IR 05000201/1980001
| ML18215A099 | |
| Person / Time | |
|---|---|
| Site: | West Valley Demonstration Project, 03038750 |
| Issue date: | 07/24/2018 |
| From: | Gattone R NRC/RGN-III |
| To: | Steven Rose James E. Cary Cancer Ctr |
| References | |
| IR 2018001 | |
| Download: ML18215A099 (2) | |
Text
NRC FORM 591M PART 1 U.S. NUCLEAR REGULA TORY COMMISSION (07-2012)
10CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED:
2. NRG/REGIONAL OFFICE :5" tk "'e i f. C << rt_ C r;..J.Jce r C e"'1er ~er~ s Hu! f'; ('. I Dr i V e r1'<A.Nr,1ib<A.f, /7\iJsour~
J?.egio11 rit . .i If lf 3 v/tA.rrt"i
"' lie {( ,J"J S' v, f l IO L.isl~1.X.lli"oi5, o51'l. Select a location (Use keyboard arrows to select) ... REPORT NUMBER(S}
- 2 D I g (} 0 I 3. DOCKET NUMBER(S)
4. LICENSE NUMBER(S)
5. DATE(S) OF INSPECTION a 3 O ._ J 7 7 ~() LICENSEE:
The inspection was an examination of the activities conducted under your license as they relate to radiation safety and to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your license. The inspection consisted of selective examinations of procedures and representative records, interviews with personnel, and observations by the inspecto The inspection findings are as follows: ~1. Based on the inspection findings, no violations were identifie D 2. Previous violation(s)
closed. D 3. D 4. The violations(s), specifically described to you by the inspector as non-cited violations, are not being cited because they were self-identified, non-repetitive, and corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy, to exercise discretion, were satisfie Non-cited violation(s)
were discussed involving the following requirement(s):
During this inspection, certain of your activities, as described below and/or attached, were in violation of NRC requirements and are being cited in accordance with NRC Enforcement Policy. This form is a NOTICE OF VIOLATION, which may be subject to posting in accordance with 10 CFR 19.11. (Violations and Corrective Actions) Statement of Corrective Actions I hereby state that, within 30 days, the actions described by me to the Inspector will be taken to correct the violations identifie This statement of corrective actions is made in accordance with the requirements of 10 CFR 2.201 (corrective steps already taken, corrective steps which will be taken, date when full compliance will be achieved).
I understand that no further written response to NRC will be required, unless specifically requeste TITLE PRINTED NAME SIGNATURE DATE LICENSEE'S REPRESENTATIVE NRCINSPECTOR BRANCH CHIEF NRC FORM 591M PART 1 (07-2012) )h,V _ fbr A-TM V NRC FORM 591 M PART 3 (07-2012)
10 CFR2.201 U.S. NUCLEAR REGULA TORY COMMISSION Docket File Information SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED:
James E. Cary Cancer Center 5985 Hospital Drive Hannibal, Missouri REPORT NUMBER(S)
201800 I 3. DOCKET NUMBER(S)
030-37750 6. INSPECTION PROCEDURES USED 87132 2. NRG/REGIONAL OFFICE 4. LICENSE NUMBER(S)
24-32681-01 Region III U.S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 5. DATE(S) OF INSPECTION 7/24/18 7. INSPECTION FOCUS AREAS 02.01 through 02.07 SUPPLEMENTAL INSPECTION INFORMATION 1. PROGRAM CODE(S) 02230 2. PRIORITY 2 [{] Main Office Inspection D Field Office Inspection D Temporary Job Site Inspection 3. LICENSEE CONTACT Stephen Rose, RSO Next Inspection Date: 4. TELEPHONE NUMBER (573) 406-5801 07/24/2020
PROGRAM SCOPE This was an unannounced, routine inspectio The licensee conducted High Dose Rate (HDR) remote afterloader brachytherapy using an authorized HDR remote afterloading brachytherapy device. The treatments included breast treatments involving Mammosite or Contura applicators, In addition, the licensee conducted vaginal treatment As of the inspection, the licensee conducted 5 HDR treatments since January 1, 2018. An authorized user was as require The licensee's radiation safety officer (RSO)
was the licensee's authorized medical physicis The RSO reported to the Director of Radiation Oncology (DRD), and the DRD reported to the Vice President of Operation There were 3 radiation therapists, one of which was the DRD. There were no HDR treatments during the inspectio Performance Observations The inspector: (I) observed that the HDR device was properly secured during storage; (2) discussed Elekta's Notice Reference 806-01-BTP-OOI regarding potential Oncentra software issues, and the inspector verified that the licensee's Oncentra software was Version 4.5.3 which does not have the software issues; (3) observed the licensee's HDR emergency procedure posted at the HDR treatment area; ( 4) observed the RSO demonstrate how he conducted HDR spot checks and there was no concern; (5) noted that the RSO stated that none of the HDR treatments deviated from the written directive or treatment plan; (6) observed that the licensee's survey instrument was calibrated as required; (7) used an NRC-owned survey meter to conduct a side-by-side ambient exposure survey at the surface of the HDR unit containing an iridium-192 source containing 7. 7 curies, and the inspector's survey result was O .2 milliRoentgen per hour and the RSO measured the same result with the licensee's survey instrument; (8) observed that the HDR facility was as authorized; (9) noted that the facility was posted as required; (10) noted that the licensee placed emergency response equipment (i.e., wire cutters, large pig, and a remote handling tool) near the patient during treatment in the event that a problem occurs that results in high radiation dose rates; ( 11) reviewed selected HDR treatment records for vaginal and breast treatments, including overlays of anatomy and dose information, written directives, treatment plans, and pre-and post-treatment HDR computer printouts that were used to verify that the HDR unit was set to conduct the proper HDR treatment prior to treatment and ensuring that the HDR unit conducted the proper HDR treatment post treatment; and (12) reviewed dosimeter badge results for 2016 through 6/30/18, and the highest annual extremity and whole body doses were 38 millirem (mrem) and 4 mrem, respectivel No violations ofNRC regulatory requirements were identified as a result of this inspectio \J flit. A-t;J'J ff/i../, t NRC FORM 591M PART 3 (07-2012)