ML18215A099

James E. Cary Cancer Center - NRC Form 591M Parts 1 & 3, Inspection Report 03037750/2018001 (DNMS)

ML18215A099
Person / Time
Site:	03037750
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)

See also: IR 05000201/1980001

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

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REPORT NUMBER(S} :2 D I g (} 0 I

3. DOCKET NUMBER(S) 4. LICENSE NUMBER(S) 5. DATE(S) OF INSPECTION

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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 inspector. The inspection findings are as follows:

~1. Based on the inspection findings, no violations were identified.

D 2. Previous violation(s) closed.

D 3. 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 satisfied.

Non-cited violation(s) were discussed involving the following requirement(s):

D 4. 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 identified. 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 requested.

TITLE PRINTED NAME SIGNATURE DATE

LICENSEE'S

REPRESENTATIVE

NRCINSPECTOR

BRANCH CHIEF )h,V _ fbr A-TM

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NRC FORM 591M PART 1 (07-2012)

NRC FORM 591 M PART 3 U.S. NUCLEAR REGULA TORY COMMISSION

(07-2012)

10 CFR2.201 Docket File Information

SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION

1. LICENSEE/LOCATION INSPECTED: 2. NRG/REGIONAL OFFICE

James E. Cary Cancer Center Region III

5985 Hospital Drive U.S. Nuclear Regulatory Commission

Hannibal, Missouri 2443 Warrenville Road, Suite 210

Lisle, IL 60532-4352

REPORT NUMBER(S) 201800 I

3. DOCKET NUMBER(S) 4. LICENSE NUMBER(S) 5. DATE(S) OF INSPECTION

030-37750 24-32681-01 7/24/18

6. INSPECTION PROCEDURES USED 7. INSPECTION FOCUS AREAS

87132 02.01 through 02.07

SUPPLEMENTAL INSPECTION INFORMATION

1. PROGRAM CODE(S) 2. PRIORITY 3. LICENSEE CONTACT 4. TELEPHONE NUMBER

02230 2 Stephen Rose, RSO (573) 406-5801

[{] Main Office Inspection Next Inspection Date: 07/24/2020

D Field Office Inspection

D Temporary Job Site Inspection

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PROGRAM SCOPE

This was an unannounced, routine inspection. 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 treatments. As of

the inspection, the licensee conducted 5 HDR treatments since January 1, 2018. An authorized user was as required.

The licensee's radiation safety officer (RSO) was the licensee's authorized medical physicist. The RSO reported to the

Director of Radiation Oncology (DRD), and the DRD reported to the Vice President of Operations. There were 3

radiation therapists, one of which was the DRD. There were no HDR treatments during the inspection.

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, respectively. No violations ofNRC regulatory requirements were identified as a

result of this inspection. 6\J flit. A-t;J'J

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NRC FORM 591M PART 3 (07-2012)