Traceability to NIST for Reference, Monitoring and Service Laboratories
Objectives for MPD B.7.2
- Develop a national approach, consistent with ANSI N42.23, for reference, monitoring, and service laboratories to establish and maintain traceability to NIST
- Establish NIST traceability for the reference laboratories of sponsored performance evaluation programs
Background: The term “traceability” has become a complex concept having subtle differences in meaning depending on the specific application and the organization effected. In 1996, as a result of the American National Standards Institute (ANSI) process, a national standard was developed for the purpose of clarifying a process of how laboratory measurements can become traceable to NIST. The standard ANSI N42.22–1995, entitled “Traceability of Radioactive Sources to the National Institute of Standards and Technology (NIST) and Associated Instrument Quality Control,” was primarily developed to address the needs of the commercial radioactive source manufacturers related to NIST traceability for the materials that they manufacturer, produce or sell. However, the guidance and concepts provided within the standard are applicable to any organization preparing radioactive materials that desires to be traceable to NIST. ANSI N42.23-1996 was developed to address a national concern to establish a national approach to measurement assurance for the radioassay laboratory community, especially for the environmental and bioassay applications. This standard, entitled “Measurement and Associated Instrumentation Quality Assurance for Radioassay Laboratories,” was published in 1997 after nearly ten years of preparation. The purpose of the standard was to provide the basis for the creation of a national measurement quality assurance (MQA) process to support the optimization of the quality of radioassays performed by service laboratories in the United States. Within the framework of the national MQA program description is the delineation of the responsibilities and interaction of NIST, the accrediting/administering organization and the reference, monitoring and service laboratories.
1 – NIST should establish a steering committee comprised of NIST and government and commercial laboratory stakeholders. It should work closely with the working group that is being established to revise the current version of ANSI N42.23. This steering committee should focus on:
a) Recommending the program elements required at NIST to support a consistent national approach to Measurement Assurance, and facilitate the necessary working relationship between NIST, reference, monitoring and service laboratories and the administrating agency. b) Developing a “needs” table of sample matrix, radionuclides, media type and analyte concentration level. Test matrices would have to be specific to the needs of each program. These MAPs will vary greatly, from drinking water standards, to radiobioassay standards, to soil samples, to emergency responder tests. The levels needed would also be program specific.
c) Developing guidelines for the development of measurement quality objectives for the preparation and distribution of performance testing samples by NIST and the reference laboratories.
d) Developing guidelines and criteria for sample preparation procedure verification and validation applicable to test matrices and analyte concentrations prepared by NIST or the reference laboratories.
e) Establishing common testing requirements for NIST traceability between NIST and the reference /participating laboratories.
f) Developing quality assurance assessment criteria for conducting onsite assessments of the reference laboratories.
g) Developing a consistent mechanism for funding NIST support of a national approach to MQA involving government and private testing laboratories.
h) Make recommendations on resources at NIST that would be needed to adequately support this effort. These might include but are not limited to: additional scientific and staff, expanded measurement capabilities, dedicated laboratory facilities, and additional programmatic oversight and management.
1 – For the Radiochemical Intercomparison Program (NRIP), three full-time employees or contractor equivalent at NIST are needed for program administration, development of the necessary technical capability and the preparation and analysis of the test samples of the programs. The scientists will also be responsible for the development and maintenance of the radioanalytical procedures, and the development of the test sample preparation and verification protocols.
2 – Sufficient and dedicated laboratory facilities and resources to conduct the radioanalytical portion of the programs.
3 – Maintenance of calibrated nuclear instrumentation and primary test solutions for the conduct of the programs.
4 – Sufficient resources for programmatic oversight and management to update the programs and meet the communities needs.
NOTE: In the CIRMS “Second Report on National Needs in Ionizing Radiation Measurements and Standards,” published in October, 1998, this MPD appeared as MPD B.1. A new MPD number has been assigned, MPD B.7, to avoid confusion with MPD B.1 that had appeared in the first CIRMS “Report on National Needs in Ionizing Radiation Measurements and Standards,” published in January, 1995, that covered a different topic.
Figure B.7.1 – Diagram of national performance testing program per ANSI N42.23