Financial impact of implementing draft ANSI Standard N13. 30, performance criteria for radiobioassay

In order to establish standards of bioassay performance upon which a uniform national program of performance testing might be based, the Health Physics Society Standards Committee (HPSSC) formed Working Group 2.5 to prepare the draft American National Standards Institute, Inc. (ANSI) Standard N13.30, Performance Criteria for Radiobioassay. Because the US Nuclear Regulatory Commission (NRC) is considering whether to require that all bioassay service laboratories meet the criteria of the draft Standard, the NRC staff requested that the Pacific Northwest Laboratory (PNL) estimate the costs that may be incurred in implementing the draft Standard. Two types of laboratories were involved in the cost study: service laboratories and a performance testing laboratory. Cost estimates based on responses to questionnaires sent to seven facilities performing radiobioassays varied in relation to the extent of each facility's radiobioassay program and to their perception of their readiness for accreditation. Implementation of accreditation was estimated to cost each facility between a few thousand dollars to over one-quarter million dollars depending on the facility type. Likewise, annual costs ranged from a few hundred dollars to $170,000. For all but one facility, annual costs were estimated to be less than $25,000. In addition to these costs, startup cost formore » the testing laboratory were estimated to be approximately $322,000. 5 refs., 22 tabs.« less