COMMONWEALTH of VIRGINIA Department of Health

Transcription

1 COMMONWEALTH of VIRGINIA Department of Health CYNTHIA C. ROMERO, MD, FAAFP PO BOX 2448 TTY OR STATE HEALTH COMMISSIONER RICHMOND, VA December 11, 2013 Office of Environmental Health and Safety University of Virginia Debbie Steva 515 Edgemont Road Charlottesville VA Dear Ms. Steva: This refers to the inspection conducted by this office on November of activities authorized by the Code of Virginia and to the discussion of our findings with UVA staff including yourself at the conclusion of this inspection. This inspection was an examination of the activities conducted under your Radioactive Material License number , a selective examination of procedures and representative records, observations and interviews with personnel as they relate to radiation safety and to compliance with 12VAC5-481, Virginia Radiation Protection Regulations. Areas of your program that could be improved to meet nationally accepted standards of practice are addressed in the recommendations. Recommendations are included for areas of health and safety that should be reviewed (see enclosure). Based on the results of this inspection, certain of your activities were not conducted in full compliance as set forth in the enclosed notice of noncompliance. On December 2 nd this office received an from you with corrective actions taken regarding the identified violation. This office considers the issue resolved.

2 This is to advise you that you are required to post the enclosed notice of non compliance of radiological working conditions and your response in accordance with 12VAC If you have any questions or concerns regarding this inspection, please contact me at or at Sincerely, Michael Welling Director, Radioactive Materials Program Encl.

3 COMMONWEALTH of VIRGINIA Department of Health CYNTHIA C. ROMERO, MD, FAAFP PO BOX 2448 TTY OR STATE HEALTH COMMISSIONER RICHMOND, VA NOTICE OF NON COMPLIANCE University of Virginia (UVA) Radioactive Material License Number Based on the results of the inspection of UVA, license number conducted on November 18-20, 2013, certain of your activities are not in compliance with 12VAC5-481, Virginia Radiation Protection Regulations as indicated below: 1. 12VAC (10 CFR 35.40) requires that the written directive for high dose-rate remote afterloading brachytherapy include: the radionuclide, treatments site, dose per fraction, number of fractions, and total dose. Contrary to this, on November 19 th it was discovered that the written directives did not include the treatment site. This is a severity level IV violation.

4 RECOMMENDATIONS University of Virginia (UVA) Radioactive Material License Number Maintain a list of the approved RSC members including the term dates. 2. Ensure the President s office approves the RSC members. 3. Include the non-present RSC members on the meeting minutes. 4. Close out issues raised during an RSC meeting at the next meeting 5. Include a summary of the votes for approving authorized users in the minutes. The agenda lists the proposed authorized users being presented during the meeting but the minutes do not include a summary. 6. Install an interlock switch for the HDR room to prevent the unintentional use of the HDR and CT unit at the same time. 7. Update the T&R list by removing an individual s name and saving the tab with the revision number and date. 8. Have the T&R official approve and document the removal of T&R individuals from the list. 9. Document that unmonitored individual radiation exposure will not exceed 10% of the annual occupational exposure limit of 12VAC (5 rem). 10. Secure the HDR inside the vault room when not in use. 11. Ensure a percentage of each procedure requiring a WD is reviewed to assure all required information is recorded.

5 University of Virginia Response to Notice of Non Compliance On December 2 nd, a copy of a corrected written directive for use of the HDR Contura Applicator for the Breast treatment site was provided to Mike Welling, Director of the Radioactive Materials Program. On December 2 nd, the following response was provided to UVA: On December 2nd this office received an from you with corrective actions taken regarding the identified violation. This office considers the issue resolved.