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Volumn 33, Issue 1, 2013, Pages 12-23

Accreditation of the activity of molecular pathology according to ISO 15189: Key steps to follow and the main potential pitfalls;Accréditation de l'activité de pathologie moléculaire selon la norme ISO 15189. Principales étapes à respecter et principaux écueils possibles

Author keywords

Accreditation; ISO 15189; Molecular biology; Molecular pathology; Quality assurance

Indexed keywords

ACCREDITATION; ARTICLE; HUMAN; MEDICAL SOCIETY; MOLECULAR PATHOLOGY; PATHOLOGIST; PERSONALIZED MEDICINE; QUALITY CONTROL;

EID: 84875278942     PISSN: 02426498     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.annpat.2012.11.004     Document Type: Article
Times cited : (13)

References (42)
  • 1
    • 0032954093 scopus 로고    scopus 로고
    • How shall we apply the new biology to diagnostics in surgical pathology?
    • Jones D., Fletcher C.D. How shall we apply the new biology to diagnostics in surgical pathology?. J Pathol 1999, 187:147-154.
    • (1999) J Pathol , vol.187 , pp. 147-154
    • Jones, D.1    Fletcher, C.D.2
  • 3
    • 84855944905 scopus 로고    scopus 로고
    • Development of molecular biomarkers in individualized treatment of colorectal cancer
    • De Mattos-Arruda L., Dienstmann R., Tabernero J. Development of molecular biomarkers in individualized treatment of colorectal cancer. Clin Colorectal Cancer 2011, 10:279-289.
    • (2011) Clin Colorectal Cancer , vol.10 , pp. 279-289
    • De Mattos-Arruda, L.1    Dienstmann, R.2    Tabernero, J.3
  • 4
    • 79956335981 scopus 로고    scopus 로고
    • Molecular diagnostics of lung carcinomas
    • Dacic S. Molecular diagnostics of lung carcinomas. Arch Pathol Lab Med 2011, 135:622-629.
    • (2011) Arch Pathol Lab Med , vol.135 , pp. 622-629
    • Dacic, S.1
  • 5
    • 45549090039 scopus 로고    scopus 로고
    • General morphological and biological features of neoplasms: integration of molecular findings
    • Diaz-Cano S.J. General morphological and biological features of neoplasms: integration of molecular findings. Histopathology 2008, 53:1-19.
    • (2008) Histopathology , vol.53 , pp. 1-19
    • Diaz-Cano, S.J.1
  • 6
    • 39749144726 scopus 로고    scopus 로고
    • Biomarkers of response to epidermal growth factor receptor inhibitors in Non-Small-Cell Lung Cancer Working Group: standardization for use in the clinical trial setting
    • Eberhard D.A., Giaccone G., Johnson B. Biomarkers of response to epidermal growth factor receptor inhibitors in Non-Small-Cell Lung Cancer Working Group: standardization for use in the clinical trial setting. J Clin Oncol 2008, 26:983-994.
    • (2008) J Clin Oncol , vol.26 , pp. 983-994
    • Eberhard, D.A.1    Giaccone, G.2    Johnson, B.3
  • 8
    • 84860390334 scopus 로고    scopus 로고
    • Predictive biomarkers: a paradigm shift towards personalized cancer medicine
    • La Thangue N.B., Kerr D.J. Predictive biomarkers: a paradigm shift towards personalized cancer medicine. Nat Rev Clin Oncol 2011, 8:587-596.
    • (2011) Nat Rev Clin Oncol , vol.8 , pp. 587-596
    • La Thangue, N.B.1    Kerr, D.J.2
  • 9
  • 10
    • 80155150303 scopus 로고    scopus 로고
    • Personalized medicine in lung cancer: what we need to know
    • Mok T.S. Personalized medicine in lung cancer: what we need to know. Nat Rev Clin Oncol 2011, 8:661-668.
    • (2011) Nat Rev Clin Oncol , vol.8 , pp. 661-668
    • Mok, T.S.1
  • 11
    • 84857718958 scopus 로고    scopus 로고
    • New strategies in melanoma: molecular testing in advanced disease
    • Woodman S.E., Lazar A.J., Aldape K.D., Davies M.A. New strategies in melanoma: molecular testing in advanced disease. Clin Cancer Res 2012, 18:1195-1200.
    • (2012) Clin Cancer Res , vol.18 , pp. 1195-1200
    • Woodman, S.E.1    Lazar, A.J.2    Aldape, K.D.3    Davies, M.A.4
  • 12
    • 33744730025 scopus 로고    scopus 로고
    • Personalized medicine and development of targeted therapies: the upcoming challenge for diagnostic molecular pathology. A review
    • Dietel M., Sers C. Personalized medicine and development of targeted therapies: the upcoming challenge for diagnostic molecular pathology. A review. Virchows Arch 2006, 448:744-755.
    • (2006) Virchows Arch , vol.448 , pp. 744-755
    • Dietel, M.1    Sers, C.2
  • 13
    • 84859934797 scopus 로고    scopus 로고
    • The times have changed: molecular pathology is here to stay: a commentary on: Analytical performance of a PCR assay for the detection of KRAS mutations (codons 12/13 and 61) in formalin-fixed paraffin-embedded tissue samples of colorectal carcinoma, by Lee et al. In this issue
    • van Krieken J.H., Hoefler G. The times have changed: molecular pathology is here to stay: a commentary on: Analytical performance of a PCR assay for the detection of KRAS mutations (codons 12/13 and 61) in formalin-fixed paraffin-embedded tissue samples of colorectal carcinoma, by Lee et al. In this issue. Virchows Arch 2012, 460:129-130.
    • (2012) Virchows Arch , vol.460 , pp. 129-130
    • Van Krieken, J.H.1    Hoefler, G.2
  • 14
    • 84875276704 scopus 로고    scopus 로고
    • Cofrac. Guide technique d'accréditation en biologie médicale. Document SH GTA 01. Révision 00. Mai
    • Cofrac. Guide technique d'accréditation en biologie médicale. Document SH GTA 01. Révision 00. Mai 2011.
    • (2011)
  • 15
    • 0033374631 scopus 로고    scopus 로고
    • Effect of accreditation schemes on the setting of quality specifications by laboratories
    • Libeer J.C. Effect of accreditation schemes on the setting of quality specifications by laboratories. Scand J Clin Lab Invest 1999, 59:575-578.
    • (1999) Scand J Clin Lab Invest , vol.59 , pp. 575-578
    • Libeer, J.C.1
  • 16
    • 84875259399 scopus 로고    scopus 로고
    • Medical Laboratories. Particular requirements for quality and competence. International Standard ISO 15189:2007
    • Medical Laboratories. Particular requirements for quality and competence. International Standard ISO 15189:2007, 2007.
    • (2007)
  • 17
    • 84875269378 scopus 로고    scopus 로고
    • ISO 15189. Laboratoires d'analyses de biologie médicale. Exigences particulières concernant la qualité et la compétence. AFNOR
    • Norme NF ISO 15189. Laboratoires d'analyses de biologie médicale. Exigences particulières concernant la qualité et la compétence. AFNOR; 2007.
    • (2007)
    • Norme, N.F.1
  • 18
    • 84875237801 scopus 로고    scopus 로고
    • Guide de bonne exécution des analyses (GBEA). Arrêté du 26 novembre 1999 relatif à la bonne exécution des analyses de biologie médicale. JO du 11 décembre modifié par arrêté du 28 avril 2002 (JO du 4 mai 2002).
    • Guide de bonne exécution des analyses (GBEA). Arrêté du 26 novembre 1999 relatif à la bonne exécution des analyses de biologie médicale. JO du 11 décembre 1999 modifié par arrêté du 28 avril 2002 (JO du 4 mai 2002).
    • (1999)
  • 19
    • 28844482257 scopus 로고    scopus 로고
    • The preanalytical phase-can the requirements of the DIN-EN-ISO 15189 be met practically for all laboratories? A view of the " German situation"
    • Wood W.G. The preanalytical phase-can the requirements of the DIN-EN-ISO 15189 be met practically for all laboratories? A view of the " German situation" . Clin Lab 2005, 51:665-671.
    • (2005) Clin Lab , vol.51 , pp. 665-671
    • Wood, W.G.1
  • 20
    • 84875234119 scopus 로고    scopus 로고
    • Journal officiel
    • Arrêté du 16 juillet 2007 fixant les mesures techniques de prévention, notamment de confinement, à mettre en œuvre dans les laboratoires de recherche, d'enseignement, d'analyses, d'anatomie et cytologie pathologiques, les salles d'autopsie et les établissements industriels et agricoles ou les travailleurs sont suceptibles d'être exposés à des agents biologiques pathogènes. JO du 4 août
    • Journal officiel. Arrêté du 16 juillet 2007 fixant les mesures techniques de prévention, notamment de confinement, à mettre en œuvre dans les laboratoires de recherche, d'enseignement, d'analyses, d'anatomie et cytologie pathologiques, les salles d'autopsie et les établissements industriels et agricoles ou les travailleurs sont suceptibles d'être exposés à des agents biologiques pathogènes. JO du 4 août 2007.
    • (2007)
  • 21
    • 84875269198 scopus 로고    scopus 로고
    • Organisation mondiale de la santé. Manuel de sécurité biologique en laboratoire. 3e éd
    • Organisation mondiale de la santé. Manuel de sécurité biologique en laboratoire. 3e éd. 2005.
    • (2005)
  • 22
    • 77952573812 scopus 로고    scopus 로고
    • Rôle du laboratoire d'anatomie-pathologique dans l'approche pré-analytique des examens de biologie moléculaire réalisés en pathologie tumorale
    • Hofman V., Ilie M., Gavric-Tanga V., Lespinet V., Mari M., Lassalle S., et al. Rôle du laboratoire d'anatomie-pathologique dans l'approche pré-analytique des examens de biologie moléculaire réalisés en pathologie tumorale. Ann Pathol 2010, 30:85-93.
    • (2010) Ann Pathol , vol.30 , pp. 85-93
    • Hofman, V.1    Ilie, M.2    Gavric-Tanga, V.3    Lespinet, V.4    Mari, M.5    Lassalle, S.6
  • 23
    • 79952698311 scopus 로고    scopus 로고
    • External quality assessment for KRAS testing is needed: setup of a European program and report of the first joined regional quality assessment rounds
    • Bellon E., Ligtenberg M.J., Tejpar S., Cox K., de Hertogh G., de Stricker K., et al. External quality assessment for KRAS testing is needed: setup of a European program and report of the first joined regional quality assessment rounds. Oncologist 2011, 16:467-478.
    • (2011) Oncologist , vol.16 , pp. 467-478
    • Bellon, E.1    Ligtenberg, M.J.2    Tejpar, S.3    Cox, K.4    De Hertogh, G.5    de Stricker, K.6
  • 24
    • 77955620636 scopus 로고    scopus 로고
    • Personalized medicine in oncology: tailoring the right drug to the right patient
    • Jiang Y., Wang M. Personalized medicine in oncology: tailoring the right drug to the right patient. Biomark Med 2010, 4:523-533.
    • (2010) Biomark Med , vol.4 , pp. 523-533
    • Jiang, Y.1    Wang, M.2
  • 25
    • 79953763922 scopus 로고    scopus 로고
    • New classification of pulmonary cancer: application to small size biopsy sampling
    • Brambilla E., Lantuejoul S. New classification of pulmonary cancer: application to small size biopsy sampling. Ann Pathol 2010, 30:60-63.
    • (2010) Ann Pathol , vol.30 , pp. 60-63
    • Brambilla, E.1    Lantuejoul, S.2
  • 26
    • 79961008460 scopus 로고    scopus 로고
    • Emerging concepts in the pathology and molecular biology of advanced non-small cell lung cancer
    • Kulesza P., Ramchandran K., Patel J.D. Emerging concepts in the pathology and molecular biology of advanced non-small cell lung cancer. Am J Clin Pathol 2011, 136:228-238.
    • (2011) Am J Clin Pathol , vol.136 , pp. 228-238
    • Kulesza, P.1    Ramchandran, K.2    Patel, J.D.3
  • 27
    • 83255193971 scopus 로고    scopus 로고
    • Establishing an EGFR mutation screening service for non-small cell lung cancer - Sample quality criteria and candidate histological predictors
    • Leary A.F., Castro D.G., Nicholson A.G., Ashley S., Wotherspoon A., O'Brien M.E., et al. Establishing an EGFR mutation screening service for non-small cell lung cancer - Sample quality criteria and candidate histological predictors. Eur J Cancer 2012, 48:61-67.
    • (2012) Eur J Cancer , vol.48 , pp. 61-67
    • Leary, A.F.1    Castro, D.G.2    Nicholson, A.G.3    Ashley, S.4    Wotherspoon, A.5    O'Brien, M.E.6
  • 28
    • 79551563284 scopus 로고    scopus 로고
    • International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society international multidisciplinary classification of lung adenocarcinoma
    • Travis W.D., Brambilla E., Noguchi M., Nicholson A.G., Geisinger K.R., Yatabe Y., et al. International Association for the Study of Lung Cancer/American Thoracic Society/European Respiratory Society international multidisciplinary classification of lung adenocarcinoma. J Thorac Oncol 2011, 6:244-285.
    • (2011) J Thorac Oncol , vol.6 , pp. 244-285
    • Travis, W.D.1    Brambilla, E.2    Noguchi, M.3    Nicholson, A.G.4    Geisinger, K.R.5    Yatabe, Y.6
  • 29
    • 15044365131 scopus 로고    scopus 로고
    • DNA and RNA obtained from Bouin's fixed tissues
    • Bonin S., Petrera F., Rosai J., Stanta G. DNA and RNA obtained from Bouin's fixed tissues. J Clin Pathol 2005, 58:313-316.
    • (2005) J Clin Pathol , vol.58 , pp. 313-316
    • Bonin, S.1    Petrera, F.2    Rosai, J.3    Stanta, G.4
  • 30
    • 70449403654 scopus 로고    scopus 로고
    • Assessment of morphology, antigenicity, and nucleic acid integrity for diagnostic thyroid pathology using formalin substitute fixatives
    • Lassalle S., Hofman V., Ilie M., Gavric-Tanga V., Brest P., Havet K., et al. Assessment of morphology, antigenicity, and nucleic acid integrity for diagnostic thyroid pathology using formalin substitute fixatives. Thyroid 2009, 19:1239-1248.
    • (2009) Thyroid , vol.19 , pp. 1239-1248
    • Lassalle, S.1    Hofman, V.2    Ilie, M.3    Gavric-Tanga, V.4    Brest, P.5    Havet, K.6
  • 31
    • 0036898005 scopus 로고    scopus 로고
    • Effect of fixatives and tissue processing on the content and integrity of nucleic acids
    • Srinivasan M., Sedmak D., Jewell S. Effect of fixatives and tissue processing on the content and integrity of nucleic acids. Am J Pathol 2002, 161:1961-1971.
    • (2002) Am J Pathol , vol.161 , pp. 1961-1971
    • Srinivasan, M.1    Sedmak, D.2    Jewell, S.3
  • 32
    • 65649128973 scopus 로고    scopus 로고
    • Mutation-specific antibodies for the detection of EGFR mutations in non-small-cell lung cancer
    • Yu J., Kane S., Wu J., Benedettini E., Li D., Reeves C., et al. Mutation-specific antibodies for the detection of EGFR mutations in non-small-cell lung cancer. Clin Cancer Res 2009, 15:3023-3028.
    • (2009) Clin Cancer Res , vol.15 , pp. 3023-3028
    • Yu, J.1    Kane, S.2    Wu, J.3    Benedettini, E.4    Li, D.5    Reeves, C.6
  • 33
    • 77957956767 scopus 로고    scopus 로고
    • Usefulness of tissue microarrays for assessment of protein expression, gene copy number and mutational status of EGFR in lung adenocarcinoma
    • Ilie M.I., Hofman V., Bonnetaud C., Havet K., Lespinet-Fabre V., Coelle C., et al. Usefulness of tissue microarrays for assessment of protein expression, gene copy number and mutational status of EGFR in lung adenocarcinoma. Virchows Arch 2010, 457:483-495.
    • (2010) Virchows Arch , vol.457 , pp. 483-495
    • Ilie, M.I.1    Hofman, V.2    Bonnetaud, C.3    Havet, K.4    Lespinet-Fabre, V.5    Coelle, C.6
  • 34
    • 78650928556 scopus 로고    scopus 로고
    • Detection of EGFR mutations with mutation-specific antibodies in stage IV non-small-cell lung cancer
    • Simonetti S., Molina M.A., Queralt C., de Aguirre I., Mayo C., Bertran-Alamillo J., et al. Detection of EGFR mutations with mutation-specific antibodies in stage IV non-small-cell lung cancer. J Transl Med 2010, 8:135.
    • (2010) J Transl Med , vol.8 , pp. 135
    • Simonetti, S.1    Molina, M.A.2    Queralt, C.3    De Aguirre, I.4    Mayo, C.5    Bertran-Alamillo, J.6
  • 35
    • 84864296896 scopus 로고    scopus 로고
    • Immunohistochemistry to identify EGFR mutations or ALK rearrangements in patients with lung adenocarcinoma
    • Hofman P., Ilie M., Hofman V., Roux S., Valent A., Bernheim A., et al. Immunohistochemistry to identify EGFR mutations or ALK rearrangements in patients with lung adenocarcinoma. Ann Oncol 2012, 23:1738-1743.
    • (2012) Ann Oncol , vol.23 , pp. 1738-1743
    • Hofman, P.1    Ilie, M.2    Hofman, V.3    Roux, S.4    Valent, A.5    Bernheim, A.6
  • 36
    • 0034080372 scopus 로고    scopus 로고
    • The interface between molecular biology and cancer research
    • Cairns J. The interface between molecular biology and cancer research. Mutat Res 2000, 462:423-428.
    • (2000) Mutat Res , vol.462 , pp. 423-428
    • Cairns, J.1
  • 37
    • 35348852486 scopus 로고    scopus 로고
    • Laboratory accreditation and inspection
    • Rauch C.A., Nichols J.H. Laboratory accreditation and inspection. Clin Lab Med 2007, 27:845-858.
    • (2007) Clin Lab Med , vol.27 , pp. 845-858
    • Rauch, C.A.1    Nichols, J.H.2
  • 38
    • 79952588449 scopus 로고    scopus 로고
    • MolecularDiagnostics.be working group. Reflections and proposals to assure quality in molecular diagnostics
    • Raymaekers M., Bakkus M., Boone E., de Rijke B., El Housni H., Descheemaeker P., et al. MolecularDiagnostics.be working group. Reflections and proposals to assure quality in molecular diagnostics. Acta Clin Belg 2011, 66:33-41.
    • (2011) Acta Clin Belg , vol.66 , pp. 33-41
    • Raymaekers, M.1    Bakkus, M.2    Boone, E.3    De Rijke, B.4    El Housni, H.5    Descheemaeker, P.6
  • 39
    • 79958835059 scopus 로고    scopus 로고
    • Comprehensive next-generation cancer genome sequencing in the era of targeted therapy and personalized oncology
    • Cronin M., Ross J.S. Comprehensive next-generation cancer genome sequencing in the era of targeted therapy and personalized oncology. Biomark Med 2011, 5:293-305.
    • (2011) Biomark Med , vol.5 , pp. 293-305
    • Cronin, M.1    Ross, J.S.2
  • 40
    • 78649992228 scopus 로고    scopus 로고
    • Cancer biology and genomics: translating discoveries, transforming pathology
    • Ladanyi M., Hogendoorn P.C. Cancer biology and genomics: translating discoveries, transforming pathology. J Pathol 2011, 223:99-101.
    • (2011) J Pathol , vol.223 , pp. 99-101
    • Ladanyi, M.1    Hogendoorn, P.C.2
  • 41
    • 34548849132 scopus 로고    scopus 로고
    • Epidermal growth factor receptor mutation testing in lung cancer: searching for the ideal method
    • Pao W., Ladanyi M. Epidermal growth factor receptor mutation testing in lung cancer: searching for the ideal method. Clin Cancer Res 2007, 13:4954-4955.
    • (2007) Clin Cancer Res , vol.13 , pp. 4954-4955
    • Pao, W.1    Ladanyi, M.2
  • 42
    • 84858439267 scopus 로고    scopus 로고
    • Recent advances in pathway-targeted cancer drug therapies emerging from cancer genome analysis
    • Yauch R.L., Settleman J. Recent advances in pathway-targeted cancer drug therapies emerging from cancer genome analysis. Curr Opin Genet Dev 2012, 22:45-49.
    • (2012) Curr Opin Genet Dev , vol.22 , pp. 45-49
    • Yauch, R.L.1    Settleman, J.2


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