalytical phases in clinical biochemistry laboratory according to IFCC laboratory errors and patient safety specifications. Biochem Med (Zagreb). 2022; 32(3):030701. doi: 10.11613/BM.2022.030701. PMID: 35966260; PMCID: PMC9344872.
2. Bajaña R, L., Baque, Z, G., Pincay, P, M., Valero, C, N., (2020) Incidencia en falsos positivos y negativos en los resultados del laboratorista. Pol Con. 2020; 5(6):849-862. Disponible en: https://polodelconocimiento.com/ojs/index.php/es.
3. Cadamuro, J., Bergsten, P., Mörwald, K., Forslund, A., Dahlbom, M., Bergquist, J., Ciba, I., Brunner S, M., Jabbour, J., Weghuber, D. (2022) Deviating glucose results in an international dual-center study. A root cause investigation. Biochem Med (Zagreb). 2022; 32(1):011001. doi: 10.11613/BM.2022.011001. PMID: 34955677; PMCID: PMC8672384.
4. Cadamuro, J., Lippi, G., Meyer, A., Ibarz, M., Dongen, E., Cornes, M., Et al. .(2019) European survey on preanalytical sample handling – Part 2: Practices of European laboratories on monitoring and processing haemolytic, icteric and lipemic samples.On behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical 39 Phase (WG-PRE). Biochemia Medica.; 29 (2). https://doi.org/10.11613/BM.2019.020705
5. Cassim, N., Ramdin, N., Moodly, S., Glencross, D, K., (2022) Cost of running a full-service receiving office at a centralised testing laboratory in South Africa. Afr J Lab Med.;11(1):1504. doi: 10.4102/ajlm.v11i1.1504. PMID: 35937761; PMCID: PMC9350462.
6. Chandra, S., Kusum, A., Gaur, D,S., Chandra, H., ( 2022) Analytical and Post Analytical Phase of an ISO 15189:2012 Certified Cytopathology Laboratory-A Five Year Institutional Experience. J Cytol. 2022; 39(1):37-43. doi: 10.4103/JOC.JOC_90_20. PMID: 35341112; PMCID: PMC8955700.
7. Cornes M. (2020) The preanalytical phase - Past, present and future. Ann Clin Biochem.; 57(1):4-6. doi:10.1177/0004563219867989. PMID: 31324119
8. De la Salle B. (2019) Pre- and postanalytical errors in haematology. Int J Lab Hematol.; 41 Suppl 1:170-176. doi: 10.1111/ijlh.13007. PMID: 31069968.
9. Eren, F., Tuncay, M,E., Oguz, E,F., Neselioglu, S., Erel, O., (2021) The response of total testing process in clinical laboratory medicine to COVID-19 pandemic. Biochem Med (Zagreb). ;31(2):020713. doi: 10.11613/BM.2021.020713. PMID: 34140836; PMCID: PMC8183122.
10. Huf, W., Mohns, M., Garmatiuk, T., Lister, R., Buchta, C., Ettl, B., Köller, U., (2022) Benchmarking diagnostic laboratory performance: Survey results for Germany, Austria, and Switzerland. Wien Klin Wochenschr.;134(3-4):174-181. doi:10.1007/s00508-021-01962-4. PMID: 34709471; PMCID: PMC8552210.
11. Jafri, L., Abid, M,A., Rehman, J., Ahmed, S., Abbas, G., Ali, H., Kanani, F., Ali, U., Alavi, N., Aslam. F., Iqbal, S., Ijaz, A., Munir, M,U., Dildar, S., Nawaz, S, H., Adnan, K., Khan, A, H., Zubairi, A,M., Siddiqui, I., (2022) Development of a virtual classroom for pre-analytical phase of laboratory medicine for undergraduate medical students using the Delphi technique. PLoS One. 2022 Apr 6;17(4):e0264447. doi: 10.1371/journal.pone.0264447. PMID: 35385486; PMCID: PMC8985926.
12. Jnah, A., Yagoubi, M., Seffar, M., El Hamzaoui, S., Hamamouchi, J., Zouhdi, M., (2022)Control of non-conformities in the pre-analytical phase at the Bacteriology Laboratory of the Ibn Sina University Hospital in Rabat (Morocco). Tunis Med. 2022;100(3):247-254. English. PMID: 36005917; PMCID: PMC9387638.
13. Kang, F., Li, W., Xia, X., Shan, Z., (2021)Three years' experience of quality monitoring program on pre-analytical errors in china. J Clin Lab Anal. 2021; 35(3):e23699. doi: 10.1002/jcla.23699. PMID: 33458892; PMCID: PMC7958002.
14. Lima, O, G., Volanski, W., Lippi, G., Picheth, G., Guidi, G, C.,(2017) Pre-analytical phase management: A review of the procedures from patient preparation to laboratory analysis. Scandinavian Journal of Clinical and Laboratory Investigation.; 77(3): 153- 163. https://doi.org/10.1080/00365513.2017.1295317.
15. Lippi, G., Betsou, F., Cadamuro, J., Cornes, M., Fleischhacker, M., Fruekilde, P., Neumaier, M., Nybo, M., Padoan, A., Plebani, M., Sciacovelli, L., Vermeersch, P,, Von M, A., Simundic A, M., (2019) Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Preanalytical challenges - time for solutions. Clin Chem Lab Med.;57(7):974-981. doi: 10.1515/cclm-2018-1334. PMID: 30710481.
16. Lippi, G., Von Meyer, A., Cadamuro, J., Simundic, A,M., (2019) Blood sample quality. Diagnosis (Berl).;6(1):25-31. doi: 10.1515/dx-2018-0018. PMID: 29794250.
17. Mrazek, C., Lippi, M., Keppel, M,H., Felder, T,K., Oberkofler, H., Haschke B, E., Cadamuro, J., (2020) Errors within the total laboratory testing process, from test selection to medical decision-making. A review of causes, consequences, surveillance and solutions.; 30(2):020502. DOI: https://doi.org/10.11613/BM.2020.020502.
18. Nybo, M., Cadamuro, J., Cornes, M,P., Gómez, R, R., Grankvist, K., (2019) Sample transportation - an overview. Diagnosis (Berl).; 6(1):39-43. doi: 10.1515/dx-2018-0051. PMID: 30808159.
19. Romero, A, Gómez, J., Romero, A., Ruiz, C.,(2018) Utilization of a healthcare failure mode and effects analysis to identify error sources in the preanalytical phase in two tertiary hospital laboratories. Biochem Med (Zagreb).; 28(2):020713. doi: 10.11613/BM.2018.020713. PMID: 30022888; PMCID: PMC6039167.
20. Romero, A., Gómez S, J., Romero A, A., Gómez, J, A., Cobos, A., Ramos, M,C., Iglesias, M,R.,(2020) Preanalytical errors in emergency department samples: Investigating error sources. J Med Biochem.;39(4):474-480. doi: 10.5937/jomb0-25263. PMID: 33312064; PMCID: PMC7710373.
21. San Miguel A, De la Fuente, P., Garrote, J., Lobo, R., Lurueña, M., Eiros, J., (2018) Minimización de errores preanalíticos y su repercusión en el control del laboratorio clínico. Revista del Laboratorio Clínico, 11(1): 51-58. 10.1016/j.labcli.2017.02.001.
22. Schneider,F., Maurer, C., Friedberg, R.C.,(2017) International Organization for Standardization (ISO) 15189. Ann Lab Med. ; 37(5):365-370. Disponible en: https://doi.org/10.3343/alm.2017.37.5.365 . PMID: 28643484; PMCID: PMC5500734.
23. Sciacovelli, L., Lippi, G., Sumarac, Z., Garcia del Pino Castro, I., Ivanov, A., De Guire. V., Coskun, C., Aita, A., Padoan, A., Plebani, M.,(2019) Pre-analytical quality indicators in laboratory medicine: Performance of laboratories participating in the IFCC working group “Laboratory Errors and Patient Safety” Project. Clinica Chimica Acta. ; 497: 35-40. https://doi.org/10.1016/j.cca.2019.07.007
24. Simundic, A,M., Bölenius, K., Cadamuro, J., Church, S., Cornes, M,P., Van Dongen-Lases E,C., Eker, P., Erdeljanovic, T., Grankvist, K., Guimaraes, J,T., Hoke, R., Ibarz, M., Ivanov, H., Kovalevskaya, S., Kristensen, G,B., Lima-Oliveira, G., Lippi, G., Von Meyer, A., Nybo, M., De la Salle B, Seipelt, C., Sumarac, Z., Vermeersch, P., (2019) Recommandations communes EFLM-COLABIOCLI relatives au prélèvement sanguin veineux [Joint EFLM-COLABIOCLI recommendation for venous blood sampling]. Ann Biol Clin (Paris).;77(2):131-154. French. doi: 10.1684/abc.2019.1419. PMID: 30998194.
25. Van, H, V., Bench, S., Soto, A, B., Luppa, P, P., Malpass, A., Schilling, U, M., Rooney, K, D., Stretton, A., Tintu, A,N.,(2022) Failure Mode and Effects Analysis (FMEA) at the preanalytical phase for POCT blood gas analysis: proposal for a shared proactive risk analysis model. Clin Chem Lab Med. 2022;60(8):1186-1201. doi: 10.1515/cclm-2022-0319. PMID: 35607775.
26. Zorbozan, N., Zorbozan, O., (2022) Evaluation of preanalytical and postanalytical phases in clinical biochemistry laboratory according to IFCC laboratory errors and patient safety specifications. Biochem Med (Zagreb). 2022; 32(3):030701. doi: 10.11613/BM.2022.030701. PMID: 35966260; PMCID: PMC9344872.
Publicado
2022-11-19
Cómo citar
Katherine Lisbet Mera Parrales, & William Antonio Lino Villacreses. (2022). Sistema de gestión de calidad en fase preanalítica y su influencia en disminución de errores. Revista Científica FIPCAEC (Fomento De La investigación Y publicación científico-técnica multidisciplinaria). ISSN : 2588-090X . Polo De Capacitación, Investigación Y Publicación (POCAIP), 7(4), 449-4470. Recuperado a partir de https://fipcaec.com/index.php/fipcaec/article/view/643
Sección
Artículos de Investigación
