ISO 19238:2023
Radiological protection — Performance criteria for service laboratories performing biological dosimetry by cytogenetics — Dicentric assay
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
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Dicentric assay
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
8 Confidentiality of personal information
8.1 Overview
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
9 Laboratory safety requirements
9.1 Overview
9.2 Microbiological safety requirements
9.3 Chemical safety
9.4 Optical safety requirements
10 Sample processing
10.1 Culturing
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
10.2.4 Laboratory scoring expertise
11 Calibration curves
11.1 Calibration source(s)
11.2 Establishment of calibration curve(s)
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
12.3 Comparison with the background level: Characterisation of the minimum detectable dose
12.4 Confidence limits on the number of dicentrics
12.5 Calculation of absorbed dose for whole-body exposures
12.6 Calculation of uncertainty on absorbed dose
12.7 Acute and non-acute exposure cases
12.8 Partial body and prior exposure cases
12.9 Other exposure scenarios
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
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
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
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
Annex A (informative) Sample instructions for requestor
Annex B (informative) Sample questionnaire
Annex C (informative) Sample of report
Annex D (informative) Fitting of the low-LET dose-response curve by the method of maximum likelihood and calculating the error of dose estimate
Annex E (informative) Odds ratio method for cases of suspected exposure to a low dose
Annex F (informative) Decision threshold and detection limit
Annex G (informative) Sample data sheet for recording aberrations
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 Dicentric assay
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
8 Confidentiality of personal information
8.1 Overview
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
9 Laboratory safety requirements
9.1 Overview
9.2 Microbiological safety requirements
9.3 Chemical safety
9.4 Optical safety requirements
10 Sample processing
10.1 Culturing
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
10.2.4 Laboratory scoring expertise
11 Calibration curves
11.1 Calibration source(s)
11.2 Establishment of calibration curve(s)
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
12.3 Comparison with the background level: Characterisation of the minimum detectable dose
12.4 Confidence limits on the number of dicentrics
12.5 Calculation of absorbed dose for whole-body exposures
12.6 Calculation of uncertainty on absorbed dose
12.7 Acute and non-acute exposure cases
12.8 Partial body and prior exposure cases
12.9 Other exposure scenarios
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
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
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
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
Annex A (informative) Sample instructions for requestor
Annex B (informative) Sample questionnaire
Annex C (informative) Sample of report
Annex D (informative) Fitting of the low-LET dose-response curve by the method of maximum likelihood and calculating the error of dose estimate
Annex E (informative) Odds ratio method for cases of suspected exposure to a low dose
Annex F (informative) Decision threshold and detection limit
Annex G (informative) Sample data sheet for recording aberrations
Bibliography