Dr. Gerard F. Payne Program Manager 865-574-5014 N.E. Bores 865-576-5078 J.M. Rankin 865-576-7131		External Quality Control for In-Vitro and In-Vivo Bioassay   Categories Description of Program and Services Provided Intercomparison Studies Program Elements Intercomparison Studies Facilities and Instrumentation Sample Rates for FY2004 Samples Pages from our Quarterly Report Intercomparison Studies Program FY 2004
C.D. (Denise) McNelly Secretary

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Description of Program and Services Provided The External QC Program for in-vitro bioassay located at Oak Ridge National Laboratory (ORNL) has been in place since May 1991. The program was originally created to fill a need in the Radiobioassay area at ORNL, specifically in the areas of Quality Control, Quality Assurance, and Performance Testing. However, it soon became obvious, that if the program was to have any validity (NIST traceability for urine not being an option at that time), the QC spike samples needed to be analyzed by more than one bioassay facility in order to verify the accuracy of the spike. In the beginning, this consisted of two or three laboratories working in a "pilot" program. However, once it was determined that it could work effectively, the program began to seek additional members to cross-check the various bioassay samples. The program became formalized with a quarterly report and a regular cost-per-sample January 1, 1992. The program provides cross-check blind/double-blind urine samples spiked with known amounts of radioactivity to various DOE facilities throughout the United States. These samples can be packaged according to ORNL procedures i.e., ORNL sample bottles, ORNL chain-of-custody forms, tamper seals, etc., or according to the needs of a particular facility if the double blind sample mode is to be maintained. The External QC Laboratory is set up to function in the same manner as a routine bioassay facility. This includes having the capability to perform all the separations and analyses that would be carried out in a typical radiobioassay laboratory, along with the necessary policies, procedures, and document controls that go along with these techniques. The External QC Laboratory also maintains archive samples which can be analyzed in the QC laboratory at the request of any of the participating laboratories if a conflict or discrepancy in a sample analysis/result occurs. Below is a list of the radionuclides* and the spike levels available:   Radionuclide Spike Level Nat-Th less than 1 dpm/liter Nat-Th 1-5 dpm/liter Nat-Th 5-15 dpm/liter Nat-U less than 1 dpm/liter Nat-U 1-5 dpm/liter Nat-U 5-15 dpm/liter Pu-238 less than 1 dpm/liter Pu-238 1-5 dpm/liter Pu-239 less than 1 dpm/liter Pu-239 1-5 dpm/liter Np-237 less than 1 dpm/liter Np-237 1-5 dpm/liter Am-241 less than 1 dpm/liter Am-241 1-5 dpm/liter Cm-244 less than 1 dpm/liter Sr-90 5-100 dpm/liter Sr-90 50-500 dpm/liter Tc-99 50-1000 dpm/liter Tc-99 1000-2000 dpm/liter Co-60 50-1000 dpm/liter Cs-137 50-1000 dpm/liter H-3 less than 250 dpm/mL H-3 250-500 dpm/mL                         Back to Top *All radionuclides are NIST (National Institute of Standards and Technology) standards with the following exception: Nat-Th is an Analytics standard. Blank samples (urine samples which have not been spiked with radioactivity) are also provided as cross-check samples. In addition, samples which are not in the above ranges can be provided if special arrangements are made. Below are examples of the types of statistical analyses/results. These are published once per quarter: (1) A short term report consisting of intercomparison data from the last quarter (2) A report of each laboratory's individual data Note: The quarterly report is published three months after the last spike sample to be included in the report has been shipped to the service laboratory. This is so that the service laboratories have time to process their samples, complete their analyses, and relay the data to the testing facility. Fecal Program: Paticipation in the Fecal Program is usually on a quarterly basis. The following isotopes will be available at two different spike levels (less than 1 dpm/sample and 1-5 dpm/sample with each sample weighing approximately 30 grams):   Th-232 (also available at 5-15 dpm/sample) Nat-U Pu-238 Pu-239 Am-241 Cm-244 All the above radionuclides are NIST or Analytics standards. The results from the fecal program will be included in a quarterly report similar to that established for the urinalysis program.

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Intercomparison Studies Facilities & Instrumentation   State-of-the-art detection equipment for analysis/confirmation of archive samples Oxford High Purity Germanium Spectroscopy System for Gamma Analysis Packard 1050TR/LL Liquid Scintillation Counter Protean IPC 9025 Gas Flow Proportional Counter Four partially depleted silicon surface barrier alpha detectors   Laboratory Facilities Intercomparison Studies Laboratories located in Building 5510A and 301 Refrigeration equipment for maintaining spiking solution Counting rooms Chemical hoods for standards dilution, sample preparation and analysis

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