Service standards for the bioassay performance testing program

The National Calibration Reference Centre for Bioassay and In Vivo Monitoring (The Centre), operated by the National Internal Radiation Assessment Section (NIRAS) of the Radiation Health Assessment Division, offers performance testing (PT) samples for the bioassay of tritium, carbon-14, combined tritium/carbon-14, uranium and fission/activation products in urine. These samples allow facilities to establish that the quality of their monitoring program meets the requirements of the Canadian Nuclear Safety Commission (CNSC).

The PT samples sent to participants are prepared by adding a known amount of a standard solution of the appropriate radionuclide(s) to human urine. Replicate samples are provided to participants at several concentration levels to allow participants to test their laboratory procedures and staff for measurement of accuracy and precision. Participating laboratories analyse the samples and report results to the Centre within a specified period of time. The results are evaluated and a formal written report on accuracy and precision is sent to all participants. The Centre provides advice and assistance to participating facilities to solve problems identified through their participation in the PT programs.

Service pledge

The Bioassay PT Programs are designed according to guidelines in CNSC Regulatory Standard, “REGDOC 2.7.2 Dosimetry, Volume 2: Technical and Management System Requirements for Dosimetry Services”.

Participation in this service satisfies the requirement for independent testing given in REGDOC 2.7.2 Dosimetry, Volume 2.

Participants receive their individual results as well as aggregate reports which protect the anonymity of individual laboratories. The aggregate reports and facility identities are also provided to the CNSC.

The Centre’s Quality Manual and relevant Quality Records will be made available to a client, on request, for a mutually agreed period.

Service delivery targets

The Centre provides an annual PT service to facilities that perform in vitro measurements on urine which includes:

• Annual distribution of urine samples that allow determination of the precision and bias of the client’s procedures, staff and counting systems from the analytical results.
• Radionuclide levels or concentrations that allow the client to demonstrate compliance with CNSC licence requirements.
• Activity levels/concentration of the analyte(s) in the PT samples are guaranteed to be within ± 10 % of target values based on gravimetric preparation.
• Allowed response time of 30 calendar days from date of shipment for reporting results to the Centre. Participants are informed of the specific date for submitting their reports.
• A table of radionuclide or elemental concentrations in the samples is sent to all participants in the PT within a week following the deadline for submission of results.
• A Performance Report within 90 days of sample shipment containing tables and graphs that enable the facility to assess its bias and precision performance against CNSC performance criteria and other participants. The report protects the client’s anonymity.
• Response to participants’ enquiries within two working days and issue(s) raised addressed within two weeks.
• A quality assurance program to confirm the reliability and accuracy of the PT samples which includes the purchase of radionuclide standards from either the National Institute of Standards and Technology (NIST) or a laboratory traceable to NIST.
• Documented procedures written in accordance with ISO 9001:2015 available for review.

Additional information

The following document describing some of these tests is available at no cost.

Kramer, G.H. and Limson Zamora, M. The Canadian National Calibration Reference Centre for Bioassay and In Vivo Monitoring: A Programme Summary. Health Physics 67: 192-196; 1994.

Feedback mechanisms

Comments, suggestions for improvement or complaints may be made to:

Head, NCRC
Radiation Protection Bureau
775 Brookfield Road, Address Locator 6302D
Ottawa, Ontario K1A 1C1
CANADA

Telephone: 613-954-6667
Facsimile: 613-960-1372
E-Mail: hml-lsh@canada.ca