Guidance from the SAC

2024 Scientific Advisory Committee Meeting

 

Comments on Previous Recommendations

1. We recommended that the plan for QA of data entry of Health Physics records in addition to the radiochemistry be implemented through software updates and be incorporated into the QA Plan. We believe QA of data entry of radiochemistry primary information also needs to be addressed in the plan.
   The graphing of data for consistency is good. The review of the entered data prior to use meets the recommendation and is recommended to be added to the QA plan.
2. We recommended that the use of Access as a database or as a front-end interface be replaced with newer, more robust, programing language that will not be overwhelmed by data size.
   Check into Autoscribe by Informatics for a LIMS.
3. We recommended that the quality control equations in the DQO document be fully implemented for use in quality control.
   See recommendations below for further application.
4. We recommended that all radiochemistry procedures be reviewed and updated as necessary in accordance with the QA plan. Method validation records may also need to be updated.
   Make sure that any method procedures that are revised are re-validated.
5. We recommended that USTUR participate in some form of analytical Performance Testing (PT) program and obtain an independent audit.
   Make sure that inconsistencies discovered in the PT program are investigated and resolved. Continuing involvement in PT programs is advised.
6. We recommend that a safety review be performed for the laboratory.
   Make sure logs are kept of eye wash, safety shower, and fire extinguisher checks.
7. We recommend considering the training and use of additional laboratory personnel for increased productivity and long-term continuity.
   Productivity has been addressed, but not long-term continuity. We encourage continued planning and training for backup and replacement of staff to keep long term continuity.
8. We recommend an evaluation of the scheduled plan for completion of the radionuclide backlog, including completion of sample analysis from any new cases from active or potentially active living cases, and the continued vision of the purpose for the USTUR, including the laboratory, after completion of those analyses.
   We appreciate the plan developed. We recommend including this in publicity material (see recommendation below).

Observations

1. We appreciate the installation of the new hoods and restart of the production of sample analyses. We are also pleased that funding for additional infrastructure and instrumentation has been obtained for the future.
2. We recognize the significant number of publications and presentations that have been made in the past year and the ones scheduled to be published soon.
3. The USTUR is to be congratulated for the journal article accepted in (PLoS One) on misclassification of deaths among a small group of nuclear workers (McComish et al 2024). The evaluation of misclassification rates based on the comparison of death certificates vs. autopsies is carefully considered and appropriate. (Note: work not presented but deserving of comment).
4. We agree that the impact of death certificate misclassifications on epidemiological risk models is an important topic, and Xirui Liu is to be congratulated for her clear presentation. The results Xirui presented demonstrate that misclassification of disease can affect the decision of a statistically significant association of dose to cause of death. However, issues of central concern were not addressed: whether under/over ascertainment of the correct cause of death (e.g., as evaluated by McComish et al.) would lead to a mischaracterization of the dose response. It is notable that other studies/reviews (see Linet et al, Sposto et al.) have concluded that – based on reasonable assumptions – it is unlikely that under/over ascertainment would result in a substantial bias.
5. We still support the effort to search for the status of inactive cases, including the Pension Benefit Information. https://www.pbinfo.com/.
6. We appreciate the continued research efforts that are using the USTUR data.

Recommendations

1. We recommend developing a brochure for opportunities for research and use of the data and services of the USTUR. We recommend this include the vision for the USTUR and lab following completion of receipt and analysis of all registrant samples.
2. We recommend the USTUR perform an informal literature review on impacts of over/under-ascertainment on risk estimates. Notable references are attached. If feasible, arrange for collaborations (e.g., with NCI) for these types of analyses/reviews.
3. We recommend the USTUR plan on sending staff to next year’s (2025) NCI course on Epidemiology and Dosimetry and to the 2024 RRMC.
4. We recommend the USTUR send staff (e.g. Xirui) for training to the REAC/TS internal dosimetry training courses and other ORAU or MJW professional training courses.
5. We recommend Martin’s research results be published.
6. We recommend inserting the Python code in the DQO document for documentation.
7. We recommend applying the DQO equations retroactively to some previous sample cases to explore the input to decisions.