This document provides criteria for quality assurance and quality control, evaluation of the performance and the accreditation of biological dosimetry by cytogenetic service laboratories using the dicentric assay performed with manual scoring. This document is applicable to a) the confidentiality of personal information, for the requestor and the service laboratory, b) the laboratory safety requirements, c) the calibration sources and calibration dose ranges useful for establishing the reference dose-response curves that contribute to the dose estimation from unstable chromosome aberration frequency and the detection limit, d) the scoring procedure for unstable chromosome aberrations used for biological dosimetry, e) the criteria for converting a measured aberration frequency into an estimate of absorbed dose, f) the reporting of results, g) the quality assurance and quality control, and h) informative annexes containing sample instructions for requestor (see Annex A), sample questionnaire (see Annex B), sample report (see Annex C), fitting of the low dose-response curve by the method of maximum likelihood and calculating the error of the dose estimate (see Annex D), odds ratio method for cases of suspected exposure to a low dose (see Annex E), a method for determining the decision threshold and detection limit (see Annex F) and sample data sheet for recording aberrations (see Annex G).<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4 Abbreviated terms <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 5 Dicentric assay <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 6 Responsibility of the requestor 7 Responsibility of the service laboratory 7.1 Setup and sustainment of the QA program 7.2 Responsibility during service <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 8 Confidentiality of personal information 8.1 Overview <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 8.2 Applications of the principle of confidentiality 8.2.1 Delegation of responsibilities within the laboratory 8.2.2 Requests for analysis 8.2.3 Transmission of confidential information 8.2.4 Anonymity of samples 8.2.5 Reporting of results 8.2.6 Storage 8.2.7 Data security plan <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 9 Laboratory safety requirements 9.1 Overview 9.2 Microbiological safety requirements 9.3 Chemical safety <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 9.4 Optical safety requirements 10 Sample processing 10.1 Culturing <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 10.2 Scoring 10.2.1 Coding of samples and slides 10.2.2 Scoring techniques 10.2.3 Procedure for scoring first-division metaphases <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 10.2.4 Laboratory scoring expertise 11 Calibration curves 11.1 Calibration source(s) 11.2 Establishment of calibration curve(s) <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 12 Criteria for converting a measured aberration frequency into an estimate of absorbed dose 12.1 General 12.2 Testing the distribution of aberrations per cell <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 12.3 Comparison with the background level: Characterisation of the minimum detectable dose <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 12.4 Confidence limits on the number of dicentrics <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 12.5 Calculation of absorbed dose for whole-body exposures 12.6 Calculation of uncertainty on absorbed dose <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 12.7 Acute and non-acute exposure cases 12.8 Partial body and prior exposure cases <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 12.9 Other exposure scenarios <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 13 Reporting of results 13.1 General 13.2 Content of the report (see Annex C for a standard form) 13.3 Interpretation of the results <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 14 Quality assurance and quality control 14.1 Overview 14.2 Specific requirements 14.2.1 General 14.2.2 Performance checks by laboratory inter-comparisons <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 14.2.3 Periodical performance check of scorer qualification 14.2.4 Performance checks of sample transport integrity 14.2.5 Performance checks of sample integrity by service laboratory <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 14.2.6 Performance checks for instrumentation 14.2.7 Performance checks of sample protocol 14.2.8 Performance checks of sample scoring 14.2.9 Performance checks of dose and confidence limits estimation 14.2.10 Performance checks for result report generation <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | Annex A (informative) Sample instructions for requestor <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Annex B (informative) Sample questionnaire <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | Annex C (informative) Sample of report <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Annex D (informative) Fitting of the low-LET dose-response curve by the method of maximum likelihood and calculating the error of dose estimate <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Annex E (informative) Odds ratio method for cases of suspected exposure to a low dose <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Annex F (informative) Decision threshold and detection limit <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Annex G (informative) Sample data sheet for recording aberrations <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Radiological protection. Performance criteria for service laboratories performing biological dosimetry by cytogenetics. Dicentric assay<\/b><\/p>\n |