Parameter Actor Requirement For SBR, cause to have placed volumes of interest (VOI) on Technologist or structures of interest and appropriate reference tissue. VOIs Place VOI image analysis include caudate, anterior putamen, and posterior putamen on specialist each side of brain. Technologist or Calculate analysis calculate time-point measurand (SBR or %dose/mL) measurand specialist Qualified Shall either (1) agree with region boundaries, (2) reject Certify VOI physician boundaries and return for reprocessing, or (3) make revisions “on the fly” as indicated. Qualified Shall either (1) agree with region boundaries, (2) reject Certify physician boundaries and return for reprocessing, or (3) make revisions “on measurand the fly” as indicated. Qualified Claim 1: interpret measurand as consistent with, or not consistent physician with, Parkinson’s disease. Claim 2: interpret measurand a consistent with a value of X +/- y, where x is the measured value, and y is the confidence interval classification described in Section 2 under Claim 2 Claim 3: interpret the measurand as consistent with, or not diagnostic of, change greater than the Repeatability Coefficient (RC) described above 4. Assessment Procedures
Parameter Actor Requirement Place VOI Technologist or image analysis specialist For SBR, cause to have placed volumes of interest (VOI) on structures of interest and appropriate reference tissue. VOIs include caudate, anterior putamen, and posterior putamen on each side of brain. Calculate measurand Technologist or analysis specialist calculate time-point measurand (SBR or %dose/mL) Certify VOI Qualified physician Shall either (1) agree with region boundaries, (2) reject boundaries and return for reprocessing, or (3) make revisions “on the fly” as indicated. Certify measurand Qualified physician Shall either (1) agree with region boundaries, (2) reject boundaries and return for reprocessing, or (3) make revisions “on the fly” as indicated. classification Qualified physician Claim 1: interpret measurand as consistent with, or not consistent with, Parkinson’s disease. Claim 2: interpret measurand a consistent with a value of X +/- y, where x is the measured value, and y is the confidence interval described in Section 2 under Claim 2 Claim 3: interpret the measurand as consistent with, or not diagnostic of, change greater than the Repeatability Coefficient (RC) described above 4. Assessment Procedures
002.QIBA_SPECT_Profile_Checklist_Extract.2016_10_22.docx