3.1.2 Specification Parameter Actor Requirement Shall be capable of storing protocols and performing scans with all Acquisition the parameters set as specified in section 3.4.2 "Protocol Design Device Specification". Acquisition Protocol Shall prepare a protocol conformant with section 3.4.2 "Protocol Acquisition Design Specification" and validate that protocol as described in Device section 3.4.2. Shall also validate the protocol under varying conditions from each preferred protocol setting using a Design of Experiments (DOE) Acquisition Protocol Acquisition approach. Variation Device See section 4.2 Equipment Vendor Procedures for more information on DOE methods. Number of Detector Acquisition Shall have 16 or more detector rows. Rows Device Shall record in the DICOM image header the actual values for the Acquisition Image Header tags listed in the DICOM Tag column in section 3.4.2 "Protocol Device Design Specification". Image Analysis Shall present Images from both time points side-by-side for Reading Paradigm Tool comparison. Shall calculate change as the difference in volume between two Image Analysis Change Calculation time points relative to the volume at the earlier time point, Tool expressed in mm3 units. Image Analysis Shall have appropriate scientific validation, including the properties Scientific Validation Tool of measurement linearity, coefficient of variation, and zero bias. 3.2. Staff Qualification This activity involves evaluating the human Actors (Radiologist, Physicist, and Technologist) prior to their participation in the Profile. It includes training, qualification or performance assessments that are necessary to reliably meet the Profile Claim. 3.2.1 Discussion These requirements, as with any QIBA Profile requirements, are focused on achieving the Profile Claim. Evaluating the medical or professional qualifications of participating actors is beyond the scope of this profile. In clinical practice, it is expected that the Radiologist interpreting the examination often will be the Image Analyst. In some clinical practice situations, and in the clinical research setting, the image analyst may be a non-radiologist professional. Analyst Training should be at a level appropriate for the setting and the purpose of the measurements, and may include instruction in topics such as the generation and components of volumetric CT images; principles of image reconstruction and processing; technical factors influencing quantitative assessment;
3.1.2 Specification Parameter Actor Requirement Acquisition Protocol Acquisition Device Shall be capable of storing protocols and performing scans with all the parameters set as specified in section 3.4.2 "Protocol Design Specification". Acquisition Device Shall prepare a protocol conformant with section 3.4.2 "Protocol Design Specification" and validate that protocol as described in section 3.4.2. Acquisition Protocol Variation Acquisition Device Shall also validate the protocol under varying conditions from each preferred protocol setting using a Design of Experiments (DOE) approach. See section 4.2 Equipment Vendor Procedures for more information on DOE methods. Number of Detector Rows Acquisition Device Shall have 16 or more detector rows. Image Header Acquisition Device Shall record in the DICOM image header the actual values for the tags listed in the DICOM Tag column in section 3.4.2 "Protocol Design Specification". Reading Paradigm Image Analysis Tool Shall present Images from both time points side-by-side for comparison. Change Calculation Image Analysis Tool Shall calculate change as the difference in volume between two time points relative to the volume at the earlier time point, expressed in mm3 units. Scientific Validation Image Analysis Tool Shall have appropriate scientific validation, including the properties of measurement linearity, coefficient of variation, and zero bias. 3.2. Staff Qualification This activity involves evaluating the human Actors (Radiologist, Physicist, and Technologist) prior to their participation in the Profile. It includes training, qualification or performance assessments that are necessary to reliably meet the Profile Claim. 3.2.1 Discussion These requirements, as with any QIBA Profile requirements, are focused on achieving the Profile Claim. Evaluating the medical or professional qualifications of participating actors is beyond the scope of this profile. In clinical practice, it is expected that the Radiologist interpreting the examination often will be the Image Analyst. In some clinical practice situations, and in the clinical research setting, the image analyst may be a non-radiologist professional. Analyst Training should be at a level appropriate for the setting and the purpose of the measurements, and may include instruction in topics such as the generation and components of volumetric CT images; principles of image reconstruction and processing; technical factors influencing quantitative assessment;