【国外标准】 American National Standard Measurement and Associated Instrumentation Quality Assurance for Radioassay Laboratories

This standard serves as a guide for MQA programs developed for specialized sectors of the radioassay community, that is bioassay, routine environmental monitoring, environmental restoration and waste management, radiopharmaceuticals, and nuclear power chemistry. The standard also provides the means for establishing the more limited objectives that govern day-to-day operations of an individual laboratory, including mandated protocols, recommendations, and information to implement and maintain a… read more radioassay QA program. The overall utility of radioassay data results from the combination of defensible and traceable measurements, preceded by careful planning to determine data quality objectives (DQO). This standard addresses only those aspects of the user's program that deal with measurement-related issues. Guidance on the use of DQOs is provided in annex . This standard addresses a)The operational framework of a national measurement assurance program b)The roles of the accrediting organization; the National Institute of Standards and Technology (NIST); and the reference, monitoring, and service laboratories c)The protocol for the preparation and distribution of test media by the monitoring or reference laboratories d)The bases for calculating the required accuracy and precision parameters of radioassay measurements e)The protocol for the evaluation and reporting of test results f)The protocol for the assessment and evaluation of test results and reporting assessment findings by the accrediting organization g)Guidance for determining the decision limit concentration and the a priori minimum detectable concentration for each radionuclide (see annex ) h)The requirements for reporting radioassay results by service laboratories to the customer i)Eleven key elements of a viable QA program applicable to the service, monitoring, and reference laboratories j)The QA and QC programs for the service, monitoring, and reference laboratories Since this is an umbrella MQA standard, no guidance or requirements have been established for the minimum performance criteria of precision, accuracy, or detection limits applicable to the routine operation of a radioassay laboratory. However, this standard requires that the service laboratory and its client (either from within the same company or governmental organization, or external) establish precision, bias, detection limit, and other quality performance specifications for each radionuclide within a preprocessing agreement or contract. These quality performance specifications shall be related to the data quality objectives requiring the radioassays. For radioassays requiring a quality measurement assurance program, this standard requires the use of a third-party monitoring laboratory to evaluate the ongoing capability of the service laboratory to meet pre-established, contractual performance specifications. If agreed by the client and service laboratory, the internal QA program of the service laboratory may function as a monitoring laboratory as long as the requirements for the monitoring laboratory as established in this standard are met. This standard has outlined the minimum requirements necessary to maintain a viable measurement assurance program by a radioassay laboratory. As outlined in this standard, the testing of the reference, monitoring, and service laboratories to assay radionuclides specified in the various testing categories properly is for accreditation purposes only. This testing program has been developed to ensure that all radioassay laboratories have, at a minimum, radiation measurement instrumentation, representing each radioactive emission type, that has been calibrated with radioactive materials traceable to NIST. This testing is considered a minimum effort in the accreditation process. As stated previously, it is the responsibility of a person or organization requiring radioassays to incorporate detailed performance specifications for each radionuclide and matrix within a contract for the service laboratory. A monitoring laboratory shall be utilized to evaluate the compliance by the service laboratory with the performance specifications. Several annexes have been developed to provide additional background information, clarifications, and, in some cases, requirements of the standard. Annex is considered part of this standard and, as such, the requirements specified shall be followed. Annexes , , and provide information and guidance to support the general concepts and recommendations outlined in this standard. read less