Has the laboratory validated new antibodies 5.2.7 prior to use in patient diagnosis? Are new lots of antibody and detection 5.2.8 system reagents tested in parallel with old lots? Are the immunohistochemical stains 5.2.9 produced of acceptable technical quality? Fluorescence and Non-Fluorescence 5.3 Hybridization (FISH, ISH) Is there documentation of validation of 5.3.1 commercially available ISH and FISH probes used? Is there documentation of validation of 5.3.2 probes that are developed in-house? Are there documented procedures for 5.3.3 scoring results, including the number of cells scored? Are quantitative and semi-quantitative 5.3.4 analyses scored according to these procedures? Are control loci (internal or external) used 5.3.5 with and documented for each FISH analysis? Are photographic or digitized images 5.3.6 retained for documentation of all FISH assays? Is the morphologic interpretation and correlation of results performed by a 5.3.7 qualified pathologist as appropriate for situ hybridization studies? Are interpretations of in hybridization 5.3.8 results provided in the report? 5.4 Predictive Markers For immunohistochemical and FISH/ISH tests that provide independent predictive 5.4.1 information, does the patient report include information on: specimen processing 5.4.1.1 antibody clone/probe 5.4.1.2 scoring method used 5.4.1.3 For immunohistochemical and FISH/ISH tests that provide independent predictive 5.4.2 information, does the laboratory (at least annually) compare its patient results with published benchmarks, and evaluate
5.2.7 Has the laboratory validated new antibodies prior to use in patient diagnosis? 5.2.8 Are new lots of antibody and detection system reagents tested in parallel with old lots? 5.2.9 Are the immunohistochemical stains produced of acceptable technical quality? 5.3 Fluorescence and Non-Fluorescence Hybridization (FISH, ISH) 5.3.1 Is there documentation of validation of commercially available ISH and FISH probes used? 5.3.2 Is there documentation of validation of probes that are developed in-house? 5.3.3 Are there documented procedures for scoring results, including the number of cells scored? 5.3.4 Are quantitative and semi-quantitative analyses scored according to these procedures? 5.3.5 Are control loci (internal or external) used with and documented for each FISH analysis? 5.3.6 Are photographic or digitized images retained for documentation of all FISH assays? 5.3.7 Is the morphologic interpretation and correlation of results performed by a qualified pathologist as appropriate for hybridization studies? 5.3.8 Are interpretations of in situ hybridization results provided in the report? 5.4 Predictive Markers 5.4.1 For immunohistochemical and FISH/ISH tests that provide independent predictive information, does the patient report include information on: 5.4.1.1 specimen processing 5.4.1.2 antibody clone/probe 5.4.1.3 scoring method used 5.4.2 For immunohistochemical and FISH/ISH tests that provide independent predictive information, does the laboratory (at least annually) compare its patient results with published benchmarks, and evaluate
CRA-F-05-15189-S-01-Anatomic%20Pathology.docx