The purpose of this document is to provide criteria for quality assurance (QA), quality control (QC) and evaluation of the performance of biological dosimetry by cytogenetic service laboratories.<\/p>\n
This document addresses:<\/p>\n
the responsibilities of both the customer and the laboratory;<\/p>\n<\/li>\n
the confidentiality of personal information, for the customer and the laboratory;<\/p>\n<\/li>\n
the laboratory safety requirements;<\/p>\n<\/li>\n
sample processing; culturing, staining and scoring, including the criteria for scoring for translocation analysis by FISH;<\/p>\n<\/li>\n
the calibration sources and calibration dose ranges useful for establishing the reference dose\u2011response curves that contribute to the dose estimation from chromosome aberration frequency and the detection limit;<\/p>\n<\/li>\n
the scoring procedure for translocations stained by FISH used for evaluation of exposure;<\/p>\n<\/li>\n
the criteria for converting a measured aberration frequency into an estimate of absorbed dose (also appears as \u201cdose\u201d);<\/p>\n<\/li>\n
the reporting of results;<\/p>\n<\/li>\n
the QA and QC;<\/p>\n<\/li>\n
Annexes A to F containing sample instructions for the customer, sample questionnaire, sample datasheet for recording aberrations, sample of report and fitting of the low dose-response curve by the method of maximum likelihood and calculating the uncertainty of dose estimate.<\/p>\n<\/li>\n<\/ol>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 4 Translocation assay by FISH 4.1 General 4.2 Culturing and fixation 4.3 Types of staining <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4.4 Scoring 4.5 General requirement of the laboratory 5 Responsibility of the customer <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 6 Responsibility of the laboratory 6.1 Setup and sustainment of the QA program 6.2 Responsibility during service <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 7 Confidentiality of personal information 7.1 Overview 7.2 Applications of the principle of confidentiality 7.2.1 Delegation of responsibilities within the laboratory <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 7.2.2 Requests for analysis 7.2.3 Transmission of confidential information 7.2.4 Anonymity of samples 7.2.5 Reporting of results 7.2.6 Storage of data and results 8 Laboratory safety requirements 8.1 Overview <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 8.2 Microbiological safety requirements 8.3 Chemical safety requirements <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 8.4 Optical safety requirements 8.5 Safety plan 9 Sample processing 9.1 Culturing and staining <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 9.2 Scoring 9.2.1 Criteria for scoring 9.2.2 Conversion of translocation frequencies to genome equivalence <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 10 Background levels of translocations <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 11 Calibration curves 11.1 Calibration source(s) 11.2 Establishment of calibration curve(s) <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 12 Criteria for converting a measured aberration frequency into an estimate of absorbed dose 12.1 Determination of estimated whole-body absorbed dose and confidence limits 12.1.1 General 12.1.2 Comparison with the background level: Characterisation of the minimum detectable dose <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 12.1.3 Confidence limits on the number of translocations <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 12.1.4 Adjustment for background yield <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 12.1.5 Calculation of absorbed dose <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 12.1.6 Calculation of uncertainty on absorbed dose 12.1.7 Acute and non-acute exposure cases <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 12.1.8 Other exposure scenarios 13 Reporting of results 13.1 General 13.2 Content of the report (see Annex C for an example of a standard form) <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 13.3 Interpretation of the results 14 Quality assurance and quality control 14.1 Overview 14.2 Specific requirements 14.2.1 General 14.2.2 Performance checks by inter-laboratory comparisons <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 14.2.3 Performance check of scorer qualification 14.2.4 Performance checks of sample transport integrity <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 14.2.5 Performance checks of sample integrity by service laboratory 14.2.6 Performance checks of instrumentation 14.2.7 Performance checks of sample protocol 14.2.8 Performance checks of sample scoring 14.2.9 Performance checks of result report generation <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | Annex A (informative) Sample instructions for customer <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex B (informative) Sample questionnaire <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | Annex C (informative) Sample of report <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Annex D (informative) Sample data sheets for recording painted aberrations <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | Annex E (informative) Fitting of the dose response-curve by the method of maximum likelihood and calculating the uncertainty of the absorbed dose estimate <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Annex F (informative) Process for dose estimation <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Radiological protection. Performance criteria for laboratories using Fluorescence In Situ Hybridization (FISH) translocation assay for assessment of exposure to ionizing radiation<\/b><\/p>\n |